Tennessee

Tennessee Department of Health, Public Health Division. Clinical Laboratories. 
Tennessee Forms

(1) Any facility that performs laboratory tests on human specimens for the purpose of diagnosis and/or treatment is required by federal law to have a CLIA certificate. If a facility performs tests for these purposes, regardless of whether there is reimbursement for such tests, it is considered to be a laboratory according to the definition by CLIA, and must obtain and maintain CLIA certification.

Tests for which a CLIA certificate IS NOT required include:

• forensic testing;
• blood draws;
• specimen collections;
• drug testing for purposes of employment.

If you do not perform any testing on-site you do not need a CLIA certificate. However, CMS allows for certain exceptions to this rule, such as mobile units, home health agencies with multiple branches and temporary testing sites. In these cases, a separate certificate is not issued to each testing location but to a designated primary site, parent location or home base.

Lab Director/Lab Personnel

For laboratories performing moderate and/or high complexity testing the credentials of the Laboratory Director must be verified. In addition to the director’s current TN state license, the information needed to qualify medical doctors or doctors of osteopathy include:

• For moderate complexity testing, evidence of 1 year’s experience directing/supervising a nonwaived laboratory; or completion of 20 hours’ continuing medical education (CME) credits for laboratory directors of moderate complexity laboratories as listed on the CMS website; or documentation of lab training equivalent to 20 CME credit hours in lab practice during medical residency is required.
• For high complexity testing, documentation of board certification in Anatomic and/or Clinical Pathology; or documentation of 1 year of high complexity lab experience during residency; or documentation of 2 year’s experience directing/supervising high complexity lab testing is required.

For Ph.D. applicants the following documentation is required:

• A copy of the doctoral degree (in a chemical, physical, biological, or clinical laboratory science) indicating specialty; or a copy of transcripts indicating specialty; and
• A copy of a current board certification approved by HHS.

A resume or CV is not acceptable evidence of experience, nor does a copy of a CLIA certificate from another non-waived laboratory showing the applicant as director verify the required years of experience.

Tennessee CLIA State Agency (SA)

Address: Division of Health Licensure and Regulation

Office of Health Care Facilities, CLIA Certification
665 Mainstream Drive, 2nd Floor
Nashville, TN 37243

(for overnight delivery or courier mail use zip code 37228)

Phone: (615) 741-7023
Fax: (615) 532-2700
Email: CLIA.Health@tn.gov

Tennessee CLIA Regional Offices

East TN Regional Office

Address: 7175 Strawberry Plains Pike, Suite 103
Knoxville, TN 37914
Fax: (865) 594-5759

Middle TN Regional Office

Address: 665 Mainstream Dr, Second Floor
Nashville, TN 37243
Fax: (615) 532-2700

West TN Regional Office

Address: 295 Summar Dr, Second Floor
Jackson, TN 38301
Fax: (731) 512-0065

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.