In this subtitle, the following terms have the meanings indicated. Terms Defined. “American Board of Medical Specialties (ABMS)” means the umbrella organization for the 24 approved medical specialty boards in the United States. “Commercial Ambulance Service Advisory Council” means the advisory committee to the EMS Board on commercial ambulance service matters. “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. “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. “EMS provider-in-charge” means the highest medically certified or licensed EMS provider who assesses or provides care to a patient. “House officer” means an individual in a postgraduate medical training program who: Has completed at least the first year of that program; Is authorized to practice medicine without a license under Health Occupations Article, §14-302, Annotated Code of Maryland; and Is functioning as a resident in a residency program at a hospital that has a base station. “Jurisdictional Advisory Committee” means the advisory committee to the EMS Board on jurisdictional EMS operational program matters. “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. “Medical direction” has the meaning stated in Education Article, §13-516(a)(12), Annotated Code of Maryland. “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. “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. On-Line Medical Direction. “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. “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. “Pediatric Emergency Medical Advisory Group” means the advisory committee to the EMS Board on pediatric matters. “Privileges” means the ability of an EMS provider to provide EMS under the delegated authority of an EMS operational program medical director. “Quality assurance (QA)” means an organized method of auditing and evaluating care provided within an EMS system. “Specialty care transport” has the meaning defined in COMAR 30.09.01.02B(40). “System medical director” means any of the following: The Executive Director of MIEMSS; The State EMS Medical Director; The Associate State Medical Director for Pediatrics; The regional medical directors; The associate regional pediatric medical directors; The EMS operational program medical directors; and The assistant EMS operational program medical directors. Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland Effective date: December 15, 1999 (26:24 Md. R. 1859) 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) Jurisdictional EMS operational programs shall be approved by the EMS Board under this chapter. Commercial services shall be licensed under COMAR 30.09. To be eligible for approval an applicant: May not be subject to licensure as a commercial service under Education Article, §13-515, Annotated Code of Maryland; Shall retain an EMS operational program medical director whose qualifications and duties are consistent with the requirements of COMAR 30.03.03; Shall have a written agreement with the EMS operational program medical director addressing: The medical director's: Duties, Authority, and Responsibilities; and The jurisdictional EMS operational program's: Duties, Authority, and Responsibilities; and Other terms as the parties may agree upon; Shall maintain a comprehensive quality assurance program consistent with the requirements of COMAR 30.03.04; 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; Shall provide remedial education as necessary for affiliated EMS providers; If also seeking approval as an emergency medical dispatch program shall utilize: EMDs to provide medical: Interrogation, Prioritization, Resource allocation, Resource management, and Prearrival instructions; and An emergency medical dispatch priority reference system approved by MIEMSS; If also seeking approval as a specialty care transport program, meet the requirements of COMAR 30.09.14; and Designate an EMS operational program quality assurance officer whose qualifications and duties are consistent with the requirements of COMAR 30.03.04.08. Shall have an Infection Control Program consistent with the requirements of COMAR 30.03.09. 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: The jurisdictional EMS operational program is approved as a specialty care transport ambulance service; or The following conditions are met: A staffed and equipped specialty care transport ambulance is not available within a clinically reasonable time, as determined by the referring physician; 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 Required specialty equipment is available. 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. 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: Was recognized by MIEMSS as a jurisdictional EMS operational program for purposes of EMS provider affiliation on December 31, 1998; and Meets the requirements of this chapter for a jurisdictional EMS operational program on the effective date of this regulation. An applicant for approval as a jurisdictional EMS operational program shall apply to MIEMSS. MIEMSS may make an on-site review of an applicant as necessary to ensure the applicant meets the requirements of this chapter. The EMS Board may: Approve an application; Provisionally approve an application for up to 18 months under Regulation .04 of this chapter; or Deny an application under Regulation .05 of this chapter. The EMS Board shall notify the applicant of the action taken on its application. An applicant granted provisional approval may file an appeal with the EMS Board under Regulation .08 of this chapter. The EMS Board may require that a provisional jurisdictional EMS operational program: Have a written work plan to rectify deficiencies; and Demonstrate progress on the work plan throughout the provisional period. At the end of the provisional period, the EMS Board may: Grant full approval of the jurisdictional EMS operational program; or Deny approval. The EMS Board may deny an application for approval if it finds that the applicant is unable to meet the requirements of this chapter. Notice of Denial. The EMS Board shall issue a written notice of denial to an applicant that shall include the reasons for denial. The notice of denial shall conform to the requirements of State Government Article, §10-207, Annotated Code of Maryland. An applicant denied approval may file an appeal with the EMS Board under Regulation .08 of this chapter. If an applicant does not file a timely appeal under Regulation .08 of this chapter, the EMS Board's decision is final. If an application is denied the EMS Board may request that the applicant reapply under this chapter. 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. 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. The EMS Board shall give written notice of the investigation to the jurisdictional EMS operational program. The EMS Board may direct MIEMSS to make such on-site review as necessary as a part of its investigation. If the EMS Board finds that a jurisdictional EMS operational program has materially failed to comply with this chapter, the EMS Board may: Require corrective action; Restrict available EMS Board funding for the jurisdictional EMS operational program; or 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. 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. 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. 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. If an applicant does not file a timely appeal under Regulation .08 of this chapter, the EMS Board's decision is final. 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. The appeal shall state with specificity the reasons why the EMS Board should reconsider its decision. 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. An appeal hearing is governed by COMAR 28.02.01. If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply. 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. Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland Effective date: December 15, 1999 (26:24 Md. R. 1859) Regulation .02 amended effective January 15, 2005 (32:16 Md. R. 1866) 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) Regulation .02B amended effective September 1, 2014 (41:17 Md. R. 971) This chapter governs the requirements for medical direction of EMS providers. All medical direction shall be in accordance with the “Maryland Medical Protocols for Emergency Medical Services Providers”. An EMS operational program shall have an EMS operational program medical director appointed by the EMS operational program. Qualifications of an EMS Operational Program Medical Director. An EMS operational program medical director shall: Be a Maryland-licensed physician or a physician employed in the service of the federal government performing duties incident to that employment; Be familiar with the design and operation of EMS operational programs and systems including medical dispatch and communications; Have experience in and current knowledge of emergency care of patients who are acutely ill or injured; and Possess current knowledge of the Maryland EMS System including: Applicable laws and regulations, The Maryland Medical Protocols for Emergency Medical Services Providers, Applicable EMD protocols, Disaster and mass casualty plans, Organization and structure, and Medical quality assurance process. Duties of an EMS Operational Program Medical Director. The EMS operational program medical director shall: Be responsible for providing medical oversight of patient care, including emergency medical dispatch, in the EMS operational program; Approve, participate in, and provide medical expertise for the EMS operational program in: A comprehensive quality assurance plan covering all aspects of EMS patient care, including emergency medical dispatch under COMAR 30.03.04, Standard operating procedures for the EMS operational program under the Maryland Medical Protocols for Emergency Medical Services Providers, Appropriate EMS provider remedial and continuing educational programs, Credentialing of EMS providers, 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 All aspects of the EMS operational program which impact patient care, including planning, development, and operations; 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; Review patient care disciplinary matters under COMAR 30.02.05 concerning EMS providers affiliated with the EMS operational program; and Provide a liaison to the medical community as well as regional and State EMS medical directors. The EMS operational program medical director may delegate any of the duties listed in §C(1) of this regulation to an assistant medical director. The EMS operational program shall notify MIEMSS immediately of any proposal to change its medical director. Appointment of a Regional Medical Director. Each EMS region shall have a regional medical director: Recommended by the EMS regional council; and Appointed by the State EMS Medical Director. Qualifications of a Regional Medical Director. A regional medical director shall meet the requirements of Regulation .03B of this chapter. The requirements of Regulation .03B(4) of this chapter may be satisfied by completing: The Maryland Medical Director Orientation Course; or A MIEMSS-approved equivalent. Duties of the Regional Medical Director. The regional medical director shall: Serve as the principal medical advisor to the: EMS regional council, Hospital base stations within the region, Jurisdictional EMS operational program medical directors, and MIEMSS regional staff; Assist jurisdictional EMS operational programs with recruitment and orientation of medical directors; Verify the qualifications of jurisdictional EMS operational program medical directors; Make recommendations regarding the designation of hospital base stations; Assist the State EMS Medical Director in planning and coordinating base station activities; Provide medical oversight of base station quality assurance activities in the EMS region; Serve on the Regional Medical Directors Committee; and Participate in a regional interjurisdictional quality assurance program. Appointment of Associate Regional Pediatric Medical Directors. Each EMS region shall have an associate regional pediatric medical director: Nominated by the EMS regional council; Approved by the State EMS Medical Director; and Appointed by the Associate State EMS Medical Director for Pediatrics. Qualifications of an Associate Regional Pediatric Medical Director. An associate regional pediatric medical director shall: Meet the requirements of Regulation .03(B) of this chapter; and Be Board certified or Board prepared in a specialty relating to pediatrics approved by the American Board of Medical Specialties. The requirements of Regulation .03B(4) of this chapter may be satisfied by completing: The Maryland Medical Director Orientation Course; or A MIEMSS-approved equivalent. Duties of an Associate Regional Pediatric Medical Director. The associate regional pediatric medical director shall: Serve as principal pediatric medical advisor to the EMS regional council, and regional and jurisdictional medical directors; Participate in the development of the protocols on pediatric content; Serve on the State Pediatric Emergency Medical Advisory Group (PEMAG); Serve as a resource for professional education in pediatrics within the region; 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 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. 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. 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. 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. 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. 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: The circumstances and grounds for the action; Specific plans for remedial education; and The process, including reevaluation, by which the EMS provider may be able to regain privileges. 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. 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. An EMS provider shall utilize online medical direction as required in the Maryland Medical Protocols for Emergency Medical Services Providers from: An approved base station; or A system medical director. An EMS provider may receive online medical direction from a licensed physician present at the scene. Any such online medical direction, received under §B of this regulation, shall be consistent with the Maryland Medical Protocols for Emergency Medical Services Providers. 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: An appropriate base station; or A system medical director. Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland Effective date: December 15, 1999 (26:24 Md. R. 1859) Regulation .03B amended effective November 10, 2025 (52:22 Md. R. 1096) Regulation .04A, C amended effective July 1, 2002 (29:12 Md. R. 931) Regulation .05C amended effective July 1, 2002 (29:12 Md. R. 931) Regulation .06 amended effective January 15, 2005 (31:26 Md. R. 1866) This chapter governs the requirements for quality assurance in an EMS operational program. Every EMS operational program shall have a written quality assurance plan approved by its medical director. The quality assurance plan shall include provisions for: Reviewing data concerning patient care rendered by EMS providers affiliated with the EMS operational program; Identifying and analyzing trends in EMS care rendered by EMS providers affiliated with the EMS operational program; Annually reporting to MIEMSS on quality assurance issues on a form required by MIEMSS; Providing remedial action to resolve any patient care issues involving EMS providers or the EMS system which should be addressed at the jurisdictional level; Identifying violations of the Maryland Medical Protocols for Emergency Medical Services Providers; Notifying MIEMSS within 30 days of discovery of any incidents, protocol variations, or trends which in the opinion of the medical director: May have resulted in harm to a patient, May require disciplinary action by MIEMSS, or Suggest the need for changes to the Statewide EMS system by MIEMSS; and Reviewing oral or written allegations that: An EMS provider failed to act in accordance with applicable law or protocols, or Prehospital patient care was below the applicable standard of care. Every EMS operational program shall have a medical review committee. The EMS operational program in conjunction with the EMS operational program medical director shall select the medical review committee. 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. Each attendee at any meeting of a medical review committee shall be advised in writing of the confidential nature of committee proceedings. 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. 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: That responds to a call within the State; That responds to a call from within the State; That provides EMS care; That provides EMS transport; or That applies the Maryland Medical Protocols for Emergency Medical Services Providers. The highest medically licensed or certified EMS provider on each unit shall ensure the accurate and timely completion of the eMEDS® patient care report. The eMEDS® patient care report shall be complete without reference to any other documentation except another eMEDS® patient care report. EMS Documentation Delivered to the Receiving Facility. 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. If an eMEDS® patient care report is not completed and submitted prior to leaving the health care facility, the transporting unit shall: 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 Complete and submit an eMEDS® patient care report no later than 24 hours after the call’s dispatch. 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. 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. 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. 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. 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. 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. Each EMS operational program shall deliver monthly to MIEMSS a report of occupational exposures to blood in a form acceptable to MIEMSS. Each EMS operational program shall designate a Quality Assurance (QA) Officer in concurrence with the EMS operational program medical director. Qualifications of an EMS Operational Program Quality Assurance Officer. An EMS operational program Quality Assurance Officer shall: Be certified or licensed as an emergency medical technician, CRT, or paramedic in Maryland; Either: Successfully complete a QA officer course as defined by MIEMSS within six months of designation; or Have been serving as a Quality Assurance Officer for an EMS operational program for a period of at least 5 years; and Successfully complete a Quality Assurance Officer continuing education course annually. Duties of an EMS Operational Program QA Officer. The EMS operational program QA officer shall be responsible for: Implementing the EMS operational program quality assurance plan under Regulation .02 of this chapter; Serving as a member of the EMS operational program Medical Review Committee; Internal audits of medical records and field evaluations to develop strategies for improvement; Remedial action plans for individual medical practice and system variances as directed by the Medical Review Committee; Tracking and investigating customer complaints and sentinel events; Completing reports to MIEMSS as required under COMAR 30.03.04; and 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. Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland Effective date: December 15, 1999 (26:24 Md. R. 1859) Regulation .03C amended effective July 1, 2002 (29:12 Md. R. 931); December 19, 2005 (32:25 Md. R. 1945) Regulation .03E amended effective October 8, 2007 (34:20 Md. R. 1742) Regulation .04 repealed and new Regulation .04 adopted effective November 1, 2010 (37:21 Md. R. 1437) Regulation .04 amended effective January 6, 2014 (40:26 Md. R. 2166) Regulation .05 adopted effective December 15, 2003 (30:24 Md. R. 1746) Regulation .06 adopted effective December 19, 2005 (32:25 Md. R. 1946) Regulation .06 repealed and new Regulation .06 adopted effective November 1, 2010 (37:21 Md. R. 1437) Regulation .07 adopted effective December 19, 2005 (32:25 Md. R. 1946) Regulation .07 repealed effective November 1, 2010 (37:21 Md. R. 1437) Regulation .08 adopted effective October 8, 2007 (34:20 Md. R. 1742) Regulation .08B, C amended effective December 12, 2013 (40:24 Md. R. 2017) This chapter governs the development of the Maryland Medical Protocols for Emergency Medical Services Providers. The EMS Board shall approve and issue the Maryland Medical Protocols for Emergency Medical Services Providers and any protocol revisions or supplemental protocols. 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. 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. MIEMSS shall appoint the protocol review committee which shall be composed of: One representative from each of the following groups: The EMS Board; The State Board of Physicians; The Statewide Emergency Medical Services Advisory Council; The Pediatric Emergency Medical Advisory Committee; The Jurisdictional Advisory Committee; The Commercial Ambulance Service Advisory Committee; The EMS operational program medical directors; Volunteer EMS BLS Providers; Volunteer EMS ALS Providers; Career EMS BLS Providers; Career EMS ALS Providers; Commercial EMS BLS Providers; Commercial EMS ALS Providers; The Maryland Chapter of ACEP; the State Board of Nursing; and Trauma Net; and The regional medical directors. The protocol review committee shall review the fiscal impact of any proposed protocol, protocol revision, or supplemental protocol. 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. All recommendations for protocols, protocol revisions, or supplemental protocols concerning the practice of nursing shall be presented to the Board of Nursing. The Executive Director of MIEMSS shall present all recommendations for protocols, protocol revisions, or supplemental protocols to the EMS Board. 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. The EMS Board may grant a pilot supplemental protocol for the benefit of optimal patient care upon: The recommendation of the Executive Director of MIEMSS; and A determination that the pilot supplemental protocol has the potential to become a Statewide protocol or an optional supplemental protocol. 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: A plan for appropriate: Training, Examination, and Oversight; and A needs assessment which justifies the requested supplement. The EMS Board may approve a research supplemental protocol upon the recommendation of the Executive Director of MIEMSS with the approval of the: EMS operational medical director and EMS operational program where the research will be conducted; and MIEMSS Institutional Review Board. An individual seeking to conduct research that would require a supplement to the protocols shall: Submit the proposed research project and the proposed research protocol, including provisions for the expiration of the research supplemental protocol, to the: State EMS Medical Director, EMS operational program where the research is to be conducted, EMS operational program medical director for the EMS operational program where the research is to be conducted, and MIEMSS Institutional Review Board; and Provide further information and meet certain requirements as determined by the MIEMSS Institutional Review Board. The MIEMSS Institutional Review Board shall suspend or terminate approval of a research supplemental protocol that is not: Conducted in accordance with requirements of this regulation; or Determined to be associated with unexpected serious harm to research subjects. 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. The EMS Board may establish minimum training requirements and standards for the implementation of optional supplemental protocols by EMS operational programs. 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. 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. 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. The appeal shall state with specificity the reasons why the EMS Board should reconsider its decision. 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. An appeal hearing is governed by COMAR 28.02.01. If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 shall also apply. 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. Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland Effective date: December 15, 1999 (26:24 Md. R. 1859) Regulation .02D amended effective December 12, 2011 (38:25 Md. R. 1583) Regulation .02D, F amended effective July 1, 2002 (29:12 Md. R. 931); December 19, 2005 (32:25 Md. R. 1946) This chapter governs the approval and operation of EMS base stations as part of the Maryland Emergency Medical Services Plan. Definitions. In this chapter, the following terms have the meanings indicated. Terms Defined. “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. “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. “Hospital Dashboard/Hub” means the application that allows hospital personnel/users to access a Prehospital Care Report (PCR) produced by the EMS personnel. Maryland Emergency Medical Resource Alert Database (MEMRAD). “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. “MEMRAD” includes the County Hospital Alert Tracking System (CHATS) which shows health care providers the status of hospitals throughout Maryland and in surrounding jurisdictions. “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. “MEMRAD” includes the Maryland patient and resource tracking system. “State-Designated Health Information Exchange” means the State-Designated Health Information Exchange described in Health-General Article, §19-143, Annotated Code of Maryland. An EMS base station designated by MIEMSS shall: Be a unit of a licensed hospital; Operate 24 hours a day; Have communications equipment as required by MIEMSS to provide necessary communications with ambulances and MIEMSS; In collaboration with MIEMSS, maintain all MIEMSS required communications equipment in working order, including: EMRC Radio with voice recorder; and Demstel Telephone, where deployed; Monitor and provide timely responses to MEMRAD; Provide admission/discharge/transfer messages to MIEMSS through the State-Designated Health Information Exchange; 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; Have a designated EMS space with computer, and internet connectivity suitable for EMS provider eMEDS® reporting; 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; 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; 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 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. 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. 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. Physician Authorized to Provide Online Medical Direction. A physician authorized to provide online medical direction shall: Be licensed or otherwise authorized to practice medicine in Maryland; Be Board certified or Board eligible in a specialty approved by the American Board of Medical Specialties appropriate for a base station; Have successfully completed a MIEMSS-approved base station course with a minimum score of 80 percent; and Annually complete a Maryland Medical Protocols for Emergency Medical Services Providers update by July 1 of each year. 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: Be licensed as a registered nurse, a physician assistant or a nurse practitioner in Maryland; Have successfully completed a MIEMSS-approved base station course with a minimum score of 80 percent; and Annually complete a Maryland Medical Protocols for Emergency Medical Services Providers update by July 1 of each year. 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: Be a licensed Maryland physician; Have successfully completed a MIEMSS-approved base station course with a minimum score of 80 percent; and Annually complete a Maryland Medical Protocols for Emergency Medical Services Providers update by July 1 of each year. Online medical direction as required in the Maryland Medical Protocols for Emergency Medical Services Provider shall be: Given directly by a physician authorized to provide medical direction; or Given directly by a resident or fellow under the direct supervision of a physician authorized to provide medical direction; or 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. 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; All personnel providing online medical direction and all EMS providers shall ensure that online communications are understood by speaking: Slowly; Clearly; and At a proper volume to be heard. Scope. 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. 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. 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. 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: Describe the entity through which the limited-scope medical direction will be provided; 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; 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; 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; Provide for a semi-annual report to MIEMSS that includes at a minimum: The number of patients evaluated or treated through telemedicine resulting in limited-scope medical direction; A record of the patients’ presenting chief complaints and any interventions provided; and A record of referrals for follow-up medical care; 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 Be consistent with the Emergency Medical System Plan approved by the EMS Board. To provide limited-scope medical direction through an EMS operational program’s plan, an individual shall at a minimum: Be licensed to practice medicine in the State of Maryland; Hold active board certification in: Emergency medicine; Emergency medical services; Family medicine; or Internal medicine; Be knowledgeable of EMS and the local treatment options for low-acuity patients; 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 Meet the requirements of Regulation .03C of this chapter. MIEMSS may approve, modify, or deny a proposed plan of an EMS operational program to provide limited-scope medical direction. 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. 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. 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. EMS Clinicians. 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. 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. 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. 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: Monitor and participate in MEMRAD; Monitor their utilization of CHATS alerts; and Participate in mitigation strategies to improve systems efficiencies and patient safety. The base station director and base station coordinator shall: Assure that online medical direction and consultation provided by the base station is: Timely; Appropriate; and Otherwise consistent with Maryland Medical Protocols for Emergency Medical Services Providers; Assure the MIEMSS approved Prehospital Consultation/Interventions Radio Report Forms are complete, signed and linked to the patient record through a patient identifier; Develop and implement a process which facilitates monthly quality assurance/quality improvement review of EMS consults which: Reviews all priority one/critical patient consults and select lower priority consults for a minimum of 30 consults per month; Allows for ongoing documentation of tracking, trending, loop closure and retention of Quality Assurance/Quality Improvement review findings for 5 years; Notifies EMS operational programs upon discovery of patient care, quality or protocol variance issues involving EMS providers or the EMS system; 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; Monitors hospital’s response rates to MEMRAD notifications and alerts; Participates in local, regional, and State EMS quality improvement activities; Provides patient follow-up data as required by MIEMSS for public health oversight purposes to determine the appropriateness and outcome of EMS care for: Inpatients; and Outpatients; and Reports as required by MIEMSS for quality assurance and performance improvement purposes. The State EMS Medical Director through the MIEMSS regional medical directors shall: Coordinate online medical direction functions; and Regularly review the quality improvement activities of approved base stations. An applicant for designation or redesignation as a base station shall apply by filing an approved application with MIEMSS. Upon receipt of a completed application, MIEMSS shall: Visit the applicant; Interview the physician designated as base station director; Interview the licensed registered nurse designated as the base station coordinator; 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: 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. MIEMSS shall decide whether to make a designation based on the: Results of the visit, interviews, and consultations conducted by MIEMSS; and Information in the application. Provisional or Full Designation. 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; MIEMSS shall require each provisional base station to: Have a written work plan to rectify deficiencies; and Demonstrate progress on the work plan throughout the provisional period. At the end of the provisional period, including any extension thereof, MIEMSS may: Grant full designation to the base station; or Deny the base station’s designation under §E of this regulation. MIEMSS may grant full designation to a base station in full compliance with this chapter for a period not to exceed 5 years. Denial or Rescission. MIEMSS may deny initial designation, renewal, or redesignation, or rescind designation, for a base station that fails to: Satisfy the requirements of this chapter; or Provide appropriate medical direction consistent with the Maryland Medical Protocols for Emergency Medical Services Providers. 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: State the reasons for the decision; Advise the applicant of appeal rights; Require the Hospital to submit within 45 days a corrective action plan to MIEMSS for approval; and Otherwise comply with State Government Article, §10-207, Annotated Code of Maryland. Applications for renewal or approval shall be filed with MIEMSS at least 90 days before expiration of the approved period. 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. 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. An appeal hearing is governed by COMAR 28.02.01. If the hearing is conducted by the Office of Administrative Hearings, COMAR 30.02.06.22 and .23 also apply. 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. 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. MIEMSS may designate base stations as specialty consultation centers for pediatrics, hazardous materials, and other specialties as necessary. 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. 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. Education Article, §§13-509, 13-510, and 13-516, Annotated Code of Maryland Effective date: December 15, 1999 (26:24 Md. R. 1859) Regulation .02A amended effective July 1, 2002 (29:12 Md. R. 931) Regulation .03A amended effective December 19, 2005 (32:25 Md. R. 1946) Regulation .05 amended effective July 1, 2002 (29:12 Md. R. 931) Regulation .07B amended effective December 19, 2005 (32:25 Md. R. 1946) Regulation .08 amended effective July 1, 2002 (29:12 Md. R. 931) Regulation .09A amended effective July 1, 2002 (29:12 Md. R. 931) Chapter revised effective October 10, 2016 (43:20 Md. R. 1110) Regulation .01B amended effective March 8, 2021 (48:5 Md. R. 218) Regulation .02E amended effective March 8, 2021 (48:5 Md. R. 218) Regulation .02E-1 adopted effective March 8, 2021 (48:5 Md. R. 218) Regulation 04-1 adopted effective February 5, 2024 (51:2 Md. R. 77) 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). 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. In this chapter, the following terms have the meanings indicated. Terms Defined. “Ambulance provider” means the person who owns or operates an ambulance. “Ambulance transport” means a transport by ambulance, together with attendant medical services, medical supplies, drugs, and linens provided by the ambulance provider. “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. “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. “Emergency call” means a call placed through 9-1-1 or some other emergency access number. “EMS provider” means an individual licensed or certified by the Maryland State EMS Board under Education Article, §13-516, Annotated Code of Maryland. “Receiving facility” means a hospital or other facility that provides emergency medical services. “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. 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: The ambulance provider does not bill any insurer or patient for the items restocked; or The hospital and other receiving facility do not bill any insurer or patient for the items restocked. 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. Restocking shall include the following drugs, medical supplies, and linens used in the course of an ambulance transport restocked under this chapter: 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; 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 Linens, including sheets, pillow cases, and blankets. 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. 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. Education Article, §§13-509, 13-510, 13-515, and 13-516, Annotated Code of Maryland Effective date: March 31, 2003 (30:6 Md. R. 423) This chapter governs the requirements for an infection control program in an EMS operational program. Each EMS operational program shall designate an Infection Control Officer. Duties of an EMS Operational Program Infection Control Officer. The EMS operational program Infection control officer shall be responsible for: Implementing the EMS operational program infection control plan under Regulation .03 of this Chapter; and Reporting occupational exposures to MIEMSS under COMAR 30.03.04.06. Every EMS operational program shall have a written infection control plan. The infection control plan shall include provisions for: Ensuring compliance with: 29 CFR §1910.1030; 29 CFR §1910.1200; Labor and Employment Article, §5-702, Annotated Code of Maryland; COMAR 30.03.04.06; and All other State and federal regulations as they pertain to infection control; Post-exposure notice, testing, and treatment consistent with Health General Article, §18-338.3, Annotated Code of Maryland; Ensuring that all EMS providers affiliated with the EMS operational program have notice of the plan and its contents; and 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. Education Article, §§13-509, 13-515, and 13-516, Annotated Code of Maryland Effective date: January 13, 2011 (38:1 Md. R. 12)