Kentucky Administrative Regulations › Title 202 - INDEPENDENT ADMINISTRATIVE BODIES › Chapter 7 - Kentucky Board of Emergency Medical Services › Section 202 KAR 7:565 - Clinical pilot programs

Current through Register Vol. 51, No. 1, July 1, 2024
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.