Clinical Laboratory Improvement Amendments (CLIA)

CLIA transitioned to a paperless system. We no longer mail CLIA certificates or paper fee coupons. Additionally, all CLIA certification and survey fees must be paid online (payments by paper check are no longer accepted).

Laboratories must have a valid email address on file to receive electronic CLIA certificates*, fee coupons*, and other CMS communications.

*This does not apply to CLIA exempt states or state licensure.

Tip: Use a business email address, or one that many staffers can access and use.

Need help?

Contact your State Agency or Accreditation Organization to update your email.
Refer to the FAQs about the Transition to Paperless, which provide key information to support your laboratory following the transition.

Online

Laboratories must pay their CLIA certification and survey fees online though pay.gov, a secure platform hosted by the U.S. Treasury Department.

Get Online Payment Info (PDF)

Apply for CLIA Certification

Use the Certification Quick Start Guide to help you complete the CMS-116 application.

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:

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.

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

Clinical Laboratory Improvement Amendments (CLIA)

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