CLSI QMS24 : 3ED 2016

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - The proficiency Testing Process
Chapter 3 - Option for Proficiency Testing
Chapter 4 - Review of Proficiency Testing Reports
Chapter 5 - Result Recorded, Communicated, and Retained
Chapter 6 - Ongoing performance Review and Assessment
            of the Proficiency Testing process
Chapter 7 - Other users for proficiency Testing Samples and Reports
Chapter 8 - Special Circumstances for Proficiency Testing in
            Specific Laboratory Disciplines
Chapter 9 - Conclusion
Chapter 10 - Supplemental Information
References
Appendix A - Examples of worksheets for Tracking Proficiency
             Testing
Appendix B - Examples of Attestation Statements
Appendix C - Proficiency Testing provider Performance Statistics
             for Quantitative Results
Appendix D - Statistical Evaluation of Qualitative spilt-sample Results
Appendix E - Procedure to Determine Allowable Differences
             Between Laboratories X and Y in a split-sample
             program
Appendix F - Examples of Proficiency Testing Results
Appendix G - Proficiency Testing Troubleshooting Guide
Appendix H - Examples of Proficiency Testing Result Review,
             Evaluation, and investigation forms
Appendix I - Molecular Proficiency Testing Report Examples
Appendix J - Sample Form for Documenting Unsatisfactory
             Gynecological Cytology Proficiency Testing
             Performance
The Quality Management system Approach
Related CLSI References Materials

Defines an approach for a complete proficiency testing (PT) process and provides assistance to laboratories in using PT as a quality improvement tool.

The purpose of this guideline is to help medical laboratories useproficiency testing (PT) as a quality improvement tool.1-6 This guidelinepresents a systematic approach for designing the PT process as acomponent of the laboratory QMS.QMS24 is intended for clinical laboratory managers and analysts inboth the public and private sectors, and is applicable to any setting inwhich clinical laboratory testing is performed, from bedside testingto large multispecialty laboratories. This guideline applies to bothqualitative and quantitative laboratory testing, including detectionand quantification of blood and fluid measurands and blood and tissuetyping. Some discussions apply only to examinations with quantitativeresults, whereas other discussions apply to examinations withqualitative results.The processes described in this guideline can help laboratories designa PT process, monitor PT results, and investigate and respond tounacceptable PT results. Part of this response may include preparation ofinformation for submission to regulatory or accreditation organizations.Laboratories are cautioned, however, that regulatory and accreditationorganizations may have additional requirements not supported by theguidance in QMS24.QMS24 also provides guidance for how to use PT as a tool to preventproblems through analysis of acceptable results, education of laboratorypersonnel, and monitoring of internal processes.This guideline does not recommend specific corrective actions forspecific root causes (see CLSI document QMS117).