(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
Cont'd... |