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
Hardcopy , PDF
English
30-01-2013
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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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