Colorado State Licensing Requirements
National Links
- Nationwide Laboratory Director Regulations
- Dec. 28, 2024 CLIA Changes effective Dec. 28, 2024
- Nationwide High Complexity Requirements
- CE Courses for Laboratory Director
- Online Access to CLIA Certificates QCOR (See below)
- Pay your CLIA fees at Pay.gov
- Forms CMS116 Application
- eCFR 42 CFR Part 493
- State Operations Manual
State-Specific CLIA Applications
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.
Online Access to CLIA Certificates
CMS is now making CLIA certificates available online at no cost via the QCOR Lookup Tool. All certificates generated after September 27, 2023 should be available for download. Click HERE to access the Tool and choose “CLIA Laboratory Lookup” from the left menu bar (2nd option from the top). When you click the entry for the laboratory, a box containing the laboratory information and a link to the certificate will pop up in a new window.