Abstract
Committee Membership
Foreword
1 Scope
2 Terminology
2.1 Note on Terminology
2.2 Definitions
2.3 Abbreviations/Acronyms
3 Rationale
4 Circumstances Under Which Proficiency Testing Is Not
Available
5 Alternative Assessment Procedures (AAPs)
5.1 Split-Sample Procedures
5.2 Audit-Sample Procedure
5.3 Analysis of Manufacturer's Product Calibrator or
Trueness Control Material
5.4 Analysis of Interlaboratory Quality Control Data
5.5 Analysis of Patient Data
5.6 Reevaluation of Interpreted Results
5.7 Direct Observation of Technique-Dependent Tests
5.8 Clinical Correlation Studies
5.9 Surrogate Organisms
5.10 Government and University Interlaboratory Comparison
Programs
6 Analysis of Data From Qualitative Alternative Assessment
Procedures
References
Additional References
Appendix A - Procedure to Determine Allowed Differences
Between Laboratories X and Y in a
Split-Sample Program
Appendix B - Method for Determination of Agreement With a
Reference Method
Appendix C - Statistical Evaluation of Qualitative
Split-Sample Results
Summary of Consensus Comments and Working Group Responses
Summary of Delegate Comments and Working Group Responses
The Quality Management System Approach
Related CLSI Reference Materials