Do you need to know if a is still considered exempt? I can provide more detailed information on those topics. Share public link
Which specific (CAP, Joint Commission, etc.) inspects your laboratory? Do you need a template for a Media Quality Control Log ?
Maintain viable, properly stored ATCC strains (or equivalent quality control strains) required to test your non-exempt media.
The specific document you mentioned, "M22-A3," is likely related to quality management systems for clinical laboratories. If it's not freely available, you might need to purchase it from the CLSI website.
: Media types that have a historically low failure rate when prepared by a reputable commercial manufacturer. Laboratories are not required to perform full maintenance QC (such as sterility and performance testing) on these media batches, provided the manufacturer supplies documentation of compliance. clsi m22a3 pdf link
Offers the PDF version with electronic download capabilities.
The document establishes a rigorous framework dividing media into distinct categories based on historical failure rates and preparation complexity. User vs. Manufacturer Responsibilities
CLSI continuously updates its standards. Unauthorized PDFs may be older editions that do not reflect current regulatory expectations.
Published originally in 2004, it superseded the M22-A2 standard. Although it is now considered an archived document, it remains technically valid and is highly valued for its clear, concise instructions on QC practices. Key Objectives of the M22-A3 Standard Do you need to know if a is still considered exempt
The standard is built on three surveys conducted by the CAP. The third survey, performed in the fall of 2001, was conducted in response to numerous requests for further expansion of the exempt media list, resulting in the addition of .
The CLSI M22-A3 standard is essential for ensuring the accuracy and reliability of laboratory test results. Proper handling and processing of clinical specimens are critical for:
: Maintaining strains in a way that prevents genetic drift or loss of viability.
Testing growth-supporting characteristics with specific control organisms. Do you need a template for a Media Quality Control Log
: The official M22 product page allows you to purchase the PDF or a print version.
The FDA's recognition applies to a broad range of culture media product codes, including non-selective and non-differential media (JSG), multiple biochemical test media (JSE), single biochemical test media (JSF), enriched media (KZI), and several other classifications.
Having the official PDF document allows laboratory directors and managers to: Properly categorize new inventory as exempt or non-exempt.
International standard for medical laboratories that requires robust verification of examination procedures, including culture media performance. How to Implement CLSI M22-A3 in Your Lab