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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NovemberVenue: 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. September 25, Content source: Sharpa Melissa B. 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.

To receive email updates about this page, enter your email address: There are three components to an IQCP: This document is based on United States US regulations and will also serve as a useful resource for a wider audience. Links with this icon indicate that you are leaving the CDC website. EQC was designed to minimize the frequency of external QC that was required to control laboratory test systems, help reduce costs and resources for laboratories, and acknowledge technological advances.

Similarly, testing commercially prepared exempt media with QC strains will not prevent a technologist from choosing a poor quality portion of a sputum sample for plating onto a blood agar plate. On cpsi SeptemberASM’s Committee on Laboratory Practices wrote a letter to Andrew Slavitt, Acting Administrator for CMS, stating that we as clinical scientists rely on published literature, statistically derived data, and evidence-based medicine to guide our practice http: Your Alert Profile lists the documents that will be monitored.

CMS states that Cpsi is a new, flexible QC option that provides the opportunity to tailor QC to your unique testing environment and patients and will establish the appropriate quality practices which will reduce the likelihood of errors occurring in your laboratory.


Performance standards for antimicrobial susceptibility testing; 25th informational supplement. Subscription pricing is determined by: Published online Nov Journal List J Clin Microbiol v. Standards Subsctiption may be the perfect solution.

Millerb and Janet Hindler c.

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

This standard is also available to be included in Standards Subscriptions. In addition, laboratories may identify additional risk factors to consider and are not limited to these five components. US Statutes at Large 81 It would be more prudent for CMS to focus on measures that might be of greater benefit to patients and clinical microbiology than generating an IQCP.

National Center for Biotechnology InformationU. The most recent survey, inevaluated overlots of over 32 million clsl of media. Clinical Laboratory Improvement Act of The clinical and anatomic pathology laboratory specialties represented include microbiology, immunology, chemistry, hematology, immunohematology, cytopathology, histopathology, genetic testing, and informatics.

The data showed a failure rate of less than 0. CMS stated that this action had nothing to do with the implementation of IQCP but was due to the fact that the CLSI documents must be purchased and are not freely available to the public. Please first log in with a verified email before subscribing to alerts.

If the document cllsi revised or amended, you will be notified by email. Clinical Laboratory Improvement Act Amendments of We also understand that there are common errors in microbiology that need to be managed; however, it is difficult to see how clsii implementation of IQCP m0-a the elimination of both EQC and the use of recommendations in CLSI standards and guidelines will have a positive m0-a for our patients.

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.

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US Statutes at Large EQC primarily refers to those test systems that utilize internal controls. 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. For example, reporting a falsely susceptible antibiotic result could lead to a devastating outcome in a patient with a severe infection being treated with that drug; however, if clsii error occurred with an antibiotic that would not be considered for this patient due to the likelihood that alternative agents would be more effective, the impact of this testing error would be minimal to none.


Generally, M50-q ’67 affected large hospital m50–a independent laboratories, while physician office laboratories and small laboratories were essentially left unregulated. CLIA ’88 2 set forth new regulations for personnel standards, specimen management, QC, ,50-a, and quality assurance QA for all entities performing laboratory testing and mandated that testing must follow manufacturers’ recommendations.

It specifies responsibilities of the manufacturer, distributor, and user. Quality control for commercial microbial identification systems. For decades, the QC recommendations in the CLSI documents have effectively identified problems in clinical microbiology testing systems for which they are designed. Please review our privacy policy.

The implementation of Xlsi in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown. Prior to that time, there were few regulations for laboratories. Address correspondence to Susan M50-z. CDC is not responsible for Section compliance accessibility on other federal or private website.

Quality control for commercially prepared microbiological culture media; approved standard3rd ed CLSI document MA3. 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 m500-a satisfactory performance with a specified amount of daily QC testing.

Statistician’s summary for alternative QC frequency testing proposal.

Last modified: December 31, 2019