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.

COVID-19 Updates

In an effort to provide support to workplaces who may be doing COVID-19 testing, CMS has prepared materials to outline the simple steps necessary to do this. Generally, a CLIA certificate of waiver is necessary for a workplace to do testing. For information regarding CLIA requirements and the application process for workplace COVID-19 testing, please see the Quick Start Guide for COVID-19 Testing in the Workplace and the Workplace COVID-19 Testing Fact Sheet.

Please note: CMS is temporarily exercising enforcement discretion and allowing employers to start waived SARS-CoV-2 Point of Care testing after a facility has submitted a CMS-116 application.

Contact Information

Chief: Azzie Y. Conley, Azzie.Conley@dhhs.nc.gov

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

Fax: 919-733-0176

For initials, changes, other requests: DHSR.CLIA@dhhs.nc.gov

Survey Staff:

Support Staff: