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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 Document C64—Quantitative Measurement of Proteins and Peptides by Mass Spectrometry, 1st Edition

June 11, 2021

The Clinical and Laboratory Standards Institute (CLSI) has published the first edition of C64—Quantitative Measurement of Proteins and Peptides by Mass Spectrometry. C64 provides a framework for developing clinical protein and peptide assays from conception to validation and is intended for those who have experience with traditional small-molecule liquid chromatography–mass spectrometry (LC-MS) but not with protein and peptide analysis.

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CLSI Publishes New Guideline QMS26—Managing Laboratory Records

May 10, 2021

The Clinical and Laboratory Standards Institute (CLSI) has published the first edition of QMS26—Managing Laboratory Records. QMS26 is intended to help laboratories meet quality management system requirements for the records portion of quality system essential documents and records management. It presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records.

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CLSI Publishes New Edition of NBS01—Dried Blood Spot Specimen Collection for Newborn Screening

April 29, 2021

The Clinical and Laboratory Standards Institute (CLSI) has published the 7th edition of NBS01—Dried Blood Spot Specimen Collection for Newborn Screening. NBS01 provides descriptive, stepwise processes and procedures for collecting blood spot specimens for newborn screening. This standard was developed and continues to be updated to promote uniform practices for demographic newborn data and specimen collection. An expanded appendix section provides additional images and descriptions of unacceptable blood spot specimens.

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CLSI Publishes New Edition of M54—Principles and Procedures for Detection and Culture of Fungi in Clinical Specimens

January 18, 2021

The Clinical and Laboratory Standards Institute (CLSI) has published the second edition of M54—Principles and Procedures for Detection and Culture of Fungi in Clinical Specimens. This guideline describes recommended processes for plating and examining fungal cultures as well as principles and procedures for the direct detection of fungi in clinical specimens, including criteria for performing and interpreting direct microscopic examinations. Safety considerations unique to mycology laboratories and a discussion of appropriate levels of laboratory service (eg, when to refer samples to more experienced laboratories) are highlighted.

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CLSI Publishes New Edition of EP06—Evaluation of Linearity of Quantitative Measurement Procedures

December 15, 2020

The Clinical and Laboratory Standards Institute (CLSI) has published the 2nd Edition of EP06—Evaluation of Linearity of Quantitative Measurement Procedures. EP06 is intended to provide both manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval. This guideline also can be used to determine the extent to which a quantitative measurement procedure meets medical requirements or the manufacturer’s linearity interval claims.

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CLSI Publishes New Edition of QMS20—The Cost of Quality in Medical Laboratories

November 19, 2020

The Clinical and Laboratory Standards Institute (CLSI) has published QMS20—The Cost of Quality in Medical Laboratories, 2nd Edition. This guideline describes quality costs in laboratory expenditures (including prevention, appraisal, internal failure, and external failure costs) and suggests ways that laboratories can apply this information to continually improve their processes, services, and financial performance.

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