Skip to main content
U.S. flag

An official website of the United States government

Return to Search

How to Apply for a CLIA Certificate, Including International Laboratories

Guidance for applying for Clinical Laboratory Improvement Amendments (CLIA) certificates.

Final

Issued by: Centers for Medicare & Medicaid Services (CMS)

Issue Date: December 31, 2019

Applying for a CLIA Certificate

What Form Do I Use to Apply?

Complete the Application for Certification Form (CMS-116) (PDF), unless you're:

  • A New York state non-physician office laboratory applicant. Email  or call the New York State Department of Health at (518) 485-5378 for guidance.
  • A Washington state applicant. Email  or call the Washington State Agency at 253-395-6746 for guidance.
  • Applying from outside the U.S. and its territories. Email the International Laboratory CLIA Certification Process (PDF) (PDF)before completing the CMS-116 form.

Where Do I Send My Completed CLIA Form?

Submit the  CMS-116 form (PDF) and other required documents to your State Agency (PDF), which will process your application.

What Credentials Do I Need to Apply?

Directors Who Perform Non-Waived Testing

Laboratory directors who perform non-waived testing (including Provider Performed Microscopy (PPM)) must meet specific CLIA education, training, and experience requirements. As mentioned in the CMS-116 form (PDF) instructions, proof that the laboratory director has met these requirements must be submitted with the CMS-116 form, as noted in the instructions (PDF).

Applicants Who Attended Foreign Schools

Applicants who attended foreign schools must have their credentials evaluated to be sure their education is equivalent to education obtained in the U.S. Failure to submit this information will delay your application's processing.

What credentials are needed to be a laboratory director for a CLIA certificate of waiver (CoW)?

A laboratory with a CLIA CoW must have a laboratory director, but there are no federal CLIA educational nor experiential qualifications for the laboratory director.

Which Facilities Need to Apply?

Under CLIA, a facility is a laboratory if it performs even one test on “materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings.” This includes tests categorized as waived complexity tests. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service aren't considered laboratories.

A CLIA certificate isn't required for:

  • Forensic testing
  • Blood draws
  • Specimen collections
  • Drug testing for purposes of employment; unless employment drug testing is done and individual treatment is offered or made available, then a CLIA certificate is required

Are There Additional State Requirements?

Some states also have laboratory licensing laws separate from the CLIA regulations, but laboratories in these states must meet both the CLIA  and state requirements. Contact your State Agency (PDF) to find out if you need to submit additional forms or documentation.

 

 

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.