CLSI EP21 A : 1ED 2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
07-12-2016
01-12-2013
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
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