IRB notes: What are CLIA requirements?

The Research Integrity Office has recently received a few questions regarding Clinical Laboratory Improvement Amendments, particularly in reference to the Washington state exemption. Here is a quick overview and refresher.

The Clinical Laboratory Improvement Amendments (CLIA) were enacted by congress in 1988 as a result of a troubling number of inaccurate results from Pap smears intended to detect cervical cancer. The program is run by the federal Centers for Medicare and Medicaid Services (CMS). CMS is the regulatory authority for all clinical laboratory services for humans.

To ensure subjects in OHSU studies are given dependable information, the Institutional Review Board (IRB) requires current CLIA certificates for all studies where laboratory testing takes place outside of OHSU’s clinical labs (which have CLIA approval) when testing results are given to subjects or to their care providers.  CLIA labs have met requirements that ensure quality laboratory testing.

The states of Washington and New York are exempt from CLIA certification requirements. CMS has state-level programs in these states which exceed federal requirements. Washington labs are given a comparable “Medical Test Site License” the IRB will accept in lieu of a current CLIA. New York labs may have a CLIA or particular permits from their Department of Health.

Expiration dates are included in the titles of CLIA certificates in the eIRB. It is the principal investigator’s responsibility to ensure that CLIAs are in place and updated prior to expiration. CLIA certification can be checked at their website.