Verified October 10, 2026 against the statutes, regulations and sources cited below. The state decides every application. All states
What testing sites miss in Tennessee
- The waived testing rule and form PH-3653 still list pharmacies, but a 2021 law exempts a pharmacy holding a CLIA Certificate of Waiver from the Medical Laboratory Act.
- Tennessee waived testing sites must document training and competency before testing and at least annually, record results with the analyst's identity, and may be inspected by state surveyors.
- A newly licensed lab may get a temporary license of up to 3 months, and must be fully operational, including reporting results, by its on-site inspection.
Does Tennessee require a state lab license on top of CLIA?
Tennessee licenses medical laboratories through its Medical Laboratory Board, one application per address. Its rules also require clinical labs and other state-licensed facilities running waived tests to file a Waived Testing Notification and have a physician or lab director approve the testing. Whether a physician office running only waived tests needs a license was not confirmed.
- Medical laboratory license; Waived Testing Notification for waived testing sites
- Issued by Tennessee Medical Laboratory Board
Citation: T.C.A. 68-29-101 et seq.; Tenn. Comp. R. & Regs. 1200-06-03-.02, -.17
Who is exempt in Tennessee?
Since 2021, a pharmacy holding an active CLIA Certificate of Waiver is exempt from the Medical Laboratory Act. Other exemptions in T.C.A. 68-29-104 were not read.
Citation: T.C.A. 68-29-104(12) (Public Chapter 495 of 2021)
What does Tennessee charge?
Medical laboratory license: $1,000 initial application and $1,000 annual renewal, plus a $5 annual state regulatory fee; $500 late renewal penalty; $100 for a change of owner, director or location; collection station $700 initial and $700 renewal (as of October 2026).
Citation: Tenn. Comp. R. & Regs. 1200-06-03-.02(3)
How often does a Tennessee lab registration renew?
- Renews every year
- Due A lab license expires each year on the anniversary of its original issue date and must be renewed on or before that date.
Do labs in other states need a Tennessee license to test its specimens?
An out-of-state lab doing temporary testing in Tennessee, such as health screens, may use its home-state CLIA certificate but must send a CMS-116 marked "For Information Only" with a cover sheet for each event, and should check state licensure with the Medical Laboratory Board.
Does Tennessee add a form to the CMS-116?
Waived Testing Notification (form PH-3653) to the Medical Laboratory Board, naming the tests, the people performing them and the Tennessee-licensed physician or director responsible.
Where does a Tennessee CMS-116 go?
- Tennessee Department of Health, Office of Health Care Facilities (CLIA State Agency)
- Email: CLIA.Health@tn.gov
- Phone: (615) 741-7023
Opening a testing site in Tennessee?
We prepare the CMS-116 and any Tennessee 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.
Sources
- stateAgency (CMS list updated May 2026)
- stateLicense, fees.other, notes (temporary license)
- stateLicense (waived testing notification and approval), notes (training, records, inspection)
- renewal
- supplement (form PH-3653, Wayback copy of July 2024)
- outOfStateLabs (Wayback copy, 2025)
- exemptions (68-29-104(12) pharmacy exemption), notes
- exemptions (Board summary of Public Chapter 495)
- fees.other (initial $1,000 plus $5 regulatory fee)