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.
