Implement laboratory information management systems (LIMS) that scan barcodes and link certificates automatically.

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.

Which you are looking to classify (e.g., blood agar, anaerobic media, transport media). Your primary accrediting body (e.g., CAP, COLA, CLIA).

The CLSI M22-A3 document is a cornerstone in the field of clinical microbiology. Formally titled "Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition," this standard has long served as a critical reference for laboratories and manufacturers worldwide. This article provides a comprehensive overview of the CLSI M22-A3 standard, its historical context, its technical content, the structure of its famous "exempt media" list, and importantly, how to legitimately obtain a copy of the CLSI M22-A3 PDF.

Appendix and reference material

Interpretive criteria and breakpoints

These media have higher inherent failure rates, are highly complex to manufacture, or degrade easily during transport. Laboratories must perform full user quality control on every lot of non-exempt media before clinical use. Examples include Chocolate agar, Campylobacter agar, and selective media for fastidious organisms. 2. Responsibilities of the Manufacturer

Maintain proper storage conditions as specified by the manufacturer. Perform user QC testing on non-exempt media. 3. Exempt vs. Non-Exempt Culture Media

The laboratory must maintain documentation showing that the manufacturer is compliant with CLSI M22-A3 standards and has provided a Certificate of Quality Control for that specific lot.

Quality control (QC) in the microbiology laboratory is the cornerstone of accurate diagnostic testing. Among the most critical variables in this environment is the quality of culture media. The Clinical and Laboratory Standards Institute (CLSI) addresses this standard in its document, , titled "Quality Control for Commercially Prepared Microbiological Culture Media."

Media with a documented failure rate of are categorized as Exempt , meaning clinical laboratories are not required to perform their own routine QC testing on these products, provided certain conditions are met. Conversely, media with a failure rate greater than 0.5% are designated as Nonexempt , and user quality control is required.