CLIA

What is CLIA?

CLIA stands for the Clinical Laboratory Improvement Amendments of 1988. These US federal rules set quality standards for any lab that tests human specimens to diagnose, prevent or treat disease, or to assess health. The aim is accurate, reliable and timely results wherever the test is done.

The program is run by the Centers for Medicare & Medicaid Services (CMS), working with the FDA and the CDC. Labs must hold a CLIA certificate that matches the tests they perform.

Test complexity

• Waived: simple tests with a low risk of error, such as some rapid tests.
• Moderate complexity: many routine chemistry and hematology tests.
• High complexity: tests that need more skill and judgment.

Certificate types

Certificates include a Certificate of Waiver, a Certificate for Provider-Performed Microscopy Procedures, a Certificate of Registration, a Certificate of Compliance and a Certificate of Accreditation. Labs doing moderate or high complexity testing face rules on personnel, quality control, proficiency testing and inspections.

Some states run their own programs that CMS recognizes in place of CLIA. CLIA applies to labs, not to the software they use.

This is a plain-language summary for general information, not legal advice. Check the current rules with a qualified adviser for your lab.

Related terms

• Critical value: A result so far outside the expected range that it may signal an urgent risk and must be reported to a clinician right away.
• HIPAA: The US law that sets national rules for protecting the privacy and security of health information.
• Turnaround time: The time it takes a lab to deliver a result, measured between two agreed points such as collection and report.