Current through Register Vol. 49, No. 18, September 16, 2024
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.
*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.