The Centers for Medicare and Medicaid (CMS) has released a new resource, “Laboratory Quick Start Guide for CLIA Certification,” which outlines all of the necessary steps laboratories must follow to receive federal government certification to perform testing on human specimens.

Any laboratory, or entity, that tests 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 is considered under CLIA to be a laboratory and must be certified by the CLIA program.

The Quick Start Guide directs laboratories in the processes for:

  • Completing the CLIA application form, CMS-116
  • Finding the appropriate state agency to submit the form
  • Receiving the fee coupon
  • Paying applicable fees
  • Receiving laboratory certificate and beginning testing
  • Maintaining the certificate

Covid-19 Testing

The guide also includes specific information regarding the CLIA Program’s decision to expedite the review process for applications, helping labs to begin covid-19 testing before receiving their mailed paper certificate so long as applicable CLIA requirements have been met.

For More Information 

The CLIA website also offers information for CLIA certification.

For any questions about certification and fees, contact the appropriate State Agency.

For additional questions, email [email protected].

For more information on CLIA, visit the CLIA Program website.