Streamline your breakpoint implementation process to meet new CAP requirements effective January 2024, with the Breakpoint Implementation Toolkit (BIT). To make breakpoint updates easier, CLSI has developed—in partnership with APHL, ASM, CAP, and CDC—a comprehensive and user-friendly BIT.
CLSI Celebrates One Health Day 2023
November 3, 2023 is the eighth annual One Health Day. This global campaign highlights the need for an integrated approach to tackle shared health threats around the world. The One Health approach spans a multitude of disciplines and sectors to achieve optimal health outcomes for people, animals, plants, and their shared ecosystems, through coordinated interventions.
This guideline provides recommendations for establishing and maintaining a process to assist the laboratory in achieving a continuous state of readiness for assessment by an external organization. This includes selecting and evaluating an external assessment organization, preparing for and undergoing a successful assessment, and sustaining ongoing readiness for assessment.
CLSI EP12IG | Verification of Performance of a Qualitative, Binary Output Examination Implementation Guide, 3rd Edition
This implementation guide describes the minimum procedures necessary for a medical laboratory to verify the performance of qualitative, binary output (yes or no, positive or negative, target condition present or absent) examinations.
CLSI M53 | Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection, 2nd Edition
This guideline includes recommendations for performing human immunodeficiency virus testing and for interpretation of results by health care providers in advanced diagnostic laboratories.
CLSI POCT18 | Selection Process for CLIA-Waived Testing for SARS-CoV-2, Respiratory Syncytial Virus, and Influenza Viruses, 1st Edition
This white paper includes information related to selection considerations of CLIA-waived SARS-CoV-2, respiratory syncytial virus, and influenza virus testing.
This guideline provides recommendations based on risk management for laboratories to develop quality control plans tailored to the combination of measuring system, laboratory setting, and clinical application of the test.
Learn More About CLSI
CLSI and our volunteer members actively identify and develop new guidance on standards that raise laboratory testing quality, safety, and efficiency. We are setting the bar for how that guidance is delivered.Learn more
Press Releases View All
- Clinical and Laboratory Standards Institute (CLSI) Receives 2023 Power of Associations Gold Award for its MicroFree Program
- CLSI Publishes Second Edition of M24S—Performance Standards for Susceptibility Testing of Mycobacteria, Nocardia spp., and Other Aerobic Actinomycetes
- CLSI Publishes the Third Edition of EP12—Evaluation of Qualitative, Binary Output Examination Performance