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CLSI GP27 A2 : 2ED 2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY

Superseded date

29-09-2016

Superseded by

CLSI QMS24 : 3ED 2016

Published date

12-01-2013

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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 PT: a Tool for Improvement in Laboratory Testing
  4.1 Selection of PT Programs
  4.2 Sample Handling Procedures
  4.3 Treatment of Unsatisfactory Scores
5 Monitoring PT Performance
  5.1 Procedures for Quantitative Results
  5.2 Monitoring Qualitative Results
  5.3 Evaluating Method Performance Using Summary
      Statistics
6 Investigating an Unacceptable PT Result
  6.1 Gathering and Reviewing Data
  6.2 Classifying the Problem
  6.3 Root Cause
  6.4 Impact Investigation and Remedial Action
  6.5 Corrective Actions
  6.6 Documentation
  6.7 Assessment of Pre- and Postexamination Phases of
      Laboratory Testing
7 Proficiency Testing as an Education Tool
  7.1 Postevent Information Sheets
  7.2 Commentaries
  7.3 Educational or Ungraded Samples
  7.4 Participant Meetings
8 Implementing the Recommendations
  8.1 Laboratory Responsibilities
  8.2 Proficiency Testing Program Provider Responsibilities
  8.3 Oversight Body Responsibilities
References
Appendix A. Example of Long-term Monitoring of Quantitative
            Analytes
Appendix B1. Sample Form for Discordant Proficiency Testing
             Findings in Transfusion Medicine
Appendix B2. Sample Form for Discordant Proficiency Testing
             Findings in Bacteriology
Appendix B3. Sample Form for Discordant Proficiency Testing
             Findings in Clinical Chemistry
Appendix C. Sample Form for Documenting Unacceptable PT
            Investigations
Summary of Comments and Working Group Responses
Summary of Delegate Comments and Working Group Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Provides assistance to laboratories in using proficiency testing as a quality improvement tool.

DevelopmentNote
Supersedes NCCLS GP27 A. (03/2007)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

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CLSI MM1 A3 : 3ED 2012 MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
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PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
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CLSI NBS04 A : 1ED 2010 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY<br>
CLSI QMS18 : 1ED 2015 PROCESS MANAGEMENT
11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
CLSI M52 : 1ED 2015 Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems, 1st Edition
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
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CLSI H26 A2 : 2ED 2010 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
CLSI NBS05 A : 1ED 2011 NEWBORN SCREENING FOR CYSTIC FIBROSIS
CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
CLSI POCT4 : 3ED 2016 ESSENTIAL TOOLS FOR IMPLEMENTATION AND MANAGEMENT OF A POINT-OF-CARE TESTING PROGRAM
CLSI I/LA32 P : 1ED 2009 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
CLSI MM20 A : 1ED 2012 QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING
CLSI MM3 A3 : 3ED 2015 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
CLSI M53 A : 1ED 2011 CRITERIA FOR LABORATORY TESTING AND DIAGNOSIS OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION
CLSI GP35 P : 1ED 2009 DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY
CLSI POCT8 P : 1ED 2009 QUALITY PRACTICES IN NON-INSTRUMENTED NEAR-PATIENT TESTING: AN INSTRUCTIONAL MANUAL AND RESOURCES FOR HEALTH CARE WORKERS
CLSI C50 A : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
CLSI QMS12 A : 1ED 2010 DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY

CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
CLSI GP29 A : 1ED 2002 VALIDATION OF LABORATORY TESTS WHEN PROFICIENCY TESTING IS NOT AVAILABLE
CLSI MM14 A : 1ED 2005 PROFICIENCY TESTING (EXTERNAL QUALITY ASSESSMENT) FOR MOLECULAR METHODS
CLSI GP26 A3 : 3ED 2004 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES
CLSI GP22 A2 : 2ED 2004 CONTINUOUS QUALITY IMPROVEMENT: INTEGRATING FIVE KEY QUALITY SYSTEM COMPONENTS
CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS

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