If you want to evaluate your laboratory's current media verification workflow, let me know:
Maintain rigorous quality systems (often aligned with ISO 13485).
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Ensure media is stored at the temperature specified by the manufacturer (usually 2°C to 8°C) and monitor storage logs. clsi m22a3 pdf
These are media that, when purchased from a reputable manufacturer, do not need to be tested by the user for sterility and performance (e.g., ability to support growth) upon receipt.
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| Feature | Detail | |---|---| | | Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition | | Document Number | M22-A3 | | Edition | Third | | Publication Date | June 20, 2004 | | Pages | 44 | | ISBN | 1-56238-536-4 | | Replaces | M22-A2 (Approved Standard—Second Edition, December 1996) | | Current Status | Archived; no longer updated by CLSI consensus process but retained in CLSI’s library for technical validity | | FDA Recognition | The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement. | If you want to evaluate your laboratory's current
For non-exempt or in-house prepared media, M22-A3 outlines specific target organisms required for testing. Laboratories must use specific strains, typically sourced from the ATCC, to evaluate two primary metrics:
Obtaining the is essential for laboratory accreditation (such as CAP or CLIA) and for ensuring that the lab is operating under the latest, most reliable guidelines. The document is widely recognized as the industry standard, providing a scientific basis for QC protocols. Accessing the Standard
The third edition (M22-A3) introduced several significant updates and clarifications: If you share with third parties, their policies apply
provides essential guidelines for both manufacturers and laboratory users to ensure the reliability of ready-to-use culture media. ANSI Webstore Core Purpose and Scope
MacConkey Agar, Blood Agar (Sheep), Eosin Methylene Blue (EMB) Agar, and Nutrient Agar. 2. Non-Exempt Media (High Failure Rate / Highly Selective)
Clinical laboratories must perform full user quality control testing on every new lot/shipment received, regardless of the manufacturer's certification. Examples of Non-Exempt Media: Campylobacter Agar