CLSI POCT4 A2 : 2ED 2006

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.