CLSI M22

Quality Control for Commercially Prepared Microbiological Culture Media, 3rd Edition

This standard contains quality assurance procedures for manufacturers and users of prepared, ready-to-use microbiological culture media.

CLSI document M22-A3 no longer applies to US laboratories subject to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The guidance provided in this standard does not replace the need for assessment of an individualized quality control plan (IQCP). The Centers for Medicare & Medicaid Services no longer recognizes the categories of “exempt” and “nonexempt” media for the purposes of quality control but, as of January 2016, instead directs laboratories to develop an IQCP for applicable media used in their facilities or to follow the CLIA quality assurance regulations as written. M22-A3 might be applicable to international laboratories.

This document is available in electronic format only.

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Chairholder: Karen Krisher, PhD, D(ABMM)

Date of Publication: June 20, 2004

Order Code PDF: CLSI M22A3E
ISBN Number: 1-56238-536-4

Order Code Print: print not available

Edition: Third

Pages: 44

CLSI M22 Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid of as October 2022. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI M22 Abstract

The M22 standard provides information on quality control of commercially prepared microbiological culture media to users and manufacturers. M22-A3 is a revision of the approved standard, M22-A2, published in December 1996. The standard applies to all commercial media listed in Table 2 regardless of packaging, plate, or tube design. The media included in M22-A3 are from three surveys conducted by the College of American Pathologists. The third survey, conducted in the fall of 2001, was performed in response to the many requests for further expansion of the exempt media list. M22-A3 lists an additional 27 exempt media.