RELATES TO:
KRS
311A.030,
311A.190, 14 C.F.R. Parts 91,
135
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
311A.020 requires the board to exercise all
administrative functions in the regulation of the emergency medical services
system and the practice of emergency medical services, except those functions
regulated by the Board of Medical Licensure or the Cabinet for Health and
Family Services.. KRS 311A.030 requires the board
to promulgate administrative regulations for the licensing, inspection, and
regulation of air ambulance providers. This administrative regulation
establishes minimum licensing requirements for air ambulance providers.
Section 1. Provider Licensing Requirements.
(1) A person or entity shall not provide,
advertise, or profess to engage in the provision of air ambulance service
originating in Kentucky without having first obtained a license from the board
pursuant to this administrative regulation.
(2) A provider shall comply with local
ordinances, state and federal statutes and administrative
regulations.
(3) A
provider shall
display its license in a prominent public area at the service
base station and
all satellite locations. The following information shall be included on the
license:
(a) Operating name of the
provider;
(b) Physical location of
the base station;
(c) The number
and physical location of satellite stations, if any, operated by the
licensee;
(d) The license
classification;
(e) The level of
service provided;
(f) The number of
rotor and fixed-wing aircraft operated by the provider; and
(g) The specific geographic area to be served
by the licensee.
(4)
Providers shall provide the KBEMS Office with an accurate map and a written
description of its geographic service area within the commonwealth, which shall
identify with specificity the complete boundary of the area served by the
provider when applying for initial licensure or if the service area has changed
since the last map was provided to the KBEMS Office.
(5) A licensed
provider may respond to
emergency calls outside of its geographic service area only if the
provider is
providing:
(a) Mutual aid under an existing
agreement with another licensed provider whose geographic service area includes
the area in which the emergency call is made;
(b) Disaster assistance; or
(c) Nonemergency transfers from damaged or
closed health facilities.
Section 2. Licensing, Inspection and Change
of Ownership.
(1) To obtain a license, an air
ambulance provider shall file a "Kentucky Application for Ambulance Service
Licensing", Form EMS-1 (6/96), with the KBEMS Office.
(2) An applicant for a license or a licensee
shall, as a condition precedent to licensing or relicensing, be in compliance
with all applicable sections of this administrative regulation as determined
through means including a physical inspection process, subject to subsection
(4)(b) of this section.
(3) A
license shall expire on December 31 following the original date of issue and
shall subsequently expire annually on December 31 of each year.
(4) A license may be renewed upon:
(a) Payment of the prescribed fee;
and
(b) Action by the board, based
upon recommendation of staff following the physical inspection of the
provider.
(5) A license
to operate shall be issued only for the person or entity, service area, and
premises, including the number of aircraft, named in the application, and shall
not be transferable.
(6) A new
application shall be filed if a change of ownership of an air ambulance service
occurs. A change of ownership for licenses shall be deemed to occur if more
than fifty (50) percent of the assets, capital stock, or voting rights of a
corporation or provider operating an air ambulance is purchased, transferred,
leased, or acquired by comparable arrangement by one (1) person or entity from
another.
(7) If a new application
for a license is filed due to change of ownership, the new license shall be
issued for the remainder of the current licensure period.
(8) There shall be full disclosure to the
board of the changes in ownership, including the name and address, of:
(a) Each person having direct or indirect
ownership interest of ten (10) percent or more in the service;
(b) Officers and directors of the
corporation, if a service is organized as a corporation; or
(c) Partners, if a provider is organized as a
partnership.
(9)
Representatives of the board shall have access to the service during hours that
the service operates.
(10) A
regulatory violation identified during an inspection shall be transmitted in
writing by the board and given to the provider.
(11) The provider shall submit a written plan
for the elimination or correction of a regulatory violation to the KBEMS Office
within ten (10) working days after receipt of the statement of violation and
shall include the specific date by which the violation may be
corrected.
(12) Within ten (10)
working days following a review of the plan, the KBEMS Office shall notify the
provider in writing whether or not the plan is accepted as providing for the
elimination or correction of the violation.
(13) The KBEMS Office may conduct a follow-up
visit to verify compliance with the plan.
(14) If a portion or all of the plan is
insufficient:
(a) The KBEMS Office shall
specify the reasons why the plan cannot be accepted; and
(b) The provider shall modify or amend the
plan and resubmit it to the KBEMS Office within ten (10) days after receipt of
notice that the plan is insufficient.
(15) Unannounced inspections may be conducted
at the discretion of the board or its representative.
(16) Any licensed
provider may be recommended
for discipline based upon:
(a) Failure to
submit, amend, or modify a plan of correction to eliminate or correct
regulatory violations;
(b) Failure
to eliminate or correct regulatory violations;
(c) Falsifying an application for
licensing;
(d) Changing a license
issued by the board;
(e) Attempting
to obtain or obtaining a license by:
1.
Fraud;
2. Forgery;
3. Deception;
4. Misrepresentation; or
5. Subterfuge;
(f) Providing false or misleading
advertising;
(g) Falsifying, or
causing to be falsified a:
1. Patient
record;
2. Service run report;
or
3. Other reports provided to the
KBEMS Office;
(h)
Providing an unauthorized level of service;
(i) Demonstrating a history of staff
violations that have resulted in disciplinary action;
(j) Failing to provide the board or its
representative with information upon request, or obstructing an investigation
regarding alleged or confirmed violations of statutes or administrative
regulations;
(k) Issuing a check
for a license on an invalid account or an account with insufficient funds to
pay fees to KBEMS;
(l) Submitting
fraudulent or misleading claims for reimbursement to:
1. An individual;
2. A private insurance company;
3. A governmental agency; or
(m) Any violation of KRS Chapter
311A or 202 KAR Chapter 7.
Section 3. Utilization of Aircraft by
Licensed Providers.
(1) At the time of initial
inspection, each provider shall inform the KBEMS Office of the make, model,
year, serial number, and FAA identification number for each aircraft it
uses.
(2) Except as provided by
this administrative regulation, an aircraft shall not be placed into operation
until after the board has been notified and has verified through a physical
inspection that the aircraft meets the requirements of this administrative
regulation.
(3) Each provider shall
notify the KBEMS Office via U.S. mail, email, or fax, no later than the next
board business day, of the permanent removal of any licensed aircraft from
service by the license holder.
(4)
A licensed
provider may use a replacement aircraft on a temporary basis if an
approved aircraft is out of service, if:
(a)
The KBEMS Office receives notice within twenty-four (24) hours or on the next
business day by fax or email of the need for the provider to place an aircraft
into service on a temporary basis; and
(b) Within five (5) business days, the
provider provides the board written notice identifying:
1. The make, model, year, serial number, and
FAA identification number for the aircraft being removed from service and for
the aircraft being placed into temporary service; and
2. The temporary replacement aircraft meets
the requirements of this administrative regulation.
(5) A temporary replacement
aircraft shall not be used for more than sixty (60) days, unless the KBEMS
Office has verified through a physical inspection that it meets the
requirements of this administrative regulation.
(6) The KBEMS Office shall be notified by
email or fax within twenty-four (24) hours or on the next business day when a
temporary aircraft is removed from service and the original licensed aircraft
is returned to service.
(7) A
provider that fails to meet the reporting requirements for use of a temporary
aircraft may be required to immediately cease use of the replacement aircraft
until the reporting requirements are met.
(8) A provider that fails to remove a
temporary aircraft from service upon written order may be fined an amount not
to exceed $1,000 per day for each day or partial day the aircraft is in service
and the reporting requirements are not met.
(9) This administrative regulation shall not
prevent a
provider from utilizing other means of transporting patients in:
(a) Disasters;
(b) Mass casualty incidents; or
(c) Extraordinary scene conditions that may
impair the safety of the patient or personnel operating at the scene.
Section 4. Provider
Management Requirements.
(1) All providers
shall:
(a) Maintain an organizational chart
that establishes lines of authority, including the designation of:
1. An administrator responsible for assuring
compliance with this administrative regulation during the daily operation of
the service; and
2. A designee who
shall serve in the absence of the administrator;
(b) Maintain records and reports at the
ambulance service
base station or at a location where the records can be made
readily available to
KBEMS staff including an original, microfilm, electronic
equivalent, or copy of all run reports whether reported on:
1. The EMS-8A and EMS-8B "Kentucky Emergency
Medical Ambulance Run Report" (9/98), with all nonshaded portions of the run
report completed as appropriate for each patient and each run; or
2. A paper or electronic run form developed
by the provider that contains all of the data components of the nonshaded areas
of the EMS-8A and EMS-8B (9/98);
(c) Maintain a copy of all completed run
report forms, maintained to ensure confidentiality and safekeeping, for a
minimum of five (5) years from the date on which the service was rendered, or
in the case of a minor, until five (5) years after the minor reaches eighteen
(18) years of age. Copies of run reports shall be accessible so as to be
immediately available to the board, KBEMS Office, or representatives upon
request;
(d) Maintain personnel
files for each employee or volunteer who staffs an aircraft. Personnel files
shall be maintained for a minimum of five (5) years following separation from
employment. As a minimum, personnel files shall contain:
1. Current certification or licensure with
corresponding numbers and expiration dates for the position that the individual
fulfills on the aircraft;
2. Proof
that the provider has conducted a pre-employment criminal background check;
and
3. Health records, maintained
in accordance with state and federal laws and administrative regulations, in a
separate secure file, that include:
a. A
post-offer of employment health assessment;
b. Annual tuberculin skin testing or other
method of evaluation;
c.
Hepatitis-B vaccinations and seroconversion testing unless exempted by the
employees' physician, or an employee signed waiver; and
d. A record of all work-related illnesses or
injuries;
(e)
Maintain a plan and records for the provision of continuing education for staff
and volunteers including a written plan for the method of assessment of staff
continuing education needs and a coordinated plan to meet those needs
including:
1. Training or continuing education
rosters that include the printed name, signature, and certification or license
number of those in attendance;
2. A
curriculum vitae for the instructor; and
3. A brief outline of the presentation
including the educational objective for the offering and the method of
presentation used for the presentation;
(f) Maintain an infection control plan in
accordance with KyOSHA guidelines;
(g) Maintain a written plan for training or
educating personnel for responding to hazardous materials, criminal, and
potential terrorist incidents, including plans for the protection and
decontamination of patients, aircraft, equipment, and staff;
(h) Maintain a written plan for the quality
assessment of patient care and
provider quality improvement including a
periodic review of ambulance run report forms, and evaluation of staff
performance related to patient care. This plan shall address as a minimum:
1. Aircraft maintenance as it impacts the
clinical aspects of patient care delivery, employee health and
safety;
2. Compliance with
protocols and operating procedures;
3. Transport response and transport
limitations;
4. Assessment of
dispatch procedures;
5. Aircraft
operations and safety;
6. Equipment
preventive maintenance programs; and
7. A process for the resolution of customer
complaints;
(i) Maintain
a written plan for training personnel and responding to mass casualty incidents
and disasters, which shall include an internal incident command structure and
how it will integrate into a community response plan;
(j) Maintain an orientation program for all
personnel related to:
1. Aircraft, scene,
ground, and base safety;
2.
Communication equipment at the base station and on each aircraft;
3. The location and use of fire
extinguishers;
4. Transport
response and transport limitation standards;
5. Map reading and geographic
orientation;
6. Mutual aid
agreements;
7. Cleaning of
equipment including aircraft;
8.
Stretcher operations and use;
9.
Completion of run reports; and
10.
Other standard operating procedures that have been established by the
provider;
(k) Maintain
proof of professional liability malpractice insurance;
(l) Maintain proof of aircraft liability
insurance;
(m) Provide a copy of
the current FAA Air Carrier Certificate; and
(n) Maintain a written policy regarding
patient criteria for interfacility transfers including a written statement of
medical necessity signed by a physician for each patient transferred.
(2) Each
provider shall, in the
county in which their
base station or a substation is located:
(a) Document evidence of participation in
county emergency management disaster exercises, if conducted;
(b) Coordinate with the county emergency
management director plans for the possible utilization of a provider's
personnel for use in the emergency operations center in a disaster;
and
(c) Maintain a copy of the
county and state emergency management agency's emergency operations plan at the
ambulance base station.
Section 5. Operating Requirements.
(1) All air ambulance providers shall provide
service twenty-four (24) hours a day, seven (7) days a week, subject to safety
issues and weather conditions established in Part 135 of the FAR. These
provisions may be met through a call system or through mutual aid
agreements.
(2) A
provider shall
have a written plan, developed in consultation with the air ambulance
provider's
medical director, that requires:
(a) Utilization of the air medical intake
flow chart;
(b) Dispatch of
requests for emergency service within two (2) minutes of the call taker's
determination of the correct address or location of the emergency incident site
and completion of a weather check;
(c) Disclosure of the accurate availability
of provider's aircraft, including the estimated time of arrival to the
requesting agency. If the provider's closest aircraft is not available, and so
requested by the requesting agency, the provider shall attempt to contact the
closest known aircraft to the scene; and
(d) The air ambulance provider to share
current aircraft position data, through computer interface with other air
ambulance providers, if the air ambulance provider utilizes a satellite
tracking position mechanism.
(3) A provider may enter into mutual aid
agreements with other Kentucky licensed air ambulance services operating within
the same geographic area.
(4) A
provider may accept a request to provide service outside of its service area
except it shall require documentation from the requesting facility or provider
that a good faith effort was made to utilize a provider licensed for the
area.
(5) A preventive maintenance
program shall be maintained that complies with Part 135 FAR or Part 92
FAR.
(6) Minimally, documentation
of annual inspections or annual preventative maintenance records in addition to
any records of maintenance performed shall be maintained by the provider to
support evidence of periodic inspections or calibrations required for
maintenance and operation of medical equipment utilized on the
aircraft.
(7) Each aircraft and its
equipment shall be checked after each use to ensure that it is in a clean and
sanitary condition, unless precluded by emergency conditions. Minimally,
documentation shall be maintained by the provider to support the evidence of a
daily medical equipment checklist.
(8) A communications system shall be
developed, coordinated, and maintained by each ambulance
provider. The
communication system shall meet the following requirements:
(a) Radio equipment used in emergency medical
services aircraft shall be appropriately licensed through the FCC. Copies of
the current FCC licenses shall be on file in the provider's office;
(b) Aircraft shall be equipped with two (2)
way radio communication equipment capable, under normal conditions, of
contacting dispatch centers and hospitals;
(c) Aircraft shall have air-to-air,
ground-to-air, and air-to-ground communication capabilities and shall be
capable of communicating with ground personnel to properly coordinate the
landing and primary medical responders on the ground who may be caring for the
patient;
(d) Aircraft shall have a
minimum of two (2) portable communication devices capable of operating on the
provider frequency that shall be provided for personnel when away from the
aircraft; and
(e) All aircraft when
approaching and departing a landing zone in uncontrolled airspace shall
announce their intentions to other aircraft via 123.025 MHz.
(9) Air ambulance providers shall
comply with FAR specifications for flight following and position plotting by a
provider based or maintained communication center. The communication center
shall be equipped with communications equipment and staffed by a properly
trained ACS to receive and coordinate all calls as provided for by FAR. If
providing fixed-wing service, this requirement may be met by filing an FAA
flight plan.
(10) An
ACS shall have
documented training appropriate to the transport of the
provider that shall as
a minimum address the following areas:
(a) FAA
and FCC regulations pertinent to air ambulance operations;
(b) Air medical radio
communications;
(c) Medical
terminology;
(d) Flight
coordination and utilization;
(e)
Navigation and weather interpretation;
(f) Flight following; and
(g) Emergency procedures.
(11) An air ambulance
provider
shall provide proof that it:
(a) Complies with
FAR pertaining to maintenance inspections, flight, and duty time;
(b) Complies with FAA and FAR required
maintenance activities; and
(c)
Holds FAR required air ambulance operations specifications.
Section 6. Aircraft
Requirements.
(1) Fixed and rotor-wing air
ambulance aircraft shall:
(a) Have an entry
that allows patient loading and unloading without tilting the patient greater
than thirty (30) degrees from the horizontal axis;
(b) Be climate controlled and maintain a
temperature of not less than sixty-five (65) degrees nor more than eighty-five
(85) degrees Fahrenheit in the patient compartment during patient transport or
demonstrate a procedure for maintaining patient temperature sufficient to
prevent hypothermia and hyperthermia;
(c) Keep all pharmaceuticals within the
recommended temperature range as established by the manufacturer or as
otherwise established by FDA standards;
(d) Utilize an alternate aircraft or
alternate mode of transportation, if the environment within the aircraft is
such that it would be detrimental to the staff's physical welfare or the
patient's condition, until those conditions are alleviated;
(e) Be configured in such a way that air
medical personnel shall have access to the patient to begin and maintain both
basic and advanced life support;
(f) Have interior lighting adequate to ensure
complete observation of the patient;
(g) Have a procedure in place to limit light
in the cockpit area during night operation;
(h) Have an electric inverter, with two (2)
outlets, to convert direct current (DC) to alternating current (AC) for
operation of specialized equipment, such as an isolette or intra-aortic balloon
pump;
(i) Have equipment,
stretchers, and seating:
1. Arranged so as not
to block rapid egress by air ambulance personnel or patients; and
2. Affixed or secured in FAA approved racks,
compartments, or strap restraints which meet FAR "G" loading
requirements;
(j) Have a
patient stretcher or litter which:
1. Has the
capability to raise the head of the patient; and
2. Has appropriate devices to secure the
patient to the stretcher;
(k) Provide proof of an FAR Part 135
certificate with an FAR required air ambulance specification; and
(l) Not transport more patients, personnel,
and other persons than can be safely secured by means of seat safety belts or
similar devices in the aircraft during flight.
(2) Fixed-wing aircraft shall be pressurized
if patient flights are to exceed 6000 feet mean sea level.
Section 7. Air Ambulance Medical Personnel.
(1) A rotor-wing air ambulance service
operating an ALS aircraft shall assure that it is minimally staffed by:
(a) A pilot as required by this
administrative regulation; and
(b)
Two (2) attendants that meet one (1) of the following staffing configurations:
1. A Kentucky licensed paramedic and RN
authorized to practice in the state of Kentucky pursuant to KRS Chapter
314;
2. A RN and RN both of which
are authorized to practice in the state of Kentucky pursuant to KRS Chapter
314; or
3. A physician authorized
to practice in the state of Kentucky pursuant to KRS Chapter 311 and RN
authorized to practice in the state of Kentucky pursuant to KRS Chapter
314.
(2) Each
attendant required by subsection (1)(b) of this section shall additionally
maintain documentation of current certification or the equivalent thereof as
approved by the board of the following:
(a)
ACLS;
(b) BLS;
(c) PALS;
(d)
1.
PHTLS;
2. ITLS; or
3. TNATC; and
(e) NRP.
(3) BLS fixed-wing patient transports shall
be minimally staffed by:
(a) A pilot as
required by this administrative regulation; and
(b) Two (2) attendants whom shall be
minimally certified as EMT's by the board.
(4) ALS fixed-wing patient transports shall
be minimally staffed by:
(a) A pilot as
required by this administrative regulation; and
(b) Two (2) attendants of which:
1. The first patient attendant shall be:
a. A flight nurse; or
b. A RN authorized to practice in the state
of Kentucky pursuant to KRS Chapter 314, qualified by specific patient
population, experience, and current competencies in emergency and critical
care; and
2. The second
patient attendant shall be:
a. A RN authorized
to practice in the state of Kentucky pursuant to KRS Chapter 314, qualified by
specific patient population, experience, and current competency in emergency
and critical care;
b. A licensed
paramedic;
c. A certified or
registered respiratory therapist qualified by specific patient population,
experience, and current competency in mission-specific patient care;
or
d. A physician authorized to
practice in the state of Kentucky pursuant to KRS Chapter 311 and qualified by
relevant training, experience, and current competency in mission-specific
patient care.
(5) A staffing variance on an ALS fixed-wing
patient mission necessitated by staffing or patient care requirements shall not
be permitted unless prior approval is granted by the medical director or
designee.
(6) ALS specialty care
patient transports by rotor or fixed wing air ambulance shall be minimally
staffed by:
(a) A pilot meeting the
requirements of this administrative regulation; and
(b) Two (2) attendants with relevant
training, experience, and current competency in transport-specific patient care
as authorized by the
medical director or designee of which:
1. The first patient attendant shall be:
a. A RN authorized to practice in the state
of Kentucky pursuant to KRS Chapter 314;
b. A nurse practitioner; or
c. A physician authorized to practice in the
state of Kentucky pursuant to KRS Chapter 311; and
2. The second patient attendant shall be:
a. A RN authorized to practice in the state
of Kentucky pursuant to KRS Chapter 314;
b. A Kentucky licensed paramedic;
c. A certified or registered respiratory
therapist;
d. A nurse practitioner;
or
e. A physician authorized to
practice in the state of Kentucky pursuant to KRS Chapter 311.
(7) All
regular and specialty care air ambulance patient attendants shall attend and
document flight orientation training. Flight orientation training shall
include:
(a) Altitude physiology;
(b) Aircraft-specific operations and
in-flight safety;
(c) Emergency
egress and survival training;
(d)
Crew resource management; and
(e)
Communication equipment utilization and emergency procedures.
(8) All regular air ambulance
patient attendants shall complete and document additional flight orientation
training to include:
(a) Scene
safety;
(b) Use of extrication
equipment;
(c) Scene
triage;
(d) Kentucky EMS statutes
and administrative regulations;
(e)
Advanced airway management;
(f)
Anatomy, physiology, and assessment of adult, pediatric, and neonatal patients
as outlined within the program's scope of care;
(g) Cardiac emergencies and advanced critical
car;
(h) Burns;
(i) Environmental emergencies;
(j) High risk OB;
(k) Multitrauma emergencies;
(l) Toxicology;
(m) Hazardous materials awareness level
training;
(n) Hemodynamic
monitoring;
(o) Mechanical
ventilation and respiratory physiology; and
(p) Pharmacology;
(9) All regular air ambulance patient
attendants shall complete and document annual continuing education which shall
include a review of:
(a) Infection
control;
(b) Kentucky EMS
administrative regulations regarding ground and air transport;
(c) Crew resource management;
(d) Stressors of flight if not included in
crew resource management;
(e)
Survival training; and
(f) Skill
maintenance program or competency program for invasive, high risk, or low
volume procedures as outlined in the program's scope of care.
(10) An attendant shall remain
with the patient, in the patient compartment, at all times during
transport.
(11) All aircraft
responding to flights originating in Kentucky shall be licensed by the
board.
(12) Aircraft that are
licensed in Kentucky may use the staffing requirements of the state in which
they are located if they are licensed in that state and the staffing
requirements for that state, at a minimum, for scene flights shall be:
(a) Paramedic and RN;
(b) RN and RN; or
(c) Physician and RN.
(13) This administrative regulation shall not
prevent a
provider from utilizing staff other than that required by this
administrative regulation in:
(a)
Disasters;
(b) Mass casualty
incidents; or
(c) Extraordinary
scene conditions that may impair the safety of the patient or personnel
operating at the scene.
(14)
(a)
Staffing configurations as outlined in this administrative regulation may
supplement or replace the patient care attendants on a ground ambulance
licensed in Kentucky for the purpose of facilitating the care and the transport
of a patient if:
1. The aircraft was unable to
complete a patient flight due to deteriorating weather conditions or other
unplanned events; or
2. For the
purpose of providing a continuum of care from the scene to the aircraft or from
the aircraft to the patient destination.
(b) Air ambulance personnel shall assure the
availability of necessary equipment to care for the patient during
transport.
Section
8. Provider Requirements for Air Ambulance Pilots. The air
ambulance provider shall assure that prior to performing emergency medical
service transports the PIC complies with all requirements as set forth in 14
FAR Part 135.4. All documentation of having met this requirement shall be
provided upon request.
Section 9.
Basic Life Support Equipment and Supplies.
(1)
All rotor air ambulance providers shall carry and maintain, in full operational
order, the following minimum BLS equipment and supplies:
(a) Suction equipment, which shall include:
1. Two (2) sources of suction apparatus, one
(1) of which shall be fixed, and one (1) of which shall be portable;
2. Rigid catheters;
3. Flexible catheters in adult, pediatric,
and infant sizes;
4. Bulb syringe
or meconium aspiration device for infant and neonate suction;
(b) Oxygen and airway supplies and
equipment, including:
1. An installed oxygen
system with a capacity of at least 2,000 liters of oxygen for each
aircraft;
2. Portable oxygen system
supplying at least 300 liters;
3. A
backup source of oxygen, which may be the required portable tank if it is
carried in the patient care area during flight in the event the main system
fails. The backup source shall be delivered via a nongravity dependent delivery
device;
4. Pressure gauge and flow
rate regulator for fixed and portable units with a range of zero to fifteen
(15) liters per minute;
5. Oxygen
supply tubing;
6. Transparent
nonrebreather oxygen masks for adults and pediatrics;
7. Nasal cannulas for adults and
pediatrics;
8. Disposable adult,
pediatric, and infant bag-valve-mask ventilation units with oxygen reservoir,
oxygen tubing, and masks;
9.
Nasopharyngeal and oropharyngeal airway kits in sizes for adult and children
with water soluble lubricant; and
10. Bite stick;
(c) Trauma equipment and supplies including:
1. Two (2) sterile universal dressings at
least 10 in. x 30 in., compactly folded and packaged;
2. Four (4) by four (4) gauze pads;
3. Soft roller self-adhering bandages,
various sizes;
4. Four (4) rolls of
adhesive tape, minimum of two (2) sizes;
5. Two (2) sterile burn sheets;
6. Two (2) eye protector pads and shields or
an approved substitute;
7. Two (2)
occlusive dressings;
8. Shears for
bandages;
9. Splints, including:
a. Lower extremity mechanical traction splint
in adult and pediatric sizes; and
b. Splints for arm, full leg and foot using
semi-rigid immobilization devices; and
10. Immobilization devices, including:
a. Lower adult and pediatric long spine
boards or other full body immobilization device with straps and cervical
immobilization accessories;
b. Five
(5) rigid, still cervical collars in four (4) different sizes including
pediatric sizes; and
c. Towel rolls
or other bulk dressings to be used for cervical immobilization for
infants;
(d)
Patient assessment and management equipment and supplies, including:
1. Adult, obese adult, pediatric, and infant
sphygmomanometer cuffs with stethoscope. A permanently mounted sphygmomanometer
shall not satisfy this requirement;
2. One (1) penlight;
3. An AED with a minimum of two (2) complete
sets of pads for all non-ALS air ambulances;
4. A device for monitoring pulse oximetry;
and
5. Thermometer;
(e) Personal protective equipment,
which shall be available to each staff member responding on the aircraft,
including:
1. One (1) clean scrub gown or
substitute, such as disposable coveralls;
2. Simple disposable face mask;
3. Clear protective goggles or safety
glasses;
4. Disposable
gloves;
5. One (1) particulate
filter mask rated at N95 or better without an exhaust port for patient
use;
6. One (1) particulate filter
mask rated at N95 or better with or without an exhaust port for protection of
crew members; and
7. A means of
cleansing the hands, such as disposable towelettes or other
solutions;
(f) Patient
comfort items including:
1. Two (2) clean
blankets and sheets; and
2. An
emesis container or similar substitute; and
(g) Miscellaneous supplies, including:
1. Hand held flashlight capable of providing
adequate lighting to assess a scene or a patient away from the
aircraft;
2. One (1) sterile
obstetrical kit;
3. Instant
glucose; and
4. One (1)
multipurpose fire extinguisher which meets FAA requirements for each specific
aircraft and configuration.
(2) All aircraft shall have a stretcher or
litter with:
(a) Head-raising
capabilities;
(b) An FAA approved
aircraft-specific mechanism for securing the stretcher or litter in the
aircraft during transit; and
(c) An
FAA approved aircraft-specific patient to stretcher securing
mechanism.
(3) Cleaning
materials shall be available, including:
(a)
Hospital type disinfectants;
(b)
Glass or multisurface cleaner;
(c)
Trash bags for disposal of nonbiohazard waste materials;
(d) Biohazard bags for the disposable of
biohazard waste; and
(e)
Environment, terrain, and mission-specific rescue and survival
supplies
(4) Current
expiration dates shall be required for any item that carries an expiration
date.
Section 10.
Advanced Life Support Equipment and Supplies.
(1) All ALS providers shall maintain evidence
in the form of a letter that medical protocols have been reviewed and approved
by the board.
(2) In addition to
the BLS equipment required in Section 9 of this administrative regulation, an
ALS
provider shall carry on each aircraft, and maintain in fully-operational
order, supplies and equipment required by the providers protocols, including as
a minimum:
(a) Endotracheal intubation
equipment consisting of:
1. Laryngoscope
handle;
2. Various laryngoscope
blades in adult, pediatric, and infant sizes;
3. Extra batteries and bulbs for handles or
blades;
4. A minimum of seven (7)
different sizes of endotracheal tubes for oral and nasal placement in adult,
pediatric, and infant sizes;
5.
Equipment necessary to perform emergency cricothyrotomy;
6. Alternative airway device to include at
least one (1) of the following:
a.
LMA;
b. Combitube;
c. King Airway; or
d. Additional alternative airway device as
approved by the service medical director;
7. End tidal carbon dioxide detection
devices, including:
a. A Capnography device
that provides continuous waveform and digital readout of end tidal CO2;
and
b. A disposable colormetric
device;
8. Stylettes in
adult and pediatric sizes;
9.
Magill forceps in adult and pediatric sizes;
10. One-half (1/2) inch wide twill tape or
equivalent for securing endotracheal tubes; and
11. Water soluble lubricant for lubrication
of endotracheal and nasotracheal tubes;
(b) A portable monitor defibrillator that:
1. Is capable of displaying a visual display
of cardiac electrical activity;
2.
Is capable of providing a hard copy of cardiac electrical activity
measure;
3. Is capable of
delivering direct current energy over a variable range, which is suitable for
pediatric and adult usage;
4. Is
capable of providing external cardiac pacing;
5. Has adult and pediatric external paddle
electrodes or pads, capable of utilization for immediate monitoring of heart
activity and delivery of counter shock in both the adult and pediatric
patient;
6. Is capable of being
operated from internal rechargeable batteries;
7. Has synchronized counter-shock capability
for cardioversion; and
8. Has a
patient monitoring cable with:
a. Electrode
paste or gel or equivalent;
b.
Electrode pads or equivalent for use with the patient monitoring cable;
and
c. One (1) additional roll of
paper for hard copy printout;
(c) Pulse oximeter;
(d) Mechanical ventilation device;
(e) Sterile, disposable needles in types and
sizes sufficient for personnel to administer medications and perform procedures
allowed by the providers' patient treatment protocols;
(f) Disposable syringes in types and sizes
sufficient for personnel to administer medications and perform procedures
allowed by the providers' patient treatment protocols;
(g) Restriction band appropriate for use with
venipuncture procedure;
(h)
Dextrostix or equivalent for the measure of blood glucose levels;
(i) Disposable, individually-packaged
antiseptic wipes;
(j) Intravenous
fluids as required by the provider's protocol, with macrodrip and microdrip
fluid sets, extension sets and accessory items including over-the-needle
catheter devices in sizes fourteen (14) to twenty-four (24) gauge;
(k) Intraosseous needles; and
(l) Pediatric drug dosage tape or equivalent
that provides easy reference for pediatric and infant treatment and drug
dosages.
(3) An ALS
provider shall stock and maintain drugs and medications as required by the
master drug list contained in protocols established in accordance with this
section.
(4) Controlled drugs shall
be stored in a locked storage box in a locked compartment on the aircraft. A
provider that stores and utilizes controlled substances shall show proof of
having submitted the provider's protocols to the Cabinet for Health Services'
Drug Control Branch.
(5) A provider
may maintain other supplies or equipment that are required to carry out its
protocols as approved by the board.
(6) Current expiration dates shall be
required for any item that carries an expiration date.
(7) Drugs and fluids maintained on the
aircraft shall be stored based on manufacturer's recommendations.
Section 11. Specialty Care
Equipment. A provider may maintain other equipment specified by the medical
director if needed for the transport of neonates or other special needs
patients.
Section 12. Medical
Directors.
(1) All providers of air ambulance
services shall have a medical director.
(2) Medical directors shall meet the
requirements as set forth in
202 KAR
7:801.
Section 13. Request for Waiver.
(1) A provider licensed or contemplating
licensure under this administrative regulation may make a written request to
the board for certain provisions of this administrative regulation to be
waived.
(2) A request shall justify
that a proposed waiver, if approved, shall not jeopardize the quality of
patient care or public safety.
(3)
The board may approve a request based on at least one (1) of the following:
(a) Circumstances where public health and
safety is a factor;
(b) Extenuating
or mitigating circumstances that warrant consideration to assure the delivery
of adequate emergency medical services;
(c) Substitution of equipment authorized by
this administrative regulation; or
(d) Testing of new procedures, techniques, or
equipment in a pilot study authorized by the board.
(4) The board shall establish time limits and
conditions on all waivers.
Section
14. Exemptions from Regulations.
(1) The following situations shall be exempt
from the provisions of this administrative regulation:
(a) First aid or transportation provided in
accordance with KRS
216B.020(2)(f);
(b) An aircraft serving as an ambulance
during a disaster or major catastrophe; or
(c) An aircraft operated by the United States
government on property owned by the United States government.
(2) In addition, the following
out-of-state providers shall be exempt from the provisions of this
administrative regulation:
(a) An aircraft
licensed by another state that is transporting a patient from out of state to a
Kentucky medical facility or other location in Kentucky;
(b) An aircraft licensed by another state
that is transporting a patient from out of state through Kentucky to another
location out of state; and
(c) An
aircraft licensed in an adjoining state that responds to a mutual aid request
from a Kentucky licensed
provider for
emergency assistance if the out-of-state
service is the closest service appropriately capable of responding to the
request or if Kentucky licensed providers:
1.
Are unavailable;
2. Have already
responded; or
3. Are physically
unable to reach the incident.
Section 15. Public Notice of Negative Action.
The board office shall cause to be published, in the KBEMS News or similar
publication of the board, or otherwise disseminate, the name of an ambulance
provider that is fined, placed on probationary status, placed on restricted
status, suspended, or had a license revoked.
Section 16. Incorporation by Reference.
(1) The following material is incorporated by
reference:
(a) Form EMS-8A, "Kentucky
Emergency Medical Services Ambulance Run Report", 9/98;
(b) Form EMS-8B, "Kentucky Emergency Medical
Services Ambulance Run Report", 9/98;
(c) Form EMS-1, "Kentucky Application for
Ambulance Service Licensing", 6/96; and
(d) "Air Medical Intake Flow Chart",
10/2008.
(2) This
material may be inspected, copied, or obtained, subject to applicable copyright
law, at the Office of the Kentucky Board of Emergency Medical Services, 500
Mero Street, 5th Floor 5SE32, Frankfort, Kentucky 40601, Monday through Friday,
8 a.m. to 4:30 p.m.