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CLSI Press Releases

CLSI is your source for laboratory standards news and information.

Find important updates, industry news, and information on CLSI’s upcoming events. Check out past CLSI press releases, upcoming Committees Week, and newsworthy items.

 CLSI Publishes New General Laboratory Document GP33—Accuracy in Patient and Specimen Identification

April 23, 2019

The Clinical and Laboratory Standards Institute has published GP33—Accuracy in Patient and Specimen Identification. GP33 specifies the processes required to ensure accurate patient and specimen identification in manual or electronic systems across health care organizations. Processes include system design considerations, differences in requirements for patients with or without ID bands, and provisions for patients with communication barriers. Guidance on bar-code system implementation and user training is included. Validation of patient identification systems or programs and ongoing monitoring as a quality measure are also covered.

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CLSI Publishes New Quality Management Document QMS12— Developing and Using Quality Indicators for Laboratory Improvement  

March 25, 2019

The Clinical and Laboratory Standards Institute has published QMS12—Developing and Using Quality Indicators for Laboratory Improvement. QMS12 describes how to develop and use quality indicators in the medical laboratory. These indicators include measures developed within a single laboratory for local use, as well as indicators developed or required by regulatory and accreditation organizations. This guideline also provides criteria for developing quantitative and qualitative indicators. The process flow, concepts, and indicator development form presented in this guideline can also be used to create indicators to measure the effectiveness of the laboratory’s quality management system processes.

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 CLSI Publishes New Chemistry Document C34—Sweat Testing: Specimen Collection and Quantitative Chloride Analysis

February 13, 2019

The Clinical and Laboratory Standards Institute has published C34—Sweat Testing: Specimen Collection and Quantitative Chloride Analysis. C34 describes methods for performing sweat testing for cystic fibrosis diagnosis. Sweat stimulation, collection, and quantitative measurement of sweat chloride are described, along with results evaluation and reporting, quality assurance, and method validation.

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CLSI Publishes New Antifungal Guideline

December 21, 2018

The Clinical and Laboratory Standards Institute announces the publication of CLSI guideline M44—Method for Antifungal Disk Diffusion Susceptibility Testing of Yeasts. M44 provides an approved method for determining zone diameter breakpoints for select Candida spp. with antifungal agents after 24 hours incubation, as well as quality control parameters for the same agents.

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CLSI Publishes New Microbiology Standard and Supplement

December 4, 2018

Wayne, Pennsylvania, Clinical and Laboratory Standards Institute has published M24--Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes, 3rd Edition and M62--Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes, 1st Edition.

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CLSI Publishes New Chemistry Document C49—Analysis of Body Fluids in Clinical Chemistry

November 16, 2018

The Clinical and Laboratory Standards Institute has published C49—Analysis of Body Fluids in Clinical Chemistry. This guideline provides guidance to medical laboratories for the appropriate application of measurement procedures for body fluid testing and for reporting results. This guideline primarily focuses on the recommended practice for verification of measurement procedures for measurands in body fluids and is applicable for laboratory testing requests on body fluids that do not have performance claims in the manufacturer’s package insert or an equivalent validated laboratory-developed test.

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CLSI Publishes New Antimicrobial Susceptibility Testing Document

October 24, 2018

The Clinical and Laboratory Standards Institute announces the publication of M11--Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria. M11 describes the reference standard agar dilution method (Wadsworth) and the alternative broth microdilution method.

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CLSI Publishes New Microbiology Guideline, M48

September 25, 2018

Clinical and Laboratory Standards Institute has published M48—Laboratory Detection and Identification of Mycobacteria. This guideline covers topics related to laboratory diagnosis of mycobacterial infections.

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