Apply for a CLIA Certificate

• Download Form CMS-116 (fillable online), type your responses, and save the form.

Tip: Before you start, check with your State Agency for state-specific requirements.

• Exceptions:

  • New York or Washington State follow separate state processes. More information for exempt states.
  • Applicants from facilities outside the U.S. and its territories (international laboratories) must email DCLIQSurveyBranch@cms.hhs.gov to determine eligibility for a CLIA certificate. 

An international laboratory is a facility outside the U.S. or its territories that performs testing on human specimens when tests are referred by and returned to a facility or authorized individual in the U.S. or its territories. 

If specimens are transported abroad for testing, the international laboratory performing those tests must comply with CLIA regulations. For laboratories that perform multiple types of tests, only the tests conducted on specimens from the U.S. or its territories are subject to CLIA (Example: if a lab performs several types of testing but only molecular genetics testing on U.S. specimens, CLIA applies only to those molecular genetics tests).

Individuals who have degrees from foreign institutions must have their academic credentials evaluated to determine U.S. equivalency. Evaluations should be completed on a course-by-course basis and may be performed by a nationally recognized organization.

International laboratories may obtain CLIA certification through a CMS-approved accreditation organization or apply directly for the appropriate level of CLIA certification.

• Choose the Right Certificate Type

There are several types of CLIA Certificates, each with specific requirements based on the complexity of the tests your facility performs. Apply for the certificate that matches the highest level of test complexity your facility performs. 

All certificate types: 

• Are effective for two years
• Allow waived testing

You can search the FDA database to find more information about test categorization.

• For Waived Tests 

  A laboratory with a CLIA Certificate of Waiver (CoW) must have a laboratory director. There are no federal education or experience qualifications required for the laboratory director.

• For Non-Waived Tests (moderate and high complexity tests, including Provider-performed Microscopy (PPM))

  Laboratory directors must meet specific CLIA education, training, and experience requirements. Submit proof with your application.

• Applicants Who Attended Schools Outside the U.S.

  Applicants must submit credential evaluations to show foreign-education equivalency. Failure to submit this information will delay your application.

Send the completed  Form CMS-116 Application and other required documents to your  State Agency for processing.

Some states may have additional licensing requirements. Laboratories in these states must meet both the CLIA and state requirements. Confirm whether you need to submit additional forms or documentation with your State Agency. 

Tip: Send your completed CLIA application to the State Agency for the state in which your laboratory resides.

You’ll receive a fee notification by email that includes your unique ten-character alpha-numeric CLIA identification number. Your certification fee varies based on the type of certificate and volume of tests your laboratory performs. 

Pay your certification fee on pay.gov. We accept bank account (ACH), debit, or credit cards. Your secure payment gets processed overnight. 

• You’ll receive your CLIA Certificate via email after we receive your payment. 
• You can begin testing once you receive it. 
• You can view, print (and reprint) online.

You need to pay certain fees every two years to maintain your CLIA certificate. 

• More information about the CLIA Certificate Fee Schedule.

If your laboratory’s certificate is updated and you need a replacement copy, a reprint fee may apply.

• Visit Quality, Certification and Oversight Reports (QCOR) to access or reprint your laboratory’s CLIA certificate.