Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Kentucky
- A Kentucky license runs on the calendar year, so a lab licensed in November renews again on December 31.
- A physician office lab that accepts even some referred work from other practices loses its exemption.
Does Kentucky require a state lab license on top of CLIA?
No one may operate a medical laboratory in Kentucky without a state license, one per location, unless an exemption applies. The exemptions cover physician-run labs testing their own patients and pharmacies doing CLIA-waived tests, so other waived sites, such as employer clinics or clinics not run by physicians, need the license.
- Medical laboratory license
- Issued by Cabinet for Health and Family Services, Office of Inspector General
- Reaches labs doing only waived tests
Citation: KRS 333.030, 333.040; 902 KAR 11:010
Who is exempt in Kentucky?
Labs run by a licensed physician or physician group solely for their own patients; hospital labs; federal labs; research-only labs; and permitted pharmacies with a CLIA certificate doing CLIA-waived tests from stock or testing under collaborative care agreements. Any referred work ends the physician and pharmacy exemptions.
Citation: KRS 333.040
What does Kentucky charge?
$155 with each license application and $80 to renew (as of October 2026).
Citation: 902 KAR 11:010 Section 1
How often does a Kentucky lab registration renew?
- Renews every year
- Due Licenses expire December 31 after issue
Do labs in other states need a Kentucky license to test its specimens?
Kentucky's chapter covers labs within the state. A collection station in Kentucky may represent an out-of-state lab only if that lab is licensed or approved by its own state.
Citation: KRS 333.040, 333.170(2)
Where does a Kentucky CMS-116 go?
- Kentucky CLIA Program, Office of Inspector General, Division of Healthcare
- Email: KYCLIALabinquiries@ky.gov
- Phone: (502) 564-7963
Opening a testing site in Kentucky?
We prepare the CMS-116 and any Kentucky filing for your owner or director to sign, and track both to approval. You pay CMS and the state directly. A Certificate of Waiver application is $399 per site.