CLSI EP21 A : 1ED 2003

Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 General Principles
   4.1 Cause and Effect Diagram of Medical Errors
   4.2 The Importance of Total Analytical Error
   4.3 Obtaining Total Analytical Error
   4.4 Different Uses of Total Analytical Error
5 Protocols
   5.1 Using NCCLS Document EP9 - Method Comparison and
       Bias Estimation Using Patient Samples as the Basis
       for Collecting the Data
   5.2 Using Quality Control Samples
6 Data Analysis
   6.1 Graphical Analysis
   6.2 Total Analytical Error Estimation: Introduction
   6.3 Total Analytical Error Estimation: outliers
   6.4 Total Analytical Error Estimation: Nonparametric
       Analysis
   6.5 Parametric Analysis
   6.6 A Review of Modeling Approaches
   6.7 An Outline of a Simulation Method to Estimate
       Total Analytical Error
   6.8 Comparison of the Total Analytical Error Evaluation
       Protocol With Other Evaluation Methods
7 Presentation of Results with Examples
   7.1 Result Report Format
   7.2 Result Report Interpretation
   7.3 Example 1. LDL Cholesterol
   7.4 Example 2. Sodium
References
Appendix A Factors (k) to Calculate Normal Distribution
           Tolerance Intervals
Appendix B Number of Extreme Observations v to Be Removed
           from the Ends of a Sample Size n to Obtain a
           Two-Sided Distribution-Free Tolerance Interval
           or to Obtain a One-Sided Distribution-Free
           Tolerance Bound That Contains at Least 100 %
           of the Sample Population with 100 (infinite)%
           Confidence
Appendix C A Mathematical Representation of Total Analytical
           Error
Summary of Consensus Comments and Committee Responses
Summary of Delegate Comments and Subcommittee Responses
The Quality System Approach
Related NCCLS Publications

Specifies protocols and procedures to estimate and report analytical error for clinical laboratory assays. These protocols and procedures are applicable to all quantitative analytical clinical laboratory methods.