CMS updates acceptable control materials

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. The clarifications include:

•    Acceptable control materials will now include on-board controls (i.e., ampules or cartridges containing the same quality control (QC) material that would traditionally be considered as external QC).
•    Instrument/electronic function checks and procedural controls don’t fulfill the regulatory requirement for control materials.
•    The laboratory director is responsible for determining what control materials to use in his or her laboratory.
•    Surveyors will ensure that the laboratory is following its own established policies, specifically its QC procedures, in the context of the Outcome Oriented Survey Process.
•    Laboratories that intend to perform less QC than the regulatory requirements must develop and implement an Individualized Quality Control Program that supports their QC plan. It will be the decision of the laboratory director to determine what control materials to use.

The clarification is effective immediately and the full CMS letter on the change can be read here.