Current through Reg. 49, No. 38; September 20, 2024
(a)
Fixed wing aircraft operated by a licensed EMS provider shall be at the mobile
intensive care level. Persons or entities operating fixed wing air ambulances
must direct and control the integrated activities of both the medical and
aviation components. Although the aircraft operator is directly responsible to
the Federal Aviation Administration (FAA) for the operation of the aircraft,
one organization, typically the one in charge of the medical functions, directs
the combined efforts of the aviation and medical components during patient
transport operations. Licensed fixed wing aircraft must also meet the
requirements of §
157.11
of this title (relating to Requirements for an EMS Provider License), as long
as the rule does not violate the Federal Aviation Act of 1958, 49 U.S.C.
§§ et seq. and Airline Deregulation Act of 1978,
49 U.S.C.
§
41713(b)(1).
(b) When being used as an ambulance, a fixed
wing aircraft shall:
(1) be multi-engine or
be a single, turbo-prop engine capable of maintaining cabin
pressurization;
(2) maintain a
cabin altitude consistent with patient diagnosis, condition, and
destination;
(3) be equipped and
kept current for instrument flight rules (IFR) flight;
(4) have a door large enough to allow a
patient on a stretcher with the manufacturer's recommended or FAA approved
stretcher restraint system in place to be enplaned without excessive
maneuvering or tipping of the patient which compromises the function of
monitoring devices, intravenous (IV) lines or ventilation equipment;
(5) be designed or modified to accommodate at
least one stretcher patient with the manufacturer's recommended or FAA approved
stretcher restraint system in place;
(6) have a lighting system which can provide
adequate intensity to illuminate the patient care area and an adequate method
(curtain, distance) to limit the cabin light from entering the cockpit and
impeding cockpit crew vision during night operations;
(7) have permanently installed climate
control equipment to provide an environment appropriate for the medical needs
of the patient(s);
(8) have an
interior cabin configuration large enough to accommodate the number of air
medical personnel needed to provide care to the patient, as well as an adult
stretcher in the cabin area with access to the patient. The configuration shall
not impede the normal or emergency evacuation routes;
(9) have an electrical system capable of
servicing the power needs of electrically powered on-board patient care
equipment;
(10) have all installed
and carry-on equipment secured using FAA-approved devices and
methods;
(11) shall assure that all
specialized medical equipment is secured throughout transport with adequately
engineered designated mounts as approved by FAA.
(12) have sufficient space in the cabin area
where the patient stretcher is installed so that equipment can be stored and
secured with FAA approved devices in such a manner that it is accessible to the
air medical personnel; and
(13)
have two FAA approved fire extinguishers approved for aircraft use. Each shall
be fully charged with valid inspection certification and capable of
extinguishing type A, B, or C fires. One extinguisher shall be accessible to
the cockpit crew and one shall be in the cabin area accessible to the medical
crew member.
(c) An
operator of aircraft in an air ambulance program shall be FAA certified as an
air taxi and commercial operator (ACTO) with operation specifications allowing
air ambulance operations.
(d) The
fixed-wing air ambulance provider shall meet the responsibilities of EMS
providers as in §
157.11
of this title (relating to Requirements for an EMS Provider License) and shall
also:
(1) submit proof that the fixed-wing
aircraft provider carries bodily injury and property damage insurance with a
company licensed to do business in Texas, in order to secure payment for any
loss or damage resulting from any occurrence arising out of or caused by the
operation or use of any of the certificate holder's aircraft.
(2) submit proof that the air ambulance
provider carries professional liability insurance coverage in the minimum
amount of $500,000 per occurrence, with a company licensed to do business in
Texas in order to secure payment for any loss or damage resulting from any
occurrence arising out of or caused by the care or lack of care of a patient;
and
(3) submit a letter of
agreement that all fixed-wing aircraft shall meet the specifications of
subsection (b) of this section, if the aircraft is leased from a pool;
and
(4) submit a copy of current
Federal Aviation Administration Air Taxi and Commercial Operator
Certification.
(e) The
air ambulance provider shall employ a medical director who shall meet the
following qualifications:
(1) be a physician
approved by the Texas Department of Health and in practice;
(2) have knowledge and experience consistent
with the transport of patients by air;
(3) be knowledgeable in aeromedical
physiology, stresses of flight, aircraft safety, patient care, and resource
limitations of the aircraft, medical staff and equipment;
(4) have access to consult with medical
specialists for patient(s) whose illness and care needs are outside the medical
director's area of practice; and
(5) shall comply with the requirements in the
Medical Practice Act, Occupations Code, Chapters 151 - 168, and 22 Texas
Administrative Code, Chapter 197;
(f) The physician shall fulfill the following
responsibilities:
(1) ensure that there is a
comprehensive plan/policy to address selection of appropriate aircraft,
staffing and equipment;
(2) be
involved in the selection, hiring, educating, training and continuing education
of all medical personnel;
(3) be
responsible for overseeing the development and maintenance of a continuous
quality improvement program;
(4)
ensure that there is a plan to provide direction of patient care to the air
medical personnel during transport. The system shall include on-line
(radio/telephone) medical control, and/or an appropriate system for off-line
medical control such as written guidelines, protocols, procedures, patient
specific written orders or standing orders;
(5) participate in administrative decision
making processes that affect patient care;
(6) ensure that there is an adequate method
for on-line medical control, and that there is a defined plan or procedure and
resources in place to allow off-line medical control;
(7) oversee the review, revision and
validation of written policies and protocols annually for the treatment and
transportation of adult, pediatric, and neonatal patients to include a policy
defining the specific instances in which a patient could be accompanied by only
one attendant; and
(8) attest to
the following capabilities:
(A) experience
consistent with the transport of patients by air;
(B) knowledge of aeromedical physiology,
stresses of flight, aircraft safety, resources limitations of the
aircraft;
(C) knowledge on Texas
EMS laws and regulations affecting local, regional and state
operations;
(D) awareness that the
EMS provider has provided safety education for ground emergency services
personnel.
(g) There shall be at least one licensed or
certified paramedic, registered nurse, or physician on board an air ambulance
to perform patient care duties on that air ambulance. The qualifications and
numbers of air medical personnel shall be appropriate to patient care needs.
Personnel employed by providers who are based in another state, do not need
Texas certification/licensure but shall be certified/licensed in their
respective state.
(1) Documentation of
successful completion of education specific to the fixed-wing transport
environment in general and the licensee's operation specifically shall be
required. The curriculum shall be consistent with the Department of
Transportation (DOT) Air Medical Crew - National EMS Education Standards, or
equivalent program.
(2) Each
attendant's qualifications shall be documented.
(3) Air medical personnel shall not be
assigned or assume the cockpit duties of the flight crew members concurrent
with patient care duties and responsibilities.
(4) The aircraft shall be operated by a pilot
or pilots certified in accordance with applicable Federal Aviation
Regulations.
(h) Medical
supplies and equipment shall be consistent with the service's scope of care as
defined in the protocols/standing orders for adult, pediatric, and neonatal
patients. Medical equipment shall be functional without interfering with the
avionics nor should avionics interfere with the function of the medical
equipment. Additionally, the following equipment, clean and in working order,
must be on the aircraft or immediately available for all providers:
(1) one or more stretchers installed in the
aircraft cabin which meet the following criteria:
(A) can accommodate an adult, 6 feet tall,
weighing 212 pounds except for a neonatal stretcher, with recommended
manufacturer's or FAA approved restraint system in place, which has been fitted
with an isolette. There shall be restraining devices or additional appliances
available to provide adequate restraint of all patients including those under
60 pounds or 36 inches in height;
(B) the head of each stretcher, with
recommended manufacturer's or FAA approved restraint system in place, shall be
capable of being elevated up to 45 degrees. The elevating section must hinge at
or near the patient's hips and shall not interfere with or require that the
patient or stretcher securing straps and hardware be removed or
loosened;
(C) each stretcher, with
recommended manufacturer's or FAA approved restraint system in place, shall be
positioned in the cabin to allow the air medical personnel clear view of the
patient and shall ensure that medical personnel always have access to the
patient's head and upper body for airway control procedures as well as
sufficient space over the area where the patient's chest is to adequately
perform closed chest compression or abdominal thrusts on the patient;
(D) a pad or mattress impervious to moisture
and easily cleaned and disinfected according to Occupation Safety and Health
Administration (OSHA) bloodborne pathogen requirements;
(E) a device to make the stretcher surface
rigid enough if the surface of the stretcher under the patient's torso is not
firm enough to support adequate chest compressions; and
(F) shall have a supply of linen for each
patient;
(2) an adequate
and manually-controlled supply of gaseous or liquid medical oxygen, attachments
for humidification, and a variable flow regulator for each patient;
(A) a humidifier, if used, shall be a
sterile, disposable, one-time usage item;
(B) the licensee shall have and demonstrate
the method used to calculate the volume of oxygen required to provide
sufficient oxygen for the patient's needs for the duration of the
transport;
(C) the licensee shall
have a plan to provide the calculated volume of oxygen plus a reserve equal
1000 liters or the volume required to reach an appropriate airport, whichever
is longer;
(D) all necessary
regulators, gauges and accessories shall be present and in good working
order;
(E) the oxygen system shall
be securely fastened to the airframe using FAA approved restraining devices;
(i) a separate emergency backup supply of
oxygen of not less than 57 liters with regulator and flow meter;
(ii) one adult, one child, one pediatric, one
neonatal size non- rebreathing mask, one adult size nasal cannula and necessary
connective tubings and appliances.
(3) an electrically-powered suction apparatus
with wide bore tubing, a large reservoir and various sizes suction catheters.
The suction system may be built into the aircraft or provided with a portable
unit. Backup suction is required and can be a manually operated device. (Bulb
syringe not acceptable);
(4) hand
operated bag-valve-mask ventilators of adult, pediatric and infant sizes with
clear masks in adult, pediatric, and neonatal patients. It shall be capable of
use with a supplemental oxygen supply and have an oxygen reservoir;
(5) airway adjuncts as follows:
(A) oropharyngeal airways in at least five
assorted sizes, including for adult, pediatric, and neonatal patients;
and
(B) nasopharyngeal airways in
at least three sizes with water soluble lubricant;
(6) assessment equipment as follows:
(A) equipment suitable to determine blood
pressure of the adult, pediatric, and neonatal patients during
flight;
(B) stethoscope;
(C) penlight/flashlight;
(D) heavy duty bandage scissors;
and
(E) pulse oximeter;
(7) bandages and dressings as
follows:
(A) sterile dressings such as 4x4s,
ABD pads;
(B) bandages such as
Kerlix, Kling; and
(C) tape in
various sizes.
(8)
container(s) and methods to collect, contain, and dispose of body fluids such
as emesis, oral secretions, and blood consistent with OSHA bloodborne pathogen
requirements;
(9) urinal and bedpan
with toilet tissue;
(10) infection
control equipment. The licensee shall have a sufficient quantity of the
following supplies for all air medical personnel, each flight crew member, and
all ground personnel with incidental exposure risks according to OSHA
requirements which includes but is not limited to:
(A) protective gloves;
(B) protective gowns;
(C) protective eyewear;
(D) protective face masks, National Institute
for Occupational Safety and Health (NIOSH) approved N95 or greater;
(E) an approved bio-hazardous waste plastic
bag or impervious container to receive and dispose of used supplies;
and
(F) handwashing capabilities or
antiviral towelettes.
(11) an adequate trash disposal system
exclusive of bio-hazardous waste control provisions;
(12) the following additional equipment in
amounts and sizes specified by the medical director is required for an air
ambulance provider to function at the advanced level:
(A) advanced airway management equipment
appropriate to the patient's needs;
(B) sterile crystalloid solutions in plastic
containers, IV catheters, and administration tubing sets;
(C) hanger for IV solutions;
(D) pressure bag;
(E) tourniquets, tape, dressings;
(F) container appropriate to contain used
sharp devices, needles, scalpels which meets OSHA requirements;
(G) a list signed by medical director
defining quantities and types of drugs to be carried; and
(H) any specialized equipment required in
medical treatment protocols/standing orders.
(13) cardiac monitor defibrillator-DC battery
powered portable monitor/defibrillator with paper printout, accessories and
supplies, with sufficient power supply to meet demands of the mission;
and
(14) survival kit which shall
include, but not be limited to, the following items which are appropriate to
the terrain and environments the provider operates over:
(A) instruction manual;
(B) water;
(C) shelter-space blanket;
(D) knife;
(E) signaling devices;
(F) compass; and
(G) fire starting items.
(i) A system for security of
medications, fluids, and controlled substances shall be maintained by each air
ambulance licensee in compliance with local, state, and federal drug
laws.
(j) The air ambulance
provider shall own the following equipment or shall have a written lease
agreement explaining the availability of the equipment for use when the
patient's condition indicates the need:
(1)
external cardiac pacing device;
(2)
IV infusion pump capable of strict mechanical control of an IV infusion drip
rate. Passive devices such as dial-a-flow are not acceptable; and
(3) a mechanical ventilator that can deliver
up to 100% oxygen concentration at pressures, rates and volumes appropriate for
the size of the patient.