RELATES TO:
KRS
216B.020(2)(f),
311A.030,
311A.060,
311A.180,
311A.190
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
311A.020 requires the board to exercise all
administrative functions in the regulation of the EMS system and the licensing
of ambulance services and medical first response agencies.
KRS
311A.035 authorizes the board to develop,
monitor, and encourage other projects and programs that may be of benefit to
emergency medical services in the Commonwealth. This administrative regulation
establishes the process for agencies to submit clinical pilot programs and the
standards for approval by the board.
Section
1.
(1) A clinical
pilot program
shall allow for the use of assessment techniques or clinical procedures beyond
the regular scope of practice of
emergency medical responders established in
202 KAR
7:701.
(2)
(a) A licensed agency seeking authorization
for a clinical
pilot program shall submit a written proposal that includes a:
1. Letter of intent;
2. Description of the type of pilot
project;
3. General project
description;
4. Patient Interaction
Plan;
5. Staffing Plan;
6. Training and Education Plan;
7. Medical Direction and Quality of
Improvement Plan;
8. Data
Collection and Quantitative Reporting;
9. Completed "Request for Expedited or Full
Review" form located on pages 42 through 45 of the "Kentucky Community and
Technical College System Human Subjects Review Board Handbook for
Investigators: For the Protection of Human Subjects in Research," (6/2015), if
applicable; and
10. Nonrefundable
application fee of $500.
(b) The applicant agency's administrator and
medical director shall appear before the Medical Oversight Committee and
subsequent meeting of the board to present the applicant agency's proposed
pilot program for review or additional information.
(c) The Medical Oversight Committee shall
review the applicant's proposal and assess on its individual merits if the
project or program to be developed or implemented by the applicant is likely to
benefit patients and providers of emergency medical services. The Medical
Oversight Committee shall present its recommendation of approval or denial to
the board at the next regularly scheduled board meeting.
(d) Upon approval of a clinical
pilot
program, the board shall develop quarterly report deadlines and data points for
quarterly review by the Medical Oversight Committee.
1. The data points shall relate to the
specific methods and goals identified in the applicant's proposal.
2. The reporting deadlines and data points
shall be incorporated into a Memorandum of Understanding between the board and
the applicant.
(3) An individual certified or licensed by
the board who successfully completes an approved educational
pilot program in
accordance with
202 KAR
7:601 shall perform the procedures relevant to the
training and education received in the
pilot program subject to protocols
established by the
medical director and approved by the board in accordance
with
KRS
311A.180.
(4) The board may limit:
(a) The geographic area or service location
where the procedure is performed; and
(b) The performance of the procedure subject
to a:
1. Specific and defined
event;
2. Disaster; or
3. Designated directive.
(5) The board shall authorize the
use of physicians or other medical professionals to supervise and monitor the
training and education of providers involved in a pilot program.
(6) The board may restrict actions that
involve the performance of an invasive procedure or the administration of
medication subject to:
(a) Physician or
medical director oversight; or
(b)
The use of protocols that have been submitted to the board for review and
approved by the state medical advisor and the board in accordance with
KRS
311A.180.
(7) The office of the board shall retract the
approval of any Clinical
Pilot Program immediately if:
(a) The agency is in violation of any
provisions approved by the board, including data submission requirements;
or
(b) There is evidence the
assessment technique or procedure has caused physical or psychological harm to
a patient.
(8) Violation
of any provision of a Clinical Pilot Program shall be grounds for discipline in
accordance with KRS Chapter 311A.060.
Section 2. Public Notice of Negative Action.
The board office shall publish on the KBEMS web site or similar publication of
the board the name of any licensed agency that is fined, placed on probationary
status, placed on restricted status, suspended, or had a license
revoked.
Section 3. Incorporation
by Reference.
(1) "Kentucky Community and
Technical College System Human Subjects Review Board Handbook for
Investigators: For the Protection of Human Subjects in Research", (6/2015), is
incorporated by reference.
(2) This
material may be inspected, copied, or obtained, subject to applicable copyright
law, at the Kentucky Board of Emergency Medical Services, 118 James Court,
Suite 50, Lexington, Kentucky 40505, Monday through Friday, 8 a.m. to 4:30
p.m.
