News

The Clinical and Laboratory Standards Institute (CLSI) has published the 3rd Edition of EP19—A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods. The 3rd Edition of the EP19 Report is available free, and introduces the Test Life Phases Model, which points users to CLSI evaluation protocol documents to establish and implement commercially manufactured or laboratory-developed test (LDT) methods.

CLSI has announced that a new and updated version of the I/LA37 Database, Supplemental Data for Allergen Specificity for IgE Antibody Autoanalyzers, is now available. The updated database provides essential allergen information for allergy testing manufacturers and hospitals performing allergy testing, both laboratories and clinicians.

The Clinical and Laboratory Standards Institute (CLSI) announces that the Pan American Health Organization (PAHO) Member States have admitted CLSI into official relations as a non-state actor with PAHO for a period of three years (2022-2024). PAHO acts as the Regional Office for the Americas of the World Health Organization (WHO).

Romney M. Humphries, Vanderbilt University Medical Center, Nashville, TN The College of American Pathologists (CAP) is introducing two new requirements for clinical laboratories to use updated...

Candida auris is an emerging yeast that is causing numerous outbreaks in health care settings, and life-threatening infections in patients worldwide.1 Most isolates of C. auris are multidrug resistant.

The Clinical and Laboratory Standards Institute (CLSI) has published the second edition of QMS15—Laboratory Internal Audit Program. This guideline provides recommendations for establishing an internal audit program and related processes for enhanced quality and continual improvement in the laboratory.

The Clinical and Laboratory Standards Institute (CLSI) has published the second edition of M47—Principles and Procedures for Blood Cultures.