CLSI QMS11 A : 1ED 2007

Abstract
Committee Membership
Foreword
1 Scope
2 Definitions
3 Overview of a Nonconforming Event Management Program
4 Human Error
5 Creating a Culture to Discover and Report Nonconforming
   Events
   5.1 A Just Culture
   5.2 Nonconforming Event Management Program Support
   5.3 Detecting or Discovering Nonconforming Events
6 Initiating a Nonconforming Event Report
7 Remedial Action
   7.1 Distinction Between Remedial and Corrective Action
   7.2 Remedial Action as Corrective Action
8 Investigation
   8.1 Path of Workflow
   8.2 Investigating the Nonconformance
   8.3 Documentation of Investigation
   8.4 Feedback
9 Short-term Corrective Action
10 Classification
   10.1 The National Center for Patient Safety (NCPS) - Safety
         Assessment Code (SAC)
   10.2 Laboratory Event Classification rective Action
11 Analysis of Event Information and Data Presentation
   11.1 Reporting Data
   11.2 A Medical Laboratory Example
12 Management Review and Referral to Process Improvement
   for Long-term Corrective Action
   12.1 Management Review
   12.2 RCA
   12.3 When to Perform RCA
   12.4 Conducting an RCA
   12.5 Commonly Identified Root Causes
   12.6 Process Improvement
13 Application of Nonconforming Event Management to a
   Laboratory Example
   13.1 Initiating the Nonconforming Event Report
   13.2 Remedial Action
   13.3 Investigation - How It Happened
   13.4 Investigation - Who and What
   13.5 Investigation - Why It Happened
   13.6 Documentation of Investigation
   13.7 Short-term Corrective Action
   13.8 Classification
   13.9 Review and Referral
   13.10 RCA
   13.11 Process Improvement
14 Last Words of Advice
References
Additional Resources
Appendix A1. Sample of a Simple Generic Nonconforming Event
             Report
Appendix A2. Sample Laboratory Nonconforming Event Report
Appendix A3. Second Example of a Laboratory Nonconforming
             Event Report Form
Appendix A4. Example of Another Laboratory Event Management
             Form
Appendix B. The Safety Assessment Code (SAC) Matrix
Appendix C. Data Collection Tools
Appendix D. Investigation and Data Reporting Tools
Appendix E. A Formal Process for Using Root Cause Analysis
            (RCA) and Related Quality Tools
Summary of Delegate Comments and Committee Responses
The Quality Management System Approach
Related CLSI Reference Materials