Clinical Laboratory Improvement Amendments (CLIA)

What we do

Medical (clinical) laboratories are registered through the certification program under the Clinical Laboratory Improvement Amendments (CLIA) federal regulation to ensure quality laboratory testing. All labs that test human specimens for diagnosis, treatment, or health assessment in the United States must have the appropriate CLIA certificate. CLIA regulations set standards for personnel, records, quality control, and quality assurance. The greater the complexity of a test, the greater the requirements.

Completed CMS-116 CLIA applications or changes to existing information on a CLIA certificate and email them to cdphe_cliaprogram@state.co.us. For questions or assistance, call 303-692-3681.


Compliance oversight

U.S. Centers for Medicare and Medicaid Services (CMS) is responsible for achieving regulatory compliance. The agency has given compliance inspections and management of application information to state health departments.


Laboratory complaints or concerns

Have a concern or complaint about a laboratory’s operation? Send an email to cdphe_cliaprogram@state.co.us. You may request to remain anonymous.

CMS' final rule increasing laboratory fees and changes to personnel requirements

Effective January 27, 2024.


Contact information

Clinical Laboratory Improvement Amendments (CLIA)
Email: cdphe_cliaprogram@state.co.us 
Phone: 303-692-3681