Home >> Tag Archives: CLSI (formerly NCCLS)

Tag Archives: CLSI (formerly NCCLS)

CLSI guidelines

November 2020—The Clinical and Laboratory Standards Institute released two new guidelines, MM13: Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods, 2nd ed., and GP42: Collection of Capillary Blood Specimens, 7th ed.

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CLSI publishes 30th edition of M100

April 2020—The Clinical and Laboratory Standards Institute has published its annually updated antimicrobial susceptibility testing supplement, “M100: Performance Standards for Antimicrobial Susceptibility Testing, 30th ed.” M100 is available as part of a package with either “M02: Performance Standards for Antimicrobial Disk Susceptibility, 13th ed.” or “M07: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, 11th ed.,” or all three documents can be purchased together. A free, read-only web version of M100 is available at https://j.mp/2UEHgtj.

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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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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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Lab personnel management document, 12/15

December 2015—The Clinical and Laboratory Standards Institute published a new document titled “Laboratory Personnel Management (QMS16-Ed1).” This guideline describes the process for meeting the regulatory and accreditation requirements of personnel management in the laboratory environment.

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Point-of-care testing standards, 10/15

CLSI released new and revised standards on point-of-care testing in relation to glucose measuring and monitoring. “Effects of Different Sample Types on Glucose Measurements, 1st Edition (POCT06-Ed1)” provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests and is intended for use by clinicians, point-of-care teams, pathologists, laboratory directors, and manufacturers of glucose testing devices.

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CLSI Excellence Awards, 9/15

CLSI’s Excellence Awards are bestowed on volunteers who are dedicated and committed to the organization’s mission and who significantly contribute their services to the development, implementation, and promotion of consensus standards. The winners were nominated by their peers and then selected by the CLSI Awards Committee and announced in July.

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Process management guideline, 6/15

June 2015—The Clinical and Laboratory Standards Institute has published a new document, “Process Management (QMS18-Ed1).” The guideline defines four requirements for managing laboratory processes and provides suggestions for meeting regulatory and accreditation requirements ...

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Process management guideline, 5/15

May 2015—The Clinical and Laboratory Standards Institute has published a new document, “Process Management (QMS18-Ed1).” This guideline describes four requirements for managing laboratory processes and provides suggestions for effectively meeting regulatory and accreditation requirements, optimizing efficient use of resources, and contributing to patient safety and positive outcomes.

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Antimicrobial susceptibility testing standards, 4/15

April 2015—The Clinical and Laboratory Standards Institute released a new edition of its annual supplement “Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement (M100-S25).” This document provides the revised breakpoints, new testing recommendations, and reporting changes needed to incorporate into routine practice for improving detection and reporting of antimicrobial resistance.

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Guide for the FDA’s regulation of LDTs, 4/15

April 2015—The Clinical and Laboratory Standards Institute has published “Quality System Regulation for Laboratory-Developed Tests: A Practical Guide for the Laboratory.” The guide is intended to clarify how to implement the Quality System Regulation, 21 CFR 820, that may be required for some classifications of LDTs.

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Emergency prep guidelines, 3/15

March 2014—The Clinical and Laboratory Standards Institute has published a new document, “Planning for Laboratory Operations During a Disaster; Approved Guideline (GP36-A).” The document provides guidance for laboratory and health care leadership for development, implementation, and sustainment of effective emergency preparedness plans (all hazards) supporting nonanalytical components of clinical and public health laboratory services that may pertain to various natural and manmade disasters.

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Updated nongynecological cytology specimens standard, 2/15

February 2014—The Clinical and Laboratory Standards Institute has released Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition (GP23-A2). This document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimens to ensure suitable specimens for diagnosis of cancer, infectious diseases, and other inflammatory conditions. CLSI, 610-688-0100

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CLSI updated standards and software

January 2015—The Clinical and Laboratory Standards Institute has published two updated standards and released a new version of its StatisPro software. User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition (EP15-A3) describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed in five days.

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Standard on microbiological transport systems QC, 10/14

October 2014—The Clinical and Laboratory Standards Institute released a new edition of its document Quality Control of Microbiological Transport Systems; Approved Standard—Second Edition (M40-A2). This document provides criteria to assist manufacturers and end users of transport devices in providing and selecting dependable products for the transport of microbiological clinical specimens.


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CLSI guidelines, 8/14

August 2014—The Clinical and Laboratory Standards Institute published H52-A2—Red Blood Cell Diagnostic Testing Using Flow Cytometry; Approved Guideline—Second Edition. This standard addresses the diagnostic red blood cell assays performed as fluorescence-based assays on a flow cytometry platform, including testing procedures for fetomaternal hemorrhage detection, paroxysmal nocturnal hematuria screening, membrane defect anemia testing for hereditary spherocytosis, and nucleated RBC counting. Caveats of interpretation and points of validation and quality control are also discussed.

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New molecular methods standards, 7/14

July 2014—The Clinical and Laboratory Standards Institute released Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition (MM09-A2) and published a new document, Microarrays for Diagnosis and Monitoring of Infectious Diseases; Approved Guideline (MM22-A). 


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CLSI QMS15 guideline, 5/14

May 2014—The Clinical and Laboratory Standards Institute released a new quality management systems standard: QMS15-A—Laboratory Internal Audit Program; Approved Guideline. The document provides guidance on how a laboratory can establish an internal audit program to enhance the quality of its services through continual improvement. CLSI, 610-688-0100

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New CLSI editions: M100-S24, eM100, 4/14

April 2014—The Clinical and Laboratory Standards Institute released a new edition of its document M100-S24: Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement, which provides updated tables for the CLSI antimicrobial susceptibility testing standards M02-A11, M07-A9, and M11-A8.

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Updated molecular methods document, 11/13

The Clinical and Laboratory Standards Institute has published an updated version of “MM07-A2–Fluorescence In Situ Hybridization Methods for Clinical Laboratories; Approved Guideline–Second Edition.” This document addresses FISH methods for medical genetic determinations, identification of chromosomal abnormalities, and gene amplification.

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Updated CLSI standard on newborn screening, 10/13

The Clinical and Laboratory Standards Institute has released an updated edition of its standard NBS01-A6 (replaces LA04-A5), “Blood Collection on Filter Paper for Newborn Screening Programs; Approved Standard-Sixth Edition.” This document contains new information and insight for personnel on the essentials of correctly collecting a high-quality specimen, handling the specimen after it has been collected, transporting it to the testing facility, and sorting the residual specimen that remains after laboratory testing.

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Guideline on detecting fungi, 2/13:112

The Clinical and Laboratory Standards Institute has published “M54-APrinciples and Procedures for Detection of Fungi in Clinical Specimens-Direct Examination and Culture; Approved Guideline.” The document addresses the protocols for detecting fungi in clinical specimens and highlights direct microscopic examinations and fungal culturing methods.

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