: M22-A3 is currently considered an archived standard by CLSI. Many laboratories now transition to using an Individualized Quality Control Plan (IQCP) as outlined by CMS to manage their media QC.
| Source | Details | |---|---| | | The primary source. Members can access the document at a reduced price. Non-members can purchase it directly. As an archived document, it will be less expensive than active standards. Visit clsi.org and search for "M22-A3" or "M22A3E". | | ANSI Webstore | The American National Standards Institute (ANSI) is a key partner. The PDF purchased through ANSI is the official CLSI document. Visit webstore.ansi.org . | | Accuris (formerly Techstreet) | A major standards distributor. They typically offer a "Printed Edition + PDF" package for immediate download. However, note that the CLSI no longer offers a print edition for this specific document. | | Intertek Inform | Another reputable source for purchasing standards, offering both hardcopy and PDF formats. |
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Laboratories must store the media according to the manufacturer’s instructions (typically 2°C to 8°C) and log daily refrigerator temperatures to ensure the integrity of the media is maintained until its expiration date. Impact on Laboratory Compliance and Accreditation
The document, titled Quality Control for Commercially Prepared Microbiological Culture Media , is a critical standard used by microbiology laboratories to ensure the reliability of their culture media while optimizing operational efficiency. Published by the Clinical and Laboratory Standards Institute (CLSI) , this third edition established the widely used "exempt" media list based on extensive performance data. Understanding the CLSI M22-A3 Standard clsi m22a3 pdf
Through extensive multi-center studies, CLSI determined that certain types of commercially prepared media have exceptionally low failure rates (often less than 0.1%). Under M22-A3, if a laboratory purchases these media from a manufacturer that certifies compliance with CLSI standards, the laboratory is from performing full, routine microbial performance testing on those batches. Examples of typically exempt media include: Sheep Blood Agar (SBA) MacConkey Agar (MAC)
A valid copy of the manufacturer's M22-A3 certification is accessible.
Use the standard to establish rigorous QC protocols for every lot.
Maintain a certified Quality Management System (QMS), such as ISO 13485. : M22-A3 is currently considered an archived standard
Verify that the manufacturer’s Certificate of Quality matches the lot numbers received.
To obtain a legitimate, fully compliant PDF copy of the document:
Many labs validate in neat solvent (e.g., methanol/water) but not in biological matrix (serum, urine, plasma). M22-A3 is explicit: validation must occur in the biological matrix of interest. Failure to do this invalidates your LLOQ and recovery numbers.
Exempt vs. Non-Exempt Media: The Breakthrough Classification Members can access the document at a reduced price
: It serves as a guide for both manufacturers producing media and clinical laboratories using it. Media Types
Test with appropriate ATCC control organisms to verify growth, inhibition, and biochemical reactions. Why Laboratories Search for the CLSI M22-A3 PDF
Confirm that the media arrived within the acceptable expiration date and temperature range.