Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
4.1 Definitions
4.2 Acronyms and Abbreviations
5 Survey of Regulatory and Guidance Documents Regarding
Proficiency Testing
5.1 Documents Providing Guidelines for Proficiency
Testing
5.2 Stakeholders in the PT Process and the Documents
That May Be Useful
6 Design
6.1 Regulatory Considerations
6.2 Sample Composition
6.3 Number and Variety of Test Specimens
6.4 Process Checklist
6.5 Interpretive Questions
6.6 Clinical Interpretations
6.7 Quantitative/Qualitative Considerations
7 Material Sourcing/Collection
7.1 Laws and Guidelines Governing Human Specimen
Acquisition
7.2 Confidentiality and Privacy
7.3 Sample Sourcing
7.4 Authentic Versus Synthetic Source Materials
8 Production/Manufacture
8.1 Sample Preservation
8.2 Production
8.3 Characterization
8.4 Product Stability
8.5 Sample Retention
9 Transportation of Samples for Proficiency Testing
Programs
9.1 Specimen Types
9.2 Packaging and Transport
9.3 Specimen Rejection Criteria
10 Documentation
10.1 Letter of Instruction
10.2 Reporting Form
11 Provider Results Review and Evaluation
11.1 Issues to be Considered
11.2 Defining the "Correct" Result
12 Reports
12.1 Reporting Responsibilities of Proficiency Test
Providers/Organizations
12.2 Discrepancies, Complaints, and Inquiries
12.3 Assessment
13 Alternative Proficiency Testing Procedures
References
Additional References
Appendix A. Example of a Process Checklist
Appendix B. Sample Letter of Instruction
Appendix C. Sample Reporting Form
Summary of Consensus/Delegate Comments and Committee Responses
The Quality System Approach
Related CLSI/NCCLS Publications