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 Automation and Informatics Document (AUTO15)

September 12, 2019

The Clinical and Laboratory Standards Institute (CLSI) has published AUTO15—Autoverification of Medical Laboratory Results for Specific Disciplines provides general guidance, as well as discipline-specific direction, on design and validation of an autoverification system. Autoverification is the process by which laboratory analyte results are accepted or rejected for automatic delivery to a patient data repository. This process uses a predetermined set of criteria applied at one or more points during the electronic flow of information. This guideline is provided for use by laboratorians, personnel responsible for information systems, and vendors for medical informatics and in vitro diagnostics.

CLSI Publishes Newborn Screening Document NBS03—Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns, 2nd Edition

August 14, 2019

The Clinical and Laboratory Standards Institute (CLSI) has published NBS03—Newborn Screening for Preterm, Low Birth Weight, and Sick Newborns. NBS03 describes newborn screening (NBS) of preterm, low birth weight (LBW), and sick newborns worldwide to detect treatable diseases before physical damage can occur. In developed countries, treatment advances have improved survival rates, making early disease detection by NBS even more important.

ENAS and CLSI - Improving Medical Laboratory Testing in the United Arab Emirates

August 13, 2019

Emirates National Accreditation System (ENAS) and the Clinical and Laboratory Standards Institute (CLSI) join forces in the pursuit of improving medical laboratory testing in the United Arab Emirates.

CLSI Publishes New Veterinary Antimicrobial Susceptibility Testing Document—VET09— Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings

August 8, 2019

The Clinical and Laboratory Standards Institute has published the first edition of VET09—Understanding Susceptibility Test Data as a Component of Antimicrobial Stewardship in Veterinary Settings. VET09 provides veterinarians with the information needed to successfully acquire and interpret antimicrobial susceptibility test results. It promotes common understanding between the veterinarian and the veterinary microbiology laboratory by providing example culture and susceptibility reports and animal species–specific guidance on applying breakpoints to interpret susceptibility test results.

CLSI Publishes Revised Quality Management System Document QMS01—A Quality Management System Model for Laboratory Services

June 19, 2019

The Clinical and Laboratory Standards Institute has published the fifth edition of QMS01—A Quality Management System Model for Laboratory Services and other press releases from the Clinical and Laboratory Standards Institute.

 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.

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.

 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.

CLSI Announces the Recipients of the 2019 CLSI Excellence Awards

January 15, 2019

The Clinical and Laboratory Standards Institute announces the recipients of its 2019 Excellence Awards. These awards celebrate the achievements of CLSI volunteers who have helped improve the quality of medical care worldwide.

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.