CLSI H57 A : 1ED 2008

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Stages of Evaluation
6 Determination of Instrument Options
7 Time Scale
8 Preliminary Evaluation
9 Preacquisition Assessment by the End User
   9.1 Instrument Specifications
   9.2 Specifications of the Device That Are Provided by
         the Manufacturer to the Laboratory
   9.3 Assessment of the Laboratory Characteristics and
         Environment by the Manufacturer
   9.4 Assessment of Operational Requirements of the Device
         by the Laboratory
   9.5 Selection of Assays for Preacquisition Assessment
   9.6 Selection of Reagents for Preacquisition Assessment
10 Performance Evaluation by the End User
   10.1 Selection of Specimens for Evaluation
   10.2 Selection of Assays for Evaluation
   10.3 Selection of Reagents for Evaluation
   10.4 Precision Testing
   10.5 Accuracy
   10.6 Reference Intervals
   10.7 Comparability
   10.8 Carryover
   10.9 Statistical Analysis
   10.10 QC Ranges and Stability of Calibration Curve
   10.11 On-Instrument Reagent Stability
   10.12 Efficiency Assessment
   10.13 Site's Operational Throughput
   10.14 Reliability
11 Implementation (Procedure Manuals, Training, Education,
   LIS Interface)
   11.1 Method Validation of All Tests
   11.2 Calculation of Reference Intervals and Therapeutic
         Ranges
   11.3 Dissemination of New Ranges
   11.4 Procedure Manual
   11.5 Instrument Operator Training
   11.6 LIS Testing
References
Additional References
Appendix A - Carryover Procedure
Appendix B - Statistical Analysis for Comparability
Summary of Delegate Comments and Committee Responses
The Quality Management System Approach
Related CLSI Reference Materials

This document provides guidance and procedures to the end user and manufacturer for the selection, evaluation, validation, and implementation of a laboratory coagulometer.