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 EP34—Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking

August 16, 2018

CLSI announces 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.

CLSI Publishes QMS22—Management of Paper-based and Electronic Laboratory Information

July 25, 2018

The Clinical and Laboratory Standards Institute announces the upcoming publication of QMS22—Management of Paper-based and Electronic Laboratory Information.This guideline is intended to help laboratories meet quality management system requirements for quality system essential (QSE) Information Management. In addition to discussing the requirements for how data and information are generated and entered into paper-based or electronic recordkeeping systems, this guideline also offers suggestions and examples for meeting the intent of the requirements.

CLSI Publishes New Molecular Methods Document on Interpretive Criteria for Identification of Bacteria and Fungi

July 17, 2018

The Clinical and Laboratory Standards Institute announces the publication of MM18—Interpretive Criteria for Identification of Bacteria and Fungi by Targeted DNA Sequencing. MM18 includes information on sequencing DNA targets of cultured isolates, provides a quantitative metric for perceiving microbial diversity, and can serve as the basis to identify microorganisms. By establishing interpretive criteria for microorganism identification by targeted DNA sequencing, this guideline provides structure to laboratories that identify microorganisms for medical use.

CLSI Publishes New Veterinary Medicine Standard and Supplement

July 5, 2018

Clinical and Laboratory Standards Institute has published VET01–Performance Standards for Antimicrobial Disk and Dilution Susceptibility Tests for Bacteria Isolated From Animals and its supplement, VET08.

CLSI Publishes New Laboratory Support for Pain Management Document

June 29, 2018

Clinical and Laboratory Standards Institute guideline C63—Laboratory Support for Pain Management Programs, provides recommendations for medical laboratory toxicology-based testing services for the care and treatment of persons in pain management programs. The intended users of this guideline include medical laboratory scientists and personnel, medical technologists, hospital administrators, physician office personnel, risk managers, pharmacists, and health care providers tasked with implementing pain management testing for their institutions or networks.

CLSI Publishes Validation and Verification of Multiplex Nucleic Acid Assays—MM17

June 12, 2018

The Clinical and Laboratory Standards Institute has published Validation and Verification of Multiplex Nucleic Acid Assays—MM17. MM17 discusses analytical validation and verification of qualitative multiplex nucleic acid assays. Topics covered include sample preparation, a general discussion of multiplex methods and technologies, reference and quality control materials, data analysis, and results reporting. Clinical validity and utility are briefly reviewed. Detailed recommendations for appropriate analytical validation and verification, based on the most current guidance documents, are provided.

CLSI Announces 2018 Excellence Awards Recipients

January 26, 2018

Wayne, Pennsylvania, USA—January 2018—CLSI Excellence Awards are bestowed upon volunteers who are committed to CLSI’s mission. Recipients are recognized for dedicating significant time and effort to the development, implementation, and promotion of voluntary consensus standards. The recipients are nominated by their peers and selected by the CLSI Awards Committee. CLSI celebrates the achievements of volunteers, as they are fundamental to the development of best practices in clinical and laboratory testing.

FDA Makes Up-to-Date Susceptibility Test Interpretive Criteria (Breakpoint) Resources Available Online

December 14, 2017

The US Food & Drug Administration (FDA) has taken an important step to improve public health by creating a website to make critical updates regarding antimicrobial drugs available to health care professionals. This information helps laboratories report the most current information to health care providers about what type of infection a patient has and what the most effective treatment will be. The website provides information on the most up-to-date Susceptibility Test Interpretive Criteria (STIC), also known as breakpoints. Breakpoints help determine whether a specific bacteria or fungi are susceptible to (ie, will respond to treatment with) antibacterial or antifungal drugs. According to the FDA, “This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria.”

CLSI Publishes New and Updated Microbiology Documents

December 4, 2017

The Clinical and Laboratory Standards Institute has published four antifungal Microbiology documents: Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts (M27-Ed4), Performance Standards for Antifungal Susceptibility Testing of Yeasts (M60-Ed1), Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi (M38-Ed3), and Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi (M61-Ed1).

CLSI Publishes New Quality Management Document

September 29, 2017

QMS19 provides information on how laboratories can develop and maintain a customer focus and meet the regulatory and accreditation requirements for managing external and internal customers. The document is intended to assist laboratories in meeting customer-based requirements for their quality management system (QMS).