Quality Control for Commercially Prepared Microbiological Culture Media
The M22-A3 standard clearly delineates the quality control responsibilities between the commercial manufacturer and the end-user clinical laboratory. Manufacturer Responsibilities
Despite this shift in U.S. regulatory practice, the standard remains a technically sound and historically important document. As noted on CLSI’s website, the standard is no longer being reviewed through their active consensus process but is being retained in their library because it is "technically valid" and of ongoing value to the international laboratory community. For international laboratories not bound by CLIA regulations, M22-A3 may still be a current and applicable resource. clsi m22a3 pdf
In the highly regulated world of clinical diagnostics and pharmaceutical analysis, precision is not just a goal—it is a legal and ethical requirement. For laboratories performing chromatographic assays, particularly those dealing with therapeutic drug monitoring (TDM), toxicology, and clinical chemistry, the document known as serves as the definitive roadmap.
Challenging the media with specific American Type Culture Collection (ATCC) reference strains to verify expected growth (fertility) and inhibition (selectivity). As noted on CLSI’s website, the standard is
By staying up-to-date with the latest guidelines and recommendations, laboratories and healthcare professionals can ensure that patients receive optimal care and that antimicrobial stewardship programs are effective in promoting responsible antimicrobial use.
Ensure the media was transported and stored within the temperature ranges specified by the manufacturer. For laboratories performing chromatographic assays
Maintain rigorous Quality Assurance (QA) programs (such as ISO 13485 certification).
Exempt media are formulations that have historically demonstrated an exceptionally low failure rate when prepared by commercial manufacturers under controlled conditions.