CLSI M Quality Control for Commercial Microbial Identification Systems; Approved Guideline. Final document was approved through the CLSI voting process. – Publication of CLSI M Quality Control for. Commercial Microbial. Buy CLSI M50 A Ed. 1 () Quality Control For Commercial Microbial Identification Systems from SAI Global.

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Clinical Laboratory Improvement Act Amendments of Spring Meeting Summary Report Cdc-pdf. IQCP will soon be the law of the land for clinical microbiology laboratories; time will tell if it improves our ability to decrease adverse patient outcomes.

CLSI MA – Quality Control for Commercial Microbial Identification Systems; Approved Guideline

Developing an IQCP involves a review of the entire testing process, beginning with specimen collection preanalytic and continuing through the analysis of the specimen analytic until the final test result is reported postanalytic. Performance standards for antimicrobial susceptibility testing; 25th informational supplement. US Statutes at Large 81 Notes The views expressed in this Commentary do not necessarily reflect m50-x views of the journal or of ASM.

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Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

Subsequently, CAP conducted three surveys among clinical microbiology laboratories, and to determine the failure rates of commercially prepared media. National Clei for Biotechnology InformationU. Last, a nonvoting liaison representing the laboratory industry participates on the Committee. Prior to that time, there were few regulations for laboratories. The QC recommendations in the CLSI standards are supported by data demonstrating that following CLIA default QC daily testing of QC strains will not improve the quality of patient results for laboratories that have documented satisfactory performance with a specified amount of daily QC testing.


This standard is also available to be included in Standards Subscriptions. Facebook Twitter Email Syndicate.

It defines QC as the set of operations, processes, and procedures designed to monitor the measuring system to ensure the results are reliable for the intended clinical use. CDC is not responsible for Section compliance accessibility on other federal or private website. Subscription pricing is determined by: These data showed that the failure rate due to the MIS itself was less than 0.

For example, daily QC testing with antimicrobial susceptibility tests will not prevent a laboratory from reporting results from a mixed population of organisms.

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Clinical Laboratory Improvement Advisory Committee (CLIAC) | DLS |CDC

These two options would apply to all nonwaived tests and would become effective on 1 January There are three components to an IQCP: Clinical and Laboratory Standards Institute. Stakeholders expressed concerns at this meeting that manufacturers did not provide laboratories with sufficient information regarding QC and that a one-size-fits-all requirement for QC would not work with all new technologies.

These data demonstrated that retesting of many types of commercially prepared microbiological culture media with QC strains in-house will not improve the quality of patient results. Results of the survey of the quality assurance for commercially prepared microbiology media. You can download and open this file to your own computer but DRM prevents opening this file on another computer, including a networked server.


Due to the refinement and advancement of MIS, this requirement has become difficult and costly for clinical microbiology laboratories and has not been shown to prevent errors when testing patients’ isolates.

All five of the CLSI documents mentioned here are available and used by most clinical microbiology laboratories in the United States; they are data driven, evidence based, and have proven efficacy. Support Center Support Center. CLIA ’88 2 set forth new regulations for personnel standards, specimen management, QC, PT, and quality assurance QA for all entities performing laboratory testing and mandated that testing must follow manufacturers’ recommendations.

It is anticipated that MA will be used extensively in the United States and internationally to reduce resources spent on excessive QC testing. Undoubtedly, our goals are common and flsi all wish to optimize the use clsj our resources and talents to best serve our patients.

Clinical Laboratory Improvement Advisory Committee (CLIAC)

This article has been cited by other articles in PMC. MA includes guidelines that may be followed when using an MIS of proven reliability to take a modified QC approach, rather than meeting requirements included in the Clinical Laboratory Improvement Amendments of regulations. Registration is now closed. However, there were concerns expressed by some in industry and in laboratories, as well as by other experts, about the rigidity and the limit of scope with EQC.