CLSI QMS12 A : 1ED 2010

Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Planning (Selection of Quality Indicators in a Laboratory)
5 Development of Quality Indicators in a Laboratory
6 Implementation of Quality Indicators in a Laboratory
7 Analysis, Presentation and Interpretation of Quality
   Indicator Data
8 Acting on Quality Indicator Data
9 Special Considerations
10 Conclusion
References
Additional References
Appendix A - Plan-Do-Check-Act
Appendix B - Example of a Template for Developing Quality
             Indicators
Appendix C - Sample Quality Indicator: Assessing Community
             Provides/Physician Satisfaction With Laboratory
             Services
Appendix D - Sample Quality Indicator: Rate of Mislabeled or
             Unlabeled Samples
Appendix E - Sample Quality Indicator: Quantity Not Sufficient
             Rates for Sweat Testing
Appendix F - Sample Quality Indicator: Verification of
             Abstracted Results Into the Electronic Medical
             Record
Appendix G - Sample Quality Indicator: Monitoring the Timeless
             of Critical Value Reporting and Documentation of
             the Read-Back of Critical Results
Appendix H - Sample Quality Indicator: Blood Wastage Reduction
Appendix I - Sample Data Presentation for Key Performance
             Indicators
Summary of Delegate Comments and Subcommittee Responses
The Quality Management System Approach
Related CLSI Reference Materials

Specifies guidance on development of quality indicators and their use in the medical laboratory.

This document provides guidance on development of quality indicators and their use in the medical laboratory. These indicators include measures developed in a single laboratory for local use and indicators developed by other organizations and national bodies. The document includes criteria for development of quantitative, ordinal, and qualitative indicators; it also includes procedures for gathering data, presenting and interpreting results, monitoring performance over time, and comparing performance with other laboratories or national norms. This guideline is intended for use by laboratory directors, managers, supervisors, and the quality manager as a means to ensure that their laboratories implement an effective approach to selection, development, interpretation, and application of information derived from well-designed quality indicators.