The page below is a sample from the LabCE course Quality Control. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

Learn more about Quality Control (online CE course) »
How to Subscribe
MLS & MLT Comprehensive CE Package
Includes 94 CE courses, most popular
$95 Add to cart
Pick Your Courses
Up to 8 CE hours
$50 Add to cart
Individual course$20 Add to cart

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.