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.
Member price:
Nonmembers:Details
Chairholder: Karen Krisher, PhD, D(ABMM)
Date of Publication: June 20, 2004
Order Code PDF: M22A3E
ISBN Number: 1-56238-536-4
Order Code Print: M22A3
ISBN Number: 1-56238-536-4
Edition: Third
Pages: 44
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.