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CLSI POCT4 A2 : 2ED 2006

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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POINT-OF-CARE IN VITRO DIAGNOSTIC (IVD) TESTING

Superseded date

30-06-2016

Published date

12-01-2013

Abstract
Committee Membership
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Definitions
   4.1 Abbreviations and Acronyms
5 POCT Consideration
6 Regulatory Considerations
7 Development of Policy
   7.1 Designate Authority
   7.2 Assign Responsibility
   7.3 Maintain Accountability
8 Procedures
9 Organizational Structure
   9.1 Hospital-Based POCT
   9.2 Nonhospital-Based POCT
10 Personnel Considerations
   10.1 Hospital Setting
   10.2 POCT Personnel Outside the Hospital
11 Method and Instrument Considerations and Selection
   11.1 Gathering Information
   11.2 Beginning the Process
12 Training
13 Cost Accounting Considerations
14 Cost/Benefit Analysis
15 Safety and Waste Disposal
   15.1 Safety
   15.2 Exposure-Incident Follow-up
   15.3 Avoiding Accidental Skin Puncture With Sharps
   15.4 Personal Protective Equipment
   15.5 Handwashing/Sanitizing
   15.6 Food, Drink, Cigarettes, and Cosmetics
   15.7 Routine Cleaning and Disposal
   15.8 Infectious Waste Handling and Disposal
   15.9 Electrical Precautions
   15.10 Safety Manual
16 Patient/Client Preparation/Specimen Collection and
   Identification
   16.1 Patient/Client Preparation and Identification
   16.2 Specimen Collection
   16.3 Specimen Identification
   16.4 Special Precautions
17 Calibration and Calibration Verification
   17.1 Calibration
   17.2 Calibration Verification
   17.3 Frequency of Calibration and Calibration Verification
18 Quality Control
   18.1 Purpose of Controls
   18.2 Applicability of QC Procedures
   18.3 Considerations in Designing a QC Program
   18.4 Guidelines for QC Applied to Various Testing Devices
19 Reportable Range
20 Maintenance
21 Evaluation/Surveillance of Proficiency
22 Result Reporting/Recordkeeping
   22.1 Confidentiality
   22.2 Reporting and Forms
   22.3 Reporting Test Results
   22.4 Medical Alert Values
23 Interpretation of Results
24 Quality Control Documentation
   24.1 QC Documentation
25 Quality Assurance
   25.1 General Recommendations for QA
   25.2 QA Documentation
26 Risk Management/Liability
References
Additional References
Appendix A - Sample Procedure Format
Appendix B - Sample QC Log Sheet
Appendix C - Sample Preventive Maintenance Record Form
Appendix D - Sources for Practice Parameters and American
             College of Physicians Guidelines
Appendix E - Point-of-Care Training Checklist
Summary of Delegate Comments and Subcommittee Responses
The Quality System Approach
Related CLSI/NCCLS Publications

Provides guidance to users of in vitro diagnostic (IVD) devices outside the clinical laboratory, to ensure reliable results comparable to those obtained within the clinical laboratory.

DevelopmentNote
Supersedes NCCLS AST2 A (09/2006) Supersedes NCCLS AST3 A. (05/2011)
DocumentType
Miscellaneous Product
PublisherName
Clinical Laboratory Standards Institute
Status
Superseded
SupersededBy
Supersedes

CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
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
ASTM E 2538 : 2006 : R2011 Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures (Withdrawn 2020)
CLSI NBS06 A : 1ED 2013 NEWBORN BLOOD SPOT SCREENING FOR SEVERE COMBINED IMMUNODEFICIENCY BY MEASUREMENT OF T-CELL RECEPTOR EXCISION CIRCLES
CLSI POCT9 A : 1ED 2010 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
CLSI MM17 P : 1ED 2007 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
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
ASTM E 2538 : 2006 Standard Practice for Defining and Implementing Pharmacotherapy Information Services within the Electronic Health Record (EHR) Environment and Networked Architectures
CLSI POCT9 P : 1ED 2009 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
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 MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS

CLSI H3 A5 : 5ED 2003 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY VENIPUNCTURE
CLSI GP16 A2 : 2ED 2001 ROUTINE URINALYSIS AND COLLECTION, TRANSPORTATION, AND PRESERVATION OF URINE SPECIMENS
CLSI GP11 A : 1ED 98 BASIC COST ACCOUNTING FOR CLINICAL SERVICES
CLSI POCT13 A2 : 2ED 2005 GLUCOSE MONITORING IN SETTINGS WITHOUT LABORATORY SUPPORT
CLSI M29 A3 : 3ED 2005 ACQUIRED INFECTIONS; APPROVED GUIDELINE
CLSI GP21 A2 : 2ED 2004 TRAINING AND COMPETENCE ASSESSMENT
CLSI HS1 A2 : 2ED 2004 A QUALITY MANAGEMENT SYSTEM MODEL FOR HEALTH CARE
CLSI C30 A2 : 2ED 2002 POINT-OF-CARE BLOOD GLUCOSE TESTING IN ACUTE AND CHRONIC CARE FACILITIES
CLSI GP26 A3 : 3ED 2004 APPLICATION OF A QUALITY MANAGEMENT SYSTEM MODEL FOR LABORATORY SERVICES
CLSI H4 A3 : 1991 PROCEDURES FOR THE COLLECTION OF DIAGNOSTIC BLOOD SPECIMENS BY SKIN PUNCTURE
CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
CLSI H4 A5 : 5ED 2004 PROCEDURES AND DEVICES FOR THE COLLECTION OF DIAGNOSTIC CAPILLARY BLOOD SPECIMENS
CLSI EP18 A : 1ED 2002 QUALITY MANAGEMENT FOR UNIT-USE TESTING
CLSI EP9 A2 : 2ED 2002 METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
CLSI POCT14 A : 1ED 2004 POINT-OF-CARE MONITORING OF ANTICOAGULATION THERAPY
CLSI GP2 A5 : 5ED 2006 LABORATORY DOCUMENTS - DEVELOPMENT AND CONTROL

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