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Title
Policy Clarification on Acceptable Control Materials Used when Quality Control (QC) is Performed in Laboratories
Memo #
16-20-CLIA
Posting Date
2016-04-08
Fiscal Year
2016
Summary
The Centers for Medicare & Medicaid Services (CMS) is providing clarification regarding the policy on acceptable control materials, which includes: • Acceptable control materials: Acceptable control materials will now include on-board controls, i.e. ampules or cartridges containing the same QC material that would traditionally be considered as external QC. • Function checks and procedural controls: Instrument/electronic function checks and procedural controls do not fulfill the regulatory requirement for control materials. • Guidance for surveyors: The laboratory Director is responsible for the determination of what control materials to use in his/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.