EP19
Clinical and Laboratory Standards InstituteA Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd ed.
Clinical and Laboratory Standards Institute Products & Reviews
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A not-for-profit membership organization, the Clinical and Laboratory Standards Institute (CLSI) brings together the global laboratory community for a common cause: fostering excellence in laboratory medicine. We do so by facilitating a unique process of developing clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals. As an international organization, our members include 1,400+ organizations and 400+ individuals that come from over 60 countries. Through our unified efforts, we set and uphold the standards that drive quality test results, enhance patient care delivery, and improve public health around the world. For nearly 50 years, our members, volunteers, and customers have made CLSI a respected, transformative leader in the development and implementation of medical laboratory testing standards. Standardization in the laboratory improves the quality and efficiency of testing, which ultimately improves patient care outcomes.
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M23
Clinical and Laboratory Standards InstituteDevelopment of In Vitro Susceptibility Testing Criteria and Quality Control Parameters. 5th ed
M100
Clinical and Laboratory Standards InstituteM100 - Performance Standards for Antimicrobial Susceptibility Testing, 33rd Edition is currently available for preorder on the manufacturer’s website. Performance Standards for Antimicrobial Susceptibility Testing. 32nd Edition.
EP23
Clinical and Laboratory Standards InstituteLaboratory Quality Control Based on Risk Management, 1st Edition
MR01
Clinical and Laboratory Standards InstituteColistin Breakpoints for Pseudomonas aeruginosa and Acinetobacter spp.
QMS01
Clinical and Laboratory Standards InstituteA Quality Management System Model for Laboratory Services
AUTO16
Clinical and Laboratory Standards InstituteNext-Generation In Vitro Diagnostic Instrument Interface
C63
Clinical and Laboratory Standards InstituteLaboratory Support for Pain Management Programs, 1st Edition
EP36
Clinical and Laboratory Standards InstituteHarmonization of Symbology and Equations, 1st Edition
EP06, Evaluation of Linearity of Quantitative Measurement Procedures
Clinical and Laboratory Standards InstituteThis document provides both manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval. EP06 can also be used to determine the extent to which a quantitative measurement procedure meets medical requirements or the manufacturer’s linearity interval claims.
EP06, Evaluation of Linearity of Quantitative Measurement Procedures
Clinical and Laboratory Standards InstituteThis document provides both manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval. EP06 can also be used to determine the extent to which a quantitative measurement procedure meets medical requirements or the manufacturer’s linearity interval claims.
C64, Quantitative Measurement of Proteins and Peptides by Mass Spectrometry
Clinical and Laboratory Standards InstituteThis guideline describes the design, development, and validation of quantitative assays for proteins and peptides by mass spectrometry.
EP43, Implementing a Laboratory Test Under Emergency Use Conditions
Clinical and Laboratory Standards InstituteThis white paper covers public health emergencies in general, the ways in which emergency use authorizations (EUAs) may be used, and the ramifications of EUAs for medical laboratories and other testing sites.
EP26IG
Clinical and Laboratory Standards InstituteUser Evaluation of Acceptability of a Reagent Lot Change Implementation Guide, 1st Edition
Method Navigator
Clinical and Laboratory Standards InstituteMethod Navigator is an online subscription product that provides users with quick and easy access to specific guidance from CLSI documents. Method Navigator was designed to help test developers—whether they are test manufacturers or laboratories developing tests—fulfill FDA, CLIA, ISO, and other requirements.
Gap Analysis Tool
Clinical and Laboratory Standards InstituteLearn how to perform a gap analysis of laboratory quality activities to help your laboratory meet minimum QMS requirements.