CLIAWaiver

A CLIA waiver is a designation under the Clinical Laboratory Improvement Amendments (CLIA) that allows certain simple, low-risk diagnostic tests to be performed outside traditional laboratories. Tests granted a waiver are considered easy to perform correctly when used according to the manufacturer’s instructions and are unlikely to produce erroneous results.

Administration and scope. The CLIA program is administered by the Centers for Medicare and Medicaid Services (CMS). The Food and Drug Administration (FDA) designates which tests are waived, and CMS issues certificates of waiver to facilities that perform only waived testing. State health departments may enforce CLIA provisions in addition to federal requirements. Waived testing is intended for settings such as clinics, physician offices, urgent care centers, and home use where laboratory infrastructure is limited.

Eligibility and requirements. A facility that performs only waived tests must obtain a CLIA certificate of waiver. The tests used must be on the FDA’s list of waived tests and generally include simple immunoassays, dipstick analyses, and similar procedures. Operators are required to follow the manufacturer’s instructions and maintain appropriate records. Proficiency testing is not required for waived testing, and the regulatory burden is lighter than for moderate- or high-complexity testing, though facilities should implement basic quality assurance and safety practices. Inspections may occur to verify compliance.

Limitations and implications. Only tests designated as waived may be performed under this status; performing non-waived tests requires a different CLIA certificate and oversight. Waiver status does not itself authorize untrained use of tests in all settings; facilities must adhere to applicable standards and labeling. Examples of waived tests include many home pregnancy tests, certain urine analyses, and various rapid immunoassays.