Non-waived Information and Courses from MediaLab, Inc.
These are the MediaLab courses that cover Non-waived and links to relevant pages within the course.
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| 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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| Verification for Non-waived Testing Laboratories that do non-waived testing must verify that they can obtain performance specifications comparable to those established by the manufacturer. Generally this can be accomplished by doing split sample comparison studies with another laboratory to estimate any inaccuracy or bias, plus linearity studies to estimate imprecision and determine the reportable range. The laboratory can do studies to determine its own reference ranges or the laboratory director can document that the manufacturer’s ranges are appropriate.For those laboratories doing non-waived tests that have been modified or developed in-house, additional verification studies are required.
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