What is Non-waived Testing? from Quality Control, presented by MediaLab

Establishment of Verification of Method Performance Specifications

What is Non-waived Testing?

In 2003, the Center for Disease Control and Prevention and the Center for Medicare and Medicaid Services published the Clinical Laboratory Improvement Amendment (CLIA).
Under CLIA, the term "Non-waived" replaces the terms “Moderate” and “High Complexity” testing.
Before a laboratory can report patient results for a non-waived, FDA-approved test for the first time, the laboratory must verify that the test’s performance is similar to the manufacturer’s claims for accuracy, precision, and reportable range.

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