CLSI Publishes New Method Evaluation Document
January 8, 2020
CLSI Publishes New Method Evaluation Document—EP35—Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition
Read MoreCLSI 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 Newborn Screening Document NBS05—Newborn Screening for Cystic Fibrosis, 2nd Edition
December 23, 2019
The Clinical and Laboratory Standards Institute (CLSI) has published the second edition of NBS05—Newborn Screening for Cystic Fibrosis. NBS05 describes newborn screening (NBS) laboratory tests and screening strategies used worldwide to identify newborns at increased risk of developing cystic fibrosis (CF).
Read MoreCLSI Publishes Newborn Screening Document NBS08—Newborn Screening for Hemoglobinopathies, 1st Edition
November 5, 2019
The Clinical and Laboratory Standards Institute (CLSI) has published NBS08—Newborn Screening for Hemoglobinopathies, 1st Edition. NBS08 describes the newborn screening (NBS) processes for testing dried blood spot specimens to detect hemoglobinopathies and thalassemias not usually evident at birth. Hemoglobinopathies and thalassemias are clinically significant congenital red blood cell disorders caused by structural or other hemoglobin abnormalities, resulting in various clinical manifestations.
Read MoreCLSI 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.
Read MoreCLSI 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.
Read MoreENAS 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.
Read MoreCLSI 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.
Read MoreCLSI 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.
Read MoreCLSI 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.
Read MoreCLSI 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.
Read More