Clinical Laboratory Improvement Amendments (CLIA)

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 perform testing on human specimens for diagnosis, treatment or health assessment in the United States must hold the appropriate CLIA certificate. The CLIA regulations set standards for personnel, records, quality control and quality assurance. The greater the complexity of a test, the greater the requirements.
 CMS-116 CLIA Application for Certification
Instructions for completing the CLIA application begin on page 7.
Completed CMS-116 CLIA applications or changes to existing information on a CLIA certificate may be faxed to 303-344-9965 or emailed to For questions or assistance, please call 303-692-3029.
Compliance oversight
U.S. Centers for Medicare and Medicaid Services is responsible for achieving regulatory compliance. The agency has given compliance inspections and management of application information to state health departments.
Reporting a complaint about a laboratory’s operation