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  • CLSI EP19 : 2ED 2015

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES

    Available format(s): 

    Superseded date:  09-04-2020

    Language(s): 

    Published date:  25-08-2018

    Publisher:  Clinical Laboratory Standards Institute

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    Table of Contents - (Show below) - (Hide below)

    Abstract
    Committee Membership
    Foreword
    Chapter 1: Introduction
    Chapter 2: Introduction of Measurement Procedure Lifecycle
    Chapter 3: Establishment
    Chapter 4: Implementation
    Chapter 5: Special Cases
    Chapter 6: Conclusion
    Chapter 7: Supplemental Information
    References
    Appendix A - Basic Statistical Concepts in the Evaluation of
                 Measurement Procedure Performance Characteristics
    Appendix B - Checklists for Laboratory Use With the Evaluation
                 Protocols Documents
    The Quality Management System Approach
    Related CLSI References Materials

    Abstract - (Show below) - (Hide below)

    Defines the 'measurement procedure lifecycle' framework to aid users of CLSI evaluation protocols documents during establishment and implementation of measurement procedures developed by both commercial manufactures and clinical laboratories, ie, for laboratory-developed tests.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes CLSI EP19 R. (06/2015)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    CLSI C52 : 3ED 2017 TOXICOLOGY AND DRUG TESTING IN THE MEDICAL LABORATORY
    CLSI C49:2018(R2023) Analysis of Body Fluids in Clinical Chemistry

    Standards Referencing This Book - (Show below) - (Hide below)

    CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
    CLSI GP29 A : 1ED 2002 VALIDATION OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
    CLSI AUTO13 A2 : 2ED 2003 LABORATORY INSTRUMENTS AND DATA MANAGEMENT SYSTEMS: DESIGN OF SOFTWARE USER INTERFACES AND END-USER SOFTWARE SYSTEMS VALIDATION, OPERATION, AND MONITORING
    CLSI EP27 A : 1ED 2012 HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR QUANTITATIVE DIAGNOSTIC ASSAYS
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI EP23 A : 1ED 2011 LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
    CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI EP5 A3 : 3ED 2014 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
    CLSI AUTO3 A2 : 2ED 2009 LABORATORY AUTOMATION: COMMUNICATIONS WITH AUTOMATED CLINICAL LABORATORY SYSTEMS, INSTRUMENTS, DEVICES, AND INFORMATION SYSTEMS
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
    CLSI EP26 A : 1ED 2013 USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION
    CLSI EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    CLSI EP24 A2 : 2ED 2011 ASSESSMENT OF THE DIAGNOSTIC ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC CURVES
    CLSI EP9 A3 : 3ED 2013 MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
    CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
    CLSI M28 A2 : 2ED 2005 PROCEDURES FOR THE RECOVERY AND IDENTIFICATION OF PARASITES FROM THE INTESTINAL TRACT
    CLSI AUTO7 A : 1ED 2004 LABORATORY AUTOMATION: DATA CONTENT FOR SPECIMEN IDENTIFICATION
    CLSI M27 A3 : 3ED 2008 REFERENCE METHOD FOR BROTH DILUTION ANTIFUNGAL SUSCEPTIBILITY TESTING OF YEASTS
    CLSI M50 A : 1ED 2008 QUALITY CONTROL FOR COMMERCIAL MICROBIAL IDENTIFICATION SYSTEMS
    CLSI AUTO10 A : 1ED 2006 AUTOVERIFICATION OF CLINICAL LABORATORY TEST RESULTS
    CLSI EP14 A3 : 2014 EVALUATION OF COMMUTABILITY OF PROCESSED SAMPLES
    CLSI M40 A2 : 2014 QUALITY CONTROL OF MICROBIOLOGICAL TRANSPORT SYSTEMS
    CLSI M22 A3 : 3ED 2004 QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA
    CLSI M11 A8 : 8ED 2012 METHODS FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ANAEROBIC BACTERIA
    CLSI EP15 A3 : 3ED 2014 USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS
    CLSI M23 A3 : 3ED 2008 DEVELOPMENT OF IN VITRO SUSCEPTIBILITY TESTING CRITERIA AND QUALITY CONTROL PARAMETERS
    CLSI M100 S25 : 25ED 2015 PERFORMANCE STANDARDS FOR ANTIMICROBIAL DISK SUSCEPTIBILITY TESTS
    CLSI M7 A10 : 10ED 2015 METHODS FOR DILUTION ANTIMICROBIAL SUSCEPTIBILITY TESTS FOR BACTERIA THAT GROW AEROBICALLY
    CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI MM3 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    CLSI EP10 A3 : 2006 + A1 2014 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI QMS02 A6 : 6ED 2013 QUALITY MANAGEMENT SYSTEM: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS
    CLSI AUTO8 A : 1ED 2006 MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS
    CLSI C56 A : 1ED 2012 HEMOLYSIS, ICTERUS, AND LIPEMIA/TURBIDITY INDICES AS INDICATORS OF INTERFERENCE IN CLINICAL LABORATORY ANALYSIS
    CLSI M29 A4 : 4ED 2014 Protection of Laboratory Workers From Occupationally Acquired Infections
    CLSI EP30 A : 1ED 2010 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    CLSI EP18 A2 : 2ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
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