Clinical and Laboratory Standards Institute
The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. For healthcare professionals, CLSI documents offer practical operating guidelines that lead to consistent practices, precision, and efficient use of resources. For industry, they promote effective use of healthcare technologies, and provide cost-and time-saving procedures for product development and approval. For government, these tools streamline the regulatory process. For the entire healthcare community, CLSI documents assure the levels of excellence and consistency that promote improved quality of life.
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline, Second Edition; EP18P3
standard by Clinical and Laboratory Standards Institute, 11/01/2009
Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition, EP21Ed2E
standard by Clinical and Laboratory Standards Institute, 07/01/2016
Laboratory Quality Control Based on Risk Management; Approved Guideline, EP23AE
standard by Clinical and Laboratory Standards Institute, 10/01/2011
Laboratory Quality Control Based on Risk Management, Second Edition, EP23Ed2E
standard by Clinical and Laboratory Standards Institute, 08/01/2023
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline – Second Edition, EP24A2E
standard by Clinical and Laboratory Standards Institute, 11/30/2011
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, EP25A
standard by Clinical and Laboratory Standards Institute, 09/01/2009
Evaluation of Stability of In Vitro Medical Laboratory Test Reagents, 2nd Edition, EP25Ed2E
standard by Clinical and Laboratory Standards Institute, 04/26/2023
User Evaluation of Between-Reagent Lot Variation; Approved Guideline, EP26Ed2E
standard by Clinical and Laboratory Standards Institute, 04/01/2022
User Evaluation of Between-Reagent Lot Variation; Approved Guideline, EP26AE
standard by Clinical and Laboratory Standards Institute, 09/01/2013
User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide, EP26-Ed2-IG
standard by Clinical and Laboratory Standards Institute, 11/01/2022
Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures, 2nd Edition EP27
standard by Clinical and Laboratory Standards Institute, 06/14/2022
How to Construct and Interpret an Error Grid for Diagnostic Assays; Proposed Guideline, EP27A
standard by Clinical and Laboratory Standards Institute, 09/27/2012
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition, EP28A3E
standard by Clinical and Laboratory Standards Institute, 10/01/2010
Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline, EP29AE
standard by Clinical and Laboratory Standards Institute, 01/01/2012
Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine; Approved Guideline, EP30AE
standard by Clinical and Laboratory Standards Institute, 05/01/2010
Verification of Comparability of Patient Results Within One Health Care System; Approved Guideline, EP31AIRE
standard by Clinical and Laboratory Standards Institute, 08/01/2012
Metrological Traceability and Its Implementation; A Report, EP32RE
standard by Clinical and Laboratory Standards Institute, 02/17/2006
Use of Delta Checks in the Medical Laboratory, 1st Edition, EP33Ed1E
standard by Clinical and Laboratory Standards Institute, 03/01/2016
Use of Delta Checks in the Medical Laboratory, 2nd Edition, EP33Ed2E
standard by Clinical and Laboratory Standards Institute, 06/01/2023
Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st Edition, EP34Ed1E
standard by Clinical and Laboratory Standards Institute, 08/13/2018