Chapter 02. Designation of Trauma and Specialty Referral Centers
Regulation .01 Trauma Care Levels and Specialty Referral Centers.LinkCopy Citation
A.
MIEMSS shall designate a hospital by level of care capability as set forth for:
(1)
Trauma centers, in COMAR 30.08.05; or
(2)
Specialty referral centers, in the appropriate specialty care standards within this subtitle.
B.
The levels of trauma care are:
(1)
Primary Adult Resource Center;
(2)
Level I trauma center;
(3)
Level II trauma center; or
(4)
Level III trauma center.
C.
Multiple Clinical Locations.
(1)
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:
(a)
Clinical requirements are met at each separate location;
(b)
There is a designated individual with administrative oversight of the designated trauma or specialty center program;
(c)
There is a designated individual with clinical oversight of the designated trauma or specialty center program who is responsible for:
(i)
Data collection;
(ii)
Quality improvement;
(iii)
Education;
(iv)
Research; and
(v)
Prevention;
(d)
There is a designated individual responsible for administrative oversight at each clinical location; and
(e)
There is a designated individual responsible for clinical oversight at each clinical location.
(2)
In this subtitle, in the case of a designated trauma or specialty center with more than one clinical location:
(a)
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
(b)
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.
Regulation .02 Criteria for Designation.LinkCopy Citation
A.
The EMS Board shall:
(1)
Establish criteria for the number and level of trauma and specialty referral centers to be designated; and
(2)
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.
B.
For each region, the criteria shall address:
(1)
Access to trauma or specialty care;
(2)
Level of care;
(3)
Capacity to provide the care; and
(4)
Timeliness of care received.
C.
MIEMSS may consult with appropriate State agencies in determining the need for trauma or specialty services for a hospital's geographic service area.
D.
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.
Regulation .03 Initial Application Process.LinkCopy Citation
A.
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.
B.
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.
C.
MIEMSS may periodically solicit applications for trauma and specialty referral center designation, as needed, by publication of the solicitation in the Maryland Register.
D.
MIEMSS shall provide the applicant with appropriate application materials in paper or electronic form for trauma or specialty referral center designation.
E.
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.
F.
MIEMSS shall review each application submitted for completeness.
G.
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.
H.
As necessary, MIEMSS shall provide technical assistance to a hospital throughout the designation process by answering questions about this subtitle and the designation process.
I.
An applicant's designation application is the property of MIEMSS and is confidential information in accordance with:
(1)
Health Occupations Article, Title 1, Subtitle 4, and §14-506, Annotated Code of Maryland; and
(2)
General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.
Regulation .04 Denial of Application for Designation.LinkCopy Citation
A.
MIEMSS may deny an application for designation without conducting an on-site review if it finds that the hospital:
(1)
Would add unnecessary duplication of services to a geographic service area where there is not a sufficient need for additional trauma or specialty services;
(2)
Is unable to meet the requirements of this subtitle for the level of designation sought;
(3)
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;
(4)
Is less qualified than another applicant hospital in the same geographic service area;
(5)
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
(6)
Should not be designated for any other relevant reason.
B.
Notice of Denial of Application for Designation.
(1)
MIEMSS shall issue a written notice of denial to the hospital.
(2)
The notice of denial shall conform to State Government Article, §10-207, Annotated Code of Maryland.
(3)
MIEMSS shall send the notice of denial to the chief executive officer of the hospital.
(4)
MIEMSS shall notify the EMS Board of the action taken.
C.
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.
D.
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.
E.
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.
Regulation .05 On-Site Review for Initial Trauma Center Designation.LinkCopy Citation
A.
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.
B.
On-Site Review Teams.
(1)
MIEMSS shall establish multidisciplinary on-site review teams composed of individuals knowledgeable in trauma or specialty care and trauma or specialty care systems.
(2)
The composition of the team shall be appropriate to the level of designation sought.
(3)
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:
(a)
Trauma surgeon;
(b)
Emergency physician;
(c)
Trauma nurse coordinator;
(d)
Administrator.
(4)
A staff person from MIEMSS shall accompany and coordinate the functions of the review team.
(5)
A team shall consist of professionals who do not have any conflict or competitive interest with the applicant.
(6)
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.
(7)
Contact with Members of On-Site Review Team.
(a)
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.
(b)
A violation of §B(7)(a) of this regulation may be grounds for denial by MIEMSS of the hospital's application.
(8)
The on-site review team shall:
(a)
Evaluate the appropriateness and capability of the applicant to provide trauma care services, according to the designation standards described in COMAR 30.08.05;
(b)
Verify the hospital's ability to meet the:
(i)
Responsibilities of, and the resources, equipment, and performance standards for, the level of designation sought, and
(ii)
Overall needs of the trauma system in that region;
(c)
Familiarize themselves with the hospital's application and the designation standards;
(d)
Inspect the hospital's physical plant;
(e)
Interview trauma team members and management personnel;
(f)
Examine the hospital's trauma-related documents, including patient care records;
(g)
Review other materials considered appropriate by MIEMSS;
(h)
Provide an exit interview of preliminary findings to the applicant upon completion of the on-site review; and
(i)
Provide a brief written summary of preliminary findings upon completion of the on-site review.
(9)
Confidentiality of On-Site Review Records.
(a)
MIEMSS shall require and maintain confidentiality of an on-site review record.
(b)
An on-site review record is confidential and exempt from public disclosure under General Provisions Article, Title 4, Subtitle 3, Annotated Code of Maryland.
(c)
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.
(d)
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.
C.
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.
Regulation .06 On-Site Review for Initial Specialty Referral Center Designation.LinkCopy Citation
A.
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.
B.
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:
(1)
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;
(2)
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;
(3)
MIEMSS shall select a team, which, at a minimum, shall include MIEMSS staff and three representatives from the following categories:
(a)
Specialty physician;
(b)
Emergency physician;
(c)
Specialty nurse;
(d)
Administrator;
(4)
The on-site review team members shall:
(a)
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;
(b)
Verify the hospital's ability to meet the:
(i)
Responsibilities of, and the resources, equipment, and performance standards for, the type of specialty referral center designation sought, and
(ii)
Overall needs of that particular specialty system in that region;
(c)
Familiarize themselves with the hospital's application and the designation standards;
(d)
Inspect the hospital's physical plant;
(e)
Interview team members and management personnel;
(f)
Examine the hospital's specialty care-related documents, including patient care records;
(g)
Review other materials considered appropriate by MIEMSS;
(h)
Provide an exit interview of preliminary findings to the applicant upon the completion of the on-site review; and
(i)
Provide a brief written summary of preliminary findings upon the completion of the on-site review.
Regulation .07 Designation Decision by MIEMSS.LinkCopy Citation
A.
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.
B.
MIEMSS may:
(1)
Designate the hospital as a trauma or specialty referral center as proposed by the applicant;
(2)
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;
(3)
Adjust the level of an applicant's designation based on system needs and the hospital's ability to meet those needs; or
(4)
Deny designation as a trauma center at any level or as a specialty referral center.
C.
Provisional or Full Designation.
(1)
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;
(2)
MIEMSS shall require each provisional trauma or specialty referral center to:
(a)
Have a written work plan to rectify deficiencies; and
(b)
Demonstrate progress on the work plan throughout the provisional period.
(3)
At the end of the provisional period, including any extensions, MIEMSS may:
(a)
Grant full designation to the trauma or specialty referral center; or
(b)
Deny the trauma or specialty referral center's designation under §D of this regulation.
(4)
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.
D.
Denial of Designation. MIEMSS may deny a hospital's designation as a trauma or specialty referral center if it finds that the hospital:
(1)
Does not meet the requirements of this subtitle for the level of designation or specialty;
(2)
Has engaged in unauthorized contact with an on-site review team member, as prohibited by Regulation .05B(7) of this chapter;
(3)
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;
(4)
Is less qualified than another applicant hospital in the same geographic service area; or
(5)
Should not be designated for another relevant reason.
E.
Notice of Denial of Designation.
(1)
MIEMSS shall issue a written notice of denial of designation to a hospital.
(2)
The notice of denial of designation shall conform to State Government Article, §10-207, Annotated Code of Maryland.
(3)
MIEMSS shall send the notice of denial of designation to the chief executive officer of the hospital.
(4)
MIEMSS shall notify the EMS Board of the action taken.
F.
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.
G.
A hospital may file an appeal with the EMS Board in accordance with Regulation .08 of this chapter if MIEMSS:
(1)
Approves the hospital at a level of designation lower than the applicant proposed;
(2)
Designates the hospital as provisional; or
(3)
Denies designation as a trauma center at any level or as a specialty center.
H.
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.
I.
If the hospital does not timely appeal MIEMSS' decision, MIEMSS' decision is the final agency decision.
Regulation .08 Appeal to the EMS Board.LinkCopy Citation
A.
Procedures for Appeal by Hospital.
(1)
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.
(2)
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.
(3)
The exceptions shall state with specificity the reasons why MIEMSS' decision should be overturned.
(4)
The hospital shall mail a copy of the exceptions to MIEMSS by first class mail, postage prepaid.
B.
MIEMSS' Response.
(1)
Not later than 20 business days from the date the exceptions are filed with the Executive Director, MIEMSS may file a response.
(2)
MIEMSS shall mail a copy of its response to the hospital by first class mail, postage prepaid.
C.
Decision of EMS Board.
(1)
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.
(2)
If the EMS Board denies the exceptions, the proposed decision, as affirmed by the EMS Board, is the final agency decision.
(3)
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.
(4)
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.
Regulation .09 Change in Designation Status of Trauma or Specialty Referral Center.LinkCopy Citation
A.
A designated trauma or specialty referral center:
(1)
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
(2)
Shall provide the Office of Hospital Programs with 90 calendar days advance written notice of its request to change its designation status.
B.
If the designated trauma center applies for a lower level of designation, MIEMSS:
(1)
At its discretion, may repeat all or part of the designation process set forth in this chapter; and
(2)
Shall consider the request based upon the criteria described in Regulation .02 of this chapter.
C.
Temporary Inability to Comply with Standards.
(1)
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.
(2)
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.
(3)
MIEMSS shall determine whether the temporary inability to comply with the standards warrants disciplinary action under COMAR 30.08.13.
Regulation .10 Reverification of Trauma or Specialty Referral Center Designation.LinkCopy Citation
A.
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.
B.
A designated adult or pediatric burn center shall:
(1)
Complete the reverification process every 3 years; and
(2)
If verified by the American Burn Association:
(a)
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
(b)
Notify MIEMSS immediately of any change in their verification status.
C.
At MIEMSS’ discretion:
(1)
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;
(2)
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
(3)
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.
D.
If a designated trauma or specialty referral center is in good standing:
(1)
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
(2)
Designated trauma or specialty referral center shall retain its current designation status until the reverification process is completed.
E.
At the time of the reverification process, MIEMSS shall publish a notice in the Maryland Register that:
(1)
Lists the trauma and specialty referral centers that have requested reverification of their designation status;
(2)
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
(3)
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.
Chapter annotations
Authority: Education Article, §13-509, Annotated Code of Maryland
History: Effective date: March 24, 1997 (24:6 Md. R. 488)
History: Regulations .01—.10 amended effective July 1, 2002 (29:12 Md. R. 932)
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)
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)
History: Regulation .03D amended effective October 3, 2011 (38:20 Md. R. 1205)
History: Regulation .03I amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265)
History: Regulation .04A amended effective October 3, 2011 (38:20 Md. R. 1205)
History: Regulation .05B amended effective December 19, 2005 (32:25 Md. R. 1947); October 12, 2015 (42:20 Md. R. 1265)
History: Regulation .07C, G amended effective October 3, 2011 (38:20 Md. R. 1205)
History: Regulation .10 amended effective October 3, 2011 (38:20 Md. R. 1205); July 1, 2020 (47:5 Md. R. 313)