As of January 2016, a significant regulatory change took effect in the U.S. The Centers for Medicare & Medicaid Services (CMS), which enforces the Clinical Laboratory Improvement Amendments (CLIA), ceased recognizing the concept of "exempt" and "nonexempt" media as defined by CLSI standards like M22-A3.

: You can buy the PDF version directly from the American National Standards Institute.

Many hospitals, university libraries, clinical labs, and research institutions have CLSI eLabs or digital library access. Ask your lab manager or librarian if they can provide the document.

: It clearly defines the duties of both parties. Manufacturers must verify growth, selectivity, and biochemical responses, while users must inspect each shipment for physical defects (e.g., contamination, cracked plates, or improper filling). Standardized Procedures : The document provides protocols for maintaining QC organism stock cultures

Are you looking to update your for media log templates?

While you might be looking for a free version of the document, it is a copyrighted professional standard and is typically not available for free legally. However, understanding its role in the lab is a great way to see why it's so highly valued. The Story of CLSI M22-A3: Keeping the Lab Safe

It clearly defines what quality control operations must be performed by the commercial manufacturer and what remains the responsibility of the end-user (the laboratory).

Free downloads often contain missing pages, poor scans, or outdated revisions. Using inaccurate specifications can cause a laboratory to fail external audits (such as CAP, COLA, or ISO 15189 inspections).

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Microbiological culture media must support the growth of target microorganisms while inhibiting commensal flora. If a batch of media is defective, it can lead to false-negative results, delayed diagnoses, or incorrect treatment plans for patients. CLSI M22-A3 standardizes how these media are evaluated before they are used on patient samples. Core Objectives of the Standard

Not Required (Unless local regulations or specific corporate policies mandate it)

. An IQCP allows labs to use historical data and risk assessments (such as the failure rate cutoffs established in M22-A3) to customize their QC frequency, moving beyond a "one-size-fits-all" approach while still meeting regulatory standards like

Just let me know what you need to streamline your laboratory's workflow.