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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| Verification of Performance Specifications for Nonwaived Testing On April 24, 2003, the Clinical Laboratory Improvement Amendments (CLIA) Final Rules went into effect.As of that date, each laboratory that introduces a nonwaived, unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: Accuracy. Precision. Reportable range of test results for the test system. Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. | View Page |
| Verification for Nonwaived Testing Laboratories that do nonwaived 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 nonwaived tests that have been modified or developed in-house, additional verification studies are required. | View Page |