• CLSI QMS03 A3 : 3ED 2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    TRAINING AND COMPETENCE ASSESSMENT

    Available format(s): 

    Superseded date:  22-02-2021

    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
    1 Scope
    2 Introduction
    3 Definitions
    4 Quality Management System Approach
    5 Education, Training and Competence - The Differences
    6 Training - A Four-Stage Process
    7 Documentation of Training and Competence Assessment
    8 How to get Started
    9 Conclusion
    References
    Additional References
    Appendix A1 - Example Work Process Flowchart
    Appendix A2 - Example ABC Analyzer Process as a Table
    Appendix B - Sample Training Guide Form
    Appendix C1 - Sample Trainer Responsibilities Form
    Appendix C2 - Sample Learner Responsibilities Form
    Appendix D - Sample Training Schedule Form
    Appendix E - Sample Training Checklist Form
    Appendix F - sample Learner Evaluation Form
    Appendix G - Sample Written Assessment Form
    Appendix H1 - Preparing a Direct Observation Checklist
    Appendix H2 - Example of a Direct Observation Checklist for
                  a Procedure
    Appendix I1 - Example of a Direct Observation Form for
                  Technologists
    Appendix I2 - Example of a Direct Observation Form for
                  Laboratory Assistants
    Appendix J1 - Sample Competence Assessment Form for
                  Quantitative Testing
    Appendix J2 - Sample Competence Assessment form for
                  Qualitative Testing
    Appendix J3 - Example of a Competence Assessment Form for
                  an Instrument
    Appendix K - Sample Form for Follow-up of Competence or
                 Learning Assessment Requiring Remediation
    Appendix L1 - Example of a Training Guide for the ABC Analyzer
                  Testing Process
    Appendix L2 - Example of Trainer Responsibilities for ABC
                  Analyzer Testing Process
    Appendix L3 - Example of Learner Responsibilities for ABC
                  Analyzer Testing Process
    Appendix L4 - Example of a Training Schedule for the ABC
                  Analyzer Testing Process
    Appendix L5 - Example of a Training Checklist for the ABC
                  Analyzer Testing Process
    Appendix L6 - Example of a Direct Observation Checklist for
                  the ABC Analyzer Testing Process
    Appendix L7 - Example of a Written Assessment for the ABC
                  Analyzer Testing Process
    Appendix L8 - Example of Evaluation of Training for the ABC
                  Analyzer Testing Process
    Appendix M - Sample Group Training Record
    Appendix N1 - Example of an Annual Competence Assessment Plan
                  for a Laboratory Assistant
    Appendix N2 - Example of an Annual Competence Assessment Plan
                  for a Laboratory Technologist/Scientist
    Summary of Delegate Voting Comments and Working Group Responses
    The Quality Management System Approach
    Related CLSI Reference Materials

    Abstract - (Show below) - (Hide below)

    Describes background information and recommended processes for the development of training and competence assessment programs that meet quality and regulatory objectives.

    Scope - (Show below) - (Hide below)

    QMS03 provides the necessary background information and processes to develop training and competence assessment programs that meet regulatory and accreditation requirements and help ensure knowledgeableand competent personnel in all laboratory disciplines.

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

    Development Note Supersedes NCCLS GP21 A2. (02/2009) Formerly CLSI GP21 A3 (07/2013)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

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

    CLSI QMS16 : 2015 LABORATORY PERSONNEL MANAGEMENT
    CLSI QMS25 : 1ED 2016 HANDBOOK FOR DEVELOPING A LABORATORY QUALITY MANUAL
    CLSI QMS20 R : 1ED 2014 UNDERSTANDING THE COST OF QUALITY IN THE LABORATORY
    CLSI GP5 A3 : 3ED 2011 CLINICAL LABORATORY WASTE MANAGEMENT
    CLSI GP17 A3 : 3ED 2012 CLINICAL LABORATORY SAFETY
    CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
    CLSI QMS15 A : 1ED 2013 ASSESSMENTS: LABORATORY INTERNAL AUDIT PROGRAM
    CLSI QMS17 : 2017 EXTERNAL ASSESSMENTS, AUDITS, AND INSPECTIONS OF THE LABORATORY
    CLSI POCT8 A : 1ED 2010 QUALITY PRACTICES IN NONINSTRUMENTED POINT-OF-CARE TESTING: AN INSTRUCTIONAL MANUAL AND RESOURCES FOR HEALTH CARE WORKERS
    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 QMS06 A3 : 3ED 2011 QUALITY MANAGEMENT SYSTEM: CONTINUAL IMPROVEMENT
    CLSI QMS18 : 1ED 2015 PROCESS MANAGEMENT
    DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    CLSI M29 A4 : 4ED 2014 Protection of Laboratory Workers From Occupationally Acquired Infections
    CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI QMS24 : 3ED 2016 USING PROFICIENCY TESTING AND ALTERNATIVE ASSESSMENT TO IMPROVE MEDICAL LABORATORY QUALITY
    CLSI GP41 : 7ED 2017 COLLECTION OF DIAGNOSTIC VENOUS BLOOD SPECIMENS
    CLSI GP33 P : 1ED 2009 ACCURACY IN PATIENT AND SAMPLE IDENTIFICATION
    CLSI GP23 A2 : 2ED 2014 NONGYNECOLOGICAL CYTOLOGY SPECIMENS: PREEXAMINATION, EXAMINATION, AND POSTEXAMINATION PROCESSES
    CLSI I/LA33 A : 1ED 2009 VALIDATION OF AUTOMATED SYSTEMS FOR IMMUNOHEMATOLOGICAL TESTING BEFORE IMPLEMENTATION
    11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    CLSI QMS02 A6 : 6ED 2013 QUALITY MANAGEMENT SYSTEM: DEVELOPMENT AND MANAGEMENT OF LABORATORY DOCUMENTS
    CLSI EP15 A3 : 3ED 2014 USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI GP48 : 1ED 2017 ESSENTIAL ELEMENTS OF A PHLEBOTOMY TRAINING PROGRAM
    CLSI M53 A : 1ED 2011 CRITERIA FOR LABORATORY TESTING AND DIAGNOSIS OF HUMAN IMMUNODEFICIENCY VIRUS INFECTION
    CLSI I/LA33 P : 1ED 2009 VALIDATION OF AUTOMATED DEVICES FOR IMMUNOHEMATOLOGIC TESTING PRIOR TO IMPLEMENTATION
    CLSI GP33 A : 1ED 2010 ACCURACY IN PATIENT AND SAMPLE IDENTIFICATION

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

    CLSI HS1 A2 : 2ED 2004 A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE
    CLSI GP26 A3 : 3ED 2004 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES
    CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
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