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 jeff.groff@state.co.us. For questions or assistance, please call 303-692-3029.
 

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.

 
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