• CLSI C24 A3 : 3ED 2006

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS

    Available format(s): 

    Superseded date:  29-09-2016

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Clinical Laboratory Standards Institute

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

    Abstract
    Committee Membership
    Foreword
    1 Scope
    2 Introduction
    3 Standard Precautions
    4 Definitions
    5 Purpose of Statistical Quality Control
    6 Planning a Statistical Quality Control Procedure
      6.1 Define the Quality Specifications
      6.2 Select Control Materials
      6.3 Determine Method Performance
      6.4 Identify Candidate Statistical Quality Control
          Strategies
      6.5 Predict QC Performance
      6.6 Set Goals for QC Performance
      6.7 Select Appropriate QC Rules
      6.8 Example Applications of QC Planning
    7 Analytical Run
      7.1 Concept of Analytical Run
      7.2 Length of Analytical Run
    8 QC Applications
      8.1 Statement of QC Strategy
      8.2 Frequency of Control Measurements
      8.3 Location of Control Samples
      8.4 Decision Criteria for Control Rules
      8.5 Control Charts
      8.6 Setting Control Limits
      8.7 Out-of-Control Situations
    9 Interlaboratory QC Programs
    References
    Appendix - Selection of QC Procedures - Examples Using
               Practical Tools
    References for Appendix
    Summary of Consensus Comments and Working Group Responses
    Summary of Delegate Comments and Working Group Responses
    The Quality System Approach
    Related CLSI/NCCLS Publications

    Abstract - (Show below) - (Hide below)

    Provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications.

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

    Development Note Supersedes NCCLS C24 A2 (07/2006)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

    CLSI EP19 : 2ED 2015 A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI H48 : 2ED 2016 DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY
    CLSI C58 A : 1ED 2011 ASSESSMENT OF FETAL LUNG MATURITY BY THE LAMELLAR BODY COUNT
    CLSI C52 : 3ED 2017 TOXICOLOGY AND DRUG TESTING IN THE MEDICAL LABORATORY
    BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI POCT4 A2 : 2ED 2006 POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING
    CLSI EP29 A : 1ED 2012 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
    CLSI POCT9 A : 1ED 2010 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
    CLSI EP12 A2 : 2ED 2008 USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE
    CLSI C51 P : 1ED 2010 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    CLSI MM3 A3 : 3ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    CLSI H26 P2 : 2ED 2009 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
    CLSI EP21 : 2ED 2016 EVALUATION OF TOTAL ANALYTICAL ERROR FOR QUANTITATIVE MEDICAL LABORATORY MEASUREMENT PROCEDURES
    CLSI C52 A2 : 2ED 2007 TOXICOLOGY AND DRUG TESTING IN THE CLINICAL LABORATORY
    PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    UNE-EN ISO 15189:2013 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    CLSI EP23 A : 1ED 2011 LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
    CLSI I/LA28 A2 : 2ED 2011 QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS
    CLSI I/LA32 P : 1ED 2009 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
    CLSI MM6 A2 : 2ED 2010 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
    CLSI I/LA20 : 3ED 2016 ANALYTICAL PERFORMANCE CHARACTERISTICS, QUALITY ASSURANCE, AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E ANTIBODIES OF DEFINED ALLERGEN SPECIFICITIES
    CLSI NBS04 A : 1ED 2010 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
    DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI H26 A2 : 2ED 2010 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
    CLSI EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI C28 P3 : 3ED 2008 DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    CLSI I/LA20 A2 : 2ED 2009 ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
    CLSI H47 A2 : 2ED 2008 ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST
    CLSI C50 P : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
    CLSI C54 P : 1ED 2007 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI EP28 A3 : 3ED 2010 DEFINING, ESTABLISHING, AND VERIFYING REFERENCE INTERVALS IN THE CLINICAL LABORATORY
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI I/LA25 A2 : 2011 MATERNAL SERUM SCREENING
    CLSI EP15 A3 : 3ED 2014 USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS
    ISO 15189:2012 Medical laboratories — Requirements for quality and competence
    BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI EP5 A3 : 3ED 2014 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI C40 A2 : 2ED 2013 MEASUREMENT PROCEDURES FOR THE DETERMINATION OF LEAD CONCENTRATIONS IN BLOOD AND URINE
    CLSI MM16 A : 1ED 2006 USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS
    CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
    CLSI C50 A : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
    CLSI POCT12 A3 : 3ED 2013 Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition
    CLSI C43 A2 : 2ED 2010 GAS CHROMATOGRAPHY/MASS SPECTROMETRY CONFIRMATION OF DRUGS
    CLSI C46 A2 : 2ED 2009 BLOOD GAS AND PH ANALYSIS AND RELATED MEASUREMENTS

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

    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    CLSI EP10 A2 : 2ED 2002 PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY METHODS
    CLSI H42 A : 1ED 98 CLINICAL APPLICATIONS OF FLOW CYTOMETRY: QUALITY ASSURANCE AND IMMUNOPHENOTYPING OF LYMPHOCYTES
    CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
    CLSI M22 A3 : 3ED 2004 QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA
    CLSI H26 A : 1ED 96 PERFORMANCE GOALS FOR THE INTERNAL QUALITY CONTROL OF MULTICHANNEL HEMATOLOGY ANALYZERS
    CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
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