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ORR # 2001-015
DEPARTMENT OF CONSUMER AND INDUSTRY SERVICES DIRECTOR’S OFFICE
EMERGENCY MEDICAL SERVICES - LIFE SUPPORT AGENCIES & MEDICAL CONTROL
Filed with the Secretary of State on
These rules take effect 7 days after filing with the Secretary of State
(By authority conferred on the department of consumer and industry services by sections 2226(d), 2233, 20115, 20171, and 20771 of 1978 PA 368 and Executive Orders Nos. 1996-1 and 1996-2,
being MCL 333.2226(d), 333.2233, 333.20115, 333.20171, 333.20771, 330.3101, and 445.2001)
PART 1. GENERAL PROVISIONS
R 325.22101. Definitions; A to D.
As used in these rules:
(a) "Accountable” means ensuring compliance on the part of each life support agency or emergency medical services personnel in carrying out emergency medical services based upon protocols established by the medical control authority and approved by the department.
(b) “Board certified in emergency medicine” means current certification by the American board of emergency medicine, the American board of osteopathic emergency medicine, or other organization approved by the department that meets the standards of these organizations.
(c) “Code” means 1978 PA 368, MCL 333.1101 et seq. and known as the public health code.
(d) "Direct communication” means a communication methodology that ensures medical control authority supervision of a life support agency when performing emergency medical services through any of the following methods:
(i) Direct interpersonal communications at the scene of the emergency.
(ii) Direct verbal communication by means of an approved two-way telecommunications system operating within the medcom requirements.
(iii) Protocols adopted by the medical control authority and approved by the department.
(iv) Other means approved by the department that are not in conflict with the medcom requirements.
(e) “Disciplinary action” means an action taken by the department against a medical control authority, a life support agency, or individual, or an action taken by a medical control authority against a life support agency or individual for failure to comply with the code, rules, or protocols approved by the department. Action may include suspension, limitation, or removal of medical control from a life support agency of a medical control authority providing medical control, from an individual providing emergency medical services care, or any other action authorized by the code.
R 325.22102. Definitions; E to O. As used in these rules:
(a) “Emergency medical services intercept” means a situation where an ambulance operation is transporting an emergency patient from the scene of an emergency, and requests patient care intervention from another transporting ambulance operation.
(b) “Emergency medical services telecommunications” means the reception and transmission of voice or data, or both, information in the emergency medical services system consistent with the medcom requirements prescribed by the department.
(c) “Fixed wing aircraft” means a non-rotary aircraft transport vehicle that is primarily used or available to provide patient transportation between health facilities and is capable of providing patient care according to orders issued by the patient’s physician.
(d) “Ground ambulance” means a vehicle that complies with design and structural specifications, as defined in these rules, and is licensed as an ambulance to provide transportation and basic life support, limited advanced life support, or advanced life support.
(e) “Hold itself out” means the agency advertises, announces, or charges specifically for providing emergency medical services as defined in the code.
(f) “License” means written authorization issued by the department to a life support agency and its life support vehicles to provide emergency medical services as defined in the code.
(g) “License expiration date” means the date of expiration indicated on the license issued by the department.
(h) “Licensure action” means probation, suspension, limitation, or removal by the department of a license for a life support agency or a life support vehicle for violations of the code or these rules.
(i) “Life support vehicle” means an ambulance, a nontransport prehospital life support vehicle, or a medical first response vehicle as defined in the code.
(j) “Medcom requirements” means medical communication requirements for an emergency medical services communication system.
(k) “Medical control” means supervising and coordinating emergency medical services through a medical control authority, as prescribed, adopted, and enforced through department-approved protocols, within an emergency medical services system.
(l) “Medical control authority” means an organization designated by the department to provide medical control.
(m) “Medical control authority board” means a board appointed by the participating organizations to carry out the responsibilities and functions of the medical control authority.
(n) “Medical control authority region” means the geographic area composed of a county, group of counties, or parts of an individual county, as designated by the department.
R 325.22103 Definitions; P to T As used in these rules:
(a) “Physician” means a doctor of medicine or doctor of osteopathy who possesses a valid license to practice medicine in the state.
(b) “Primary dispatch service area” means a service area.
(c) “Quality improvement program” means actions taken by a life support agency, medical control authority, or jointly between a life support agency and medical control authority with a goal of continuous improvement of emergency medical services in accordance with section 20919(1)(g) of the code.
(d) “Rotary aircraft” means a helicopter that is licensed under the code as an ambulance.
(e) “Service area” means the geographic area in which a life support agency is licensed to provide emergency medical services for responding to an emergency.
R 325.22104 Terms in code.
Terms defined in the code have the same meanings when used in these rules.
PART 2. LIFE SUPPORT AGENCIES-GENERAL
R 325.22111 Life support agencies; general provisions.
(1) A life support agency shall not operate unless it is licensed by the department and operates under the direction of a medical control authority in accordance with department-approved protocols.
(2) A life support agency license shall do all of the following:
(a) State the level of life support the agency is licensed to provide. A life support agency shall not operate at a level that exceeds its license or violates approved medical control authority protocols.
(b) Be responsible for communicating approved protocols to appropriate emergency medical services personnel.
(c) Provide emergency medical services in accordance with protocols established by the medical control authority and approved by the department.
(3) A life support agency application shall not be approved by the department unless signed by the medical director of each medical control authority responsible for the service area of the life support agency in accordance with rule 325.22205(2). The medical director signature shall serve as confirmation that the medical control authority intends to provide medical control to the life support agency.
(4) A life support agency, except a fixed wing aircraft transport operation, shall provide at least 1 life support vehicle for response to requests for emergency assistance on a 24-hour-a-day, 7-day-a- week basis in accordance with its licensure level and medical control authority protocols.
(5) A life support agency shall respond, or ensure a response is provided, to each request for emergency assistance originating within the bounds of its service area.
R 325.22112 Patient destination; transporting agencies.
(1) An ambulance operation, both ground and rotary, shall transport an emergency patient only to an organized emergency department located in and operated by a hospital licensed under part 215 of the code or to a freestanding surgical outpatient facility licensed under part 208 of the code that operates a service for treating emergency patients 24 hours a day, 7 days a week and complies with medical control authority protocols.
(2) Subrule (1) of this rule shall not apply when a determination is made that an emergency no longer exists in accordance with department-approved protocols.
R 325.22113 Patient transfers; ground, rotary, aircraft transport.
(1) A person shall not transport a patient by stretcher, cot, litter, or isolette unless it is done in a licensed ambulance or aircraft transport vehicle. The life support agency transporting the patient shall require that any applicable department-approved protocols of the medical control authority are followed in accordance with section 20921 (4) and (5) of the code.
(2) An out-of-state service that is coming in this state to transfer a patient from a Michigan facility to a facility in another state or country shall be licensed or certified within its own jurisdiction.
R 325.22114 Professional standards review organization; data collection.
Each life support agency or medical control authority, or both, shall establish a professional standards review organization for improving the quality of emergency medical services. As part of the organization, each life support agency shall collect data to assess the need for and quality of emergency medical services. The data shall be submitted to the medical control authority as determined by department-approved medical control authority protocol as required in rule 325.22207(1)(h).
R 325.22115 Use of descriptive words, phrases, symbols, advertising.
A person shall not use words, phrases, signs, symbols, or insignia that advertise or convey to the public that it provides emergency medical services or that it provides emergency medical services at a particular level unless it is licensed to do so.
R 325.22116 Inability to provide service.
(1) If a life support agency cannot operate or staff at least 1 vehicle for response to an emergency within its service area in accordance with the code, these rules, or applicable protocols, then the life support agency shall do all of the following:
(a) Immediately notify the department and medical control authority within its service area when it cannot provide at least 1 ambulance available for response to requests for emergency assistance on a 24-hour-a-day, 7-day-a-week basis in accordance with medical control authority protocols.
(b) Immediately notify the department of a change that would alter the information contained on its application.
(c) Notify the dispatch center that regularly receives requests for its services, and other public safety agencies if appropriate, that it is not available to respond. The notification shall advise the dispatch center of the period in which the agency will be out of service and the name of the agency that will be covering its service area.
(d) Notify life support agencies providing secondary response capabilities.
(2) The life support agency shall comply with rule 325.22202(4).
(3) A life support agency that does not comply with section 20921(1)(a) of the code shall be subject to disciplinary action by the department.
R 325.22117 Maintenance of medical records.
A life support agency shall maintain an accurate record of each case where care is rendered on a form approved by the medical control authority. Medical records shall be maintained for 5 years. However, records of minors shall be maintained until they reach 23 years of age.
R 325.22118 Removal of vehicle from service; licensure; interagency vehicle transfer, lease, loan, from another life support agency.
(1) A life support agency shall notify the department when it permanently removes a vehicle from service. If a vehicle is permanently removed from service, then the agency shall contact the department, in writing, within 30 days of removal. Notification shall include the make, model, year, and vehicle identification number on a form prescribed by the department.
(2) A life support vehicle license is nontransferable. A life support agency may temporarily use a state licensed life support vehicle of another licensed life support agency through a loan. Vehicle
loans may occur if mechanical problems prevent an agency from deploying its existing vehicles. The life support agency acquiring the vehicle shall do all of the following:
(a) Notify the department of the loan within 3 business days on a form prescribed by the department.
(b) Replace an existing licensed vehicle with the loaned vehicle at the agency. The loaned vehicle shall not increase the total number of vehicles the agency is licensed to use.
(c) Use the loan for a maximum of 60 calendar days.
(d) Extend the loan 1 time for 60 additional calendar days if the agency notifies the department on a form prescribed by the department.
(3) A life support agency that obtains a vehicle through a gift, lease, transfer, or purchase from another life support agency shall comply with both of the following:
(a) Submit an application for the vehicle in accordance with rule 325.22190 (2) or (3).
(b) Comply with rule 325.22181.
(4) A life support agency that gives, leases, transfers, or sells a vehicle to another life support agency shall comply with subrule (1) of this rule.
R 325.22119 Operational routine vehicle and equipment inspection.
A life support agency shall have a written policy in place to ensure vehicles and equipment are operational and provide documentation of not less than a weekly inspection program for all vehicles, communications equipment, and mechanical and electronic medical equipment.
R 325.22120 Life support agencies licensed in other states or dominion of Canada.
(1) A life support agency licensed in another state or the dominion of Canada that responds to emergencies in this state shall be licensed by the department unless specific intergovernmental agreements exist between the department, the dominion of Canada, or the other state.
(2) A life support agency licensed in another state or in the dominion of Canada that responds to emergencies shall be accountable to the medical control authority in whose geographical boundaries initial patient contact is made.
R 325.22121 Inquiry into ability to pay.
Life support agencies shall not inquire about ability to pay or source of payment before providing life support consistent with its license and approved medical control authority protocols to each emergency patient.
R 325.22122 Misleading information concerning emergency response.
A life support agency shall not knowingly provide a person with false or misleading information concerning the time at which an emergency response will be initiated or the location from which the response is being initiated. The department or medical control authority may investigate any allegation of wrongdoing submitted under this rule. If a violation of this rule occurs, the department or medical control authority may take any corrective action authorized under the code and these rules.
R 325.22123 Spontaneous use of vehicle under exceptional circumstances; written report.
(1) If an ambulance operation is unable to respond to an emergency patient within a reasonable time, then the ambulance operation may use a vehicle under exceptional circumstances to provide, without charge or fee and as a humane service, transportation for the emergency patient.
Emergency medical personnel who transport, or who make the decision to transport, an emergency patient shall file a written report describing the incident with the medical control authority.
(2) A life support agency that transports an emergency patient under subrule (1) of this rule shall file a written report within 7 days with the medical control authority describing the incident.
R 325.22124 Enforcement.
(1) The department may take any action authorized by sections 20162, 20165, 20168 of the code or other provisions of the code in response to a violation of the code or these rules. Enforcement actions include any of the following:
(a) Denial, suspension, limitation or revocation of a life support agency license.
(b) The issuance of a nonrenewable conditional license effective for not more than 1 year.
(c) The issuance of an administrative order to correct deficiencies and prescribing the actions the department determines to be necessary to obtain compliance with the code or to protect the public health, safety, and welfare.
(2) A life support agency that is granted a 1 year nonrenewable conditional license by the department shall comply with at least all of the following.
(a) Provide at least 1 vehicle for response to requests for emergency assistance on a 24-hour-a-day, 7-day-a-week basis in accordance with its licensure level.
(b) Submit a statement of the reasons for the life support agency’s inability to comply with the code for licensure.
(c) Develop a plan of action to meet all licensure requirements. The plan shall be submitted to the medical control authority and the department.
(d) Submit a monthly report to the medical control authority that outlines the progress made on the plan.
(e) Report all out-of-service time to each involved medical control authority.
(3) A life support agency that is granted a 1 year nonrenewable conditional license shall comply with all licensure fee requirements in the code.
R 325.22125 Life support agency; licensure at higher level of care; requirements.
(1) A life support agency seeking licensure at a higher level shall qualify for that license only if the life support agency meets the following requirements:
(a) Under the provisions of the code, a life support agency that is licensed to provide medical first response life support may apply for licensure at the basic, limited advanced, or advanced life support level. A life support agency that is licensed to provide basic life support may apply for licensure at the limited advanced or advanced life support level. In the same manner, a life support agency that is licensed to provide limited advanced life support may apply for licensure at the advanced life support level.
(b) Each life support agency that meets the requirements of subdivision (a) of this subrule shall apply for a higher level of licensure on forms provided by the department and shall meet the requirements of the code and these rules. Included with the application shall be the required fee and identification of level of life support of the operation.
(2) A life support agency that obtains licensure at a higher level shall provide that level of care 24- hours-a-day, 7-days-a-week.
(3) If a life support agency applies to the department for licensure at a higher level than that of its current level, then the department shall conduct an inspection of the agency and its vehicles. Verification
of compliance with this subrule shall be included with the application for license for each ground ambulance or nontransport prehospital life support vehicle by both of the following methods:
(a) Provide, as part of the application, the name and address of the medical control authority or authorities under which the life support agency is operating. The agency shall complete an application for licensure, as prescribed by the department, for each medical control authority under which it operates. The signature on the application of the emergency medical services medical director, from each medical control authority, shall verify that the medical control authority agrees to provide medical control to the life support agency.
(b) Attest by signing the application that the radio communication system for each ambulance or nontransport prehospital life support vehicle complies with the medcom requirements, that each vehicle meets minimum equipment requirements, and that minimum staff requirements are being met in order to operate at least 1 vehicle on a 24 hour-a-day, 7 day-a-week basis. In addition, the agency shall document that each ground ambulance licensed by the department has a manufacturer certificate of compliance. Verification of compliance with this subrule shall be available to the department upon request.
R 325.22126 Life support agency; medical control; disciplinary action.
(1) A medical control authority may exercise disciplinary action against a life support agency and its emergency medical services personnel that may result in the life support agency or its personnel not being permitted to provide prehospital emergency care. The basis for these actions shall be for noncompliance with protocols established by the medical control authority and approved by the department. Disciplinary action may include the suspension, limitation, or removal of medical control for the life support agency or its personnel to provide emergency medical services.
(2) If disciplinary action against an agency or individual under subrule (1) of this rule results in the suspension, limitation, or removal of medical control, then the medical control authority shall advise the department, in writing, of such action within 1 business day of the removal.
(3) If a suspension or removal of medical control for a life support agency or individual occurs, the life support agency or individual shall not operate or practice in that medical control authority region until medical control is restored by the medical control authority.
(4) If a suspension or removal of medical control for a life support agency or individual occurs, the life support agency or individual may appeal the decision to the medical control authority. After appeals to the medical control authority have been exhausted, the life support agency or individual may appeal the medical control authority’s decision to the statewide emergency medical services coordination committee. An appeal to the emergency medical services coordination committee shall be filed with the department in writing not more than 30 calendar days following notification to the agency or individual of the final determination of the medical control authority.
(5) The emergency medical services coordination committee shall review the appeal of a life support agency or individual and make a recommendation to the department. The department will consider the emergency medical services coordination committee recommendation and conduct its own review of the appeal. If the department determines that licensure action is required, the department shall provide for a hearing in accordance with the code and Chapter 4 of the Administrative Procedures Act of 1969 MCL 24.271 et seq. The hearing officer shall issue a determination that constitutes a final disposition of the proceedings to each party within 30 days after the conclusion of the haring. The determination of the hearings officer shall become the final agency order upon receipt by the parties.
R 325.22127 Life support agency; life support vehicle; inspection; contractor requirements.
(1) The department shall, at least annually, inspect or provide for the inspection of each life support agency. The department shall conduct random inspections of life support vehicles during the agency licensure period.
(2) A life support agency that receives accreditation from the commission on accreditation of ambulance services or other organizations approved by the department as having equivalent expertise and competency in the accreditation of life support agencies may not be subject to an agency inspection by the department if the life support agency meets both of the following requirements:
(a) Submits verification of accreditation described in this rule.
(b) Maintains accreditation as described in this rule.
(3) Accreditation of a life support agency does not prevent the department from conducting a life support agency inspection.
(4) Pursuant to section 20910(2)(b) of the code, if emergency medical services activities apply to contracts with agencies or individuals for purposes of providing life support agency and life support vehicle inspections, the department shall notify each life support agency and medical control authority of the existence of the contracts, including the roles and responsibilities of those agencies or individuals having been awarded contracts.
PART 3. AMBULANCE OPERATIONS
R 325.22131 Ambulance operation; initial application; ground; rotary.
An ambulance operation and its ambulances shall be licensed by the department in accordance with section 20920 of the code. The application for initial licensure shall include all of the following:
(1) Be on forms provided by the department and include the required fees and identification of level of life support of the operation.
(2) Specify each ambulance to be operated, the level of life support being provided by that ambulance, and include a certificate of insurance covering each ambulance as identified in subrule (6).
(3) Provide as part of the application, the name and address of each medical control authority under which the life support agency is operating. The agency shall complete an application for licensure, as prescribed by the department, for each medical control authority under which it operates. A signature on the application by the emergency medical services medical director, from each medical control authority, shall be proof that the medical control authority agrees to provide medical control to the life support agency.
(4) An attestation, as evidenced by signing the application, of all of the following:
(a) Radio communications for each ambulance comply with the medcom requirements.
(b) Each vehicle meets minimum equipment requirements.
(c) Minimum staff requirements will be met in order to operate at least 1 vehicle on a 24 hour-a- day, 7 day-a-week basis, consistent with section 20921 (3) and (4) of the code.
(d) A manufacturer certificate of compliance for each ground ambulance licensed by the department.
(5) Verification of compliance with subrules (3) and (4) of this rule is available to the department upon request.
(6) Include evidence that the operation possesses not less than $1,000,000.00 insurance coverage or is under a self-insurance program authorized under 1951 PA 35, MCL 124.1 et seq. for property damage and personal injury, except for rotary winged aircraft. An application for rotary winged aircraft shall include evidence that the operation possesses not less than $5,000,000.00 insurance coverage or is under a self-insurance program authorized under 1951 PA 35, MCL 124.1 et seq. for property damage and personal injury.
(7) Include full disclosure of the operation ownership, including all of the following:
(a) Copies of documents relating to the official type of legal organization of the operation, stating whether it is an individual proprietorship, partnership, corporation or subsidiary of any other corporation or unit of government. These documents shall be maintained by the operation and shall be available to the department upon request.
(b) Copies of registration of the operation with the secretary of state or other designated official in each state that the agency is chartered, incorporated, or authorized to do business. These documents shall be maintained by the operation and shall be available to the department upon request.
(c) Disclose all legally responsible individuals, owners, or officers of the ambulance operation at the time of license application, including any trade names under which the organization operates. These shall include, but not limited to, the name or names that the ambulance operation is known to the public.
(d) Disclose all parent organizations and any person as defined in the code that have at least a 10% interest in the applicant operation.
(7) Identify 1 individual who will serve as the primary contact person for the operation.
R325.22132 Ambulance operation; operating requirements.
In addition to requirements prescribed in the code and these rules, an ambulance operation shall do all of the following:
(1) Establish and maintain a written procedure that explains the steps that will be followed when a complaint is received by the operation. This procedure shall be maintained by the operation and shall be available to the department upon request.
(2) Maintain evidence of participation in the county, local, or regional disaster plan. Approved protocols may be used to meet this requirement. These documents shall be maintained by the operation and shall be available to the department upon request.
(3) Comply with medical record keeping requirements in accordance with rule 325.22117.
(4) Maintain written policies and procedures that address safety and accident reduction and comply with all applicable state and federal health and safety laws as prescribed on the department-approved agency inspection form. These procedures shall be maintained by the operation and shall be available to the department upon request.
(5) Require that each individual staffing an ambulance is in compliance with the code and complies with applicable medical control authority protocols.
(6) Require that an ambulance is not operated while transporting a patient unless the ambulance is staffed in accordance with section 20921(3)(4) and (5) of the code.
(7) Maintain evidence of an orientation process of emergency medical services personnel that familiarizes them with the agency’s policies and procedures and are trained in the use and application of all the equipment carried in the ambulance. Included, at a minimum, shall be an introduction to personnel duties and responsibilities in addition to medical control authority protocols.
(8) Maintain a copy of all applicable protocols for each medical control authority under which the agency operates.
(9) Participate in data collection and quality improvement activities authorized under medical control authority protocols.
(10) Ensure that each licensed ambulance meets all applicable vehicle standards and state equipment requirements prescribed by the department and department-approved medical control authority protocols.
(11) Require compliance with medcom requirements.
(12) Not knowingly respond to or advertise its services for prehospital emergency patients from outside its service area as defined in these rules, except for mutual aide requests.
(13) Require that each individual operating a licensed life support vehicle during an emergency response or patient transport has completed a vehicle operation education and competency assessment.
R 325.22133 Ambulance operation; ground; rotary licensure requirements. An ambulance operation shall comply with all of the following:
(1) Provide not less than 1 staffed ambulance as defined in section 20921(3) of the code, at the agency level of licensure, available for response to requests for emergency assistance 24-hours-a- day, 7-days-a-week.
(2) Respond or ensure a response is provided to each request for emergency assistance originating from within the bounds of its service area.
(3) Ensure compliance with the code and these rules.
(4) Advise the department immediately of any changes that would alter the information contained on its licensure application, including any of the following:
(a) Change of ownership.
(b) Change of facility name.
(c) Change in vehicle status.
(d) Circumstances which preclude the ambulance operation from complying with subrule (1) of this rule or minimum equipment requirements.
(e) Change in communication ability to comply with medcom requirements.
(f) Change in service area.
(5) While transporting a patient, require compliance with minimum staffing requirements prescribed in section 20921 (3)(4) and (5) of the code.
(6) Require that an individual whose license is at least equal to the level of vehicle license is in the patient compartment when transporting an emergency patient, or consistent with department approved medical control authority protocols.
(7) Ensure that patient care and safety equipment carried on an ambulance meet the minimum requirements prescribed by the department and approved medical control authority protocols.
(8) Ensure that each ambulance is equipped with a communications system consistent with the medcom requirements developed by the department.
R 325.22134 Additional licensure requirements for limited advanced life support and advanced life support ambulance operations.
In addition to meeting the other licensure requirements of the code and these rules, an ambulance operation licensed at the limited advanced and advanced life support level shall do all of the following:
(1) Comply with the procedures of drug acquisition, storage, security, dispensing, and accountability in accordance with the criteria established by the medical control authority, in compliance with federal and state law and approved by the department and rule 325.22207(1)(k) and 325.22207(3).
(2) Comply with the acquisition, storage, security, dispensing and accountability procedures for intravenous solutions, tubing and related apparatus in accordance with medical control authority protocols and in compliance with the federal and state law.
(3) Lock and secure storage as required by federal and state law.
R 325.22135 Rotary aircraft ambulance operations; additional licensure requirements.
(1) In addition to meeting other licensure requirements of the code and these rules, an ambulance operation providing rotary aircraft transport shall do all of the following:
(a) Meet all equipment requirements of the federal aviation administration for the specific type of aircraft and flying conditions under which the aircraft will operate, as specified by the air taxi certificate of operation of the aircraft transport provider.
(b) Maintain accurate medical flight records concerning the transportation of each emergency patient in intrastate flights or interstate flights originating in Michigan. The records shall be available to the department and the medical control authority of the originating scene, when requested.
(c) Meet department licensure requirements and certificate of need requirements when providing on- scene emergency care.
(d) Meet department licensure requirements and certificate of need requirements when providing interfacility transfers.
(2) An ambulance operation licensed in Michigan that provides rotary aircraft services and has entered into a mutual aid agreement with a rotary aircraft service outside of Michigan shall meet both of the following requirements:
(a) A rotary aircraft service outside of Michigan that has an agreement to assist with scene emergency care is not required to have a certificate of need.
(b) A rotary aircraft service outside of Michigan that has an agreement to assist with patient transfers from 1 in-state health facility to another in-state health facility is required to have a certificate of need.
R 325.22136 Ambulance operation; issuance of ground and rotary ambulance license.
Receipt of the completed application by the department serves as attestation by the operation that the operation and ambulances being licensed are in compliance with the minimum standards required by the department. Upon approval of the application, the department shall issue a license to the ambulance operation. The license shall identify each ambulance being licensed.
R 325.22137 Ambulance operation; false advertising; conflict of interest. An ambulance operation shall not do any of the following:
(1) Induce or seek to induce any person engaging an ambulance to patronize a long-term care facility, mortuary, or hospital.
(2) Advertise, or permit advertising of, within or on the premises of the ambulance operation or within or on an ambulance, the name or the services of an attorney, accident investigator, nurse, physician, long-term care facility, mortuary, or hospital. If 1 of those persons or facilities owns or operates an ambulance operation, then the person or facility may use its business name in the
name of the ambulance operation and may display the name of the ambulance operation within or on the premises of the ambulance operation or within or on an ambulance.
(3) Advertise or disseminate information for the purpose of obtaining contracts under a name other than the name of the person holding an ambulance operation license or the trade or assumed name of the ambulance operation.
(4) Use the terms “ambulance” or “ambulance operation” or a similar term to describe or refer to the person unless the department under section 20920 of the code licenses the person.
(5) Advertise or disseminate information leading the public to believe that the person provides an ambulance operation unless that person does in fact provide that service and is licensed by the department.
R 325.22138 Ambulance operation; relicensure.
(1) An ambulance operation shall complete an application for relicensure and shall return the completed application to the department before the date of license expiration. Failure to receive a notice for relicensure from the department does not relieve the licensee of the responsibility to apply for relicensure.
(2) The license of an ambulance operation and its ambulances shall expire on the same date.
(3) An application for licensure renewal received by the department after the license expiration date, but within 60 calendar days after the expiration date of the license, shall require the ambulance operation to comply with section 20936 of the code.
(4) An ambulance operation may provide emergency medical services during the 60 days following its license expiration date, whether or not the department has received an application.
(5) An application for licensure renewal not received by the department within 60 calendar days following the date of license expiration shall be considered revoked, effective on the sixty-first day.
(6) Reinstatement of the ambulance operation and vehicle licenses shall require completion of a new application for licensure, including all fees prescribed in section 20936 (1) and (2) of the code.
PART 4. NONTRANSPORT PREHOSPITAL LIFE SUPPORT OPERATIONS
R 325.22141 Nontransport prehospital life support operation; initial application for licensure.
A nontransport prehospital life support operation and its vehicles shall be licensed by the department in accordance with section 20926 of the code. Application for initial licensure shall include all of the following:
(1) Be on forms provided by the department and include the required fees and identification of level of life support of the operation.
(2) Specify each vehicle to be operated, the level of life support being provided by that vehicle, and include a certificate of insurance covering each vehicle as identified in subrule (5) of this rule.
(3) Provide as part of the application, the name and address of each medical control authority under which the life support agency is operating. The agency shall complete an application for licensure, as prescribed by the department, for each medical control authority in which it operates. Signature on the application of the emergency medical services medical director, from each medical control authority, shall be proof that the medical control authority agrees to provide medical control to the life support agency.
(4) Attest, as evidenced by signing the application, to all of the following:
(a) Radio communications for each vehicle are in compliance with the medcom requirements.
(b) Each vehicle meets minimum equipment requirements.
(c) Minimum staff requirements will be met in order to operate at least 1 vehicle on a 24 hour-a- day, 7 day-a-week basis, consistent with section 20927 (3) of the code.
(d) Verification of compliance with subrules (3) and (4) of this rule, shall be available to the department upon request.
(5) Include evidence that the operation possesses not less than $1,000,000.00 insurance coverage or is under a self-insurance program authorized under 1951 PA 35, MCL 124.1 et seq. for property damage and personal injury.
(6) Include full disclosure of the operation ownership, including all of the following:
(a) Copies of documents relating to the official type of legal organization of the operation, stating whether it is an individual proprietorship, partnership, corporation, or subsidiary of any other corporation or unit of government. These documents shall be maintained by the operation and shall be available to the department upon request.
(b) Copies of official registration of the entity with the secretary of state or other designated official in each state in which the agency is chartered, incorporated, or authorized to do business. These documents shall be maintained by the operation and shall be available to the department upon request.
(c) Disclose all legally responsible individuals, owners, or officers of the operation at the time of license application, including any trade names under which the organization operates. These shall include, but not limited to the name or names under which the operation is known to the public.
(d) Disclose all parent organizations and any person as defined in the code, that have at least a 10% interest in the applicant operation.
(7) Identify 1 individual who will serve as the primary contact person for the operation.
R 325.22142 Nontransport prehospital life support operation -- operating requirements.
In addition to requirements prescribed in the code and these rules, a nontransport prehospital life support operation shall do all of the following:
(1) Establish and maintain a written procedure that explains the steps that will be followed when a complaint is received by the operation. This procedure shall be maintained by the operation and shall be available to the department upon request.
(2) Maintain evidence of participation in the county, local, or regional disaster plan and response. Approved protocols may be used to satisfy this requirement. These documents shall be maintained by the operation and shall be available to the department upon request.
(3) Comply with medical record keeping requirements in accordance with rule 325.22117.
(4) Maintain written policies and procedures that address safety and accident reduction and comply with all applicable state and federal health and safety laws as prescribed on the department-approved agency inspection form. These procedures shall be maintained by the operation and shall be available to the department upon request.
(5) Require that each individual staffing a nontransport prehospital life support vehicle complies with the code and applicable medical control authority protocols.
(6) Require that a nontransport prehospital life support vehicle is not operated unless it is staffed in accordance with section 20927(3) of the code.
(7) Maintain evidence of an orientation process for emergency medical services personnel to familiarize them with the agency’s policies and procedures and are trained in the use and application of all the equipment carried in the nontransport prehospital life support vehicle. At a minimum, this shall include an introduction to the duties to be performed as well as medical control authority protocols.
(8) Maintain a copy of all applicable protocols for each medical control authority under which the agency operates.
(9) Participate in data collection and quality improvement activities authorized under medical control authority protocols.
(10) Ensure that vehicles licensed by the operation meet all vehicle standards, and meet state equipment requirements prescribed by the department and department-approved medical control authority protocols.
(11) Require compliance with medcom requirements.
(12) Not knowingly respond to or advertise its services for prehospital emergency patients from outside its service area as defined in these rules, except for mutual aid requests.
(13) Require that an individual operating a licensed life support vehicle during an emergency response has completed a vehicle operation education and competency assessment.
R 325.22143 Nontransport prehospital life support operation; licensure requirements. A nontransport prehospital life support operation shall comply with all of the following:
(1) Provide not less than 1 staffed nontransport prehospital life support vehicle as defined in section 20921(3) of the code, at the agency licensure level, available for response to requests for emergency assistance 24-hours-a-day, 7-days-a-week.
(2) Respond or ensure a response is provided to each request for emergency assistance from within its service area.
(3) Ensure compliance with the code and these rules.
(4) Immediately advise the department of any changes that would alter the information contained on its licensure application, including any of the following:
(a) Change of ownership.
(b) Change of facility name.
(c) Change in vehicle status.
(d) Circumstances which preclude the nontransport prehospital life support operation from complying with subrule (1) of this rule or minimum equipment requirements.
(e) Change in ability to comply with medcom requirements.
(f) Change in service area.
(5) Ensure compliance with the minimum staffing requirements prescribed in section 20927(3) of the code.
(6) Ensure that patient care and safety equipment carried on a nontransport vehicle meet the minimum requirements prescribed by the department and approved medical control authority protocols.
(7) Ensure that each vehicle is equipped with a communications system consistent with the medcom requirements developed by the department.
R 325.22144 Nontransport prehospital life support operations operating at the limited advanced or advanced life support level; additional licensure requirements.
In addition to meeting the other licensure requirements of the code and these rules, a nontransport prehospital life support agency at the limited advanced or advanced life support level shall do all of the following:
(1) Comply with the procedures of drug acquisition, storage, security, dispensing, and accountability in accordance with the criteria established by the medical control authority, in
compliance with federal and state law, and approved by the department and rule 325.22207(1)(k) and 325.22207(3).
(2) Comply with the acquisition, storage, security, dispensing and accountability procedures of intravenous solutions, tubing and related apparatus in accordance with medical control authority protocols and in compliance with the federal and state law.
(3) Ensure storage areas are locked and secured as required by federal and state law.
R 325.22146 Nontransport prehospital life support operation; issuance of nontransport prehospital life support license.
Receipt of the completed application by the department serves as attestation, that the operation and vehicles being licensed comply with the minimum standards required by the department. Upon approval of the application, the department shall issue a license to the nontransport prehospital life support operation. The license shall identify each vehicle being licensed. The license may be renewed on an annual basis.
R 325.22147 Nontransport prehospital life support operation; relicensure.
(1) A nontransport prehospital life support operation shall complete an application for relicensure and return the completed application to the department before the date of license expiration. Failure to receive a notice for relicensure from the department does not relieve the licensee of the responsibility to apply for relicensure.
(2) The license of a nontransport prehospital life support operation and its vehicles shall expire on the same date.
(3) An application for licensure renewal received by the department after the license expiration date, but within 60 calendar days after the expiration date of the license, shall require the nontransport prehospital life support operation to comply with section 20936 of the code.
(4) A nontransport prehospital life support operation may provide emergency medical services during the 60 days following its license expiration date, whether or not the department has received an application.
(5) An application for licensure renewal not received by the department within 60 calendar days following the date of license expiration shall be considered revoked, effective on the sixty-first day.
(6) Reinstatement of the nontransport prehospital life support operation and vehicle licenses shall require completion of a new application for licensure, including all fees prescribed in section 20936 (1) and (2) of the code.
PART 5. AIRCRAFT TRANSPORT OPERATIONS
R 325,22151 Aircraft transport operation; fixed wing; initial application for licensure.
An aircraft transport operation and its vehicles shall be licensed by the department in accordance with section 20931 of the code. Application for initial licensure shall do all of the following:
(1) Be on forms provided by the department and include the required fees and identification of level of life support of the operation.
(2) Specify each aircraft transport vehicle to be operated, the level of life support being provided by the vehicle, and include a certificate of insurance covering each vehicle as prescribed in subrule
(6) of this rule.
(3) Provide as part of the application, the name and address of each medical control authority under which the life support agency is operating . The agency shall complete an application for
licensure, as prescribed by the department, for each medical control authority in which it operates. Signature on the application of the emergency medical services medical director, from each medical control authority, shall be proof that the medical control authority is in agrees to provide medical control to the life support agency.
(4) Attest, as evidenced by signing the application, to all of the following:
(a) Rradio communications for each aircraft transport vehicle are in compliance with the medcom requirements.
(b) Each vehicle meets minimum equipment requirements.
(c) Minimum staff requirements will be met to operate each vehicle consistent with section 20932(2) of the code.
(5) Verification of compliance with subrules (3) and (4) of this rule, shall be available to the department upon request.
(6) Include evidence that the operation possesses not less than $10,000,000.00 insurance coverage or is under a self-insurance program authorized under 1951 PA 35, MCL 124.1 et seq., for property damage and personal injury.
(7) Include full disclosure of the operation ownership, including all of the following:
(a) Documents relating to the official type of legal organization of the operation, stating whether it is an individual proprietorship, partnership, corporation, or subsidiary of any other corporation or unit of government. These documents shall be maintained by the operation and shall be available to the department upon request.
(b) Official registration of the entity with the secretary of state or other designated official in each state in which the agency is chartered, incorporated, or authorized to do business. These documents shall be maintained by the operation and shall be available to the department upon request.
(c) Disclosure of all legally responsible individuals, owners, or officers of the aircraft transport operation at the time of license application, including any trade name under which the organization operates. These shall include, but not limited to, the name or names under which the aircraft transport operation is known to the public.
(d) Disclosure of all parent organizations and any person as defined in the code, that have at least a10% interest in the applicant operation.
(8) Identify 1 individual who will serve as the primary contact person for the operation.
R325.22152 Aircraft transport operation; operating requirements.
In addition to requirements prescribed in the code and these rules, an aircraft transport operation shall do all of the following:
(1) Establish and maintain a written procedure that explains the steps that will be followed when a complaint is received by the operation. This procedure shall be maintained by the operation and shall be available to the department upon request.
(2) Maintain evidence which may show participation in the county, local, or regional disaster plan and response. Approved protocols may be used to satisfy this requirement. These documents shall be maintained by the operation and shall be available to the department upon request.
(3) Comply with medical record keeping requirements in accordance with rule 325.22117.
(4) Maintain written policies and procedures to address safety and accident reduction and comply with all applicable state and federal health and safety laws as prescribed on the department- approved agency inspection form. These procedures shall be maintained by the operation and shall be available to the department upon request.
(5) Require that each individual staffing an aircraft transport vehicle complies with the code and applicable medical control authority protocols.
(6) Require that an aircraft transport vehicle is not operated while transporting a patient unless the ambulance is staffed in accordance with section 20932(2) of the code.
(7) Ensure compliance with additional staffing requirements established by local medical control authority, and approved by the department, or as needed, and for life support during that transportation according to the written orders of the patient’s physician.
(8) Maintain evidence of an orientation process for emergency medical services personnel to familiarize them with the agency’s policies and procedures and are trained in the use and application of all the equipment carried in the vehicle. At a minimum, the evidence shall include an introduction to the duties to be performed as well as medical control authority protocols.
(9) Maintain a copy of all applicable protocols for each medical control authority under which the agency operates.
(10) Participate in data collection and quality improvement activities authorized under medical control authority protocols.
(11) Ensure that aircraft transport vehicles licensed by the operation meet all applicable vehicle standards, state equipment requirements as established by the department and department- approved medical control authority protocols.
(12) Require compliance with medcom requirements.
R 325.22153 Aircraft transport operation; licensure requirements.
An aircraft transport operation shall comply with section 20932 of the code and all of the following:
(1) Provide an aircraft transport vehicle for patient transportation between health facilities, as needed, and for life support during that transportation according to the written orders of the patient’s physician.
(2) Operate in accordance with the code, rules, and orders established by the patient’s physician. The operation shall not provide life support at a level that exceeds its license, department approved medical control authority protocols, or violates those orders established by the patient’s physician.
(3) Ensure compliance with the rule 325.22111(1)(4)(5) and 325.22113.
(4) Immediately advise the department of any changes that would alter the information contained on its licensure application, including any of the following:
(a) Change of ownership.
(b) Change of facility name.
(c) Change in vehicle status.
(d) Circumstances which preclude the operation from providing patient transportation between health facilities, as needed, or for not being capable of meeting minimum staffing or equipment requirements.
(e) Change in ability to comply with medcom requirements.
(f) Change in service area.
(5) While transporting a patient, ensure that the aircraft transport operation complies with the minimum staffing and equipment requirements prescribed in section 20932(2) of the code.
(6) Ensure that an aircraft transport vehicle is equipped with a communications system consistent with the medcom requirements developed by the department.
R 325.22156 Aircraft transport operations operating at the limited advanced life support or advanced life support levels; additional licensure requirements.
In addition to meeting licensure requirements of the code and these rules, an aircraft transport operation licensed at the limited advanced or advanced life support level shall do all of the following:
(1) Comply with the procedures of drug acquisition, storage, security, dispensing, and accountability in accordance with the criteria established by the medical control authority, federal and state law, and approved by the department and rule 325.22207(1)(k) and 325.22207(3).
(2) Comply with the acquisition, storage, security, dispensing and accountability procedures of intravenous solutions, tubing and related apparatus in accordance with medical control authority protocols and federal and state law.
(3) Ensure storage areas are locked and secured as required by federal and state law.
R 325.22155 Aircraft transport operation; issuance of license.
(1) Receipt of the completed application by the department serves as attestation, to the department, that the operation and aircraft transport vehicles being licensed are in compliance with the minimum standards required by the department. Upon approval of the application, the department shall issue a license to the aircraft transport operation. The license shall include the vehicles being licensed. The license may be renewed on an annual basis.
(2) An aircraft transport operation providing fixed wing transport shall comply with rule325.22151 and shall do both of the following:
(a) The aircraft transport vehicle and equipment shall be in compliance with current federal aviation administration regulations for the specific type of aircraft and flying conditions under which the aircraft will operate, as specified by the air taxi certificate of operation of the aircraft transport provider.
(b) Maintain accurate medical flight records concerning the transportation of an emergency patient in intrastate flights or interstate flights originating in this state. The records shall be available to the department and the medical control authority of the originating scene, when requested.
R 325.22156 Aircraft transport operation; relicensure.
(1) An aircraft transport operation shall complete an application for relicensure and return the completed application to the department before the date of license expiration. Failure to receive a notice for relicensure from the department does not relieve the licensee of the responsibility to apply for relicensure.
(2) The license of an aircraft transport operation and its vehicles shall expire on the same date.
(3) An application for licensure renewal received by the department after the license expiration date, but within 60 calendar days after the expiration date of the license shall require the aircraft transport operation to comply with section 20936 of the code.
(4) An aircraft transport operation may provide emergency medical services during the 60 days following its license expiration date, whether or not the department has received an application.
(5) An application for licensure renewal not received by the department within 60 calendar days following the date of license expiration shall be considered revoked, effective on the sixty-first day.
(6) Reinstatement of the aircraft transport operation and vehicle licenses shall require completion of a new application for licensure, including all fees prescribed in section 20936(1) and (2) of the code.
PART 6. MEDICAL FIRST RESPONSE SERVICES
R325.22161 Medical first response service; initial application.
A medical first response service and its vehicles shall be licensed by the department in accordance with section 20941 of the code and its application for initial licensure shall comply with all of the following:
(1) Be on forms provided by the department.
(2) Specify each medical first response vehicle to be operated and include a certificate of insurance for each vehicle as identified in subrule (6) of this rule. Each vehicle licensed shall meet minimum equipment and staffing requirements.
(3) Provide as part of the application, the name and address of each medical control authority under which the life support agency is operating. The agency shall complete an application for licensure, as prescribed by the department, for each medical control authority in which it operates. Signature on the application of the emergency medical services medical director, from each medical control authority, shall be proof that the medical control authority agrees to provide medical control to the life support agency.
(4) Attest, as evidenced by signing the application, to all of the following:
(a) Radio communications for each vehicle is in compliance with the medcom requirements.
(b) Each vehicle meets minimum equipment requirements.
(c) Minimum staff requirements will be met to operate each vehicle on a 24 hour-a-day, 7 day-a- week basis, consistent with section section 20906(10) of the code.
(5) Verification of compliance with subrules (3) and (4) of this rule, shall be available to the department upon request.
(6) Include evidence that the service possesses not less than $1,000,000.00 insurance coverage or is be under a self-insurance program authorized under 1951 PA 35, MCL 124.1 et seq., for property damage and personal injury.
(7) Include full disclosure of the agency ownership, including all of the following:
(a) Documents relating to the official type of legal organization of the operation, stating whether it is an individual proprietorship, partnership, corporation, or subsidiary of any other corporation or unit of government. These documents shall be maintained by the operation and shall be available to the department upon request.
(b) Official registration of the entity with the secretary of state or other designated official in each state in which the agency is chartered, incorporated, or authorized to do business. These documents shall be maintained by the operation and shall be available to the department upon request.
(c) Disclosure of all legally responsible individuals, owners, or officers of the service at the time of license application, including any trade names under which the organization operates. These shall include, but not limited to, the name or names that the medical first response service is known to the public.
(d) Disclose all parent organizations and persons as defined in the code, that have at least a 10% interest in the applicant operation.
(8) Staff each vehicle with at least 1 medical first responder.
(9) Identify 1 individual who will serve as the primary contact person for the service. R 325.22162 Medical first response services; operating requirements.
In addition to requirements prescribed in the code and these rules, a medical first response service shall do all of the following:
(1) Establish and maintain a written procedure that explains the steps that will be followed when a complaint is received by the operation. This procedure shall be maintained by the operation and shall be available to the department upon request.
(2) Maintain evidence of participation in the county, local, or regional disaster plan and response. Approved protocols may satisfy this requirement. These documents shall be maintained by the service and shall be available to the department upon request.
(3) Comply with medical record keeping requirements in accordance with rule 325.22117.
(4) Maintain written policies and procedures that address safety and accident reduction and comply with all applicable state and federal health and safety laws as prescribed on the department-approved agency inspection form. These procedures shall be maintained by the service and shall be available to the department upon request.
(5) Require that each individual staffing a medical first response vehicle is in compliance with the code and applicable medical control authority protocols.
(6) Maintain evidence of an orientation process for emergency medical services personnel that familiarizes them with the agency’s policies and procedures and trains in the use and application of all equipment carried in the vehicle. At a minimum, this evidence must include a proper introduction to the duties to be performed as well as medical control authority protocols.
(7) Maintain a copy of all applicable protocols for each medical control authority under which the agency operates.
(8) Participate in data collection and quality improvement activities authorized under medical control authority protocols.
(9) Ensure that all vehicles meet state equipment requirements as established by the department and department-approved medical control authority protocols.
(10) Require compliance with medcom requirements.
(11) Not knowingly respond to or advertise its services for prehospital emergency patients from outside its service area as defined in these rules, except for mutual aid requests.
(12) Require that each individual operating a licensed life support vehicle during an emergency response has completed a vehicle operation education and competency assessment.
R 325.22163 Medical first response service; licensure requirements.
A medical first response service shall comply with section 20941 of the code and do all of the following:
(1) Provide, at a minimum, 1 staffed vehicle available for response to requests for emergency assistance, 24-hours-a-day, 7-days-a-week.
(2) Respond or ensure a response is provided to each request for emergency assistance originating from within the bounds of its service area.
(3) Ensure compliance with the code and these rules.
(4) Immediately advise the department of any changes that alters the information contained on its licensure application, including all of the following:
(a) Change of ownership.
(b) Change of facility name.
(c) Change in vehicle status.
(d) Circumstances which preclude the medical first response service from complying with subrule
(1) of this rule or equipment requirements.
(e) Change in ability to comply with medcom requirements.
(f) Change in service area.
(5) Ensure compliance with the minimum staffing requirements prescribed in section 20906(10) of the code.
(6) Ensure that patient care and safety equipment carried on a medical first response vehicle meets the minimum requirements prescribed by the department.
(7) Ensure that each vehicle is equipped with a communications system consistent with the medcom requirements developed by the department.
R 325.22164 Medical first response service; issuance of license.
Receipt of the completed application by the department serves as attestation by the service that the service and vehicles being licensed are in compliance with the minimum standards required by the department. Upon approval of the application, the department shall issue a license to the medical first response service. The license shall include the vehicles being licensed. The license may be renewed on an annual basis.
R 325.22165 Medical first response service; law enforcement; fire suppression agency.
(1) A medical first response service means a person licensed by the department to respond under medical control to an emergency scene with a medical first responder and equipment required by the department before the arrival of the ambulance. This includes a fire suppression agency only if it is dispatched for medical first response life support.
(2) A fire suppression agency shall be licensed as a medical first response service, in accordance with rule 325.22161, and provide medical first response life support as described in the code and these rules if it is dispatched to provide any care a medical first responder is qualified to provide under section 20906(8) of the code.
(3) A law enforcement agency must be licensed as a medical first response service, in accordance with rule 325.22161, and provide medical first response life support as described in the code and these rules if both of the following conditions are met:
(a) “Holds itself out” as a medical first response service.
(b) Be dispatched to provide medical first response life support.
(4) A law enforcement agency holds itself out as a medical first response service if it advertises or announces that it will provide patient care that may include any care a medical first responder is qualified to provide under section 20906(8) of the code or charges for those services.
R 325.22166 Medical first response service and vehicles; relicensure.
(1) A medical first response service shall complete an application for relicensure and shall return the completed application to the department before the date of license expiration. Failure to receive a notice for relicensure from the department does not relieve the licensee of the responsibility to apply for relicensure.
(2) The license of a medical first response service and its vehicles shall expire on the same date.
(3) An application for licensure renewal received by the department after the license expiration date, but within 60 calendar days after the expiration date of the license, shall require the medical first response service to comply with section 20936 of the code.
(4) A medical first response service may provide emergency medical services during the 60 days following its license expiration date, whether or not the department has received an application.
(5) An application for licensure renewal not received by the department within 60 calendar days following the date of license expiration shall be considered revoked, effective on the sixty-first day.
(6) Reinstatement of the medical first response service and vehicle licenses shall require completion of a new application for licensure.
PART 7. AMBULANCE OPERATION UPGRADE LICENSE
R 325.22171 Ambulance operation upgrade license; application process.
An ambulance operation described in sections 20920 (7) to (12) of the code that applies for an ambulance operation upgrade license shal do all of the following:
(1) Have been a licensed ambulance operation at the transporting basic life support or transporting limited advanced life support on or before July 22, 1997.
(2) Have been owned, operated, or under contract to a local unit of government and providing first line emergency medical response to that local unit of government on or before July 22, 1997. Emergency services provided under an upgraded license shall be provided only to the local unit of government and only in response to a 9-1-1 call or other call for emergency transport within jurisdiction of local unit of government.
(3) A transporting basic ambulance operation shall staff and equip 1 or more ambulances for the transport of emergency patients at a life support level higher than basic life support.
(4) A transporting limited advanced ambulance operation shall staff and equip 1 or more ambulances for the transport of emergency patients at the advanced life support level.
(5) Make application for licensure to the department on forms prescribed by the department. Included with the application shall be the required $100.00 fee and identification of the current level of life support of the operation and the higher level of life support being sought. The application shall include verification of all of the following:
(a) The ambulance operation was licensed on, or before, July 22, 1997.
(b) The ambulance operation was licensed, at a minimum, as a basic transporting ambulance operation on, or before, July 22, 1997.
(c) The ambulance operation is owned, operated by, or under contract with a local unit of government.
(d) Services described in the application shall be provided only to the local unit of government and only in response to 9-1-1 calls or other calls for emergency transport within the jurisdiction of the local unit of government.
(e) The ambulance operation complies with all patient care and radio equipment requirements for the level of upgrade requested.
(f) The ambulance operation provides a description of the staffing for each vehicle under the upgrade provision.
(g) The ambulance operation provides a 2-year plan of action to upgrade, on a full-time basis, to the higher level. A letter of commitment by the local unit of government supporting this plan of action shall be part of the plan.
(h) The ambulance operation provides patient care protocols and a formal recommendation from the medical control authority under which the ambulance operation operates.
(i) Quality monitoring procedures and use and protection of equipment protocols have been developed and approved by the medical control authority. Use and protection equipment protocols shall describe procedures the operation will use to limit access to the limited advanced or advanced, or both, equipment and supplies when not operating at the higher level.
(6) Provide additional information as prescribed by the department to process the application.
R 325.22172 Ambulance operation upgrade license; limited advanced life support; advanced life support; security, control, and exchange of pharmaceuticals.
An ambulance operation upgrade licensed at the limited advanced or advanced life support level shall do all of the following:
(1) Comply with the procedures of drug acquisition, storage, security, dispensing, and accountability in accordance with the criteria established by the medical control authority, in compliance with federal and state law and approved by the department and rule 325.22207(1)(k) and 325.22207(3).
(2) Comply with the acquisition, storage, security, dispensing and accountability procedures for intravenous solutions, tubing, and related apparatus in accordance with medical control authority protocols and federal and state law.
(3) Ensure storage areas are locked and secured as required by federal and state law.
R 325.22173 Ambulance operation upgrade license; review process and licensure.
An application submitted under rule 325.22171 shall be reviewed by the emergency medical services coordination committee. The emergency medical services coordination committee shall make a recommendation to the department if an ambulance operation upgrade license should be granted to the applicant.
(1) If the emergency medical services coordination committee recommend a license upgrade, then the department shall conduct a communication and equipment inspection at the upgrade level before issuing a license
(2) If the emergency medical services coordination committee does not recommend a license upgrade, then the department shall send a communication to the ambulance operation upgrade applicant identifying concerns and advising the operation of non-approval of licensure.
(3) A license issued under rule 325.22173(1) shall be valid for 2 years from date of issuance by the department.
(4) The medical control authority under which the ambulance operation operates shall submit to the emergency medical services coordination committee an annual written progress report on the ambulance operation upgrade plan of action. The progress report shall include, but is not limited to, information on training, equipment, and personnel. The report shall demonstrate progress being made by the ambulance operation to achieve licensure and the higher level and comply with the 24-hour-a-day, 7-day-a-week requirements of the code.
R 325.22174 Ambulance operation upgrade license; renewal process.
An ambulance operation upgrade license is renewable for 1 additional 2-year period provided the following requirements are met:
(1) The medical control authority has complied with rule 325.22173(4).
(2) The ambulance operation has renewed and is currently licensed at the basic transporting life support or limited advanced transporting life support level.
(3) The ambulance operation meets the renewal upgrade licensure application requirements prescribed by the department, including the $100.00 fee.
(4) The ambulance operation submits, with the renewal upgrade licensure application, a progress report on the initial plan of action.
(5) Provides a description of the staffing for each vehicle under the upgrade license.
(6) Provides an updated 2-year plan of action to upgrade, on a full-time basis, to the higher level. A letter of commitment by the local unit of government supporting this plan of action shall be part of the plan.
R 325.22175 Ambulance operation upgrade license; revocation or denial of renewal.
The department may revoke or fail to renew an ambulance operation upgrade license for a violation of the code or rules or for failure to comply with the plan of action filed with the department. The ambulance operation’s regular license is not affected if the ambulance operation upgrade license is revoked or not renewed.
R 325.22176 Ambulance operation upgrade license; nonrenewal.
An ambulance operation upgrade license that is not renewed or failure of the operation to achieve the higher level after the second 2-year period shall not provide life support at the higher level effective the day after the ambulance operation upgrade license expiration date.
R 325.22177 Ambulance operation upgrade license; advertisement.
(1) An ambulance operation licensed under rule 325.22173(1) shall not advertise or hold itself out as a full-time transporting limited-advanced or transporting advanced life support service unless the ambulance operation actually provides those services on a 24-hour-a-day, 7-days-a-week basis.
(2) An ambulance operation licensed under this rule that is providing services at the limited advanced or advanced life support level on a 24-hour-a-day, 7-day-a-week basis and is advertising these services, shall not qualify for licensure under this rule. The ambulance operation shall make application to the department to upgrade its regular ambulance operation license to the level of licensure being provided.
PART 8. LIFE SUPPORT VEHICLES
R 325.22181 Ground ambulance; requirements.
(1) An ambulance operation shall maintain the manufacturer’s certificate of compliance on file at the time of application to the department for licensure of each ground ambulance. The certificate of compliance shall be executed by the final manufacturer of each ground ambulance and be on a form prescribed by the department.
(2) The manufacturer of a ground ambulance executing a certificate of compliance shall comply with the ambulance structural and mechanical specifications in compliance with federal (KKK) standards, excluding the paint scheme, that were in effect at the time of manufacture and shall maintain test data demonstrating compliance. Once licensed for service, an ambulance shall not be required to meet later modified state vehicle standards during its use by the ambulance operation that obtained the license.
(3) A ground ambulance referred to in subrule (2) of this rule shall not be modified to alter its original design upon which the certificate of compliance was based, unless a new certificate is issued verifying that the modifications have not altered the integrity of the vehicle.
(4) The patient compartment of a ground ambulance that has met applicable federal standards at the time of manufacture may be remounted on to a different chassis by a qualified vehicle modifier as designated by the chassis manufacturer. A new manufacturer’s certificate of compliance shall be issued that identifies the new vehicle identification number and demonstrates compliance with KKK standards in accordance with subrule (2) of this rule.
R 325.22182 Non-qualifying vehicles for licensure.
(1) A ground ambulance that was originally manufactured before January 1, 1982 shall not qualify for licensure by the department and shall not be sold or donated in this state for use as a ground ambulance. This subrule shall not apply to a ground ambulance that has been licensed and is currently licensed by the department and has been in continuous service before January 1, 1982.
(2) A ground ambulance manufactured after January 1, 1982, whose age from the date of manufacture exceeds 2 years, shall have a safety inspection by a certified mechanic being sold to provide ground ambulance services. The inspection shall be documented on a form developed by the department and shall include a notarized statement by the previous owner attesting that the ground ambulance has not been involved in a vehicular accident altering its safety. The documents required by this subrule shall be submitted to the department by the purchaser as part of the application for licensure by the new owner.
R 325.22183 Ground ambulance sanitation.
A ground ambulance operation shall require that equipment, linen, and supplies shall be cleaned or exchanged following each patient care use.
R 325.22184 Life support vehicles; displaying of name.
(1) A life support agency name shall be prominently displayed on the left and right side of all licensed life support vehicles.
(2) If the life support agency is operated by or advertised with a name different than the company name, then the name may be displayed on the left and right side of the life support vehicle below the name of the company.
R325.22185 Life support vehicles; equipment requirements.
(1) A ground ambulance, rotary ambulance, and aircraft transport vehicle shall be equipped with equipment and patient care supplies as prescribed by the department including temperature control in the patient compartment. The agency shall require that equipment is available and in working order on each vehicle.
(2) A nontransport and medical first response vehicle shall be equipped with patient care equipment and patient care supplies as prescribed by the department. The agency shall require that equipment is available and in working order on each vehicle.
(3) Each life support vehicle shall be equipped with communication capability in accordance with the medcom requirements.
R 325.22186 Life support vehicles; patient care and safety equipment; review.
(1) The department shall, with the advice of the emergency medical services coordination committee, annually review and modify, as necessary, the patient care and safety equipment standards for life support vehicles.
(2) The department shall, with the advice of the emergency medical services coordination committee, review and modify, as necessary, the patient care critical equipment items.
R 325.22187 Rotary ambulance; requirements.
A rotary ambulance shall meet all of the following standards:
(a) Be capable of on-scene response and transportation of emergency patients.
(b) Be staffed in accordance with section 20921 (3) (4) and (5) of the code.
(c) Allow for patient access and treatment to the patient by the rotary ambulance personnel.
(d) Possess access that allows for safe loading and unloading of a patient without excessive maneuvering of the patient.
(e) Be temperature controlled for the comfort of the patient.
(f) Have adequate lighting for patient care and observation.
(g) Be equipped with communication capability with hospitals, ground units, and medical control in accordance with the medcom requirements.
(h) Be capable of carrying a minimum of 1 patient in a horizontal position on a litter located so as not to obstruct the pilot's vision or interfere with the performance of any member of the flight crew or required air medical personnel.
(i) Securely store equipment and make readily accessible.
(j) Operate under the medical control authority for the geographic area where on-scene patient care is being provided.
R 325.22188 Rotary ambulance sanitation.
A rotary ambulance operation shall require that any equipment, linen, and supplies be cleaned or exchanged following each patient care use.
R 325.22189 Fixed wing vehicle; requirements.
A fixed wing vehicle shall comply with all of the following:
(a) Be authorized as part of a licensed aircraft transport operation.
(b) Be capable of carrying a minimum of 1 patient in a horizontal position on a litter located so as not to obstruct the pilot's vision or interfere with the performance of any member of the flight crew or air medical personnel.
(c) Provide a means of securing the litter while supporting a patient to the floor, walls, seats, specific litter rack, or any combination thereof.
(d) If transporting more than 1 patient, there shall be a minimum vertical spacing of 30 inches between each patient’s litter.
(e) Ensure that the upper surface of the single or upper litter is not less than 30 inches from the ceiling of the aircraft.
(f) Ensure that the head and thorax of a patient secured to a litter is accessible to air medical personnel from at least 1 side of the litter without obstruction.
(g) Ensure that the patient compartment has adequate lighting available for patient observation.
(h) Require that equipment is secured to the aircraft, readily accessible, and when not in use, securely stored.
(i) Ensure that the interior of each vehicle affords an adequate patient care and treatment area.
(j) Ensure that each vehicle is equipped with a cargo door or other entry that allows for loading and unloading of the patient without excessive maneuvering of the patient.
(k) Ensure that the interior of each vehicle is equipped with temperature control for the comfort of the patient.
R 325.22190 Life support vehicles; licensure and relicensure inspections; new and replacement vehicles; licensure at higher level of care.
Life support vehicles shall be inspected as follows:
(1) The department may conduct random renewal inspections of life support vehicles, including medical first response vehicles. Inspections shall be unannounced unless circumstances warrant notifying a life support agency in advance that an inspection of its life support vehicles will be conducted. The department shall determine if prior notification of an inspection is warranted. A vehicle license may be renewed without an inspection.
(2) Submission of a licensure renewal application shall be considered an attestation by the life support agency that the vehicle meets all licensure requirements.
(3) A life support agency that is adding a new or higher licensure level for a life support vehicle shall submit an application, on forms provided by the department, and include the required fee. New and higher level of care vehicles shall be inspected before being placed into service. Upon receipt of the application and required fee, the department shall inspect new or upgrade vehicles within 15 days of receipt of application.
(4) A life support agency that is replacing a life support vehicle shall submit an application, on forms provided by the department, and include the required fee. A replacement vehicle means a life support agency has removed a vehicle from service and has replaced the vehicle with another.
(5) Replacement vehicles may be placed into service upon submission of an application and the required fee to the department. Upon receipt of the application and required fee, the department shall inspect the replacement vehicle within 15 days of receipt of the application.
R 325.22191 Life support vehicles inspected; non-compliance; corrective measures.
If the department determines that a life support vehicle is not in compliance with the requirements of the code and these rules, then the following shall apply:
(1) If an agency has a vehicle determined to be noncompliant on critical equipment items as identified on the inspection form, the agency shall have 24 hours to bring the vehicle into compliance and to notify the department in writing of the corrections made. The vehicle may be returned to service before a reinspection with approval of the department. A reinspection shall occur within 15 days of notification by the life support agency.
(2) An agency has 24 hours to bring a vehicle into compliance from the time it is determined to be out of compliance due to missing critical equipment items. The agency shall remove the vehicle from service until the life support agency submits a written explanation of corrective action to the department and the department reinspects the vehicle. A vehicle taken out of service shall not function as an ambulance or life support vehicle until the vehicle passes the department reinspection.
(3) If a vehicle remains out of compliance for more than 15 calendar days from the date of inspection, then its license shall be automatically revoked. Reinstatement of the life support vehicle license shall require reapplication for licensure, payment of the licensure fee prescribed in the code, and a reinspection of the vehicle.
(4) If an agency has a vehicle determined to be noncompliant, but not missing critical equipment items, the agency shall be allowed 15 calendar days from the date of inspection to provide the department with a written explanation of corrective action. The life support vehicle may remain in service during the 15-day period unless the department has ordered that the vehicle be taken out of service pursuant to subrule (3) of this rule.
(5) The department may immediately order a life support vehicle out of service if it determines that the health and welfare of a patient may be in jeopardy due to noncompliance with critical equipment standards or defective and nonfunctional critical equipment. A notice of such action shall be immediately provided to the life support agency by the department based upon the deficiencies found.
(6) A life support agency that takes corrective measures to bring a life support vehicle into compliance during the time of a department inspection shall not receive notice of noncompliance. The inspection report shall reflect that the corrective action and compliance have been met.
PART 9. COMMUNICATIONS REQUIREMENTS
R 325.22192 Communications requirements; life support agencies.
A life support agency providing emergency medical services shall use applicable communication systems consistent with its level of licensure in compliance with the code, these rules, and the medcom requirements as prescribed by the department.
R 325.22193 Medcom requirements.
Medcom requirements shall be reviewed annually and updated, if necessary, with the advice and recommendations of the emergency medical services coordination committee.
R 325.22194 Illegal interception of radio communications.
A person who receives any radio communication not intended for the general public shall not use the contents of the communication for initiating an emergency medical service response as described in section 20963 (2) of the code.
R 325.22195 Communications system application process; life support agencies; medical control authorities.
(1) A life support agency shall comply with the ambulance-to-hospital radio communications system consistent with the medcom requirements in the medical control authorities in which they operate.
(2) A medical control authority shall comply with the ambulance-to-hospital radio communications system approval process, as prescribed by the medcom requirements, under any of the following conditions:
(a) A medical control authority upgrades to provide limited advanced or advanced life support oversight.
(b) An existing medical control authority changes the infrastructure of its communication system affecting ambulance-to-hospital communications.
(c) A change is made in an existing communications system that results in an inability of an agency or hospital to communicate with each other.
PART 10. MEDICAL CONTROL AUTHORITY
R 325.22201 Medical control authorities; designation.
(1) The department shall designated a medical control authority to provide medical control for emergency medical services for a particular geographic area. The Medical Control Authority shall operate in accordance with the terms and level of its designation within its medical control authority region.
(2) Level of designation shall be basic life support, limited advanced life support, or advanced life support. Basic designation includes medical first responder. Limited advanced life support designation includes medical first responder and basic life support. Advanced life support designation includes medical first responder, basic and limited life support.
(3) The department shall designate medical control authorities to cover a county or part of a county, except that the department may designate a medical control authority to cover 2 or more
counties if the department determines that the available resources would be better utilized under a multiple county medical control authority. In designating a medical control authority, the department shall assure that there is a reasonable relationship between the existing emergency medical services capacity in the geographical area to be served by the medical control authority and the estimated demand for emergency medical services in that area.
(4) A medical control authority shall be administered by the participating hospitals of the designated medical control authority region.
(5) Each hospital licensed under part 215 of the code that operates a service for treating emergency patients 24 hours a day, 7 days a week may participate and serve on the medical control authority board in the ongoing planning and development activities of the medical control authority designated by the department.
(6) Each freestanding surgical outpatient facility licensed under part 208 of the code that operates a service for treating emergency patients 24 hours a day, 7 days a week and meets standards established by the medical control authority may participate and serve on the medical control authority board in the ongoing planning and development activities of the medical control authority designated by the department. If a freestanding surgical outpatient facility participates in the medical control authority as described in this rule, the facility shall meet all applicable standards established by the medical control authority.
(7) Each hospital and freestanding surgical outpatient facility shall comply with protocols for providing services to a patient before care of the patient is transferred to hospital personnel.
R 325.22202 Medical control authorities; authority board; advisory body; medical director; responsibilities; approval.
(1) A medical control authority, as defined in the code, shall be approved by the department and do all of the following:
(a) Develop bylaws that define the medical control authority organizational structure.
(b) Appoint a medical control authority board, as defined in these rules, to administer the medical control authority. The majority of the board shall be comprised, at a minimum, of members of the hospitals and, when applicable, freestanding surgical outpatient facilities. The board may include representation of life support agencies.
(c) If the board also functions as the advisory body to the medical control authority as described in this rule, then the board shall include a representative of each type of life support agency and emergency medical services personnel functioning within the medical control authority’s region.
(d) Appoint an advisory body as defined in section 20918 (2) and (4) of the code. The advisory body shall meet at least quarterly.
(e) Appoint a medical director, with the advice of the advisory body, in accordance with section 20918 (3) of the code. The medical director is responsible for medical control for the emergency medical services system served by the medical control authority. The medical control authority, with the advice of the advisory body, may appoint more than 1 physician to serve as medical director provided the individual meets all applicable criteria, and is approved by the department.
(f) Appoint a professional standards review organization, as defined in these rules, for the purpose of improving the quality of medical care.
(g) Make each licensed life support agency and individual accountable to the medical control authority in the provision of emergency medical services, as defined in department-approved protocols.
(h) Establish written protocols for the practice of life support agencies and emergency medical services personnel. Protocols shall be provided to all affected life support agencies.
(i) Collect data as necessary to assess the quality and needs of emergency medical services throughout its medical control authority region.
(2) Each participating and nonparticipating hospital within a medical control authority region shall follow all standards, policies, procedures and protocols established by the medical control authority as approved by the department.
(3) Each medical control authority shall submit to the department current protocols for department review and approval. Department approval shall be on a 3-year cycle as defined by the department.
(4) The medical control authority shall notify the department ig a life support agency is consistently unable to provide at least 1 life support vehicle 24- hours-a-day, 7-days-a-week.
R 325.22203 Medical control authority; denial, revocation, or suspension of designation.
(1) The department may deny, revoke, limit, or suspend designation of a medical control authority upon finding that the medical control authority meets 1 or more of the following:
(a) Is guilty of fraud or deceit in securing its medical control designation.
(b) Has failed to perform in accordance with the terms of its designation and its department- approved protocols.
(c) Has not maintained minimum criteria for medical control authorities, as established by the department.
(d) Has failed to develop protocols as identified in the code to protect the public health.
(2) If the department denies, revokes, limits, or suspends a medical control authority designation, then the department shall designate a medical control authority to serve that medical control authority region.
(3) The department shall provide notice of intent to deny, revoke, limit or suspend medical control authority designation and shall provide for a hearing in accordance with the code and Chapter 4 of the Administrative Procedures Act of 1969 MCL 24.271 et seq. The hearing officer shall issue a determination that constitutes a final disposition of the proceedings to each party within 30 days after the conclusion of the haring. The determination of the hearings officer shall become the final agency order upon receipt by the parties.
R 325.22204 Medical control authority; advisory body.
A medical control authority shall appoint an advisory body as defined in section 20918 (2) and (4) of the code. The advisory body shall, at a minimum do all of the following:
(1) Advise the medical control authority on the appointment of a medical director.
(2) Advise the medical control authority on the development of protocols.
(3) Meet at least quarterly.
R 325.22205 Medical control authority; medical director; responsibilities.
(1) The medical director is an agent of the medical control authority and is responsible for medical control for the emergency medical services system.
(2) The medical director shall ensure the provision of medical control. The medical director’s signature on a life support agency’s application for licensure or relicensure affirms that the medical control authority intends to provide medical control to the life support agency. If the
medical director refuses to sign the life support agency application for licensure or relicensure, then the medical director shall notify the department in writing, within 5 business days, providing justification for denial. Refusal of a medical director to sign a life support agency application shall result in denial justification review by the department.
(3) The medical director shall do all of the following:
(a) Participate every 2 years in not less than 1 department-approved educational program relating to medical control issues.
(b) Be responsible for the supervision, coordination, implementation, and compliance with protocols of the medical control authority.
(c) Receive input from, and be responsive to, the advisory body.
(d) Complete, within 1 year of initial appointment, a medical director’s educational program provided by the department.
R 325.22206 Medical control authority; region.
(1) Not more than 1 medical control authority shall be approved in each designated region.
(2) A medical control authority shall obtain approval from the department to change or combine medical control authority regions, or to assume a temporary contractual responsibility for a portion of another medical control authority's region.
R 325.22207 Medical control authority; protocol development; promulgation of protocols; emergency protocol.
(1) Each medical control authority shall establish written protocols as defined in section 20919 of the code, which shall include, but not be limited to all of the following:
(a) The acts, tasks, or functions that may be performed by each level of emergency medical services personnel licensed under this part. Emergency medical services personnel shall not provide life support at a level that exceeds the life support agency license and approved medical control authority protocols.
(b) Procedures to assure that life support agencies are providing clinical competency assessments to emergency medical services personnel before the individual provides emergency medical services within the medical control authority region.
(c) Medical protocols to require the appropriate dispatching of a life support agency based upon medical need and the capability of the emergency medical services system.
(d) A do-not-resuscitate protocol consistent with section 20919(1)(c) of the code.
(e) Protocols defining the process, actions, and sanctions a medical control authority may use in holding a life support agency or personnel accountable. This shall include disciplinary action against a life support agency or emergency medical services personnel.
(f) Protocols defining the process to immediately remove medical control if the medical control authority determines that an immediate threat to the public health, safety or welfare exists. These protocols shall specify that a medical control authority has 3 business days to hold a hearing and make a determination.
(g) Protocols that ensure that if medical control has been removed or suspended from a participant within their medical control authority, then the participant shall not provide prehospital care until medical control is reinstated. If medical control is removed from a participant in the medical control authority, then the department and life support agency shall be notified within 1 business day of the removal.
(h) Protocols that ensure a quality improvement program is in place. The quality improvement program shall include a requirement that each life support agency collects and submits data to the medical control authority. Data shall be reviewed by the medical control authority professional standards review organization. Data shall be protected in accordance with section 20919(1) (g) of the code.
(i) Protocols that ensure an appeals process of a medical control decision is in effect.
(j) Protocols that delineate that if life support agencies routinely transport prehospital patients to hospitals outside of their originating medical control authority region, they will comply with their own medical control authority protocols.
(k) Written procedures for the security, control, dispensing, and exchange of pharmaceuticals, intravenous solutions, tubing, and related apparatus. Life support agency medication exchange shall only take place with a participating hospital or freestanding surgical outpatient facility.
(2) Each medical control authority shall develop standards for the withdrawal of a hospital or free standing surgical outpatient facility from a medical control authority or the restoration of a hospital or free standing surgical outpatient facility to a medical control authority.
(3) Each medical control authority shall develop specific protocols applicable to the acquisition, storage, and use of drugs, intravenous fluids and medical devices. All drug and intravenous fluids shall be under the control of a pharmacist licensed in this state affiliated with a participating medical control authority hospital or free standing surgical outpatient facility.
(4) Each medical control authority considering the adoption of protocols shall comply with section 20919 (3) (a) of the code.
(5) Each medical control authority may establish an emergency protocol necessary to preserve the health or safety of individuals within its region in response to a present medical emergency or disaster in accordance with section 20919 (3) (e) of the code. Emergency protocols developed in accordance with section 20919 (3) (e) of the code shall be submitted to the department, within 5 business days, for review and shall remain in effect for not more than 60 days unless approved by the department.
R 325.22208 Medical control authority protocols; department review; approval; adoption by medical control authority.
(1) A medical control authority shall circulate, at least 60 days before adoption, a draft of proposed protocols to all affected life support agencies within the emergency medical services system under the medical control authority.
(2) A medical control authority shall submit a written draft of proposed protocols to the department for review by the quality assurance task force not later than the tenth day of any given month. A protocol received not later than the tenth day of a given month will be reviewed that month. A protocol received after the tenth day of a given month will be reviewed the next month following the date of receipt by the department.
(3) The department shall consider any written comments received from persons within the medical control authority when reviewing a protocol.
(4) The department shall provide written recommendations to the medical control authority within 60 days of receipt of a protocol in compliance with this rule, and comments, suggested changes, deletions, denial, or approval on the proposed protocol. Protocols resubmitted with changes or modifications by the medical control authority fall under the 60-day response deadline as prescribed in this rule.
(5) Following department approval of a protocol, the medical control authority may formally adopt the protocol.
R 325.22209 Medical control authority; additional standards.
A medical control authority may adopt protocols that require additional or more stringent standards for life support agencies, equipment, and personnel than those already required by the department to enhance its system in the interest of prehospital emergency care. If a life support agency or emergency medical services personnel within the medical control authority disagree with the proposed protocol, then the medical control authority shall provide the department with the medical and economic considerations such enhancements may have on the local community. The quality assurance task force shall review and make recommendations to the department before department approval.
R 325.22210 Medical control authority; life support agencies and personnel; compliance with protocols.
(1) Each life support agency and emergency medical services personnel licensed under this part is accountable to the medical control authority in the provision of emergency medical services within the medical control authority region, as defined in department-approved protocols.
(2) A medical control authority shall establish written procedures defining the process, actions, and sanctions a medical control authority may use in holding a life support agency or personnel accountable. These procedures shall include disciplinary action against a life support agency or emergency medical services personnel to assure compliance with standards of medical care, protocols, and operational procedures or to protect the public health, safety, or welfare.
(3) A medical control authority may exercise disciplinary action against a life support agency and its emergency medical services personnel that may result in the life support agency or its personnel not being permitted to provide emergency medical services care. The basis for these actions shall be for noncompliance with policies, procedures, or protocols established by the medical control authority. Such disciplinary action may include the suspension, limitation, or removal of a life support agency or its personnel to provide emergency medical services within the medical control authority region.
(4) If disciplinary action against an agency or individual under subrule (1) of this rule results in the suspension, limitation, or removal of medical control, the medical control authority shall advise the department, in writing, of such action within 1 business day.
(5) If a suspension or removal of medical control to a life support agency or individual occurs by the medical control authority, the the life support agency or individual shall not operate or practice in that medical control authority region until medical control is restored by the medical control authority.
(6) If a suspension or removal of medical control to a life support agency or individual occurs, then the life support agency or individual may appeal the decision to the medical control authority. After appeals to the medical control authority have been exhausted, the life support agency or individual may appeal the medical control authority’s decision to the statewide emergency medical services coordination committee. An appeal to the emergency medical services coordination committee shall be filed with the department in writing not more than 30 calendar days following notification to the agency or individual of the final determination of the medical control authority.
(7) In cases of malfeasance, misfeasance, or nonfeasance on the part of the medical control authority, the department shall implement that preserve medical control in a medical control authority region.
R 325.22211 Medical control authority; quality improvement.
A medical control authority shall establish a quality improvement protocol to ensure a quality improvement program is in place and functional.
(1) Data submitted by the life support agencies within the medical control authority region shall be reviewed by the medical control authority professional standards review organization for the purpose of improving the quality of medical care within the medical control authority region.
(2) A quality improvement program shall comply with section 20919(1)(g) of the code.
R 325.22212 Medical control authority; appeals.
(1) A medical control authority shall incorporate procedures for the appeal of decisions made by the authority against a life support agency and emergency medical services personnel. Once appeals to the medical control authority have been exhausted, the decision made by the medical control authority may be appealed to the statewide emergency medical services coordination committee. An appeal to the emergency medical services coordination committee shall be filed with the department in writing not more than 30 calendar days following notification to the agency or individual of the final determination of the medical control authority. The emergency medical services coordination committee shall issue an opinion on whether the actions or decisions of the medical control authority are in accordance with the department-approved protocols of the medical control authority and the code.
(2) If a decision of the medical control authority is appealed to the emergency medical services coordination committee, then the medical control authority shall document their decision to the statewide emergency medical services coordination committee for their review.
(3) If the statewide emergency medical services coordination committee determines that the actions or decisions of the medical control authority are not in accordance with department- approved protocols or the code, then the emergency medical services coordination committee shall recommend to the department that it not take enforcement action under the code.
(4) If the statewide emergency medical services coordination committee determines that the actions or decisions of the medical control authority are in accordance with department approved protocols or the code, then the emergency medical services coordination committee shall recommend to the department that it take enforcement action a under the code.
R 325.22213 Medical control authority; data collection; data confidentiality.
(1) A medical control authority shall collect data under the department-approved quality improvement protocol from each life support agency within the medical control authority region. Data collected shall be reviewed by the medical control authority professional standards review organization to improve the quality of medical care within the medical control authority region and shall comply with section 20919(1)(g) of the code. All data collected under this section of the code are confidential, not public record, not discoverable, and shall not be used as evidence in a civil action or administrative proceeding.
(2) A medical control authority shall submit data to the department as prescribed by the department and approved by the emergency medical services coordination committee.
R 325.22214 Medical control authority; special studies.
(1) A medical control authority that intends to establish a protocol involving skills, techniques, procedures, or equipment that is not included in this state or national approved curriculum, but
are consistent with the emergency medical services personnel licensure is not a special study. This skill, technique, procedure, or equipment is not a special study if it complies with the following:
(a) Provide documentation that the skill, technique, procedure, or equipment complies with either of the following:
(i) Is recognized by a national organization as an acceptable guideline.
(ii) Published studies that support the safety and efficacy in their application within the emergency setting.
(b) Provide the educational outline that will be implemented to instruct the emergency medical services personnel in the new skill, technique, procedure, or equipment.
(2) A medical control authority that intends to establish a protocol involving skills, techniques, procedures, or equipment that is not included in this state or national approved curriculum, and is not consistent with its level of licensure shall require a special study and comply with all of the following:
(a) The department shall support the study.
(b) Submit endorsements by the medical control authority and medical director.
(c) Obtain and submit a hospital institutional review board approval. If a hospital does not have an institutional review board, then all of the following are acceptable alternatives:
(i) Hospital risk management or equivalent.
(ii) Hospital quality review committee or equivalent.
(iii) A clinical department involved with emergency medical services that has an ongoing quality review process.
(d) Submit a time line clarifying the duration of study. The timeline shall include the number of cases to reach conclusion of the study with an estimated date to reach requirement.
(e) Submit initial and refresher education requirements. Refresher education
requirements shall include frequency and content of refresher to maintain proficiency in skill, technique, procedure, or equipment. Education requirements shall include minimum proficiency requirements.
(f) 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.
(g) 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.
(h) Identify a special study coordinator.
(i) Identify data parameters to be collected and the quality review process that
shall be implemented. The medical control authority shall submit quarterly reports, and upon completion of a special study, submit a final report to the department.
(j) Submit protocols that shall be included in the special 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 or national approved curriculum, but is consistent with generally accepted practices at their level of licensure shall not require a special study. Those skills, techniques, procedures, or types of equipment shall not require a special study if it complies with all of the following:
(a) The department shall support the protocol.
(b) Submit endorsements by the medical control authority and medical director.
(c) Submit initial and refresher education requirements. Refresher education requirements shall include frequency and content of refresher to maintain proficiency in skill, technique, procedure, or equipment. Education requirements shall include minimum proficiency requirements.
(d) Identify life support agencies involved, their licensure level, the number of emergency medical services personnel to be trained, and their respective licensure levels.
(e) 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.
(f) Identify the quality review process that will be implemented.
(g) Submit protocols that will be included.
(4) A special study may be terminated by the department, with the advice of the emergency medical services coordination committee 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.
R 325.22215 Medical control authority; communication requirements.
(1) A medical control authority shall comply with the ambulance-to-hospital radio communications system approval process, as prescribed by the medcom requirements, under any of the following conditions:
(a) A medical control authority upgrades to provide limited advanced or advanced life support oversight.
(b) An existing medical control authority changes the infrastructure of its communication system affecting ambulance-to-hospital communications.
(c) A change is made in an existing communications system that results in the inability of an agency or hospital to communicate with each other.
(2) Each medical control authority shall designate an individual or organization to be responsible for maintaining records of the telecommunications activities in support of medical control. The records shall be in the form of electronic recordings and shall be kept for 60 days.
(3) The department may add additional frequencies or other methods of communications to the medcom requirements. The department, before implementation, shall approve new requirements and technologies for ambulance-to-hospital communication.
(4) A medical control authority shall comply with all of the following:
(a) Operate under a department-approved radio communications system plan applicable to each level of care proposed by each life support agency and its geographic service area. The plan shall be consistent with the medcom requirements, established by the department, for radio conservation, regional compatibility, channel utilization, and medical control.
(b) Utilize medcom channel assignments and operating procedures as established by the department under the code.
(c) Develop protocols to assure all components of the communications system comply with medcom requirements.
R 325.22216 Medical control authority; interface with public safety agencies; authority for management of patient.
A medical control authority shall establish protocols that do all of the following:
(a) Clarify the authority for the management of a patient in an emergency is vested in the licensed health professional or licensed emergency medical services personnel at the scene of the emergency who has the most training specific to the provision of emergency medical care.
(b) Identify when a life support agency is present at the scene of an emergency, authority for the management of an emergency patient in an emergency is vested in the physician responsible for medical control until that physician relinquishes management of the patient to a licensed physician at the scene of an emergency.
(c) Specify that the appropriate public safety agency shall manage the scene of an emergency.
(d) Specify if an emergency is declared, the declaration that an emergency no longer exists shall be made only by an individual licensed under the code or a health professional licensed under the code who has training specific to the provision of emergency medical services in accordance with department-approved protocols.
R 325.22218 Medical control authority; interfacility transfers.
(1) A medical control authority may adopt a protocol that governs the transport of a patient from
1 health facility to another. If a medical control authority has not established department- approved protocols for the interfacility transport of a patient, then patient care shall be determined according to written orders of the transferring physician within the scope of practice of the emergency medical services personnel.
(2) A life support agency shall be accountable as defined in these rules to a medical control authority in which it has been approved to operate.
