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CLSI POCT9 P : 1ED 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES

Superseded date

04-30-2010

Published date

01-12-2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Why Consider Point-of -Care Testing
6 Clinical Needs Assessment
7 Operational Needs Assessment
8 Point-of-Care Testing System Selection
9 Regulatory and Accreditation Requirements
10 Implementation Checklist
11 Continuing Process for Quality Point-of-Care Testing
References
Appendix A - Determination of Needs for a New Point-of-Care
             testing System
Appendix B - Clinical Needs Assessment Comparison Worksheet
Appendix C - Items to consider When Comparing Point-of-Care
             Testing System Specifications
Appendix D - Cost Assessment Worksheets
Appendix E - Point-of-Care Testing Personnel Evaluation
Appendix F - Preimplementation Checklist
The Quality Management system Approach
Related CLSI Reference Materials

Gives guidance on selection of point-of-care testing devices based on the patient care setting and clinical needs.

DocumentType
Proposed Guideline
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy

CLSI EP14 A2 : 2ED 2005 EVALUATION OF MATRIX EFFECTS
CLSI POCT4 A2 : 2ED 2006 POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING
CLSI EP21 A : 1ED 2003 ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
CLSI GP11 A : 1ED 98 BASIC COST ACCOUNTING FOR CLINICAL SERVICES
CLSI EP6 A : 1ED 2003 EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI C3 A2 : 1991 PREPARATION AND TESTING OF REAGENT WATER IN THE CLINICAL LABORATORY
CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL

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