Section R. 325.22214 - Medical control authority; special studiesRule 214.
(1) A medical control authority that intends to establish a protocol involving skills, techniques, procedures, or equipment that is not included in this state's approved curriculum, may need to establish the practice as a special study. Determination that a proposed protocol is acceptable under current practice or requires a special study is decided by the quality assurance task force. A protocol may be approved as a medical control authority protocol under the following conditions:(a) The medical control authority provides documentation that the skill, technique, procedure, or equipment complies with 1 of the following: (i) The practice is recognized by a national organization as acceptable.(ii) The practice has existing precedent in Emergency Medical System outside of this state.(iii) There are published studies that support the safety and efficacy in its application of the practice within the emergency setting.(b) The medical authority provides the educational outline that will be implemented to instruct the emergency medical services personnel in the new skill, technique, procedure, or equipment, as well as the verification of competency that will be utilized.(c) A letter of support, justifying the need for the practice, signed by the medical director for the medical control authority participating in the practice implementation.(d) The medical control authority submits protocols that will be used for the practice.(e) The quality assurance task force may require data submission to this state for approval of the practice. If data is required for approval, the approval must be indicated as approval of the practice as a special study.(2) A medical control authority that intends to establish a protocol involving skills, techniques, procedures, or equipment that is not included in this state's approved curriculum, and is not consistent with its level of licensure requires a special study and must comply with all of the following:(a) Provide any available studies or supporting documentation indicating the practice has been studied. Published studies supporting the safety and efficacy of its applications within the emergency setting must also be submitted.(b) The medical control authority provides an educational outline that will be implemented to instruct the emergency medical services personnel in the new skill, technique, procedure, or equipment, as well as the verification of competency that will be utilized and the plan for continued competency assurance, such as a continuing education plan.(c) Provide a letter of support, justifying the need for the practice, signed by the medical director for the medical control authority participating in the special study.(d) The medical control authority shall submit protocols that will be used for the practice.(e) Identify life support agencies involved in the special study, their licensure level, the number of emergency medical services personnel to be trained, and their respective licensure levels.(f) Submit a timeline indicating the proposed duration of the study.(g) Describe the proposed data to be submitted to this state during the study. Generally, data submission is required quarterly.(h) If the medical control authority designs the study to develop or contribute to generalizable knowledge, the medical control authority shall also submit documentation of Institutional Review Board approval, exemption, or not regulated status for the study.(3) A medical control authority that intends to establish a protocol involving skills, techniques, procedures, or equipment that is not included in this state's approved curriculum and is not consistent with either the level of licensure or scope of practice, involves human subject research under 45 CFR part 46 , or intends to publish the human subject research, shall require a special study if it complies with all of the following:(a) Provide any available studies or supporting documentation indicating the practice has been studied. Published studies supporting the safety or efficacy of its application within the emergency setting must also be submitted.(b) Submit initial and refresher education requirements and provide an educational outline to be implemented to instruct the emergency medical services personnel in the new skill, technique, procedure, or equipment, as well as verification of competency that will be utilized. Refresher education requirements must include frequency and content of refresher to maintain proficiency in skill, technique, procedure, or equipment.(c) Identify life support agencies involved, their licensure level, the number of emergency medical services personnel to be trained, and their respective licensure levels.(d) If providing mutual aid outside its medical control authority region, the medical control authority shall have a written agreement with another medical control authority to continue to utilize its protocols.(e) Identify the quality review process that will be implemented.(f) Submit protocols that will be included in the special study.(g) Identify data parameters to be collected and the quality review process that will be implemented. The medical control authority shall submit quarterly reports, and upon completion of the study, submit a final report to the department.(h) Obtain and submit an institutional review board approval or an institutional review board official exemption. If the medical control authority used a randomized study, include the consent form, method of institutional review board approval, and institutional review board approval letter.(4) A special study may be terminated by the department, with the advice of the quality assurance task force, for any of the following reasons: (a) The special study jeopardizes the health, safety, or welfare of the citizens of this state.(b) There is evidence of failure to follow study parameters.(c) There is evidence of failure to submit reports.(d) The medical control authority or medical director requests termination.(e) There is not sufficient data to support continuation.(5) A special study may be considered complete when outcomes have been met, the timeline has been completed, or the study has been terminated by the department with the advice of the quality assurance task force. A final report must be submitted to the department by the medical control authority when the study is complete, unless the study is terminated by the department. The medical control authority may request any of the following for the protocol being studied: (a) That it become a standard protocol for the requesting medical control authority.(b) That it become a standard protocol for this state.(d) That it be terminated.(6) Disposition of the protocol is determined by the quality assurance task force.Mich. Admin. Code R. 325.22214
2004 AACS; 2023 MR 10, Eff. 5/26/2023