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)