A CLIA waiver is a certificate issued under the federal Clinical Laboratory Improvement Amendments framework, which governs who may perform laboratory testing and under what conditions. A CLIA waiver applies to tests that federal regulators have categorized as simple enough, and low-risk enough, to be performed outside a traditional clinical laboratory setting — provided the testing site meets baseline requirements around how the test is run.
Holding a CLIA waiver is a facility-level certification, distinct from any individual pharmacist’s professional license. A pharmacy that wants to offer point-of-care testing generally needs the location itself to hold a current CLIA waiver covering the relevant tests, in addition to any state authorization for pharmacists to perform or act on those tests.
Why it matters
The CLIA waiver is the federal building block underneath most pharmacy-based point-of-care testing programs — without it, the testing itself isn’t permitted regardless of what state pharmacy law otherwise allows. Pharmacists evaluating whether their pharmacy can add testing services need to confirm both the facility’s CLIA waiver status and the separate state-level scope-of-practice rules that govern what pharmacists may do with the results.
This entry describes the federal certification concept only. RxByState tracks how state-level pharmacist testing and treatment authority interacts with CLIA-waived testing at https://app.rxbystate.com/signup.