, the Centers for Medicare & Medicaid Services (CMS) changed the regulatory landscape for media quality control in the United States. CMS no longer recognizes the "exempt" and "nonexempt" categories established in M22-A3 for the purposes of quality control. Instead, clinical laboratories subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) must either:
Audit manufacturer quality certificates against CLSI requirements.
CLSI M22-A3 is a globally recognized consensus standard. It establishes responsibilities for both manufacturers and laboratory users regarding the quality control of commercially prepared media. clsi m22a3 pdf link
Non-Exempt media possess a higher risk of failure, deterioration, or require highly fastidious conditions to function correctly. Laboratories perform full quality control testing on every new lot number of these media before clinical use. Examples of non-exempt media include: Campylobacter Agar Chocolate Agar (specifically for Neisseria isolation) Selective media for fastidious pathogens
This is the most direct and reliable method. The CLSI official website (clsi.org) allows for immediate PDF download after purchase. , the Centers for Medicare & Medicaid Services
An important nuance for US laboratories is the relationship between CLSI M22-A3 and the Clinical Laboratory Improvement Amendments (CLIA) regulations. While M22-A3 provides a valuable, risk‑based framework, CLIA regulations for media QC have evolved since the standard's publication.
Prices listed are subject to change. CLSI members can save up to 70% on list prices. Always check the official website for the most current pricing and available options. CLSI M22-A3 is a globally recognized consensus standard
, is a crucial document that outlines quality assurance procedures for manufacturers and end-users of ready-to-use culture media.
is an approved standard that defines quality assurance procedures for both manufacturers and users of ready-to-use microbiological culture media. It serves as a definitive guideline for ensuring that commercially prepared media—ranging from petri dishes to broth tubes—meet necessary performance standards before being used to test patient samples.
Adhering to CLSI guidelines is a cornerstone of laboratory excellence for several reasons: Accreditation Compliance
Free PDFs online are often superseded drafts or missing critical errata sheets.