Home >> Tag Archives: CLSI (formerly NCCLS) —

Tag Archives: CLSI (formerly NCCLS) —

CLSI publishes new method evaluation guideline

September 2018—The Clinical and Laboratory Standards Institute announced the publication of “EP34—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st ed.” EP34 provides recommendations for establishing a dilution scheme to be used for patient specimens that contain measurand concentrations in the extended measuring interval above a measurement procedure’s upper limit of quantitation.

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Updated CLSI Supplement M100, 3/18

March 2018—The Clinical and Laboratory Standards Institute published its annually updated antimicrobial susceptibility testing supplement, “M100: Performance Standards for Antimicrobial Susceptibility Testing, 28th ed.,” as well as its associated methodology standards, “M02: Performance Standards for Antimicrobial Disk Susceptibility Tests, 13th ed.” and “M07: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 11th ed.” M100 is available packaged with either M02 or M07 or the three documents are available packaged together.

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Procedures up to date? Fighting injury in phlebotomy

February 2018—Requiring strict adherence to the latest industry standard for venipuncture can go a long way to minimizing the risk of phlebotomy-related lawsuits and multimillion-dollar jury awards. “It revolves right back to education,” says Nancy Erickson, PBT(ASCP), an expert witness in more than 30 phlebotomy-related lawsuits. She says lack of education and failure to follow the standard of care cause the two most common patient complaints that lead to phlebotomy-related litigation: nerve damage and syncope.

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Antimicrobial testing standards, 8/17

August 2017—The Clinical and Laboratory Standards Institute has published a revised edition of “M100: Performance Standards for Antimicrobial Susceptibility Testing, 27th ed.,” its annual supplement that provides revised breakpoints, new testing recommendations, and reporting changes needed to incorporate into routine practice.

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IgE assay design guidance, 7/17

July 2017—To define the current state of reagents and serological assay technology used to measure total human immunoglobulin E and IgE antibodies of defined allergen specificities in human blood, the Clinical and Laboratory Standards Institute published a revised document that focuses on IgE assay design and calibration, validation methods, quality assurance of assay reagents, quality control strategies, and clinical applications.

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IQCP without agony at the point of care

April 2016—For many point-of-care testing coordinators, the prospect of developing Individualized Quality Control Plans is far from enticing. But there has never been much chance that laboratories could opt out of the Centers for Medicare and Medicaid Services’ new quality control framework for much of their nonwaived testing.

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Document on management of high-risk test results, 2/16

February 2016—The Clinical and Laboratory Standards Institute has published a new document titled “Management of Critical- and Significant-Risk Results (GP47-Ed1).” This guideline provides current best practice recommendations for developing and implementing a policy and procedures for the identification, reporting, and management of critical- and significant-risk laboratory results.

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