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Montana Administrative Register Notice 37-1017 No. 13   07/07/2023    
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BEFORE THE DEPARTMENT OF PUBLIC

HEALTH AND HUMAN SERVICES

OF THE STATE OF MONTANA

 

In the matter of the adoption of New Rules I through XIV and the repeal of ARM 37.104.101, 37.104.102, 37.104.105, 37.104.106, 37.104.107, 37.104.108, 37.104.109, 37.104.110, 37.104.111, 37.104.112, 37.104.114, 37.104.115, 37.104.120, 37.104.201, 37.104.202, 37.104.203, 37.104.204, 37.104.205, 37.104.206, 37.104.208, 37.104.212, 37.104.213, 37.104.218, 37.104.301, 37.104.305, 37.104.306, 37.104.307, 37.104.311, 37.104.312, 37.104.316, 37.104.319, 37.104.320, 37.104.321, 37.104.325, 37.104.326, 37.104.329, 37.104.330, 37.104.335, 37.104.336, 37.104.401, 37.104.404, 37.104.405, and 37.104.410 pertaining to emergency medical services

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NOTICE OF PUBLIC HEARING ON PROPOSED ADOPTION AND REPEAL

 

TO: All Concerned Persons

 

1.  On July 31, 2023, at 2:00 p.m., the Department of Public Health and Human Services will hold a public hearing via remote conferencing to consider the proposed adoption and repeal of the above-stated rules. Interested parties may access the remote conferencing platform in the following ways:

(a) Join Zoom Meeting at: https://mt-gov.zoom.us/j/84786068741?pwd=WlkvWC95VVZGbXhTOEdOTWxvOHdIdz09, meeting ID: 847 8606 8741, and password: 363007; or

(b) Dial by telephone: +1 646 558 8656, meeting ID: 847 8606 8741, and password: 363007. Find your local number: https://mt-gov.zoom.us/u/kuvJ8BAzj.

 

2. The Department of Public Health and Human Services will make reasonable accommodations for persons with disabilities who wish to participate in this rulemaking process or need an alternative accessible format of this notice. If you require an accommodation, contact the Department of Public Health and Human Services no later than 5:00 p.m. on July 17, 2023, to advise us of the nature of the accommodation that you need. Please contact Bailey Yuhas, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail [email protected].

 

3. The rules as proposed to be adopted provide as follows:

 

NEW RULE I  DEFINITIONS As used in this subchapter, the following definitions apply:

(1) "Accrediting body" means a national or international organization which:

(a) reviews the facilities, vehicles, equipment, and operations of an ambulance service;

(b) uses trained site-surveyors with experience in medical transport at the level of accreditation and license;

(c)  provides ambulance service accreditation for no more than three consecutive years without an updated inspection and reaccreditation;

(d) assures that ambulance services with identified deficiency standards will implement corrective action or improvement plans to correct any deficiencies; and

(e) provides transparency by making publicly available its standards, policies, procedures, and a list of accredited programs.

(2) "Advanced emergency medical technician" has the meaning provided for under 37-3-102, MCA.

(3) "Advanced life support (ALS)" means a level of care provided by an EMT with any endorsement issued by the board, an AEMT, or a paramedic.

(4) "Advanced life support (ALS) kit" means, at a minimum, the equipment and supplies set forth under Table 5 of the Emergency Medical Services Rule Appendix.

(5) "Advanced life support emergency medical service" means an ambulance service or nontransporting medical unit having capacity and licensed by the department to provide advanced life support 24 hours a day, seven days a week.

(6) "Advisory committee" means the advisory committee specified in 50-6-324, MCA.

(7) "Ambulance service" means an emergency medical service licensed by the department to utilize an ambulance for the transportation of patients.

(8) "Automated external defibrillator (AED)" has the meaning provided for under 50-6-501, MCA.

(9) "Basic life support (BLS)" means a basic life support level of care provided by an EMR or EMT that does not meet Advanced Life Support qualification.

(10) "Basic life support emergency medical service" means an ambulance service or nontransporting medical unit capable of providing care at the basic life support level and licensed as a provider under [NEW RULE VII]

(11) "Basic life support kit" means the equipment and supplies set forth under Table 4 of the Emergency Medical Services Rule Appendix.

(12) "Board" means the Montana Board of Medical Examiners administratively attached to the Department of Labor and Industry.

(13) "Emergency care provider (ECP)" has the meaning provided for under 37-3-102, MCA, and for the purposes of this chapter, includes registered nurses with supplemental training.

(14) "Emergency medical responder (EMR)" has the meaning provided for under 37-3-102, MCA.

(15) "Emergency medical service incident" means an instance in which an ambulance service or nontransporting medical unit is requested to provide services, including community integrated health or a mutual aid request, and with respect to which any of the following occur:

(a) a patient was assessed;

(b) medical care was rendered;

(c) a patient was transported;

(d) a patient was pronounced dead at the scene;

(e) a patient was transferred to another licensed service;

(f) a patient was transferred from one medical facility to another; or

(g) the person or persons for whom emergency medical service was dispatched refused treatment, transport, or both.

(16)  "Emergency Medical Services Rule Appendix" means the department's Emergency Medical Services Rule Appendix (Version 1.0), which sets forth operational requirements for Emergency Medical Service providers.  The department adopts and incorporates by reference the Appendix.  A copy of the Appendix is available electronically at https://dphhs.mt.gov/publichealth/EMSTS/ems/resources and may also be obtained from the Department of Public Health and Human Services, Public Health and Safety Division, Emergency Medical Services and Trauma Systems Section, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951.

(17) "Emergency medical technician (EMT)" has the meaning provided for under 37-3-102, MCA.

(a) An EMT is equivalent to the emergency medical technician-basic as required under 50-6-322, MCA.

(18) "FAA" means the Federal Aviation Administration.

(19) "Level of emergency medical service" means basic life support, basic life support with authorization for limited advanced life support, or advanced life support.

(20) "Montana ECP Practice Guidelines" means the board-approved guidelines in ARM 24.156.2701.

(21) "Montana EMS Registry" means the electronic repository of data submitted by Montana emergency medical service agencies that is administered by the department for quality improvement and public health reporting purposes.

(22) "Paramedic" has the meaning provided for under 37-3-102, MCA.

(23) "Patient care report" means an accurate and complete record of the response by an ambulance service or nontransporting medical unit to each emergency medical service incident.

(24) "Permit" means the sticker affixed to a ground ambulance or a certificate placed in an air or ground ambulance indicating the ambulance vehicle has met the requirements of these rules.

(25) "Provisional license" means a temporary emergency medical service license granted by the department that is valid for a maximum of 90 days.

(26) "RN with supplemental training" means a registered nurse who has completed the supplemental training required to work on an ambulance or nontransporting medical unit.

(27) "Safety and extrication equipment kit" means the equipment and supplies set forth under Table 6 of the Emergency Medical Services Rule Appendix.

(28) "Service manager" means the individual identified on the Emergency Medical Services license application as the service manager and who is responsible for ensuring service operations are conducted in compliance with all applicable statutory and regulatory requirements.

(29) "Service medical director" means a person who meets the requirements of a medical director as provided in ARM 24.156.2701 and provides offline medical direction for an emergency medical service pursuant to ARM 24.156.2732.

(30) "Stipulations" mean those conditions specified by the department at the time of licensing which must be met by the applicant in order to be licensed as an emergency medical service.

(31) "Supplemental training" means training for registered nurses approved by the service manager of an emergency medical service licensed at the basic life support level of service, or the service medical director for all other levels of service.

(a) The training must recognize the registered nurse's education and experience and result in emergency medical competency at the emergency medical service's license level.

(32) "Temporary permit" means a written, non-transferable authorization of limited duration indicating an ambulance vehicle may be used by a licensed ambulance service until a permit can be issued.

(33) "Transportation equipment kit" means the equipment and supplies set forth under Table 7 of the Emergency Medical Services Rule Appendix.

(34) "Type of emergency medical service" means either an air ambulance fixed wing, air ambulance rotor wing, ground ambulance, or nontransporting medical unit.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE II  EMS AGENCY SERVICE MANAGER DUTIES (1) The service manager of an emergency medical service must ensure:

(a) when the service is a BLS service, the care provided by ECP conforms to the general standard of care promulgated by the board;

(b) when the service is an ALS service, the service medical director fulfills the requirements of offline medical direction as defined in ARM 24.156.2732 and 50-6-302, MCA;

(c) the service is operated in a manner that does not threaten or endanger the public health, safety, or welfare;

(d) required basic life support, advanced life support, transportation equipment, and safety and extrication kits are available as described in Table 3 of the Emergency Medical Services Rule Appendix;

(e) service staffing meets minimum requirements set forth under [NEW RULE VI];

(f) the service meets communication, reporting, and sanitation requirements set forth under this subchapter;

(g) the service establishes written policies and procedures and maintains written documentation for the preventive maintenance of ambulances and emergency medical equipment;

(h) the service personnel are alert and capable during an emergency response;

(i) ambulance vehicles and all emergency medical services equipment are maintained in a safe and operating condition;

(j) all personnel functioning on the emergency medical service have documentation of appropriate licensure to function;

(k) service personnel use only that equipment and perform those skills for which they are trained, certified, or licensed and legally permitted to use or perform;

(l)  communication items set forth in Table 2 of the Emergency Medical Services Rule Appendix are always available.

(2) When functioning under the conditions defined in ARM 24.156.2771(7), a licensed service may use ECPs licensed in another state.

(3) All ambulances must have at least one of the required personnel attending the patient, and when providing care at an ALS level, the person licensed at the corresponding level must attend the patient.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE III  EMS AGENCY SERVICE MEDICAL DIRECTOR DUTIES 

(1) The service medical director must:

(a) perform all duties and responsibilities consistent with ARM 24.156.2732 and offline medical direction under 50-6-302, MCA;

(b) ensure that care provided by ECP staff conforms to the service's board-approved guidelines or the Montana ECP Practice Guidelines;

(c) ensure that the service is operated in a manner that does not threaten or endanger the public health, safety, or welfare; and

(d) ensure the minimum content requirements for the Advanced Life Support Kit are met and that the kit contains any additional supplies necessary to support the level of care and endorsements authorized by the service medical director consistent with board-approved service guidelines or the Montana ECP Practice Guidelines.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE IV  EMS AGENCY RECORDS AND REPORTS (1) Each emergency medical service must maintain a patient care record for every emergency medical service incident.

(a) In incidents where more than one patient is encountered, one patient care record shall be completed for each patient.

(b) In the event more than one emergency medical service arrives at the scene of an emergency medical service incident, each service having actual contact with a patient is responsible for completing a patient care record on the patient.

(2) Every ambulance service must electronically submit data to the department for each emergency medical service incident within 48 hours of the conclusion of the emergency medical service incident. The department may extend this timeframe in cases of unusual circumstances.

(3) Electronic data submitted to the department must be in the format prescribed by the National Emergency Medical Services Information System (NEMSIS) and include all NEMSIS state and national data elements. The department adopts and incorporates by reference the National Emergency Medical Services Information System (NEMSIS) Uniform Pre-Hospital Emergency Medical Services Dataset, Version 3.5.0 (March 17, 2023) published by the National Highway Traffic Safety Administration (NHTSA). A copy may be obtained at https://nemsis.org/media/nemsis_v3/release-3.5.0/DataDictionary/PDFHTML/EMSDEMSTATE/NEMSISDataDictionary.pdf or from the Department of Public Health and Human Services, Public Health and Safety Division, Emergency Medical Services and Trauma Systems Section, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951.

(a) For ambulance services directly using the reporting system provided by the department, the data is considered submitted to the department as soon as it has been entered or updated in the department-provided system.

(b) For ambulance services using third-party software, the data is considered submitted to the department as soon as it has been uploaded or updated into the department-provided system.

(4) Ambulance services are not required to submit other NEMSIS data elements but may do so. Non-transporting medical units are not required to submit NEMSIS data but may do so.

(5) Other software may be used to submit required data, but agencies must consult with the department before purchasing such software to ensure that the system is capable of submitting data to the Montana EMS Registry.

(6) Patient care reports may be reviewed by the department.

(7) Patient care reports must be maintained by the emergency medical service for a minimum of seven years.

(8) Immediately or as soon as possible upon arrival, but no later than 24 hours after the end of the patient transport, an ambulance service must provide a copy of the patient care report to the health care facility that receives the patient.

(a) If a completed patient care report cannot be left at the health care facility at the end of the patient transfer, an abbreviated patient encounter form containing information essential to continued patient care as set forth under Table 8 of the Emergency Medical Services Rule Appendix shall be provided until a patient care record can be provided to the health care facility.

(b) If an immediate response to another patient is required of an ambulance delivering a patient to a health care facility, a complete oral report on the patient being delivered must be given to the receiving health care facility until an abbreviated patient encounter form or patient care record can be provided.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE V  EMS AGENCY GENERAL SERVICE REQUIREMENTS 

(1) Except as otherwise specifically provided in this subchapter, no person may:

(a) advertise the provision of an emergency medical service without first having obtained a license from the department; or

(b) advertise, allow advertisement of, or otherwise imply provision of emergency medical services at a level of care higher than that for which the service is licensed.

(2) An emergency medical service must store, handle, and dispose of infectious waste in accordance with the Infectious Waste Management Act, 75-10-1001, et seq., MCA.

(3) Each emergency medical service must develop and adhere to a written sanitation policy that includes at least a method to dispose of contaminated materials meeting the requirements set forth in (2) and the following standards:

(a) Products used for cleaning must be EPA registered disinfectants.

(b) Disposable equipment must be disposed of after use.

(c) Any equipment that comes into contact with body fluids or secretions must be cleaned using an EPA registered disinfectant.

(d) Linens must be changed after each use.

(e) Oxygen humidifiers must be single service and disposable.

(f) Needles must not be recapped, bent, or broken, and must be disposed of in a container that provides protection to personnel from a needle puncture.

(4) The use of smoking and vaping products is prohibited in all ambulances.

(5) With the exception of a physician or the circumstances described in [NEW RULE X], individual personnel must not provide a level of care higher than the level and type for which the emergency medical service is licensed. The emergency medical service must be licensed or authorized to operate at the highest level it plans to allow individuals to provide care.

(6) Each emergency medical service approved for a BLS license with authorization for advanced life support or advanced life support level shall have a service medical director. The requirements and responsibilities of the service medical director are described in [NEW RULE III].

(7) An emergency medical service must have a two-way communication system that enables online medical direction.

(8) If a licensed ambulance service is not reasonably available, occasional and infrequent transportation by other means is permitted.

(9) In a disaster or major emergency when licensed ambulances are insufficient to render services required, non-licensed emergency medical services may be used.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE VI  EMS AGENCY MINIMUM STAFFING REQUIREMENTS 

(1) Except as provided in (a) through (d), ambulance services shall adhere to the minimum staffing requirements set forth in Table 1 of the Emergency Medical Services Rule Appendix when responding to a request for service that has not been medically triaged:

(a) An ambulance service medical director may authorize a process for medical evaluation of a patient and the use of a basic life support crew configuration if that configuration meets the clinical needs of the patient.

(b) During periods of extraordinary call volume, a service licensed at the advanced life support level of service may temporarily utilize a crew configuration equal to the minimum staffing standard for a service licensed at the basic life support level of service.

(c) During inter-facility transfers by air ambulance, the service medical director may alter the crew configuration to match the medical needs of the patient, so long as one of the personnel is an ECP, a physician, or a physician assistant.

(d) An air ambulance may transport a patient with only one ECP crew member in addition to the pilot when advisable for weather, weight, or other extenuating circumstances on a case-by-case basis.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE VII  EMS AGENCY LICENSE TYPES AND LEVELS (1) A license will be issued for, and authorize performance of, emergency medical services for the following types of service:

(a) air ambulance fixed wing;

(b) air ambulance rotor wing;

(c) ground ambulance; or

(d) nontransporting medical unit.

(2) A license will be issued for, and authorize performance of, emergency medical services for the following levels of service:

(a) basic life support;

(b) basic life support with authorization for limited advanced life support; or

(c) advanced life support.

(3) An emergency medical service that seeks to provide advanced life support but cannot reasonably provide it 24 hours per day, seven days per week, may request a basic life support license with authorization for limited advanced life support.

 

AUTH: 50-6-323, MCA

IMP: 50-6-306, 50-6-323, MCA

 

NEW RULE VIII  EMS AGENCY LICENSE APPLICATION REQUIREMENTS 

(1) Applications for licensing and renewal of licensing must be made using department-approved electronic forms. Except as provided under (10), the term of an EMS license is two years. Applications must be accompanied by the license fee and proof of current single occurrence malpractice insurance and liability insurance coverage. Copies of the accrediting body certifications must be included if the application is for renewal of a license and the service is accredited by an accrediting body without variance or limitations. The application, license fee, and all required supporting documents must be received by the department not less than 30 days prior to the commencement of a new emergency medical service or 15 days prior to the expiration of the license, in the case of an application for renewal.

(2) An application for a ground ambulance service license, including for renewal of a license, must include documentation of current single occurrence automobile vehicle liability insurance coverage, unless exempt under 61-6-303, MCA.

(3) An application for an air ambulance service, including the renewal of a license, must include documentation of current and unrestricted FAA air medical ambulance certification and an attestation that the operations comply with FAA Regulations at 14 CFR Part 135 and related circulars in effect as of the date of application. If the applicant intends to provide rotor wing service, the applicant must also submit an attestation that the operations comply with FAA regulations at 14 CFR Part 135, Subpart L, and related circulars in effect as of the date of the application. The same documentation and attestation requirements also apply to contractor operations if the applicant contracts for service with another provider.

(4) Within 30 working days after an emergency medical service application has been initiated, the emergency medical service's manager must complete the required fields in the department's licensing management system.

(5) Within 30 days from receipt of an emergency medical service license application or, if the department requests additional information about the application, within 30 days from receipt of that information, the department shall:

(a) issue the license;

(b) issue the license with stipulations;

(c) issue a provisional license; or

(d) deny the license.

(6) The department may deny an emergency medical service license if:

(a) the application does not provide all of the requested information; or

(b) there is evidence that the applicant is not complying with these rules.

(7) If the department does not take action on the application within 30 days after its receipt, the emergency medical services license must be issued unless the applicant is known to be in violation of these rules.

(8) Except as provided under (9), the department shall inspect each emergency medical service prior to issuing a license. If an inspection cannot be conducted, the department may issue a provisional license until an inspection can be completed.

(9) An ambulance service renewing its service license at the same level of service that holds valid and current accreditation without variance or limitations from an accrediting body is exempt from vehicle, equipment, and operation inspections. The ambulance service must still request, pay for, and display state-issued permits for each ambulance.

(10) To establish staggered terms of licensing:

(a) when the department receives a completed license application for a new emergency medical service, it will assign that service a number; and

(b) if the department grants the license:

(i) an odd-numbered service will be issued a license expiring December 31 of the year in which it was issued; and

(ii) an even-numbered service will be issued a license expiring December 31 of the year following the year in which it was issued.

(11) The service license must be updated within ten days when any information contained in the service license application changes.

(12) If an emergency medical service from another state identifies Montana as part of its service area, and if it regularly provides an initial emergency medical services response into Montana, the emergency medical service must obtain a Montana emergency medical services license as provided by these rules, unless the other state's licensing standards are substantially comparable to those of Montana, in which case the department may license these services through a reciprocal agreement with the other state.

(13) An emergency medical service responding into Montana to transfer patients from a Montana medical facility to a non-Montana medical facility is not required to obtain a Montana license if it is licensed in its state of origin.

 

AUTH: 50-6-323, MCA

IMP: 50-6-306, 50-6-323, MCA

 

NEW RULE IX  NONTRANSPORTING MEDICAL UNIT SERVICE REQUIREMENTS  (1) A nontransporting medical unit must have an agreement with a licensed ambulance service to ensure continuity of care and adequate transportation for its patients. An ambulance service is not required to approve of, or enter into an agreement with, a nontransporting medical unit.

(2) A law enforcement agency, fire department, search and rescue unit, ski patrol, or mine rescue unit which does not hold itself out as a provider of emergency medical care to the public and does not routinely offer to provide services to the general public beyond the boundaries of a single recreational site, work site, school, or other facility shall not be considered a nontransporting medical unit solely because members of the unit provide medical care at the scene of a medical emergency to which they were dispatched for other purposes.

(3) A nontransporting medical unit must:

(a) ensure that patients are transported by a licensed ambulance service, unless a licensed service is not reasonably available;

(b) ensure either that the patient is transported by an ambulance service licensed to provide at least the same level of patient care commenced by the nontransporting medical unit or that the ambulance service carries the personnel and equipment of the nontransporting medical unit with the patient to the hospital if a level of care has commenced which the ambulance service cannot legally continue; and

(c) have a written dispatch policy and procedure coordinated with a licensed ambulance service.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE X  GROUND AMBULANCE SERVICE REQUIREMENTS

(1) The interior of an ambulance, including all storage areas, must be kept clean and free from dirt, grease, and other contaminants.

(2) Persons utilized as drivers of ambulances must have a valid driver's license and have completed the service's vehicle operations training.

(3) If an ambulance service publicly advertises a telephone number to receive calls for emergency assistance, that telephone number must be answered 24 hours a day, seven days per week.

(4) An ambulance service may transport patients who are receiving care at a higher level than the level for which the service is licensed if:

(a) the higher level of care is initiated by a licensed emergency medical service authorized to perform that level of care; and

(b) the personnel and the equipment of the emergency medical services licensed at the higher level accompany the patient in the ambulance.

(5) An ambulance service may perform inter-facility (including between a physician's office and hospital) transfers at a higher level of care than the level to which the service is licensed if personnel trained and legally authorized to provide the higher level of care, as well as appropriate equipment, accompany the patient in the ambulance to ensure continuity of patient care.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE XI  GROUND AMBULANCE SPECIFICATIONS  (1) All ground ambulances must have or meet the following specifications:

(a) the word "ambulance" must be affixed in mirror image in reflectorized lettering at least four inches tall, centered above the grill on the front of the vehicle; and

(b) the word "ambulance" must be affixed to the rear of the vehicle in reflectorized lettering at least four inches tall.

(2) The required markings may not appear on nonlicensed ambulances, with the exception of those ambulances temporarily in transit within the state.

(3) All oxygen cylinders must be secured so that they will not roll, tip over, or become projectiles in the event of a sudden vehicular maneuver.

(4) All ground ambulances must meet the requirements set forth under Table 9 of the Emergency Medical Services Rule Appendix.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE XII  AMBULANCE PERMITS (1) Except as provided in (7), no ambulance may be utilized by an ambulance service until the department has found it is, at the time of inspection, in compliance with these rules and issued a permit to the ambulance service for the ambulance.  The department may issue a temporary permit, by mail or otherwise, until an inspection can be completed.

(2) Effective [18 months from the date of publication of the adoption notice], all ground ambulances, including remounts, that have not previously been permitted by the department must meet ambulance design criteria from:

(a) The Commission on Accreditation of Ambulance Services Ground Vehicle Standard for Ambulances (GVS), Version 3.0, effective July 1, 2022; or

(b) The National Fire Protection Association (NFPA) 1917 Standard for Automotive Ambulances - 2019 Edition.

(3) Vehicles that do not meet these standards may be permitted by the department if the ambulance service can demonstrate that the vehicle meets substantially similar standards in effect on the year of the vehicle's manufacture.

(4) A decal or letter of verification from the manufacturer certifying that the vehicle meets the standard shall be made available upon inspection.

(5) The department adopts and incorporates by reference the GVS Version 3.0 and the NFPA 1917 Standard for Automotive Ambulances 2019 Edition. The GVS Version 3.0 is available at https://www.groundvehiclestandard.org/. The NFPA 2019 Edition is available at https://www.nfpa.org/.  Copies of each standard are available for review by contacting the Department of Public Health and Human Services, Public Health and Safety, Division, Emergency Medical Services and Trauma Systems Section, 1400 Broadway, P.O. Box 202951, Helena, MT 59620-2951.

(6) Any ambulance that has a salvage title must undergo an inspection pursuant to 49 CFR 396.17 before the vehicle may be permitted or returned to service.

(7) If an ambulance service has current accreditation without variance or limitations from an accrediting body, inspection of ambulances may be waived; however, the ambulance service must submit current accreditation documentation and attest that each ambulance is compliant with the ambulance specifications. Accredited ambulance services must request, pay for, and display state-issued permits for each ambulance.

(8) The ambulance permit must be displayed either on or in the ambulance as the department directs.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE XIII  GROUND AND AIR AMBULANCE INSPECTIONS 

(1) Each ambulance must be inspected every 24 months unless:

(a) the ambulance service has current and valid ambulance accreditation without variance or limitations from an accrediting body and provides the department with documentation of current accreditation; or

(b) the ambulance service has current and valid documentation that the vehicle has passed an inspection within the past 12 months pursuant to 49 CFR 396.17.

(2) Ground ambulance service providers must comply with applicable motor vehicle laws under Title 61, MCA.

(3) The inspector will provide a written or electronic inspection record for each vehicle upon completion of a ground ambulance inspection.

(4) If the inspector identifies and lists a minor defect in the ground ambulance inspection report, the inspector will issue a permit. The ambulance service manager has 180 days to repair the defect and notify the department that the repair has been accomplished.

(5) If the inspector identifies and lists a major defect in the ground ambulance inspection report, a vehicle permit will be issued only after the ambulance service manager notifies the inspector that the major defect has been repaired.

(6) Major and minor defects for ground ambulances are described under Table 10 of the Emergency Medical Services Rule Appendix.

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

NEW RULE XIV ADVISORY COMMITTEE (1) The purpose of the advisory committee is to advise the department consistent with 50-6-323, MCA, on matters including:

(a)  the equipment and materials required for an emergency medical service;

(b)  the data to be collected and submitted to the department;

(c)  the information contained in an abbreviated patient encounter form submitted to a hospital; and

(d)  in consultation with the Department of Labor and Industry or the board, patient care standards and guidelines.

(2) The membership of the advisory committee consists of 17 individuals appointed by the department director, taking into consideration the geography and demography of Montana, as follows:

(a) an emergency medical services fellowship trained or national board-certified emergency medical services physician who will serve as chair;

(b) two service medical directors, one of whom is employed by an emergency medical service serving a population greater than 20,000 persons;

(c) a representative from the Department of Labor and Industry;

(d) a representative from the department's Emergency Medical Services for Children Committee;

(e) a representative from the department's State Trauma Advisory Council;

(f) a service manager from a government-owned ground ambulance service;

(g) a service manager from a privately owned ground ambulance service;

(h) a service manager from a hospital-owned ground ambulance service;

(i) a service manager from a not-for-profit ground ambulance service;

(j) an ECP service manager of a nontransporting medical unit;

(k) an ECP service manager of an air ambulance;

(l) an ECP from a tribal emergency medical service provider;

(m) an RN with supplemental training that is on an emergency medical service roster;

(n) a sworn officer representative from a law enforcement agency;

(o) a representative of a 9-1-1 dispatch organization who is trained in emergency medical dispatch; and

(p) a member of the public not affiliated with the emergency medical service system.

(3) Individuals who are interested in serving on the advisory committee must submit to the department an application that is available on the department's web site along with a resume and letter of interest.

(4) The membership term is three years with the initial terms of membership randomly assigned for the purpose of ensuring staggered terms. Members of the advisory committee may seek reappointment to serve additional terms.

(5) The advisory committee will meet publicly at least twice each year and will conduct its business in person or, when appropriate, by electronic means.

 

AUTH: 50-6-323, MCA

IMP: 50-6-324, MCA

 

4. The department proposes to repeal the following rules:

 

37.104.101 DEFINITIONS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.102 PERSONNEL: AEMT GROUND AMBULANCE SERVICE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.105 LICENSE TYPES AND LEVELS

 

AUTH: 50-6-323, MCA

IMP: 50-6-306, 50-6-323, MCA

 

37.104.106 LICENSE APPLICATION REQUIREMENTS

 

AUTH: 50-6-323, MCA

IMP: 50-6-306, 50-6-313, 50-6-323, MCA

 

37.104.107 WAIVERS

 

AUTH: 50-6-323, MCA

IMP: 50-6-325, MCA

 

37.104.108 ADVERTISING RESTRICTIONS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.109 BASIC LIFE SUPPORT SERVICE LICENSING

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.110 SERVICE OPERATION

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.111 NONTRANSPORTING MEDICAL UNIT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.112 STANDARD OF CARE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.114  LICENSE RENEWALS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.115 APPEAL FROM ORDER

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, 50-6-327, MCA

 

37.104.120 ADVISORY COMMITTEE

 

AUTH: 50-6-323, MCA

IMP: 50-6-324, MCA

 

37.104.201 COMMUNICATIONS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.202 SAFETY: GENERAL REQUIREMENTS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.203 EQUIPMENT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.204 BASIC EQUIPMENT KIT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.205 SAFETY AND EXTRICATION KIT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.206 TRANSPORTATION EQUIPMENT KIT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.208 SANITATION

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.212 RECORDS AND REPORTS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.213 PERSONNEL REQUIREMENTS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.218 OFFLINE AND ONLINE MEDICAL DIRECTION

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.301 AMBULANCE PERMITS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.305 AMBULANCE SPECIFICATIONS: GENERAL

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.306 AMBULANCE SPECIFICATIONS: GROUND AMBULANCES

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.307 AMBULANCE SPECIFICATIONS: AIR AMBULANCE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.311 SAFETY: GROUND AMBULANCE SERVICES

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.312 SAFETY: AIR AMBULANCE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.316 PERSONNEL REQUIREMENTS: BASIC LIFE SUPPORT GROUND AMBULANCE SERVICE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.319 PERSONNEL: ADVANCED LIFE SUPPORT GROUND AMBULANCE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.320 AUTHORIZATION

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.321 PERSONNEL: AEMT LIFE SUPPORT AIR AMBULANCE SERVICE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.325 PERSONNEL: AIR AMBULANCE, GENERAL

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.326 PERSONNEL: BASIC LIFE SUPPORT AIR AMBULANCE SERVICE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.329 PERSONNEL: ADVANCED LIFE SUPPORT AIR AMBULANCE SERVICE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.330 ECP LEVEL OF CARE LIMITATIONS

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.335 OTHER REQUIREMENTS: AMBULANCE SERVICES

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.336 OTHER REQUIREMENTS: AIR AMBULANCE SERVICE

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.401 PERSONNEL: BASIC LIFE SUPPORT NONTRANSPORTING UNIT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.404 PERSONNEL: ADVANCED LIFE SUPPORT NONTRANSPORTING UNIT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.405 PERSONNEL: AEMT LIFE SUPPORT NONTRANSPORTING UNIT

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

37.104.410 OTHER REQUIREMENTS: NONTRANSPORTING SERVICES

 

AUTH: 50-6-323, MCA

IMP: 50-6-323, MCA

 

5. STATEMENT OF REASONABLE NECESSITY

 

The Department of Public Health and Human Services (department) proposes this rulemaking to update, consolidate, simplify, and make more user friendly the administrative rules governing licensure of emergency medical service providers.

 

There are currently 43 administrative rules governing emergency medical service providers.  These rules are contained in ARM Title 37, chapter 104, subchapters 1 through 4.  Many of these rules have not been updated in over 20 years and no longer reflect industry best practices and/or federal standards.  The department has reviewed and applied the Regulatory Reform Initiative criteria to the rules by assessing if each rule serves a legitimate purpose, is not redundant, creates the lowest burden possible to meet the identified need, and is clear in language and intent.

 

The department is proposing to repeal each of the current rules and to adopt New Rules I through XIV in their place.  Many of the new rules consolidate and incorporate existing requirements from the current rules. The department is also proposing to update the rules to:

 

  • clarify the role and composition of the Advisory Committee established under 50-6-324, MCA;

  • clarify which ECP personnel are considered advanced life support personnel and remove inconsistent Advanced Life Support and Advanced Life Support Emergency Medical Service definitional language;

  • clarify industry and department requirements for ambulance vehicle standards, including professional and liability insurance;

  • eliminate redundant air ambulance regulatory requirements that are covered under the Federal Aviation Administration's oversight responsibilities;

  • revise ambulance permitting requirements and establish ambulance criteria consistent with nationally recognized ambulance design criteria while allowing exceptions for vehicles currently permitted; and

  • incorporate by reference a newly created Emergency Medical Services Rule Appendix.

     

Technical, stylistic, and nonsubstantive updates are also proposed to make the rules clearer and more user friendly.

 

The proposed rulemaking decreases unnecessary regulatory barriers, maintains requirements necessary for the safe operation of emergency medical services, and incorporates stakeholder feedback expressing the need for increased regulatory clarity and consistency.

 

Between January and June of 2022, the department's EMS and Trauma System Section staff met monthly with a stakeholder working group to review existing rule language and identify needed changes. Between each monthly meeting, the EMS and Trauma System Section staff prepared an updated version of the rule language based upon stakeholder recommendations. Each meeting began with a review of the changes suggested during the previous meeting in an effort to achieve consensus on the proposed rule changes. This iterative process was used throughout the six months of meetings.

 

Stakeholders represented in these meetings included members of the Advisory Committee, air medical ambulance services, public, private and hospital-based ambulance services, the Montana Fire Chief's Association, the Montana Hospital Association, and the Montana Department of Labor and Industry.

 

NEW RULE I  DEFINITIONS

The department proposes to adopt a new definitions rule to clarify the meaning of terms used throughout the rules and to provide for a better understanding of the rules. The new rule incorporates much of the existing language from the current definitions rule under ARM 37.104.101. New definitions have been added to align with updates being made to the other rules.

 

The department also proposes creation of an Emergency Medical Services Rule Appendix to be adopted and incorporated by reference under the rule. The appendix sets forth, in a clear and concise manner, basic requirements for EMS providers including minimum staffing levels, required equipment, and minimum ambulance specifications. A copy of the proposed appendix is electronically accessible at: https://dphhs.mt.gov/publichealth/EMSTS/ems/resources.

 

NEW RULE II EMS AGENCY SERVICE MANAGER DUTIES

The department proposes this rule to clarify the duties and responsibilities of the EMS service manager. This rule consolidates requirements from several of the current rules for which there was no assigned responsible party and assigns them to, and establishes in a single rule the duties and responsibilities of, the service manager. The rule also addresses stakeholder concerns regarding the existing rules and their lack of adequate guidance for service managers. Additionally, the new rule more clearly sets forth required communication tools and equipment kits for ambulance services. The required communication tools are listed in Table 2 of the Emergency Medical Services Rule Appendix. The required EMS equipment kits are listed in Table 3 of the Emergency Medical Services Rule Appendix. The department has also made updates to the required equipment kit lists to reflect industry best practices and nationally recognized standards.

 

NEW RULE III EMS AGENCY SERVICE MEDICAL DIRECTOR DUTIES

The department proposes this rule to clarify the duties and responsibilities of the EMS medical director.  This rule consolidates clinical and medical oversight components from several of the current rules for which there was no assigned responsible party and assigns them to, and establishes into a single rule the duties and responsibilities of, the service medical director.

 

NEW RULE IV EMS AGENCY RECORDS AND REPORTS

The department is proposing this rule to specify records and reports ambulance service providers must maintain and/or submit to the department. This rule replaces ARM 37.104.212.  The new rule reduces the length of time an ambulance service has before a medical report must be submitted from 3 months to 48 hours. An exemption is provided for services that are unable to meet the requirement due to extenuating circumstances. These changes reflect contemporary industry standards for most emergency medical services in Montana in that over 70% of the reports are currently submitted within 24 hours of a service request. The rule also clarifies the party responsible for identifying essential patient care information that must be shared with hospital staff when a patient is delivered to a hospital.

 

NEW RULE V EMS AGENCY GENERAL SERVICE REQUIREMENTS

The department proposes this rule to consolidate into a single rule the general requirements applicable to all EMS service types.  These requirements are currently scattered throughout the EMS rules.  Consolidating these requirements into a single rule will increase the clarity and user-friendliness of the rules.

 

NEW RULE VI EMS AGENCY MINIMUM STAFFING REQUIREMENTS

The department proposes this rule to consolidate current rules pertaining to staffing of EMS services into a single rule. The new rule changes the minimum staffing requirement for air ambulances by requiring a second ECP crew member in most circumstances. This proposed change aligns with contemporary industry standards in Montana. The minimum staffing requirements are set forth in Table 1 of the Emergency Medical Services Rule Appendix.

 

NEW RULE VII EMS AGENCY LICENSE TYPES AND LEVELS

The department proposes this rule to set forth the type and level of available EMS agency licenses. The rule replaces ARM 37.104.105. The rule also includes removal of the AEMT license level previously identified in rule. The AEMT license level is no longer needed because the updated definition of the Advanced Life Support license level encompasses the AEMT license level.

 

NEW RULE VIII EMS AGENCY LICENSE APPLICATION REQUIREMENTS

The department is proposing this rule to set forth license application requirements for EMS providers. The rule replaces ARM 37.104.106. As compared to the current rule, this rule reduces licensing requirements for EMS services holding national accreditation. The rule adds the requirement for EMS providers to possess vehicle and professional liability insurance. This change reflects contemporary industry standards in Montana. The rule also requires air ambulance services to submit appropriate FAA documentation, which in turn eliminates the need for several existing air ambulance rules proposed for repeal in this rulemaking.

 

NEW RULE IX NONTRANSPORTING MEDICAL UNIT SERVICE REQUIREMENTS

The department is proposing this rule to clearly and concisely set forth requirements applicable to nontransporting medical units. The new rule consolidates requirements contained in several of the current rules, including ARM 37.104.111 and 37.104.410.

 

NEW RULE X GROUND AMBULANCE SERVICE REQUIREMENTS

The department is proposing this rule to clearly and concisely set forth requirements applicable to ground ambulance services. The new rule consolidates requirements contained in several of the current rules, including ARM 37.104.316 and 37.104.335.

 

NEW RULE XI GROUND AMBULANCE SPECIFICATIONS  

The department is proposing this rule to set forth required specifications for ground ambulances. The rule incorporates requirements from ARM 37.104.305 and 37.104.306.

 

NEW RULE XII AMBULANCE PERMITS

The department is proposing this rule to more clearly set forth permitting requirements for ambulances. This rule replaces ARM 37.104.301, which requires permitting of ambulances but lacks specific permitting criteria. The proposed new rule sets forth permitting criteria ambulances must meet based upon nationally recognized ambulance design criteria. The rule grandfathers existing, permitted ambulances and reduces permitting inspection requirements for services holding national accreditation.

 

NEW RULE XIII GROUND AND AIR AMBULANCE INSPECTIONS

The department is proposing this rule to clarify inspection procedures for ambulances and to establish a comprehensive list of inspection criteria. The rule establishes and identifies minor and major defect categories for ambulances. These defect categories are set forth in Table 10 of the Emergency Medical Services Rule Appendix and are designed to ensure that ground ambulances are operated in a safe working manner. The rule removes inspection requirements for ambulance services holding national accreditation and for ambulance services that document inspections pursuant to Federal Motor Carrier Safety Regulations under 49 CFR 396.17.

 

NEW RULE XIV ADVISORY COMMITTEE

The department is proposing this rule to clarify the role and composition of the Advisory Committee established under 50-6-324, MCA. The rule replaces ARM 37.104.120.

 

RULES REPEALED

The department is proposing to repeal ARM 37.104.101 through 37.104.410 based upon the proposed adoption of New Rules I through XIV and to allow for re-organization of the emergency medical service provider rules into a single subchapter.

 

Fiscal Impact

 

There is no anticipated fiscal impact associated with this rulemaking.

 

6. Concerned persons may submit their data, views, or arguments either orally or in writing at the hearing. Written data, views, or arguments may also be submitted to: Bailey Yuhas, Department of Public Health and Human Services, Office of Legal Affairs, P.O. Box 4210, Helena, Montana, 59604-4210; telephone (406) 444-4094; fax (406) 444-9744; or e-mail [email protected], and must be received no later than 5:00 p.m., August 4, 2023.

 

7. The Office of Legal Affairs, Department of Public Health and Human Services, has been designated to preside over and conduct this hearing.

 

8. The department maintains a list of interested persons who wish to receive notices of rulemaking actions proposed by this agency.  Persons who wish to have their name added to the list shall make a written request that includes the name, e-mail, and mailing address of the person to receive notices and specifies for which program the person wishes to receive notices. Notices will be sent by e-mail unless a mailing preference is noted in the request. Such written request may be mailed or delivered to the contact person in 6 above.

 

9. An electronic copy of this notice is available on the department's web site at https://dphhs.mt.gov/LegalResources/administrativerules, or through the Secretary of State's web site at http://sosmt.gov/ARM/register.

 

10. The bill sponsor contact requirements of 2-4-302, MCA, do not apply.

 

11. With regard to the requirements of 2-4-111, MCA, the department has determined that the adoption and repeal of the above-referenced rules will not significantly and directly impact small businesses.

 

 

/s/ Robert Lishman                                      /s/ Charles T. Brereton                   

Robert Lishman                                           Charles T. Brereton, Director

Rule Reviewer                                              Department of Public Health and Human Services

 

 

Certified to the Secretary of State June 27, 2023.

 
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