Clinical Laboratory Improvement Amendments (CLIA)

What is CLIA?

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) establish quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.

The Centers for Medicare & Medicaid Services (CMS) implements the CLIA program which is based on regulations found in 42 Code of Federal Regulations (CFR) Part 493. CMS registers and certifies laboratories, collects fees, develops guidelines and provides training to laboratory surveyors, and performs enforcement activities when required. The Centers for Disease Control and Prevention provides scientific and technical support to CMS.

Contact Information

Chief: Azzie Y. Conley, [email protected]

Physical Address: 1205 Umstead Drive (Lineberger Building.) Dorothea Dix Hospital Campus, Raleigh, NC 27603

Mailing Address: Division of Health Service Regulation/CLIA Certification, 2713 Mail Service Center, Raleigh, NC 27699-2713

Telephone: 919-855-4620

For initials, changes, other requests: [email protected]

Survey Staff:

Support Staff: