(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.
Licensed rotary 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 Airline Deregulation Act of 1978, 49 U.S.C. §41713
(b)(1) et seq. is not violated.
(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;
(E) secure positioning of cardiac monitors, defibrillators,
and external pacers so that displays are visible to medical personnel;
and
(F) shall assure that all specialized medical equipment
is secured throughout transport with adequately engineered designated
mounts as approved by FAA.
(c) An 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 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.
(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) carrier, operational, and airworthiness certification, as per
U.S, Code of Federal Regulations, Title 14, Subchapter G, Part 135).
(d) The air ambulance provider shall employ a medical
director who shall meet the following qualifications:
(1) be a physician approved by the department 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;
(5) shall comply with the requirements in the Medical
Practice Act, Occupations Code, Chapters 151 - 168, and 22 Texas Administrative
Code, Chapter 197; and
(6) have knowledge on Texas EMS laws and regulations
affecting local, regional and state operations.
(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, 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 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 defined plan or procedure and
resources in place to allow off-line medical control;
(7) oversee the review, revision and validation of
written medical policies and protocols annually for the treatment
and transportation of adult, pediatric, and neonatal patients; 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; and
(D) awareness that the EMS provider has provided safety
education for ground emergency services personnel.
(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, Kansas, Colorado 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 education
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 EMS Education Standards 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 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 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, with
recommended manufacturer's or FAA approved restraint system in place,
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 and masks (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). A 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 for adult, pediatric, and neonatal patients; 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 is 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 an adult, pediatric, and neonatal patients during flight;
(B) stethoscope;
(C) penlight/flashlight;
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