KENTUCKY COMMUNITY AND TECHNICAL COLLEGE SYSTEM
Kentucky Board of Emergency Medical Services
(New Administrative Regulation)
202 KAR 7:565. Clinical pilot programs.
RELATES TO: KRS 216B.020(2)(f), 311A.030, 311A.060, 311A.180, 311A.190
STATUTORY AUTHORITY: KRS 311A.020, 311A.025, 311A.030, 311A.035, 311A.165, 311A.170, 311A.175, 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.
JIM DUKE, Chairperson
APPROVED BY AGENCY: December 7, 2017
FILED WITH LRC: December 13, 2017 at 2 p.m.
PUBLIC HEARING AND PUBLIC COMMENT PERIOD: A public hearing on this administrative regulation shall be held on January 24, 2018 at 10 a.m. Eastern Standard Time at 118 James Court, Suite 50, Lexington, Kentucky 40505. Individuals interested in being heard at this hearing shall notify this agency in writing by 5 workdays prior to the hearing of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through January 31, 2018. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.
CONTACT PERSON: Angela Evans; Legal Counsel, Kentucky Fire Commission; McBrayer, McGinnis, Leslie & Kirkland, PLLC, 201 East Main Street Suite 900, Lexington, Kentucky 40507, phone (859) 231-8780, fax (859) 281-6480, email firstname.lastname@example.org
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person: Angela Evans
(1) Provide a brief summary of:
(a) What this administrative regulation does: This administrative regulation establishes the application monitoring process for clinical pilot programs.
(b) The necessity of this administrative regulation: This administrative regulation is necessary to establish uniform process for agencies to submit a clinical pilot project for approval by the Kentucky Board of Emergency Medical Services.
(c) How this administrative regulation conforms to the content of the authorizing statutes: This administrative regulation conforms with the board’s delegated authority to develop and monitor programs that may be of benefit to emergency medical services.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes: This administrative regulation sets forth the board’s application process and specifies the requirements to obtain approval for a clinical pilot project.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation: This is a new regulation.
(b) The necessity of the amendment to this administrative regulation: This is a new regulation.
(c) How the amendment conforms to the content of the authorizing statutes: This is a new regulation.
(d) How the amendment will assist in the effective administration of the statutes: This is a new regulation.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation: There are approximately 213 ambulance providers and medical first response agencies that could present a pilot program to the board.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment: The agencies are not required to submit a pilot program, therefore no action is required of them to be in compliance.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3): There is a $500 application fee for any agency that chooses to submit a pilot program for approval by the board.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3): The agencies choosing to submit a pilot project will have a uniform application process with clear expectations of the project set forth by the board.
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation: None
(a) Initially: None
(b) On a continuing basis: None
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation: Board funds.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment: No fee increase is necessary to implement this amendment.
(8) State whether or not this administrative regulation established any fees or directly or indirectly increased any fees: This administrative regulation establishes a $500 application fee that goes towards the cost of staff time to process and review the application.
(9) TIERING: Is tiering applied? Tiering was not applied as the regulation is applicable to all credential holders. This regulation does not distinguish between similarly situated individuals on the basis of any factor.
FISCAL NOTE ON STATE OR LOCAL GOVERNMENT
1. What units, parts or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation? Ambulance providers and first response agencies.
2. Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation: KRS 311A.020, 311A.025, 311A.030, 311A.190
3. Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year? This administrative regulation will not generate revenue.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years? This administrative regulation will not generate revenue.
(c) How much will it cost to administer this program for the first year? The cost to administer the program is approximately $500, which is the cost of the application.
(d) How much will it cost to administer this program for subsequent years? The cost to administer the program is approximately $500, which is the cost of the application.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-): None
Expenditures (+/-): None
Other Explanation: None