CLSI M22
Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard
The M22 standard provides essential guidelines for the quality control of commercially prepared microbiological culture media, supporting both users and manufacturers in ensuring reliable laboratory performance. It applies to all commercial media listed in Table 2, regardless of packaging, plate, or tube design.
This latest revision, M22-A3, expands on previous editions by incorporating data from three surveys conducted by the College of American Pathologists (CAP), including a third survey in 2001 that led to the addition of 27 exempt media. Note that M22-A3 no longer applies to US laboratories subject to CLIA regulations. As of January 2016, the Centers for Medicare & Medicaid Services (CMS) requires laboratories to develop an individualized quality control plan (IQCP) for applicable media or follow CLIA quality assurance guidelines. However, M22-A3 remains applicable to international laboratories.
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{{FormatPrice(nonMemberPrice)}} List PriceThe 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.
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 basic premise of this standard is that the retesting of commercially prepared microbiological culture media is unnecessary for those media that are of proven reliability. The categorization of media that do not require retesting by the user is based on quality control data collected from surveys of clinical laboratories enrolled in the bacteriology proficiency-testing program conducted by the College of American Pathologists (CAP).
The media types listed in the M22 standard are well established for recovery of clinically significant microorganisms. Exemption of certain media from routine quality control by the clinical laboratories assumes that media performance is monitored by an overall quality program that correlates test methods with clinical information, and monitors test procedures and specimen quality. Media used for antimicrobial susceptibility testing have different quality control recommendations that are detailed in separate NCCLS documents. Changes or additions to this newest revision are the following: 1) Designation of the responsibilities of the manufacturer, distributor, and user; 2) clarification of the media included in various categories; 3) simplification of the basic protocols for the maintenance of quality control organisms; 4) incubation conditions for media quality control; 5) recommendations for the quality control of media used for certain fastidious organisms; and 6) expansion of the cutoff for acceptable failure rate from 0.3% to 0.5% and the categorization of an additional 27 media as exempt from user testing.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.
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.
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 basic premise of this standard is that the retesting of commercially prepared microbiological culture media is unnecessary for those media that are of proven reliability. The categorization of media that do not require retesting by the user is based on quality control data collected from surveys of clinical laboratories enrolled in the bacteriology proficiency-testing program conducted by the College of American Pathologists (CAP).
The media types listed in the M22 standard are well established for recovery of clinically significant microorganisms. Exemption of certain media from routine quality control by the clinical laboratories assumes that media performance is monitored by an overall quality program that correlates test methods with clinical information, and monitors test procedures and specimen quality. Media used for antimicrobial susceptibility testing have different quality control recommendations that are detailed in separate NCCLS documents. Changes or additions to this newest revision are the following: 1) Designation of the responsibilities of the manufacturer, distributor, and user; 2) clarification of the media included in various categories; 3) simplification of the basic protocols for the maintenance of quality control organisms; 4) incubation conditions for media quality control; 5) recommendations for the quality control of media used for certain fastidious organisms; and 6) expansion of the cutoff for acceptable failure rate from 0.3% to 0.5% and the categorization of an additional 27 media as exempt from user testing.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.