Clinical Laboratory Improvement Amendments (CLIA)

The Centers for Medicare & Medicaid Services (CMS) regulates laboratory testing performed on humans in the U.S. for health assessment or to diagnose, prevent, or treat disease 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:

• Accurate
• Reliable
• Timely

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. 

Accredited laboratories should contact their Accreditation Organization for guidance.

Tip: Include your laboratory’s name and CLIA ID when contacting your State Agency or Accreditation Organization.