As used in this part, unless the context indicates otherwise, the following definitions apply:

(1) “Automated external defibrillator” or “AED” means a medical device that:

(a) has received approval for marketing from the U.S. food and drug administration;

(b) is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia and of determining, without intervention by an operator, whether defibrillation should be performed;

(c) upon determining that defibrillation should be performed, automatically charges and indicates that it is ready to deliver an electrical impulse to an individual's heart; and

(d) may be used by an operator of the device to deliver an electrical impulse to an individual's heart.

(2) “Department” means the department of public health and human services provided for in 2-15-2201.

(3) “Emergency medical service” means an emergency medical service as defined by 50-6-302.

(4) “Entity” means a public agency, department, office, board, or commission or other governmental organization or a private corporation, partnership, group, or business or other private organization.

(5) “Physician” means an individual licensed to practice medicine pursuant to Title 37, chapter 3, part 3.

(6) “Public safety answering point” means a communications facility operated on a 24-hour basis that first receives 9-1-1 calls from persons in a 9-1-1 service area and that may, as appropriate, directly dispatch public or private safety services or transfer or relay 9-1-1 calls to appropriate public safety agencies.

In order for an entity to use or allow the use of an automated external defibrillator, the entity shall:

(1) establish a program for the use of an AED that includes a written plan that complies with this part and rules adopted by the department pursuant to 50-6-503. The plan must specify:

(a) where the AED will be placed;

(b) the individuals who are authorized to operate the AED;

(c) how AED use will be coordinated with an emergency medical service providing services in the area where the AED is located;

(d) the medical oversight that will be provided;

(e) the maintenance that will be performed on the AED;

(f) records that will be kept by the program;

(g) reports that will be made of AED use; and

(h) other matters as specified by the department;

(2) adhere to the written plan required by subsection (1);

(3) ensure that before using the AED, an individual authorized to operate the AED receives appropriate training approved by the department in cardiopulmonary resuscitation and the proper use of an AED;

(4) maintain, test, and operate the AED according to the manufacturer's guidelines and maintain written records of all maintenance and testing performed on the AED;

(5) each time an AED is used for an individual in cardiac arrest, require that an emergency medical service is summoned to provide assistance as soon as possible and that the AED use is reported to the department as required by the written plan;

(6) before allowing any use of an AED, provide the following to all licensed emergency medical services and any public safety answering point or emergency dispatch center providing services to the area where the AED is located:

(a) a copy of the plan prepared pursuant to this section; and

(b) written notice, in a format prescribed by department rules, stating:

(i) that an AED program is established by the entity;

(ii) where the AED is located; and

(iii) how the use of the AED is to be coordinated with the local emergency medical service system; and

(7) comply with this part and rules adopted by the department pursuant to 50-6-503.

(1) The department shall adopt rules specifying the following:

(a) the contents of the written notice required by 50-6-502(6);

(b) reporting requirements for each use of an AED;

(c) the contents of a plan prepared in accordance with 50-6-502 and requirements applicable to the subject matter of the plan;

(d) training requirements in cardiopulmonary resuscitation and AED use for any individual authorized by an AED program plan to use an AED;

(e) guidelines for medical oversight of an AED program;

(f) minimum requirements for a medical protocol for use of an AED;

(g) performance requirements for an AED in order for the AED to be used in an AED program; and

(h) a list of the AED training programs approved by the department.

(2) The department may not adopt rules for any purpose other than those in subsection (1).

(1) If the department receives information that an AED is being used in violation of this part or a rule adopted by the department pursuant to 50-6-503, it may send a written order to the entity responsible for use of the AED, as specified in the plan prepared pursuant to 50-6-502, ordering the entity to cease the violation immediately. The order is effective upon receipt by the entity, and the entity shall comply with the terms of the order. If the department receives information that the violation has been corrected, the department may rescind its order by sending a notice to that effect to the entity. The rescission is effective upon its receipt by the entity.

(2) The entity may request a hearing to contest an order issued by the department pursuant to subsection (1) by submitting a written request to the department within 30 days after receipt of the order. A request for a hearing does not stay the enforceability of the department's order. The hearing must be held within 30 days after the department receives the request, unless the hearings officer sets a later date for good cause. The hearing must be held pursuant to the contested case provisions of the Montana Administrative Procedure Act.

(3) Either the county attorney for the county in which the violation occurred or the department may bring an action in the district court of the county where the violation occurred to enforce the department's order or to directly enjoin a violation of this part or a rule adopted pursuant to 50-6-503.

(1) An individual who provides emergency care or treatment by using an AED in compliance with this part and rules adopted by the department pursuant to 50-6-503 and an individual providing cardiopulmonary resuscitation to an individual upon whom an AED is or may be used are immune from civil liability for a personal injury that results from that care or treatment or from civil liability as a result of any act or failure to act in providing or arranging further medical treatment for the individual upon whom the AED was used unless the individual using the AED or the person providing cardiopulmonary resuscitation, as applicable, acts with gross negligence or with willful or with wanton disregard for the care of the person upon whom the AED is or may be used.

(2) The following individuals or entities are immune from civil liability for any personal injury that results from an act or omission that does not amount to willful or wanton misconduct or gross negligence if applicable provisions of this part and rules adopted by the department pursuant to 50-6-503 have been met by the individual or entity:

(a) a person providing medical oversight of the AED program, as designated in the plan prepared pursuant to 50-6-502;

(b) the entity responsible for the AED program, as designated in the plan prepared pursuant to 50-6-502;

(c) an individual providing training to others on the use of an AED.

This part does not apply to the use of an AED by:

(1) a patient or the patient's caretaker if use of the AED is ordered by a physician; or

(2) a licensed health care professional, including an emergency medical technician, whose scope of practice includes the use of an AED.

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;

(c) the names of the individuals currently authorized to use the AED;

(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;

(c) the age of the patient;

(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/132/18suppl2.

(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.

(5) First aid kits and AEDs must be provided and stored in accessible locations that are easily identifiable to staff and trained personnel.