CMS recently clarified policy on acceptable control materials for lab testing. While not changing any of the standards, the agency explained some of the key points to §493.1256(c) of the Clinical Laboratory Improvement Amendments (CLIA) Interpretive Guidelines (IG).
The regulation states that control procedures must detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. It also required facilities to monitor the accuracy and precision of test performance that might be influenced by environmental or outside factors over time.
Comments