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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The views expressed in this Commentary do not necessarily reflect the views of the journal or of ASM. Registration is now closed. The frequency of errors can be determined by reviewing historical data; lcsi, the accurate determination of patient harm resulting from these errors is highly variable and a nearly impossible task. Errors in laboratory medicine can certainly have significant effects on patient care, and we in the clinical microbiology community clearly m5-a quality improvement measures which have the potential to positively impact patient outcomes.

Likewise, the use of EQC for the past decade for our diagnostic microbiology test systems has proven reliable.

Support Center Support Center. Standards Subsctiption may be the perfect solution. Sharpa Melissa B. We have no amendments or corrections for this standard. 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. The clinical and vlsi pathology laboratory specialties represented include m5-0a, immunology, chemistry, hematology, immunohematology, cytopathology, histopathology, genetic testing, and informatics.

Journal List J Clin Microbiol v.

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

NovemberVenue: The QC recommendations in mm50-a 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.

These data showed that the failure rate due to the MIS itself was less than 0.

Please first verify your email before subscribing to alerts. Likewise, daily external QC of self-contained molecular test systems that have internal controls also does not mitigate the risk of cartridge-specific errors or inadequate specimen collection.


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.

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

Proceed to Checkout Continue Shopping. Need more than one copy? College of American Pathologists. We thank the following for their thoughtful discussions of IQCP over the past year: 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.

MIS have proven reliability based on peer-reviewed scientific publications and are manufactured by companies that must meet quality standards and applicable regulations. Author information Copyright and License information Disclaimer. As the voice of the U. 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.

Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; approved standard10th ed CLSI document MA Last, a nonvoting liaison representing the laboratory industry participates on the Committee.

To this end, our clinical microbiology community is more m50-s willing to have its members assist CMS in this endeavor. Generally, CLIA ’67 affected large hospital and independent laboratories, while physician office laboratories and small laboratories were essentially left unregulated.

US Statutes at Large M50-z clinical microbiology laboratories in the United States have access to CLSI documents, and the continuation of their use should be a stand-alone option for microbiology laboratories.

Subsequently, CAP conducted three surveys among clinical microbiology laboratories, and to determine the failure rates of commercially prepared media.

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

Already Subscribed to this document. CLIA ’67 required these large laboratories to adhere to quality control QCproficiency testing PTtest performance, and personnel standards. In addition, the Committee provides advice and guidance on specific questions related to possible revision of the CLIA standards.

This document is based on United States US regulations and will also serve as a useful resource for a wider audience. CLSI document EP23 also describes good laboratory practice for developing and maintaining a quality control program for medical laboratory testing using recognized risk management principles. Address correspondence to Susan E.


The data showed a failure rate of less than 0. There are three components to an IQCP: Add to Alert PDF. Statutes at Large 81 Linking to a non-federal website does not constitute an endorsement by CDC or any of its employees of the sponsors or the information and products presented on the website.

We also understand that there are common errors in microbiology that need to be managed; however, it is difficult to see how the implementation of IQCP and the elimination of both EQC and the use of recommendations in CLSI standards and guidelines will have a positive effect for our patients. Published online Nov This standard is also available to be included in Standards Subscriptions.

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.

On 2 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: Partially in response to public furor over deaths attributed to false-negative Pap smear readings, Congress passed the Clinical Laboratory Improvement Act of However, it is unlikely that the development of an IQCP for these tests will discover that additional QC will lead to improved patient care.

Links with this icon indicate that you are leaving the CDC website. This document uses a risk assessment approach to the management of policies, procedures, and practices for the tasks of analyzing, evaluating, controlling, and monitoring risk.