Tennessee's Medical Laboratory Rules for Waived Testing

Tennessee regulates lab testing on two levels. The Tennessee Medical Laboratory Act (T.C.A. 68-29-101 et seq.) and the Medical Laboratory Board's rules (Tenn. Comp. R. & Regs. chapter 1200-06-03) license medical laboratories, with a $1,000 initial fee. And a separate rule, 1200-06-03-.17, sets requirements for waived testing that apply at "any and all testing sites." For a practice, pharmacy or clinic planning waived tests in Tennessee, the questions are which of those applies, and what the waived testing rule asks.

What does Tennessee's waived testing rule require?

Rule 1200-06-03-.17(3) says "Clinical laboratories, pharmacies, and other health care facilities licensed by the State of Tennessee who perform waived testing must comply with the following minimum guidelines":

1. Notification. "Notification must be provided to the Administrative Office for the Board using Board approved forms and protocols." The form is PH-3653, Waived Testing Notification.
2. Approval of the tests. In a licensed medical laboratory, a Medical Laboratory Director approves waived testing. "In the absence of a Medical Laboratory Director," waived testing "must be approved by the physician legally responsible for laboratory testing performed by that health care facility or pharmacy."
3. Manufacturer's instructions, "including quality control."
4. Records. "Patient test results must be recorded in a clinical record, to include date and time of specimen collection, units of measurement and identity of analyst performing the test."
5. Named staff. The facility "must identify personnel responsible for performing and supervising the waived testing."
6. Training and competency. Testing staff "must demonstrate satisfactory levels of competence before performing patient testing, and at a minimum, annually thereafter."
7. Inspection. "Performance of waived testing will be evaluated by Laboratory surveyors at the time of inspection."

Several of those go beyond federal CLIA, which asks a Certificate of Waiver lab mainly to follow the manufacturer's instructions. A Tennessee site needs a written competency record for every person running tests, and a chart entry that names the analyst.

Which details go on form PH-3653?

The Waived Testing Notification (PH-3653, revised 5/09) asks for the facility type (clinical laboratory, imaging center, pharmacy or EMS), its name, address, hours and contact; its Tennessee facility or pharmacy license number with a copy of that license; its CLIA number; each test "to be Performed (include test name and methodology)"; the professional classifications of the people performing tests; and the Medical Laboratory Director or physician responsible, with a copy of that physician's current Tennessee medical license. The physician signs an affirmation that they are "legally responsible for the clinical laboratory testing procedures listed in this notification" and familiar with Tennessee's waived testing rules on personnel, supervision, training, quality control and records.

Because the form asks for a CLIA number, the federal Certificate of Waiver comes first. The CMS-116 goes to Tennessee's CLIA State Agency, which CMS lists (May 2026) at CLIA.Health@tn.gov and (615) 741-7023, and the lab pays CMS from its emailed coupon: $248 every two years for a Certificate of Waiver, as of October 2026.

Are pharmacies exempt?

From the Act, yes, since 2021. Public Chapter 495, signed May 25, 2021, added to T.C.A. 68-29-104 an exemption for "A pharmacy possessing an active Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certificate of Waiver." The Medical Laboratory Board's own summary says the law "exempts pharmacies, who possess a CLIA waiver, from the Medical Laboratory Act." The same law redefined "waived" to mean test systems cleared by FDA for home use and tests approved for waiver under CLIA.

The waived testing rule and form PH-3653 were written before that law and still list pharmacies. A pharmacy should confirm with the Board whether it still expects a notification; the statute is the stronger authority.

Does a physician office running only waived tests need a license?

That is the part we could not confirm from primary text. The full list of exemptions in T.C.A. 68-29-104 was not available to read, and the Board's rule on licensing exemptions (1200-06-03-.02(5)) lists only one narrow Department of Health exemption. The waived testing rule speaks of "health care facilities licensed by the State of Tennessee," which suggests a waived-only site is expected to notify the Board rather than hold a full lab license, but that is an inference. A practice in this position should ask the Board in writing before it begins testing.

When a full license applies, how does it work?

For sites that need one, rule 1200-06-03-.02 sets the terms:

• Fees. $1,000 initial application, nonrefundable; $1,000 annual renewal; a $5 annual state regulatory fee; $500 late renewal penalty; $100 for a change in ownership, directorship or location; collection stations $700 initial and $700 renewal, as of October 2026. The Board's application, PH-1020, asks for $1,005 with the initial filing.
• Who applies. The application "shall be made under oath, by the owner and director of the medical laboratory," with "a separate application for each laboratory address."
• Temporary license. After a complete application, the Board may issue "a letter of temporary license" valid "not longer than three (3) months," and the lab "shall be fully operational, including but not limited to the reporting of patient results, at the time of the on-site inspection."
• Annual renewal. A license "shall expire annually on the anniversary of the date that the license was originally issued" (rule 1200-06-03-.21), with a renewal form signed by the owner and director.

What about labs from other states?

Tennessee's CLIA program has addressed temporary testing such as health screens. An out-of-state facility may test in Tennessee with a valid CLIA certificate from its home state, but must send, for each event, a CMS-116 "flagged as 'For Information Only'" with its CLIA number and a cover sheet listing the locations, dates and tests, and "should notify the Tennessee Medical Laboratory Board Administrative Office to ensure that they are in compliance with all state licensure requirements." See mobile units and temporary testing sites.

Our part in a Tennessee opening

We prepare the CMS-116, then form PH-3653 with the test list and methodology from each kit's instructions, and set out the competency and record templates the rule calls for. The responsible physician or director reviews and signs the affirmation; your organization pays CMS and any Board fee. A single site is $399 under our Certificate of Waiver Application, or $549 with the Compliance Binder, which covers the training and record requirements above. Where a full license applies, our State Lab License or Permit service is $699 per state. The Tennessee requirements page tracks what the Board confirms.