| (a) Rotary wing aircraft (helicopters) operated by a licensed
emergency medical services (EMS) provider shall be at the mobile intensive
care level. Persons or entities operating rotary 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, typically
the organization in charge of the medical functions directs the combined efforts
of the aviation and medical components during patient transport operations.
(b) When being used as an ambulance, the helicopter shall:
(1) be configured so that the medical personnel have adequate
access to the patient in order to begin and maintain basic and advanced life
support treatment;
(2) have an entry that allows loading and unloading of
a patient without excessive maneuvering (no more than 45 degrees about the
lateral axis and 30 degrees about the longitudinal axis); and does not compromise
functioning of monitoring systems, intravenous (IV) lines, or manual or mechanical
ventilation;
(3) have a supplemental lighting system in the event standard
lighting is insufficient for patient care that includes:
(A) a self-contained lighting system powered by a battery pack
or a portable light with a battery source; and
(B) a means to protect the pilot's night adaptation vision.
(Use of red lighting or low intensity lighting in the patient care area is
acceptable if not able to isolate the patient care area);
(4) have an electric power outlet with an inverter
or appropriate power source of sufficient output to meet the requirements
of the complete specialized equipment package without compromising the operation
of any electrical aircraft equipment;
(5) have protection of the pilot's flight controls, throttles
and radios from any intended or accidental interference by the patient, air
medical personnel or equipment and supplies; and
(6) have an internal medical configuration located so
that air medical personnel can provide patient care consistent with the scope
of care of the air medical service, to include:
(A) the space necessary to ensure the patient's airway is maintained
and to provide adequate ventilatory support from the secured, seat-belted
position of the air medical personnel;
(B) those aircraft with gaseous oxygen systems have equipment
installed so that medical personnel can determine if oxygen is on by in-line
pressure gauges mounted in the patient care area. Aircraft using liquid or
gaseous oxygen should have equipment installed:
(i) with each gas outlet clearly marked for identification;
(ii) with oxygen flow capable of being stopped at the oxygen
source from inside the aircraft; and
(iii) so that the measurement of the liter flow and quantity
of oxygen remaining is accessible to air medical personnel while in flight.
All flow meters and outlets must be padded, flush mounted, or so located as
to prevent injury to air medical personnel; or there shall be an operational
policy stating that attendants wear helmets;
(C) hangers/hooks available to secure (IV) solutions in place
or a mechanism to provide high flow fluids if needed:
(i) all IV hooks shall be padded, flush mounted, or so located
as to prevent head trauma to the air medical personnel in the event of a hard
landing or emergency with the aircraft; or an operational policy stating that
attendants wear helmets; and
(ii) glass containers shall not be used unless required by
medication specifications and properly vented;
(D) provision for medication which allows for protection from
extreme temperatures if it becomes environmentally necessary; and
(E) secure positioning of cardiac monitors, defibrillators,
and external pacers so that displays are visible to medical personnel.
(c) An air ambulance provider shall meet the responsibilities
of EMS providers as in §157.11(l) of this title (relating to Requirements
for an EMS Provider License) and in addition shall:
(1) submit proof that the rotor-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. Coverage amounts shall insure that:
(A) each aircraft shall be insured for the minimum amount of
$1 million for injuries to, or death of, any one person arising out of any
one incident or accident;
(B) the minimum amount of $3 million for injuries to, or death
of, more than one person in any one accident; and
(C) the minimum amount of $500,000 for damage to property arising
from any one accident;
(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;
(3) submit a list of all aircraft with the registration
number or "N" number for the helicopters in the possession of the provider.
(4) submit a letter of agreement that all helicopters
shall meet the specifications of subsection (b) of this section, if the aircraft
is leased from a pool;
(5) allow visual and physical inspection of each aircraft
and of the equipment to be used on each vehicle for the purpose of determining
compliance with the vehicle and equipment specifications within this section;
and
(6) submit a copy of current Federal Aviation Administration
(FAA) operational certification.
(d) The air ambulance provider shall designate or 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) comply with the requirements in Chapter 6, Medicine,
Article 4495B, Medical Practice Act, §197.3(a)(2-7) and (b).
(e) 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, 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 any 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 well defined plan or procedure and resources
in place to allow off-line medical control; and
(7) oversee the review, revision and validation of written
medical policies and protocols annually.
(f) There shall be two Texas licensed/certified personnel on
board the helicopter when in service. A waiver to the Texas license/certification
may be granted for personnel employed by providers in New Mexico, Oklahoma,
Arkansas, and Louisiana who respond in Texas and are licensed in their respective
state. Staffing of vehicles shall be as follows:
(1) when responding to an emergency scene, at least one of
the personnel shall be a paramedic;
(2) when responding for an inter-facility transfer, at
least one of the personnel performing patient care duties shall be a certified
or licensed paramedic, registered nurse or physician. The qualifications and
numbers of air medical personnel shall be appropriate to patient care needs;
(3) when responding as in paragraphs (1) and (2) of this
subsection, the second person may be a certified or licensed paramedic, registered
nurse, or a physician; and
(4) air medical personnel shall not be assigned or assume
the cockpit duties of the flight crew members concurrent with patient care
duties and responsibilities.
(g) Documentation of successful completion of training specific
to the helicopter 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 Standard Curriculum
or equivalent program and each attendant's qualifications shall be documented.
(h) Medical supplies and equipment shall be consistent with
the service's scope of care as defined in the protocols/standing orders. 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 capable of being secured in the
aircraft which meet the following criteria:
(A) can accommodate an adult, 6 feet tall, weighing 212 pounds.
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) shall have the head of the primary stretcher capable of
being elevated up to 30 degrees. The elevating section shall not interfere
with or require that the patient or stretcher securing straps and hardware
be removed or loosened;
(C) shall be sturdy and rigid enough that it can support cardiopulmonary
resuscitation. If a backboard or equivalent device is required to achieve
this, such device will be readily available;
(D) shall have a pad or mattress impervious to moisture and
easily cleaned and disinfected according to Occupational Safety and Health
Administration (OSHA) bloodborne pathogen requirements; and
(E) shall have a supply of linen for each patient;
(2) adequate amounts of oxygen (for anticipated liter
flow and length of flight with an emergency reserve) available for every mission;
(3) one portable oxygen tank;
(4) a back-up source of oxygen (of sufficient quantity
to get safely to a facility for replacements). Back-up source may be the required
portable tank if the tank is accessible in the patient care area during flight;
(5) airway adjuncts as follows:
(A) oropharyngeal airways in at least five assorted sizes,
including adult, child, and infant; and
(B) nasopharyngeal airways in at least three sizes with water
soluble lubricant;
(6) at least one suction unit which is portable (bulb
syringes or foot pump not acceptable);
(7) the following items in amounts and sizes as specified
on a list signed by the medical director:
(A) IV solutions;
(B) IV catheters;
(C) endotracheal tubes;
(D) medications;
(E) any specialized equipment required in medical treatment
protocols/standing orders;
(F) pressure bag;
(G) tourniquets, tape, dressings; and
(H) container appropriate to contain used sharp devices (needles,
scalpels) which meets OSHA requirements;
(8) assessment equipment as follows:
(A) equipment suitable to determine blood pressure of the adult,
pediatric and infant patient(s) during flight;
(B) stethoscope;
(C) penlight/flashlight;
(D) heavy duty bandage scissors;
(E) pulse oximeter;
(F) external cardiac pacing device; and
(G) IV infusion pump capable of strict mechanical control of
an IV infusion drip rate. Passive devices such as dial-a-flow are not acceptable;
(9) bandages and dressings as follows:
(A) sterile dressings such as 4x4s, ABD pads;
(B) bandages such as Kerlix, Kling; and
Cont'd... |
