Kentucky State Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Directors
- Online Access to CLIA Certificates QCOR (See below)
- Pay your CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
Kentucky Department of Public Health, Clinical Laboratories.
https://apps.legislature.ky.gov/law/statutes/chapter.aspx?id=38871
(1) Title XXVI. Occupations and Professions. Chapter 333. Medical Laboratories
“Application for a medical laboratory license shall be made under oath by the director of the medical laboratory. The license shall be issued only for the performance of those medical laboratory procedures which the particular laboratory, by virtue of the educational and experience background of its laboratory personnel and the nature of its equipment and facilities, is competent to perform. A license shall not be issued unless the cabinet determines that the medical laboratory is adequately staffed and equipped to operate in conformity with the requirements of this chapter and the regulations promulgated hereunder.”
Application: http://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads//cms116.pdf
Lab Application: https://www.chfs.ky.gov/agencies/os/oig/dhc/Documents/LABapplication.pdf
Online Access to CLIA Certificates
CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool. All certificates generated after September 27, 2023 should be available for download. Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top). When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.