About CLIA
The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) program.
The objective of CLIA is to ensure quality laboratory testing. In 1988, Congress passed CLIA regulations to establish quality standards for all testing laboratories to ensure that all patient test results are:
CLIA regulations are based on the complexity of the test method. The more complicated the test, the more stringent the requirements. More information about laboratory test categorization and complexity.
CLIA covers approximately 320,000 laboratory entities. State Survey Agencies are authorized to set and enforce CLIA standards.
Although all laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.
Contact your State Agency about:
- CLIA fees or payment
- CMS-116 applications
- Demographic updates
- Certificate status or upgrades
- Laboratory Director changes
- Filing a complaint
For other questions about the CLIA program, email us at LabExcellence@cms.hhs.gov.
Resources for You
Apply for a CLIA Certificate Information about the application process and forms you need to submit Get Certified | CLIA Brochures Helpful resources to learn about CLIA and laboratory requirements Learn More |
