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CLSI POCT12 A3 : 3ED 2013

Current

Current

The latest, up-to-date edition.

Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-01-2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Policy
6 Appropriate Uses of Point-of-Care Blood
   Glucose Meter System
7 Administrative Responsibilities
8 Performance Demonstration of Point-of-Care
   Blood Glucose Meter Systems
9 Quality Assurance Program
10 Procedure
11 Institutional Authorization Process
References
Appendix A - Evaluation of Point-of Care Glucose
             Meters Using Leftover Human Specimens
Appendix B - Evaluation of Point-of Care Glucose
             Meters Using Capillary Blood
The Quality Management System Approach
Related CLSI Reference Materials

Provides guidelines for performance of point-of-care blood glucose meter systems that stress quality control, training, and administrative responsibility.

DevelopmentNote
Supersedes CLSI C30 A2. (02/2013)
DocumentType
Standard
ISBN
1-56238-867-3
Pages
40
PublisherName
Clinical Laboratory Standards Institute
Status
Current
Supersedes

ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
CLSI EP21 : 2ED 2016 EVALUATION OF TOTAL ANALYTICAL ERROR FOR QUANTITATIVE MEDICAL LABORATORY MEASUREMENT PROCEDURES
ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
CLSI POCT6 : 1ED 2015 EFFECTS OF DIFFERENT SAMPLE TYPES ON GLUCOSE MEASUREMENTS
BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
CLSI POCT4 : 3ED 2016 ESSENTIAL TOOLS FOR IMPLEMENTATION AND MANAGEMENT OF A POINT-OF-CARE TESTING PROGRAM
CLSI POCT13 : 3ED 2015 GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT

CLSI EP23 A : 1ED 2011 LABORATORY QUALITY CONTROL BASED ON RISK MANAGEMENT
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 NBS01 A5 : 5ED 2007 BLOOD COLLECTION ON FILTER PAPER FOR NEWBORN SCREENING PROGRAMS
CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
CLSI GP41 A6 : 6ED 2007 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
CLSI GP43 A4 : 4ED 2004 PROCEDURES FOR THE COLLECTION OF ARTERIAL BLOOD SPECIMENS
CLSI GP42 A6 : 6ED 2008 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
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 GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL
CLSI EP30 A : 1ED 2010 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
CLSI EP18 A2 : 2ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES

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