Abstract
Committee Membership
Foreword
Laboratory Error Sources and CLSI Evaluation Protocols
Documents
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
4.1 A Note on Terminology
4.2 Definitions
4.3 Acronyms/Abbreviations
5 User-Manufacturer Quality Partnership
5.1 Manufacturer's Responsibility
5.2 User's Responsibility
6 FMEA, FTA and FRACAS
6.1 Description of FMEA, FTA and FRACAS
6.2 Definition and Purpose
6.3 Some General Guidelines for FMEA, FTA and FRACAS
6.4 Description of FMEA Table Entries
6.5 Fault Trees
6.6 Control Measures (FMEA) or Corrective Action (FRACAS)
6.7 Validation (FMEA)
6.8 Rate Measure (FRACAS)
6.9 Other Considerations
6.10 Pareto Analysis
6.11 More on FRACAS for Clinical Laboratories
6.12 Other Aids to Facilitate FMEA and FRACAS
References
Appendix A - Example of a "System-Specific Sources of Error"
Matrix - an FMEA
Appendix B - An Example of a Manufacturer's FMEA
Appendix C - Laboratory FMEA: Manufacturer completed part
and Clinical Laboratory completed part
Appendix D - Example of a FRACAS
Appendix E - A Note on Unit-Use Devices
Summary of Consensus Comments and Committee Responses
The Quality Management System Approach
Related CLSI Publications