Contents in Print Preface . ix QUALITY AND RELATED ISSUES 1. Quality Management Systems: Principles and Practice . .1 Eva D. Quinley, MS, MT(ASCP)SBB, CQA(ASQ), and Patricia C. Grace, RN, BSN Background . 1 Concepts in Quality . 2 Quality Management Systems Approach . 4 Evaluation of the Quality Management System . 5 The Quality Management System in Practice . 5 Key Points . 23 References . 24 Appendix 1-1. Glossary of Commonly Used Quality Terms . 26 Appendix 1-2. Code of Federal Regulations Quality-Related References . 28 Appendix 1-3. Suggested Quality Control Performance Intervals for Equipment and Reagents . 29 2. Facilities, Work Environment, and Safety . 33 J. Wade Atkins, MS, MT(ASCP)SBB, CQA(ASQ), and Colleen Bowman, MT(ASCP)SBB, CQA(ASQ) Safety Program . 35 Fire Prevention . 39 Electrical Safety . 40 Biosafety . 41 Chemical Safety . 48 Radiation Safety . 53 Shipping Hazardous Materials . 56 General Waste Management . 56 Key Points . 57 References . 57 Appendix 2-1. Safety Regulations and Recommendations Applicable to Health-Care Settings . 61 Appendix 2-2. General Guidance for Safe Work Practices, Personal Protective Equipment, and Engineering Controls . 63 xi xii AABB TECHNICAL MANUAL Appendix 2-3. Biosafety Level 2 Precautions . 66 Appendix 2-4. Sample List of Hazardous Chemicals That May Be Encountered in a Blood Bank . 67 Appendix 2-5. Chemical Categories and How to Work Safely with Them. 69 Appendix 2-6. Incidental Spill Response . 71 Appendix 2-7. Managing Hazardous Chemical Spills . 74 3. Regulatory Considerations in Transfusion Medicine and Cellular Therapies . 77 Joseph Schwartz, MD, MPH; Orieji Illoh, MD; and Yvette C. Tanhehco, PhD, MD, MS FDA Oversight of Blood Establishments . 78 Medical Laboratory Laws and Regulations . 84 Local Laws, Hospital Regulations, and Accreditation . 85 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/PS) . 86 Immune Effector Cells . 89 Key Points . 90 References . 90 4. National Hemovigilance: The Current State . 95 Kevin J. Land, MD; Barbee I. Whitaker, PhD; and Lynne Uhl, MD International Hemovigilance . 96 US Hemovigilance . 97 Recipient Hemovigilance in the United States . 100 Blood Donor Hemovigilance in the United States . 103 Next Steps in US Hemovigilance . 106 Key Points . 112 References . 113 Appendix 4-1. Protocol for Hospital Reporting Adverse Events to Blood Suppliers . 116 Appendix 4-2. Severity Grading Tool for Blood Donor Adverse Events . 124 BLOOD COLLECTION AND TESTING 5. Allogeneic and Autologous Blood Donor Selection . 127 Debra A. Kessler, RN, MS, and Susan N. Rossmann, MD, PhD Overview of Blood Donor Screening . 127 Selection of Allogeneic Blood Donors . 128 Abbreviated DHQ for Frequent Donors . 132 Blood-Center-Defined Donor Eligibility Criteria . 133 Recipient-Specific “Designated” or “Directed” Blood Donation . 135 Key Points . 137 References . 137 Table of Contents xiii 6. Whole Blood and Apheresis Collection of Blood Components Intended for Transfusion. 141 Jason Acker, MBA, PhD, and Anna Razatos, PhD Donor Preparation and Care. 141 Blood Collection . 145 Blood Component Storage . 153 Postcollection Processing/Blood Component Modification . 158 Quarantine of Blood Components. 164 Labeling of Blood Components . 164 Key Points . 165 References . 166 7. Infectious Disease Screening. 173 Lauren A. Crowder, MPH; Whitney R. Steele, PhD, MPH; and Susan L. Stramer, PhD Historical Overview of Blood Donor Screening . 173 Donor Screening Tests . 177 Residual Infectious Risks of Transfusion . 196 Screening for Specific Agents . 199 Pathogen Inactivation Technology . 215 Summary . 217 Key Points . 217 References . 218 BLOOD GROUPS 8. Molecular Biology and Immunology in Transfusion Medicine . 229 Sean R. Stowell, MD, PhD, and James D. Gorham, MD, PhD Analysis of DNA . 229 Analysis of Protein . 238 Basic Immunology . 243 Key Points . ..