| (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.
(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
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;
(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 an environmental system (heating and cooling)
capable of maintaining a comfortable temperature at all times;
(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) 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
(12) have two 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(l) 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. 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) for 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; 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 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) shall comply with the requirements in Chapter 6, Medicine,
Article 4495b, Medical Practice Act, §197.3 subparagraphs (a)(2)-(7)
and (b).
(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, 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 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
policies and protocols annually to include a policy defining the specific
instances in which a patient could be accompanied by only one attendant.
(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 training 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 Standard Curriculum,
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. 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 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 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 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 patients 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 patients 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 pediatric 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 infant
sizes. 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 adult, child and infant; 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 infant patient(s) 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;
(E) an approved bio-hazardous waste plastic bag or impervious
container to receive and dispose of used supplies; and
Cont'd... |
