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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
09-29-2016
01-12-2013
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
Provides definitions of analytical intervals, planning of quality control procedures, and guidance for quality control applications.
| DevelopmentNote |
Supersedes NCCLS C24 A2 (07/2006)
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| DocumentType |
Miscellaneous Product
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| PublisherName |
Clinical Laboratory Standards Institute
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| 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<br> |
| 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<br> |
| 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<br> |
| 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 |
| 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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