Clsi M22a3 Pdf Jun 2026

CLSI M22-A3 is the third edition of the approved standard titled It provides protocols and criteria for both manufacturers and end-user laboratories to verify that culture media performs as intended.

Educate medical laboratory scientists (MLSs) and technicians on how to properly recognize compromised media. Important Note on Document Access

CLSI M22‑A3 remains a landmark standard in the field of clinical microbiology, providing a rigorous quality‑control framework for commercially prepared culture media. While its applicability in the United States has been overtaken by the newer IQCP approach, it continues to serve as a valuable reference for international laboratories, manufacturers, and regulatory bodies. clsi m22a3 pdf

Susceptibility testing is a critical component of clinical microbiology, as it helps determine the effectiveness of antimicrobial agents against specific microorganisms. Accurate susceptibility testing results enable healthcare professionals to make informed decisions about patient treatment, reducing the risk of treatment failure, and minimizing the development of antimicrobial resistance.

The document contains comprehensive quality assurance (QA) procedures for both and users of prepared, ready‑to‑use microbiological culture media. It applies to all commercial culture media, regardless of packaging (plates, tubes, or other designs), and its recommendations are based on data collected through surveys of clinical laboratories by the College of American Pathologists (CAP). CLSI M22-A3 is the third edition of the

CLSI M22-A3 serves as a foundational guideline for manufacturers and clinical laboratories regarding the quality control (QC) of antimicrobial susceptibility testing (AST) materials. Specifically, it addresses the evaluation and verification of commercial control materials used to monitor the performance of AST methods (such as disk diffusion and MIC testing). While the document provided essential protocols for QC verification, users must note that this standard has been retired and its contents redistributed into broader CLSI standards.

: 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. While its applicability in the United States has

Regulatory and accreditation relevance

Non-exempt media comprises formulations that are inherently unstable, highly selective, or prone to degradation during shipping and storage. Laboratories perform complete quality control testing on every lot number of non-exempt media received. Examples of non-exempt media include: Campylobacter Agar

The document provides clear protocols for maintaining QC organisms, incubation conditions, and documenting media receipt. Key Sections of the M22-A3 Standard

Outlines specific maintenance protocols, storage conditions, and quality control organisms required to verify media performance.