CLSI H57 P : 1ED 2007
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
23-01-2008
12-01-2013
Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
5 Stages of Evaluation
6 Determination of Instrument Options
7 Timescale
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 Validation by the End User
10.1 Selection of Specimens for Validation
10.2 Selection of Assays for Validation
10.3 Selection of Reagents for Validation
10.4 Precision Testing
10.5 Accuracy
10.6 Reference Intervals
10.7 Comparability
10.8 Carryover
10.9 Statistical Analysis
10.10 Quality Control 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
The Quality Management System Approach
Related CLSI/NCCLS Publications
Provides guidance and procedures to the end-user and manufacturer for the selection, evaluation, validation and implementation of a laboratory coagulometer.
DocumentType |
Proposed Guideline
|
PublisherName |
Clinical Laboratory Standards Institute
|
Status |
Superseded
|
SupersededBy |
CLSI H54 A : 1ED 2005 | PROCEDURES FOR VALIDATION OF INR AND LOCAL CALIBRATION OF PT/INR SYSTEMS |
CLSI AUTO13 A2 : 2ED 2003 | LABORATORY INSTRUMENTS AND DATA MANAGEMENT SYSTEMS: DESIGN OF SOFTWARE USER INTERFACES AND END-USER SOFTWARE SYSTEMS VALIDATION, OPERATION, AND MONITORING |
CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
CLSI C28 A2 : 2ED 2000 | HOW TO DEFINE AND DETERMINE REFERENCE INTERVALS IN THE CLINICAL LABORATORY |
CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
CLSI EP7 A2 : 2ED 2005 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
CLSI H47 A : 1ED 96 | ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST |
CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
CLSI EP10 A3 : 2006 + A1 2014 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
CLSI AUTO8 A : 1ED 2006 | MANAGING AND VALIDATING LABORATORY INFORMATION SYSTEMS |
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