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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 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 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 ...... 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” ...... 135 Key Points ...... 137 References ...... 137 Table of Contents xiii

6. and 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 ...... 238 Basic Immunology ...... 243 Key Points ...... 251 References ...... 251

9. Blood Group Genetics ...... 255 Margaret A. Keller, PhD, and Sandy Wortman, MT(ASCP)CMSBB Genomic Organization and Regulation...... 256 Genetic Variation ...... 262 Inheritance of Genetic Traits ...... 266 Structural Variation ...... 270 Chimerism...... 273 Gene Position Effects ...... 274 xiv AABB TECHNICAL MANUAL

Genetic Modifiers of Blood Group Expression...... 274 Population Genetics ...... 275 Relationship Testing ...... 278 Blood Group Gene Mapping ...... 279 Gene, Protein, and Blood Group Terminology ...... 280 Blood Group Genomics...... 281 Summary ...... 291 Key Points ...... 292 References ...... 293

10. ABO and Other Carbohydrate Blood Group Systems ...... 297 Martin L. Olsson, MD, PhD, and Julia S. Westman, PhD The ABO system (001) ...... 297 The H System (018) ...... 310 The LE System (007) ...... 313 I and i of the I Blood Group System (027) and I Blood Group Collection . . 315 P1PK (003) and GLOB (028) Blood Group Systems ...... 318 The FORS Blood Group System (031) ...... 323 The SID Blood Group System (038)...... 323 Key Points ...... 323 References ...... 324

11. The Rh System ...... 329 Thierry Peyrard, PharmD, PhD, EurSpLM, and Franz F. Wagner, MD Historical Perspective ...... 329 Terminology ...... 332 Rh Locus ...... 333 RHD ...... 334 Antigens ...... 337 Rh Genotyping ...... 346

Rhnull Syndrome and the RhAG (030) Blood Group System ...... 347 to Antigens...... 347 Technical Considerations for Rh Typing...... 348 Key Points ...... 349 References ...... 350

12. Other Blood Group Systems and Antigens...... 355 Cami Melland, MLS(ASCP)CMSBB, and Sandra Nance, MS, MT(ASCP)SBB The MNS System (002) ...... 359 The LU System (005) ...... 363 The KEL (006) and Xk (019) Systems ...... 364 The FY System (008) ...... 368 The JK System (009) ...... 370 The DI System (010) ...... 372 The YT System (011) ...... 373 The XG System (012) ...... 374 Table of Contents xv

The SC System (013) ...... 374 The DO System (014) ...... 374 The CO System (015) ...... 375 The LW System (016) ...... 375 The CH/RG System (017) ...... 377 The GE System (020) ...... 377 The CROM System (021) ...... 378 The KN System (022) ...... 378 The IN System (023) ...... 379 The OK System (024) ...... 379 The RAPH System (025) ...... 379 The JMH System (026) ...... 379 The GIL System (029) ...... 380 The RHAG System (030) ...... 380 The JR System (032) ...... 380 The LAN System (033) ...... 380 The VEL System (034) ...... 381 The CD59 System (035) ...... 381 The AUG System (036) ...... 381 The KANNO System (037) ...... 382 The SID System (038) ...... 382 The CTL2 System (039) ...... 382 Antigens that Do Not Yet Belong to a Blood Group System ...... 382 Erythroid Caused by Mutations in Transcription Factor ...... 384 Key Points ...... 384 References ...... 385

13. Identification of Antibodies to Red Cell Antigens ...... 389 Lay See Er, MSTM, SBB(ASCP)CM, CQA(ASQ), and Debra J. Bailey, MT(ASCP)SBB Basic Concepts in Red Cell Antigen Expression...... 390 Initial Identification Considerations ...... 391 Basic Antibody Identification ...... 394 Complex Antibody Identification ...... 402 Selected Procedures ...... 414 Considerations Following Antibody Identification ...... 421 Immunohematology Reference Laboratories ...... 424 Key Points ...... 424 References ...... 425 Suggested Readings ...... 428

14. The Positive Direct Antiglobulin Test and Immune- Mediated ...... 429 P. Dayand Borge Jr, MD, PhD, and Paul M. Mansfield, MT(ASCP)CMSBB The DAT ...... 430 Autoimmune Hemolytic ...... 434 Drug-Induced Immune ...... 445 xvi AABB TECHNICAL MANUAL

Key Points ...... 449 References ...... 449 Appendix 14-1. Drugs Associated with Immune Hemolytic Anemia ...... 452

15. and Granulocyte Antigens and Antibodies ...... 457 David F. Stroncek, MD, and Ralph R. Vassallo, MD, FACP Platelet Antigens and Antibodies ...... 457 Granulocyte Antigens and Antibodies ...... 469 Key Points ...... 473 References ...... 473

16. The HLA System...... 479 Jeremy Ryan Peña, MD, PhD; Arthur B. Eisenbrey III, MD, PhD; and Patricia M. Kopko, MD Biochemistry, Tissue Distribution, and Structure ...... 479 Genetics of the MHC ...... 484 HLA Typing ...... 488 Other Non-HLA Histocompatibility Determinants ...... 489 Crossmatching and Detection of HLA Antibodies...... 490 The HLA System and Transfusion ...... 491 HLA Testing and Transplantation ...... 493 Other Clinically Significant Aspects of HLA ...... 495 Clinical Consultation in HLA...... 497 Regulatory Aspects of Clinical Histocompatibility...... 498 Future Directions ...... 498 Summary ...... 499 Key Points ...... 499 References ...... 499

ESSENTIALS OF TRANSFUSION PRACTICE

17. Transfusion-Service-Related Activities: Pretransfusion Testing and Storage, Monitoring, Processing, Distribution, and Inventory Management of Blood Components...... 503 Caroline R. Alquist, MD, PhD, and Sarah K. Harm, MD Samples and Requests ...... 503 Pretransfusion Testing of Recipient Blood ...... 504 Blood and Blood Component Storage and Monitoring ...... 509 Pretransfusion Processing ...... 518 Distribution ...... 522 Issuing of Components ...... 523 Inventory Management ...... 527 Key Points ...... 529 Table of Contents xvii

References ...... 530 Appendix 17-1. Sources of False-Positive Results in Antiglobulin Testing ...... 533 Appendix 17-2. Sources of False-Negative Results in Antiglobulin Testing ...... 534 Appendix 17-3. Causes of Positive Pretransfusion Test Results...... 535

18. Administration of Blood Components ...... 537 Melanie Jorgenson, RN, BSN, LSSGB Events and Considerations Before Dispensing Components ...... 537 Blood Component Transportation and Dispensing ...... 542 Blood Administration ...... 543 Documentation of the Transfusion ...... 547 Unique Transfusion Settings ...... 548 Conclusion ...... 549 Key Points ...... 549 References ...... 550

19. Hemotherapy Decisions and Their Outcomes...... 553 Nadine Shehata, MD, FRCP, and Yunchuan Delores Mo, MD Transfusion...... 553 ...... 561 Plasma Transfusion ...... 567 Transfusion ...... 569 Granulocyte Transfusion...... 570 Massive Transfusion Protocols ...... 571 Key Points ...... 573 References ...... 573

20. Patient Blood Management...... 583 Steven M. Frank, MD, and Nicole R. Guinn, MD Definition and Scope of Patient Blood Management ...... 583 Resources to Support a PBM Program ...... 584 Patient Blood Management Standards and Certification ...... 585 Methods of Patient Blood Management ...... 585 Data Collection ...... 600 Extremes of Transfusion ...... 605 Summary ...... 606 Key Points ...... 607 References ...... 607

21. Approaches to Blood Utilization Auditing...... 613 Ira A. Shulman, MD; Jay Hudgins, DO; and Irina Maramica, MD, PhD, MBA The Auditing Process ...... 614 Defining Audit Criteria ...... 615 Types of Blood Utilization Review ...... 617 Blood Utilization Review of Transfusions to High-Risk Patients ...... 620 xviii AABB TECHNICAL MANUAL

The Role of a Computerized Provider Order Entry System in Blood Utilization Review ...... 620 Use of “Big Data” to Assess Performance and Progress Measures in Transfusion Medicine...... 621 Key Points ...... 623 References ...... 624

22. Noninfectious Complications of ...... 627 Eldad A. Hod, MD, and Richard O. Francis, MD, PhD Hemovigilance ...... 627 Recognition and Evaluation of a Suspected Transfusion Reaction ...... 627 Acute or Immediate Transfusion Reactions ...... 634 Delayed Transfusion Reactions ...... 648 Fatality Reporting Requirements ...... 652 Key Points ...... 653 References ...... 653

SPECIAL PATIENTS AND SITUATIONS

23. Perinatal Issues in Transfusion Practice ...... 659 Lani Lieberman, MD; Gwen Clarke, MD; and Annika M. Svensson, MD, PhD Hemolytic Disease of the Fetus and Newborn ...... 659 Pregnancy-Related Thrombocytopenia ...... 665 Key Points ...... 668 References ...... 668

24. Neonatal and Pediatric Transfusion Practice ...... 673 Edward C.C. Wong, MD, and Rowena C. Punzalan, MD Hematopoiesis, Coagulation, and Physiology ...... 673 RBC Transfusion in Neonates ...... 675 RBC Transfusion in Infants Older than 4 Months and Children ...... 682 Platelet Transfusion in Neonates and Children ...... 685 Plasma and Cryoprecipitate Transfusion in Neonates and Children ...... 687 Granulocyte Transfusion in Neonates and Children ...... 688 Other Considerations Common to Transfusion of Neonates and Children ...... 689 Adverse Effects and Prevention ...... 694 Key Points ...... 695 References ...... 696

25. Therapeutic Apheresis...... 705 Jennifer Webb, MD, MSCE, and Chester Andrzejewski Jr, PhD, MD General Principles ...... 705 Device Modalities ...... 706 Patient Evaluation and Management ...... 707 Table of Contents xix

Vascular Access ...... 709 Anticoagulation ...... 711 Adverse Effects ...... 711 Pediatric Apheresis ...... 713 Therapeutic Apheresis Indications ...... 713 Therapeutic Apheresis Procedure Documentation, Payment, and Provider Credentialing ...... 727 Key Points ...... 729 References ...... 730

26. The Collection and Processing of Hematopoietic Progenitor Cells ...... 737 Laura S. Connelly-Smith, MBBCh, DM, and Michael L. Linenberger, MD, FACP Clinical Utility ...... 737 Histocompatibility, Donor Type, and Graft Source ...... 741 HPC Collection ...... 743 Processing Human Progenitor Cells ...... 748 Specialized Cell-Processing Methods ...... 750 Cryopreservation ...... 751 Quality Control ...... 752 Shipping and Transporting HPC Cellular Products ...... 754 Patient Care ...... 754 Regulatory and Accreditation Considerations ...... 756 Conclusion ...... 757 Key Points ...... 757 References ...... 758

27. Transfusion Support for Hematopoietic Stem Cell Transplant Recipients ...... 767 James M. Kelley, MD, PhD, and Melissa M. Cushing, MD ABO Compatibility for Blood Component Selection Following HSCT ...... 768 Blood Component Support for HSCT Patients ...... 772 Pediatric Considerations ...... 773 Key Points ...... 774 References ...... 774

28. Human Tissue Allografts and the Hospital Transfusion Service ...... 777 Annette J. Schlueter, MD, PhD; Fran Rabe, MS; and Cassandra D. Josephson, MD Tissue Donation and Transplantation ...... 777 Federal Regulations, State Laws, and Professional Standards ...... 782 Hospital Tissue Services ...... 784 Key Points ...... 789 References ...... 790

Index...... 793 xx AABB TECHNICAL MANUAL

Contents Online

METHODS

1. General Laboratory Methods

Method 1-1. Shipping Hazardous Materials Method 1-2. Monitoring Temperature During Shipment of Blood Method 1-3. Treating Incompletely Clotted Specimens Method 1-4. Solution Preparation Procedure Method 1-5. Serum Dilution Procedure Method 1-6. Dilution of Percentage Solutions Procedure Method 1-7. Preparing a 3% Red Cell Suspension Method 1-8. Preparing and Using Phosphate Buffer Method 1-9. Reading and Grading Tube

2. Red Cell Typing Methods

Method 2-1. Determining ABO Group of Red Cells—Slide Test Method 2-2. Determining ABO Group of Red Cells and Serum—Tube Test Method 2-3. Determining ABO Group of Red Cells and Serum—Microplate Test Method 2-4. Initial Investigation of ABO Grouping Discrepancies Procedure Method 2-5. Detecting Weak A and B Antigens and Antibodies by Cold Temperature Enhancement Method 2-6. Confirming Weak A and B Antigens Using Enzyme-Treated Red Cells Method 2-7. Confirming Weak A or B Subgroup by Adsorption and Elution Method 2-8. Testing Saliva for A, B, H, Lea, and Leb Antigens

Method 2-9. Confirming Anti-A1 in an A2 or Weak A Subgroup Method 2-10. Resolving ABO Discrepancies Caused by Unexpected Alloantibodies Method 2-11. Determining Serum Group Without Centrifugation Method 2-12. Determining Rh(D) Type—Slide Test Method 2-13. Determining Rh(D) Type—Tube Test Method 2-14. Determining Rh(D) Type—Microplate Test Method 2-15. Testing for Weak D Method 2-16. Preparing and Using Lectins Method 2-17. Removing Autoantibody by Warm Saline Washes Method 2-18. Using Sulfhydryl Reagents to Disperse Autoagglutination Method 2-19. Using Gentle Heat Elution to Test Red Cells with a Positive DAT Result Method 2-20. Dissociating IgG by Chloroquine for Antigen Testing of Red Cells with a Positive DAT Result Method 2-21. Using Acid Glycine/EDTA to Remove Antibodies from Red Cells Method 2-22. Separating Transfused from Autologous Red Cells by Simple Centrifugation Method 2-23. Separating Transfused from Autologous Red Cells in Patients with Hemoglobin S Disease Table of Contents xxi

3. Antibody Detection, Identification, and Compatibility Testing

Method 3-1. Using Immediate-Spin Compatibility Testing to Demonstrate ABO Incompatibility Method 3-2. Saline Indirect Antiglobulin Test Procedure Method 3-3. Albumin or LISS-Additive Indirect Antiglobulin Test Procedure Method 3-4. LISS-Suspension Indirect Antiglobulin Test Procedure Method 3-5. PEG Indirect Antiglobulin Test Procedure Method 3-6. Prewarming Procedure Method 3-7. Detecting Antibodies in the Presence of Rouleaux—Saline Replacement Method 3-8. Preparing Ficin Enzyme Stock, 1% w/v Method 3-9. Preparing Papain Enzyme Stock, 1% w/v Method 3-10. Standardizing Enzyme Procedures Method 3-11. Evaluating Enzyme-Treated Red Cells Method 3-12. One-Stage Enzyme Procedure Method 3-13. Two-Stage Enzyme Procedure Method 3-14. Performing a Direct Antiglobulin Test Method 3-15. Antibody Titration Procedure Method 3-16. Using Sulfhydryl Reagents to Distinguish IgM from IgG Antibodies Method 3-17. Using Plasma Inhibition to Distinguish Anti-Ch and -Rg from Other Antibodies with Similar Characteristics Method 3-18. Treating Red Cells Using DTT or AET Method 3-19. Neutralizing Anti-Sda with Urine Method 3-20. Adsorption Procedure Method 3-21. Using the American Rare Donor Program

4. Investigation of a Positive DAT Result

Method 4-1. Cold-Acid Elution Procedure Method 4-2. Glycine-HCl/EDTA Elution Procedure Method 4-3. Heat Elution Procedure Method 4-4. Lui Freeze-Thaw Elution Procedure Method 4-5. Cold Autoadsorption Procedure Method 4-6. Determining the Specificity of Cold-Reactive Autoagglutinins Method 4-7. Cold Agglutinin Titer Procedure Method 4-8. Adsorbing Warm-Reactive Autoantibodies Using Autologous Red Cells Method 4-9. Adsorbing Warm-Reactive Autoantibodies Using Allogeneic Red Cells Method 4-10. Polyethylene Glycol Adsorption Procedure Method 4-11. Performing the Donath-Landsteiner Test Method 4-12. Detecting Drug Antibodies by Testing Drug-Treated Red Cells Method 4-13. Detecting Drug Antibodies by Testing in the Presence of Drug

5. Hemolytic Disease of the Fetus and Newborn

Method 5-1. Testing for Fetomaternal Hemorrhage—The Rosette Test Method 5-2. Testing for Fetomaternal Hemorrhage—Modified Kleihauer-Betke Test Method 5-3. Using Antibody Titration Studies to Assist in Early Detection of Hemolytic Disease of the Fetus and Newborn xxii AABB TECHNICAL MANUAL

6. Blood Collection, Component Preparation, and Storage

Method 6-1. Screening Female Donors for Acceptable Hemoglobin Level—Copper Sulfate Method Method 6-2. Preparing the Donor’s Arm for Blood Collection Method 6-3. Collecting Blood and Samples for Processing and Testing Method 6-4. Preparing Red Blood Cells from Whole Blood Method 6-5. Preparing Prestorage Red Blood Cells Leukocytes Reduced from Whole Blood Method 6-6. Using High-Concentration Glycerol to Cryopreserve Red Cells—Meryman Method Method 6-7. Using High-Concentration Glycerol to Cryopreserve Red Cells—Valeri Method Method 6-8. Checking the Adequacy of Deglycerolization of Red Blood Cells Method 6-9. Preparing from Whole Blood Method 6-10. Preparing Cryoprecipitated AHF from Whole Blood Method 6-11. Thawing and Pooling Cryoprecipitated AHF Method 6-12. Preparing from Whole Blood Method 6-13. Removing Plasma from Platelets (Volume Reduction)

7. Transplantation of Cells and Tissue

Method 7-1. Infusing Cryopreserved Hematopoietic Cells Method 7-2. Processing Umbilical Cord Blood Method 7-3. Investigating Adverse Events and Infections Following Tissue Allograft Use

8. Quality Control Methods

Method 8-1. Validating Copper Sulfate Solution Method 8-2. Calibrating Liquid-in-Glass Laboratory Thermometers Method 8-3. Calibrating Electronic Oral Thermometers Method 8-4. Testing Refrigerator Alarms Method 8-5. Testing Freezer Alarms Method 8-6. Calibrating Centrifuges for Platelet Separation Method 8-7. Calibrating a Serologic Centrifuge for Immediate Agglutination Method 8-8. Calibrating a Serologic Centrifuge for Washing and Antiglobulin Testing Method 8-9. Testing Automatic Cell Washers Method 8-10. Monitoring Cell Counts of Apheresis Components Method 8-11. Counting Residual White Cells in Leukocyte-Reduced Blood and Components—Manual Method

APPENDICES Appendix 1. Normal Values in Adults Appendix 2. Selected Normal Values in Children Appendix 3. Typical Normal Values in Tests of Hemostasis and Coagulation (Adults) Appendix 4. Coagulation Factor Values in Platelet Concentrates Appendix 5. Approximate Normal Values for Red Cell, Plasma, and Blood Volumes Appendix 6. Blood Group Antigens Assigned to Systems Table of Contents xxiii

Appendix 7. Examples of Gene, Antigen, and Symbols in Conventional and International Society of Blood Transfusion Terminology Appendix 8. Examples of Correct and Incorrect Terminology Appendix 9. Distribution of ABO/Rh Phenotypes by Race or Ethnicity Appendix 10. Abbreviations Used in the Technical Manual, 20th Edition

ACKNOWLEDGMENT Special thanks to Maureen Beaton, MT(ASCP)BB, CQA(ASQ), for review of the methods and appendices.