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