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CLSI GP35 P : 1ED 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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DEVELOPMENT AND USE OF QUALITY INDICATORS FOR PROCESS IMPROVEMENT AND MONITORING OF LABORATORY QUALITY

Superseded date

29-12-2010

Superseded by

CLSI QMS12 A : 1ED 2010

Published date

12-01-2013

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Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
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 Examples of Laboratory Quality Indicators
11 Conclusion
References
Additional References
Appendix A - Example of a Template for Developing Quality
             Indicators
Appendix B - Sample Quality Indicator: Assessing Community
             Provider/Physician Satisfaction of Laboratory
             Services
Appendix C - Sample Quality Indicator: Rate of Mislabeled
             or Unlabeled Samples
Appendix D - Sample Quality Indicator: Quantity Not Sufficient
             Rates for Sweat Testing
Appendix E - Sample Quality Indicator: Verification of
             Abstracted Results Into the Electronic Medical
             Record (EMR)
Appendix F - Sample Quality Indicator: Monitoring the Timeliness
             of Critical Value Reporting and Documentation of
             the Read-Back of Critical Results
Appendix G - Sample Quality Indicator: Blood Wastage Reduction
The Quality Management System Approach
Related CLSI Reference Materials

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

DocumentType
Proposed Guideline
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
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)
11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
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
ISO 15189:2012 Medical laboratories — Requirements for quality and competence
BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence

CLSI GP27 A2 : 2ED 2007 USING PROFICIENCY TESTING TO IMPROVE THE CLINICAL LABORATORY
CLSI HS1 A2 : 2ED 2004 A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE
CLSI QMS11 A : 1ED 2007 MANAGEMENT OF NONCONFORMING LABORATORY EVENTS
CLSI GP26 A3 : 3ED 2004 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES

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