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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 ARM 37.104.509.

(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;

(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 list of suggested training is set forth in Table 11 of the Emergency Medical Services Rule Appendix.

(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.

(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;

(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 ARM 37.104.508;

(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.

(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.

(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.

(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 ARM 37.104.514, 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 ARM 37.104.505.

(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.

(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.

(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;

(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

(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.

(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;

(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.

(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

(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.

(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.

(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 March 8, 2025, 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.

(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.

(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;

(d) in consultation with the Department of Labor and Industry or the board, patient care standards and guidelines and guidance on supplemental training for registered nurses.

(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;

(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.

The following definitions apply to this chapter, in addition to the definitions contained in 50-6-501, MCA:

(1) "Automated external defibrillators (AED) training program" means a course of instruction approved by the department which provides the initial education in the use of the AED and CPR.

(2) "CPR" means cardiopulmonary resuscitation.

(3) "Entity manager" means the individual responsible for maintaining the automated external defibrillator (AED) according to manufacturer recommendations, registering the device with the state electronic registration site, recording all upkeep/maintenance and training information, and reporting all uses/incidents.

(1) An entity wishing to use or allow the use of an AED shall register the AED with the department using the electronic registration site. Registration includes the following information:

(a) for a stationary location, the physical address where the AED will be located;

(b) for a mobile location, the geographic area in which the AED will be used;

(d) assurances the AED use will be coordinated with each licensed emergency medical service providing coverage in the area where the AED is located, including how emergency medical services will be activated every time that an AED is attached to a patient;

(e) the maintenance procedures for the AED, including how it will be maintained, tested, and operated according to the manufacturer's guidelines;

(f) assurances that written or electronic records of all maintenance and testing performed on the AED will be kept; and

(g) assurances that the required electronic reports of AED use will be made to the department.

(1) Prior to allowing any use of an AED, an entity must provide the following, in addition to a copy of the plan required by ARM 37.104.604, to each licensed emergency medical service and public safety answering point or emergency dispatch center in the area where the AED is located:

(a) a written notice, on a form provided by the department, that includes the following information:

(i) the name of the entity that is establishing the AED program;

(ii) the business address and telephone number, including physical location, of the entity;

(iii) the name, telephone number and address of the individual who is responsible for the onsite management of the AED program;

(iv) the starting date of the AED program; and

(v) where the AED is physically located.

(1) Every time an AED is attached to a patient, the entity manager shall provide to the department, the following information through the electronic portal:

(a) the name of the entity responsible for the AED;

(b) the date of the call;

(d) the gender of the patient;

(e) location of the cardiac arrest;

(f) estimated time of the cardiac arrest;

(g) whether or not CPR was initiated prior to the application of the AED;

(h) whether or not the cardiac arrest was witnessed;

(i) the time the first shock was delivered to the patient;

(j) the total number of shocks delivered;

(k) whether or not there was a pulse after the shocks and whether or not the pulse was sustained; and

(l) whether or not the patient was transported, and if so, the name of the transporting agency and the location to which the patient was transported.

(1) In order to be authorized by an AED program plan to use an AED, an individual must:

(a) complete a cardiopulmonary resuscitation and AED training program that meets the standards of the American Heart Association and must renew this training at intervals not to exceed two years.

(1) A medical protocol for defibrillation use must be consistent with the requirements for defibrillation set out in the "2015 AHA Guidelines Update for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC) Science" published in "Circulation," a journal of the American Heart Association, November 3, 2015, Volume 132, Issue 18 Supplement 2 and in the 2015 American Heart Association Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiovascular Care (ECC).

(2) The department adopts and incorporates by reference the guidelines for defibrillation referred to in (1), which set guidelines for proper defibrillation. A copy of the documents referred to in (1) may be obtained from the American Heart Association at https://www.ahajournals.org/toc/circ/132/18_suppl_2.

(1) An AED used by an AED program must be a unit approved by the U.S. Food and Drug Administration in accordance with its Final Order established Feb 2015.

(2) A copy of the Final Order referred to in (1) may be obtained from the U.S. Food and Drug Administration: https://www.federalregister.gov/documents/2015/02/03/2015-02049/effective-date-of-requirement-for-premarket-approval-for-automated-external-defibrillator-systems.

(1) The following infectious diseases are designated as having the potential of being transmitted to emergency services providers through an exposure described in ARM 37.104.804:

(a) human immunodeficiency virus infection (AIDS or HIV infection);

(b) hepatitis B;

(d) hepatitis D;

(e) communicable pulmonary tuberculosis;

(f) meningococcal meningitis; and

(g) any disease attributed to a specific bacterial, parasitic, or other agent recognized by "The Control of Communicable Diseases Manual" as transmittable person to person by any of the exposures listed in ARM 37.104.804.

(2) For purposes of the reporting requirements of 50-16-702 (2), MCA, communicable pulmonary tuberculosis and meningococcal meningitis are considered airborne infectious diseases.

(3) For the purpose of (1)(g) above, the department hereby adopts and incorporates by reference the "The Control of Communicable Diseases Manual" published by American Public Health Association, 16th edition, 1995, which contains a list of transmission and control measures for communicable diseases. A copy of the manual may be obtained from the American Public Health Association, 1015 15th Street NW, Washington, DC 20005.

(1) The types of exposures that a designated officer shall report to a health care facility upon the request of an emergency services provider are:

(a) any person to person contact in which a co-mingling of respiratory secretion (saliva and sputum) of the patient and the emergency services provider may have taken place;

(b) transmittal of the blood or bloody body fluids of the patient onto the mucous membranes of the emergency services provider (mouth, nose, eyes) and/or into breaks in the skin of the emergency services provider;

(c) transmittal of other body fluids (semen, vaginal secretion, amniotic fluid, feces, wound drainage, or cerebral spinal fluid) onto the mucous membranes of the emergency services provider;

(d) any non-barrier protected contact of the emergency services provider with the mucous membranes or non-intact skin of the patient.

(1) A report of exposure must be filed with the health care facility by the designated officer on a form developed and approved by the department, entitled "Report of Exposure".

(2) The report form will require the following, at a minimum:

(a) name, address, and phone numbers of the emergency services provider who sustained an exposure;

(b) date and time of the exposure;

(c) a narrative description of the type of exposure that occurred, a detailed description of how the exposure took place, and a description of any precautions taken;

(d) the name and, if available, the date of birth of the patient;

(e) the name of the health care facility receiving the patient and the health care facility's infectious disease control officer;

(f) the name of the emergency services organization with which the health care provider was officially responding;

(g) the names and phone numbers of the designated officer and the alternate;

(h) the address of the designated officer to which the written notification required by 50-16-702 (2)(c), MCA, is to be sent; and

(i) the signature of the designated officer filing the report.

(3) A copy of the required form is available 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, telephone: (406)444-3895.

(4) An emergency service provider should, but is not required to, notify his designated officer within 72 hours after the exposure if he wishes a report of exposure to be filed.

(5) It is the department's interpretation that the information in 50-16-702 (2)(c), MCA requires a health care facility to provide to a designated officer in response to the filing with the facility of a report of exposure is limited to information related to the health care facility stay directly resulting from the incident that generated the exposure, and not to any subsequent emergency transport to that facility involving the same patient and the same emergency medical service. This interpretation is advisory only and not binding upon anyone.

(1) At a minimum, a health care facility that notifies the designated officer of the emergency services provider who attended a patient prior to or during transport or who transported a patient who has been diagnosed as having one of the infectious diseases listed in ARM 37.104.801 must recommend that the exposed emergency services provider take the medical precautions and treatment:

(a) specified in "The Control of Communicable Diseases Manual", published by the American Public Health Association, 16th Edition, 1995; and

(b) other additional medical precautions and treatment recommended by the health care facility.

(2) The designated officer must then forward these recommendations to the emergency medical services provider(s) who was/were exposed.

(3) The department hereby adopts and incorporates by reference "The Control of Communicable Diseases Manual", published by the American Public Health Association, 16th Edition, 1995, which lists and specifies control measures for communicable diseases. A copy of "The Control of Communicable Diseases Manual" may be obtained from the American Public Health Association, 1015 15th Street NW, Washington, DC 20005.

In addition to the definitions in 50-6-401, MCA, the following definitions apply to this subchapter:

(1) "Application" means the submission of written information by a health care facility, on forms required by the department, requesting designation as a specific level of trauma facility and providing information regarding its compliance with the Montana Trauma Facility Designation Criteria concerning the resources a facility must have to qualify as that level of trauma facility.

(2) "Area trauma hospital" means a health care facility that is designated by the department as having met the essential standards for area trauma hospitals as specified in the Montana Trauma Facility Designation Criteria.

(3) "Community trauma facility" means a health care facility that is designated by the department as having met the standards for a community trauma facility as described in the Montana Trauma Facility Designation Criteria.

(4) "Comprehensive trauma center" means a health care facility that is designated by the department as having met the standards for a comprehensive trauma center as described in the Montana Trauma Facility Designation Criteria.

(5) "Corrective action plan" means the specific actions that are required of a health care facility by the department in order to be in compliance with trauma facility requirements and that are included in a plan written by the health care facility and approved by the site review team.

(6) "Designated facility" refers to a health care facility that has been determined by the department to satisfy the requirements of one of the four categories of trauma facilities as described in the Montana Trauma Facility Designation Criteria.

(7) "Designation" means a formal determination by the department that a health care facility has met the requirements for a level of trauma facility as described in the Montana Trauma Facility Designation Criteria.

(8) "Designation subcommittee" means members of the State Trauma Care Committee's Performance Improvement Subcommittee that are selected by the Trauma Care Committee's chairperson to evaluate a site review team's report and who make recommendations to the department concerning a health care facility's designation.

(9) "Emergency department" means an area of a licensed health care facility that customarily receives patients in need of emergency evaluation or care.

(10) "Focused review" means a method established by the department to assess a health care facility's compliance with a corrective action plan to meet the resource criteria in the Montana Trauma Facility Designation Criteria.

(11) "Montana Trauma Facility Designation Criteria" means the document within the Montana Trauma System Plan that contains the requirements for a facility to meet in order to be designated as a particular type of trauma care facility. The department adopts and incorporates by reference the department's Montana Trauma Facility Designation Criteria (2024). A copy of the Montana Trauma Facility Designation Criteria (2024) may 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 or electronically at

https://dphhs.mt.gov/publichealth/emsts/Trauma/Regulation.

(12) "Nurse practitioner" means a person who is licensed as a professional registered nurse and approved by the Montana Board of Nursing as a nurse practitioner.

(13) "Peer review" means the confidential review by health care practitioners from multiple disciplines of provider performance in order to reduce morbidity and mortality and to improve the care of patients.

(14) "Physician" means a person licensed to practice medicine in Montana by the Montana Board of Medical Examiners.

(15) "Physician's assistant" means a person who is licensed to practice as a physician assistant by the Montana Board of Medical Examiners.

(16) "Practitioner" means a physician, nurse practitioner, or physician's assistant.

(17) "Provisional designation" means that a health care facility has substantially, although not completely, complied with the requirements for a given level of trauma facility, that a corrective action plan has been submitted by the facility to the department, and that the facility has been authorized by the department to serve as a trauma facility on a temporary basis.

(18) "Regional trauma center" means a health care facility that is designated by the department as having met the criteria for a regional trauma center as described in the Montana Trauma Facility Designation Criteria.

(19) "Regional Trauma Care Advisory Committee" means a regional committee composed of representatives from each of the region's trauma facilities established pursuant to 50-6-411, MCA.

(20) "Site review team" means a group of individuals selected by the department who have expertise in trauma care and trauma program administration and that evaluates a medical facility's compliance with required trauma facility criteria.

(21) "Site survey" means the process by which the site review team visits a health care facility that has applied for trauma facility designation, reviews the compliance of the medical facility with the applicable trauma facility criteria, and makes recommendations regarding designation to the department.

(22) "Trauma diversion" means a health care facility that temporarily does not have all the resources available to optimally resuscitate a seriously injured patient, with the result that such a patient is diverted from that hospital prior to arrival there and arrangements are made simultaneously for the patient to be received and treated at another facility that can provide more readily available and appropriate medical care.

(23) "Trauma patient" means an individual suffering from a trauma as defined in 50-6-401, MCA.

(24) "Trauma receiving facility" means a health care facility that is designated by the department as having met the criteria for a trauma receiving facility as described in the Montana Trauma Facility Designation Criteria.

(1) The following regions are designated as trauma regions:

(a) the western trauma region, consisting of Beaverhead, Deer Lodge, Flathead, Granite, Lake, Lincoln, Mineral, Missoula, Powell, Ravalli, Sanders, and Silver Bow counties;

(b) the central trauma region, consisting of Blaine, Broadwater, Cascade, Chouteau, Glacier, Hill, Jefferson, Judith Basin, Lewis and Clark, Liberty, Meagher, Pondera, Teton, and Toole counties; and

(c) the eastern trauma region, consisting of Big Horn, Carbon, Carter, Custer, Daniels, Dawson, Fallon, Fergus, Gallatin, Garfield, Golden Valley, Madison, McCone, Musselshell, Park, Petroleum, Phillips, Powder River, Prairie, Richland, Roosevelt, Rosebud, Sheridan, Stillwater, Sweet Grass, Treasure, Valley, Wheatland, Wibaux, and Yellowstone counties.

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(1) In addition to the requirements specified in 50-6-412, MCA, each Regional Trauma Care Advisory Committee must do the following:

(a) meet quarterly to identify specific regional trauma needs and to define corrective strategies;

(b) propose trauma care guidelines or protocol, backed by evidence and research showing their efficacy, to the State Trauma Care Committee;

(i) prehospital trauma communications and dispatch;

(ii) medical control and treatment protocols for prehospital caregivers;

(iii) triage and transportation of trauma victims;

(iv) facility resources in the region for trauma patients;

(v) interfacility transfer of trauma patients;

(vi) rehabilitation resources;

(vii) criteria to determine what the composition of a patient's trauma team should be given the nature of the patient's trauma;

(viii) trauma performance improvement; and

(ix) disaster management; and

(d) keep minutes of each Regional Trauma Care Advisory Committee meeting and submit a copy to the State Trauma Care Committee.

(2) Each Regional Trauma Care Committee must have a structure that addresses each of the following elements:

(a) trauma performance improvement;

(b) the Regional Trauma Plan;

(d) prehospital trauma issues; and

(e) injury prevention and control.

(3) In accordance with 50-6-415, MCA, Regional Trauma Care Advisory Committee and subcommittee meetings must be open to the public, and the information presented at such meetings is public as well, unless the committee or subcommittee determines that the meeting, or a portion thereof, will perform peer review and performance improvement activities, in which case:

(a) the meeting, or the relevant portion thereof, is limited to:

(i) members of the committee or subcommittee; and

(ii) guests who further the process of performance improvement, are invited by the performance improvement subcommittee chairperson, and are approved by the Regional Trauma Care Advisory Committee chairperson in advance;

(b) each committee or subcommittee member and guest must sign a form indicating they will not divulge any proceedings of the closed meeting, conversations during the meeting, or documents used during the meeting; and

(c) the minutes and the information presented, including all records and deliberations of the meeting, are confidential and not discoverable.

(4) If a meeting is closed pursuant to (3), the Regional Trauma Care Advisory Committee may still develop summary reports, findings, and recommendations to the State Trauma Care Committee, Regional Trauma Care Advisory Committee, an Individual Trauma Facility Trauma Program, or an individual health care practitioner.

(1) The State Trauma Care Committee shall:

(a) meet quarterly to identify specific statewide trauma needs and to define corrective strategies;

(b) keep minutes and provide copies of those minutes to each Regional Trauma Care Advisory Committee;

(d) assist in the development and oversight of the State Trauma System Plan; and

(e) approve the State Trauma System plan.

(2) The Trauma Care Committee must have a structure that addresses each of the following:

(a) trauma performance improvement;

(b) organization and emergency preparedness;

(d) injury prevention and control;

(e) public advocacy and legislation; and

(f) designation of trauma facilities.

(3) The subcommittee of the State Trauma Care Committee responsible for designation of trauma facilities must review the site survey report and make a recommendation to the department regarding actions to be taken on the trauma designation application of a potential trauma facility.

(4) In accordance with 50-6-415, MCA, State Trauma Care Committee and subcommittee meetings are open to the public and the information presented is considered public information unless the committee or subcommittee determines that the meeting, or a portion thereof, will perform peer review and performance improvement activities, in which case:

(a) the meeting, or the relevant portion thereof, is limited to:

(i) members of the committee or subcommittee; and

(ii) guests who further the process of performance improvement, are invited by the Performance Improvement Subcommittee chairperson, and are approved by the Trauma Care Committee chairperson in advance;

(b) each committee or subcommittee member and guest must sign a form indicating they will not divulge any proceedings of the meeting, conversations during the meeting, or documents used during the meeting; and

(c) the minutes and the information presented, including all records and deliberations of the meeting pertaining to the peer review and performance improvement activities, are confidential and not discoverable.

(5) If a meeting is closed pursuant to (4), the committee or subcommittee may still develop summary reports, findings, and recommendations to the State Trauma Care Committee, Regional Trauma Care Advisory Committee, an individual Trauma Facility Trauma Program, or an individual health care practitioner.

(1) The department may designate a health care facility as belonging to one of the following levels of trauma facilities:

(a) comprehensive trauma center;

(b) regional trauma center;

(d) community trauma facility; or

(e) trauma receiving facility.

(2) Requirements for each level are contained in the Montana Trauma Facility Designation Criteria.

(1) A designated trauma facility must:

(a) adhere to these rules;

(b) continue to be a health care facility; and

(c) continue to provide the resources required for its designated level of trauma facility, as described in the Montana Trauma Facility Designation Criteria of the State Trauma Plan.

(2) If the designated facility is unable to provide the care required by (1), it must:

(a) observe the trauma diversion plan required by the Montana Trauma Facility Designation Criteria of the State Trauma Plan for its facility; and

(b) immediately notify the department if the facility becomes unable to provide trauma services commensurate with its designation level for a period of more than one week.

(3) A designated facility may, without cause, terminate its trauma designation after giving 90 days written notice to the department, the State Trauma Care Committee, and the Regional Trauma Care Advisory Committee.

(4) If, following its voluntary termination of trauma designation, a health care facility wishes to be reinstated as a trauma facility, the facility must reapply for designation by completing the requirements of ARM 37.104.3021 or 37.104.3022, whichever is applicable.

(1) For the purpose of improving the quality of trauma care, all Montana health care facilities, as defined in 50-6-401, MCA, must participate in the state trauma register by collecting and reporting to the department the data listed in (4), on the schedule required by (2).

(2) Within 60 days after the end of each quarter, each health care facility that provides service or care to trauma patients within Montana must submit to the department the information required by (4) concerning any trauma patient that it serves during any month of the quarter and who meets the criteria for inclusion in the trauma register that are set forth in the State Trauma Plan.

(3) The data must be submitted to the department's trauma register in the same format as the state register uses, unless the department allows an alternate means of submission if use of the department's prescribed format would impose a severe hardship on the reporting facility. All health care facilities must submit the data electronically.

(4) The following data fields must be reported to the department:

(a) patient information that includes:

(i) a unique trauma patient identifier;

(ii) date of birth;

(iii) age;

(iv) sex;

(v) race; and

(vi) address;

(b) injury information that includes:

(i) date, time, and location of injury;

(ii) trauma injury diagnostic codes;

(iii) injury cause;

(iv) protective devices used by the patient, if any;

(v) results of alcohol or drug testing, if any; and

(vi) trauma injury diagnoses;

(i) prehospital transport agencies;

(ii) patient extrication time;

(iii) emergency medical service (EMS) dispatch date;

(iv) EMS notification time;

(v) time of arrival at scene;

(vi) departure time from scene;

(vii) time of arrival at the facility;

(viii) triage criteria, including physiologic and anatomic conditions, injury circumstances, and comorbid factors;

(ix) EMS activation of trauma team;

(x) vital and neurologic signs;

(xi) treatment and procedures provided; and

(xii) whether a prehospital report is included in the facility patient medical record;

(d) interfacility transfer information that includes:

(i) the names of the referring and receiving facilities;

(ii) trauma team activation;

(iii) patient arrival and discharge date and times from the referring facility;

(iv) vital and neurologic signs;

(v) date, time, and results of tests and procedures performed;

(vi) treatment at the referring facility;

(vii) payor source; and

(e) inpatient care information that includes:

(i) the name of the facility;

(ii) emergency department admission and discharge dates and times;

(iii) trauma team activation;

(iv) emergency department vital and neurologic signs;

(v) status of intubation and ventilation;

(vi) date, time, and results of tests and procedures performed;

(vii) post emergency department destination;

(viii) admitting service;

(ix) previous admission for the injury in question, if any;

(x) total days in the intensive care unit;

(xi) total days on ventilator;

(xii) date for rehabilitation consult;

(xiii) date nutrition addressed;

(xiv) substance counseling, if applicable;

(xv) use of blood products, if applicable;

(xvi) facility discharge date and time;

(xvii) discharge disposition;

(xviii) functional ability at discharge;

(xix) payor source;

(xx) hospital charges and payments received;

(xxi) for all deaths, if an autopsy was performed; and

(xxii) for all deaths, whether there was any donation of tissue or organs.

(5) Failure of a designated trauma facility to timely and accurately report to the department all data required by these rules is grounds for revocation of designation status.

(1) The site review team for comprehensive trauma centers, regional trauma centers, area trauma hospitals, and community trauma facilities must be composed of either out-of-state or in-state surveyors from a trauma center that is not owned or operated by the same entity as the applicant and must include a general surgeon, a trauma nurse coordinator, department staff, and other members determined to be necessary by the department or requested by the health care facility being reviewed.

(2) The site review team for a trauma receiving facility must be composed of either out-of-state or in-state surveyors from a trauma center that is not owned or operated by the same entity as the applicant and must include a physician, a trauma nurse coordinator, department staff, and other members determined to be necessary by the department or requested by the health care facility being reviewed.

(1) A Montana health care facility that is not currently verified by the American College of Surgeons as meeting the American College of Surgeons' criteria to qualify for verification as a trauma facility and that wishes a designation or renewal of designation as a Montana trauma facility must submit to the department an application for trauma facility designation, supplied by the department.

(2) The application must:

(a) specify the level of designation for which the facility is applying; and

(b) provide information about the facility's compliance with the Montana Trauma Facility Designation Criteria of the State Trauma Plan that are required for that level of trauma facility.

(3) The department will review the application for completeness and within 30 days, after receiving the application, notify the health care facility that:

(a) the application is complete; or

(b) the application is incomplete and request additional information.

(4) When the application is complete, the department will:

(a) select a site review team; and

(b) with a minimum of 60 days advance notice, notify the facility of the scheduled dates for the site survey and of the site review team members.

(5) The health care facility must:

(a) notify the department in writing within ten working days if it objects to one or more members of the site review team due to a perceived conflict of interest, and provide documentation of clear and convincing evidence for its concern including, but not limited to, the member's past or potential financial or personal gain, past or potential employment, or gain from the use of confidential information; and

(b) prohibit its administration, faculty, medical staff, employees, and representatives from having any contact with site review members prior to the site survey, except as directed by the department.

(6) The site review team will:

(a) review the commitment and capabilities of the applicant health care facility to meet the resource criteria described in the Montana Trauma Facility Designation Criteria of the State Trauma Plan for the level of designation sought, based upon consideration of all pertinent information, including:

(i) review of the application for designation;

(ii) inspection of the facility and required equipment;

(iii) interview with appropriate individuals;

(iv) review of medical records;

(v) review of inpatient logs and hospital emergency department logs;

(vi) review of hospital trauma registry entries and reports;

(vii) review of documentation of trauma performance improvement;

(viii) review of call rosters, staffing schedules, and meeting minutes;

(ix) review of injury prevention and education programs; and

(x) other documentation as necessary to assess the facility's compliance with these rules;

(b) make a verbal report of its findings through an exit interview to the applicant upon completion of the site survey and prior to leaving the facility; and

(c) make a written report of its findings and recommendations to the department within 30 days following the on-site survey of the facility.

(7) The department will review the report of the site review team and forward a copy to the designation subcommittee.

(8) The designation subcommittee will review the report of a site review team at the next quarterly State Trauma Care Committee meeting and make a recommendation to the department regarding the trauma designation of the applicant facility.

(9) The department must:

(a) determine the final designation of the facility based on consideration of the application, the recommendations of the site review team, and the recommendations of the designation subcommittee; and

(b) notify the applicant of its decision in writing within 30 days after receiving the recommendation from the designation subcommittee.

(10) The department will take one of the following actions:

(a) designate the applicant as qualifying for the trauma facility level requested, providing there is compliance with the trauma facility resource criteria in the Montana Trauma Facility Designation Criteria of the State Trauma Plan;

(b) issue a provisional designation to the applicant provided:

(i) there are deficiencies noted but the facility is substantially compliant with the resource criteria and any deficiencies will not have an immediate detrimental impact on trauma patient care; and

(ii) the applicant has submitted to the site review team a corrective action plan, acceptable to the team, for the correction of the identified deficiencies;

(c) designate the applicant as a trauma facility at a different level from that for which the applicant applied, provided that:

(i) the applicant meets all of the requirements of the alternative trauma facility designation level; and

(ii) the applicant agrees to be designated at the alternative trauma facility designation level; or

(d) deny any trauma facility designation if:

(i) there is substantial noncompliance with the requirements; or

(ii) the deficiencies are fundamental or may have an immediate detrimental impact on trauma patient care.

(1) A health care facility with a current certificate of verification from the American College of Surgeons as a trauma facility qualifies as one of the following types of Montana trauma facility as set out in (2), providing it submits an application, department staff attend the on-site or virtual review conducted by the American College of Surgeons, and the facility demonstrates compliance with all requirements described in the Montana Trauma Facility Designation Criteria that may differ from the American College of Surgeons' standards in the college's document entitled "Resources for Optimal Care of the Injured Patient: 2022 standards." A copy of this document may be obtained as set forth in (8).

(2) A current certificate of verification for the following levels established by the American College of Surgeons qualifies a health care facility as the following type of Montana trauma facility:

(a) a level I trauma center qualifies as a comprehensive trauma center;

(b) a level II trauma center qualifies as a regional trauma center;

(d) a level IV trauma center qualifies as a community trauma facility.

(3) A Montana health care facility that is seeking verification or reverification by the American College of Surgeons as a trauma center and wishes to be designated as a Montana trauma facility must submit to the department:

(a) an application for designation, on a form approved by the department, that:

(i) specifies the level of designation for which the facility is applying; and

(ii) includes a copy of the American College of Surgeons' prereview questionnaire;

(b) any additional information required by the department to verify compliance with any requirements described in the Montana Trauma Facility Designation Criteria that differ from the American College of Surgeons' standards;

(c) notification of the scheduled dates of the American College of Surgeons' site survey to allow for department participation in the site review; and

(d) upon receipt, a copy of the American College of Surgeons' letter indicating if the facility was successfully verified as a trauma facility.

(4) The department will review the application for completeness and within 30 days after receiving the application:

(a) notify the facility that the application is complete; or

(b) notify the facility that the application is incomplete and request additional information.

(5) When the application and the site review are complete, and the American College of Surgeons' letter is received that indicates whether the facility is verified as a trauma facility, the department will provide a copy of the application and the letter to the designation subcommittee at the next quarterly State Trauma Care Committee meeting.

(6) The designation subcommittee will review the application and American College of Surgeons' letter at the next quarterly State Trauma Care Committee meeting and make a recommendation to the department regarding the trauma designation of the applicant facility.

(7) Within 30 days after receiving a recommendation from the designation subcommittee, the department will take one of the following actions:

(a) designate the applicant at the trauma facility level requested providing there is compliance with these rules;

(b) issue a provisional designation to the applicant provided that:

(i) there are deficiencies noted but the facility is substantially compliant with the resource criteria and the deficiencies will not have an immediate detrimental impact on trauma patient care; and

(ii) the applicant has submitted to the department a corrective action plan, acceptable to the department, for the correction of the deficiencies;

(c) designate the applicant as a trauma facility at a different level from that for which the applicant applied, provided that:

(i) the applicant meets all of the requirements of the alternative trauma facility designation level; and

(ii) the applicant agrees to be designated at the alternative trauma facility designation level; or

(d) deny any designation if there is substantial noncompliance with the requirement, or the deficiencies may be a threat to public health and safety.

(8) The department adopts and incorporates by reference "Resources for Optimal Care of the Injured Patient: 2022 standards," published by the American College of Surgeons. The document contains the trauma facility criteria used by the American College of Surgeons in its process for verification of trauma facilities. A copy may 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.

(1) When a trauma facility is designated as such pursuant to ARM 37.104.3021, the period of designation is for three years beginning from the date the notice of designation is issued.

(2) When a trauma facility is designated as such pursuant to ARM 37.104.3022, the expiration date of the designation shall coincide with the expiration date of the American College of Surgeons' Certificate of Verification. Upon expiration of the Certificate of Verification, the facility may be granted a Montana designation extension of up to six months if the department receives documentation that an American College of Surgeons' verification survey is anticipated.

(3) A provisional designation imposed pursuant to ARM 37.104.3030 is valid for a period determined by the department in consultation with the designation subcommittee, but not longer than 12 months. The provisional designation expires on the date set by the department unless the provisionally designated trauma facility:

(a) receives a focused review by the department in consultation with the designation subcommittee to determine if the corrective action plan has resulted in compliance with the required criteria; and

(b) the department determines that the corrective action plan has resulted in the facility successfully meeting the required criteria, in which case the department shall issue a designation as a trauma facility.

(4) A trauma facility may renew its designation by completing the requirements of ARM 37.104.3021 or 37.104.3022.

(5) The department may waive any designation expiration dates if the facility provides sufficient written justification and/or the department determines a waiver is necessary due to an emergency or disaster declaration by the governor, county, or city, or in the event of an unforeseen natural disaster. A waiver will be issued only if the following criteria are met:

(a) the waiver is necessary to avoid significant financial or other hardship to the facility; and

(b) granting the waiver would not jeopardize patient care or public health and safety.

(6) A waiver issued under (5) will be issued on a temporary basis not to exceed a period of 12 months.

(1) The department may review, inspect, evaluate, and audit trauma patient medical records, inpatient logs, hospital emergency department logs, trauma performance improvement documentation, and any other documents relevant to trauma care by any trauma facility at any time to verify compliance with these rules.

(2) The confidentiality of such records will be maintained by the department in accordance with state and federal law.

(3) The department will investigate written complaints alleging violation of these rules in the following manner:

(a) The department will request and the designated facility shall provide information that the department determines necessary to the investigation of the complaint.

(b) The results of a department investigation will be reviewed with the designation subcommittee.

(4) Following the completion of the investigation and review, the department may:

(a) take no action;

(b) initiate an emergency suspension of the facility's trauma designation;

(d) change the designation of a trauma facility to provisional; or

(e) revoke the designation of the designated facility.

(5) The department will suspend the designation of a designated trauma facility on an emergency basis if the violation of these rules creates a substantial threat to public health or if the designated facility ceases to be a health care facility. The designated facility may appeal the emergency suspension pursuant to 50-6-410 , MCA, but the emergency suspension shall remain in effect until a final decision is made by the department.

(6) The department may revoke a trauma facility designation if the facility:

(a) fails to comply with these rules;

(b) no longer is a health care facility;

(c) makes a false statement of a material fact in the application for designation, in any record required by these rules, or in a matter under investigation;

(d) prevents, interferes with, or attempts to impede in any way, the work of a department representative in the lawful enforcement of these rules; or

(e) falsely advertises or in any way misrepresents the facility's ability to care for trauma patients based on its trauma designation status.

(7) If a designated facility notifies the department that it will be temporarily noncompliant with its trauma facility designation criteria for longer than one week, the department, after consultation with the designation subcommittee, may take one or more of the following actions:

(a) conduct a focused review;

(b) modify the facility's designation status to provisional and require that a plan of correction be submitted to the department outlining how the deficiency will be corrected;

(c) change its designation level to be consistent with the trauma facility level for which it has the required resources; or

(d) suspend the trauma facility's designation on an emergency basis.