<subtitle num="01" heading="General"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines terms used throughout Title 30.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this title, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced life support (ALS)” means care that may only be rendered by paramedics or CRTs under the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> <paragraph num="(2)"> <text>“Affiliated” means having employment or membership as an EMS provider with an EMS operational program.</text> </paragraph> <paragraph num="(3)"> <text>“Automated external defibrillator (AED)” means a medical heart monitor and defibrillator device that:</text> <paragraph num="(a)"> <text>Has been cleared for market by the Food and Drug Administration;</text> </paragraph> <paragraph num="(b)"> <text>Is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia and determining, without intervention by an operator, whether defibrillation should be performed; and</text> </paragraph> <paragraph num="(c)"> <text>Upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual's heart and requires user intervention to deliver the electrical impulse or automatically continues with the delivery of the electrical impulse.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Base station” means a unit of a hospital which has been approved by the EMS Board under COMAR 30.03.06 to provide online medical direction to EMS providers.</text> </paragraph> <paragraph num="(5)"> <text>“Basic life support (BLS)” means care rendered by emergency medical technicians or emergency medical responders under the Maryland Medical Protocols for Emergency Medical Services Providers that is not ALS care.</text> </paragraph> <paragraph num="(6)"> <text>“Cardiac rescue technician (CRT)” means an individual licensed by the EMS Board as a CRT.</text> </paragraph> <paragraph num="(6-1)"> <text>“Electronic Maryland EMS Data System (eMEDS®)” means the web-based electronic prehospital data collection system operated by MIEMSS.</text> </paragraph> <paragraph num="(7)"> <text>“Electronic Maryland Ambulance Information System (EMAIS®)” means the Web-based electronic prehospital data collection system developed and operated by MIEMSS.</text> </paragraph> <paragraph num="(8)"> <text>“Emergency medical dispatcher (EMD)” means an individual licensed by the EMS Board as an EMD.</text> </paragraph> <paragraph num="(9)"> <text>“Emergency medical responder (EMR)” means an individual certified by the EMS Board as an emergency medical responder.</text> </paragraph> <paragraph num="(10)"> <text>“Emergency medical services (EMS)” has the meaning stated in Education Article, §13-516(a)(5), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(11)"> <text>“Emergency Medical Services (EMS) Board” means the Board established by Education Article, §13-503, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(12)"> <text>“Emergency medical services (EMS) operational program” means:</text> <paragraph num="(a)"> <text>A jurisdictional EMS operational program; or</text> </paragraph> <paragraph num="(b)"> <text>An institution, agency, corporation, or other entity that is licensed by MIEMSS as a commercial service under Education Article, §13-515, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(13)"> <text>“Emergency medical technician (EMT)” means an individual certified by the EMS Board as an emergency medical technician.</text> </paragraph> <paragraph num="(13-1)"> <text>“EMS clinician” means an individual licensed or certified by the EMS Board to provide emergency medical services.</text> </paragraph> <paragraph num="(14)"> <text>“EMS provider” means an individual licensed or certified by the EMS Board to provide emergency medical services.</text> </paragraph> <paragraph num="(15)"> <text>“Executive Director” means the Executive Director of MIEMSS.</text> </paragraph> <paragraph num="(16)"> <text>“Institutional review board” means a group of individuals designated by an institution in compliance with 45 CFR 46, to review the use of human subjects in proposed research.</text> </paragraph> <paragraph num="(17)"> <text>“Jurisdictional EMS operational program (jurisdiction)” means an EMS operational program which is approved under COMAR 30.03.02.03 and is not licensed as a commercial service under Education Article, §13-515, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(18)"> <text>“Maryland Ambulance Information System (MAIS)” means the prehospital patient care record system for Maryland.</text> </paragraph> <paragraph num="(19)"> <text>“Maryland Institute for Emergency Medical Services Systems (MIEMSS)” means the State agency established by Education Article, §13-503, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(20)"> <text>“Paramedic” means an individual licensed by the EMS Board as a paramedic.</text> </paragraph> <paragraph num="(21)"> <text>“Statewide Emergency Medical Services Advisory Council (SEMSAC)” means the body established by Education Article, §13-511, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective July 1, 2002 (29:12 Md. R. 929); December 19, 2005 (32:25 Md. R. 1944)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective November 1, 2010 (37:21 Md. R. 1437); December 12, 2013 (40:24 Md. R. 2017); January 6, 2014 (40:26 Md. R. 2165); June 9, 2025 (52:11 Md. R. 533)</annotation> </annotations> </chapter> <chapter num="02" heading="Documents Incorporated by Reference"> <regulation prefix="Regulation" num=".01" heading="Incorporation by Reference."> <paragraph num="A."> <text>In this title, the following documents are incorporated by reference.</text> </paragraph> <paragraph num="B."> <text>Documents Incorporated.</text> <paragraph num="(1)"> <text>“Maryland Medical Protocols for Emergency Medical Services (MIEMSS July 1, 2023 Edition)”. This document can be obtained through the Maryland Institute for Emergency Medical Services Systems at 653 W. Pratt Street, Baltimore, Maryland 21201 (410-706-4449).</text> </paragraph> <paragraph num="(2)"> <text>“Maryland State Trauma Registry Data Dictionary for Adult Patients (MIEMSS July 1, 2025 Edition)”. This document can be obtained through the Maryland Institute for Emergency Medical Services Systems at 653 W. Pratt Street, Baltimore, Maryland 21201 (410-706-4449).</text> </paragraph> <paragraph num="(3)"> <text>“Maryland State Trauma Registry Data Dictionary for Pediatric Patients (MIEMSS October 1, 2025 Edition)”. This document can be obtained through the Maryland Institute for Emergency Medical Services Systems at 653 W. Pratt Street, Baltimore, Maryland 21201 (410-706-4449).</text> </paragraph> <paragraph num="(4)"> <text>"Maryland State Trauma Registry Data Dictionary for Burn Patients (MIEMSS May 21, 2020 Edition)”. This document can be obtained through the Maryland Institute for Emergency Medical Services Systems at 653 W. Pratt Street, Baltimore, Maryland 21201 (410-706-4449).</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509 and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective October 11, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 30, 2000 (27:21 Md. R. 1977); October 11, 2004 (31:20 Md. R. 1486); May 19, 2008 (35:10 Md. R. 976); January 14, 2010 (37:1 Md. R. 16); April 2, 2012 (39:6 Md. R. 411); October 15, 2012 (39:20 Md. R. 1310); March 17, 2014 (41:5 Md. R. 347); October 13, 2014 (41:20 Md. R. 1113); October 12, 2015 (42:20 Md. R. 1265); December 19, 2016 (43:25 Md. R. 1386); January 29, 2018 (45:2 Md. R. 69); August 13, 2018 (45:16 Md. R. 776); November 5, 2018 (45:22 Md. R. 1028); December 16, 2019 (46:25 Md. R. 1132); November 16, 2020 (47:23 Md. R. 979); November 1, 2021 (48:22 Md. R. 938); January 9, 2023 (49:27 Md. R. 1112); March 18, 2024 (51:5 Md. R. 233); June 8, 2026 (53:11 Md. R. 486)</annotation> </annotations> </chapter> <chapter num="03" heading="Open Meetings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs attendance at open sessions of the:</text> <paragraph num="A."> <text>Emergency Medical Services Board; and</text> </paragraph> <paragraph num="B."> <text>Statewide Emergency Medical Services Advisory Council.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Public Attendance."> <paragraph num="A."> <text>The general public is invited to attend and observe any open session of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council.</text> </paragraph> <paragraph num="B."> <text>A member of the public attending an open session may only participate in the session if the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council expressly invites public testimony, questions, comments, or other forms of public participation, or when public participation is otherwise authorized by law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Disruptive Conduct."> <paragraph num="A."> <text>An individual attending an open session of the Emergency Medical Services Board or the Emergency Medical Services Advisory Council may not engage in any conduct, including visual demonstrations such as the waiving of placards, signs, or banners, that:</text> <paragraph num="(1)"> <text>Disrupts the session; or</text> </paragraph> <paragraph num="(2)"> <text>Interferes with the right of members of the public to attend and observe the session.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Action to Restore Order. The presiding officer may:</text> <paragraph num="(1)"> <text>Order an individual who engages in conduct prohibited by §A of this regulation, or who violates any other regulation concerning the conduct of an open session, removed from the session;</text> </paragraph> <paragraph num="(2)"> <text>Request police assistance to restore order; and</text> </paragraph> <paragraph num="(3)"> <text>Recess the session while order is restored.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Recording, Photographing, Videotaping, and Broadcasting Open Sessions."> <paragraph num="A."> <text>A member of the public, including a representative of the news media, may record an open session of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council by means of a tape recorder or another recording device if the:</text> <paragraph num="(1)"> <text>Device does not create excessive noise that interferes with the:</text> <paragraph num="(a)"> <text>Participation in a session by a member of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council, or</text> </paragraph> <paragraph num="(b)"> <text>Observation of the session by a member of the public;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Device does not otherwise interfere with an individual's observation of or participation in the session; and</text> </paragraph> <paragraph num="(3)"> <text>Recording is done openly so that it is obvious to those in attendance that the session is being recorded.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A member of the public, including a representative of the news media, may photograph or videotape the proceedings of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council at an open session by means of any type of camera if the camera:</text> <paragraph num="(1)"> <text>Is operated without excessively bright artificial light or excessive noise that interferes with the:</text> <paragraph num="(a)"> <text>Participation of a member of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council in the session, or</text> </paragraph> <paragraph num="(b)"> <text>Observation of the session by a member of the public;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Does not otherwise interfere with an individual's observation of or participation in the session; and</text> </paragraph> <paragraph num="(3)"> <text>Is used openly so that it is obvious to those in attendance that the session is being photographed or videotaped.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A representative of the news media may broadcast or televise the proceedings of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council at an open session if the equipment used:</text> <paragraph num="(1)"> <text>Is operated without excessively bright artificial light or excessive noise that interferes with the:</text> <paragraph num="(a)"> <text>Participation of a member of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council in the session, or</text> </paragraph> <paragraph num="(b)"> <text>Observation of the session by a member of the public;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Does not otherwise interfere with an individual's observation of or participation in the session; and</text> </paragraph> <paragraph num="(3)"> <text>Is used openly so that it is obvious to those in attendance that the session is being broadcast or televised.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The presiding officer may restrict the movement of an individual who is using a recording device, camera, or broadcasting or televising equipment if the restriction is necessary to maintain the orderly conduct of the session.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Recordings Not Part of the Record."> <text>A recording of an open session made by a member of the public or any other transcript derived from a recording is not a part of the record of any proceeding of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Advanced Registration Required."> <text>An individual who intends to record, photograph, videotape, broadcast, or televise the proceedings of the Emergency Medical Services Board or the Statewide Emergency Medical Services Advisory Council at an open session shall notify the Executive Director of MIEMSS of that intention in writing at least 24 hours before the beginning of the session.</text> </regulation> <annotations> <annotation type="Authority">State Government Article, §10-507(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> </annotations> </chapter> <chapter num="04" heading="Procedures for Access to Public Records"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for requesting and gaining access to public records of the Maryland Institute for Emergency Medical Services Systems (MIEMSS) under the Maryland Public Information Act. It is the policy of MIEMSS to facilitate public access to the public records of MIEMSS, when the access is allowed by law, by minimizing costs and time delays to persons requesting information.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Applicant” means a person requesting disclosure of public records.</text> </paragraph> <paragraph num="(2)"> <text>“Custodian” means an authorized individual employed by MIEMSS having physical custody and control of public records of MIEMSS.</text> </paragraph> <paragraph num="(3)"> <text>Official Custodian.</text> <paragraph num="(a)"> <text>“Official Custodian” means the individual in MIEMSS authorized by the Executive Director to be responsible for the maintenance, care, and keeping of MIEMSS' public records, regardless whether these records are in the official custodian's actual personal custody and control.</text> </paragraph> <paragraph num="(b)"> <text>“Official custodian” in the absence of an appointment means the Executive Director.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Person in interest” has the meaning stated in General Provisions Article, §4-101(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(5)"> <text>“Public Information Act” means General Provisions Article, §§4-101—4-601, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>“Public record” has the meaning defined in General Provisions Article, §4-101(h), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Working day” means a day other than Saturday, Sunday, or a State holiday.</text> </paragraph> <paragraph num="(8)"> <text>“Written documents” means all books, papers, maps, photographs, cards, tapes, recordings, computerized records, and other documentary materials, regardless of physical form or characteristics.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Who May Request."> <text>Any person may request to inspect or copy public records of MIEMSS.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Necessity for Written Request."> <paragraph num="A."> <text>The custodian may require a person or government unit that wishes to inspect or copy a public record to submit a written request to the custodian. Otherwise, the custodian shall make public records available for inspection or copying.</text> </paragraph> <paragraph num="B."> <text>The custodian shall require a written request if the custodian reasonably believes that:</text> <paragraph num="(1)"> <text>The Public Information Act or any other law may prevent the disclosure of the record to the applicant; or</text> </paragraph> <paragraph num="(2)"> <text>A written request will materially assist MIEMSS in responding to the request.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Contents of Written Request."> <text>A written request shall:</text> <paragraph num="A."> <text>Contain the applicant's name and address;</text> </paragraph> <paragraph num="B."> <text>Be signed by the applicant;</text> </paragraph> <paragraph num="C."> <text>Reasonably identify by brief description the record sought; and</text> </paragraph> <paragraph num="D."> <text>Be on a form required by MIEMSS if a form is available.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Filing Written Request."> <text>A written request shall be addressed to the custodian of the record. If the custodian is unknown to the applicant, the request may be addressed to the Executive Director.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Response to Written Request."> <paragraph num="A."> <text>If the custodian decides to grant a written request for inspection, the custodian shall produce the record for inspection immediately or within a reasonable period, not exceeding 30 days from the date of the request when a period of time is needed to retrieve the information.</text> </paragraph> <paragraph num="B."> <text>A decision to deny a written request shall be made within 30 days after receipt of the application. Upon deciding to deny a request, the custodian shall:</text> <paragraph num="(1)"> <text>Immediately notify the applicant; and</text> </paragraph> <paragraph num="(2)"> <text>Within 10 working days give the applicant the written statement required under General Provisions Article, §4-203(c)(2), Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Any reasonably severable portion of a record shall be provided to the applicant after deletion of those portions which may be withheld from disclosure.</text> </paragraph> <paragraph num="D."> <text>If a requested public record is not in the custody or control of the individual to whom the written application is made, that individual shall, within 10 working days of receipt of the request, so notify the applicant. If that individual knows the name of the custodian of the record or the location or possible location of the record, this information shall also be given to the applicant.</text> </paragraph> <paragraph num="E."> <text>With consent of the applicant, any time limit imposed by §§A—D of this regulation may be extended for an additional period of up to 30 days.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Notification of Persons Who May Be Affected by Disclosure."> <text>Unless prohibited by law, the custodian may notify any person who could be adversely affected by disclosure of a record that a request for inspection or copying of the record has been made. The custodian may consider the views of that person before deciding whether to disclose the record to the applicant.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Records Temporarily Unavailable."> <text>If a requested public record otherwise subject to inspection or copying is in the custody and control of the individual to whom written application is made but is not immediately available for inspection or copying, the custodian shall, within 10 working days of the receipt of the request, so notify the applicant and set a date and hour within a reasonable time for inspection or copying.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Records Destroyed or Lost."> <text>If a requested record otherwise subject to inspection or copying has been destroyed or lost, the custodian to whom the application is made shall, within 10 working days of the request, notify the applicant of this fact and explain in the response the reasons why the record cannot be produced.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Review of the Denial."> <paragraph num="A."> <text>If a written request is denied by the custodian for a reason other than that the record is temporarily unavailable, the applicant may, within 30 days after receipt of the notice of the denial, seek administrative review by filing a written request for a hearing with the Executive Director.</text> </paragraph> <paragraph num="B."> <text>If the applicant requests a hearing, the hearing shall be conducted by the EMS Board or the Office of Administrative Hearings if the EMS Board so elects.</text> </paragraph> <paragraph num="C."> <text>The hearing procedures in COMAR 28.02.01 apply.</text> </paragraph> <paragraph num="D."> <text>If the hearing is conducted by the Office of Administrative Hearings, the hearing procedures of COMAR 30.02.06.22 and .23 also apply.</text> </paragraph> <paragraph num="E."> <text>If the hearing results in a total or partial denial of the written request, the applicant may file an appropriate action in circuit court under General Provisions Article, §4-362, Annotated Code of Maryland. The EMS Board shall be a party to any proceeding.</text> </paragraph> <paragraph num="F."> <text>If the applicant does not request a hearing, the applicant may file an action for judicial enforcement under General Provisions Article, §4-362, Annotated Code of Maryland, without exhausting the administrative remedy. The EMS Board shall be a party to any proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11-1" heading="Disclosure for Compelling Public Purpose."> <text>A custodian of MIEMSS may find that a compelling public purpose warrants disclosure of information in a certification, licensing, or investigative file, regardless of whether there has been a request for the information, if the information concerns:</text> <paragraph num="A."> <text>Possible criminal activity, and is disclosed to a federal, state, or local law enforcement or prosecutorial official or authority;</text> </paragraph> <paragraph num="B."> <text>A possible violation of law, and is disclosed to a federal, state, or local authority that has jurisdiction over the individual whose conduct may be a violation or over a facility in which the individual is practicing or has practiced and the information disclosed is limited to that information relevant to the possible violation by that individual;</text> </paragraph> <paragraph num="C."> <text>Conduct by an individual who the custodian reasonably believes may pose a risk to the public health, safety, or welfare, and is disclosed to a law enforcement authority, administrative official, or agency that regulates the individual or regulates a facility in which the individual has practiced, or to an EMS Operational Program, a hospital, or other health care facility where the individual has privileges;</text> </paragraph> <paragraph num="D."> <text>Home addresses and is disclosed to an educational program approved under COMAR 30.04; or</text> </paragraph> <paragraph num="E."> <text>Continuing education requirements and is disclosed to an EMS Operational Program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Disclosure Against Public Interest."> <text>If, in the opinion of the official custodian, disclosure of a public record that may otherwise be subject to disclosure under the Public Information Act would do substantial injury to the public interest, the Executive Director may temporarily deny the request in writing and apply, within 10 working days of the denial, to the appropriate circuit court for an order permitting continued denial or restriction of access. Notice of the application filed with the circuit court shall be served on the applicant in the same manner that is provided for service of process by the Maryland Rules of Procedure.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Fees."> <paragraph num="A."> <text>Fee Schedule.</text> <paragraph num="(1)"> <text>Copies. The fee for each copy is 25 cents per page if reproduction is made by a photocopying machine within MIEMSS. If records are not susceptible to photocopying (for example, punch cards, magnetic tapes, blueprints, and microfilm), the fee for copies will be based on the actual cost of reproduction.</text> </paragraph> <paragraph num="(2)"> <text>Computer Output. If MIEMSS is required to provide computer output, including printed documents or discs, the charge for the computer output is determined on a case-by-case basis, taking into account computer and peripheral equipment usage, programming, and material costs.</text> </paragraph> <paragraph num="(3)"> <text>Certification of Copies. If a person requests that a copy of a record be certified as a true copy, an additional fee of $1 per page or, if appropriate, per item shall be charged.</text> </paragraph> <paragraph num="(4)"> <text>Minimal Fee Charged. A charge will not be made if the total amount of the fee would be $1 or less.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notwithstanding §A of this regulation, if the fees for copies, computer output, photographs, or certified copies of a record are specifically required by a law other than the Public Information Act or this regulation, the required fee shall be charged.</text> </paragraph> <paragraph num="C."> <text>If the custodian is unable to copy a record within MIEMSS, the custodian shall make arrangements for the prompt reproduction of the record at public or private facilities outside MIEMSS. The custodian shall either collect from the applicant a fee to cover the actual cost of reproduction or direct the applicant to pay the cost of reproduction directly to the facility making the copy.</text> </paragraph> <paragraph num="D."> <text>Before copying a record, the custodian shall:</text> <paragraph num="(1)"> <text>Estimate the cost of reproduction; and</text> </paragraph> <paragraph num="(2)"> <text>Either obtain the agreement of the applicant to pay the cost or demand prepayment of any estimated fee before reproducing the record.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Except as provided in §F of this regulation, the official custodian may charge reasonable fees for:</text> <paragraph num="(1)"> <text>An official's or an employee's time expended searching for requested records; or</text> </paragraph> <paragraph num="(2)"> <text>Any time expended preparing records for inspection and copying.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The official custodian may not charge a search or preparation fee for the first 2 hours of official or employee time that is needed to respond to a request for information.</text> </paragraph> <paragraph num="G."> <text>Upon request, the official custodian may waive or reduce any fee charged under this regulation if the custodian determines that the waiver or reduction is in the public interest. The official custodian shall consider, among other relevant factors, the ability of the applicant to pay the cost or fee.</text> </paragraph> <paragraph num="H."> <text>If the applicant requests that copies be mailed or delivered to the applicant, the custodian may charge the applicant for the cost of postage or delivery to the applicant.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Time of Inspection."> <text>An applicant may inspect any public record that the applicant is entitled to inspect during the normal working hours of MIEMSS.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Place of Inspection."> <text>The place of inspection shall be where the document is located unless the custodian, after taking into account the applicant's expressed wish, determines another place of inspection is more suitable and convenient.</text> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §4-201(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11E, F amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11-1 adopted effective December 19, 2005 (32:25 Md. R. 1944)</annotation> </annotations> </chapter> <chapter num="05" heading="Correction or Amendment of Public Records"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for a person in interest to request the correction or amendment of public records under General Provisions Article, §4-502, Annotated Code of Maryland, in the Maryland Institute for Emergency Medical Services Systems (MIEMSS).</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Custodian” means an authorized individual employed by MIEMSS having physical custody and control of public records of MIEMSS.</text> </paragraph> <paragraph num="(2)"> <text>“Person in interest” has the meaning stated in General Provisions Article, §4-101(e), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>“Public record” has the meaning defined in General Provisions Article, §4-101(h), Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Who May Request."> <text>A person in interest may request that MIEMSS correct or amend any public record under General Provisions Article, §4-502, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Contents of Request."> <text>The person in interest shall request the correction or amendment in writing. Each request shall:</text> <paragraph num="A."> <text>Identify the public record the person is seeking to correct or amend;</text> </paragraph> <paragraph num="B."> <text>State the precise correction or amendment requested;</text> </paragraph> <paragraph num="C."> <text>State the reason the correction or amendment is sought;</text> </paragraph> <paragraph num="D."> <text>Include the statement that the public record is, to the belief of the person in interest, currently inaccurate or incomplete; and</text> </paragraph> <paragraph num="E."> <text>Represent that the requested correction or amendment will make the public record accurate or complete.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Filing the Request."> <text>A request for correction or amendment of the record shall be filed with MIEMSS by addressing it to the custodian of the record. If the custodian is unknown to the person in interest, the request may be addressed to the Executive Director.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Return of Request."> <text>A request for correction or amendment is considered filed with MIEMSS when received only to the extent that it reasonably complies with Regulation .04 of this chapter. If a request does not reasonably comply with Regulation .04 of this chapter, it shall be returned to the person who filed it with an explanation of the reason for the return and a statement that, upon completion, it may be refiled with MIEMSS.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Response to Request."> <text>Within 30 days after the completed request for correction or amendment that complies with Regulations .04 and .05 of this chapter is received, the custodian of the record shall:</text> <paragraph num="A."> <text>Make the requested correction or amendment and inform the person in interest in writing of the action;</text> </paragraph> <paragraph num="B."> <text>Inform the person who made the request in writing of:</text> <paragraph num="(1)"> <text>MIEMSS' refusal to make the requested correction or amendment, and</text> </paragraph> <paragraph num="(2)"> <text>The reason for the refusal; or</text> </paragraph> </paragraph> <paragraph num="C."> <text>Inform the person who made the request in writing that the request will not be acted on because:</text> <paragraph num="(1)"> <text>The person who made the request is not a person in interest,</text> </paragraph> <paragraph num="(2)"> <text>The record sought to be corrected or amended is not a public record,</text> </paragraph> <paragraph num="(3)"> <text>The person who made the request is not entitled to inspect the record under Parts I—IV of the Public Information Act; or</text> </paragraph> <paragraph num="(4)"> <text>Of any reason that is authorized by law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Refusal of Request."> <text>If MIEMSS' final determination under Regulation .07 of this chapter is to refuse the requested correction or amendment, as authorized by Regulation .07B of this chapter, the person in interest may file with MIEMSS a concise statement of the reasons for:</text> <paragraph num="A."> <text>The requested correction or amendment; and</text> </paragraph> <paragraph num="B."> <text>Disagreement with MIEMSS' refusal to make the correction or amendment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Requirements for Statement of Disagreement."> <text>The statement specified in Regulation .08 of this chapter shall be filed on pages up to 8 1/2 x 11 inches in size. Only one side of the page shall contain the statement. More than 5 pages will not be accepted by MIEMSS in connection with a single request for correction and amendment.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Information Provided to Third Parties."> <text>When MIEMSS discloses to a third party information from public records about which a statement in compliance with Regulations .08 and .09 of this chapter has been filed, MIEMSS shall furnish a copy of the statement to the third party.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Administrative Review."> <paragraph num="A."> <text>A person who has made a request under this chapter for an amendment or correction may request an administrative review by the EMS Board by filing a request for a hearing with the Executive Director, if the person has been denied:</text> <paragraph num="(1)"> <text>An amendment or correction record;</text> </paragraph> <paragraph num="(2)"> <text>The right to file a statement; or</text> </paragraph> <paragraph num="(3)"> <text>The right to have a statement to a third party forwarded under Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A request for a hearing shall be filed within 30 days of the date the person is advised of MIEMSS' action.</text> </paragraph> <paragraph num="C."> <text>If a hearing is requested, the hearing shall be conducted by the EMS Board or the Office of Administrative hearings if the EMS Board so elects.</text> </paragraph> <paragraph num="D."> <text>The hearing procedures in COMAR 28.02.01 apply.</text> </paragraph> <paragraph num="E."> <text>If the hearing is conducted by the Office of Administrative Hearings, the hearing procedures of COMAR 30.02.06.22 and .23 also apply.</text> </paragraph> <paragraph num="F."> <text>A person who has requested administrative review may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">General Provisions Article, §§4-201(b) and 4-502, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> </annotations> </chapter> <chapter num="06" heading="Declaratory Rulings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the procedures for obtaining a declaratory ruling from the EMS Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Declaratory ruling” means a ruling made by a promulgating authority with respect to the manner in which the promulgating authority would apply a regulation or order of the promulgating authority, or a statute that the promulgating authority enforces, to a person or a property based on a given set of facts.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Petition for Declaratory Ruling."> <paragraph num="A."> <text>A person may file a petition for a declaratory ruling by the EMS Board by delivering a copy of the petition to the Executive Director of MIEMSS.</text> </paragraph> <paragraph num="B."> <text>The petition for a declaratory ruling shall:</text> <paragraph num="(1)"> <text>Be written; and</text> </paragraph> <paragraph num="(2)"> <text>Describe in detail:</text> <paragraph num="(a)"> <text>The interest of the person making the request,</text> </paragraph> <paragraph num="(b)"> <text>The issues involved,</text> </paragraph> <paragraph num="(c)"> <text>A statement of the facts,</text> </paragraph> <paragraph num="(d)"> <text>A list of documents or statements which should be considered, and</text> </paragraph> <paragraph num="(e)"> <text>A statement under the penalties of perjury by the person requesting the ruling that the facts contained in the petition are true.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Consideration and Disposition."> <text>The EMS Board shall:</text> <paragraph num="A."> <text>Consider the petition and may issue the declaratory ruling requested; and</text> </paragraph> <paragraph num="B."> <text>Notify the person seeking the ruling in writing of the:</text> <paragraph num="(1)"> <text>Action taken, and</text> </paragraph> <paragraph num="(2)"> <text>Reasons for the decision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Publication and Inspection."> <paragraph num="A."> <text>The EMS Board shall keep a record of each declaratory ruling issued, indexed by reference to statutes or regulations involved.</text> </paragraph> <paragraph num="B."> <text>The EMS Board may publish and allow inspection of declaratory rulings of general interest subject to the requirements of law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Appeal."> <text>A declaratory ruling is subject to judicial review under State Government Article, §10-305, Annotated Code of Maryland. The EMS Board shall be a party to any judicial review.</text> </regulation> <annotations> <annotation type="Authority">State Government Article, §10-304(b), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> </annotations> </chapter> </subtitle> <subtitle num="02" heading="Emergency Medical Services Providers"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Basic telecommunicator course” means a course specified by the Maryland 9-1-1 Board dealing with the basic skills required to function as a call taker or call allocator in a communications center.</text> </paragraph> <paragraph num="(2)"> <text>“Communications center” means a public safety answering point (PSAP) or dispatch center, or a dispatch center operated by a licensed commercial ambulance service.</text> </paragraph> <paragraph num="(3)"> <text>“Course approved by the EMS Board” means a course of study and training intended to prepare an individual for licensure, certification, or renewal as a Maryland EMS provider which is conducted by an education program approved by the EMS Board under COMAR 30.04.</text> </paragraph> <paragraph num="(4)"> <text>“Curriculum” means the required educational content of an EMS training course as established by the EMS Board.</text> </paragraph> <paragraph num="(5)"> <text>“Emergency medical services (EMS)” means:</text> <paragraph num="(a)"> <text>Medical services provided prehospital to prevent imminent death or aggravation of illness or injury;</text> </paragraph> <paragraph num="(b)"> <text>Transport from the scene of a medical emergency to a hospital or appropriate facility whether or not medical services are provided;</text> </paragraph> <paragraph num="(c)"> <text>Medical interfacility transport services to an appropriate facility; or</text> </paragraph> <paragraph num="(d)"> <text>Medical interfacility critical care transport to an appropriate facility.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Licensed nurse” means an individual holding a current and valid license issued by the Board of Nursing to practice nursing in Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed physician” means an individual holding a current and valid license issued by the State Board of Physicians to practice medicine in Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Maryland 9-1-1 Board” means the Board established by the Public Safety Article, §1-305, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“National Registry of Emergency Medical Technicians” means the not-for-profit independent nongovernment agency that provides standardized national testing and registration for emergency medical technicians based on national training standards.</text> </paragraph> <paragraph num="(10)"> <text>“Physician assistant” means an individual licensed by the State Board of Physicians as a physician assistant to practice under a collaborative agreement.</text> </paragraph> <paragraph num="(11)"> <text>“Proprietary emergency medical dispatch (EMD) training program” means a private corporation, organization, or other entity which provides emergency medical dispatch training and materials consistent with the standards established by the National Highway Traffic Safety Administration.</text> </paragraph> <paragraph num="(12)"> <text>“Public safety answering point (PSAP)” has the meaning stated in Public Safety Article, §1-301(q), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Service member” means an individual who is an active duty member of:</text> <paragraph num="(a)"> <text>The Armed Forces of the United States;</text> </paragraph> <paragraph num="(b)"> <text>A reserve component of the Armed Forces of the United States; or</text> </paragraph> <paragraph num="(c)"> <text>The National Guard of any state.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 1, 2002 (29:12 Md. R. 930)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 19, 2005 (32:25 Md. R. 1944); May 12, 2014 (41:9 Md. R. 523); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 1, 2000 (27:8 Md. R. 806)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed effective October 30, 2000 (27:21 Md. R. 1977)</annotation> </annotations> </chapter> <chapter num="02" heading="Licensure and Certification"> <regulation prefix="Regulation" num=".01" heading="Application."> <paragraph num="A."> <text>An applicant for licensure, certification, or renewal shall submit to MIEMSS a completed application on a form the EMS Board requires.</text> </paragraph> <paragraph num="B."> <text>Each application shall be signed by the applicant and any other individuals required by the EMS Board.</text> </paragraph> <paragraph num="C."> <text>An applicant for licensure, certification, or renewal shall submit, with the application, evidence demonstrating that the applicant has successfully met all requirements.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Fees."> <paragraph num="A."> <text>The fee for licensure or certification, renewal of licensure or certification, examination, and reexamination is waived for an applicant who, on the date of application, is a member or employee of a fire, rescue, public safety, or EMS agency of a unit of State or federal government or political subdivision of the State, or a volunteer fire, rescue, or ambulance company, association, or agency, or an employee of a commercial ambulance service licensed under Education Article, §13-515, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The fee for the emergency medical responder, emergency medical technician, and paramedic written examinations and each reexamination are established by the National Registry of Emergency Medical Technicians.</text> </paragraph> <paragraph num="C."> <text>The fee for the practical examination for emergency medical technician is $65.</text> </paragraph> <paragraph num="D."> <text>The fee for reciprocal certification or licensure is $35.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Requirements."> <paragraph num="A."> <text>An individual applying for reciprocal licensure or certification shall meet the requirements of Regulation .04 of this chapter.</text> </paragraph> <paragraph num="B."> <text>To qualify for licensure or certification, an applicant other than an applicant under §A of this regulation shall be 18 years old or older, except an individual:</text> <paragraph num="(1)"> <text>Who is between the ages of 16 and 18 may apply for emergency medical responder or emergency medical technician examination and certification with written permission from a parent or legal guardian;</text> </paragraph> <paragraph num="(2)"> <text>Shall be 16 years old or older before participating in any BLS clinical training or internship; and</text> </paragraph> <paragraph num="(3)"> <text>Shall be 18 years old or older before participating in any ALS clinical training or internship.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements of §B of this regulation, an applicant for emergency medical responder certification shall:</text> <paragraph num="(1)"> <text>Have successfully completed an emergency medical responder course approved by the EMS Board;</text> </paragraph> <paragraph num="(2)"> <text>Submit to MIEMSS evidence of current active status registration as an emergency medical responder with the National Registry of Emergency Medical Technicians, including:</text> <paragraph num="(a)"> <text>Successfully completing the practical certification examination administered in conjunction with the emergency medical responder course; and</text> </paragraph> <paragraph num="(b)"> <text>Passing an emergency medical responder cognitive certification examination administered by the National Registry of Emergency Medical Technicians.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the requirements of §B of this regulation, an applicant for emergency medical technician certification shall:</text> <paragraph num="(1)"> <text>Have successfully completed:</text> <paragraph num="(a)"> <text>An emergency medical technician course approved by the EMS Board; or</text> </paragraph> <paragraph num="(b)"> <text>If the applicant is a licensed nurse, licensed physician, or certified physician assistant, the health care provider to emergency medical technician program;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have successfully completed an internship approved by MIEMSS;</text> </paragraph> <paragraph num="(3)"> <text>Submit to MIEMSS evidence of current active status registration as an emergency medical technician with the National Registry of Emergency Medical Technicians, including:</text> <paragraph num="(a)"> <text>Successfully completing the emergency medical technician practical certification examination administered by MIEMSS; and</text> </paragraph> <paragraph num="(b)"> <text>Passing an emergency medical technician cognitive certification examination administered by the National Registry of Emergency Medical Technicians; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Be currently affiliated with an EMS operational program.</text> </paragraph> </paragraph> <paragraph num="E."> <text>In addition to the requirements of §B of this regulation, an applicant for initial paramedic licensure shall:</text> <paragraph num="(1)"> <text>Have successfully completed:</text> <paragraph num="(a)"> <text>A paramedic course approved by the EMS Board;</text> </paragraph> <paragraph num="(b)"> <text>If the applicant is a licensed nurse, licensed physician, or certified physician assistant, the health care provider to paramedic program; or</text> </paragraph> <paragraph num="(c)"> <text>If the applicant is a CRT, the paramedic bridge course;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have successfully completed immediately before application for licensure:</text> <paragraph num="(a)"> <text>At least 12 full months of experience in providing patient care as an emergency medical technician with an EMS operational program;</text> </paragraph> <paragraph num="(b)"> <text>At least 150 documented ambulance responses providing patient care, including patient assessment, with an EMS operational program;</text> </paragraph> <paragraph num="(c)"> <text>If the applicant is a licensed nurse, licensed physician, or certified physician assistant, the health care provider to paramedic program; or</text> </paragraph> <paragraph num="(d)"> <text>If the applicant is a CRT, the paramedic bridge course;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Submit evidence of current active status registration as a paramedic with the National Registry of Emergency Medical Technicians;</text> </paragraph> <paragraph num="(4)"> <text>Successfully complete a MIEMSS-approved protocol orientation; and;</text> </paragraph> <paragraph num="(5)"> <text>Be currently affiliated with an ALS EMS operational program.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In addition to the requirements of §B of this regulation, an applicant for EMD licensure shall:</text> <paragraph num="(1)"> <text>Have successfully completed:</text> <paragraph num="(a)"> <text>The basic telecommunicator course or an equivalent course approved by the Maryland 9-1-1 Board; or</text> </paragraph> <paragraph num="(b)"> <text>2,000 hours of public safety call-taking or call-allocating experience;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Have successfully completed an EMD training program approved by the EMS Board; and</text> </paragraph> <paragraph num="(3)"> <text>Be affiliated with an EMD operational program which has been approved by the EMS Board.</text> </paragraph> </paragraph> <paragraph num="G."> <text>In determining whether any experience or internship required for licensure or certification has been completed, the EMS Board shall give credit to the individual for all relevant experience as a service member.</text> </paragraph> <paragraph num="H."> <text>The EMS Board shall credit any training and education provided by the military and completed by a service member toward any training or education requirements for licensure or certification if the training or education is determined by the EMS Board to be:</text> <paragraph num="(1)"> <text>Substantially equivalent to the training or education required by the EMS Board; and</text> </paragraph> <paragraph num="(2)"> <text>Not otherwise contrary to any other licensing requirement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Reciprocity."> <paragraph num="A."> <text>To obtain reciprocal licensure or certification, an applicant shall:</text> <paragraph num="(1)"> <text>Submit to MIEMSS a completed application on a form the EMS Board requires;</text> </paragraph> <paragraph num="(2)"> <text>Be at least the minimum age required for licensure or certification as set forth in Regulation .03B(2) of this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>Be currently affiliated with an EMS operational program providing at least the level of services for which the individual is seeking reciprocal licensure or certification, unless applying for reciprocal certification as an emergency medical responder.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In addition to the requirements of §A of this regulation, an applicant for emergency medical responder reciprocal certification shall:</text> <paragraph num="(1)"> <text>Submit evidence of current:</text> <paragraph num="(a)"> <text>Certification as an emergency medical responder in another state; or</text> </paragraph> <paragraph num="(b)"> <text>Registration with the National Registry of Emergency Medical Technicians as an emergency medical responder.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>In addition to the requirements of §A of this regulation, an applicant for emergency medical technician reciprocal certification shall:</text> <paragraph num="(1)"> <text>Submit evidence of current:</text> <paragraph num="(a)"> <text>Certification as an emergency medical technician, advanced emergency medical technician, or paramedic in another state if that state follows the national educational standards; or</text> </paragraph> <paragraph num="(b)"> <text>Registration with the National Registry of Emergency Medical Technicians as an emergency medical technician, advanced emergency medical technician, or paramedic; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Successfully complete a:</text> <paragraph num="(a)"> <text>MIEMSS-approved protocol orientation; and</text> </paragraph> <paragraph num="(b)"> <text>MIEMSS-approved technical proficiency verification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>In addition to the requirements of §A of this regulation, an applicant for reciprocal paramedic licensure shall:</text> <paragraph num="(1)"> <text>Submit evidence of active status registration as a paramedic with the National Registry of Emergency Medical Technicians; and</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete a MIEMSS-approved protocol orientation.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Expiration Date.</text> <paragraph num="(1)"> <text>For an EMR or EMT who is issued a certificate by reciprocity:</text> <paragraph num="(a)"> <text>Between February 1 and July 31, the expiration date shall be July 31 plus 1 year; or</text> </paragraph> <paragraph num="(b)"> <text>Between August 1 and January 31, the expiration date shall be January 31 plus 1 year.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a paramedic who is issued a license by reciprocity, the expiration shall be 30 days after the individual’s current National Registry of Emergency Medical Technicians certification expires.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Examination and Reexamination."> <paragraph num="A."> <text>An applicant for EMD licensure who has completed an approved training program which provides its own examination shall be examined and reexamined in accordance with the policies of that training program.</text> </paragraph> <paragraph num="B."> <text>An applicant for emergency medical technician certification or paramedic licensure is subject to the examination and reexamination policies and procedures of the National Registry of Emergency Medical Technicians..</text> </paragraph> <paragraph num="C."> <text>If an applicant for emergency medical technician fails a first or second practical certification examination, the applicant may retake the practical examination:</text> <paragraph num="(1)"> <text>Within 6 months of failing the first or second practical examination as provided in this regulation; and</text> </paragraph> <paragraph num="(2)"> <text>Only after receiving remedial instruction in the areas of practical examination deficiency.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If an applicant for emergency medical technician certification fails the third practical certification examination, the applicant shall successfully complete a minimum of 9 hours of remedial education, which shall include technical skills, and pass the National Registry of Emergency Medical Technicians certification examination, after which the applicant may attempt the practical certification examination three more times, consistent with the procedure in §C of this regulation.</text> </paragraph> <paragraph num="E."> <text>If an applicant for emergency medical technician certification fails the fourth, fifth, and sixth practical certification examination authorized under §D of this regulation, then the applicant shall successfully complete an approved emergency medical technician course in its entirety and pass the National Registry of Emergency Medical Technicians certification examination before taking another emergency medical technician practical certification examination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Issuance of License or Certificate."> <paragraph num="A."> <text>A license or certificate shall be issued to each applicant meeting all applicable requirements of this subtitle for the level of licensure or certification sought.</text> </paragraph> <paragraph num="B."> <text>The license or certificate shall bear the emergency medical service clinician’s name, identification number, the effective date of the license or certificate, and the expiration date of the license or certificate.</text> </paragraph> <paragraph num="C."> <text>An applicant may not provide patient care as an EMS clinician until the applicant has received a current license or certificate from the EMS Board, except under supervision and in the course of participating in an education program that has been approved by the EMS Board.</text> </paragraph> <paragraph num="D."> <text>An EMS clinician shall, whenever possible, carry the identification card issued by MIEMSS showing the clinician is licensed or certified by the EMS Board while performing the EMS clinician’s duties.</text> </paragraph> <paragraph num="E."> <text>MIEMSS shall maintain a registry of licensed or certified EMS clinicians.</text> </paragraph> <paragraph num="F."> <text>An EMS provider shall notify the MIEMSS Office of Education, Licensure and Certification in writing within 30 days of any change in:</text> <paragraph num="(1)"> <text>Name;</text> </paragraph> <paragraph num="(2)"> <text>Address;</text> </paragraph> <paragraph num="(3)"> <text>Email;</text> </paragraph> <paragraph num="(4)"> <text>Phone number; or</text> </paragraph> <paragraph num="(5)"> <text>Affiliation with an EMS operational program.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Unless renewed or extended, the term of a license or certificate shall expire on the expiration date shown on the license or certificate.</text> </paragraph> <paragraph num="H."> <text>Unless the certificate is the initial certificate issued under COMAR 30.02.02.04 or is extended, revoked, or suspended, the certificate of an emergency medical responder or emergency medical technician is valid:</text> <paragraph num="(1)"> <text>In the initial certification period for at least 36 months, but not more than 42 months, as follows:</text> <paragraph num="(a)"> <text>Applicants for emergency medical responder and emergency medical technician certification who successfully complete the certification requirements between February 1 and July 31 are issued a certificate which is effective from the date of successful completion of all certification requirements and expires on July 31, 3 years from the year of issuance; or</text> </paragraph> <paragraph num="(b)"> <text>Applicants for emergency medical responder and emergency medical technician certification who successfully complete the emergency medical technician [examination] requirements between August 1 and January 31 are issued a certificate which is effective from the date of successful completion of all certification requirements and expires on January 31, 3 years from the year of issuance; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In each subsequent certification period, for a period of 3 years from the previous expiration date.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Unless the license is extended, revoked, or suspended, the license of a CRT is valid for 2 years from the previous expiration date.</text> </paragraph> <paragraph num="J."> <text>Unless the license is extended, revoked, or suspended, the license of a paramedic is valid:</text> <paragraph num="(1)"> <text>In the initial licensure period, from the date of successful completion of all licensure requirements until 30 days after the expiration of the individual's registration with the National Registry of Emergency Medical Technicians; and</text> </paragraph> <paragraph num="(2)"> <text>In each subsequent licensure period, until 30 days after the expiration of the individual’s registration with the National Registry of Emergency Medical Technicians.</text> </paragraph> </paragraph> <paragraph num="K."> <text>Unless the license is extended, revoked, or suspended, the license of an EMD is valid:</text> <paragraph num="(1)"> <text>In the initial licensure period, for at least 24 months, but not more than 32 months, as follows:</text> <paragraph num="(a)"> <text>Applicants for EMD licensure who register with a national organization approved by the EMS Board between January 1 and June 30 are issued a license that is effective from the date of successful completion of all required certification examinations and expires on June 30, 2 years from the year of issuance; or</text> </paragraph> <paragraph num="(b)"> <text>Applicants for EMD licensure who register with a national organization approved by the EMS Board between July 1 and December 31 are issued a certificate that is effective from the date of successful completion of all required certification examinations and expires on December 31, 2 years from the year of issuance; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In each subsequent licensure period, for a period of 2 years from the previous expiration date.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Renewal."> <paragraph num="A."> <text>Prior to the expiration date of each license or certificate, MIEMSS shall send renewal notices to each EMS clinician whose license or certificate is expiring using the clinician’s contact information required under Regulation .06F of this chapter.</text> </paragraph> <paragraph num="B."> <text>The renewal notice shall state the date the current license or certificate expires.</text> </paragraph> <paragraph num="C."> <text>An EMS clinician who wishes to renew a license or certificate shall submit an application and any required supporting materials as specified in each applicable part of this chapter to MIEMSS on a form approved by MIEMSS at least 2 weeks before the expiration date.</text> </paragraph> <paragraph num="D."> <text>For an emergency medical responder whose certificate, including any extension, expires after July 31, 2025, and is applying for renewal as an emergency medical responder, the individual shall submit to MIEMSS evidence of:</text> <paragraph num="(1)"> <text>Current active status registration as an emergency medical responder or higher with the National Registry of Emergency Medical Technicians; or</text> </paragraph> <paragraph num="(2)"> <text>Documentation of the successful completion of:</text> <paragraph num="(a)"> <text>8 hours of continuing education in categories designated by the State EMS Medical Director during the clinician’s current certification cycle;</text> </paragraph> <paragraph num="(b)"> <text>Three of the most recent years of Annual EMS Protocol Updates; and</text> </paragraph> <paragraph num="(c)"> <text>A MIEMSS-approved technical proficiency verification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>For an emergency medical technician whose certificate, including any extension, expires after July 31, 2025, and is applying for renewal as an emergency medical technician, the individual shall submit to MIEMSS evidence of:</text> <paragraph num="(1)"> <text>Affiliation with an EMS operational program;</text> </paragraph> <paragraph num="(2)"> <text>Completion of the 3 most recent years of Annual EMS Protocol Updates; and</text> </paragraph> <paragraph num="(3)"> <text>Either:</text> <paragraph num="(a)"> <text>Current active status registration as an emergency medical technician or higher with the National Registry of Emergency Medical Technicians; or</text> </paragraph> <paragraph num="(b)"> <text>Successful completion of 24 hours of continuing education in categories designated by the State EMS Medical Director during the clinician’s current certification cycle, of which a minimum of 1 hour up to a maximum of 9 hours may be devoted to technical skills, including MIEMSS-approved technical proficiency verification.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>For a CRT whose license, including any extension, expires after July 31, 2025, and is applying for renewal as a CRT the individual shall submit to MIEMSS evidence of:</text> <paragraph num="(1)"> <text>Affiliation with an EMS operational program;</text> </paragraph> <paragraph num="(2)"> <text>Completion of the two most recent years of Annual EMS Protocol Updates; and</text> </paragraph> <paragraph num="(3)"> <text>Either:</text> <paragraph num="(a)"> <text>Current active status registration as a paramedic with the National Registry of Emergency Medical Technicians and completion of any MIEMSS-assigned ALS education; or</text> </paragraph> <paragraph num="(b)"> <text>Documentation of successful completion of:</text> <paragraph num="(i)"> <text>60 hours of continuing education equivalent to the requirements of a paramedic renewing with the National Registry of Emergency Medical Technicians including any MIEMSS-assigned ALS education during the clinician’s renewal cycle; and</text> </paragraph> <paragraph num="(ii)"> <text>A MIEMSS-approved technical proficiency verification.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>For a paramedic whose license, including any extension, expires after July 31, 2025, and is applying for renewal as a paramedic, the individual shall submit to MIEMSS evidence of:</text> <paragraph num="(1)"> <text>Affiliation with an EMS operational program;</text> </paragraph> <paragraph num="(2)"> <text>Completion of the two most recent years of Annual EMS Protocol Updates;</text> </paragraph> <paragraph num="(3)"> <text>Completion of any MIEMSS-assigned ALS education during the clinician’s current renewal cycle; and</text> </paragraph> <paragraph num="(4)"> <text>Current active status registration as a paramedic with the National Registry of Emergency Medical Technicians.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If applying for renewal as an EMD the individual shall submit evidence of:</text> <paragraph num="(1)"> <text>Affiliation with an EMS operational program; and</text> </paragraph> <paragraph num="(2)"> <text>Either:</text> <paragraph num="(a)"> <text>Continued, active status certification as an EMD by a national organization approved by the EMS Board; or</text> </paragraph> <paragraph num="(b)"> <text>Successful completion of 24 hours of approved EMD-related continuing education offered by an approved EMD educational program.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>MIEMSS may extend a license or certificate for up to 6 months upon receipt of a written request for an extension before the expiration date.</text> </paragraph> <paragraph num="J."> <text>Upon completion of the requirements for renewal, the individual shall receive a certificate or license valid for the appropriate certification or licensure period minus the period of any extension.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inactive Status."> <paragraph num="A."> <text>The EMS Board may place an EMS clinician on inactive status if the EMS clinician:</text> <paragraph num="(1)"> <text>Fails to maintain affiliation with any required EMS operational program;</text> </paragraph> <paragraph num="(2)"> <text>Applies for inactive status by submitting an application on a form the EMS Board requires;</text> </paragraph> <paragraph num="(3)"> <text>In the case of a paramedic [or a CRT initially licensed after June 30, 2001], fails to maintain continuous, active status registration with the National Registry of Emergency Medical Technicians [as a provider], unless the [provider] paramedic has requested and received an extension of the individual's license from MIEMSS[.]; or</text> </paragraph> <paragraph num="(4)"> <text>Fails to complete a MIEMSS-approved technical proficiency verification for renewal.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An EMS clinician on inactive status may not provide emergency medical services in this State except in rare instances at the scene of a medical emergency.</text> </paragraph> <paragraph num="C."> <text>An EMS clinician on inactive status may apply for active status if the individual:</text> <paragraph num="(1)"> <text>Submits an application on a form the EMS Board requires;</text> </paragraph> <paragraph num="(2)"> <text>Is affiliated with any required EMS operational program;</text> </paragraph> <paragraph num="(3)"> <text>If applying for reinstatement as a paramedic, provides evidence of current active status registration as a paramedic with the National Registry of Emergency Medical Technicians; and</text> </paragraph> <paragraph num="(4)"> <text>If the individual has been on inactive status for a period greater than 1 year, [attends a skills review session approved by MIEMSS, or conducted by an approved ALS training program.] completes the most recent protocol update course and a MIEMSS-approved technical proficiency verification.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A clinician whose license is on inactive status, as specified in §A, may apply for renewal if all other requirements for renewal are met.</text> </paragraph> <paragraph num="E."> <text>Except in the instance of an EMS clinician on active military duty, inactive status does not affect the term of an EMS clinician's license or certificate.</text> </paragraph> <paragraph num="F."> <text>An EMS clinician on active military duty may be granted an extended inactive status that shall end 1 year after the date of deactivation from active military duties that otherwise prevent the clinician from completing the requirements to maintain certification or licensure.</text> </paragraph> <paragraph num="G."> <text>A fee is not charged to change from inactive to active status.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Reinstatement."> <paragraph num="A."> <text>An individual whose license or certificate has expired and who has failed to renew the license or certificate may be reinstated as an EMS clinician if all requirements for reinstatement are met.</text> </paragraph> <paragraph num="B."> <text>An applicant for reinstatement as an EMS clinician shall apply for reinstatement:</text> <paragraph num="(1)"> <text>As an emergency medical responder, not later than 3 years after the expiration of the applicant’s emergency medical responder certification, or at any time if the applicant has current active status registration as an emergency medical responder with the National Registry of Emergency Medical Technicians;</text> </paragraph> <paragraph num="(2)"> <text>As an emergency medical technician, not later than 3 years after the expiration of the applicant’s emergency medical technician certification, or at any time if the applicant has active status registration as an emergency medical technician with the National Registry of Emergency Medical Technicians;</text> </paragraph> <paragraph num="(3)"> <text>As an EMD, not later than 2 years after the expiration of the applicant’s EMD licensure, or at any time if the applicant has current active status registration with a nationally-recognized EMD program;</text> </paragraph> <paragraph num="(4)"> <text>As a CRT, not later than 2 years after the expiration of the applicant’s CRT licensure, or at any time if the applicant has current active registration as a paramedic with the National Registry of Emergency Medical Technicians; or</text> </paragraph> <paragraph num="(5)"> <text>As a paramedic, at any time if the applicant has current active status registration as a paramedic with the National Registry of Emergency Medical Technicians.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant for reinstatement as an EMS clinician shall:</text> <paragraph num="(1)"> <text>Successfully complete all requirements for renewal;</text> </paragraph> <paragraph num="(2)"> <text>If applying for reinstatement as an EMD, emergency medical technician, CRT, or paramedic, be affiliated with an EMS operational program; and</text> </paragraph> <paragraph num="(3)"> <text>If applying for reinstatement as an emergency medical technician, CRT, or paramedic, successfully complete a MIEMSS-approved EMS protocol orientation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Upon fulfilling the requirements for reinstatement of a certificate or license, the date of expiration of the new certificate or license shall be:</text> <paragraph num="(1)"> <text>The date of expiration of the certificate or license had not lapsed; or</text> </paragraph> <paragraph num="(2)"> <text>The date of an initial certificate or license under Regulation .06 of this chapter if the expiration date of the lapsed certificate or license has passed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Surrender."> <text>Subject to COMAR 30.02.05.13, an EMS provider who possesses a valid license or certificate issued by the EMS Board may surrender that license or certificate and be issued a license or certificate for a lower level of EMS provider licensure or certification which is valid for up to 1 year.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Replacement."> <text>A duplicate license or certificate shall be issued for a lost, stolen, or destroyed license or certificate upon:</text> <paragraph num="A."> <text>Written request of the EMS provider; and</text> </paragraph> <paragraph num="B."> <text>Payment of a fee of $5.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Denials."> <paragraph num="A."> <text>The EMS Board may deny a license or certificate to an individual who has engaged in prohibited conduct under COMAR 30.02.04.</text> </paragraph> <paragraph num="B."> <text>Any proceedings concerning a complaint of misconduct by an applicant shall be in accordance with COMAR 30.02.05 and 30.02.06.</text> </paragraph> <paragraph num="C."> <text>Procedures for Denial.</text> <paragraph num="(1)"> <text>The EMS Board shall deny a license or certificate to individuals failing to submit the documentation or meet the standards and requirements established by statute or regulation for the licensing or certification of an EMS provider.</text> </paragraph> <paragraph num="(2)"> <text>The EMS Board may delegate its functions under this section to MIEMSS.</text> </paragraph> <paragraph num="(3)"> <text>Notice of denial of an application for initial licensure, certification, renewal or reinstatement of licensure or certification, or reciprocal licensure or certification under this section shall be sent to the applicant by first class mail at the address provided by the applicant on the application.</text> </paragraph> <paragraph num="(4)"> <text>The denial notice shall inform the applicant of the:</text> <paragraph num="(a)"> <text>Basis for the denial;</text> </paragraph> <paragraph num="(b)"> <text>Applicant's right to request a hearing on the denial; and</text> </paragraph> <paragraph num="(c)"> <text>Procedures for requesting a hearing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Hearings under §C of this regulation shall be governed by COMAR 30.02.06.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Requirements for Individuals with a Provisional License or Certificate to Obtain a Full License or Certificate."> <paragraph num="A."> <text>A holder of a provisional EMS license or certificate issued pursuant to either the Executive Order Augmenting the Emergency Medical Services Workforce (Order Number 20-03-19-03) under authority of the Proclamation of March 5, 2020, as extended from time to time, in which the Governor of Maryland proclaimed that a state of emergency and catastrophic health emergency existed within the entire State of Maryland in an effort to control and prevent the spread of COVID-19, or the Executive Order Augmenting the Emergency Medical Services Workforce (Order Number 22-01-04-02) under authority of the Proclamation of January 4, 2022, as extended from time to time, in which the Governor of Maryland proclaimed that a state of emergency and catastrophic health emergency existed within the entire State of Maryland in an effort to control and prevent the spread of COVID-19, shall receive a license or certificate under Education Article, §13-516, Annotated Code of Maryland, provided the holder submits an application and completes the requirements set forth below within the required time frame and provided the holder does not have a pending disciplinary matter or is otherwise subject to denial. During the required time frame, the holder will remain provisionally licensed or certified and may continue to practice EMS. If the holder fails to submit an application or complete the requirements within the required time frame, the provisional certificate or license will expire.</text> </paragraph> <paragraph num="B."> <text>Emergency Medical Technician.</text> <paragraph num="(1)"> <text>Provisional EMT Certification Obtained as a Student.</text> <paragraph num="(a)"> <text>A provisional EMT who obtained provisional EMT certification as a student shall complete the requirements of Regulation .03D of this chapter by May 11, 2022, if the provisional EMT certification was received prior to August 12, 2021, or by November 30, 2022, if the provisional EMT certification was received after January 4, 2022.</text> </paragraph> <paragraph num="(b)"> <text>A provisional EMT who obtained provisional EMT certification as a student and who was affiliated with an EMS operational program and provided EMS during the catastrophic health emergency shall have met the requirement to complete an internship under Regulation .03D(2) of this chapter.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provisional EMT Certification Obtained via Reciprocity. A provisional EMT who obtained EMT certification via reciprocity shall by May 11, 2022, if the provisional EMT certification was received prior to August 12, 2021, or by November 30, 2022, if the provisional EMT certification was received after January 4, 2022:</text> <paragraph num="(a)"> <text>If registered with the National Registry of Emergency Medical Technicians (NREMT) as an EMT, successfully complete a protocol review session approved by MIEMSS; or</text> </paragraph> <paragraph num="(b)"> <text>If not registered with the NREMT as an EMT:</text> <paragraph num="(i)"> <text>Document successful completion of 24 hours of EMS continuing education within the past 12 months; and</text> </paragraph> <paragraph num="(ii)"> <text>Successfully complete a protocol review session approved by MIEMSS.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provisional EMT Certification Obtained Through Reinstatement. A provisional EMT who held an expired EMT certificate and was reinstated with a provisional certificate shall meet the following requirements by May 11, 2022, if the provisional EMT certification was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMT certification was received after January 4, 2022:</text> <paragraph num="(a)"> <text>If the provisional EMT has previously passed the NREMT cognitive exam, the provisional EMT shall:</text> <paragraph num="(i)"> <text>Provide documentation that while holding a provisional certificate the provisional EMT was affiliated with an EMS operational program and provided EMS during the catastrophic health emergency; and</text> </paragraph> <paragraph num="(ii)"> <text>Document successful completion of 24 hours of EMS continuing education in the past 12 months;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>If the provisional EMT has never passed the NREMT cognitive examination and was lapsed for 1 year or less, the provisional EMT shall by May 11, 2022, if the provisional EMT certification was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMT certification was received after January 4, 2022:</text> <paragraph num="(i)"> <text>Provide documentation that while holding a provisional certificate the provisional EMT was affiliated with an EMS operational program and provided EMS during the catastrophic health emergency; and</text> </paragraph> <paragraph num="(ii)"> <text>Document successful completion of 24 hours of EMS continuing education within the past 12 months;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>If the provisional EMT has never passed the NREMT cognitive examination and was lapsed for more than 1 year but not more than 3 years, the provisional EMT shall by May 22, 2022, if the provisional EMT certification was received prior to August 5, 2021, or by November 30, 2022, if the provisional EMT certification was received after January 4, 2022:</text> <paragraph num="(i)"> <text>Provide documentation that while holding a provisional certificate the provisional EMT was affiliated with an EMS operational program and provided EMS during the catastrophic health emergency;</text> </paragraph> <paragraph num="(ii)"> <text>Document successful completion of 24 hours of EMS continuing education within the past 12 months; and</text> </paragraph> <paragraph num="(iii)"> <text>Successfully complete the cognitive reinstatement examination approved by MIEMSS; or</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If the provisional EMT has never passed the NREMT cognitive examination and was lapsed for more than 3 years, the provisional EMT shall by May 11, 2022, if the provisional EMT certification was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMT certification was received after January 4, 2022:</text> <paragraph num="(i)"> <text>Provide documentation that while holding a provisional certificate the provisional EMT was affiliated with an EMS operational program and provided EMS during the catastrophic health emergency;</text> </paragraph> <paragraph num="(ii)"> <text>Document successful completion of 24 hours of EMS continuing education within the past 12 months; and</text> </paragraph> <paragraph num="(iii)"> <text>Successfully complete the cognitive and psychomotor reinstatement examinations approved by MIEMSS.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Paramedic.</text> <paragraph num="(1)"> <text>Provisional Paramedic License Obtained as a Student. A provisional paramedic who obtained provisional licensure as a student shall:</text> <paragraph num="(a)"> <text>Pass the NREMT cognitive examination by May 11, 2022, if the provisional paramedic license was received prior to August 15, 2021, or by November 30, 2022, if the provisional paramedic license was received after January 4, 2022; and</text> </paragraph> <paragraph num="(b)"> <text>Pass the NREMT psychomotor examination and document current active, nonprovisional status registration as a paramedic with the NREMT by May 11, 2022, if the provisional paramedic license was received prior to August 15, 2021, or by November 30, 2022, if the provisional paramedic license was received after January 4, 2022.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provisional Paramedic License Obtained via Reciprocity. A provisional paramedic who obtained provisional licensure via reciprocity shall by May 11, 2022, if the provisional paramedic license was received prior to August 15, 2021, or by November 30, 2022, if the provisional paramedic license was received after January 4, 2022:</text> <paragraph num="(a)"> <text>Document current active, nonprovisional status as a paramedic with the NREMT; and</text> </paragraph> <paragraph num="(b)"> <text>Successfully complete a protocol review session approved by MIEMSS.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provisional Paramedic License Obtained Through Reinstatement. A provisional paramedic who obtained provisional licensure through reinstatement shall by May 11, 2022, if the provisional paramedic license was received prior to August 15, 2021, or by November 30, 2022, if the provisional paramedic license was received after January 4, 2022, provide documentation that while holding a provisional license the provisional paramedic was affiliated with an EMS operational program and provided EMS during the catastrophic health emergency, and documentation of:</text> <paragraph num="(a)"> <text>Both of the following:</text> <paragraph num="(i)"> <text>Current active, nonprovisional status as a paramedic with the NREMT; and</text> </paragraph> <paragraph num="(ii)"> <text>Successful completion of a protocol review session approved by MIEMSS; or</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>All of the following:</text> <paragraph num="(i)"> <text>A passing score on the NREMT cognitive examination by May 11, 2022, if the provisional paramedic license was received prior to August 15, 2021, or by November 30, 2022, if the provisional paramedic license was received after January 4, 2022;</text> </paragraph> <paragraph num="(ii)"> <text>A passing score on the NREMT psychomotor examination and current active, nonprovisional status registration as a paramedic with the NREMT by May 11, 2022, if the provisional paramedic license was received prior to August 15, 2021, or by November 30, 2022, if the provisional paramedic license was received after January 4, 2022; and</text> </paragraph> <paragraph num="(iii)"> <text>Successful completion of a protocol review session approved by MIEMSS by May 11, 2022, if the provisional paramedic license was received prior to August 15, 2021, or by November 30, 2022, if the provisional paramedic license was received by January 4, 2022.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Emergency Medical Responder.</text> <paragraph num="(1)"> <text>Provisional EMR Certification Obtained as a Student. A provisional EMR who obtained EMR certification as a student shall complete the requirements of Regulation .03C of this chapter by May 11, 2022, if the provisional EMR certificate was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMR certificate was received by January 4, 2022.</text> </paragraph> <paragraph num="(2)"> <text>Provisional EMR Certification Obtained Through Reinstatement. A provisional EMR who obtained provisional EMR certification through reinstatement shall by May 11, 2022, if the provisional EMR certificate was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMR certificate was received after January 4, 2022, provide documentation that the provisional EMR was affiliated with an EMS operational program and provided EMS during the catastrophic health emergency.</text> </paragraph> <paragraph num="(3)"> <text>Provisional EMR Certification Obtained via Reciprocity. A provisional EMR who obtained provisional EMR certification via reciprocity shall by May 11, 2022, if the provisional EMR certificate was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMR certificate was received after January 4, 2022, provide documentation that while holding the provisional certificate the provisional EMR affiliated with an EMS operational program and provided EMS during the catastrophic health emergency.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Cardiac Rescue Technician. Provisional CRT License Obtained Through Reinstatement. A provisional CRT who held an expired CRT license and was reinstated with a provisional license shall by May 11, 2022, if the provisional CRT license was received prior to August 15, 2021, or by November 30, 2022, if the provisional CRT license was received after January 4, 2022:</text> <paragraph num="(1)"> <text>Document successful completion of 60 hours of continuing education equivalent to the requirements for National Registry paramedic renewal within the past 24 months; and</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete a protocol review session approved by MIEMSS.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Emergency Medical Dispatcher.</text> <paragraph num="(1)"> <text>Provisional EMD License Obtained as a Student. A provisional EMD who obtained provisional EMD licensure as a student shall complete the requirements of COMAR 30.02.03.03G by May 11, 2022, if the provisional EMD license was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMD license was received by January 4, 2022.</text> </paragraph> <paragraph num="(2)"> <text>Provisional EMD License Obtained via Reciprocity. A provisional EMD who obtained provisional licensure via reciprocity shall meet the requirements of Regulation .04D of this chapter by May 11, 2022, if the provisional EMD license was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMD license was received by January 4, 2022.</text> </paragraph> <paragraph num="(3)"> <text>Provisional EMD Licensure Obtained Through Reinstatement. A provisional EMD who held an expired EMD license and was reinstated with a provisional EMD license shall meet the requirements of Regulation .09D of this chapter by May 11, 2022, if the provisional EMD license was received prior to August 15, 2021, or by November 30, 2022, if the provisional EMD license was received by January 4, 2022.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09 amended effective July 1, 2002 (29:12 Md. R. 930)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 30, 2011 (38:11 Md. R. 672); December 12, 2013 (40:24 Md. R. 2017); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 30, 2011 (38:11 Md. R. 672); December 12, 2013 (40:24 Md. R. 2017); May 12, 2014 (41:9 Md. R. 523); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended as an emergency provision effective March 3, 2022 (49:7 Md. R. 462); amended permanently effective July 11, 2022 (49:14 Md. R. 705)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended as an emergency provision effective December 22, 2008 (36:2 Md. R. 98); amended permanently effective March 23, 2009 (36:6 Md. R. 492); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 30, 2011 (38:11 Md. R. 672); December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D, E amended effective May 12, 2014 (41:9 Md. R. 523)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 30, 2011 (38:11 Md. R. 672); December 12, 2013 (40:24 Md. R. 2017); May 9, 2016 (43:9 Md. R. 531); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 30, 2011 (38:11 Md. R. 672); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D amended effective December 19, 2005 (32:25 Md. R. 1944)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06H, J amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed and new Regulation .07 adopted effective October 4, 2010 (37:20 Md. R. 1396)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective December 12, 2013 (40:24 Md. R. 2017); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07F amended effective April 9, 2018 (45:7 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08A, C amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 12, 2013 (40:24 Md. R. 2017); June 9, 2025 (52:11 Md. R. 533)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B amended effective April 9, 2018 (45:7 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09B, D amended effective May 30, 2011 (38:11 Md. R. 672)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 adopted as an emergency provision effective June 1, 2020 (47:13 Md. R. 640); adopted permanently effective October 5, 2020 (47:20 Md. R. 877)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended as an emergency provision effective March 2, 2022 (49:7 Md. R. 462); amended permanently effective July 11, 2022 (49:14 Md. R. 705)</annotation> </annotations> </chapter> <chapter num="03" heading="Scope of Practice and Duties"> <regulation prefix="Regulation" num=".01" heading="Scope of Practice."> <paragraph num="A."> <text>Except as provided in §B of this regulation, an EMS provider shall provide emergency medical services in accordance with the “Maryland Medical Protocols for EMS Providers”.</text> </paragraph> <paragraph num="B."> <text>The following EMS providers shall provide emergency medical services in accordance with the procedures indicated in this section:</text> <paragraph num="(1)"> <text>An EMD shall provide emergency medical dispatch services in accordance with the curriculum and protocols approved by the EMS Board for the EMD program with which the EMD is affiliated;</text> </paragraph> <paragraph num="(2)"> <text>An emergency medical responder not utilizing an AED shall provide emergency medical services in accordance with the emergency medical responder curriculum approved by the EMS Board; and</text> </paragraph> <paragraph num="(3)"> <text>An emergency medical responder utilizing an AED shall provide emergency medical services in accordance with the emergency medical responder curriculum approved by the EMS Board and the portions of the “Maryland Medical Protocols for EMS Providers” concerning use of an AED.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An EMS provider shall provide emergency medical services under the oversight of an EMS operational program except in rare instances when an EMS provider happens upon the scene of a medical emergency.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Limitations upon Delegation."> <paragraph num="A."> <text>This regulation governs the delegation of medical duties by a physician to an EMS provider while providing emergency medical services.</text> </paragraph> <paragraph num="B."> <text>An EMS provider shall accept only that delegation which is in accordance with the regulations of the EMS Board.</text> </paragraph> <paragraph num="C."> <text>Except as provided by standing orders consistent with the “Maryland Medical Protocols for EMS Providers”, an EMS provider may not accept physician delegation of the:</text> <paragraph num="(1)"> <text>Ultimate responsibility for diagnosis or therapy; and</text> </paragraph> <paragraph num="(2)"> <text>Duty of independently administering or dispensing drugs.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> </annotations> </chapter> <chapter num="04" heading="Prohibited Conduct"> <regulation prefix="Regulation" num=".01" heading="Prohibited Conduct."> <text>The following conduct is prohibited:</text> <paragraph num="A."> <text>Fraudulently or deceptively obtaining or attempting to obtain a certificate or license for oneself or for another;</text> </paragraph> <paragraph num="B."> <text>Fraudulently or deceptively using a certificate or license;</text> </paragraph> <paragraph num="C."> <text>Engaging in unprofessional or immoral conduct while providing emergency medical services;</text> </paragraph> <paragraph num="D."> <text>Being adjudicated incompetent;</text> </paragraph> <paragraph num="E."> <text>Abandoning a patient;</text> </paragraph> <paragraph num="F."> <text>Habitual intoxication;</text> </paragraph> <paragraph num="G."> <text>Addiction to or abuse of any narcotic or controlled dangerous substance as defined in Criminal Law Article, Annotated Code of Maryland, or abusing any other drug or substance in a manner that is harmful;</text> </paragraph> <paragraph num="H."> <text>Providing emergency medical services while:</text> <paragraph num="(1)"> <text>Under the influence of alcohol, or</text> </paragraph> <paragraph num="(2)"> <text>Using any narcotic or controlled dangerous substance, as defined in Criminal Law Article, Annotated Code of Maryland, that is in excess of therapeutic amounts or without valid medical indication;</text> </paragraph> </paragraph> <paragraph num="I."> <text>Willfully making or filing a false report or record related to the provision of emergency medical services;</text> </paragraph> <paragraph num="J."> <text>Willfully failing to file or record, willfully impeding or obstructing the filing or recording, or willfully destroying a report required to be filed by statute or regulation;</text> </paragraph> <paragraph num="K."> <text>Knowingly providing emergency medical services with an unauthorized individual, or knowingly aiding an unauthorized individual in providing emergency medical services;</text> </paragraph> <paragraph num="L."> <text>Being disciplined by a licensing or disciplinary authority, or convicted or disciplined by a court of any state or country, or disciplined by any branch of the United States Government for an act that would be grounds for disciplinary action under this regulation;</text> </paragraph> <paragraph num="M."> <text>Failing to meet or violating appropriate protocols or standards of care for the delivery of quality emergency medical services;</text> </paragraph> <paragraph num="N."> <text>Willfully submitting false statements to collect fees;</text> </paragraph> <paragraph num="O."> <text>As a result of an investigation or disciplinary action by a certifying, licensing, or disciplinary authority or by a court of any state or country for an act that would be grounds for disciplinary action under this regulation:</text> <paragraph num="(1)"> <text>Surrendering the certificate or license issued by the state or country, or</text> </paragraph> <paragraph num="(2)"> <text>Allowing the certificate or license issued by the state or country to expire or lapse;</text> </paragraph> </paragraph> <paragraph num="P."> <text>Knowingly failing to report suspected child abuse or neglect in violation of Family Law Article, §5-704, Annotated Code of Maryland, or abuse or neglect of a vulnerable adult under Family Law Article, §14-302, Annotated Code of Maryland;</text> </paragraph> <paragraph num="Q."> <text>Selling, prescribing, giving away, or administering drugs for illegal purposes;</text> </paragraph> <paragraph num="R."> <text>Breaching patient confidentiality in violation of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="S."> <text>Providing emergency medical services beyond the individual's authorized scope of practice;</text> </paragraph> <paragraph num="T."> <text>Being convicted of or pleading guilty or nolo contendere to or receiving probation before judgment with respect to a felony, a serious crime of violence against a person, a crime involving controlled dangerous substances, a serious crime against property, a crime involving sexual misconduct, a crime in which the victim is a patient or other individual entrusted to the care or protection of the applicant or EMS provider, or a crime involving moral turpitude, whether any appeal or other proceeding is pending to have the conviction or plea set aside, except that the individual may apply for reinstatement upon any successful appeal or upon the conviction being set aside;</text> </paragraph> <paragraph num="U."> <text>Providing or attempting to provide any medical procedure without having received the required education, internship, or experience in the use of the procedure, except as authorized in COMAR 30.02.03;</text> </paragraph> <paragraph num="V."> <text>Refusing, withholding from, denying, or discriminating against an individual in need of emergency medical services, with regard to the provision of services which the licensee or certificate holder is licensed or certified and qualified to render because the individual is HIV positive;</text> </paragraph> <paragraph num="W."> <text>Except in a situation when it is not feasible or practicable, failing to comply with the MIEMSS' guidelines on standard precautions;</text> </paragraph> <paragraph num="X."> <text>Intentionally misrepresenting the level of emergency medical services licensure or certification held by the individual;</text> </paragraph> <paragraph num="Y."> <text>Failing to comply with terms of probation, suspension, or a disposition agreement;</text> </paragraph> <paragraph num="Z."> <text>Failing to comply with any regulations in this subtitle; or</text> </paragraph> <paragraph num="AA."> <text>For incidents occurring before January 1, 1999, any act prohibited under the applicable regulations of the Board of Physician Quality Assurance in effect at that time.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Actions Taken as a Result of Prohibited Conduct."> <text>Subject to the hearing provisions of Education Article, §13-516, Annotated Code of Maryland, and this chapter, the EMS Board may take the following actions against an EMS provider or an applicant who has engaged in prohibited conduct:</text> <paragraph num="A."> <text>Reprimand or place an EMS provider on probation;</text> </paragraph> <paragraph num="B."> <text>Suspend or revoke the license or certificate of an EMS provider;</text> </paragraph> <paragraph num="C."> <text>Deny a license or certificate to an applicant; or</text> </paragraph> <paragraph num="D."> <text>Refuse to renew an applicant's license or certificate.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective May 1, 1999 (26:11 Md. R. 852); emergency status extended at 26:22 Md. R. 1689; emergency status expired January 1, 2000; amended permanently effective May 1, 2000 (27:8 Md. R. 806)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 1, 2002 (29:12 Md. R. 930); December 19, 2005 (32:25 Md. R. 1944)</annotation> </annotations> </chapter> <chapter num="05" heading="Disciplinary Procedures"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs procedures for disciplinary, licensing, and certification matters concerning EMS providers, applicants, and individuals providing emergency medical services without a license or certificate.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Case resolution conference” means a committee established in MIEMSS composed of one EMS Board member, an assistant attorney general, and MIEMSS staff which is available to a respondent as a means to explore the possibility of a consent order or other resolution of a matter before the EMS Board on a voluntary, informal, and confidential basis.</text> </paragraph> <paragraph num="(2)"> <text>“Complaint” means a written report prepared for the provider review panel by the incident review committee based on an incident report which sets forth information which the incident review committee considers necessary to a proper review by the provider review panel and final action by the EMS Board.</text> </paragraph> <paragraph num="(3)"> <text>“Disposition agreement” means a formal agreement, which may be nonpublic, in which a respondent agrees to comply with certain conditions and the EMS Board foregoes further investigation or other action.</text> </paragraph> <paragraph num="(4)"> <text>Incident Report.</text> <paragraph num="(a)"> <text>“Incident report” means a written allegation that an individual has committed an act or acts which violate Education Article, §13-516, Annotated Code of Maryland, or the regulations adopted under it.</text> </paragraph> <paragraph num="(b)"> <text>“Incident report” includes:</text> <paragraph num="(i)"> <text>Notification that an applicant for a license or certificate or a renewal is alleged to have committed an act or acts which violate Education Article, §13-516, or the regulations adopted under it;</text> </paragraph> <paragraph num="(ii)"> <text>A law enforcement report;</text> </paragraph> <paragraph num="(iii)"> <text>A report from a hospital or other medical facility;</text> </paragraph> <paragraph num="(iv)"> <text>A report from another country, state, the armed services of the United States, a unit of State government, or a unit of local government;</text> </paragraph> <paragraph num="(v)"> <text>A consumer complaint;</text> </paragraph> <paragraph num="(vi)"> <text>A news article, report, or media tape;</text> </paragraph> <paragraph num="(vii)"> <text>A malpractice claim;</text> </paragraph> <paragraph num="(viii)"> <text>A Maryland Ambulance Information System runsheet; or</text> </paragraph> <paragraph num="(ix)"> <text>Other information, from any source, that warrants investigation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Incident review committee” means a committee established in MIEMSS and composed of the State EMS Medical Director or designee, an assistant attorney general, and MIEMSS staff, including staff investigators, which acts on incident reports.</text> </paragraph> <paragraph num="(6)"> <text>“Noncompliance notice” means a written notice of EMS Board action issued by the EMS Board to a respondent alleged to have committed an act or acts which violate Education Article, §13-516, Annotated Code of Maryland, or the regulations adopted under it, which sets forth:</text> <paragraph num="(a)"> <text>The act or acts alleged;</text> </paragraph> <paragraph num="(b)"> <text>The reason for the action;</text> </paragraph> <paragraph num="(c)"> <text>The statutory or regulatory basis for the action;</text> </paragraph> <paragraph num="(d)"> <text>The right of the respondent to request a hearing within 30 days of receipt of the noncompliance notice;</text> </paragraph> <paragraph num="(e)"> <text>Notice that, if a hearing is not requested or if a hearing is requested and the respondent does not appear, the EMS Board will take the proposed action which is final and binding on the respondent; and</text> </paragraph> <paragraph num="(f)"> <text>Further information as State Government Article, §10-207, Annotated Code of Maryland, may require.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Provider review panel” means the body created by Education Article, §13-516(e), Annotated Code of Maryland, and Regulation .14 of this chapter.</text> </paragraph> <paragraph num="(8)"> <text>“Respondent” means an individual against whom action is contemplated by the EMS Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Investigation of Incident Reports."> <paragraph num="A."> <text>An incident review committee investigator shall initially investigate each incident report. Upon completion of the investigation, as may be required, the incident review committee investigator shall refer the incident report, together with the results of the investigation, to the other members of the incident review committee.</text> </paragraph> <paragraph num="B."> <text>If the incident report warrants summary action in the case of an EMS provider, the investigator shall promptly refer the incident report to the incident review committee for summary action under COMAR 30.02.07 pending further action under this regulation.</text> </paragraph> <paragraph num="C."> <text>If the incident report warrants immediate action in the case of an individual providing emergency medical services without a license or certificate, the investigator shall promptly refer the incident report to the EMS Board which may seek injunctive relief from a court of competent jurisdiction. If the EMS Board elects to issue a cease and desist order, it shall issue a noncompliance notice and proceed under Regulation .05 of this chapter.</text> </paragraph> <paragraph num="D."> <text>The incident review committee shall:</text> <paragraph num="(1)"> <text>Review each incident report referred to it by the investigator together with the investigation results; and</text> </paragraph> <paragraph num="(2)"> <text>Conduct further investigation as may be required.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Upon completion of its review, the incident review committee may:</text> <paragraph num="(1)"> <text>Determine no further action is required;</text> </paragraph> <paragraph num="(2)"> <text>Refer the matter to the appropriate EMS operational program for further investigation or action; or</text> </paragraph> <paragraph num="(3)"> <text>Prepare a complaint which shall be referred:</text> <paragraph num="(a)"> <text>If the respondent is not a licensed or certified EMS provider and is alleged to be providing emergency medical services, directly to the EMS Board,</text> </paragraph> <paragraph num="(b)"> <text>If the respondent is a licensed or certified EMS provider or an applicant, to the provider review panel, or</text> </paragraph> <paragraph num="(c)"> <text>If the respondent is licensed as a registered nurse or licensed practical nurse by the Board of Nursing, to the Board of Nursing.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Complaint Notification.</text> <paragraph num="(1)"> <text>Submission of Complaint to Respondent. If a complaint is referred to the provider review panel, the incident review committee shall advise the respondent of the complaint by letter and afford the respondent the opportunity to provide the provider review panel with a written statement concerning the substance of the complaint. The letter shall be sent by certified and regular mail to the address the EMS provider or applicant maintains for purposes of licensure or certification notice, or any other last known address. If certified mail is twice returned unclaimed, service may be effected by delivery to each of the provider's affiliations of record shown on the records of MIEMSS.</text> </paragraph> <paragraph num="(2)"> <text>Right to Representation. The respondent shall be notified of the respondent's right to be represented by an attorney admitted to practice law in Maryland when the complaint is sent to the respondent.</text> </paragraph> <paragraph num="(3)"> <text>Entry of Appearance. In order to represent a respondent at any stage of a disciplinary matter before the EMS Board, an attorney shall file an entry of appearance in the matter and include the attorney's phone number and address.</text> </paragraph> </paragraph> <paragraph num="G."> <text>MIEMSS may notify appropriate EMS operational programs of incident reports, complaints, noncompliance notices, or hearings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Review by the Provider Review Panel."> <text>Upon review of each complaint referred to it by the incident review committee and any written statement provided by the respondent, the provider review panel shall recommend to the EMS Board any further action it considers necessary based upon the patient care and any allegations of misconduct.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Action by the EMS Board."> <paragraph num="A."> <text>Upon review of the complaint and any recommendations of the provider review panel together with the results of any investigations and any further inquiry the EMS Board may require, the EMS Board may:</text> <paragraph num="(1)"> <text>Dismiss the complaint;</text> </paragraph> <paragraph num="(2)"> <text>Request that the respondent enter into a disposition agreement with the EMS Board; or</text> </paragraph> <paragraph num="(3)"> <text>Issue a noncompliance notice.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the provider review panel does not affirmatively recommend disciplinary action of an EMS provider in cases concerning patient care, the EMS Board shall dismiss the complaint to the extent it relates to patient care.</text> </paragraph> <paragraph num="C."> <text>Noncompliance Notice.</text> <paragraph num="(1)"> <text>The noncompliance notice shall specify which of the following actions the EMS Board proposes to take:</text> <paragraph num="(a)"> <text>Reprimand or probation;</text> </paragraph> <paragraph num="(b)"> <text>Suspension or revocation of a license or certificate;</text> </paragraph> <paragraph num="(c)"> <text>Denial of a license or certificate to an applicant;</text> </paragraph> <paragraph num="(d)"> <text>Refusal to renew an applicant's license or certificate; or</text> </paragraph> <paragraph num="(e)"> <text>Issuance of a cease and desist order.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The noncompliance notice shall specify whether the hearing will be delegated to the Office of Administrative Hearings. If the noncompliance notice does not delegate the hearing to the Office of Administrative Hearings, the hearing shall be conducted by the EMS Board.</text> </paragraph> <paragraph num="(3)"> <text>The EMS Board shall serve the noncompliance notice on the EMS provider or applicant by hand delivery or certified and regular mail at the address the EMS provider or applicant maintains for purposes of licensure or certification notice, or any other last known address. If certified mail is twice returned unclaimed, service on a provider may be effected by delivery to each of the provider's affiliations of record shown on the records of MIEMSS.</text> </paragraph> <paragraph num="(4)"> <text>An individual who is not an EMS provider or applicant shall be served by hand delivery or certified and regular mail at the person's last known address.</text> </paragraph> <paragraph num="(5)"> <text>The individual effecting service shall complete a certificate of service attesting to the method and date of service.</text> </paragraph> <paragraph num="(6)"> <text>Upon the issuance of a noncompliance notice, the EMS Board shall refer the matter to an assistant attorney general assigned to the EMS Board.</text> </paragraph> <paragraph num="(7)"> <text>The EMS Board shall issue a final decision under the noncompliance notice if:</text> <paragraph num="(a)"> <text>A hearing is not requested by the respondent within 30 days of receipt of the noncompliance notice;</text> </paragraph> <paragraph num="(b)"> <text>After due notice, the respondent fails to appear; or</text> </paragraph> <paragraph num="(c)"> <text>A request for a hearing is withdrawn.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>A copy of the final decision shall be served on the respondent by certified and regular mail. If certified mail is twice returned unclaimed, service on a provider may be effected by delivery to each of the provider's affiliations of record shown on the records of MIEMSS.</text> </paragraph> <paragraph num="(9)"> <text>If the respondent makes a timely request for a hearing, the body designated to conduct the hearing shall schedule a hearing and provide notice to all parties under State Government Article, §10-208, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Case Resolution Conference."> <paragraph num="A."> <text>After service of the noncompliance notice and upon receipt of a request for a hearing, the EMS Board shall offer the respondent an opportunity to resolve the matter through a case resolution conference.</text> </paragraph> <paragraph num="B."> <text>If the matter is resolved through a case resolution conference, the EMS Board and the respondent shall enter into a disposition agreement setting forth the terms and conditions of the resolution.</text> </paragraph> <paragraph num="C."> <text>If a resolution is not achieved after opportunity for a case resolution conference, the matter shall proceed to hearing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Hearing."> <paragraph num="A."> <text>Except to the extent provisions of this chapter specifically provide for a different procedure, the hearing shall be conducted under the procedures set forth in COMAR 30.02.06.</text> </paragraph> <paragraph num="B."> <text>At least 6 members of the EMS Board shall be present for EMS Board hearings under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="EMS Board Action."> <paragraph num="A."> <text>The EMS Board shall issue a final decision based on its findings of fact and conclusions of law upon:</text> <paragraph num="(1)"> <text>Receipt of the decision of the administrative law judge and upon the conclusion of the exception process provided in COMAR 30.02.06.22, if any exceptions are filed; or</text> </paragraph> <paragraph num="(2)"> <text>The conclusion of the hearing before the EMS Board, if the matter is heard by the EMS Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the hearing has been delegated to the Office of Administrative Hearings, the EMS Board is the final decision maker and is not bound by the administrative law judge's proposed findings of fact, conclusions of law, or decision.</text> </paragraph> <paragraph num="C."> <text>The EMS Board shall issue any disciplinary action against a respondent who is licensed as a registered nurse or licensed practical nurse by the Board of Nursing in accordance with the recommendation of the Board of Nursing for any complaint which has been referred to the Board of Nursing under Regulation .03 of this chapter.</text> </paragraph> <paragraph num="D."> <text>A copy of the EMS Board's final decision shall be served on the respondent by certified and regular mail. If certified mail is twice returned unclaimed, service on a provider may be effected by delivery to each of the provider's affiliations of record shown on the records of MIEMSS.</text> </paragraph> <paragraph num="E."> <text>Within 30 days of the date of the final decision of the EMS Board, either party may file a motion for reconsideration. The motion is granted at the EMS Board's discretion. There is no automatic right to a hearing on a motion for reconsideration before the EMS Board. The EMS Board may or may not ask for a response from the opposing party. If a party moves for reconsideration, the time for seeking judicial review is calculated from the date the EMS Board rules on the reconsideration motion.</text> </paragraph> <paragraph num="F."> <text>When a final decision states a time for reinstatement of or reapplication for a license or certificate, the respondent shall petition the EMS Board for reinstatement or reapplication under the final decision. The respondent shall complete the appropriate forms, include the appropriate fee, and submit these to the EMS Board with the petition. When a time is not stated in the final decision, a petition for reinstatement or reapplication may not be entertained before 1 year after the date of the final decision. When reinstatement or reapplication is made contingent upon the occurrence of an event, the respondent shall establish the occurrence to the satisfaction of the EMS Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Judicial Review."> <paragraph num="A."> <text>A respondent may seek judicial review of the EMS Board's final decision under State Government Article, §10-222, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The EMS Board shall be party to the proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Subpoenas."> <paragraph num="A."> <text>At any stage of investigation and at any hearing, the EMS Board may issue a subpoena requiring a person to:</text> <paragraph num="(1)"> <text>Testify under oath;</text> </paragraph> <paragraph num="(2)"> <text>Answer interrogatories under oath;</text> </paragraph> <paragraph num="(3)"> <text>Produce documents and tangible things; or</text> </paragraph> <paragraph num="(4)"> <text>Permit inspection and copying of documents.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A subpoena shall:</text> <paragraph num="(1)"> <text>Describe generally the nature of the investigation;</text> </paragraph> <paragraph num="(2)"> <text>Specify the date, time, and place for the taking of required testimony;</text> </paragraph> <paragraph num="(3)"> <text>Contain a copy of any interrogatories requiring answers;</text> </paragraph> <paragraph num="(4)"> <text>Describe with reasonable specificity any things or documents to be produced together with the date, time, and place at which production is required;</text> </paragraph> <paragraph num="(5)"> <text>Advise of the right to representation; and</text> </paragraph> <paragraph num="(6)"> <text>Identify the individual who may be contacted on behalf of the EMS Board in reference to the subpoena.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A subpoena shall be issued over the signature of one of the following officials on behalf of the EMS Board:</text> <paragraph num="(1)"> <text>Chair of the EMS Board;</text> </paragraph> <paragraph num="(2)"> <text>Executive Director of MIEMSS;</text> </paragraph> <paragraph num="(3)"> <text>Chair of the provider review panel; or</text> </paragraph> <paragraph num="(4)"> <text>State EMS Medical Director.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Subpoenas to Corporations and Other Entities. A subpoena directed to a corporation, partnership, or other entity shall:</text> <paragraph num="(1)"> <text>Describe with reasonable particularity the subject matter sought by the subpoena; and</text> </paragraph> <paragraph num="(2)"> <text>Require that the entity designate one or more authorized individuals to provide the testimony, interrogatory answers, things, or documents requested by the subpoena.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Petition to Quash or Modify Subpoena.</text> <paragraph num="(1)"> <text>A person served with a subpoena under this regulation may request that the subpoena be quashed or modified by filing a request in writing with the contact person identified in the subpoena within 10 days of service or before the action required by the subpoena, whichever is earlier. The request shall set forth good cause why the subpoena should be quashed or modified.</text> </paragraph> <paragraph num="(2)"> <text>The EMS Board, upon any further inquiry it may require, shall act promptly on any petition to quash or modify the subpoena.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Enforcement of Subpoena. If a person fails to comply with a subpoena served under this regulation, the EMS Board may apply to a court of competent jurisdiction for punishment of contempt.</text> </paragraph> <paragraph num="G."> <text>Service of Subpoena.</text> <paragraph num="(1)"> <text>A subpoena may be served by hand delivery or certified mail.</text> </paragraph> <paragraph num="(2)"> <text>The individual serving the subpoena shall complete a certificate of service attesting to the method and date of service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Oaths."> <paragraph num="A."> <text>The Chair of the EMS Board, the Executive Director of MIEMSS, the Chair of the provider review panel, and the State EMS Medical Director may administer oaths in connection with any investigation or hearing under this subtitle.</text> </paragraph> <paragraph num="B."> <text>If an individual, without lawful excuse, disobeys an order by the EMS Board to testify or answer a question, the EMS Board may apply to a court of competent jurisdiction for punishment for contempt.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Representation."> <paragraph num="A."> <text>The respondent may appear in proper person or be represented by counsel admitted to practice in Maryland in any matter before the EMS Board and during any stage of the proceedings.</text> </paragraph> <paragraph num="B."> <text>An assistant attorney general shall present:</text> <paragraph num="(1)"> <text>Evidence at evidentiary hearings; and</text> </paragraph> <paragraph num="(2)"> <text>Arguments before the EMS Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Licensure and Certification Pending EMS Board Action."> <paragraph num="A."> <text>Unless the EMS Board agrees to accept the surrender of a license or certificate, a holder of a license or certificate may not surrender the license or certificate.</text> </paragraph> <paragraph num="B."> <text>A license or certificate may not lapse by operation of law while:</text> <paragraph num="(1)"> <text>The holder of the license or certificate is under investigation; or</text> </paragraph> <paragraph num="(2)"> <text>Charges are pending against the holder of the license or certificate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The EMS Board may set conditions on its agreement with the holder of the license or certificate under investigation or against whom charges are pending to accept the surrender of the license or certificate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Provider Review Panel."> <paragraph num="A."> <text>The provider review panel consists of 11 voting members appointed by the EMS Board and 2 nonvoting members.</text> </paragraph> <paragraph num="B."> <text>Appointed Members.</text> <paragraph num="(1)"> <text>Provider Representatives.</text> <paragraph num="(a)"> <text>Eight of the appointed members shall be licensed or certified emergency medical service providers who are actively providing emergency medical services at the time of their appointment.</text> </paragraph> <paragraph num="(b)"> <text>In appointing the provider representatives, the EMS Board shall give consideration to providing for reasonable representation from throughout the State.</text> </paragraph> <paragraph num="(c)"> <text>Three of these members shall be members of a governmental fire, rescue, or emergency medical services company.</text> </paragraph> <paragraph num="(d)"> <text>Three of these members shall be members of a volunteer fire, rescue, or emergency services company.</text> </paragraph> <paragraph num="(e)"> <text>One of these members shall be an employee of a commercial ambulance service.</text> </paragraph> <paragraph num="(f)"> <text>One of these members shall be an emergency medical dispatcher.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>One of the appointed members shall be a physician appointed by the Board of Physicians.</text> </paragraph> <paragraph num="(3)"> <text>One of the appointed members shall be a medical director with emergency medical services experience.</text> </paragraph> <paragraph num="(4)"> <text>One of the appointed members shall be a representative of the Medical and Chirurgical Faculty of the State of Maryland who has emergency medical services experience.</text> </paragraph> <paragraph num="(5)"> <text>The appointed members shall serve terms of 4 years, except that the terms of the first appointed members shall be staggered by the Board as follows:</text> <paragraph num="(a)"> <text>Four members shall serve a 4-year term;</text> </paragraph> <paragraph num="(b)"> <text>Four members shall serve a 3-year term; and</text> </paragraph> <paragraph num="(c)"> <text>Three members shall serve a 2-year term.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The Executive Director of MIEMSS and the State EMS Medical Director shall serve as nonvoting ex officio members.</text> </paragraph> <paragraph num="D."> <text>The provider review panel shall elect a chair from among its members.</text> </paragraph> <paragraph num="E."> <text>Provider Review Panel Action.</text> <paragraph num="(1)"> <text>The provider review panel shall take action by majority vote when at least six voting members are present. Ordinarily at least six members shall be present in person in the same meeting room, provided that in infrequent urgent matters, with the concurrence of a majority of the provider review panel, including the PRP chair if available, the provider review panel may take action when at least six members are present in person or by phone.</text> </paragraph> <paragraph num="(2)"> <text>When reviewing a complaint concerning an EMS provider:</text> <paragraph num="(a)"> <text>At least one voting provider review panel member present shall be an EMS provider of the same level as the respondent; and</text> </paragraph> <paragraph num="(b)"> <text>At least one voting provider review panel member present shall have the same governmental, volunteer, or commercial service affiliation as the respondent.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A tie vote on an issue is considered a recommendation that no action be taken.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The EMS Board may remove any member of the provider review panel for just cause.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Right of Entry."> <text>A duly authorized agent or investigator of the Board may enter, at any reasonable hour, a place of business of a licensed or certified emergency medical services provider or public premises if the entry is necessary to carry out a duty under this regulation or under Education Article, §13-516, Annotated Code of Maryland.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Confidentiality and Admissibility of Proceedings, Records, and Files."> <paragraph num="A."> <text>The incident review committee, the case review committee, the provider review panel, the case resolution conference, and, in connection with a disciplinary matter other than a hearing and the issuance of a final decision, the EMS Board, are medical review committees and committees in MIEMSS under Health Occupations Article, §1-401, Annotated Code of Maryland, and, except for formal noncompliance notices or as otherwise provided by law, their proceedings, records, and files are confidential, nondiscoverable, and nonadmissible as provided in Health Occupations Article, §§1-401 and 14-506, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>To the extent possible, even after a final decision is entered by the EMS Board, the parties shall refrain from revealing legal documents, oral statements, or information that would reveal the identity of any patients referenced in the final decision.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F, G amended effective July 1, 2002 (29:12 Md. R. 930)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective July 1, 2002 (29:12 Md. R. 930)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08D amended effective July 1, 2002 (29:12 Md. R. 930)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14B, E amended effective December 19, 2005 (32:25 Md. R. 1945)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective December 19, 2005 (32:25 Md. R. 1945)</annotation> </annotations> </chapter> <chapter num="06" heading="Hearings"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>This chapter contains procedures for administrative hearings concerning the licensure, certification, or discipline of EMS providers, applicants, and unlicensed or uncertified individuals before the EMS Board.</text> </paragraph> <paragraph num="B."> <text>A hearing concerning summary suspensions shall be in accordance with COMAR 30.02.07.</text> </paragraph> <paragraph num="C."> <text>A hearing before an administrative law judge of the Office of Administrative Hearings shall be conducted in accordance with the rules of procedure of the Office of Administrative Hearings in COMAR 28.02.01, and this chapter. To the extent that this chapter conflicts with COMAR 28.02.01, this chapter prevails.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” has the meaning stated in COMAR 28.02.01.02.</text> </paragraph> <paragraph num="(2)"> <text>“Party” means an individual or agency, including the EMS Board, named in an administrative proceeding before the EMS Board.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Delegation of Hearing Authority."> <paragraph num="A."> <text>The EMS Board may delegate authority to conduct a hearing to the Office of Administrative Hearings in accordance with State Government Article, §10-205(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Scope of Delegation. The EMS Board may delegate authority to the Office of Administrative Hearings to issue proposed findings of fact, proposed conclusions of law, or a proposed disposition.</text> </paragraph> <paragraph num="C."> <text>Authority to Revoke Delegation. The EMS Board may revoke all or part of a delegation of authority to hear a contested case.</text> </paragraph> <paragraph num="D."> <text>Criteria for Revocation. The EMS Board may revoke all or part of a delegation to the Office of Administrative Hearings if the case may:</text> <paragraph num="(1)"> <text>Involve novel or unanticipated factual or legal issues;</text> </paragraph> <paragraph num="(2)"> <text>Have significant social or fiscal consequences;</text> </paragraph> <paragraph num="(3)"> <text>Involve policy issues of general applicability; or</text> </paragraph> <paragraph num="(4)"> <text>Be likely to have precedential value.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Procedures for Revocation.</text> <paragraph num="(1)"> <text>The EMS Board shall provide written notice of a revocation of hearing authority to all parties and the Office of Administrative Hearings. The written notice shall contain a brief statement of the reason for the revocation.</text> </paragraph> <paragraph num="(2)"> <text>Delegation of authority to hear a contested case may be revoked at any time before the earlier occurrence of the following:</text> <paragraph num="(a)"> <text>The issuance of a ruling by the administrative law judge on a substantive issue; or</text> </paragraph> <paragraph num="(b)"> <text>The taking of oral testimony from the first witness.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The EMS Board shall specify whether all or part of the delegation to hear a contested case has been revoked.</text> </paragraph> <paragraph num="(4)"> <text>If only part of the delegation has been revoked, the EMS Board shall specify in the written notice of revocation the portions of the contested case for which delegation is revoked.</text> </paragraph> <paragraph num="(5)"> <text>A decision issued by the EMS Board shall reflect the fact that delegation to the Office of Administrative Hearings was revoked and a copy of the revocation notice shall be included as part of the record.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Procedures upon Revocation. If the EMS Board revokes the delegation to hear a contested case, the hearing shall be conducted by the EMS Board in accordance with this chapter within 90 days of the issuance of the revocation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Request for Hearing."> <paragraph num="A."> <text>A written request for a hearing shall be filed with MIEMSS not later than 30 days from the date of the notice of the action.</text> </paragraph> <paragraph num="B."> <text>A request for a hearing is considered filed on the earlier of the date the request is postmarked or when actually received by MIEMSS.</text> </paragraph> <paragraph num="C."> <text>The request shall include the following:</text> <paragraph num="(1)"> <text>The name, mailing address, and telephone number of the person filing the request and the person's attorney, if any;</text> </paragraph> <paragraph num="(2)"> <text>The action, sanction, decision, or order being contested; and</text> </paragraph> <paragraph num="(3)"> <text>A brief statement of the basis for the request for hearing and other information required by law.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A request for hearing shall be signed by the party or the party's attorney.</text> </paragraph> <paragraph num="E."> <text>If a hearing request is received without the necessary information, or is otherwise improper, MIEMSS may:</text> <paragraph num="(1)"> <text>Return the request;</text> </paragraph> <paragraph num="(2)"> <text>Require submission of supplemental information; or</text> </paragraph> <paragraph num="(3)"> <text>Require an amended request.</text> </paragraph> </paragraph> <paragraph num="F."> <text>In any matter that has been delegated to the Office of Administrative hearings, within 15 days of receiving a request for a hearing, MIEMSS shall forward the request to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="G."> <text>In any matter that has not been delegated to the Office of Administrative Hearings, MIEMSS shall forward the request to the Chair of the EMS Board within 15 days.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Notice of Hearing."> <text>The EMS Board or Office of Administrative Hearings, as appropriate, shall give written notice of the hearing of a contested case to the respondent in accordance with State Government Article, §10-208, Annotated Code.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Service."> <paragraph num="A."> <text>Unless otherwise required by law, service of the following documents shall be made by personal delivery, by certified mail, or by regular mail:</text> <paragraph num="(1)"> <text>Notice of the hearing;</text> </paragraph> <paragraph num="(2)"> <text>Default orders;</text> </paragraph> <paragraph num="(3)"> <text>Prehearing orders;</text> </paragraph> <paragraph num="(4)"> <text>Final decisions;</text> </paragraph> <paragraph num="(5)"> <text>Exceptions to proposed decisions; and</text> </paragraph> <paragraph num="(6)"> <text>Appeals of final decisions.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Service upon a party to whom a certificate or license has been issued by the EMS Board may be made by delivering a copy to the:</text> <paragraph num="(1)"> <text>Most recent address provided by that party to MIEMSS; or</text> </paragraph> <paragraph num="(2)"> <text>Address of the individual's attorney of record.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Service upon or filing with the EMS Board may be made by delivering the document to the Office of the Executive Director at MIEMSS.</text> </paragraph> <paragraph num="D."> <text>Proof of Service. The individual serving a document shall certify:</text> <paragraph num="(1)"> <text>To whom the document was sent or delivered;</text> </paragraph> <paragraph num="(2)"> <text>The address to which the copy was sent or delivered;</text> </paragraph> <paragraph num="(3)"> <text>The date the copy was sent or delivered;</text> </paragraph> <paragraph num="(4)"> <text>The manner of service; and</text> </paragraph> <paragraph num="(5)"> <text>The name of the person who sent or delivered the document.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Absent evidence to the contrary, it is presumed that any document served by mail in accordance with these regulations was received by the addressee 3 days after the date the document was mailed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Representation."> <text>The respondent may appear in proper person or be represented by counsel who is authorized to practice law in Maryland.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Discovery."> <paragraph num="A."> <text>Not later than 20 days before the scheduled hearing, each party shall provide all other parties with a list of all witnesses, including expert witnesses, who are expected to testify for that party at the hearing.</text> </paragraph> <paragraph num="B."> <text>With respect to any matter which is relevant to the subject matter of the hearing and which is not privileged or otherwise nondiscoverable, a party, by written request served upon all other parties and filed with the EMS Board or Office of Administrative Hearings, as appropriate, not later than 30 days before the scheduled hearing, may require any other party to:</text> <paragraph num="(1)"> <text>Produce within 15 days, for inspection or copying, any file, memorandum, correspondence, document, expert report, object, or tangible thing; and</text> </paragraph> <paragraph num="(2)"> <text>Respond to not more than 15 interrogatories, which will be counted separately irrespective of the manner in which they are grouped, combined, or arranged.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Stipulations. The parties by written stipulation may modify the discovery procedures provided by this chapter, except that the parties may not modify any discovery procedure if the effect of the modification would be to impair or delay:</text> <paragraph num="(1)"> <text>A prehearing conference;</text> </paragraph> <paragraph num="(2)"> <text>An order specifying the time for filing a motion or other paper; or</text> </paragraph> <paragraph num="(3)"> <text>The hearing.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Sanctions.</text> <paragraph num="(1)"> <text>The EMS Board or administrative law judge, as appropriate, may impose sanctions against any party for failing to:</text> <paragraph num="(a)"> <text>Provide all other parties with a list of all witnesses, including expert witnesses; and</text> </paragraph> <paragraph num="(b)"> <text>Fully comply with a discovery request.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The sanctions may include, but are not limited to:</text> <paragraph num="(a)"> <text>Refusing to admit the testimony of a witness who was not disclosed as required by this chapter;</text> </paragraph> <paragraph num="(b)"> <text>Refusing to admit a report prepared by an expert;</text> </paragraph> <paragraph num="(c)"> <text>Refusing the failing party the ability to support or oppose designated claims, defenses, or matters by introducing any documentary or testimonial evidence that was not disclosed under a discovery request; and</text> </paragraph> <paragraph num="(d)"> <text>Dismissing the contested case.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Unless otherwise provided by law or by agreement of the parties, no other discovery procedure may be noticed.</text> </paragraph> <paragraph num="F."> <text>Copies of requested documents and records shall be made at the expense of the party making the request.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Prehearing Conference."> <paragraph num="A."> <text>The EMS Board or the administrative law judge, as appropriate, may hold a prehearing conference to resolve matters preliminary to the hearing.</text> </paragraph> <paragraph num="B."> <text>The EMS Board or the administrative law judge, as appropriate, may require the parties to submit information before the prehearing conference.</text> </paragraph> <paragraph num="C."> <text>The EMS Board or the administrative law judge, as appropriate, may order that each party make available to the other parties the names and written reports of experts and other witnesses the party expects to call as well as copies of the documents that will be used for direct examination during the hearing. Failure to comply in good faith with this order is grounds to refuse to admit:</text> <paragraph num="(1)"> <text>A report of that expert; or</text> </paragraph> <paragraph num="(2)"> <text>Any document not furnished to the other parties.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A prehearing conference may be convened to address the following matters:</text> <paragraph num="(1)"> <text>Factual and legal issues;</text> </paragraph> <paragraph num="(2)"> <text>Stipulations and admissions of fact;</text> </paragraph> <paragraph num="(3)"> <text>Stipulations as to the authenticity and admissibility of documents;</text> </paragraph> <paragraph num="(4)"> <text>Requests for official notice;</text> </paragraph> <paragraph num="(5)"> <text>Identification and exchange of documentary evidence;</text> </paragraph> <paragraph num="(6)"> <text>Admissibility of evidence;</text> </paragraph> <paragraph num="(7)"> <text>Identification and qualification of witnesses;</text> </paragraph> <paragraph num="(8)"> <text>Motions;</text> </paragraph> <paragraph num="(9)"> <text>Discovery disputes;</text> </paragraph> <paragraph num="(10)"> <text>Order of presentation;</text> </paragraph> <paragraph num="(11)"> <text>Scheduling;</text> </paragraph> <paragraph num="(12)"> <text>Settlement possibilities or conferences; and</text> </paragraph> <paragraph num="(13)"> <text>Any other matter than will promote the orderly and prompt conduct of the hearing.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Conduct.</text> <paragraph num="(1)"> <text>At the discretion of the EMS Board or the administrative law judge, as appropriate, all or part of the prehearing conference may be recorded.</text> </paragraph> <paragraph num="(2)"> <text>The prehearing conference may be conducted by telephone, video, or other electronic means.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Prehearing Orders.</text> <paragraph num="(1)"> <text>The EMS Board or the administrative law judge, as appropriate, may issue a prehearing order addressing any matter raised at the prehearing conference.</text> </paragraph> <paragraph num="(2)"> <text>The prehearing order is part of the record.</text> </paragraph> <paragraph num="(3)"> <text>Whether or not a prehearing conference is held, the EMS Board or the administrative law judge, as appropriate, may issue a prehearing order to regulate the conduct of the proceedings.</text> </paragraph> </paragraph> <paragraph num="G."> <text>All parties shall be bound by the EMS Board's or administrative law judge's prehearing order regardless of whether a party attends a prehearing conference.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Stipulations and Affidavits."> <paragraph num="A."> <text>Stipulations.</text> <paragraph num="(1)"> <text>The parties, by stipulation, may agree to any substantive or procedural matter.</text> </paragraph> <paragraph num="(2)"> <text>A stipulation may be filed in writing or entered on the record at the hearing.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Affidavits. The EMS Board or the administrative law judge, as appropriate, may admit an affidavit as evidence.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Subpoenas."> <paragraph num="A."> <text>Issuance of Subpoenas. In addition to any authority to issue subpoenas in COMAR 30.02.05.10, upon the request of a party, the EMS Board or Office of Administrative Hearings, as appropriate, may issue subpoenas requiring the attendance and testimony of witnesses and production of documents or tangible items at any hearing.</text> </paragraph> <paragraph num="B."> <text>Request for Subpoenas.</text> <paragraph num="(1)"> <text>A request for issuance of a subpoena shall:</text> <paragraph num="(a)"> <text>Be made in writing to the EMS Board or Office of Administrative Hearings, as appropriate; and</text> </paragraph> <paragraph num="(b)"> <text>State:</text> <paragraph num="(i)"> <text>The name and address of the individual to be subpoenaed,</text> </paragraph> <paragraph num="(ii)"> <text>If production of documents or tangible items is sought, a particular description of the documents or tangible items sought, and</text> </paragraph> <paragraph num="(iii)"> <text>The name, address, and telephone number of the party requesting the subpoena; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Be mailed to each party.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To the extent practicable, a request for subpoena shall be filed at least 30 days before:</text> <paragraph num="(a)"> <text>A prehearing conference, if one has been scheduled; or</text> </paragraph> <paragraph num="(b)"> <text>The hearing, if no prehearing conference has been scheduled.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Service of Subpoenas. A subpoena may be served by personal service, by certified mail, or by mail.</text> </paragraph> <paragraph num="D."> <text>If the subpoena is served by an individual other than the Office of Administrative Hearings, a certificate of service attesting to the method of service and date of service shall be filed with the EMS Board or Office of Administrative Hearings, as appropriate.</text> </paragraph> <paragraph num="E."> <text>Objections to Subpoenas. A party or an individual who has been served a subpoena may object to the subpoena by filing a motion to modify or quash the subpoena within 10 days of service of the subpoena or by the date of the hearing, whichever is earlier.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Motions."> <paragraph num="A."> <text>Process.</text> <paragraph num="(1)"> <text>Unless otherwise provided by this chapter, a party:</text> <paragraph num="(a)"> <text>May move for appropriate relief before or during a hearing; and</text> </paragraph> <paragraph num="(b)"> <text>Shall submit all motions in writing in accordance with §A(2) of this regulation, or orally at a hearing.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A written motion shall:</text> <paragraph num="(a)"> <text>Be filed not later than:</text> <paragraph num="(i)"> <text>10 days before the date of a prehearing conference, or</text> </paragraph> <paragraph num="(ii)"> <text>20 days before the date of the hearing;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>State concisely the question to be determined;</text> </paragraph> <paragraph num="(c)"> <text>Be accompanied by all supporting documentation;</text> </paragraph> <paragraph num="(d)"> <text>Be accompanied by a memorandum of points and authorities; and</text> </paragraph> <paragraph num="(e)"> <text>Be served on each party.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A response to a written motion shall be filed on the earlier of:</text> <paragraph num="(a)"> <text>10 days after service of the motion; or</text> </paragraph> <paragraph num="(b)"> <text>The date of the hearing.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The EMS Board or the administrative law judge, as appropriate, may schedule a hearing to consider a written motion.</text> </paragraph> <paragraph num="(5)"> <text>Decision.</text> <paragraph num="(a)"> <text>The EMS Board or the administrative law judge, as appropriate, may reserve ruling on a motion until after a hearing.</text> </paragraph> <paragraph num="(b)"> <text>The EMS Board may issue a written decision or state the decision on the record.</text> </paragraph> <paragraph num="(c)"> <text>The administrative law judge may issue a ruling on the motion.</text> </paragraph> <paragraph num="(d)"> <text>If a ruling on a motion is reserved, the ruling shall be in writing and may be included in the final decision.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Failure of a party to attend a scheduled hearing may be grounds for a decision adverse to that party.</text> </paragraph> <paragraph num="(7)"> <text>The filing or pendency of a motion does not alter or extend any time limit otherwise established by this chapter.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Motion to Dismiss. Upon motion, the EMS Board or the administrative law judge, as appropriate, may issue a proposed decision or final decision dismissing:</text> <paragraph num="(1)"> <text>An agency action; or</text> </paragraph> <paragraph num="(2)"> <text>A request for hearing which fails to state a claim for which agency relief may be granted.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Motion for Summary Decision.</text> <paragraph num="(1)"> <text>A party may move for summary decision on any substantive issue in the case.</text> </paragraph> <paragraph num="(2)"> <text>Upon written motion, a proposed decision or a final decision may dismiss a request for hearing if the EMS Board or the administrative law judge, as appropriate, finds that:</text> <paragraph num="(a)"> <text>There is no genuine issue as to any material fact; and</text> </paragraph> <paragraph num="(b)"> <text>The moving party is entitled to prevail as a matter of law.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Motion for Postponement.</text> <paragraph num="(1)"> <text>The EMS Board or the administrative law judge, as appropriate, may postpone or continue a hearing:</text> <paragraph num="(a)"> <text>For good cause; or</text> </paragraph> <paragraph num="(b)"> <text>Upon a joint request of the parties.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Absent extenuating circumstances, a hearing may be postponed only upon written request filed not later than 10 days before the hearing and served on all parties.</text> </paragraph> <paragraph num="(3)"> <text>The failure of the respondent to retain counsel or to timely request a subpoena is not considered good cause for the purposes of a postponement.</text> </paragraph> <paragraph num="(4)"> <text>Upon postponement, the hearing shall be rescheduled for a date certain.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Conduct of Hearings."> <paragraph num="A."> <text>On a genuine issue in a contested case, each party is entitled to:</text> <paragraph num="(1)"> <text>Call witnesses;</text> </paragraph> <paragraph num="(2)"> <text>Offer evidence, including rebuttal evidence;</text> </paragraph> <paragraph num="(3)"> <text>Cross-examine opposing witnesses; and</text> </paragraph> <paragraph num="(4)"> <text>Make opening and closing statements.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Telephone Hearings.</text> <paragraph num="(1)"> <text>The EMS Board or the administrative law judge, as appropriate, may conduct all or part of the hearing by telephone, video conferencing, or other electronic means, by consent of all parties.</text> </paragraph> <paragraph num="(2)"> <text>All substantive and procedural rights apply to telephone, video or other electronic hearings, subject only to the limitations of the physical arrangement.</text> </paragraph> <paragraph num="(3)"> <text>Documentary Evidence. For a telephone hearing, a party shall provide documentary evidence to be offered to all parties so that it is received by each party and the EMS Board or the administrative law judge, as appropriate, at least 5 days before the hearing.</text> </paragraph> <paragraph num="(4)"> <text>Default. For a telephone hearing, the following may be considered a failure to appear and grounds for a default:</text> <paragraph num="(a)"> <text>Failure to answer the telephone for 15 minutes;</text> </paragraph> <paragraph num="(b)"> <text>Failure to free the telephone for a hearing; or</text> </paragraph> <paragraph num="(c)"> <text>Any other failure without good cause to be ready to proceed with the hearing as scheduled.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>At least 6 members of the EMS Board shall be present for EMS Board hearings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Evidence."> <paragraph num="A."> <text>Evidence shall be admitted in accordance with this chapter and State Government Article, §10-213, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>Evidence may not be excluded solely on the grounds that it is hearsay.</text> </paragraph> <paragraph num="C."> <text>Exclusion of Witnesses.</text> <paragraph num="(1)"> <text>Upon request by a party, the EMS Board or the administrative law judge, as appropriate, may exclude witnesses other than parties from the hearing room.</text> </paragraph> <paragraph num="(2)"> <text>The EMS Board or the administrative law judge, as appropriate, may order the witnesses, parties, attorneys, and all others present in the hearing room not to disclose to any witness excluded under this section the nature, substance, or purpose of testimony, exhibits, or other evidence introduced during the witness' absence.</text> </paragraph> <paragraph num="(3)"> <text>An expert witness who is to render an opinion based on testimony given at the hearing may remain during the testimony.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Prefiled Testimony.</text> <paragraph num="(1)"> <text>In the discretion of the EMS Board or the administrative law judge, as appropriate, testimony may be received in written form.</text> </paragraph> <paragraph num="(2)"> <text>The testimony shall be filed with the EMS Board or the administrative law judge, as appropriate, and served on opposing parties so that it is received at least 5 days before the hearing.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Expert Testimony."> <text>Expert testimony may be accepted by the EMS Board or the administrative law judge, as appropriate, if the testimony, as proffered, would aid in an understanding of the case.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Appointment of Interpreter."> <paragraph num="A."> <text>If a party or witness cannot readily hear, speak, or understand the spoken or written English language, on motion timely submitted, the EMS Board or the administrative law judge, as appropriate, shall appoint a qualified interpreter to provide assistance during the hearing.</text> </paragraph> <paragraph num="B."> <text>An interpreter shall take an oath or affirmation that the interpreter will accurately translate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Failure to Attend Hearing and Default."> <paragraph num="A."> <text>If, after receiving notice, a party fails to attend a prehearing conference, hearing, or other scheduled proceeding, the EMS Board may issue a final decision or the administrative law judge may issue a proposed decision, as appropriate, against the defaulting party.</text> </paragraph> <paragraph num="B."> <text>Within 7 days after service of a default order, the party may file a written motion:</text> <paragraph num="(1)"> <text>Requesting that the default order be vacated or modified; and</text> </paragraph> <paragraph num="(2)"> <text>Stating the grounds for the request.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the EMS Board or administrative law judge, as appropriate, finds that there is a substantial and sufficient basis for an actual controversy on the merits and that there is good cause to excuse the default, the EMS Board or administrative law judge, as appropriate, may vacate the default order.</text> </paragraph> <paragraph num="D."> <text>A final default order is:</text> <paragraph num="(1)"> <text>A final decision; and</text> </paragraph> <paragraph num="(2)"> <text>Reviewable as a final decision.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Burdens of Going Forward and Persuasion."> <paragraph num="A."> <text>In any proceeding under this chapter, the EMS Board bears the burden of going forward to establish a prima facie case as to the existence of grounds for its action.</text> </paragraph> <paragraph num="B."> <text>In a proceeding following notice by the EMS Board that the EMS Board intends to suspend or revoke a certificate or license, the EMS Board bears the burden or persuasion that the certificate or license should be revoked or suspended.</text> </paragraph> <paragraph num="C."> <text>In a proceeding to issue an order for sanctions, the EMS Board bears the burden of persuasion that the order be issued.</text> </paragraph> <paragraph num="D."> <text>In a proceeding following notice that the EMS Board intends to deny licensure or certification or renewal of a license or certificate, the individual has the burden of persuasion that the license or certificate should be issued or renewed.</text> </paragraph> <paragraph num="E."> <text>The EMS Board or the administrative law judge, as appropriate, shall find against a party with the burden of:</text> <paragraph num="(1)"> <text>Going forward if that party has not presented sufficient evidence to establish a prima facie case for the party's claim or defense; or</text> </paragraph> <paragraph num="(2)"> <text>Persuasion if that party has not presented evidence sufficient to establish the correctness of the party's claim or defense by a preponderance of the evidence.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Record of Hearings."> <paragraph num="A."> <text>The EMS Board or the Office of Administrative Hearings, as appropriate, shall prepare an official record of each hearing.</text> </paragraph> <paragraph num="B."> <text>The record shall consist of:</text> <paragraph num="(1)"> <text>Any document giving rise to the proceeding;</text> </paragraph> <paragraph num="(2)"> <text>Any request for the hearing;</text> </paragraph> <paragraph num="(3)"> <text>Notices of all proceedings;</text> </paragraph> <paragraph num="(4)"> <text>Any prehearing order;</text> </paragraph> <paragraph num="(5)"> <text>Motions, pleadings, briefs, petitions, requests, and intermediate rulings;</text> </paragraph> <paragraph num="(6)"> <text>Evidence received or considered;</text> </paragraph> <paragraph num="(7)"> <text>A statement of each fact officially noticed;</text> </paragraph> <paragraph num="(8)"> <text>Proffers of proof, objections, and rulings on them;</text> </paragraph> <paragraph num="(9)"> <text>Proposed and final findings of fact, conclusions of law, and requested orders;</text> </paragraph> <paragraph num="(10)"> <text>Matters placed on the record after an ex parte communication;</text> </paragraph> <paragraph num="(11)"> <text>A recording of the hearing, any transcript of the recording, or any transcript prepared by a court reporting service; and</text> </paragraph> <paragraph num="(12)"> <text>Any order.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Ex Parte Communications."> <paragraph num="A."> <text>A party or a party's representative may not communicate ex parte with members of the EMS Board or an administrative law judge regarding the merits of any issue in the hearing.</text> </paragraph> <paragraph num="B."> <text>Members of the EMS Board may communicate with:</text> <paragraph num="(1)"> <text>MIEMSS staff or the Office of Administrative Hearings staff who otherwise do not participate in the contested case; or</text> </paragraph> <paragraph num="(2)"> <text>Any counsel for the EMS Board who otherwise does not participate in the contested case.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Actions taken by the EMS Board or an administrative law judge following an ex parte communication shall be governed by State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Transcripts, Costs."> <paragraph num="A."> <text>The hearing shall be recorded by tape recording.</text> </paragraph> <paragraph num="B."> <text>Transcript. If a party requests a transcript of the hearing, the requesting party shall bear the cost of transcription.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Proposed Orders; Exceptions."> <paragraph num="A."> <text>In any matter which has been delegated to the Office of Administrative Hearings, the administrative law judge shall issue proposed findings of fact and conclusions of law and a proposed decision which shall be served upon the parties.</text> </paragraph> <paragraph num="B."> <text>In any matter which has been delegated to the Office of Administrative Hearings, the parties may file exceptions with the EMS Board within 20 days of receiving the proposed decision. A response to the exceptions may be filed within 15 days from the filing of the exceptions. If either party orders a transcript of the hearing before the Office of Administrative Hearings within 10 days of receiving the proposed decision, the time for filing exceptions is automatically extended to 20 days from the date the transcript is received.</text> </paragraph> <paragraph num="C."> <text>The exceptions or response shall:</text> <paragraph num="(1)"> <text>Contain the legal and factual basis for the exceptions or response; and</text> </paragraph> <paragraph num="(2)"> <text>Be accompanied by copies of any portions of the record referred to in the exceptions.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A party who desires a transcript to be made a part of the proceedings shall, at the party's own expense, file a copy of the transcript with the EMS Board.</text> </paragraph> <paragraph num="E."> <text>Upon a showing of good cause, the EMS Board may grant an extension for the filing of exceptions or any response.</text> </paragraph> <paragraph num="F."> <text>The parties may request oral argument on the exceptions.</text> </paragraph> <paragraph num="G."> <text>If oral argument is requested, a hearing shall be set as soon as practicable and all parties shall be notified of the date, time, and place for oral argument.</text> </paragraph> <paragraph num="H."> <text>The presiding officer, ordinarily the Chair or Vice-Chair of the EMS Board, may limit the time given to each party for oral argument.</text> </paragraph> <paragraph num="I."> <text>The presiding officer, ordinarily the Chair or Vice-Chair of the EMS Board, shall determine all procedural issues and may make any rulings necessary to facilitate the effective and efficient consideration of the exceptions.</text> </paragraph> <paragraph num="J."> <text>If oral argument is not requested the EMS Board shall:</text> <paragraph num="(1)"> <text>Consider the matter as soon as practicable; and</text> </paragraph> <paragraph num="(2)"> <text>Notify all parties of the date that the matter will be considered.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The entire record shall be provided to the Chair of the EMS Board before consideration of the exceptions.</text> </paragraph> <paragraph num="L."> <text>Copies of the exceptions, responses, and any accompanying documents shall be provided to the EMS Board at least 5 days before the matter is to be considered.</text> </paragraph> <paragraph num="M."> <text>Additional evidence may not be introduced upon consideration of exceptions unless the party seeking to introduce it:</text> <paragraph num="(1)"> <text>Requests leave to submit the evidence at least 15 days before the EMS Board considers the exceptions; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrates to the satisfaction of the EMS Board that the new evidence:</text> <paragraph num="(a)"> <text>Is relevant and material,</text> </paragraph> <paragraph num="(b)"> <text>Was not discovered before the hearing, and</text> </paragraph> <paragraph num="(c)"> <text>Could not have been discovered before the hearing with the exercise of due diligence.</text> </paragraph> </paragraph> </paragraph> <paragraph num="N."> <text>A majority of the EMS Board shall be present to consider the exceptions.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".23" heading="Final Decision."> <paragraph num="A."> <text>In any matter which has been delegated to the Office of Administrative Hearings after considering the record and any exceptions, the EMS Board by majority vote of those present shall:</text> <paragraph num="(1)"> <text>Adopt the proposed decision as the final decision of the agency;</text> </paragraph> <paragraph num="(2)"> <text>Modify the proposed findings of fact, proposed conclusions of law, or proposed disposition, in whole or in part, and then adopt the modified proposed decision as the final decision of the agency;</text> </paragraph> <paragraph num="(3)"> <text>Reverse the proposed decision and issue its own findings of fact, conclusions of law, or order; or</text> </paragraph> <paragraph num="(4)"> <text>Remand the matter for further proceedings.</text> </paragraph> </paragraph> <paragraph num="B."> <text>In any matter which has not been delegated to the Office of Administrative Hearings as soon as practicable after the conclusion of the hearing, the EMS Board shall issue a written decision.</text> </paragraph> <paragraph num="C."> <text>The decision of the EMS Board is the final decision of the agency for purposes of judicial review. Unless the matter is remanded for further proceedings, or a motion for reconsideration is filed, the date of the written decision of the EMS Board is the date of the final decision of the agency for purposes of judicial review.</text> </paragraph> <paragraph num="D."> <text>A final decision shall:</text> <paragraph num="(1)"> <text>Be in writing;</text> </paragraph> <paragraph num="(2)"> <text>Be served on all parties; and</text> </paragraph> <paragraph num="(3)"> <text>Contain:</text> <paragraph num="(a)"> <text>Findings of fact and conclusions of law, separately stated,</text> </paragraph> <paragraph num="(b)"> <text>An order, and</text> </paragraph> <paragraph num="(c)"> <text>A statement of the available procedures and time limitations for review.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Reconsideration."> <text>In the event of fraud, mistake, or irregularity, a final decision may be reconsidered and corrected at any time.</text> </regulation> <regulation prefix="Regulation" num=".25" heading="Judicial Review."> <text>A party who is aggrieved by a final decision is entitled to judicial review in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland. The EMS Board shall be a party to the proceeding.</text> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516; State Government Article, §10-205; Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .22B amended effective July 1, 2002 (29:12 Md. R. 930)</annotation> </annotations> </chapter> <chapter num="07" heading="Summary Suspension of License or Certification"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs summary procedures for suspending an EMS provider license or certificate to protect the public health, safety, or welfare.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Summary Action."> <paragraph num="A."> <text>State Government Article, §10-226(c), Annotated Code of Maryland, governs summary suspension of a license or certificate.</text> </paragraph> <paragraph num="B."> <text>If the incident review committee finds, based on information gathered during an investigation, that the public health, safety, or welfare imperatively requires emergency action pending further action under COMAR 30.02.05:</text> <paragraph num="(1)"> <text>The incident review committee shall notify the chair of the provider review panel, the State EMS Medical Director, the Executive Director of MIEMSS, and the Chair of the EMS Board, or their designees, of that finding on an expedited basis; and</text> </paragraph> <paragraph num="(2)"> <text>Upon the recommendation of the Chair of the provider review panel or the Chair's designee and the recommendation of the State EMS Medical Director or the Director's designee and upon any further inquiry as they may require, the license or certification of an EMS provider may be summarily suspended pending further action under COMAR 30.02.05.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Procedure for Summary Suspension after Notice and an Opportunity To Be Heard."> <paragraph num="A."> <text>The Executive Director of MIEMSS or the Director's designee and the Chair of the EMS Board or the Chair's designee shall issue a written summary suspension notice to the respondent that:</text> <paragraph num="(1)"> <text>Includes the proposed summary suspension order which shall state the:</text> <paragraph num="(a)"> <text>Statutory and regulatory authority upon which it is based,</text> </paragraph> <paragraph num="(b)"> <text>Facts upon which it is based, and</text> </paragraph> <paragraph num="(c)"> <text>Summary action which is to be taken;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provides the respondent the right to show cause why the proposed summary suspension order should not be issued;</text> </paragraph> <paragraph num="(3)"> <text>Advises the respondent of the right:</text> <paragraph num="(a)"> <text>To a summary suspension hearing within 5 business days of receipt of the summary suspension notice and how to request a hearing,</text> </paragraph> <paragraph num="(b)"> <text>To a full evidentiary hearing to review any summary suspension which is ordered following a summary suspension hearing and how to request a hearing,</text> </paragraph> <paragraph num="(c)"> <text>To review by a circuit court if the respondent has exhausted the administrative remedies provided in this regulation,</text> </paragraph> <paragraph num="(d)"> <text>To representation by counsel,</text> </paragraph> <paragraph num="(e)"> <text>To call witnesses and submit documents under State Government Article, §10-213(f), Annotated Code of Maryland,</text> </paragraph> <paragraph num="(f)"> <text>To subpoena witnesses and other evidence subject to payment of the actual cost of service, and</text> </paragraph> <paragraph num="(g)"> <text>Of the parties to agree on the evidence and waive the right to appear at the hearing;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Advises the respondent that if a summary suspension hearing is not requested or if a hearing is requested and the respondent does not appear, the summary suspension will be entered as provided in the proposed summary suspension order and will be final and binding until further action by the EMS Board under COMAR 30.02.05; and</text> </paragraph> <paragraph num="(5)"> <text>Provides further information as required by State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Service of the summary suspension notice and proposed summary suspension order shall be by personal delivery.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Procedure for Summary Suspension before Notice and an Opportunity To Be Heard."> <paragraph num="A."> <text>The Executive Director of MIEMSS or the Director's designee and the Chair of the EMS Board or the Chair's designee, after consultation with the EMS Board's counsel, may order immediate suspension of a license or certification before notice and the opportunity for a hearing if:</text> <paragraph num="(1)"> <text>They determine that the health, safety, and welfare of the public or the respondent imperatively requires immediate suspension;</text> </paragraph> <paragraph num="(2)"> <text>The respondent is provided the opportunity for a summary suspension hearing within 5 business days of notice of the summary suspension; and</text> </paragraph> <paragraph num="(3)"> <text>Notice of the summary suspension and the summary suspension order is served on the respondent as soon as reasonably practical.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Executive Director of MIEMSS or the Director's designee and the Chair of the EMS Board or the Chair's designee may issue an order that suspends the respondent's license or certification pending further action by the EMS Board under COMAR 30.02.05. The order shall include the:</text> <paragraph num="(1)"> <text>Statutory and regulatory authority upon which it is based;</text> </paragraph> <paragraph num="(2)"> <text>Facts upon which it is based; and</text> </paragraph> <paragraph num="(3)"> <text>Summary action which has been taken.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Executive Director of MIEMSS or the Director's designee and the Chair of the EMS Board or the Chair's designee shall then issue a written summary suspension notice to the respondent that:</text> <paragraph num="(1)"> <text>Includes a copy of the order for summary suspension;</text> </paragraph> <paragraph num="(2)"> <text>Provides the respondent the right to show cause why the summary suspension order should be rescinded;</text> </paragraph> <paragraph num="(3)"> <text>Advises the respondent of the right:</text> <paragraph num="(a)"> <text>To a summary suspension hearing within 5 business days of receipt of the summary suspension notice and how to request a hearing,</text> </paragraph> <paragraph num="(b)"> <text>To a full evidentiary hearing to review any summary suspension which is ordered or reaffirmed following a summary suspension hearing and how to request a hearing,</text> </paragraph> <paragraph num="(c)"> <text>To review by a circuit court if the respondent has exhausted the administrative remedies provided in this regulation,</text> </paragraph> <paragraph num="(d)"> <text>To representation by counsel,</text> </paragraph> <paragraph num="(e)"> <text>To call witnesses and submit documents under State Government Article, §10-213(f), Annotated Code of Maryland,</text> </paragraph> <paragraph num="(f)"> <text>To subpoena witnesses and other evidence subject to payment of the actual cost of service, and</text> </paragraph> <paragraph num="(g)"> <text>Of the parties to agree on the evidence and waive the right to appear at the hearing;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Advises the respondent that if a summary suspension hearing is not requested or if a hearing is requested and the respondent does not appear, the summary suspension order will be final and binding until further action by the EMS Board under COMAR 30.02.05; and</text> </paragraph> <paragraph num="(5)"> <text>Provides further information as required by State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Service of the summary suspension notice and order shall be as soon as reasonably practical by personal delivery.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Representation."> <paragraph num="A."> <text>The respondent may appear in proper person or be represented by counsel admitted to practice in Maryland in any matter before the EMS Board and during any stage of the proceedings.</text> </paragraph> <paragraph num="B."> <text>An assistant attorney general shall present the case.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Summary Suspension Hearing."> <paragraph num="A."> <text>If a respondent requests a summary suspension hearing, the hearing shall be held within 5 business days of the receipt of the summary suspension notice by the respondent unless all parties agree to a later hearing date. The Executive Director of MIEMSS shall give all parties notice of the summary suspension hearing date and other information as required by State Government Article, §10-208, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The summary suspension hearing shall be conducted by:</text> <paragraph num="(1)"> <text>The Executive Director of MIEMSS or in the absence of the Executive Director of MIEMSS, the State EMS Medical Director; or in the absence of both the Executive Medical Director of MIEMSS and the State EMS Medical Director, the administrative officer of MIEMSS; and</text> </paragraph> <paragraph num="(2)"> <text>The Chair of the EMS Board or, in the absence of the Chair of the EMS Board, some other member of the EMS Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Unless otherwise ordered by the individuals conducting the summary suspension hearing, the presentation of each side shall be limited to 30 minutes.</text> </paragraph> <paragraph num="D."> <text>Oral presentation and documents shall be relevant and not unduly repetitious.</text> </paragraph> <paragraph num="E."> <text>The individuals conducting the summary suspension hearing may question the parties and any witnesses.</text> </paragraph> <paragraph num="F."> <text>After the hearing the individuals conducting the summary suspension hearing shall:</text> <paragraph num="(1)"> <text>Order or reaffirm a summary suspension if it is established by a preponderance of the evidence that the health, safety, and welfare of the public imperatively requires that the provider's license or certificate be suspended;</text> </paragraph> <paragraph num="(2)"> <text>Deny or rescind a summary suspension;</text> </paragraph> <paragraph num="(3)"> <text>Enter any order to which the parties may agree; or</text> </paragraph> <paragraph num="(4)"> <text>Enter an interim order as the circumstances may warrant.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Copies of the action taken shall be served on all parties by certified and regular mail at their addresses of record. If certified mail is twice returned unclaimed, service may be effected by delivery to each of the provider's affiliations of record shown on the records of MIEMSS.</text> </paragraph> <paragraph num="H."> <text>All records, files, and other documents exchanged between parties in the course of a summary suspension hearing and preparation for a summary suspension hearing are considered subject to a confidentiality order prohibiting disclosure to anyone except the parties and their counsels of record unless otherwise agreed in writing by the parties.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Evidentiary Hearing."> <paragraph num="A."> <text>A respondent who has requested a summary suspension hearing may, within 10 days of the issuance of a summary suspension order or order reaffirming a summary suspension, request a full evidentiary hearing.</text> </paragraph> <paragraph num="B."> <text>At least 6 members of the EMS Board shall be present for a full evidentiary hearing before the EMS Board.</text> </paragraph> <paragraph num="C."> <text>If a full evidentiary hearing is requested, the EMS Board, if it so elects, may expedite the pending proceeding under COMAR 30.02.05 so that the hearing under COMAR 30.02.05.07 is combined with the full evidentiary hearing on the summary suspension order. The EMS Board may issue a final decision on the merits.</text> </paragraph> <paragraph num="D."> <text>If a full evidentiary hearing is requested by the respondent, the EMS Board shall give all parties notice of the hearing date and other information as required by State Government Article, §10-208, Annotated Code of Maryland. The notice shall also state whether the EMS Board has expedited the COMAR 30.02.05.07 hearing so that the matter is finally resolved with a single EMS Board hearing if the EMS Board has so elected.</text> </paragraph> <paragraph num="E."> <text>The full evidentiary hearing is conducted under COMAR 30.02.06, except that the provisions of this chapter govern if there is any conflict between this chapter and COMAR 30.20.06.</text> </paragraph> <paragraph num="F."> <text>The full evidentiary hearing shall take place within 60 days of the request for a full evidentiary hearing unless the parties agree to a later date.</text> </paragraph> <paragraph num="G."> <text>The EMS Board may delegate the full evidentiary hearing to the Office of Administrative Hearings by written notice to the respondent within 10 days of the respondent's request for an evidentiary hearing.</text> </paragraph> <paragraph num="H."> <text>If the full evidentiary hearing is before the Office of Administrative Hearings, after the hearing, the administrative law judge shall provide the EMS Board with proposed findings of fact and conclusions of law and a proposed disposition.</text> </paragraph> <paragraph num="I."> <text>The EMS Board is the final decision maker and is not bound by the proposed decision of the administrative law judge.</text> </paragraph> <paragraph num="J."> <text>Upon receipt of the decision of the administrative law judge and upon the conclusion of the exception process provided in COMAR 30.02.06.22, if any exceptions are filed, or, if the hearing is before the EMS Board, upon the conclusion of the hearing before the EMS Board, the EMS Board shall issue a final decision based on its findings of fact and conclusions of law which shall be served on the respondent by certified and regular mail.</text> </paragraph> <paragraph num="K."> <text>Within 30 days of the final decision of the EMS Board, either party may file a motion for reconsideration which is granted at the EMS Board's discretion.</text> </paragraph> <paragraph num="L."> <text>There is no automatic right to a reconsideration hearing before the Board.</text> </paragraph> <paragraph num="M."> <text>The EMS Board may or may not ask for a response from the opposing party.</text> </paragraph> <paragraph num="N."> <text>If a party moves for reconsideration, the time for seeking judicial review of the EMS Board's final decision is calculated from the date the EMS Board rules on the reconsideration motion.</text> </paragraph> <paragraph num="O."> <text>The EMS Board shall rule promptly on a motion for reconsideration.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Judicial Review."> <paragraph num="A."> <text>A respondent who has exhausted the administrative remedies under this chapter may seek judicial review of EMS Board action under State Government Article, §10-222, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>The EMS Board shall be a party to the proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Notice."> <paragraph num="A."> <text>Except as otherwise provided in this chapter, notice shall be by certified and regular mail.</text> </paragraph> <paragraph num="B."> <text>Notice to an EMS provider shall be mailed to:</text> <paragraph num="(1)"> <text>The address the EMS provider maintains for purposes of licensure or certification notice; or</text> </paragraph> <paragraph num="(2)"> <text>Any other last known address.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Notice to any other person shall be to the person's last known address.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Confidentiality."> <text>Summary suspension proceedings are subject to the confidentiality provisions of this chapter and COMAR 30.02.05.16.</text> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516, Annotated Code of Maryland;</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 1999 (25:26 Md. R. 1926)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B, F, and G amended effective July 1, 2002 (29:12 Md. R. 931)</annotation> </annotations> </chapter> </subtitle> <subtitle num="03" heading="Ems Operational Programs"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“American Board of Medical Specialties (ABMS)” means the umbrella organization for the 24 approved medical specialty boards in the United States.</text> </paragraph> <paragraph num="(2)"> <text>“Commercial Ambulance Service Advisory Council” means the advisory committee to the EMS Board on commercial ambulance service matters.</text> </paragraph> <paragraph num="(3)"> <text>“Credentialing” means the process by which an EMS operational program medical director and EMS operational program review and evaluate the qualifications and skills of an EMS provider in the course of delegating aspects of the practice of medicine to the EMS provider.</text> </paragraph> <paragraph num="(4)"> <text>“Direct supervision” means oversight exercised by a supervising physician who is close enough to the individual being supervised that the supervising physician can hear, see, and intervene as necessary.</text> </paragraph> <paragraph num="(4-1)"> <text>“EMS provider-in-charge” means the highest medically certified or licensed EMS provider who assesses or provides care to a patient.</text> </paragraph> <paragraph num="(5)"> <text>“House officer” means an individual in a postgraduate medical training program who:</text> <paragraph num="(a)"> <text>Has completed at least the first year of that program;</text> </paragraph> <paragraph num="(b)"> <text>Is authorized to practice medicine without a license under Health Occupations Article, §14-302, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(c)"> <text>Is functioning as a resident in a residency program at a hospital that has a base station.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Jurisdictional Advisory Committee” means the advisory committee to the EMS Board on jurisdictional EMS operational program matters.</text> </paragraph> <paragraph num="(7)"> <text>“Licensed physician” means a physician licensed or otherwise authorized to practice medicine by the State Board of Physicians or its predecessor under Health Occupations Article, Title 14, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Medical direction” has the meaning stated in Education Article, §13-516(a)(12), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(9)"> <text>“MIEMSS Institutional Review Board” means the group of individuals designated by the EMS Board in compliance with 45 CFR 46, to review the use of human subjects in proposed research.</text> </paragraph> <paragraph num="(10)"> <text>“Off-line medical direction” means prospective and retrospective medical oversight of an EMS operational program by a medical director including credentialing, quality assurance, education, and planning.</text> </paragraph> <paragraph num="(11)"> <text>On-Line Medical Direction.</text> <paragraph num="(a)"> <text>“On-line medical direction” means oversight and orders by licensed physicians at base stations to EMS providers or members of the transport team providing patient care at an advanced life support (ALS) or basic life support (BLS) level.</text> </paragraph> <paragraph num="(b)"> <text>“On-line medical direction” includes medical orders and oversight by a licensed practitioner at a specialty care unit at a hospital to a registered nurse during a specialty care transport provided the licensed practitioner is permitted by the facility to provide these services and the services are within the scope of the individual’s license.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Pediatric Emergency Medical Advisory Group” means the advisory committee to the EMS Board on pediatric matters.</text> </paragraph> <paragraph num="(13)"> <text>“Privileges” means the ability of an EMS provider to provide EMS under the delegated authority of an EMS operational program medical director.</text> </paragraph> <paragraph num="(14)"> <text>“Quality assurance (QA)” means an organized method of auditing and evaluating care provided within an EMS system.</text> </paragraph> <paragraph num="(15)"> <text>“Specialty care transport” has the meaning defined in COMAR 30.09.01.02B(40).</text> </paragraph> <paragraph num="(16)"> <text>“System medical director” means any of the following:</text> <paragraph num="(a)"> <text>The Executive Director of MIEMSS;</text> </paragraph> <paragraph num="(b)"> <text>The State EMS Medical Director;</text> </paragraph> <paragraph num="(c)"> <text>The Associate State Medical Director for Pediatrics;</text> </paragraph> <paragraph num="(d)"> <text>The regional medical directors;</text> </paragraph> <paragraph num="(e)"> <text>The associate regional pediatric medical directors;</text> </paragraph> <paragraph num="(f)"> <text>The EMS operational program medical directors; and</text> </paragraph> <paragraph num="(g)"> <text>The assistant EMS operational program medical directors.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 1, 2002 (29:12 Md. R. 931); January 15, 2005 (31:26 Md. R. 1866); December 19, 2005 (32:25 Md. R. 1945); November 1, 2010 (37:21 Md. R. 1437); September 1, 2014 (41:17 Md. R. 971)</annotation> </annotations> </chapter> <chapter num="02" heading="Jurisdictional EMS Operational Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <paragraph num="A."> <text>Jurisdictional EMS operational programs shall be approved by the EMS Board under this chapter.</text> </paragraph> <paragraph num="B."> <text>Commercial services shall be licensed under COMAR 30.09.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Criteria for Approval as a Jurisdictional EMS Operational Program."> <paragraph num="A."> <text>To be eligible for approval an applicant:</text> <paragraph num="(1)"> <text>May not be subject to licensure as a commercial service under Education Article, §13-515, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Shall retain an EMS operational program medical director whose qualifications and duties are consistent with the requirements of COMAR 30.03.03;</text> </paragraph> <paragraph num="(3)"> <text>Shall have a written agreement with the EMS operational program medical director addressing:</text> <paragraph num="(a)"> <text>The medical director's:</text> <paragraph num="(i)"> <text>Duties,</text> </paragraph> <paragraph num="(ii)"> <text>Authority, and</text> </paragraph> <paragraph num="(iii)"> <text>Responsibilities; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The jurisdictional EMS operational program's:</text> <paragraph num="(i)"> <text>Duties,</text> </paragraph> <paragraph num="(ii)"> <text>Authority, and</text> </paragraph> <paragraph num="(iii)"> <text>Responsibilities; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Other terms as the parties may agree upon;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Shall maintain a comprehensive quality assurance program consistent with the requirements of COMAR 30.03.04;</text> </paragraph> <paragraph num="(5)"> <text>Shall meet the requirements of the Maryland Ambulance Information System under Public Safety Article, §8-103(b)(7), Annotated Code of Maryland, and COMAR 30.03.04.04;</text> </paragraph> <paragraph num="(6)"> <text>Shall provide remedial education as necessary for affiliated EMS providers;</text> </paragraph> <paragraph num="(7)"> <text>If also seeking approval as an emergency medical dispatch program shall utilize:</text> <paragraph num="(a)"> <text>EMDs to provide medical:</text> <paragraph num="(i)"> <text>Interrogation,</text> </paragraph> <paragraph num="(ii)"> <text>Prioritization,</text> </paragraph> <paragraph num="(iii)"> <text>Resource allocation,</text> </paragraph> <paragraph num="(iv)"> <text>Resource management, and</text> </paragraph> <paragraph num="(v)"> <text>Prearrival instructions; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An emergency medical dispatch priority reference system approved by MIEMSS;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>If also seeking approval as a specialty care transport program, meet the requirements of COMAR 30.09.14; and</text> </paragraph> <paragraph num="(9)"> <text>Designate an EMS operational program quality assurance officer whose qualifications and duties are consistent with the requirements of COMAR 30.03.04.08.</text> </paragraph> <paragraph num="(10)"> <text>Shall have an Infection Control Program consistent with the requirements of COMAR 30.03.09.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A jurisdictional EMS operational program may not provide interfacility specialty care transport from one hospital to another unless the ambulance used is at least an ALS ambulance, and either:</text> <paragraph num="(1)"> <text>The jurisdictional EMS operational program is approved as a specialty care transport ambulance service; or</text> </paragraph> <paragraph num="(2)"> <text>The following conditions are met:</text> <paragraph num="(a)"> <text>A staffed and equipped specialty care transport ambulance is not available within a clinically reasonable time, as determined by the referring physician;</text> </paragraph> <paragraph num="(b)"> <text>The sending facility provides health care personnel authorized by law to provide the level of care required by the patient during transport, which may include a nurse meeting the requirements of COMAR 10.27.09.04C(2); and</text> </paragraph> <paragraph num="(c)"> <text>Required specialty equipment is available.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The EMS Board shall approve only jurisdictional EMS operational programs that are consistent with the goals and objectives of the EMS plan under Education Article, §13-509, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Approval Process."> <paragraph num="A."> <text>An institution, government agency, corporation, or other entity responsible for EMS oversight may continue to function as a jurisdictional EMS operational program and shall be considered approved as of January 1, 1999, without submitting an application if it:</text> <paragraph num="(1)"> <text>Was recognized by MIEMSS as a jurisdictional EMS operational program for purposes of EMS provider affiliation on December 31, 1998; and</text> </paragraph> <paragraph num="(2)"> <text>Meets the requirements of this chapter for a jurisdictional EMS operational program on the effective date of this regulation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An applicant for approval as a jurisdictional EMS operational program shall apply to MIEMSS.</text> </paragraph> <paragraph num="C."> <text>MIEMSS may make an on-site review of an applicant as necessary to ensure the applicant meets the requirements of this chapter.</text> </paragraph> <paragraph num="D."> <text>The EMS Board may:</text> <paragraph num="(1)"> <text>Approve an application;</text> </paragraph> <paragraph num="(2)"> <text>Provisionally approve an application for up to 18 months under Regulation .04 of this chapter; or</text> </paragraph> <paragraph num="(3)"> <text>Deny an application under Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The EMS Board shall notify the applicant of the action taken on its application.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Provisional Approval."> <paragraph num="A."> <text>An applicant granted provisional approval may file an appeal with the EMS Board under Regulation .08 of this chapter.</text> </paragraph> <paragraph num="B."> <text>The EMS Board may require that a provisional jurisdictional EMS operational program:</text> <paragraph num="(1)"> <text>Have a written work plan to rectify deficiencies; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate progress on the work plan throughout the provisional period.</text> </paragraph> </paragraph> <paragraph num="C."> <text>At the end of the provisional period, the EMS Board may:</text> <paragraph num="(1)"> <text>Grant full approval of the jurisdictional EMS operational program; or</text> </paragraph> <paragraph num="(2)"> <text>Deny approval.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Denial of Application for Approval."> <paragraph num="A."> <text>The EMS Board may deny an application for approval if it finds that the applicant is unable to meet the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>Notice of Denial.</text> <paragraph num="(1)"> <text>The EMS Board shall issue a written notice of denial to an applicant that shall include the reasons for denial.</text> </paragraph> <paragraph num="(2)"> <text>The notice of denial shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant denied approval may file an appeal with the EMS Board under Regulation .08 of this chapter.</text> </paragraph> <paragraph num="D."> <text>If an applicant does not file a timely appeal under Regulation .08 of this chapter, the EMS Board's decision is final.</text> </paragraph> <paragraph num="E."> <text>If an application is denied the EMS Board may request that the applicant reapply under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Verification of Approval."> <text>MIEMSS shall verify that each jurisdictional EMS operational program approved under this chapter is in compliance with this chapter at 5-year intervals from the date of program approval.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Compliance."> <paragraph num="A."> <text>The EMS Board may initiate an investigation of a jurisdictional EMS operational program upon information that the program has failed to comply with this chapter.</text> </paragraph> <paragraph num="B."> <text>The EMS Board shall give written notice of the investigation to the jurisdictional EMS operational program.</text> </paragraph> <paragraph num="C."> <text>The EMS Board may direct MIEMSS to make such on-site review as necessary as a part of its investigation.</text> </paragraph> <paragraph num="D."> <text>If the EMS Board finds that a jurisdictional EMS operational program has materially failed to comply with this chapter, the EMS Board may:</text> <paragraph num="(1)"> <text>Require corrective action;</text> </paragraph> <paragraph num="(2)"> <text>Restrict available EMS Board funding for the jurisdictional EMS operational program; or</text> </paragraph> <paragraph num="(3)"> <text>If the EMS Board finds that the jurisdictional EMS operational program is unable or unwilling to take the required corrective action within a reasonable time set by the EMS Board, take further action as necessary to ensure proper medical direction and oversight of EMS providers, including, but not limited to, revoking approval of the jurisdictional EMS operational program.</text> </paragraph> </paragraph> <paragraph num="E."> <text>At the conclusion of the investigation, the EMS Board shall provide its findings and any proposed action in writing to the jurisdictional EMS operational program.</text> </paragraph> <paragraph num="F."> <text>The report shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland, and contain the reasons for the proposed EMS Board action.</text> </paragraph> <paragraph num="G."> <text>Upon receipt of the report of the EMS Board's findings and proposed action, a jurisdictional EMS operational program may file an appeal with the EMS Board under Regulation .08 of this chapter.</text> </paragraph> <paragraph num="H."> <text>If an applicant does not file a timely appeal under Regulation .08 of this chapter, the EMS Board's decision is final.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Procedures for Appeals."> <paragraph num="A."> <text>An applicant or jurisdictional EMS operational program may appeal a disputed final decision by filing a notice of appeal to the EMS Board with the Executive Director of MIEMSS not later than 20 days from receipt of the EMS Board's decision.</text> </paragraph> <paragraph num="B."> <text>The appeal shall state with specificity the reasons why the EMS Board should reconsider its decision.</text> </paragraph> <paragraph num="C."> <text>An applicant or jurisdictional EMS operational program that files an appeal shall be granted a hearing before the EMS Board or, if the Board so elects and notifies the applicant or jurisdictional EMS operational program, the Office of Administrative Hearings.</text> </paragraph> <paragraph num="D."> <text>An appeal hearing is governed by COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply.</text> </paragraph> <paragraph num="F."> <text>An applicant or jurisdictional EMS operational program which has participated in a hearing under this regulation may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective January 15, 2005 (32:16 Md. R. 1866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective December 19, 2005 (32:25 Md. R. 1945); October 8, 2007 (34:20 Md. R. 1742); January 13, 2011 (38:1 Md. R. 12)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective September 1, 2014 (41:17 Md. R. 971)</annotation> </annotations> </chapter> <chapter num="03" heading="Medical Direction"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the requirements for medical direction of EMS providers.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Maryland Medical Protocols for Emergency Medical Services Providers."> <text>All medical direction shall be in accordance with the “Maryland Medical Protocols for Emergency Medical Services Providers”.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="EMS Operational Program Medical Directors."> <paragraph num="A."> <text>An EMS operational program shall have an EMS operational program medical director appointed by the EMS operational program.</text> </paragraph> <paragraph num="B."> <text>Qualifications of an EMS Operational Program Medical Director. An EMS operational program medical director shall:</text> <paragraph num="(1)"> <text>Be a Maryland-licensed physician or a physician employed in the service of the federal government performing duties incident to that employment;</text> </paragraph> <paragraph num="(2)"> <text>Be familiar with the design and operation of EMS operational programs and systems including medical dispatch and communications;</text> </paragraph> <paragraph num="(3)"> <text>Have experience in and current knowledge of emergency care of patients who are acutely ill or injured; and</text> </paragraph> <paragraph num="(4)"> <text>Possess current knowledge of the Maryland EMS System including:</text> <paragraph num="(a)"> <text>Applicable laws and regulations,</text> </paragraph> <paragraph num="(b)"> <text>The Maryland Medical Protocols for Emergency Medical Services Providers,</text> </paragraph> <paragraph num="(c)"> <text>Applicable EMD protocols,</text> </paragraph> <paragraph num="(d)"> <text>Disaster and mass casualty plans,</text> </paragraph> <paragraph num="(e)"> <text>Organization and structure, and</text> </paragraph> <paragraph num="(f)"> <text>Medical quality assurance process.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Duties of an EMS Operational Program Medical Director.</text> <paragraph num="(1)"> <text>The EMS operational program medical director shall:</text> <paragraph num="(a)"> <text>Be responsible for providing medical oversight of patient care, including emergency medical dispatch, in the EMS operational program;</text> </paragraph> <paragraph num="(b)"> <text>Approve, participate in, and provide medical expertise for the EMS operational program in:</text> <paragraph num="(i)"> <text>A comprehensive quality assurance plan covering all aspects of EMS patient care, including emergency medical dispatch under COMAR 30.03.04,</text> </paragraph> <paragraph num="(ii)"> <text>Standard operating procedures for the EMS operational program under the Maryland Medical Protocols for Emergency Medical Services Providers,</text> </paragraph> <paragraph num="(iii)"> <text>Appropriate EMS provider remedial and continuing educational programs,</text> </paragraph> <paragraph num="(iv)"> <text>Credentialing of EMS providers,</text> </paragraph> <paragraph num="(v)"> <text>Timely review and approval of medical equipment used by the EMS operational program to implement the Maryland Medical Protocols for Emergency Medical Services Providers, and</text> </paragraph> <paragraph num="(vi)"> <text>All aspects of the EMS operational program which impact patient care, including planning, development, and operations;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Provide timely approval of applications to MIEMSS for licensure and certification and renewal of licensure and certification for all EMS providers affiliated with the EMS operational program;</text> </paragraph> <paragraph num="(d)"> <text>Review patient care disciplinary matters under COMAR 30.02.05 concerning EMS providers affiliated with the EMS operational program; and</text> </paragraph> <paragraph num="(e)"> <text>Provide a liaison to the medical community as well as regional and State EMS medical directors.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The EMS operational program medical director may delegate any of the duties listed in §C(1) of this regulation to an assistant medical director.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The EMS operational program shall notify MIEMSS immediately of any proposal to change its medical director.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Regional Medical Directors."> <paragraph num="A."> <text>Appointment of a Regional Medical Director. Each EMS region shall have a regional medical director:</text> <paragraph num="(1)"> <text>Recommended by the EMS regional council; and</text> </paragraph> <paragraph num="(2)"> <text>Appointed by the State EMS Medical Director.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Qualifications of a Regional Medical Director.</text> <paragraph num="(1)"> <text>A regional medical director shall meet the requirements of Regulation .03B of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The requirements of Regulation .03B(4) of this chapter may be satisfied by completing:</text> <paragraph num="(a)"> <text>The Maryland Medical Director Orientation Course; or</text> </paragraph> <paragraph num="(b)"> <text>A MIEMSS-approved equivalent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Duties of the Regional Medical Director. The regional medical director shall:</text> <paragraph num="(1)"> <text>Serve as the principal medical advisor to the:</text> <paragraph num="(a)"> <text>EMS regional council,</text> </paragraph> <paragraph num="(b)"> <text>Hospital base stations within the region,</text> </paragraph> <paragraph num="(c)"> <text>Jurisdictional EMS operational program medical directors, and</text> </paragraph> <paragraph num="(d)"> <text>MIEMSS regional staff;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Assist jurisdictional EMS operational programs with recruitment and orientation of medical directors;</text> </paragraph> <paragraph num="(3)"> <text>Verify the qualifications of jurisdictional EMS operational program medical directors;</text> </paragraph> <paragraph num="(4)"> <text>Make recommendations regarding the designation of hospital base stations;</text> </paragraph> <paragraph num="(5)"> <text>Assist the State EMS Medical Director in planning and coordinating base station activities;</text> </paragraph> <paragraph num="(6)"> <text>Provide medical oversight of base station quality assurance activities in the EMS region;</text> </paragraph> <paragraph num="(7)"> <text>Serve on the Regional Medical Directors Committee; and</text> </paragraph> <paragraph num="(8)"> <text>Participate in a regional interjurisdictional quality assurance program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Associate Regional Pediatric Medical Directors."> <paragraph num="A."> <text>Appointment of Associate Regional Pediatric Medical Directors. Each EMS region shall have an associate regional pediatric medical director:</text> <paragraph num="(1)"> <text>Nominated by the EMS regional council;</text> </paragraph> <paragraph num="(2)"> <text>Approved by the State EMS Medical Director; and</text> </paragraph> <paragraph num="(3)"> <text>Appointed by the Associate State EMS Medical Director for Pediatrics.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Qualifications of an Associate Regional Pediatric Medical Director.</text> <paragraph num="(1)"> <text>An associate regional pediatric medical director shall:</text> <paragraph num="(a)"> <text>Meet the requirements of Regulation .03(B) of this chapter; and</text> </paragraph> <paragraph num="(b)"> <text>Be Board certified or Board prepared in a specialty relating to pediatrics approved by the American Board of Medical Specialties.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The requirements of Regulation .03B(4) of this chapter may be satisfied by completing:</text> <paragraph num="(a)"> <text>The Maryland Medical Director Orientation Course; or</text> </paragraph> <paragraph num="(b)"> <text>A MIEMSS-approved equivalent.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Duties of an Associate Regional Pediatric Medical Director. The associate regional pediatric medical director shall:</text> <paragraph num="(1)"> <text>Serve as principal pediatric medical advisor to the EMS regional council, and regional and jurisdictional medical directors;</text> </paragraph> <paragraph num="(2)"> <text>Participate in the development of the protocols on pediatric content;</text> </paragraph> <paragraph num="(3)"> <text>Serve on the State Pediatric Emergency Medical Advisory Group (PEMAG);</text> </paragraph> <paragraph num="(4)"> <text>Serve as a resource for professional education in pediatrics within the region;</text> </paragraph> <paragraph num="(5)"> <text>Chair the regional pediatric EMS advisory committee and provide a liaison between that committee and the EMS regional council, regional medical director, and PEMAG; and</text> </paragraph> <paragraph num="(6)"> <text>Provide pediatric consultation on regional and State EMS system quality assurance matters to the regional medical director, Associate State EMS Medical Director for Pediatrics and the State EMS Medical Director.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Credentialing of EMS Providers."> <paragraph num="A."> <text>The EMS operational program medical director and EMS operational program shall determine, through clinical evaluation and other means as necessary, the capabilities and skills level of each affiliated EMS provider including the ability of the provider to function independently within that EMS operational program.</text> </paragraph> <paragraph num="B."> <text>The EMS operational program medical director and the EMS operational program are responsible for monitoring all EMS providers through a comprehensive quality assurance program under COMAR 30.03.04.</text> </paragraph> <paragraph num="C."> <text>The medical director of a specialty care transport program may delegate aspects of credentialing to an associate medical director or Maryland licensed critical care transport nurse.</text> </paragraph> <paragraph num="D."> <text>In association with or through the granted authority of an EMS operational program, an EMS operational program medical director may suspend or limit the privileges of an EMS provider within that EMS operational program if, in the opinion of the EMS operational program medical director, the EMS provider poses an imminent threat to the health or well-being of patients.</text> </paragraph> <paragraph num="E."> <text>If the EMS operational program medical director suspends or limits the privileges of an EMS provider under §C of this regulation, the EMS operational program medical director and the EMS operational program shall immediately notify the State EMS Medical Director of:</text> <paragraph num="(1)"> <text>The circumstances and grounds for the action;</text> </paragraph> <paragraph num="(2)"> <text>Specific plans for remedial education; and</text> </paragraph> <paragraph num="(3)"> <text>The process, including reevaluation, by which the EMS provider may be able to regain privileges.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The EMS operational program's policies and procedures, which shall include procedures for due process as the EMS operational program may require, shall govern suspensions and limitations of EMS provider privileges.</text> </paragraph> <paragraph num="G."> <text>This regulation does not otherwise affect the rights of parties under an employer-employee relationship or other contractual relationship including the rights of discipline and termination.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Online Medical Direction."> <paragraph num="A."> <text>An EMS provider shall utilize online medical direction as required in the Maryland Medical Protocols for Emergency Medical Services Providers from:</text> <paragraph num="(1)"> <text>An approved base station; or</text> </paragraph> <paragraph num="(2)"> <text>A system medical director.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An EMS provider may receive online medical direction from a licensed physician present at the scene.</text> </paragraph> <paragraph num="C."> <text>Any such online medical direction, received under §B of this regulation, shall be consistent with the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> <paragraph num="D."> <text>Any online medical direction, received under §B of this regulation, which deviates from the Maryland Medical Protocols for Emergency Medical Services Providers shall be approved through consultation with:</text> <paragraph num="(1)"> <text>An appropriate base station; or</text> </paragraph> <paragraph num="(2)"> <text>A system medical director.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective November 10, 2025 (52:22 Md. R. 1096)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective July 1, 2002 (29:12 Md. R. 931)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective July 1, 2002 (29:12 Md. R. 931)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective January 15, 2005 (31:26 Md. R. 1866)</annotation> </annotations> </chapter> <chapter num="04" heading="Quality Assurance"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the requirements for quality assurance in an EMS operational program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Quality Assurance Plan."> <paragraph num="A."> <text>Every EMS operational program shall have a written quality assurance plan approved by its medical director.</text> </paragraph> <paragraph num="B."> <text>The quality assurance plan shall include provisions for:</text> <paragraph num="(1)"> <text>Reviewing data concerning patient care rendered by EMS providers affiliated with the EMS operational program;</text> </paragraph> <paragraph num="(2)"> <text>Identifying and analyzing trends in EMS care rendered by EMS providers affiliated with the EMS operational program;</text> </paragraph> <paragraph num="(3)"> <text>Annually reporting to MIEMSS on quality assurance issues on a form required by MIEMSS;</text> </paragraph> <paragraph num="(4)"> <text>Providing remedial action to resolve any patient care issues involving EMS providers or the EMS system which should be addressed at the jurisdictional level;</text> </paragraph> <paragraph num="(5)"> <text>Identifying violations of the Maryland Medical Protocols for Emergency Medical Services Providers;</text> </paragraph> <paragraph num="(6)"> <text>Notifying MIEMSS within 30 days of discovery of any incidents, protocol variations, or trends which in the opinion of the medical director:</text> <paragraph num="(a)"> <text>May have resulted in harm to a patient,</text> </paragraph> <paragraph num="(b)"> <text>May require disciplinary action by MIEMSS, or</text> </paragraph> <paragraph num="(c)"> <text>Suggest the need for changes to the Statewide EMS system by MIEMSS; and</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Reviewing oral or written allegations that:</text> <paragraph num="(a)"> <text>An EMS provider failed to act in accordance with applicable law or protocols, or</text> </paragraph> <paragraph num="(b)"> <text>Prehospital patient care was below the applicable standard of care.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Medical Review Committee."> <paragraph num="A."> <text>Every EMS operational program shall have a medical review committee.</text> </paragraph> <paragraph num="B."> <text>The EMS operational program in conjunction with the EMS operational program medical director shall select the medical review committee.</text> </paragraph> <paragraph num="C."> <text>The medical review committee shall be a committee established in MIEMSS subject to the confidentiality and immunity provisions of Health Occupations Article, §1-401, Annotated Code of Maryland, as well as the other provisions of that statute.</text> </paragraph> <paragraph num="D."> <text>Each attendee at any meeting of a medical review committee shall be advised in writing of the confidential nature of committee proceedings.</text> </paragraph> <paragraph num="E."> <text>It shall be the duty of the quality assurance officer to carry out the quality assurance plan with the participation of the EMS operational program medical director and the Medical Review Committee.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Maryland Ambulance Information System."> <paragraph num="A."> <text>Each jurisdictional EMS operational program shall, within 24 hours of a call's dispatch, ensure the completion and submission of an eMEDS® patient care report for each unit:</text> <paragraph num="(1)"> <text>That responds to a call within the State;</text> </paragraph> <paragraph num="(2)"> <text>That responds to a call from within the State;</text> </paragraph> <paragraph num="(3)"> <text>That provides EMS care;</text> </paragraph> <paragraph num="(4)"> <text>That provides EMS transport; or</text> </paragraph> <paragraph num="(5)"> <text>That applies the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The highest medically licensed or certified EMS provider on each unit shall ensure the accurate and timely completion of the eMEDS® patient care report.</text> </paragraph> <paragraph num="C."> <text>The eMEDS® patient care report shall be complete without reference to any other documentation except another eMEDS® patient care report.</text> </paragraph> <paragraph num="D."> <text>EMS Documentation Delivered to the Receiving Facility.</text> <paragraph num="(1)"> <text>If a patient is transported to a health care facility, an eMEDS® patient care report shall, if possible, be completed and submitted before the EMS unit leaves the facility.</text> </paragraph> <paragraph num="(2)"> <text>If an eMEDS® patient care report is not completed and submitted prior to leaving the health care facility, the transporting unit shall:</text> <paragraph num="(a)"> <text>Provide documentation of the patient's prehospital care on the MIEMSS Preliminary EMS Report Short Form for inclusion in the patient care record before leaving the facility; and</text> </paragraph> <paragraph num="(b)"> <text>Complete and submit an eMEDS® patient care report no later than 24 hours after the call’s dispatch.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Changes to a completed and submitted eMEDS® patient care report shall be managed as an amendment to the original record or dataset and will not overwrite the original file.</text> </paragraph> </paragraph> <paragraph num="E."> <text>eMEDS® patient care report data will be made available to a jurisdictional EMS operational program by MIEMSS in accordance with the Maryland Confidentiality of Medical Records Act, Health-General Article, §4-301 et seq., Annotated Code of Maryland, and, if applicable, the federal Health Insurance Portability and Accountability Act of 1996, the federal Health Information Technology for Economic and Clinical Health Act of 2009, and the regulations promulgated under those statutes, for treatment, quality assurance, and billing, if requested by the jurisdictional EMS operational program and pursuant to the terms of a memorandum of understanding with MIEMSS.</text> </paragraph> <paragraph num="F."> <text>Compliance with this regulation shall be required for a jurisdictional EMS operational program to meet the requirements for funding under Public Safety Article, §8-103(b)(7), Annotated Code of Maryland, (Amoss Fund) with respect to the Maryland Ambulance Information System and to be eligible for MIEMSS grants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Direct Treatment Quality Assessment and Quality Improvement."> <paragraph num="A."> <text>For the purpose of quality assessment and quality improvement, an EMS provider licensed or certified by the EMS Board under Education Article §13-516, Annotated Code of Maryland, who has or has had a direct treatment relationship with a patient, may request and receive follow-up data or information on that patient pertinent to the treatment relationship from the facility to which the patient is transported by the EMS provider.</text> </paragraph> <paragraph num="B."> <text>A request for data or information under this regulation is a request for data or information from a person acting under the authority of MIEMSS.</text> </paragraph> <paragraph num="C."> <text>A person receiving data or information under this regulation may not disclose the data or information to any person other than a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Occupational Exposure Reporting."> <text>Each EMS operational program shall deliver monthly to MIEMSS a report of occupational exposures to blood in a form acceptable to MIEMSS.</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Repealed." /> <regulation prefix="Regulation" num=".08" heading="Quality Assurance Officer."> <paragraph num="A."> <text>Each EMS operational program shall designate a Quality Assurance (QA) Officer in concurrence with the EMS operational program medical director.</text> </paragraph> <paragraph num="B."> <text>Qualifications of an EMS Operational Program Quality Assurance Officer. An EMS operational program Quality Assurance Officer shall:</text> <paragraph num="(1)"> <text>Be certified or licensed as an emergency medical technician, CRT, or paramedic in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Either:</text> <paragraph num="(a)"> <text>Successfully complete a QA officer course as defined by MIEMSS within six months of designation; or</text> </paragraph> <paragraph num="(b)"> <text>Have been serving as a Quality Assurance Officer for an EMS operational program for a period of at least 5 years; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Successfully complete a Quality Assurance Officer continuing education course annually.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Duties of an EMS Operational Program QA Officer. The EMS operational program QA officer shall be responsible for:</text> <paragraph num="(1)"> <text>Implementing the EMS operational program quality assurance plan under Regulation .02 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Serving as a member of the EMS operational program Medical Review Committee;</text> </paragraph> <paragraph num="(3)"> <text>Internal audits of medical records and field evaluations to develop strategies for improvement;</text> </paragraph> <paragraph num="(4)"> <text>Remedial action plans for individual medical practice and system variances as directed by the Medical Review Committee;</text> </paragraph> <paragraph num="(5)"> <text>Tracking and investigating customer complaints and sentinel events;</text> </paragraph> <paragraph num="(6)"> <text>Completing reports to MIEMSS as required under COMAR 30.03.04; and</text> </paragraph> <paragraph num="(7)"> <text>Ensuring that issues regarding Advance Life Support providers are delegated to a member of the Medical Review Committee who is an Advance Life Support provider for review if the QA officer is certified as an emergency medical technician.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective July 1, 2002 (29:12 Md. R. 931); December 19, 2005 (32:25 Md. R. 1945)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective October 8, 2007 (34:20 Md. R. 1742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 repealed and new Regulation .04 adopted effective November 1, 2010 (37:21 Md. R. 1437)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective January 6, 2014 (40:26 Md. R. 2166)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 adopted effective December 15, 2003 (30:24 Md. R. 1746)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 adopted effective December 19, 2005 (32:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted effective November 1, 2010 (37:21 Md. R. 1437)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 adopted effective December 19, 2005 (32:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 repealed effective November 1, 2010 (37:21 Md. R. 1437)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective October 8, 2007 (34:20 Md. R. 1742)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, C amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> </annotations> </chapter> <chapter num="05" heading="Protocol Development"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the development of the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Protocol Development."> <paragraph num="A."> <text>The EMS Board shall approve and issue the Maryland Medical Protocols for Emergency Medical Services Providers and any protocol revisions or supplemental protocols.</text> </paragraph> <paragraph num="B."> <text>MIEMSS shall develop the Maryland Medical Protocols for Emergency Medical Services Providers and any protocol revisions or supplemental protocols with the advice of a protocol review committee.</text> </paragraph> <paragraph num="C."> <text>Any individual may recommend a protocol, protocol revision or supplemental protocol to the protocol review committee by forwarding the recommendation to the protocol review committee and the office of the State EMS Medical Director at MIEMSS.</text> </paragraph> <paragraph num="D."> <text>MIEMSS shall appoint the protocol review committee which shall be composed of:</text> <paragraph num="(1)"> <text>One representative from each of the following groups:</text> <paragraph num="(a)"> <text>The EMS Board;</text> </paragraph> <paragraph num="(b)"> <text>The State Board of Physicians;</text> </paragraph> <paragraph num="(c)"> <text>The Statewide Emergency Medical Services Advisory Council;</text> </paragraph> <paragraph num="(d)"> <text>The Pediatric Emergency Medical Advisory Committee;</text> </paragraph> <paragraph num="(e)"> <text>The Jurisdictional Advisory Committee;</text> </paragraph> <paragraph num="(f)"> <text>The Commercial Ambulance Service Advisory Committee;</text> </paragraph> <paragraph num="(g)"> <text>The EMS operational program medical directors;</text> </paragraph> <paragraph num="(h)"> <text>Volunteer EMS BLS Providers;</text> </paragraph> <paragraph num="(i)"> <text>Volunteer EMS ALS Providers;</text> </paragraph> <paragraph num="(j)"> <text>Career EMS BLS Providers;</text> </paragraph> <paragraph num="(k)"> <text>Career EMS ALS Providers;</text> </paragraph> <paragraph num="(l)"> <text>Commercial EMS BLS Providers;</text> </paragraph> <paragraph num="(m)"> <text>Commercial EMS ALS Providers;</text> </paragraph> <paragraph num="(n)"> <text>The Maryland Chapter of ACEP;</text> </paragraph> <paragraph num="(o)"> <text>the State Board of Nursing; and</text> </paragraph> <paragraph num="(p)"> <text>Trauma Net; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The regional medical directors.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The protocol review committee shall review the fiscal impact of any proposed protocol, protocol revision, or supplemental protocol.</text> </paragraph> <paragraph num="F."> <text>All recommendations for protocols, protocol revisions, or supplemental protocols concerning the practice of medicine shall be presented to the Practice of Medicine Committee of the State Board of Physicians.</text> </paragraph> <paragraph num="G."> <text>All recommendations for protocols, protocol revisions, or supplemental protocols concerning the practice of nursing shall be presented to the Board of Nursing.</text> </paragraph> <paragraph num="H."> <text>The Executive Director of MIEMSS shall present all recommendations for protocols, protocol revisions, or supplemental protocols to the EMS Board.</text> </paragraph> <paragraph num="I."> <text>In an emergency situation in which a delay in the issuance of a protocol, protocol revision, or supplemental protocol would pose a threat to the health and welfare of patients, the Executive Director of MIEMSS, with the concurrence of the Chair of the EMS Board, may issue an immediate emergency protocol or revision which shall be effective pending action by the EMS Board at the next meeting of the EMS Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Pilot Supplemental Protocol."> <paragraph num="A."> <text>The EMS Board may grant a pilot supplemental protocol for the benefit of optimal patient care upon:</text> <paragraph num="(1)"> <text>The recommendation of the Executive Director of MIEMSS; and</text> </paragraph> <paragraph num="(2)"> <text>A determination that the pilot supplemental protocol has the potential to become a Statewide protocol or an optional supplemental protocol.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An EMS operational program medical director may request a pilot supplement to the protocols by submitting the request in writing to the State EMS medical director along with:</text> <paragraph num="(1)"> <text>A plan for appropriate:</text> <paragraph num="(a)"> <text>Training,</text> </paragraph> <paragraph num="(b)"> <text>Examination, and</text> </paragraph> <paragraph num="(c)"> <text>Oversight; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A needs assessment which justifies the requested supplement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Research Supplemental Protocol."> <paragraph num="A."> <text>The EMS Board may approve a research supplemental protocol upon the recommendation of the Executive Director of MIEMSS with the approval of the:</text> <paragraph num="(1)"> <text>EMS operational medical director and EMS operational program where the research will be conducted; and</text> </paragraph> <paragraph num="(2)"> <text>MIEMSS Institutional Review Board.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An individual seeking to conduct research that would require a supplement to the protocols shall:</text> <paragraph num="(1)"> <text>Submit the proposed research project and the proposed research protocol, including provisions for the expiration of the research supplemental protocol, to the:</text> <paragraph num="(a)"> <text>State EMS Medical Director,</text> </paragraph> <paragraph num="(b)"> <text>EMS operational program where the research is to be conducted,</text> </paragraph> <paragraph num="(c)"> <text>EMS operational program medical director for the EMS operational program where the research is to be conducted, and</text> </paragraph> <paragraph num="(d)"> <text>MIEMSS Institutional Review Board; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide further information and meet certain requirements as determined by the MIEMSS Institutional Review Board.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The MIEMSS Institutional Review Board shall suspend or terminate approval of a research supplemental protocol that is not:</text> <paragraph num="(1)"> <text>Conducted in accordance with requirements of this regulation; or</text> </paragraph> <paragraph num="(2)"> <text>Determined to be associated with unexpected serious harm to research subjects.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Upon suspension or termination of approval of a research supplemental protocol by the MIEMSS Institutional Review Board, the Executive Director shall immediately suspend or terminate the research supplemental protocol. The suspension shall be effective pending action by the EMS Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Optional Supplemental Protocol."> <paragraph num="A."> <text>The EMS Board may establish minimum training requirements and standards for the implementation of optional supplemental protocols by EMS operational programs.</text> </paragraph> <paragraph num="B."> <text>An EMS operational program may approve an optional supplemental protocol as authorized under the Maryland Medical Protocols for Emergency Medical Services Providers if the EMS operational program meets the minimum training requirements and standards for implementation of the optional supplemental protocol as established by the EMS Board.</text> </paragraph> <paragraph num="C."> <text>The EMS Board shall suspend or terminate an optional supplemental protocol for an EMS operational program if the EMS operational program fails to comply with the minimum training requirements and standards for the implementation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Appeals."> <paragraph num="A."> <text>A person may appeal a disputed final decision of the EMS Board regarding protocols by filing a notice of appeal to the EMS Board with the Executive Director of MIEMSS within 20 days from receipt of the EMS Board's decision or 45 days from the date of the decision, whichever occurs first.</text> </paragraph> <paragraph num="B."> <text>The appeal shall state with specificity the reasons why the EMS Board should reconsider its decision.</text> </paragraph> <paragraph num="C."> <text>A person who files an appeal will be granted a hearing before the EMS Board or, if the Board so elects and notifies the appealing party, the Office of Administrative Hearings.</text> </paragraph> <paragraph num="D."> <text>An appeal hearing is governed by COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 shall also apply.</text> </paragraph> <paragraph num="F."> <text>A person who is party to a hearing under this regulation may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective December 12, 2011 (38:25 Md. R. 1583)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D, F amended effective July 1, 2002 (29:12 Md. R. 931); December 19, 2005 (32:25 Md. R. 1946)</annotation> </annotations> </chapter> <chapter num="06" heading="Base Stations"> <regulation prefix="Regulation" num=".01" heading="Scope and Definitions."> <paragraph num="A."> <text>This chapter governs the approval and operation of EMS base stations as part of the Maryland Emergency Medical Services Plan.</text> </paragraph> <paragraph num="B."> <text>Definitions.</text> <paragraph num="(1)"> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="(2)"> <text>Terms Defined.</text> <paragraph num="(a)"> <text>“Digital Emergency Medical Services Telephone System (DEMSTEL) Telephone” means the telephone system by which hospitals and public safety agencies Statewide can maintain communications in emergency situations when the Public Switched Telephone Network may not be available.</text> </paragraph> <paragraph num="(b)"> <text>“Emergency Medical Resource Center (EMRC) Communications” means the medical channel radio communications system that links EMS providers in the field with hospital-based medical consultation. The EMRC operator receives calls from EMS providers in the field, directs the provider to the appropriate med-channel, and establishes a patch to the appropriate medical facility. Consultation facilities and multiple hospitals can be patched into a single consultation. The EMRC plays a critical role that aids in ensuring a coordinated response to major incidents and catastrophic events. The EMRC can also be accessed by local and 800-service dial telephone.</text> </paragraph> <paragraph num="(c)"> <text>“Hospital Dashboard/Hub” means the application that allows hospital personnel/users to access a Prehospital Care Report (PCR) produced by the EMS personnel.</text> </paragraph> <paragraph num="(d)"> <text>Maryland Emergency Medical Resource Alert Database (MEMRAD).</text> <paragraph num="(i)"> <text>“Maryland Emergency Medical Resource Alert Database (MEMRAD)” means the internet-based program that alerts all components of the Maryland Emergency Medical Services (EMS) System of an emergency medical situation.</text> </paragraph> <paragraph num="(ii)"> <text>“MEMRAD” includes the County Hospital Alert Tracking System (CHATS) which shows health care providers the status of hospitals throughout Maryland and in surrounding jurisdictions.</text> </paragraph> <paragraph num="(iii)"> <text>“MEMRAD” includes the Facility Resource Emergency Database (FRED) which alerts all health care response partners of an incident and allows them to indicate what resources they have to lend to the response.</text> </paragraph> <paragraph num="(iv)"> <text>“MEMRAD” includes the Maryland patient and resource tracking system.</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>“State-Designated Health Information Exchange” means the State-Designated Health Information Exchange described in Health-General Article, §19-143, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Base Stations in General."> <text>An EMS base station designated by MIEMSS shall:</text> <paragraph num="A."> <text>Be a unit of a licensed hospital;</text> </paragraph> <paragraph num="B."> <text>Operate 24 hours a day;</text> </paragraph> <paragraph num="C."> <text>Have communications equipment as required by MIEMSS to provide necessary communications with ambulances and MIEMSS;</text> </paragraph> <paragraph num="D."> <text>In collaboration with MIEMSS, maintain all MIEMSS required communications equipment in working order, including:</text> <paragraph num="(1)"> <text>EMRC Radio with voice recorder; and</text> </paragraph> <paragraph num="(2)"> <text>Demstel Telephone, where deployed;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Monitor and provide timely responses to MEMRAD;</text> </paragraph> <paragraph num="E-1."> <text>Provide admission/discharge/transfer messages to MIEMSS through the State-Designated Health Information Exchange;</text> </paragraph> <paragraph num="F."> <text>Develop and implement a process to ensure utilization of State standardized and approved quality improvement/quality review tools and retain reviewed records for 5 years;</text> </paragraph> <paragraph num="G."> <text>Have a designated EMS space with computer, and internet connectivity suitable for EMS provider eMEDS® reporting;</text> </paragraph> <paragraph num="H."> <text>Participate in and provide clinical sites for training EMS personnel under a current memorandum of understanding with one or more EMS academies, educational institutions, or EMS Operational Programs, and maintain documentation of EMS participation;</text> </paragraph> <paragraph num="I."> <text>Receive from the EMS personnel at time of hand off either the completed eMEDS® report on the Hospital Dashboard or MIEMSS standardized and approved short form;</text> </paragraph> <paragraph num="J."> <text>Include in the patient’s hospital medical record the downloaded eMEDS® patient care report forms from the eMEDS® Hospital Dashboard /Hub and, when used, the MIEMSS standardized and approved short forms; and</text> </paragraph> <paragraph num="K."> <text>Develop and implement a process for linking the MIEMSS-approved Prehospital Consultation/Interventions Radio Report Forms to the radio consult and incorporation into the hospital patient medical record.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Personnel."> <paragraph num="A."> <text>Base Station Medical Director. The Base Station Medical Director shall be a licensed Maryland physician authorized to provide online medical direction who has been appointed by the hospital pursuant to a written job description.</text> </paragraph> <paragraph num="B."> <text>Base Station Coordinator. The Base Station Coordinator shall be a licensed Maryland registered nurse authorized to participate in online medical direction who has been appointed by the hospital pursuant to a written job description.</text> </paragraph> <paragraph num="C."> <text>Physician Authorized to Provide Online Medical Direction. A physician authorized to provide online medical direction shall:</text> <paragraph num="(1)"> <text>Be licensed or otherwise authorized to practice medicine in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Be Board certified or Board eligible in a specialty approved by the American Board of Medical Specialties appropriate for a base station;</text> </paragraph> <paragraph num="(3)"> <text>Have successfully completed a MIEMSS-approved base station course with a minimum score of 80 percent; and</text> </paragraph> <paragraph num="(4)"> <text>Annually complete a Maryland Medical Protocols for Emergency Medical Services Providers update by July 1 of each year.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A licensed registered nurse, a physician assistant or a nurse practitioner authorized to participate in online medical direction at a base station under the direct supervision of a licensed physician shall:</text> <paragraph num="(1)"> <text>Be licensed as a registered nurse, a physician assistant or a nurse practitioner in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Have successfully completed a MIEMSS-approved base station course with a minimum score of 80 percent; and</text> </paragraph> <paragraph num="(3)"> <text>Annually complete a Maryland Medical Protocols for Emergency Medical Services Providers update by July 1 of each year.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A physician resident or fellow authorized to participate in online medical direction at a base station under the direct supervision of a licensed physician authorized to provide medical direction shall:</text> <paragraph num="(1)"> <text>Be a licensed Maryland physician;</text> </paragraph> <paragraph num="(2)"> <text>Have successfully completed a MIEMSS-approved base station course with a minimum score of 80 percent; and</text> </paragraph> <paragraph num="(3)"> <text>Annually complete a Maryland Medical Protocols for Emergency Medical Services Providers update by July 1 of each year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Online Medical Direction."> <paragraph num="A."> <text>Online medical direction as required in the Maryland Medical Protocols for Emergency Medical Services Provider shall be:</text> <paragraph num="(1)"> <text>Given directly by a physician authorized to provide medical direction; or</text> </paragraph> <paragraph num="(2)"> <text>Given directly by a resident or fellow under the direct supervision of a physician authorized to provide medical direction; or</text> </paragraph> <paragraph num="(3)"> <text>Relayed from a physician authorized to provide medical direction through a registered nurse, a physician assistant or a nurse practitioner authorized to participate in medical direction.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Base Station Medical Director and Base Station Coordinator shall participate in and attend a combined minimum of 50 percent of the scheduled MIEMSS Regional Council meetings;</text> </paragraph> <paragraph num="C."> <text>All personnel providing online medical direction and all EMS providers shall ensure that online communications are understood by speaking:</text> <paragraph num="(1)"> <text>Slowly;</text> </paragraph> <paragraph num="(2)"> <text>Clearly; and</text> </paragraph> <paragraph num="(3)"> <text>At a proper volume to be heard.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04-1" heading="Limited-Scope Medical Direction."> <paragraph num="A."> <text>Scope.</text> <paragraph num="(1)"> <text>This regulation applies to an EMS operational program that seeks to facilitate telemedicine appointments between certain low-acuity patients and independent physicians that are not affiliated with a base station or system medical director, nor under the direct supervision of the EMS operational program or its medical director.</text> </paragraph> <paragraph num="(2)"> <text>This regulation does not limit the use or scope of medical direction offered through a base station in accordance with the Maryland Medical Protocols for Emergency Medical Services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Definition. In this regulation, “limited-scope medical direction” means the specific instruction of a licensed physician during a telemedicine encounter regarding the need for transport and the transport destination for a patient 18 years or older and determined to be Priority 3 or Priority 4 under the Maryland Medical Protocols for Emergency Medical Services.</text> </paragraph> <paragraph num="C."> <text>An EMS operational program may submit to MIEMSS a plan for the use of limited-scope medical direction through an entity that is not an approved EMS base station or system medical director. The plan shall:</text> <paragraph num="(1)"> <text>Describe the entity through which the limited-scope medical direction will be provided;</text> </paragraph> <paragraph num="(2)"> <text>Include the minimum standards that the EMS operational program will require of the entity that will supply and direct physicians in providing limited-scope medical direction authorized by this regulation;</text> </paragraph> <paragraph num="(3)"> <text>Contain a quality assurance/quality improvement plan that provides MIEMSS with access to any records produced and maintained by the EMS operational program and to any records and recordings of an encounter with the entity’s physicians who provide limited-scope medical direction;</text> </paragraph> <paragraph num="(4)"> <text>Include the manner by which the EMS operational program or other entity will inform a patient of any financial obligations of the patient associated with a telemedicine appointment provided under this regulation;</text> </paragraph> <paragraph num="(5)"> <text>Provide for a semi-annual report to MIEMSS that includes at a minimum:</text> <paragraph num="(a)"> <text>The number of patients evaluated or treated through telemedicine resulting in limited-scope medical direction;</text> </paragraph> <paragraph num="(b)"> <text>A record of the patients’ presenting chief complaints and any interventions provided; and</text> </paragraph> <paragraph num="(c)"> <text>A record of referrals for follow-up medical care;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Provide a system for recording communications between an entity’s physician providing limited-scope medical direction and EMS personnel as well as a system for storing any such recordings for a minimum of 90 days; and</text> </paragraph> <paragraph num="(7)"> <text>Be consistent with the Emergency Medical System Plan approved by the EMS Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>To provide limited-scope medical direction through an EMS operational program’s plan, an individual shall at a minimum:</text> <paragraph num="(1)"> <text>Be licensed to practice medicine in the State of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Hold active board certification in:</text> <paragraph num="(a)"> <text>Emergency medicine;</text> </paragraph> <paragraph num="(b)"> <text>Emergency medical services;</text> </paragraph> <paragraph num="(c)"> <text>Family medicine; or</text> </paragraph> <paragraph num="(d)"> <text>Internal medicine;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Be knowledgeable of EMS and the local treatment options for low-acuity patients;</text> </paragraph> <paragraph num="(4)"> <text>Certify to the EMSOP that the individual has not been subject to disciplinary action by any professional licensing body within the 5 years prior to providing limited-scope medical direction; and</text> </paragraph> <paragraph num="(5)"> <text>Meet the requirements of Regulation .03C of this chapter.</text> </paragraph> </paragraph> <paragraph num="E."> <text>MIEMSS may approve, modify, or deny a proposed plan of an EMS operational program to provide limited-scope medical direction.</text> </paragraph> <paragraph num="F."> <text>Subject to a MIEMSS-approved plan for use of limited-scope medical direction, an EMS operational program may allow an entity whose physicians meet the requirements of Regulation .03C of this chapter and §D of this regulation to provide limited-scope medical direction to EMS personnel affiliated with the EMS operational program.</text> </paragraph> <paragraph num="G."> <text>No later than June 30 of each year, each EMS operational program seeking to use or continue to use limited-scope medical direction shall submit to MIEMSS a list that identifies each physician by full name and Maryland license number who will provide limited-scope medical direction to the EMS personnel affiliated with the EMS operational program.</text> </paragraph> <paragraph num="H."> <text>An individual or entity may not provide or offer to provide limited-scope medical direction unless that individual or entity is doing so pursuant to an EMS operational program’s MIEMSS-approved plan.</text> </paragraph> <paragraph num="I."> <text>EMS Clinicians.</text> <paragraph num="(1)"> <text>An EMS clinician may not receive or attempt to receive limited-scope medical direction unless the EMS clinician is doing so pursuant to an EMS operational program’s MIEMSS-approved plan.</text> </paragraph> <paragraph num="(2)"> <text>This regulation does not affect an EMS clinician from receiving or attempting to receive medical direction that includes transport instructions from any base station in accordance with the Maryland Medical Protocols for Emergency Medical Services.</text> </paragraph> </paragraph> <paragraph num="J."> <text>MIEMSS may revoke the previously approved plan of an EMS operational program for the use of limited-scope medical direction if MIEMSS determines that the EMS operational program has violated the terms of its previously approved plan or any requirements of this regulation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quality Improvement."> <paragraph num="A."> <text>The hospital of which the base station is a unit, or the free standing emergency center if the base station is within a free standing emergency center, shall:</text> <paragraph num="(1)"> <text>Monitor and participate in MEMRAD;</text> </paragraph> <paragraph num="(2)"> <text>Monitor their utilization of CHATS alerts; and</text> </paragraph> <paragraph num="(3)"> <text>Participate in mitigation strategies to improve systems efficiencies and patient safety.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The base station director and base station coordinator shall:</text> <paragraph num="(1)"> <text>Assure that online medical direction and consultation provided by the base station is:</text> <paragraph num="(a)"> <text>Timely;</text> </paragraph> <paragraph num="(b)"> <text>Appropriate; and</text> </paragraph> <paragraph num="(c)"> <text>Otherwise consistent with Maryland Medical Protocols for Emergency Medical Services Providers;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Assure the MIEMSS approved Prehospital Consultation/Interventions Radio Report Forms are complete, signed and linked to the patient record through a patient identifier;</text> </paragraph> <paragraph num="(3)"> <text>Develop and implement a process which facilitates monthly quality assurance/quality improvement review of EMS consults which:</text> <paragraph num="(a)"> <text>Reviews all priority one/critical patient consults and select lower priority consults for a minimum of 30 consults per month;</text> </paragraph> <paragraph num="(b)"> <text>Allows for ongoing documentation of tracking, trending, loop closure and retention of Quality Assurance/Quality Improvement review findings for 5 years;</text> </paragraph> <paragraph num="(c)"> <text>Notifies EMS operational programs upon discovery of patient care, quality or protocol variance issues involving EMS providers or the EMS system;</text> </paragraph> <paragraph num="(d)"> <text>Notifies EMS operational programs and MIEMSS Office of the State Medical Director upon discovery of conduct that is specifically prohibited under the requirements of COMAR 30.02.04.01;</text> </paragraph> <paragraph num="(e)"> <text>Monitors hospital’s response rates to MEMRAD notifications and alerts;</text> </paragraph> <paragraph num="(f)"> <text>Participates in local, regional, and State EMS quality improvement activities;</text> </paragraph> <paragraph num="(g)"> <text>Provides patient follow-up data as required by MIEMSS for public health oversight purposes to determine the appropriateness and outcome of EMS care for:</text> <paragraph num="(i)"> <text>Inpatients; and</text> </paragraph> <paragraph num="(ii)"> <text>Outpatients; and</text> </paragraph> <paragraph num="(iii)"> <text>Reports as required by MIEMSS for quality assurance and performance improvement purposes.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The State EMS Medical Director through the MIEMSS regional medical directors shall:</text> <paragraph num="(1)"> <text>Coordinate online medical direction functions; and</text> </paragraph> <paragraph num="(2)"> <text>Regularly review the quality improvement activities of approved base stations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Base Station Approval and Renewal."> <paragraph num="A."> <text>An applicant for designation or redesignation as a base station shall apply by filing an approved application with MIEMSS.</text> </paragraph> <paragraph num="B."> <text>Upon receipt of a completed application, MIEMSS shall:</text> <paragraph num="(1)"> <text>Visit the applicant;</text> </paragraph> <paragraph num="(2)"> <text>Interview the physician designated as base station director;</text> </paragraph> <paragraph num="(3)"> <text>Interview the licensed registered nurse designated as the base station coordinator;</text> </paragraph> <paragraph num="(4)"> <text>Consult the EMS regional councils most likely to use the applicant for online medical direction to verify the applicant satisfies the requirements of Regulations .02 and .04 of this chapter; and:</text> </paragraph> <paragraph num="(5)"> <text>Consult the EMS medical directors of EMS operational jurisdictions most likely to use the applicant for online medical direction to verify the applicant satisfies the requirements of Regulations .02 and .04 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>MIEMSS shall decide whether to make a designation based on the:</text> <paragraph num="(1)"> <text>Results of the visit, interviews, and consultations conducted by MIEMSS; and</text> </paragraph> <paragraph num="(2)"> <text>Information in the application.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Provisional or Full Designation.</text> <paragraph num="(1)"> <text>MIEMSS may designate or redesignate a base station which does not fully comply with the requirements of this chapter as provisional on such conditions and for such provisional period, including any extensions thereof, which MIEMSS deems appropriate;</text> </paragraph> <paragraph num="(2)"> <text>MIEMSS shall require each provisional base station to:</text> <paragraph num="(a)"> <text>Have a written work plan to rectify deficiencies; and</text> </paragraph> <paragraph num="(b)"> <text>Demonstrate progress on the work plan throughout the provisional period.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At the end of the provisional period, including any extension thereof, MIEMSS may:</text> <paragraph num="(a)"> <text>Grant full designation to the base station; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the base station’s designation under §E of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>MIEMSS may grant full designation to a base station in full compliance with this chapter for a period not to exceed 5 years.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Denial or Rescission. MIEMSS may deny initial designation, renewal, or redesignation, or rescind designation, for a base station that fails to:</text> <paragraph num="(1)"> <text>Satisfy the requirements of this chapter; or</text> </paragraph> <paragraph num="(2)"> <text>Provide appropriate medical direction consistent with the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The applicant shall be notified by mail of MIEMSS' decision. If the decision is other than a 5-year approval or 5-year renewal, the notice shall:</text> <paragraph num="(1)"> <text>State the reasons for the decision;</text> </paragraph> <paragraph num="(2)"> <text>Advise the applicant of appeal rights;</text> </paragraph> <paragraph num="(3)"> <text>Require the Hospital to submit within 45 days a corrective action plan to MIEMSS for approval; and</text> </paragraph> <paragraph num="(4)"> <text>Otherwise comply with State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Applications for renewal or approval shall be filed with MIEMSS at least 90 days before expiration of the approved period.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Appeal Process."> <paragraph num="A."> <text>A base station may appeal a designation decision by MIEMSS to the EMS Board by filing a notice of appeal with the Executive Director of MIEMSS within 15 days after receipt of the decision.</text> </paragraph> <paragraph num="B."> <text>A base station that files an appeal will be granted a hearing before the EMS Board or, if the Board so elects and notifies the applicant, the Office of Administrative Hearings.</text> </paragraph> <paragraph num="C."> <text>An appeal hearing is governed by COMAR 28.02.01.</text> </paragraph> <paragraph num="D."> <text>If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply.</text> </paragraph> <paragraph num="E."> <text>A base station may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Specialty Base Stations and Consultation Centers."> <paragraph num="A."> <text>MIEMSS may designate base stations as specialty base stations consistent with the particular base station's affiliation with a Maryland designated trauma or specialty center.</text> </paragraph> <paragraph num="B."> <text>MIEMSS may designate base stations as specialty consultation centers for pediatrics, hazardous materials, and other specialties as necessary.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Out-of-State Trauma and Specialty Consultation Centers."> <paragraph num="A."> <text>Out-of-State trauma and specialty hospitals which have entered agreements with MIEMSS under COMAR 30.08.01.03 shall have the equipment necessary to conduct a dual consult between EMS and a Maryland base station for each Maryland patient transported to the out-of-State trauma or specialty center.</text> </paragraph> <paragraph num="B."> <text>Physicians not authorized to practice in Maryland must have a dual consult with a Maryland base station in order to have a Maryland licensed physician give the orders to Maryland EMS providers.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: December 15, 1999 (26:24 Md. R. 1859)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective July 1, 2002 (29:12 Md. R. 931)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A amended effective December 19, 2005 (32:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective July 1, 2002 (29:12 Md. R. 931)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective December 19, 2005 (32:25 Md. R. 1946)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 1, 2002 (29:12 Md. R. 931)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective July 1, 2002 (29:12 Md. R. 931)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective October 10, 2016 (43:20 Md. R. 1110)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective March 8, 2021 (48:5 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective March 8, 2021 (48:5 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E-1 adopted effective March 8, 2021 (48:5 Md. R. 218)</annotation> <annotation type="History" subtype="Administrative History">Regulation 04-1 adopted effective February 5, 2024 (51:2 Md. R. 77)</annotation> </annotations> </chapter> <chapter num="07" heading="" reason="Vacant" /> <chapter num="08" heading="Ambulance Restocking Plan"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>This chapter is intended to make available to hospitals and other receiving facilities that replenish drugs and medical supplies used by ambulance providers or first responders, when transporting patients to the hospitals or receiving facilities, an EMS agency plan that fulfills the requirements of 42 CFR §1001.952(v)(3)(i)(B)(1)(ii) of the safe harbor regulations promulgated by the United States Department of Health and Human Services to protect such an arrangement from the anti-kickback provisions of the Social Security Act, 42 U.S.C. §1320a-7b(b)(1)(A).</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Scope."> <text>This chapter does not apply to the restocking of ambulances that only provide nonemergency services or to the general stocking of an ambulance provider's inventory.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Ambulance provider” means the person who owns or operates an ambulance.</text> </paragraph> <paragraph num="(2)"> <text>“Ambulance transport” means a transport by ambulance, together with attendant medical services, medical supplies, drugs, and linens provided by the ambulance provider.</text> </paragraph> <paragraph num="(3)"> <text>“Emergency ambulance” means an ambulance used to provide emergency ambulance transport an average of three times per week, as measured over a reasonable period of time.</text> </paragraph> <paragraph num="(4)"> <text>“Emergency ambulance transport” means an ambulance transport initiated by an emergency call or a call from another acute care facility unable to provide the higher level care required by the patient and available at the receiving facility.</text> </paragraph> <paragraph num="(5)"> <text>“Emergency call” means a call placed through 9-1-1 or some other emergency access number.</text> </paragraph> <paragraph num="(6)"> <text>“EMS provider” means an individual licensed or certified by the Maryland State EMS Board under Education Article, §13-516, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>“Receiving facility” means a hospital or other facility that provides emergency medical services.</text> </paragraph> <paragraph num="(8)"> <text>“Restock” means the replenishment of drugs, medical supplies, and linens used for a patient prior to delivery of the patient to the hospital and other receiving facility on a one to one basis without charge to an ambulance provider.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Duties of Hospital and Receiving Facility."> <text>A hospital and other receiving facility that elects to restock ambulances under this chapter shall restock emergency ambulances owned or operated by not-for-profit and State or local government ambulance providers, including, but not limited to, municipal and volunteer ambulance providers, that bring a patient to the hospital and other receiving facility, if one and only one of the following billing conditions applies:</text> <paragraph num="A."> <text>The ambulance provider does not bill any insurer or patient for the items restocked; or</text> </paragraph> <paragraph num="B."> <text>The hospital and other receiving facility do not bill any insurer or patient for the items restocked.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Drugs, Medical Supplies, and Linens—User."> <text>Drugs, medical supplies, and linens initially used by an EMS provider that responds to an emergency call and treats the patient, but does not transport the patient to the hospital and other receiving facility, which are replenished at the scene of the illness or injury by an ambulance provider that transports the patient to the hospital and other receiving facility shall be deemed to have been used by the ambulance provider.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Restocking."> <text>Restocking shall include the following drugs, medical supplies, and linens used in the course of an ambulance transport restocked under this chapter:</text> <paragraph num="A."> <text>Drugs listed in the ALS and BLS pharmacology sections of the Maryland Medical Protocols for Emergency Medical Services Providers incorporated by reference under COMAR 30.01.02.01;</text> </paragraph> <paragraph num="B."> <text>Consumable medical supplies ordinarily carried on an ALS or BLS ambulance in accordance with the Maryland Medical Protocols for Emergency Medical Services Providers incorporated by reference under COMAR 30.01.02.01; and</text> </paragraph> <paragraph num="C."> <text>Linens, including sheets, pillow cases, and blankets.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Documentation of Restocking."> <text>Restocked drugs, medical supplies, and linens shall be documented by recordation on the narrative portion of the Maryland Ambulance Information Runsheet which shall be maintained by the ambulance provider for at least 5 years. A copy of the runsheet shall be supplied to the hospital or other receiving facility as part of the patient's medical record.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Compliance with Federal Requirements."> <text>All participants under this chapter that bill federal health care programs for restocked medical supplies, drugs, or linens shall comply with all applicable federal program billing and claims filing rules and regulations.</text> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-510, 13-515, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 31, 2003 (30:6 Md. R. 423)</annotation> </annotations> </chapter> <chapter num="09" heading="Infection Control Program"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the requirements for an infection control program in an EMS operational program.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Infection Control Officer."> <paragraph num="A."> <text>Each EMS operational program shall designate an Infection Control Officer.</text> </paragraph> <paragraph num="B."> <text>Duties of an EMS Operational Program Infection Control Officer. The EMS operational program Infection control officer shall be responsible for:</text> <paragraph num="(1)"> <text>Implementing the EMS operational program infection control plan under Regulation .03 of this Chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Reporting occupational exposures to MIEMSS under COMAR 30.03.04.06.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Plan."> <paragraph num="A."> <text>Every EMS operational program shall have a written infection control plan.</text> </paragraph> <paragraph num="B."> <text>The infection control plan shall include provisions for:</text> <paragraph num="(1)"> <text>Ensuring compliance with:</text> <paragraph num="(a)"> <text>29 CFR §1910.1030;</text> </paragraph> <paragraph num="(b)"> <text>29 CFR §1910.1200;</text> </paragraph> <paragraph num="(c)"> <text>Labor and Employment Article, §5-702, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(d)"> <text>COMAR 30.03.04.06; and</text> </paragraph> <paragraph num="(e)"> <text>All other State and federal regulations as they pertain to infection control;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Post-exposure notice, testing, and treatment consistent with Health General Article, §18-338.3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>Ensuring that all EMS providers affiliated with the EMS operational program have notice of the plan and its contents; and</text> </paragraph> <paragraph num="(4)"> <text>Training of all EMS providers affiliated with the EMS operational program in blood-borne pathogens, universal precautions, and infection control before assigning duties and at least annually thereafter.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509, 13-515, and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 13, 2011 (38:1 Md. R. 12)</annotation> </annotations> </chapter> </subtitle> <subtitle num="04" heading="Emergency Medical Services Education Programs and Courses"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Advanced life support (ALS)” means the level of care which may be rendered by an individual licensed under Education Article, §13-516, Annotated Code of Maryland, as an:</text> <paragraph num="(a)"> <text>Emergency medical technician-paramedic; or</text> </paragraph> <paragraph num="(b)"> <text>Cardiac rescue technician licensed.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Automated external defibrillator (AED)” means a medical heart monitor and defibrillator device that:</text> <paragraph num="(a)"> <text>Is cleared for market by the federal Food and Drug Administration;</text> </paragraph> <paragraph num="(b)"> <text>Recognizes the presence or absence of ventricular fibrillation or rapid ventricular tachycardia;</text> </paragraph> <paragraph num="(c)"> <text>Determines, without intervention by the operator, whether defibrillation should be performed;</text> </paragraph> <paragraph num="(d)"> <text>On determining that defibrillation should be performed, automatically charges; and</text> </paragraph> <paragraph num="(e)"> <text>Either:</text> <paragraph num="(i)"> <text>Requires operator intervention to deliver the electrical impulse; or</text> </paragraph> <paragraph num="(ii)"> <text>Automatically continues with delivery of electrical impulse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>“Advanced life support (ALS) education program” means an individual, agency, corporation, association, or other entity that prepares individuals for Maryland emergency medical services (EMS) licensure at the ALS level.</text> </paragraph> <paragraph num="(4)"> <text>“Basic life support (BLS)” means the level of care which may be rendered by an individual certified under Education Article, §13-516, Annotated Code of Maryland, as:</text> <paragraph num="(a)"> <text>An emergency medical technician (EMT); or</text> </paragraph> <paragraph num="(b)"> <text>An emergency medical responder.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>“Basic life support (BLS) education program” means an individual, agency, corporation, association, or other entity that prepares individuals for Maryland EMS certification at the BLS level.</text> </paragraph> <paragraph num="(6)"> <text>“BLS instructor” means an individual who meets the requirements of COMAR 30.04.03.09A or .11.</text> </paragraph> <paragraph num="(7)"> <text>“CAPCE” means the Commission on Accreditation for Pre-Hospital Continuing Education, which is a national organization designed to approve continuing education.</text> </paragraph> <paragraph num="(8)"> <text>“CoAEMSP” means the Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions which is a national committee that accredits programs instructing EMS curricula.</text> </paragraph> <paragraph num="(9)"> <text>“Commercial ambulance service” means a commercial ambulance service required to be licensed under Education Article, §13-515, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(10)"> <text>“Continuing education” means education used for renewal of EMS licensure or certification.</text> </paragraph> <paragraph num="(11)"> <text>“Continuing education program” means a program offering continuing education courses for EMS providers in conjunction with and through an EMS operational program.</text> </paragraph> <paragraph num="(12)"> <text>“Curriculum” means the required educational content of an EMS course approved by the EMS Board for licensure or certification as an EMS provider under Education Article, §13-516(a), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(13)"> <text>“Distance education” means a method of acquiring knowledge and skills through mediated information and instruction, encompassing all technologies and other forms of learning at a distance.</text> </paragraph> <paragraph num="(14)"> <text>“Emergency medical dispatcher (EMD)” means an individual licensed by the EMS Board as an emergency medical dispatcher.</text> </paragraph> <paragraph num="(15)"> <text>“EMD education program” means an individual, agency, corporation, association, or other entity that prepares individuals for licensure as a Maryland EMD.</text> </paragraph> <paragraph num="(16)"> <text>“EMD instructor” means an individual who is currently approved by MIEMSS to teach an approved EMD education program and approved continuing education.</text> </paragraph> <paragraph num="(17)"> <text>“Emergency medical responder instructor” means an individual who is currently approved by MIEMSS to teach FR courses and approved continuing education.</text> </paragraph> <paragraph num="(18)"> <text>“Emergency medical services (EMS) operational program” means:</text> <paragraph num="(a)"> <text>A jurisdictional EMS operational program; or</text> </paragraph> <paragraph num="(b)"> <text>An institution, agency, corporation, or other entity that is licensed by MIEMSS as a commercial service.</text> </paragraph> </paragraph> <paragraph num="(19)"> <text>“Emergency medical technician instructor” means an individual who can teach emergency medical technician or EMR courses and meets the requirements of COMAR 30.04.03.09A.</text> </paragraph> <paragraph num="(20)"> <text>“FR instructor” means an individual who is currently approved by MIEMSS to teach FR courses and approved continuing education.</text> </paragraph> <paragraph num="(21)"> <text>“JCAHO” means the Joint Commission on Accreditation of Healthcare Organizations.</text> </paragraph> <paragraph num="(22)"> <text>“MDH” means the Maryland Department of Health.</text> </paragraph> <paragraph num="(23)"> <text>“MFRI” means the Maryland Fire and Rescue Institute, University of Maryland.</text> </paragraph> <paragraph num="(24)"> <text>“MICRB” means the Maryland Instructor Certification Review Board as defined in COMAR 13B.03.01.02B(6).</text> </paragraph> <paragraph num="(25)"> <text>“Nationally recognized EMD education program” means an individual, agency, corporation, association, or other entity which conducts EMD education courses and has:</text> <paragraph num="(a)"> <text>Nationally recognized expertise and resources to:</text> <paragraph num="(i)"> <text>Set minimum standards for EMD instruction; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide adequate quality assurance of its instruction and instructors; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A valid and reliable instrument for the evaluation of EMD students.</text> </paragraph> </paragraph> <paragraph num="(26)"> <text>“NHTSA” means the National Highway Transportation Safety Administration.</text> </paragraph> <paragraph num="(27)"> <text>“Proprietary education program” means an individual, agency, corporation, association, or other entity which conducts EMS education and has:</text> <paragraph num="(a)"> <text>The expertise and resources to:</text> <paragraph num="(i)"> <text>Set minimum standards for the instruction of EMS content; and</text> </paragraph> <paragraph num="(ii)"> <text>Provide adequate quality assurance of its instruction and instructors; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A valid and reliable instrument for the evaluation of participants.</text> </paragraph> </paragraph> <paragraph num="(28)"> <text>“Person” includes an individual, agency, corporation, association, or other entity.</text> </paragraph> <paragraph num="(29)"> <text>“Refresher course” means a continuing education course which provides continuing education requirements required for renewal of an EMS license or certificate under COMAR 30.02.07.</text> </paragraph> <paragraph num="(30)"> <text>“Skills course” means a continuing education course which fulfills the skills requirements required for renewal of an EMS license or certificate under COMAR 30.02.07.</text> </paragraph> <paragraph num="(31)"> <text>“Specialty care transport” has the meaning stated in COMAR 30.09.01.02B(1).</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1784)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective September 27, 2004 (31:19 Md. R. 1434); December 12, 2013 (40:24 Md. R. 2017); April 9, 2018 (45:7 Md. R. 347)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10B amended effective January 15, 2005 (32:16 Md. R. 1866)</annotation> </annotations> </chapter> <chapter num="02" heading="Advanced Life Support Education Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs ALS education programs approved by the EMS Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Operational Policies."> <paragraph num="A."> <text>Each ALS education program shall have written criteria for:</text> <paragraph num="(1)"> <text>Admission;</text> </paragraph> <paragraph num="(2)"> <text>Frequent evaluation of each student during the course of study including evaluation of competency in providing patient care;</text> </paragraph> <paragraph num="(3)"> <text>Student requirements for:</text> <paragraph num="(a)"> <text>Attendance;</text> </paragraph> <paragraph num="(b)"> <text>Educational performance including:</text> <paragraph num="(i)"> <text>Attitudes;</text> </paragraph> <paragraph num="(ii)"> <text>Knowledge; and</text> </paragraph> <paragraph num="(iii)"> <text>Skills; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Behavior;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Student access to program information including:</text> <paragraph num="(a)"> <text>Fees;</text> </paragraph> <paragraph num="(b)"> <text>Requirements;</text> </paragraph> <paragraph num="(c)"> <text>Policies;</text> </paragraph> <paragraph num="(d)"> <text>Procedures; and</text> </paragraph> <paragraph num="(e)"> <text>Support services;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Selection of:</text> <paragraph num="(a)"> <text>A medical director;</text> </paragraph> <paragraph num="(b)"> <text>A program coordinator;</text> </paragraph> <paragraph num="(c)"> <text>Faculty; and</text> </paragraph> <paragraph num="(d)"> <text>Other necessary personnel;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Nondiscrimination and fair practices with regard to students, faculty, and program personnel; and</text> </paragraph> <paragraph num="(7)"> <text>Review and improvement of the effectiveness of student evaluation techniques.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each ALS education program shall require that each student wear distinctive identification during field and clinical internship that clearly identifies the:</text> <paragraph num="(1)"> <text>Student's name;</text> </paragraph> <paragraph num="(2)"> <text>Student's status; and</text> </paragraph> <paragraph num="(3)"> <text>ALS education program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Organizational Chart."> <text>Each ALS education program shall maintain an organizational chart that shows the relationship among students, faculty, medical director, program coordinator, and other personnel for each ALS course.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Records and Reports."> <paragraph num="A."> <text>Each ALS education program shall maintain accurate and appropriate records of:</text> <paragraph num="(1)"> <text>Students;</text> </paragraph> <paragraph num="(2)"> <text>Faculty;</text> </paragraph> <paragraph num="(3)"> <text>Courses including:</text> <paragraph num="(a)"> <text>Course statistics; and</text> </paragraph> <paragraph num="(b)"> <text>Demographics of applicants; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Written agreements with facilities and agencies providing clinical and field experience which include:</text> <paragraph num="(a)"> <text>Liability policies;</text> </paragraph> <paragraph num="(b)"> <text>Scope of practice for the student;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation criteria; and</text> </paragraph> <paragraph num="(d)"> <text>The responsibility for and level of supervision of students.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Records shall be maintained for at least 5 years following course completion in a manner to prevent loss, destruction, or unauthorized use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Content."> <paragraph num="A."> <text>Each ALS education program shall teach the appropriate ALS curriculum.</text> </paragraph> <paragraph num="B."> <text>Each ALS education program shall provide:</text> <paragraph num="(1)"> <text>Didactic instruction which imparts fundamental knowledge, skills, and attitudes which contribute to the delivery of state-of-the-art prehospital emergency medical care, including:</text> <paragraph num="(a)"> <text>Assessment of signs and symptoms;</text> </paragraph> <paragraph num="(b)"> <text>Performance of therapeutic interventions; and</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of response to interventions;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Supervised clinical experience which includes practice of skills within clinical education facilities; and</text> </paragraph> <paragraph num="(3)"> <text>Supervised field internship which includes practice of skills while functioning in a prehospital ALS environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Distance Education. Training programs may utilize distance education for cognitive components of initial training leading to EMS licensure if the program:</text> <paragraph num="(1)"> <text>Demonstrates the methods of distance education utilized are educationally and technically appropriate for the content and audience; and</text> </paragraph> <paragraph num="(2)"> <text>Ensures the quality of the distance education method including:</text> <paragraph num="(a)"> <text>Learning and teaching considerations;</text> </paragraph> <paragraph num="(b)"> <text>Communication;</text> </paragraph> <paragraph num="(c)"> <text>Educational and technology design; and</text> </paragraph> <paragraph num="(d)"> <text>Program and system management.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Human Resources."> <paragraph num="A."> <text>There shall be written agreements and position descriptions stating the roles and responsibilities of the individuals who have the responsibilities listed in this regulation.</text> </paragraph> <paragraph num="B."> <text>Medical Director.</text> <paragraph num="(1)"> <text>Each ALS education program shall have a medical director who:</text> <paragraph num="(a)"> <text>Is a physician licensed to practice medicine in Maryland;</text> </paragraph> <paragraph num="(b)"> <text>Has current knowledge and experience in emergency medical care of acutely ill or injured patients;</text> </paragraph> <paragraph num="(c)"> <text>Has knowledge of the Maryland EMS System; and</text> </paragraph> <paragraph num="(d)"> <text>Has knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The medical director shall:</text> <paragraph num="(a)"> <text>Be responsible for oversight of the medical educational content of the ALS education program curriculum;</text> </paragraph> <paragraph num="(b)"> <text>Play an active role and participate in the delivery and evaluation of the education program; and</text> </paragraph> <paragraph num="(c)"> <text>Oversee with the recruitment and selection of faculty.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Program Coordinator.</text> <paragraph num="(1)"> <text>Each ALS education program shall have a program coordinator who may be the medical director and who has:</text> <paragraph num="(a)"> <text>At least 2 years experience instructing and evaluating ALS students;</text> </paragraph> <paragraph num="(b)"> <text>Experience with the development and administration of an education program;</text> </paragraph> <paragraph num="(c)"> <text>An ALS license or equivalent; and</text> </paragraph> <paragraph num="(d)"> <text>Knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The program coordinator shall:</text> <paragraph num="(a)"> <text>Have overall responsibility for the success of the ALS education program including continuous quality review and improvement of the ALS education program;</text> </paragraph> <paragraph num="(b)"> <text>Assist the medical director with the recruitment and selection of faculty;</text> </paragraph> <paragraph num="(c)"> <text>Serve as the education program student/faculty liaison; and</text> </paragraph> <paragraph num="(d)"> <text>Identify sites where students can fulfill clinical and field internship requirements.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Faculty.</text> <paragraph num="(1)"> <text>Each ALS education program shall have faculty and guest lecturers with the education and experience necessary to teach in the ALS course.</text> </paragraph> <paragraph num="(2)"> <text>All faculty shall have:</text> <paragraph num="(a)"> <text>Experience instructing and evaluating students;</text> </paragraph> <paragraph num="(b)"> <text>Working knowledge of current Maryland Medical Protocols for Emergency Medical Services Providers;</text> </paragraph> <paragraph num="(c)"> <text>The express written endorsement of the program's medical director and program coordinator to teach designated lessons;</text> </paragraph> <paragraph num="(d)"> <text>Working knowledge of the Maryland EMS system; and</text> </paragraph> <paragraph num="(e)"> <text>An annual written evaluation by the program medical director or program coordinator.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Clinical Preceptor.</text> <paragraph num="(1)"> <text>Each ALS education program shall have clinical preceptors who shall supervise and evaluate each student's performance in approved clinical education facilities.</text> </paragraph> <paragraph num="(2)"> <text>Clinical preceptors shall have:</text> <paragraph num="(a)"> <text>Working knowledge of:</text> <paragraph num="(i)"> <text>ALS curricula; and</text> </paragraph> <paragraph num="(ii)"> <text>The Maryland Medical Protocols for Emergency Medical Services Providers;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The expertise to supervise required clinical skills; and</text> </paragraph> <paragraph num="(c)"> <text>Completed a local clinical preceptor orientation program.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The ratio of students to preceptor shall be adequate to assure effective learning.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Field Preceptor.</text> <paragraph num="(1)"> <text>Each ALS education program shall have a field preceptor who shall supervise and evaluate each student's performance in an approved EMS operational program setting or equivalent as approved by MIEMSS.</text> </paragraph> <paragraph num="(2)"> <text>The ratio of students to field preceptor shall be one to one to assure effective learning and supervision.</text> </paragraph> <paragraph num="(3)"> <text>A field preceptor shall:</text> <paragraph num="(a)"> <text>Have working knowledge of:</text> <paragraph num="(i)"> <text>ALS curricula; and</text> </paragraph> <paragraph num="(ii)"> <text>The Maryland Medical Protocols for Emergency Medical Services Providers;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Have the expertise to supervise required skills;</text> </paragraph> <paragraph num="(c)"> <text>Have been licensed to perform the skills supervised for at least 2 years;</text> </paragraph> <paragraph num="(d)"> <text>Have completed a local field preceptor orientation program; and</text> </paragraph> <paragraph num="(e)"> <text>Be approved by an EMS operational program.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Physical Resources."> <paragraph num="A."> <text>Instructional Facilities. Each ALS education program shall have adequate space at instructional facilities to accommodate the program.</text> </paragraph> <paragraph num="B."> <text>Clinical Facilities.</text> <paragraph num="(1)"> <text>Each ALS education program shall have access to clinical facilities that provide necessary clinical experience with appropriate medical oversight and supervision.</text> </paragraph> <paragraph num="(2)"> <text>The clinical facilities shall have a patient population representative of that encountered in the delivery of prehospital emergency medical care.</text> </paragraph> <paragraph num="(3)"> <text>The clinical facilities shall provide adequate educational experiences to meet the program's clinical objectives.</text> </paragraph> <paragraph num="(4)"> <text>If clinical facilities are located outside of Maryland, the ALS program shall comply with the laws of the state where the facilities are located.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Field Internships.</text> <paragraph num="(1)"> <text>Each ALS education program shall provide students access to field internships with appropriate medical oversight and supervision within any ALS component of an EMS operational program.</text> </paragraph> <paragraph num="(2)"> <text>The field internships shall have a patient population representative of that encountered in the delivery of prehospital emergency medical care.</text> </paragraph> <paragraph num="(3)"> <text>The field internships shall provide adequate educational experiences to meet the program's clinical objectives.</text> </paragraph> <paragraph num="(4)"> <text>If field internships are located outside of Maryland, the ALS program shall:</text> <paragraph num="(a)"> <text>Comply with the laws of the state where the field internships are located; and</text> </paragraph> <paragraph num="(b)"> <text>Notify the appropriate EMS officials in the state where the field internships are located of the presence of program students in those internships.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Financial Resources."> <text>Each ALS education program shall have sufficient financial resources to assure complete ALS course delivery for all enrolled students.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Special Needs."> <text>Each ALS education program shall advise MIEMSS in writing of any students requesting accommodations for documented disabilities at least 5 days before the scheduled licensure examinations.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Program Evaluation."> <paragraph num="A."> <text>Each ALS education program shall have a written policy and procedure for evaluation of the ALS education program.</text> </paragraph> <paragraph num="B."> <text>The evaluation shall be annually and provide written objective evidence that the program is meeting its objectives and the changing needs of EMS care.</text> </paragraph> <paragraph num="C."> <text>The evaluation plan shall include methods for gathering and analyzing data on the effectiveness of the:</text> <paragraph num="(1)"> <text>Program;</text> </paragraph> <paragraph num="(2)"> <text>Resources;</text> </paragraph> <paragraph num="(3)"> <text>Responsiveness to recommendations for change;</text> </paragraph> <paragraph num="(4)"> <text>Faculty; and</text> </paragraph> <paragraph num="(5)"> <text>Students' ability to function as entry-level providers upon successful completion of the ALS course.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The results of evaluations shall provide the basis for continuous quality improvement and future direction of the program.</text> </paragraph> <paragraph num="E."> <text>Each ALS education program shall submit an annual report to MIEMSS in an approved format.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Curriculum and Education."> <paragraph num="A."> <text>The EMS Board shall establish standard curricula and learning objectives for ALS education programs.</text> </paragraph> <paragraph num="B."> <text>Each ALS education program shall prepare the student for entry-level practice.</text> </paragraph> <paragraph num="C."> <text>The amount of time devoted to the delivery of the ALS course may vary depending on the students' ability to demonstrate proficiency in the educational objectives utilizing:</text> <paragraph num="(1)"> <text>Written examinations;</text> </paragraph> <paragraph num="(2)"> <text>Oral examinations; and</text> </paragraph> <paragraph num="(3)"> <text>Practical examinations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="ALS Education Program Approval."> <paragraph num="A."> <text>An ALS education program may apply for approval by submitting a MIEMSS-approved application to MIEMSS, Office of Education, Licensure, and Certification, ALS Program, 653 West Pratt Street, Baltimore, Maryland 21201-1528.</text> </paragraph> <paragraph num="B."> <text>An ALS education program providing ALS courses on the effective date of this regulation may continue to offer ALS courses for not more than 3 years from that date unless the program is approved under this chapter.</text> </paragraph> <paragraph num="C."> <text>CoAEMSP Accredited Programs. CoAEMSP accredited programs shall apply for approval under this regulation. Sections of the application approval process that parallel the CoAEMSP accreditation process may be waived if a MIEMSS representative participates in the CoAEMSP site visit as an observer and the ALS education program:</text> <paragraph num="(1)"> <text>Complies with COMAR 30.04.02;</text> </paragraph> <paragraph num="(2)"> <text>Remains an accredited program in good standing with CoAEMSP; and</text> </paragraph> <paragraph num="(3)"> <text>Provides MIEMSS a copy of the self study submitted to CoAEMSP and a copy of documentation provided to the program by CoAEMSP.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Application Deadlines. Application for ALS education program approval shall be received at least 6 months before the first ALS course begins.</text> </paragraph> <paragraph num="E."> <text>Site Visit.</text> <paragraph num="(1)"> <text>After a completed application is accepted by MIEMSS, a site visit shall be scheduled at a mutually convenient time.</text> </paragraph> <paragraph num="(2)"> <text>The site review team shall be selected by MIEMSS and consist of:</text> <paragraph num="(a)"> <text>A system medical director or an ALS education program medical director;</text> </paragraph> <paragraph num="(b)"> <text>ALS faculty or ALS program coordinator;</text> </paragraph> <paragraph num="(c)"> <text>MIEMSS representative; and</text> </paragraph> <paragraph num="(d)"> <text>Others as necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an applicant can demonstrate a reasonable basis for concern, MIEMSS shall consider allegations that conflicts of interest exist between a site reviewer and an applicant.</text> </paragraph> <paragraph num="(4)"> <text>The site review team shall send a written report to MIEMSS within 30 days after the site visit.</text> </paragraph> <paragraph num="(5)"> <text>The site review team and MIEMSS shall finalize the site visit and report and MIEMSS shall submit a recommendation to the EMS Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>EMS Board Action.</text> <paragraph num="(1)"> <text>Five-Year Approval. If the EMS Board determines that the applicant meets the requirements of this chapter, the EMS Board shall grant the applicant a 5-year approval as an ALS education program.</text> </paragraph> <paragraph num="(2)"> <text>To maintain approval, the ALS education program shall:</text> <paragraph num="(a)"> <text>Comply with COMAR 30.04.02;</text> </paragraph> <paragraph num="(b)"> <text>Advise MIEMSS in writing within 30 days of any changes in:</text> <paragraph num="(i)"> <text>Program personnel other than instructional faculty;</text> </paragraph> <paragraph num="(ii)"> <text>Organizational changes; or</text> </paragraph> <paragraph num="(iii)"> <text>Programmatic changes;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintain a process of continuous quality improvement;</text> </paragraph> <paragraph num="(d)"> <text>Conduct at least one full length ALS course every 2 years.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provisional Approval.</text> <paragraph num="(a)"> <text>If the EMS Board determines that the application and the site visit indicate limitations in meeting requirements for full approval, it may approve the application provisionally on the conditions and for the provisional period, including any extensions, which the EMS Board deems appropriate.</text> </paragraph> <paragraph num="(b)"> <text>An applicant receiving provisional approval shall submit written progress reports to MIEMSS as required by the EMS Board.</text> </paragraph> <paragraph num="(c)"> <text>MIEMSS may conduct one or more additional site visits to verify the resolution of limitations.</text> </paragraph> <paragraph num="(d)"> <text>Before any additional site visit, the applicant shall prepare a revised report that includes changes made since the prior site visit.</text> </paragraph> <paragraph num="(e)"> <text>Upon satisfactory resolution of limitations, or at the end of the provisional period, including any extensions, the EMS Board shall:</text> <paragraph num="(i)"> <text>Confer approval for the remainder of the 5-year period if the applicant has satisfied all requirements for approval; or</text> </paragraph> <paragraph num="(ii)"> <text>Deny or revoke approval.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Denial or Revocation of Approval. The EMS Board may deny or revoke program approval if an ALS education program is not in compliance with this chapter. The program shall be notified by mail of the EMS Board's decision. If the decision is other than a 5-year approval, the notice shall:</text> <paragraph num="(a)"> <text>State the reasons for the decision;</text> </paragraph> <paragraph num="(b)"> <text>Advise the ALS education program of appeal rights; and</text> </paragraph> <paragraph num="(c)"> <text>Otherwise comply with State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>MIEMSS personnel may attend course sessions for quality assurance.</text> </paragraph> </paragraph> <paragraph num="G."> <text>National Registry. To be state approved for purposes of the National Registry for Emergency Medical Technicians, an ALS education program must obtain approval under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Renewal."> <text>ALS education programs shall apply for renewal of approval at least 6 months before the expiration of current approval.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Course Number."> <paragraph num="A."> <text>Each ALS course shall have a number assigned by MIEMSS.</text> </paragraph> <paragraph num="B."> <text>Each ALS education program approved under this chapter shall notify MIEMSS and request a course number at least 45 days before the first class of each ALS course which it proposes to provide. Requests for a course number shall:</text> <paragraph num="(1)"> <text>Be sent to MIEMSS in an approved format; and</text> </paragraph> <paragraph num="(2)"> <text>Be signed by the:</text> <paragraph num="(a)"> <text>Medical director; and</text> </paragraph> <paragraph num="(b)"> <text>Program director.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>An ALS course may not have more than 25 students without prior written approval from MIEMSS.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="No Effect on Other Laws."> <text>This chapter does not relieve the ALS education program from the requirements of any statute or regulation that would otherwise apply.</text> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1784)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12C amended effective September 27, 2004 (31:19 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12F amended effective October 3, 2011 (38:20 Md. R. 1205)</annotation> </annotations> </chapter> <chapter num="03" heading="Basic Life Support Education Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs BLS education programs approved by the EMS Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Operational Policies."> <paragraph num="A."> <text>Each BLS education program shall have written criteria for:</text> <paragraph num="(1)"> <text>Admission;</text> </paragraph> <paragraph num="(2)"> <text>Frequent evaluation of each student during the course of study including evaluation of competency in providing patient care;</text> </paragraph> <paragraph num="(3)"> <text>Student requirements for:</text> <paragraph num="(a)"> <text>Attendance;</text> </paragraph> <paragraph num="(b)"> <text>Educational performance including:</text> <paragraph num="(i)"> <text>Attitudes;</text> </paragraph> <paragraph num="(ii)"> <text>Knowledge; and</text> </paragraph> <paragraph num="(iii)"> <text>Skills; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Behavior;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Student access to program information including:</text> <paragraph num="(a)"> <text>Fees;</text> </paragraph> <paragraph num="(b)"> <text>Requirements;</text> </paragraph> <paragraph num="(c)"> <text>Policies;</text> </paragraph> <paragraph num="(d)"> <text>Procedures; and</text> </paragraph> <paragraph num="(e)"> <text>Support services;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Selection of:</text> <paragraph num="(a)"> <text>A medical director;</text> </paragraph> <paragraph num="(b)"> <text>A program coordinator;</text> </paragraph> <paragraph num="(c)"> <text>Faculty; and</text> </paragraph> <paragraph num="(d)"> <text>Other necessary personnel;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Nondiscrimination and fair practices with regard to students, faculty, and program personnel; and</text> </paragraph> <paragraph num="(7)"> <text>Review and improvement of the effectiveness of student evaluation techniques.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each BLS education program shall require that each student wear distinctive identification during field and clinical internship that clearly identifies the:</text> <paragraph num="(1)"> <text>Student's name;</text> </paragraph> <paragraph num="(2)"> <text>Student's status; and</text> </paragraph> <paragraph num="(3)"> <text>BLS education program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Organizational Chart."> <text>Each BLS education program shall maintain an organizational chart that shows the relationships among students, the program coordinator, the medical director, and the instructors for each BLS course.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Records and Reports."> <paragraph num="A."> <text>Each BLS education program shall maintain accurate and appropriate records of:</text> <paragraph num="(1)"> <text>Students;</text> </paragraph> <paragraph num="(2)"> <text>Faculty;</text> </paragraph> <paragraph num="(3)"> <text>Courses including:</text> <paragraph num="(a)"> <text>Course statistics; and</text> </paragraph> <paragraph num="(b)"> <text>Demographics of applicants; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Written agreements with facilities and agencies providing clinical and field experience which include:</text> <paragraph num="(a)"> <text>Liability policies;</text> </paragraph> <paragraph num="(b)"> <text>Scope of practice for the student;</text> </paragraph> <paragraph num="(c)"> <text>Evaluation criteria; and</text> </paragraph> <paragraph num="(d)"> <text>The responsibility for and level of supervision of students.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Records shall be maintained for at least 5 years following course completion in a manner to prevent loss, destruction, or unauthorized use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Content."> <paragraph num="A."> <text>Each BLS education program shall teach the appropriate BLS curriculum.</text> </paragraph> <paragraph num="B."> <text>Each BLS education program shall provide:</text> <paragraph num="(1)"> <text>Didactic instruction which shall impart fundamental knowledge, skills, and attitudes which contribute to the delivery of state-of-the-art prehospital emergency medical care including:</text> <paragraph num="(a)"> <text>Assessment of signs and symptoms;</text> </paragraph> <paragraph num="(b)"> <text>Performance of therapeutic interventions; and</text> </paragraph> <paragraph num="(c)"> <text>Evaluation of response to interventions; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Supervised field internship which includes practice of skills while functioning in a prehospital BLS environment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Distance Education. Training programs may utilize distance education for cognitive components of initial training leading to EMS certification if the program:</text> <paragraph num="(1)"> <text>Demonstrates the methods of distance education utilized are educationally and technically appropriate for the content and audience; and</text> </paragraph> <paragraph num="(2)"> <text>Ensures the quality of the distance education method including:</text> <paragraph num="(a)"> <text>Learning and teaching considerations;</text> </paragraph> <paragraph num="(b)"> <text>Communication;</text> </paragraph> <paragraph num="(c)"> <text>Educational and technology design; and</text> </paragraph> <paragraph num="(d)"> <text>Program and system management.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Human Resources — General."> <paragraph num="A."> <text>There shall be written agreements and position descriptions stating the roles and responsibilities of the following program positions:</text> <paragraph num="(1)"> <text>Medical director;</text> </paragraph> <paragraph num="(2)"> <text>Program coordinator; and</text> </paragraph> <paragraph num="(3)"> <text>BLS instructors.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All education programs shall have adequate clerical and support staffing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Human Resources — Medical Director."> <paragraph num="A."> <text>Each BLS education program offering emergency medical technician courses or emergency medical responder courses, which include the automated external defibrillator module, shall have a medical director who:</text> <paragraph num="(1)"> <text>Is a physician licensed to practice medicine in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Has current working knowledge and experience in emergency medical care of acutely ill or injured patients;</text> </paragraph> <paragraph num="(3)"> <text>Has working knowledge of the Maryland EMS system; and</text> </paragraph> <paragraph num="(4)"> <text>Has working knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The medical director is responsible for oversight of the medical educational content of the BLS curriculum.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Human Resources — Program Coordinator."> <paragraph num="A."> <text>Each education program offering emergency medical technician courses shall have a program coordinator who has:</text> <paragraph num="(1)"> <text>At least 2 years experience instructing and evaluating EMT-B students;</text> </paragraph> <paragraph num="(2)"> <text>Experience with administration of educational programs;</text> </paragraph> <paragraph num="(3)"> <text>A BLS certification or equivalent; and</text> </paragraph> <paragraph num="(4)"> <text>Knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The emergency medical technician program coordinator shall:</text> <paragraph num="(1)"> <text>Have overall responsibility for the success of the emergency medical technician education program, including continuous quality review and improvement of the education program;</text> </paragraph> <paragraph num="(2)"> <text>Serve as the education program student/faculty liaison; and</text> </paragraph> <paragraph num="(3)"> <text>Identify sites where students can fulfill field internship requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Human Resources — Emergency Medical Technician Instructors."> <paragraph num="A."> <text>Each emergency medical technician course shall be taught by an emergency medical technician instructor, or an interim instructor under the supervision of an emergency medical technician instructor, who:</text> <paragraph num="(1)"> <text>Is currently certified as an MICRB Level II emergency services instructor who has successfully:</text> <paragraph num="(a)"> <text>Completed at least 12 hours of an emergency medical technician instructor skills development course;</text> </paragraph> <paragraph num="(b)"> <text>Completed two practice teachings (one didactic and one practical) evaluated by an emergency medical technician instructor who is also approved as an MICRB evaluator; and</text> </paragraph> <paragraph num="(c)"> <text>Taught one emergency medical technician course as an interim instructor, and been twice successfully evaluated by an emergency medical technician instructor who is also approved as an MICRB evaluator; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Has at least 3 consecutive years of experience as an emergency medical technician or higher;</text> </paragraph> <paragraph num="(3)"> <text>Maintains a Maryland EMS certification or license as an emergency medical technician or higher; and</text> </paragraph> <paragraph num="(4)"> <text>Has current knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The emergency medical technician instructor is responsible for:</text> <paragraph num="(1)"> <text>The course instruction; and</text> </paragraph> <paragraph num="(2)"> <text>Any interim or additional emergency medical technician instructors assisting with the course.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An emergency medical technician instructor shall remain current by:</text> <paragraph num="(1)"> <text>Completing requirements as an MICRB instructor and:</text> <paragraph num="(a)"> <text>Receiving a satisfactory emergency medical technician course teaching evaluation and no subsequent unsatisfactory evaluations from an emergency medical technician instructor who is also an approved MICRB evaluator; and</text> </paragraph> <paragraph num="(b)"> <text>One of the following:</text> <paragraph num="(i)"> <text>Instructing at least 60 hours of emergency medical technician course material; or</text> </paragraph> <paragraph num="(ii)"> <text>If a training supervisor, instructing at least 9 hours of emergency medical technician course material;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintaining a valid Maryland EMS certification of emergency medical technician or higher; and</text> </paragraph> <paragraph num="(3)"> <text>Attending mandatory protocol updates.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If qualified, the emergency medical technician instructor may also function as the emergency medical technician program coordinator.</text> </paragraph> <paragraph num="E."> <text>Emergency Medical Technician Instructor Reinstatement.</text> <paragraph num="(1)"> <text>A former emergency medical technician instructor whose approval has lapsed may apply to the sponsoring agency for reinstatement within 3 years of expiration. The emergency medical technician instructor reinstatement candidate shall:</text> <paragraph num="(a)"> <text>Be certified as an MICRB Level II emergency services instructor;</text> </paragraph> <paragraph num="(b)"> <text>Maintain Maryland EMS certification or licensure as an emergency medical technician or higher; and</text> </paragraph> <paragraph num="(c)"> <text>Maintain current working knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An emergency medical technician instructor whose approval status has been expired for more than 3 years shall meet initial emergency medical technician instructor requirements.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Emergency Medical Technician Field Training Coaches.</text> <paragraph num="(1)"> <text>Each BLS education program shall have access to emergency medical technician field training coaches who shall supervise and evaluate each student's internship performance in an approved prehospital setting or MIEMSS-approved equivalent.</text> </paragraph> <paragraph num="(2)"> <text>An emergency medical technician field training coach shall possess appropriate:</text> <paragraph num="(a)"> <text>Working knowledge of the emergency medical technician curriculum;</text> </paragraph> <paragraph num="(b)"> <text>Working knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers; and</text> </paragraph> <paragraph num="(c)"> <text>Expertise to supervise students during the emergency medical technician internship.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The ratio of students to emergency medical technician field training coach shall be one to one to ensure effective learning and supervision.</text> </paragraph> <paragraph num="(4)"> <text>Each emergency medical technician field training coach shall complete emergency medical technician field training coach orientation, and be approved by the local EMS operational program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Human Resources — EMR Program Coordinator."> <paragraph num="A."> <text>Each education program offering EMR courses shall have a program coordinator who:</text> <paragraph num="(1)"> <text>Has a current EMS certification at least equivalent to the level of education being taught; and</text> </paragraph> <paragraph num="(2)"> <text>Is experienced with the administration of education programs.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The EMR program coordinator shall have overall responsibility for the success of the education program including:</text> <paragraph num="(1)"> <text>Administration;</text> </paragraph> <paragraph num="(2)"> <text>Program planning;</text> </paragraph> <paragraph num="(3)"> <text>Effectiveness;</text> </paragraph> <paragraph num="(4)"> <text>Evaluation;</text> </paragraph> <paragraph num="(5)"> <text>Supervision;</text> </paragraph> <paragraph num="(6)"> <text>Quality of the:</text> <paragraph num="(a)"> <text>Didactic instruction; and</text> </paragraph> <paragraph num="(b)"> <text>Practical instruction;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Organization;</text> </paragraph> <paragraph num="(8)"> <text>The competency of each graduate at the time of course completion; and</text> </paragraph> <paragraph num="(9)"> <text>Continuous quality review and improvement of the EMR education program.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The emergency medical technician program coordinator can also be the EMR program coordinator.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Human Resources — EMR Instructors."> <paragraph num="A."> <text>EMR courses shall be taught by:</text> <paragraph num="(1)"> <text>EMR instructors;</text> </paragraph> <paragraph num="(2)"> <text>Interim EMR instructors under the supervision of an EMR instructor; or</text> </paragraph> <paragraph num="(3)"> <text>Emergency medical technician instructors.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An EMR instructor who is not an emergency medical technician instructor shall:</text> <paragraph num="(1)"> <text>Successfully complete a MIEMSS-approved instructor training course;</text> </paragraph> <paragraph num="(2)"> <text>Successfully complete a MIEMSS EMR instructor course and a MIEMSS-approved EMR written examination, with a minimum score as approved by MIEMSS;</text> </paragraph> <paragraph num="(3)"> <text>Successfully complete 2 hours of supervised practice teaching consisting of 1 hour didactic and 1 hour practical skills, and receive a satisfactory evaluation from a MIEMSS-approved EMR instructor evaluator or an emergency medical technician instructor who is also an approved MICRB evaluator;</text> </paragraph> <paragraph num="(4)"> <text>Teach 40 hours as an interim instructor and receive two consecutive satisfactory evaluations from a MIEMSS-approved EMR instructor evaluator, or an emergency medical technician instructor who is also an approved MICRB evaluator; and</text> </paragraph> <paragraph num="(5)"> <text>Submit to MIEMSS at the end of the interim teaching:</text> <paragraph num="(a)"> <text>All course paperwork; and</text> </paragraph> <paragraph num="(b)"> <text>A completed EMR instructor application showing two consecutive successful evaluations and practice teaching dates.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Approval as an EMR instructor shall be for up to 3 years.</text> </paragraph> <paragraph num="D."> <text>Maintaining EMR Instructor Approval. To maintain EMR instructor approval, an individual during the 3-year period of approval shall:</text> <paragraph num="(1)"> <text>Satisfy all of the following:</text> <paragraph num="(a)"> <text>Teach at least:</text> <paragraph num="(i)"> <text>20 hours of EMR instruction with 6 hours devoted to skills; or</text> </paragraph> <paragraph num="(ii)"> <text>14 hours of EMR instruction and attend an approved skills refresher;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Receive at least one satisfactory teaching evaluation with no subsequent unsatisfactory evaluation by a MICRB evaluator who is an emergency medical technician instructor or MIEMSS-approved EMR instructor evaluator;</text> </paragraph> <paragraph num="(c)"> <text>Maintain current Maryland EMS provider certification or licensure;</text> </paragraph> <paragraph num="(d)"> <text>Attend EMR instructor workshops as necessary;</text> </paragraph> <paragraph num="(e)"> <text>Provide MIEMSS with documentation of hours taught; and</text> </paragraph> <paragraph num="(f)"> <text>Apply to MIEMSS for renewal as an EMR instructor; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintain current MIEMSS approval as an emergency medical technician instructor and attend EMR instructor workshops as necessary.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The EMR instructor may also function as the EMR program coordinator if qualified.</text> </paragraph> <paragraph num="F."> <text>EMR Instructor Reinstatement.</text> <paragraph num="(1)"> <text>A former EMR instructor whose approval has expired may apply to MIEMSS for reinstatement within 3 years of expiration. The EMR instructor reinstatement candidate shall:</text> <paragraph num="(a)"> <text>Be certified or licensed as a Maryland EMR or higher level EMS provider;</text> </paragraph> <paragraph num="(b)"> <text>Have successfully completed, within the last 3 years, 1 hour didactic and 1 hour practical skills supervised practice teaching with a satisfactory evaluation from a MIEMSS-approved EMR instructor evaluator or an emergency medical technician instructor who is an approved MICRB evaluator; and</text> </paragraph> <paragraph num="(c)"> <text>A completed EMR instructor application showing two consecutive successful evaluations from practice teaching.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Approval as an EMR instructor shall be for 3 years or concurrent with the EMR, the emergency medical technician, or the MICRB certification period.</text> </paragraph> <paragraph num="(3)"> <text>An EMR instructor whose lapsed approval status is in excess of 3 years is required to meet initial EMR instructor requirements.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="BLS Physical Resources."> <paragraph num="A."> <text>Instructional Facilities. Each BLS education program shall have adequate space at facilities to accommodate the program.</text> </paragraph> <paragraph num="B."> <text>Emergency Medical Technician Internships. Each BLS education program shall provide students access to internships with appropriate medical oversight and supervision within any MIEMSS-approved EMS operational program which shall include:</text> <paragraph num="(1)"> <text>Patient assessments;</text> </paragraph> <paragraph num="(2)"> <text>EMS orientation; and</text> </paragraph> <paragraph num="(3)"> <text>Additional components as approved by MIEMSS.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If field internships are located outside Maryland, the BLS program shall:</text> <paragraph num="(1)"> <text>Comply with the laws of the state where the field internships are located; and</text> </paragraph> <paragraph num="(2)"> <text>Notify the appropriate EMS officials in the state where the field internships are located of the presence of program students in those internships.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="BLS Financial Resources."> <text>Each emergency medical technician education program shall have sufficient financial resources to ensure complete course delivery for all enrolled students.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Special Needs."> <text>Each BLS education program shall advise MIEMSS in writing of any students requiring accommodations for documented disabilities at least 5 days before the scheduled certification examinations.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Program Evaluation."> <paragraph num="A."> <text>Each BLS education program shall have a written policy and procedure for evaluation of the BLS education program.</text> </paragraph> <paragraph num="B."> <text>The evaluation shall be at least annually and provide written evidence that the program is meeting its objectives and the changing needs of EMS care.</text> </paragraph> <paragraph num="C."> <text>The evaluation plan shall include methods for gathering and analyzing data on the effectiveness of the following:</text> <paragraph num="(1)"> <text>Instruction;</text> </paragraph> <paragraph num="(2)"> <text>Resources;</text> </paragraph> <paragraph num="(3)"> <text>Responsiveness to recommendations for change;</text> </paragraph> <paragraph num="(4)"> <text>Instructors; and</text> </paragraph> <paragraph num="(5)"> <text>Students' ability to function as entry-level providers upon successful completion of the course.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The results of the evaluations shall provide the basis for continuous quality improvement and future direction of the BLS courses.</text> </paragraph> <paragraph num="E."> <text>Annual Report. Each BLS education program shall submit an annual report to MIEMSS in an approved format to:</text> <paragraph num="(1)"> <text>Update program information; and</text> </paragraph> <paragraph num="(2)"> <text>Identify any major changes in the program during the year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Curriculum and Education."> <paragraph num="A."> <text>The EMS Board shall establish standard curricula and learning objectives for the BLS courses.</text> </paragraph> <paragraph num="B."> <text>Each BLS course shall prepare the student for entry-level practice.</text> </paragraph> <paragraph num="C."> <text>The amount of time devoted to the delivery of the course may vary depending on the students' ability to demonstrate proficiency in the educational objectives utilizing:</text> <paragraph num="(1)"> <text>Written examinations;</text> </paragraph> <paragraph num="(2)"> <text>Oral examinations; and</text> </paragraph> <paragraph num="(3)"> <text>Practical examinations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Program Approval."> <paragraph num="A."> <text>A BLS education program may apply for approval by submitting a MIEMSS-approved application to MIEMSS, Office of Education, Licensure, and Certification, BLS Program, 653 West Pratt Street, Baltimore, Maryland 21201-1528.</text> </paragraph> <paragraph num="B."> <text>A BLS education program providing BLS courses on the effective date of this regulation may continue to offer BLS courses for not more than 3 years from that date unless the program is approved under this chapter.</text> </paragraph> <paragraph num="C."> <text>Maryland Police and Correctional Training Commission approved programs shall apply for approval under this regulation. Sections of the approval process that parallel the Commission approval process may be waived if the FR program:</text> <paragraph num="(1)"> <text>Complies with COMAR 30.04.02; and</text> </paragraph> <paragraph num="(2)"> <text>Remains an accredited program in good standing with the Commission.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Application Deadlines. Applications for BLS education program approval shall be received at least 6 months before the first BLS course begins.</text> </paragraph> <paragraph num="E."> <text>Site Visit.</text> <paragraph num="(1)"> <text>After a completed application is accepted by MIEMSS, a site visit shall be scheduled at a mutually convenient time.</text> </paragraph> <paragraph num="(2)"> <text>The site review team shall be selected by MIEMSS and consist of:</text> <paragraph num="(a)"> <text>A system medical director or an BLS education program medical director;</text> </paragraph> <paragraph num="(b)"> <text>A BLS educator or BLS program director;</text> </paragraph> <paragraph num="(c)"> <text>MIEMSS representative; and</text> </paragraph> <paragraph num="(d)"> <text>Others as necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an applicant can demonstrate a reasonable basis for concern, MIEMSS shall consider allegations that conflicts of interest exist between a site reviewer and an applicant.</text> </paragraph> <paragraph num="(4)"> <text>The site review team shall send a written report to MIEMSS after the site visit.</text> </paragraph> <paragraph num="(5)"> <text>The site review team shall send a written report to MIEMSS within 30 days after the site visit.</text> </paragraph> <paragraph num="(6)"> <text>The site review team and MIEMSS shall finalize the site visit and report and MIEMSS shall submit a recommendation to the EMS Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>EMS Board Action.</text> <paragraph num="(1)"> <text>Five-Year Approval. If the EMS Board determines that the applicant is in compliance with this chapter, the EMS Board shall grant the applicant a 5-year approval as a BLS education program.</text> </paragraph> <paragraph num="(2)"> <text>To maintain approval the BLS education program shall:</text> <paragraph num="(a)"> <text>Comply with COMAR 30.04.03;</text> </paragraph> <paragraph num="(b)"> <text>Advise MIEMSS in writing within 30 days of any changes in:</text> <paragraph num="(i)"> <text>Program personnel other than instructional faculty;</text> </paragraph> <paragraph num="(ii)"> <text>Organizational changes; or</text> </paragraph> <paragraph num="(iii)"> <text>Programmatic changes;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintain a process of continuous quality improvement; and</text> </paragraph> <paragraph num="(d)"> <text>Conduct at least one full length BLS course every 3 years.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provisional Approval.</text> <paragraph num="(a)"> <text>If the EMS Board determines that the application and the site visit indicate limitations in meeting requirements for full approval, it may approve the application provisionally on the conditions and for the provisional period, including any extensions, which the EMS Board deems appropriate.</text> </paragraph> <paragraph num="(b)"> <text>An applicant receiving provisional approval shall submit written progress reports to MIEMSS as required by the EMS Board.</text> </paragraph> <paragraph num="(c)"> <text>MIEMSS may conduct one or more additional site visits to verify the resolution of limitations.</text> </paragraph> <paragraph num="(d)"> <text>Before any additional site visit, the applicant shall prepare and submit a revised report that includes changes made since the prior site visit.</text> </paragraph> <paragraph num="(e)"> <text>Upon satisfactory resolution of limitations, or at the end of the provisional period, including any extensions, the EMS Board shall:</text> <paragraph num="(i)"> <text>Confer approval for the remainder of the 5-year period if the applicant has satisfied all requirements for approval; or</text> </paragraph> <paragraph num="(ii)"> <text>Deny or revoke approval.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Denial or Revocation of Approval. The EMS Board may deny or revoke program approval if a BLS education program is not in compliance with this chapter. The program shall be notified by mail of the EMS Board's decision. If the decision is other than a 5-year approval, the notice shall:</text> <paragraph num="(a)"> <text>State the reasons for the decision;</text> </paragraph> <paragraph num="(b)"> <text>Advise the BLS education program of appeal rights; and</text> </paragraph> <paragraph num="(c)"> <text>Otherwise comply with State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>MIEMSS may approve out-of-State BLS education programs that meet the standards set by the EMS Board to allow out-of-State BLS students enrolled in these programs to participate in Maryland internship and ride along programs in the course of their training under Education Article, §13-516(b)(1)(ii), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(6)"> <text>MIEMSS personnel may attend course sessions for quality assurance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Renewal."> <text>BLS education programs shall make application for renewal of approval at least 6 months before the expiration of current approval.</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Course Number."> <paragraph num="A."> <text>Each BLS education course shall have a number assigned by MIEMSS.</text> </paragraph> <paragraph num="B."> <text>Each BLS education program approved under this chapter shall notify MIEMSS and request a course number at least 20 days before the first class of each BLS course which it proposes to provide. Requests for a course number shall:</text> <paragraph num="(1)"> <text>Be sent to MIEMSS in an approved format; and</text> </paragraph> <paragraph num="(2)"> <text>Be signed by the program director.</text> </paragraph> </paragraph> <paragraph num="C."> <text>ALS Education Program.</text> <paragraph num="(1)"> <text>Approved ALS education programs may offer BLS courses.</text> </paragraph> <paragraph num="(2)"> <text>The ALS education program shall request MIEMSS approval of BLS courses and request a course number at least 20 days before the first class.</text> </paragraph> <paragraph num="(3)"> <text>Sections of the course application that parallel the ALS education program approval process may be waived if the ALS education program complies with COMAR 30.04.03.</text> </paragraph> <paragraph num="(4)"> <text>ALS education program requests for BLS course approval and a course number shall be sent to MIEMSS in an approved format and signed by the program director.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="No Effect On Other Laws."> <text>This chapter does not relieve the BLS education program from the requirements of any statute or regulation which would otherwise apply.</text> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1784)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12B amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17F amended effective October 3, 2011 (38:20 Md. R. 1205)</annotation> </annotations> </chapter> <chapter num="04" heading="Emergency Medical Dispatcher Education Programs"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs EMD education programs and EMD courses approved by the EMS Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Operational Policies."> <paragraph num="A."> <text>Each EMD education program shall have written criteria for:</text> <paragraph num="(1)"> <text>Admission;</text> </paragraph> <paragraph num="(2)"> <text>Frequent evaluation of each student during the course of study including evaluation of competency in providing patient care;</text> </paragraph> <paragraph num="(3)"> <text>Student requirements for:</text> <paragraph num="(a)"> <text>Attendance;</text> </paragraph> <paragraph num="(b)"> <text>Educational performance including:</text> <paragraph num="(i)"> <text>Attitudes;</text> </paragraph> <paragraph num="(ii)"> <text>Knowledge; and</text> </paragraph> <paragraph num="(iii)"> <text>Skills; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Behavior;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Student access to program information including:</text> <paragraph num="(a)"> <text>Fees;</text> </paragraph> <paragraph num="(b)"> <text>Requirements;</text> </paragraph> <paragraph num="(c)"> <text>Policies;</text> </paragraph> <paragraph num="(d)"> <text>Procedures; and</text> </paragraph> <paragraph num="(e)"> <text>Support services;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Selection of:</text> <paragraph num="(a)"> <text>A medical director;</text> </paragraph> <paragraph num="(b)"> <text>A program coordinator;</text> </paragraph> <paragraph num="(c)"> <text>Faculty; and</text> </paragraph> <paragraph num="(d)"> <text>Other necessary personnel;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Nondiscrimination and fair practices with regard to students, faculty and program personnel; and</text> </paragraph> <paragraph num="(7)"> <text>Review and improvement of the effectiveness of student evaluation techniques.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Organizational Chart."> <text>An EMD education program shall maintain an organizational chart that shows the relationship among students, the program coordinator, the medical director, and the instructors for each EMD course.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Records and Reports."> <paragraph num="A."> <text>Each EMD education program shall maintain accurate and appropriate records of:</text> <paragraph num="(1)"> <text>Students;</text> </paragraph> <paragraph num="(2)"> <text>Faculty; and</text> </paragraph> <paragraph num="(3)"> <text>Courses including:</text> <paragraph num="(a)"> <text>Course statistics; and</text> </paragraph> <paragraph num="(b)"> <text>Demographics of applicants.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Records shall be maintained for at least 5 years following course completion in a manner to prevent loss, destruction, or unauthorized use.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Content."> <paragraph num="A."> <text>Each EMD education program shall teach the appropriate EMD curriculum.</text> </paragraph> <paragraph num="B."> <text>Distance Education. A training program may utilize distance education for cognitive components of initial training leading to EMS licensure if the program:</text> <paragraph num="(1)"> <text>Demonstrates the methods of distance education utilized are educationally and technically appropriate for the content and audience; and</text> </paragraph> <paragraph num="(2)"> <text>Ensures the quality of the distance education method including:</text> <paragraph num="(a)"> <text>Learning and teaching considerations;</text> </paragraph> <paragraph num="(b)"> <text>Communication;</text> </paragraph> <paragraph num="(c)"> <text>Educational and technology design; and</text> </paragraph> <paragraph num="(d)"> <text>Program and system management.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Human Resources—General."> <paragraph num="A."> <text>There shall be written agreements and position descriptions stating the roles and responsibilities of the following program positions:</text> <paragraph num="(1)"> <text>Medical director;</text> </paragraph> <paragraph num="(2)"> <text>Program coordinator;</text> </paragraph> <paragraph num="(3)"> <text>Instructor.</text> </paragraph> </paragraph> <paragraph num="B."> <text>All education programs shall have adequate clerical and support staffing to provide for the program needs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Human Resources—Medical Director."> <paragraph num="A."> <text>Each EMD education program shall have a medical director who:</text> <paragraph num="(1)"> <text>Is a physician licensed to practice medicine in Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Has current working knowledge and experience in emergency medical care of acutely ill or injured patients;</text> </paragraph> <paragraph num="(3)"> <text>Has working knowledge of the Maryland EMS system;</text> </paragraph> <paragraph num="(4)"> <text>Has working knowledge of the Maryland Medical Protocols for Emergency Medical Services Providers; and</text> </paragraph> <paragraph num="(5)"> <text>Has current working knowledge of EMD operations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The medical director is responsible for oversight of the medical educational content of the EMD education program curriculum.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Human Resources—Program Coordinator."> <paragraph num="A."> <text>Each EMD education program shall have a program coordinator with:</text> <paragraph num="(1)"> <text>At least 3 years public safety call taking and call allocating experience;</text> </paragraph> <paragraph num="(2)"> <text>Experience in EMD education programs; and</text> </paragraph> <paragraph num="(3)"> <text>An EMD license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The program coordinator shall:</text> <paragraph num="(1)"> <text>Have overall responsibility for the success of the EMD education program including quality review and improvement; and</text> </paragraph> <paragraph num="(2)"> <text>Assist the medical director with the recruitment and selection of instructors.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Human Resources—Instructor."> <paragraph num="A."> <text>Each EMD course shall be taught by an EMD instructor, or an interim instructor under the supervision of an EMD instructor, who:</text> <paragraph num="(1)"> <text>Satisfies all of the following:</text> <paragraph num="(a)"> <text>Is certified as an MICRB Level II emergency services instructor who has successfully:</text> <paragraph num="(i)"> <text>Completed one didactic and one practical teaching session evaluated by an EMD instructor approved as an MICRB evaluator; and</text> </paragraph> <paragraph num="(ii)"> <text>Taught one EMD course as an interim instructor and been twice successfully evaluated by an EMD instructor approved as an MICRB evaluator;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has at least 3 years of public safety call taking and call allocating experience; and</text> </paragraph> <paragraph num="(c)"> <text>Is licensed as a Maryland EMD and ALS provider; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Is approved by a nationally recognized EMD education program approved by the EMS Board or the equivalent.</text> </paragraph> </paragraph> <paragraph num="B."> <text>An EMD instructor is responsible for:</text> <paragraph num="(1)"> <text>The education program instruction; and</text> </paragraph> <paragraph num="(2)"> <text>Any interim or additional EMD instructors assisting with the course.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The EMD instructor approval period shall be concurrent with the MICRB emergency services certification or the instructor approval period of a nationally recognized EMD education program approved by the EMS Board or the equivalent.</text> </paragraph> <paragraph num="D."> <text>EMD Instructor Renewal. An EMD instructor shall remain current by:</text> <paragraph num="(1)"> <text>Satisfying all of the following:</text> <paragraph num="(a)"> <text>Completing requirements as an MICRB instructor including:</text> <paragraph num="(i)"> <text>Receiving a satisfactory EMD course teaching evaluation and no subsequent unsatisfactory evaluations from an EMD instructor who is also an approved MICRB evaluator; and</text> </paragraph> <paragraph num="(ii)"> <text>Instructing at least 16 hours in an EMD course or, if a training supervisor, at least 4 hours in an EMD course; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Maintaining a Maryland EMD and ALS license; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintaining instructor approval by a nationally recognized EMD education program approved by the EMS Board or the equivalent.</text> </paragraph> </paragraph> <paragraph num="E."> <text>If qualified, the EMD instructor may also function as the EMD program coordinator.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Physical Resources."> <text>Each EMD education program shall have adequate space at instructional facilities to accommodate the program.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Financial Resources."> <text>Each EMD education program shall have sufficient financial resources to ensure complete EMD course delivery for all enrolled students.</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Special Needs."> <text>Each EMD education program shall advise MIEMSS in writing of any students requiring accommodations for documented disabilities at least 5 days before a scheduled licensure examination.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Program Evaluation."> <paragraph num="A."> <text>Each EMD education program shall have a written policy and procedure for evaluation of the EMD courses.</text> </paragraph> <paragraph num="B."> <text>The evaluation shall be annually and provide written evidence the program is meeting its objectives and changing needs of EMS care.</text> </paragraph> <paragraph num="C."> <text>The evaluation plan shall include methods for gathering and analyzing data on the effectiveness of the following:</text> <paragraph num="(1)"> <text>Instruction;</text> </paragraph> <paragraph num="(2)"> <text>Resources;</text> </paragraph> <paragraph num="(3)"> <text>Responsiveness to recommendations for change;</text> </paragraph> <paragraph num="(4)"> <text>EMD instructors; and</text> </paragraph> <paragraph num="(5)"> <text>Students' ability to function as entry-level providers upon successful completion of the EMD education program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The results of the evaluations shall provide the basis for continuous quality improvement and future direction of the EMD courses.</text> </paragraph> <paragraph num="E."> <text>Annual Report. Each EMD education program shall submit an annual report to MIEMSS in an approved format.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Curriculum and Education."> <paragraph num="A."> <text>The EMS Board shall establish standard curricula and learning objectives for the EMD education programs.</text> </paragraph> <paragraph num="B."> <text>Each EMD course shall prepare the student for entry-level practice.</text> </paragraph> <paragraph num="C."> <text>The amount of time devoted to the delivery of the EMD course may vary depending on the students' ability to demonstrate proficiency in the educational objectives utilizing:</text> <paragraph num="(1)"> <text>Written examinations;</text> </paragraph> <paragraph num="(2)"> <text>Oral examinations; and</text> </paragraph> <paragraph num="(3)"> <text>Practical examinations.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="EMD Education Program Approval."> <paragraph num="A."> <text>An EMD education program shall apply for approval by submitting a MEIMSS-approved application and a copy of the course curriculum to MIEMSS, Office of Education, Licensure, and Certification, EMD Program, 653 West Pratt Street, Baltimore, Maryland 21201-1528.</text> </paragraph> <paragraph num="B."> <text>An EMD education program providing EMD courses on the effective date of this regulation may continue to offer EMD courses for not more than 3 years from that date unless the program is approved under this chapter.</text> </paragraph> <paragraph num="C."> <text>Site Visit.</text> <paragraph num="(1)"> <text>After a completed application is accepted by MIEMSS, a site visit shall be scheduled at a mutually convenient time.</text> </paragraph> <paragraph num="(2)"> <text>The site review team shall be selected by MIEMSS and consist of:</text> <paragraph num="(a)"> <text>A system medical director or an EMD education program medical director;</text> </paragraph> <paragraph num="(b)"> <text>A BLS instructor or EMD program director;</text> </paragraph> <paragraph num="(c)"> <text>MIEMSS representative; and</text> </paragraph> <paragraph num="(d)"> <text>Others as necessary.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an applicant can demonstrate a reasonable basis for concern, MIEMSS shall consider allegations that conflicts of interest exist between a site reviewer and an applicant.</text> </paragraph> <paragraph num="(4)"> <text>The site review team shall send a written report to MIEMSS within 30 days after the site visit.</text> </paragraph> <paragraph num="(5)"> <text>The site review team and MIEMSS shall finalize the site visit and report and MIEMSS shall submit a recommendation to the EMS Board.</text> </paragraph> </paragraph> <paragraph num="D."> <text>EMS Board Action.</text> <paragraph num="(1)"> <text>Five-Year Approval. If the EMS Board determines that the applicant meets the requirements of this chapter, the EMS Board shall grant the applicant a 5-year approval as an EMD education program.</text> </paragraph> <paragraph num="(2)"> <text>To maintain approval the EMD education program shall:</text> <paragraph num="(a)"> <text>Comply with COMAR 30.04.04;</text> </paragraph> <paragraph num="(b)"> <text>Advise MIEMSS in writing within 30 days of any changes in:</text> <paragraph num="(i)"> <text>Program personnel other than instructors;</text> </paragraph> <paragraph num="(ii)"> <text>Organizational changes; or</text> </paragraph> <paragraph num="(iii)"> <text>Programmatic changes;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Maintain a process of continuous quality improvement; and</text> </paragraph> <paragraph num="(d)"> <text>Conduct at least one full length EMD course every 2 years.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provisional Approval.</text> <paragraph num="(a)"> <text>If the EMS Board determines that the application and the site visit indicate limitations in meeting requirements for full approval, it may approve the application provisionally on the conditions and for the provisional period, including any extensions, which the EMS Board deems appropriate.</text> </paragraph> <paragraph num="(b)"> <text>An applicant receiving provisional approval shall submit written progress reports to MIEMSS as required by the EMS Board.</text> </paragraph> <paragraph num="(c)"> <text>MIEMSS may conduct one or more additional site visits to verify the resolution of limitations.</text> </paragraph> <paragraph num="(d)"> <text>Before any additional site visit, the applicant shall prepare a revised report that includes changes made since the prior site visit.</text> </paragraph> <paragraph num="(e)"> <text>Upon satisfactory resolution of limitations, or at the end of the provisional period, including any extensions, the EMS Board shall:</text> <paragraph num="(i)"> <text>Confer approval for the remainder of the 5-year period if the applicant has satisfied all requirements for approval; or</text> </paragraph> <paragraph num="(ii)"> <text>Deny or revoke approval.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Denial or Revocation of Approval. The EMS Board may deny or revoke program approval if an EMD education program is not in compliance with this chapter. The program shall be notified by mail of the EMS Board's decision. If the decision is other than a 5-year approval, the notice shall:</text> <paragraph num="(a)"> <text>State the reasons for the decision;</text> </paragraph> <paragraph num="(b)"> <text>Advise the EMD education program of appeal rights; and</text> </paragraph> <paragraph num="(c)"> <text>Otherwise comply with State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>MIEMSS personnel may attend course sessions for quality assurance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Renewal."> <text>EMD education programs shall make application for renewal of approval at least 6 months before the expiration of current approval.</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Course Number."> <paragraph num="A."> <text>Each EMD course shall have a number assigned by MIEMSS.</text> </paragraph> <paragraph num="B."> <text>An EMD education program approved under this chapter shall apply for EMD course approval and a course number for each course it proposes to provide by submitting a MIEMSS-approved application at least 20 days before the first class to MIEMSS, Office of Education, Licensure, and Certification, EMD Programs, 653 West Pratt Street, Baltimore, Maryland 21201-1528.</text> </paragraph> <paragraph num="C."> <text>Requests for approval of EMD courses shall be signed by the program director.</text> </paragraph> <paragraph num="D."> <text>ALS and BLS Education Programs.</text> <paragraph num="(1)"> <text>EMS Board approved ALS and BLS education programs may offer EMD education courses in accordance with this chapter.</text> </paragraph> <paragraph num="(2)"> <text>The ALS or BLS education program shall request MIEMSS approval of an EMD course and request a course number at least 20 days before the first class of each course which the program purposes to provide.</text> </paragraph> <paragraph num="(3)"> <text>Sections of the course application that parallel the ALS or BLS education program approval process may be waived if the ALS or BLS education program complies with COMAR 30.04.04.</text> </paragraph> <paragraph num="(4)"> <text>ALS or BLS education program requests for EMD course approval and a course number shall be signed by the program director and sent to MIEMSS in a MIEMSS-approved format.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Nationally Recognized Programs.</text> <paragraph num="(1)"> <text>An EMS Board approved nationally recognized EMD education program or the equivalent as determined by the EMS Board may offer EMD education courses.</text> </paragraph> <paragraph num="(2)"> <text>The nationally recognized EMD education program or equivalent shall request an EMD course number at least 20 days before the first class of each course it proposes to provide.</text> </paragraph> <paragraph num="(3)"> <text>The request shall be filed with MIEMSS in a format approved by MIEMSS.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="No Effect on Other Laws."> <text>This chapter does not relieve the EMD education program from the requirements of any statute or regulation which would otherwise apply.</text> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1784)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15D amended effective October 3, 2011 (38:20 Md. R. 1205)</annotation> </annotations> </chapter> <chapter num="05" heading="Continuing Education"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs MIEMSS-approved continuing education courses for renewal of licensure or certification for Maryland EMS providers.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Continuing Education Courses Eligible for Credit under COMAR 30.02.02.07."> <paragraph num="A."> <text>Skills and full refresher courses eligible for credit under COMAR 30.02.02.07 shall be provided under the requirements of this chapter by EMS Board approved:</text> <paragraph num="(1)"> <text>ALS education programs;</text> </paragraph> <paragraph num="(2)"> <text>BLS education programs;</text> </paragraph> <paragraph num="(3)"> <text>EMD education programs; or</text> </paragraph> <paragraph num="(4)"> <text>Programs listed in COMAR 30.04.05.02C which:</text> <paragraph num="(a)"> <text>Complete an application approved by MIEMSS;</text> </paragraph> <paragraph num="(b)"> <text>Have policies and procedures in place which address:</text> <paragraph num="(i)"> <text>Student attendance;</text> </paragraph> <paragraph num="(ii)"> <text>Nondiscrimination and fair practices with regard to students, faculty, and program personnel;</text> </paragraph> <paragraph num="(iii)"> <text>Selection of a medical director, coordinator, and faculty;</text> </paragraph> <paragraph num="(iv)"> <text>Evaluation of the courses and evidence to demonstrate continuous quality improvement; and</text> </paragraph> <paragraph num="(v)"> <text>Record maintenance for at least 5 years following course completion in a manner to prevent loss, destruction, or unauthorized use;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Have adequate physical resources to effectively deliver courses including necessary equipment;</text> </paragraph> <paragraph num="(d)"> <text>Have sufficient financial resources to ensure complete course delivery for all enrolled students;</text> </paragraph> <paragraph num="(e)"> <text>Have faculty or instructors approved by the medial director;</text> </paragraph> <paragraph num="(f)"> <text>Utilize only emergency medical technician refresher or skills courses instructors who meet the requirements under COMAR 30.04.03.09; and</text> </paragraph> <paragraph num="(g)"> <text>Submit an annual report to MIEMSS in an approved format.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The period for which EMS Board approval for programs offering skills and full refresher courses is valid:</text> <paragraph num="(1)"> <text>Coincides with the program approval for approved ALS, BLS, or EMD education programs; and</text> </paragraph> <paragraph num="(2)"> <text>Is 5 years for other programs.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Other continuing education courses eligible for credit under COMAR 30.02.02.07 shall be provided by:</text> <paragraph num="(1)"> <text>EMS operational programs;</text> </paragraph> <paragraph num="(2)"> <text>Hospitals accredited by the Joint Commission on Accreditation of Healthcare Organizations;</text> </paragraph> <paragraph num="(3)"> <text>EMS Board approved proprietary education programs;</text> </paragraph> <paragraph num="(4)"> <text>Entities accredited by the Emergency Numbers Systems Board; or</text> </paragraph> <paragraph num="(5)"> <text>Education programs listed in §A of this regulation.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Distance Education.</text> <paragraph num="(1)"> <text>Scope. Training programs may use distance education for cognitive components of continuing education leading to EMS relicensure or recertification if the program:</text> <paragraph num="(a)"> <text>Demonstrates the methods of distance education used are educationally and technically appropriate for the content and audience; and</text> </paragraph> <paragraph num="(b)"> <text>Ensures the quality of the distance education method including:</text> <paragraph num="(i)"> <text>Learning and teaching considerations;</text> </paragraph> <paragraph num="(ii)"> <text>Communication;</text> </paragraph> <paragraph num="(iii)"> <text>Educational and technology design; and</text> </paragraph> <paragraph num="(iv)"> <text>Program and system management.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Distance education programs may apply for a course number and approval as outlined in Regulation .06 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Records and Reports."> <paragraph num="A."> <text>Each continuing education program shall maintain accurate and appropriate records including:</text> <paragraph num="(1)"> <text>Student attendance records;</text> </paragraph> <paragraph num="(2)"> <text>Names of instructors;</text> </paragraph> <paragraph num="(3)"> <text>Presentation outlines;</text> </paragraph> <paragraph num="(4)"> <text>Objectives;</text> </paragraph> <paragraph num="(5)"> <text>Handouts; and</text> </paragraph> <paragraph num="(6)"> <text>An evaluation mechanism.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Records shall be securely maintained to prevent loss, destruction, or unauthorized use for at least 5 years following course completion.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Instructors."> <paragraph num="A."> <text>All non-distance education continuing education courses shall be taught by:</text> <paragraph num="(1)"> <text>An ALS faculty member of an ALS education program;</text> </paragraph> <paragraph num="(2)"> <text>An EMS Board approved proprietary education program instructor;</text> </paragraph> <paragraph num="(3)"> <text>An EMS operational program medical director or designee who has experience or knowledge with the topic to be presented;</text> </paragraph> <paragraph num="(4)"> <text>An EMD, emergency medical technician, or EMR instructor; or</text> </paragraph> <paragraph num="(5)"> <text>A certified MICRB emergency services instructor.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The following continuing education instructors shall teach skills at the level for which they are approved:</text> <paragraph num="(1)"> <text>EMD instructors may only teach EMD material;</text> </paragraph> <paragraph num="(2)"> <text>EMR instructors may only teach EMR material;</text> </paragraph> <paragraph num="(3)"> <text>Emergency medical technician instructors may only teach BLS material;</text> </paragraph> <paragraph num="(4)"> <text>ALS faculty may only teach material they are approved to teach in their ALS education program; and</text> </paragraph> <paragraph num="(5)"> <text>MICRB-certified instructors may only teach the material they are approved to teach with their education program.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Approval and Course Number."> <paragraph num="A."> <text>Each continuing education course shall have a number assigned by MIEMSS.</text> </paragraph> <paragraph num="B."> <text>Except as provided in §E of this regulation, each person shall apply for approval of each continuing education course they propose to offer, and for a course number, by submitting a MIEMSS-approved application at least 14 days before the course begins to MIEMSS, Office of Education, Licensure, and Certification, Continuing Education, 653 West Pratt Street, Baltimore, Maryland 21201-1528.</text> </paragraph> <paragraph num="C."> <text>If MIEMSS determines that the continuing education course is in compliance with this chapter, MIEMSS shall assign:</text> <paragraph num="(1)"> <text>The course's continuing education category;</text> </paragraph> <paragraph num="(2)"> <text>The number of credit hours which can be obtained from the course; and</text> </paragraph> <paragraph num="(3)"> <text>A course number.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Continuing education courses that are statewide or nationally recognized may be assigned a permanent course number by MIEMSS. A course with a permanent number may be offered without further approval from MIEMSS if it continues to meet the requirements of this chapter.</text> </paragraph> <paragraph num="E."> <text>Continuing education courses developed, designed, and used at or within an EMS operational program shall be coordinated through that EMS operational program. The request for MIEMSS approval of these courses shall be reviewed by the EMS operational program.</text> </paragraph> <paragraph num="F."> <text>MIEMSS may deny or revoke course approval if a continuing education course is not in compliance with this chapter. The continuing education course shall be notified by mail of MIEMSS' decision. The notice shall:</text> <paragraph num="(1)"> <text>State the reasons for the decision;</text> </paragraph> <paragraph num="(2)"> <text>Advise the continuing education course of appeal rights; and</text> </paragraph> <paragraph num="(3)"> <text>Otherwise comply with State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="G."> <text>MIEMSS personnel may attend course sessions for quality assurance.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Other Courses."> <paragraph num="A."> <text>Requests for approval of credit for continuing education courses for other courses attended shall be submitted to MIEMSS accompanied by:</text> <paragraph num="(1)"> <text>Documentation of successful completion; and</text> </paragraph> <paragraph num="(2)"> <text>Course content.</text> </paragraph> </paragraph> <paragraph num="B."> <text>CAPCE-approved continuing education shall be submitted to MIEMSS for approval.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1784)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective September 27, 2007 (31:19 Md. R. 1434)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective April 9, 2018 (45:7 Md. R. 347)</annotation> </annotations> </chapter> <chapter num="06" heading="Curricula Approval"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs EMS Board approval of curricula for Maryland EMS licensure, certification, or renewal.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Approval of Curricula."> <paragraph num="A."> <text>To be eligible for approval, a curriculum shall:</text> <paragraph num="(1)"> <text>Be submitted to MIEMSS;</text> </paragraph> <paragraph num="(2)"> <text>Contain cognitive, psychomotor, and affective learning objectives specific to EMS providers; and</text> </paragraph> <paragraph num="(3)"> <text>Conform with, and instruct, current acceptable EMS standards.</text> </paragraph> </paragraph> <paragraph num="B."> <text>EMS Board Action.</text> <paragraph num="(1)"> <text>Upon the recommendation of MIEMSS concerning a curriculum, the EMS Board shall:</text> <paragraph num="(a)"> <text>Approve the curriculum for a particular level of EMS education;</text> </paragraph> <paragraph num="(b)"> <text>Approve the curriculum for a pilot program; or</text> </paragraph> <paragraph num="(c)"> <text>Deny or revoke approval of the curriculum.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>To maintain approval by the EMS Board, a curriculum shall be updated to remain current with nationally accepted healthcare provider standards.</text> </paragraph> </paragraph> <paragraph num="C."> <text>All EMS Board approved curricula used for training EMS providers as of the effective date of these regulations are deemed approved by the EMS Board under this regulation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1784)</annotation> </annotations> </chapter> <chapter num="07" heading="Appeals"> <regulation prefix="Regulation" num=".01" heading="Appeal."> <paragraph num="A."> <text>A person may appeal to the EMS Board from a decision by MIEMSS or the EMS Board under this subtitle by filing a notice of appeal with MIEMSS within 15 days after receipt of the decision.</text> </paragraph> <paragraph num="B."> <text>A person who files an appeal will be granted a hearing before the EMS Board or, if the Board so elects and notifies the appellant, the Office of Administrative Hearings.</text> </paragraph> <paragraph num="C."> <text>An appeal hearing shall be governed by COMAR 28.02.01.</text> </paragraph> <paragraph num="D."> <text>If the hearing is conducted by the Office of Administrative Hearings, the hearing procedures of COMAR 30.02.06.22 and .23 also apply.</text> </paragraph> <paragraph num="E."> <text>The EMS Board may make the final decision in any appeal as provided by COMAR 30.02.06.23.</text> </paragraph> <paragraph num="F."> <text>A person may seek judicial review of the EMS Board's final decision under the State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-516(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2001 (28:20 Md. R. 1784)</annotation> </annotations> </chapter> <chapter num="08" heading="Specialty Care Transport Education Courses"> <regulation prefix="Regulation" num=".01" heading="Scope"> <text>This chapter governs ALS education programs approved by the EMS Board which have been approved to provide education in specialty care transport.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements."> <paragraph num="A."> <text>In order to be approved to provide a specialty care transport education course, an education program shall:</text> <paragraph num="(1)"> <text>Meet all requirements for an ALS education program found in COMAR 30.04.02 except for the requirement in COMAR 30.04.02.12F(2)(d) to conduct at least one full length ALS course every 2 years;</text> </paragraph> <paragraph num="(2)"> <text>Have a medical director who, in addition to the other requirements for medical directors in COMAR 30.04.02.06B:</text> <paragraph num="(a)"> <text>Has education and experience in the care of critically ill patients; and</text> </paragraph> <paragraph num="(b)"> <text>Uses specialty physicians as appropriate;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Use a curriculum which has been approved by the EMS Board; and</text> </paragraph> <paragraph num="(4)"> <text>Use instructors who:</text> <paragraph num="(a)"> <text>Meet the requirements of COMAR 30.04.02; and</text> </paragraph> <paragraph num="(b)"> <text>Have additional education, experience, and expertise in the care and transport of a critically ill patient.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-509 and 13-516, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 15, 2005 (31:26 Md. R. 1866)</annotation> </annotations> </chapter> </subtitle> <subtitle num="05" heading="Emergency Medical Services Regions and Regional Programs"> <chapter num="01" heading="Regional EMS Advisory Councils"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the organization of regional emergency medical services (EMS) councils pursuant to the general administrative authority of the EMS Board.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Regional EMS council (regional council)” means an EMS advisory body created by this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="EMS Regions."> <paragraph num="A."> <text>The State is organized in five regions to coordinate EMS activities.</text> </paragraph> <paragraph num="B."> <text>Region I consists of:</text> <paragraph num="(1)"> <text>Allegany County; and</text> </paragraph> <paragraph num="(2)"> <text>Garrett County.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Region II consists of:</text> <paragraph num="(1)"> <text>Frederick County; and</text> </paragraph> <paragraph num="(2)"> <text>Washington County.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Region III consists of:</text> <paragraph num="(1)"> <text>Baltimore City;</text> </paragraph> <paragraph num="(2)"> <text>Anne Arundel County;</text> </paragraph> <paragraph num="(3)"> <text>Baltimore County;</text> </paragraph> <paragraph num="(4)"> <text>Carroll County;</text> </paragraph> <paragraph num="(5)"> <text>Harford County; and</text> </paragraph> <paragraph num="(6)"> <text>Howard County.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Region IV consists of:</text> <paragraph num="(1)"> <text>Caroline County;</text> </paragraph> <paragraph num="(2)"> <text>Cecil County;</text> </paragraph> <paragraph num="(3)"> <text>Dorchester County;</text> </paragraph> <paragraph num="(4)"> <text>Kent County;</text> </paragraph> <paragraph num="(5)"> <text>Queen Anne's County;</text> </paragraph> <paragraph num="(6)"> <text>Somerset County;</text> </paragraph> <paragraph num="(7)"> <text>Talbot County;</text> </paragraph> <paragraph num="(8)"> <text>Wicomico County; and</text> </paragraph> <paragraph num="(9)"> <text>Worchester County.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Region V consists of:</text> <paragraph num="(1)"> <text>Calvert County;</text> </paragraph> <paragraph num="(2)"> <text>Charles County;</text> </paragraph> <paragraph num="(3)"> <text>Montgomery County;</text> </paragraph> <paragraph num="(4)"> <text>Prince George's County; and</text> </paragraph> <paragraph num="(5)"> <text>St. Mary's County.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Regional EMS Councils."> <paragraph num="A."> <text>In each region, a regional EMS council shall advise MIEMSS and EMS operational programs in that region on matters concerning the delivery of emergency medical services.</text> </paragraph> <paragraph num="B."> <text>Each region shall appoint members to serve on its regional EMS council according to the by-laws of the regional council.</text> </paragraph> <paragraph num="C."> <text>The members shall include representatives in the region from:</text> <paragraph num="(1)"> <text>Jurisdictional EMS operational programs;</text> </paragraph> <paragraph num="(2)"> <text>Commercial ambulance services;</text> </paragraph> <paragraph num="(3)"> <text>Local governments;</text> </paragraph> <paragraph num="(4)"> <text>Public safety answering points;</text> </paragraph> <paragraph num="(5)"> <text>Hospital administration;</text> </paragraph> <paragraph num="(6)"> <text>Dispatch centers; and</text> </paragraph> <paragraph num="(7)"> <text>The following providers:</text> <paragraph num="(a)"> <text>Volunteer EMS;</text> </paragraph> <paragraph num="(b)"> <text>Career EMS;</text> </paragraph> <paragraph num="(c)"> <text>Medical directors; and</text> </paragraph> <paragraph num="(d)"> <text>Nurses.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of Regional EMS Councils."> <text>Each regional EMS council shall:</text> <paragraph num="A."> <text>Advise MIEMSS on matters of policy, protocols, rules, and regulations;</text> </paragraph> <paragraph num="B."> <text>Provide a representative to the State Emergency Medical Services Advisory Council and specified subcommittees formed by MIEMSS;</text> </paragraph> <paragraph num="C."> <text>Recommend to the State EMS Medical Director candidates for regional medical director;</text> </paragraph> <paragraph num="D."> <text>Recommend to the Associate State EMS Medical Director for Pediatrics candidates for associate regional medical director for pediatrics;</text> </paragraph> <paragraph num="E."> <text>Solicit and prioritize expressions of interest for highway safety grants awarded by the federal or State government;</text> </paragraph> <paragraph num="F."> <text>Advise the following on matters concerning emergency medical services:</text> <paragraph num="(1)"> <text>State government;</text> </paragraph> <paragraph num="(2)"> <text>Local governments; and</text> </paragraph> <paragraph num="(3)"> <text>EMS operational programs;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Serve as a forum for coordinating EMS activities among EMS operational programs in the region; and</text> </paragraph> <paragraph num="H."> <text>Establish interjurisdictional quality assurance and quality improvement programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Assistance from MIEMSS."> <text>MIEMSS shall provide regional EMS councils:</text> <paragraph num="A."> <text>Administrative and programmatic support;</text> </paragraph> <paragraph num="B."> <text>Assistance in implementing projects sponsored by MIEMSS and the regional councils;</text> </paragraph> <paragraph num="C."> <text>Regular communications about State EMS activities;</text> </paragraph> <paragraph num="D."> <text>Technical assistance in developing the following materials related to the delivery of emergency medical services:</text> <paragraph num="(1)"> <text>Guidelines;</text> </paragraph> <paragraph num="(2)"> <text>Models;</text> </paragraph> <paragraph num="(3)"> <text>Procedures;</text> </paragraph> <paragraph num="(4)"> <text>Manuals; and</text> </paragraph> <paragraph num="(5)"> <text>Summary reports on EMS activities in each region.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Advice from Regional EMS Councils."> <paragraph num="A."> <text>Each regional EMS council shall be MIEMSS' primary advisory body for its region.</text> </paragraph> <paragraph num="B."> <text>MIEMSS is not required to accept or implement any regional EMS council recommendation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2002 (29:12 Md. R. 932)</annotation> </annotations> </chapter> </subtitle> <subtitle num="06" heading="Public Access Automated External Defibrillator Program"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Automated external defibrillator (AED)” means a medical heart monitor and defibrillator device that:</text> <paragraph num="(a)"> <text>Is cleared for market by the federal Food and Drug Administration;</text> </paragraph> <paragraph num="(b)"> <text>Recognizes the presence or absence of ventricular fibrillation or rapid ventricular tachycardia;</text> </paragraph> <paragraph num="(c)"> <text>Determines, without intervention by the operator, whether defibrillation should be performed;</text> </paragraph> <paragraph num="(d)"> <text>On determining that defibrillation should be performed, automatically charges; and</text> </paragraph> <paragraph num="(e)"> <text>Either:</text> <paragraph num="(i)"> <text>Requires operator intervention to deliver the electrical impulse, or</text> </paragraph> <paragraph num="(ii)"> <text>Automatically continues with delivery of electrical impulse.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Event (code) summary” means the electronic report of an AED operation produced by an AED.</text> </paragraph> <paragraph num="(3)"> <text>“Expected operator” means any individual identified by a registered facility to operate an AED at a registered facility</text> </paragraph> <paragraph num="(4)"> <text>“Facility” means an agency, association, corporation, firm, partnership, or other entity.</text> </paragraph> <paragraph num="(5)"> <text>“Operate” means to use or attempt to use an AED to defibrillate an individual whether or not any electrical impulse is delivered.</text> </paragraph> <paragraph num="(6)"> <text>“Public safety answering point (PSAP)” has the meaning stated in Public Safety Article, §1-301(q), Annotated Code of Maryland.</text> </paragraph> <paragraph num="(7)"> <text>Registered Facility.</text> <paragraph num="(a)"> <text>“Registered facility” means an organization, business, association, or agency that meets the requirements of the EMS Board for providing automated external defibrillation.</text> </paragraph> <paragraph num="(b)"> <text>“Registered facility” may include multiple sites.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>“Response” means the removal of the AED from its storage location for the purposes of rendering care whether or not the care is actually rendered.</text> </paragraph> <paragraph num="(9)"> <text>“Site” means a building, plant, unit, branch, vehicle, or other ancillary location that is part of or affiliated with a facility.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-517, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 142); adopted permanently effective April 17, 2000 (27:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective June 5, 2006 (33:11 Md. R. 952); May 4, 2009 (36:9 Md. R. 654); January 7, 2013 (39:26 Md. R. 1666)</annotation> </annotations> </chapter> <chapter num="02" heading="Approval of Facilities and Compliance"> <regulation prefix="Regulation" num=".01" heading="Criteria for Registration of Facilities."> <text>To be eligible for registration, or renewal of registration, to operate an AED under this subtitle, a registered facility shall:</text> <paragraph num="A."> <text>Designate an AED coordinator who shall:</text> <paragraph num="(1)"> <text>Have successfully completed CPR and AED Training, and subsequent refresher training, in accordance with their training course requirements that at a minimum includes content consistent with the recommendations for layperson CPR and AED training in the most current publication of the American Heart Association Guidelines for CPR and ECC;</text> </paragraph> <paragraph num="(2)"> <text>Be responsible for implementing and administering the AED program at the registered facility; and</text> </paragraph> <paragraph num="(3)"> <text>Ensure that monthly safety inspections of all supplemental and AED equipment, including assurance of adequate battery charge, per the manufacturer’s guidelines are conducted and maintain written logs of the inspections.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Provide information regarding the operation, maintenance, and location of the registered facility's AEDs to all individuals employed by or volunteering for the registered facility;</text> </paragraph> <paragraph num="C."> <text>Place all AEDs in locations which are visible and readily accessible to any person willing to operate the AED in the event of a cardiac arrest;</text> </paragraph> <paragraph num="D."> <text>Have a telephone or other communication service available at all times at each site at which an AED is operated, for the notification of the public safety answering point;</text> </paragraph> <paragraph num="E."> <text>Submit data or other information concerning the AED program which may be periodically requested by MIEMSS; and</text> </paragraph> <paragraph num="F."> <text>Ensure that expected operators have completed CPR and AED Training, and subsequent refresher training, in accordance with their training course requirements that at a minimum includes content consistent with the recommendations for layperson CPR and AED training in the most current publication of the American Heart Association Guidelines for CPR and ECC.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Protocol."> <text>All personnel who are expected to operate an AED at a registered facility shall utilize the AED in accordance with their training. When an individual's training conflicts with the auditory and visual prompts of the device, the individual shall follow the auditory and visual prompts.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Quality Assurance and Maintenance."> <text>Each registered facility shall:</text> <paragraph num="A."> <text>Comply the federal Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992;</text> </paragraph> <paragraph num="B."> <text>Maintain:</text> <paragraph num="(1)"> <text>The certificate issued by MIEMSS in a place where it is readily available;</text> </paragraph> <paragraph num="(2)"> <text>Each AED and all related equipment and supplies in accordance with the standards established by the device manufacturer and the federal Food and Drug Administration;</text> </paragraph> <paragraph num="(3)"> <text>Supplemental equipment with the AED at all times as follows:</text> <paragraph num="(a)"> <text>Two sets of defibrillator chest pads;</text> </paragraph> <paragraph num="(b)"> <text>Disposable gloves; and</text> </paragraph> <paragraph num="(c)"> <text>Maryland Facility AED Report Forms for Cardiac Arrest;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Submit:</text> <paragraph num="(1)"> <text>A report for each incident of suspected cardiac arrest at the facility on the Maryland Facility AED Report Form for Cardiac Arrests, including, when available, any event (code) summary, recording, or tape created by the AED to MIEMSS, and be available for follow up as necessary; and</text> </paragraph> <paragraph num="(2)"> <text>If the AED fails when operated, in addition to submitting the required report to the federal Food and Drug Administration, a copy of the report to MIEMSS; and</text> </paragraph> </paragraph> <paragraph num="D."> <text>Ensure the confidentiality of any medical records maintained by the registered facility as required by law.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Application and Registration Process."> <paragraph num="A."> <text>A facility seeking registration or renewal of registration shall submit an application and all required documentation to MIEMSS on the form required by MIEMSS.</text> </paragraph> <paragraph num="B."> <text>MIEMSS may make the inspection and require the verification necessary to ensure that an applicant meets the requirements of this chapter, including an inspection of the facility, any sites, equipment, and records.</text> </paragraph> <paragraph num="C."> <text>MIEMSS shall issue a certificate of registration or renewal to a facility that meets the requirements of Regulation .01 of this chapter.</text> </paragraph> <paragraph num="D."> <text>The certificate of registration or renewal is valid for a period of 3 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Denial of Registration."> <paragraph num="A."> <text>MIEMSS may deny an application if it finds that the applicant fails to meet the requirements of this chapter.</text> </paragraph> <paragraph num="B."> <text>Notice of Denial.</text> <paragraph num="(1)"> <text>MIEMSS shall issue a written notice of denial to an applicant that includes the reasons for denial.</text> </paragraph> <paragraph num="(2)"> <text>The notice shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant denied approval may file an appeal with the EMS Board under Regulation .05 of this chapter.</text> </paragraph> <paragraph num="D."> <text>If an applicant does not file a timely appeal under Regulation .05 of this chapter, the decision is final.</text> </paragraph> <paragraph num="E."> <text>If an application is denied, the applicant may reapply under this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Compliance."> <paragraph num="A."> <text>MIEMSS may initiate a compliance review of a registered facility upon information that the registered facility has failed to comply with this subtitle.</text> </paragraph> <paragraph num="B."> <text>MIEMSS shall give written notice of the compliance review to the registered facility.</text> </paragraph> <paragraph num="C."> <text>In the course of its compliance review, MIEMSS may:</text> <paragraph num="(1)"> <text>Inspect all:</text> <paragraph num="(a)"> <text>Sites where the registered facility maintains an AED;</text> </paragraph> <paragraph num="(b)"> <text>Records relating to the AED maintained by the facility; and</text> </paragraph> <paragraph num="(c)"> <text>Equipment related to the AED; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Interview employees of the registered facility regarding the AED program.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If MIEMSS finds that a registered facility has failed to comply with this subtitle, MIEMSS may:</text> <paragraph num="(1)"> <text>Suspend the facility's registration;</text> </paragraph> <paragraph num="(2)"> <text>Revoke the facility's registration;</text> </paragraph> <paragraph num="(3)"> <text>Refuse to renew a facility's registration; or</text> </paragraph> <paragraph num="(4)"> <text>Take other action as appropriate.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Within 30 days after the conclusion of the compliance review, MIEMSS shall provide its findings, decision and any proposed action in writing to the:</text> <paragraph num="(1)"> <text>Registered facility; and</text> </paragraph> <paragraph num="(2)"> <text>EMS Board.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The report shall:</text> <paragraph num="(1)"> <text>Conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Contain the reasons for the decision and the proposed action.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Upon receipt of the report and proposed action, a registered facility may file an appeal with the EMS Board under Regulation .05 of this chapter.</text> </paragraph> <paragraph num="H."> <text>If an applicant does not file a timely appeal under Regulation .05 of this chapter, MIEMSS' proposed decision is final.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Procedure for Appeals."> <paragraph num="A."> <text>An applicant or registered facility may appeal a disputed decision by filing a notice of appeal to the EMS Board with the Executive Director of MIEMSS not later than 20 days after receipt of the decision.</text> </paragraph> <paragraph num="B."> <text>The appeal shall state with specificity the reasons why the disputed decision should be modified.</text> </paragraph> <paragraph num="C."> <text>An applicant or registered facility that files an appeal shall be granted a hearing before the:</text> <paragraph num="(1)"> <text>EMS Board; or</text> </paragraph> <paragraph num="(2)"> <text>Office of Administrative Hearings, if the Board so elects and notifies the applicant or registered facility.</text> </paragraph> </paragraph> <paragraph num="D."> <text>An appeal hearing shall be governed by COMAR 28.02.01.</text> </paragraph> <paragraph num="E."> <text>If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply.</text> </paragraph> <paragraph num="F."> <text>An applicant or registered facility which has participated in a hearing under this regulation may seek judicial review of the EMS Board's final action under State Government Article, §10-222, Annotated Code of Maryland. The EMS Board shall be party to the proceeding.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Confidentiality of Records."> <text>MIEMSS shall maintain the confidentiality of records referred to in this subtitle in accordance with:</text> <paragraph num="A."> <text>Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Health Occupations Article, Title 1, Subtitle 4, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="C."> <text>General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-517, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 142); adopted permanently effective April 17, 2000 (27:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 5, 2006 (33:11 Md. R. 952); May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01I amended and J adopted effective March 31, 2003 (30:6 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 7, 2013 (39:26 Md. R. 1666)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08C amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> </annotations> </chapter> <chapter num="03" heading="Protocol"> <regulation prefix="Regulation" num=".01" heading="Repealed." /> <annotations> <annotation type="Authority">Education Article, §13-517, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 142); adopted permanently effective April 17, 2000 (27:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 31, 2003 (30:6 Md. R. 423); October 15, 2004 (31:20 Md. R. 1486); June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted as an emergency provision effective December 15, 2006 (34:3 Md. R. 296); emergency status extended at 34:13 Md. R. 1150</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 repealed and new Regulation .03 adopted effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 28, 2011 (38:24 Md. R. 1503)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 repealed effective January 7, 2013 (39:26 Md. R. 1666)</annotation> </annotations> </chapter> <chapter num="04" heading="Quality Assurance and Maintenance" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 142); adopted permanently effective April 17, 2000 (27:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B, C amended effective June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective March 31, 2003 (30:6 Md. R. 423); June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02E amended effective June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02 repealed effective January 7, 2013 (39:26 Md. R. 1666)</annotation> </annotations> </chapter> <chapter num="05" heading="Training Programs" reason="Repealed"> <annotations> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 adopted as an emergency provision effective January 1, 2000 (27:2 Md. R. 142); adopted permanently effective April 17, 2000 (27:7 Md. R. 707)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective October 15, 2004 (31:20 Md. R. 1486); June 5, 2006 (33:11 Md. R. 952); May 4, 2009 (36:9 Md. R. 654)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C amended and D adopted effective March 31, 2003 (30:6 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective March 31, 2003 (30:6 Md. R. 423)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 repealed effective January 7, 2013 (39:26 Md. R. 1666)</annotation> </annotations> </chapter> </subtitle> <subtitle num="07" heading="Emergency Medical Services Communications System"> <chapter num="01" heading="Helicopter Communications"> <regulation prefix="Regulation" num=".01" heading="Helicopter Communications to SYSCOM."> <paragraph num="A."> <text>Definitions.</text> <paragraph num="(1)"> <text>“7AG60” means the conventional 700MHz National Interoperability channel designated for commercial and non-allied helicopter communications with SYSCOM.</text> </paragraph> <paragraph num="(2)"> <text>“7AIRMED” means the conventional 700MHz multicast radio system operated by MIEMSS to provide medical communications with commercial and non-allied helicopters.</text> </paragraph> <paragraph num="(3)"> <text>“EMRC” means the Emergency Medical Resource Center operated by MIEMSS for the Emergency Medical Services Communications System.</text> </paragraph> <paragraph num="(4)"> <text>“EMSCS” means the Emergency Medical Services Communications System.</text> </paragraph> <paragraph num="(5)"> <text>“HELIMED1” means the Maryland FiRST statewide radio system talkgroup utilized by Maryland State Police Aviation Command helicopters as a secondary means of medical communications with EMRC.</text> </paragraph> <paragraph num="(6)"> <text>“Hospital” means an institution that is required to be licensed as a hospital by the Secretary of Health and Mental Hygiene pursuant to Health-General Article, §19-301, Annotated Code of Maryland, and COMAR 10.07.01.</text> </paragraph> <paragraph num="(7)"> <text>“MIEMSS” means the Maryland Institute for Emergency Medical Services Systems established pursuant to Education Article, §13-503, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(8)"> <text>“Patient transport” means the helicopter transport of a patient from one hospital to another or to or from a specialty center.</text> </paragraph> <paragraph num="(9)"> <text>“Specialty center” means a hospital specified by MIEMSS to be a specialty referral center or trauma center participating in the Emergency Medical Services System.</text> </paragraph> <paragraph num="(10)"> <text>“SYSCOM” means the Systems Communication Center operated by MIEMSS for the Emergency Medical Services Communications System.</text> </paragraph> <paragraph num="(11)"> <text>“SYSCOM-TG” means the Maryland FiRST statewide radio system talkgroup utilized by Maryland State Police Aviation Command helicopters as a secondary means of communications with SYSCOM.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Patient Transports.</text> <paragraph num="(1)"> <text>The pilot or other crew member of a helicopter conducting patient transport or landing at a Maryland hospital or specialty center shall notify SYSCOM as provided in this section.</text> </paragraph> <paragraph num="(2)"> <text>The pilot shall contact SYSCOM directly using law enforcement frequency 44.74 MHz, tone code 110.9 Hz, SYSCOM-TG, or 7AG60.</text> </paragraph> <paragraph num="(3)"> <text>The programming information for 7AG60 is:</text> </paragraph> <paragraph num="(4)"> <text>The pilot shall inform SYSCOM 15 minutes before landing at a hospital or specialty referral center or as soon as practical, whichever is earlier.</text> </paragraph> <paragraph num="(5)"> <text>The pilot shall inform SYSCOM again within 3 minutes of the estimated landing time at the hospital or specialty referral center.</text> </paragraph> <paragraph num="(6)"> <text>In the initial communication with SYSCOM, the pilot shall:</text> <paragraph num="(a)"> <text>Provide identification of the agency or helicopter service making the patient transport; and</text> </paragraph> <paragraph num="(b)"> <text>Indicate the destination and estimated time of arrival.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Within 3 minutes after departure from a hospital, specialty referral center, or the scene of an accident where the patient was picked up for transport or delivered after transport, the pilot shall notify SYSCOM of the helicopter's departure point, route, and estimated time of arrival at its next destination.</text> </paragraph> <paragraph num="(8)"> <text>Helicopters which do not have frequency 44.74 MHz, tone code 110.9 Hz, or 7AG60, but have air-to-ground telephone capability shall call SYSCOM at (410) 706-7814 via air-to-ground telephone to provide the data required in §B(4)—(7) of this regulation.</text> </paragraph> <paragraph num="(9)"> <text>Helicopter services not having operational communications on any of the radio or air-to-ground telephone services described in this section shall contact its base medical or dispatching operations center to have patient and estimated time of arrival data forward to SYSCOM at (410) 706-7814 via a conventional public switched telephone.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Medical Communications.</text> <paragraph num="(1)"> <text>Upon the helicopter medic’s request for medical communications, SYSCOM shall instruct the helicopter medic to switch to medical frequency 47.66 MHz, tone code 100.0 Hz, HELIMED1, or 7AIRMED.</text> </paragraph> <paragraph num="(2)"> <text>The programming information for 7AIRMED is:</text> </paragraph> <paragraph num="(3)"> <text>The medic shall provide the nature of injury or illness and the related information necessary to coordinate the receipt of the patient at the hospital receiving facility.</text> </paragraph> <paragraph num="(4)"> <text>Helicopters which do not have communications capability on medical frequency 47.66 MHz, tone code 100.0 Hz, or 7AIRMED, but have air-to-ground telephone capability shall call SYSCOM at (410) 706-7814 via air-to-ground telephone to provide the data required in §C(3) of this regulation.</text> </paragraph> <paragraph num="(5)"> <text>Helicopter services not having operational communications capabilities on any of the radio or air-to-ground telephone services described in this section shall contact their home base medical or dispatching operations center to have patient and estimated time of arrival data forwarded to SYSCOM at (410) 706-7814 via a conventional public switched telephone.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509(d), Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1986 (13:6 Md. R. 684)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective May 31, 1991 (18:12 Md. R. 1318); revised permanently effective August 19, 1991 (18:16 Md. R. 1813)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.17.01 to COMAR 30.07.01, August 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective November 10, 2025 (52:22 Md. R. 1096)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective December 19, 2005 (32:25 Md. R. 1946)</annotation> </annotations> </chapter> </subtitle> <subtitle num="08" heading="Designation of Trauma and Specialty Referral Centers"> <chapter num="01" heading="General Provisions"> <regulation prefix="Regulation" num=".01" heading="Purpose."> <text>This subtitle establishes:</text> <paragraph num="A."> <text>Procedures for designating a hospital as a trauma or specialty referral center;</text> </paragraph> <paragraph num="B."> <text>Standards for a designated center to provide trauma or specialty care service;</text> </paragraph> <paragraph num="C."> <text>Procedures for disciplinary action to be taken if a trauma or specialty referral center fails to comply with this subtitle; and</text> </paragraph> <paragraph num="D."> <text>Procedures for the collection and use of trauma or specialty care data by MIEMSS to monitor and evaluate the trauma and specialty care systems.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Adult burn center” means:</text> <paragraph num="(a)"> <text>An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive burn treatment services to burn patients 15 years old or older; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide comprehensive burn treatment services to burn patients 15 years old or older.</text> </paragraph> </paragraph> <paragraph num="(1-1)"> <text>“Adult trauma center” means:</text> <paragraph num="(a)"> <text>An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive trauma services to trauma patients 15 years old and older; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide comprehensive trauma treatment services to trauma patients 15 years old and older.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Advanced Burn Life Support (ABLS®)” means a course developed and approved by the American Burn Association.</text> </paragraph> <paragraph num="(2-1)"> <text>“Advanced Pediatric Life Support (APLS®)” means a course developed and approved by the American Academy of Pediatrics (AAP) and American College of Emergency Physicians (ACEP).</text> </paragraph> <paragraph num="(2-2)"> <text>“Advanced practice professionals (APPs)” are non-physicians that are educated at an advanced level to provide patient care in a range of settings; they include nurse practitioners (NPs), nurse anesthetists, midwives, clinical nurse specialists (CNS) and physician assistants (PAs).</text> </paragraph> <paragraph num="(3)"> <text>“Advanced Trauma Life Support (ATLS®)” means a course developed and approved by the American College of Surgeons.</text> </paragraph> <paragraph num="(4)"> <text>“Appropriately trained” means a health care provider who has received the necessary training to develop the knowledge and skills needed for the appropriate care of the trauma or specialty care patient.</text> </paragraph> <paragraph num="(5)"> <text>“Approved” means a formal process of review and acceptance by the appropriate authority.</text> </paragraph> <paragraph num="(6)"> <text>“Attending”</text> </paragraph> <paragraph num="(7)"> <text>“Attending burn staff surgeon” means a surgical member of the burn team appointed by the adult or pediatric burn center director with credentials and privileges appropriate to the burn service.</text> </paragraph> <paragraph num="(8)"> <text>“Board certified” means a physician certified by an appropriate specialty board recognized by the American Board of Medical Specialties.</text> </paragraph> <paragraph num="(9)"> <text>“Board eligible” means a physician qualified to take the examination to complete the certification process as specified by an appropriate specialty board that is recognized by the American Board of Medical Specialties.</text> </paragraph> <paragraph num="(10)"> <text>“Burn care director” means a surgeon designated by the institution and medical staff to coordinate the activities of the adult or pediatric burn center.</text> </paragraph> <paragraph num="(11)"> <text>“Burn care system” means a coordinated component of an emergency medical services system which encompasses one or more adult or pediatric burn centers and features communication links to, and triage-transfer protocols between, health care facilities, prehospital personnel, and transportation services.</text> </paragraph> <paragraph num="(12)"> <text>“Burn Center” means an adult or pediatric burn center in Maryland unless otherwise indicated.</text> </paragraph> <paragraph num="(13)"> <text>“Burn service” means a clinical service established by the medical staff which has responsibility for burn patients.</text> </paragraph> <paragraph num="(14)"> <text>“Burn team” means a group of health care professionals organized to provide care to the burn patient in a coordinated system of care.</text> </paragraph> <paragraph num="(15)"> <text>“Burn unit” means a specific area within the adult or pediatric burn center that:</text> <paragraph num="(a)"> <text>Has committed the resources necessary to meet the criteria for an adult or pediatric burn center; and</text> </paragraph> <paragraph num="(b)"> <text>Contains beds and other physical equipment related to care of the patient with burn injury.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Bypass” means the diversionary status of a trauma or specialty referral center that is requested and identified in the County/Hospital Alert Tracking System (CHATS) in accordance with a MIEMSS or regional program due to a lack of staff, facilities, or equipment.</text> </paragraph> <paragraph num="(16-1)"> <text>“Continuing education (CE)” means education provided for adults after they have left the formal education system consisting of short or part-time courses that brings participants up to date in a particular area of knowledge or skills.</text> </paragraph> <paragraph num="(17)"> <text>“Continuing medical education (CME)” means training approved by the Accreditation Council of Continuing Medical Education or accredited by a state medical society recognized by that Council.</text> </paragraph> <paragraph num="(18)"> <text>“Credentialing” means a hospital's process for granting practice privileges to health care providers.</text> </paragraph> <paragraph num="(19)"> <text>“Data quality guideline” means a written procedure for ascertaining the accuracy and completeness of data.</text> </paragraph> <paragraph num="(20)"> <text>“Dedicated” means a designated resource whose primary use is for a specific trauma or specialty care program.</text> </paragraph> <paragraph num="(21)"> <text>“Definitive care” means a level of therapeutic intervention capable of providing comprehensive services for the patient's particular injuries, or associated conditions, or both.</text> </paragraph> <paragraph num="(22)"> <text>“Designation” means a process by which a hospital is identified by MIEMSS as an appropriate facility to receive patients with particular injuries or illnesses.</text> </paragraph> <paragraph num="(23)"> <text>“Desirable” means a component of the standards whose presence or availability is encouraged but not required for designation.</text> </paragraph> <paragraph num="(24)"> <text>“Emergency department (ED)” means a department or patient care area within a hospital which:</text> <paragraph num="(a)"> <text>Is organized to provide emergency medical care 24 hours a day; and</text> </paragraph> <paragraph num="(b)"> <text>Meets the applicable standards in COMAR 30.08.05.</text> </paragraph> </paragraph> <paragraph num="(25)"> <text>Emergency Medical Services.</text> <paragraph num="(a)"> <text>“Emergency medical services (EMS)” means a comprehensive system of emergency medical care that starts with prevention and continues through rehabilitation.</text> </paragraph> <paragraph num="(b)"> <text>“Emergency medical services (EMS)” includes:</text> <paragraph num="(i)"> <text>Comprehensive EMS, trauma, and specialty care system legislation, regulations, and policies;</text> </paragraph> <paragraph num="(ii)"> <text>Medical oversight and physician involvement;</text> </paragraph> <paragraph num="(iii)"> <text>Trained volunteer, career, and commercial personnel;</text> </paragraph> <paragraph num="(iv)"> <text>State and local government resource management and administration;</text> </paragraph> <paragraph num="(v)"> <text>Integrated communications system including 911 centers, medical consultation centers, ambulances, and receiving hospitals;</text> </paragraph> <paragraph num="(vi)"> <text>Medical ground, air, and water transportation systems;</text> </paragraph> <paragraph num="(vii)"> <text>Cooperating facilities including hospitals, trauma centers, and specialty referral centers;</text> </paragraph> <paragraph num="(viii)"> <text>Public information, education, and prevention programs; and</text> </paragraph> <paragraph num="(ix)"> <text>Data collection, evaluation, quality improvement, and research.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(26)"> <text>“EMS Plan” means the plan to ensure effective coordination and evaluation of emergency medical services delivered in the State, as developed and approved by the EMS Board.</text> </paragraph> <paragraph num="(27)"> <text>“EMS provider” means an individual certified or licensed by a state to provide out-of-hospital emergency medical services.</text> </paragraph> <paragraph num="(27-1)"> <text>“Emergent consultation” means a physician consultation required for evaluation of known or potentially unstable injuries, injuries requiring time sensitive surgical interventions, or other reasons as determined and documented by the attending trauma, or general surgeon, or ED attending physician.</text> </paragraph> <paragraph num="(28)"> <text>“Essential” means a component of the standards that is required for designation.</text> </paragraph> <paragraph num="(29)"> <text>“Executive Director” means the Executive Director of MIEMSS.</text> </paragraph> <paragraph num="(30)"> <text>Repealed.</text> </paragraph> <paragraph num="(31)"> <text>“Fellowship” means formal, advanced, postresidency, specialty training.</text> </paragraph> <paragraph num="(32)"> <text>“Geographic proximity” means that distance, which is optional for Level III perinatal centers and mandatory for Level III+ perinatal centers, so that patients requiring Level IV services may be transported from a Level III or Level III+ sending facility to the Level IV perinatal center in less than 30 minutes by nonemergency transport.</text> </paragraph> <paragraph num="(33)"> <text>“Geographic service area” means the area defined by the EMS Board that is normally served by a designated hospital for patients with a particular illness or injury.</text> </paragraph> <paragraph num="(34)"> <text>“Immediately available” means a source available as soon as it is requested.</text> </paragraph> <paragraph num="(35)"> <text>“Immediate response” means reacting at once to a patient care need.</text> </paragraph> <paragraph num="(36)"> <text>“In-house” means physically present in the hospital.</text> </paragraph> <paragraph num="(37)"> <text>“Injury surveillance” means routine monitoring of the type of injury and incidence for a specific population.</text> </paragraph> <paragraph num="(38)"> <text>“Inpatient discharge data” means certain information from inpatient hospital records that is submitted by the hospital to the Health Services Cost Review Commission as required by law.</text> </paragraph> <paragraph num="(39)"> <text>“Interfacility transfer” means the transfer of a patient from one hospital to another hospital.</text> </paragraph> <paragraph num="(40)"> <text>“Learning outcomes” means an individual's performance, which can be measured by objective means, that results from the individual's participation in an educational program.</text> </paragraph> <paragraph num="(41)"> <text>“Level I trauma center” means a hospital that:</text> <paragraph num="(a)"> <text>Meets the Level I trauma center standards in COMAR 30.08.05; and</text> </paragraph> <paragraph num="(b)"> <text>Is designated by MIEMSS and approved by the EMS Board.</text> </paragraph> </paragraph> <paragraph num="(42)"> <text>“Level II trauma center” means a hospital that:</text> <paragraph num="(a)"> <text>Meets the Level II trauma center standards in COMAR 30.08.05; and</text> </paragraph> <paragraph num="(b)"> <text>Is designated by MIEMSS and approved by the EMS Board.</text> </paragraph> </paragraph> <paragraph num="(43)"> <text>Repealed.</text> </paragraph> <paragraph num="(44)"> <text>“Level III perinatal referral center” means a hospital that:</text> <paragraph num="(a)"> <text>Meets the Level III perinatal referral center standards in COMAR 30.08.12;</text> </paragraph> <paragraph num="(b)"> <text>Is designated by MIEMSS and approved by the EMS Board as capable of providing medical intensive care to newborns of all:</text> <paragraph num="(i)"> <text>Gestational ages; and</text> </paragraph> <paragraph num="(ii)"> <text>Birth weights.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(45)"> <text>“Level III trauma center” means a community hospital with a trauma program which meets the Level III trauma center standards in COMAR 30.08.05.</text> </paragraph> <paragraph num="(46)"> <text>“Level IV perinatal referral center” means a hospital that:</text> <paragraph num="(a)"> <text>Meets the Level IV perinatal referral center standards in COMAR 30.08.12; and</text> </paragraph> <paragraph num="(b)"> <text>Provides comprehensive neonatal and obstetrical services, including all subspecialty services.</text> </paragraph> </paragraph> <paragraph num="(47)"> <text>“Maryland Trauma Registry Data Dictionary for Adult Patients” means the listing of data inclusion criteria, data elements and audit filters to be collected on patients with traumatic injuries treated in a Maryland Trauma Center which is incorporated by reference in COMAR 30.01.02.01(B)(2).</text> </paragraph> <paragraph num="(48)"> <text>“Maternal-fetal medicine” means a subspecialty recognized by the American Board of Obstetrics and Gynecology which addresses the medical care of high-risk pregnant women and their fetuses.</text> </paragraph> <paragraph num="(49)"> <text>Most Critical Patients.</text> <paragraph num="(a)"> <text>“Most critical patients” means those patients who:</text> <paragraph num="(i)"> <text>Have confirmed BP< 90 mmHg at any time in adults and age-specific hypotension;</text> </paragraph> <paragraph num="(ii)"> <text>Have GSW to the head, neck, chest, or abdomen attributed to trauma;</text> </paragraph> <paragraph num="(iii)"> <text>Have a GCS score <9 with mechanism attributed to trauma;</text> </paragraph> <paragraph num="(iv)"> <text>Are transferred from other hospitals receiving blood or vasoactives to maintain vital signs;</text> </paragraph> <paragraph num="(v)"> <text>Are intubated and transferred from the scene; or</text> </paragraph> <paragraph num="(vi)"> <text>Have a respiratory compromise or are in need of an emergent airway, including intubated patients who are transferred from another facility with ongoing respiratory compromise.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>“Most critical patients” includes those patients who:</text> <paragraph num="(i)"> <text>Are intubated and are currently stable from a respiratory standpoint;</text> </paragraph> <paragraph num="(ii)"> <text>Have a tourniquet or pelvic binder applied;</text> </paragraph> <paragraph num="(iii)"> <text>Are currently in Cardiac arrest or receiving CPR;</text> </paragraph> <paragraph num="(iv)"> <text>Have presence of motor paralysis;</text> </paragraph> <paragraph num="(v)"> <text>Have an amputation proximal to the ankle or wrist;</text> </paragraph> <paragraph num="(vi)"> <text>Have Hypoxia as evidenced by saturation <90 percent;</text> </paragraph> <paragraph num="(vii)"> <text>Have uncontrolled external hemorrhage; or</text> </paragraph> <paragraph num="(viii)"> <text>Penetrating torso injury with evisceration.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(50)"> <text>“Multidisciplinary committee” means a group of health care professionals from two or more professional disciplines within a trauma or specialty referral center that reflects the multidisciplinary nature of trauma or specialty care.</text> </paragraph> <paragraph num="(51)"> <text>“Multiple casualty incident (MCI)” means two or more injured people requiring emergency care simultaneously.</text> </paragraph> <paragraph num="(51-1)"> <text>“National Trauma Data Bank (NTDB)” means the American College of Surgeons (ACS) aggregated trauma registry of standardization of key trauma data elements for research and improving care for the surgical patient.</text> </paragraph> <paragraph num="(52)"> <text>“Neonatal referral center” means an out-of-State facility that has entered into an agreement with MIEMSS which has been approved by the EMS Board to accept transfers in order to provide neonatal care.</text> </paragraph> <paragraph num="(53)"> <text>“Neonate” means a patient who is less than 28 days old.</text> </paragraph> <paragraph num="(54)"> <text>“Neonatologist” means a pediatrician certified by the American Board of Pediatrics in neonatology.</text> </paragraph> <paragraph num="(54-1)"> <text>“Neurotrauma center” means an in-State hospital designated by MIEMSS and approved by the EMS Board to provide specialized care of traumatic brain injured and spinal cord injured patients.</text> </paragraph> <paragraph num="(55)"> <text>“Nurse manager” means a registered nurse who has a full-time commitment to a specific patient care unit and is administratively responsible for the nursing service of that unit.</text> </paragraph> <paragraph num="(56)"> <text>“Office of Administrative Hearings (OAH)” means the unit within Maryland's Executive Branch responsible for scheduling and conducting administrative hearings.</text> </paragraph> <paragraph num="(57)"> <text>“Office of Hospital Programs” means the office within MIEMSS that is responsible for the designation, verification, and reverification of the trauma and specialty care programs.</text> </paragraph> <paragraph num="(58)"> <text>“On call” means committed for a specific time period to be available and respond within the specific amount of time to provide care for a patient in the hospital.</text> </paragraph> <paragraph num="(59)"> <text>On-Site Review Record.</text> <paragraph num="(a)"> <text>“On-site review record” means any record of the on-site visit and of the on-site review team.</text> </paragraph> <paragraph num="(b)"> <text>“On-site review record” includes, but is not limited to:</text> <paragraph num="(i)"> <text>Proceedings;</text> </paragraph> <paragraph num="(ii)"> <text>Records;</text> </paragraph> <paragraph num="(iii)"> <text>Files;</text> </paragraph> <paragraph num="(iv)"> <text>Notes;</text> </paragraph> <paragraph num="(v)"> <text>Deliberations;</text> </paragraph> <paragraph num="(vi)"> <text>Reports;</text> </paragraph> <paragraph num="(vii)"> <text>Documents;</text> </paragraph> <paragraph num="(viii)"> <text>Statements;</text> </paragraph> <paragraph num="(ix)"> <text>Minutes; and</text> </paragraph> <paragraph num="(x)"> <text>Any other oral or written communication.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(60)"> <text>“Optional” means a component of the standards that may be present or available but is not required for designation.</text> </paragraph> <paragraph num="(61)"> <text>“Outcome” means a measurable health status that follows as a result of an injury or illness.</text> </paragraph> <paragraph num="(62)"> <text>“Patient care log” means a list of patients' names and other information that is recorded by hospitals or prehospital care agencies.</text> </paragraph> <paragraph num="(63)"> <text>“Patient care record” means a record that contains information regarding the assessment and the care provided to a patient by any health care provider in any practice setting.</text> </paragraph> <paragraph num="(64)"> <text>“Patient discharge summary” means an abbreviated narrative, created after discharge from a health care facility, of a patient's record during that hospitalization.</text> </paragraph> <paragraph num="(65)"> <text>“Patient identifier” means a unique number that is assigned to only one patient in order to identify records pertaining to the evaluation and care of that particular patient.</text> </paragraph> <paragraph num="(66)"> <text>“Pediatric Advanced Life Support (PALS®)” means a pediatric resuscitation course developed and approved by the American Heart Association.</text> </paragraph> <paragraph num="(66-1)"> <text>“Pediatric burn center” means:</text> <paragraph num="(a)"> <text>An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive burn treatment services to burn patients that have not reached their fifteenth (15th) birthday; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide comprehensive burn treatment services to burn patients that have not reached their fifteenth (15th) birthday.</text> </paragraph> </paragraph> <paragraph num="(66-2)"> <text>“Pediatric trauma center” means:</text> <paragraph num="(a)"> <text>An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive trauma services to trauma patients who have not reached their fifteenth (15th) birthday; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-State hospital that has entered into an agreement with MIEMSS and that has been approved by the EMS Board to provide compressive trauma treatment services to trauma patients who have not reached their fifteenth (15th) birthday.</text> </paragraph> </paragraph> <paragraph num="(67)"> <text>“Perinatal referral center” means:</text> <paragraph num="(a)"> <text>An in-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive obstetrical and neonatal services; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-State hospital that has entered into an agreement with MIEMSS which has been approved by the EMS Board to provide comprehensive obstetrical and neonatal services.</text> </paragraph> </paragraph> <paragraph num="(68)"> <text>“Person” means:</text> <paragraph num="(a)"> <text>An individual or group of individuals;</text> </paragraph> <paragraph num="(b)"> <text>A State or federal agency; or</text> </paragraph> <paragraph num="(c)"> <text>A business entity.</text> </paragraph> </paragraph> <paragraph num="(69)"> <text>“Physical plant” means a building and associated structures.</text> </paragraph> <paragraph num="(70)"> <text>“Postgraduate year (PGY)” means a classification system for residents indicating the year of post-medical school residency.</text> </paragraph> <paragraph num="(71)"> <text>“Prehospital service” means a service that is provided from the time of injury or illness until the patient arrives in the hospital.</text> </paragraph> <paragraph num="(72)"> <text>“Preliminary investigation” means fact finding and information gathering to enable MIEMSS to determine whether justification exists to initiate disciplinary action or to conduct a further investigation.</text> </paragraph> <paragraph num="(73)"> <text>“Primary Adult Resource Center (PARC)” means a comprehensive trauma program, including a dedicated trauma care facility, dedicated staff and services, and designated, specialized, advanced training and research programs, which meets the PARC standards in COMAR 30.08.05 and which, in Maryland, is defined in statute as the R Adams Cowley Shock Trauma Center.</text> </paragraph> <paragraph num="(74)"> <text>“Promptly available” means a resource available within 30 minutes of the time it was requested.</text> </paragraph> <paragraph num="(75)"> <text>“Protocol” means a written procedure to ensure standardization of a process.</text> </paragraph> <paragraph num="(76)"> <text>“Quality management (QM)” means the quality management of trauma and specialty care services.</text> </paragraph> <paragraph num="(77)"> <text>“Quality management program record” means a documented record related to quality management activities.</text> </paragraph> <paragraph num="(78)"> <text>“Readily available” means a resource available for use a short time after it is requested.</text> </paragraph> <paragraph num="(79)"> <text>“Resuscitation” means the phase of trauma or specialty care where emergency life support treatment is provided to sustain vital body functions.</text> </paragraph> <paragraph num="(80)"> <text>“Reverification” means the process by which MIEMSS renews a trauma or specialty referral center's designation status.</text> </paragraph> <paragraph num="(81)"> <text>“Sonologist” means a physician with special training in ultrasonography.</text> </paragraph> <paragraph num="(82)"> <text>“Specialty referral center” means:</text> <paragraph num="(a)"> <text>An in-State hospital that has been designated by MIEMSS and approved by the EMS Board to provide care for a specific patient population with special care needs; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-State facility that has entered into an agreement with MIEMSS which has been approved by the EMS Board to provide specialty care.</text> </paragraph> </paragraph> <paragraph num="(83)"> <text>“State trauma registry” means a database of information, submitted to MIEMSS by hospitals, relating to the care of trauma and burn patients that is used to evaluate the quality of care provided.</text> </paragraph> <paragraph num="(84)"> <text>“SYSCOM” means the Systems Communications Center, an EMS communications center located within MIEMSS, that is used for coordination of medical communication on a Statewide basis.</text> </paragraph> <paragraph num="(85)"> <text>“Transfer agreement” means a formal agreement between hospitals for the transfer and acceptance of patients.</text> </paragraph> <paragraph num="(86)"> <text>“Transporting service” means an agency or entity providing patient care transport.</text> </paragraph> <paragraph num="(87)"> <text>“Transport vehicle” means a vehicle or other conveyance used to transport patients.</text> </paragraph> <paragraph num="(88)"> <text>“Trauma” means a major single system or multisystem injury or mechanism of injury which has a reasonable probability of disability or death.</text> </paragraph> <paragraph num="(89)"> <text>Trauma Center.</text> <paragraph num="(a)"> <text>“Trauma center” means a hospital that has been designated by MIEMSS and approved by the EMS Board to provide care to trauma patients.</text> </paragraph> <paragraph num="(b)"> <text>“Trauma center” includes an out-of-State facility that has entered into an agreement with MIEMSS which has been approved by the EMS Board to provide care to trauma patients.</text> </paragraph> </paragraph> <paragraph num="(90)"> <text>“Trauma Network (TraumaNet)” means an organization of representatives of trauma centers which includes trauma surgeons, trauma coordinators, and hospital administrators.</text> </paragraph> <paragraph num="(91)"> <text>“Trauma panel” means the group of physicians within a specific trauma center credentialed by the trauma center hospital to provide trauma care.</text> </paragraph> <paragraph num="(92)"> <text>“Trauma patient care resource” means the physical facilities, equipment, supplies, and medical personnel that are:</text> <paragraph num="(a)"> <text>Used to provide care to trauma patients; and</text> </paragraph> <paragraph num="(b)"> <text>Identified as immediately available, readily available, or promptly available.</text> </paragraph> </paragraph> <paragraph num="(92-1)"> <text>“Trauma Quality Improvement Committee (TQIC)” is a medical review committee established by MIEMSS as an advisory body for quality issue and evaluation affecting the care of trauma patients and the Maryland Trauma System. The TQIC will address issues primarily related to the system-wide delivery of trauma care across the continuum (pre-hospital care to discharge from the trauma center) identifying performance improvement activities and indicators to support resolution strategies.</text> </paragraph> <paragraph num="(93)"> <text>“Trauma resuscitation team” means a group of trauma trained health care providers required to be present at the patient’s bedside following trauma team activation. The minimum team requirements for all levels of activation include: trauma attending/general surgeon/PGY4/APP, ED lead physician, ED RN’s, and a recorder/documenter. The highest level of response requires, at a minimum, the trauma resuscitation team, an anesthesiologist or CRNA (as per institutional-specific criteria), and Respiratory Therapy.</text> </paragraph> <paragraph num="(93-1)"> <text>“Trauma service” means a group of trauma-trained physicians that are responsible for the initial resuscitation and care of the trauma patient, including trauma/general surgeon, emergency medicine, neurosurgery, and orthopedic surgery.</text> </paragraph> <paragraph num="(94)"> <text>“Trend” means a tendency towards a particular conclusion or end point, usually determined by an analysis of data.</text> </paragraph> <paragraph num="(95)"> <text>“Triage” means the sorting of patients in terms of priority, treatment, transportation, and destination, so that the patient can be transported to the appropriate hospital according to triage protocols.</text> </paragraph> <paragraph num="(96)"> <text>“Unit of care” means the hospital subunit where the patient is receiving care at any point in time.</text> </paragraph> <paragraph num="(97)"> <text>“Verification” means the process by which MIEMSS determines that a hospital, which is applying for a particular designation status, is in substantial compliance with the standards for the designation requested.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="System Administration."> <paragraph num="A."> <text>Under Education Article, §13-504, Annotated Code of Maryland, MIEMSS is the State administrative agency responsible for the coordination of all emergency medical services.</text> </paragraph> <paragraph num="B."> <text>MIEMSS shall:</text> <paragraph num="(1)"> <text>With the approval of the EMS Board, designate and verify hospitals to be trauma or specialty referral centers;</text> </paragraph> <paragraph num="(2)"> <text>Establish standards for trauma and specialty care, triage, and transfer protocols for injured patients;</text> </paragraph> <paragraph num="(3)"> <text>Establish and manage the State trauma registry;</text> </paragraph> <paragraph num="(4)"> <text>Facilitate the establishment of Statewide, inclusive, trauma and specialty care systems by encouraging all hospitals to participate in:</text> <paragraph num="(a)"> <text>The Statewide data collection process, and</text> </paragraph> <paragraph num="(b)"> <text>Prevention programs;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Develop a quality management and improvement program to:</text> <paragraph num="(a)"> <text>Monitor compliance with this subtitle by hospitals in the Statewide trauma and specialty care systems, and</text> </paragraph> <paragraph num="(b)"> <text>Identify areas for enhancement;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>With the consultation and advice of appropriate persons, develop and periodically review:</text> <paragraph num="(a)"> <text>Prehospital trauma and specialty referral center triage criteria guidelines,</text> </paragraph> <paragraph num="(b)"> <text>Interfacility transfer criteria for adult and pediatric patients,</text> </paragraph> <paragraph num="(c)"> <text>Trauma and specialty referral center standards, and</text> </paragraph> <paragraph num="(d)"> <text>Trauma registry and specialty referral center data;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Annually evaluate the effectiveness of the Statewide trauma and specialty care systems and its component subsystems by using trauma registry and other appropriate data to identify and analyze system and patient care trends and outcomes;</text> </paragraph> <paragraph num="(8)"> <text>Periodically conduct special studies of the Statewide trauma and specialty care systems to evaluate:</text> <paragraph num="(a)"> <text>System access,</text> </paragraph> <paragraph num="(b)"> <text>Capacity,</text> </paragraph> <paragraph num="(c)"> <text>Quality,</text> </paragraph> <paragraph num="(d)"> <text>Patient care outcomes, and</text> </paragraph> <paragraph num="(e)"> <text>The financial condition of the system components;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Consult with appropriate persons in determining the need for trauma or specialty care services;</text> </paragraph> <paragraph num="(10)"> <text>Facilitate and, where necessary, develop and maintain, public information, education, and prevention programs as an integral component of the trauma and specialty care systems;</text> </paragraph> <paragraph num="(11)"> <text>As necessary, recommend to the EMS Board additional regulations to ensure the quality of the Statewide trauma and specialty care systems;</text> </paragraph> <paragraph num="(12)"> <text>Provide technical assistance and support to hospitals and providers as necessary to implement the components of the EMS Plan; and</text> </paragraph> <paragraph num="(13)"> <text>As necessary, verify compliance with trauma and specialty care standards by:</text> <paragraph num="(a)"> <text>Reviewing, inspecting, evaluating, and auditing trauma and specialty care patient records, trauma and specialty care quality improvement committee minutes, and any other documents relevant to trauma and specialty care in any trauma or specialty referral center, and</text> </paragraph> <paragraph num="(b)"> <text>Inspecting a trauma or specialty center's physical plant.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>With the approval of the EMS Board, MIEMSS may enter into agreements with out-of-State trauma and specialty center hospitals where necessary to ensure access of patients to appropriate levels of trauma and specialty care. Such agreements are tantamount to designation by MIEMSS and approval by the EMS Board.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Confidentiality of Records."> <text>MIEMSS shall maintain the confidentiality of records referred to in this subtitle in accordance with:</text> <paragraph num="A."> <text>Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="B."> <text>General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 amended effective July 1, 2002 (29:12 Md. R. 932)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23, 2006 (33:21 Md. R. 1678)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 4, 2007 (34:11 Md. R. 972); January 13, 2011 (38:1 Md. R. 12); March 30, 2015 (42:6 Md. R. 514); July 1, 2018 (45:9 Md. R. 463); July 1, 2020 (47:5 Md. R. 313); October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective December 19, 2005 (32:25 Md. R. 1947)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 12, 2015 (42:20 Md. R. 1265)</annotation> </annotations> </chapter> <chapter num="02" heading="Designation of Trauma and Specialty Referral Centers"> <regulation prefix="Regulation" num=".01" heading="Trauma Care Levels and Specialty Referral Centers."> <paragraph num="A."> <text>MIEMSS shall designate a hospital by level of care capability as set forth for:</text> <paragraph num="(1)"> <text>Trauma centers, in COMAR 30.08.05; or</text> </paragraph> <paragraph num="(2)"> <text>Specialty referral centers, in the appropriate specialty care standards within this subtitle.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The levels of trauma care are:</text> <paragraph num="(1)"> <text>Primary Adult Resource Center;</text> </paragraph> <paragraph num="(2)"> <text>Level I trauma center;</text> </paragraph> <paragraph num="(3)"> <text>Level II trauma center; or</text> </paragraph> <paragraph num="(4)"> <text>Level III trauma center.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Multiple Clinical Locations.</text> <paragraph num="(1)"> <text>A single hospital or one or more hospitals under common ownership may be designated as a single trauma or specialty center program with more than one clinical location if:</text> <paragraph num="(a)"> <text>Clinical requirements are met at each separate location;</text> </paragraph> <paragraph num="(b)"> <text>There is a designated individual with administrative oversight of the designated trauma or specialty center program;</text> </paragraph> <paragraph num="(c)"> <text>There is a designated individual with clinical oversight of the designated trauma or specialty center program who is responsible for:</text> <paragraph num="(i)"> <text>Data collection;</text> </paragraph> <paragraph num="(ii)"> <text>Quality improvement;</text> </paragraph> <paragraph num="(iii)"> <text>Education;</text> </paragraph> <paragraph num="(iv)"> <text>Research; and</text> </paragraph> <paragraph num="(v)"> <text>Prevention;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>There is a designated individual responsible for administrative oversight at each clinical location; and</text> </paragraph> <paragraph num="(e)"> <text>There is a designated individual responsible for clinical oversight at each clinical location.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>In this subtitle, in the case of a designated trauma or specialty center with more than one clinical location:</text> <paragraph num="(a)"> <text>The term “hospital” shall be interpreted as meaning each separate clinical location which is operated as part of the designated trauma or specialty center program for the purposes of clinical requirements; and</text> </paragraph> <paragraph num="(b)"> <text>The term “hospital” shall be interpreted to mean all clinical locations operated as part of the designated trauma or specialty center program collectively for the purposes of nonclinical requirements.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Criteria for Designation."> <paragraph num="A."> <text>The EMS Board shall:</text> <paragraph num="(1)"> <text>Establish criteria for the number and level of trauma and specialty referral centers to be designated; and</text> </paragraph> <paragraph num="(2)"> <text>For specialty referral centers that require a certificate of need from the Maryland Health Care Commission, establish the criteria for the number of specialty referral centers in coordination with the Maryland Health Care Commission.</text> </paragraph> </paragraph> <paragraph num="B."> <text>For each region, the criteria shall address:</text> <paragraph num="(1)"> <text>Access to trauma or specialty care;</text> </paragraph> <paragraph num="(2)"> <text>Level of care;</text> </paragraph> <paragraph num="(3)"> <text>Capacity to provide the care; and</text> </paragraph> <paragraph num="(4)"> <text>Timeliness of care received.</text> </paragraph> </paragraph> <paragraph num="C."> <text>MIEMSS may consult with appropriate State agencies in determining the need for trauma or specialty services for a hospital's geographic service area.</text> </paragraph> <paragraph num="D."> <text>To be eligible for consideration by MIEMSS as a designated trauma or specialty referral center, a hospital shall meet the standards set forth for such a center in this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Initial Application Process."> <paragraph num="A."> <text>A hospital that is currently functioning as a trauma or specialty referral center may continue to function as a trauma or specialty referral center until MIEMSS has completed the designation process under this subtitle with respect to that hospital, if the hospital makes application for designation. The application must be received complete within 6 months of the publication date of the initial solicitation in the Maryland Register in accordance with §B of this regulation.</text> </paragraph> <paragraph num="B."> <text>MIEMSS shall solicit applications for trauma and specialty referral center designation from any interested hospital, including all current trauma and specialty referral centers, by publication of the solicitation in the Maryland Register.</text> </paragraph> <paragraph num="C."> <text>MIEMSS may periodically solicit applications for trauma and specialty referral center designation, as needed, by publication of the solicitation in the Maryland Register.</text> </paragraph> <paragraph num="D."> <text>MIEMSS shall provide the applicant with appropriate application materials in paper or electronic form for trauma or specialty referral center designation.</text> </paragraph> <paragraph num="E."> <text>An applicant for trauma or specialty referral center designation shall submit an application to the Office of Hospital Programs in a form specified by MIEMSS, which shall include, but not be limited to, submitting evidence of the applicant's financial capability to provide this care.</text> </paragraph> <paragraph num="F."> <text>MIEMSS shall review each application submitted for completeness.</text> </paragraph> <paragraph num="G."> <text>MIEMSS shall notify an applicant if an application is incomplete, and the applicant shall be afforded the opportunity to complete the application within 30 business days of the date of the notification.</text> </paragraph> <paragraph num="H."> <text>As necessary, MIEMSS shall provide technical assistance to a hospital throughout the designation process by answering questions about this subtitle and the designation process.</text> </paragraph> <paragraph num="I."> <text>An applicant's designation application is the property of MIEMSS and is confidential information in accordance with:</text> <paragraph num="(1)"> <text>Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Denial of Application for Designation."> <paragraph num="A."> <text>MIEMSS may deny an application for designation without conducting an on-site review if it finds that the hospital:</text> <paragraph num="(1)"> <text>Would add unnecessary duplication of services to a geographic service area where there is not a sufficient need for additional trauma or specialty services;</text> </paragraph> <paragraph num="(2)"> <text>Is unable to meet the requirements of this subtitle for the level of designation sought;</text> </paragraph> <paragraph num="(3)"> <text>Makes a false statement or omits a material fact in the hospital records, documentation, or materials required to be submitted that pertain to the designation process;</text> </paragraph> <paragraph num="(4)"> <text>Is less qualified than another applicant hospital in the same geographic service area;</text> </paragraph> <paragraph num="(5)"> <text>Is applying for designation as a specialty center that requires a certificate of need from the Maryland Health Care Commission but does not have the required certificate of need or a waiver of the certificate of need; or</text> </paragraph> <paragraph num="(6)"> <text>Should not be designated for any other relevant reason.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Denial of Application for Designation.</text> <paragraph num="(1)"> <text>MIEMSS shall issue a written notice of denial to the hospital.</text> </paragraph> <paragraph num="(2)"> <text>The notice of denial shall conform to State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS shall send the notice of denial to the chief executive officer of the hospital.</text> </paragraph> <paragraph num="(4)"> <text>MIEMSS shall notify the EMS Board of the action taken.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A hospital may file an appeal with the EMS Board, in accordance with Regulation .08 of this chapter, if MIEMSS denies its application for designation.</text> </paragraph> <paragraph num="D."> <text>If the EMS Board overturns MIEMSS' decision to deny the application for designation, MIEMSS shall continue the application process by scheduling an on-site review of the hospital.</text> </paragraph> <paragraph num="E."> <text>If the hospital does not timely appeal MIEMSS' decision to deny the application for designation, MIEMSS' decision is the final agency decision and is not subject to judicial review.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="On-Site Review for Initial Trauma Center Designation."> <paragraph num="A."> <text>After a hospital's application for designation has been accepted, MIEMSS shall conduct an on-site review of a hospital that has applied to be a Primary Adult Resource Center, or a Level I, II, or III trauma center.</text> </paragraph> <paragraph num="B."> <text>On-Site Review Teams.</text> <paragraph num="(1)"> <text>MIEMSS shall establish multidisciplinary on-site review teams composed of individuals knowledgeable in trauma or specialty care and trauma or specialty care systems.</text> </paragraph> <paragraph num="(2)"> <text>The composition of the team shall be appropriate to the level of designation sought.</text> </paragraph> <paragraph num="(3)"> <text>For trauma center designation, MIEMSS shall select a team which, at a minimum, shall include MIEMSS staff and representatives from three of the following categories:</text> <paragraph num="(a)"> <text>Trauma surgeon;</text> </paragraph> <paragraph num="(b)"> <text>Emergency physician;</text> </paragraph> <paragraph num="(c)"> <text>Trauma nurse coordinator;</text> </paragraph> <paragraph num="(d)"> <text>Administrator.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>A staff person from MIEMSS shall accompany and coordinate the functions of the review team.</text> </paragraph> <paragraph num="(5)"> <text>A team shall consist of professionals who do not have any conflict or competitive interest with the applicant.</text> </paragraph> <paragraph num="(6)"> <text>If a hospital can demonstrate a reasonable basis for concern, MIEMSS shall consider allegations that conflicts of interest exist between an on-site reviewer and an applicant.</text> </paragraph> <paragraph num="(7)"> <text>Contact with Members of On-Site Review Team.</text> <paragraph num="(a)"> <text>Except as authorized by MIEMSS, an applicant's administration, faculty, medical staff, employees, and representatives may not have any contact with an on-site review team member relating to the review process after the team members are announced and before the on-site review is conducted.</text> </paragraph> <paragraph num="(b)"> <text>A violation of §B(7)(a) of this regulation may be grounds for denial by MIEMSS of the hospital's application.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>The on-site review team shall:</text> <paragraph num="(a)"> <text>Evaluate the appropriateness and capability of the applicant to provide trauma care services, according to the designation standards described in COMAR 30.08.05;</text> </paragraph> <paragraph num="(b)"> <text>Verify the hospital's ability to meet the:</text> <paragraph num="(i)"> <text>Responsibilities of, and the resources, equipment, and performance standards for, the level of designation sought, and</text> </paragraph> <paragraph num="(ii)"> <text>Overall needs of the trauma system in that region;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Familiarize themselves with the hospital's application and the designation standards;</text> </paragraph> <paragraph num="(d)"> <text>Inspect the hospital's physical plant;</text> </paragraph> <paragraph num="(e)"> <text>Interview trauma team members and management personnel;</text> </paragraph> <paragraph num="(f)"> <text>Examine the hospital's trauma-related documents, including patient care records;</text> </paragraph> <paragraph num="(g)"> <text>Review other materials considered appropriate by MIEMSS;</text> </paragraph> <paragraph num="(h)"> <text>Provide an exit interview of preliminary findings to the applicant upon completion of the on-site review; and</text> </paragraph> <paragraph num="(i)"> <text>Provide a brief written summary of preliminary findings upon completion of the on-site review.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Confidentiality of On-Site Review Records.</text> <paragraph num="(a)"> <text>MIEMSS shall require and maintain confidentiality of an on-site review record.</text> </paragraph> <paragraph num="(b)"> <text>An on-site review record is confidential and exempt from public disclosure under General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(c)"> <text>Except as provided in Health Occupations Article, Title 1, Subtitle 4, Annotated Code of Maryland, an on-site review record is not discoverable or admissible in evidence.</text> </paragraph> <paragraph num="(d)"> <text>A member of the on-site review team may not divulge, and may not be compelled to divulge, any information obtained or included in on-site review records submitted to MIEMSS relating to the on-site review, including in any civil action resulting from MIEMSS' designation process.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Notwithstanding §§A and B of this regulation, instead of conducting an on-site review, MIEMSS may take into consideration or coordinate with verification surveys by the American College of Surgeons or other specialty medical organizations.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="On-Site Review for Initial Specialty Referral Center Designation."> <paragraph num="A."> <text>At MIEMSS' discretion, MIEMSS may accept verification of a specialty referral center by a nationally recognized medical specialty organization, without conducting an on-site review.</text> </paragraph> <paragraph num="B."> <text>The on-site review process for initial designation of specialty referral centers shall be conducted in accordance with Regulation .05 of this chapter, with the following exceptions:</text> <paragraph num="(1)"> <text>The on-site review team shall consist of MIEMSS staff, as well as medical, administrative, and nursing professionals having expertise in the specialty being designated;</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director may appoint additional staff from other State agencies to the on-site review team when those agencies have shared regulatory oversight in the specialty referral center;</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS shall select a team, which, at a minimum, shall include MIEMSS staff and three representatives from the following categories:</text> <paragraph num="(a)"> <text>Specialty physician;</text> </paragraph> <paragraph num="(b)"> <text>Emergency physician;</text> </paragraph> <paragraph num="(c)"> <text>Specialty nurse;</text> </paragraph> <paragraph num="(d)"> <text>Administrator;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>The on-site review team members shall:</text> <paragraph num="(a)"> <text>Evaluate the appropriateness and capability of the applicant to provide specialty care services, according to the designation standards for that particular specialty, as described at COMAR 30.08.06—30.08.12;</text> </paragraph> <paragraph num="(b)"> <text>Verify the hospital's ability to meet the:</text> <paragraph num="(i)"> <text>Responsibilities of, and the resources, equipment, and performance standards for, the type of specialty referral center designation sought, and</text> </paragraph> <paragraph num="(ii)"> <text>Overall needs of that particular specialty system in that region;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Familiarize themselves with the hospital's application and the designation standards;</text> </paragraph> <paragraph num="(d)"> <text>Inspect the hospital's physical plant;</text> </paragraph> <paragraph num="(e)"> <text>Interview team members and management personnel;</text> </paragraph> <paragraph num="(f)"> <text>Examine the hospital's specialty care-related documents, including patient care records;</text> </paragraph> <paragraph num="(g)"> <text>Review other materials considered appropriate by MIEMSS;</text> </paragraph> <paragraph num="(h)"> <text>Provide an exit interview of preliminary findings to the applicant upon the completion of the on-site review; and</text> </paragraph> <paragraph num="(i)"> <text>Provide a brief written summary of preliminary findings upon the completion of the on-site review.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Designation Decision by MIEMSS."> <paragraph num="A."> <text>As soon as practicable, but not later than 45 business days after completion of the on-site review, MIEMSS shall provide written notice to a hospital of its designation status.</text> </paragraph> <paragraph num="B."> <text>MIEMSS may:</text> <paragraph num="(1)"> <text>Designate the hospital as a trauma or specialty referral center as proposed by the applicant;</text> </paragraph> <paragraph num="(2)"> <text>Designate the hospital at a level of designation lower than the applicant proposed, if the on-site review determined that the hospital does not meet the standards for the level of designation proposed;</text> </paragraph> <paragraph num="(3)"> <text>Adjust the level of an applicant's designation based on system needs and the hospital's ability to meet those needs; or</text> </paragraph> <paragraph num="(4)"> <text>Deny designation as a trauma center at any level or as a specialty referral center.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Provisional or Full Designation.</text> <paragraph num="(1)"> <text>MIEMSS may initially designate a trauma or specialty referral center as provisional on the conditions and for the provisional period, including any extensions, which MIEMSS deems appropriate;</text> </paragraph> <paragraph num="(2)"> <text>MIEMSS shall require each provisional trauma or specialty referral center to:</text> <paragraph num="(a)"> <text>Have a written work plan to rectify deficiencies; and</text> </paragraph> <paragraph num="(b)"> <text>Demonstrate progress on the work plan throughout the provisional period.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At the end of the provisional period, including any extensions, MIEMSS may:</text> <paragraph num="(a)"> <text>Grant full designation to the trauma or specialty referral center; or</text> </paragraph> <paragraph num="(b)"> <text>Deny the trauma or specialty referral center's designation under §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>MIEMSS may grant full designation to a hospital in full compliance with this chapter for a period not to exceed 5 years, excluding an extension during the reverification process as set forth in Regulation .10 of this chapter.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Denial of Designation. MIEMSS may deny a hospital's designation as a trauma or specialty referral center if it finds that the hospital:</text> <paragraph num="(1)"> <text>Does not meet the requirements of this subtitle for the level of designation or specialty;</text> </paragraph> <paragraph num="(2)"> <text>Has engaged in unauthorized contact with an on-site review team member, as prohibited by Regulation .05B(7) of this chapter;</text> </paragraph> <paragraph num="(3)"> <text>Made a false statement or omitted a material fact in the hospital records, documentation, or materials required to be submitted that pertain to the designation process;</text> </paragraph> <paragraph num="(4)"> <text>Is less qualified than another applicant hospital in the same geographic service area; or</text> </paragraph> <paragraph num="(5)"> <text>Should not be designated for another relevant reason.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Notice of Denial of Designation.</text> <paragraph num="(1)"> <text>MIEMSS shall issue a written notice of denial of designation to a hospital.</text> </paragraph> <paragraph num="(2)"> <text>The notice of denial of designation shall conform to State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS shall send the notice of denial of designation to the chief executive officer of the hospital.</text> </paragraph> <paragraph num="(4)"> <text>MIEMSS shall notify the EMS Board of the action taken.</text> </paragraph> </paragraph> <paragraph num="F."> <text>If MIEMSS approves a hospital's designation as a trauma or specialty referral center as proposed by the applicant, MIEMSS shall require the hospital to accept or decline the proposed designation within 30 business days from the date the hospital receives the notice.</text> </paragraph> <paragraph num="G."> <text>A hospital may file an appeal with the EMS Board in accordance with Regulation .08 of this chapter if MIEMSS:</text> <paragraph num="(1)"> <text>Approves the hospital at a level of designation lower than the applicant proposed;</text> </paragraph> <paragraph num="(2)"> <text>Designates the hospital as provisional; or</text> </paragraph> <paragraph num="(3)"> <text>Denies designation as a trauma center at any level or as a specialty center.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the EMS Board overturns MIEMSS' decision, MIEMSS shall designate the hospital as a trauma or specialty referral center as directed by the EMS Board.</text> </paragraph> <paragraph num="I."> <text>If the hospital does not timely appeal MIEMSS' decision, MIEMSS' decision is the final agency decision.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Appeal to the EMS Board."> <paragraph num="A."> <text>Procedures for Appeal by Hospital.</text> <paragraph num="(1)"> <text>Not later than 20 business days from the date a hospital receives MIEMSS' decision, the hospital may appeal MIEMSS' decision by filing written exceptions with the Executive Director for consideration by the EMS Board.</text> </paragraph> <paragraph num="(2)"> <text>For the written exceptions to be considered timely, a hospital shall file the written exceptions with the Executive Director within 20 business days from the date the hospital receives MIEMSS' decision.</text> </paragraph> <paragraph num="(3)"> <text>The exceptions shall state with specificity the reasons why MIEMSS' decision should be overturned.</text> </paragraph> <paragraph num="(4)"> <text>The hospital shall mail a copy of the exceptions to MIEMSS by first class mail, postage prepaid.</text> </paragraph> </paragraph> <paragraph num="B."> <text>MIEMSS' Response.</text> <paragraph num="(1)"> <text>Not later than 20 business days from the date the exceptions are filed with the Executive Director, MIEMSS may file a response.</text> </paragraph> <paragraph num="(2)"> <text>MIEMSS shall mail a copy of its response to the hospital by first class mail, postage prepaid.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Decision of EMS Board.</text> <paragraph num="(1)"> <text>Not later than 90 calendar days from the date of the filing of the hospital's exceptions or MIEMSS' response, whichever is later, the EMS Board shall issue a written decision granting or denying the exceptions.</text> </paragraph> <paragraph num="(2)"> <text>If the EMS Board denies the exceptions, the proposed decision, as affirmed by the EMS Board, is the final agency decision.</text> </paragraph> <paragraph num="(3)"> <text>If the EMS Board grants the exceptions, in whole or in part, the EMS Board shall modify the proposed decision accordingly and the modified decision is the final agency decision.</text> </paragraph> <paragraph num="(4)"> <text>An appeal to the EMS Board is not a contested case as defined in State Government Article, §10-202(d), Annotated Code of Maryland, and the decision of the EMS Board is the final agency decision and is not subject to judicial review.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Change in Designation Status of Trauma or Specialty Referral Center."> <paragraph num="A."> <text>A designated trauma or specialty referral center:</text> <paragraph num="(1)"> <text>Has the right to relinquish its designation as a trauma or specialty referral center or to request a designation lower than its current level of designation; and</text> </paragraph> <paragraph num="(2)"> <text>Shall provide the Office of Hospital Programs with 90 calendar days advance written notice of its request to change its designation status.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If the designated trauma center applies for a lower level of designation, MIEMSS:</text> <paragraph num="(1)"> <text>At its discretion, may repeat all or part of the designation process set forth in this chapter; and</text> </paragraph> <paragraph num="(2)"> <text>Shall consider the request based upon the criteria described in Regulation .02 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Temporary Inability to Comply with Standards.</text> <paragraph num="(1)"> <text>A designated trauma or specialty referral center shall notify the Office of Hospital Programs within 5 business days if it is temporarily unable to comply with the requirements for designated trauma or specialty centers as set forth in COMAR 30.08.03.</text> </paragraph> <paragraph num="(2)"> <text>The notice shall be in writing and shall specify the reasons for and the anticipated duration of the temporary inability to comply with the standards.</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS shall determine whether the temporary inability to comply with the standards warrants disciplinary action under COMAR 30.08.13.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Reverification of Trauma or Specialty Referral Center Designation."> <paragraph num="A."> <text>A designated trauma or specialty referral center, other than a designated adult or pediatric burn center, shall repeat the designation process, as set forth in this chapter, every 5 years.</text> </paragraph> <paragraph num="B."> <text>A designated adult or pediatric burn center shall:</text> <paragraph num="(1)"> <text>Complete the reverification process every 3 years; and</text> </paragraph> <paragraph num="(2)"> <text>If verified by the American Burn Association:</text> <paragraph num="(a)"> <text>Concurrently submit to MIEMSS the application submitted to the American Burn Association, along with such supplements as may be required by MIEMSS to demonstrate compliance with COMAR 30.08.06; and</text> </paragraph> <paragraph num="(b)"> <text>Notify MIEMSS immediately of any change in their verification status.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>At MIEMSS’ discretion:</text> <paragraph num="(1)"> <text>MIEMSS may accept verification of a trauma or specialty referral center by a nationally recognized medical specialty organization in lieu of conducting an on-site reverification review;</text> </paragraph> <paragraph num="(2)"> <text>MIEMSS may determine that there is sufficient data available to MIEMSS concerning the ongoing operation of the trauma or specialty center so that an on-site review is not necessary for a determination of reverification; or</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS may conduct an on-site review for reverification with MIEMSS staff and representatives, if any, from among the categories required for an initial designation site-review team as MIEMSS deems appropriate.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If a designated trauma or specialty referral center is in good standing:</text> <paragraph num="(1)"> <text>MIEMSS shall send written notice to the chief executive officer of the trauma or specialty referral center requesting that the trauma or specialty referral center submit, within 60 calendar days, a request for reverification of its designation status; and</text> </paragraph> <paragraph num="(2)"> <text>Designated trauma or specialty referral center shall retain its current designation status until the reverification process is completed.</text> </paragraph> </paragraph> <paragraph num="E."> <text>At the time of the reverification process, MIEMSS shall publish a notice in the Maryland Register that:</text> <paragraph num="(1)"> <text>Lists the trauma and specialty referral centers that have requested reverification of their designation status;</text> </paragraph> <paragraph num="(2)"> <text>Requests a person with knowledge of any reason why a designated trauma or specialty referral center should not have its designation status reverified to submit a written statement of the reason to MIEMSS within 20 business days following publication of the notice; and</text> </paragraph> <paragraph num="(3)"> <text>Requests that a hospital not designated that wishes to be considered for designation as a trauma or specialty referral center submit a written application to the Office of Hospital Programs in accordance with Regulation .03 of this chapter within 60 calendar days following publication of the notice.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 amended effective July 1, 2002 (29:12 Md. R. 932)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23. 2006 (33:21 Md. R. 1678)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23. 2006 (33:21 Md. R. 1678)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03D amended effective October 3, 2011 (38:20 Md. R. 1205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03I amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective October 3, 2011 (38:20 Md. R. 1205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07C, G amended effective October 3, 2011 (38:20 Md. R. 1205)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective October 3, 2011 (38:20 Md. R. 1205); July 1, 2020 (47:5 Md. R. 313)</annotation> </annotations> </chapter> <chapter num="03" heading="Requirements for Designated Trauma or Specialty Referral Centers"> <regulation prefix="Regulation" num=".01" heading="Requirements for Trauma or Specialty Referral Centers."> <paragraph num="A."> <text>A hospital designated as a trauma or specialty referral center shall:</text> <paragraph num="(1)"> <text>Comply with the applicable standards for trauma or specialty care as developed by MIEMSS and set forth in COMAR 30.08.05—30.08.12;</text> </paragraph> <paragraph num="(2)"> <text>Receive all trauma or specialty patients, regardless of race, color, religion, age, sex, marital status, national origin, ancestry, physical or mental disability, or ability to pay;</text> </paragraph> <paragraph num="(3)"> <text>Upon MIEMSS' request, provide data to MIEMSS related to trauma or specialty care programs;</text> </paragraph> <paragraph num="(4)"> <text>Allow MIEMSS to monitor compliance with applicable regulations and standards as set forth by MIEMSS, including providing MIEMSS with access to:</text> <paragraph num="(a)"> <text>Patient discharge summaries,</text> </paragraph> <paragraph num="(b)"> <text>Patient care logs,</text> </paragraph> <paragraph num="(c)"> <text>Patient care records,</text> </paragraph> <paragraph num="(d)"> <text>Hospital trauma or specialty care quality management program records, including minutes, and</text> </paragraph> <paragraph num="(e)"> <text>Other documents that MIEMSS determines to be relevant; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Require confidentiality of information relating to an individual patient, provider, and hospital care outcomes in accordance with:</text> <paragraph num="(a)"> <text>Health Occupations Article, Title 1, Subtitle 4, Annotated Code of Maryland, and</text> </paragraph> <paragraph num="(b)"> <text>General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency Standards.</text> <paragraph num="(1)"> <text>MIEMSS may impose additional requirements on a trauma or specialty referral center if it determines that the requirements are necessary for the immediate protection of trauma or specialty patients.</text> </paragraph> <paragraph num="(2)"> <text>MIEMSS shall provide the designated trauma or specialty referral center with advance written notice of an additional emergency standard.</text> </paragraph> <paragraph num="(3)"> <text>The designated trauma or specialty referral center shall have reasonable time to comply with the emergency standard.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Prehospital Triage and Transport."> <paragraph num="A."> <text>MIEMSS shall develop and distribute to health care providers prehospital triage and transport protocols for patients needing trauma or specialty referral services to ensure that patients who meet the triage criteria established by the protocols are transported directly to an appropriate facility.</text> </paragraph> <paragraph num="B."> <text>In the absence of extenuating circumstances, a health care provider shall transport a patient to the closest appropriate trauma or specialty referral center, consistent with the triage protocols.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prohibited Acts."> <paragraph num="A."> <text>A hospital may not represent itself to be a trauma or specialty referral center unless it is so designated by MIEMSS and approved by the EMS Board.</text> </paragraph> <paragraph num="B."> <text>A designated trauma or specialty referral center may not advertise services or capabilities for the treatment of patients above the trauma care level or specialty for which it has been designated.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03 amended effective July 1, 2002 (29:12 Md. R. 932)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1276); amended permanently effective October 23, 2006 (33:21 Md. R. 1678)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265)</annotation> </annotations> </chapter> <chapter num="04" heading="Data Collection and Quality Management"> <regulation prefix="Regulation" num=".01" heading="Responsibilities of MIEMSS."> <text>MIEMSS shall:</text> <paragraph num="A."> <text>Maintain the State trauma registry to collect and analyze data including, but not limited to, data concerning the incidence, severity, and causes of trauma and burns;</text> </paragraph> <paragraph num="B."> <text>Establish criteria to identify patients to be included in the State trauma registry;</text> </paragraph> <paragraph num="C."> <text>Collect data about patients to be included in the State trauma registry from:</text> <paragraph num="(1)"> <text>EMS providers;</text> </paragraph> <paragraph num="(2)"> <text>Hospitals, both designated and nondesignated including, but not limited to:</text> <paragraph num="(a)"> <text>The primary adult resource center;</text> </paragraph> <paragraph num="(b)"> <text>Level I trauma centers;</text> </paragraph> <paragraph num="(c)"> <text>Level II trauma centers;</text> </paragraph> <paragraph num="(d)"> <text>Level III trauma centers; and</text> </paragraph> <paragraph num="(e)"> <text>Maryland Trauma Specialty Referral Centers as defined in Health-General Article, §19-130(a)(3), Annotated Code of Maryland;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Office of Medical Examiner reports; and</text> </paragraph> <paragraph num="(4)"> <text>Other sources outside of the trauma and specialty care systems including, but not limited to:</text> <paragraph num="(a)"> <text>Death certificates,</text> </paragraph> <paragraph num="(b)"> <text>Hospital inpatient discharge data,</text> </paragraph> <paragraph num="(c)"> <text>Health care provider and third-party payer billing data, and</text> </paragraph> <paragraph num="(d)"> <text>Law enforcement agency records;</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Require hospitals to have a case specific patient identifier common to all data sources used in the State trauma registry; and</text> </paragraph> <paragraph num="E."> <text>Establish procedures and specifications for electronic and hard copy submission of data.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Trauma and Specialty Care Quality Management Plan."> <paragraph num="A."> <text>MIEMSS shall design a trauma and specialty care quality management plan for continued monitoring and evaluation of the State trauma and specialty care systems.</text> </paragraph> <paragraph num="B."> <text>The trauma and specialty care quality management plan shall include the establishment, publication, and periodic review of the data required to be submitted to provide information regarding injury, trauma and specialty care, and system operation in the following categories:</text> <paragraph num="(1)"> <text>Demography;</text> </paragraph> <paragraph num="(2)"> <text>Anatomy;</text> </paragraph> <paragraph num="(3)"> <text>Physiology;</text> </paragraph> <paragraph num="(4)"> <text>Severity;</text> </paragraph> <paragraph num="(5)"> <text>Epidemiology;</text> </paragraph> <paragraph num="(6)"> <text>Resource utilization;</text> </paragraph> <paragraph num="(7)"> <text>Quality improvement;</text> </paragraph> <paragraph num="(8)"> <text>Outcomes; and</text> </paragraph> <paragraph num="(9)"> <text>Finance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>MIEMSS shall establish committees for trauma and specialty care quality management as structural units of the Maryland EMS Quality Leadership Council to coordinate the trauma and specialty care systems quality management and quality improvement activities set forth in this subtitle.</text> </paragraph> <paragraph num="D."> <text>MIEMSS shall develop a system and reporting mechanism for quality improvement by:</text> <paragraph num="(1)"> <text>Determining the data standards for the State trauma registry;</text> </paragraph> <paragraph num="(2)"> <text>Setting forth the data standards for the State trauma registry in:</text> <paragraph num="(a)"> <text>The Maryland State Trauma Registry Data Dictionary for Adult Patients for patients 15 years old and older; and</text> </paragraph> <paragraph num="(b)"> <text>The Maryland State Trauma Registry Data Dictionary for Pediatric Patients for patients younger than 15 years old.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Establishing protocols for quality monitoring, consistent with MIEMSS' most current data quality guidelines;</text> </paragraph> <paragraph num="(4)"> <text>Conducting studies to assess the completeness and accuracy of case identification and data collection; and</text> </paragraph> <paragraph num="(5)"> <text>Ensuring that the data entered in the State trauma registry is complete and accurate.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Trauma and Specialty Care Quality Management Programs."> <paragraph num="A."> <text>A designated trauma or specialty referral center shall have a hospital-wide quality management plan to reflect and demonstrate continuous quality improvement in the delivery of trauma and specialty care.</text> </paragraph> <paragraph num="B."> <text>The quality management program includes, but is not limited to, the requirements for trauma and specialty referral centers in COMAR 30.08.03.</text> </paragraph> <paragraph num="C."> <text>A designated trauma and specialty referral center shall have a system for continuous monitoring and trend analysis of trauma patient bypass status.</text> </paragraph> <paragraph num="D."> <text>Designated trauma and specialty referral centers shall participate in State trauma and specialty care quality management activities sponsored by MIEMSS.</text> </paragraph> <paragraph num="E."> <text>If appropriate for quality assurance purposes, designated trauma and specialty centers shall provide EMS providers licensed or certified by the EMS Board under Education Article §13-516, Annotated Code of Maryland, who have or have had a direct treatment relationship with a patient, follow-up data or information on that patient. Quality assurance information provided under this action is considered to be provided in accordance with COMAR 30.03.04.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Use of State Trauma Registry and Specialty Care Data."> <text>MIEMSS may use State trauma registry and specialty care data to:</text> <paragraph num="A."> <text>Monitor and provide information necessary to evaluate major trauma or specialty patient care, outcome, and cost;</text> </paragraph> <paragraph num="B."> <text>Assess compliance of EMS providers, designated trauma and specialty referral centers, and other hospitals with the trauma and specialty care standards, regulations, and protocols;</text> </paragraph> <paragraph num="C."> <text>Provide information necessary for resource planning and management;</text> </paragraph> <paragraph num="D."> <text>Provide data for injury surveillance, analysis, and prevention programs; and</text> </paragraph> <paragraph num="E."> <text>Provide a data resource for research and education.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Responsibilities of Emergency Medical Services Providers."> <paragraph num="A."> <text>Prehospital services shall provide prehospital MAIS runsheets or EMAIS patient care reports that include trauma or specialty care patient data about:</text> <paragraph num="(1)"> <text>Trauma victims dead at the scene of the trauma;</text> </paragraph> <paragraph num="(2)"> <text>Patients meeting State trauma or specialty triage criteria who are transported to a hospital;</text> </paragraph> <paragraph num="(3)"> <text>Patients transported in accordance with interfacility transfer policies to receive a higher level of care or for special resources; and</text> </paragraph> <paragraph num="(4)"> <text>Patients transported to specialty referral centers.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The transporting service is responsible for submitting patient care data designated in the MAIS runsheet or the EMAIS patient care report to the receiving hospital.</text> </paragraph> <paragraph num="C."> <text>Designated trauma or specialty care centers shall use the patient criteria described in Regulation .01B and C of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Access to Trauma Registry and Specialty Care Information."> <paragraph num="A."> <text>Data that identifies individual patients, providers, and hospital outcomes is confidential.</text> </paragraph> <paragraph num="B."> <text>MIEMSS may only release confidential information:</text> <paragraph num="(1)"> <text>As required by the Health Services Cost Review Commission under Health-General Article, §19-130, Annotated Code of Maryland; or</text> </paragraph> <paragraph num="(2)"> <text>In accordance with:</text> <paragraph num="(a)"> <text>The provisions of Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Other criteria as developed by MIEMSS pertaining to patient confidentiality and quality management records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>MIEMSS may approve requests for data and other information from the State trauma registry and specialty care databases for special studies and analyses in accordance with §B of this regulation.</text> </paragraph> <paragraph num="D."> <text>A person having access to information collected under this subtitle may use the information only for the purposes allowed under Regulation .04 of this chapter.</text> </paragraph> <paragraph num="E."> <text>MIEMSS may require a person who requests data or other information from the State trauma registry and specialty care databases to pay all or part of the reasonable costs associated with special preparation of the request.</text> </paragraph> <paragraph num="F."> <text>MIEMSS may not disclose confidential information to any person, except on request:</text> <paragraph num="(1)"> <text>To an approved regional or State quality improvement program if the regional or State quality improvement program is subject to the same confidentiality guidelines as MIEMSS;</text> </paragraph> <paragraph num="(2)"> <text>To a scientific research professional associated with a scientific research organization, if:</text> <paragraph num="(a)"> <text>MIEMSS has reviewed and approved the research professional's written research proposal with respect to scientific merit and confidentiality safeguards, and</text> </paragraph> <paragraph num="(b)"> <text>The data does not identify specific hospitals or patients; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>MIEMSS shall provide aggregate State trauma registry and specialty care data to hospitals, public or private agencies, and other interested parties for:</text> <paragraph num="(a)"> <text>Prevention activities,</text> </paragraph> <paragraph num="(b)"> <text>Epidemiological or demographic studies, or</text> </paragraph> <paragraph num="(c)"> <text>Education and research projects.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04 amended effective July 1, 2002 (29:12 Md. R. 932)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E adopted effective December 15, 2003 (30:24 Md. R. 1746)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective July 1, 2002 (29:12 Md. R. 932); December 19, 2005 (32:25 Md. R. 1947)</annotation> </annotations> </chapter> <chapter num="05" heading="Trauma Center Designation and Verification Standards"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“E” means the standard is essential.</text> </paragraph> <paragraph num="(2)"> <text>“D” means the standard is desirable.</text> </paragraph> <paragraph num="(3)"> <text>“NA” means the standard does not apply.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Types of Trauma Centers."> <paragraph num="A."> <text>“PARC” is a Primary Adult Resource Center.</text> </paragraph> <paragraph num="B."> <text>“I” is a Level I trauma center.</text> </paragraph> <paragraph num="C."> <text>“II” is a Level II trauma center.</text> </paragraph> <paragraph num="D."> <text>“III” is a Level III trauma center.</text> </paragraph> <paragraph num="E."> <text>“ED” is an emergency department for which the indicated standards are recommended, not required.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Organization."> <text>PARC I II III ED A. A hospital’s board of directors, administration, and medical and nursing staffs shall demonstrate commitment to the optimal care of injured patients by: (1) Formulating a board of director’s resolution stating that: E E E E E (a) The hospital agrees to meet the Trauma Center designation standards for the hospital’s specific level of designation; E E E E E (b) The hospital has a commitment to the infrastructure and the financial, human, and physical resources necessary to support the hospital’s specific level of designation; and E E E E E (c) The hospital has a commitment to the Quality Management (QM) process of the trauma patient; and E E E E E (2) Establishing an identifiable program whose dedication to the care of the injured is shown in: (a) Its mission statement; E E E E NA (b) The configuration of its medical, administrative, and support staffs; E E E E NA (c) The configuration of its physical plant; E E E E NA (d) Demonstrated participation and involvement in state and regional trauma system planning, development, and operations required for all designated Trauma Centers; E E E E E (e) Assurance that all trauma patients receive medical care commensurate with the level of the hospital’s designation; and E E E E E (f) Demonstrated commitment to the infrastructure and financial, human, and physical resources necessary to support the hospital’s level of trauma center designation through the hospital’s bylaws, contracts, and budget specific to the trauma program; E E E E E B. A hospital shall be licensed by the Department of Health as an acute care hospital. E E E E E C. A hospital shall be accredited by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services, and approved by the Maryland Department of Health to accredit hospitals in the State. E E E E E D. A hospital shall maintain current equipment and technology to support optimal trauma care for the level of the hospital’s Trauma Center designation. E E E E E E. A hospital shall have: (1) A heliport or helipad positioned so there is a limited distance from the helipad to the hospital, and positioned at the closest safe location, in order to minimize effects to the patient; or E E E E NA (2) Access to a helicopter-landing zone near the hospital. NA NA NA NA E F. To administer the trauma program, a hospital shall have a trauma leadership team that includes: (1) A Trauma Medical Director (TMD) who: E E E E D (a) Has administrative oversight for the trauma program; (b) With the Trauma Program Manager (TPM), has the authority and is empowered by the hospital’s governing body to lead the trauma program; (c) Has the authority and scope for administering all aspects of trauma care and is responsible for overall clinical coordination; (d) Is responsible for all trauma patients through the QM process; (e) Directs the Trauma QM Program and reports QM activity as directed by the institutional reporting structure; (f) Has a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR; (g) Appears on the hospital’s organizational chart where the relationship between the medical director and other hospital services are depicted and delineated; and (h) Participates in regional and state education, QM, and injury prevention activities; (2) A full-time director of patient care services, who is a registered nurse, with direct authority for all nursing and ancillary trauma patient care services, operations, and the QM associated with these services; E NA NA NA NA (3) An in-house resource coordinator who is available 24 hours a day and is responsible for the timely coordination of trauma patient care resources, services, patient flow and throughput; E E E E E (4) A TPM who is dedicated full-time to the management of the trauma program and in collaboration with the TMD and nursing management, has oversight for, monitors, and coordinates the components of the trauma program, including: E E E E NA (a) Patient care; (b) Provider education; (c) Public education and prevention activities; (d) Program management; (e) The hospital’s participation in the Maryland State Trauma Registry; (f) QM for the trauma program; and (g) Show evidence of 16 hours of external trauma-related CE a year and over a 2-year period, half of the CE hours shall be obtained outside the hospital and be recognized by a national accrediting body; G. The Trauma Center shall have one or more committees that provide expert input to the hospital’s management of trauma program issues that shall: (1) Under the leadership of the TMD and TPM or designee, provide trauma multidisciplinary peer review and include representatives from general surgery, to address clinical care issues; E E E E NA (2) Conduct trauma multidisciplinary peer review that includes Orthopedic surgery, Emergency Medicine, Critical Care, Anesthesia, Neurosurgery, Radiology and Nursing, to address clinical care issues; E E E E E (3) Monitor trauma patient care among hospital departments, medical and nursing staffs, and representative disciplines across the trauma care continuum; and E E E E NA (4) Collaborate with the Emergency Department (ED) Committee to address trauma care issues. NA E E E E H. The Trauma Resuscitation Team shall: (1) Be in the Trauma Resuscitation Unit on arrival for all trauma patients; E NA NA NA NA (2) Be in the trauma resuscitation area at the bedside within 15 minutes of being called for the highest level of activation; NA E E NA NA (3) Be activated by an emergency physician or nurse using clearly defined Trauma Center criteria for activation protocol; NA E E E E (4) Be directed by an in-house emergency physician who has experience and training in trauma resuscitation until the patient is formally transferred to the care of the trauma surgeon; NA E E E E (5) Be in the trauma resuscitation area at the bedside within 30 minutes of being called for the highest level of activation; NA NA NA E D (6) Be oriented to the trauma care system; E E E E D (7) Be required to complete annual continuing education and demonstrate competence for trauma care that is appropriate and specific to each member’s specialty roles; E E E E E (8) Participate in: (a) Trauma Quality Management (QM); and E E E E E (b) Ongoing medical education or continuing education in trauma; E E E E E (9) Be oriented to the internal trauma patient clinical management protocols or clinical practice guidelines, and algorithms derived from evidenced-based validated resources; E E E E E (10) Be defined in writing, specifying the roles and responsibilities of each member; and E E E E E (11) Be accountable to the trauma surgeon who becomes the team leader upon arrival in the resuscitation area. NA E E E NA I. A hospital shall have written policies and procedures to direct the organized, safe, intra-hospital and inter-hospital transfer process of trauma patients. E E E E E J. A hospital shall complete transfers to in-State hospitals, or to out-of-State hospitals listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, in accordance with the guidelines contained in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual without the need for separate transfer agreements. E E E E E K. A hospital shall have a written transfer agreement in place for transfer of a patient to an out-of-State hospital not listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, if the hospital transfers to such out-of-State hospital more than five times a year. E E E E E L. A hospital shall have a multidisciplinary plan of care specific to the needs of each trauma patient and address all phases of care, including discharge disposition, and rehabilitation needs. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Medical Staff."> <text>PARC I II III ED A. Credentialing Process. Each physician and Advanced Practice Professional (APP) shall be credentialed by the hospital for the appropriate specialty, including trauma care. E E E E E B. Delineation or Reevaluation of Privileges: E E E E NA (1) The trauma physicians and APPs shall be limited to those with demonstrated skills, commitment, experiences, and interest in trauma care. E E E E NA (2) The trauma medical director shall serve on the medical staff as the trauma chief of service. E E E E NA (3) Appointment and reappointment to the trauma admitting or consulting staff shall be coordinated by the trauma medical director and based on the following criteria: E E E E NA (a) Maintenance of good standing in the primary specialty; E E E E NA (b) Evidence of the required continuing medical education in trauma, including: (i) For general surgeons taking trauma calls evidence of 16 hours of trauma-related CME credits a year; E E E E NA (ii) Over a 2-year period, half of the CME hours shall be obtained outside the hospital and be recognized by a national accrediting body; E E D D NA (iii) ATLSTM which may be counted in required CME credits; and E E E E NA (iv) Physician CME credits shall be documented in accordance with hospital policy. E E E E NA (c) Documented attendance at Trauma QM meetings, as those meetings are institutionally defined, of no less than monthly averaged over 12 months; E NA NA NA NA (d) Documented attendance at Trauma multidisciplinary meetings, Morbidity and Mortality (MandM) rounds, or hospital peer-review conference that deal with the care of injured patients; and NA E E E NA (e) Satisfactory performance in managing trauma patients based on performance assessment and outcome analysis. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Trauma Service."> <text>PARC I II III ED Trauma Service requirements are as follows: A. The Trauma Service shall be established by the medical staff and shall be responsible for the care of injured patients. E E E E NA B. Privileges for physicians on the trauma service shall be determined by the medical credentialing process. E E E E NA C. The trauma service attending surgeon shall retain responsibility for the patient and coordinate all therapeutic decisions while the patient is on the Trauma Service. E E E E NA D. Injured patients may be observed by or admitted to an individual surgeon, but the structure of the program shall allow the Trauma Medical Director to have oversight authority for the care of these patients. E E E E NA E. The Trauma Center shall have a clearly defined response requirement for the trauma surgical evaluation of injured patients. E E E E NA F. Patients with injuries having a high index of suspicion, such as a significant mechanism of injury, shall be evaluated by the trauma service in compliance with hospital protocol. E E E E NA G. The emergency physician may initially evaluate the trauma patient, but the Trauma Center shall have a clearly defined response requirement for the trauma surgical evaluation of those patients requiring observation or admission. NA E E E E H. Patients with multiple system or complex single system injuries shall be evaluated by the trauma surgery service. E E E E NA I. The surgeon responsible for a patient’s care shall be identified. E E E E NA J. The hospital shall document: (1) Current certification as ATLS® instructors for all attending general trauma surgeons; E NA NA NA NA (2) Successful completion and continued certification of an ATLS® course for all general trauma surgeons; E E E D NA (3) Successful completion and continued certification of an ATLS® course for the TMD and all APP’s who provide initial evaluation of trauma patients, treatment and care; and E E E E E (4) Current APLS® certification for physicians providing pediatric trauma care; D D D D D</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Trauma Medical Director."> <text>PARC I II III ED The Trauma Medical Director (TMD) shall: A. Be an expert in and committed to the care of the injured with a special interest in trauma care; E E E E NA B. Be board certified in general surgery or other surgical specialties; E E E E NA C. Be able to devote the time needed to fulfill the TMD responsibilities as delineated in COMAR; E E E D NA D. Have the following educational preparation and clinical experience: (1) Successful completion of advanced specialty training in trauma care or Trauma/Critical Care fellowship for at least 1 year; E E E D NA (2) Demonstrated experience at a designated Level I Trauma Center in trauma systems management, trauma research, and quality management functions; and E D NA NA NA (3) Documented interest in trauma center or trauma system issues as evidenced by education, publications, professional experience, and involvement in planning and prevention efforts; E D D D NA E. Maintain membership and active participation in local, regional, state or national trauma-related activities and trauma organizations; E E E E NA F. Participate in trauma educational activities such as: (1) Trauma/Critical Care fellowship programs; E D NA NA NA (2) Undergraduate medical education; E E NA NA NA (3) Continuing education; and E E E E NA (4) ATLS® courses; E E E E NA G. Participate in trauma research and publication efforts; and E E D D NA H. Demonstrate active participation in the resuscitation of multi system trauma patients, or surgery of multi system trauma patients or both. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Surgery Department."> <text>PARC I II III ED A. General Surgery. A hospital shall have a surgery department including: (1) For the “most critical patients” an in-house, fellowship trained attending trauma surgeon, trauma fellow or trauma fellow equivalent/PGY5+ general surgery resident should be at the bedside upon arrival, documented at least 80 percent of the time. E NA NA NA NA (2) Either: (a) A trauma or general surgeon trained in trauma care who shall be at the bedside within 15 minutes of being called for the highest level of activation and should be at the bedside within 15 minutes with compliance demonstrated at least 80 percent of the time; NA E E NA NA (b) An in-house PGY4 or more senior resident who shall be at the bedside with the attending trauma or general surgeon within 15 minutes of being called for the highest level of activation and should be at the bedside within 15 minutes with compliance demonstrated at least 80 percent of the time; or NA E E NA NA (c) An in-house APP trained in trauma care who shall be at the bedside with the attending trauma or general surgeon within 15 minutes of being called for the highest level of activation and should be at the bedside within 15 minutes with compliance demonstrated at least 80 percent of the time; NA E E D NA (3) An attending trauma surgeon taking trauma call who shall be at the bedside within 30 minutes from patient arrival for the highest level of activation with the surgeons’ presence with compliance demonstrated at least 80 percent of the time; NA NA NA E NA (4) Trauma or general surgeons who are board certified or board eligible, E E E E NA (5) Trauma or general surgeons who agree to actively participate in a defined continuing education program; E E E E D (6) Criteria and protocols for the notification and response of a trauma or general surgeon; E E E E NA (7) General Surgery APPs taking trauma call who have evidence of average of 16 hours a year or 32 hours in 2 years of trauma-related education; and E E E E NA (8) A liaison to the trauma QM program with 50 percent attendance. E E E E NA B. Neurosurgery. Neurosurgery requirements are as follows: (1) Neurosurgeons who are board certified or board eligible; E E E E E (2) A Board-certified or board-eligible, trauma fellowship-trained in-house neurosurgery attending or PGY2 or higher, dedicated 24 hours a day to trauma care with a Neurosurgery Attending on-call and who shall be at the patient bedside within 30 minutes after Emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria; E E NA NA NA (3) The on-call Neurosurgery Attending taking trauma call shall be at the bedside within 30 minutes after Emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria and with in-house physician capable of initiating stabilization and diagnostic procedures; NA NA E E NA (4) If a neurosurgeon taking trauma call covers more than one hospital within the same geographic area, there shall be a written contingency plan in place for times in which a neurosurgeon is unavailable upon the arrival of a Neurotrauma case; NA NA E E E (5) A qualified Neurosurgeon shall be regularly involved in the care of patients with neurologic injuries and shall be credentialed by the hospital with general neurosurgical privileges; E E E E E (6) Neurosurgery APP or PGY2 or higher with attending on-call; NA NA E E E (7) Neurosurgery APPs taking trauma call shall have evidence of average of 16 hours a year or 32 hours in 2 years of trauma-related education; and E E E E NA (8) A liaison to the trauma QM program with 50 percent attendance. E E E E NA C. Orthopedic Surgery. Orthopedic surgery requirements are as follows: (1) A Board-certified or board-eligible, trauma fellowship-trained in-house orthopedic attending or PGY2 or higher, dedicated 24 hours a day to trauma care with an Orthopedic Attending on-call and who shall be at the patient bedside within 30 minutes after Emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria; E E NA NA NA (2) Orthopedic team members shall have dedicated call at their institution or have an effective backup call system. If the on-call orthopedic surgeon is able to respond promptly, a backup consultant on-call surgeon shall be available; E E E E E (3) Board-certified or board-eligible on-call attending with a 30-minute response after emergent response is requested; NA NA E E NA (4) Orthopedic APPs taking trauma call who have evidence of average of 16 hours a year or 32 hours in 2 years of trauma-related education; and E E E E NA (5) A liaison to the trauma QM program with 50 percent attendance. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Non-Surgical Specialty."> <text>PARC I II III ED A. Anesthesia. Anesthesia requirements are as follows: (1) Board-certified, fellowship trained Anesthesiology Attending in-house, dedicated 24 hours a day to trauma care should be at the bedside upon arrival, and documented at least 80 percent of the time; E NA NA NA NA (2) Board-certified or board-eligible, in-house attending 24 hours a day; NA E E E NA (3) Attending anesthesiologist or CRNA taking trauma call shall be at the bedside within 15 minutes of being called with institution-specific criteria defining conditions requiring an immediate response, and present for all operations; and NA E E E NA (4) A liaison to the trauma QM program with 50 percent attendance. E E E E E B. Emergency Medicine. Emergency Medicine (EM) requirements are as follows: (1) Physician Director or designated Director of Trauma Services in Emergency Medicine who: (a) Is Board certified or board eligible in EM with evidence of active participation in daily emergency care; NA E E E D (b) Has administrative duties in the Emergency Department (ED); NA E E E D (c) Demonstrates the successful completion of the ATLS® course, at least once; and NA E E E E (d) Maintains ATLS® certification; NA E E E E (2) Emergency physician in-house 24 hours a day who is: (a) Board certified or board eligible in EM; NA E E E E (b) Board certified or board eligible in a non-EM specialty with at least 7,000 hours of emergency practice and current ATLS® certification; NA NA NA E E (c) If certified by boards other than EM and treating trauma patients in the ED, current ATLS® status; or NA E E E E (d) Has demonstrated special capabilities through commitment, continuing education, and experience; NA NA NA NA E (3) Advanced Practice Professionals (APP) providing care to the trauma patient who have current ATLS® certification; and NA E E E E (4) A liaison to the trauma QM program with 50 percent attendance. NA E E E E C. Critical Care. Critical care requirements are as follows: (1) Intensive care with a designated surgical director who is fellowship trained and board certified in surgery or critical care; E E D NA NA (2) A board certified surgeon who serves as director or co-director of the ICU and is actively involved in, and responsible for, setting policies and administrative decisions related to trauma ICU patients; NA NA E D NA (3) A trauma surgeon who retains responsibility for the patient and coordinates all therapeutic decisions; NA E E E NA (4) If Telemedicine is used, physician/s who have privileges in critical care and be approved by the TMD; and E E E E NA (5) A liaison to the trauma QM program with 50 percent attendance. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Additional Surgical Specialties."> <text>The following surgical specialties shall be on call and available with a 30-minute response time: PARC I II III ED A. Cardiac; E E D NA NA B. Hand; E E D D NA C. Microvascular replant or flaps; E E D D NA D. Obstetric and gynecologic; E E E E NA E. Ophthalmic; E E E D NA F. Oral or maxillofacial; E E E D NA G. Otorhinolaryngologic; E E E D NA H. Pediatric; E E D D NA I. Plastic; E E E D NA J. Thoracic; E E E E NA K. Urologic; and E E E E NA L. Vascular. E E E D NA</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Additional Non-Surgical Specialties."> <text>PARC I II III ED The following non-surgical specialties shall be on-call and available 24 hours a day and shall be at the bedside within 60 minutes after Emergent consultation has been requested by the surgical trauma team leader based on institution-specific criteria: A. Cardiology; E E E E D B. Pulmonary medicine; E E E E D C. Interventional Radiology (perform complex imaging studies, or interventional procedures); E E E D NA D. Interventional Angiography; and E E E D D E. Pediatrics. E E D D NA</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Additional Non-Surgical Specialties."> <text>PARC I II III ED The following non-surgical specialties shall be on-call: A. Gastroenterology; E E E D NA B. Infectious Disease; E E E D NA C. Internal Medicine; E E E E D D. Nephrology; E E E E D E. Neurology; E E E E NA F. Pathology; E E E E NA G. Physiatry; and D D D D NA H. Psychiatry. E E E E D</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Nursing Services."> <text>PARC I II III ED A. Responsibility shall be assigned within the department of nursing for trauma care. Oversight of trauma nursing care services shall be with the Department of Nursing. NA E E E NA B. A written plan shall exist and be approved by nursing that shall include the ability to immediately mobilize qualified staff for initial resuscitation. E E E E E C. There shall be a written plan for providing adequate and appropriate nursing staff to meet the acuity needs of trauma patients in each unit. E E E E E D. The nursing department shall participate in multidisciplinary quality management monitoring of trauma care. E E E E E E. There shall be an introductory education program for all nurses caring for Trauma patients that addresses the learning outcomes approved by the Maryland Trauma Quality Improvement Committee (TQIC). This introductory education program shall include 16 hours of content within 1 year of hire. E E E E E F. After completion of the introductory education mandated in this regulation, continuing education shall be current, meeting the following requirements: E E E E D (1) 8 hours of trauma-related education every year for emergency and critical care, OR, and PACU nurses caring for trauma patients; or (2) 4 hours of trauma-related education every year for nurses caring for trauma patients and are from other clinical areas.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Facility or Unit Capabilities."> <text>PARC I II III ED A. Emergency Department. Emergency Department (ED) requirements are as follows: (1) A designated ED physician director and nurse manager; NA E E E E (2) Board-certified or board-eligible attending physician with demonstrated competence in the care of critically injured patients in-house 24 hours a day; NA E E E D (3) A dedicated Trauma Resuscitation Unit (TRU) with dedicated staff, equipment and supplies 24 hours a day; E NA NA NA NA (4) Dedicated trauma resuscitation area with dedicated staff, equipment, and supplies 24 hours a day; NA E E E E (5) Senior attending trauma surgeon available 24 hours a day through EMRC/SYSCOM as a resource for trauma consultation Statewide; E NA NA NA (6) A sufficient number of registered nurses and other providers, who are competent to provide care during trauma resuscitation and present in sufficient numbers to manage projected case load, and a plan to reinforce the number of staff on immediate notice of multiple admissions; E E E E E (7) Defined and agreed on roles and responsibilities approved by the TMD with the overall goal to have available ED resources needed to care for patients; NA E E E E (8) Verification of functioning life-safety emergency equipment and supplies organized for trauma resuscitation present and immediately available 24 hours a day; E E E E E (9) Direct communication link to pre hospital providers and transport vehicles; E E E E E (10) Designated as Base Station by MIEMSS; E E E E E (11) Emergency Equipment located in the Resuscitation area/ED for: E E E E E (a) Airway control or cricothyrotomy; E E E E E (b) Difficult Airway Equipment; E E E E E (c) Thoracotomy; E E E E E (d) Vascular access; E E E E E (e) Thoracostomy/Chest decompression; E E E E E (f) Peritoneal Lavage; E E E E E (g) Bedside Ultrasound; E E E E E (h) Extremity Hemorrhage Control devises/Tourniquet; E E E E E (i) Rapid Infuser and Warmer; and E E E E E (j) Access to compartment measurement device; E E E E E (12) Policies and protocols for trauma team response and roles in ED trauma resuscitation in accordance with Regulation .11 of this chapter; and E E E E E (13) Drugs necessary for emergency care; E E E E E B. Operating Room. Operating Room (OR) requirements are as follows: (1) OR rooms adequately staffed with in-house personnel dedicated to trauma 24 hours a day; E D NA NA NA (2) OR available within 15 minutes of notification with adequate in-house staff; E E E E NA (3) X-ray capability including C-arm image intensifier 24 hours a day; E E E E NA (4) Equipment and instrumentation appropriate for: (a) Neurosurgery; E E E E NA (b) Vascular surgery; E E E E NA (c) Pelvic and long-bone fracture fixation; and E E E E NA (d) Cardiopulmonary bypass: (i) Cardiopulmonary bypass; E E D NA NA (ii) If cardiopulmonary bypass equipment is not immediately available, a written contingency plan, including immediate patient transfer to an appropriate center with a 100 percent performance improvement review of all patients transferred; NA E E E NA (5) Rapid fluid infusers, thermal control equipment for patients and resuscitation fluids, intraoperative radiologic capabilities, equipment for fracture fixation, and equipment for bronchoscopy and gastrointestinal endoscopy; E E E E NA (6) Equipment for continuous monitoring of temperature, hemodynamics, and gas exchange; and E E E E NA (7) Endoscopes. E E E E NA C. Post-Anesthesia Care Unit (PACU) requirements are as follows: (1) Dedicated to trauma and staffed 24 hours a day; E NA NA NA NA (2) PACU Room/s available to trauma patients with registered nurses and other essential staff 24 hours a day; and NA E E E NA (3) The necessary equipment to monitor and resuscitate patients including equipment for continuous monitoring of temperature, hemodynamics, and gas exchange. E E E E NA D. Intensive Care Unit (ICU). Intensive care unit requirements are as follows: (1) Dedicated ICU for trauma with appropriately trained registered nurse staff; E NA NA NA NA (2) Designated ICU bed availability for trauma patients with appropriately trained trauma registered nurses in sufficient numbers based on patient acuity; E E E E NA (3) Written plan for triaging patients from the intensive care unit to free up beds for trauma patients when necessary or provision of alternate critical care beds for trauma patients with appropriately trained registered nurse staff; E E E E NA (4) The means to ensure that the trauma surgeon is kept informed and concurs with major therapeutic and management decisions made by the ICU team which can collaboratively manage many of the daily care requirements; E E E E NA (5) The means to ensure that trauma patients are not admitted or transferred by a primary care physician without the knowledge and consent of the trauma service; E E E E NA (6) The necessary equipment to monitor and resuscitate patients; E E E E NA (7) Support services with immediate access to clinical diagnostic services such as arterial blood gases, hematocrits, and chest X-rays available within 30 minutes; E E E E NA (8) A Respiratory Therapist available in the hospital 24 hours per day; E E E E E (9) Nutrition support services available; and E E E E NA (10) Acute continuous hemodialysis capability. E E E E NA E. Acute Spinal Cord and Head Injury Management Capability. Acute spinal cord or head injury management requirements are as follows: (1) Dedicated Neurotrauma units with dedicated, specialty trained nursing and support staff; E NA NA NA NA (2) Neuro-intensive services with intracranial pressure capabilities for trauma patients; NA E D D NA (3) Intracranial pressure monitoring equipment available with neurosurgical coverage; E E E E E (4) Dedicated services to care for spinal cord injury and patient management; and E NA NA NA NA (5) Orthopedics or Neurosurgery management of the spine patients with appropriate neuro monitoring consistent with current standards of care to meet the needs of the patient. E E E E E F. Burn Care. Burn care requirements are as follows: (1) Ability to provide initial resuscitation for burn patients; E E E E E (2) Proper equipment for the care of burned patients, prior to transfer to burn center; and E E E E E (3) A hospital shall complete transfers to in-State hospitals, or to out-of-State hospitals listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, in accordance with the guidelines contained in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual without the need for separate transfer agreements. E E E E E (4) A hospital shall have a written transfer agreement in place for transfer of a patient to an out-of-State hospital not listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, if the hospital transfers to such out-of-State hospital more than five times a year. E E E E E G. Radiological Special Capabilities. Radiological special capabilities requirements are as follows: (1) Qualified radiologists and staff available within 60 minutes of consultation notification to perform complex imaging studies, or interventional procedures; E E E E E (2) A Board-certified or board-eligible, in-house Radiology Attending on-call who shall provide interpretations of radiographs within 30 minutes; E NA NA NA NA (3) Qualified in-house Radiology or Teleradiology available 24 hours a day for the interpretations of radiographs; NA E E E E (4) Changes in interpretation between preliminary and final reports, as well as missed injuries, monitored through the QM program; E E E E NA (5) A mechanism in place to view radiographic imaging from referring hospitals; E D D D NA (6) In-house trauma-dedicated technicians 24 hours a day; E NA NA NA NA (7) In-house radiology technicians 24 hours a day; E E E E E (8) Dedicated computed tomography (CT) scan and angiography facilities and staff 24 hours a day; E NA NA NA NA (9) Interventional Angiography; E E E D NA (10) Sonography; E E E E D (11) Nuclear scanning; E E E E NA (12) Magnetic resonance imaging (MRI) capability available 24 hours per day; E E E D D (13) An MRI technologist who may respond from outside the hospital with the QM program documenting and reviewing arrival within 60 minutes of being called; and E E E D D (14) Computed tomography (CT): (a) Computed tomography (CT) in-house and available 24 hours a day; E E E E NA (b) In-house CT technician 24 hours a day; and E E E E NA (c) Back-up CT scan capabilities. E E E E NA H. Rehabilitation. Rehabilitation requirements are as follows: (1) Rehabilitation services staffed by personnel trained in rehabilitative care and properly equipped for acute care of the critically injured patient; E E D D NA (2) Rehabilitation consultation services, occupational therapy, speech therapy, physical therapy, and social services available in the critical care phase as needed; E E D D NA (3) Full in-house service or transfer process in place to a rehabilitation service for Long-term care or sub-acute care; E E E E NA (4) Ongoing continuity of care for patients with traumatic brain, musculoskeletal, and soft tissue injuries provided in affiliated rehabilitation facility by attending trauma center specialists and sub-specialists; and E NA NA NA NA (5) Transfer agreements to Rehabilitation hospitals, for the primary three rehabilitation hospitals the trauma center utilizes which may be a joint transfer agreement if the Trauma Center is a part of a health system that utilizes a particular rehabilitation center. E E E E NA I. Clinical Laboratory Service. (1) A clinical laboratory service shall be available 24 hours a day capable of providing: E E E E E (a) Standard analysis of blood, urine, and other body fluids; (b) Blood-typing and cross-matching; (c) Comprehensive blood bank or access to a central blood bank in the community and adequate storage facilities with stock minimums set by protocol for blood products; (d) Blood gases and pH determinations; (e) Coagulation studies; (f) Microbiology; and (g) Drug and alcohol screening. (2) The blood bank shall have an adequate in-house supply of red blood cells, fresh frozen plasma, platelets, cryoprecipitate, and appropriate coagulation factors to meet the needs of injured patients. E E E E E (3) A massive transfusion protocol developed collaboratively between the trauma service and the blood bank. E E E E E (4) A dedicated satellite lab or Point-of-Care available near or in the trauma resuscitation area for essential lab studies. E E D D NA J. Equipment for Resuscitation. Equipment for resuscitation of patients of all Ages in the ED, OR, PACU, and ICU shall be immediately available and include: (1) Airway control and ventilation equipment, difficult airway equipment, including laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, pocket masks, and oxygen; E E E E E (2) Suction devices; E E E E E (3) Pulse oximetry; E E E E E (4) Electrocardiograph-oscilloscope-defibrillator; E E E E E (5) Standard intravenous fluids and administration devices, including large-bore intravenous catheters; E E E E E (6) End-tidal CO2 determination; E E E E E (7) Apparatus to establish hemodynamic monitoring; E E E E NA (8) Skeletal traction devices, including capabilities for cervical traction; E E E E E (9) Arterial catheters; E E E E NA (10) Thermal control equipment for patient and fluids; E E E E E (11) Rapid Infuser and Warmer; E E E E E (12) Compartmental pressure measuring device; and E E E E D (13) Portable ultrasound. E E E E E</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Quality Management."> <text>PARC I II III ED A. The ongoing Quality Management (QM) of the trauma program shall be: E E E E E (1) Integrated into the hospital’s overall quality management program; and E E E E E (2) Reported to the hospital’s governing body. E E E E E B. Trauma Centers shall have: (1) A QM comprehensive written plan outlining the configuration and identifying both adequate personnel to implement that plan and an operational data management system: and E E E E E (2) A designated QM Process Improvement (PI) position in Trauma Centers with a trauma registry volume greater than 1500 patients per year which is separate from the TPM position. This position should initiate the concurrent review process and, in conjunction with the TPM, facilitate the PI process to loop closure. This position should report directly to the TPM. E E E D NA C. The TMD shall have a leadership role in trauma center QM. E E E E E D. The following shall be included in the QM of the trauma program: (1) Structure to ensure that defined program outcomes and performance measures are developed and monitored regularly; to include: E E E E E (a) Trauma Patient Identification; E E E E E (b) Peer Review; and E E E E E (c) Audit filters; E E E E E (2) A hospital trauma registry with participation in the State trauma registry; E E E E E (3) Special audit of all trauma deaths; E E E E E (4) Morbidity and Mortality reviews; E E E E E (5) Evaluation of nursing care, medical care, utilization review, tissue review, and pre hospital care; E E E E E (6) Trauma center by-pass status including, if applicable, both medevac fly-by and ground unit re-route statistics; and E E E E E (7) Documentation of quality management available to demonstrate the multidisciplinary approach to the quality management program including and if appropriate: E E E E E (a) Problem Identification; (b) Analysis; (c) Action plan; (d) Implementation; (e) Reevaluation; and (f) Loop Closure/Resolution. E. The liaisons on the multidisciplinary trauma peer review committee shall attend a minimum of 50 percent of those committee meetings. E E E E E F. The TMD shall be involved in the development of the trauma center’s bypass (diversion) protocol. E E E E E G. The trauma surgeon shall be involved in the decision regarding bypass (diversion) each time the center goes on bypass. E E E E E H. The Trauma Center shall minimize trauma bypass hours with a goal of less than 5 percent per month of the total monthly hours. E E E E E I. Trauma center diversion-bypass hours shall be routinely monitored, documented, and reported, including the reason for initiating the diversion policy. E E E E E J. Monthly Review. (1) At one or more appropriate forums in the hospital, the trauma program shall be reviewed monthly, including both clinical care and administration. E E E E E (2) When a resource is required to be within a specified period of time, the time the resource is requested and the time the resource is available shall be documented as part of the QM process and the response times shall be reviewed monthly. E E E E E (3) The following aspects shall be addressed: E E E E E (a) Trends; (b) All deaths; (c) All transfers; (d) Morbidities; (e) Problem identification and solution; (f) Issues identified from the quality management process; and (g) Other trauma system issues. (4) Minutes shall be maintained for all meetings and shall reflect the review of operational events and, when appropriate, the analysis and proposed corrective actions. E E E E E</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Injury Prevention and Public Education."> <text>PARC I II III ED A. The trauma center shall: (1) Collaborate closely with MIEMSS in developing, monitoring, and evaluating the effectiveness of prevention and public education programs; E E E E NA (2) Conduct epidemiology research concerning injury control; E E NA NA NA (3) Collaborate with other hospitals or agencies in research; and E E E E D (4) Monitor progress of prevention programs in cooperation with State quality monitoring activities. E E E E NA B. The Trauma centers hall have: (1) An organized and effective approach to injury prevention that prioritizes those efforts based on local trauma registry and epidemiologic data; E E E E NA (2) A dedicated injury prevention coordinator in the trauma center, separate from the TPM position who, in conjunction with the TPM, facilitates outreach and injury prevention strategies specific to the population of the Trauma Center; E NA NA NA NA (3) A designated injury prevention individual in the trauma center, separate from the TPM position, who, in conjunction with the TPM, facilitates outreach and injury prevention strategies specific to the population of the Trauma Center; NA E E D NA (4) Outreach activities and program development that address one of the major causes of injury in the community; E E E E E (5) Information resources; and E E E E E (6) Collaboration with existing national, regional, state and local programs. E E E E E</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Trauma Research."> <text>PARC I II III ED A. A trauma center shall have: E E NA NA NA (1) An organized trauma research program with a designated physician director and documented research plan; (2) Regular meetings of the research group; and (3) Evidence of productivity through peer review. B. The Trauma Center shall have: (1) Proposals reviewed by an institutional review board; E E D D NA (2) Presentations at local, regional, or national meetings; E E D D NA (3) Publications in peer-reviewed journals on an average of seven per year; and E E D D NA (4) Clinical research trials designed to enhance the trauma system’s ability to resuscitate, stabilize, and treat trauma patients in the most cost-effective manner. E E D D NA</text> </regulation> <regulation prefix="Regulation" num=".17" heading="Education."> <text>PARC I II III ED A. A trauma center shall: (1) Assist MIEMSS with developing, monitoring, and evaluating the effectiveness of out-of-hospital training programs; and E E E E NA (2) Engage in public and professional education. E E E E NA B. The hospital shall offer: (1) Trauma education for: E E E E D (a) Hospital Nurses and physicians; (b) Community Nurses and Physicians; (c) Pre-hospital personnel; and (d) Allied health personnel; (2) A trauma critical care fellowship training program; E NA NA NA NA (3) A surgical residency program accredited by the Accreditation Council for Graduate Medical Education; and E E NA NA NA (4) Participation in undergraduate medical education. E E NA NA NA</text> </regulation> <regulation prefix="Regulation" num=".18" heading="Continuing Education Programs."> <text>PARC I II III ED A hospital shall have: A. Formal internal continuing education programs concerning the treatment and care of the trauma patients for: E E E E D (1) Physicians; (2) Nurses; and (3) Allied health personnel; B. Special training for personnel exclusively on trauma protocols and trauma care for all new physicians, nurses, and allied health personnel assigned to units where trauma care is provided; and E E E E E C. A continuing education program concerning the care and treatment of trauma patients for physicians, nurses, and allied health personnel in the region. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".19" heading="Policies and Procedures."> <text>PARC I II III ED The following patient treatment and care documents shall be written, distributed, and monitored for quality: E E E E E A. Resuscitation policy; B. Transfusion and Massive Transfusion policy; C. Infection control plan(can utilize hospital plan); D. Trauma team activation policy; E. Physician call schedule; F. Subspecialty notification policy; G. Inter-hospital transfer policy; H. A policy providing that trauma patients may not be admitted or transferred by a primary care physician without the knowledge and consent of the trauma service, with monitoring of adherence by the QM program; I. Helicopter safety policy; and J. Organ procurement policy. E E E E E</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Trauma Program Manager."> <text>PARC I II III ED A. There shall be a Trauma Program Manager (TPM) who is a registered nurse and who is responsible for the organization of services and systems necessary for a multidisciplinary approach to providing care to the injured patient in collaboration and conjunction with the Trauma Medical Director (TMD). E E E E NA B. There shall be a defined organizational structure which delineates the roles and responsibilities of the TPM. E E E E NA C. This must be a full-time (1.0 FTE) position dedicated to the management of the trauma program. NA E E E NA D. The institution’s organization shall define the structural role of the TPM to include responsibility, accountability, and authority. NA E E E NA E. The TPM shall: (1) Possess evidence of appropriate qualifications including academic and trauma-related education and clinical experience; E E E E NA (2) Have a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR, and be shown on an organizational chart depicting the relationship between the TPM and other services, including the Department of Nursing; E E E E NA (3) Attend and participate in local, state and national trauma-related activities, including but are not limited to: EMS Advisory Councils, State trauma-related committees and events, National trauma-related activities and events; E E E E NA (4) Participate in trauma educational activities external to the institution’s staff development programs; E E E E NA (5) As requested, participate in multidisciplinary trauma research; E E D D NA (6) Have sufficient administrative and budgetary commitment in order to support the needs of the Trauma Program inclusive of clerical and clinical nursing personnel that help fulfills needs of the concurrent performance Improvement, outreach and injury prevention; E E E E NA (7) Supervise the Trauma Registry staff and trauma clinical QM staff and have oversite for injury prevention and outreach; NA E E E NA (8) Identify an alternate supervisor to supervise the trauma registry if needed; and E NA NA NA NA (9) The TPM and/or TMD will have the oversight and approval of internal trauma-related education programs within each trauma center. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".21" heading="Trauma Registry."> <text>PARC I II III ED A. The Trauma Center shall maintain a Trauma Registry. E E E E NA B. The Trauma Registry shall include at a minimum, all of the data elements compliant with the Maryland Trauma Registry Data Dictionary for Adult Patients, including: E E E E NA (1) Demographic Data; E E E E NA (2) Pre-hospital Data; E E E E NA (3) Process of acute Care; E E E E NA (4) Clinical Data; E E E E NA (5) Outcome Data; E E E E NA (6) Final Anatomical Diagnosis; E E E E NA (7) Procedure Codes; E E E E NA (8) Quality Management Data; E E E E NA (9) Standard Report Utilization; and E E E E NA (10) Case Inclusion Criteria. E E E E NA C. The Trauma Registry shall support the Trauma Center with evidence of active interface with the institution and State QM process to improve the care of the injured patient across the continuum from injury prevention to outcomes measurement. E E E E NA D. The Trauma Registry may be under a separate department that provides support and conducts the registry data abstraction and ensures that: E NA NA NA NA (1) There is a reporting structure from the Trauma Registry to the TPM; and NA E E E NA (2) The trauma registry content staff will be under the direct supervision of the TPM/TMD. NA E E E NA E. The Trauma Program Manager shall have the authority, responsibility, accountability and oversight of the Trauma Registry inclusive of data submission as required by MIEMSS. E E E E NA F. The Trauma Registry shall have: (1) A staffing plan that includes workload analysis that defines personnel needs necessary to comply with the MIEMSS data submission requirements; and E E E E NA (2) Either: (a) One Trauma Registrar (1.0 FTE) dedicated to the trauma program for every 500-750 patients, subject to meeting performance standards and MIEMSS defined submissions per year; or E E E E NA (b) An electronic interfaced data-content mechanism. E D D D NA G. All discharged trauma patient records, with the minimum quarterly and annual data elements with the number of patients shall be verified no later than 6 weeks after the end of each quarter. E E E E NA H. All records shall be completed within 60 days of patient discharge; validation and NTDB checks shall be completed and the records shall be closed. An exception to the completeness of the MTR record is with Medical Examiner (ME) where autopsies are unavailable for registry record abstraction. E E E E NA I. The Trauma Registry shall have a plan to ensure Inter-rater reliability of the data entered into the MTR at the individual trauma centers. Ongoing review and evaluation shall ensure the quality, reliability and validity of the institution’s MTR registry data. E E E E NA J. The Trauma Center shall submit data to the National Trauma Data Bank. E E E E NA K. Trauma Registry Staff shall have: (1) A job description developed by the hospital to reflect the role and responsibilities as defined by COMAR; E E E E NA (2) A core set of skill requirements including: E E E E NA (a) Anatomy and Physiology; E E E E NA (b) Medical Terminology; and E E E E NA (c) Education to be completed within 1 year of hire includes: E E E E NA (i) American Trauma Society Trauma Registrar Course; and E E E E NA (ii) Association of the Advancement of Automotive Medicine’s Injury Scaling Course; and E E E E NA (3) Job responsibilities to include: (a) Ensuring assigned cases are compliant with MD Data Dictionary Inclusion Criteria or other Trauma Center self-defined criteria; E E E E NA (b) Compiling abstracted data for MTR case from various sources; and E E E E NA (c) Appropriately coding injuries, complications and procedures. E E E E NA L. The Trauma Registry staff liaison shall: (1) Attend a minimum of 50 percent all trauma multidisciplinary/peer review meetings that are held; and E E E E NA (2) Actively participate in the MD Trauma Quality Improvement Committee (TQIC) via attendance in person or phone as defined by the individual institution. E E E E NA</text> </regulation> <regulation prefix="Regulation" num=".22" heading="Emergency Preparedness."> <text>PARC I II III ED A. The Trauma Center shall have a hospital Emergency Preparedness/Disaster plan described in the hospital’s policy and procedure manual or equivalent. E E E E E B. The hospital disaster plan shall have a hazards vulnerability analysis to guide the response plan. E E E E E C. The Hospital Incident Command System (HICS) shall be used as a management system for incident command, planning logistics, operations and finance/administrative functions. E E E E E D. A tiered – approach depending on the magnitude of the event and alternatives for care shall be identified. E E E E E E. The Trauma Center shall be represented on the hospital’s Emergency Preparedness/Disaster Committee. E E E E NA F. The Trauma Center hospital shall: E E E E E (1) Participate in local, state and/or national disaster management meetings, plans and exercises; and (2) Conduct hospital drills that test the individual hospital’s disaster plan at least twice a year, including actual plan activations that can substitute for drills. E E E E E G. A written plan for supporting Trauma Center incident debriefing shall be accessible for all staff members. E E E E E</text> </regulation> <regulation prefix="Regulation" num=".23" heading="Criteria for the Number and Level of Trauma Centers To Be Designated or Reverified."> <paragraph num="A."> <text>MIEMSS shall use the following criteria when designating or reverifying trauma centers from among those applicant hospitals that apply for designation or reverification:</text> <paragraph num="(1)"> <text>Standards in this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Patient volume;</text> </paragraph> <paragraph num="(3)"> <text>Geographic coverage;</text> </paragraph> <paragraph num="(4)"> <text>Population;</text> </paragraph> <paragraph num="(5)"> <text>Competing applications; and</text> </paragraph> <paragraph num="(6)"> <text>New applications.</text> </paragraph> </paragraph> <paragraph num="B."> <text>When applying the criteria, MIEMSS may consider:</text> <paragraph num="(1)"> <text>Applicable guidelines and professional standards;</text> </paragraph> <paragraph num="(2)"> <text>Trauma outcome standards; and</text> </paragraph> <paragraph num="(3)"> <text>Published results of peer-reviewed trauma research.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An applicant hospital shall comply with the applicable standards for trauma care in Regulations .01—.19 of this chapter.</text> </paragraph> <paragraph num="D."> <text>Patient Volume.</text> <paragraph num="(1)"> <text>When considering an applicant hospital for designation or reverification, MIEMSS shall take into account the number and distribution of trauma centers that allow designated trauma centers to:</text> <paragraph num="(a)"> <text>Minimize duplication of services;</text> </paragraph> <paragraph num="(b)"> <text>Achieve and sustain the volumes necessary for:</text> <paragraph num="(i)"> <text>Optimal outcome;</text> </paragraph> <paragraph num="(ii)"> <text>Cost efficiency;</text> </paragraph> <paragraph num="(iii)"> <text>Maintenance of expertise;</text> </paragraph> <paragraph num="(iv)"> <text>Quality care; and</text> </paragraph> <paragraph num="(v)"> <text>Where applicable, research and physician and nurse education; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Minimize the potential adverse effect on quality of care that may result if volumes are reduced.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Unless the volume criteria are waived under the geographic coverage criteria in §E of this regulation, the minimum acceptable annual volume of admissions for an applicant hospital requesting designation or reverification at the following levels is:</text> <paragraph num="(a)"> <text>For PARC:</text> <paragraph num="(i)"> <text>2,000 total trauma hospital admissions; and</text> </paragraph> <paragraph num="(ii)"> <text>800 hospital admissions of patients with severe injury;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For Level I:</text> <paragraph num="(i)"> <text>800 total trauma hospital admissions; and</text> </paragraph> <paragraph num="(ii)"> <text>240 hospital admissions of patients with severe injury;</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>For Level II:</text> <paragraph num="(i)"> <text>400 total trauma hospital admissions; and</text> </paragraph> <paragraph num="(ii)"> <text>120 hospital admissions of patients with severe injury; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>For Level III:</text> <paragraph num="(i)"> <text>300 total trauma hospital admissions; and</text> </paragraph> <paragraph num="(ii)"> <text>75 hospital admissions of patients with severe injury.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>In the volume criteria:</text> <paragraph num="(a)"> <text>Total trauma hospital admissions include all trauma patients who meet the case inclusion criteria, as defined in the Maryland State Trauma Registry Data Dictionaries issued by MIEMSS, and who are treated at the hospital:</text> <paragraph num="(i)"> <text>As an inpatient admission; or</text> </paragraph> <paragraph num="(ii)"> <text>For trauma resuscitation, as an outpatient; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Hospital admissions of patients with severe injury include only injured patients who:</text> <paragraph num="(i)"> <text>Are admitted as inpatients; and</text> </paragraph> <paragraph num="(ii)"> <text>Meet the injury severity criteria in Regulation .21 of this chapter.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Geographic Coverage.</text> <paragraph num="(1)"> <text>When considering an applicant hospital for designation or reverification, MIEMSS shall:</text> <paragraph num="(a)"> <text>Ensure reasonable geographic access to the trauma system;</text> </paragraph> <paragraph num="(b)"> <text>Minimize duplicative services within close proximity; and</text> </paragraph> <paragraph num="(c)"> <text>Consider the number, geographic distribution, and resource capabilities of other hospitals and trauma centers within the Statewide trauma system.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>An applicant hospital that is located within 30 linear miles of a same or higher level trauma center shall meet the volume requirements contained in §D of this regulation.</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS may waive the volume requirements contained in §D of this regulation for an applicant hospital that is located at a distance greater than 30 linear miles from an existing trauma center.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Population. When considering an applicant hospital for designation or reverification, MIEMSS:</text> <paragraph num="(1)"> <text>Shall take into account the applicant hospital's geographic trauma patient catchment area given the current and projected population density within that area;</text> </paragraph> <paragraph num="(2)"> <text>Shall require a population base of approximately 1 million for designation or reverification as a PARC or Level I or Level II trauma center;</text> </paragraph> <paragraph num="(3)"> <text>Shall utilize the most recent population data published by the State Data Center of the Maryland Office of Planning; and</text> </paragraph> <paragraph num="(4)"> <text>May waive the population requirement contained in this section for an applicant hospital that meets the volume requirements contained in §D of this regulation.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Competing Applications.</text> <paragraph num="(1)"> <text>MIEMSS may give preference to an applicant hospital with a designated specialty referral center which may support or be supported by the presence of a trauma center.</text> </paragraph> <paragraph num="(2)"> <text>If there are two or more applicants for the same level in the same geographic coverage area where patient volumes or population would likely be insufficient to support both applicants, based on the criteria in §§C—F of this regulation and Regulation .21 of this chapter, MIEMSS shall:</text> <paragraph num="(a)"> <text>Give preference to the applicant with an established trauma program that can demonstrate that its past experience and performance:</text> <paragraph num="(i)"> <text>Is indicative of quality patient care;</text> </paragraph> <paragraph num="(ii)"> <text>Is consistent with professional standards; and</text> </paragraph> <paragraph num="(iii)"> <text>Results in optimal patient outcome; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Consider demonstrated patient outcomes and the recommendation of the site survey team to determine the most qualified applicant if both applicants have been verified through MIEMSS' inspection as meeting the standards for the requested level.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If two or more applicants for different levels in the same geographic coverage area meet all criteria, and patient volumes would likely be insufficient to support both applicants, MIEMSS may give preference to the applicant seeking the higher level trauma designation or reverification.</text> </paragraph> </paragraph> <paragraph num="H."> <text>New Applicants. A hospital applying for designation as a trauma center that has not been previously designated as a trauma center pursuant to this subtitle shall:</text> <paragraph num="(1)"> <text>Meet the trauma designation criteria; and</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate that its proposed trauma center can generate sufficient patient volume without adversely affecting patient volumes at other existing, designated trauma centers.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".24" heading="Injury Severity Criteria."> <text>For the purposes of Regulation .20D(2)—(3) of this chapter, a patient with severe injury shall have:</text> <paragraph num="A."> <text>An injury severity score (ISS) greater than or equal to 13;</text> </paragraph> <paragraph num="B."> <text>A penetrating injury with systolic blood pressure of less than or equal to 90 millimeters of mercury;</text> </paragraph> <paragraph num="C."> <text>A thoracic injury classified as one or more of the following International Classification of Diseases 9th Revision Clinical Modification (ICD-9-CM) codes:</text> <paragraph num="(1)"> <text>861.21 — Lung contusion, without open wound to thorax;</text> </paragraph> <paragraph num="(2)"> <text>861.31 — Lung contusion, with open wound into thorax; or</text> </paragraph> <paragraph num="(3)"> <text>807.4 — Flail chest;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A blunt injury to the abdomen with major solid visceral injury classified as one or more of the following ICD-9-CM codes:</text> <paragraph num="(1)"> <text>864.03 — Moderate laceration injury to liver without mention of open wound into cavity;</text> </paragraph> <paragraph num="(2)"> <text>864.04 — Major laceration injury to liver without mention of open wound into cavity;</text> </paragraph> <paragraph num="(3)"> <text>864.13 — Moderate laceration injury to liver with open wound into cavity;</text> </paragraph> <paragraph num="(4)"> <text>864.14 — Major laceration of liver with open wound into cavity;</text> </paragraph> <paragraph num="(5)"> <text>865.03 — Injury to spleen with laceration extending into parenchyma without mention of open wound into cavity;</text> </paragraph> <paragraph num="(6)"> <text>865.04 — Injury to spleen with massive parenchymal disruption without mention of open wound into cavity;</text> </paragraph> <paragraph num="(7)"> <text>865.13 — Injury to spleen with laceration extending into parenchyma and open wound into cavity;</text> </paragraph> <paragraph num="(8)"> <text>865.14 — Injury to spleen with massive parenchymal disruption and open wound into cavity;</text> </paragraph> <paragraph num="(9)"> <text>866.01 — Hematoma of kidney without rupture of capsule or mention of open wound into cavity;</text> </paragraph> <paragraph num="(10)"> <text>866.02 — Laceration of kidney without mention of open wound into cavity;</text> </paragraph> <paragraph num="(11)"> <text>866.11 — Hematoma of kidney without rupture of capsule but with open wound into cavity; or</text> </paragraph> <paragraph num="(12)"> <text>866.12 — Laceration of kidney with open wound into cavity;</text> </paragraph> </paragraph> <paragraph num="E."> <text>A major surgical procedure in the cranial, thoracic, vascular, abdominal, or spinal body regions, classified as one or more of the following ICD-9-CM procedure codes:</text> <paragraph num="(1)"> <text>Cranial:</text> <paragraph num="(a)"> <text>01.2X — Craniotomy and craniectomy;</text> </paragraph> <paragraph num="(b)"> <text>01.3X — Incision of brain and cerebral meninges;</text> </paragraph> <paragraph num="(c)"> <text>01.52 — Hemispherectomy;</text> </paragraph> <paragraph num="(d)"> <text>01.53 — Lobectomy of brain;</text> </paragraph> <paragraph num="(e)"> <text>02.0X — Cranioplasty;</text> </paragraph> <paragraph num="(f)"> <text>02.1X — Repair of cerebral meninges;</text> </paragraph> <paragraph num="(g)"> <text>02.3 — Extracranial ventricular shunt;</text> </paragraph> <paragraph num="(h)"> <text>02.92 — Repair of brain; or</text> </paragraph> <paragraph num="(i)"> <text>02.94 — Insertion of replacement of skull tongs or halo traction device;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Thoracic:</text> <paragraph num="(a)"> <text>34.02 — Exploratory thoracotomy;</text> </paragraph> <paragraph num="(b)"> <text>34.82 — Suture of laceration of diaphragm;</text> </paragraph> <paragraph num="(c)"> <text>34.84 — Other repair of diaphragm;</text> </paragraph> <paragraph num="(d)"> <text>37.1X — Cardiotomy and pericardiotomy; or</text> </paragraph> <paragraph num="(e)"> <text>37.91 — Open chest cardiac massage;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Vascular:</text> <paragraph num="(a)"> <text>38.3 — Resection of vessel with anastomosis (use 4th digits 2, 3, 4, 5, 6, 7, 8, 9);</text> </paragraph> <paragraph num="(b)"> <text>38.4 — Resection of vessel with replacement (use 4th digits 2, 3, 4, 5, 6, 7, 8, 9);</text> </paragraph> <paragraph num="(c)"> <text>38.8 — Other surgical occlusion of vessels (use 4th digits 2, 3, 4, 5, 6, 7, 8, 9);</text> </paragraph> <paragraph num="(d)"> <text>39.3 — Suture of vessel;</text> </paragraph> <paragraph num="(e)"> <text>39.56 <MD >Repair of blood vessel with tissue patch graft;</text> </paragraph> <paragraph num="(f)"> <text>39.57 — Repair of blood vessel with synthetic patch graft;</text> </paragraph> <paragraph num="(g)"> <text>39.58 — Other repair of vessel;</text> </paragraph> <paragraph num="(h)"> <text>39.6X — Extracorporeal circulation and procedures auxiliary to heart surgery; or</text> </paragraph> <paragraph num="(i)"> <text>39.98 — Control of hemorrhage, not otherwise specified;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Abdominal:</text> <paragraph num="(a)"> <text>41.43 — Partial splenectomy;</text> </paragraph> <paragraph num="(b)"> <text>41.5 — Total splenectomy;</text> </paragraph> <paragraph num="(c)"> <text>41.95 — Repair and plastic operations on spleen;</text> </paragraph> <paragraph num="(d)"> <text>42.82 — Suture of laceration of esophagus;</text> </paragraph> <paragraph num="(e)"> <text>42.89 — Other repair of esophagus;</text> </paragraph> <paragraph num="(f)"> <text>44.61 — Suture of laceration of stomach;</text> </paragraph> <paragraph num="(g)"> <text>44.69 — Other repair of stomach, not otherwise specified;</text> </paragraph> <paragraph num="(h)"> <text>45.0X — Enterotomy;</text> </paragraph> <paragraph num="(i)"> <text>45.5X — Isolation of intestinal segment;</text> </paragraph> <paragraph num="(j)"> <text>45.6X — Other excision of small intestine;</text> </paragraph> <paragraph num="(k)"> <text>45.7X — Partial excision of large intestine;</text> </paragraph> <paragraph num="(l)"> <text>45.8 — Total intra-abdominal colectomy;</text> </paragraph> <paragraph num="(m)"> <text>46.0 through 46.03 — Other operations on intestine;</text> </paragraph> <paragraph num="(n)"> <text>46.7X — Other repair of intestine;</text> </paragraph> <paragraph num="(o)"> <text>50.0 — Hepatotomy;</text> </paragraph> <paragraph num="(p)"> <text>50.22 — Partial hepatectomy;</text> </paragraph> <paragraph num="(q)"> <text>50.3 — Lobectomy of liver;</text> </paragraph> <paragraph num="(r)"> <text>50.4 — Total hepatectomy;</text> </paragraph> <paragraph num="(s)"> <text>50.6X — Repair of liver;</text> </paragraph> <paragraph num="(t)"> <text>52.5X — Partial pancreatectomy;</text> </paragraph> <paragraph num="(u)"> <text>52.6 — Total pancreatectomy;</text> </paragraph> <paragraph num="(v)"> <text>52.95 — Other repair of the pancreas;</text> </paragraph> <paragraph num="(w)"> <text>54.11 — Exploratory laparotomy;</text> </paragraph> <paragraph num="(x)"> <text>55.4 — Partial nephrectomy;</text> </paragraph> <paragraph num="(y)"> <text>55.5X — Complete nephrectomy;</text> </paragraph> <paragraph num="(z)"> <text>55.8X — Other repair of kidney;</text> </paragraph> <paragraph num="(aa)"> <text>56.8X — Repair of ureter; or</text> </paragraph> <paragraph num="(bb)"> <text>57.8X — Other repair of urinary bladder; or</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Spinal:</text> <paragraph num="(a)"> <text>03.53 — Repair of vertebral fracture;</text> </paragraph> <paragraph num="(b)"> <text>81.00 — Spinal fusion, not otherwise specified;</text> </paragraph> <paragraph num="(c)"> <text>81.01 — Atlas-axis spinal fusion;</text> </paragraph> <paragraph num="(d)"> <text>81.02 — Other cervical fusion, anterior technique;</text> </paragraph> <paragraph num="(e)"> <text>81.03 — Other cervical fusion, posterior technique;</text> </paragraph> <paragraph num="(f)"> <text>81.04 — Dorsal and dorsolumbar fusion anterior technique;</text> </paragraph> <paragraph num="(g)"> <text>81.05 — Dorsal and dorsolumbar fusion, posterior technique; or</text> </paragraph> <paragraph num="(h)"> <text>81.06 — Lumbar and lumbosacral fusion, anterior technique;</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A major pelvic fracture, classified as one or more of the following ICD-9-CM codes:</text> <paragraph num="(1)"> <text>808.43 — Multiple, closed, pelvic fractures with disruption of pelvic circle; or</text> </paragraph> <paragraph num="(2)"> <text>808.53 — Multiple, open, pelvic fractures with disruption of pelvic circle; or</text> </paragraph> </paragraph> <paragraph num="G."> <text>Two or more long bone lower extremity fractures that can be either ipsilateral or contralateral, classified as one or more of the following ICD-9-CM codes:</text> <paragraph num="(1)"> <text>820.XX — Fractures of neck of femur;</text> </paragraph> <paragraph num="(2)"> <text>821.XX — Fractures of other and unspecified parts of femur; or</text> </paragraph> <paragraph num="(3)"> <text>823.X2 — Fractures of fibula with tibia.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03F amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13F amended as an emergency provision effective June 1, 2006 (33:15 Md. R. 1277); amended permanently effective October 23, 2006 (33:21 Md. R. 1679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15B amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .17A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulations .20 and .21 adopted as an emergency provision effective November 7, 1997 (24:25 Md. R. 1718); adopted permanently effective March 9, 1998 (25:5 Md. R. 371)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .20D amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 1, 2018 (45:9 Md. R. 463)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective July 21, 2025 (52:14 Md. R. 714)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13A, B amended effective April 17, 2023 (50:7 Md. R. 302)</annotation> </annotations> </chapter> <chapter num="06" heading="Adult and Pediatric Burn Center Standards"> <regulation prefix="Regulation" num=".01" heading="Burn Center Organization."> <paragraph num="A."> <text>A Burn center shall:</text> <paragraph num="(1)"> <text>Maintain a designated unit or units for specialized acute burn care;</text> </paragraph> <paragraph num="(2)"> <text>Be a hospital designated as a Level II or higher trauma center;</text> </paragraph> <paragraph num="(3)"> <text>If an in-State hospital, have one of the following issued by the Maryland Health Care Commission:</text> <paragraph num="(a)"> <text>A certificate of need; or</text> </paragraph> <paragraph num="(b)"> <text>An exception from the requirement for a certificate of need;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Demonstrate commitment to the optimal care of the hospital’s burn injured patients by the hospital’s board of directors, administration, medical staff, and nursing staff by formulating a board of director’s resolution, updated yearly, stating that:</text> <paragraph num="(a)"> <text>The hospital agrees to meet the burn center designation standards;</text> </paragraph> <paragraph num="(b)"> <text>The hospital has a commitment to the infrastructure and the financial, human, and physical resources necessary to support the hospital’s burn center designation; and</text> </paragraph> <paragraph num="(c)"> <text>The hospital has a commitment to the quality management (QM) process of the burn patient;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Complete transfers to in-State hospitals, or to out-of-State hospitals listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, in accordance with the guidelines contained in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual without the need for separate transfer agreements;</text> </paragraph> <paragraph num="(6)"> <text>Have a written transfer agreement in place for transfer of a patient to an out-of-State hospital not listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, if the hospital transfers to such out-of-State hospital more than five times a year;</text> </paragraph> <paragraph num="(7)"> <text>Have a written transfer agreement in place for transfer of a patient to a rehabilitation hospital if the hospital transfers to such a rehabilitation hospital more than two times a year;</text> </paragraph> <paragraph num="(8)"> <text>Have and maintain current accreditation by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State;</text> </paragraph> <paragraph num="(9)"> <text>Use the resources of the burn center for patients with burn injuries and those suffering from burn-like diseases; and</text> </paragraph> <paragraph num="(10)"> <text>Have administrative and budgetary commitment in order to support the needs of the burn center, inclusive of clerical and clinical nursing personnel, that helps fulfill needs of the concurrent PI, outreach, injury prevention, and research.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prehospital Care. A burn center shall:</text> <paragraph num="(1)"> <text>Maintain access to an EMS system for the transport of patients (public safety and commercial services) with burns from referral sources within the geographic service area;</text> </paragraph> <paragraph num="(2)"> <text>Participate in regional or State EMS committees and councils at least three times per year;</text> </paragraph> <paragraph num="(3)"> <text>Have a written hospital emergency preparedness/multiple casualty incident (MCI) plan for the triage and early treatment of adult and pediatric patients burned in an MCI;</text> </paragraph> <paragraph num="(4)"> <text>Ensure that the MCI plan for the geographic service area is reviewed and updated on an annual basis by the hospital Emergency Preparedness Committee and EMS liaisons and drill inclusive of burn patients annually; and</text> </paragraph> <paragraph num="(5)"> <text>Provide education on the current concepts in triage and burn care treatment to prehospital and hospital care providers within its geographic service area.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Organizational Structure."> <paragraph num="A."> <text>Documentation of Policies and Procedures.</text> <paragraph num="(1)"> <text>A burn center shall formally establish and maintain an organized burn service that is responsible for coordinating the care of the burn patient.</text> </paragraph> <paragraph num="(2)"> <text>A burn center shall maintain an organizational chart relating personnel within the burn unit to other hospital staff; a combined leadership model for trauma and burn center is acceptable.</text> </paragraph> <paragraph num="(3)"> <text>A burn center shall maintain an appropriate policy and procedure manual that:</text> <paragraph num="(a)"> <text>Is reviewed annually by the burn center director and the burn nursing leader; and</text> </paragraph> <paragraph num="(b)"> <text>Addresses:</text> <paragraph num="(i)"> <text>Administration of the burn center;</text> </paragraph> <paragraph num="(ii)"> <text>Staffing and programs of the burn center;</text> </paragraph> <paragraph num="(iii)"> <text>Criteria for admission to the burn unit by the burn service;</text> </paragraph> <paragraph num="(iv)"> <text>Usage of the burn unit beds by other medical or surgical services;</text> </paragraph> <paragraph num="(v)"> <text>Criteria for discharge and follow-up care;</text> </paragraph> <paragraph num="(vi)"> <text>Availability of beds and the transfer of burn patients to other medical or surgical units within the hospital; and</text> </paragraph> <paragraph num="(vii)"> <text>Care of patients with burns in areas of the burn center other than the burn units.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Consistency of Data Collected and Reported.</text> <paragraph num="(1)"> <text>The burn center shall participate in the State Burn Registry for burn patients, both inpatient and outpatient modules.</text> </paragraph> <paragraph num="(2)"> <text>The State Burn Registry shall include all patients who are treated at the burn center inclusive of outpatient and inpatient venues for burn care treatment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Minimum Volume for the Burn Center.</text> <paragraph num="(1)"> <text>A burn center shall treat an average of 100 or more unique inpatients and outpatients (ED treat and discharge and first clinic visit) with acute burn injuries annually.</text> </paragraph> <paragraph num="(2)"> <text>A burn center shall admit at least 60 patients annually who meet the referral criteria in Regulation .17 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Burn Center Director."> <paragraph num="A."> <text>General.</text> <paragraph num="(1)"> <text>A burn center director is authorized to direct and coordinate all medical services for patients admitted to the burn service.</text> </paragraph> <paragraph num="(2)"> <text>Medical care for patients in the burn center shall be provided by the burn center director or qualified physicians approved by the director and shall conform to burn center care protocols.</text> </paragraph> <paragraph num="(3)"> <text>Privileges for physicians participating in the burn service shall be approved by the burn center director and determined by the medical staff credentialing process.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Qualifications and Activities of a Burn Center Director.</text> <paragraph num="(1)"> <text>A burn center shall appoint a qualified burn center director to oversee the care of patients in the burn service.</text> </paragraph> <paragraph num="(2)"> <text>A burn center director shall meet the requirements in Regulation .05 of this chapter.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Responsibilities of a Burn Center Director. The responsibilities of a burn center director are identified in a job description and include but are not limited to:</text> <paragraph num="(1)"> <text>Creation of policies and procedures within the burn center that specify the care of burn patients and ensures that medical care conforms to burn center protocols;</text> </paragraph> <paragraph num="(2)"> <text>Creation of policies and protocols for use throughout the burn care system for initial care, triage, and transport of burn patients;</text> </paragraph> <paragraph num="(3)"> <text>Cooperation with regional EMS authorities in regard to all aspects of burn treatment;</text> </paragraph> <paragraph num="(4)"> <text>Communication with physicians and other authorities regarding patients who have been referred and admitted for follow-up and/or feedback;</text> </paragraph> <paragraph num="(5)"> <text>Direction of a burn center’s administrative functions;</text> </paragraph> <paragraph num="(6)"> <text>Direction and active participation in a burn center quality management program;</text> </paragraph> <paragraph num="(7)"> <text>Acting as liaison between adjacent and regional burn centers;</text> </paragraph> <paragraph num="(8)"> <text>Development of and participation in both internal and external continuing medical education programs in the care of burn injuries;</text> </paragraph> <paragraph num="(9)"> <text>Maintaining current ABLS®; and</text> </paragraph> <paragraph num="(10)"> <text>Oversight of the burn prevention program and initiatives.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Appointment and Qualifications of Attending Burn Staff Surgeons."> <paragraph num="A."> <text>A burn center director may appoint qualified attending burn staff surgeons to participate in the care of patients in the burn service.</text> </paragraph> <paragraph num="B."> <text>An attending burn staff surgeon shall meet the requirements in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="C."> <text>The burn medical director shall serve on the medical staff as the burn chief of service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Qualifications for Burn Center Director and Surgeons."> <text>Director Surgeon A. Certification. Certification qualifications are as follows: (1) Board certified or board eligible in general or plastic surgery; E E (2) Board certification of special qualification in critical care; and D D (3) For the pediatric burn center, the pediatric burn medical director and the burn surgeons have Board certification or Board eligibility in pediatric surgery, plastic surgery, and general/acute care surgery. E E B. Training. Training qualifications are as follows: (1) 2 or more years of burn care experience during the previous 5 years; and E D (2) Either: (a) Completion of a fellowship in burn treatment or training; or E E (b) Completion of a general surgical residency. C. Clinical Activity. The clinical activity qualification requires participation in the care of 35 or more acutely burned patients annually who meet regulation criteria in Regulation.17 of this chapter. E E D. Have at least one full-time equivalent (FTE) attending burn staff surgeon involved in the management of burn patients for the equivalent of 200 acute inpatient admissions annually, with five new unique outpatients equating to one inpatient. E E E. Have an attending burn staff surgeon available on call 24 hours a day, who shall be at the bedside within 30 minutes after emergent consultation has been requested based on institution-specific criteria. E E F. Have an in-house physician assigned to the burn service on call and available at the patient’s bedside available within 15 minutes of the call for the burn units. E E G. Continuing Medical Education (CME). The CME qualification requires annual participation in 16 hours or more of burn-related CME. E E H. Research Participation. The research participation qualification is to demonstrate a commitment to clinical or basic science burn care research, which can be met by: (1) Submission of an abstract at least every 5 years to a national meeting dealing with burns, emergency medicine, or trauma; or E D (2) Research projects, completed or in progress. E D I. Community Education and Burn Prevention. The community education and burn preventions qualification is: (1) Participation in: E D (a) The development or revision of community or EMS burn treatment protocols; or D D (b) Representation on a State or regional EMS or trauma committee; and D D (2) At least 1 of the following: E D (a) Annual participation in one or more prehospital training/certification courses in burn care which can be met by prehospital basic life support or advanced life support courses or equivalent courses (ABLS®, ATLS®); (b) Annual development of presentation of acute burn care courses or lectures which can be met by prehospital basic life support or advanced life support courses or equivalent courses; or (c) Participation in a burn prevention program.</text> <text>Note: E = Essential; D = Desired</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Provider Coverage for Burn Care."> <paragraph num="A."> <text>Emergency department attending physicians may provide coverage for acute resuscitation when the burn surgeon is not on-site. In the absence of the burn surgeon, the emergency department physician shall have the authority to provide initial resuscitation and treatment of the burn injured patient.</text> </paragraph> <paragraph num="B."> <text>Burn unit coverage (i.e., hospitalists, intensivists, etc.) shall:</text> <paragraph num="(1)"> <text>Be assigned to the burn service;</text> </paragraph> <paragraph num="(2)"> <text>Be available within 15 minutes, 24 hours a day;</text> </paragraph> <paragraph num="(3)"> <text>For the adult burn center, be current in ATLS® or ABLS®; and</text> </paragraph> <paragraph num="(4)"> <text>Have a liaison to the burn QM program with 50 percent attendance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The burn center shall maintain an on-call schedule and back-up call list for residents and attending burn staff surgeons who are assigned to the burn service.</text> </paragraph> <paragraph num="D."> <text>Advanced practice professionals (APPs) providing initial resuscitation to the burn patient shall have:</text> <paragraph num="(1)"> <text>For the adult burn center, be current in ATLS® or ABLS®; and</text> </paragraph> <paragraph num="(2)"> <text>A liaison to the burn QM program with 50 percent attendance.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The following surgical specialties shall be on call and available 24 hours a day and shall be at the bedside within 30 minutes after emergent consultation has been requested by the surgical trauma team leader based on institution-specific criteria:</text> <paragraph num="(1)"> <text>General surgery/pediatric surgery;</text> </paragraph> <paragraph num="(2)"> <text>Thoracic surgery;</text> </paragraph> <paragraph num="(3)"> <text>Neurologic surgery;</text> </paragraph> <paragraph num="(4)"> <text>Obstetrics/gynecology;</text> </paragraph> <paragraph num="(5)"> <text>Ophthalmology;</text> </paragraph> <paragraph num="(6)"> <text>Orthopedic surgery;</text> </paragraph> <paragraph num="(7)"> <text>Otorhinolaryngology;</text> </paragraph> <paragraph num="(8)"> <text>Plastic surgery;</text> </paragraph> <paragraph num="(9)"> <text>Urology; and</text> </paragraph> <paragraph num="(10)"> <text>Vascular.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The following nonsurgical specialties shall be on call and available 24 hours a day and shall be at the bedside within 30 minutes after emergent consultation has been requested by the surgical trauma team leader based on institution-specific criteria:</text> <paragraph num="(1)"> <text>Anesthesiology;</text> </paragraph> <paragraph num="(2)"> <text>Critical care medicine;</text> </paragraph> <paragraph num="(3)"> <text>Pediatrics;</text> </paragraph> <paragraph num="(4)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(5)"> <text>Interventional radiology (perform complex imaging studies or interventional procedures); and</text> </paragraph> <paragraph num="(6)"> <text>Interventional angiography.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The following nonsurgical specialties shall be on call and available 24 hours a day and shall be at the bedside within 60 minutes after emergent consultation has been requested by the burn attending team leader based on institution-specific criteria:</text> <paragraph num="(1)"> <text>Cardiology;</text> </paragraph> <paragraph num="(2)"> <text>Patient protection service (adult or child);</text> </paragraph> <paragraph num="(3)"> <text>Gastroenterology;</text> </paragraph> <paragraph num="(4)"> <text>Hematology;</text> </paragraph> <paragraph num="(5)"> <text>Infectious disease;</text> </paragraph> <paragraph num="(6)"> <text>Nephrology;</text> </paragraph> <paragraph num="(7)"> <text>Neurology;</text> </paragraph> <paragraph num="(8)"> <text>Pathology; and</text> </paragraph> <paragraph num="(9)"> <text>Pulmonology.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The following nonsurgical specialties shall be on call and available for consultation 24 hours a day based on institution-specific criteria:</text> <paragraph num="(1)"> <text>Psychology; and</text> </paragraph> <paragraph num="(2)"> <text>Physiatry.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Nursing Personnel."> <paragraph num="A."> <text>Clinical Nurse Managers for Burn Units.</text> <paragraph num="(1)"> <text>A burn center shall have a clinical nurse manager who is administratively responsible for the burn unit.</text> </paragraph> <paragraph num="(2)"> <text>A nurse manager shall:</text> <paragraph num="(a)"> <text>Be a registered nurse;</text> </paragraph> <paragraph num="(b)"> <text>Have a baccalaureate or higher degree in nursing;</text> </paragraph> <paragraph num="(c)"> <text>Have at least two of the following qualifications:</text> <paragraph num="(i)"> <text>An active role in burn QM program and processes;</text> </paragraph> <paragraph num="(ii)"> <text>An active role in nursing research;</text> </paragraph> <paragraph num="(iii)"> <text>An active role in burn prevention;</text> </paragraph> <paragraph num="(iv)"> <text>12 months or more of experience in acute burn care;</text> </paragraph> <paragraph num="(v)"> <text>2 years or more of experience in intensive care unit or surgical care unit appropriate to the specific unit; or</text> </paragraph> <paragraph num="(vi)"> <text>6 months or more managerial experience; and</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Participate in QM, burn research, and burn prevention.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>A burn center shall have an organizational chart relating the nurse manager to the burn service and other members of the burn team.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Nursing Staff. A burn center shall:</text> <paragraph num="(1)"> <text>Have qualified nurses to take care of burn patients;</text> </paragraph> <paragraph num="(2)"> <text>Have a plan to determine staffing and overall care including:</text> <paragraph num="(a)"> <text>Nurse staffing for each patient in the burn unit; and</text> </paragraph> <paragraph num="(b)"> <text>Daily staffing, including for surge and capacity needs;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Have a burn unit orientation program that documents nursing competencies specific to care and treatment of burn patients, including critical care, wound care, psychosocial, and rehabilitation, inclusive of a basic trauma course;</text> </paragraph> <paragraph num="(4)"> <text>Require each new staff nurse hired for the burn units to complete the orientation program before assuming independent practice in the burn units; and</text> </paragraph> <paragraph num="(5)"> <text>Provide burn center staff with a minimum of continuing education annually of:</text> <paragraph num="(a)"> <text>8 hours divided annually between burn care and trauma care, including a minimum of 2 hours of burn specific content for ED, OR, PACU, and critical care nurses;</text> </paragraph> <paragraph num="(b)"> <text>4 hours divided between burn care and trauma care, including a minimum of 1 hour of burn specific content for other acute care nurses; and</text> </paragraph> <paragraph num="(c)"> <text>For the adult burn center, within 2 years of the completion of burn orientation, an RN shall have current ABLS®.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Rehabilitation Personnel."> <text>A burn center shall:</text> <paragraph num="A."> <text>Have a rehabilitation program, including physical therapy, occupational therapy, and speech therapy, that is designed for the burn patient and identifies specific goals;</text> </paragraph> <paragraph num="B."> <text>Require therapists to be appropriately licensed or registered in their specific disciplines;</text> </paragraph> <paragraph num="C."> <text>Base staffing upon both inpatient and outpatient activity with at least one full-time equivalent (FTE) burn therapist for the burn unit;</text> </paragraph> <paragraph num="D."> <text>Assign a therapist to the burn center for both inpatients and outpatients, either:</text> <paragraph num="(1)"> <text>Permanently; or</text> </paragraph> <paragraph num="(2)"> <text>On a rotating basis for at least 1 year;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Provide therapists with regular supervision from individuals with at least 1 year of experience in the treatment of burn patients;</text> </paragraph> <paragraph num="F."> <text>Provide a competency-based burn therapy orientation program for all new therapists assigned to the burn unit; and</text> </paragraph> <paragraph num="G."> <text>Provide burn unit therapists with a minimum of two burn-related continuing education opportunities annually.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Other Personnel."> <paragraph num="A."> <text>A burn center shall:</text> <paragraph num="(1)"> <text>Have a social service consultation available to the burn service; and</text> </paragraph> <paragraph num="(2)"> <text>Assign a social worker to the burn center for both inpatients and outpatients, either:</text> <paragraph num="(a)"> <text>Permanently; or</text> </paragraph> <paragraph num="(b)"> <text>On a rotating basis for at least 1 year.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A burn center shall have a licensed dietician available daily for consultation.</text> </paragraph> <paragraph num="C."> <text>A burn center shall have the following personnel available 24 hours a day:</text> <paragraph num="(1)"> <text>A pharmacist available for consultation;</text> </paragraph> <paragraph num="(2)"> <text>A respiratory therapist to assess and manage patients on the burn service; and</text> </paragraph> <paragraph num="(3)"> <text>For pediatric burn centers, a child life specialist.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Quality Management (QM) Program."> <paragraph num="A."> <text>Policies and Procedures.</text> <paragraph num="(1)"> <text>A burn service shall have a QM program that is multidisciplinary.</text> </paragraph> <paragraph num="(2)"> <text>A burn center director is responsible for the QM program.</text> </paragraph> <paragraph num="(3)"> <text>A burn unit multidisciplinary committee shall:</text> <paragraph num="(a)"> <text>Oversee the QM program;</text> </paragraph> <paragraph num="(b)"> <text>Meet at least monthly; and</text> </paragraph> <paragraph num="(c)"> <text>Maintain sufficient documentation to:</text> <paragraph num="(i)"> <text>Verify problems;</text> </paragraph> <paragraph num="(ii)"> <text>Identify opportunities for improvement;</text> </paragraph> <paragraph num="(iii)"> <text>Take corrective actions; and</text> </paragraph> <paragraph num="(iv)"> <text>Demonstrate evidence of loop closure.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Weekly Patient Care Conferences.</text> <paragraph num="(1)"> <text>A burn center shall hold patient care conferences at least weekly to review and evaluate the status of each patient admitted to the burn center.</text> </paragraph> <paragraph num="(2)"> <text>Each clinical discipline shall be represented to appropriately contribute to the treatment plan for each patient.</text> </paragraph> <paragraph num="(3)"> <text>Patient care conferences shall be documented in the progress notes of each patient or in minutes of the conferences.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A burn center shall:</text> <paragraph num="(1)"> <text>Hold morbidity and mortality conferences at least monthly; and</text> </paragraph> <paragraph num="(2)"> <text>Maintain appropriate documentation of morbidity and mortality conferences.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A burn center shall conduct focused quality reviews at least annually that shall include:</text> <paragraph num="(1)"> <text>Severity of burns;</text> </paragraph> <paragraph num="(2)"> <text>Mortality;</text> </paragraph> <paragraph num="(3)"> <text>Incidence of complications;</text> </paragraph> <paragraph num="(4)"> <text>Length of hospitalizations; and</text> </paragraph> <paragraph num="(5)"> <text>Hospital charges for care.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Other Programs."> <paragraph num="A."> <text>Medical Staff Education.</text> <paragraph num="(1)"> <text>A burn center shall have an educational program for the medical staff.</text> </paragraph> <paragraph num="(2)"> <text>If residents rotate on the burn service, a burn service director or the director’s designee shall provide an orientation program for new residents.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Infection Control Program.</text> <paragraph num="(1)"> <text>A burn center shall have effective means of isolation that are consistent with principles or universal precautions and barrier techniques to decrease the risk of cross-infection and cross-contamination.</text> </paragraph> <paragraph num="(2)"> <text>A burn center shall:</text> <paragraph num="(a)"> <text>Provide ongoing review and analysis of nosocomial infection data and risk factors that relate to infection prevention and control for burn patients; and</text> </paragraph> <paragraph num="(b)"> <text>Make these data available to the burn service in order to assess infection risk for burn unit patients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Continuity of Care Program. A burn center shall have access to the following services:</text> <paragraph num="(1)"> <text>Recreational or child-life therapy;</text> </paragraph> <paragraph num="(2)"> <text>Psychosocial support for family members or other significant persons;</text> </paragraph> <paragraph num="(3)"> <text>Availability for continuing age appropriate academic courses for the patient;</text> </paragraph> <paragraph num="(4)"> <text>Coordinated discharge planning;</text> </paragraph> <paragraph num="(5)"> <text>Follow-up after hospital discharge;</text> </paragraph> <paragraph num="(6)"> <text>Access to community resources;</text> </paragraph> <paragraph num="(7)"> <text>Evaluation of the patient’s physical, psychological, developmental, and vocational status; and</text> </paragraph> <paragraph num="(8)"> <text>Planning for future rehabilitative and reconstructive needs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Equipment."> <text>A burn unit shall have:</text> <paragraph num="A."> <text>At least four burn unit beds with critical care capacity; and</text> </paragraph> <paragraph num="B."> <text>The following equipment in the adult burn center:</text> <paragraph num="(1)"> <text>Weight measurement devices for kilogram measurement;</text> </paragraph> <paragraph num="(2)"> <text>Difficult airway equipment capable for surgical intervention;</text> </paragraph> <paragraph num="(3)"> <text>Emergency carts with age-appropriate equipment; and</text> </paragraph> <paragraph num="(4)"> <text>Temperature control/measurement devices for:</text> <paragraph num="(a)"> <text>The patient;</text> </paragraph> <paragraph num="(b)"> <text>Intravenous fluids; and</text> </paragraph> <paragraph num="(c)"> <text>Blood products.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Other Services."> <text>A burn center shall have available the following services for burn patients 24 hours a day:</text> <paragraph num="A."> <text>Renal dialysis;</text> </paragraph> <paragraph num="B."> <text>Radiographs;</text> </paragraph> <paragraph num="C."> <text>Angiography;</text> </paragraph> <paragraph num="D."> <text>Ultrasonography;</text> </paragraph> <paragraph num="E."> <text>Nuclear medicine scanning;</text> </paragraph> <paragraph num="F."> <text>CT scanning;</text> </paragraph> <paragraph num="G."> <text>Clinical laboratory services; and</text> </paragraph> <paragraph num="H."> <text>Blood bank services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Operating Rooms."> <text>A burn center shall have an operating room available to the burn service 24 hours a day for appropriate and timely treatment.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Emergency Services."> <text>An emergency department shall have written protocols for treating acutely burned patients that are consistent with the burn treatment protocols.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Allograft Service."> <text>A burn center shall:</text> <paragraph num="A."> <text>Maintain a written policy stating:</text> <paragraph num="(1)"> <text>That allograft tissues are to be obtained only from those tissues banks that adhere to the standards of the American Association of Tissue Banks, if applicable; and</text> </paragraph> <paragraph num="(2)"> <text>Compliance with U.S. Food and Drug Administration regulations published in 21 CFR Part 1270 Human Tissue Intended for Transplantation;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Develop and implement policies and procedures related to obtaining, storing, and handling of homograft and heterograft skin, if the use of biological membranes is a component of care provided by the burn center in compliance with the Joint Commission standards; and</text> </paragraph> <paragraph num="C."> <text>Ensure that the operative notes and record support the documentation of all allograft transplants.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Burn Center Referral Criteria."> <text>A burn injury requiring referral to a burn center includes:</text> <paragraph num="A."> <text>A partial thickness or full thickness burn greater than 10 percent total body surface area (TBSA) in patients younger than 10 years old;</text> </paragraph> <paragraph num="B."> <text>A partial thickness or full thickness burn greater than 20 percent TBSA in other age groups;</text> </paragraph> <paragraph num="C."> <text>A partial thickness or full thickness burn that involves the face, hands, feet, genitalia, perineum, and major joints;</text> </paragraph> <paragraph num="D."> <text>All full thickness burns greater than 5 percent TBSA in any age group;</text> </paragraph> <paragraph num="E."> <text>An electrical/lightening injury;</text> </paragraph> <paragraph num="F."> <text>A chemical injury;</text> </paragraph> <paragraph num="G."> <text>An inhalation injury;</text> </paragraph> <paragraph num="H."> <text>Frostbite and cold injury;</text> </paragraph> <paragraph num="I."> <text>A burn injury in patients with preexisting medical disorders that could:</text> <paragraph num="(1)"> <text>Complicate management;</text> </paragraph> <paragraph num="(2)"> <text>Prolong recovery; and</text> </paragraph> <paragraph num="(3)"> <text>Affect mortality;</text> </paragraph> </paragraph> <paragraph num="J."> <text>A burn injury with concomitant trauma, such as a fracture, in which the burn injury poses the greatest risk of morbidity in accordance with the following considerations:</text> <paragraph num="(1)"> <text>If trauma poses the greater immediate risk, the patient may be treated initially in the trauma center until stable before being transferred to a burn center; and</text> </paragraph> <paragraph num="(2)"> <text>Physician judgment is necessary in these situations and shall be in concert with the regional medical control plan and triage protocols;</text> </paragraph> </paragraph> <paragraph num="K."> <text>A burn injury in a child who has not reached their fifteenth (15th) birthday, who shall be treated in a pediatric burn center designated by MIEMSS; and</text> </paragraph> <paragraph num="L."> <text>A burn injury in patients who will require special social, emotional, or long-term rehabilitative support including cases involving suspected child abuse or substance abuse.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Injury Prevention and Public Education."> <text>The burn center shall:</text> <paragraph num="A."> <text>Collaborate closely with MIEMSS and other State agencies in developing, monitoring, and evaluating the effectiveness of prevention and public education programs;</text> </paragraph> <paragraph num="B."> <text>Conduct epidemiology research concerning burn injury control;</text> </paragraph> <paragraph num="C."> <text>Collaborate with other hospitals, MIEMSS, or other agencies in burn injury prevention initiatives and research;</text> </paragraph> <paragraph num="D."> <text>Have an organized and effective approach to burn injury prevention that prioritizes those efforts based on burn registry and epidemiologic data;</text> </paragraph> <paragraph num="E."> <text>Have a designated burn injury prevention coordinator, separate from the BPM position, who, in conjunction with the BPM, facilitates outreach and injury prevention strategies specific to the population of the burn center; and</text> </paragraph> <paragraph num="F."> <text>Collaborate with existing national, regional, State and local programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Burn Research."> <text>A burn center shall have: A. An organized burn-related research program with a designated physician director; E B. A written research plan developed and reviewed yearly; E C. A dedicated master’s prepared researcher, separate from the BPM; D D. Regular meetings of the research group; E E. Evidence of productivity through peer review; E F. Proposals reviewed by an institutional review board; E G. Presentations at local, regional, or national meetings; and E H. Publications in three or greater peer-reviewed journals. E</text> <text>Note: E = Essential; D = Desired</text> </regulation> <regulation prefix="Regulation" num=".20" heading="Burn Program Manager."> <paragraph num="A."> <text>There shall be a burn program manager (BPM) who is a registered nurse and is responsible for the organization of services and systems necessary for a multidisciplinary approach to providing care to the injured patient in collaboration and conjunction with the burn medical director (BMD).</text> </paragraph> <paragraph num="B."> <text>This shall be a full-time (1.0 FTE) position dedicated to the management of the burn center.</text> </paragraph> <paragraph num="C."> <text>Where the burn center has 1.0 FTE for the burn and trauma manager, it shall have a dedicated 1.0 FTE QM nurse coordinator.</text> </paragraph> <paragraph num="D."> <text>The institution’s organization shall define the structural role of the BPM to include responsibility, accountability, and authority as reflected in the organizational chart.</text> </paragraph> <paragraph num="E."> <text>The BPM shall:</text> <paragraph num="(1)"> <text>Provide evidence and maintenance of qualifications including academic and burn-related education and clinical experience;</text> </paragraph> <paragraph num="(2)"> <text>Comply with a job description developed by the hospital that reflects the role and responsibilities as defined by COMAR, and an organizational chart depicting the relationship between the BPM and other services, including the Department of Nursing/Trauma and Burn Nursing;</text> </paragraph> <paragraph num="(3)"> <text>Ensure participation in local, State, and national burn-related activities, including but not limited to EMS Advisory Councils, State burn-related committees and events, and national burn-related activities and events;</text> </paragraph> <paragraph num="(4)"> <text>Participate in burn educational activities external to the institution’s staff development programs;</text> </paragraph> <paragraph num="(5)"> <text>Maintain and provide evidence of 8 hours annually of internal and 8 hours external burn-related CE; and</text> </paragraph> <paragraph num="(6)"> <text>Supervise burn registry staff, burn clinical performance improvement staff, injury prevention staff, and outreach staff.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="State Burn Registry."> <paragraph num="A."> <text>The burn center shall maintain the State Burn Registry (BR).</text> </paragraph> <paragraph num="B."> <text>The State Burn Registry shall include, at a minimum, all of the data elements compliant with the Maryland Trauma Registry Data Dictionary for Burn Registry and American Burn Association National Burn Repository (NBR), including:</text> <paragraph num="(1)"> <text>Demographic data;</text> </paragraph> <paragraph num="(2)"> <text>Injury data;</text> </paragraph> <paragraph num="(3)"> <text>Hospital data;</text> </paragraph> <paragraph num="(4)"> <text>Description of injury;</text> </paragraph> <paragraph num="(5)"> <text>Diagnosis;</text> </paragraph> <paragraph num="(6)"> <text>Comorbidities;</text> </paragraph> <paragraph num="(7)"> <text>Procedure codes;</text> </paragraph> <paragraph num="(8)"> <text>Complications;</text> </paragraph> <paragraph num="(9)"> <text>Outcome; and</text> </paragraph> <paragraph num="(10)"> <text>Outpatient module, which includes outpatient information, Lund and Browder, treatment, complications, and comorbidities.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The BR shall support the burn center with evidence of active interface with the institution and State QA/QI process to improve the care of the injured patient across the continuum from injury prevention to outcomes measurement.</text> </paragraph> <paragraph num="D."> <text>The BR content staff shall be under the direct supervision of the BPM/BMD.</text> </paragraph> <paragraph num="E."> <text>The BPM shall have the authority, responsibility, accountability, and oversight of the BR, inclusive of data submission (i.e., ED treat and release, admission, clinic and outpatient) as required by MIEMSS.</text> </paragraph> <paragraph num="F."> <text>The BR shall have one burn registrar (1.0 FTE) dedicated to the burn center for every 500—750 MIEMSS defined encounters per year.</text> </paragraph> <paragraph num="G."> <text>All discharged burn patient records, with the minimum quarterly and annual data elements with the number of patients, shall be verified no later than 6 weeks after the end of the quarter, as required by MIEMSS.</text> </paragraph> <paragraph num="H."> <text>Within 60 days of patient discharge, all records shall be completed, validation and NBR checks shall be done, and the records shall be closed. An exception to the completeness of the BR record is with Medical Examiner (ME) cases where an autopsy is unavailable for registry record abstraction.</text> </paragraph> <paragraph num="I."> <text>There shall be a plan to ensure inter-rater reliability of the data entered into the BR at the individual burn centers. Ongoing review and evaluation shall ensure the quality, reliability, and validity of the institution’s BR data.</text> </paragraph> <paragraph num="J."> <text>Burn center data shall be submitted to the National Burn Registry Repository per the annual call for data.</text> </paragraph> <paragraph num="K."> <text>The BR staff shall have a core set of skill requirements including:</text> <paragraph num="(1)"> <text>Anatomy and physiology; and</text> </paragraph> <paragraph num="(2)"> <text>Medical terminology.</text> </paragraph> </paragraph> <paragraph num="L."> <text>Education to be completed within 1 year of hire includes the American Trauma Society Trauma Registrar Course.</text> </paragraph> <paragraph num="M."> <text>Education to be completed within 1 year of hire includes an International Classification of Diseases Coding Course (most recent version).</text> </paragraph> <paragraph num="N."> <text>Job responsibilities include:</text> <paragraph num="(1)"> <text>Ensuring assigned cases are compliant with MD Data Dictionary Inclusion Criteria or other burn center self-defined criteria;</text> </paragraph> <paragraph num="(2)"> <text>Compiling abstracted data for BR case from various sources; and</text> </paragraph> <paragraph num="(3)"> <text>Appropriately coding injuries, complications, and procedures.</text> </paragraph> </paragraph> <paragraph num="O."> <text>A job description developed by the hospital to reflect the role and responsibilities as defined by COMAR.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised as an emergency provision effective June 1, 2006 (33:15 Md. R. 1277); revised permanently effective October 23. 2006 (33:21 Md. R. 1679)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.18 repealed and new Regulations .01—.21 adopted effective July 1, 2020 (47:5 Md. R. 313)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective July 21, 2025 (52:14 Md. R. 714)</annotation> </annotations> </chapter> <chapter num="07" heading="Specialty Referral Center Designation Criteria"> <regulation prefix="Regulation" num=".01" heading="General Criteria."> <text>Unless otherwise indicated in this subtitle, MIEMSS shall use the following criteria when designating or reverifying specialty referral centers from among those applicant hospitals that apply for designation or reverification and when contracting with out-of-State specialty referral center hospitals:</text> <paragraph num="A."> <text>Applicable standards in this subtitle;</text> </paragraph> <paragraph num="B."> <text>Patient volume;</text> </paragraph> <paragraph num="C."> <text>Geographic coverage;</text> </paragraph> <paragraph num="D."> <text>Population;</text> </paragraph> <paragraph num="E."> <text>Demonstrated expertise of the professional staff in the specific specialty care area;</text> </paragraph> <paragraph num="F."> <text>Active research program focused on specific specialty care area;</text> </paragraph> <paragraph num="G."> <text>Competing applications; and</text> </paragraph> <paragraph num="H."> <text>New applications.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Exceptions."> <text>The criteria listed in Regulation .01 of this chapter do not apply to burn, perinatal, neonatal, or designated primary stroke specialty referral centers.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Additional Considerations."> <text>When applying the criteria, MIEMSS may consider:</text> <paragraph num="A."> <text>Applicable guidelines and professional standards;</text> </paragraph> <paragraph num="B."> <text>Patient outcome standards; and</text> </paragraph> <paragraph num="C."> <text>Published results of peer-reviewed research.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Compliance with Standards."> <text>An applicant hospital shall comply with the applicable standards for specialty referral centers in this subtitle.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Patient Volume."> <paragraph num="A."> <text>When considering an applicant hospital, MIEMSS shall take into account the number and distribution of specialty referral centers that will allow designated or contract specialty referral centers to:</text> <paragraph num="(1)"> <text>Minimize duplication of services;</text> </paragraph> <paragraph num="(2)"> <text>Achieve and sustain the volumes necessary for:</text> <paragraph num="(a)"> <text>Optimal outcome,</text> </paragraph> <paragraph num="(b)"> <text>Cost efficiency,</text> </paragraph> <paragraph num="(c)"> <text>Maintenance of expertise,</text> </paragraph> <paragraph num="(d)"> <text>Quality care,</text> </paragraph> <paragraph num="(e)"> <text>Research, and</text> </paragraph> <paragraph num="(f)"> <text>Physician and nurse education; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Minimize the potential adverse effect on quality of care that may result if patient volumes are reduced,</text> </paragraph> </paragraph> <paragraph num="B."> <text>Volume criteria will be evaluated for each specialty referral center based on the:</text> <paragraph num="(1)"> <text>Projected number of patients who would require access to that specialty referral center; and</text> </paragraph> <paragraph num="(2)"> <text>Number of physicians who would provide medical care for that population.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Geographic Coverage."> <text>When considering an applicant hospital, MIEMSS shall:</text> <paragraph num="A."> <text>Minimize duplicative services within close proximity; and</text> </paragraph> <paragraph num="B."> <text>Consider the number, geographic distribution, and resource capabilities of other specialty referral centers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Population."> <text>When considering an applicant hospital, MIEMSS shall take into account the applicant hospital's geographic specialty patient catchment area given the current and projected population density within an area.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Professional Staff Expertise."> <text>When considering an applicant hospital, MIEMSS shall take into account the education and specialty training of the following hospital staff:</text> <paragraph num="A."> <text>Physicians;</text> </paragraph> <paragraph num="B."> <text>Nurses; and</text> </paragraph> <paragraph num="C."> <text>Technicians and support staff.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Active Research Program."> <text>When considering an applicant hospital, MIEMSS may give preference to the applicant with an established and ongoing clinical research program focusing on the specific specialty care area.</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Competing Applications."> <paragraph num="A."> <text>MIEMSS may give preference to an applicant hospital with a designated trauma center which supports or is supported by the presence of a specialty referral center.</text> </paragraph> <paragraph num="B."> <text>If there are two or more applicants for the same type of specialty referral center in the same geographic coverage area where patient volumes or population would likely be insufficient to support both applicants, based on the criteria in Regulations .04—.09 of this chapter, MIEMSS shall:</text> <paragraph num="(1)"> <text>Give preference to the applicant with an established specialty referral program that can demonstrate that its past experience and performance:</text> <paragraph num="(a)"> <text>Are indicative of quality patient care,</text> </paragraph> <paragraph num="(b)"> <text>Are consistent with professional standards, and</text> </paragraph> <paragraph num="(c)"> <text>Result in optimal patient outcome; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Consider demonstrated patient outcomes and the recommendations of the site survey team to determine the most qualified applicant if both applicants have been verified through MIEMSS' inspection as meeting the standards for the requested specialty referral center.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="New Applicants."> <text>An applicant hospital that, under this subtitle, has not previously been designated as a specialty referral center by MIEMSS or contracted with MIEMSS as a specialty referral center shall:</text> <paragraph num="A."> <text>Be subject to the specialty referral center designation criteria; and</text> </paragraph> <paragraph num="B."> <text>Demonstrate that its proposed specialty referral center can generate sufficient patient volume without adversely affecting patient volumes at other existing, designated, or contract specialty referral centers.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 9, 1999 (26:16 Md. R. 1247)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulations .05 —.11 amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> </annotations> </chapter> <chapter num="08" heading="Pediatric Trauma Center Standards"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Level I pediatric trauma center (level I PTC)” means a hospital that is capable of and committed to providing comprehensive pediatric trauma care to children younger than 15 years old, meets the standards of this chapter, and is an:</text> <paragraph num="(1)"> <text>In-State hospital designated by MIEMSS and approved by the EMS Board to provide comprehensive pediatric trauma care services; or</text> </paragraph> <paragraph num="(2)"> <text>Out-of-State hospital that has entered into an agreement with MIEMSS and been approved by the EMS Board to provide comprehensive pediatric trauma services to Maryland patients.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Organization."> <paragraph num="A."> <text>The hospital's board of directors, administrators, and medical and nursing staffs shall demonstrate commitment to the optimal care of injured pediatric patients by:</text> <paragraph num="(1)"> <text>Formulating a board of director's resolution stating that:</text> <paragraph num="(a)"> <text>The hospital agrees to meet the Maryland Pediatric Trauma Center designation standards; and</text> </paragraph> <paragraph num="(b)"> <text>The hospital has a commitment to the infrastructure and the financial, human, and physical resources necessary to support the hospital’s designation as a pediatric trauma center;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Establishing an identifiable organization whose dedication to the care of injured children is shown in:</text> <paragraph num="(a)"> <text>Its mission statement;</text> </paragraph> <paragraph num="(b)"> <text>The configuration of its medical, administrative, and support staffs; and</text> </paragraph> <paragraph num="(c)"> <text>The configuration of its physical plant;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Participating in the Statewide trauma system, including submission of patient care data to the State Trauma Registry for system and quality management (QM);</text> </paragraph> <paragraph num="(4)"> <text>Assuring that all pediatric trauma patients shall receive medical care commensurate with the hospital's designation as a pediatric trauma center; and</text> </paragraph> <paragraph num="(5)"> <text>A board of director's resolution, bylaws, contracts, and budgets, all specific to the pediatric trauma center, indicating the hospital's commitment to the financial, human, and physical resource infrastructure that is necessary to support the hospital's designation as a pediatric trauma center.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospital shall:</text> <paragraph num="(1)"> <text>Be licensed as an acute care hospital by the Maryland Department of Health or, if located outside Maryland, in the state in which it is located;</text> </paragraph> <paragraph num="(2)"> <text>Be accredited by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State;</text> </paragraph> <paragraph num="(3)"> <text>Maintain current equipment and technology to support optimal pediatric trauma care;</text> </paragraph> <paragraph num="(4)"> <text>Admit annually 200 or more injured children who are younger than 15 years old;</text> </paragraph> <paragraph num="(5)"> <text>Have the ability to treat effectively all types of pediatric injuries, including:</text> <paragraph num="(a)"> <text>Brain injury;</text> </paragraph> <paragraph num="(b)"> <text>Spinal cord injury;</text> </paragraph> <paragraph num="(c)"> <text>Solid organ injury;</text> </paragraph> <paragraph num="(d)"> <text>Chest injury;</text> </paragraph> <paragraph num="(e)"> <text>Complex musculoskeletal injury;</text> </paragraph> <paragraph num="(f)"> <text>Burns;</text> </paragraph> <paragraph num="(g)"> <text>Eye injury;</text> </paragraph> <paragraph num="(h)"> <text>Hand and upper extremity injury; and</text> </paragraph> <paragraph num="(i)"> <text>Lower extremity injury; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Have a heliport or helipad positioned at the closest safe location so there is a limited distance from the helipad to the hospital.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The pediatric trauma center shall have a pediatric trauma leadership team responsible for monitoring and coordinating all components of the pediatric trauma program, including:</text> <paragraph num="(1)"> <text>A pediatric trauma medical director (TMD) who:</text> <paragraph num="(a)"> <text>Is a board-certified pediatric surgeon;</text> </paragraph> <paragraph num="(b)"> <text>Demonstrates expertise and commitment to the care of injured children;</text> </paragraph> <paragraph num="(c)"> <text>With the trauma program manager (TPM), is empowered by the hospital’s governing body to lead the pediatric trauma center;</text> </paragraph> <paragraph num="(d)"> <text>Has the authority and scope for administering all aspects of trauma care and is responsible for the overall clinical coordination of the pediatric trauma center;</text> </paragraph> <paragraph num="(e)"> <text>Has the responsibility for the oversight of the QM process related to all pediatric trauma patients;</text> </paragraph> <paragraph num="(f)"> <text>Participates in and publishes pediatric trauma research;</text> </paragraph> <paragraph num="(g)"> <text>Has a job description developed by the hospital to reflect the role and responsibilities as defined by COMAR;</text> </paragraph> <paragraph num="(h)"> <text>Appears on the hospital’s organizational chart where the relationship between the TMD and other hospital services are depicted and delineated;</text> </paragraph> <paragraph num="(i)"> <text>Participates in local, regional, state and national activities related to pediatric injury care and prevention; and</text> </paragraph> <paragraph num="(j)"> <text>Participates in pediatric trauma education activities such as undergraduate medical education, postgraduate training programs, and continuing education (CE); and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A pediatric trauma program manager (TPM) who:</text> <paragraph num="(a)"> <text>Is a 1.0 full-time equivalent (FTE) committed to the management of the pediatric trauma center;</text> </paragraph> <paragraph num="(b)"> <text>Meets the requirements of Regulation .20 of this chapter; and</text> </paragraph> <paragraph num="(c)"> <text>If the 1.0 FTE TPM has oversight of additional centers or services, the TPM is assisted by a 1.0 FTE QM nurse coordinator for each additional center or service.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>There shall be one or more committees that provide expert input to the hospital’s management of the pediatric trauma program. The committees shall:</text> <paragraph num="(1)"> <text>Under the leadership of the TMD and TPM or designee, ensure physician trauma peer review includes active participation by representatives from general surgery to address clinical care issues;</text> </paragraph> <paragraph num="(2)"> <text>Under the leadership of the TMD, conduct trauma multidisciplinary review that includes orthopedic surgery, emergency medicine, critical care, anesthesia, neurosurgery, radiology, rehabilitation, and nursing to address and ensure multidisciplinary review of clinical care and systematic issues; and</text> </paragraph> <paragraph num="(3)"> <text>Monitor, track, and trend pediatric trauma care within hospital departments, medical and nursing staffs, and representative disciplines across the trauma care continuum.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The pediatric trauma center shall have a pediatric trauma resuscitation team:</text> <paragraph num="(1)"> <text>Whose members are:</text> <paragraph num="(a)"> <text>Present in house and immediately available upon notification;</text> </paragraph> <paragraph num="(b)"> <text>Oriented to the internal pediatric trauma clinical management protocols and policies; and</text> </paragraph> <paragraph num="(c)"> <text>Have demonstrated skills for pediatric trauma care that are appropriate and specific to their specialty roles;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>That is available in the trauma resuscitation areas upon arrival of all trauma patients when there is advanced notification;</text> </paragraph> <paragraph num="(3)"> <text>That follows clearly defined policies and protocols for activation criteria and roles and responsibilities;</text> </paragraph> <paragraph num="(4)"> <text>That includes a team leader, who shall be either:</text> <paragraph num="(a)"> <text>An attending pediatric surgeon; or</text> </paragraph> <paragraph num="(b)"> <text>A postgraduate, year-3 or above general surgeon; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>That includes an in-house emergency medicine physician who has experience and training in pediatric trauma resuscitation, and shall act as the pediatric trauma resuscitation team leader until relieved by the pediatric trauma surgeon in the resuscitation area.</text> </paragraph> </paragraph> <paragraph num="F."> <text>There is a pediatric trauma multidisciplinary team that, in addition to physicians and nurses, consists of professionals with a focus on the unique needs of children and families, including:</text> <paragraph num="(1)"> <text>Social work;</text> </paragraph> <paragraph num="(2)"> <text>Child psychiatry;</text> </paragraph> <paragraph num="(3)"> <text>Child life therapy;</text> </paragraph> <paragraph num="(4)"> <text>Rehabilitation services, that is, physical, occupational, and speech therapies; and</text> </paragraph> <paragraph num="(5)"> <text>Respiratory therapy.</text> </paragraph> </paragraph> <paragraph num="G."> <text>The hospital shall have a completed interdisciplinary plan of care specific to the needs of each pediatric trauma patient that addresses all phases of care, including acute care of injuries, disposition, discharge, and rehabilitation needs.</text> </paragraph> <paragraph num="H."> <text>The hospital shall have written policies and procedures to direct the organized and safe interhospital transfer process of pediatric trauma patients. The hospital shall:</text> <paragraph num="(1)"> <text>Complete transfers to in-State hospitals, or to out-of-State hospitals listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, in accordance with the guidelines contained in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, without the need for separate transfer agreements; and</text> </paragraph> <paragraph num="(2)"> <text>Have a written transfer agreement in place for transfer of a patient to an out-of-State hospital not listed in the Maryland Emergency Medical Services Interhospital Transfer Resource Manual, if the hospital transfers to such an out-of-State hospital more than five times a year.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Medical Staff."> <paragraph num="A."> <text>The hospital shall have a credentialing process. Each physician and all advance practice professionals (APPs) shall be credentialed by the hospital for the appropriate specialty, including pediatric trauma care.</text> </paragraph> <paragraph num="B."> <text>The hospital shall have a process for delineation and reevaluation of privileges that includes:</text> <paragraph num="(1)"> <text>A pediatric trauma panel, which shall be limited to those with demonstrated skills, commitment, experience, and interest in pediatric trauma care;</text> </paragraph> <paragraph num="(2)"> <text>Appointment and reappointment to the pediatric trauma admitting or consulting staff that is coordinated by the medical staff office; and</text> </paragraph> <paragraph num="(3)"> <text>The delineation of privileges for the pediatric trauma admitting or consulting staff approved by the pediatric TMD based on the following criteria:</text> <paragraph num="(a)"> <text>Maintenance of good standing in the primary specialty;</text> </paragraph> <paragraph num="(b)"> <text>Evidence of the required continuing medical education in trauma;</text> </paragraph> <paragraph num="(c)"> <text>Documented attendance at multidisciplinary meetings, morbidity and mortality (M&M) rounds, and hospital peer-review conferences that deal with the care of injured patients; and</text> </paragraph> <paragraph num="(d)"> <text>Satisfactory performance in managing pediatric trauma patients based on performance assessment and outcome analysis.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The hospital shall have continuing medical education (CME) requirements as follows:</text> <paragraph num="(1)"> <text>Pediatric surgeons taking trauma calls shall have evidence of 16 hours of trauma-related CME credits per year;</text> </paragraph> <paragraph num="(2)"> <text>ATLS® may be counted toward the required CME credits;</text> </paragraph> <paragraph num="(3)"> <text>Successful completion of an ATLS® course, at least once, is required for all attending pediatric surgeons providing pediatric trauma care;</text> </paragraph> <paragraph num="(4)"> <text>The TMD and APPs providing pediatric trauma care must maintain a current ATLS® certification; and</text> </paragraph> <paragraph num="(5)"> <text>Physician CME credits shall be documented in accordance with hospital policy.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Clinical service requirements are as follows:</text> <paragraph num="(1)"> <text>Pediatric surgery:</text> <paragraph num="(a)"> <text>Board-certified or board-eligible pediatric surgeons trained in trauma care;</text> </paragraph> <paragraph num="(b)"> <text>Either:</text> <paragraph num="(i)"> <text>An in-house PGY3 or higher resident or attending surgeon, who shall be at the bedside within 15 minutes of being called, with compliance demonstrated at least 80 percent of the time; or</text> </paragraph> <paragraph num="(ii)"> <text>An attending pediatric trauma surgeon who takes out-of-the-hospital trauma calls shall be immediately available for consultation and at the bedside within 30 minutes of being called, with compliance demonstrated at least 80 percent of the time; and</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>General surgery APPs taking trauma call who have documentation of an average of 16 hours per year of trauma-related education.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Pediatric neurosurgery:</text> <paragraph num="(a)"> <text>Either:</text> <paragraph num="(i)"> <text>A board-certified or board-eligible, trauma fellowship-trained attending neurosurgeon, or PGY2 or higher resident with an attending neurosurgeon on call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested; or</text> </paragraph> <paragraph num="(ii)"> <text>A Neurosurgery APP with an attending neurosurgeon on-call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Neurosurgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and</text> </paragraph> <paragraph num="(c)"> <text>A liaison to the trauma QM program with 50 percent attendance.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pediatric Orthopedic surgery:</text> <paragraph num="(a)"> <text>Either:</text> <paragraph num="(i)"> <text>A board-certified or board-eligible trauma-fellowship-trained attending orthopedic surgeon or PGY2 or higher resident with an attending orthopedic surgeon on call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested; or</text> </paragraph> <paragraph num="(ii)"> <text>A PGY2 or higher orthopedic surgeon in house with an attending orthopedic surgeon on call, who shall be at the patient’s bedside within 30 minutes after emergent consultation has been requested;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Orthopedic surgery APPs taking trauma call shall have documentation of average of 16 hours a year of trauma-related education; and</text> </paragraph> <paragraph num="(c)"> <text>A liaison to the trauma QM program with 50 percent attendance.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Pediatric anesthesia:</text> <paragraph num="(a)"> <text>A board-certified or board-eligible in-house attending physician 24 hours a day; and</text> </paragraph> <paragraph num="(b)"> <text>A liaison to the trauma QM program with 50 percent attendance.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Pediatric emergency medicine:</text> <paragraph num="(a)"> <text>A physician director who is board certified in pediatric emergency medicine;</text> </paragraph> <paragraph num="(b)"> <text>Board-certified or board-eligible pediatricians, emergency medicine physicians, or pediatric emergency medicine physicians in house 24 hours a day;</text> </paragraph> <paragraph num="(c)"> <text>Physicians who have demonstrated special capabilities through commitment, CME, and experience in the care of injured children; and</text> </paragraph> <paragraph num="(d)"> <text>A liaison to the trauma QM program with 50 percent attendance.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Pediatric critical care:</text> <paragraph num="(a)"> <text>A board-eligible or board-certified pediatric critical care physician in house 24 hours a day for the ICU;</text> </paragraph> <paragraph num="(b)"> <text>A designated liaison from pediatric surgery; and</text> </paragraph> <paragraph num="(c)"> <text>A liaison to the trauma QM program with 50 percent attendance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The hospital shall have the following additional pediatric surgical specialties on call and available 24 hours a day, and shall be at the bedside within 30 minutes after emergent consultation has been requested by the trauma resuscitation team leader based on institution-specific criteria:</text> <paragraph num="(1)"> <text>Plastic surgery;</text> </paragraph> <paragraph num="(2)"> <text>Urology;</text> </paragraph> <paragraph num="(3)"> <text>Oral-maxillofacial surgery;</text> </paragraph> <paragraph num="(4)"> <text>Ophthalmology;</text> </paragraph> <paragraph num="(5)"> <text>Otolaryngology, head, and neck surgery;</text> </paragraph> <paragraph num="(6)"> <text>Cardiovascular surgery; and</text> </paragraph> <paragraph num="(7)"> <text>Hand surgery.</text> </paragraph> </paragraph> <paragraph num="F."> <text>The hospital shall have the following additional nonsurgical pediatric specialties on call and available 24 hours a day within 60 minutes after emergent consultation has been requested by the trauma resuscitation team leader based on institution-specific criteria:</text> <paragraph num="(1)"> <text>Radiology;</text> </paragraph> <paragraph num="(2)"> <text>Neuroradiology;</text> </paragraph> <paragraph num="(3)"> <text>Interventional radiology;</text> </paragraph> <paragraph num="(4)"> <text>Physiatry;</text> </paragraph> <paragraph num="(5)"> <text>Psychiatry;</text> </paragraph> <paragraph num="(6)"> <text>Infectious disease;</text> </paragraph> <paragraph num="(7)"> <text>General pediatrics;</text> </paragraph> <paragraph num="(8)"> <text>Neurology;</text> </paragraph> <paragraph num="(9)"> <text>Gastroenterology;</text> </paragraph> <paragraph num="(10)"> <text>Nephrology;</text> </paragraph> <paragraph num="(11)"> <text>Cardiology;</text> </paragraph> <paragraph num="(12)"> <text>Hematology-oncology;</text> </paragraph> <paragraph num="(13)"> <text>Pulmonology;</text> </paragraph> <paragraph num="(14)"> <text>Endocrinology;</text> </paragraph> <paragraph num="(15)"> <text>Pathology;</text> </paragraph> <paragraph num="(16)"> <text>Allergy and immunology; and</text> </paragraph> <paragraph num="(17)"> <text>Angiography.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Nursing Service."> <paragraph num="A."> <text>The oversight and responsibility for pediatric trauma nursing care shall be assigned within the Department of Nursing.</text> </paragraph> <paragraph num="B."> <text>There shall be a plan for providing adequate and appropriate nursing staff to meet the acuity needs of pediatric trauma patients in each unit of care.</text> </paragraph> <paragraph num="C."> <text>The nursing department shall participate in the interdisciplinary QM monitoring of pediatric trauma care.</text> </paragraph> <paragraph num="D."> <text>There shall be an education program for all nurses providing care for pediatric trauma patients addressing the specific care needs of the patients and their families.</text> </paragraph> <paragraph num="E."> <text>The education program developed and approved by the trauma quality improvement committee (TQIC) shall include:</text> <paragraph num="(1)"> <text>An introductory 16-hour trauma nursing curriculum that:</text> <paragraph num="(a)"> <text>Addresses resuscitation and definitive care for pediatric trauma patients; and</text> </paragraph> <paragraph num="(b)"> <text>Covers the continuum of care; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A CE requirement of:</text> <paragraph num="(a)"> <text>8 hours every year for emergency and critical care nurses; and</text> </paragraph> <paragraph num="(b)"> <text>4 hours every year for nurses providing pediatric trauma care in other clinical areas.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>Nursing shall have representation at pediatric trauma multidisciplinary meetings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Pediatric Emergency Department (PED)."> <text>The hospital shall have an ED dedicated to pediatric care, including:</text> <paragraph num="A."> <text>A designated and dedicated ED physician director and nurse manager;</text> </paragraph> <paragraph num="B."> <text>A sufficient number of registered nurses and other clinicians who:</text> <paragraph num="(1)"> <text>Have the necessary knowledge and skills to provide care during trauma resuscitation;</text> </paragraph> <paragraph num="(2)"> <text>Are present to manage projected caseloads; and</text> </paragraph> <paragraph num="(3)"> <text>Immediately reinforce the number of staff upon notice of multiple admissions;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Defined and agreed upon roles and responsibilities approved by the TMD to ensure availability of ED resources;</text> </paragraph> <paragraph num="D."> <text>Verification of functioning life-safety emergency equipment and supplies organized for trauma resuscitation present and immediately available 24 hours a day;</text> </paragraph> <paragraph num="E."> <text>An identified pediatric trauma resuscitation room with dedicated staff, equipment, and supplies 24 hours a day;</text> </paragraph> <paragraph num="F."> <text>Designation by MIEMSS as a pediatric base station;</text> </paragraph> <paragraph num="G."> <text>Policies and protocols for trauma team response and roles in ED trauma resuscitation in accordance with Regulation .20 of this chapter; and</text> </paragraph> <paragraph num="H."> <text>Equipment for resuscitation of patients of all ages, including:</text> <paragraph num="(1)"> <text>Airway management equipment and supplies including a “difficult airway cart”;</text> </paragraph> <paragraph num="(2)"> <text>Emergency equipment located in the resuscitation area/ED for:</text> <paragraph num="(a)"> <text>Thoracotomy;</text> </paragraph> <paragraph num="(b)"> <text>Vascular access;</text> </paragraph> <paragraph num="(c)"> <text>Thoracostomy or chest decompression;</text> </paragraph> <paragraph num="(d)"> <text>Bedside ultrasound;</text> </paragraph> <paragraph num="(e)"> <text>Extremity hemorrhage control devices/tourniquet; and</text> </paragraph> <paragraph num="(f)"> <text>Rapid infuser and warmer;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Medications necessary for the resuscitation and emergency care of children with immediate capability for appropriate pediatric dosages based on weight in kilograms;</text> </paragraph> <paragraph num="(4)"> <text>Printed pre-calculated pediatric drug dosage reference materials, including, but not limited to, charts, wall posters, and length-based dosage tapes;</text> </paragraph> <paragraph num="(5)"> <text>The following monitoring devices:</text> <paragraph num="(a)"> <text>ECG monitor/defibrillator capable of providing a hard copy rhythm strip, and with internal and external pediatric paddles capable of delivering from 0 to 360 joules;</text> </paragraph> <paragraph num="(b)"> <text>Pulse oximeter with adult and pediatric probes;</text> </paragraph> <paragraph num="(c)"> <text>Blood pressure cuffs in infant, child, adult, and thigh sizes;</text> </paragraph> <paragraph num="(d)"> <text>Thermometer probe capable of reading from 28 to 42 degrees centigrade;</text> </paragraph> <paragraph num="(e)"> <text>Otoscope;</text> </paragraph> <paragraph num="(f)"> <text>Ophthalmoscope;</text> </paragraph> <paragraph num="(g)"> <text>Transport monitor with pediatric capabilities;</text> </paragraph> <paragraph num="(h)"> <text>Doppler and noninvasive blood pressure monitoring devices for infant, child, and adult;</text> </paragraph> <paragraph num="(i)"> <text>End-tidal carbon dioxide monitor; and</text> </paragraph> <paragraph num="(j)"> <text>Pressure monitor for central venous pressure and arterial line pressure;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Standard intravenous fluids and administration devices, including large-bore intravenous catheters;</text> </paragraph> <paragraph num="(7)"> <text>Newborn resuscitation supplies;</text> </paragraph> <paragraph num="(8)"> <text>Compartmental pressure measuring devices immediately available; and</text> </paragraph> <paragraph num="(9)"> <text>Cervical and skeletal traction devices immediately available.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Pediatric Operating Room (OR)."> <paragraph num="A."> <text>The hospital shall have an OR adequately staffed and immediately available and equipped to care for injured children of all ages.</text> </paragraph> <paragraph num="B."> <text>The OR shall have supplies, equipment, medications, and staff approved by the TMD to ensure availability of optimal resources.</text> </paragraph> <paragraph num="C."> <text>The OR shall have equipment and supplies for microvascular and microneural surgery</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Pediatric Post Anesthesia Care Unit (PACU)."> <paragraph num="A."> <text>The hospital shall have a PACU adequately staffed, immediately available, and equipped to care for injured children.</text> </paragraph> <paragraph num="B."> <text>The PACU shall:</text> <paragraph num="(1)"> <text>Be available to pediatric trauma patients with an appropriately trained registered nurse and other essential staff 24 hours a day to care for the multiply injured child;</text> </paragraph> <paragraph num="(2)"> <text>Have equipment for continuous monitoring of temperature, hemodynamics, and gas exchange; and</text> </paragraph> <paragraph num="(3)"> <text>Have available pediatric resuscitation equipment and medications</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Pediatric Intensive Care Unit (PICU)."> <paragraph num="A."> <text>The hospital shall have a separate PICU with the capability to care for all significantly injured children.</text> </paragraph> <paragraph num="B."> <text>The PICU shall:</text> <paragraph num="(1)"> <text>Have appropriately trained registered nurse staff to care for the critically injured child to include:</text> <paragraph num="(a)"> <text>Brain injury;</text> </paragraph> <paragraph num="(b)"> <text>Spinal cord injury;</text> </paragraph> <paragraph num="(c)"> <text>Solid organ injury;</text> </paragraph> <paragraph num="(d)"> <text>Chest injury;</text> </paragraph> <paragraph num="(e)"> <text>Complex musculoskeletal injury;</text> </paragraph> <paragraph num="(f)"> <text>Burns;</text> </paragraph> <paragraph num="(g)"> <text>Eye injury;</text> </paragraph> <paragraph num="(h)"> <text>Hand and upper extremity injury; and</text> </paragraph> <paragraph num="(i)"> <text>Lower extremity injury;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards;</text> </paragraph> <paragraph num="(3)"> <text>Have a written plan to:</text> <paragraph num="(a)"> <text>Triage children from the PICU to accommodate acute admissions; or</text> </paragraph> <paragraph num="(b)"> <text>Provide alternative critical care beds with appropriately trained pediatric critical care registered nurses;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have available the pediatric resuscitation equipment and medications;</text> </paragraph> <paragraph num="(5)"> <text>Have the equipment and capability for continuous invasive monitoring of the critically injured child;</text> </paragraph> <paragraph num="(6)"> <text>Have extracorporeal membrane oxygenation capability;</text> </paragraph> <paragraph num="(7)"> <text>Have capability for all renal replacement therapies; and</text> </paragraph> <paragraph num="(8)"> <text>Have support services with immediate access to clinical diagnostic services and stat lab.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="General Pediatric Unit."> <paragraph num="A."> <text>The hospital shall have a general pediatric unit, ideally a dedicated surgical unit to include trauma, adequately staffed 24 hours a day and equipped to care for all injured children.</text> </paragraph> <paragraph num="B."> <text>The general pediatric unit shall:</text> <paragraph num="(1)"> <text>Have the equipment and capability to care for the child with multiple traumatic injuries;</text> </paragraph> <paragraph num="(2)"> <text>Have appropriately trained registered nursing staff to care for the multiply injured child;</text> </paragraph> <paragraph num="(3)"> <text>Be staffed at a level to ensure appropriate nurse-patient ratios as determined by written nursing standards;</text> </paragraph> <paragraph num="(4)"> <text>Have written plans for discharge and transfer of injured children to:</text> <paragraph num="(a)"> <text>Appropriate inpatient rehabilitation;</text> </paragraph> <paragraph num="(b)"> <text>Pediatric home care; and</text> </paragraph> <paragraph num="(c)"> <text>Outpatient follow-up; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Have the support services available for psychological support, rehabilitative therapy, and educational liaison with schools.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Radiological Specialty Capabilities."> <text>The hospital shall have:</text> <paragraph num="A."> <text>Radiological specialty capabilities and equipment to handle all injured children;</text> </paragraph> <paragraph num="B."> <text>Qualified pediatric radiologists and staff available within 60 minutes of consultation notification to perform complex imaging studies or interventional procedures 24 hours a day;</text> </paragraph> <paragraph num="C."> <text>A board-certified or board-eligible radiology attending physician on call who shall provide interpretations of radiographs within 30 minutes, in house or via teleradiology, available 24 hours a day;</text> </paragraph> <paragraph num="D."> <text>Changes in interpretation between preliminary and final reports, as well as missed injuries, monitored through the QM program;</text> </paragraph> <paragraph num="E."> <text>In-house radiology technicians 24 hours a day;</text> </paragraph> <paragraph num="F."> <text>Computed tomography (CT) scan with an in-house CT technician 24 hours a day;</text> </paragraph> <paragraph num="G."> <text>Back-up CT scan capabilities;</text> </paragraph> <paragraph num="H."> <text>Angiography;</text> </paragraph> <paragraph num="I."> <text>Sonography;</text> </paragraph> <paragraph num="J."> <text>Magnetic resonance imaging;</text> </paragraph> <paragraph num="K."> <text>Nuclear scanning; and</text> </paragraph> <paragraph num="L."> <text>Trans-esophageal echocardiography</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Rehabilitation Services."> <text>The hospital shall have:</text> <paragraph num="A."> <text>Rehabilitation capabilities adequately staffed with equipment available to treat all injured children while in the pediatric trauma center;</text> </paragraph> <paragraph num="B."> <text>Rehabilitation consultation services, occupational therapy, speech therapy, and physical therapy, available in the critical care phase as needed;</text> </paragraph> <paragraph num="C."> <text>Pediatric rehabilitation services staffed by personnel trained in pediatric rehabilitation care and properly equipped for acute care of injured pediatric patients;</text> </paragraph> <paragraph num="D."> <text>Full in-house service or transfer process in place to a rehabilitation service for long-term care or sub-acute care; and</text> </paragraph> <paragraph num="E."> <text>Transfer agreements to rehabilitation hospitals, for the primary three rehabilitation hospitals the trauma center utilizes, which may be a joint transfer agreement if the trauma center is a part of a health system that utilizes a particular rehabilitation center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Follow-Up Services."> <paragraph num="A."> <text>The hospital shall have follow-up services adequately staffed and equipped to treat injured children.</text> </paragraph> <paragraph num="B."> <text>Pediatric trauma clinic outpatient follow-up shall be available with coordination of the interdisciplinary team.</text> </paragraph> <paragraph num="C."> <text>Pediatric surgical and medical subspecialty clinics shall be available for follow-up care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Clinical Laboratory Service."> <paragraph num="A."> <text>The hospital shall have clinical laboratory service available 24 hours a day, adequately staffed and immediately available and equipped for injured children.</text> </paragraph> <paragraph num="B."> <text>The clinical laboratory service shall have the following services available:</text> <paragraph num="(1)"> <text>Stat lab capabilities;</text> </paragraph> <paragraph num="(2)"> <text>Standard analysis of blood, urine, and other body fluids;</text> </paragraph> <paragraph num="(3)"> <text>Blood-typing and cross match;</text> </paragraph> <paragraph num="(4)"> <text>Comprehensive blood bank or access to a central blood bank in the community and adequate storage facilities with stock minimums set by protocol for blood products;</text> </paragraph> <paragraph num="(5)"> <text>Blood gas analysis;</text> </paragraph> <paragraph num="(6)"> <text>Coagulation studies;</text> </paragraph> <paragraph num="(7)"> <text>Microbiology; and</text> </paragraph> <paragraph num="(8)"> <text>Toxicological screening.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Quality Management."> <paragraph num="A."> <text>The hospital shall have ongoing QM of the pediatric trauma program that is integrated into the hospital's overall QM program and reported to the hospital's governing body.</text> </paragraph> <paragraph num="B."> <text>The following shall be included in the pediatric QM program:</text> <paragraph num="(1)"> <text>A structure to ensure that defined program outcomes and performance measures are developed and monitored regularly;</text> </paragraph> <paragraph num="(2)"> <text>A special audit of all pediatric trauma deaths;</text> </paragraph> <paragraph num="(3)"> <text>Review of morbidity and mortality;</text> </paragraph> <paragraph num="(4)"> <text>Evaluation of medical care, nursing care, utilization review, tissue review, and prehospital care;</text> </paragraph> <paragraph num="(5)"> <text>Monthly review, at an appropriate interdisciplinary forum, of the performance of the pediatric trauma program, including:</text> <paragraph num="(a)"> <text>Trends;</text> </paragraph> <paragraph num="(b)"> <text>All deaths;</text> </paragraph> <paragraph num="(c)"> <text>All transfers;</text> </paragraph> <paragraph num="(d)"> <text>Morbidities;</text> </paragraph> <paragraph num="(e)"> <text>Problem identification and solution;</text> </paragraph> <paragraph num="(f)"> <text>Issues identified from the QM process; and</text> </paragraph> <paragraph num="(g)"> <text>System or administrative issues;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Maintenance of minutes for all meetings in accordance with the hospital QM program;</text> </paragraph> <paragraph num="(7)"> <text>Requirements for designated liaisons (medical and nursing) to attend at least 50 percent of the trauma peer review meetings, and with supporting documentation;</text> </paragraph> <paragraph num="(8)"> <text>Requirements for all pediatric general surgeons who take pediatric trauma call to attend at least 50 percent of the trauma peer review meetings;</text> </paragraph> <paragraph num="(9)"> <text>Documentation of QM to demonstrate the interdisciplinary approach to the QM program, including:</text> <paragraph num="(a)"> <text>Problem identification;</text> </paragraph> <paragraph num="(b)"> <text>Analysis;</text> </paragraph> <paragraph num="(c)"> <text>Action planning;</text> </paragraph> <paragraph num="(d)"> <text>Implementation;</text> </paragraph> <paragraph num="(e)"> <text>Reevaluation; and</text> </paragraph> <paragraph num="(f)"> <text>Corrective action; and</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>Monitoring of Level I Pediatric Trauma Center bypass status including “fly-by” and re-route events.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Injury Prevention and Public Education."> <text>The level I pediatric trauma center shall:</text> <paragraph num="A."> <text>Collaborate closely with MIEMSS and other State agencies in developing, monitoring, and evaluating the effectiveness of prevention and public education programs;</text> </paragraph> <paragraph num="B."> <text>Conduct epidemiology research including studies in injury control;</text> </paragraph> <paragraph num="C."> <text>Collaborate with other hospitals, MIEMSS, or other agencies in pediatric injury prevention initiatives and research;</text> </paragraph> <paragraph num="D."> <text>Have an organized and effective approach to injury that prioritizes those efforts based on the Maryland State Trauma Registry (MSTR) and epidemiologic data;</text> </paragraph> <paragraph num="E."> <text>Monitor progress of prevention programs in cooperation with State QM activities;</text> </paragraph> <paragraph num="F."> <text>Have a designated prevention coordinator;</text> </paragraph> <paragraph num="G."> <text>Have outreach and program development activities targeted to pediatric injury prevention within the region and State;</text> </paragraph> <paragraph num="H."> <text>Have information resources for children and families; and</text> </paragraph> <paragraph num="I."> <text>Collaborate with existing national, regional, and State programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".16" heading="Trauma Research."> <text>The level I pediatric trauma center shall:</text> <paragraph num="A."> <text>Have an organized pediatric trauma research program with a designated physician director and a documented research plan;</text> </paragraph> <paragraph num="B."> <text>Hold regular meetings of the research group;</text> </paragraph> <paragraph num="C."> <text>Show evidence of productivity;</text> </paragraph> <paragraph num="D."> <text>Have research proposals reviewed by an institutional review board;</text> </paragraph> <paragraph num="E."> <text>Conduct clinical research designed to enhance the trauma system’s ability to resuscitate, stabilize, and treat trauma patients in the most cost-effective manner;</text> </paragraph> <paragraph num="F."> <text>Present research study results at local, regional, and national meetings; and</text> </paragraph> <paragraph num="G."> <text>Produce publications in peer-reviewed journals on an average of seven times per year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Education."> <text>The hospital shall:</text> <paragraph num="A."> <text>Assist MIEMSS with developing, monitoring, and evaluating the effectiveness of EMS training programs;</text> </paragraph> <paragraph num="B."> <text>Offer and participate in formal pediatric trauma CE for hospital personnel and community health care clinicians;</text> </paragraph> <paragraph num="C."> <text>Have a pediatric surgery fellowship program accredited by the Accreditation Council of Graduate Medical Education (ACGME);</text> </paragraph> <paragraph num="D."> <text>Participate in a general surgical residency program accredited by the ACGME;</text> </paragraph> <paragraph num="E."> <text>Participate in a pediatric emergency medicine fellowship program; and</text> </paragraph> <paragraph num="F."> <text>Participate in undergraduate medical and nursing education.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Continuing Education (CE)."> <paragraph num="A."> <text>The hospital shall provide and participate in periodic continuing education programs for physicians, nurses, and allied health personnel concerning the treatment and care of the pediatric trauma patient and family.</text> </paragraph> <paragraph num="B."> <text>The hospital shall:</text> <paragraph num="(1)"> <text>Provide formal internal continuing education programs for physicians, nurses, and allied health professionals;</text> </paragraph> <paragraph num="(2)"> <text>Provide orientation on pediatric trauma protocols and trauma care for all rotating physicians, nurses, and allied health personnel assigned to units where pediatric trauma care is provided; and</text> </paragraph> <paragraph num="(3)"> <text>Provide external continuing education programs concerning the care and treatment of pediatric trauma patients for physicians, nurses, and allied health personnel within the region and in the State.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".19" heading="Policies, Protocols, and Agreements."> <paragraph num="A."> <text>The hospital shall develop, distribute, and monitor implementation of the following patient treatment and care protocols:</text> <paragraph num="(1)"> <text>Pediatric resuscitation protocol;</text> </paragraph> <paragraph num="(2)"> <text>Procedural sedation protocols for children;</text> </paragraph> <paragraph num="(3)"> <text>Transfusion and massive transfusion protocol;</text> </paragraph> <paragraph num="(4)"> <text>Infection control protocol;</text> </paragraph> <paragraph num="(5)"> <text>Pediatric trauma resuscitation team activation protocol;</text> </paragraph> <paragraph num="(6)"> <text>Physician call schedule and notification protocol;</text> </paragraph> <paragraph num="(7)"> <text>Interhospital transfer protocol;</text> </paragraph> <paragraph num="(8)"> <text>Helicopter safety protocol;</text> </paragraph> <paragraph num="(9)"> <text>Organ procurement protocol;</text> </paragraph> <paragraph num="(10)"> <text>Child protection team protocol;</text> </paragraph> <paragraph num="(11)"> <text>Pediatric psychosocial care protocol; and</text> </paragraph> <paragraph num="(12)"> <text>Pediatric rehabilitation care protocol.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospital shall have written transfer agreements with specialty and pediatric rehabilitation centers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".20" heading="Trauma Program Manager."> <paragraph num="A."> <text>There shall be a TPM who is a registered nurse responsible for the organization of services and systems necessary for a multidisciplinary approach to providing care to the injured patient in collaboration and conjunction with the TMD.</text> </paragraph> <paragraph num="B."> <text>There shall be a defined organizational structure, which delineates the roles and responsibilities of the TPM.</text> </paragraph> <paragraph num="C."> <text>The TPM shall be a 1.0 FTE position dedicated to the management of the pediatric trauma center.</text> </paragraph> <paragraph num="D."> <text>The institution’s organization shall define the structural role of the TPM to include responsibility, accountability, and authority.</text> </paragraph> <paragraph num="E."> <text>The TPM shall:</text> <paragraph num="(1)"> <text>Have a job description developed by the hospital to reflect the role and responsibilities and identified on an organizational chart depicting the relationship between the TPM and other services, including the Department of Nursing;</text> </paragraph> <paragraph num="(2)"> <text>Attend and participate in local, state and national trauma-related activities, including but not limited to EMS community, state trauma-related committees and events, and national trauma-related activities and events;</text> </paragraph> <paragraph num="(3)"> <text>Show evidence of 16 hours of trauma-related CE a year, and, over a 2-year period, half of the CE hours shall be obtained outside the hospital and be recognized by a national accrediting body;</text> </paragraph> <paragraph num="(4)"> <text>As requested, participate in multidisciplinary trauma research;</text> </paragraph> <paragraph num="(5)"> <text>Have sufficient administrative and budgetary commitment in order to support the needs of the trauma center inclusive of clerical and clinical nursing personnel that help fulfill the needs of concurrent performance improvement, outreach, and injury prevention functions;</text> </paragraph> <paragraph num="(6)"> <text>Supervise the Trauma Registry staff and trauma clinical QM staff and have oversite for injury prevention and outreach; and</text> </paragraph> <paragraph num="(7)"> <text>With the TMD, have oversight and approval of internal trauma-related education programs.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".21" heading="Trauma Registry."> <paragraph num="A."> <text>The Trauma Center shall maintain a pediatric Trauma Registry with participation in the MSTRB. The Trauma Registry shall include, at a minimum, all of the data elements compliant with the MSTR Data Dictionary for Pediatric Patients, including:</text> <paragraph num="(1)"> <text>Demographic data;</text> </paragraph> <paragraph num="(2)"> <text>Pre-hospital data;</text> </paragraph> <paragraph num="(3)"> <text>Process of acute care;</text> </paragraph> <paragraph num="(4)"> <text>Clinical data;</text> </paragraph> <paragraph num="(5)"> <text>Outcome data;</text> </paragraph> <paragraph num="(6)"> <text>Final anatomical diagnoses;</text> </paragraph> <paragraph num="(7)"> <text>Procedure codes;</text> </paragraph> <paragraph num="(8)"> <text>QM data;</text> </paragraph> <paragraph num="(9)"> <text>Standard report utilization; and</text> </paragraph> <paragraph num="(10)"> <text>Case inclusion criteria.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The Trauma Registry shall support the trauma center with evidence of active interface with the institution and State QM process to improve the care of injured patients across the continuum from injury prevention to outcomes measurement.</text> </paragraph> <paragraph num="C."> <text>The Trauma Registry may be under a separate department that provides support and conducts the registry data abstraction with a reporting structure to the TMD and TPM.</text> </paragraph> <paragraph num="D."> <text>The Trauma Program Manager shall have the authority, responsibility, accountability, and oversight of the Trauma Registry, inclusive of data submission as required by MIEMSS.</text> </paragraph> <paragraph num="E."> <text>The Trauma Registry shall have:</text> <paragraph num="(1)"> <text>A staffing plan that includes workload analysis that defines personnel needs necessary to comply with the MIEMSS data submission requirements, and</text> </paragraph> <paragraph num="(2)"> <text>One trauma registrar (1.0 FTE) dedicated to the trauma program for every 500—750 patients, subject to meeting performance standards and MIEMSS-defined submissions per year.</text> </paragraph> </paragraph> <paragraph num="F."> <text>All discharged trauma patient records, with the minimum quarterly and annual data elements with the number of patients, shall be verified no later than 6 weeks after the end of each quarter.</text> </paragraph> <paragraph num="G."> <text>All records shall be completed within 60 days of patient discharge.</text> </paragraph> <paragraph num="H."> <text>Validation and National Trauma Data Bank (NTDB) checks shall be completed and the records shall be closed except when a medical examiner (ME) autopsy report is not yet available for registry record abstraction.</text> </paragraph> <paragraph num="I."> <text>The Trauma Registry shall have a plan to ensure Inter-rater reliability of the data entered. Ongoing review and evaluation shall ensure the quality, reliability and validity of the institution’s MSTR data.</text> </paragraph> <paragraph num="J."> <text>The Trauma Center shall submit data to the NTDB.</text> </paragraph> <paragraph num="K."> <text>Trauma Registry staff shall have:</text> <paragraph num="(1)"> <text>A job description developed by the hospital to reflect roles and responsibilities;</text> </paragraph> <paragraph num="(2)"> <text>Core requirements including:</text> <paragraph num="(a)"> <text>Anatomy and physiology;</text> </paragraph> <paragraph num="(b)"> <text>Medical terminology; and</text> </paragraph> <paragraph num="(c)"> <text>Education to be completed within 1 year of hire includes:</text> <paragraph num="(i)"> <text>American Trauma Society Trauma Registrar Course; and</text> </paragraph> <paragraph num="(ii)"> <text>Association of the Advancement of Automotive Medicine’s Injury Scaling Course; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Job responsibilities to include:</text> <paragraph num="(a)"> <text>Ensuring assigned cases are compliant with Maryland Data Dictionary Inclusion Criteria or other trauma center self-defined criteria;</text> </paragraph> <paragraph num="(b)"> <text>Compiling abstracted data for MSTR case from various sources; and</text> </paragraph> <paragraph num="(c)"> <text>Appropriately coding injuries, complications, and procedures.</text> </paragraph> </paragraph> </paragraph> <paragraph num="L."> <text>The Trauma Registry staff liaison shall:</text> <paragraph num="(1)"> <text>Attend a minimum of 50 percent all trauma multidisciplinary/peer review meetings that are held; and</text> </paragraph> <paragraph num="(2)"> <text>Actively participate in the Maryland TQIC.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".22" heading="Emergency Preparedness."> <paragraph num="A."> <text>The trauma center shall have a hospital emergency preparedness or disaster plan described in the hospital’s policy and procedure manual or equivalent.</text> </paragraph> <paragraph num="B."> <text>The hospital disaster plan shall have a hazards vulnerability analysis to guide the response plan.</text> </paragraph> <paragraph num="C."> <text>Hospital Incident Command System shall be used as a management system for incident command, planning, logistics, operations, and finance/administrative functions.</text> </paragraph> <paragraph num="D."> <text>A tiered approach depending on the magnitude of the event and alternatives for care shall be identified.</text> </paragraph> <paragraph num="E."> <text>The trauma center shall be represented on the hospital’s emergency preparedness or disaster committee.</text> </paragraph> <paragraph num="F."> <text>The trauma center hospital shall:</text> <paragraph num="(1)"> <text>Participate in local, state, or national disaster management meetings, plans, and exercises;</text> </paragraph> <paragraph num="(2)"> <text>Conduct hospital drills that test the hospital’s disaster plan at least twice a year, including actual plan activations that can substitute for drills; and</text> </paragraph> <paragraph num="(3)"> <text>Have a written plan for supporting trauma center.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: September 7, 1998 (25:18 Md. R. 1439)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03E amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06C amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .16 amended effective June 4, 2007 (34:11 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .18A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.20 repealed and new regulations .01 — .22 adopted effective July 24, 2023 (50:14 Md. R. 594)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective July 21, 2025 (52:14 Md. R. 714)</annotation> </annotations> </chapter> <chapter num="09" heading="Eye Trauma Center Standards"> <regulation prefix="Regulation" num=".01" heading="Organization."> <text>The hospital shall:</text> <paragraph num="A."> <text>Be designated by MIEMSS and approved by the EMS Board as a Level II, Level I, or PARC trauma center;</text> </paragraph> <paragraph num="B."> <text>Have a board of directors' resolution that states its commitment to provide state-of-the-art optimal eye trauma care as part of the Statewide emergency medical system;</text> </paragraph> <paragraph num="C."> <text>Have an organized eye trauma center with a medical director who has:</text> <paragraph num="(1)"> <text>Authority to run the eye trauma center; and</text> </paragraph> <paragraph num="(2)"> <text>Responsibility for:</text> <paragraph num="(a)"> <text>Clinical coordination of the eye trauma center;</text> </paragraph> <paragraph num="(b)"> <text>Quality management; and</text> </paragraph> <paragraph num="(c)"> <text>Participation in the State and regional EMS system quality management, education, and prevention activities; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Have a designated eye trauma center nurse manager who has authority and responsibility for nursing and patient care services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Medical Staff."> <text>The hospital shall have:</text> <paragraph num="A."> <text>The following physician coverage:</text> <paragraph num="(1)"> <text>An ophthalmology fellow or ophthalmology resident in house 24 hours a day, to be at the bedside within 30 minutes for emergent consultation requests, with a board-certified or board-eligible ophthalmologist on call and available to be at the bedside within 60 minutes for emergent consultation requests; and</text> </paragraph> <paragraph num="(2)"> <text>A board-certified or board-eligible emergency medicine physician in house 24 hours a day for eye trauma triage, with a board-certified or board-eligible attending ophthalmologist on call and available be at the bedside within 60 minutes for emergent consultation; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Ophthalmic subspecialty coverage on call and available 24 hours a day for vitreoretinal, oculoplastics, and anterior segment surgery.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Nursing Services."> <paragraph num="A."> <text>The hospital shall provide all nurses who care for patients in the eye trauma center with:</text> <paragraph num="(1)"> <text>Special education in ophthalmic emergencies and eye trauma care; and</text> </paragraph> <paragraph num="(2)"> <text>Specific orientation to eye trauma center procedures and protocols for ophthalmic emergencies.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A nurse working in the eye trauma center, adult and pediatric ED RN involved with eye trauma triage and care in that setting, and pre/post op and OR eye surgery staff shall have at least 4 hours of continuing education in ophthalmic emergencies every 2 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Facility."> <paragraph num="A."> <text>Ophthalmic Treatment Area. The hospital shall have:</text> <paragraph num="(1)"> <text>An ophthalmic treatment area that is identified for and dedicated to the examination of ophthalmic emergencies;</text> </paragraph> <paragraph num="(2)"> <text>A medical director of the eye trauma center to oversee the management of the ophthalmic treatment area;</text> </paragraph> <paragraph num="(3)"> <text>A nurse manager responsible for the ophthalmic treatment area;</text> </paragraph> <paragraph num="(4)"> <text>Organized equipment and supplies to care for eye trauma, including:</text> <paragraph num="(a)"> <text>A slitlamp biomicroscope;</text> </paragraph> <paragraph num="(b)"> <text>An indirect ophthalmoscope;</text> </paragraph> <paragraph num="(c)"> <text>A visual acuity chart (that is, Snellen and near chart);</text> </paragraph> <paragraph num="(d)"> <text>Color plates, either Ishihara, or Hardy-Rand-Rittler;</text> </paragraph> <paragraph num="(e)"> <text>Applanation Tonometry (that is, Tonopen, iCare®); and</text> </paragraph> <paragraph num="(f)"> <text>Diagnostic ophthalmic lenses for gonioscopy and ophthalmoscopy;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The following readily available medications necessary for the treatment and diagnosis of ophthalmic emergencies (in the event of regional or national drug shortages, pharmacy will assist with sourcing of appropriate, alternative options):</text> <paragraph num="(a)"> <text>Systemic eye pressure lowering medications;</text> </paragraph> <paragraph num="(b)"> <text>Topical intraocular pressure lowering medications of different classes;</text> </paragraph> <paragraph num="(c)"> <text>Mydriatic and cycloplegic drops;</text> </paragraph> <paragraph num="(d)"> <text>Topical anesthetics, such as proparacaine and tetracaine; and</text> </paragraph> <paragraph num="(e)"> <text>Fluorescein drops or strips;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Sterile surgical sets specifically for ophthalmic trauma care readily available and located in the ophthalmic treatment area, including:</text> <paragraph num="(a)"> <text>Vitreous tap and inject equipment;</text> </paragraph> <paragraph num="(b)"> <text>Lateral canthotomy set;</text> </paragraph> <paragraph num="(c)"> <text>Ocular lavage set-up; and</text> </paragraph> <paragraph num="(d)"> <text>pH strips;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Equipment for skin laceration repair;</text> </paragraph> <paragraph num="(8)"> <text>The following equipment:</text> <paragraph num="(a)"> <text>Laser iridotomy (YAG or Argon);</text> </paragraph> <paragraph num="(b)"> <text>Argon laser for retinopexy;</text> </paragraph> <paragraph num="(c)"> <text>Cryoprobe available for retinopexy; and</text> </paragraph> <paragraph num="(d)"> <text>Either of the following equipment for pneumatic retinopexy:</text> <paragraph num="(i)"> <text>SF6; or</text> </paragraph> <paragraph num="(ii)"> <text>C3 F8 gas; and</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Corneal foreign body removal equipment such as 27-30 gauge needle and corneal burr;</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Pharmacy support available to obtain intravitreal antimicrobial medications and steroids within 1 hour, 24 hours a day; and</text> </paragraph> <paragraph num="(10)"> <text>Pharmacy support available to obtain topical fortified antimicrobial medications within 1 hour, 24 hours a day.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Operating Room (OR). The hospital shall have an OR:</text> <paragraph num="(1)"> <text>With adequately trained staff in ophthalmic surgery available with 1-hour response for ophthalmic emergencies 24 hours a day as needed per eye trauma center policies and procedures;</text> </paragraph> <paragraph num="(2)"> <text>Available ophthalmic surgery within 1 hour of notice; and</text> </paragraph> <paragraph num="(3)"> <text>With operating microscope equipment readily available for:</text> <paragraph num="(a)"> <text>Vitreoretinal surgery;</text> </paragraph> <paragraph num="(b)"> <text>Oculoplastic surgery;</text> </paragraph> <paragraph num="(c)"> <text>Anterior segment surgery; and</text> </paragraph> <paragraph num="(d)"> <text>Pediatric patients.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The hospital shall have an inpatient unit available with inpatient beds with nursing staff who have knowledge and skills specific for the care of post-operative patients.</text> </paragraph> <paragraph num="D."> <text>Ongoing care management and disposition of care may be integrated into the outpatient setting as indicated.</text> </paragraph> <paragraph num="E."> <text>A hospital shall have CT scan and ocular echography available 24 hours a day.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Quality Management."> <text>The hospital shall:</text> <paragraph num="A."> <text>Have ongoing QM of the eye trauma center that is integrated into the hospital's overall QM program;</text> </paragraph> <paragraph num="B."> <text>Participate in the State EMS system QM activities, as described in this subtitle;</text> </paragraph> <paragraph num="C."> <text>Maintain an eye trauma registry;</text> </paragraph> <paragraph num="D."> <text>Participate in and maintain the State eye trauma registry; and</text> </paragraph> <paragraph num="E."> <text>Have QM activities, including:</text> <paragraph num="(1)"> <text>Problem identification;</text> </paragraph> <paragraph num="(2)"> <text>Problem analysis;</text> </paragraph> <paragraph num="(3)"> <text>Action planning;</text> </paragraph> <paragraph num="(4)"> <text>Implementation of the plan;</text> </paragraph> <paragraph num="(5)"> <text>Reevaluation of the plan; and</text> </paragraph> <paragraph num="(6)"> <text>Loop closure.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Prevention and Public Education."> <text>The hospital shall:</text> <paragraph num="A."> <text>Provide leadership and coordination for the development and implementation of prevention and public education programs for eye injuries; and</text> </paragraph> <paragraph num="B."> <text>Monitor the progress of eye trauma prevention programs in cooperation with State quality monitoring activities.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Research."> <text>The hospital shall:</text> <paragraph num="A."> <text>Have an organized eye clinical research program with a documented research plan; and</text> </paragraph> <paragraph num="B."> <text>Conduct research and submit to MIEMSS a summary of publications that may span topics of prevention, interventions, outcomes, or costs of treatment.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Training."> <text>The Eye Trauma Center shall develop and provide education and training concerning ophthalmic injuries for:</text> <paragraph num="A."> <text>Physicians;</text> </paragraph> <paragraph num="B."> <text>Nurses;</text> </paragraph> <paragraph num="C."> <text>EMS clinicians; and</text> </paragraph> <paragraph num="D."> <text>Other appropriate allied health personnel.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 3, 1999 (26:9 Md. R. 731)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01A amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01C, D amended effective March 7, 2022 (49:5 Md. R. 367)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 7, 2022 (49:5 Md. R. 367)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective March 7, 2022 (49:5 Md. R. 367)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective March 7, 2022 (49:5 Md. R. 367)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective June 4, 2007 (34:11 Md. R. 972); March 7, 2022 (49:5 Md. R. 367)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05D amended effective July 1, 2002 (29:12 Md. R. 933)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07B amended effective July 1, 2002 (29:12 Md. R. 933); March 7, 2022 (49:5 Md. R. 367)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 1, 2002 (29:12 Md. R. 933); March 7, 2022 (49:5 Md. R. 367)</annotation> </annotations> </chapter> <chapter num="10" heading="Neurotrauma Center Standards"> <regulation prefix="Regulation" num=".01" heading="Organization."> <text>A neurotrauma center hospital shall:</text> <paragraph num="A."> <text>Maintain a specialized unit dedicated to traumatic brain injury and spinal cord injury;</text> </paragraph> <paragraph num="B."> <text>Be designated as Level 1 trauma center or PARC by MIEMSS;</text> </paragraph> <paragraph num="C."> <text>Demonstrate both a medical and administrative commitment to the care of the neurotrauma patient by:</text> <paragraph num="(1)"> <text>Having a board of director's resolution stating:</text> <paragraph num="(a)"> <text>That the hospital agrees to meet the neurotrauma standards for designation; and</text> </paragraph> <paragraph num="(b)"> <text>The hospital's commitment to the infrastructure and the financial, human, and physical resources necessary to support the neurotrauma center;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Establishing an identifiable organization whose dedication to the care of the neurotrauma patient is shown in:</text> <paragraph num="(a)"> <text>Its mission statement;</text> </paragraph> <paragraph num="(b)"> <text>The configuration of its medical, administrative, and support staffs; and</text> </paragraph> <paragraph num="(c)"> <text>The configuration of its physical plant; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Maintain current hospital accreditation by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Neurotrauma Center."> <paragraph num="A."> <text>A neurotrauma center shall:</text> <paragraph num="(1)"> <text>Participate in the Statewide trauma and specialty care system, including submission of patient care data to the State trauma registry for quality management; and</text> </paragraph> <paragraph num="(2)"> <text>Receive a minimum annual volume of 100 traumatic brain injured patients, spinal cord injured patients, or both.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Prehospital Care. A neurotrauma center shall:</text> <paragraph num="(1)"> <text>Maintain access to an EMS system for the transport of patients with neurotrauma injuries from referral sources within the geographic service area;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate participation and involvement in local, regional, or State trauma EMS systems; and</text> </paragraph> <paragraph num="(3)"> <text>Provide education on the current concepts in emergency and inpatient neurotrauma treatment to prehospital and hospital care clinicians within its geographic service area.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Neurotrauma Center Director."> <paragraph num="A."> <text>A neurotrauma center shall have a director who provides oversight to all care for neurotrauma patients admitted to the center.</text> </paragraph> <paragraph num="B."> <text>The neurotrauma center director shall meet the requirements in Regulation .05 of this chapter.</text> </paragraph> <paragraph num="C."> <text>Responsibilities of the neurotrauma center director include:</text> <paragraph num="(1)"> <text>Creation of policies procedures, and protocols/guidelines for the neurotrauma center that specify the care of neurotrauma patients;</text> </paragraph> <paragraph num="(2)"> <text>Participation with the State EMS system in development of policies and protocols for use throughout the EMS system for initial care, triage, and transport of neuro-injured patients;</text> </paragraph> <paragraph num="(3)"> <text>Communication on a regular basis with physicians and other authorities regarding patients who have been referred;</text> </paragraph> <paragraph num="(4)"> <text>Direction of the neurotrauma center administrative functions in collaboration with Level I/PARC leadership;</text> </paragraph> <paragraph num="(5)"> <text>Direction and active participation in the neurotrauma quality management (QM) program; and</text> </paragraph> <paragraph num="(6)"> <text>Development of and participation in both internal and external continuing medical education (CME) programs in the care and prevention of neuro injuries.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Medical Staff."> <paragraph num="A."> <text>A neurotrauma center shall have the following team members:</text> <paragraph num="(1)"> <text>A Board-certified or board-eligible, in-house neurosurgery attending or PGY2 or higher, dedicated 24 hours a day to trauma care, with a neurosurgery attending on call who shall be at the patient bedside within 30 minutes after emergent consultation has been requested by the trauma team leader for injured patients based on institution-specific criteria;</text> </paragraph> <paragraph num="(2)"> <text>A trauma fellowship-trained general surgeon;</text> </paragraph> <paragraph num="(3)"> <text>A board-certified anesthesia attending;</text> </paragraph> <paragraph num="(4)"> <text>A board-certified orthopedic or neurosurgery spine attending surgeon or PGY2 or higher orthopedic or neurosurgery resident with an attending on call with a 30-minute response to the patient bedside;</text> </paragraph> <paragraph num="(5)"> <text>A board-certified or board-eligible trauma/critical care attending or critical care fellow with a trauma/critical care attending on call with a 30-minute response to the patient bedside; and</text> </paragraph> <paragraph num="(6)"> <text>An on-call schedule for residents, fellows, and attendings who are assigned to the neurotrauma center.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Appointment and Qualifications of Attending Neurosurgeons.</text> <paragraph num="(1)"> <text>The neurotrauma center director shall appoint qualified attending staff surgeons to participate in the care of patients in the center.</text> </paragraph> <paragraph num="(2)"> <text>An attending neurosurgeon shall meet the requirements in Regulation .05 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Qualifications for Neurotrauma Surgeons."> <text>Category/Description Director Staff Surgeons A. Certification. All neurosurgeons shall be board-certified or board-eligible in neurosurgery. A qualified Neurosurgeon shall be regularly involved in the care of patients with neurologic injuries and shall be credentialed by the hospital with general neurosurgical privileges. Required Required B. Continuing Medical Education. The CME qualification requires annual participation in at least 16 hours or more of trauma or neurotrauma related CME per year. Required Required C. Research Participation. The research participation qualification is to demonstrate a commitment to clinical or basic science neurotrauma care which can be met by: Required Desirable (1) Annual submission of an abstract or publication related to neuro injuries; or (2) Research projects in progress. D. Community Education and Neurotrauma Injury Prevention. The community education and neurotrauma injury prevention qualification is to participate in: Required Desirable (1) The development or revision of community or EMS neurotruama treatment protocols, or representation on a State or local EMS committee; and (2) At least one of the following: (a) Annual participation in one or more prehospital training/certification courses in neurotrauma care which can be met by prehospital basic life support or advanced life support courses or equivalent courses; (b) Annual development or presentation of neurotrauma care courses or lectures which can be met by prehospital basic life support or advance life support courses or equivalent courses; or (c) Participation in a neurotrauma injury prevention program.</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Nursing Personnel."> <paragraph num="A."> <text>A neurotrauma center shall have:</text> <paragraph num="(1)"> <text>A nurse manager who is administratively responsible for the center;</text> </paragraph> <paragraph num="(2)"> <text>An organizational chart relating the nurse manager to other members of the neurotrauma center and the hospital; and</text> </paragraph> <paragraph num="(3)"> <text>A masters-prepared advanced practice nurse with clinical expertise in neurotrauma care with responsibility for clinical nursing oversight and nursing staff consultation.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The nurse manager shall have:</text> <paragraph num="(1)"> <text>A registered nurse license;</text> </paragraph> <paragraph num="(2)"> <text>A baccalaureate or higher degree in nursing;</text> </paragraph> <paragraph num="(3)"> <text>At least 2 or more years of experience in acute neurotrauma care; and</text> </paragraph> <paragraph num="(4)"> <text>At least 1 year or more of experience in an intensive care unit (ICU).</text> </paragraph> </paragraph> <paragraph num="C."> <text>The neurotrauma center nursing department shall:</text> <paragraph num="(1)"> <text>Have a patient classification system/staffing matrix for nurse staffing that meets the care needs for each patient in the neurotrauma center;</text> </paragraph> <paragraph num="(2)"> <text>Have a neurotrauma center orientation program that documents nursing competencies specific to the care and treatment of acute neurologic injuries;</text> </paragraph> <paragraph num="(3)"> <text>Have appropriately trained nursing staff to manage the complex physical and emotional needs of neurotrauma patients;</text> </paragraph> <paragraph num="(4)"> <text>Have a neurotrauma orientation program that each new staff nurse hired shall complete before assuming independent practice in the center;</text> </paragraph> <paragraph num="(5)"> <text>After completion of the introductory education mandated in this regulation, have continuing education (CE) that is current, meeting the following requirements:</text> <paragraph num="(a)"> <text>8 hours of neuro/trauma-related CE every year for emergency and neurotrauma critical care or intermediate care nurses caring primarily for neurotrauma patients; or</text> </paragraph> <paragraph num="(b)"> <text>4 hours of neuro/trauma-related CE every year for nurses who care for trauma patients and are from other clinical areas; and</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Promote specialty certification for nurses working in the neurotrauma ICU and units within 3 years of assignment to neurotrauma.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nurses in the ICU shall spend 50 percent of their clinical practice caring for patients with neurologic injury.</text> </paragraph> <paragraph num="E."> <text>Neurotrauma nursing staff shall be involved with the centers injury prevention and outreach education programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Facility and Equipment."> <text>A neurotrauma center shall have:</text> <paragraph num="A."> <text>For emergency resuscitation:</text> <paragraph num="(1)"> <text>Immediate access to a computed tomography (CT) scanner; and</text> </paragraph> <paragraph num="(2)"> <text>Intracranial Pressure (ICP) monitoring equipment;</text> </paragraph> </paragraph> <paragraph num="B."> <text>In its operating room (OR):</text> <paragraph num="(1)"> <text>Neurotrauma-specific instrumentation/trays;</text> </paragraph> <paragraph num="(2)"> <text>Intraoperative ultrasound; and</text> </paragraph> <paragraph num="(3)"> <text>Evoked potential monitoring;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A post-anesthesia care unit (PACU) with the necessary equipment and medications to manage the traumatic brain or spinal cord injured patient resuscitation and monitoring;</text> </paragraph> <paragraph num="D."> <text>In the ICU:</text> <paragraph num="(1)"> <text>ICP monitoring equipment; and</text> </paragraph> <paragraph num="(2)"> <text>Advanced Neuro-monitoring equipment;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Radiological specialty capabilities, including:</text> <paragraph num="(1)"> <text>In-house trauma-dedicated technicians 24 hours a day;</text> </paragraph> <paragraph num="(2)"> <text>CT scan available 24 hours a day; and</text> </paragraph> <paragraph num="(3)"> <text>Access to magnetic resonance imaging (MRI) capability 24 hours a day; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Clinical laboratory service that meets the standards for PARC and Level I trauma center standard as specified in COMAR 30.08.05.15.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Inpatient Acute Care Rehabilitation Program."> <text>A neurotrauma center shall:</text> <paragraph num="A."> <text>Have a rehabilitation program that is designed for neurotrauma patients and directed by a board-certified physiatrist;</text> </paragraph> <paragraph num="B."> <text>Meet rehabilitation requirements as follows:</text> <paragraph num="(1)"> <text>Rehabilitation services staffed by personnel trained in rehabilitative care and properly equipped for acute care of the traumatic brain injured or spinal cord injured patient; and</text> </paragraph> <paragraph num="(2)"> <text>Rehabilitation consultation services, appropriately licensed or registered in their specific disciplines (that is, occupational therapy, speech therapy, physical therapy, and social services), available in the critical care phase as needed;</text> </paragraph> </paragraph> <paragraph num="C."> <text>Provide therapists with regular supervision from individuals with at least 1 year of experience with the neuro injury for which the patient is being treated (that is, brain injury or spinal cord injury);</text> </paragraph> <paragraph num="D."> <text>Have an orientation program that documents therapists competencies specific to the treatment of acute neurologic injuries and require that each newly hired therapist complete the orientation program before assuming independent practice in the center; and</text> </paragraph> <paragraph num="E."> <text>Promote specialty certification for therapists working in the neurotrauma rehabilitation program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Neurotrauma Rehabilitation."> <text>A neurotrauma center shall have:</text> <paragraph num="A."> <text>Transfer agreements to rehabilitation hospitals, for the primary three rehabilitation hospitals the trauma center utilizes, which may be joint transfer agreements if the trauma center is a part of a health system that utilizes a particular rehabilitation center with appropriate services tailored to the needs of traumatic brain and spinal cord injured patients;</text> </paragraph> <paragraph num="B."> <text>A referral process/case management plan for timely assessment for, and placement in, an appropriate rehabilitation program;</text> </paragraph> <paragraph num="C."> <text>Full in-house service or transfer process in place to a rehabilitation service for acute care or sub-acute care; and</text> </paragraph> <paragraph num="D."> <text>Ongoing continuity of care for patients with traumatic brain and spinal cord injuries provided in affiliated rehabilitation acute or sub-acute facilities, by attending neurotrauma center specialists and sub-specialists.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Quality Management Program."> <paragraph num="A."> <text>A neurotrauma center shall have an ongoing QM program that is multidisciplinary and coordinated with the trauma QM program.</text> </paragraph> <paragraph num="B."> <text>The neurotrauma center director is responsible for the QM program for neurotrauma patients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Research."> <text>A neurotrauma center shall:</text> <paragraph num="A."> <text>An organized neurotrauma research program and a documented research plan;</text> </paragraph> <paragraph num="B."> <text>Evidence of productivity through peer-reviewed publications;</text> </paragraph> <paragraph num="C."> <text>Proposals reviewed by an institutional review board;</text> </paragraph> <paragraph num="D."> <text>Presentations at local, regional, or national meetings;</text> </paragraph> <paragraph num="E."> <text>Publications in peer-reviewed journals on an average of six per year; and</text> </paragraph> <paragraph num="F."> <text>Clinical research trials designed to enhance the trauma system's ability to resuscitate, stabilize, and treat neurotrauma patients in the most cost-effective manner.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Education."> <text>A neurotrauma center shall:</text> <paragraph num="A."> <text>Provide outreach education to health care providers throughout the State related to current standards of care for neurotrauma patients;</text> </paragraph> <paragraph num="B."> <text>Participate in an ACGME-approved program for neurosurgical residency training;</text> </paragraph> <paragraph num="C."> <text>Serve as a clinical site for education for health care providers; and</text> </paragraph> <paragraph num="D."> <text>Participate in professional continuing education programs and professional meetings.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Policies, Protocols, and Agreements."> <text>The hospital shall have patient treatment and care documents as specified in COMAR 30.08.05.19 with the addition of:</text> <paragraph num="A."> <text>Resuscitation and treatment protocols/guidelines for traumatic brain injury; and</text> </paragraph> <paragraph num="B."> <text>Resuscitation and treatment protocols/guidelines for spinal cord injury.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 27, 2002 (29:10 Md. R. 827)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended effective July 21, 2025 (52:14 Md R. 714)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, C amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, C amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective March 7, 2022 (49:5 Md. R. 368)</annotation> </annotations> </chapter> <chapter num="11" heading="Designated Primary Stroke Center Standards"> <regulation prefix="Regulation" num=".01" heading="Designated Primary Stroke Center."> <text>A designated primary stroke center hospital shall:</text> <paragraph num="A."> <text>Be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located;</text> </paragraph> <paragraph num="B."> <text>Be a hospital accredited by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State;</text> </paragraph> <paragraph num="C."> <text>If located in Maryland, be a base station approved under COMAR 30.03.06;</text> </paragraph> <paragraph num="D."> <text>Provide assessment and management of the stroke patient consistent with the most current AHA/ASA consensus based clinical practice guidelines to meet the needs of the patient;</text> </paragraph> <paragraph num="E."> <text>Have a stroke center medical director;</text> </paragraph> <paragraph num="F."> <text>Have a dedicated stroke center nurse coordinator;</text> </paragraph> <paragraph num="G."> <text>Have sufficient personnel and resources needed to facilitate healthcare data management and concurrent review of quality metrics and program objectives;</text> </paragraph> <paragraph num="H."> <text>Meet the requirements of Regulations .03—.14 of this chapter;</text> </paragraph> <paragraph num="I."> <text>Satisfy the MIEMSS requirements for designation as a primary stroke center; and</text> </paragraph> <paragraph num="J."> <text>Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either:</text> <paragraph num="(1)"> <text>An on-site review by MIEMSS; or</text> </paragraph> <paragraph num="(2)"> <text>A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a primary stroke center if the hospital:</text> <paragraph num="(a)"> <text>Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission;</text> </paragraph> <paragraph num="(b)"> <text>Allows MIEMSS to participate in the accreditation site survey; and</text> </paragraph> <paragraph num="(c)"> <text>Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Organization."> <text>The hospital's board of directors, administrators, and medical and nursing staffs shall demonstrate commitment to the hospital's designation as a primary stroke center by:</text> <paragraph num="A."> <text>A board of directors' resolution stating that the hospital agrees to meet the standards of this chapter for designation as a primary stroke center;</text> </paragraph> <paragraph num="B."> <text>An organizational chart showing key stroke center personnel including the stroke center medical director and stroke center nurse coordinator and their relationship within the hospital;</text> </paragraph> <paragraph num="C."> <text>Establishing mechanisms to guide and assure cooperative relationships with community and professional groups committed to increasing public awareness and improving acute stroke care;</text> </paragraph> <paragraph num="D."> <text>Maintaining documentation of stroke center leadership including:</text> <paragraph num="(1)"> <text>An appointment letter for the stroke center medical director; and</text> </paragraph> <paragraph num="(2)"> <text>Curricula vitae of key stroke program personnel with training and expertise in cerebrovascular disease including:</text> <paragraph num="(a)"> <text>Physicians;</text> </paragraph> <paragraph num="(b)"> <text>A stroke center nurse coordinator; and</text> </paragraph> <paragraph num="(c)"> <text>Other key health care personnel; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Maintaining bylaws, contracts, and budgets specific to acute stroke care, indicating the hospital's commitment to the financial, human, and physical resources necessary to support the hospital's designation as a primary stroke center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Emergency Department."> <text>The hospital shall maintain an emergency department which:</text> <paragraph num="A."> <text>Has written documentation on the process used to notify the stroke team of a patient with an acute stroke; and</text> </paragraph> <paragraph num="B."> <text>Has sufficient emergency department clinical staff to meet the requirements of Regulation .05. of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Operating Room."> <text>The hospital shall have:</text> <paragraph num="A."> <text>Operating room neurosurgical services available 24 hours a day with appropriately trained support staff, and:</text> <paragraph num="(1)"> <text>Necessary equipment and tools to aid in the care of acute stroke patients including equipment necessary for continuous hemodynamic monitoring; and</text> </paragraph> <paragraph num="(2)"> <text>A written plan for neurosurgical procedures or evaluations to be performed within 2 hours of the determination they are clinically necessary which is approved by:</text> <paragraph num="(a)"> <text>The neurosurgeons providing coverage; and</text> </paragraph> <paragraph num="(b)"> <text>The stroke center medical director; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>A written agreement with another hospital which:</text> <paragraph num="(1)"> <text>Meets the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Has operating room neurosurgical facilities that meet the requirements of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Is available to provide the required neurosurgical services to the patient.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Stroke Team."> <paragraph num="A."> <text>The hospital shall establish one or more acute stroke teams which shall respond to the emergency department with coordinated services for the effective delivery of emergency and acute stroke treatment.</text> </paragraph> <paragraph num="B."> <text>Presence at Bedside.</text> <paragraph num="(1)"> <text>A member of the emergency department clinical staff shall evaluate each patient with stroke-like symptoms within 10 minutes of the patient’s arrival at the emergency department.</text> </paragraph> <paragraph num="(2)"> <text>At least one member of the acute stroke team shall be present at the patient's bedside to provide care and to treat an acute stroke patient within 15 minutes of notification.</text> </paragraph> <paragraph num="(3)"> <text>The National Institutes of Health Stroke Scale (NIHSS) shall be used for the initial and serial assessment of patients with acute stroke. Clinicians performing an NIHSS will have documented training in the completion of the NIHSS.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The acute stroke team shall include at a minimum:</text> <paragraph num="(1)"> <text>A physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in:</text> <paragraph num="(a)"> <text>Neurology;</text> </paragraph> <paragraph num="(b)"> <text>Critical care medicine;</text> </paragraph> <paragraph num="(c)"> <text>Emergency medicine;</text> </paragraph> <paragraph num="(d)"> <text>Family medicine; or</text> </paragraph> <paragraph num="(e)"> <text>Internal medicine; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least one additional health care provider with experience in caring for the acute stroke patient who may be:</text> <paragraph num="(a)"> <text>An emergency physician;</text> </paragraph> <paragraph num="(b)"> <text>A family medicine physician;</text> </paragraph> <paragraph num="(c)"> <text>An internist;</text> </paragraph> <paragraph num="(d)"> <text>A neurology resident or fellow;</text> </paragraph> <paragraph num="(e)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(f)"> <text>A physician's assistant; or</text> </paragraph> <paragraph num="(g)"> <text>A nurse practitioner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If the physician who satisfies §C(1) of this regulation is not Board certified or Board eligible in neurology, a Board certified or Board eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by:</text> <paragraph num="(1)"> <text>Telephone; or</text> </paragraph> <paragraph num="(2)"> <text>Audio/visual communication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Transfer of Stroke Patients in Need of Higher Level of Care."> <text>The hospital shall:</text> <paragraph num="A."> <text>Transfer the clinically appropriate stroke patient requiring a higher level of care after initial treatment and stabilization to a MIEMSS designated primary stroke center that has endovascular capability or a MIEMSS designated comprehensive stroke center; and</text> </paragraph> <paragraph num="B."> <text>Maintain an agreement or agreements with a commercial ambulance service to:</text> <paragraph num="(1)"> <text>Transfer stroke patients as clinically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Ensure the appropriate delivery of care during transport; and</text> </paragraph> <paragraph num="(3)"> <text>Limit utilization of local emergency medical services (EMS) resources unless by pre-existing agreement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Stroke Unit."> <text>The hospital shall maintain a stroke unit that meets the requirements of this regulation which:</text> <paragraph num="A."> <text>Has designated beds for the care of acute stroke patients beyond the acute treatment period;</text> </paragraph> <paragraph num="B."> <text>Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulation .09 of this chapter;</text> </paragraph> <paragraph num="C."> <text>Develops a standardized process originating in clinical practice guidelines or evidence-based practice to deliver or facilitate the delivery of clinical care;</text> </paragraph> <paragraph num="D."> <text>Develops an individualized plan of care that is based on the patient’s assessed needs and reflects coordination of care with other programs as determined by patient comorbidities; and</text> </paragraph> <paragraph num="E."> <text>Maintains written documentation delineating the function of the stroke unit including:</text> <paragraph num="(1)"> <text>Admission criteria;</text> </paragraph> <paragraph num="(2)"> <text>Discharge criteria;</text> </paragraph> <paragraph num="(3)"> <text>Acute stroke care protocols;</text> </paragraph> <paragraph num="(4)"> <text>Interdisciplinary rounding;</text> </paragraph> <paragraph num="(5)"> <text>Patient census;</text> </paragraph> <paragraph num="(6)"> <text>Rehabilitation in the hospital;</text> </paragraph> <paragraph num="(7)"> <text>Rehabilitation after discharge; and</text> </paragraph> <paragraph num="(8)"> <text>Outcomes data.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Laboratory/Diagnostic Services."> <text>The hospital shall have the ability 24 hours a day to perform laboratory and diagnostic services within 45 minutes of written order including, but not limited to:</text> <paragraph num="A."> <text>A complete blood count;</text> </paragraph> <paragraph num="B."> <text>Blood chemistries;</text> </paragraph> <paragraph num="C."> <text>Coagulation studies;</text> </paragraph> <paragraph num="D."> <text>Troponin;</text> </paragraph> <paragraph num="E."> <text>Electrocardiograms; and</text> </paragraph> <paragraph num="F."> <text>Chest radiographs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Neuroimaging Services."> <paragraph num="A."> <text>The hospital shall have the ability 24 hours a day, within 20 minutes of the patient’s arrival, to complete:</text> <paragraph num="(1)"> <text>All of the following:</text> <paragraph num="(a)"> <text>Brain computed tomography;</text> </paragraph> <paragraph num="(b)"> <text>CT Angiography; and</text> </paragraph> <paragraph num="(c)"> <text>CT Perfusion; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Magnetic resonance imaging.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospital shall have the ability 24 hours a day to have the neuroimages referred to in this regulation interpreted within 20 minutes of their completion by a physician experienced in interpreting computed tomographic studies.</text> </paragraph> <paragraph num="C."> <text>The hospital shall have the ability 24 hours a day to have the neuroimages referred to in this regulation interpreted within 30 minutes of their completion by a physician experienced in interpreting:</text> <paragraph num="(1)"> <text>CT angiography;</text> </paragraph> <paragraph num="(2)"> <text>CT Perfussion; and</text> </paragraph> <paragraph num="(3)"> <text>Magnetic resonance imaging studies.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The hospital shall:</text> <paragraph num="(1)"> <text>Have the ability to upload emergent imaging scans into CRISP (Chesapeake Regional Information System for our Patients), which will facilitate sharing of emergent imaging with the receiving center; and</text> </paragraph> <paragraph num="(2)"> <text>Have the imaging ability to rapidly identify core (nonviable) infarct versus (potentially salvageable) penumbra.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Qualifications of Stroke Center Director and Clinicians."> <paragraph num="A."> <text>The stroke center medical director shall be a physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in:</text> <paragraph num="(1)"> <text>Neurology;</text> </paragraph> <paragraph num="(2)"> <text>Emergency medicine;</text> </paragraph> <paragraph num="(3)"> <text>Neurosurgery;</text> </paragraph> <paragraph num="(4)"> <text>Neuro interventional radiology; or</text> </paragraph> <paragraph num="(5)"> <text>Internal medicine.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The stroke center medical director’s qualifications shall include:</text> <paragraph num="(1)"> <text>Active participation in the stroke Quality Improvement Council (QIC); and</text> </paragraph> <paragraph num="(2)"> <text>8 hours of category 1 CME credits related to stroke care annually.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Qualifications for stroke center physicians who care for acute stroke patients shall include 4 or more hours of category 1 or 2 CME credits per year related to stroke care.</text> </paragraph> <paragraph num="D."> <text>Training for non-physician stroke center professional staff who care for acute stroke patients shall include 4 or more hours per year of continuing education in areas related to cerebrovascular disease.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Qualifications of Emergency Department Clinical Staff."> <paragraph num="A."> <text>Emergency department clinical staff shall participate in cerebrovascular disease educational activities at least two times a year if they:</text> <paragraph num="(1)"> <text>Triage patients in the emergency department; or</text> </paragraph> <paragraph num="(2)"> <text>Care for acute stroke patients.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency department clinical staff who triage patients in the emergency department or care for acute stroke patients shall be trained in:</text> <paragraph num="(1)"> <text>Diagnosis of acute stroke;</text> </paragraph> <paragraph num="(2)"> <text>Treatment of acute stroke; and</text> </paragraph> <paragraph num="(3)"> <text>Use of clinically appropriate fibrinolytics and educated on the indication and referral for endovascular therapy in acute ischemic stroke.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Prevention/Public Education."> <paragraph num="A."> <text>Surviving acute stroke patients and their families shall receive instruction on:</text> <paragraph num="(1)"> <text>Signs and symptoms of acute stroke, including the importance of activating EMS;</text> </paragraph> <paragraph num="(2)"> <text>Effects and prognosis of acute stroke;</text> </paragraph> <paragraph num="(3)"> <text>Potential complications of acute stroke;</text> </paragraph> <paragraph num="(4)"> <text>Needs and rationales for treatment;</text> </paragraph> <paragraph num="(5)"> <text>Patient compliance instructions for risk reduction of individual risk factors and secondary prevention programs; and</text> </paragraph> <paragraph num="(6)"> <text>Post-stroke support services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospital shall support or participate, or both, in acute stroke educational activities developed for EMS personnel which are conducted at least once a year.</text> </paragraph> <paragraph num="C."> <text>The hospital shall conduct at least two times per year public education programs on:</text> <paragraph num="(1)"> <text>Stroke prevention;</text> </paragraph> <paragraph num="(2)"> <text>Recognition of signs and symptoms of acute stroke and the need to activate EMS;</text> </paragraph> <paragraph num="(3)"> <text>Diagnosis of acute stroke; and</text> </paragraph> <paragraph num="(4)"> <text>Treatment of acute stroke.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Policies, Protocols, Guidelines, and Agreements."> <text>The hospital shall develop and implement:</text> <paragraph num="A."> <text>A written policy which demonstrates that the hospital has established the stroke center to:</text> <paragraph num="(1)"> <text>Monitor the care delivered to acute stroke patients;</text> </paragraph> <paragraph num="(2)"> <text>Improve the quality of care delivered to acute stroke patients;</text> </paragraph> <paragraph num="(3)"> <text>Move patients through the initial acute care phase of their hospital stay in a timely fashion; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that all stroke patients will receive medical care commensurate with the hospital's designation as a primary stroke center;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Written procedures for rapidly activating the stroke team to care for potentially eligible fibrinolytic and endovascular candidates within 15 minutes of notification; and</text> </paragraph> <paragraph num="C."> <text>Written care protocols for the treatment of acute stroke which:</text> <paragraph num="(1)"> <text>Address:</text> <paragraph num="(a)"> <text>Evaluation of each patient by a member of the emergency department clinical staff within 10 minutes of the patient's arrival at the hospital emergency department;</text> </paragraph> <paragraph num="(b)"> <text>At least one member of the stroke team arriving at the acute stroke patient's bedside within 15 minutes of notification;</text> </paragraph> <paragraph num="(c)"> <text>Ischemic stroke;</text> </paragraph> <paragraph num="(d)"> <text>Hemorrhagic stroke;</text> </paragraph> <paragraph num="(e)"> <text>Stabilization of vital functions;</text> </paragraph> <paragraph num="(f)"> <text>Initial diagnostic tests;</text> </paragraph> <paragraph num="(g)"> <text>The use of medications including fibrinolytics;</text> </paragraph> <paragraph num="(h)"> <text>Care of the potential endovascular candidate;</text> </paragraph> <paragraph num="(i)"> <text>Timely and safe patient transfer; and</text> </paragraph> <paragraph num="(j)"> <text>The hospital's plan for updating the protocols at least annually;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Are maintained up-to-date in:</text> <paragraph num="(a)"> <text>The emergency department;</text> </paragraph> <paragraph num="(b)"> <text>The stroke unit;</text> </paragraph> <paragraph num="(c)"> <text>The intensive care unit; and</text> </paragraph> <paragraph num="(d)"> <text>All other locations where stroke care is provided.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Quality Management."> <paragraph num="A."> <text>The hospital shall participate, in a manner approved by the EMS Board, in a stroke registry that includes the data elements tracked by the Centers for Medicare and Medicaid Services and the American Heart/American Stroke Get With the Guidelines® — Stroke Registry.</text> </paragraph> <paragraph num="B."> <text>The hospital shall authorize the stroke registry to provide the hospital's data to MIEMSS for health oversight activities in a manner approved by the EMS Board.</text> </paragraph> <paragraph num="C."> <text>Outcome Objectives.</text> <paragraph num="(1)"> <text>The hospital shall establish at least 2 outcome objectives that are:</text> <paragraph num="(a)"> <text>Time-specific;</text> </paragraph> <paragraph num="(b)"> <text>Measurable;</text> </paragraph> <paragraph num="(c)"> <text>Reflective of tracking and trending of performance measures and indicators; and</text> </paragraph> <paragraph num="(d)"> <text>Reviewed in annual comparison studies.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The hospital shall monitor IV fibrinolytic complications, which include symptomatic intracerebral hemorrhage and serious life-threatening systemic bleeding.</text> </paragraph> <paragraph num="(3)"> <text>The hospital shall monitor and demonstrate tracking and trending of modified Rankin Scores (mRS) at discharge and at 90 days post-discharge on patients with acute ischemic stroke.</text> </paragraph> <paragraph num="(4)"> <text>The hospital shall establish at least one stroke center quality assurance medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which, at least three times a year:</text> <paragraph num="(a)"> <text>Meets;</text> </paragraph> <paragraph num="(b)"> <text>Reviews practice patterns; and</text> </paragraph> <paragraph num="(c)"> <text>Modifies practice patterns as appropriate.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>In cases where the administration of fibrinolytics is appropriate, the hospital shall administer fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 50 percent of eligible patients. The hospital shall demonstrate progress towards administering fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 75 percent of eligible patients.</text> </paragraph> <paragraph num="(6)"> <text>The hospital shall demonstrate progress towards reducing time of administration of fibrinolytics to 45 minutes for greater than or equal to 50 percent of eligible patients.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The hospital shall incorporate into the hospital’s quality assurance process progress reports about:</text> <paragraph num="(1)"> <text>Specific acute stroke treatment benchmarks;</text> </paragraph> <paragraph num="(2)"> <text>Outcomes data on patients transferred for higher level of care; and</text> </paragraph> <paragraph num="(3)"> <text>Stroke treatment quality improvement goals.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospital shall provide MIEMSS with documentation of quality management of the stroke program for review including, if appropriate:</text> <paragraph num="(1)"> <text>Problem identification;</text> </paragraph> <paragraph num="(2)"> <text>Problem analysis;</text> </paragraph> <paragraph num="(3)"> <text>An action plan;</text> </paragraph> <paragraph num="(4)"> <text>Implementation of the plan; and</text> </paragraph> <paragraph num="(5)"> <text>Reevaluation of the plan.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: June 5, 2006 (33:11 Md. R. 952)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06B amended effective June 4, 2007 (34:11 Md. R. 973)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective July 1, 2021 (48:9 Md. R. 360)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective July 21, 2025 (52:14 Md. R. 714)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 repealed effective October 18, 2021 (48:21 Md. R. 892)</annotation> </annotations> </chapter> <chapter num="12" heading="Perinatal and Neonatal Referral Center Standards"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Capability” means having the necessary equipment and supplies as well as staff with the skill and experience in its use.</text> </paragraph> <paragraph num="(2)"> <text>“Current” means generally accepted, used, practiced, or prevalent at the moment.</text> </paragraph> <paragraph num="(3)"> <text>“Dedicated” means a resource is assigned to or for the exclusive use by a unit and not shared with any other unit</text> </paragraph> <paragraph num="(4)"> <text>“E” means the standard is essential.</text> </paragraph> <paragraph num="(5)"> <text>“O” means the standard is optional.</text> </paragraph> <paragraph num="(6)"> <text>“NA” means the standard does not apply.</text> </paragraph> <paragraph num="(7)"> <text>“Programmatic responsibility” means the writing, review, and maintenance of practice guidelines, policies, and procedures; development of the operating budget in collaboration with hospital administration and other program directors; evaluation and guiding of the purchase of equipment; planning, development, and coordinating of educational programs, both in-hospital and outreach; participation in the evaluation of perinatal care; and participation in perinatal quality improvement and patient safety activities.</text> </paragraph> <paragraph num="(8)"> <text>“Readily available” means a resource is available for use a short time after it is requested.</text> </paragraph> <paragraph num="(9)"> <text>“Telemedicine” means the use of interactive audio, video, or other telecommunications or electronic technology by a licensed health care provider to deliver a health care service within the scope of practice of the health care provider at a site other than the site at which the patient is located, in compliance with COMAR 10.32.05.and including at least two forms of communication.</text> </paragraph> <paragraph num="(10)"> <text>“Thirty (30) minutes” means in-house within thirty (30) minutes under normal driving conditions which include, but are not limited to, weather, traffic, and other circumstances which may be beyond the individual’s control.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Types of Perinatal Referral Centers."> <paragraph num="A."> <text>“III” is a Level III perinatal referral center.</text> </paragraph> <paragraph num="B."> <text>“IV” is a Level a Level IV perinatal referral center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Organization."> <text>III IV A. The hospital’s Board of Directors, administration, and medical and nursing staffs shall demonstrate commitment to its specific level of perinatal center designation and to the care of perinatal patients. This commitment shall be demonstrated by: (1) A Board resolution that the hospital agrees to meet the current Maryland Perinatal System Standards for its specific level of designation and assures that all perinatal patients shall receive medical care commensurate with that designation; E E (2) Submission of patient care data to the Maryland Department of Health (MDH) and the Maryland Institute for Emergency Medical Services Systems (MIEMSS), for system and quality management; and E E (3) A Board resolution, bylaws, contracts, and budgets indicating the hospital’s commitment to the financial, human, and physical resources and to the infrastructure that are necessary to support the hospital’s level of perinatal center designation. E E B. The hospital shall be licensed by the Maryland Department of Health (MDH) as an acute care hospital. E E C. The hospital shall be accredited by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State. E E D. The hospital shall have an agreement with the Health Services Cost Review Commission that addresses how the cost of neonatal intensive care services will be incorporated into the hospital’s population health budget, and the hospital shall have a certificate of need (CON) from the Maryland Health Care Commission (MHCC) in order to provide neonatal intensive care services, defined as a Level III or IV perinatal program, unless establishment of the hospital’s neonatal intensive care services preceded this requirement. A hospital shall obtain a CON in order to establish Level III or IV perinatal program or to expand a Level III perinatal program to Level IV. E E E. The hospital shall obtain and maintain current equipment and technology, as described in these standards, to support optimal perinatal care for the level of the hospital’s perinatal center designation. E E F. If maternal or neonatal air transports are accepted, then the hospital shall have a heliport, helipad, or access to a helicopter landing site near the hospital. E E G. The hospital shall provide specialized maternal and neonatal transport capability and have extensive Statewide perinatal educational outreach programs in both specialties in collaboration with the Maryland Institute for Emergency Medical Services Systems (MIEMSS) and the Maryland Department of Health (MDH). O E</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Obstetrical Unit Capabilities."> <text>III IV A hospital shall: A. Demonstrate its capability of providing obstetrical care through written standards, protocols, or guidelines, including those for the following: (1) Management of uncomplicated pregnancy; E E (2) Detection, stabilization, and initiation of management of unanticipated maternal-fetal problems; E E (3) Fetal monitoring, including internal scalp electrode monitoring; E E (4) Ability to begin emergency cesarean delivery within a time interval that best incorporates maternal and fetal risks and benefits with the provision of emergency care; and E E (5) Selection and management of obstetrical patients at a maternal risk level appropriate to its capability. E E B. Have an on-site intensive care unit that accepts obstetrical patients and has critical care providers on-site to actively collaborate with obstetricians or maternal-fetal medicine specialists at all times. E E</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Neonatal Unit Capabilities."> <text>III IV A hospital shall demonstrate its capability of providing neonatal care through written standards, protocols, or guidelines, including those for the following: A. Resuscitation and stabilization of the neonate according to the current American Academy of Pediatrics/American Heart Association (AAP/AHA) Neonatal Resuscitation Program (NRP) guidelines at every delivery; E E B. Detection, stabilization, and initiation of management of unanticipated neonatal problems; E E C. Evaluation and care of stable term newborn infants. E E</text> </regulation> <regulation prefix="Regulation" num=".06" heading="Obstetric Personnel."> <text>III IV A hospital shall have: A. A physician board-certified in obstetrics/gynecology shall be a member of the medical staff and have programmatic responsibility for obstetrical services; E NA B. A physician board-certified in maternal-fetal medicine shall be a member of the medical staff and have programmatic responsibility for obstetrical services; O E C. A physician board-certified in maternal-fetal medicine shall be a member of the medical staff and have programmatic responsibility for high-risk obstetrical services; E E D. A physician board-certified in anesthesiology shall be a member of the medical staff and have programmatic responsibility for obstetrical anesthesia services; E E E. A physician board-certified or an active candidate for board certification in maternal-fetal medicine on the medical staff, in active practice available at all times and, if needed, in-house within 30 minutes; and E E F. A physician board-certified or an active candidate for board-certification in obstetrics/gynecology shall be present in-house 24 hours a day and immediately available to the delivery area when a patient is in active labor. E E</text> </regulation> <regulation prefix="Regulation" num=".07" heading="Pediatric Personnel."> <text>III IV A hospital shall have: A. A physician board-certified in pediatrics, neonatal-perinatal medicine, or family medicine shall be a member of the medical staff and have privileges for neonatal care and have programmatic responsibility for neonatal services in the newborn nursery and/or the mother-baby unit; E E B. A physician board-certified in neonatal-perinatal medicine shall be a member of the medical staff and have programmatic responsibility for neonatal services in the special care nursery or NICU; E E C. Neonatal Resuscitation Program (NRP) trained professional(s) with experience in acute care of the depressed newborn and skilled in neonatal endotracheal intubation and resuscitation shall be immediately available to the delivery and neonatal units; E E D. A physician who has completed postgraduate pediatric training, a nurse practitioner, or a physician assistant with privileges for neonatal care appropriate to the level of the nursery and who shall be present in-house 24 hours a day and assigned to the delivery area and neonatal units and not shared with other units in the hospital; E E E. A physician board-certified or an active candidate for board certification in neonatal-perinatal medicine shall be on the medical staff, in active practice, available at all times, and, if needed, in-house within 30 minutes; E E F. An ophthalmologist with experience in neonatal retinal examination and an organized program for the monitoring, treatment, and follow up of retinopathy of prematurity; E E G. The following pediatric subspecialists on staff, in active practice, and, if needed, readily available in-house or via telemedicine: (1) Cardiology; (2) Neurology; and (3) General Pediatric Surgery; E NA H. The following pediatric subspecialties on staff, in active practice, available at all times, and, if needed, in-house within 30 minutes: cardiology, endocrinology, gastroenterology, genetics, hematology, nephrology, neurology, and pulmonology; and O E I. General Pediatric Surgery and the following pediatric surgical subspecialists on staff, in active practice, available at all times, and, if needed, in-house within 30 minutes: (1) Neurosurgery; (2) Cardiothoracic surgery; (3) Orthopedic surgery; (4) Plastic surgery; and (5) Ophthalmology. O E</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Other Personnel."> <text>III IV A hospital shall have: A. A physician board-certified or an active candidate for board certification in anesthesiology or nurse-anesthetist who shall be available at all times to provide labor analgesia and surgical anesthesia so that cesarean delivery may be initiated per hospital protocol as required by Regulation .04A of this chapter; E E B. A physician board-certified or an active candidate for board-certification in anesthesiology who shall be present in-house 24 hours a day, readily available to the delivery area; E E C. If the hospital performs neonatal surgery, a physician board-certified or an active candidate for board certification in anesthesiology with experience in neonatal anesthesia who shall be present for the surgery; E E D. A physician on the medical staff with privileges for providing critical interventional radiology services for: (1) Obstetrical patients; and E E (2) Neonatal patients; O E E. On staff, a licensed registered dietician with knowledge of and experience in the management of obstetrical and neonatal parenteral/enteral nutrition; E NA F. On staff, a licensed registered dietician with knowledge of and experience in the management of obstetrical and neonatal parenteral/enteral nutrition, with one dietician dedicated to the NICU; O E G. At least one full-time equivalent International Board Certified Lactation Consultant who shall have programmatic responsibility for lactation support services which shall include education and training of additional hospital staff members in order to ensure availability of lactation support 7 days per week; E E H. A written plan to address lactation consultant/patient ratios recommended in the current Association of Women’s Health, Obstetric, and Neonatal Nurses Guidelines; E E I. At least one licensed social worker with a Master’s degree (either an LMSW, Licensed Master Social Worker, or an LCSW, Licensed Certified Social Worker) and experience in psychosocial assessment and intervention with women and their families dedicated to the perinatal service; E E J. At least one licensed social worker with a Master’s Degree (either an LMSW, Licensed Master Social Worker, or an LCSW, Licensed Certified Social Worker) and experience in psychosocial assessment and intervention with women and their families dedicated to the NICU; K. Respiratory therapists skilled in neonatal ventilator management; (1) Present in-house 24 hours a day; and E NA (2) Dedicated to the NICU 24 hours a day; O E L. At least one occupational or physical therapist with neonatal expertise; E E M. At least one individual skilled in evaluation and management of neonatal feeding and swallowing disorders such as a speech-language pathologist; E E N. Genetic diagnostic and counseling services or written consultation and referral agreements for these services in place; E E O. A pediatric neurodevelopmental follow-up program or written referral agreements for neurodevelopmental follow-up; E E P. Pharmacy personnel with knowledge of and experience in pediatric pharmacy; E E Q. Hospital perinatal program shall have on its administrative staff at least one registered nurse with a Master’s degree or higher degree in nursing or a health-related field and experience in high-risk obstetrical and/or neonatal nursing who shall have programmatic responsibility for the obstetrical and neonatal nursing services; E E R. On its perinatal program staff at least one registered nurse with a Master’s or higher degree in nursing or a health or education-related field and experience in high-risk obstetrical and/or neonatal nursing who shall have programmatic responsibility for the obstetrical and neonatal nursing services; E E S. Hospital perinatal program shall have on its staff at least one registered nurse with a Master’s or higher degree in nursing or a health or education-related field and experience in high-risk obstetrical and/or neonatal nursing responsible for staff education; E E T. Obstetrical service shall have continuous availability of adequate numbers of registered nurses with competence in assessment and care of obstetrical patients as well as the recognition and nursing management of obstetrical complications; E E U. Neonatal service shall have continuous availability of adequate numbers of registered nurses with competence in assessment and care of neonatal patients appropriate to the designated level of care; E E V. Neonatal service shall have continuous availability of adequate numbers of registered nurses with competence in assessment and care of neonatal patients appropriate to the designated level of care; E E W. A written plan to address registered nurse/patient ratios recommended in the current Association of Women’s Health, Obstetric, and Neonatal Nurses Guidelines. E E</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Laboratory."> <text>III IV A hospital shall: A. The programmatic leaders of the perinatal service and the hospital laboratory shall establish laboratory processing and reporting times that are appropriate for samples drawn from obstetrical and neonatal patients with specific consideration for the acuity of the patient and the integrity of the samples. E E B. Demonstrate the capability to immediately receive, process, and report urgent/emergent obstetric and neonatal laboratory requests. E E C. Have a process in place to report critical results to the obstetric and neonatal services. E E D. Make laboratory results from standard maternal antepartum testing available to the providers caring for the mother and the neonate prior to discharge. If test results are not available or if testing was not performed prior to admission, such testing shall be performed during the hospitalization of the mother and results available prior to discharge of the newborn. E E E. Have the capacity to conduct rapid HIV testing 24 hours a day. E E F. Have available the equipment and trained personnel to perform newborn hearing screening prior to discharge on all infants born at or transferred to the institution as required by COMAR 10.11.02. E E G. Have available the equipment and trained personnel to perform critical congenital heart disease screening between 24 and 48 hours of age on all well infants born at or transferred to the institution and report screening results as required by COMAR 10.52.15. E E H. Have a protocol to perform critical congenital heart disease screening on all infants in the special care nursery or neonatal intensive care unit born at or transferred to the institution and to report screening results as required by COMAR 10.52.15. E E I. Have available the equipment and trained personnel to collect newborn blood-spot screening on all infants born at or transferred to the institution at the appropriate time/intervals and to transport blood-spot specimens to the Maryland State Newborn Screening Laboratory as required by COMAR 10.52.12 and 10.10.13.14. E E J. Have blood bank technicians present in-house 24 hours a day. E E K. Have molecular, cytogenetic, and biochemical genetic testing. E E</text> </regulation> <regulation prefix="Regulation" num=".10" heading="Diagnostic Imaging Capabilities."> <text>III IV A hospital shall have: A. The capability of providing emergency ultrasound imaging and interpretation for obstetrical patients 24 hours per day; E E B. The capability of providing detailed ultrasonography and fetal assessment, including Doppler studies, with interpretation for obstetrical patients 24 hours a day; E E C. The capability of providing maternal echocardiology with interpretation for obstetrical patients 24 hours a day; E E D. The capability of providing portable x-ray imaging with interpretation for neonatal patients 24 hours a day; E E E. The capability of providing portable head ultrasound with interpretation for neonatal patients; E E F. The capability on campus of providing computerized tomography (CT) and magnetic resonance imaging (MRI) with interpretation; O E G. Neonatal echocardiography equipment and an experienced technician shall be available on campus as needed with interpretation by a pediatric cardiologist; E E H. A pediatric cardiac catheterization laboratory and appropriate staff; and O E I. The capability of providing interventional radiology services for: (1) Obstetrical patients; and E E (2) Neonatal patients. O E</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Equipment."> <text>III IV A hospital shall have: A. All of the following equipment and supplies immediately available for existing patients and for the next potential patient: (1) O2 analyzer, stethoscope, intravenous infusion pumps; (2) Radiant heated bed in delivery room and available in the neonatal units; (3) Oxygen hood with humidity; (4) Bag and masks and/or T-piece resuscitator capable of delivering a controlled concentration of oxygen to the infant; (5) Orotracheal tubes; (6) CO2 detector; (7) Aspiration equipment; (8) Laryngoscope; (9) Bowel bags; (10) Umbilical vessel catheters and insertion tray; (11) Cardiac monitor; (12) Pulse oximeter; (13) Transilluminator; (14) Phototherapy unit; (15) Doppler blood pressure for neonates; (16) Cardioversion/defibrillation capability for obstetrical patients and neonates; (17) Resuscitation equipment for obstetrical patients; (18) Resuscitation equipment for neonates including equipment outlined in the current NRP; (19) Individual oxygen, air, and suction outlets for obstetrical patients and neonates; and (20) Emergency call system for both obstetrical and neonatal units as well as an emergency communication system among units. E E B. Special equipment and facilities needed to accommodate the care and services needed for obese women. E E C. A neonatal stabilization bed set up and equipment available at all times for an emergency admission; E E D. Fetal diagnostic testing and monitoring equipment for: (1) Fetal heart rate monitoring; E E (2) Ultrasound examinations; and E E (3) Amniocentesis; E E E. The capability to monitor neonatal intra-arterial pressure; E E F. The capability on campus of providing laser coagulation for retinopathy of prematurity; E E G. The capability on campus of providing a full range of invasive maternal monitoring including equipment for central venous pressure and arterial pressure monitoring; E E H. Appropriate equipment, including back-up equipment, for neonatal respiratory care as well as protocols for the use and maintenance of the equipment as required by its level of neonatal care; E E I. The capability of providing advanced ventilatory support, beyond conventional mechanical ventilation, for neonates of all birth weights; and O E J. The capability of providing continuing therapeutic hypothermia. O E</text> </regulation> <regulation prefix="Regulation" num=".12" heading="Medications."> <text>III IV A hospital shall have: A. Emergency medications, as listed in the current Neonatal Resuscitation Program (NRP) guidelines, shall be immediately available in the delivery area and neonatal units; E E B. The following medications shall be immediately available to the neonatal units: (1) Antibiotics, anticonvulsants, and emergency cardiovascular drugs; and E E (2) Surfactant, prostaglandin E1; E E C. All emergency resuscitation medications to initiate and maintain resuscitation, in accordance with current Advanced Cardiac Life Support (ACLS) guidelines of the American Heart Association (AHA), shall be immediately available in the delivery area; E E D. The following medications shall be immediately available for management of obstetrical hemorrhage in the delivery area and postpartum floor: (1) Oxytocin (Pitocin); (2) Methylergonovine (Methergine); (3) Misoprostol (Cytotec); (4) Carboprost tromethamine (Hemabate); (5) Tranezamic acid (TXA); and E E E. The following medications shall be immediately available for management of hypertensive crisis in all obstetrical care areas: (1) Hydralazine; (2) Labetalol; and (3) Nifedipine. E E</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Education Programs."> <text>III IV A hospital shall: A. Identify minimum competencies for obstetrical and neonatal clinical staff, not otherwise credentialed, that are assessed prior to independent practice and on a regular basis thereafter; E E B. Provide continuing education programs available to all obstetrical and neonatal clinical staff concerning the treatment and care of obstetrical and neonatal patients; E E C. Conduct multidisciplinary clinical drills or simulations including post-drill debriefs to help prepare obstetrical and neonatal staff for high risk, high complexity, low frequency events; E E D. Provide evidence-based education every two years to all staff caring for newborns (nurses, respiratory therapist, technicians, etc.) that includes at a minimum stabilization after immediate resuscitation to address glucose metabolism, thermoregulation, respiratory support hemodynamic monitoring and stability, risk and treatment of infection, and support for the family; and E E E. Accept maternal or neonatal primary transports and provide the following to the referring hospital/providers: (1) Guidance on indications for consultation and referral of patients at high risk; (2) Information about the accepting hospital’s response times and clinical capabilities; (3) Information about alternative sources for specialized care not provided by the accepting hospital; (4) Guidance on the pre-transport stabilization of patients; and (5) Feedback on the pre-transport and post-transport care of patients. E E</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Quality Improvement."> <text>III IV A hospital shall: A. Have a multi-disciplinary Perinatal Quality Improvement Program which meets at least quarterly to evaluate maternal and neonatal health outcomes and to identify process changes to improve patient safety and perinatal outcomes. E E B. The Perinatal Quality Improvement Program shall conduct internal case reviews, collect and analyze perinatal program data, conduct trend analyses, set quality improvement goals annually, and use data to assess progress toward those goals. E E C. The Perinatal Quality Improvement Program shall conduct reviews of all cases of the following as well as cases related to other patient safety and systems issues identified: (1) Maternal, intrapartum fetal, and neonatal deaths; (2) Transports to a higher or comparable level of care; and (3) Elective delivery at less than 39 weeks gestation. E E D. Participate with the Maryland Department of Health and local health department Fetal and Infant Mortality Review program. E E E. Participate in the collaborative collection and assessment of data with the Maryland Department of Health and/or the Maryland Institute for Emergency Medical Services Systems, for the purpose of improving perinatal health outcomes. E E F. Maintain membership in the Vermont Oxford Network. E E</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Policies and Protocols."> <text>III IV A hospital shall have: A. Written policies and protocols for the initial stabilization and continuing care of all obstetrical and neonatal patients appropriate to the designated level of care; E E B. Maternal and neonatal resuscitation protocols; E E C. A medical staff credentialing process that shall include documentation of competency to perform obstetrical and neonatal invasive procedures appropriate to its designated level of care; E E D. A written protocol for the initiating maternal and neonatal transports to an appropriate level of care; E NA E. A written protocol for the acceptance of maternal and neonatal transports; E E F. Written protocols for accepting or transferring obstetrical patients or neonates as “back transports”; E E G. A licensed neonatal transport service or written agreement with a licensed neonatal transport service; E E H. Policies that allow families (including siblings) to be together in the hospital following the birth of an infant and that promote parental involvement in the care of the neonate including those in the NICU; E E I. A policy to eliminate deliveries by induction of labor or by cesarean section prior to 39 weeks gestation without a medical indication with a systematic internal review process to evaluate any occurrences and a plan for corrective action; J. Written protocols and capabilities in place for the following: (1) Assessment of risk for obstetrical hemorrhage; (2) Maximizing accuracy in determining obstetrical blood loss; (3) Massive transfusion; (4) Emergency release of blood products before full compatibility testing is complete; and (5) Management of multiple component therapy; E E K. Written protocol to evaluate all infants born at or transferred to the institution for birth defects and to report findings to the Birth Defects Reporting and Information System as required by Health-General Article, §18-206, Annotated Code of Maryland; E E L. Written policy for the management of obstetrical patients with opioid use and opioid use disorder that addresses the following and other relevant issues: (1) Universal screening of obstetrical patients for opioid use; (2) Pharmacotherapy of the pregnant, laboring, and postpartum patient; (3) Breastfeeding; (4) Linkages to appropriate postpartum psychosocial support services including substance use treatment and relapse prevention program; and (5) Reproductive health planning; E E M. Written policy for the identification and management of neonatal abstinence syndromes; E E N. Written policy for optimizing post-delivery care of obstetrical patients that addresses the following and other relevant issues: (1) Identification of postpartum patients at risk for poor health outcomes; (2) Breastfeeding support; (3) Linkages to appropriate medical and psychosocial services; and (4) Reproductive health planning; E E O. Written policy to address infant safety issues including safe sleep, abusive head trauma (shaken baby) and car seat safety. E E</text> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03A, D amended effective July 1, 2002 (29:12 Md. R. 934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, C amended effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05A amended effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 repealed and new Regulation .06 adopted effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A—D amended effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A amended effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective August 7, 2000 (27:15 Md. R. 1403)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective May 15, 2005 (32:9 Md. R. 850)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.15 repealed and new Regulations .01—.15 adopted effective January 13, 2011 (38:1 Md. R. 12)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.15 amended effective March 30, 2015 (42:6 Md. R. 514)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C amended effective July 21, 2025 (52:14 Md. R. 714)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .10 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .11I amended effective December 10, 2015 (42:24 Md. R. 1506)</annotation> <annotation type="History" subtype="Administrative History">Regulation .12 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .13 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .14 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> <annotation type="History" subtype="Administrative History">Regulation .15 amended effective October 3, 2022 (49:20 Md. R. 913)</annotation> </annotations> </chapter> <chapter num="13" heading="Disciplinary Action for Violation of Subtitle"> <regulation prefix="Regulation" num=".01" heading="Grounds for Disciplinary Action."> <text>MIEMSS may take disciplinary action against a designated trauma or specialty referral center if the trauma or specialty referral center:</text> <paragraph num="A."> <text>Is out of compliance with the requirements of this subtitle, and has been unable or has refused to comply as required by MIEMSS;</text> </paragraph> <paragraph num="B."> <text>Fails to comply with, or otherwise violates the provisions of, State or federal law;</text> </paragraph> <paragraph num="C."> <text>Fails to provide data to MIEMSS, as required by COMAR 30.08.03.01;</text> </paragraph> <paragraph num="D."> <text>Makes a false statement or omits a material fact in:</text> <paragraph num="(1)"> <text>Its application for designation,</text> </paragraph> <paragraph num="(2)"> <text>A record required by this subtitle, or</text> </paragraph> <paragraph num="(3)"> <text>A matter under investigation;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Prevents, interferes with, or attempts to impede in any way, the work of a representative of MIEMSS in the lawful enforcement of this subtitle or any other applicable State law;</text> </paragraph> <paragraph num="F."> <text>Uses false, fraudulent, or misleading advertising, or makes any public claims regarding the center's ability to care for nontrauma or nonspecialty care patients based on its trauma or specialty referral center designation status; or</text> </paragraph> <paragraph num="G."> <text>Fails to cooperate in providing documentation and interviews with appropriate staff for MIEMSS' investigation of complaints.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Preliminary and Further Investigations."> <paragraph num="A."> <text>Receipt of Information.</text> <paragraph num="(1)"> <text>MIEMSS shall initiate a preliminary investigation if it receives information that might form the basis for action against a trauma or specialty referral center.</text> </paragraph> <paragraph num="(2)"> <text>A person may file a signed, written complaint with the Office of Hospital Programs regarding an alleged violation of this subtitle.</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS may begin an investigation without a signed written complaint if it determines that sufficient cause exists.</text> </paragraph> </paragraph> <paragraph num="B."> <text>MIEMSS may initiate a further investigation if it needs additional information to determine whether disciplinary action is warranted.</text> </paragraph> <paragraph num="C."> <text>Not later than 10 business days after MIEMSS decides to begin an investigation, MIEMSS shall give written notice of the investigation to the trauma or specialty referral center being investigated, unless extenuating circumstances exist that would reasonably preclude notification.</text> </paragraph> <paragraph num="D."> <text>At the conclusion of MIEMSS' investigation, MIEMSS shall report its findings, in writing, to the chief executive officer of the trauma or specialty referral center, including requirements for corrective action, if MIEMSS determines that corrective action is appropriate.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Confidentiality of Records of Investigation."> <paragraph num="A."> <text>MIEMSS shall take reasonable precautions to ensure that an investigation is conducted in a confidential manner.</text> </paragraph> <paragraph num="B."> <text>MIEMSS shall maintain a record for each designated trauma and specialty referral center in Maryland.</text> </paragraph> <paragraph num="C."> <text>If MIEMSS begins an investigation, it shall create a confidential record containing the investigatory material, which:</text> <paragraph num="(1)"> <text>Is exempt from disclosure under Health Occupations Article, §§1-401 and 14-506, Annotated Code of Maryland, and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(2)"> <text>Shall be placed in the designated trauma or specialty referral center's official record.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A request for records maintained by MIEMSS shall be processed under Health Occupations Article, §§1-401 and 14-506, Annotated Code of Maryland, and General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Finding of Violation."> <text>If MIEMSS finds that a trauma or specialty referral center has violated this subtitle, MIEMSS may:</text> <paragraph num="A."> <text>Require a trauma or specialty referral center to submit a plan of corrective action;</text> </paragraph> <paragraph num="B."> <text>Place a designated trauma or specialty referral center on probation;</text> </paragraph> <paragraph num="C."> <text>Lower a trauma center's level of designation;</text> </paragraph> <paragraph num="D."> <text>Suspend a trauma or specialty referral center's designation; or</text> </paragraph> <paragraph num="E."> <text>Revoke a trauma or specialty referral center's designation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Plan of Corrective Action."> <paragraph num="A."> <text>If MIEMSS requires a trauma or specialty referral center to submit a plan of corrective action, the notice required by Regulation .02D of this chapter shall include a deadline for submission of the plan of corrective action by the trauma or specialty referral center.</text> </paragraph> <paragraph num="B."> <text>The plan shall include:</text> <paragraph num="(1)"> <text>Steps that the trauma or specialty referral center intends to take to correct deficiencies; and</text> </paragraph> <paragraph num="(2)"> <text>The projected date of completion.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Not later than 15 business days after it receives the plan, MIEMSS shall:</text> <paragraph num="(1)"> <text>Decide whether to approve the plan; and</text> </paragraph> <paragraph num="(2)"> <text>Provide written notice of its decision to the trauma or specialty referral center.</text> </paragraph> </paragraph> <paragraph num="D."> <text>If MIEMSS disapproves the plan, not later than 15 business days from the date of disapproval, the trauma or specialty referral center may request an informal meeting in accordance with Regulation .06D of this chapter.</text> </paragraph> <paragraph num="E."> <text>If MIEMSS approves the plan of correction, the trauma or specialty referral center shall:</text> <paragraph num="(1)"> <text>Begin implementation of the plan immediately upon receiving notice of approval; and</text> </paragraph> <paragraph num="(2)"> <text>Notify MIEMSS upon completion of the plan.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Review of Compliance with Plan.</text> <paragraph num="(1)"> <text>MIEMSS may conduct an on-site review to determine whether the trauma or specialty referral center has complied with the plan of correction.</text> </paragraph> <paragraph num="(2)"> <text>If MIEMSS determines that the trauma or specialty referral center has satisfactorily complied with the plan, the trauma or specialty referral center shall retain its designation status.</text> </paragraph> <paragraph num="(3)"> <text>If MIEMSS determines that the trauma or specialty referral center has not satisfactorily complied with the plan, MIEMSS may take further disciplinary action against the trauma or specialty referral center under Regulation .06 of this chapter.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Procedures for Disciplinary Actions."> <paragraph num="A."> <text>MIEMSS shall initiate an action to place a trauma or specialty referral center on probation or to lower, suspend, or revoke a trauma or specialty referral center's designation if MIEMSS:</text> <paragraph num="(1)"> <text>Determines that the violation warrants probation, lowered level of designation, suspension, or revocation; or</text> </paragraph> <paragraph num="(2)"> <text>Has required a plan of corrective action, and:</text> <paragraph num="(a)"> <text>The trauma or specialty referral center fails to submit a plan within the time set by MIEMSS, or</text> </paragraph> <paragraph num="(b)"> <text>MIEMMS determines that the trauma or specialty referral center has not satisfactorily complied with the plan.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Notice of Action.</text> <paragraph num="(1)"> <text>MIEMSS shall notify a trauma or specialty referral center of the disciplinary action by issuing a written notice of suspension, revocation, lowered level of designation, or probation to the chief executive officer of the hospital.</text> </paragraph> <paragraph num="(2)"> <text>The notice of suspension, revocation, lowered level of designation, or probation shall conform to State Government Article, §10-207, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(3)"> <text>MIEMSS shall notify the EMS Board of the action taken.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Except in the case of an emergency suspension or revocation under §F of this regulation, the suspension, revocation, lowered level of designation, or probation is stayed pending the final agency decision.</text> </paragraph> <paragraph num="D."> <text>Informal Meeting.</text> <paragraph num="(1)"> <text>Not later than 15 business days from the date a trauma or specialty referral center receives a notice of suspension, revocation, lowered level of designation, or probation, the trauma or specialty referral center may request, in writing, an informal meeting with MIEMSS to discuss MIEMSS' action.</text> </paragraph> <paragraph num="(2)"> <text>The meeting shall be held not later than 10 business days from the date MIEMSS receives the request.</text> </paragraph> <paragraph num="(3)"> <text>If the trauma or specialty referral center does not timely request an informal meeting, MIEMSS' notice of suspension, revocation, lowered level of designation, or probation is the final agency decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Request for Hearing.</text> <paragraph num="(1)"> <text>This section does not apply to an emergency revocation or suspension hearing under §F of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>If the trauma or specialty referral center is not satisfied with the result of the informal meeting, not later than 15 business days from the date of the meeting, it may request a hearing by sending a written request for a hearing by certified mail, return receipt requested, addressed to the MIEMSS Office of Hospital Programs in Baltimore, Maryland.</text> </paragraph> <paragraph num="(3)"> <text>Not later than 5 business days from the date of receipt of a timely request for a hearing, MIEMSS shall forward the request to OAH.</text> </paragraph> <paragraph num="(4)"> <text>From the date OAH receives the hearing request, OAH shall schedule a hearing as soon as practicable for all parties and OAH, but not later than:</text> <paragraph num="(a)"> <text>60 calendar days for temporary suspensions or revocations; or</text> </paragraph> <paragraph num="(b)"> <text>90 calendar days for all other hearings.</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>The hearing is conducted in accordance with the procedures set forth in §G of this regulation.</text> </paragraph> <paragraph num="(6)"> <text>If the trauma or specialty referral center does not request a hearing in a timely manner, MIEMSS' notice of suspension, revocation, lowered level of designation, or probation is the final agency decision.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Emergency Revocation or Suspension.</text> <paragraph num="(1)"> <text>If MIEMSS determines that grounds exist that require immediate suspension or revocation of designation for the public's protection, MIEMSS may issue a notice of immediate suspension or revocation of designation to the chief executive officer of the trauma or specialty referral center.</text> </paragraph> <paragraph num="(2)"> <text>The suspension or revocation of designation is effective immediately upon service of the notice of immediate suspension or revocation of designation.</text> </paragraph> <paragraph num="(3)"> <text>Request for Hearing.</text> <paragraph num="(a)"> <text>Not later than 15 business days after service of the notice of immediate suspension or revocation of designation, the trauma or specialty referral center may request a hearing by sending a written request for a hearing by certified mail, return receipt requested, addressed to the MIEMSS Office of Hospital Programs in Baltimore, Maryland.</text> </paragraph> <paragraph num="(b)"> <text>Requesting a hearing does not negate, or act as a stay of, the suspension or revocation.</text> </paragraph> <paragraph num="(c)"> <text>If the trauma or specialty referral center does not request a hearing in a timely manner, MIEMSS' notice of immediate suspension or revocation of designation is the final agency decision.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Upon receipt of a hearing request, MIEMSS shall send a written request to OAH to schedule a hearing.</text> </paragraph> <paragraph num="(5)"> <text>OAH shall conduct the hearing within 10 business days of the date it receives the hearing request, except that the time period may be extended by:</text> <paragraph num="(a)"> <text>OAH for good cause; or</text> </paragraph> <paragraph num="(b)"> <text>Agreement of the trauma or specialty referral center and MIEMSS.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Except as modified in this section, the hearing shall be conducted in accordance with the procedures set forth in §G of this regulation.</text> </paragraph> <paragraph num="(7)"> <text>Not later than 10 business days after the close of the hearing record, OAH shall issue a proposed decision that includes proposed findings of fact and conclusions of law and a proposed order, except that the time period may be extended by:</text> <paragraph num="(a)"> <text>OAH for good cause; or</text> </paragraph> <paragraph num="(b)"> <text>Agreement of the trauma or specialty referral center and MIEMSS.</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Appeal to the EMS Board.</text> <paragraph num="(a)"> <text>Filing of Exceptions.</text> <paragraph num="(i)"> <text>Not later than 5 business days from the date it receives the proposed decision, a party aggrieved by the proposed decision may appeal by filing written exceptions with the Executive Director, for consideration by the EMS Board.</text> </paragraph> <paragraph num="(ii)"> <text>The exceptions shall state with specificity the reasons why the proposed decision should be overturned.</text> </paragraph> <paragraph num="(iii)"> <text>A party filing exceptions may request an oral argument and shall submit the request with the exceptions.</text> </paragraph> <paragraph num="(iv)"> <text>A party filing exceptions shall mail a copy of its exceptions to the opposing party by first class mail, postage prepaid.</text> </paragraph> <paragraph num="(v)"> <text>If exceptions are not filed within the specified time period, the OAH proposed decision is the final agency decision.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Response to Exceptions.</text> <paragraph num="(i)"> <text>Not later than 5 business days after the opposing party receives a copy of the exceptions, the opposing party may file a response with the EMS Board.</text> </paragraph> <paragraph num="(ii)"> <text>A party filing a response may request an oral argument and shall submit the request with the response.</text> </paragraph> <paragraph num="(iii)"> <text>A party filing a response shall mail a copy of its response to the party filing exceptions by first class mail, postage prepaid.</text> </paragraph> </paragraph> <paragraph num="(c)"> <text>Decision of EMS Board.</text> <paragraph num="(i)"> <text>Not later than 30 calendar days after the filing of the exceptions or the response, whichever is later, the EMS Board shall issue a written decision granting or denying the exceptions.</text> </paragraph> <paragraph num="(ii)"> <text>The EMS Board may, in its discretion, rule on the exceptions with or without oral argument.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>If the EMS Board denies the exceptions, the proposed decision, as affirmed by the EMS Board, is the final agency decision.</text> </paragraph> <paragraph num="(e)"> <text>If the EMS Board grants the exceptions, in whole or in part, the EMS Board shall modify the proposed decision accordingly and the modified decision is the final agency decision.</text> </paragraph> <paragraph num="(f)"> <text>The EMS Board shall issue its final decision in accordance with State Government Article, §§10-220 and 10- 221, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A party aggrieved by a final agency decision may seek judicial review in accordance with State Government Article, §10-222, Annotated Code of Maryland, and the Maryland Rules of Civil Procedure.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Hearing Procedures.</text> <paragraph num="(1)"> <text>A hearing shall be conducted in accordance with the procedures and regulations of OAH set forth in COMAR 28.02.01, except as modified by this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Confidential Materials Not Discoverable.</text> <paragraph num="(a)"> <text>In addition to the restrictions on discovery of documents under COMAR 28.02.01.10, a party is not entitled to discovery of any confidential:</text> <paragraph num="(i)"> <text>Record;</text> </paragraph> <paragraph num="(ii)"> <text>File;</text> </paragraph> <paragraph num="(iii)"> <text>Memorandum;</text> </paragraph> <paragraph num="(iv)"> <text>Correspondence;</text> </paragraph> <paragraph num="(v)"> <text>Document;</text> </paragraph> <paragraph num="(vi)"> <text>Object; or</text> </paragraph> <paragraph num="(vii)"> <text>Other tangible thing.</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For purposes of this regulation, all records, files, memoranda, correspondence, documents, objects, other tangible things, notes, minutes of conferences, and any other communications of members of an on-site review team are confidential.</text> </paragraph> <paragraph num="(c)"> <text>This subsection does not restrict the rights of:</text> <paragraph num="(i)"> <text>MIEMSS to obtain any information to which it is entitled under this subtitle; and</text> </paragraph> <paragraph num="(ii)"> <text>A hospital to information originating from the hospital's files.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>In a proceeding before an administrative law judge or a court:</text> <paragraph num="(a)"> <text>MIEMSS may disclose information or present evidence that contains or might reveal confidential information if the information is relevant to the case; and</text> </paragraph> <paragraph num="(b)"> <text>If there is an objection, before the information is disclosed, the administrative law judge or court that is conducting the proceeding shall determine whether the information is confidential and, if it is, enter an order that it determines is appropriate to protect the confidentiality of the information.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>MIEMSS has the burden of proving, by a preponderance of the evidence, the grounds for suspension, revocation, lowered level of designation, or probation.</text> </paragraph> <paragraph num="(5)"> <text>Except for an emergency suspension or revocation under §F of this regulation, not later than 60 business days after the close of the hearing, OAH shall issue a proposed decision that shall include proposed findings of fact and conclusions of law and a proposed order.</text> </paragraph> </paragraph> <paragraph num="H."> <text>Appeal to the EMS Board.</text> <paragraph num="(1)"> <text>This section does not apply to an emergency revocation or suspension under §F of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>Filing of Exceptions.</text> <paragraph num="(a)"> <text>Not later than 15 business days from the date it receives the proposed decision, a party aggrieved by the proposed decision may appeal by filing written exceptions with the Executive Director, for consideration by the EMS Board.</text> </paragraph> <paragraph num="(b)"> <text>The exceptions shall state with specificity the reasons why the proposed decision should be overturned.</text> </paragraph> <paragraph num="(c)"> <text>A party filing exceptions may request an oral argument and shall submit the request with the exceptions.</text> </paragraph> <paragraph num="(d)"> <text>A party filing exceptions shall mail a copy of its exceptions to the opposing party by first class mail, postage prepaid.</text> </paragraph> <paragraph num="(e)"> <text>If exceptions are not filed within the specified time period, the proposed decision is the final agency decision.</text> </paragraph> <paragraph num="(f)"> <text>Response to Exceptions.</text> <paragraph num="(i)"> <text>Not later than 15 business days from the date of the filing of the exceptions with the EMS Board, the opposing party may file a response with the EMS Board.</text> </paragraph> <paragraph num="(ii)"> <text>A party filing a response may request an oral argument and shall submit the request with the response.</text> </paragraph> <paragraph num="(iii)"> <text>A party filing a response shall mail a copy of its response to the party filing exceptions by first class mail, postage prepaid.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Decision of EMS Board.</text> <paragraph num="(a)"> <text>The EMS Board may, in its discretion, rule on the exceptions with or without oral argument.</text> </paragraph> <paragraph num="(b)"> <text>If the EMS Board denies the exceptions, in whole or in part, the proposed decision is the final agency decision.</text> </paragraph> <paragraph num="(c)"> <text>If the EMS Board grants the exceptions, the EMS Board shall modify the proposed decision accordingly and the modified decision is the final agency decision.</text> </paragraph> <paragraph num="(d)"> <text>The EMS Board shall issue its final decision in accordance with State Government Article, §§10-220 and 10- 221, Annotated Code of Maryland.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>A party aggrieved by a final agency decision of the EMS Board may seek judicial review in accordance with State Government Article, §10-222, Annotated Code of Maryland, and the Maryland Rules of Civil Procedure.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: March 24, 1997 (24:6 Md. R. 488)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06 amended effective July 1, 2002 (29:12 Md. R. 934)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03C, D amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265)</annotation> </annotations> </chapter> <chapter num="14" heading="Hand and Upper Extremity Trauma Center Standards"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Accreditation Council for Graduate Medical Education (ACGME)” means the private, nonprofit council that evaluates and accredits medical residency programs in the United States.</text> </paragraph> <paragraph num="(2)"> <text>“Commission on Accreditation of Rehabilitation Facilities (CARF)” means the international independent, nonprofit accreditor of human service providers in the areas of rehabilitation, employment, child, and family.</text> </paragraph> <paragraph num="(3)"> <text>“Hand and upper extremity physician trauma team” means the physician team required by Regulation .03 of this chapter.</text> </paragraph> <paragraph num="(4)"> <text>“Hand Therapy Certification Commission (HTCC)” means an independent, nonprofit accrediting body for the testing and credentialing of hand therapists.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Organization."> <paragraph num="A."> <text>A hand and upper extremity trauma center shall:</text> <paragraph num="(1)"> <text>Be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located;</text> </paragraph> <paragraph num="(2)"> <text>Be accredited by [the Joint Commission on Accreditation of Health Care Organizations] an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State, with a designated hand surgery service;</text> </paragraph> <paragraph num="(3)"> <text>Have an emergency department which offers comprehensive emergency care 24 hours a day with:</text> <paragraph num="(a)"> <text>At least one physician experienced in emergency care on duty in the emergency care area; and</text> </paragraph> <paragraph num="(b)"> <text>In-hospital physician coverage by members of the medical staff or by senior-level residents who are postgraduate year 3 or higher for the following services:</text> <paragraph num="(i)"> <text>Medical;</text> </paragraph> <paragraph num="(ii)"> <text>Surgical;</text> </paragraph> <paragraph num="(iii)"> <text>Orthopedic; and</text> </paragraph> <paragraph num="(iv)"> <text>Anesthesia;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Have a resolution adopted by the Board of Directors of the hospital committing the hospital to:</text> <paragraph num="(a)"> <text>Participate in State and regional emergency medical services; and</text> </paragraph> <paragraph num="(b)"> <text>Maintain the infrastructure necessary to support the hospital's provision of state-of-the-art hand and upper extremity trauma care including the following resources necessary to the provision of such service:</text> <paragraph num="(i)"> <text>Financial;</text> </paragraph> <paragraph num="(ii)"> <text>Human; and</text> </paragraph> <paragraph num="(iii)"> <text>Physical.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>The hand and upper extremity trauma center shall have:</text> <paragraph num="(1)"> <text>A medical director;</text> </paragraph> <paragraph num="(2)"> <text>Appropriately educated nurse leaders and clinical staff to provide care for hand and upper extremity trauma patients;</text> </paragraph> <paragraph num="(3)"> <text>A fellowship training program in hand surgery accredited by the ACGME;</text> </paragraph> <paragraph num="(4)"> <text>A comprehensive post-trauma rehabilitation program accredited by CARF;</text> </paragraph> <paragraph num="(5)"> <text>A quality improvement program which participates in State and regional emergency medical services quality management;</text> </paragraph> <paragraph num="(6)"> <text>An educational program for physicians, nurses, and therapists who treat trauma patients with single system upper extremity trauma;</text> </paragraph> <paragraph num="(7)"> <text>A policy committee that oversees the activities of the hand and upper extremity trauma center;</text> </paragraph> <paragraph num="(8)"> <text>An internal morbidity and mortality conference scheduled to meet at least monthly to record and discuss any complications;</text> </paragraph> <paragraph num="(9)"> <text>A maintained hand registry; and</text> </paragraph> <paragraph num="(10)"> <text>Timely submission of data to the MIEMSS State trauma registry.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Medical Staff."> <paragraph num="A."> <text>The hospital shall have a hand and upper extremity physician trauma team that shall include at least eight physicians who are Board-eligible or Board-certified in the following specialties:</text> <paragraph num="(1)"> <text>General surgery;</text> </paragraph> <paragraph num="(2)"> <text>Plastic surgery; or</text> </paragraph> <paragraph num="(3)"> <text>Orthopedic surgery.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A member of the hand and upper extremity physician trauma team shall be on call 24 hours a day with a response time of 30 minutes or less.</text> </paragraph> <paragraph num="C."> <text>As back-up, a second member of the hand and upper extremity physician trauma team shall be on call 24 hours a day with a response time of 30 minutes or less.</text> </paragraph> <paragraph num="D."> <text>The physicians who satisfy §A of this regulation shall also hold or be eligible to hold a Certificate of Added Qualifications in Hand Surgery through:</text> <paragraph num="(1)"> <text>The American Board of Orthopedic Surgery;</text> </paragraph> <paragraph num="(2)"> <text>The American Board of Plastic Surgery; or</text> </paragraph> <paragraph num="(3)"> <text>The American Board of Surgery.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Each member of the hand and upper extremity trauma physician trauma team shall be competent in:</text> <paragraph num="(1)"> <text>Microsurgery of the upper extremity;</text> </paragraph> <paragraph num="(2)"> <text>Neurovascular surgery of the upper extremity;</text> </paragraph> <paragraph num="(3)"> <text>Emergency skeletal reconstruction;</text> </paragraph> <paragraph num="(4)"> <text>Emergency soft tissue reconstruction; and</text> </paragraph> <paragraph num="(5)"> <text>Upper limb replantation.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A call roster for the hand and upper extremity physician trauma team shall be published and available in the emergency department and operating room.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Nursing Services."> <paragraph num="A."> <text>The hospital shall staff the hand and upper extremity trauma center with registered nurses competent in the care of patients with hand and upper extremity disorders.</text> </paragraph> <paragraph num="B."> <text>The hospital shall provide all nurses who care for patients in the hand and upper extremity trauma center with:</text> <paragraph num="(1)"> <text>Specific orientation to procedures and protocols for hand and upper extremity emergencies; and</text> </paragraph> <paragraph num="(2)"> <text>Education in hand and upper extremity emergencies and trauma care that meets the learning outcomes approved by MIEMSS.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Nursing staff caring for hand and upper extremity trauma patients shall at a minimum have 8 hours of continuing medical education in hand trauma related topics every 2 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Facility and Unit Capabilities."> <paragraph num="A."> <text>Hand and upper extremity trauma facilities shall be able to optimally and comprehensively care for every patient with an isolated upper extremity injury from the time the patient arrives at the hospital through acute treatment, rehabilitation, reconstruction, and re-entry into the work force.</text> </paragraph> <paragraph num="B."> <text>Hand and upper extremity trauma area facilities shall have:</text> <paragraph num="(1)"> <text>A suite of rooms identified and specialized for examination and treatment of hand and upper extremity trauma emergencies in the hospital's emergency department with:</text> <paragraph num="(a)"> <text>A medical director or representative on the hospital's emergency services committee that shall oversee the management of the hand and upper extremity trauma center; and</text> </paragraph> <paragraph num="(b)"> <text>Appropriate nurse leaders who shall be responsible for all venues in which hand and upper extremity trauma care is rendered;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Organized and specialized equipment and supplies to care for hand and upper extremity trauma including specialized prepackaged sterile surgical sets located in the hand trauma rooms to enable the performance of procedures including, but not limited to:</text> <paragraph num="(a)"> <text>Exploration and debridement of complex hand injuries;</text> </paragraph> <paragraph num="(b)"> <text>Bony debridement and shortening;</text> </paragraph> <paragraph num="(c)"> <text>Thermal injury care;</text> </paragraph> <paragraph num="(d)"> <text>Tendon repair;</text> </paragraph> <paragraph num="(e)"> <text>Full and partial thickness skin grafts;</text> </paragraph> <paragraph num="(f)"> <text>Composite tissue grafts; and</text> </paragraph> <paragraph num="(g)"> <text>Repair of simple and complex skin lacerations;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Pneumatic tourniquets;</text> </paragraph> <paragraph num="(4)"> <text>High intensity light;</text> </paragraph> <paragraph num="(5)"> <text>Surgical loupes;</text> </paragraph> <paragraph num="(6)"> <text>Power equipment for skeletal fixation;</text> </paragraph> <paragraph num="(7)"> <text>Figure traps for fracture reduction;</text> </paragraph> <paragraph num="(8)"> <text>Casting material in a variety of sizes and compositions;</text> </paragraph> <paragraph num="(9)"> <text>Metallic malleable splints;</text> </paragraph> <paragraph num="(10)"> <text>Plastic or prefabricated splits;</text> </paragraph> <paragraph num="(11)"> <text>Specialized dressings for hand injuries including burns;</text> </paragraph> <paragraph num="(12)"> <text>Local anesthetics; and</text> </paragraph> <paragraph num="(13)"> <text>Doppler unit for vascular assessment.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The hospital shall have appropriate staffing and equipment readily available to offer the following services to patients in the hand and upper extremity trauma area:</text> <paragraph num="(1)"> <text>Standard stationary radiography;</text> </paragraph> <paragraph num="(2)"> <text>Portable C-Arm fluoroscopy;</text> </paragraph> <paragraph num="(3)"> <text>Diagnostic vascular imaging;</text> </paragraph> <paragraph num="(4)"> <text>Interventional vascular procedures;</text> </paragraph> <paragraph num="(5)"> <text>CT and MRI scans;</text> </paragraph> <paragraph num="(6)"> <text>MR angiography;</text> </paragraph> <paragraph num="(7)"> <text>Radionuclide scanning; and</text> </paragraph> <paragraph num="(8)"> <text>Ultrasonography.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The hospital shall have a direct communication link to the State communication network including:</text> <paragraph num="(1)"> <text>SYSCOM;</text> </paragraph> <paragraph num="(2)"> <text>Prehospital providers; and</text> </paragraph> <paragraph num="(3)"> <text>Referring hospitals.</text> </paragraph> </paragraph> <paragraph num="E."> <text>The hospital shall have pharmacy support to provide all needed medications 24 hours a day.</text> </paragraph> <paragraph num="F."> <text>The hand and upper extremity trauma center operating room shall have:</text> <paragraph num="(1)"> <text>Equipment for the treatment of all hand and upper extremity injuries reconstructive procedures;</text> </paragraph> <paragraph num="(2)"> <text>A specially trained and dedicated operating room team for hand surgery, musculoskeletal care, or both;</text> </paragraph> <paragraph num="(3)"> <text>Continuous availability of the operating suite with an in-house operating room scrub team 24 hours a day; and</text> </paragraph> <paragraph num="(4)"> <text>Specialized equipment readily available to enable:</text> <paragraph num="(a)"> <text>Microvascular tissue replantation;</text> </paragraph> <paragraph num="(b)"> <text>Microvascular free tissue transfer;</text> </paragraph> <paragraph num="(c)"> <text>Microsurgical nerve repair;</text> </paragraph> <paragraph num="(d)"> <text>Internal and external fixation of all bones of the upper extremity;</text> </paragraph> <paragraph num="(e)"> <text>Intraoperative vascular evaluation;</text> </paragraph> <paragraph num="(f)"> <text>Upper extremity endoscopy; and</text> </paragraph> <paragraph num="(g)"> <text>Upper extremity arthroscopy.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>The hand and upper extremity trauma center inpatient unit shall have a nursing unit for the care of the patient with upper extremity injuries that provides nursing staff who are:</text> <paragraph num="(1)"> <text>Specially educated and demonstrate competencies in the postoperative evaluation of limb replantation and revascularization;</text> </paragraph> <paragraph num="(2)"> <text>Able to independently monitor the tissue perfusion of replanted limbs; and</text> </paragraph> <paragraph num="(3)"> <text>Specially educated in the care and postoperative monitoring of free tissue transfers.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The hand and upper extremity trauma center hand therapy unit shall have:</text> <paragraph num="(1)"> <text>A specialized area for inpatient and outpatient care utilizing individualized occupational and physical therapy techniques directed specifically towards the rehabilitation of the upper extremity;</text> </paragraph> <paragraph num="(2)"> <text>Certified and licensed occupational and physical therapists;</text> </paragraph> <paragraph num="(3)"> <text>Staff designated or qualified to be designated as certified hand therapist by the “Hand Therapy Certification Commission”;</text> </paragraph> <paragraph num="(4)"> <text>Regular educational programs presented by the therapy staff;</text> </paragraph> <paragraph num="(5)"> <text>A facility for the fabrication of custom individualized splints; and</text> </paragraph> <paragraph num="(6)"> <text>The ability to care for the following types of clinical problems:</text> <paragraph num="(a)"> <text>Flexor tendon repair and reconstruction;</text> </paragraph> <paragraph num="(b)"> <text>Extensor tendon repair and reconstruction;</text> </paragraph> <paragraph num="(c)"> <text>Nerve repair or reconstruction;</text> </paragraph> <paragraph num="(d)"> <text>Tendon transfers;</text> </paragraph> <paragraph num="(e)"> <text>Thermal injuries;</text> </paragraph> <paragraph num="(f)"> <text>Repetitive stress and cumulative trauma disorders;</text> </paragraph> <paragraph num="(g)"> <text>Training in the use of prosthetic devices; and</text> </paragraph> <paragraph num="(h)"> <text>Upper extremity replantation.</text> </paragraph> </paragraph> </paragraph> <paragraph num="I."> <text>The hand and upper extremity trauma center work rehabilitation services shall have:</text> <paragraph num="(1)"> <text>A CARF-accredited area dedicated to facilitating the transition of the injured worker back into the workforce;</text> </paragraph> <paragraph num="(2)"> <text>Equipment to stimulate and practice the activities required at the majority of work sites;</text> </paragraph> <paragraph num="(3)"> <text>Computerized analysis of multiple physical parameters required for performance in the workplace;</text> </paragraph> <paragraph num="(4)"> <text>The ability to evaluate ergonomic factors in the scenario of the workers' stations; and</text> </paragraph> <paragraph num="(5)"> <text>Social services to aid in the transition of the injured worker back into the workplace.</text> </paragraph> </paragraph> <paragraph num="J."> <text>The hand and upper extremity trauma center outpatient clinical area shall have:</text> <paragraph num="(1)"> <text>A dedicated adaptation hand clinic area for the evaluation and treatment of hand and upper extremity trauma patients on a nonemergent basis; and</text> </paragraph> <paragraph num="(2)"> <text>A hand and upper extremity medical staff physician responsible for the overall clinical coordination and care delivery.</text> </paragraph> </paragraph> <paragraph num="K."> <text>The hand and upper extremity trauma center microvascular laboratory shall have:</text> <paragraph num="(1)"> <text>A facility to practice the microsurgical techniques needed in the acute treatment and reconstruction of upper extremity trauma victims;</text> </paragraph> <paragraph num="(2)"> <text>Animal surgery available to simulate the human situation; and</text> </paragraph> <paragraph num="(3)"> <text>Individualized instruction in microsurgery.</text> </paragraph> </paragraph> <paragraph num="L."> <text>The hand and upper extremity trauma center anatomy laboratory shall:</text> <paragraph num="(1)"> <text>Have a facility for the dissection of human and animal specimens; and</text> </paragraph> <paragraph num="(2)"> <text>Facilitate instruction in pertinent anatomy implicit in the treatment of hand and upper extremity trauma victims.</text> </paragraph> </paragraph> <paragraph num="M."> <text>The hand and upper extremity trauma center information support services shall:</text> <paragraph num="(1)"> <text>Provide educational support services including:</text> <paragraph num="(a)"> <text>Preparation and dissemination of hand and upper extremity trauma educational information for:</text> <paragraph num="(i)"> <text>Patients;</text> </paragraph> <paragraph num="(ii)"> <text>Providers; and</text> </paragraph> <paragraph num="(iii)"> <text>The public;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>An Internet server for disseminating information regarding patient education and public safety;</text> </paragraph> <paragraph num="(c)"> <text>Audiovisual facilities to produce materials for presentations and patient education; and</text> </paragraph> <paragraph num="(d)"> <text>A robust conference schedule with rotating didactic lectureships covering the germinal information in the field of hand and upper extremity surgery;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide psychosocial support, including a certified psychologist and a licensed social worker with special expertise in the evaluation and treatment of hand and upper extremity trauma victims; and</text> </paragraph> <paragraph num="(3)"> <text>Provide an amputee-prosthetic clinic as a regional resource for amputee prosthetics using a team approach for management of post trauma patients with hand or upper extremity amputations, which team shall include one or more of each of the following:</text> <paragraph num="(a)"> <text>Prosthetist;</text> </paragraph> <paragraph num="(b)"> <text>Social worker;</text> </paragraph> <paragraph num="(c)"> <text>Hand therapist;</text> </paragraph> <paragraph num="(d)"> <text>Hand resident;</text> </paragraph> <paragraph num="(e)"> <text>Hand fellow; and</text> </paragraph> <paragraph num="(f)"> <text>Attending hand surgeon.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Quality Management."> <paragraph num="A."> <text>The hand and upper extremity trauma center shall have an ongoing quality management program integrated with the hospital's overall quality management system.</text> </paragraph> <paragraph num="B."> <text>Quality management for the hand and upper extremity trauma center shall include:</text> <paragraph num="(1)"> <text>Maintaining the hand physician representative on the following hospital committees to discuss quality management issues during monthly meetings:</text> <paragraph num="(a)"> <text>The hospital operating room committee; and</text> </paragraph> <paragraph num="(b)"> <text>The hospital emergency room committee;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Attendance by the hand and upper extremity trauma center representative responsible for quality management and quality improvement activities at:</text> <paragraph num="(a)"> <text>The hand policy committee meetings; and</text> </paragraph> <paragraph num="(b)"> <text>The monthly hospital quality management meetings;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Participation in State emergency medical services quality management activities;</text> </paragraph> <paragraph num="(4)"> <text>Maintenance of a hand and upper extremity trauma registry on patients admitted to the hand and upper extremity trauma center;</text> </paragraph> <paragraph num="(5)"> <text>Monthly review of hand and upper extremity trauma registry data and reports;</text> </paragraph> <paragraph num="(6)"> <text>Maintenance of a patient care database on patients treated through the hand and upper extremity trauma rehabilitation unit and evaluation of the various outcomes, measures, and protocols;</text> </paragraph> <paragraph num="(7)"> <text>Monthly review of morbidity and mortality data from the hand and upper extremity trauma center weekly patient sessions for trainees in which cases and complications can be discussed;</text> </paragraph> <paragraph num="(8)"> <text>Making available to MIEMSS documentation of quality management including:</text> <paragraph num="(a)"> <text>Problem identification;</text> </paragraph> <paragraph num="(b)"> <text>Analysis;</text> </paragraph> <paragraph num="(c)"> <text>Action plan;</text> </paragraph> <paragraph num="(d)"> <text>Implementation; and</text> </paragraph> <paragraph num="(e)"> <text>Reevaluation; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>A monthly ethics in medicine forum to discuss ethical considerations that confront today's physician.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Prevention and Public Education."> <text>The hand and upper extremity trauma center shall provide leadership and coordination for the development and implementation of prevention and public education programs for hand and upper extremity injuries, by, among other activities:</text> <paragraph num="A."> <text>Participation in MIEMSS outcome studies when requested;</text> </paragraph> <paragraph num="B."> <text>Training and teaching emergency medical services personnel;</text> </paragraph> <paragraph num="C."> <text>Serving as a public resource for the prevention and safety of hand and upper extremity injuries;</text> </paragraph> <paragraph num="D."> <text>Participation in media public service announcements for seasonal hand and upper extremity injuries; and</text> </paragraph> <paragraph num="E."> <text>Monitoring the progress of prevention programs in cooperation with State monitoring programs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Research."> <text>The hand and upper extremity trauma center shall participate in an organized clinical research program which shall include:</text> <paragraph num="A."> <text>A research committee; and</text> </paragraph> <paragraph num="B."> <text>A research director who shall:</text> <paragraph num="(1)"> <text>Coordinate ongoing research projects;</text> </paragraph> <paragraph num="(2)"> <text>Meet monthly with hand and upper extremity trauma injury center staff to discuss the progress of research projects;</text> </paragraph> <paragraph num="(3)"> <text>Assist in the preparation of projects for presentation and publication; and</text> </paragraph> <paragraph num="(4)"> <text>Prepare documentation of ongoing research grants.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Formal Medical Staff Education."> <text>Education of the hand and upper extremity trauma center medical staff shall include:</text> <paragraph num="A."> <text>Formal didactic lectures available weekly to all hand and upper extremity trauma center staff;</text> </paragraph> <paragraph num="B."> <text>At least every other week, cadaver prosections and dissections at the Maryland State Anatomy Board performed on various areas of the upper extremity performed by:</text> <paragraph num="(1)"> <text>Residents;</text> </paragraph> <paragraph num="(2)"> <text>Fellows; and</text> </paragraph> <paragraph num="(3)"> <text>Attending physicians;</text> </paragraph> </paragraph> <paragraph num="C."> <text>An annual course for free tissue transfer and brachial plexus dissections at the Maryland State Anatomy Board;</text> </paragraph> <paragraph num="D."> <text>The availability of cadaver specimens to evaluate and practice new surgical techniques and procedures for upcoming clinical cases; and</text> </paragraph> <paragraph num="E."> <text>An ACGME accredited fellowship program.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Continuing Education Programs."> <paragraph num="A."> <text>Internal Continuing Education.</text> <paragraph num="(1)"> <text>Medical staff internal continuing education shall consist of:</text> <paragraph num="(a)"> <text>Participation in weekly case management conferences;</text> </paragraph> <paragraph num="(b)"> <text>Participation in weekly lecture series;</text> </paragraph> <paragraph num="(c)"> <text>Attendance at monthly specialized conferences that include the following subject areas:</text> <paragraph num="(i)"> <text>Amputee;</text> </paragraph> <paragraph num="(ii)"> <text>Microsurgery;</text> </paragraph> <paragraph num="(iii)"> <text>Plastic surgery;</text> </paragraph> <paragraph num="(iv)"> <text>Congenital deformities; and</text> </paragraph> <paragraph num="(v)"> <text>Anatomy;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Participation in monthly hand surgery journal club;</text> </paragraph> <paragraph num="(e)"> <text>Attendance at yearly visiting professor lecture and anatomy laboratory;</text> </paragraph> <paragraph num="(f)"> <text>Access to electronic educational materials in the specialty;</text> </paragraph> <paragraph num="(g)"> <text>Access to video library including:</text> <paragraph num="(i)"> <text>Hand surgery; and</text> </paragraph> <paragraph num="(ii)"> <text>Microsurgery topics; and</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Completion of microsurgery laboratory refresher course.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Operating room and inpatient nursing staff internal continuing education shall consist of:</text> <paragraph num="(a)"> <text>Participation in nurse specialty education opportunities and American Society for Surgery of the Hand meetings;</text> </paragraph> <paragraph num="(b)"> <text>Attendance at lectures by attending hand surgeons;</text> </paragraph> <paragraph num="(c)"> <text>Access to hand and upper extremity trauma center lecture series;</text> </paragraph> <paragraph num="(d)"> <text>Access to hand surgery and hospital library services; and</text> </paragraph> <paragraph num="(e)"> <text>Participation in case presentations and discussions as appropriate;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Hand therapist internal continuing education shall consist of:</text> <paragraph num="(a)"> <text>Access to full schedule of hand center lecture series;</text> </paragraph> <paragraph num="(b)"> <text>Access to monthly congenital conference;</text> </paragraph> <paragraph num="(c)"> <text>Access to monthly hand surgery journal club; and</text> </paragraph> <paragraph num="(d)"> <text>Attendance at National Hand Therapy and American Society for Surgery of the Hand meetings.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Special Training in Trauma Protocols. Training in trauma protocols shall include:</text> <paragraph num="(1)"> <text>Review of the new attending and house staff manual;</text> </paragraph> <paragraph num="(2)"> <text>Completion of an orientation/training session for new:</text> <paragraph num="(a)"> <text>Physicians;</text> </paragraph> <paragraph num="(b)"> <text>Nurses; and</text> </paragraph> <paragraph num="(c)"> <text>Therapists; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Review of trauma registry data including:</text> <paragraph num="(a)"> <text>Inclusion criteria;</text> </paragraph> <paragraph num="(b)"> <text>Definitions; and</text> </paragraph> <paragraph num="(c)"> <text>Reports.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>External Continuing Education. External continuing education programs concerning the care and treatment of hand and upper extremity trauma injury including attendance at external symposia and lectures are required.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Policies and Procedures."> <text>A hand and upper extremity trauma center shall maintain written policies and protocols for:</text> <paragraph num="A."> <text>Emergency triage and protocol for massive upper extremity injuries and replantation;</text> </paragraph> <paragraph num="B."> <text>Preoperative and postoperative orders for replantations and free flaps;</text> </paragraph> <paragraph num="C."> <text>Care and treatment of a upper extremity injuries;</text> </paragraph> <paragraph num="D."> <text>The physician on-call schedule for the hand and upper extremity trauma center;</text> </paragraph> <paragraph num="E."> <text>The interhospital transfer protocol;</text> </paragraph> <paragraph num="F."> <text>House staff privileges for:</text> <paragraph num="(1)"> <text>Educational activities;</text> </paragraph> <paragraph num="(2)"> <text>Responsibilities; and</text> </paragraph> <paragraph num="(3)"> <text>Grievances;</text> </paragraph> </paragraph> <paragraph num="G."> <text>The scope of care for the hand and upper extremity trauma center; and</text> </paragraph> <paragraph num="H."> <text>Extramural hospital house staff program agreements for rotation in the hand and upper extremity trauma center.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: August 13, 2007 (34:16 Md. R. 1433)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective July 21, 2025 (52:14 Md. R. 714)</annotation> </annotations> </chapter> <chapter num="15" heading="Freestanding Emergency Medical Facilities"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following term has the meaning indicated.</text> </paragraph> <paragraph num="B."> <text>Term Defined. “Freestanding emergency medical facility” means a facility licensed by the Maryland Department of Health under Health-General Article, §19-3A-02, Annotated Code of Maryland.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Freestanding Emergency Medical Facility."> <paragraph num="A."> <text>Freestanding Emergency Medical Facility. A freestanding emergency medical facility:</text> <paragraph num="(1)"> <text>Shall be licensed under Health-General Article, §19-3A-02, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Shall comply with COMAR 10.07.08;</text> </paragraph> <paragraph num="(3)"> <text>Shall abide by the protocols approved by the EMS Board for the transport by EMS of patients to freestanding emergency departments;</text> </paragraph> <paragraph num="(4)"> <text>Shall abide by the Maryland Emergency Medical Services Interfacility Transfer Guidelines published by MIEMSS;</text> </paragraph> <paragraph num="(5)"> <text>Shall participate in the County Hospital Alert Tracking System (CHATS) program;</text> </paragraph> <paragraph num="(6)"> <text>Shall have radios and the ability to communicate with EMS and base stations;</text> </paragraph> <paragraph num="(7)"> <text>Shall advise MIEMSS immediately of any change in status regarding the freestanding emergency department; and</text> </paragraph> <paragraph num="(8)"> <text>Shall participate in data collection and quality management as required in COMAR 30.08.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>MIEMSS shall designate a freestanding emergency medical facility that meets these requirements in accordance with COMAR 30.08.02.</text> </paragraph> <paragraph num="C."> <text>Notwithstanding COMAR 30.08.02.06, MIEMSS may designate a freestanding emergency medical facility licensed by the Maryland Department of Health under Health-General Article, §19-3A-02, Annotated Code of Maryland, without conducting an on-site review.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Determination of Adequacy and Appropriateness of Emergency Care Delivery Associated with Conversion of a Hospital to a Freestanding Medical Facility."> <paragraph num="A."> <text>The EMS Board shall consider the following factors in determining whether the conversion of a general hospital to a freestanding medical facility under COMAR 10.24.19.04C will maintain adequate and appropriate delivery of emergency care within the Statewide emergency medical services system:</text> <paragraph num="(1)"> <text>The EMS resources in the jurisdictions affected by the proposed hospital conversion, including staffing, equipment, and units;</text> </paragraph> <paragraph num="(2)"> <text>Any additional resources which will be provided by the hospital seeking to convert to augment the resources available in the affected jurisdiction.</text> </paragraph> <paragraph num="(3)"> <text>The EMS call volume of affected jurisdictions by priority;</text> </paragraph> <paragraph num="(4)"> <text>The projected number of patients who could require transport to a general acute hospital rather than the proposed freestanding medical facility for appropriate medical care;</text> </paragraph> <paragraph num="(5)"> <text>EMS transport times in the jurisdictions affected by the proposed hospital conversion and the potential for extended transport and out-of-service times resulting from the proposed conversion to a freestanding medical facility, relative to the current pattern of transport times;</text> </paragraph> <paragraph num="(6)"> <text>Commercial ambulance services availability and response times in the jurisdictions affected by the proposed hospital conversion;</text> </paragraph> <paragraph num="(7)"> <text>The number of general hospitals likely to be affected by the proposed hospital conversion and the distance to the closest general hospital ED for appropriate patients if the hospital converts to a freestanding medical facility relative to current patterns of hospital use;</text> </paragraph> <paragraph num="(8)"> <text>The expected additional ED visit volume and associated increases in admission and observation patient volumes for the general hospitals likely to be affected by the proposed hospital conversion;</text> </paragraph> <paragraph num="(9)"> <text>Recent diversion utilization at the converting hospital and other general hospitals likely to be affected by the proposed hospital conversion and the potential impact of the proposed conversion on diversion utilization;</text> </paragraph> <paragraph num="(10)"> <text>The size, scope, configuration, services, and staffing of the proposed project; and</text> </paragraph> <paragraph num="(11)"> <text>Reasonable changes in the EMS system that are planned or can be made to maintain adequate and appropriate delivery of emergency care within the Statewide emergency medical services system if the hospital converts to a freestanding medical facility.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A general hospital seeking an exemption from a certificate of need to convert to a freestanding medical facility shall:</text> <paragraph num="(1)"> <text>Notify MIEMSS in writing of its intent to seek an exemption at least 14 days prior to a public informational hearing required by the Maryland Health Care Commission;</text> </paragraph> <paragraph num="(2)"> <text>Notify and seek input from EMS providers in jurisdictions affected by the proposed conversion at least 14 days prior to a public informational hearing required by the Maryland Health Care Commission, by publishing a physical address and email address on its website for receipt of comments;</text> </paragraph> <paragraph num="(3)"> <text>Provide to MIEMSS the information required in COMAR 10.24.19C(8)(a),(b), (d), (e),(i), and (j) to MIEMSS within 7 days of the public informational hearing required by Maryland Health Care Commission regulations; and</text> </paragraph> <paragraph num="(4)"> <text>Submit all notices and information required pursuant to COMAR 10.24.19.04(C) simultaneously to both the Maryland Health Care Commission and MIEMSS.</text> </paragraph> </paragraph> <paragraph num="C."> <text>MIEMSS will continue to accept direct input from stakeholders for a period of 10 business days following the public informational hearing. MIEMSS will provide any direct input from stakeholders to the hospital proposing the conversion and allow the hospital 5 business days to respond.</text> </paragraph> <paragraph num="D."> <text>The EMS Board will issue the determination concerning the proposed hospital conversion under §A of this regulation within 45 days of the required public informational hearing held by the hospital proposing the conversion, in consultation with the Maryland Health Care Commission.</text> </paragraph> <paragraph num="E."> <text>MIEMSS will provide a copy of any determination issued by the EMS Board under this regulation to the Maryland Health Care Commission upon its issuance.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509; Health-General Article, §19-120(o)(3); Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 5, 2008 (35:9 Md. R. 900)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective December 12, 2013 (40:24 Md. R. 2018)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 adopted effective July 31, 2017 (44:15 Md. R. 761)</annotation> </annotations> </chapter> <chapter num="16" heading="Cardiac Interventional Center Standards"> <regulation prefix="Regulation" num=".01" heading="Definitions."> <paragraph num="A."> <text>In this chapter, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Cardiac Interventional Center” means:</text> <paragraph num="(a)"> <text>An in-State hospital that meets the requirements in Regulation .02 of this chapter and is designated by MIEMSS and approved by the EMS Board to receive patients transported by ambulance with acute ST-segment elevation myocardial infarction (STEMI) who need Primary Percutaneous Coronary Intervention; or</text> </paragraph> <paragraph num="(b)"> <text>An out-of-State hospital that has entered into an agreement with MIEMSS and has been approved by the EMS Board to receive patients with acute ST-segment elevation myocardial infarction who need Primary Percutaneous Coronary Intervention.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>“Jurisdiction” means a state, commonwealth, or the District of Columbia.</text> </paragraph> <paragraph num="(3)"> <text>“Percutaneous coronary intervention (PCI)” means a variety of catheter-based techniques, including balloon angioplasty, capable of relieving coronary vessel narrowing.</text> </paragraph> <paragraph num="(4)"> <text>“Primary PCI” means PCI capable of relieving coronary vessel narrowing associated with acute ST-segment elevation myocardial infarction (STEMI).</text> </paragraph> <paragraph num="(5)"> <text>“STEMI” means coronary vessel narrowing associated with ST-segment elevation myocardial infarction.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Cardiac Interventional Center."> <paragraph num="A."> <text>A Cardiac Interventional Center shall be licensed as an acute care hospital by the hospital licensing authority in the jurisdiction in which it is located.</text> </paragraph> <paragraph num="B."> <text>If located in Maryland, a Cardiac Interventional Center shall:</text> <paragraph num="(1)"> <text>Have one of the following:</text> <paragraph num="(a)"> <text>A Certificate of Need (CON) issued by the Maryland Health Care Commission for a cardiac surgery and percutaneous coronary intervention (PCI) program; or</text> </paragraph> <paragraph num="(b)"> <text>A current waiver issued by the Maryland Health Care Commission to provide primary percutaneous coronary intervention (PCI) services to STEMI patients meeting certain criteria without on-site cardiac surgery; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Be a base station approved under COMAR 30.03.06.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If not located in Maryland, a Cardiac Interventional Center shall:</text> <paragraph num="(1)"> <text>Possess all government approvals required to provide Primary PCI under the laws of the jurisdiction in which it is located including, if required, a CON; and</text> </paragraph> <paragraph num="(2)"> <text>Satisfy one of the following:</text> <paragraph num="(a)"> <text>Be a base station approved under COMAR 30.03.06; or</text> </paragraph> <paragraph num="(b)"> <text>Have the equipment necessary to conduct a dual consult between EMS and a Maryland base station for each Maryland patient transported to the Cardiac Interventional Center.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A Cardiac Interventional Center shall:</text> <paragraph num="(1)"> <text>Provide primary PCI as soon as possible and not to exceed 90 minutes from patient arrival, that is, door to balloon time of less than 90 minutes, for 75% of appropriate STEMI patients;</text> </paragraph> <paragraph num="(2)"> <text>Provide primary PCI for appropriate STEMI patients 24 hours per day, 7 day per week;</text> </paragraph> <paragraph num="(3)"> <text>Have adequate physician, nursing, and technical staff to provide cardiac catheterization and coronary care unit services 24 hours per day, 7 days per week;</text> </paragraph> <paragraph num="(4)"> <text>Have a single call access system for receiving patients with STEMI;</text> </paragraph> <paragraph num="(5)"> <text>Participate in the County Hospital Alert Tracking System (CHATS) program;</text> </paragraph> <paragraph num="(6)"> <text>Abide by the Maryland Emergency Medical Services Inter-Hospital Transfer Guidelines published by MIEMSS in addition to any applicable transfer requirements in COMAR 10.24.17;</text> </paragraph> <paragraph num="(7)"> <text>Communicate as soon as possible with the STEMI patient's primary physician and cardiologist regarding patient outcome;</text> </paragraph> <paragraph num="(8)"> <text>Establish a Cardiac Interventional Center medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which:</text> <paragraph num="(a)"> <text>Meets at least three times a year;</text> </paragraph> <paragraph num="(b)"> <text>Reviews practice patterns; and</text> </paragraph> <paragraph num="(c)"> <text>Modifies practice patterns as appropriate; and</text> </paragraph> </paragraph> <paragraph num="(9)"> <text>Comply with the requirements of COMAR 30.08.04, including participating in:</text> <paragraph num="(a)"> <text>A Cardiovascular Data registry jointly approved by MHCC and MIEMSS, including any registry data reporting requirements established by either MIEMSS or MHCC; and</text> </paragraph> <paragraph num="(b)"> <text>State specialty care quality management activities of MIEMSS or of MHCC that are approved by MIEMSS.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Catheterization Lab."> <text>A Cardiac Interventional Center may receive STEMI patients transported by ambulance directly to the catheterization lab when approved by the base station physician if the catheterization lab has a physician, appropriately credentialed to evaluate and stabilize an acute cardiac patient, a registered nurse, and a technician, capable of activating the catheterization lab, immediately available in house when:</text> <paragraph num="A."> <text>The 12 lead EKG in the field is interpreted by an advanced life support EMS provider as a high probability of a STEMI; or</text> </paragraph> <paragraph num="B."> <text>The 12 lead EKG in the field has been reviewed by an ED physician, a cardiologist, or both, and determined to be a STEMI.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Site Reviews."> <paragraph num="A."> <text>Notwithstanding COMAR 30.08.02.06, MIEMSS may designate any Cardiac Interventional Center without a site review.</text> </paragraph> <paragraph num="B."> <text>Notwithstanding §A of this regulation, MIEMSS staff may conduct an onsite review to verify compliance with this chapter, including:</text> <paragraph num="(1)"> <text>Inspecting the hospital's physical plant;</text> </paragraph> <paragraph num="(2)"> <text>Interviewing team members and management personnel;</text> </paragraph> <paragraph num="(3)"> <text>Examining the hospital's Cardiac Interventional Center related documents, including patient care records; and</text> </paragraph> <paragraph num="(4)"> <text>Reviewing other materials considered appropriate by MIEMSS.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The Maryland Health Care Commission staff may participate in any review conducted by MIEMSS to verify compliance with COMAR 30.08.15, including reviewing application materials, and participating in any on-site review.</text> </paragraph> <paragraph num="D."> <text>MIEMSS staff may participate in any review conducted by the Maryland Health Care Commission to verify compliance with COMAR 10.24.17, including reviewing application materials, and participating in any on-site visits.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: May 3, 2010 (37:9 Md. R. 674)</annotation> </annotations> </chapter> <chapter num="17" heading="Comprehensive Stroke Center Standards"> <regulation prefix="Regulation" num=".01" heading="Designated Comprehensive Stroke Center."> <text>In addition to meeting the requirements of COMAR 30.08.11.01, a designated comprehensive stroke center hospital shall:</text> <paragraph num="A."> <text>Be designated by MIEMSS as a primary stroke center at the time of application for designation as a comprehensive stroke center;</text> </paragraph> <paragraph num="B."> <text>Continue to meet the primary stroke center requirements in COMAR 30.08.11 to the extent such requirements are consistent with designation as a comprehensive stroke center;</text> </paragraph> <paragraph num="C."> <text>Act as a resource center for other facilities in its region or state;</text> </paragraph> <paragraph num="D."> <text>Annually care for at least 20 Subarachnoid Hemorrhage by aneurysm patients per year;</text> </paragraph> <paragraph num="E."> <text>Annually perform a combined total of 15 endovascular coiling and surgical clippings per year for aneurysm;</text> </paragraph> <paragraph num="F."> <text>Annually administer fibrinolytics to 25 eligible patients per year or 50 eligible patients over 2 years:</text> <paragraph num="(1)"> <text>IV fibrinolytic ordered and monitored via telemedicine at another hospital is acceptable; and</text> </paragraph> <paragraph num="(2)"> <text>IV fibrinolytic administered at an outside hospital and transferred to CSC site is acceptable;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Satisfy the MIEMSS requirements for designation as a comprehensive stroke center by MIEMSS; and</text> </paragraph> <paragraph num="H."> <text>Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either:</text> <paragraph num="(1)"> <text>An on-site review by MIEMSS; or</text> </paragraph> <paragraph num="(2)"> <text>A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a comprehensive stroke center if the hospital:</text> <paragraph num="(a)"> <text>Authorized The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission's certification of the hospital as a comprehensive stroke center;</text> </paragraph> <paragraph num="(b)"> <text>Allows MIEMSS to participate in the accreditation site survey; and</text> </paragraph> <paragraph num="(c)"> <text>Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Organization."> <text>The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.02.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Emergency Department."> <text>The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.03.</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Neuroscience Intensive Care Unit."> <text>The designated comprehensive stroke center shall maintain a dedicated neuroscience intensive care unit that meets the requirements of this regulation and:</text> <paragraph num="A."> <text>Has designated beds for the care of acute stroke patients;</text> </paragraph> <paragraph num="B."> <text>Has 24/7 on-site practitioners with neurovascular training, including, for example, APNs, PAs, neuro-intensivists, fellows, or residents;</text> </paragraph> <paragraph num="C."> <text>Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulations .12—.15 of this chapter;</text> </paragraph> <paragraph num="D."> <text>Follows standardized processes derived from evidence-based practice clinical practice guidelines to facilitate clinical care;</text> </paragraph> <paragraph num="E."> <text>Incorporates individualized plans of care that are based on the patient’s assessed needs and reflect coordination of care with other programs, as determined by patient comorbidities;</text> </paragraph> <paragraph num="F."> <text>Has a process to assess the abilities and resources of family members to be involved in post-acute care; and</text> </paragraph> <paragraph num="G."> <text>Maintains written documentation delineating the function of the neuroscience intensive care unit, including:</text> <paragraph num="(1)"> <text>Admission criteria;</text> </paragraph> <paragraph num="(2)"> <text>Discharge criteria;</text> </paragraph> <paragraph num="(3)"> <text>Acute stroke care protocols;</text> </paragraph> <paragraph num="(4)"> <text>Interdisciplinary rounding;</text> </paragraph> <paragraph num="(5)"> <text>Rehabilitation assessment and services in the hospital; and</text> </paragraph> <paragraph num="(6)"> <text>Outcome data.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Stroke Unit."> <text>In addition to meeting the requirements of COMAR 30.08.11.07, the designated comprehensive stroke center shall:</text> <paragraph num="A."> <text>Have sufficient personnel available to respond to health care personnel at other hospitals to provide them with guidance and recommendations about the diagnosis and treatment of stroke and referral to an appropriate facility if transfer is required or requested;</text> </paragraph> <paragraph num="B."> <text>Have written policies or procedures to direct the organized, safe, intra-hospital and inter-hospital transport of stroke patients;</text> </paragraph> <paragraph num="C."> <text>Have priority bed availability for stroke patients with appropriately trained registered nurses in sufficient numbers based on patient acuity; and</text> </paragraph> <paragraph num="D."> <text>Have a written plan for triaging patients from the neuroscience intensive care unit and/or the dedicated this unit to make beds available for other stroke patients when necessary or for provision of alternate critical care beds for stroke patients with appropriately trained registered nurse staff.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Stroke Team."> <paragraph num="A."> <text>In addition to meeting the requirement of COMAR 30.08.11.05, the hospital shall:</text> <paragraph num="(1)"> <text>Establish one or more acute stroke teams which shall respond to the emergency department with coordinated services for the effective delivery of emergency and acute stroke treatment;</text> </paragraph> <paragraph num="(2)"> <text>Use the National Institutes of Health Stroke Scale (NIHSS) for the initial assessment of patients with acute stroke, with clinicians performing an NIHSS having documented training in the completion of the NIHSS; and</text> </paragraph> <paragraph num="(3)"> <text>Perform ongoing neurological assessment on patients with acute stroke.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The acute stroke team shall include at a minimum:</text> <paragraph num="(1)"> <text>A physician, with special competence in caring for the acute stroke patient, who is Board-certified or Board-eligible in:</text> <paragraph num="(a)"> <text>Neurology;</text> </paragraph> <paragraph num="(b)"> <text>Critical care medicine; or</text> </paragraph> <paragraph num="(c)"> <text>Emergency medicine; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least one additional health care provider, with experience in caring for the acute stroke patient, who may be:</text> <paragraph num="(a)"> <text>An emergency physician;</text> </paragraph> <paragraph num="(b)"> <text>A neurology resident or fellow;</text> </paragraph> <paragraph num="(c)"> <text>An internist;</text> </paragraph> <paragraph num="(d)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(e)"> <text>A physician assistant; or</text> </paragraph> <paragraph num="(f)"> <text>A nurse practitioner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>If a physician otherwise satisfies §B(1) of this regulation but is not Board-certified or Board-eligible in neurology, a Board-certified or Board-eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by:</text> <paragraph num="(1)"> <text>Telephone; or</text> </paragraph> <paragraph num="(2)"> <text>Audio/visual communication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Operating Room."> <text>In addition to meeting the requirements of COMAR 30.08.11.04, the hospital shall have:</text> <paragraph num="A."> <text>An attending board certified/board eligible neurosurgeon on call with a 45-minute arrival time to the hospital;</text> </paragraph> <paragraph num="B."> <text>Written procedures demonstrating the ability to care for two complex neurosurgical stroke patients at one time using appropriate clinical staff; and</text> </paragraph> <paragraph num="C."> <text>Written documentation demonstrating on-call and back-up on-call schedules for physicians and staff for 24/7 coverage.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Endovascular Interventional Services."> <text>The hospital shall have:</text> <paragraph num="A."> <text>Interventional services promptly available 24 hours a day with appropriately trained support staff and equipment, including:</text> <paragraph num="(1)"> <text>Intra-arterial reperfusion therapy;</text> </paragraph> <paragraph num="(2)"> <text>Endovascular treatment of vasospasm;</text> </paragraph> <paragraph num="(3)"> <text>Endovascular ablation of arterial venous malformations;</text> </paragraph> <paragraph num="(4)"> <text>Stenting/angioplasty of extracranial vessels; and</text> </paragraph> <paragraph num="(5)"> <text>Stenting/angioplasty of intracranial vessels;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A neurointerventionalist who may be a board-certified/board-eligible neuroradiologist, neurologist, or neurosurgeon on call with a 45-minute arrival time to the hospital;</text> </paragraph> <paragraph num="C."> <text>An on-call schedule for primary and back-up neurointerventionalists or neuroradiologists;</text> </paragraph> <paragraph num="D."> <text>A written protocol to accept the inter-facility transfer of acute ischemic stroke patients requiring endovascular therapy that includes communication and feedback to the sending facility; and</text> </paragraph> <paragraph num="E."> <text>A written protocol to accept the inter-facility transfer of acute stroke patients requiring a higher level of care.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Neuroimaging Services."> <text>In addition to meeting the requirements of COMAR 30.08.11.09, a designated comprehensive stroke center shall have the following diagnostic capability available when indicated:</text> <paragraph num="A."> <text>Carotid duplex ultrasound;</text> </paragraph> <paragraph num="B."> <text>Transcranial ultrasonography; and</text> </paragraph> <paragraph num="C."> <text>Transesophageal or transthorasic echocardiogram.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Laboratory/Diagnostic Services."> <text>The hospital shall meet the requirements of COMAR 30.08.11.08.</text> </regulation> <regulation prefix="Regulation" num=".11" heading="Qualifications of Stroke Center Director and Clinicians."> <paragraph num="A."> <text>Director.</text> <paragraph num="(1)"> <text>The stroke center medical director shall be a physician with competence in caring for the acute stroke patient and be Board-certified or Board-eligible in:</text> <paragraph num="(a)"> <text>Neurology;</text> </paragraph> <paragraph num="(b)"> <text>Neurosurgery; or</text> </paragraph> <paragraph num="(c)"> <text>Vascular neurology.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The stroke center medical director’s qualifications shall include:</text> <paragraph num="(a)"> <text>Completion of a stroke fellowship or vascular neurosurgery fellowship and obtained vascular neurology certification by the American Board of Psychiatry and Neurology;</text> </paragraph> <paragraph num="(b)"> <text>Active participation in the Stroke Quality Improvement Council (QIC);</text> </paragraph> <paragraph num="(c)"> <text>12 hours of category 1 CME credits related to stroke care annually;</text> </paragraph> <paragraph num="(d)"> <text>Participation in at least one regional, national, or international stroke conference annually;</text> </paragraph> <paragraph num="(e)"> <text>Participation in stroke patient morbidity and mortality reviews; and</text> </paragraph> <paragraph num="(f)"> <text>Participation in stroke research and publication efforts.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Neurologists, Neurosurgeons, NeurInterventionalists, NeuroRadiologisst, NeuroIntensivists, and Vascular Surgeons. Qualifications for neurologists, neurosurgeons, neurointerventionalists, neuroradiologists, vascular surgeons and neurointensivists shall include:</text> <paragraph num="(1)"> <text>Board certification or Board eligibility in their specialty as approved by the American Board of Medical Specialties;</text> </paragraph> <paragraph num="(2)"> <text>Completion of:</text> <paragraph num="(a)"> <text>A fellowship;</text> </paragraph> <paragraph num="(b)"> <text>Demonstrated experience equivalent to completion of a stroke specialty fellowship appropriate to their area of expertise; or</text> </paragraph> <paragraph num="(c)"> <text>Both of these;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>8 or more hours of category 1 or 2 CME credits per year related to stroke care;</text> </paragraph> <paragraph num="(4)"> <text>Participation in stroke patient morbidity and mortality reviews; and</text> </paragraph> <paragraph num="(5)"> <text>Participation in stroke research and publication efforts.</text> </paragraph> </paragraph> <paragraph num="C."> <text>Emergency Physicians. The qualifications of emergency physicians who care for stroke patients shall include:</text> <paragraph num="(1)"> <text>Board certification or Board eligibility in emergency medicine as approved by the American Board of Medical Specialties;</text> </paragraph> <paragraph num="(2)"> <text>Participation in stroke patient morbidity and mortality reviews;</text> </paragraph> <paragraph num="(3)"> <text>4 or more hours of category 1 or 2 CME credits per year related to stroke care; and</text> </paragraph> <paragraph num="(4)"> <text>Participation in stroke research and publication efforts.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Nurse Practitioners. Nurse Practitioners who care for stroke patients shall:</text> <paragraph num="(1)"> <text>Hold a current license with the Maryland State Board of Nursing to practice as a registered nurse;</text> </paragraph> <paragraph num="(2)"> <text>Maintain certification as a nurse practitioner from the American Nurses Credentialing Center or other certification organization as deemed appropriate by the Maryland State Board of Nursing; and</text> </paragraph> <paragraph num="(3)"> <text>Be credentialed through the hospital’s credentialing process.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Physician Assistants. Physician assistants who care for stroke patients shall:</text> <paragraph num="(1)"> <text>Have graduated from a physician assistant educational program accredited by the Accreditation Review Commission on Education for the Physician Assistant or its successor;</text> </paragraph> <paragraph num="(2)"> <text>Maintain current certification by the National Commission on Certification of Physician Assistants;</text> </paragraph> <paragraph num="(3)"> <text>Maintain an approved delegation agreement on file with the Maryland Board of Physicians; and</text> </paragraph> <paragraph num="(4)"> <text>Be credentialed through the hospital credentialing process.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Qualifications of Nurses, Nurse Practitioners, and Physician Assistants in the Neuroscience Intensive Care Unit."> <paragraph num="A."> <text>Clinical nurses, nurse practitioners, and physician assistants providing care to stroke patients in the neuroscience intensive care unit shall be trained in assessment of neurological function and management and treatment of all aspects of neurocritical care, including:</text> <paragraph num="(1)"> <text>Function of ventriculostomy and external ventricular drainage apparatus;</text> </paragraph> <paragraph num="(2)"> <text>Monitoring and treatment of increased intracranial pressure;</text> </paragraph> <paragraph num="(3)"> <text>Care of patients with intracranial hemorrhage and subarachnoid hemorrhage;</text> </paragraph> <paragraph num="(4)"> <text>Care of patients post fibrinolytic therapy;</text> </paragraph> <paragraph num="(5)"> <text>Care of patients post mechanical thrombectomy;</text> </paragraph> <paragraph num="(6)"> <text>Treatment of blood pressure abnormalities with parenteral vasoactive agents;</text> </paragraph> <paragraph num="(7)"> <text>Management of intubated/ventilated patients; and</text> </paragraph> <paragraph num="(8)"> <text>Detailed neurological assessments and scales (i.e., National Institute of Health Stroke Scale and the Glasgow Coma Scale).</text> </paragraph> </paragraph> <paragraph num="B."> <text>Continuing education requirements for nurses, nurse practitioners, and physician assistants who care for the acute stroke patients in the neuroscience intensive care unit shall include at least 5 hours of stroke-specific education annually.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Qualifications of Nurses, Nurse Practitioners, and Physician Assistants in the Emergency Department."> <paragraph num="A."> <text>Emergency department nurses, nurse practitioners, and physician assistants who triage patients in the emergency department or care for acute stroke patients shall be trained in:</text> <paragraph num="(1)"> <text>Assessment of acute stroke;</text> </paragraph> <paragraph num="(2)"> <text>Treatment of acute stroke;</text> </paragraph> <paragraph num="(3)"> <text>Use of clinically appropriate fibrinolytic in acute ischemic stroke and the indication for endovascular therapy in acute ischemic stroke;</text> </paragraph> <paragraph num="(4)"> <text>Mechanical thrombectomy protocols;</text> </paragraph> <paragraph num="(5)"> <text>Treatment of blood pressure abnormalities with parenteral vasoactive agents;</text> </paragraph> <paragraph num="(6)"> <text>Neurological assessments and scales (i.e., National Institute of Health Stroke Scale and the Glasgow Coma Scale);</text> </paragraph> <paragraph num="(7)"> <text>Management of intubated/ventilated patients; and</text> </paragraph> <paragraph num="(8)"> <text>Care of patients post fibrinolytic therapy.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Continuing education requirements for nurses, nurse practitioners, and physician assistants who care for the acute stroke patients in the emergency department shall include at least 5 hours of stroke-specific education annually.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Continuing Medical Education Requirements for Nurses, Nurse Practitioners, and Physician Assistants in the Stroke Unit."> <text>Continuing education requirements for nurses, nurse practitioners and physician assistants who care for the acute stroke patients in the stroke unit shall include a minimum of 5 hours of stroke-specific education annually.</text> </regulation> <regulation prefix="Regulation" num=".15" heading="Prevention/Public Education."> <text>The designated comprehensive stroke center shall meet the requirements of COMAR 30.08.11.12.</text> </regulation> <regulation prefix="Regulation" num=".16" heading="Policies, Protocols, Guidelines, and Agreements."> <text>In addition to meeting the requirements of COMAR 30.08.11.13, the hospital shall:</text> <paragraph num="A."> <text>Have written policies ensuring that:</text> <paragraph num="(1)"> <text>Transfer of patients from another facility is appropriate and patients are received in a timely manner; and</text> </paragraph> <paragraph num="(2)"> <text>All stroke patients receive care commensurate with the hospital’s designation as a comprehensive stroke center;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Have written care protocols for advanced treatment of complex stroke patients, including, but not limited to, acute ischemic stroke patients, acute intra-arterial therapeutic interventions, management of intracranial hemorrhage, and management of subarachnoid hemorrhage;</text> </paragraph> <paragraph num="C."> <text>Have written procedures demonstrating the ability of neurosurgery and interventional radiology to care for two complex stroke patients at one time with appropriate clinicians;</text> </paragraph> <paragraph num="D."> <text>Maintain up-to-date written care protocols for the treatment of acute stroke in:</text> <paragraph num="(1)"> <text>The neuroscience intensive care unit;</text> </paragraph> <paragraph num="(2)"> <text>The stroke unit;</text> </paragraph> <paragraph num="(3)"> <text>The emergency department; and</text> </paragraph> <paragraph num="(4)"> <text>All other locations where stroke care is provided;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Have established mechanisms to serve and act as a resource center for other facilities in their region or state, which shall include:</text> <paragraph num="(1)"> <text>Providing expertise in managing particular cases through the use of telemedicine or other alternative means;</text> </paragraph> <paragraph num="(2)"> <text>Offering guidance for triage of patients;</text> </paragraph> <paragraph num="(3)"> <text>Providing advanced diagnostic, surgical or interventional procedures and treatment to patients initially treated at a non-primary stroke center or a primary stroke center; and</text> </paragraph> <paragraph num="(4)"> <text>Acting as an educational resource for other hospitals and health care professionals; and</text> </paragraph> </paragraph> <paragraph num="F."> <text>Have written policies and or protocols delineating the scope of practice and the roles and responsibilities of nurse practitioners and physician assistants providing care to the acute stroke patient in the neuroscience intensive care unit, the emergency department, and the stroke unit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".17" heading="Quality Management."> <paragraph num="A."> <text>In addition to the requirements of COMAR 30.08.11.14, the hospital shall incorporate into the hospital’s quality assurance process reports about:</text> <paragraph num="(1)"> <text>Specific acute stroke treatment benchmarks; and</text> </paragraph> <paragraph num="(2)"> <text>Stroke treatment quality improvement goals.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The hospital shall establish a multidisciplinary institutional quality assurance/performance improvement committee that meets on a regular basis to:</text> <paragraph num="(1)"> <text>Monitor quality benchmarks;</text> </paragraph> <paragraph num="(2)"> <text>Review complications; and</text> </paragraph> <paragraph num="(3)"> <text>Review and modify practice patterns as appropriate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>In cases where mechanical endovascular reperfusion therapy is appropriate, the hospital shall achieve door-to-device times (arrival to first pass of thrombectomy device) in 50 percent or more of eligible acute ischemic stroke patients within 120 minutes (for direct arriving patients) and within 60 minutes (for inter-facility transfer patients) treated with endovascular therapy.</text> </paragraph> <paragraph num="D."> <text>The hospital shall demonstrate progress towards reducing door-to-device times in 50 percent or more of eligible acute ischemic stroke patients within 90 minutes for direct arriving patients.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".18" heading="Acute Stroke Research."> <text>A hospital shall:</text> <paragraph num="A."> <text>Have an acute stroke research program and acute stroke research plan; and</text> </paragraph> <paragraph num="B."> <text>Demonstrate participation in clinical research trials in acute stroke care.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 17, 2011 (38:21 Md. R. 1280)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective January 1, 2022 (48:22 Md. R. 938)</annotation> </annotations> </chapter> <chapter num="18" heading="Designated Acute Stroke Ready Center"> <regulation prefix="Regulation" num=".01" heading="Designated Acute Stroke Ready Center."> <text>A designated acute stroke ready center shall:</text> <paragraph num="A."> <text>Be licensed as a hospital or freestanding medical center by the licensing authority in the jurisdiction in which it is located;</text> </paragraph> <paragraph num="B."> <text>If a hospital, be accredited by an organization that has been granted deeming authority by the Centers for Medicare & Medicaid Services and approved by the Maryland Department of Health to accredit hospitals in the State;</text> </paragraph> <paragraph num="C."> <text>If located in Maryland, be a base station approved under COMAR 30.03.06;</text> </paragraph> <paragraph num="D."> <text>Provide assessment and management of the stroke patient consistent with the most current AHA/ASA consensus based clinical practice guidelines to meet the needs of the patient;</text> </paragraph> <paragraph num="E."> <text>Have a stroke center medical director;</text> </paragraph> <paragraph num="F."> <text>Have a stroke center nurse coordinator dedicated to the facility;</text> </paragraph> <paragraph num="G."> <text>Have sufficient personnel and resources needed to facilitate healthcare data management and concurrent review of quality metrics and program objectives;</text> </paragraph> <paragraph num="H."> <text>Meet the requirements of Regulations .02—.14 of this chapter;</text> </paragraph> <paragraph num="I."> <text>Satisfy the MIEMSS requirements for designation as an Acute Stroke Ready Center; and</text> </paragraph> <paragraph num="J."> <text>Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either:</text> <paragraph num="(1)"> <text>An on-site review by MIEMSS; or</text> </paragraph> <paragraph num="(2)"> <text>A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as an acute stroke ready center if the facility:</text> <paragraph num="(a)"> <text>Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission’s certification of the hospital as an acute stroke ready center;</text> </paragraph> <paragraph num="(b)"> <text>Allows MIEMSS to participate in the accreditation site survey; and</text> </paragraph> <paragraph num="(c)"> <text>Provides MIEMSS any additional information required to determine it has satisfied the requirements for designation under this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Organization."> <text>The facility’s board of directors, administrators, and medical and nursing staff shall demonstrate commitment to the facility’s designation as an acute stroke ready center by:</text> <paragraph num="A."> <text>A board of directors’ resolution stating that the facility agrees to meet the standards of this chapter for designation as an acute stroke ready center;</text> </paragraph> <paragraph num="B."> <text>An organizational chart showing key stroke center personnel, including the stroke center medical director and the stroke center nurse coordinator and their relationship with the facility;</text> </paragraph> <paragraph num="C."> <text>Establishing mechanisms to guide and assure cooperative relationships with community and professional groups committed to increasing public awareness and improving acute stroke care;</text> </paragraph> <paragraph num="D."> <text>Maintaining documentation of stroke center leadership, including:</text> <paragraph num="(1)"> <text>An appointment letter for the stroke center medical director; and</text> </paragraph> <paragraph num="(2)"> <text>Curricula vitae of key stroke program personnel with training and expertise in cerebrovascular disease, including:</text> <paragraph num="(a)"> <text>Physicians;</text> </paragraph> <paragraph num="(b)"> <text>Stroke center nurse coordinator; and</text> </paragraph> <paragraph num="(c)"> <text>Other key health care personnel; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>Maintaining bylaws, contracts, and budgets specific to acute stroke care, indicating the facility’s commitment to the financial, human, and physical resources necessary to support the facility’s designation as an acute stroke ready center.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Emergency Department."> <text>The facility shall maintain an emergency department which:</text> <paragraph num="A."> <text>Has written documentation on the process used to notify the stroke team of a patient with an acute stroke; and</text> </paragraph> <paragraph num="B."> <text>Has sufficient emergency department clinical staff to meet the requirements of COMAR 30.08.11.05.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Operating Room."> <paragraph num="A."> <text>The facility shall have a written agreement with a hospital which has operating room neurosurgical services available 24 hours a day with appropriately trained support staff.</text> </paragraph> <paragraph num="B."> <text>Neurosurgical coverage shall be documented in a written plan approved by the covering neurosurgeon or neurosurgeons, stroke program leaders, and any involved facilities.</text> </paragraph> <paragraph num="C."> <text>Neurosurgical services shall be available to patients within 2 hours of it being deemed necessary.</text> </paragraph> <paragraph num="D."> <text>There shall be a written protocol for transfer that includes communication and feedback from the receiving facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Stroke Team."> <paragraph num="A."> <text>The facility shall establish one or more acute stroke teams which shall respond to the emergency department with coordinated services for the effective delivery of emergency and acute stroke treatment.</text> </paragraph> <paragraph num="B."> <text>The facility shall have the following present at the patient’s bedside:</text> <paragraph num="(1)"> <text>A member of the emergency department clinical staff shall evaluate each patient with stroke-like symptoms within 10 minutes of the patient’s arrival at the emergency department; and</text> </paragraph> <paragraph num="(2)"> <text>At least one member of the acute stroke team to provide care and to treat an acute stroke patient within 15 minutes of notification.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The National Institutes of Health Stroke Scale (NIHSS) shall be used for the initial and serial assessment of patients with acute stroke. Clinicians performing the NIHSS will have documented training in the completion of the NIHSS.</text> </paragraph> <paragraph num="D."> <text>The acute stroke team shall include at a minimum:</text> <paragraph num="(1)"> <text>A physician with special competence in caring for the acute stroke patient who is Board certified or Board eligible in:</text> <paragraph num="(a)"> <text>Neurology;</text> </paragraph> <paragraph num="(b)"> <text>Emergency medicine;</text> </paragraph> <paragraph num="(c)"> <text>Family medicine; or</text> </paragraph> <paragraph num="(d)"> <text>Internal medicine; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least one additional health care clinician with experience in caring for the acute stroke patient who may be:</text> <paragraph num="(a)"> <text>A family medicine physician;</text> </paragraph> <paragraph num="(b)"> <text>An internist;</text> </paragraph> <paragraph num="(c)"> <text>An emergency physician;</text> </paragraph> <paragraph num="(d)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(e)"> <text>A physician assistant; or</text> </paragraph> <paragraph num="(f)"> <text>A nurse practitioner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>If the physician who satisfies §C(1) of this regulation is not Board certified or Board eligible in neurology, a Board certified or Board eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by:</text> <paragraph num="(1)"> <text>Telephone; or</text> </paragraph> <paragraph num="(2)"> <text>Audio/visual communication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Transfer of Acute Stroke Patient."> <text>The facility shall:</text> <paragraph num="A."> <text>Transfer the clinically appropriate acute stroke patient after initial treatment and stabilization to the appropriate MIEMSS designated primary stroke center, primary stroke center with endovascular capability, or comprehensive stroke center; and</text> </paragraph> <paragraph num="B."> <text>Maintain an agreement or agreements with a commercial ambulance service to:</text> <paragraph num="(1)"> <text>Transfer stroke patients as clinically necessary;</text> </paragraph> <paragraph num="(2)"> <text>Ensure the appropriate delivery of care during transport; and</text> </paragraph> <paragraph num="(3)"> <text>Limit utilization of local emergency medical services (EMS) resources unless by pre-existing agreement.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Stroke Unit."> <text>The facility shall:</text> <paragraph num="A."> <text>If an acute care hospital, maintain a stroke unit that meets the requirements of this regulation which:</text> <paragraph num="(1)"> <text>Has designated beds for the care of patients not eligible for fibrinolytic therapy or endovascular therapy through qualified clinical staff who meet the requirements in Regulation .10 of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Develops a standardized process originating in clinical practice guidelines or evidence-based practice to deliver or facilitate the delivery of clinical care;</text> </paragraph> <paragraph num="(3)"> <text>Develops an individualized plan of care that is based on the patient’s assessed needs and reflects coordination of care with other programs, as determined by patient comorbidities; and</text> </paragraph> <paragraph num="(4)"> <text>Maintains written documentation delineating the function of the stroke unit including:</text> <paragraph num="(a)"> <text>Admission criteria;</text> </paragraph> <paragraph num="(b)"> <text>Discharge criteria;</text> </paragraph> <paragraph num="(c)"> <text>Stroke care protocols;</text> </paragraph> <paragraph num="(d)"> <text>Patient census;</text> </paragraph> <paragraph num="(e)"> <text>Rehabilitation in the hospital;</text> </paragraph> <paragraph num="(f)"> <text>Rehabilitation after discharge; and</text> </paragraph> <paragraph num="(g)"> <text>Outcomes data; or</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If not an acute care hospital, have a written transfer agreement with a hospital which:</text> <paragraph num="(1)"> <text>Meets the requirements of this chapter;</text> </paragraph> <paragraph num="(2)"> <text>Has an inpatient stroke unit that meets the requirements of this regulation; and</text> </paragraph> <paragraph num="(3)"> <text>Can admit the patient after initial treatment and stabilization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Laboratory/Diagnostic Services."> <text>The facility shall have the ability 24 hours a day to perform laboratory and diagnostic services within 45 minutes of written order, including but not limited to:</text> <paragraph num="A."> <text>Complete blood count;</text> </paragraph> <paragraph num="B."> <text>Blood chemistries;</text> </paragraph> <paragraph num="C."> <text>Coagulation studies;</text> </paragraph> <paragraph num="D."> <text>Troponin;</text> </paragraph> <paragraph num="E."> <text>Electrocardiograms; and</text> </paragraph> <paragraph num="F."> <text>Chest radiographs.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Neuroimaging Services."> <paragraph num="A."> <text>The facility shall have the ability 24 hours a day within 20 minutes of the patient’s arrival to complete:</text> <paragraph num="(1)"> <text>All of the following:</text> <paragraph num="(a)"> <text>Brain computed tomography;</text> </paragraph> <paragraph num="(b)"> <text>CT Angiography; and</text> </paragraph> <paragraph num="(c)"> <text>CT Perfusion; or</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Magnetic resonance imaging.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall have the ability 24 hours a day to have computed tomographic studies interpreted within 20 minutes of their completion by a physician experienced in interpreting computed tomographic studies.</text> </paragraph> <paragraph num="C."> <text>The facility shall have the ability 24 hours a day to have CT angiography, CT perfusion, and magnetic resonance imaging studies interpreted within 30 minutes of their completion by a physician experienced in interpreting CT angiography, CT perfusion, and magnetic resonance imaging studies.</text> </paragraph> <paragraph num="D."> <text>The acute stroke ready center shall:</text> <paragraph num="(1)"> <text>Have the ability to upload emergent imaging scans into CRISP (Chesapeake Regional Information System for our Patients) which will facilitate sharing of emergent imaging with the receiving center; and</text> </paragraph> <paragraph num="(2)"> <text>Have the imaging ability to rapidly identify core (nonviable) infarct versus (potentially salvageable) penumbra.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Qualifications of Stroke Center Director and Clinicians."> <paragraph num="A."> <text>The stroke center medical director shall be a physician with special competence in caring for the acute stroke patient who is clinically active at the facility and is Board certified or Board eligible in:</text> <paragraph num="(1)"> <text>Neurology;</text> </paragraph> <paragraph num="(2)"> <text>Internal medicine; or</text> </paragraph> <paragraph num="(3)"> <text>Emergency medicine.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The stroke center medical director’s qualifications shall include active participation in the Stroke Quality Improvement Council (QIC) and 8 or more hours of category 1 CME credits related to stroke care annually.</text> </paragraph> <paragraph num="C."> <text>Qualifications for stroke center physicians who care for stroke patients shall include 4 or more hours of category 1 or 2 CME credits per year related to stroke care.</text> </paragraph> <paragraph num="D."> <text>Training for nonphysician stroke center professional staff who care for acute stroke patients shall include 4 or more hours of continuing medical education per year in the area of cerebrovascular disease.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Qualifications of Emergency Department Clinical Staff."> <paragraph num="A."> <text>Emergency department clinical staff shall participate in cerebrovascular disease educational activities at least two times a year if they:</text> <paragraph num="(1)"> <text>Triage patients in the emergency department; or</text> </paragraph> <paragraph num="(2)"> <text>Care for acute stroke patients.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Emergency department clinical staff who triage patients in the emergency department or care for acute stroke patients shall be trained in:</text> <paragraph num="(1)"> <text>Diagnosis of acute stroke;</text> </paragraph> <paragraph num="(2)"> <text>Treatment of acute stroke; and</text> </paragraph> <paragraph num="(3)"> <text>Use of clinically appropriate fibrinolytics and educated on the indication and referral for endovascular therapy in acute ischemic stroke.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Prevention/Public Education."> <paragraph num="A."> <text>Surviving stroke patients and their families shall receive instruction on:</text> <paragraph num="(1)"> <text>Signs and symptoms of acute stroke, including the importance of activating EMS;</text> </paragraph> <paragraph num="(2)"> <text>Effects and prognosis of acute stroke;</text> </paragraph> <paragraph num="(3)"> <text>Potential complications of acute stroke;</text> </paragraph> <paragraph num="(4)"> <text>Needs and rationales for treatment;</text> </paragraph> <paragraph num="(5)"> <text>Patient compliance instructions for risk reduction of individual risk factors and secondary prevention programs; and</text> </paragraph> <paragraph num="(6)"> <text>Post-stroke support services.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The facility shall support or participate in, or both support and participate in, acute stroke educational activities developed for EMS personnel which are conducted at least once a year.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Policies, Protocols, Guidelines, and Agreements."> <text>The facility shall develop and implement:</text> <paragraph num="A."> <text>A written policy which demonstrates that the facility has established the acute stroke ready center to:</text> <paragraph num="(1)"> <text>Monitor the care delivered to acute stroke patients;</text> </paragraph> <paragraph num="(2)"> <text>Improve the quality of care delivered to acute stroke patients;</text> </paragraph> <paragraph num="(3)"> <text>Move patients through the initial acute care phase of their hospital stay in a timely fashion; and</text> </paragraph> <paragraph num="(4)"> <text>Ensure that all stroke patients will receive medical care commensurate with the hospital designation as an acute stroke ready center;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Written procedures for rapidly activating the stroke team to care for potentially eligible fibrinolytic and endovascular candidates within 15 minutes of notification;</text> </paragraph> <paragraph num="C."> <text>Written care protocols for the treatment of acute stroke which address:</text> <paragraph num="(1)"> <text>Evaluation of each patient by a member of the emergency department clinical staff within 10 minutes of the patient’s arrival at the hospital emergency department;</text> </paragraph> <paragraph num="(2)"> <text>At least one member of the stroke team arriving at the acute stroke patient’s bedside within 15 minutes of notification;</text> </paragraph> <paragraph num="(3)"> <text>Ischemic stroke;</text> </paragraph> <paragraph num="(4)"> <text>Hemorrhagic stroke;</text> </paragraph> <paragraph num="(5)"> <text>Stabilization of vital functions;</text> </paragraph> <paragraph num="(6)"> <text>Initial diagnostic tests;</text> </paragraph> <paragraph num="(7)"> <text>The use of medications including fibrinolytics;</text> </paragraph> <paragraph num="(8)"> <text>Care of the potential endovascular candidate; and</text> </paragraph> <paragraph num="(9)"> <text>Timely and safe patient transfer within 2 hours or less of emergency department arrival or when medically stable;</text> </paragraph> </paragraph> <paragraph num="D."> <text>A current agreement with a transport service to meet the timeline in §C(9) of this regulation; and</text> </paragraph> <paragraph num="E."> <text>A written protocol for transfer that includes communication and feedback from the receiving facility, which is:</text> <paragraph num="(1)"> <text>Updated at least annually; and</text> </paragraph> <paragraph num="(2)"> <text>Maintained up-to-date in:</text> <paragraph num="(a)"> <text>The emergency department; and</text> </paragraph> <paragraph num="(b)"> <text>All other locations where stroke care is provided.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".14" heading="Quality Management."> <text>The facility shall:</text> <paragraph num="A."> <text>Participate, in a manner approved by the EMS Board, in a stroke registry that includes the data elements tracked by the Centers for Medicare and Medicaid Services and the American Heart/American Stroke Get With the Guidelines®-Stroke Registry;</text> </paragraph> <paragraph num="B."> <text>Have participated in the stroke registry and maintained a stroke log for a minimum of 6 months prior to time of requesting an application;</text> </paragraph> <paragraph num="C."> <text>Demonstrate ongoing participation in the stroke registry;</text> </paragraph> <paragraph num="D."> <text>Authorize the stroke registry to provide the hospital data to MIEMSS for health oversight activities in a manner approved by the EMS Board;</text> </paragraph> <paragraph num="E."> <text>Establish at least two outcome objectives that:</text> <paragraph num="(1)"> <text>Are time-specific;</text> </paragraph> <paragraph num="(2)"> <text>Are measurable;</text> </paragraph> <paragraph num="(3)"> <text>Reflect tracking and trending of performance measures and indicators; and</text> </paragraph> <paragraph num="(4)"> <text>Are reviewed in annual comparison studies;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Maintain a stroke log which includes at a minimum the following information for each entry:</text> <paragraph num="(1)"> <text>The number of times the stroke team was activated;</text> </paragraph> <paragraph num="(2)"> <text>The stroke team’s response time to the acute stroke patient;</text> </paragraph> <paragraph num="(3)"> <text>The on-call neurologist’s response time for consultation to the acute stroke patient;</text> </paragraph> <paragraph num="(4)"> <text>The type or types of diagnostic tests and acute treatment utilized;</text> </paragraph> <paragraph num="(5)"> <text>The patient’s diagnosis;</text> </paragraph> <paragraph num="(6)"> <text>Door to IV fibrinolytic time;</text> </paragraph> <paragraph num="(7)"> <text>Patient complications;</text> </paragraph> <paragraph num="(8)"> <text>Arrival and departure/transfer times; and</text> </paragraph> <paragraph num="(9)"> <text>Disposition of the patient;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Monitor its IV fibrinolytic complications, which includes symptomatic intracerebral hemorrhage and serious life-threatening systemic bleeding;</text> </paragraph> <paragraph num="H."> <text>Establish at least one stroke center quality assurance medical review committee which shall be a medical review committee under Health Occupations Article, §1-401, Annotated Code of Maryland, as a committee established in the Maryland Institute for Emergency Medical Services Systems which, at least three times a year:</text> <paragraph num="(1)"> <text>Meets;</text> </paragraph> <paragraph num="(2)"> <text>Reviews practice patterns; and</text> </paragraph> <paragraph num="(3)"> <text>Modifies practice patterns as appropriate;</text> </paragraph> </paragraph> <paragraph num="I."> <text>In cases where the administration of fibrinolytics is appropriate:</text> <paragraph num="(1)"> <text>Administer the fibrinolytic within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 50 percent of eligible patients;</text> </paragraph> <paragraph num="(2)"> <text>Demonstrate progress towards administering fibrinolytics within 60 minutes from the time the patient arrives at the emergency department for greater than or equal to 75 percent of eligible patients; and</text> </paragraph> <paragraph num="(3)"> <text>Demonstrate progress towards reducing time of administration of fibrinolytics to 45 minutes for greater than or equal to 50 percent of eligible patients;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Incorporate into their quality assurance process progress reports about:</text> <paragraph num="(1)"> <text>Specific acute stroke treatment benchmarks;</text> </paragraph> <paragraph num="(2)"> <text>Outcomes data on patients transferred for a higher level of care; and</text> </paragraph> <paragraph num="(3)"> <text>Stroke treatment quality improvement goals; and</text> </paragraph> </paragraph> <paragraph num="K."> <text>Provide MIEMSS with documentation of quality management of the stroke program for review, including, if appropriate:</text> <paragraph num="(1)"> <text>Problem identification;</text> </paragraph> <paragraph num="(2)"> <text>Problem analysis;</text> </paragraph> <paragraph num="(3)"> <text>An action plan;</text> </paragraph> <paragraph num="(4)"> <text>Implementation of the plan; and</text> </paragraph> <paragraph num="(5)"> <text>Re-evaluation of the plan.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: July 1, 2021 (48:9 Md. R. 360)</annotation> <annotation type="History" subtype="Administrative History">Regulation effective July 21, 2025 (52:14 Md. R. 714)</annotation> </annotations> </chapter> <chapter num="19" heading="Designated Thrombectomy-Capable Primary Stroke Center Standards"> <regulation prefix="Regulation" num=".01" heading="Designated Thrombectomy-Capable Primary Stroke Center."> <text>In addition to meeting the requirements of COMAR 30.08.11, a designated thrombectomy-capable primary stroke center hospital shall:</text> <paragraph num="A."> <text>Be designated by MIEMSS as a primary stroke center at the time of application for designation as a thrombectomy-capable primary stroke center;</text> </paragraph> <paragraph num="B."> <text>Continue to meet the primary stroke center requirements in COMAR 30.08.11 to the extent such requirements are consistent with designation as a thrombectomy-capable primary stroke center;</text> </paragraph> <paragraph num="C."> <text>Require each physician who performs mechanical thrombectomy to have performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months, which may include procedures performed at other facilities;</text> </paragraph> <paragraph num="D."> <text>Perform mechanical thrombectomy and have provided post-procedure care for a minimum of 15 patients in the past 12 months or at least 30 patients over the past 24 months;</text> </paragraph> <paragraph num="E."> <text>Meet the requirements of Regulations .01—.15 of this chapter;</text> </paragraph> <paragraph num="F."> <text>Satisfy the MIEMSS requirements for designation as a thrombectomy-capable primary stroke center by MIEMSS; and</text> </paragraph> <paragraph num="G."> <text>Meet the requirements for a site review in COMAR 30.08.02.06, which may be satisfied by completing either:</text> <paragraph num="(1)"> <text>An on-site review by MIEMSS; or</text> </paragraph> <paragraph num="(2)"> <text>A site survey as part of The Joint Commission Disease Specific Care Certification Program for certification as a thrombectomy-capable primary stroke center if the hospital:</text> <paragraph num="(a)"> <text>Authorizes The Joint Commission to provide MIEMSS with survey findings, certification reports, and other information related to The Joint Commission’s certification of the hospital as a thrombectomy-capable primary stroke center;</text> </paragraph> <paragraph num="(b)"> <text>Allows MIEMSS to participate in the accreditation site survey; and</text> </paragraph> <paragraph num="(c)"> <text>Provides MIEMSS any additional information required to determine that the hospital has satisfied the requirements for designation under this chapter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".02" heading="Organization."> <text>A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.02.</text> </regulation> <regulation prefix="Regulation" num=".03" heading="Emergency Department."> <text>The emergency department of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.03</text> </regulation> <regulation prefix="Regulation" num=".04" heading="Operating Room."> <text>The operating room of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.04</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Stroke Team."> <paragraph num="A."> <text>In addition to meeting the requirements of COMAR 30.08.11.05, the acute stroke team shall include at a minimum:</text> <paragraph num="(1)"> <text>A physician, with special competence in caring for an acute stroke patient, who is Board-certified or Board-eligible in:</text> <paragraph num="(a)"> <text>Neurology;</text> </paragraph> <paragraph num="(b)"> <text>Critical care medicine;</text> </paragraph> <paragraph num="(c)"> <text>Emergency medicine; or</text> </paragraph> <paragraph num="(d)"> <text>Internal medicine; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>At least one additional health care provider, with experience in caring for the acute stroke patient, who may be:</text> <paragraph num="(a)"> <text>An emergency physician;</text> </paragraph> <paragraph num="(b)"> <text>An internal medicine physician;</text> </paragraph> <paragraph num="(c)"> <text>A neurology resident or fellow;</text> </paragraph> <paragraph num="(d)"> <text>A registered nurse;</text> </paragraph> <paragraph num="(e)"> <text>A physician’s assistant; or</text> </paragraph> <paragraph num="(f)"> <text>A nurse practitioner.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>If a physician otherwise satisfies §A(1) of this regulation but is not Board-certified or Board-eligible in neurology, a Board-certified or Board-eligible neurologist shall be available within 15 minutes for consultation under the terms of a written agreement by:</text> <paragraph num="(1)"> <text>Telephone; or</text> </paragraph> <paragraph num="(2)"> <text>Audio/visual communication.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Intensive Care Unit."> <text>A hospital designated as a thrombectomy-capable primary stroke center shall maintain an intensive care unit that:</text> <paragraph num="A."> <text>Has designated beds for the care of the acute stroke patient;</text> </paragraph> <paragraph num="B."> <text>Has 24/7 on-site practitioners with critical care privileges, including, for example, APNs, PAs, fellows, or residents;</text> </paragraph> <paragraph num="C."> <text>Provides care to acute stroke patients through qualified clinical staff who meet the requirements in Regulation .11 of this chapter;</text> </paragraph> <paragraph num="D."> <text>Follows standardized processes derived from evidence-based clinical practice guidelines to facilitate clinical care;</text> </paragraph> <paragraph num="E."> <text>Incorporates individualized plans of care that are based on the patient’s assessed needs and reflect coordination of care with other programs, as determined by patient comorbidities;</text> </paragraph> <paragraph num="F."> <text>Has a process to assess the abilities and resources of family members to be involved in post-acute care; and</text> </paragraph> <paragraph num="G."> <text>Maintains written documentation delineating the function of the intensive care unit, including:</text> <paragraph num="(1)"> <text>Admission criteria;</text> </paragraph> <paragraph num="(2)"> <text>Discharge criteria;</text> </paragraph> <paragraph num="(3)"> <text>Acute stroke care protocols;</text> </paragraph> <paragraph num="(4)"> <text>Interdisciplinary rounding;</text> </paragraph> <paragraph num="(5)"> <text>Rehabilitation assessment and services in the hospital; and</text> </paragraph> <paragraph num="(6)"> <text>Outcome data.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Stroke Unit."> <text>The stroke unit of a hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.07.</text> </regulation> <regulation prefix="Regulation" num=".08" heading="Laboratory/Diagnostic Services."> <text>A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.08.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Neuroimaging Services."> <text>In addition to meeting the requirements of COMAR 30.08.11.09, a hospital designated as a thrombectomy-capable primary stroke center shall have the following diagnostic capability available when indicated:</text> <paragraph num="A."> <text>Carotid duplex ultrasound;</text> </paragraph> <paragraph num="B."> <text>Transcranial ultrasonography; and</text> </paragraph> <paragraph num="C."> <text>Transesophageal/transthoracic echocardiogram.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Endovascular Interventional Services."> <text>A hospital designated as a thrombectomy-capable primary stroke center shall have:</text> <paragraph num="A."> <text>Interventional services promptly available 24 hours a day with appropriately trained support staff and necessary equipment;</text> </paragraph> <paragraph num="B."> <text>Interventional services that include:</text> <paragraph num="(1)"> <text>Intra-arterial reperfusion therapy; and</text> </paragraph> <paragraph num="(2)"> <text>Stenting/angioplasty of intracranial vessels;</text> </paragraph> </paragraph> <paragraph num="C."> <text>A neurointerventionalist who may be a Board-certified/Board-eligible neuroradiologist, neurologist, or neurosurgeon on-call with a 45-minute arrival time to the hospital;</text> </paragraph> <paragraph num="D."> <text>An on-call schedule for a primary and a back-up neurointerventionalist; and</text> </paragraph> <paragraph num="E."> <text>A written protocol to accept the inter-facility transfer of acute ischemic stroke patients requiring endovascular therapy that includes communication and feedback to the sending facility.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Qualifications of Stroke Center Director and Clinicians."> <text>In addition to meeting the requirements of COMAR 30.08.11.10, a neurointerventionalist shall have:</text> <paragraph num="A."> <text>4 or more hours of category 1 or 2 CME credits per year related to stroke care; and</text> </paragraph> <paragraph num="B."> <text>Performed 15 mechanical thrombectomies over the past 12 months or 30 over the past 24 months.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Qualifications of Emergency Department Clinical Staff."> <text>In addition to meeting the requirements of COMAR 30.08.11.11, the emergency department clinical staff who triage or care for acute stroke patients shall be educated, by the hospital, on mechanical thrombectomy protocols.</text> </regulation> <regulation prefix="Regulation" num=".13" heading="Prevention/Public Education."> <text>A hospital designated as a thrombectomy-capable primary stroke center shall meet the requirements of COMAR 30.08.11.12.</text> </regulation> <regulation prefix="Regulation" num=".14" heading="Policies, Protocols, Guidelines, and Agreements."> <text>In addition to meeting the requirements of COMAR 30.08.11.13, a hospital designated as a thrombectomy-capable primary stroke center shall:</text> <paragraph num="A."> <text>Have written policies ensuring that:</text> <paragraph num="(1)"> <text>Transfer of patients from another facility is appropriate and patients are received in a timely manner; and</text> </paragraph> <paragraph num="(2)"> <text>All stroke patients will receive medical care commensurate with the hospital’s designation as a thrombectomy-capable primary stroke center;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Have written procedures demonstrating the ability to care for two complex interventional radiology stroke patients at one time, using appropriate clinical staff;</text> </paragraph> <paragraph num="C."> <text>Have written documentation demonstrating on-call and back-up on-call schedules for physicians and staff for 24/7 coverage;</text> </paragraph> <paragraph num="D."> <text>Have written care protocols for advanced treatment of complex stroke patients, including, but not limited to, acute ischemic stroke patients and acute intra-arterial therapeutic interventions; and</text> </paragraph> <paragraph num="E."> <text>Document and review the scope of practice and the roles and responsibilities of nurse practitioners and physician assistants providing care to the acute stroke patient in the intensive care unit, the emergency department, and the stroke unit.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".15" heading="Quality Management."> <text>In addition to meeting the requirements of COMAR 30.08.14, a hospital designated as a thrombectomy-capable primary stroke center shall:</text> <paragraph num="A."> <text>Monitor and demonstrate 24-hour post-procedure stroke and death rates of less than or equal to 1 percent for diagnostic neuro-angiography;</text> </paragraph> <paragraph num="B."> <text>Monitor documentation of the reasons potentially eligible ischemic stroke patients did not receive mechanical thrombectomy;</text> </paragraph> <paragraph num="C."> <text>Monitor and demonstrate tracking and trending of modified Rankin Scores (mRS) at 90 days post-discharge on patients with acute ischemic stroke who received mechanical endovascular reperfusion therapy;</text> </paragraph> <paragraph num="D."> <text>In cases where mechanical endovascular reperfusion therapy is appropriate, achieve door-to-device times, arrival to first pass of thrombectomy device, in 50 percent or more of eligible acute ischemic stroke patients within 120 minutes for direct arriving patients and within 60 minutes for inter-facility transfer patients treated with endovascular therapy; and</text> </paragraph> <paragraph num="E."> <text>Demonstrate progress towards reducing door-to-device times, arrival to first pass of thrombectomy device in 50 percent or more of eligible acute ischemic stroke patients within 90 minutes for direct arriving patients.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-509, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 1, 2022 (48:22 Md. R. 939)</annotation> </annotations> </chapter> </subtitle> <subtitle num="09" heading="Commercial Ambulance Services"> <chapter num="01" heading="Definitions"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines terms used throughout this subtitle.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Definitions."> <paragraph num="A."> <text>In this subtitle, the following terms have the meanings indicated.</text> </paragraph> <paragraph num="B."> <text>Terms Defined.</text> <paragraph num="(1)"> <text>“Administrative law judge” means an individual appointed under State Government Article, §9-1605, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(2)"> <text>“Advanced life support provider" means an individual licensed by the EMS Board as a paramedic or CRT.</text> </paragraph> <paragraph num="(3)"> <text>Advertising.</text> <paragraph num="(a)"> <text>“Advertising” means information communicated by any oral, electronic, written, or graphic means including handbills, newspapers, business cards, letterhead, other business stationery, television, billboards, radio, and telephone directories.</text> </paragraph> <paragraph num="(b)"> <text>“Advertising” includes ambulance markings.</text> </paragraph> <paragraph num="(c)"> <text>“Advertising” does not include novelty items such as key chains, pens, pencils, or mugs.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>“Air ambulance” means any aircraft designed and constructed or modified and equipped to be used, maintained, or operated as an ambulance.</text> </paragraph> <paragraph num="(5)"> <text>Ambulance.</text> <paragraph num="(a)"> <text>“Ambulance” or “commercial ambulance” means any motor vehicle or aircraft designed and constructed or modified and equipped to be used, maintained, or operated for the transportation of individuals who are sick, injured, wounded, or otherwise incapacitated.</text> </paragraph> <paragraph num="(b)"> <text>“Ambulance” or “commercial ambulance” does not include a motor vehicle or aircraft designed and constructed or modified and equipped with a hydraulic lift which is used, maintained, or operated exclusively for transporting, in wheelchairs, patients who do not require the use of equipment and trained personnel found in an ambulance.</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>“Automated external defibrillator (AED)” means a medical heart monitor and defibrillator device that:</text> <paragraph num="(a)"> <text>Has been cleared for market by the Food and Drug Administration;</text> </paragraph> <paragraph num="(b)"> <text>Is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia and determining, without intervention by an operator, whether defibrillation should be performed; and</text> </paragraph> <paragraph num="(c)"> <text>Upon determination that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual's heart and requires user intervention to deliver the electrical impulse or automatically continues with the delivery of the electrical impulse.</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>“Basic life support provider” means an individual certified by the EMS Board as an emergency medical responder or an emergency medical technician.</text> </paragraph> <paragraph num="(8)"> <text>“CAMTS” means Commission on Accreditation of Medical Transport Systems.</text> </paragraph> <paragraph num="(9)"> <text>“Cardiac rescue technician (CRT)” means an individual licensed by the EMS Board as a CRT.</text> </paragraph> <paragraph num="(10)"> <text>“CMAIS” means Commercial Maryland Ambulance Information System.</text> </paragraph> <paragraph num="(11)"> <text>“Commercial ambulance crew (crew)” means:</text> <paragraph num="(a)"> <text>For ground ambulances, at least two EMS clinicians, one of whom may also be the driver; or</text> </paragraph> <paragraph num="(b)"> <text>For air ambulances, at least two health care providers, at least one of whom shall be an EMS clinician and one pilot as required by CAMTS.</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>“Commercial ambulance license” means a license issued to a commercial ambulance service by MIEMSS under this subtitle, authorizing the use of a specific commercial ambulance.</text> </paragraph> <paragraph num="(13)"> <text>Commercial Ambulance Service.</text> <paragraph num="(a)"> <text>“Commercial ambulance service” means an individual, firm, partnership, limited liability company, corporation, association, or organization engaged in the business of transporting, by ambulance, individuals who are sick, injured, wounded, or otherwise incapacitated.</text> </paragraph> <paragraph num="(b)"> <text>“Commercial ambulance service” does not include transporting individuals in an ambulance owned by, operated by, or under the jurisdiction of a unit of State government, a political subdivision of the State, a volunteer fire company, a volunteer ambulance company, or a volunteer rescue squad or other jurisdictional EMS operational program recognized by the EMS Board.</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>“Commercial ambulance service license” means a license issued to a commercial ambulance service by MIEMSS under this subtitle, authorizing the operation of a commercial ambulance service.</text> </paragraph> <paragraph num="(15)"> <text>“Confidential business information” means information that:</text> <paragraph num="(a)"> <text>Is used in the business of a commercial ambulance service;</text> </paragraph> <paragraph num="(b)"> <text>Gives the commercial ambulance service the opportunity to obtain advantage over a competitor;</text> </paragraph> <paragraph num="(c)"> <text>Is known only to the commercial ambulance service and employees or agents of the commercial ambulance service to whom the commercial ambulance service needs to confide the information; and</text> </paragraph> <paragraph num="(d)"> <text>Is kept secure from disclosure by the commercial ambulance service.</text> </paragraph> </paragraph> <paragraph num="(16)"> <text>“Consumer price index (CPI)” means the Consumer Price Index, U.S. City Average (seasonally unadjusted) For All Items/All Urban Consumers (CPI-U 1982/84 = 100), published in the “Monthly Labor Review” as well as other publications of the Bureau of Labor Statistics of the United States Department of Labor.</text> </paragraph> <paragraph num="(17)"> <text>“Emergency” means any sudden or serious symptoms in a patient which might indicate a condition which:</text> <paragraph num="(a)"> <text>Is threatening to the patient's physical or psychological well-being; and</text> </paragraph> <paragraph num="(b)"> <text>Requires immediate medical attention to prevent possible deterioration, disability, or death of the patient.</text> </paragraph> </paragraph> <paragraph num="(18)"> <text>“Emergency medical responder (EMR)” means an individual certified by the EMS Board as an emergency medical responder.</text> </paragraph> <paragraph num="(19)"> <text>“Emergency Medical Services (EMS) Board” means the Board established by Education Article, §13-505, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(19-1)"> <text>“EMS clinician” means an individual licensed or certified by the EMS Board to provide emergency medical services.</text> </paragraph> <paragraph num="(20)"> <text>“Emergency medical services (EMS) provider” means an individual licensed or certified by the EMS Board to provide emergency medical services.</text> </paragraph> <paragraph num="(21)"> <text>“Emergency medical technician (EMT)” means an individual certified by the EMS Board as an emergency medical technician.</text> </paragraph> <paragraph num="(22)"> <text>“EMRC” means the Emergency Medical Resources Center operated by MIEMSS to coordinate online medical direction.</text> </paragraph> <paragraph num="(23)"> <text>“Executive Director” means the Executive Director of the Maryland Institute for Emergency Medical Services Systems.</text> </paragraph> <paragraph num="(24)"> <text>“FAA” means the Federal Aviation Administration.</text> </paragraph> <paragraph num="(25)"> <text>“Ground ambulance” means a motor vehicle designed and constructed or equipped to be used, maintained, or operated as an ambulance.</text> </paragraph> <paragraph num="(26)"> <text>“Health care provider” means a person licensed, or otherwise certified in Maryland or authorized to practice in Maryland as a:</text> <paragraph num="(a)"> <text>Physician;</text> </paragraph> <paragraph num="(b)"> <text>Registered nurse;</text> </paragraph> <paragraph num="(c)"> <text>Nurse practitioner;</text> </paragraph> <paragraph num="(d)"> <text>Respiratory therapist; or</text> </paragraph> <paragraph num="(e)"> <text>Emergency medical services clinician</text> </paragraph> </paragraph> <paragraph num="(27)"> <text>“Helipad” means a designated area usually with a prepared surface used for take-off, landing, or parking helicopters.</text> </paragraph> <paragraph num="(28)"> <text>“Heliport” means an area of land or structure used for the landings and take-offs of helicopters and may include its buildings and facilities.</text> </paragraph> <paragraph num="(28-1)"> <text>“Infant” means a patient who is older than 28 days and up to 1 year old.</text> </paragraph> <paragraph num="(29)"> <text>“Jurisdictional EMS operational program (jurisdiction)” means an EMS operational program which is:</text> <paragraph num="(a)"> <text>Approved under COMAR 30.03.02.03; and</text> </paragraph> <paragraph num="(b)"> <text>Not licensed as a commercial ambulance service under Education Article, §13-515, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="(30)"> <text>“MIEMSS” means the Maryland Institute for Emergency Medical Services Systems established in Education Article, §13-503, Annotated Code of Maryland.</text> </paragraph> <paragraph num="(31)"> <text>“Neonatal referral center” means an out-of-State center operating under an agreement with MIEMSS to provide comprehensive neonatal services.</text> </paragraph> <paragraph num="(32)"> <text>“Neonatal Resuscitation Program” means the neonatal resuscitation course cosponsored by the American Heart Association and the American Academy of Pediatrics.</text> </paragraph> <paragraph num="(33)"> <text>“Neonate” or “neonatal patient” means a patient who is younger than 28 days.</text> </paragraph> <paragraph num="(34)"> <text>“Neonatologist” means a pediatrician certified by the American Board of Pediatrics in neonatology.</text> </paragraph> <paragraph num="(35)"> <text>“Paramedic” means an individual licensed by the EMS Board as a paramedic.</text> </paragraph> <paragraph num="(36)"> <text>“Perinatal referral center” means a center in Maryland designated by MIEMSS, or an out-of-State center operating under an agreement with MIEMSS, to provide comprehensive obstetrical and neonatal services.</text> </paragraph> <paragraph num="(37)"> <text>“Physician” means an individual authorized to practice medicine in Maryland.</text> </paragraph> <paragraph num="(38)"> <text>“Registered nurse” means an individual authorized to practice registered nursing in Maryland.</text> </paragraph> <paragraph num="(39)"> <text>“Specialty care paramedic” means a paramedic who has successfully completed a paramedic specialty care transport course approved by the EMS Board or equivalent as determined by MIEMSS, or holds current Critical Care Paramedic or Flight Paramedic certification through the International Board of Specialty Certification, and is credentialed by a specialty care transport service under COMAR 30.03.03.06.</text> </paragraph> <paragraph num="(40)"> <text>“Specialty care transport (SCT)” means the transport of a patient who either:</text> <paragraph num="(a)"> <text>Requires care or monitoring commensurate within the scope of practice of a physician or registered nurse and beyond the scope of a Specialty Care Paramedic; or</text> </paragraph> <paragraph num="(b)"> <text>Meets the following conditions:</text> <paragraph num="(i)"> <text>Requires ongoing care or monitoring which is within the scope of a Specialty Care Paramedic as defined in the Maryland Medical Protocols for Emergency Medical Services; and</text> </paragraph> <paragraph num="(ii)"> <text>Does not currently need or is not anticipated to need intervention during transport that would be beyond the scope of a Specialty Care Paramedic under the Maryland Medical Protocols for Emergency Medical Services.</text> </paragraph> </paragraph> </paragraph> <paragraph num="(41)"> <text>“State Office of Commercial Ambulance Licensing and Regulation (SOCALR)” means the MIEMSS department responsible for implementing and enforcing the provisions of this subtitle.</text> </paragraph> <paragraph num="(42)"> <text>“SYSCOM” means the Systems Communication Center operated by MIEMSS under Education Article, §13-509, Annotated Code of Maryland, and COMAR 30.07.01.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date:</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05 adopted as an emergency provision under COMAR 14.17.02 effective July 30, 1991 (18:17 Md. R. 1913); emergency status extended at 19:2 Md. R. 150 (January 24, 1992) and 19:14 Md. R. 1282 (July 10, 1992)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10 adopted effective October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01B amended as an emergency provision effective January 6, 1997 (24:2 Md. R. 114); amended permanently effective July 7, 1997 (24:10 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.01 to COMAR 30.09.01, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10, Licensing Program—In General, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02, Definitions, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02B amended effective October 15, 2004 (31:20 Md. R. 1486); January 15, 2005 (31:26 Md. R. 1866); November 1, 2010 (37:21 Md. R. 1437); December 12, 2013 (40:24 Md. R. 2017); May 3, 2021 (48:9 Md. R. 361); May 27, 2024 (51:10 Md. R. 529)</annotation> </annotations> </chapter> <chapter num="02" heading="Patient Rights"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter describes the rights of patients transported or treated by commercial ambulance services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Patient Rights."> <text>A commercial ambulance service shall provide each patient:</text> <paragraph num="A."> <text>Considerate and respectful care;</text> </paragraph> <paragraph num="B."> <text>Information from the commercial ambulance service necessary in order to give informed consent for transport or treatment, or both;</text> </paragraph> <paragraph num="C."> <text>The opportunity to refuse transport or treatment when the patient is apparently competent to do so;</text> </paragraph> <paragraph num="D."> <text>Reasonable privacy concerning a patient's transportation and care;</text> </paragraph> <paragraph num="E."> <text>Confidentiality of all communications and records relating to patient transportation and care except to the extent otherwise required by law;</text> </paragraph> <paragraph num="F."> <text>Reasonable response to a request for services once the commercial ambulance service is engaged to provide service;</text> </paragraph> <paragraph num="G."> <text>Service that is within reasonable limits of the scheduled pickup and delivery times;</text> </paragraph> <paragraph num="H."> <text>Reasonable continuity of care once the commercial ambulance service is engaged to provide service;</text> </paragraph> <paragraph num="I."> <text>An opportunity to examine and receive an explanation of the patient's bill;</text> </paragraph> <paragraph num="J."> <text>An environment in the commercial ambulance free from recognized hazards and unreasonable annoyances including but not limited to:</text> <paragraph num="(1)"> <text>Smoking,</text> </paragraph> <paragraph num="(2)"> <text>Loud radio, and</text> </paragraph> <paragraph num="(3)"> <text>Loud conversation by the crew; and</text> </paragraph> </paragraph> <paragraph num="K."> <text>Information that commercial ambulance services operating in Maryland are regulated by the Maryland Institute for Emergency Medical Services Systems.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended as an emergency provision effective January 6, 1997 (24:2 Md. R. 114); amended permanently effective July 7, 1997 (24:10 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.02 to COMAR 30.09.02, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06, Eligibility and Application, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02, Patient Rights, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> </annotations> </chapter> <chapter num="03" heading="Licensing Program—In General"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the requirement for licensing commercial ambulance services and commercial ambulances.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="State Office of Commercial Ambulance Licensing and Regulation."> <paragraph num="A."> <text>There shall be a State Office of Commercial Ambulance Licensing and Regulation within MIEMSS which shall implement and enforce the provisions of this subtitle.</text> </paragraph> <paragraph num="B."> <text>Unless otherwise specified, all communications to the Executive Director relating to this subtitle shall be addressed to Executive Director of MIEMSS, c/o State Office of Commercial Ambulance Licensing and Regulation, 653 West Pratt Street, Baltimore, Maryland 21201-1536.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Required."> <text>A person may not operate a commercial ambulance service in Maryland unless:</text> <paragraph num="A."> <text>Issued a license under Education Article, §13-515, Annotated Code of Maryland;</text> </paragraph> <paragraph num="B."> <text>Exempt from this subtitle under Regulation .04 of this chapter; or</text> </paragraph> <paragraph num="C."> <text>Issued a written waiver from SOCALR under Regulation .05 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Exempt Vehicles."> <paragraph num="A."> <text>The following vehicles are exempt from licensure under this subtitle:</text> <paragraph num="(1)"> <text>Vehicles, typically referred to as wheelchair vans, equipped with a hydraulic lift used exclusively for transporting, in wheelchairs, patients who do not require equipment or trained personnel available in an ambulance;</text> </paragraph> <paragraph num="(2)"> <text>Ambulances owned by, operated by, or under the jurisdiction of a unit of State or federal government, a political subdivision of the State, a volunteer fire company, a volunteer ambulance company, or a volunteer rescue squad; and</text> </paragraph> <paragraph num="(3)"> <text>Ambulances traveling through the State, regardless of frequency, exclusively for the purpose of interstate travel.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If SOCALR believes that an ambulance operating in this State may be required to be licensed under this subtitle, SOCALR may conduct an investigation to determine whether the ambulance service or ambulance is required to be licensed.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Exempt Services."> <paragraph num="A."> <text>The following services are exempt from licensure under this subtitle:</text> <paragraph num="(1)"> <text>Air ambulance services licensed and based outside Maryland which transport patients from or within Maryland less than 26 times per year; or</text> </paragraph> <paragraph num="(2)"> <text>Ambulance services licensed and based outside Maryland which transport patients:</text> <paragraph num="(a)"> <text>Into Maryland; or</text> </paragraph> <paragraph num="(b)"> <text>To and from Maryland for diagnostic or therapeutic services in the same calendar day.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An out-of-State ambulance service seeking an exemption from a service license shall submit a completed application on the required form to SOCALR.</text> </paragraph> <paragraph num="C."> <text>An exemption is not valid unless issued in writing by SOCALR for a specified period of time.</text> </paragraph> <paragraph num="D."> <text>A commercial ambulance service granted an exemption from this subtitle shall reapply for the exemption 30 days before expiration of the exemption.</text> </paragraph> <paragraph num="E."> <text>A service granted an exemption from this subtitle shall submit an annual report detailing the number of patients during the previous year who were transported:</text> <paragraph num="(1)"> <text>From the scene of a public safety medical emergency; and</text> </paragraph> <paragraph num="(2)"> <text>From any hospital or health care facility in Maryland.</text> </paragraph> </paragraph> <paragraph num="F."> <text>When transporting patients from the scene of a public safety medical emergency, an exempt service shall transport the patient to the closest appropriate facility according to Maryland Medical Protocol for EMS Providers.</text> </paragraph> <paragraph num="G."> <text>SOCALR may conduct an investigation to determine if an exemption should be revoked.</text> </paragraph> <paragraph num="H."> <text>A service granted on exemption shall notify SOCALR of any disciplinary action taken against the service by the licensing authority in the state in which the service is licensed.</text> </paragraph> <paragraph num="I."> <text>An exemption may be revoked if SOCALR finds the party to whom the exemption has been granted has:</text> <paragraph num="(1)"> <text>Obtained or attempted to obtain an exemption by fraud or deceit;</text> </paragraph> <paragraph num="(2)"> <text>Made material omission or misrepresentation of fact on an application for an exemption;</text> </paragraph> <paragraph num="(3)"> <text>Made a material omission or misrepresentation of fact in response to an inquiry or investigation by SOCALR;</text> </paragraph> <paragraph num="(4)"> <text>Defaced, altered, removed, or obliterated any portion of or any official entry on an exemption issued by SOCALR;</text> </paragraph> <paragraph num="(5)"> <text>Interfered with SOCALR in the performance of SOCALR's duties;</text> </paragraph> <paragraph num="(6)"> <text>Failed to reapply for an exemption;</text> </paragraph> <paragraph num="(7)"> <text>Violated any applicable federal, State, or local statute or regulation;</text> </paragraph> <paragraph num="(8)"> <text>Provided patient care which fails to meet the appropriate standard; or</text> </paragraph> <paragraph num="(9)"> <text>Been disciplined by the licensing authority in the state in which the service is licensed.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preemption of Local Legislation."> <paragraph num="A."> <text>The authority of a county or municipal corporation to regulate a commercial ambulance service with a base of operation located outside the county or municipal corporation that is licensed under this subtitle is preempted by Education Article, §13-515, Annotated Code of Maryland.</text> </paragraph> <paragraph num="B."> <text>A county or municipal corporation is not preempted from regulating a commercial ambulance service with a base of operation located within its territorial boundaries, while the commercial ambulance service is operating within those territorial boundaries, so long as local legislation does not conflict with, frustrate, or diminish the intent of Education Article, §13-515, Annotated Code of Maryland, or this subtitle.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Public Information."> <paragraph num="A."> <text>SOCALR shall:</text> <paragraph num="(1)"> <text>Maintain a current list of licensed commercial ambulances and licensed commercial ambulance services; and</text> </paragraph> <paragraph num="(2)"> <text>Provide this list as requested.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The list shall contain the:</text> <paragraph num="(1)"> <text>Name of the commercial ambulance service;</text> </paragraph> <paragraph num="(2)"> <text>Commercial ambulance designations that will be used in radio communications; and</text> </paragraph> <paragraph num="(3)"> <text>Type of license issued to each licensed commercial ambulance.</text> </paragraph> </paragraph> <paragraph num="C."> <text>COMAR 30.01.04 governs responses to requests for public records of MIEMSS.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Regulation .01D amended as an emergency provision effective January 6, 1997 (24:2 Md. R. 114); amended permanently effective July 7, 1997 (24:10 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02D adopted as an emergency provision effective January 6, 1997 (24:2 Md. R. 114); adopted permanently effective July 7, 1997 (24:10 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.03 to COMAR 30.09.03, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04, Issuance, Transfer, and Relinquishment of License, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07, Licensing Program—In General, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended as an emergency provision effective August 31, 2001 (28:19 Md. R. 1682); emergency status extended at 29:7 Md. R. 618; emergency status expired July 30, 2002</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended as an emergency provision effective May 8, 2000 (27:11 Md. R. 1076); emergency status expired November 3, 2000</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> </annotations> </chapter> <chapter num="04" heading="Eligibility, Application, and License Renewal"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the eligibility, application, and renewal procedure for commercial ambulance service licenses.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for a Commercial Ambulance Service License."> <text>To be eligible for a license, a commercial ambulance service shall:</text> <paragraph num="A."> <text>Own or operate at least one ambulance:</text> <paragraph num="(1)"> <text>Which is licensed; or</text> </paragraph> <paragraph num="(2)"> <text>For which a license has been applied under Regulation .04 of this chapter;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Have ground ambulances mechanically inspected under Regulation .05D(4) of this chapter;</text> </paragraph> <paragraph num="C."> <text>Have all ambulances properly staffed and equipped;</text> </paragraph> <paragraph num="D."> <text>Comply with all applicable statutes and regulations governing the operation of a commercial ambulance service and commercial ambulances;</text> </paragraph> <paragraph num="E."> <text>Have proper insurance required by Regulation .06 of this chapter;</text> </paragraph> <paragraph num="F."> <text>Have reliable communications as required in COMAR 30.09.10.03 and .04;</text> </paragraph> <paragraph num="G."> <text>Submit the intended name of the service to SOCALR for approval;</text> </paragraph> <paragraph num="H."> <text>Apply for a license under Regulation .03 of this chapter; and</text> </paragraph> <paragraph num="I."> <text>Pay the required fees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Application for Commercial Ambulance Service License."> <paragraph num="A."> <text>An applicant for a commercial ambulance service license shall submit a completed application to SOCALR on the required form.</text> </paragraph> <paragraph num="B."> <text>A completed application shall contain:</text> <paragraph num="(1)"> <text>The commercial ambulance service's:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Principal physical business address;</text> </paragraph> <paragraph num="(c)"> <text>Billing address;</text> </paragraph> <paragraph num="(d)"> <text>Telephone number;</text> </paragraph> <paragraph num="(e)"> <text>Facsimile number;</text> </paragraph> <paragraph num="(f)"> <text>E-mail address;</text> </paragraph> <paragraph num="(g)"> <text>Principal contact individual's name for official communications from MIEMSS;</text> </paragraph> <paragraph num="(h)"> <text>Principal contact individual's name for daily operations;</text> </paragraph> <paragraph num="(i)"> <text>Federal tax identification number; and</text> </paragraph> <paragraph num="(j)"> <text>Entity type;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>For a corporation, limited partnership, or a limited liability company:</text> <paragraph num="(a)"> <text>A statement that the commercial ambulance service:</text> <paragraph num="(i)"> <text>Is registered under the Corporations and Associations Article, Annotated Code of Maryland, in good standing;</text> </paragraph> <paragraph num="(ii)"> <text>Has filed all required annual reports; and</text> </paragraph> <paragraph num="(iii)"> <text>Has paid all required filing fees to the Maryland Department of Assessments and Taxation; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The name of the resident agent on file with the Charter Division of the Maryland Department of Assessments and Taxation;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The principal place of business on file with or recognized by the:</text> <paragraph num="(a)"> <text>Charter Division of the Maryland Department of Assessments and Taxation; or</text> </paragraph> <paragraph num="(b)"> <text>Central Registration Unit of the Comptroller of the Treasury;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>An agreement and representation that the commercial ambulance service:</text> <paragraph num="(a)"> <text>Is qualified to do business in Maryland; and</text> </paragraph> <paragraph num="(b)"> <text>Will take all necessary actions to remain qualified while licensed in Maryland;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>For an air ambulance service:</text> <paragraph num="(a)"> <text>If CAMTS accredited, a copy of the current CAMTS accreditation certificate; or</text> </paragraph> <paragraph num="(b)"> <text>If CAMTS accreditation is pending:</text> <paragraph num="(i)"> <text>A copy of the FAA operating certificate; and</text> </paragraph> <paragraph num="(ii)"> <text>Proof of compliance with CAMTS standards;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(6)"> <text>All trade names under which the commercial ambulance service and any parent or subsidiary does or has ever done business;</text> </paragraph> <paragraph num="(7)"> <text>The current Maryland Medical Assistance Program provider/vendor numbers issued by the Maryland Department of Health to the commercial ambulance service under its name or any of its trade names;</text> </paragraph> <paragraph num="(8)"> <text>The CLIA (Clinical Laboratory Improvement Amendment) identification number, if issued;</text> </paragraph> <paragraph num="(9)"> <text>The street address for each location the commercial ambulance service intends to operate including where:</text> <paragraph num="(a)"> <text>Ambulances are parked or stored;</text> </paragraph> <paragraph num="(b)"> <text>Records are kept;</text> </paragraph> <paragraph num="(c)"> <text>Supplies are stored;</text> </paragraph> <paragraph num="(d)"> <text>Ambulance crews are quartered; and</text> </paragraph> <paragraph num="(e)"> <text>Ambulances are dispatched;</text> </paragraph> </paragraph> <paragraph num="(10)"> <text>The following information about management personnel and owners:</text> <paragraph num="(a)"> <text>Names;</text> </paragraph> <paragraph num="(b)"> <text>Addresses;</text> </paragraph> <paragraph num="(c)"> <text>Telephone numbers; and</text> </paragraph> <paragraph num="(d)"> <text>Titles;</text> </paragraph> </paragraph> <paragraph num="(11)"> <text>The following information about each employee who may provide patient care:</text> <paragraph num="(a)"> <text>Name;</text> </paragraph> <paragraph num="(b)"> <text>Type of health care certification or license and the identity of the issuer; and</text> </paragraph> <paragraph num="(c)"> <text>Certification or license number;</text> </paragraph> </paragraph> <paragraph num="(12)"> <text>A listing of all commercial ambulances to be operated by the service under the service license applied for with the information required for a commercial ambulance license in Regulation .05B(2) of this chapter;</text> </paragraph> <paragraph num="(13)"> <text>A signed written statement under the penalties of perjury that:</text> <paragraph num="(a)"> <text>There has been no attempt for the purpose of obtaining or attempting to obtain a license, to knowingly and willfully:</text> <paragraph num="(i)"> <text>Falsify, conceal, or omit a material fact;</text> </paragraph> <paragraph num="(ii)"> <text>Make any false, fictitious, incomplete, or fraudulent statements or representations; or</text> </paragraph> <paragraph num="(iii)"> <text>Make or use any false writing, document, or entry knowing the same to contain any false, fictitious, or fraudulent statement; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>The signer is authorized by the commercial ambulance service identified on the application to sign the application form to execute the sworn statement;</text> </paragraph> </paragraph> <paragraph num="(14)"> <text>The signatures of:</text> <paragraph num="(a)"> <text>If a sole proprietorship, the owner;</text> </paragraph> <paragraph num="(b)"> <text>If a partnership, all general partners;</text> </paragraph> <paragraph num="(c)"> <text>If a corporation, a duly authorized corporate official accompanied by a certified corporate resolution authorizing the execution; or</text> </paragraph> <paragraph num="(d)"> <text>If a limited liability company, an authorized individual; and</text> </paragraph> </paragraph> <paragraph num="(15)"> <text>Any additional information which SOCALR may consider necessary.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The applicant shall submit with the application the applicable fees required in Regulation .07 of this chapter together with the documents required in this subtitle.</text> </paragraph> <paragraph num="D."> <text>Before accepting any license for which it applied, the commercial ambulance service shall notify SOCALR of any changes to the information previously submitted on the application which occur before the license is granted, regarding:</text> <paragraph num="(1)"> <text>The commercial ambulances;</text> </paragraph> <paragraph num="(2)"> <text>Commercial ambulance service personnel; or</text> </paragraph> <paragraph num="(3)"> <text>Any other material information in the application.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Requirements for a Commercial Ambulance License."> <paragraph num="A."> <text>To be eligible for a commercial ambulance license, an ambulance shall:</text> <paragraph num="(1)"> <text>Be owned or operated by a licensed commercial ambulance service;</text> </paragraph> <paragraph num="(2)"> <text>If a ground ambulance, be marked as follows:</text> <paragraph num="(a)"> <text>The name of the licensed commercial ambulance service in letters at least 4 inches high,</text> </paragraph> <paragraph num="(b)"> <text>For ambulances newly licensed or repainted after January 1, 2000, if other lettering is present naming a sponsoring or serviced facility, organization, or entity, the lettering of the licensed commercial ambulance service name prominently displayed in lettering at least the same size as the lettering in §A(2)(a) of this regulation, and</text> </paragraph> <paragraph num="(c)"> <text>A unit designation number assigned by the commercial ambulance service in letters that are at least 3 inches high;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If an air ambulance, be marked with:</text> <paragraph num="(a)"> <text>The name of the licensed commercial ambulance service in letters that are clearly visible, and</text> </paragraph> <paragraph num="(b)"> <text>Any other markings required by the FAA; and</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>If a ground ambulance, be mechanically inspected as required under Regulation .05D(4) of this chapter;</text> </paragraph> <paragraph num="(5)"> <text>Be properly equipped as required by COMAR 30.09.07 and 30.09.10—30.09.13;</text> </paragraph> <paragraph num="(6)"> <text>Comply with all applicable statutes and regulations governing the operation of a commercial ambulance;</text> </paragraph> <paragraph num="(7)"> <text>Be properly insured as required by Regulation .06 of this chapter; and</text> </paragraph> <paragraph num="(8)"> <text>Have proper communication equipment as required in COMAR 30.09.10.04.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Additional Lettering for Ground Ambulances.</text> <paragraph num="(1)"> <text>If the ambulance is licensed as an ALS licensed commercial ambulance, the words “Advanced Life Support” may be displayed.</text> </paragraph> <paragraph num="(2)"> <text>If the ambulance is licensed as a neonatal licensed commercial ambulance, the words “Neonatal Transport”, “Neonatal Ambulance”, or “Neonatal Intensive Care”, or similar words implying, in the judgement of SOCALR, that the ambulance is licensed as a neonatal commercial ambulance, may be displayed.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The applicant shall submit a diagram of the markings intended to be displayed on the ambulance including:</text> <paragraph num="(1)"> <text>Numbering;</text> </paragraph> <paragraph num="(2)"> <text>Lettering; and</text> </paragraph> <paragraph num="(3)"> <text>Symbols.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The applicant shall submit an application as required under Regulation .05 of this chapter.</text> </paragraph> <paragraph num="E."> <text>The applicant shall pay the required fees.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Application for Commercial Ambulance License."> <paragraph num="A."> <text>An applicant for a commercial ambulance license shall submit a completed application to SOCALR on the required form.</text> </paragraph> <paragraph num="B."> <text>A completed application shall contain:</text> <paragraph num="(1)"> <text>The following information about the commercial ambulance service:</text> <paragraph num="(a)"> <text>Name,</text> </paragraph> <paragraph num="(b)"> <text>Mailing address,</text> </paragraph> <paragraph num="(c)"> <text>Phone number, and</text> </paragraph> <paragraph num="(d)"> <text>Facsimile number;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The following information about the ambulance:</text> <paragraph num="(a)"> <text>For ground ambulances:</text> <paragraph num="(i)"> <text>The unit designation number assigned to each commercial ambulance by the commercial ambulance service for operational purposes,</text> </paragraph> <paragraph num="(ii)"> <text>The license plate number,</text> </paragraph> <paragraph num="(iii)"> <text>The state issuing the license plates,</text> </paragraph> <paragraph num="(iv)"> <text>If the license plates are temporary, the issuance and expiration dates of the temporary license plates,</text> </paragraph> <paragraph num="(v)"> <text>The vehicle identification number (VIN) issued by the chassis manufacturer,</text> </paragraph> <paragraph num="(vi)"> <text>The year of manufacture of the ambulance chassis, and</text> </paragraph> <paragraph num="(vii)"> <text>The color scheme, insignia, trademark, monogram, name, or other distinguishing characteristics used to designate the ambulance;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>For air ambulances:</text> <paragraph num="(i)"> <text>The unit designation number assigned to each air ambulance by the commercial ambulance service for operational purposes,</text> </paragraph> <paragraph num="(ii)"> <text>The FAA registration number, and</text> </paragraph> <paragraph num="(iii)"> <text>The make, model, and year of manufacture;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>The signatures of:</text> <paragraph num="(a)"> <text>If a sole proprietorship, the owner,</text> </paragraph> <paragraph num="(b)"> <text>If a partnership, all general partners,</text> </paragraph> <paragraph num="(c)"> <text>If a corporation, a duly authorized corporate official accompanied by a certified corporate resolution authorizing the execution, or</text> </paragraph> <paragraph num="(d)"> <text>If a limited liability company, an authorized individual.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>The applicant shall pay the required fees.</text> </paragraph> <paragraph num="D."> <text>The applicant shall submit with the application the following documents for each ground ambulance to be licensed:</text> <paragraph num="(1)"> <text>A copy of the motor vehicle registration certificate;</text> </paragraph> <paragraph num="(2)"> <text>A copy of the “Application for Approval of Emergency Vehicles” approved by the Maryland Motor Vehicle Administration;</text> </paragraph> <paragraph num="(3)"> <text>A certificate of motor vehicle liability insurance required under Regulation .06 of this chapter which lists the vehicle by the vehicle identification number (VIN) number; and</text> </paragraph> <paragraph num="(4)"> <text>A copy of:</text> <paragraph num="(a)"> <text>If the ambulance is 1 year old or older, the inspection certificate required by Education Article, §13-515(c)(2)(iii), Annotated Code of Maryland, together with a copy of the inspection report; or</text> </paragraph> <paragraph num="(b)"> <text>If the ambulance is less than 1 year old, the certificate of origin issued by the vehicle manufacturer which includes:</text> <paragraph num="(i)"> <text>Manufacturer's vehicle identification number (VIN),</text> </paragraph> <paragraph num="(ii)"> <text>Manufacturer's name,</text> </paragraph> <paragraph num="(iii)"> <text>General description of the body,</text> </paragraph> <paragraph num="(iv)"> <text>Vehicle make,</text> </paragraph> <paragraph num="(v)"> <text>Vehicle model, and</text> </paragraph> <paragraph num="(vi)"> <text>Year manufactured.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The applicant shall submit with the application the following documents for each air ambulance the service intends to operate in Maryland:</text> <paragraph num="(1)"> <text>Proof of adequate insurance; and</text> </paragraph> <paragraph num="(2)"> <text>A copy of the FAA air worthiness certification.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Before the license is granted, the commercial ambulance service shall notify SOCALR of any changes to the information in the application which occur after the application is submitted.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Insurance."> <paragraph num="A."> <text>A commercial ambulance service or a commercial ambulance may not be licensed or operated in Maryland unless the commercial ambulance service maintains continuous insurance, issued by an insurer authorized by the Maryland Insurance Commissioner to write these policies in Maryland, of the following types and amounts:</text> <paragraph num="(1)"> <text>Commercial general liability insurance coverage of not less than $1 million;</text> </paragraph> <paragraph num="(2)"> <text>For ground ambulances, commercial motor vehicle liability insurance coverage of not less than the minimum required under Transportation Article, §17-103, Annotated Code of Maryland; and</text> </paragraph> <paragraph num="(3)"> <text>Workers' compensation insurance in the amount required by law.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The general liability insurance coverage required by §A(1) of this regulation shall provide for payment of damages as a result of:</text> <paragraph num="(1)"> <text>Bodily injury to, or death of, individuals in accidents resulting from any cause for which the commercial ambulance service is liable; and</text> </paragraph> <paragraph num="(2)"> <text>Property damage to or loss of the property of another, including personal property, resulting from any cause for which the commercial ambulance service is liable.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The financial responsibility requirements for commercial motor vehicle liability coverage shall conform to all applicable laws including:</text> <paragraph num="(1)"> <text>Transportation Article, Title 17, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(2)"> <text>Transportation Article, Title 18, Annotated Code of Maryland;</text> </paragraph> <paragraph num="(3)"> <text>COMAR 11.18; and</text> </paragraph> <paragraph num="(4)"> <text>Insurance Article, Title 19, Subtitle 5, Annotated Code of Maryland.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The financial responsibility requirements for workers' compensation insurance shall comply with Labor and Employment Article, Title 9, Annotated Code of Maryland.</text> </paragraph> <paragraph num="E."> <text>A commercial ambulance service shall provide SOCALR, as a condition of licensure or continued licensure, a certificate of insurance that:</text> <paragraph num="(1)"> <text>Verifies that the insurance required under this regulation is in effect at the time the application is submitted; and</text> </paragraph> <paragraph num="(2)"> <text>Lists the State Office of Commercial Ambulance Licensing and Regulation, 653 West Pratt Street, Room 313, Baltimore, Maryland 21201-1536, as an additional party entitled to notification 10 days before any of the following relating to insurance required by this chapter occurs:</text> <paragraph num="(a)"> <text>Nonrenewal,</text> </paragraph> <paragraph num="(b)"> <text>Cancellation, or</text> </paragraph> <paragraph num="(c)"> <text>Substantive change in the coverage or level of insurance.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A certificate of insurance for motor vehicle insurance required under §E of this regulation shall identify all vehicles covered by the manufacturer's vehicle identification number (VIN).</text> </paragraph> <paragraph num="G."> <text>In addition to the notification requirements required by Insurance Article, §27-605, Annotated Code of Maryland, and this subtitle, a commercial ambulance service shall furnish to SOCALR, within 7 calendar days of receipt, copies of notification from an insurer of any of the following relating to insurance required by this chapter:</text> <paragraph num="(1)"> <text>Nonrenewal;</text> </paragraph> <paragraph num="(2)"> <text>Cancellation; or</text> </paragraph> <paragraph num="(3)"> <text>Substantive change in the coverage or level of insurance.</text> </paragraph> </paragraph> <paragraph num="H."> <text>If the insurance coverage provided by an insurance company or a self-insurance fund is not adequate for the purposes required, MIEMSS may not issue a license.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Fees."> <paragraph num="A."> <text>Commercial Ambulance License Fees.</text> <paragraph num="(1)"> <text>Ground ambulances.</text> <paragraph num="(a)"> <text>Annual commercial ambulance ALS or BLS license fee as of July 1,1999 — $780</text> </paragraph> <paragraph num="(b)"> <text>Semiannual commercial ambulance ALS or BLS license fee as of July 1, 1999 — $415</text> </paragraph> <paragraph num="(c)"> <text>Specialty Care Transport Service License.</text> <paragraph num="(i)"> <text>Annual commercial specialty care service license fee as of December 31, 2004 — $500.</text> </paragraph> <paragraph num="(ii)"> <text>Semiannual commercial specialty care service license fee as of December 31, 2004 — $265.</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>Annual neonatal commercial ambulance license fee as of July 1, 1999 — $940</text> </paragraph> <paragraph num="(e)"> <text>Semiannual neonatal commercial ambulance license fee as of July 1, 1999 — $500</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Commercial Air Ambulance Service License.</text> <paragraph num="(a)"> <text>Annual commercial air ambulance service license fee as of July 1, 2002 — $845.</text> </paragraph> <paragraph num="(b)"> <text>Semiannual commercial air ambulance service license fee as of July 1, 2002 — $450.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Specialty Care Transport Service License.</text> <paragraph num="(a)"> <text>Annual commercial specialty care service license fee as of December 31, 2004 — $500.</text> </paragraph> <paragraph num="(b)"> <text>Semiannual commercial specialty care service license fee as of December 31, 2004 — $265.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Miscellaneous Service Fees.</text> <paragraph num="(1)"> <text>Ambulance license transfer — $50</text> </paragraph> <paragraph num="(2)"> <text>Change in level of ambulance license — $50</text> </paragraph> <paragraph num="(3)"> <text>Preliminary determination to prospective buyer — $100</text> </paragraph> <paragraph num="(4)"> <text>Replacement of commercial ambulance vehicle license — $5</text> </paragraph> <paragraph num="(5)"> <text>Replacement of commercial ambulance service license — $5</text> </paragraph> <paragraph num="(6)"> <text>Replacement of ambulance licensing decal — $10</text> </paragraph> <paragraph num="(7)"> <text>Service license application packet — $20.</text> </paragraph> <paragraph num="(8)"> <text>Initial service license application review — $100.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The licensing fee for adding a commercial ambulance vehicle during the fiscal year is:</text> <paragraph num="(1)"> <text>One half of the semiannual fee rounded to the nearest $5 increment if the vehicle is added after April 1 and before June 30 of the current fiscal year;</text> </paragraph> <paragraph num="(2)"> <text>Equal to the semiannual fee if the vehicle is added after January 1 and before March 31 of the current fiscal year;</text> </paragraph> <paragraph num="(3)"> <text>Equal to the semiannual fee rounded to the nearest $5 increment if the vehicle is added after October 1 and before December 31 of the current fiscal year; or</text> </paragraph> <paragraph num="(4)"> <text>Equal to the annual fee if the vehicle is added after July 1 and before September 30 of the current fiscal year.</text> </paragraph> </paragraph> <paragraph num="D."> <text>SOCALR shall make noninflationary adjustments to the fees listed in §§A and B of this regulation by means of the regulatory promulgation process which affords interested parties the opportunity to make both oral and written comments to SOCALR before the adoption of a new fee schedule. The fees established in §§A and B of this regulation may be adjusted by SOCALR, from time to time, notwithstanding the inflationary adjustment in §E of this regulation, in order to provide funds sufficient to cover the actual direct and indirect costs of maintaining the licensing program in accordance with Education Article, §13-515, Annotated Code of Maryland, and this subtitle.</text> </paragraph> <paragraph num="E."> <text>SOCALR may make inflationary adjustments to the fees listed in §§A and B of this regulation before the beginning of each fiscal year by applying the percent change in the consumer price index for the most recent complete calendar year to the annual licensing fee for the fiscal year ending rounded to the nearest $5 increment. This inflationary adjustment may be made by SOCALR without any additional consultation or amendment to the regulations. If the consumer price index ceases to be published, a comparable statistic on the purchasing power of the consumer dollar shall be adopted. If the base year (1982/84 = 100) or other base year used in computing the consumer price index is changed, the figures used in making the computation below shall be changed accordingly. The following formula shall be used in determining the annual inflationary adjustment to the fees:</text> </paragraph> <paragraph num="F."> <text>SOCALR may set semiannual licensing fees that are adjusted to cover the additional costs incurred for semiannual rather than annual processing of licenses and decals. The semiannual licensing fee shall be one half of the annual licensing fee plus 6 percent of the halved annual fee, the sum of which is rounded to the nearest $5 increment.</text> </paragraph> <paragraph num="G."> <text>Additional Fees.</text> <paragraph num="(1)"> <text>SOCALR may set fees to recoup, on a cost basis, the cost of services and materials that are not covered by the licensing fees, provided to commercial ambulance services and other interested parties. These materials and services may include:</text> <paragraph num="(a)"> <text>MAIS run reports;</text> </paragraph> <paragraph num="(b)"> <text>Additional narratives;</text> </paragraph> <paragraph num="(c)"> <text>Instruction booklets;</text> </paragraph> <paragraph num="(d)"> <text>Triage tags;</text> </paragraph> <paragraph num="(e)"> <text>Protocols;</text> </paragraph> <paragraph num="(f)"> <text>Certification or license patches;</text> </paragraph> <paragraph num="(g)"> <text>Reproduction of documents;</text> </paragraph> <paragraph num="(h)"> <text>Production of statistical reports;</text> </paragraph> <paragraph num="(i)"> <text>Copies of statutes and regulations; and</text> </paragraph> <paragraph num="(j)"> <text>Bank service charges for checks returned for insufficient funds.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The price adjustments in §G(1) of this regulation may be made by SOCALR as necessary without any additional consultation or amendments to the regulations, if these fees are published in the fee schedule distributed in accordance with §H of this regulation.</text> </paragraph> </paragraph> <paragraph num="H."> <text>When the fee schedule is adjusted, SOCALR shall provide a copy of the new fee schedule to all commercial ambulance services that:</text> <paragraph num="(1)"> <text>Are licensed by SOCALR at the time of issuance of any new or revised fee schedule; or</text> </paragraph> <paragraph num="(2)"> <text>Apply for a license after the issuance of each new or revised fee schedule.</text> </paragraph> </paragraph> <paragraph num="I."> <text>All applicable fees listed in the fee schedule currently in effect shall be submitted to SOCALR with each application.</text> </paragraph> <paragraph num="J."> <text>A license fee may not be refunded, in whole or in part, to any commercial ambulance service whose service or vehicle license is suspended or revoked.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Waivers."> <paragraph num="A."> <text>SOCALR may waive any equipment requirements under COMAR 30.09 for any commercial ambulance service which is licensed by Maryland or applying for a license, which demonstrates to the satisfaction of SOCALR that the equipment offered by the commercial ambulance service is equivalent to or superior to the equipment required by this subtitle.</text> </paragraph> <paragraph num="B."> <text>Waiver of Personnel Requirements.</text> <paragraph num="(1)"> <text>SOCALR may waive any personnel requirements under COMAR 30.09 for any commercial ambulance service which is licensed by Maryland or applying for a license, which demonstrates to the satisfaction of SOCALR that the personnel offered by the commercial ambulance service is equivalent to or superior to the personnel required by this subtitle, except the requirement for a licensed or certified driver for an ambulance, which may only be waived under §B(2) of this regulation.</text> </paragraph> <paragraph num="(2)"> <text>SOCALR may waive the personnel requirements under COMAR 30.09 for a licensed or certified driver for any commercial ambulance service which is licensed by Maryland or applying for a license. The initial waiver shall be for 1 year, subject to renewal.</text> </paragraph> <paragraph num="(3)"> <text>A commercial ambulance service seeking or maintaining a waiver of the requirement for a licensed or certified driver for an ambulance under COMAR 30.09 shall meet the following requirements:</text> <paragraph num="(a)"> <text>Submit to SOCALR with the application and on a monthly basis:</text> <paragraph num="(i)"> <text>The current number of unit hours staffed over a consecutive 7-day period during the most recent 30 days; and</text> </paragraph> <paragraph num="(ii)"> <text>The name and address of each non-EMS individual designated by the commercial service to drive an ambulance;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Ensure that each non-EMS individual designated to drive an ambulance possesses a current and valid For-Hire Driver's license issued by the Public Service Commission prior to use of a non-EMS driver on an ambulance;</text> </paragraph> <paragraph num="(c)"> <text>Provide to SOCALR a photocopy of a current and valid For-Hire Driver's license issued by the Public Service Commission for each non-EMS individual designated to drive an ambulance prior to use of a non-EMS drive on an ambulance;</text> </paragraph> <paragraph num="(d)"> <text>Ensure that each non-EMS individual designated to drive an ambulance obtains an ePINS number prior to use of a non-EMS driver on an ambulance;</text> </paragraph> <paragraph num="(e)"> <text>Provide the following training to each non-EMS individual it designates to drive an ambulance prior to use of a non-EMS driver on an ambulance:</text> <paragraph num="(i)"> <text>COMAR 30.09.02.02 — Patient Rights;</text> </paragraph> <paragraph num="(ii)"> <text>COMAR 30.09.07.03 — Operational Requirements;</text> </paragraph> <paragraph num="(iii)"> <text>Bloodborne Pathogens (29 CFR 1910.1030 to include Personal Protective Equipment and Body Substance Isolation precautions);</text> </paragraph> <paragraph num="(iv)"> <text>Lifting, moving, or positioning patients, to include stretcher and stair chair operations;</text> </paragraph> <paragraph num="(v)"> <text>CPR certification training, including the use of an AED; and</text> </paragraph> <paragraph num="(vi)"> <text>Driver's training program to include safe road operations, ambulance backing, and city driving;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Provide SOCALR with a copy of the training programs required for the non-EMS driver prior to use of a non-EMS driver on an ambulance;</text> </paragraph> <paragraph num="(g)"> <text>Ensure that any ALS licensed ground ambulance that is staffed with a non-EMS driver is also staffed with at least two individuals who meet the following requirements:</text> <paragraph num="(i)"> <text>A CRT or higher who is responsible for the patient as described in COMAR 30.09.07.02A(4)(b); and</text> </paragraph> <paragraph num="(ii)"> <text>An EMT or higher; and</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Ensure that any non-EMS individual designated to drive an ambulance:</text> <paragraph num="(i)"> <text>Is not subject to a current suspension or revocation of EMS licensure or certification; and</text> </paragraph> <paragraph num="(ii)"> <text>Has not been determined by SOCALR to be a threat to the health and safety of patients or the public.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>A commercial ambulance service seeking a waiver under this regulation shall apply in writing to SOCALR.</text> </paragraph> <paragraph num="D."> <text>A waiver is not valid unless issued in writing by SOCALR for a specific period of time.</text> </paragraph> <paragraph num="E."> <text>A commercial ambulance service granted a waiver under this subtitle shall reapply for the waiver 30 days before expiration of the waiver.</text> </paragraph> <paragraph num="F."> <text>A waiver may be summarily suspended if SOCALR finds the party to whom the waiver has been granted has:</text> <paragraph num="(1)"> <text>Obtained or attempted to obtain a waiver by fraud or deceit;</text> </paragraph> <paragraph num="(2)"> <text>Made a material omission or misrepresentation of fact on an application for a waiver;</text> </paragraph> <paragraph num="(3)"> <text>Made a material omission or misrepresentation of fact in response to an inquiry or investigation by SOCALR;</text> </paragraph> <paragraph num="(4)"> <text>Defaced, altered, removed, or obliterated any portion of or any official entry on a waiver issued by SOCALR;</text> </paragraph> <paragraph num="(5)"> <text>Interfered with SOCALR in the performance of SOCALR's duties;</text> </paragraph> <paragraph num="(6)"> <text>Failed to reapply for a waiver;</text> </paragraph> <paragraph num="(7)"> <text>Violated any applicable federal, State, or local statute or regulation;</text> </paragraph> <paragraph num="(8)"> <text>Failed to comply with the terms of the waiver; or</text> </paragraph> <paragraph num="(9)"> <text>Continued to use a non-EMS driver that SOCALR has determined, in conjunction with the MIEMSS Office of Integrity, to be a threat to the health and safety of patients or the public.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Failure to comply with the terms of a waiver granted under this regulation may be grounds for further action under COMAR 30.09.09.02.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.04 to COMAR 30.09.04, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02, Advertisement and Licensure Disclosure, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07, Eligibility, Application, and License Renewal, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03B amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A, B amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06A amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective January 15, 2005 (31:26 Md. R. 1866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 adopted effective May 14, 2001 (28:9 Md. R. 892)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08 amended effective July 7, 2025 (52:13 Md. R. 657)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B, F amended as an emergency provision effective August 26, 2021 (48:20 Md. R. 850); amended permanently effective January 13, 2022 (49:1 Md. R. 16)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08G adopted as an emergency provision effective August 26, 2021 (48:20 Md. R. 850); amended permanently effective January 13, 2022 (49:1 Md. R. 16)</annotation> </annotations> </chapter> <chapter num="05" heading="Issuance, Transfer, and Relinquishment of Licenses"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the issuance, transfer, and relinquishment of licenses for commercial ambulances.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Issuance of Licenses."> <paragraph num="A."> <text>SOCALR shall issue a license to an applicant that:</text> <paragraph num="(1)"> <text>Files the required application;</text> </paragraph> <paragraph num="(2)"> <text>Files the required supporting documentation;</text> </paragraph> <paragraph num="(3)"> <text>Pays the required fees; and</text> </paragraph> <paragraph num="(4)"> <text>Meets the other requirements of this subtitle for licensure.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Before issuing a license, SOCALR may verify information relating to an application by:</text> <paragraph num="(1)"> <text>Inspecting supporting documents;</text> </paragraph> <paragraph num="(2)"> <text>Inspecting a commercial ambulance service;</text> </paragraph> <paragraph num="(3)"> <text>Inspecting commercial ambulances; and</text> </paragraph> <paragraph num="(4)"> <text>Requiring a conference with the applicant.</text> </paragraph> </paragraph> <paragraph num="C."> <text>SOCALR may not issue a license to an applicant whose name is, in the judgement of SOCALR, confusingly similar to another person doing business in Maryland, or who otherwise has the right to use the name in Maryland.</text> </paragraph> <paragraph num="D."> <text>A licensed commercial ambulance service shall produce its license upon demand of any person.</text> </paragraph> <paragraph num="E."> <text>Unless revoked or surrendered, a commercial ambulance service license or ambulance license shall expire at midnight on the date indicated on the license.</text> </paragraph> <paragraph num="F."> <text>A revoked or surrendered commercial ambulance service license or ambulance license shall expire immediately upon notification.</text> </paragraph> <paragraph num="G."> <text>SOCALR shall affix a licensing decal to a commercial ground ambulance when it is licensed. The decal shall be displayed at all times on the outside of the back surface of the ambulance in a manner clearly visible to the public.</text> </paragraph> <paragraph num="H."> <text>A licensing decal is not proof of a valid license.</text> </paragraph> <paragraph num="I."> <text>Licenses and licensing decals issued by MIEMSS at all times remain the property of MIEMSS.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="License Renewal for Commercial Ambulance Services and Ambulances."> <paragraph num="A."> <text>A licensee shall apply for a new license at least 14 calendar days before the current license expires.</text> </paragraph> <paragraph num="B."> <text>To renew a license, the licensee shall apply to SOCALR under COMAR 30.09.03—30.09.05.</text> </paragraph> <paragraph num="C."> <text>If a commercial ambulance license is not renewed, the ambulance owner shall contact SOCALR to have the ambulance licensing decals removed from its ambulances under Regulation .09 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Transfer of Licenses."> <text>A commercial ambulance service license or ambulance license issued by MIEMSS may not be transferred or assigned without the prior written approval of MIEMSS.</text> </regulation> <regulation prefix="Regulation" num=".05" heading="Merger or Acquisition."> <paragraph num="A."> <text>The owner of a Maryland licensed commercial ambulance service wishing to merge with or acquire the assets or stock of another Maryland licensed commercial ambulance service may submit a letter of intent for the purpose of transferring the service and ambulance licenses to the successor service.</text> </paragraph> <paragraph num="B."> <text>Information submitted to SOCALR relating to the possible transfer of vehicle licenses in a potential merger or acquisition are confidential until a license is issued to the successor, except as otherwise required by law.</text> </paragraph> <paragraph num="C."> <text>If a successor service continues to do business in the name of and at the principal address of a merged or acquired service as it appears on the service license issued to the merged or acquired service and vehicles are not added at the time of merger or acquisition, the ground ambulance transfer fee is not imposed on the successor service in connection with the merger or acquisition.</text> </paragraph> <paragraph num="D."> <text>If a successor service changes the name or principal address of a merged or acquired service or any other information appearing on a ground ambulance license, a transfer fee shall be paid for each ground ambulance which is relicensed.</text> </paragraph> <paragraph num="E."> <text>The licensing fee required by COMAR 30.09.04.07 shall be paid for any additional ground ambulances licensed at the time of a merger or acquisition.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Preliminary Determination for Successor Commercial Ambulance Service."> <paragraph num="A."> <text>A prospective purchaser of the stock or assets of a commercial ambulance service, with the written permission of current ownership, may apply to SOCALR for a preliminary determination of the eligibility of the prospective purchaser for a commercial ambulance service license based on the eligibility criteria in COMAR 30.09.04.</text> </paragraph> <paragraph num="B."> <text>There is a fee for preliminary review of a license application submitted by a prospective buyer.</text> </paragraph> <paragraph num="C."> <text>Any information submitted to SOCALR relating to a potential acquisition of a commercial ambulance service is confidential until a license is issued to the successor, except as otherwise required by law.</text> </paragraph> <paragraph num="D."> <text>If the purchaser changes the name or principal address of the acquired service or any information on a ground ambulance license, a vehicle license transfer fee shall apply for each vehicle to be relicensed.</text> </paragraph> <paragraph num="E."> <text>The licensing fee required in COMAR 30.09.04.07 shall be paid for any additional ground ambulance licensed at the time of purchase.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Transfer of Vehicle License."> <paragraph num="A."> <text>A licensed commercial ambulance service may apply to SOCALR to transfer a commercial ground ambulance license from one of its ambulances to another if the transfer does not result in a net increase in the number of ground ambulances operated by the licensee.</text> </paragraph> <paragraph num="B."> <text>Any net increase in the number of ground ambulances operated by the licensee is:</text> <paragraph num="(1)"> <text>Treated as an addition to the fleet rather than a transfer; and</text> </paragraph> <paragraph num="(2)"> <text>Subject to payment of the entire annual, semiannual, or quarterly ambulance licensing fee.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Sale or Cessation of Operations."> <paragraph num="A."> <text>A commercial ambulance service shall contact SOCALR to have the ambulance licensing decals removed from its ambulances:</text> <paragraph num="(1)"> <text>Before it is sold; or</text> </paragraph> <paragraph num="(2)"> <text>Within 14 calendar days of cessation of operations.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a licensed commercial ambulance service is sold or ceases to operate, the service shall return the ambulance service license and all ground ambulance licenses to SOCALR within 14 calendar days of the sale or cessation of operation.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Vehicle Sold or Permanently Placed Out of Service."> <paragraph num="A."> <text>A commercial ambulance service shall contact SOCALR to have the ambulance's licensing decals removed:</text> <paragraph num="(1)"> <text>Before the ambulance is sold; or</text> </paragraph> <paragraph num="(2)"> <text>Within 14 calendar days of the date the ambulance is permanently placed out of service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A commercial ambulance service shall return to SOCALR a commercial ambulance license:</text> <paragraph num="(1)"> <text>Before selling the ambulance; or</text> </paragraph> <paragraph num="(2)"> <text>Within 14 calendar days of permanently placing the ambulance out of service.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.05 to COMAR 30.09.05, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07, Operational Requirements, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.09, Issuance, Transfer, and Relinquishment of Licenses, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C—E amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06D, E amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07A, B amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .08B amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> </annotations> </chapter> <chapter num="06" heading="Advertisement and Licensure Disclosure"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs advertising of commercial ambulance services and required disclosure of licensing information.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Advertising Requirements."> <paragraph num="A."> <text>Commercial ambulance service advertisements shall contain:</text> <paragraph num="(1)"> <text>The legal name or trade name of the commercial ambulance service stated on the license issued by MIEMSS; and</text> </paragraph> <paragraph num="(2)"> <text>The designation "Md.Comm.Amb.Lic.#" followed by the ambulance service license number issued by MIEMSS.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The license designation number requirement under §A(2) of this regulation does not apply to the ambulance.</text> </paragraph> <paragraph num="C."> <text>A commercial ambulance service that advertises 24-hour service shall:</text> <paragraph num="(1)"> <text>Operate 24 hours a day every day of the year;</text> </paragraph> <paragraph num="(2)"> <text>Provide uninterrupted service; and</text> </paragraph> <paragraph num="(3)"> <text>Have at least one employee answering the commercial ambulance service telephone.</text> </paragraph> </paragraph> <paragraph num="D."> <text>All commercial ambulance service advertisements shall comply with applicable laws, including the Consumer Protection Act, Commercial Law Article, Title 13, Annotated Code of Maryland, which prohibits unfair or deceptive trade practices and false, misleading, or deceptive advertising.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Required Disclosure in Contracts and Invoices."> <paragraph num="A."> <text>Each commercial ambulance service proposal or contract for services shall contain the:</text> <paragraph num="(1)"> <text>Designation "Md.Comm.Amb.Lic.#" followed by the ambulance service license number issued by MIEMSS; and</text> </paragraph> <paragraph num="(2)"> <text>Following notice:</text> </paragraph> </paragraph> <paragraph num="B."> <text>Each commercial ambulance service invoice for services shall contain the designation "Md.Comm.Amb.Lic.#" followed by the ambulance service license number issued by SOCALR.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.06 to COMAR 30.09.06, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03, Personnel, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.03, Advertisement and Licensure Disclosure, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> </annotations> </chapter> <chapter num="07" heading="Operational Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the operational requirements for commercial ambulance services and commercial ambulances.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Operational Requirements for Commercial Ambulance Services."> <paragraph num="A."> <text>Staffing. A commercial ambulance service shall:</text> <paragraph num="(1)"> <text>Staff each ambulance with a minimum of two EMS providers;</text> </paragraph> <paragraph num="(2)"> <text>Require that EMS providers:</text> <paragraph num="(a)"> <text>Have a valid identification card issued by MIEMSS showing the provider is licensed or certified by the EMS Board in their possession while on duty; and</text> </paragraph> <paragraph num="(b)"> <text>Upon request of SOCALR, provide their certification or license for inspection;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Assure that each BLS licensed ground ambulance is staffed with:</text> <paragraph num="(a)"> <text>A driver who is certified as emergency medical responder or higher and possesses and, while on duty, carries a valid motor vehicle license; and</text> </paragraph> <paragraph num="(b)"> <text>An individual in addition to the driver who is an emergency medical technician or higher, who is responsible for the patient until the patient is:</text> <paragraph num="(i)"> <text>Discharged in accordance with written physician orders; or</text> </paragraph> <paragraph num="(ii)"> <text>Delivered to a medical facility, nursing home, residence, or other home care system appropriate for the patient's condition;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Assure that each ALS licensed ground ambulance is staffed with:</text> <paragraph num="(a)"> <text>A driver who is certified as an emergency medical responder or higher and possesses and, while on duty, carries a valid motor vehicle license; and</text> </paragraph> <paragraph num="(b)"> <text>An individual in addition to the driver who is a licensed CRT or higher, who is responsible for the patient until the patient is:</text> <paragraph num="(i)"> <text>Discharged in accordance with written physician orders; or</text> </paragraph> <paragraph num="(ii)"> <text>Delivered to a medical facility, nursing home, residence, or other home care system appropriate for the patient's condition;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(5)"> <text>Assure that each air ambulance is staffed with a commercial ambulance crew and as required by CAMTS;</text> </paragraph> <paragraph num="(6)"> <text>Require that each nurse who is a regular crew member be familiar with the Maryland Protocols for EMS Providers;</text> </paragraph> <paragraph num="(7)"> <text>Require all employees to clearly display personal identification in readable text which includes the:</text> <paragraph num="(a)"> <text>Employee's last name; and</text> </paragraph> <paragraph num="(b)"> <text>Certification or license held by the individual;</text> </paragraph> </paragraph> <paragraph num="(8)"> <text>Require EMS providers to wear a certification or license insignia which is clearly displayed on the EMS providers' outermost garments;</text> </paragraph> <paragraph num="(9)"> <text>Require that employees display only valid certification or license identification or insignias; and</text> </paragraph> <paragraph num="(10)"> <text>Assure that EMS providers do not wear or display identification suggesting affiliation with any other service, organization, department, company, or agency.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Premises. A commercial ambulance service shall:</text> <paragraph num="(1)"> <text>Display its commercial ambulance service license, or a copy of it, at all locations of operation in a manner clearly visible to the public, at all times;</text> </paragraph> <paragraph num="(2)"> <text>Make readily available at all times for review by employees at the operating base and all satellite bases a current copy of:</text> <paragraph num="(a)"> <text>COMAR 30.01;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 30.02;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 30.03;</text> </paragraph> <paragraph num="(d)"> <text>COMAR 30.04;</text> </paragraph> <paragraph num="(e)"> <text>COMAR 30.09; and</text> </paragraph> <paragraph num="(f)"> <text>The documents incorporated by reference in this title;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Maintain the premises identified on the application in a clean and orderly manner; and</text> </paragraph> <paragraph num="(4)"> <text>Upon request from SOCALR, allow the inspection of the areas in which are located the commercial ambulance service's:</text> <paragraph num="(a)"> <text>Primary place of business;</text> </paragraph> <paragraph num="(b)"> <text>Satellite offices; and</text> </paragraph> <paragraph num="(c)"> <text>Records.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Infection Control Standards.</text> <paragraph num="(1)"> <text>An ambulance service shall:</text> <paragraph num="(a)"> <text>Use freshly laundered linen or disposable sheets and pillowcases or their equivalent for each patient;</text> </paragraph> <paragraph num="(b)"> <text>Show evidence of sanitary laundering arrangements, acceptable to SOCALR, for reusable linen;</text> </paragraph> <paragraph num="(c)"> <text>Store medical supplies in a clean and sanitary manner;</text> </paragraph> <paragraph num="(d)"> <text>Clean all equipment used after each patient; including:</text> <paragraph num="(i)"> <text>Ambulance stretcher; and</text> </paragraph> <paragraph num="(ii)"> <text>Stretcher mattress;</text> </paragraph> </paragraph> <paragraph num="(e)"> <text>Clean the patient compartment surfaces in the ambulance at least daily, and use a disinfectant in accordance with 29 CFR §1910.1030:</text> <paragraph num="(i)"> <text>When surfaces become obviously contaminated;</text> </paragraph> <paragraph num="(ii)"> <text>After any spill of blood or other potentially infectious material; and</text> </paragraph> <paragraph num="(iii)"> <text>Routinely throughout the work shift if contamination might have occurred;</text> </paragraph> </paragraph> <paragraph num="(f)"> <text>Provide adequate hand-washing facilities with:</text> <paragraph num="(i)"> <text>Hot and cold running water;</text> </paragraph> <paragraph num="(ii)"> <text>Antiseptic soap; and</text> </paragraph> <paragraph num="(iii)"> <text>A sanitary method for hand drying;</text> </paragraph> </paragraph> <paragraph num="(g)"> <text>Require that each crew member wash their hands with an antiseptic agent before and after each patient contact;</text> </paragraph> <paragraph num="(h)"> <text>Dispose of equipment or supplies that are not reusable after use;</text> </paragraph> <paragraph num="(i)"> <text>Disinfect equipment or supplies intended to be clean but not sterile after each use or when they become soiled; and</text> </paragraph> <paragraph num="(j)"> <text>Sterilize equipment or supplies after each use or when sterility has been compromised.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>A commercial ambulance service may not transport a corpse unless:</text> <paragraph num="(a)"> <text>There is a compelling public interest for moving the body or body parts;</text> </paragraph> <paragraph num="(b)"> <text>Transport is not readily available by a funeral home; and</text> </paragraph> <paragraph num="(c)"> <text>An authorized representative of the Office of the Chief Medical Examiner requests transport.</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>After the transport of a body in accordance with §C(2) of this regulation, a commercial ambulance service shall assure that the ambulance patient compartment is disinfected.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Training and Continuing Education Requirements. A commercial ambulance service shall:</text> <paragraph num="(1)"> <text>Provide an orientation to all new employees that includes a review of:</text> <paragraph num="(a)"> <text>COMAR 30.02;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 30.09; and</text> </paragraph> <paragraph num="(c)"> <text>The documents incorporated by reference in Title 30;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Before assigning duties and at least annually thereafter provide training at no cost to all employees which includes:</text> <paragraph num="(a)"> <text>Blood-borne pathogens in accordance with 29 CFR §1910.1030;</text> </paragraph> <paragraph num="(b)"> <text>Hazard Communication Plan in accordance with 29 CFR §1910.1200;</text> </paragraph> <paragraph num="(c)"> <text>FDA Medical Device Reporting in accordance with 21 CFR 803 et al.; and</text> </paragraph> <paragraph num="(d)"> <text>Other training required by the Maryland Occupational Safety and Health regulations;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Provide for adequate training and continuing education opportunities to fulfill the minimum recertification or license renewal requirements for EMS providers; and</text> </paragraph> <paragraph num="(4)"> <text>Absorb the cost for providing training that will meet the recertification or relicensure requirements of EMS providers who worked for the commercial service an average of 20 hours per week for the previous 12 months.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Medical Direction Requirements. A commercial ambulance service shall:</text> <paragraph num="(1)"> <text>Retain one or more participating physicians who agree to:</text> <paragraph num="(a)"> <text>Assume physician responsibilities for the commercial ambulance service and its EMS providers; and</text> </paragraph> <paragraph num="(b)"> <text>Comply with all applicable sections of COMAR 30.03; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Provide an EMS skills review for the commercial ambulance service's EMS providers which meets their recertification and relicensing requirements.</text> </paragraph> </paragraph> <paragraph num="F."> <text>Compliance with Statutes and Regulations. A commercial ambulance service shall:</text> <paragraph num="(1)"> <text>Comply with all applicable laws, including:</text> <paragraph num="(a)"> <text>COMAR 30.02;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 30.03;</text> </paragraph> <paragraph num="(c)"> <text>COMAR 30.09; and</text> </paragraph> <paragraph num="(d)"> <text>The requirements contained in Maryland Medical Protocols for Emergency Medical Providers;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintain uninterrupted and continuous insurance coverage as required in COMAR 30.09.04.06;</text> </paragraph> <paragraph num="(3)"> <text>Monitor the care provided by its EMS providers and ambulance drivers on an ongoing basis;</text> </paragraph> <paragraph num="(4)"> <text>Within 72 hours of occurrence, report any violations of:</text> <paragraph num="(a)"> <text>COMAR 30.02;</text> </paragraph> <paragraph num="(b)"> <text>COMAR 30.09; or</text> </paragraph> <paragraph num="(c)"> <text>The documents incorporated by reference in this title;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Comply with all local, State, and federal laws and regulations including:</text> <paragraph num="(a)"> <text>Transportation Article, §11-101—27-109, Annotated Code of Maryland (relating to motor vehicle and emergency vehicle operations);</text> </paragraph> <paragraph num="(b)"> <text>COMAR 11.14 (relating to motor vehicle safety requirements);</text> </paragraph> <paragraph num="(c)"> <text>Maryland Department of Health regulations under COMAR Title 10;</text> </paragraph> <paragraph num="(d)"> <text>Maryland Occupational Safety and Health regulations under COMAR 09.12;</text> </paragraph> <paragraph num="(e)"> <text>29 CFR §1910.1030 (relating to blood-borne pathogens);</text> </paragraph> <paragraph num="(f)"> <text>29 CFR §1910.1200 (Hazard Communications/Employee Right to Know); and</text> </paragraph> <paragraph num="(g)"> <text>21 CFR 803 et al. (FDA Medical Device Reporting Requirements).</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Operational Requirements for Ambulances."> <text>A commercial ambulance service shall:</text> <paragraph num="A."> <text>Only dispatch an ambulance if:</text> <paragraph num="(1)"> <text>The ambulance and crew can:</text> <paragraph num="(a)"> <text>Arrive at the scene within a reasonable response time;</text> </paragraph> <paragraph num="(b)"> <text>Provide appropriate transportation; and</text> </paragraph> <paragraph num="(c)"> <text>Provide appropriate medical care;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The ambulance has available all of the following in adequate amounts to meet the needs of the patient being transported:</text> <paragraph num="(a)"> <text>Adequate supplies;</text> </paragraph> <paragraph num="(b)"> <text>Adequate equipment;</text> </paragraph> <paragraph num="(c)"> <text>All equipment assembled and ready for use, except items that are sterile;</text> </paragraph> <paragraph num="(d)"> <text>All portable oxygen cylinders which have a total of 210 liters at 1500 psi or more, excluding any cylinder with less than 500 psi;</text> </paragraph> <paragraph num="(e)"> <text>A cylinder attached to the portable oxygen administration device with more than 500 psi, and, if present, an onboard cylinder which has more than 300 psi;</text> </paragraph> <paragraph num="(f)"> <text>Sufficient oxygen available, after deducting for a safe residual pressure of 200 psi per cylinder, to meet the needs of the patient being transported based on the expected flow rate and the required duration of transport given the following formula and cylinder constants:</text> </paragraph> <paragraph num="(g)"> <text>Oxygen cylinders located in the patient compartment secured by a crash stable bracket that meets:</text> <paragraph num="(i)"> <text>For ground ambulances, the test requirements in Ambulance Manufacturers Division Oxygen Tank Retention Standard 003; or</text> </paragraph> <paragraph num="(ii)"> <text>For air ambulances, FAA requirements;</text> </paragraph> </paragraph> <paragraph num="(h)"> <text>Oxygen cylinders located in a compartment other than the patient compartment secured in a bracket appropriate for the cylinder that has:</text> <paragraph num="(i)"> <text>A positive locking latch, and</text> </paragraph> <paragraph num="(ii)"> <text>Both latch and hinges bolted to the door frame structure;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>Communication equipment required in COMAR 30.09.10.04C which:</text> <paragraph num="(i)"> <text>Is reliable, and</text> </paragraph> <paragraph num="(ii)"> <text>Can properly communicate with the ambulance services dispatch center from the time of dispatch until time call is completed;</text> </paragraph> </paragraph> <paragraph num="(j)"> <text>Communication equipment required in COMAR 30.09.10.04D which:</text> <paragraph num="(i)"> <text>Is reliable,</text> </paragraph> <paragraph num="(ii)"> <text>Can properly communicate with online medical control in Maryland, and</text> </paragraph> <paragraph num="(iii)"> <text>Meets the specifications set forth by the MIEMSS Emergency Medical Services Communications;</text> </paragraph> </paragraph> <paragraph num="(k)"> <text>A reliable means of communication from the point of dispatch until the patient reaches the final destination;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>The ambulance crew is adequately trained to safely:</text> <paragraph num="(a)"> <text>Operate an ambulance; and</text> </paragraph> <paragraph num="(b)"> <text>Use the equipment and supplies onboard;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Place medical supplies out of service as they expire and properly discard medical supplies which are expired;</text> </paragraph> <paragraph num="C."> <text>Place malfunctioning medical equipment out of service until the equipment has been repaired or replaced;</text> </paragraph> <paragraph num="D."> <text>Have an adequate number of AEDs to provide one AED on every:</text> <paragraph num="(1)"> <text>BLS licensed ambulance in service; and</text> </paragraph> <paragraph num="(2)"> <text>ALS licensed ambulance in service operating as a BLS ambulance;</text> </paragraph> </paragraph> <paragraph num="E."> <text>For ground ambulances, have each ambulance inspected every 12 months by an inspection station licensed under Transportation Article, §23-103, Annotated Code of Maryland;</text> </paragraph> <paragraph num="F."> <text>For ground ambulances, designate and maintain ambulances as emergency vehicles by equipping them with necessary:</text> <paragraph num="(1)"> <text>Lights;</text> </paragraph> <paragraph num="(2)"> <text>Sirens; and</text> </paragraph> <paragraph num="(3)"> <text>Special markings;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Under Transportation Article, §11-118, Annotated Code of Maryland, equip and operate only ambulances as emergency vehicles;</text> </paragraph> <paragraph num="H."> <text>Always operate each ambulance with due regard for the public;</text> </paragraph> <paragraph num="I."> <text>Only use emergency warning lights and audible warning devices when:</text> <paragraph num="(1)"> <text>En route to an emergency as a result of a call for assistance made directly to the commercial ambulance service; or</text> </paragraph> <paragraph num="(2)"> <text>Transporting a priority 1 patient;</text> </paragraph> </paragraph> <paragraph num="J."> <text>Maintain in proper working order and good physical condition and, where applicable, meet all manufacturers recommendations for all:</text> <paragraph num="(1)"> <text>Equipment; and</text> </paragraph> <paragraph num="(2)"> <text>Ambulances;</text> </paragraph> </paragraph> <paragraph num="K."> <text>Display the ambulance license, or a copy, in the patient compartment in a manner clearly visible to the patient;</text> </paragraph> <paragraph num="L."> <text>Prohibit smoking or the carrying of lighted tobacco products on ambulances;</text> </paragraph> <paragraph num="M."> <text>For ground ambulances, prohibit an ambulance to be driven, and may not allow any passengers or patients on board, until necessary repairs are completed and an inspection conducted if any of the following occur:</text> <paragraph num="(1)"> <text>An occupant complains of symptoms associated with or has been affected by carbon monoxide as a result of riding in the ambulance;</text> </paragraph> <paragraph num="(2)"> <text>Carbon monoxide levels at or above 9 parts per million are detected in the interior of the ambulance; or</text> </paragraph> <paragraph num="(3)"> <text>A mechanical condition is discovered that is reasonably likely to produce a carbon monoxide hazard to the occupants;</text> </paragraph> </paragraph> <paragraph num="N."> <text>Assure occupants are safely transported in ambulances by:</text> <paragraph num="(1)"> <text>Requiring all occupants to wear safety restraints, except as necessary to attend to a patient;</text> </paragraph> <paragraph num="(2)"> <text>Requiring all patients to be secured to stretchers in accordance with the stretcher manufacturer's recommendation, except as may be necessary for treatment;</text> </paragraph> <paragraph num="(3)"> <text>For ground ambulances:</text> <paragraph num="(a)"> <text>Operating an ambulance only when the ambulance is equipped with devices that comply with federal motor vehicle safety standards (49 CFR Part 571) for:</text> <paragraph num="(i)"> <text>Restraints;</text> </paragraph> <paragraph num="(ii)"> <text>Anchors; and</text> </paragraph> <paragraph num="(iii)"> <text>Mechanisms; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Transport children younger than 4 years old, who are passengers and not patients, only in the front passenger compartment when:</text> <paragraph num="(i)"> <text>The child is secured in a child passenger restraint system which meets State and federal motor vehicle safety standards; and</text> </paragraph> <paragraph num="(ii)"> <text>The vehicle is not equipped with a passenger air bag;</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="O."> <text>Stow or adequately fasten all medical devices, supplies, or equipment to the satisfaction of SOCALR to prevent items from becoming projectiles that might cause injury in an abrupt stop or crash;</text> </paragraph> <paragraph num="P."> <text>Assure that compartments used to carry heavier items, first aid kits, portable oxygen cylinders, suction units, intravenous pumps, ventilators, and monitors have positively locking latches:</text> <paragraph num="(1)"> <text>With both latch and hinge bolted to the door and frame structure; and</text> </paragraph> <paragraph num="(2)"> <text>That are designed to remain closed in an abrupt stop or crash, including rollovers; and</text> </paragraph> </paragraph> <paragraph num="Q."> <text>Carry intravenous fluids, saline, sterile water, or other fluids only in bags or plastic bottles unless:</text> <paragraph num="(1)"> <text>A specific required fluid is only available in a glass container; and</text> </paragraph> <paragraph num="(2)"> <text>Protective measures are employed to protect occupants from broken glass in the event of breakage.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Interface with Jurisdictional EMS Operational Programs—Commercial Ground Ambulance Services."> <paragraph num="A."> <text>Unless requested to do so by a jurisdiction's communications center or unless standing by under contract with the organizer of an event, a commercial ambulance service may not respond to an emergency incident which:</text> <paragraph num="(1)"> <text>Occurs on a public street, public alley, public way, or public place of the State, where emergency units of a jurisdictional EMS operational program have the responsibility for rendering emergency service;</text> </paragraph> <paragraph num="(2)"> <text>Involves mass casualties or requires care of more than one individual as a result of the same incident;</text> </paragraph> <paragraph num="(3)"> <text>Involves hazardous, incendiary, or explosive materials;</text> </paragraph> <paragraph num="(4)"> <text>Involves a trapped person who requires extrication or forcible entry;</text> </paragraph> <paragraph num="(5)"> <text>Involves an uncontained fire;</text> </paragraph> <paragraph num="(6)"> <text>Involves imminent danger to parties or property other than the patient for which the commercial ambulance service is being called upon to render service; or</text> </paragraph> <paragraph num="(7)"> <text>Requires resources that the commercial ambulance service does not have.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a commercial ambulance service and jurisdiction units respond to a call for assistance for the same patient or incident, the commercial ambulance service shall defer to the jurisdictional EMS operational unit unless the patient, or the patient's legal guardian, when competent to do so, expressly requests care or transport, or both, from the commercial ambulance service instead of the jurisdictional EMS operational unit.</text> </paragraph> <paragraph num="C."> <text>If an uncommitted commercial ambulance crew chooses to render assistance or medical care at an emergency, such as those described under §A of this regulation and can do so without the crew members themselves becoming victims, and no jurisdictional EMS providers are immediately available, the following procedure applies:</text> <paragraph num="(1)"> <text>The commercial ambulance service shall immediately contact the jurisdiction's communications center by the most expeditious means available to the ambulance service, and advise the communications center of the:</text> <paragraph num="(a)"> <text>Nature and location of the emergency,</text> </paragraph> <paragraph num="(b)"> <text>Identity of the commercial ambulance service and ambulance, and</text> </paragraph> <paragraph num="(c)"> <text>Level of care capability of the ambulance;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>If a jurisdiction dispatches units to the scene, the commercial ambulance crew shall care for the patient or patients within the scope of the ambulance crew's health care certification or license for the ambulance they are operating until representatives of the jurisdiction's emergency medical services arrive;</text> </paragraph> <paragraph num="(3)"> <text>A jurisdiction may request the commercial ambulance service to effect the transport; and</text> </paragraph> <paragraph num="(4)"> <text>A commercial ambulance service electing to comply with a jurisdiction's request may only charge the patient for services or transport rendered if the jurisdiction would have charged the patient.</text> </paragraph> </paragraph> <paragraph num="D."> <text>A commercial ambulance service that requests a jurisdiction to assist them with manpower or equipment shall:</text> <paragraph num="(1)"> <text>If requested by jurisdictional authorities immediately defer patient care and scene control to jurisdictional authorities on scene; and</text> </paragraph> <paragraph num="(2)"> <text>At the discretion of the local jurisdiction authorities on the scene, complete the call after the assistance requested has been provided.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Voluntary Service during Disasters.</text> <paragraph num="(1)"> <text>A jurisdictional EMS operational program may directly, or through MIEMSS, request assistance from commercial ambulance services licensed under this subtitle.</text> </paragraph> <paragraph num="(2)"> <text>A commercial ambulance service may, but is not required to, provide assistance in response to a request from a jurisdictional EMS operational program.</text> </paragraph> <paragraph num="(3)"> <text>A commercial ambulance service electing to respond to an incident in response to a request for assistance shall:</text> <paragraph num="(a)"> <text>Respond to a staging site established by the jurisdictional EMS operational program; and</text> </paragraph> <paragraph num="(b)"> <text>Operate under the command and control of the jurisdictional EMS operational program.</text> </paragraph> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.07 to COMAR 30.09.07, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10, Minimum Equipment, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04, Operational Requirements, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective October 15, 2004 (31:20 Md. R. 1486); December 19, 2005 (32:25 Md. R. 1948); December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended as an emergency provision effective January 1, 2020 (47:1 Md. R. 11); amended permanently effective June 15, 2020 (47:12 Md. R. 598)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> </annotations> </chapter> <chapter num="08" heading="Record-Keeping and Submission Requirements"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the record keeping and submission requirements for commercial ambulance services and commercial ambulances.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="General Record-Keeping Requirements."> <text>A commercial ambulance service shall:</text> <paragraph num="A."> <text>Maintain records in any permanent form including:</text> <paragraph num="(1)"> <text>Paper, or</text> </paragraph> <paragraph num="(2)"> <text>Magnetic media;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Organize all records in such a manner as to allow the commercial ambulance service to locate, within a reasonable time, a record, given:</text> <paragraph num="(1)"> <text>A patient's name,</text> </paragraph> <paragraph num="(2)"> <text>Date and time of a call, and</text> </paragraph> <paragraph num="(3)"> <text>Pick up or discharge location; and</text> </paragraph> </paragraph> <paragraph num="C."> <text>Retain all records for not less than 5 years and in accordance with:</text> <paragraph num="(1)"> <text>Local law,</text> </paragraph> <paragraph num="(2)"> <text>State law, and</text> </paragraph> <paragraph num="(3)"> <text>Federal law.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Patient Records."> <paragraph num="A."> <text>A commercial ambulance service shall maintain complete and accurate records regarding the care and transportation of each patient that the commercial ambulance service:</text> <paragraph num="(1)"> <text>Responds to transport;</text> </paragraph> <paragraph num="(2)"> <text>Agrees to transport; or</text> </paragraph> <paragraph num="(3)"> <text>Transports to, from, or within the State.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A record for each patient referred to in §A of this regulation shall contain the following information:</text> <paragraph num="(1)"> <text>Patient's name;</text> </paragraph> <paragraph num="(2)"> <text>Patient's residence address;</text> </paragraph> <paragraph num="(3)"> <text>Date and time of scheduled pickup;</text> </paragraph> <paragraph num="(4)"> <text>Location of pick up;</text> </paragraph> <paragraph num="(5)"> <text>Date of service;</text> </paragraph> <paragraph num="(6)"> <text>Time dispatched;</text> </paragraph> <paragraph num="(7)"> <text>Commercial ambulance number;</text> </paragraph> <paragraph num="(8)"> <text>Time en route to pick up location;</text> </paragraph> <paragraph num="(9)"> <text>Time arrived at pick up location;</text> </paragraph> <paragraph num="(10)"> <text>Time en route to destination;</text> </paragraph> <paragraph num="(11)"> <text>Patient's destination;</text> </paragraph> <paragraph num="(12)"> <text>Time arrived at destination;</text> </paragraph> <paragraph num="(13)"> <text>Referring physician;</text> </paragraph> <paragraph num="(14)"> <text>Receiving physician, if available; and</text> </paragraph> <paragraph num="(15)"> <text>Pertinent remarks.</text> </paragraph> </paragraph> <paragraph num="C."> <text>A commercial ambulance service shall use the standard Maryland Ambulance Information System runsheet and additional narrative supplied at cost by SOCALR.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Personnel Records."> <text>A commercial ambulance service shall maintain:</text> <paragraph num="A."> <text>A complete and current personnel list which includes:</text> <paragraph num="(1)"> <text>EMS providers;</text> </paragraph> <paragraph num="(2)"> <text>Ambulance drivers;</text> </paragraph> <paragraph num="(3)"> <text>Registered nurses; and</text> </paragraph> <paragraph num="(4)"> <text>Any other medical personnel employed;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Personnel lists which include each employee's:</text> <paragraph num="(1)"> <text>Full name; and</text> </paragraph> <paragraph num="(2)"> <text>Health care certification or license:</text> <paragraph num="(a)"> <text>Number,</text> </paragraph> <paragraph num="(b)"> <text>Level,</text> </paragraph> <paragraph num="(c)"> <text>Date of issuance, and</text> </paragraph> <paragraph num="(d)"> <text>Date of expiration;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Accurate and completed employee training records for:</text> <paragraph num="(1)"> <text>New employee orientation;</text> </paragraph> <paragraph num="(2)"> <text>Continuing education; and</text> </paragraph> <paragraph num="(3)"> <text>All training required for compliance with this subtitle;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Training records that document:</text> <paragraph num="(1)"> <text>Date training provided;</text> </paragraph> <paragraph num="(2)"> <text>Course outline;</text> </paragraph> <paragraph num="(3)"> <text>Employee attendance;</text> </paragraph> <paragraph num="(4)"> <text>Instructor name; and</text> </paragraph> <paragraph num="(5)"> <text>Instructor's qualifications; and</text> </paragraph> </paragraph> <paragraph num="E."> <text>Accurate records of employee:</text> <paragraph num="(1)"> <text>Communicable disease exposure histories;</text> </paragraph> <paragraph num="(2)"> <text>Immunization records; and</text> </paragraph> <paragraph num="(3)"> <text>Yearly TB screening.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Vehicle Records."> <text>A commercial ambulance service shall:</text> <paragraph num="A."> <text>Complete dated inventory sheets daily to ensure each ambulance is:</text> <paragraph num="(1)"> <text>Clean,</text> </paragraph> <paragraph num="(2)"> <text>Has adequate supplies, and</text> </paragraph> <paragraph num="(3)"> <text>Is in compliance with COMAR 11.14; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>Maintain a written policy detailing the procedures to be followed if a mechanical failure occurs with the ambulance when responding to or transporting a patient.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Submission of Reports."> <text>A commercial ambulance service shall:</text> <paragraph num="A."> <text>Upon reasonable request from SOCALR, submit within a reasonable time:</text> <paragraph num="(1)"> <text>Reports;</text> </paragraph> <paragraph num="(2)"> <text>Surveys;</text> </paragraph> <paragraph num="(3)"> <text>Complaint investigation findings;</text> </paragraph> <paragraph num="(4)"> <text>Patient care records;</text> </paragraph> <paragraph num="(5)"> <text>Personnel records;</text> </paragraph> <paragraph num="(6)"> <text>Training records; and</text> </paragraph> <paragraph num="(7)"> <text>Vehicle records;</text> </paragraph> </paragraph> <paragraph num="B."> <text>Notify SOCALR orally within 72 hours, and in writing within 5 calendar days, of all:</text> <paragraph num="(1)"> <text>New names registered with the Maryland Department of Assessments and Taxation for the purpose of doing business;</text> </paragraph> <paragraph num="(2)"> <text>Additions, or deletions, to the physical locations of operation;</text> </paragraph> <paragraph num="(3)"> <text>Changes in:</text> <paragraph num="(a)"> <text>Medical direction,</text> </paragraph> <paragraph num="(b)"> <text>ALS coordinator,</text> </paragraph> <paragraph num="(c)"> <text>Information included on an application, and</text> </paragraph> <paragraph num="(d)"> <text>Operation of the ambulance service;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Reports submitted to the deputy State health officer in accordance with COMAR 10.06.01;</text> </paragraph> <paragraph num="(5)"> <text>Reports submitted in accordance with COMAR 30.03.04;</text> </paragraph> <paragraph num="(6)"> <text>Violations of this subtitle by:</text> <paragraph num="(a)"> <text>A commercial ambulance service employee, or</text> </paragraph> <paragraph num="(b)"> <text>Anyone acting as an agent for a commercial ambulance service;</text> </paragraph> </paragraph> <paragraph num="(7)"> <text>Events involving the commercial ambulance service which results in:</text> <paragraph num="(a)"> <text>Bodily injury, or</text> </paragraph> <paragraph num="(b)"> <text>Death;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Submit every proposed change to ambulance markings for review and approval before making any changes to ambulance markings, including but not limited to:</text> <paragraph num="(1)"> <text>Numbering;</text> </paragraph> <paragraph num="(2)"> <text>Lettering; or</text> </paragraph> <paragraph num="(3)"> <text>Symbols;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Submit by the 15th of each month for the preceding month a complete and accurate MAIS report for each patient that the commercial ambulance service:</text> <paragraph num="(1)"> <text>Responds to transport;</text> </paragraph> <paragraph num="(2)"> <text>Agrees to transport; or</text> </paragraph> <paragraph num="(3)"> <text>Transports to, from, or within the State;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Submit a current personnel list quarterly, before the 15th of January, April, July, and October; and</text> </paragraph> <paragraph num="F."> <text>Submit by the 15th of each month for the preceding month a summary report listing the number of calls for the month that were:</text> <paragraph num="(1)"> <text>BLS;</text> </paragraph> <paragraph num="(2)"> <text>ALS;</text> </paragraph> <paragraph num="(3)"> <text>Neonatal;</text> </paragraph> <paragraph num="(4)"> <text>SCT;</text> </paragraph> <paragraph num="(5)"> <text>Accompanied by a physician, nurse, or other health care provider;</text> </paragraph> <paragraph num="(6)"> <text>Referred to 911; or</text> </paragraph> <paragraph num="(7)"> <text>BLS calls in which the AED was used.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.08 to COMAR 30.09.08, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.02, Record Keeping and Reporting, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06, Record Keeping and Submission Requirements, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06F amended effective January 15, 2005 (31:26 Md. R. 1866)</annotation> </annotations> </chapter> <chapter num="09" heading="Enforcement"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the enforcement of commercial ambulance statutes and regulations.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Sanctions."> <paragraph num="A."> <text>If a licensee or applicant violates Education Article, §13-515, Annotated Code of Maryland, or this subtitle, SOCALR may:</text> <paragraph num="(1)"> <text>Deny the applicant's application; or</text> </paragraph> <paragraph num="(2)"> <text>Suspend or revoke the licensee's license.</text> </paragraph> </paragraph> <paragraph num="B."> <text>If a person granted a waiver of the requirements of Education Article, §13-515, Annotated Code of Maryland, by MIEMSS violates the provisions of this subtitle, MIEMSS may rescind the waiver.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Prohibited Conduct."> <text>The following conduct is prohibited:</text> <paragraph num="A."> <text>Obtaining, attempting to obtain, or maintaining a waiver by fraud or deceit;</text> </paragraph> <paragraph num="B."> <text>Making a material omission or misrepresentation of fact on an application for a license or a waiver;</text> </paragraph> <paragraph num="C."> <text>Making a material omission or misrepresentation of fact in response to an inquiry or investigation by SOCALR for the purposes of determining compliance or investigating a complaint;</text> </paragraph> <paragraph num="D."> <text>Defacing, altering, removing, or obliterating any portion of or any official entry on a license, licensing decal, or waiver issued by SOCALR;</text> </paragraph> <paragraph num="E."> <text>Interfering with SOCALR in the performance of its duties;</text> </paragraph> <paragraph num="F."> <text>Failing to pay applicable licensing fees;</text> </paragraph> <paragraph num="G."> <text>Failing to pay the cost of services and materials provided to the commercial ambulance service by MIEMSS;</text> </paragraph> <paragraph num="H."> <text>Failing to comply with the requirements of a noncompliance notice or remedial action;</text> </paragraph> <paragraph num="I."> <text>Receiving multiple noncompliance notices which in SOCALR's judgment are of sufficient quantity, severity, or frequency to require more severe action to ensure the health, safety, and welfare of those persons utilizing the services of a particular commercial ambulance service;</text> </paragraph> <paragraph num="J."> <text>Violating Education Article, §13-515, Annotated Code of Maryland;</text> </paragraph> <paragraph num="K."> <text>Violating this subtitle; or</text> </paragraph> <paragraph num="L."> <text>Under the laws of the United States or of any state, conviction of any owner, Maryland based principal, or individual with substantial control over the finances, operations, or both of the service, for a felony or a misdemeanor that is directly related to the fitness and qualification of the applicant or licensee to provide commercial ambulance services.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Complaints."> <paragraph num="A."> <text>A commercial ambulance service licensed by SOCALR shall:</text> <paragraph num="(1)"> <text>Have a written procedure for responding to complaints about service;</text> </paragraph> <paragraph num="(2)"> <text>Provide a copy of its complaint procedure to any person upon request; and</text> </paragraph> <paragraph num="(3)"> <text>Notify each complainant of the right to file a complaint with SOCALR if not satisfied with the response of the commercial ambulance service.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Any person may file a complaint about a commercial ambulance service with SOCALR.</text> </paragraph> <paragraph num="C."> <text>SOCALR may ask a commercial ambulance service to explain a complaint before SOCALR takes further action on it.</text> </paragraph> <paragraph num="D."> <text>A complaint not covered by this subtitle may be referred by SOCALR to other appropriate parties for investigation and action.</text> </paragraph> <paragraph num="E."> <text>A commercial ambulance service shall:</text> <paragraph num="(1)"> <text>Send SOCALR any written complaint made to the commercial ambulance service alleging a potential violation of the Maryland Medical Protocols for Emergency Medical Providers within 5 days of receipt by the commercial ambulance service;</text> </paragraph> <paragraph num="(2)"> <text>Send SOCALR within 14 days a written report of the investigation by the commercial ambulance medical director;</text> </paragraph> <paragraph num="(3)"> <text>Notify SOCALR within 72 hours of receiving a written complaint alleging a potential violation of Education Article, §13-515, Annotated Code of Maryland, or this subtitle;</text> </paragraph> <paragraph num="(4)"> <text>Forward applicable complaints within 5 days of receipt;</text> </paragraph> <paragraph num="(5)"> <text>Attach a written explanation of the ambulance service's position on the complaint; and</text> </paragraph> <paragraph num="(6)"> <text>Explain the current status of the complaint.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A commercial ambulance service may not retaliate against an employee because the employee:</text> <paragraph num="(1)"> <text>Makes a complaint under this subtitle; or</text> </paragraph> <paragraph num="(2)"> <text>Participates in a proceeding under this subtitle.</text> </paragraph> </paragraph> <paragraph num="G."> <text>SOCALR does not have jurisdiction over and may not take action on complaints that relate solely to billing matters.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Inspections and Investigations."> <paragraph num="A."> <text>SOCALR may inspect a commercial ambulance service or commercial ambulance and investigate compliance by a commercial ambulance crew member to:</text> <paragraph num="(1)"> <text>Decide whether to issue a license;</text> </paragraph> <paragraph num="(2)"> <text>Ensure the health, safety, or welfare of the persons who utilize commercial ambulance services; or</text> </paragraph> <paragraph num="(3)"> <text>Respond to a complaint.</text> </paragraph> </paragraph> <paragraph num="B."> <text>SOCALR may inspect the following to verify eligibility or continued compliance with this subtitle:</text> <paragraph num="(1)"> <text>All premises designated on the application;</text> </paragraph> <paragraph num="(2)"> <text>All commercial ambulances;</text> </paragraph> <paragraph num="(3)"> <text>All required equipment and supplies;</text> </paragraph> <paragraph num="(4)"> <text>The manner of use of required equipment;</text> </paragraph> <paragraph num="(5)"> <text>The manner of operation of the commercial ambulance service;</text> </paragraph> <paragraph num="(6)"> <text>The driver's licenses and health care certification or license issued by MIEMSS for each crew member; and</text> </paragraph> <paragraph num="(7)"> <text>All records regarding the operation of the commercial ambulance service relating to this subtitle, including patient medical records when appropriate.</text> </paragraph> </paragraph> <paragraph num="C."> <text>SOCALR may conduct confidential conferences with staff or patients during any inspection or investigation.</text> </paragraph> <paragraph num="D."> <text>Upon request by SOCALR, a commercial ambulance service, and its owners, management, employees, or agents, shall, at reasonable times and without delay, allow SOCALR to enter all premises designated on the application or used in the operation of a commercial ambulance service, and all commercial ambulances used by the commercial ambulance service, for the purpose of an inspection or investigation necessary to ensure compliance with this subtitle.</text> </paragraph> <paragraph num="E."> <text>Inspections to evaluate eligibility of a commercial ambulance service or a commercial ambulance for a license shall be scheduled with the management of the commercial ambulance service at least 24 hours before the inspection unless otherwise mutually agreed.</text> </paragraph> <paragraph num="F."> <text>Inspections to ensure continued compliance with this subtitle do not require advance notice.</text> </paragraph> <paragraph num="G."> <text>Inspection Procedure. SOCALR shall:</text> <paragraph num="(1)"> <text>Identify itself at the inspection site;</text> </paragraph> <paragraph num="(2)"> <text>Inform the commercial ambulance service representative of the purpose for the inspection; and</text> </paragraph> <paragraph num="(3)"> <text>Inform the commercial ambulance service representative when the inspection has been completed.</text> </paragraph> </paragraph> <paragraph num="H."> <text>SOCALR may inspect a commercial ambulance vehicle at any reasonable time, including whenever it is present at a health care facility or other place of medical care or when picking up, transporting, or discharging any patient.</text> </paragraph> <paragraph num="I."> <text>Inspections shall be conducted without impeding patient care or unreasonably delaying patient transport unless, in the judgment of SOCALR, the patient care being rendered is detrimental or is reasonably likely to be detrimental to the patient's health, safety, or welfare.</text> </paragraph> <paragraph num="J."> <text>No one may impede SOCALR in conducting lawful inspections necessary to evaluate compliance with this subtitle.</text> </paragraph> <paragraph num="K."> <text>SOCALR may, with written permission from a commercial ambulance service's owner, which may include a hold harmless clause, ride on commercial ambulance service calls for the purpose of evaluating compliance with this subtitle.</text> </paragraph> <paragraph num="L."> <text>SOCALR may conduct surveys of patients served by a commercial ambulance service to evaluate compliance with this subtitle.</text> </paragraph> <paragraph num="M."> <text>SOCALR may take photographs or videos during an inspection or investigation under this subtitle.</text> </paragraph> <paragraph num="N."> <text>After the initial investigation, SOCALR may dismiss a complaint or terminate an investigation if it finds the complaint or alleged violation to be:</text> <paragraph num="(1)"> <text>Frivolous;</text> </paragraph> <paragraph num="(2)"> <text>Made in bad faith;</text> </paragraph> <paragraph num="(3)"> <text>Legally or factually insufficient; or</text> </paragraph> <paragraph num="(4)"> <text>Fully resolved to the satisfaction of the SOCALR.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Noncompliance Notices."> <paragraph num="A."> <text>If SOCALR finds that a commercial ambulance service, a commercial ambulance, or an individual to whom MIEMSS has issued a certification card or license is believed to have violated this subtitle or an order issued by SOCALR, SOCALR may issue a noncompliance notice.</text> </paragraph> <paragraph num="B."> <text>Each noncompliance notice shall:</text> <paragraph num="(1)"> <text>Be in writing;</text> </paragraph> <paragraph num="(2)"> <text>Describe the alleged violation;</text> </paragraph> <paragraph num="(3)"> <text>Reference the provision of this subtitle that the commercial ambulance service or individual is alleged to have violated;</text> </paragraph> <paragraph num="(4)"> <text>State the proposed remedy or corrective action required;</text> </paragraph> <paragraph num="(5)"> <text>Set a reasonable time for abatement and correction of the alleged violation, if applicable;</text> </paragraph> <paragraph num="(6)"> <text>Specify the reporting mechanism that will be required to confirm the remedy, abatement, or correction of the alleged violation; and</text> </paragraph> <paragraph num="(7)"> <text>Specify any proposed disciplinary action to be taken by SOCALR.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The noncompliance notice is the final agency action if a party does not timely request a hearing under Regulation .09 of this chapter to contest the noncompliance notice.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Summary Suspension of License."> <paragraph num="A."> <text>SOCALR may summarily suspend a license for prohibited conduct under this chapter if the public health, safety, or welfare imperatively requires the emergency action.</text> </paragraph> <paragraph num="B."> <text>If a license is summarily suspended under §A of this regulation, SOCALR shall furnish, within 3 business days, to the licensee whose license is temporarily suspended:</text> <paragraph num="(1)"> <text>Written notice of the temporary suspension, including the finding that a temporary suspension was required;</text> </paragraph> <paragraph num="(2)"> <text>The reasons supporting the finding and the temporary suspension; and</text> </paragraph> <paragraph num="(3)"> <text>An opportunity to be heard.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The written notice under §B of this regulation shall be:</text> <paragraph num="(1)"> <text>Served personally; or</text> </paragraph> <paragraph num="(2)"> <text>Sent by certified mail to the last known address of the commercial ambulance service.</text> </paragraph> </paragraph> <paragraph num="D."> <text>For a hearing on a summary suspension under Regulation .09 of this chapter, certain time periods shall be shortened, as specified in Regulation .09 of this chapter.</text> </paragraph> <paragraph num="E."> <text>The summary suspension is the final action if a party does not timely request a hearing under Regulation .09 of this chapter to contest the summary suspension.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Suspension, Revocation, or Remedial Action."> <paragraph num="A."> <text>SOCALR may suspend or revoke a license for acts that violate this chapter.</text> </paragraph> <paragraph num="B."> <text>SOCALR may require appropriate remedial action instead of suspension or revocation of a license. The requirements for the remedial action shall:</text> <paragraph num="(1)"> <text>Be written;</text> </paragraph> <paragraph num="(2)"> <text>Set a reasonable time for abatement; and</text> </paragraph> <paragraph num="(3)"> <text>Specify any proposed disciplinary action to be taken by SOCALR for failure to satisfy the requirements of the remedial action.</text> </paragraph> </paragraph> <paragraph num="C."> <text>The action taken by SOCALR is the final agency action if a party does not timely request a hearing under Regulation .09 of this chapter to contest the action.</text> </paragraph> <paragraph num="D."> <text>Upon the suspension or revocation of a commercial ambulance service license the commercial ambulance service shall immediately:</text> <paragraph num="(1)"> <text>Cease operations with all commercial ambulance vehicles;</text> </paragraph> <paragraph num="(2)"> <text>Make a reasonable effort to cease all recallable advertising; and</text> </paragraph> <paragraph num="(3)"> <text>Surrender to SOCALR all commercial ambulance licenses issued to the commercial ambulance service; and</text> </paragraph> <paragraph num="(4)"> <text>Make all licensed commercial ambulances available to SOCALR for removal of the licensing decal by or under the supervision of SOCALR.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Upon the suspension or revocation of a commercial ambulance license, the commercial ambulance service shall immediately:</text> <paragraph num="(1)"> <text>Cease operations with that specific commercial ambulance; and</text> </paragraph> <paragraph num="(2)"> <text>Surrender the commercial ambulance license to SOCALR; and</text> </paragraph> <paragraph num="(3)"> <text>Make the commercial ambulance available to SOCALR for removal of the licensing decal by or under the supervision of SOCALR.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".09" heading="Hearings."> <paragraph num="A."> <text>Initiation of a Hearing.</text> <paragraph num="(1)"> <text>If an applicant or licensee has a license denied, suspended, or revoked, or wishes to contest a noncompliance notice or remedial action, the applicant or licensee may request a hearing before an administrative law judge by filing a request for a hearing with SOCALR. The request for a hearing must be received by SOCALR not later than 7 calendar days after the applicant or licensee receives the written denial, suspension, revocation, or noncompliance notice.</text> </paragraph> <paragraph num="(2)"> <text>Within 7 calendar days of receiving a request for a hearing, SOCALR shall forward the request to the Office of Administrative Hearings.</text> </paragraph> <paragraph num="(3)"> <text>A hearing shall be scheduled as soon as practical for all parties and the Office of Administrative Hearings but shall be within the following time periods after receipt of the hearing request by SOCALR:</text> <paragraph num="(a)"> <text>For summary suspensions under Regulation .07 of this chapter, 21 calendar days; or</text> </paragraph> <paragraph num="(b)"> <text>For all other hearings, 60 calendar days.</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Failure of a party to make a timely request to contest a noncompliance notice, remedial action, or denial, suspension, or revocation of a license shall render the action taken the final agency action.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Hearing Procedures.</text> <paragraph num="(1)"> <text>A hearing is governed by COMAR Title 28, except as modified in this regulation.</text> </paragraph> <paragraph num="(2)"> <text>For denial of a license, the applicant has the burden of proving, by a preponderance of the evidence, full satisfaction of all requirements and entitlement to the license.</text> </paragraph> <paragraph num="(3)"> <text>For suspensions, revocations, and contested noncompliance or violation notices, SOCALR has the burden of proving, by a preponderance of the evidence, the violation or violations alleged.</text> </paragraph> <paragraph num="(4)"> <text>In a proceeding before an administrative law judge or a court, SOCALR may disclose information that contains or might reveal confidential business information if:</text> <paragraph num="(a)"> <text>The information is relevant to the case at hand; and</text> </paragraph> <paragraph num="(b)"> <text>Before disclosure, the administrative law judge or court that is conducting the proceeding enters an appropriate order to protect confidential business information.</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Final Decision.</text> <paragraph num="(1)"> <text>The decision of the administrative law judge is final as to all factual matters submitted at the hearing.</text> </paragraph> <paragraph num="(2)"> <text>The Executive Director retains the final decision-making authority on all penalties including denial, suspension, or revocation of a license or required remedial action.</text> </paragraph> <paragraph num="(3)"> <text>The administrative law judge shall render a proposed decision on all factual and legal matters and on the recommended penalty within the following time periods after conclusion of the hearing or after receipt of written closing statements or proposed findings of fact, whichever is later:</text> <paragraph num="(a)"> <text>For summary suspensions under Regulation .07 of this chapter, 21 calendar days; or</text> </paragraph> <paragraph num="(b)"> <text>For all other hearings, 60 calendar days.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>Exceptions.</text> <paragraph num="(1)"> <text>Any party dissatisfied with the proposed decision of the administrative law judge may file written exceptions with the Executive Director or the Executive Director's designee as provided in this section:</text> </paragraph> <paragraph num="(2)"> <text>Exceptions shall be received by the Executive Director or the Executive Director's designee within 10 calendar days after receipt of the proposed decision by the excepting party, or within 14 calendar days after the date of the proposed decision, whichever is earlier, and copies shall be promptly served on all other parties to the hearing.</text> </paragraph> <paragraph num="(3)"> <text>If exceptions are timely filed, any other party may file opposing or reply comments with the Executive Director or the Executive Director's designee within 10 calendar days of the date of filing of the original exceptions. The party shall promptly serve copies on all other parties to the hearing.</text> </paragraph> <paragraph num="(4)"> <text>If exceptions are timely filed, the Executive Director or the Executive Director's designee shall consider the proposed decision, the exceptions, and any responses to the exception, and the portions of the administrative record as cited by the parties and as considered necessary. The Executive Director or the Executive Director's designee shall render a final written decision without the receipt of any new evidence, but after the opportunity for oral arguments before the Executive Director or the Executive Director's designee.</text> </paragraph> <paragraph num="(5)"> <text>If exceptions are not timely filed, the Executive Director or the Executive Director's designee shall issue a final decision as soon as possible which shall include adoption or modification of the penalty recommended by the administrative law judge.</text> </paragraph> <paragraph num="(6)"> <text>Unless the Executive Director or the Executive Director's designee orders a summary suspension under Regulation .07 of this chapter, any suspension or revocation of a license shall be stayed during the pendency of timely filed and pursued administrative proceedings, but not after a final agency decision.</text> </paragraph> </paragraph> <paragraph num="E."> <text>Judicial Review. Final contested case decisions of the Executive Director are subject to judicial review as provided by law. MIEMSS shall be a party to any review.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Criminal Penalties."> <paragraph num="A."> <text>In addition to the civil remedies provided under this subtitle, a person who violates any provision of this subtitle may be prosecuted criminally for commission of a misdemeanor.</text> </paragraph> <paragraph num="B."> <text>Upon conviction, a person found guilty of violating any provision of this subtitle is subject to a fine not exceeding $1,000 per violation.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.09 to COMAR 30.09.09, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.05, BLS Service, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.10, Enforcement, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03J, K amended and L adopted effective October 15, 2004 (31:20 Md. R. 1486)</annotation> </annotations> </chapter> <chapter num="10" heading="Standard Commercial Ambulance Equipment"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs standard commercial ambulance equipment.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Standard Equipment."> <paragraph num="A."> <text>All commercial ambulance services shall equip operating bases and ambulances as required by this chapter unless the:</text> <paragraph num="(1)"> <text>Commercial ambulance service is specifically excluded from a specific class of commercial ambulance service in a related chapter of this subtitle; or</text> </paragraph> <paragraph num="(2)"> <text>Requirement is waived in writing by SOCALR for a specific commercial ambulance service or a specific commercial ambulance.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Additional equipment requirements for ALS and neonatal ambulances are listed in COMAR 30.09.11 and 30.09.12.</text> </paragraph> <paragraph num="C."> <text>Greater quantities of supplies and medications shall be added to the ambulance if:</text> <paragraph num="(1)"> <text>The transport time is greater than 30 minutes, and the patient is known to require supplies or medications that exceed the requirements in COMAR 30.09.10—13; or</text> </paragraph> <paragraph num="(2)"> <text>The ambulance is on standby at an event where it can reasonably be expected that there will be more than one patient.</text> </paragraph> </paragraph> <paragraph num="D."> <text>Waivers.</text> <paragraph num="(1)"> <text>A commercial ambulance service may request in writing under the requirements of COMAR 30.09.04.08 that SOCALR waive a requirement to carry equipment which is not needed for the service provided.</text> </paragraph> <paragraph num="(2)"> <text>The commercial ambulance service shall bear the burden of demonstrating to SOCALR's satisfaction that the equipment is not necessary.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Standard Operating Base Equipment."> <text>Each operating base shall have:</text> <paragraph num="A."> <text>The ability to reliably communicate with the public by telephone;</text> </paragraph> <paragraph num="B."> <text>A two-way radio or radiotelephone that will properly communicate with its ambulance within the routine area of operation; and</text> </paragraph> <paragraph num="C."> <text>An adequate amount of medical supplies to ensure stock is reasonably proportional to the size of the service and call volume.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Standard Ambulance Equipment and Supplies."> <text>Each ambulance shall carry the following equipment and supplies:</text> <paragraph num="A."> <text>Two C cell or larger, portable hand-lights;</text> </paragraph> <paragraph num="B."> <text>One A-B-C rated fire extinguisher of at least 5 pound capacity, securely mounted in a location that is readily accessible to the crew;</text> </paragraph> <paragraph num="C."> <text>One 40-channel UHF two-way radio, with the tone codes necessary to communicate with online medical control in Maryland;</text> </paragraph> <paragraph num="D."> <text>One two-way radio or cellular telephone that will properly communicate between the ambulance and the ambulance service dispatch center which may be the same radio referenced in §C of this regulation;</text> </paragraph> <paragraph num="E."> <text>For ground ambulances, three U.S. Department of Transportation approved reflective road hazard triangles;</text> </paragraph> <paragraph num="F."> <text>No Smoking signs in both the patient and driver compartment mounted in a location that is clearly visible to vehicle occupants with letters at least 1 inch tall and 3/4 inch wide; and</text> </paragraph> <paragraph num="G."> <text>One copy of the Maryland Medical Protocols for EMS Providers.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Standard Ambulance Medical Supplies."> <text>Each ambulance shall carry the following standard medical supplies:</text> <paragraph num="A."> <text>24 sterile gauze pads at least 3 inch by 3 inch;</text> </paragraph> <paragraph num="B."> <text>Three rolls of 2-inch hypoallergenic adhesive tape;</text> </paragraph> <paragraph num="C."> <text>Three rolls of 1-inch hypoallergenic adhesive tape;</text> </paragraph> <paragraph num="D."> <text>12 cravats or triangular bandages;</text> </paragraph> <paragraph num="E."> <text>12 rolls of 4-inch self-adjusting gauze bandages;</text> </paragraph> <paragraph num="F."> <text>Four chemical cold packs;</text> </paragraph> <paragraph num="G."> <text>One box of assorted, plastic, bandage strips;</text> </paragraph> <paragraph num="H."> <text>Six clean individually wrapped sanitary napkins or other highly absorbent sterile dressing;</text> </paragraph> <paragraph num="I."> <text>Five sterile trauma dressings, 5 inches by 9 inches minimum;</text> </paragraph> <paragraph num="J."> <text>Two tongue depressors;</text> </paragraph> <paragraph num="K."> <text>Two tubes of glucose supplement;</text> </paragraph> <paragraph num="L."> <text>One 30 milliliter vial of ipecac or equivalent;</text> </paragraph> <paragraph num="M."> <text>One 100 gram bottle of activated charcoal with or without sorbitol;</text> </paragraph> <paragraph num="N."> <text>Adult 0.3 milligram epinephrine auto-injector;</text> </paragraph> <paragraph num="O."> <text>Pediatric 0.15 milligram epinephrine auto-injector;</text> </paragraph> <paragraph num="P."> <text>One penlight;</text> </paragraph> <paragraph num="Q."> <text>One piece of nonadherent material for occlusive dressing, 18 inches by 25 inches minimum (metal foil not acceptable);</text> </paragraph> <paragraph num="R."> <text>Two burn sheets;</text> </paragraph> <paragraph num="S."> <text>Two emesis basins;</text> </paragraph> <paragraph num="T."> <text>One pair of all purpose utility scissors;</text> </paragraph> <paragraph num="U."> <text>One container of disinfectant meeting the requirements of 29 CFR §1910.1030;</text> </paragraph> <paragraph num="V."> <text>One box of facial tissue or roll of toilet tissue;</text> </paragraph> <paragraph num="W."> <text>Six Maryland triage/treatment tags, with color-coded plastic ribbon in:</text> <paragraph num="(1)"> <text>Red,</text> </paragraph> <paragraph num="(2)"> <text>Yellow,</text> </paragraph> <paragraph num="(3)"> <text>Green, and</text> </paragraph> <paragraph num="(4)"> <text>Black;</text> </paragraph> </paragraph> <paragraph num="X."> <text>One sterile commercially packaged obstetrical (OB) kit containing:</text> <paragraph num="(1)"> <text>One large towel or receiving blanket,</text> </paragraph> <paragraph num="(2)"> <text>One pair of sterile gloves,</text> </paragraph> <paragraph num="(3)"> <text>Two umbilical clamps or ties,</text> </paragraph> <paragraph num="(4)"> <text>One bulb syringe, and</text> </paragraph> <paragraph num="(5)"> <text>One pair of sterile scissors or scalpel;</text> </paragraph> </paragraph> <paragraph num="Y."> <text>One bed pan;</text> </paragraph> <paragraph num="Z."> <text>One urinal;</text> </paragraph> <paragraph num="AA."> <text>Four leak proof bags of at least 3 millimeter thick which are:</text> <paragraph num="(1)"> <text>Red, or</text> </paragraph> <paragraph num="(2)"> <text>Marked with the universal biohazard symbol conforming to 29 CFR §1910.145;</text> </paragraph> </paragraph> <paragraph num="BB."> <text>One receptacle to safely dispose of needles, glass, or other sharp material; and</text> </paragraph> <paragraph num="CC."> <text>One CPR board or equivalent.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Standard Ambulance Suction Units."> <text>Each ambulance shall be equipped with one:</text> <paragraph num="A."> <text>Onboard suction unit which is:</text> <paragraph num="(1)"> <text>Powered by a reliable source from:</text> <paragraph num="(a)"> <text>The engine manifold, or</text> </paragraph> <paragraph num="(b)"> <text>An electrically powered vacuum pump;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Capable of developing a:</text> <paragraph num="(a)"> <text>Vacuum pressure equivalent to at least 300 mm Hg within 4 seconds of clamping, and</text> </paragraph> <paragraph num="(b)"> <text>Free air flow of at least 20 liters/minute at the end of the collection tube;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Adjustable in suction force for use in children and intubated patients;</text> </paragraph> <paragraph num="(4)"> <text>Equipped with wide bore tubing;</text> </paragraph> <paragraph num="(5)"> <text>Equipped with one rigid pharyngeal suction tip; and</text> </paragraph> <paragraph num="(6)"> <text>Equipped with two suction catheters with integral thumb controls in assorted sizes appropriate for the patients being transported including at least one size from among:</text> <paragraph num="(a)"> <text>6, 8, 10, or 12 French catheter, and</text> </paragraph> <paragraph num="(b)"> <text>14, 16, or 18 French catheter; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Portable suction unit which is:</text> <paragraph num="(1)"> <text>Capable of operating continuously under suction for at least 20 minutes while independent of alternating current;</text> </paragraph> <paragraph num="(2)"> <text>Capable of developing:</text> <paragraph num="(a)"> <text>A vacuum pressure equivalent to 300 mm Hg within 4 seconds of clamping, and</text> </paragraph> <paragraph num="(b)"> <text>A free air flow of at least 20 liters/minute at the end of the suction tube;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Equipped with wide bore tubing;</text> </paragraph> <paragraph num="(4)"> <text>Equipped with one rigid pharyngeal suction tip; and</text> </paragraph> <paragraph num="(5)"> <text>Equipped with two suction catheters with integral thumb controls in sizes appropriate for the patients being transported including one size from among:</text> <paragraph num="(a)"> <text>6, 8, 10, or 12 French catheter, and</text> </paragraph> <paragraph num="(b)"> <text>14, 16, or 18 French catheter.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Standard Ambulance Portable Medical Equipment."> <paragraph num="A."> <text>Each ambulance shall carry a portable kit containing the following medical supplies:</text> <paragraph num="(1)"> <text>12 sterile gauze pads at least 3 inches by 3 inches in size;</text> </paragraph> <paragraph num="(2)"> <text>Two rolls of 2-inch hypoallergenic adhesive tape;</text> </paragraph> <paragraph num="(3)"> <text>Eight cravats or triangular bandages;</text> </paragraph> <paragraph num="(4)"> <text>One set of oropharyngeal airways in adult, child, and pediatric sizes;</text> </paragraph> <paragraph num="(5)"> <text>One stethoscope;</text> </paragraph> <paragraph num="(6)"> <text>One adult blood pressure cuff;</text> </paragraph> <paragraph num="(7)"> <text>One pediatric blood pressure cuff;</text> </paragraph> <paragraph num="(8)"> <text>One pair of all purpose utility scissors;</text> </paragraph> <paragraph num="(9)"> <text>One penlight;</text> </paragraph> <paragraph num="(10)"> <text>Six rolls of 4-inch self-adjusting gauze bandages;</text> </paragraph> <paragraph num="(11)"> <text>Four sterile trauma dressings at least 5 inch by 9 inches in size;</text> </paragraph> <paragraph num="(12)"> <text>One marking pen; and</text> </paragraph> <paragraph num="(13)"> <text>12 exam gloves which meet the requirements of 29 CFR §1910.1030.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The portable kit shall be:</text> <paragraph num="(1)"> <text>Dust and moisture resistant;</text> </paragraph> <paragraph num="(2)"> <text>Large enough to carry the required items; and</text> </paragraph> <paragraph num="(3)"> <text>Organized so items are readily accessible.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".08" heading="Standard Ambulance Defibrillation Equipment."> <text>Each in-service ambulance shall carry at least one automated external defibrillator.</text> </regulation> <regulation prefix="Regulation" num=".09" heading="Standard Ambulance Ventilation and Airway Maintenance Equipment."> <text>Each ambulance shall carry the following standard airway maintenance and ventilation equipment:</text> <paragraph num="A."> <text>Oxygen which meets the following criteria:</text> <paragraph num="(1)"> <text>For ground ambulances:</text> <paragraph num="(a)"> <text>Optional onboard cylinders for BLS ambulances have a capacity of at least 3,000 liters;</text> </paragraph> <paragraph num="(b)"> <text>Portable cylinders have a capacity of at least 400 liters;</text> </paragraph> <paragraph num="(c)"> <text>The following number of cylinders, if on-board oxygen is present, unless more are needed for a particular patient based on COMAR 30.09.07.03A(2)(g):</text> <paragraph num="(i)"> <text>One E size,</text> </paragraph> <paragraph num="(ii)"> <text>One jumbo D size, or</text> </paragraph> <paragraph num="(iii)"> <text>Two D size;</text> </paragraph> </paragraph> <paragraph num="(d)"> <text>The following number of cylinders, if on-board oxygen is not present, unless more are needed for a particular patient based on COMAR 30.09.07.03A(2)(g):</text> <paragraph num="(i)"> <text>Two E size,</text> </paragraph> <paragraph num="(ii)"> <text>Two jumbo D size, or</text> </paragraph> <paragraph num="(iii)"> <text>Three D size;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>For air ambulances:</text> <paragraph num="(a)"> <text>An on-board oxygen system that meets the CAMTS standards, which provide that:</text> <paragraph num="(i)"> <text>Oxygen is installed according to FAA regulations;</text> </paragraph> <paragraph num="(ii)"> <text>Medical transport personnel can determine if oxygen is on by in-line pressure gauges mounted in the patient care area;</text> </paragraph> <paragraph num="(iii)"> <text>Each gas outlet is clearly marked for identification;</text> </paragraph> <paragraph num="(iv)"> <text>Oxygen flow can be stopped at or near the oxygen source from inside the aircraft;</text> </paragraph> <paragraph num="(v)"> <text>The indicators for quantity of oxygen remaining and measurement of liter flow are accessible to medical transport personnel while enroute; and</text> </paragraph> <paragraph num="(vi)"> <text>Oxygen flow meters and outlets must be padded, flush mounted, or so located to prevent injury to medical transport personnel; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>A minimum of one portable oxygen cylinder that has a capacity of at least 400 liters;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>All cylinders are properly color coded for U.S.P. grade, medical oxygen;</text> </paragraph> <paragraph num="(4)"> <text>The system is free of:</text> <paragraph num="(a)"> <text>Grease,</text> </paragraph> <paragraph num="(b)"> <text>Oil, or</text> </paragraph> <paragraph num="(c)"> <text>Other flammable organic material; and</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>All cylinders have passed hydrostatic testing during the past:</text> <paragraph num="(a)"> <text>5 years, or</text> </paragraph> <paragraph num="(b)"> <text>10 years, if approved by the inspector based on the condition of the cylinder;</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>Regulators which:</text> <paragraph num="(1)"> <text>Have a reducing valve limiting line pressure to 50 10 psi;</text> </paragraph> <paragraph num="(2)"> <text>Have a pressure gauge, with a range of 0 to 2,500 psi, to indicate the pressure of oxygen remaining in the cylinder;</text> </paragraph> <paragraph num="(3)"> <text>Are capable of delivering at least 0 to 15 liters/minute flow in calibrated increments;</text> </paragraph> <paragraph num="(4)"> <text>Are accurate to within 1 liter/minute when at a setting equal to or less than 5 liters/minute;</text> </paragraph> <paragraph num="(5)"> <text>Are accurate to within 1.5 liters/minute when at a setting between 6 and 10 liters/minute; and</text> </paragraph> <paragraph num="(6)"> <text>Are accurate to within 2 liters/minute when at a setting equal to or greater than 11 liters/minute;</text> </paragraph> </paragraph> <paragraph num="C."> <text>At least one flow smeter dedicated to the portable oxygen system that is not gravity dependent;</text> </paragraph> <paragraph num="D."> <text>If present, positive pressure demand valves which provide:</text> <paragraph num="(1)"> <text>100 percent oxygen;</text> </paragraph> <paragraph num="(2)"> <text>An instantaneous flow rate not greater than 40 liters/minute;</text> </paragraph> <paragraph num="(3)"> <text>An inspiratory pressure relief valve that opens at 60-centimeter water pressure; and</text> </paragraph> <paragraph num="(4)"> <text>A 15/22-millimeter fitting;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Adult oxygen administration sets which are the following types and quantities:</text> <paragraph num="(1)"> <text>Four non-rebreather;</text> </paragraph> <paragraph num="(2)"> <text>Two venturi;</text> </paragraph> <paragraph num="(3)"> <text>Six nasal cannula;</text> </paragraph> <paragraph num="(4)"> <text>Disposable, single use design; and</text> </paragraph> <paragraph num="(5)"> <text>Transparent;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Pediatric oxygen administration sets which are the following types and quantities:</text> <paragraph num="(1)"> <text>Two non-rebreather;</text> </paragraph> <paragraph num="(2)"> <text>Two nasal cannula;</text> </paragraph> <paragraph num="(3)"> <text>Disposable, single use design; and</text> </paragraph> <paragraph num="(4)"> <text>Transparent;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Two sets of oxygen connecting tubing;</text> </paragraph> <paragraph num="H."> <text>One hand operated, self-reinflating adult bag valve mask with:</text> <paragraph num="(1)"> <text>Oxygen inlet;</text> </paragraph> <paragraph num="(2)"> <text>Reservoir tube;</text> </paragraph> <paragraph num="(3)"> <text>Transparent face mask; and</text> </paragraph> <paragraph num="(4)"> <text>Selectable pop off valve or no pop off valve;</text> </paragraph> </paragraph> <paragraph num="I."> <text>One hand operated, self-reinflating, pediatric bag valve mask with:</text> <paragraph num="(1)"> <text>Oxygen inlet;</text> </paragraph> <paragraph num="(2)"> <text>Reservoir tube;</text> </paragraph> <paragraph num="(3)"> <text>One transparent neonatal face mask; and</text> </paragraph> <paragraph num="(4)"> <text>One transparent pediatric or child face mask;</text> </paragraph> </paragraph> <paragraph num="J."> <text>One pocket mask with one-way valve; and</text> </paragraph> <paragraph num="K."> <text>One set of oropharyngeal airways in the following sizes:</text> <paragraph num="(1)"> <text>Adult;</text> </paragraph> <paragraph num="(2)"> <text>Child; and</text> </paragraph> <paragraph num="(3)"> <text>Infant.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".10" heading="Standard Ambulance Patient-Carrying Devices."> <text>Each ambulance shall carry the following standard equipment for carrying patients:</text> <paragraph num="A."> <text>One ambulance stretcher that:</text> <paragraph num="(1)"> <text>Is adjustable in height,</text> </paragraph> <paragraph num="(2)"> <text>Permits the elevation of the upper body,</text> </paragraph> <paragraph num="(3)"> <text>Has a mattress covered with nonabsorbent material free from defects, such as rips and tears,</text> </paragraph> <paragraph num="(4)"> <text>Has safety straps to secure the patient in accordance with the manufacturer's recommendations, and</text> </paragraph> <paragraph num="(5)"> <text>Has a stretcher-mounted IV pole or equivalent; and</text> </paragraph> </paragraph> <paragraph num="B."> <text>One folding stair chair capable of negotiating narrow hallways or stairways.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".11" heading="Standard Ambulance Fracture Immobilization Equipment."> <text>Each ambulance shall carry the following fracture immobilization equipment:</text> <paragraph num="A."> <text>One full spinal immobilization board for transportation or equivalent;</text> </paragraph> <paragraph num="B."> <text>One half spinal immobilization device;</text> </paragraph> <paragraph num="C."> <text>One orthopedic or clamshell stretcher or equivalent;</text> </paragraph> <paragraph num="D."> <text>Three 9-foot straps with buckles;</text> </paragraph> <paragraph num="E."> <text>Two long padded board splints approximately 54 inches by 3 inches;</text> </paragraph> <paragraph num="F."> <text>Two medium padded board splints approximately 36 inches by 3 inches;</text> </paragraph> <paragraph num="G."> <text>Two short padded board splints approximately 15 inches by 3 inches; and</text> </paragraph> <paragraph num="H."> <text>Rigid extrication collars in the following adult sizes:</text> <paragraph num="(1)"> <text>Two adjustable; or</text> </paragraph> <paragraph num="(2)"> <text>One of each of the following:</text> <paragraph num="(a)"> <text>Medium (regular),</text> </paragraph> <paragraph num="(b)"> <text>Small (short), and</text> </paragraph> <paragraph num="(c)"> <text>Extra small (no-neck or neckless).</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".12" heading="Standard Ambulance Personal Protective Equipment."> <paragraph num="A."> <text>Equipment or supplies required to protect personnel during the performance of their duties shall be carried in each commercial ambulance vehicle licensed under this subtitle.</text> </paragraph> <paragraph num="B."> <text>The quantities and specifications of the equipment and supplies required in this chapter shall meet at least the requirements set by the Maryland Occupational Safety and Health.</text> </paragraph> <paragraph num="C."> <text>Each ambulance shall carry the following personal protective equipment supplies:</text> <paragraph num="(1)"> <text>Adequate quantities of exam gloves in:</text> <paragraph num="(a)"> <text>Uni-size; or</text> </paragraph> <paragraph num="(b)"> <text>All of the following:</text> <paragraph num="(i)"> <text>Small,</text> </paragraph> <paragraph num="(ii)"> <text>Medium, and</text> </paragraph> <paragraph num="(iii)"> <text>Large;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(2)"> <text>Two pair non-absorbent gowns per crew member;</text> </paragraph> <paragraph num="(3)"> <text>Two surgical masks per crew member;</text> </paragraph> <paragraph num="(4)"> <text>One pair safety goggles per crew member;</text> </paragraph> <paragraph num="(5)"> <text>One particulate (TB) mask per crewmember; and</text> </paragraph> <paragraph num="(6)"> <text>At least 4 ounces of waterless hand cleaner.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".13" heading="Standard Ambulance Linen Supplies."> <text>Each ambulance shall carry the following linen supplies:</text> <paragraph num="A."> <text>Two pillows covered with nonabsorbent material or disposable;</text> </paragraph> <paragraph num="B."> <text>Four cloth or disposable pillow cases;</text> </paragraph> <paragraph num="C."> <text>Four cloth or disposable sheets; and</text> </paragraph> <paragraph num="D."> <text>Two blankets.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted as an emergency provision effective January 6, 1997 (24:2 Md. R. 114); emergency status expired July 6, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 adopted permanently effective July 7, 1997 (24:10 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.10 to COMAR 30.09.10, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1189); amended permanently effective October 5, 1998 (25:20 Md. R. 1534)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.04, ALS Service, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.13, Standard Commercial Ambulance Equipment, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04E amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> <annotation type="History" subtype="Administrative History">Regulation .09A, C amended effective October 15, 2004 (31:20 Md. R. 1486)</annotation> </annotations> </chapter> <chapter num="11" heading="ALS Service"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter defines additional requirements for ALS services.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Additional Operational Requirements."> <paragraph num="A."> <text>An ALS commercial ambulance service shall retain at least one licensed paramedic to function as an ALS coordinator who:</text> <paragraph num="(1)"> <text>Is approved by the ALS service medical director;</text> </paragraph> <paragraph num="(2)"> <text>Participates on the ALS service's quality review committee; and</text> </paragraph> <paragraph num="(3)"> <text>Oversees:</text> <paragraph num="(a)"> <text>ALS operations; and</text> </paragraph> <paragraph num="(b)"> <text>The submission of patient care reports and EMS data in accordance with COMAR 30.03.04.04.</text> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>An ALS commercial ambulance service may provide BLS service with an ambulance licensed as either:</text> <paragraph num="(1)"> <text>ALS; or</text> </paragraph> <paragraph num="(2)"> <text>BLS.</text> </paragraph> </paragraph> <paragraph num="C."> <text>An ALS commercial ambulance service may not provide scheduled ALS service with a BLS-licensed commercial ambulance vehicle unless:</text> <paragraph num="(1)"> <text>It uses a BLS-licensed ambulance for a period of not more than 30 calendar days for reasons related to:</text> <paragraph num="(a)"> <text>Routine maintenance; or</text> </paragraph> <paragraph num="(b)"> <text>Mechanical failure of an ALS-licensed commercial ambulance vehicle;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The BLS-licensed ambulance has, in addition to the equipment required in COMAR 30.09.10, all the equipment required in this chapter; and</text> </paragraph> <paragraph num="(3)"> <text>It has notified SOCALR of the proposed use before its occurrence and has been issued a confirmation number verifying authorization.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Additional Equipment Required for ALS Ambulances."> <text>In addition to the equipment required under COMAR 30.09.10, the following equipment and supplies shall be carried in commercial ambulances licensed to provide ALS service:</text> <paragraph num="A."> <text>An onboard oxygen system that meets the requirements of COMAR 30.09.10.09;</text> </paragraph> <paragraph num="B."> <text>Cardiac monitoring/defibrillating/transcutaneous pacing equipment including:</text> <paragraph num="(1)"> <text>One monitor/defibrillator which has:</text> <paragraph num="(a)"> <text>Direct current capability,</text> </paragraph> <paragraph num="(b)"> <text>Paper print out capability,</text> </paragraph> <paragraph num="(c)"> <text>Synchronized cardioversion and unsynchronized defibrillation,</text> </paragraph> <paragraph num="(d)"> <text>Two adult and one pediatric defibrillator pads,</text> </paragraph> <paragraph num="(e)"> <text>Defibrillator pads with quick look capability,</text> </paragraph> <paragraph num="(f)"> <text>One set of EKG leads, and</text> </paragraph> <paragraph num="(g)"> <text>Transcutaneous pacing; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Supplies related to EKG monitoring to include the following items:</text> <paragraph num="(a)"> <text>18 ECG electrodes,</text> </paragraph> <paragraph num="(b)"> <text>Spare set of EKG leads or equivalent,</text> </paragraph> <paragraph num="(c)"> <text>Spare monitor/defibrillator batteries,</text> </paragraph> <paragraph num="(d)"> <text>Two spare EKG paper rolls,</text> </paragraph> <paragraph num="(e)"> <text>Two adult transcutaneous pacing pads,</text> </paragraph> <paragraph num="(f)"> <text>One pediatric transcutaneous pacing pad, and</text> </paragraph> <paragraph num="(g)"> <text>One tube of electrode paste or two packages of electrolyte pads for use in defibrillation;</text> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Medications including:</text> <paragraph num="(1)"> <text>All the medications listed in the Maryland Medical Protocols for Emergency Medical Services Providers in sufficient quantities to treat and care for each patient that they respond to and care for;</text> </paragraph> <paragraph num="(2)"> <text>Sufficient quantities to provide:</text> <paragraph num="(a)"> <text>At least the maximum dosage for one 100 kilogram patient for a period of 30 minutes, or</text> </paragraph> <paragraph num="(b)"> <text>An adequate quantity to treat and care for the patient if the transport time is expected to exceed 30 minutes;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Controlled substances which are stored in a controlled access system acceptable to SOCALR; and</text> </paragraph> <paragraph num="(4)"> <text>Two nebulizers for medication administration;</text> </paragraph> </paragraph> <paragraph num="D."> <text>Intravenous equipment and supplies including:</text> <paragraph num="(1)"> <text>Two 16 gauge 1 1/4 to 1 1/2 inches long intravenous catheters with needles;</text> </paragraph> <paragraph num="(2)"> <text>Two 18 gauge, 1 1/4 to 1 1/2 inches long intravenous catheters with needles;</text> </paragraph> <paragraph num="(3)"> <text>Two 20 gauge, 1 1/4 to 1 1/2 inches long intravenous catheters with needles;</text> </paragraph> <paragraph num="(4)"> <text>Two 22 gauge, 1 1/4 to 1 1/2 inches long intravenous catheters with needles;</text> </paragraph> <paragraph num="(5)"> <text>Two 24 gauge, 1 1/4 to 1 1/2 inches long intravenous catheters with needles;</text> </paragraph> <paragraph num="(6)"> <text>Two 10 or 20 drops/milliliter or equivalent intravenous administration sets;</text> </paragraph> <paragraph num="(7)"> <text>Two 60 drops/milliliter or equivalent intravenous administration sets;</text> </paragraph> <paragraph num="(8)"> <text>Two 1000 cubic centimeter bags or equivalent of Ringer's lactate intravenous solution;</text> </paragraph> <paragraph num="(9)"> <text>Site preparation materials; and</text> </paragraph> <paragraph num="(10)"> <text>Roof-mounted hooks for hanging intravenous solutions;</text> </paragraph> </paragraph> <paragraph num="E."> <text>Parenteral administration equipment including:</text> <paragraph num="(1)"> <text>Four 1 milliliter syringes with 25 gauge needles;</text> </paragraph> <paragraph num="(2)"> <text>Four 3—5 milliliter syringes with 1-inch, 18—21 gauge needles for IM injection;</text> </paragraph> <paragraph num="(3)"> <text>Four 10 milliliter syringes; and</text> </paragraph> <paragraph num="(4)"> <text>Four 18, 19, or 20 gauge needles;</text> </paragraph> </paragraph> <paragraph num="F."> <text>Blood specimen collection equipment including:</text> <paragraph num="(1)"> <text>Two red top blood tubes;</text> </paragraph> <paragraph num="(2)"> <text>Two purple top blood tubes; and</text> </paragraph> <paragraph num="(3)"> <text>Two vacutainer barrels;</text> </paragraph> </paragraph> <paragraph num="G."> <text>Ventilation and airway maintenance equipment including:</text> <paragraph num="(1)"> <text>Laryngoscope equipment and supplies:</text> <paragraph num="(a)"> <text>One of each size 0, 1, 2, 3, and 4 Miller laryngoscope blades,</text> </paragraph> <paragraph num="(b)"> <text>One of each size 1, 2, 3, and 4 MacIntosh laryngoscope blades, and</text> </paragraph> <paragraph num="(c)"> <text>One each adult and pediatric laryngoscope handles;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Endotracheal tubes:</text> <paragraph num="(a)"> <text>One of each size 6, 7, 8, and 9 millimeter cuffed, and</text> </paragraph> <paragraph num="(b)"> <text>One of each size 2.5, 3, 3.5, 4, and 5 millimeter uncuffed;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>One adult flexible stylette;</text> </paragraph> <paragraph num="(4)"> <text>One pediatric flexible stylette;</text> </paragraph> <paragraph num="(5)"> <text>One roll of 1-inch adhesive tape;</text> </paragraph> <paragraph num="(6)"> <text>One 10 milliliter syringe;</text> </paragraph> <paragraph num="(7)"> <text>One pair adult McGill forceps;</text> </paragraph> <paragraph num="(8)"> <text>One pair pediatric McGill forceps;</text> </paragraph> <paragraph num="(9)"> <text>One 4-ounce tube or four 3-gram packets of water soluble surgical lubricant;</text> </paragraph> <paragraph num="(10)"> <text>One spare laryngoscope bulb for both MacIntosh and Miller blades;</text> </paragraph> <paragraph num="(11)"> <text>One spare set of laryngoscope batteries for both adult and pediatric handles; and</text> </paragraph> <paragraph num="(12)"> <text>One end title carbon dioxide (ETCO2) detector.</text> </paragraph> </paragraph> <paragraph num="H."> <text>One direct current to alternating current inverter power supply capable of providing proper wattage to power equipment used on an ALS ambulance; and</text> </paragraph> <paragraph num="I."> <text>Miscellaneous equipment and supplies as follows:</text> <paragraph num="(1)"> <text>One glucometer;</text> </paragraph> <paragraph num="(2)"> <text>One pulse oximeter for each in-service ALS ambulance; and</text> </paragraph> <paragraph num="(3)"> <text>One current, printed within last 2 years, copy of a drug reference.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Additional Requirements for Obstetrical Transports."> <paragraph num="A."> <text>An ALS-licensed ambulance may not transport an obstetrical patient from one hospital to another for a higher level of obstetrical care unless:</text> <paragraph num="(1)"> <text>The admitting hospital:</text> <paragraph num="(a)"> <text>Is a perinatal center;</text> </paragraph> <paragraph num="(b)"> <text>Before designation of perinatal centers by the EMS Board, has a certificate of need issued by the Maryland Health Resources Planning Commission for its neonatal intensive care unit or approval from the Health Services Cost Review Commission for a neonatal intensive care cost center; or</text> </paragraph> <paragraph num="(c)"> <text>Before the EMS Board has completed the process of entering into an agreement with an out-of-State hospital to serve as an out-of-State perinatal referral center, possesses all government approvals required to operate a neonatal intensive care unit under the laws of the jurisdiction in which it is located including, if required, a certificate of need and all necessary licenses;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The additional equipment required under §B of this regulation is onboard; and</text> </paragraph> <paragraph num="(3)"> <text>In addition to the staffing required under COMAR 30.09.07.02A(4), there is a registered nurse or physician experienced in the care of obstetrical patients onboard.</text> </paragraph> </paragraph> <paragraph num="B."> <text>Equipment Requirements.</text> <paragraph num="(1)"> <text>The additional equipment required under §B(2) of this regulation may be provided by the referring or admitting hospital and shall be onboard when transporting an obstetrical patient.</text> </paragraph> <paragraph num="(2)"> <text>In addition to the equipment required under COMAR 30.09.10 and this chapter, the following shall be onboard:</text> <paragraph num="(a)"> <text>One doppler;</text> </paragraph> <paragraph num="(b)"> <text>One reflex hammer;</text> </paragraph> <paragraph num="(c)"> <text>One neonatal bag valve mask with manometer and newborn and premature infant size masks;</text> </paragraph> <paragraph num="(d)"> <text>One IV infusion pump; and</text> </paragraph> <paragraph num="(e)"> <text>The following medications:</text> <paragraph num="(i)"> <text>Four vials oxytocin (10 units/milliliter);</text> </paragraph> <paragraph num="(ii)"> <text>Two vials methergine (0.2 milligram/milliliter);</text> </paragraph> <paragraph num="(iii)"> <text>Two vials 10 percent calcium gluconate (10 milliliters);</text> </paragraph> <paragraph num="(iv)"> <text>Three vials terbutaline (1 milligram/milliliter); and</text> </paragraph> <paragraph num="(v)"> <text>Eight vials 50 percent magnesium sulfate (10 milliliters).</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="C."> <text>Additional Record Keeping Requirements.</text> <paragraph num="(1)"> <text>In addition to the requirements in COMAR 30.09.08, the following information shall be documented on the patient report:</text> <paragraph num="(a)"> <text>Name of the referring hospital;</text> </paragraph> <paragraph num="(b)"> <text>Name of the referring physician;</text> </paragraph> <paragraph num="(c)"> <text>Name of the receiving hospital;</text> </paragraph> <paragraph num="(d)"> <text>Name of the receiving physician;</text> </paragraph> <paragraph num="(e)"> <text>Names and license or certification level of the commercial ambulance driver and commercial ambulance personnel;</text> </paragraph> <paragraph num="(f)"> <text>Time the request for transport was received by the commercial ambulance service;</text> </paragraph> <paragraph num="(g)"> <text>Time en route to the referring hospital;</text> </paragraph> <paragraph num="(h)"> <text>Time of arrival at the referring hospital;</text> </paragraph> <paragraph num="(i)"> <text>Time of departure from the referring hospital;</text> </paragraph> <paragraph num="(j)"> <text>Time of arrival at the admitting hospital;</text> </paragraph> <paragraph num="(k)"> <text>Maternal gestational age;</text> </paragraph> <paragraph num="(l)"> <text>Reason for transport; and</text> </paragraph> <paragraph num="(m)"> <text>Care provided during transport.</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Patient care reports and EMS data shall be submitted in accordance with COMAR 30.03.04.04.</text> </paragraph> </paragraph> <paragraph num="D."> <text>The additional requirements for obstetrical transports listed in §§A and B of this regulation may be waived when an ALS-licensed commercial ambulance is transporting an uncomplicated obstetrical patient from a hospital without an obstetrical service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Specialty Care Transport Restrictions."> <text>A licensed commercial ambulance service may not provide specialty care transport unless:</text> <paragraph num="A."> <text>Licensed as a specialty care transport ambulance service; or</text> </paragraph> <paragraph num="B."> <text>No more than ten times a year, if a licensed specialty care transport ambulance service is not available within a clinically reasonable time as determined by the referring physician:</text> <paragraph num="(1)"> <text>The sending facility provides health care personnel authorized by law to provide the level of care required by the patient during transport, which may include a nurse meeting the requirements of COMAR 10.27.09.04C(2);</text> </paragraph> <paragraph num="(2)"> <text>Required specialty equipment is available;</text> </paragraph> <paragraph num="(3)"> <text>The ambulance used is licensed as at least an ALS ambulance;</text> </paragraph> <paragraph num="(4)"> <text>Notice is made to SOCALR within 24 hours of the transport; and</text> </paragraph> <paragraph num="(5)"> <text>A report, reviewed and signed by the medical director, is submitted to SOCALR within 7 days of the transport, documenting the patient’s condition, the care rendered, crew configuration and efforts made by the referring physician, and the service to secure appropriate SCT resources.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 repealed and new Regulations .02—.06 adopted as an emergency provision effective January 6, 1997 (24:2 Md. R. 114); adopted permanently effective July 7, 1997 (24:10 Md. R. 711)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.11 to COMAR 30.09.11, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulation .02F amended as an emergency provision effective July 1, 1998 (25:15 Md. R. 1189); amended permanently effective October 5, 1998 (25:20 Md. R. 1534)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.06, Specialized Service, repealed and new Regulations .01—.05, ALS Service, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02A amended effective November 1, 2010 (37:21 Md. R. 1437); December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective January 15, 2005 (31:26 Md. R. 1866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective November 1, 2010 (37:21 Md. R. 1437)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 repealed and new Regulation o5 adopted effective January 15, 2005 (31:26 Md. R. 1866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective September 1, 2014 (41:17 Md. R. 971)</annotation> </annotations> </chapter> <chapter num="12" heading="Neonatal Ambulance Service and Infant Transport"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the operations of neonatal ambulance services and neonatal ambulances.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="Requirements for a Neonatal Commercial Ambulance Service."> <paragraph num="A."> <text>A commercial ambulance service wishing to provide neonatal ambulance services shall comply with the requirements of this chapter in addition to the other applicable requirements of this subtitle.</text> </paragraph> <paragraph num="B."> <text>An ambulance service transporting neonates shall obtain a neonatal commercial ambulance service license.</text> </paragraph> <paragraph num="C."> <text>An applicant for a neonatal commercial ambulance service license shall submit an application to SOCALR on the required form.</text> </paragraph> <paragraph num="D."> <text>A completed application form shall be accompanied by documentation which states to SOCALR’s satisfaction that the commercial ambulance service has:</text> <paragraph num="(1)"> <text>Retained two or more registered nurses who:</text> <paragraph num="(a)"> <text>Meet the requirements of the Board of Nursing under COMAR 10.27.09.04 to provide nursing care to neonates during interfacility transport; and</text> </paragraph> <paragraph num="(b)"> <text>Agree to assume responsibility for patient care during the transport process;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Retained one or more physicians who are board certified or are active candidates for board certification in neonatology who:</text> <paragraph num="(a)"> <text>Possess current knowledge of the Maryland EMS System as required in COMAR 30.03.03.03B(4), as well as current knowledge of:</text> <paragraph num="(i)"> <text>The effects of transport on the neonate; and</text> </paragraph> <paragraph num="(ii)"> <text>The operation of neonatal transport equipment and ambulance communications equipment; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Working with a neonatal or perinatal center, agree to:</text> <paragraph num="(i)"> <text>Serve as medical director for the neonatal service;</text> </paragraph> <paragraph num="(ii)"> <text>Provide medical direction to the commercial ambulance service's personnel-related neonatal care;</text> </paragraph> <paragraph num="(iii)"> <text>Provide training as required in neonatal care; and</text> </paragraph> <paragraph num="(iv)"> <text>Participate in a quality assurance program; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>If providing neonatal transport services in partnership with a hospital-based neonatal intensive care unit, a written MOU stating that all equipment and medications required to transport a neonate under this chapter will be readily available to the service.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A licensed neonatal commercial ambulance service shall immediately advise SOCALR of any change in the medical director named in §D(2) of this regulation.</text> </paragraph> <paragraph num="F."> <text>A licensed neonatal commercial ambulance service may not transport a neonate from one hospital to another for a higher level of care unless the admitting hospital:</text> <paragraph num="(1)"> <text>Is a perinatal center;</text> </paragraph> <paragraph num="(2)"> <text>Is a neonatal center;</text> </paragraph> <paragraph num="(3)"> <text>Before designation of perinatal centers by the EMS Board, has a certificate of need issued by the Maryland Health Resources Planning Commission for its neonatal intensive care unit or approval from Maryland Health Resources Planning Commission for a neonatal intensive care unit; or</text> </paragraph> <paragraph num="(4)"> <text>Before the EMS Board has completed the process of entering into an agreement with an out-of-State hospital to serve as an out-of-State perinatal referral center, possesses all government approvals required to operate a neonatal intensive care unit under the laws of the jurisdiction in which it is located including, if required, a certificate of need and all necessary licenses.</text> </paragraph> </paragraph> <paragraph num="G."> <text>Neonates.</text> <paragraph num="(1)"> <text>Neonates being transferred to a neonatal intensive care unit (NICU) shall be transported by a neonatal licensed transport service, as described in Regulation .04 of this chapter.</text> </paragraph> <paragraph num="(2)"> <text>Neonates being transferred to any acute care setting other than a NICU shall be transported by either:</text> <paragraph num="(a)"> <text>A neonatal licensed transport service; or</text> </paragraph> <paragraph num="(b)"> <text>A specialty care transport (SCT) service with an RN who has age-appropriate competencies and equipment.</text> </paragraph> </paragraph> </paragraph> <paragraph num="H."> <text>Infants. Infants being transferred to any acute care setting shall be transported by:</text> <paragraph num="(1)"> <text>A neonatal licensed transport service;</text> </paragraph> <paragraph num="(2)"> <text>An SCT service with a staff who has age-appropriate competencies and equipment; or</text> </paragraph> <paragraph num="(3)"> <text>An ALS unit that includes staff with age-appropriate competencies and equipment, only after a neonatal licensed transport or SCT service has reviewed the case and referred it to the ALS service.</text> </paragraph> </paragraph> <paragraph num="I."> <text>Neonates or Infants being transported for convalescent care at a rehabilitation hospital or long-term facility shall be transported by:</text> <paragraph num="(1)"> <text>A neonatal licensed transport service;</text> </paragraph> <paragraph num="(2)"> <text>An SCT service with a staff who has age-appropriate competencies and equipment; or</text> </paragraph> <paragraph num="(3)"> <text>An ALS unit that includes staff with age-appropriate competencies and equipment, only after a neonatal licensed transport or SCT service has reviewed the case and referred it to the ALS service.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Additional Requirements for Services."> <paragraph num="A."> <text>An applicant for a neonatal commercial ambulance license shall submit an application to SOCALR.</text> </paragraph> <paragraph num="B."> <text>A licensed neonatal commercial ambulance service may only provide neonatal transport service with an ALS or SCT licensed commercial ambulance that meets all the requirements of this chapter.</text> </paragraph> <paragraph num="C."> <text>A licensed neonatal commercial ambulance service shall ensure the patient is secured in a patient restraint device appropriate for the patient’s age and weight.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Staffing."> <paragraph num="A."> <text>A licensed commercial ambulance, when providing neonatal service, shall be staffed by:</text> <paragraph num="(1)"> <text>A driver who meets the requirements in COMAR 30.09.07.02A(4)(a); and</text> </paragraph> <paragraph num="(2)"> <text>At least two individuals, in addition to the driver:</text> <paragraph num="(a)"> <text>At least one of whom shall be a registered nurse or physician with advanced training in the care of neonates; and</text> </paragraph> <paragraph num="(b)"> <text>The second individual shall be a Maryland licensed health care provider, including a physician, registered nurse, respiratory therapist, nurse practitioner, physician assistant, paramedic, or CRT, who is medically qualified to care for the patient and has additional training needed to care for neonatal patients during interfacility transport including:</text> <paragraph num="(i)"> <text>Knowledge of the Maryland EMS System;</text> </paragraph> <paragraph num="(ii)"> <text>The effects of transport on the neonate; and</text> </paragraph> <paragraph num="(iii)"> <text>The operation of neonatal transport equipment and ambulance communications equipment.</text> </paragraph> </paragraph> </paragraph> </paragraph> <paragraph num="B."> <text>When more than one patient is transported simultaneously in the same ambulance:</text> <paragraph num="(1)"> <text>There shall be at least one registered nurse or physician with advanced training in the care of neonates present for each neonatal patient; and</text> </paragraph> <paragraph num="(2)"> <text>Each patient shall be secured in a separate patient restraint device appropriate for the patients age and weight.</text> </paragraph> </paragraph> <paragraph num="C."> <text>All personnel attending to neonatal patients shall:</text> <paragraph num="(1)"> <text>Prior to transporting neonatal patients, successfully complete:</text> <paragraph num="(a)"> <text>The Neonatal Resuscitation Program; and</text> </paragraph> <paragraph num="(b)"> <text>The S.T.A.B.L.E. Program;</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>Maintain a current:</text> <paragraph num="(a)"> <text>Neonatal Resuscitation Program Provider Course Completion Card; and</text> </paragraph> <paragraph num="(b)"> <text>S.T.A.B.L.E. Program Completion Certificate; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>If a physician:</text> <paragraph num="(a)"> <text>Maintain board certification in neonatology;</text> </paragraph> <paragraph num="(b)"> <text>Maintain board certification in pediatric critical care; or</text> </paragraph> <paragraph num="(c)"> <text>Be a licensed physician serving in the second or third year of a neonatology or pediatric critical care fellowship.</text> </paragraph> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Additional Record-Keeping and Quality Assurance Requirements."> <paragraph num="A."> <text>In addition to the information required in COMAR 30.09.08, the following information shall be documented on the patient runsheet:</text> <paragraph num="(1)"> <text>Mother's name;</text> </paragraph> <paragraph num="(2)"> <text>Name of the referring hospital;</text> </paragraph> <paragraph num="(3)"> <text>Name of the referring physician;</text> </paragraph> <paragraph num="(4)"> <text>Name of the receiving hospital;</text> </paragraph> <paragraph num="(5)"> <text>Name of the receiving physician;</text> </paragraph> <paragraph num="(6)"> <text>Date of birth;</text> </paragraph> <paragraph num="(7)"> <text>Time of birth;</text> </paragraph> <paragraph num="(8)"> <text>Gestational age of the patient;</text> </paragraph> <paragraph num="(9)"> <text>Weight of the patient;</text> </paragraph> <paragraph num="(10)"> <text>Primary reason for transport;</text> </paragraph> <paragraph num="(11)"> <text>Names and license or certification level of the commercial ambulance driver and all personnel;</text> </paragraph> <paragraph num="(12)"> <text>Time the request for transport was received by the commercial ambulance service;</text> </paragraph> <paragraph num="(13)"> <text>Time the transport team departed from base;</text> </paragraph> <paragraph num="(14)"> <text>Time the transport team arrived at the referral hospital;</text> </paragraph> <paragraph num="(15)"> <text>Time the transport team departed from the referral hospital;</text> </paragraph> <paragraph num="(16)"> <text>Time the transport team arrived at the receiving hospital; and</text> </paragraph> <paragraph num="(17)"> <text>Care provided during the transport.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A copy of the runsheet and all documentation of patient care during the transport shall be submitted in accordance with COMAR 30.09.08.06D.</text> </paragraph> <paragraph num="C."> <text>A licensed neonatal commercial ambulance service shall have a quality assurance program required by COMAR 30.03.04 which shall include:</text> <paragraph num="(1)"> <text>A review by registered nurses and physicians of patient care provided during neonatal transport;</text> </paragraph> <paragraph num="(2)"> <text>A review by the program medical director of each specialty care transport:</text> <paragraph num="(a)"> <text>Requiring a change in the plan of care during transport;</text> </paragraph> <paragraph num="(b)"> <text>In which the patient’s condition worsened during transport;</text> </paragraph> <paragraph num="(c)"> <text>Requiring a change in destination during transport; or</text> </paragraph> <paragraph num="(d)"> <text>During which there was an unexpected outcome or event;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Written documentation of reviews of neonatal transports which shall be available to SOCALR upon request; and</text> </paragraph> <paragraph num="(4)"> <text>A quality assurance process for call taking, call screening, and dispatch.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Equipment Requirements."> <paragraph num="A."> <text>A licensed neonatal commercial ambulance service shall comply with COMAR 30.09.11.03 when transporting a neonate.</text> </paragraph> <paragraph num="B."> <text>There shall be a written maintenance plan for all medical devices used on neonatal commercial ambulances approved by SOCALR, which shall provide that:</text> <paragraph num="(1)"> <text>All specialized medical devices used during transport shall:</text> <paragraph num="(a)"> <text>If provided by the hospital, be maintained by the hospital; or</text> </paragraph> <paragraph num="(b)"> <text>If provided by the licensed commercial ambulance service, be maintained as recommended by the manufacturer; and</text> </paragraph> </paragraph> <paragraph num="(2)"> <text>The licensed commercial service providing specialized medical devices used during transport shall maintain records documenting maintenance and repair services.</text> </paragraph> </paragraph> <paragraph num="C."> <text>All on-board medical devices shall be secured to the satisfaction of SOCALR.</text> </paragraph> <paragraph num="D."> <text>The following equipment shall be carried in a neonatal ambulance:</text> <paragraph num="(1)"> <text>All equipment listed in the current Neonatal equipment list approved by SOCALR;</text> </paragraph> <paragraph num="(2)"> <text>Any additional equipment required for the care of the patient as determined by consultation between the referring and receiving physicians; and</text> </paragraph> <paragraph num="(3)"> <text>Additional medications approved for use by the neonatal service medical director to meet the needs of the types of patients being transported.</text> </paragraph> </paragraph> <paragraph num="E."> <text>A list of the additional medications used by the neonatal service and approved by the neonatal service medical director shall be provided to SOCALR and approved by the State EMS Medical Director annually upon license renewal, and shall be available on each ambulance when in use for a neonatal transport.</text> </paragraph> <paragraph num="F."> <text>SOCALR shall be notified in writing of any changes to the list of additional medications used by the neonatal transport service within 7 days of the change.</text> </paragraph> <paragraph num="G."> <text>There shall be sufficient quantities of medications to care for one neonatal patient for the longer of:</text> <paragraph num="(1)"> <text>1 hour; or</text> </paragraph> <paragraph num="(2)"> <text>Two times the estimated time of transport.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 12, 1992 (19:20 Md. R. 1816)</annotation> <annotation type="History" subtype="Administrative History">Chapter recodified from COMAR 14.22.12 to COMAR 30.09.12, August, 1997</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.08, Enforcement, repealed effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulations .01—.07, Neonatal Ambulance Service, adopted effective January 10, 2000 (26:27 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Chapter revised effective September 1, 2014 (41:17 Md. R. 972)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02 amended effective May 3, 2021 (48:9 Md. R. 361)</annotation> <annotation type="History" subtype="Administrative History">Regulation .03 amended effective May 3, 2021 (48:9 Md. R. 361)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04A amended effective May 3, 2021 (48:9 Md. R. 361); October 16, 2023 (50:20 Md. R. 889)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04C amended effective October 16, 2023 (50:20 Md. R. 889)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05B amended effective May 3, 2021 (48:9 Md. R. 361)</annotation> <annotation type="History" subtype="Administrative History">Regulation .06 amended effective May 3, 2021 (48:9 Md. R. 361)</annotation> </annotations> </chapter> <chapter num="13" heading="Air Ambulance Service"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the requirements for a commercial air ambulance service.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="In General."> <paragraph num="A."> <text>To be licensed as a commercial care air ambulance service, a commercial air ambulance service shall comply with the requirements of this chapter in addition to the other applicable requirements of this subtitle.</text> </paragraph> <paragraph num="B."> <text>An applicant for a commercial air ambulance service license shall submit an application to SOCALR on the required form.</text> </paragraph> <paragraph num="C."> <text>An applicant for a commercial air ambulance service license shall:</text> <paragraph num="(1)"> <text>Be accredited by CAMTS; or</text> </paragraph> <paragraph num="(2)"> <text>If ineligible to apply for CAMTS accreditation, because it has been in service for less than 1 year:</text> <paragraph num="(a)"> <text>Submit to SOCALR a CAMTS consultation report indicating compliance with the CAMTS standards; and</text> </paragraph> <paragraph num="(b)"> <text>Apply for and receive full CAMTS accreditation within 18 months of being licensed by SOCALR.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>A licensed commercial air ambulance service shall notify SOCALR within 24 hours of any change in CAMTS accreditation status and the reason for the change.</text> </paragraph> <paragraph num="E."> <text>A licensed commercial air ambulance service may provide ALS, critical care, or neonatal transport service, or any combination of these, if:</text> <paragraph num="(1)"> <text>The equipment and personnel requirements of this subtitle are met for the specific type of transport;</text> </paragraph> <paragraph num="(2)"> <text>The submitted service license application includes the information required, demonstrating compliance for the specific type of transport; and</text> </paragraph> <paragraph num="(3)"> <text>The service is accredited by CAMTS at that level.</text> </paragraph> </paragraph> <paragraph num="F."> <text>A licensed commercial air ambulance service may not provide services with an unlicensed air ambulance unless:</text> <paragraph num="(1)"> <text>The unlicensed air ambulance is used as a temporary replacement for a licensed air ambulance that is out of service for routine maintenance or repair;</text> </paragraph> <paragraph num="(2)"> <text>The temporary replacement air ambulance meets all FAA requirements;</text> </paragraph> <paragraph num="(3)"> <text>The temporary replacement air ambulance has all required staffing and equipment; and</text> </paragraph> <paragraph num="(4)"> <text>It has notified SOCALR of the use of the replacement air ambulance and provided the following information:</text> <paragraph num="(a)"> <text>The unit designation number assigned for operational purposes;</text> </paragraph> <paragraph num="(b)"> <text>The FAA registration number; and</text> </paragraph> <paragraph num="(c)"> <text>The make, model, and year of manufacture.</text> </paragraph> </paragraph> </paragraph> <paragraph num="G."> <text>A licensed commercial air ambulance service that provides services with an unlicensed air ambulance shall notify SOCALR when the licensed air ambulance is returned to service.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Additional Personnel Requirements for Commercial Air Ambulance Services."> <text>A commercial air ambulance shall be staffed by:</text> <paragraph num="A."> <text>A pilot who meets the requirements of licensure established by the Federal Aviation Administration 14 CFR Parts 61, 67, and 135; and</text> </paragraph> <paragraph num="B."> <text>At least two additional individuals who meet or exceed the requirements for CAMTS accreditation at the level which the service is providing.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Additional Equipment Requirements for Air Ambulances."> <paragraph num="A."> <text>Each air ambulance shall carry sufficient equipment and supplies listed in COMAR 30.09.10—13 to assure:</text> <paragraph num="(1)"> <text>The ability to carry out all procedures in the Maryland Medical Protocols for EMS Providers; and</text> </paragraph> <paragraph num="(2)"> <text>That when transporting specialty care patients, the additional equipment necessary to care for the patient being transported is available;</text> </paragraph> </paragraph> <paragraph num="B."> <text>A list of medical equipment and supplies will be provided to SOCALR with the licensing application.</text> </paragraph> <paragraph num="C."> <text>All medical, communications, and associated equipment on-board:</text> <paragraph num="(1)"> <text>If routinely carried, shall be EMI certified for air operations; or</text> </paragraph> <paragraph num="(2)"> <text>If not routinely used, shall be approved by the pilot.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Operational Requirements for Air Ambulance Services."> <paragraph num="A."> <text>Pilots of rotary wing air ambulances shall remain with the aircraft when the aircraft is occupying a hospital helipad with room for landing a single aircraft.</text> </paragraph> <paragraph num="B."> <text>SYSCOM shall coordinate the landing sequence of multiple emergency medical services aircraft in consultation with the pilots-in-command based on patient priority.</text> </paragraph> <paragraph num="C."> <text>Commercial air ambulance services shall:</text> <paragraph num="(1)"> <text>Comply with the requirements of COMAR 30.07; and</text> </paragraph> <paragraph num="(2)"> <text>Keep SYSCOM apprised of the location of their air ambulance at all times while the aircraft is in Maryland or in geographic proximity to the Maryland border in a contiguous state.</text> </paragraph> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §§13-508 and 13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: October 15, 2004 (31:20 Md. R. 1486)</annotation> </annotations> </chapter> <chapter num="14" heading="Specialty Care Transport Services"> <regulation prefix="Regulation" num=".01" heading="Scope."> <text>This chapter governs the requirements for a specialty care transport commercial ambulance service other than neonatal ambulance services. The requirements for neonatal ambulance services are in COMAR 30.09.12.</text> </regulation> <regulation prefix="Regulation" num=".02" heading="General."> <paragraph num="A."> <text>To be licensed as a specialty care transport commercial ambulance service, a commercial ambulance service shall comply with the requirements of this chapter in addition to the other requirements of this subtitle.</text> </paragraph> <paragraph num="B."> <text>An applicant for a specialty care transport commercial ambulance service license shall submit an application to SOCALR on the required form.</text> </paragraph> <paragraph num="C."> <text>A licensed specialty care transport commercial ambulance service shall retain one or more medical directors as required by COMAR 30.03.03.</text> </paragraph> <paragraph num="D."> <text>In addition to the qualifications in COMAR 30.03.03, the medical director for a specialty care service shall:</text> <paragraph num="(1)"> <text>Have educational experience in the care of the types of critically ill patients the service is transporting;</text> </paragraph> <paragraph num="(2)"> <text>Be board-certified in an appropriate specialty;</text> </paragraph> <paragraph num="(3)"> <text>Be actively practicing within a hospital clinical setting; and</text> </paragraph> <paragraph num="(4)"> <text>Use the following consultants when appropriate:</text> <paragraph num="(a)"> <text>Designated specialty physicians; or</text> </paragraph> <paragraph num="(b)"> <text>The patient's receiving physician.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>The medical director for a licensed specialty care transport ambulance service shall participate in the development and implementation of any patient care guidelines required for interfacility transport of critically ill patients, including those guidelines to be followed by nursing personnel.</text> </paragraph> <paragraph num="F."> <text>A licensed specialty care ambulance service shall immediately advise SOCALR of any change in medical directors.</text> </paragraph> <paragraph num="G."> <text>A licensed specialty care ambulance service shall retain one or more registered nurses or nurse practitioners who:</text> <paragraph num="(1)"> <text>Are licensed by the Maryland Board of Nursing;</text> </paragraph> <paragraph num="(2)"> <text>Have knowledge of content which includes, but is not limited to:</text> <paragraph num="(a)"> <text>The transport arena (including transport team membership and role responsibility);</text> </paragraph> <paragraph num="(b)"> <text>Regulations governing COMAR 10.27.09;</text> </paragraph> <paragraph num="(c)"> <text>Documentation;</text> </paragraph> <paragraph num="(d)"> <text>Coordination with other transport team members;</text> </paragraph> <paragraph num="(e)"> <text>Knowledge and skill set appropriate to the client to be transported;</text> </paragraph> <paragraph num="(f)"> <text>Review of safety standards specific to the transport environment;</text> </paragraph> <paragraph num="(g)"> <text>Relevant components of the MIEMSS Base Station Course;</text> </paragraph> <paragraph num="(h)"> <text>Review of the MIEMSS Interhospital Transfer Resource Manual;</text> </paragraph> <paragraph num="(i)"> <text>Risk/benefit ratio assessment and triage decision-making process;</text> </paragraph> <paragraph num="(j)"> <text>Age-appropriate advanced life saving procedures, complications associated with procedures, and complications associated with delay in intervening with any of the procedures;</text> </paragraph> <paragraph num="(k)"> <text>Respiratory monitoring including differentiation between upper and lower airway obstruction, covert and overt signs of respiratory failure, and airway management;</text> </paragraph> <paragraph num="(l)"> <text>Neurological and spinal cord emergences and monitoring;</text> </paragraph> <paragraph num="(m)"> <text>Cardiovascular and hemodynamic monitoring including dysrhythmia recognition and pertinent laboratory data and interpretation;</text> </paragraph> <paragraph num="(n)"> <text>Blood and blood product administration;</text> </paragraph> <paragraph num="(o)"> <text>Knowledge of MIEMSS Maryland Medical Protocols for EMS Providers appropriate to the client population transported;</text> </paragraph> <paragraph num="(p)"> <text>Age-appropriate care algorithms and protocols;</text> </paragraph> <paragraph num="(q)"> <text>The responsibilities and accountability of the registered nurse to serve as team leader in absence of the physician;</text> </paragraph> <paragraph num="(r)"> <text>Insuring a safe environment and operational issues related to transport, including rapid egress from a trauma incident;</text> </paragraph> <paragraph num="(s)"> <text>Transport safety, which includes, but is not limited to:</text> <paragraph num="(i)"> <text>Safety briefing related to the vehicle;</text> </paragraph> <paragraph num="(ii)"> <text>Protective clothing; and</text> </paragraph> <paragraph num="(iii)"> <text>Mission profile;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(3)"> <text>Demonstrate knowledge of the EMS system by:</text> <paragraph num="(a)"> <text>Completing a MIEMSS-approved base station course; or</text> </paragraph> <paragraph num="(b)"> <text>Being a currently licensed EMS provider;</text> </paragraph> </paragraph> <paragraph num="(4)"> <text>Comply with the requirements of COMAR 10.27.09;</text> </paragraph> <paragraph num="(5)"> <text>Screen all requests for specialty care transport; and</text> </paragraph> <paragraph num="(6)"> <text>Determine, in collaboration with the referring physician and program medical director, and in accordance with Regulation .04 of this chapter, the appropriate transport team configuration required for the patient.</text> </paragraph> </paragraph> <paragraph num="H."> <text>The licensed specialty care ambulance service shall credential any registered nurse retained by the service to ensure the registered nurse meets the requirements of §G of this regulation.</text> </paragraph> <paragraph num="I."> <text>A licensed specialty care commercial ambulance service shall have a quality assurance program required by COMAR 30.03.04 which shall include:</text> <paragraph num="(1)"> <text>A review by registered nurses and physicians of patient care provided during specialty care transport;</text> </paragraph> <paragraph num="(2)"> <text>A review by the program medical director or designated specialty physician of each specialty care transport:</text> <paragraph num="(a)"> <text>Requiring a change in the plan of care during transport;</text> </paragraph> <paragraph num="(b)"> <text>Whose condition worsened during transport;</text> </paragraph> <paragraph num="(c)"> <text>In which there was a change of destination during transport; or</text> </paragraph> <paragraph num="(d)"> <text>In which there was an unexpected outcome or event;</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Written documentation of reviews of specialty care transports which shall be available to SOCALR upon request;</text> </paragraph> <paragraph num="(4)"> <text>Patient feedback on outcomes to the sending facility; and</text> </paragraph> <paragraph num="(5)"> <text>A quality assurance process for call taking, call screening, and dispatch.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".03" heading="Additional Requirements for Specialty Care Ambulances."> <paragraph num="A."> <text>The interior configuration of an ambulance used for specialty care transport shall:</text> <paragraph num="(1)"> <text>Allow medical personnel access to the airway and at least one side of the patient from a secured, seat-belted position;</text> </paragraph> <paragraph num="(2)"> <text>Allow medical personnel to see all monitor read-outs from secured, seat-belted positions;</text> </paragraph> <paragraph num="(3)"> <text>Have all medical devices, supplies, and equipment stowed or adequately fastened to prevent items from becoming projectiles that can cause injury in an abrupt stop or crash; and</text> </paragraph> <paragraph num="(4)"> <text>Have compartments used to carry heavy objects, including oxygen cylinders, suction units, intravenous pumps, monitors, or ventilators, with positively locked latches designed to remain closed in an abrupt stop or crash with both latch and hinge bolted to the door and frame structure.</text> </paragraph> </paragraph> <paragraph num="B."> <text>A licensed specialty care transport ambulance service may provide specialty care transport using:</text> <paragraph num="(1)"> <text>A dedicated licensed specialty care ambulance; or</text> </paragraph> <paragraph num="(2)"> <text>An ALS licensed ambulance staffed and equipped as a specialty care ambulance.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".04" heading="Additional Staffing Requirements for Specialty Care Commercial Ambulance Services."> <paragraph num="A."> <text>An ambulance providing specialty care transport service shall be staffed as provided in this regulation.</text> </paragraph> <paragraph num="B."> <text>If the care required is within the scope of practice of Specialty Care Paramedic and the patient requires no more than one specialty care intervention, as defined in the Maryland Medical Protocols for Emergency Medical Services:</text> <paragraph num="(1)"> <text>A driver who meets the requirements of COMAR 30.09.07.02A(4)(a); and</text> </paragraph> <paragraph num="(2)"> <text>A Specialty Care Paramedic.</text> </paragraph> </paragraph> <paragraph num="C."> <text>If the care required is within the scope of practice of a Specialty Care Paramedic and the patient requires two or more specialty care interventions, as defined in the Maryland Medical Protocols for Emergency Medical Services:</text> <paragraph num="(1)"> <text>A driver who meets the requirements of COMAR 30.09.07.02A(4)(a);</text> </paragraph> <paragraph num="(2)"> <text>At least one individual who is:</text> <paragraph num="(a)"> <text>A Specialty Care Paramedic; or</text> </paragraph> <paragraph num="(b)"> <text>A registered nurse with advanced training and certification in the care of specialty care patients and current knowledge of the EMS system as defined in Regulation .02G(3) of this chapter; and</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>At least one individual who:</text> <paragraph num="(a)"> <text>Is one of the following:</text> <paragraph num="(i)"> <text>A CRT initially licensed after July 1, 2001 or who has completed the CRT update program;</text> </paragraph> <paragraph num="(ii)"> <text>A paramedic; or</text> </paragraph> <paragraph num="(iii)"> <text>If the individual under §C(2) of this regulation is a Specialty Care Paramedic and one of the specialty care interventions involves ventilator management, a respiratory therapist; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>Has successfully completed an orientation to specialty care transport.</text> </paragraph> </paragraph> </paragraph> <paragraph num="D."> <text>If the care required is outside the scope of practice of a Specialty Care Paramedic:</text> <paragraph num="(1)"> <text>A driver who meets the requirements of COMAR 30.09.07.02A(4)(a); and</text> </paragraph> <paragraph num="(2)"> <text>At least two additional individuals who meet the following requirements:</text> <paragraph num="(a)"> <text>One shall be at least:</text> <paragraph num="(i)"> <text>A Specialty Care Paramedic; or</text> </paragraph> <paragraph num="(ii)"> <text>A paramedic who has successfully completed an orientation to specialty care transport; and</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>One shall be a registered nurse, physician assistant, or physician with advanced training and certification in the care of specialty care patients and current knowledge of the EMS system as defined in Regulation .02G(3) of this chapter.</text> </paragraph> </paragraph> </paragraph> <paragraph num="E."> <text>If an SCT service is not able to provide a staffed and equipped SCT ambulance within a clinically reasonable time as determined by the referring physician, it may conduct the SCT transport if:</text> <paragraph num="(1)"> <text>The sending facility provides health care personnel authorized by law to provide the level of care required by the patient during transport, which may include a nurse meeting the requirements of COMAR 10.27.09.04C(2);</text> </paragraph> <paragraph num="(2)"> <text>Required specialty equipment is available;</text> </paragraph> <paragraph num="(3)"> <text>The ambulance used is licensed as at least an ALS ambulance;</text> </paragraph> <paragraph num="(4)"> <text>Notice is made to SOCALR within 24 hours of the transport; and</text> </paragraph> <paragraph num="(5)"> <text>A report, reviewed and signed by the medical director, is submitted to SOCALR within 7 days of the transport, documenting the patient’s condition, the care rendered, crew configuration and efforts made by the referring physician, and the service to secure appropriate SCT resources.</text> </paragraph> </paragraph> </regulation> <regulation prefix="Regulation" num=".05" heading="Additional Requirements for Paramedic with Specialty Care Transport Training."> <paragraph num="A."> <text>The paramedic shall provide documentation to the licensed commercial ambulance service that they have successfully completed a specialty care transport course that meets the requirements of COMAR 30.04.03.</text> </paragraph> <paragraph num="B."> <text>The medical director is responsible for credentialing the paramedic as required in COMAR 30.03.03.06.</text> </paragraph> <paragraph num="C."> <text>The paramedic shall receive at least 36 hours of specialty care continuing education every 3 years.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".06" heading="Additional Documentation Requirements for Specialty Care Transport Ambulance Services."> <text>The specialty care ambulance service shall maintain documentation on file for each individual providing patient care including:</text> <paragraph num="A."> <text>Annual review of clinical competency in the skills required for the type that are transported; and</text> </paragraph> <paragraph num="B."> <text>Proof of training on the use of the equipment necessary to care for and transport the patient, including those items in Regulation .04 of this chapter.</text> </paragraph> </regulation> <regulation prefix="Regulation" num=".07" heading="Additional Equipment and Medication Requirements for Specialty Care Transport Ambulances."> <paragraph num="A."> <text>All specialized medical devices used during transport shall:</text> <paragraph num="(1)"> <text>If provided by the hospital, be maintained by the hospital; or</text> </paragraph> <paragraph num="(2)"> <text>If provided by the licensed commercial ambulance services be maintained as recommended by the manufacturer.</text> </paragraph> </paragraph> <paragraph num="B."> <text>The licensed commercial service providing specialized medical devices used during transport shall maintain records documenting maintenance and repair services.</text> </paragraph> <paragraph num="C."> <text>There shall be a means of communicating directly with the consulting specialty care physician and medical director.</text> </paragraph> <paragraph num="D."> <text>All on-board medical devices shall be secured.</text> </paragraph> <paragraph num="E."> <text>In addition to the equipment required in COMAR 30.09.10 and 30.09.11, the following shall be carried in a licensed ambulance when providing specialty care and shall be age and weight appropriate for the patient being transported:</text> <paragraph num="(1)"> <text>A means of blending oxygen and air to deliver varying concentrations of medical oxygen;</text> </paragraph> <paragraph num="(2)"> <text>One portable electric suction unit which:</text> <paragraph num="(a)"> <text>Meets the criteria in COMAR 30.09.10.06B; and</text> </paragraph> <paragraph num="(b)"> <text>Is adjustable down to 60 millimeters mercury (Hg);</text> </paragraph> </paragraph> <paragraph num="(3)"> <text>Intravascular Equipment and Supplies:</text> <paragraph num="(a)"> <text>Four infusion pumps or equivalent;</text> </paragraph> <paragraph num="(b)"> <text>Six intravenous (IV) pump tubing sets;</text> </paragraph> <paragraph num="(c)"> <text>Six extension sets;</text> </paragraph> <paragraph num="(d)"> <text>Eight stopcocks;</text> </paragraph> <paragraph num="(e)"> <text>Two blood infusion sets;</text> </paragraph> <paragraph num="(f)"> <text>Two intravenous (IV) filters;</text> </paragraph> <paragraph num="(g)"> <text>Eight total needles of assorted sizes ranging from 22 gauge to 18 gauge;</text> </paragraph> <paragraph num="(h)"> <text>When transporting adult patients:</text> <paragraph num="(i)"> <text>Two 1,000 cubic centimeter bags or equivalent of normal saline or Lactated Ringer's Solution;</text> </paragraph> <paragraph num="(ii)"> <text>Two 1,000 cubic centimeter bags or equivalent of maintenance intravenous solution; and</text> </paragraph> <paragraph num="(iii)"> <text>Twelve total syringes of assorted sizes ranging from 1 cubic centimeter to 60 cubic centimeters;</text> </paragraph> </paragraph> <paragraph num="(i)"> <text>When transporting pediatric patients:</text> <paragraph num="(i)"> <text>Two 250 cubic centimeter bags or equivalent of normal saline or Lactated Ringer's Solution;</text> </paragraph> <paragraph num="(ii)"> <text>Two 250 cubic centimeter bags or equivalent of maintenance intravenous solution; and</text> </paragraph> <paragraph num="(iii)"> <text>Twelve total syringes of assorted sizes ranging from 1 cubic centimeter to 2 cubic centimeters;</text> </paragraph> </paragraph> </paragraph> <paragraph num="(4)"> <text>Ventilation and airway maintenance equipment and supplies capable of at least the following:</text> <paragraph num="(a)"> <text>Oxygen concentrations between 21 and 100 percent;</text> </paragraph> <paragraph num="(b)"> <text>Peak pressures between 0 and 99;</text> </paragraph> <paragraph num="(c)"> <text>Adjustable inspiratory time;</text> </paragraph> <paragraph num="(d)"> <text>Selectable intermittent mandatory ventilation (IMV);</text> </paragraph> <paragraph num="(e)"> <text>Positive end expiratory pressure (PEEP) between 2—15 centimeters of water;</text> </paragraph> <paragraph num="(f)"> <text>Adjustable ventilatory rates between 0 and 60 breaths per minute;</text> </paragraph> <paragraph num="(g)"> <text>Adjustable tidal volume for adult patients between 200 milliliters and 1,000 milliliters or greater;</text> </paragraph> <paragraph num="(h)"> <text>Adjustable tidal volume for pediatric patients as low as 50 milliliters;</text> </paragraph> <paragraph num="(i)"> <text>Adjustable high and low pressure alarms; and</text> </paragraph> <paragraph num="(j)"> <text>Two ventilator circuits;</text> </paragraph> </paragraph> <paragraph num="(5)"> <text>Monitoring Equipment:</text> <paragraph num="(a)"> <text>One cardiac monitor which meets the criteria of COMAR 30.09.11.03B;</text> </paragraph> <paragraph num="(b)"> <text>Noninvasive blood pressure monitor;</text> </paragraph> <paragraph num="(c)"> <text>Invasive blood pressure monitor;</text> </paragraph> <paragraph num="(d)"> <text>End tidal carbon dioxide monitor with waveform display/recorder capable of providing quantitative reading; and</text> </paragraph> <paragraph num="(e)"> <text>Oxygen saturation monitor;</text> </paragraph> </paragraph> <paragraph num="(6)"> <text>Miscellaneous supplies and equipment:</text> <paragraph num="(a)"> <text>When transporting adult patients:</text> <paragraph num="(i)"> <text>One surgical and one needle crichthryotomy kit with transtracheal catheter ventilation system;</text> </paragraph> <paragraph num="(ii)"> <text>Replacement tracheostomy tubes, one of each size 6 and 8 millimeters;</text> </paragraph> <paragraph num="(iii)"> <text>One pleurevac;</text> </paragraph> <paragraph num="(iv)"> <text>One electronic thermometer; and</text> </paragraph> <paragraph num="(v)"> <text>Two surgical clamps capable of clamping up to a 40 french chest tube;</text> </paragraph> </paragraph> <paragraph num="(b)"> <text>When transporting pediatric patients:</text> <paragraph num="(i)"> <text>One surgical and one needle crichthryotomy kit with transtracheal catheter ventilation system;</text> </paragraph> <paragraph num="(ii)"> <text>Replacement tracheostomy tubes one each size 1, 2, 3, and 4 millimeters, and age-appropriate size during transport;</text> </paragraph> <paragraph num="(iii)"> <text>One pleurevac;</text> </paragraph> <paragraph num="(iv)"> <text>One electronic thermometer; and</text> </paragraph> <paragraph num="(v)"> <text>Two surgical clamps; and</text> </paragraph> </paragraph> </paragraph> <paragraph num="(7)"> <text>Medications including:</text> <paragraph num="(a)"> <text>All ALS medications listed in the Maryland Medical Protocols for Emergency Medical Service Providers; and</text> </paragraph> <paragraph num="(b)"> <text>Additional medications approved for use by the specialty care service medical director to meet the needs of the types of patients being transported.</text> </paragraph> </paragraph> </paragraph> <paragraph num="F."> <text>A list of the additional medications used by the specialty care service shall be provided to SOCALR and shall be available on each ambulance when in use for a specialty care transport.</text> </paragraph> <paragraph num="G."> <text>SOCALR shall be notified in writing of any changes to the list of additional medications used by the specialty care transport service, other than a temporary change resulting from a medication shortage, within 7 days of the change.</text> </paragraph> <paragraph num="H."> <text>There shall be sufficient quantities of medications to care for one patient for the longer of:</text> <paragraph num="(1)"> <text>1 hour; or</text> </paragraph> <paragraph num="(2)"> <text>Two times the estimated time of transport.</text> </paragraph> </paragraph> <paragraph num="I."> <text>If the ambulance is also licensed as a neonatal ambulance under COMAR 30.09.12, the vehicle does not need to carry duplicates of required items.</text> </paragraph> </regulation> <annotations> <annotation type="Authority">Education Article, §13-515, Annotated Code of Maryland</annotation> <annotation type="History" subtype="Administrative History">Effective date: January 15, 2005 (32:1 Md. R. 1866)</annotation> <annotation type="History" subtype="Administrative History">Regulation .02G—I amended effective September 1, 2014 (41:17 Md. R. 971)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04 amended effective May 27, 2024 (51:10 Md. R. 529)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04B, C amended effective December 12, 2013 (40:24 Md. R. 2017); September 1, 2014 (41:17 Md. R. 971); October 16, 2023 (50:20 Md. R. 889)</annotation> <annotation type="History" subtype="Administrative History">Regulation .04D adopted effective September 1, 2014 (41:17 Md. R. 971)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05 amended effective December 12, 2013 (40:24 Md. R. 2017)</annotation> <annotation type="History" subtype="Administrative History">Regulation .05C amended effective September 1, 2014 (41:17 Md. R. 971)</annotation> <annotation type="History" subtype="Administrative History">Regulation .07 amended effective September 1, 2014 (41:17 Md. R. 971)</annotation> </annotations> </chapter> </subtitle>