• CLSI POCT12 A3 : 3ED 2013

    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

    Publisher:  Clinical Laboratory Standards Institute

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes CLSI C30 A2. (02/2013)
    Document Type Standard
    Publisher Clinical Laboratory Standards Institute
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    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

    Standards Referencing This Book - (Show below) - (Hide below)

    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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