CLSI GP29 A2 : 2ED 2008

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

Describes methods to assess test performance when proficiency testing (PT) is not available; these methods include examples with statistical analyses.