About CLIA

What is CLIA?

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) is a federal program governed by the Centers for Medicare & Medicaid Services (CMS). Its purpose is to establish quality standards for clinical laboratory testing to ensure that patient test results are accurate and reliable.

In Tennessee the Health Facilities Commission administers the certification of laboratory programs in accordance with CLIA regulations. The CLIA program is regulated for compliance under guidelines set forth in Federal Regulations 42 CFR Parts §493.1 through §493.1850.

Working through the Tennessee CLIA State Agency (SA), the CLIA program monitors all clinical laboratories located in hospitals, physician offices, clinics, and other health service facilities throughout the state of Tennessee. The Agency is responsible for monitoring and certifying over 6,000 laboratories, conducting on-site inspections for compliance, ensuring accuracy and reliability of laboratory testing via proficiency desk review, and investigating complaints.

Who Needs a CLIA Certificate?

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.

Basically, 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.

Contact Information

Tennessee CLIA State Agency (SA)

Health Facilities Commission, CLIA Certification
665 Mainstream Drive, 2nd Floor
Nashville, TN 37243

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