Saves thousands of dollars annually by reducing the need for redundant ATCC organism testing on exempt media.
The CLSI M22-A3 guideline is important because it helps ensure that blood cultures are collected, transported, and processed in a way that maximizes the chances of detecting bacterial or fungal pathogens. Accurate blood culture results are critical for guiding antimicrobial therapy and improving patient outcomes.
Which you are looking to classify (e.g., blood agar, anaerobic media, transport media). Your primary accrediting body (e.g., CAP, COLA, CLIA).
Published by the , this document provides specific protocols for the quality control (QC) of commercially manufactured microbiological culture media. Its primary goal is to ensure that the media used in laboratories is capable of supporting the growth of target pathogens while remaining sterile and chemically stable. The "Exempt" vs. "Non-Exempt" Classification
is a copyrighted document and typically requires a purchase: Official Source : Available directly from the Standards Stores : Can be found at the ANSI Webstore Accuris Standards Store Free Previews : Limited previews are often available via the ANSI preview page to view the table of contents and scope. Clinical & Laboratory Standards Institute | CLSI typically exempted under this standard? clsi m22a3 pdf
Understanding CLSI M22-A3: The Standard for Quality Control of Microbiological Culture Media
Typically available as a downloadable PDF or a printed document.
Responsible for rigorous QC testing during production and providing documentation (e.g., certificates of analysis).
A single proficiency testing failure traced to media defects (undetected due to lack of proper QC) can destroy a lab’s reputation and lead to license revocation. Saves thousands of dollars annually by reducing the
Without adherence to M22-A3, a laboratory cannot scientifically prove that its culture media performed as expected on any given test day.
The Clinical and Laboratory Standards Institute (CLSI) M22-A3 document is the global gold standard for quality control (QC) of commercially prepared microbiological culture media. For clinical laboratories, implementing these guidelines is essential to ensure diagnostic accuracy, regulatory compliance, and patient safety.
The NFB-ID Resolver is a smart interpretation module integrated into a Laboratory Information System (LIS) or a standalone microbiology instrument interface. It digitizes the logic found in CLSI M22-A3 to address the most common problem in identifying Nonfermentative Gram-Negative Bacilli (NFB): conflicting or low-probability biocodes.
Inspect media for physical defects (e.g., cracking, hemolysis, freezing, contamination, or incorrect volume). Which you are looking to classify (e
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
What specific (e.g., CAP, CLIA) is auditing your laboratory?
The CLSI M22-A3 PDF is available for download from various sources:
Media must be stored at the manufacturer’s specified temperatures, typically between 2°C and 8°C for plates. Freezing must be strictly avoided as it destroys the agar gel matrix.
Limitations and cautions