CLSI MM14 A : 1ED 2005

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

Gives the guideline to complement currently available regulatory and guidance documents regarding the management and operations of proficiency testing programs.