Mo. Code Regs. tit. 19 § 30-40.308 : DEPARTMENT OF HEALTH AND SENIOR SERVICES — Division of Regulation and Licensure — Comprehensive Emergency Medical Services Systems Regulations —40.308 - Application and Licensure Requirements Standards for the Licensure and Relicensure of Air Ambulance Services

PURPOSE: This rule provides the requirement and standards related to the licensure and relicensure of air ambulance services.

PUBLISHER'S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

(1) Application Requirements for Air Ambulance Service Licensure.

(A) Each applicant for an air ambulance service license or relicense shall submit an application for licensure to the Emergency Medical Services (EMS) Bureau no less than thirty (30) days or no more than one hundred twenty (120) days prior to their desired date of licensure or relicensure.

(B) An application shall include the following information: type of license applied for (rotary wing or fixed wing); trade name of air ambulance service; location of aircraft; number of aircraft to be used as an air ambulance(s); name, address, telephone numbers, and email address (if applicable) of operator of air ambulance service; name, address, telephone numbers, and email address (if applicable) of manager; name, address, whether a medical doctor or doctor of osteopathy, telephone numbers, email address (if applicable), and signature of medical director and date signed; certification by the medical director that they are aware of the qualification requirements and the responsibilities of an air ambulance service medical director and agree to serve as medical director; name, address, telephone numbers, and email address (if applicable) of proposed licensee of air ambulance service; name of licensee's chief executive officer; all ambulance service licensure and related administrative licensure actions taken against the ambulance service or owner by any state agency in any state; and certification by the applicant that the application contains no misrepresentations or falsifications and that the information given by them is true and complete to the best of their knowledge and that the ambulance service has both the intention and the ability to comply with the regulations promulgated under the Comprehensive Emergency Medical Service Systems Act, Chapter 190, RSMo.

(C) Each air ambulance service that meets the requirements and standards of the statute and regulations shall be licensed and relicensed for a period of five (5) years. Air ambulances based inside or outside Missouri that do intra-Missouri transports shall be licensed in the state of Missouri and shall be held to the same standards.

(D) Air ambulance services which are currently accredited by the Commission on Accreditation of Medical Transportation Services (CAMTS) and have the required liability insurance coverage shall be considered to be compliant with the rules for air ambulance services. Accredited air ambulance services shall attach to their application evidence of accreditation and proof of their liability insurance coverage. The EMS Bureau shall conduct periodic site reviews and inspections of applicable records and medical equipment as necessary to verify compliance.

(E) Fixed wing air ambulances shall meet the requirements stated in this regulation except (8)(D) , (8)(F), and (12).

(2) Air ambulance services shall meet the following operation and maintenance standards:

(A) Air ambulance services shall possess or contract for a valid Federal Aviation Administration Title 14 CFR part 135 Certificate and comply with 14 CFR section 119, a regulation from the Federal Aviation Administration and be authorized to conduct helicopter air ambulance operations in accordance with Federal Aviation Regulation part 135 and this operations specification;

(B) The air ambulance service shall ensure prompt response to all requests to that service for emergency care twenty-four (24) hours per day, each and every day of the year, and shall provide patients with medically necessary care and transportation in accordance with that air ambulance service's protocols, scope of care, and capabilities.

1. If a scene request for emergency services is made to an air ambulance service which is not the recognized emergency provider, then the 911 provider or the recognized emergency provider shall be notified immediately by the air ambulance service receiving the request; and

2. Emergency transports shall not require a guarantee of payment prior to transport;

(C) Each air ambulance program shall have established information that is made available to each emergency service in the area in which they operate to include the following:

1. Aircraft capabilities;

2. Appropriate utilization of air ambulances;

3. Education and skills of the crew; and

4. Safety considerations;

(D) Public liability insurance or proof of self-insurance, condition to pay losses and damage caused by or resulting from the negligent operation, maintenance, or use of ambulance services under the service's operating authority or for loss or damage to property or others. Documents submitted as proof of insurance shall specify the limits of coverage and include the ambulance service license number. Public liability coverage for air ambulance services which transport patients shall meet or exceed:

1. Two hundred fifty thousand dollars ($250,000) for bodily injury to, or death of, one (1) person;

2. Five hundred thousand dollars ($500,000) for bodily injury to, or death of, all persons injured or killed in any one (1) accident, subject to a minimum of two hundred fifty thousand dollars ($250,000) per person; and

3. One hundred thousand dollars ($100,000) for loss or damage to property of others in one (1) accident, excluding cargo; and

(E) The aviation crew of an air ambulance shall meet all requirements of the Federal Aviation Administration Title 14 CFR part 135, and the medical crew responding to scenes shall be able to demonstrate successful completion and maintenance of the following:

1. Education-

A. Basic Cardiac Life Support (BCLS) which is incorporated by reference in this rule as published by the American Heart Association in 2005 and is available at the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231. This rule does not incorporate any subsequent amendments or additions;

B. Advanced Cardiac Life Support (ACLS) or national equivalent. ACLS is incorporated by reference in this rule as published by the American Heart Association in 2005 and is available at the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231. This rule does not incorporate any subsequent amendments or additions;

C. Pediatric Advanced Life Support (PALS) or national equivalent. PALS is incorporated by reference in this rule as published by the American Heart Association in 2005 and is available at the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231. This rule does not incorporate any subsequent amendments or additions; and

D. Trauma Nurse Core Course (TNCC) or a trauma course approved by the medical director. TNCC is incorporated by reference in this rule as published by the Emergency Nurses Association in 2007 and is available at the Emergency Nurses Association, 915 Lee Street, Des Plaines, IL 60016-9659. This rule does not incorporate any subsequent amendments or additions. Examples of equivalent courses are, but not limited to: Pediatric Education for Pre-Hospital Professionals (PEPP); Emergency Nurse Pediatric Course (ENPC); International Trauma Life Support (ITLS); Pre-Hospital Trauma Life Support (PHTLS); and Transport Nurse Advanced Trauma Course (TNATC). PEPP is incorporated by reference in this rule as published by the American Academy of Pediatrics in 2006 and is available at the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove, IL 60007. This rule does not incorporate any subsequent amendments or additions. ENPC is incorporated by reference in this rule as published by the Emergency Nurses Association in 2004 and is available at the Emergency Nurses Association, 915 Lee Street, Des Plaines, IL 60016-9659. This rule does not incorporate any subsequent amendments or additions. ITLS is incorporated by reference in this rule as published by ITLS International in 2007 and is available at ITLS International, 1 S. 280 Summit Ave., Court B-2, Oakbrook Terrace, IL 60181. This rule does not incorporate any subsequent amendments or additions. PHTLS is incorporated by reference in this rule as published by the National Association of Emergency Medical Technicians in 2006 and is available at the National Association of Emergency Medical Technicians, PO Box 1400, Clinton, MS 39060. This rule does not incorporate any subsequent amendments or additions. TNATC is incorporated by reference in this rule as published by the Air and Surface Transport Nurse's Association in 2006 and is available at the Air and Surface Transport Nurse's Association, 7995 East Prentice Avenue, Suite 100, Greenwood Village, CO 80111. This rule does not incorporate any subsequent amendments or additions; and 2. Licensure/certification-

A. Each medical crew member must hold a current and valid Missouri license as required for their level of practice.

(3) Each aircraft, when operated as an air ambulance, shall meet the following equipment requirements:

(A) Documentation that each aircraft is equipped with pediatric and/or adult medical supplies and equipment as required by the air ambulance service medical director for the various advanced life support procedures or protocols for the patient care activities in the out-of-hospital setting to which it will respond. Each service shall be able to produce these records for inspection during normal business hours;

(B) The aircraft will be equipped with all equipment to allow reliable communication and flight following;

(C) The air ambulance service shall have a policy and provide for the effective maintenance, storage, usage, and replacement of its medical equipment, devices, and medications;

(D) All medical equipment, except disposable items, shall be so designed, constructed, and of such material that under normal conditions and operations, it is durable and capable of withstanding repeated cleaning and being stored in a secure and protected manner; and

(E) The service shall:

1. Comply with Occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.1030 and section 191.694, RSMo; and

2. Monitor and direct the use, control, and security of drugs.

(4) Each aircraft operated as an ambulance shall be staffed by personnel selected by each air ambulance program to meet the mission and scope of that program, and at a minimum-

(A) On scene flights, there shall be at least two (2) air medical crew members. The primary crew member shall be a registered nurse or physician and the secondary crew member shall be an EMT-Paramedic, registered nurse, or physician; and

(B) On all transports other than scenes, there shall be at least two (2) air medical crew members, one (1) of whom will be a registered nurse or physician, and a secondary crew member who is approved by the medical director to provide critical care;

(C) A minimum of sixteen (16) hours of continuing education is required annually for each crew member to include safety, crew resource management, survival, and flight physiology; and

(D) The medical flight crew members will receive training designed by the medical director and clinical registered nurse supervisor to provide knowledge and skills needed to carry out advanced life support procedures and written protocols. The unique flight and pre-hospital environment will be addressed during training.

(5) Records and forms, policies and procedures-each air ambulance service shall maintain accurate records and forms that include the following:

(A) An air ambulance report form approved by the EMS Bureau to record information on each patient transport;

(B) Disaster/multiple casualty protocols;

(C) Medical equipment maintenance records;

(D) Air ambulance service license;

(E) Licensed service personnel records;

(F) Medical director qualifications and authorized physician-ordered treatment protocols and policies;

(G) Patient care records;

(H) Quality improvement program;

(I) Records required by other regulatory agencies including the Missouri Department of Health and Senior Services, Bureau of Narcotics and Dangerous Drugs (BNDD), and the Federal Drug Enforcement Administration (DEA);

(J) Safety program to include a safety committee and infection control policy as required by OSHA standard 29 CFR 1910.1030 and section 191.694, RSMo;

(K) Continuing education records; and

(L) Flight response records.

(6) Each air ambulance service shall have medical control policies, procedures, and standing orders that have been approved by their medical director and clinical registered nurse supervisor-

(A) The protocols will include authorization for standing orders;

(B) The written protocols will be provided to the EMS Bureau upon request; and

(C) The medical director will ensure the air medical personnel are provided appropriate training to meet standards established by the program.

(7) Each air ambulance service shall have a designated medical director, working under an agreement, who is trained and meets the requirements for a medical director in accordance with 19 CSR 30-40.303(1).

(A) Medical directors for flight programs shall also demonstrate expertise in advanced trauma life support, advanced cardiac life support, and in-flight conditions unique to the air transport of patients.

(B) Medical directors for flight programs must have a current and valid license to practice medicine in the state of Missouri and shall also maintain staff privileges at a Missouri licensed hospital that regularly receives patients from the air ambulance program.

(C) An air ambulance used for transport of trauma patients must have a medical advisor who is a trauma surgeon on the staff of a designated trauma center that regularly receives patients from the air ambulance program and who will provide expertise in cooperation with the medical director in the development of policies, procedures and quality improvement for all trauma related air ambulance activities.

(D) The medical director of the flight program shall have access to consulting physicians with expertise in specialties to include, but is not limited to:

1. Pediatrics;

2. Neonatology;

3. Burns;

4. Cardiology;

5. Trauma; and

6. Neurology/Neurosurgery.

(E) In the event of a resignation or other occurrence, and there is no medical director for the air ambulance service, the service is only authorized to operate under strict radio communications or direct written and/or verbal orders by a physician for a period not to exceed ten (10) days before appointing a new or replacement medical director.

(F) Each air ambulance service shall notify the EMS Bureau in writing of any change in medical director within five (5) days.

(8) Communication Centers and Communication Specialists.

(A) Training shall be provided in aircraft capabilities, operational limitations, navigation, and map coordination to the communication specialists.

(B) Information pertinent to each call shall be logged in order to retrieve complete activity review reports.

(C) Communication specialists shall be responsible for flight following based on requirements of the program and Federal Aviation Administration Title 14 CFR part 135.

(D) A system shall be in place to assure emergency requests are answered, the phone calls and radio traffic are recorded, and a back-up power source is available. The system shall include means to provide the crew the ability to communicate by voice with hospitals and emergency agencies.

(E) The hospital emergency ambulance radio system shall not be used for flight following.

(F) Each aircraft operated as an ambulance shall have the capability to communicate by voice with hospitals and the service's own communication center.

(G) The communication center shall:

1. Have a least one (1) dedicated telephone line for the purpose of receiving requests and the coordination of the air ambulance service;

2. Have a system for recording all incoming and outgoing telephone and radio transmissions with time recording and playback capabilities. Recordings shall be kept for a minimum of thirty (30) days;

3. Have the capability to immediately contact the aviation staff, medical crew, and online medical direction (through page, radio, or telephone, etc.);

4. Maintain all equipment in full operating condition and in good repair;

5. Have a back-up emergency power source for communications or a policy delineating methods for maintaining communications during power outages and in disaster situations; and

6. Have a communications policy and procedures manual to include:

A. A pre-arranged emergency plan to cover situations in which the aircraft is overdue, communications cannot be established, or an aircraft location cannot be verified.

(H) All helicopter air ambulance services shall have flights coordinated by designated communication specialists assigned and available twenty-four (24) hours per day to receive and coordinate the request for an air ambulance.

1. The communication specialists must advise the requesting caller of an accurate estimated time of arrival of the responding aircraft for all flight requests.

2. The communication specialists shall have training commensurate with the scope of responsibility of the communications center personnel and it shall include:

A. Federal Communications Commission regulations and appropriate provisions of the certificate holder's operations specifications and operations manual;

B. General safety rules, emergency procedures, and flight following procedures;

C. Map reading, aeronautical chart interpretation, basic navigation, and flight planning;

D. Weather terminology and procedures for flight service weather advisories;

E. Types of radio frequency bands used; and

F. Annual training that includes at least a review of the program's Post-Accident/Incident Plan (PAIP) and competency in the areas included in subsections (8)(A)-(G).

(9) There shall be an ongoing quality improvement program designed to objectively and systematically monitor, review, and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems.

(10) A safety committee shall be established and shall meet regularly to assess and evaluate the safety aspects of the operation.

(11) Each air ambulance service shall maintain policies and procedures that include the following:

(A) Safety program, including infection control program;

(B) Communications procedures;

(C) Ambulance operations procedures;

(D) Standards of clinical care (medical protocols);

(E) Equipment maintenance;

(F) Disaster/multiple casualty protocols; and

(G) Quality improvement program.

(12) Helicopter visual flight rule programs will adhere to the ceiling and visibility standards of the Federal Aviation Administration as authorized when conducting helicopter air ambulance operations in accordance with Federal Aviation Regulation part 135. These operations specifications will be available for inspection by the EMS Bureau during normal business hours.

(13) Each ambulance service shall display a copy of their ambulance service license in the patient care compartment of each ambulance aircraft operated by the ambulance service.

19 CSR 30-40.308

AUTHORITY: section 190.103, RSMo 2000, sections 190.108, 190.120, 190.160, 190.165, and 190.185, RSMo Supp. 2007 and section 190.176, HB 1790, 94th General Assembly, Second Regular Session, 2008.* Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Amended: Filed May 19, 2008, effective Jan. 30, 2009.

*Original authority: 190.103, RSMo 1998; 190.120, RSMo 1973, amended 1980, 1998, 2002; 190.160, RSMo 1973, amended 1998, 2002; 190.165, RSMo 1973, amended 1978, 1998, 2002; 190.175, RSMo 1973, amended 1998, 2002; 190.176, RSMo 1998, 2008; 190.180, RSMo 1998, amended 2002; and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002.