• Shopping Cart
    There are no items in your cart

CLSI H57 P : 1ED 2007

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS

Superseded date

23-01-2008

Superseded by

CLSI H57 A : 1ED 2008

Published date

12-01-2013

Sorry this product is not available in your region.

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Superseded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

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.