CLSI M22-A3 is the third edition of the approved standard developed by the Clinical and Laboratory Standards Institute. It establishes guidelines for both manufacturers and end-user laboratories regarding the quality control responsibilities for commercially prepared microbiological culture media.
Even when using 100% exempt media, a clinical laboratory cannot simply place media directly into service. The laboratory must perform the following:
Use the standard to establish rigorous QC protocols for every lot. clsi m22a3 pdf
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Procedures to follow when a medium fails quality control tests. Why Use the CLSI M22-A3 PDF? CLSI M22-A3 is the third edition of the
Focus on visual inspection and documentation of media upon receipt rather than full organism-based retesting for "exempt" media.
Non-Exempt media includes complex, selective, or highly sensitive formulations that are prone to deterioration during shipping or storage. Laboratories must perform full, independent quality control testing on every new lot of non-exempt media before using it for patient diagnostics. Examples of non-exempt media include: Campylobacter media (e.g., Campy-CVA) The laboratory must perform the following: Use the
Provide a Quality Control Certificate with each shipment, verifying that the specific lot meets CLSI standards. 2. Responsibilities of the Laboratory (End-User)