TM Intro

Technical Manual
1 7 T H E D I T I O N
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Technical Manual
1 7 T H E D I T I O N E d i t e d b y
John D. Roback, MD, PhD Emory University Hospital Atlanta, GA

Brenda J. Grossman, MD, MPH Washington University School of Medicine St. Louis, MO Teresa Harris, MT(ASCP)SBB, CM, CQIA, CQA(ASQ) American Red Cross Washington, DC Christopher D. Hillyer, MD New York Blood Center New York, NY
Mention of specific products or equipment by contributors to this AABB publication does not represent an endorsement of such products by the AABB nor does it necessarily indicate a preference for those products over other similar competitive products. Any forms and/or procedures in this book are examples. AABB does not imply or guarantee that the materials meet federal, state, or other applicable requirements. It is incumbent on the reader who intends to use any information, forms, policies, or procedures contained in this publication to evaluate such materials for use in light of particular circumstances associated with his or her institution. AABB authors are requested to comply with a conflict of interest policy that includes disclosure of relationships with commercial firms. A copy of the policy is located at http://www.aabb.org. Efforts are made to have publications of the AABB consistent in regard to acceptable practices. However, for several reasons, they may not be. First, as new developments in the practice of blood banking occur, changes may be recommended to the Standards for Blood Banks and Transfusion Services. It is not possible, however, to revise each publication at the time such a change is adopted. Thus, it is essential that the most recent edition of the Standards be consulted as a reference in regard to current acceptable practices. Second, the views expressed in this publication represent the opinions of authors. The publication of this book does not constitute an endorsement by the AABB of any view expressed herein, and the AABB expressly disclaims any liability arising from any inaccuracy or misstatement.
Copyright 2011 by AABB. All rights reserved. No part of this book may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the Publisher. AABB 8101 Glenbrook Road Bethesda, Maryland 20814-2749 ISBN No. 978-1-56395-315-6 Printed in the United States
Cataloging-in-Publication Data Technical manual / editor, John D. Roback17th ed. p. ; cm. Including bibliographic references and index. ISBN 978-1-56395-315-6 1. Blood BanksHandbooks, manuals, etc. I. Roback, John D. II. AABB. [DNLM: 1. Blood Banks-laboratory manuals. 2. Blood Transfusionlaboratory manuals. WH 25 T2548 2011] RM172.T43 2011 615.39dc23 DNLM/DLC
Technical Manual Authors

Colleen A. Aronson, MT(ASCP)SBB James P. AuBuchon, MD Jamie Blietz, MBA, CAE Robert A. Bray, PhD Stella T. Chou, MD Laura Cooling, MD, MS Geoff Daniels, PhD, FRCPath Robertson D. Davenport, MD Janice Davis-Sproul, MAS, MT(ASCP)SBB Katharine A. Downes, MD Anne F. Eder, MD, PhD William P. FitzGerald, LTC USA (Ret) Susan A. Galel, MD Howard M. Gebel, PhD N. Rebecca Haley, MD Betsy W. Jett, MT(ASCP), CQA(ASQ)CQM/OE Cassandra D. Josephson, MD Jana Julleis, MBA, MT(ASCP)SBB Diane M. Kadidlo, MT(ASCP)SBB Ram Kakaiya, MD, MBBS Melanie S. Kennedy, MD Patricia M. Kopko, MD Thomas A. Lane, MD Regina M. Leger, MSQA, MT(ASCP)SBB, CMQ/OE(ASQ) Jill Leonard, MT(AMT) Sandy L. Liles, MT(ASCP)SBB William B. Lockwood, PhD, MD Christine Lomas-Francis, MSc, FIBMS Catherine A. Mazzei, MD Jeffrey McCullough, MD Janice G. McFarland, MD David H. McKenna, MD John D. McMannis, PhD Tania L. Motschman, MS, MT(ASCP)SBB, CQA(ASQ) Theresa Nester, MD Marilyn S. Pollack, PhD Mark A. Popovsky, MD Glenn Ramsey, MD Donna M. Regan, MT(ASCP)SBB Rita A. Reik, MD Ira A. Shulman, MD Bonnie L. S. Sink, BSN, RN, HP(ASCP) James W. Smith, MD, PhD Steven L. Spitalnik, MD Simon Stanworth, MD, DPhil Ruth D. Sylvester, Lt Col, USAF (Ret), MS, MT(ASCP)SBB Alan Tinmouth, MD, FRCPC, MSc Christopher A. Tormey, MD Lance D. Trainor, MD Phyllis S. Walker, MS, MT(ASCP)SBB Jonathan H. Waters, MD Connie M. Westhoff, PhD, MT(ASCP)SBB Susan L. Wilkinson, EdD, MS, MT(ASCP)SBB, CQA(ASQ) James C. Zimring, MD, PhD
Acknowledgments
T
H E 1 7 T H E D I T I O N O F the Technical
Manual was the work of many dedicated individuals. In addition to the chapter authors, I would like to thank my three associate editors: Brenda Grossman, Teresa Harris, and Chris Hillyer. Their efforts and long hours in revising and rewriting chapters during the review process made my job immeasurably easier. Teresa, in particular, took the lead in revising the methods sections, a job she is eminently more qualified to undertake than I. If you enjoy the content of the 17th edition, all credit should go to the associate editors and the authors. Laurie Munk, Jennifer Boyer, Jay Pennington, and their colleagues are an unmatched publication resource. Their knowledge of transfusion medicine is encyclopedic, matched only by their grammatical acumen. If the text reads well, it is due to their efforts. Should you find problems with the 17th edition, however, the blame resides with me. We would also like to acknowledge the members of the following committees and program units for their expert review of chapters, methods, and appendices for the 17th edition of the Technical Manual.
Cellular Therapies Accreditation Program Unit Clinical Transfusion Medicine Committee Circular of Information Task Force Donor Center Accreditation Program Unit Donor History Task Force Immunohematology Reference Laboratories Standards Program Unit Immunohematology Reference Laboratories Accreditation Program Unit Information Systems Committee Molecular Testing Accreditation Program Unit Perioperative Accreditation Program Unit Perioperative Standards Program Unit Quality Management Standards Subcommittee Quality Systems Accreditation Subcommittee Relationship Testing Standards Program Unit Tissue Committee Transfusion Services Accreditation Program Unit Transfusion Transmitted Diseases Committee Finally, we would like to thank the editors, authors, and program unit members of the 16th and earlier editions of the Technical Manual for selected tables, figures, methods, and written sections of the chapters that could not be improved upon, and thus were used again in the 17th edition. John D. Roback, MD, PhD Chief Editor
RE VI E W IN G COM M I T T E E S
AABB Cellular Therapies Section AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism Cellular Therapies Standards Program Unit
Preface
H E E D I T O R S A R E pleased to present the 17th edition of the Technical Manual. This is the second edition to use the revised format, which includes listing authorship for each chapter. In preparing the 17th edition, we carefully considered the comments received after publication of the 16th edition, both from readers and from authors. Many believed that the new format was successful in bringing the necessary levels of expertise to the preparation of each chapter. However, they also suggested a number of changes that have now been incorporated into the present edition. For example, Chapter 10 was expanded through the addition of several pages of basic and applied immunology as a primer for later immunohematology chapters. A section on hemovigilance was added to Chapter 27 in keeping with AABBs expanding commitment to this important quality and safety activity. Another significant change was the inclusion of several Key Points at the end of each chapter, which should be useful for both students and experienced readers alike. We believe that with the revised format a modest amount of author rotation is beneficial. Thus, for the 17th edition we recruited new authors for three chapters; additional authorship changes were also made for five other chapters. These changes should help to keep the text of the 17th edition fresh while also maintaining continuity with earlier editions. One aspect of the Technical Manual that has not changed is the commitment of the AABB and the editors to extensive, multi-layered technical review. Each chapter was reviewed and revised at least twice by an editor. The chapters were also submitted to sub-
ject matter-appropriate committees for detailed content review (see list in Acknowledgments). All chapters were then subjected to additional regulatory, AABB standards, legal, and editorial review prior to publication. Finally, as noted above, many highly knowledgeable readers functioned as an ad hoc post-publication review committee for the 16th edition by bringing errors and omissions to the editors notice. We have carefully considered each of the issues that was raised and where appropriate included revised text in the 17th edition. Because the field of blood banking, transfusion medicine, and cellular therapy is complex, detail-oriented, and continues to evolve, we once again invite all readers to contact us if they should find omissions, errors, and inconsistencies in the 17th edition, or if they would like to suggest ways to improve the next edition of the Technical Manual. We value your opinions and look to the readership for assistance in keeping this valuable resource up to date with our dynamically evolving field. It is important for readers to realize that, in the opinions of the chapter authors and the editors, the methods chosen for inclusion in the 17th edition represent best technical practices. However, these methods are not the only approaches that fulfill the requirements of AABB Standards; readers may choose to use other approaches. Furthermore, should you find that any method or statement in the Technical Manual is in conflict with the Standards, the authority of the Standards supersedes that of the Technical Manual. John D. Roback, MD, PhD Chief Editor
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Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix
QUA LIT Y
ISS UES
1.
Quality Management Systems: Theory and Practice . . . . . . . . . . 1

Tania L. Motschman, MS, MT(ASCP)SBB, CQA(ASQ); Betsy W. Jett, MT(ASCP), CQA(ASQ)CQM/OE; and Susan L. Wilkinson, EdD, MS, MT(ASCP)SBB, CQA(ASQ) Quality Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Practical Application of Quality Management Principles . . . . . . . . . . . . . . . . . .4 Appendix 1-1. Glossary of Commonly Used Quality Terms . . . . . . . . . . . . . . . 32 Appendix 1-2 Code of Federal Regulations Quality-Related References . . . . 34 Appendix 1-3. Statistical Tables for Binomial Distribution Used to Determine Adequate Sample Size and Level of Confidence for Validation of Pass/Fail Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Appendix 1-4. Suggested Quality Control Performance Intervals for Equipment and Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
2.
Facilities, Work Environment, and Safety. . . . . . . . . . . . . . . . . . . 41

Betsy W. Jett, MT(ASCP), CQA(ASQ)CQM/OE; Susan L. Wilkinson, EdD, MS, MT(ASCP)SBB, CQA(ASQ); and Tania L. Motschman, MS, MT(ASCP)SBB, CQA(ASQ) Facilities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Safety Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Fire Prevention. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Chemical Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Radiation Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Shipping Hazardous Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . General Waste Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix 2-1. Safety Regulations and Recommendations Applicable to Health-Care Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 44 48 49 58 63 66 67 71
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Appendix 2-2. General Guidelines for Safe Work Practices, Personal Protective Equipment, and Engineering Controls . . . . . . . . . . . . . . . . . . . . . 73 Appendix 2-3. Biosafety Level 2 Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77 Appendix 2-4. Sample List of Hazardous Chemicals that May Be Encountered in the Blood Bank . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Appendix 2-5. Specific Chemical Categories and How to Work Safely with Them . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Appendix 2-6. Incidental Spill Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Appendix 2-7. Managing Hazardous Chemical Spills. . . . . . . . . . . . . . . . . . . . . 85
3.
Regulatory Issues in Blood Banking . . . . . . . . . . . . . . . . . . . . . . . . 87

Glenn Ramsey, MD Federal Laws and Regulations for Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Biological Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88 Licensure and Registration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 FDA Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Blood-Related Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Hematopoietic Progenitor Cells as Tissues. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 Managing Recalls and Withdrawals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Medical Laboratory Laws and Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Hospital Regulations and Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 State and Local Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
4.
Disaster Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

Jamie Blietz, MBA, CAE; William P. FitzGerald, LTC USA (Ret); and Ruth D. Sylvester, Lt Col, USAF (Ret), MS, MT(ASCP)SBB Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103 Business Operations Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Working with Emergency Management Agencies. . . . . . . . . . . . . . . . . . . . . . . 120 Regulatory Considerations in Emergencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122 Testing the Disaster Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124 Summary of Lessons Learned from Recent Disasters . . . . . . . . . . . . . . . . . . . 125 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125 Appendix 4-1. Internet Resources Related to State and Local Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136 Appendix 4-2. General Internet Resources for Disaster Management . . . . . 136
BL OOD
DO NA TION
AND
COL LEC TION
5.
Allogeneic and Autologous Blood Donor Selection . . . . . . . . . 137

Anne F. Eder, MD, PhD Historical Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138 Selection of Allogeneic Donors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140
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Possible Measures of the Effectiveness of the Donor Interview . . . . . . . . . . Blood-Center-Defined Donor Eligibility Criteria . . . . . . . . . . . . . . . . . . . . . . . Abbreviated Donor History Questionnaire for Frequent Donors . . . . . . . . Postdonation Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Recipient-Specific Designated or Directed Blood Donation . . . . . . . . . Appendix 5-1. Requirements for Allogeneic and Autologous Donor Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix 5-2. The Donor History Questionnaire and Corresponding Regulations and Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix 5-3. Full-Length Donor History Questionnaire . . . . . . . . . . . . . . . Appendix 5-4. Medication Deferral List for the Donor History Questionnaire . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix 5-5. Blood Donor Educational Materials: Making Your Blood Donation Safe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
147 148 152 152 153 160 163 180 184 185
6.
Whole Blood Collection and Component Processing at Blood Collection Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187
Ram Kakaiya, MD, MBBS; Colleen A. Aronson, MT(ASCP)SBB; and Jana Julleis, MBA, MT(ASCP)SBB Whole Blood Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Component Preparation and Processing . . . . . . . . . . . . . . . . . . . . . . . . Descriptions of Major Blood Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . Blood Component Modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quarantine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ISBT 128 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Quality Control of Blood Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 187 198 201 207 213 214 216 221
7.
Blood Component Collection by Apheresis . . . . . . . . . . . . . . . . 227

James W. Smith, MD, PhD Component Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227 Instruments and Systems for Donor Apheresis Collections. . . . . . . . . . . . . . 233
8.
Infectious Disease Screening. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

Susan A. Galel, MD Historical Overview of Blood Donor Screening . . . . . . . . . . . . . . . . . . . . . . . . Donor Screening Tests: General Aspects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Residual Infectious Risks of Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Screening for Specific Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pathogen Reduction Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239 241 251 254 263 264
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9.
Storage, Monitoring, Pretransfusion Processing, and Distribution of Blood Components . . . . . . . . . . . . . . . . . . . . . 271

William B. Lockwood, PhD, MD; Jill Leonard, MT(AMT); and Sandy L. Liles, MT(ASCP)SBB Blood and Blood Component Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272 Prestorage Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279 Poststorage Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279 Inspection, Shipping, Receiving into Inventory, Disposition, and Issue . . . 284
B LOOD
GR OUPS
10.
Molecular Biology and Immunology in Transfusion Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

James C. Zimring, MD, PhD, and Steven L. Spitalnik, MD Nucleic Acid Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293 Protein Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 307 Basic Immunologic Principles Underlying Transfusion Medicine . . . . . . . . 313
11.
Blood Group Genetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327

Christine Lomas-Francis, MSc, FIBMS Fundamental Principles of Genetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 328 Inheritance of Genetic Traits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 337 Population Genetics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348 Relationship Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 351 Blood Group Gene Mapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 353 Chimerism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 356 Blood Group Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 357
12.
ABO, H, and Lewis Blood Groups and Structurally Related Antigens. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363
Laura Cooling, MD, MS ABO System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 363 The H System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 373 The Lewis System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 376 I and i Antigens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 378 P Blood Groups/GLOB Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 381
13.
The Rh System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389

Stella T. Chou, MD, and Connie M. Westhoff, PhD, MT(ASCP)SBB Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 390 RH Genes and Rh Proteins . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 393 Antigens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 394 RH Genotyping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 403
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404 404 405 405
xv
Rhnull Syndrome and RhAG Blood Group System . . . . . . . . . . . . . . . . . . . . . . . Rh Structure and Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Rh Antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Technical Considerations for Rh Typing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14.
Other Blood Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 411

Geoff Daniels, PhD, FRCPath The MNS System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Lutheran System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Kell and Kx Systems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Duffy System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Kidd System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Diego System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Yt System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Xg System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Scianna System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Dombrock System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Colton System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Landsteiner-Wiener System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Chido/Rodgers System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Gerbich System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Cromer System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Knops System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Indian System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Ok System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The Raph System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The John Milton Hagen System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The GILl System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . The RHAG System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Antigens That Do Not Belong to a Blood Group System . . . . . . . . . . . . . . . . 411 417 418 421 423 425 426 426 427 427 428 429 429 429 430 430 431 431 432 432 432 432 432
A NT IGEN
A ND
AN TIB ODY
T EST ING
15.
Pretransfusion Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437

Katharine A. Downes, MD, and Ira A. Shulman, MD Requests for Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Identification of Recipients and Labeling of Blood Samples . . . . . . . . . . . . Sample Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Serologic Testing Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pretransfusion Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Tubeless Methods for Pretransfusion Testing. . . . . . . . . . . . . . . . . . . . . . . . . . Comparison of Current Testing Results with Previous Records . . . . . . . . . . Donor RBC Unit Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Donor RBC Unit Selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437 438 441 442 445 449 450 451 451
xvi
Compatibility Testing or Crossmatch (Serologic or Computer/ Electronic) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 452 Interpretation of Antibody Screening and Crossmatch Results . . . . . . . . . . . 453 Pretransfusion Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455 Availability of Compatible Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455 Labeling of Blood and Blood Components with the Recipients Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455 Special Clinical Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 457
16.
Identification of Antibodies to Red Cell Antigens . . . . . . . . . . . 463

Phyllis S. Walker, MS, MT(ASCP)SBB Significance of Alloantibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 463 Preanalytical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 464 Analytical Phase of Antibody Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . 464 Postanalytical Considerations: Selecting Blood for Transfusion . . . . . . . . . . 490
17.
The Positive Direct Antiglobulin Test and ImmuneMediated Hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 497

Regina M. Leger, MSQA, MT(ASCP)SBB, CMQ/OE(ASQ) The Direct Antiglobulin Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 497 Autoimmune Hemolytic Anemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 501 Drug-Induced Immune Hemolytic Anemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . 512 Appendix 17-1. Drugs Associated with a Positive DAT and/or Immune Hemolytic Anemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 519
18.
Platelet and Granulocyte Antigens and Antibodies . . . . . . . . . 523

Janice G. McFarland, MD Platelet Antigens and Antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 523 Granulocyte Antigens and Antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 539
19.
The HLA System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547

Howard M. Gebel, PhD; Marilyn S. Pollack, PhD; and Robert A. Bray, PhD Genetics of the Major Histocompatibility Complex . . . . . . . . . . . . . . . . . . . . . 548 Biochemistry, Tissue Distribution, and Structure. . . . . . . . . . . . . . . . . . . . . . . 552 Detection of HLA Antigens and Alleles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 557 Crossmatching and Detection of HLA Antibodies . . . . . . . . . . . . . . . . . . . . . . 559 The HLA System and Transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 560 HLA Testing and Transplantation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 562 Other Clinically Significant Aspects of HLA . . . . . . . . . . . . . . . . . . . . . . . . . . . . 565 Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 566
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CL INIC AL CONS IDE RA TION S TRA NS FU SION P RAC TIC E
IN
20.
Hemotherapy Decisions and Their Outcomes . . . . . . . . . . . . . 571

Theresa Nester, MD, and James P. AuBuchon, MD Red Cell Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Platelet Transfusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plasma Transfusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Cryoprecipitated AHF. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Granulocytes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Plasma Derivatives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 571 579 589 594 595 597
21.
Administration of Blood Components . . . . . . . . . . . . . . . . . . . . 617

Bonnie L. S. Sink, BSN, RN, HP(ASCP) Events and Considerations Before Dispensing the Component . . . . . . . . . . Dispensing and Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Events and Considerations Before Component Administration. . . . . . . . . . Administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Unique Transfusion Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 617 621 622 624 626 627
22.
Perinatal Issues in Transfusion Practice . . . . . . . . . . . . . . . . . . . 631

Melanie S. Kennedy, MD Hemolytic Disease of the Fetus and Newborn . . . . . . . . . . . . . . . . . . . . . . . . . Rh Immune Globulin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABO Hemolytic Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Immune Thrombocytopenia. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 631 636 639 639
23.
Neonatal and Pediatric Transfusion Practice . . . . . . . . . . . . . . 645

Cassandra D. Josephson, MD Transfusion in Infants Less than 4 Months of Age . . . . . . . . . . . . . . . . . . . . . . 645 Transfusion in Older Infants (More than 4 Months of Age) and Children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 660 Prevention of Adverse Effects of Transfusion in Neonates and Older Children. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 663
24.
Patient Blood Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 671

Jonathan H. Waters, MD Behavioral Changes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 671 Preoperative Anemia Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 673 Perioperative Autotransfusion Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 674
xviii
25.
Transfusion Support for Hematopoietic Stem Cell Transplant Recipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 687

Christopher A. Tormey, MD ABO and Non-ABO Red Cell Antigen Incompatible Transplantation. . . . . . 688 Blood Component Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 692 HSCT Recipients with HLA and/or Platelet Antibodies . . . . . . . . . . . . . . . . . . 698 Neutropenic Patients with Infection Unresponsive to Antimicrobial Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 699 Special Processing of Blood Components for the Recipients of HSCT . . . . . 699 Other Practical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 700
26.
Therapeutic Apheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707

Robertson D. Davenport, MD Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707 Modalities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 708 Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 709 Anticoagulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 717 Replacement Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 717 Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 718 Vascular Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 720 Patient Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 722
27.
Noninfectious Complications of Blood Transfusion . . . . . . . . 727

Catherine A. Mazzei, MD; Mark A. Popovsky, MD; and Patricia M. Kopko, MD Hemovigilance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 727 Recognition and Evaluation of a Suspected Transfusion Reaction . . . . . . . 728 Acute or Immediate Transfusion Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 737 Delayed Transfusion Reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 751 Fatality Reporting Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 757
28.
Approaches to Blood Utilization Auditing . . . . . . . . . . . . . . . . . 763

Alan Tinmouth, MD, FRCPC, MSc, and Simon Stanworth, MD, DPhil Rationale for Monitoring Blood Utilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . 764 Types of Transfusion Audits. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 764 Interventions to Change Transfusion Practice. . . . . . . . . . . . . . . . . . . . . . . . . . 769 Effectiveness of Monitoring and Interventions to Change Transfusion Practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 770 Selecting an Audit Process to Monitor Transfusions . . . . . . . . . . . . . . . . . . . . 770 Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 772 Appendix 28-1. Example of a Transfusion Order Form . . . . . . . . . . . . . . . . . 776
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T RA NS P LA NT AT ION
29.
Collecting and Processing Marrow Products for Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 779

Janice Davis-Sproul, MAS, MT(ASCP)SBB; N. Rebecca Haley, MD; and John D. McMannis, PhD Diseases Treated with Hematopoietic Cell Transplantation . . . . . . . . . . . . . Autologous Hematopoietic Cell Transplantation. . . . . . . . . . . . . . . . . . . . . . . Allogeneic Hematopoietic Cell Transplantation . . . . . . . . . . . . . . . . . . . . . . . Unrelated Donor Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Histocompatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Graft-vs-Host Disease. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Donor Eligibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Marrow Harvest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Collection Targets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CD34 Antigen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Processing of HPC(M) Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Red Cell Incompatibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Short- and Long-Term Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transportation and Shipping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Thawing and Infusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Evaluation and Quality Control of Hematopoietic Products . . . . . . . . . . . . . Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 780 780 780 782 782 783 783 784 784 785 785 785 787 790 792 792 792 794 794
30.
Hematopoietic Progenitor Cells Collected by Apheresis. . . . . 801

Thomas A. Lane, MD, and John D. McMannis, PhD Biology of HPC Mobilization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical Mobilization Regimens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preparation and Administration of HPC(A). . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical Use of HPC(A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Clinical Transplantation Outcomes of HPC(A) vs HPC(M) Grafts . . . . . . . . Selection of an HPC(A) or HPC(M) Graft vs an HPC(C) Graft . . . . . . . . . . . . 802 802 808 809 813 814
31.
Umbilical Cord Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 823

David H. McKenna, MD; Diane M. Kadidlo, MT(ASCP)SBB; Jeffrey McCullough, MD; and Donna M. Regan, MT(ASCP)SBB Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Donor-Related Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Shipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Receipt of UCB for Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Thawing and Washing of UCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 823 824 827 829 832 833 834
xx
Infusion of UCB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 835 Regulations and Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 837 Novel UCB-Derived Cellular Therapies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 839
32.
Human Tissue Allografts and the Hospital Transfusion Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 849

Lance D. Trainor, MD, and Rita A. Reik, MD Tissue Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 849 Regulations and Standards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 853 Hospital Tissue Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 854 Responsibility for Hospital-Based Tissue Services . . . . . . . . . . . . . . . . . . . . . . 854
ME TH ODS
Methods Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 863 1. General Laboratory Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 865

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 865 Method 1-1. Shipping Hazardous Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . 865 Method 1-1-1. Monitoring Temperature During Shipment of Blood . . . . . . 868 Method 1-2. Treating Incompletely Clotted Specimens . . . . . . . . . . . . . . . . . 868 Method 1-3. Solution Preparation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 869 Method 1-4. Serum Dilution Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 871 Method 1-5. Dilution of Percentage Solutions Procedure. . . . . . . . . . . . . . . . 872 Method 1-6. Preparing a 3% Red Cell Suspension . . . . . . . . . . . . . . . . . . . . . . 872 Method 1-7. Preparing and Using Phosphate Buffer . . . . . . . . . . . . . . . . . . . . 873 Method 1-8. Reading and Grading Tube Agglutination . . . . . . . . . . . . . . . . . . 873
2.
Red Cell Typing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 875

Method 2-1. Determining ABO Group of Red CellsSlide Test . . . . . . . . . . 875 Method 2-2. Determining ABO Group of Red Cells and Serum Tube Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 876 Method 2-3. Determining ABO Group of Red Cells and Serum Microplate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 877 Method 2-4. Initial Investigation of ABO Grouping Discrepancies Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 878 Method 2-5. Detecting Weak A and B Antigens and Antibodies by Cold Temperature Enhancement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 879 Method 2-6. Confirming Weak A and B Antigens Using EnzymeTreated Red Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 879 Method 2-7. Confirming Weak A or B Subgroup by Adsorption and Elution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 880 Method 2-8. Testing Saliva for A, B, H, Lea, and Leb Antigens . . . . . . . . . . . . . 881 Method 2-9. Confirming Anti-A1 in an A2 or Weak A Subgroup. . . . . . . . . . . 883 Method 2-10. Resolving ABO Discrepancies Caused by Unexpected Alloantibodies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 884
Table of Contents
xxi
Method 2-11. Determining Serum Group Without Centrifugation . . . . . . . Method 2-12. Determining Rh (D) TypeSlide Test . . . . . . . . . . . . . . . . . . . . Method 2-13. Determining Rh (D) TypeTube Test. . . . . . . . . . . . . . . . . . . . Method 2-14. Determining Rh (D) TypeMicroplate 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 2-20. Dissociating IgG by Chloroquine for Antigen Testing of Red Cells with a Positive DAT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
884 885 885 886 887 888 889 890 890 891 892 893 894
3.
Antibody Detection, Identification, and Compatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 897

Method 3-1. Using Immediate-Spin Compatibility Testing to Demonstrate ABO Incompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-2. Detecting Antibodies to Red Cell AntigensIndirect Antiglobulin Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-2-1. Saline Indirect Antiglobulin Test Procedure . . . . . . . . . . . . . Method 3-2-2. Albumin or LISS-Additive Indirect Antiglobulin Test Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-2-3. LISS Indirect Antiglobulin Test Procedure . . . . . . . . . . . . . . . Method 3-2-4. PEG Indirect Antiglobulin Test Procedure . . . . . . . . . . . . . . . Method 3-3. Prewarming Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-4. Detecting Antibodies in the Presence of Rouleaux Saline Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-5. Enzyme Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-5-1. Preparing Ficin Enzyme Stock, 1% w/v . . . . . . . . . . . . . . . . . . Method 3-5-2. Preparing Papain Enzyme Stock, 1% w/v . . . . . . . . . . . . . . . . Method 3-5-3. Standardizing Enzyme Procedures. . . . . . . . . . . . . . . . . . . . . . Method 3-5-4. Evaluating Enzyme-Treated Red Cells. . . . . . . . . . . . . . . . . . . Method 3-5-5. One-Stage Enzyme Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-5-6. Two-Stage Enzyme Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-6. Performing a Direct Antiglobulin Test. . . . . . . . . . . . . . . . . . . . . Method 3-7. Antibody Titration Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-8. Using Sulfhydryl Reagents to Distinguish IgM from IgG Antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 3-9. Using Plasma Inhibition to Distinguish Anti-Ch and -Rg from Other Antibodies with Similar Characteristics . . . . . . . . . . . . . . Method 3-10. Treating Red Cells Using DTT or AET . . . . . . . . . . . . . . . . . . . . Method 3-11. Neutralizing Anti-Sda with Urine . . . . . . . . . . . . . . . . . . . . . . . . 897 898 898 899 899 899 900 901 902 902 902 903 903 904 905 905 907 909 911 912 913
xxii
Method 3-12. Adsorption Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 914 Method 3-13. Using the American Rare Donor Program. . . . . . . . . . . . . . . . . 914
4.
Investigation of a Positive DAT . . . . . . . . . . . . . . . . . . . . . . . . . . . 917

Eluates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 917 Method 4-1. Cold-Acid Elution Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 917 Method 4-2. Glycine-HCl/EDTA Elution Procedure. . . . . . . . . . . . . . . . . . . . . 918 Method 4-3. Heat Elution Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 919 Method 4-4. Lui Freeze-Thaw Elution Procedure . . . . . . . . . . . . . . . . . . . . . . . 919 Immune Hemolytic Anemia Serum/Plasma Methods . . . . . . . . . . . . . . . . . . . 920 Method 4-5. Cold Autoadsorption Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 920 Method 4-6. Determining the Specificity of Cold-Reactive Autoagglutinins . 921 Method 4-7. Cold Agglutinin Titer Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . 923 Method 4-8. Adsorbing Warm-Reactive Autoantibodies Using Autologous Red Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 924 Method 4-9. Adsorbing Warm-Reactive Autoantibodies Using Allogeneic Red Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 925 Method 4-10. Polyethylene Glycol Adsorption Procedure . . . . . . . . . . . . . . . 927 Method 4-11. Performing the Donath-Landsteiner Test . . . . . . . . . . . . . . . . . 928 Method 4-12. Detecting Drug Antibodies by Testing Drug-Treated Red Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 929 Method 4-13. Detecting Drug Antibodies by Testing in the Presence of Drug . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 930
5.
Hemolytic Disease of the Fetus and Newborn. . . . . . . . . . . . . . 933

Method 5-1. Testing for Fetomaternal HemorrhageThe Rosette Test . . . 933 Method 5-2. Testing for fetomaternal hemorrhageModified Kleihauer-Betke Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 934 Method 5-3. Using Antibody Titration Studies to Assist in Early Detection of Hemolytic Disease of the Fetus and Newborn . . . . . . . . . . . 935
6.
Blood Collection, Component Preparation, and Storage . . . . 939

Method 6-1. Screening Donors for AnemiaCopper Sulfate Method . . . . . 939 Method 6-2. Preparing the Donors Arm for Blood Collection . . . . . . . . . . . . 940 Method 6-3. Collecting Blood and Samples for Processing and Compatibility Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 941 Method 6-4. Preparing Red Blood Cells from Whole Blood . . . . . . . . . . . . . . 944 Method 6-5. Preparing Prestorage Red Blood Cells Leukocytes Reduced from Whole Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 945 Method 6-6. Rejuvenating Red Blood Cells. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 946 Method 6-7. Using High-Concentration Glycerol to Cryopreserve Red CellsMeryman Method. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 947 Method 6-8. Using High-Concentration Glycerol to Cryopreserve Red CellsValeri Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 949 Method 6-9. Checking the Adequacy of Deglycerolization of Red Blood Cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 952 Method 6-10. Preparing Fresh Frozen Plasma from Whole Blood . . . . . . . . 953
Table of Contents
xxiii
Method 6-11. Preparing Cryoprecipitated AHF from Whole Blood . . . . . . . Method 6-12. Thawing and Pooling Cryoprecipitated AHF . . . . . . . . . . . . . . Method 6-13. Preparing Platelets from Whole Blood . . . . . . . . . . . . . . . . . . . Method 6-14. Removing Plasma from Platelets (Volume Reduction) . . . . .
953 954 955 957
7.
Transplantation of Cells and Tissue. . . . . . . . . . . . . . . . . . . . . . . 959

Method 7-1. Infusing Cryopreserved Hematopoietic Cells . . . . . . . . . . . . . . 959 Method 7-2. Processing Umbilical Cord Blood. . . . . . . . . . . . . . . . . . . . . . . . . 960 Method 7-3. Investigating Adverse Events and Infections Following Tissue Allograft Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 961
8.
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 965

Method 8-1. Validating Copper Sulfate Solution . . . . . . . . . . . . . . . . . . . . . . . Method 8-2. Standardizing and Calibrating Thermometers . . . . . . . . . . . . . Method 8-2-1. Checking Liquid-in-Glass Laboratory Thermometers . . . . . Method 8-2-2. Checking Electronic Oral Thermometers . . . . . . . . . . . . . . . . Method 8-3. Testing Blood Storage Equipment Alarms . . . . . . . . . . . . . . . . . Method 8-3-1. Testing Refrigerator Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 8-3-2. Testing Freezer Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Method 8-4. Calibrating Centrifuges for Platelet Separation . . . . . . . . . . . . . Method 8-5. Calibrating a Serologic Centrifuge . . . . . . . . . . . . . . . . . . . . . . . . Method 8-6. Testing Automatic Cell Washers . . . . . . . . . . . . . . . . . . . . . . . . . . Method 8-7. Monitoring Cell Counts of Apheresis Components . . . . . . . . . Method 8-8. Counting Residual White Cells in Leukocyte-Reduced Blood and ComponentsManual Method. . . . . . . . . . . . . . . . . . . . . . . . . . 965 965 966 967 967 967 969 970 972 974 975 975
APPEN DICE S
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 . . . . . . . . . . . . . . . . Appendix 7. Examples of Gene, Antigen, and Phenotype 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. Example of a Maximum Surgical Blood Order Schedule . . . . Appendix 11. Directory of Organizations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Appendix 12. Resources for Safety Information . . . . . . . . . . . . . . . . . . . . . . . .
979 980 982 982 983 984
989 989 990 991 992 994
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 997
Index
Page numbers in italics refer to figures or tables ABO testing of blood components, 216, 229, 286, 369370, 451 with cold autoagglutinins, 372, 373, 509-510 comparison with previous records, 450-451 discrepancies in, 370-373, 878-881, 883884, 888-890 hemolysis in, 369 for HPC transplantation, 691 interpretation of, 364, 368 microplate test for, 877-878 for organ transplantation, 860 in pediatric recipients, 457, 634, 648-650, 661 in prenatal studies, 632 reagents for, 370 of recipients, 369-370, 445 on saliva, 881-883 slide test for, 875-876 in transfusion reaction evaluation, 735 tube test for, 876-877 for weak antigens or antibodies, 879-881, 884 A(B) phenotype, 368, 370 ABTI antigen, 433 Accidents, 47, 48 Accreditation, 95, 96, 854 ACE (angiotensin-converting enzyme) inhibitors, 623, 719, 731, 743, 744 Acid elution, 501 Acid-elution stain (Kleihauer-Betke), 637-638, 934-935 Acid glycine/EDTA, 892-893 Acidosis, 681 Acitretin, 151, 184 Acquired B phenotype, 368-369, 370 Activated partial thromboplastin time (aPTT), 589, 681, 750, 981, 982 Activated protein C, 603 Acute lung injury, 745 Additive solutions, 188, 192, 201, 277, 651-652 Additives, in serologic testing, 448-449, 899900 Adenosine triphosphate, intracellular, 794 Adhesion-blocking agents, 805-806
A
A antigen, 364-366, 367, 368, 374 ABO antibodies anti-A and anti-B, 364, 365, 369, 879 anti-A1, 367, 369, 373, 883-884 anti-A,B, 369 ABO compatibility, 447, 451 of Cryoprecipitated AHF, 447, 625, 657, 695 of Granulocytes, 233, 447, 597, 625, 658 in hemolytic transfusion reactions, 737-738 of HPC transplants, 372, 688-691, 695, 787790 of organ transplants, 563, 564, 860 of plasma products, 447, 451, 625, 656-657, 693, 695 of platelet components, 447, 523-524, 584586 after HSCT transplantation, 693-694, 695 in hemolytic transfusion reactions, 740 in nonemergency settings, 625 in pediatric patients, 656, 663 of Red Blood Cells, 447, 451, 575-576, 625, 694, 695, 740 of tissue transplants, 853 of Whole Blood, 447, 575-576 ABO discrepancies, 370-373, 878-881, 883-884, 888-890 ABO hemolytic disease of the fetus and newborn, 639 ABO system, 363-373 acquired B phenotype, 368-369, 370 B(A) and A(B) phenotypes, 368, 370 biochemistry of, 364-365, 366, 374 in development and aging, 365, 372 genetics of, 339, 348, 354, 365-367, 989 nomenclature for, 354, 984, 989 phenotypes of, 363, 989, 990 on platelets, 523-524 soluble, 881-883 subgroups of, 365-368, 370, 372, 880-881, 883-884
997
998
Adsorption, 478-479, 914 allogeneic, 505-507, 925-926 autologous cold, 489, 510, 920-921 autologous warm, 505, 924-925 and elution, 480, 880-881 polyethylene glycol procedure, 927 Adverse reactions to apheresis, 229, 230, 718-720, 722 in donors, 20, 22, 196-197 to HPC infusions, 792, 808-809, 836-837 to HPC mobilization regimens, 803, 804805 to IVIG, 601-602 management of, 20-22, 23 related to medical devices, 91 related to tissue allografts, 858-859, 961-963 See also Transfusion reactions; Transfusion-transmitted diseases AET (2-aminoethylisothiouronium bromide), 373, 476, 478, 912-913 Affinity constant (Ko), 443 Age of blood samples, 441-442, 482, 488 of donors, 141, 160 effect on ABO antigens and antibodies, 365, 372 Agglutination in antiglobulin testing, 444-445 assays utilizing, 307-309 interpreting and grading reactions, 445, 873-874 mixed-field, 353, 370, 371 principles of, 442, 444 spontaneous in ABO discrepancies, 370, 372, 373 dispersing with sulfhydryl reagents, 504, 510, 890 removing with warm saline washes, 889 in Rh testing, 406 Agitators, 39 Agreements, 6-7, 9-10, 116 AHG serum, 444 AIDS (acquired immunodeficiency syndrome), 139, 170, 175, 240 AIHA. See Autoimmune hemolytic anemia Air embolism, 678, 731, 751 Alanine aminotransferase, 979 Alarm systems, 37, 272, 276, 967-969 Albumin, bovine (reagent), 448, 488, 899 Albumin solutions (colloid), 598, 654, 717, 718 Aldehyde dehydrogenase (ALDH), 786, 793 Aliquoting components, 282-284, 650-651 Alleles, 334-335 defined, 328
frequencies of, 350 terminology for, 357-359 Allergic reactions to apheresis, 718 in HSCT patients, 700 to latex, 47-48, 188, 189-190 to transfusions, 729-730, 742-745 Alloantibodies, 463. See also Antibodies, red cell Allogeneic adsorption, 505-507, 925-926 Allogeneic HPC transplantation, 780, 782 clinical outcomes of, 813-814 definition of, 687, 779 of HPC, Apheresis, 811-812 of HPC, Marrow donor eligibility for, 783-784 preparative regimens for, 688 processing marrow for, 785-786, 788, 790 storage of products for, 790 selection of graft for, 812-814 See also Hematopoietic stem cell transplantation Allografts, 850. See also Tissue transplantation Alloimmunization in hemolytic disease of the fetus and newborn, 631-632 HLA, 524, 525-526, 560-561, 587, 698-699, 732 to platelet-specific antigens, 532-533, 587, 639-640, 698, 755 prevention of, 402-403, 528 red cell, 732 in sickle cell disease, 402-403, 451, 662 See also Antibodies 1-Antitrypsin, 603 -Methyldopa, 514 1-Proteinase inhibitor, 603 AMD3100, 805-806, 807 American Rare Donor Program, 492, 914-915 2-aminoethylisothiouronium bromide (AET), 373, 476, 478, 912-913 Amniocentesis, 634 Amniotic fluid analysis, 634, 635 Amotosalen/UV-treated plasma, 206 Ana, 429, 987 Anaphylactic reactions, 730, 743-744 in apheresis, 718 differential diagnosis of, 743, 745-746 laboratory evaluation of, 736 Anaphylactoid reactions, 743 Anemia acute, 571-574 chronic, 574-575
INDEX
999
in delayed transfusion reactions, 751 in HPC transplantation, 692-693 in infants, 646, 652-653 iron deficiency, 673-674 preoperative, 673-674 RBC transfusions in, 571-579 screening donors for, 142, 144-145, 161 signs and symptoms of, 571-572 See Hemolytic disease of the fetus and newborn; Hemolytic anemia Aneuploidy, 341-342 Angioedema, 743 Angiotensin-converting enzyme (ACE) inhibitors, 623, 719, 731, 743, 744 Ankylosing spondylitis, 566 Anti-HBc, 255 Anti-HCV, 256 Anti-HIV-1, 2, 254 Anti-HTLV-I, II, 257 Anti-IgA, 736, 743-744, 745 Antibiotics, in donors, 151, 164 Antibodies drug-induced, 464, 512-515, 535-538, 587, 929-931 to Factor VIII, 599 granulocyte, 539-540 HLA, 732 detection of, 525-526, 559 in HPC transplant recipients, 698-699 in platelet refractoriness, 524, 525-528, 560-561, 587 in TRALI, 561, 746, 747 in transfusion reactions, 561, 562, 742 naturally occurring, 463, 464 platelet autoantibodies, 534-535 detecting, 533-534, 535, 536, 537, 538 drug-induced, 535-538, 587 in HPC transplantation, 689 platelet-specific, 532-534, 587, 639-640, 698, 755 to reagent components, 370, 372, 487-488 red cell. See Antibodies, red cell structure of, 317-319 See also Autoantibodies Antibodies, red cell in ABO discrepancies, 884 associated with HDFN, 412-413, 420, 485486, 632, 633 associated with hemolytic transfusion reactions, 412-413, 485-486, 752 with autoantibodies, 504-507 clinical significance of, 412-413, 448, 463464, 485-486, 490
defined, 463 detection of. See Antibody detection disease associations with, 464 distinguishing IgG and IgM, 909-911 dosage effect of, 335, 467, 481 effect of DTT on, 485-486 effect of enzymes on, 485-486 equilibrium constant of, 443 to high-prevalence antigens, 464, 465-466, 484, 486-487, 635-636 high-titer and low avidity characteristics, 481 low-affinity, 508-509 to low-prevalence antigens, 487 multiple, 483-484 naturally occuring, 463, 464 nonhemolytic, 322-323 phenotyping with, 472-473 reactions with antigens, 442-445 in selection of units, 451-452, 490-493 serologic reactivity of, 443, 485-487 in sickle cell disease, 402-403, 451, 662 in tissue transplant patients, 853 See also specific blood groups Antibody-dependent cellular cytotoxicity, 491 Antibody detection, 448-450 with autoantibodies, 504-507, 510 in blood components, 229 by ELISA, 310 frequency of testing, 490 of granulocyte antibodies, 540 of HLA antibodies, 525-526, 559 interpreting results of, 453, 454, 455 methods for, 448-450, 898-900 in pediatric recipients, 457, 648-650, 661 of platelet antibodies, 533-534, 535, 536, 537, 538 in positive DAT evaluation, 500 in prenatal evaluations, 632-633 prewarming technique for, 900-901 reagents for, 449-450, 466-467 with rouleaux present, 901-902 solid-phase assays for, 310 specimen requirements for, 441-442 in transfusion reaction evaluation, 735 Antibody identification, 463-493 anomalous reactions in, 488 of antibodies to high-prevalence antigens, 464, 465-466, 484, 486-487 of antibodies to low-prevalence antigens, 487 with antibodies to reagent components, 487-488 with autoantibodies, 504-507
1000
autologous control in, 471-472, 474-475, 488-490 exclusion (rule-out) in, 470 frequency of testing, 490 immunohematology reference labs for, 490 interpreting results of, 469 with multiple antibodies, 479, 481, 483-484 with no discernible specificity, 482-483 positive and negative reactions in, 469-470 with positive DAT, 472, 475, 487, 488-490 preanalytical considerations for, 464, 465466 in prenatal evaluations, 633 probability values in, 470-471 procedures for adsorption, 478-479, 914, 920-921, 924927 alteration of pH, 477 combined adsorption-elution, 480, 880881 dispersing autoagglutination, 510, 890 distinguishing IgM from IgG, 909-911 elution, 479-480 enzymes, 473, 476, 902-905 flowchart for, 474-475 identification panels, 467, 468, 469-471 inactivation of antigens, 476, 477-478, 912-913 increased incubation time, 476 increased serum-to-cell ratio, 476 inhibition techniques, 477, 911-912 LISS and PEG, 473, 899-900 phenotyping, 472-473 prewarming, 900-901 selected cells in, 470 temperature reduction, 476, 879 titration studies, 480-481, 633, 907-909, 935-937 reagents for, 466-469 and selection of blood, 349, 451-452, 490-493 specimen requirements for, 463-464, 466 in transfusion reaction evaluation, 735 variations in antigen expression in, 481-482 Antibody screen. See Antibody detection Antibody specificity prediction method, 527 Anticoagulant medications, 152, 590, 591 Anticoagulant-preservative solutions, 188, 191, 216, 277, 827 Anticoagulants, in apheresis, 717 Antifibrinolytic agents, 588 Antigen-matching, 402-403, 451, 662, 717 Antigen-presenting cells, 313, 314 Antigens acquired, 368-369, 370
antithetical, 334 of blood group collections, 432-433 of blood group systems, 357-359, 984-989 chromosomal location of, 354-356 granulocyte, 539-540 high-prevalence, 433, 484, 486-487, 492-493 HLA, 524, 547-548, 552-555 inactivation of, 476, 477-478, 912-913 low-prevalence, 433-434, 487 methods for detecting, 307-313 platelet-specific, 310, 528-534 terminology for, 357-359, 984-989 variations in expression of, 481-482 See also specific blood groups Antiglobulin test, 444-445 in crossmatching, 452-453 direct, 444, 497-501 indirect, 444-445 reagents for, 444, 467, 469 sources of error in, 446-447 use of IgG-coated cells, 448 Antihistamines, 619, 744, 745 Antiplatelet agents, 151, 152, 166, 184, 229, 581 Antipyretics, 619, 742 Antithrombin, 602-603 AnWj, 431 Apheresis complications of, 229, 718-720, 722 component collection by, 227-236 adverse donor reactions in, 229, 230 donation requirements for, 142, 160, 162, 166, 168 Granulocytes, 228, 232-233, 235-236 instrumentation for, 39, 228, 233-236 multicomponent donations, 231-232 Plasma, 228, 230-231, 233-234 Platelets, 228-230, 234 quality control of, 975 Red Blood Cells, 228, 231-232, 235 defined, 707 records of, 230, 232 See also HPC, Apheresis; Therapeutic apheresis Apheresis Granulocytes. See Granulocytes Apheresis Platelets. See Platelets, Apheresis aPTT (activated partial thromboplastin time), 589, 681, 750, 981, 982 Arterial puncture, in donors, 197 Aspirin, 152, 166, 229, 581 Assessments blood utilization, 24-25, 763-772 competency, 7-8 external, 25 internal, 23-24
INDEX
1001
proficiency testing, 25, 96 quality indicators, 24 in quality management, 13, 23-25 risk, 104-105, 108 Aua/Aub, 354, 417, 985 Audits, transfusion, 24, 672, 763-772 concurrent, 765, 766, 769, 770-771, 771 prospective, 765, 765-766, 767-768, 770, 771 retrospective, 765, 767-768, 769, 771-772, 772 Auto control. See Autologous control Autoadsorption. See Adsorption Autoagglutination in ABO discrepancies, 370, 372, 373 dispersing with sulfhydryl reagents, 504, 510, 890 removing with warm saline washes, 889 in Rh testing, 406 Autoantibodies with alloantibodies, 489-490, 504-507, 510 cold, 489 ABO discrepancies with, 372, 373, 509510, 884 adsorption of, 489, 510, 920-921 in cold agglutinin syndrome, 380, 509510 determining specificity of, 921-923 in mixed AIHA, 380, 511 in paroxysmal cold hemoglobinuria, 511 removing with warm saline washes, 889 in Rh testing, 406, 509 titration of, 923 use of sulfhydryl reagents with, 510, 890 in warm autoimmune hemolytic anemia, 502, 504 defined, 463 disease associations with, 464 drug-induced, 514-515, 929-931 low-affinity, 508-509 in phenotyping problems, 472-473 platelet, 534-535 warm adsorption of, 505-506, 924-927 disease associations with, 464 mimicking alloantibodies, 506-507 in mixed-type AIHA, 511 Rh testing with, 406 transfusion with, 507-508, 578 in warm autoimmune hemolytic anemia, 502, 503, 504-508 Autoclaving biohazardous waste, 58 Autografts, 850, 859-860 Autoimmune hemolytic anemia, 501-512 classification of, 502 cold agglutinin syndrome, 509-510
DAT-negative, 508-509 mixed-type, 380, 511 paroxysmal cold hemoglobinuria, 511-512 serologic findings in, 503 transfusion in, 507-508, 511, 578 warm, 502, 503, 504-508 Autoimmune neutropenia, 540 Autoimmune thrombocytopenia, 150, 534535, 588, 641 Autologous adsorption cold, 489, 510, 920-921 warm, 505, 924-925 Autologous blood collection of by blood recovery, 674, 676-678 by normovolemic hemodilution, 678679 by preoperative blood donation, 674 donor selection for, 154-155, 160-162 infectious disease testing of, 250-251 labeling, 216 for rare phenotypes, 493 separation from transfused cells, 472, 893895 Autologous control in antibody identification, 471-472, 474-475 positive, 475, 488-490 in pretransfusion testing, 449, 454 Autologous HPC transplantation. clinical outcomes of, 813 definition of, 687, 779 engraftment speed in, 810 of HPC, Apheresis, 802-804, 809-811 of HPC, Marrow, 780 donor eligibility for, 783 processing marrow for, 785 storage of products for, 790-791 tumor purging in, 787, 810-811 See also Hematopoietic stem cell transplantation Automated testing systems, 450 Autosomal inheritance codominant, 338, 340 dominant, 337, 339 recessive, 338-339, 341 Autotransfusion, perioperative, 674, 676-679 blood recovery, 674, 676-678 normovolemic hemodilution, 678-679 preoperative autologous donation, 674
B
B antigen, 364-366, 368, 374 B-cell receptor, 315 B cells, 314, 315-316
1002
Babesiosis, 138, 140, 177, 260-261 BacT/ALERT culture system, 258 Bacterial contamination, 257-259 of HPCs, 793, 809 inspecting components for, 202, 257-259, 284-285, 736 during phlebotomy, 193-194, 258 of Platelets, 258-259, 276 reactive donor screening for, 249 of Red Blood Cells, 259 of tissue allografts, 853, 858, 859 in transfusion-associated sepsis, 731, 736, 741 Band 3 glycoprotein, 425 B(A) phenotype, 368, 370 Be The Match Registry, 782, 785, 794 Benchmarking, 672 Bennett-Goodspeed (Bg) antigens, 434, 552553, 562 Bilirubin in HDFN, 632, 634, 636 hyperbilirubinemia, exchange transfusion for, 653, 654 normal values for, 979, 980 Bioassays, for radiation monitoring, 64-65 Biocontamination control system, 43 Biohazardous waste, 57-58, 116-117 Biological product deviations, 20, 22, 93, 94 Biological products, regulations for, 88-89 Biological response modifiers (BRMs), 746 Biological safety cabinets, 52, 53-54 Bioluminescence assays, 794 Biosafety, 50-58 biological safety cabinets for, 52, 53-54 biosafety levels, 51, 77 Bloodborne Pathogens Standard, 50 decontamination for, 52, 55 in donor room, 56 emergency response plan for, 56-57 engineering controls for, 51-52, 53-54, 55 hazard identification and communication for, 51 in laboratory, 55 personal protective equipment for, 55 safe work practices for, 55-56 shipping hazardous materials, 865-867 Standard Precautions, 50-51 storage of biohazards, 55, 57 training for, 51 waste management, 57-58 Biovigilance, 32, 727-728. See also Hemovigilance Bleeding acute, transfusion for, 571-574 microvascular, 750
Bleeding disorders. See Coagulopathy Bleeding time, 589, 982 Blood administration, 617-627 baseline assessment of recipient in, 621 blood warmers for, 38, 619-620, 647, 658, 751 delays in starting transfusion, 622 delivering blood to patient area, 621-622 emergency equipment for, 620-621 emergency release, 214, 287-288, 457-458, 577-578, 627 errors in, 622-623, 734, 739, 740 filters for, 623-624, 625, 659 identification procedures in, 622-623 infusion pumps for, 620, 658 infusion rates for, 624, 625, 659 infusion sets for, 623-624, 659 IV solutions for, 624 medical history in, 618 medical order for, 618-619, 622, 776-777 monitoring patient during, 624, 626 in neonates, 658-659 out-of-hospital, 627 patient education in, 618 postadministration events, 626 premedications for, 619 pressure devices for, 620 recipient consent in, 617-618 starting the transfusion, 624 for surgery and trauma, 627 syringe infusion pumps for, 620 transfusion reaction in, 626, 728, 734 venous access for, 619, 654, 658 Blood cells, specific gravity of, 195 Blood clots, in RBCs, 202 Blood collection, 187-197 adverse donor reactions in, 20, 22, 196-197 anticoagulant-preservatives for, 188, 191, 216, 277, 827 autologous, 674, 676-679 blood containers for, 188, 189-190, 192, 198, 827 of blood samples, 194, 438-441, 455, 673, 940-943 of components by apheresis, 227-236, 975 in disaster planning, 107-109 disinfecting venipuncture site for, 193-194, 258, 940-941 donation intervals for, 160, 166-167 donor and component identification in, 192 donor care after, 196 equipment quality control, 39 fatalities related to, 20, 197 phlebotomy in, 187, 192-194, 940-943
INDEX
1003
process of, 194 safety of, 43, 56 of umbilical cord blood, 827-829 vein selection in, 192-193 volume collected, 160, 194-195 Blood component selection ABO/Rh compatibility in, 447, 451, 575-576, 584-586, 625, 695 after non-group-specific transfusions, 288289, 458-459 with clinically significant antibodies, 349, 451-452, 490-493 for exchange transfusions, 654 for HPC transplantation, 685, 698 for intrauterine transfusions, 635-636 for massive transfusions, 458 of platelet components, 447, 526-528, 584586, 656 rare types, 492-493 of red cell components, 447, 451-452, 575576 in urgent situations, 288, 458 in warm autoimmune hemolytic anemia, 507-508 Blood components administration of. See Blood administration aliquoting, 282-284, 650-651 appearance of, 202, 284, 621, 622, 736 bacterial contamination of, 257-259, 284285, 736, 741 CMV-reduced-risk, 250, 597, 635, 663, 699700 cryopreservation of, 208-210, 947-952 density of, 195 disposition of, 286 expiration of, 215-216, 272, 273-275, 622 identification of, 192, 455, 457, 621, 622-623 inspection of, 284-285, 457, 621, 622, 736 intraoperative sequestration of, 679 irradiated, 210-211, 280, 664, 755 issuing, 287-288, 455, 457, 621-622 labeling, 188, 214-216, 221, 286-287, 455, 457 leukocyte reduction of, 207-208, 279, 576, 577, 663-664 nonconforming, 284-285, 286 ordering, 437-438, 455, 618, 776-777 pooling, 211-212, 280-282, 954-955 preparation and processing of, 198-201, 279-284, 944-958 product quality in, 199 quality control testing, 217-221, 221 quarantine of, 213-214, 247-250, 284-285 rare, 492-493 receiving into inventory, 285-286
records of, 457 rejuvenation of, 213, 284, 946-947 retrieval of prior donations, 247, 248-249, 250 return and reissue of, 289, 622 selection of. See Blood component selection storage of, 272-279, 575 testing ABO and Rh, 216, 286, 451 infectious disease, 216, 239-263 phenotyping, 216, 451, 491-492 transporting, 198-199, 272, 285, 621 volume-reduction of, 212-213, 282, 586, 656, 664, 957-958 washed, 280, 664, 700 See also specific components Blood containers, 188, 189-190, 198 for aliquots, 650-651 latex-free, 188, 189-190 for umbilical cord blood, 827 Blood donation. See Blood collection; Donors Blood exposure, 47, 55, 169 Blood group systems clinical significance of antibodies in, 412413, 485-486 genetics of, 327-359 chimerism, 356-357 gene mapping, 353, 354-356, 356 inheritance patterns, 337-348 population genetics, 348-351 principles of, 328-336 relationship testing, 351-353 terminology for, 357-359, 984-989 See also specific blood groups Blood loss signs and symptoms of, 572 in surgery, 674, 675, 677 transfusion for, 571-574 Blood management. See Patient blood management Blood order schedules, 286, 991 Blood pressure of donors, 161 low (hypotension) during apheresis, 719 associated with ACE inhibitors, 623, 719, 731, 743, 744 deliberate, 679-680 in recipients, 738, 744 Blood pressure cuffs, 39 Blood recovery, 674, 676-678 Blood samples age of, 441-442, 482, 488
1004
from arterial or central lines, 673 collection of, 194, 438-441, 455, 673, 940-943 hemolyzed, 441 incompletely clotted, 441, 868-869 from infusion lines, 441 labeling, 438-439, 441, 618, 867 lipemic, 441 packaging, 865-867 for PCR, 297, 300 for pretransfusion testing, 441-442, 464, 466, 618 retention and storage of, 442 transportation and shipment of, 66, 865867 Blood spills, 56-57 Blood transfusions. See Transfusions Blood utilization, 763-772 interventions for change in transfusion practice, 764, 765, 769-770 rationale for, 764 selecting audits, 770-772 types of audits, 764-769 See also Patient blood management Blood volume, 646, 983 Blood warmers, 38, 619-620, 647, 658, 741, 751 Bloodborne Pathogens Standard, 50 Bloodless medicine, 671 Bombay (Oh) phenotype, 365, 373, 375 Bonds, chemical, 443-444 Bone grafts, 169, 851 Bone marrow. See HPC, Marrow (HPC-M) Brain natriuretic peptide, 748 Bruising, in donors, 197 Buffy-coat enrichment of marrow, 786 Buffy-coat method of platelet preparation, 199, 200, 202, 956
C
C/c antigens and antibodies, 401-403 phenotypes, 395 prevalence of, 391, 392 14 C-serotonin release assay, 538 C1-esterase inhibitor deficiency, 593 Calcium, 627, 718, 732, 749 Calibration, equipment, 10, 11 cell washers, 974-975 centrifuges, 865, 970-973 defined, 32 thermometers, 965-967 Cancer, in blood donors, 148-149, 177 Cardiac surgery platelet transfusions in, 580, 581 red cell transfusions in, 573-574
Caridian apheresis systems, 228, 234, 235 Carriers, of traits, 333, 342-343 Cash reserves, 111 Catheters for apheresis, 720 for neonates, 654, 658 for normovolemic hemodilution, 679 for transfusions, 619 Cause-and-effect diagrams, 27 CCI (corrected platelet count increment), 525, 583, 587-588 CD4+ T-cells, 314-315 CD34 cells, 785 analysis and enumeration of, 793, 803-804 enrichment of, 786-787, 839 Cell counters, 39 Cell counts, 792-793, 975 Cell division, 330, 332, 333 Cell enrichment, for HPC transplantation, 786-787, 839 Cell salvage syndrome, 677-678 Cell washers, 37, 786, 974-975 Center for Biologics Evaluation and Research (CBER) inspections by, 90 regulation of biological products, 88-89 regulation of blood-related devices, 91 reporting fatalities to, 20, 756, 757 Center for Devices and Radiological Health (CDRH), 88, 91 Centers for Medicare and Medicaid Services (CMS), 89-90, 93-94, 96 Central nervous system demyelinating disorders, 713 Centrifugation apheresis separation by, 708-709 in component preparation, 200, 279 in separating autologous cells, 893-894 Centrifuges for apheresis, 708-709 calibrating, 865, 970-973 for platelet separation, 970-971 QC performance intervals for, 37, 39 serologic, 972 Centromere, 329, 330 Cephalosporins, 514, 515, 929 ceRT, 398, 399 ceSL, 398, 399 cGMP (current good manufacturing practices), 1, 7, 8, 20, 271 cGTP (current good tissue practices), 8, 20, 837 Ch1/Ch2, 355, 429, 477, 911-912, 987 Chagas disease, 138, 140, 176, 260 Change control, 32
INDEX
1005
Charts pedigree, 337, 338 process flow, 27, 28 run and control, 24, 32 Check cells, 448 Chemical bonds, 443-444 Chemical safety, 58-63 chemical categories, 59, 80-81 chemicals found in blood banks, 78-79 engineering controls for, 61 hazard identification and communication, 60-61 hazardous vapors, 62, 63 personal protective equipment for, 61 safe work practices for, 61, 80-81 spills, 62, 82-86 training for, 58-60 waste disposal, 62-63 Chemiluminescence assays, 491 Chemotherapy, 802-804, 806 Chiasma, 344 Chido/Rodgers system, 429 antigens and antibodies, 355, 413, 429, 987 plasma inhibition studies, 429, 477, 911-912 Chikungunya virus, 261 Chimerism, 356-357, 370, 561-562 Chloroquine diphosphate, 478, 891-892 Chromatin, 328 Chromosomes, 328-330, 331 autosomes, 329 homologous, 328-329 locations of blood group genes, 353, 354356, 356 sex, 329 X chromosome inactivation, 332-334 Chronic granulomatous disease, 421, 597 Circular of Information for the Use of Human Blood and Blood Components, 215 Circular of Information for the Use of Cellular Therapy Products, 93, 959 Circulatory overload, transfusion-associated, 731, 746, 747-748 Cirrhosis, 590 Cis product antigens, 347, 401 Citrate toxicity, 718, 732, 749 CJD. See Creutzfeldt-Jakob disease Clean rooms, 42-43 Cleaning and decontamination, 52, 55, 57-58 Clinical Laboratory Improvement Amendments (CLIA), 93-94, 96 Clocks, 38 Clopidogrel, 151, 184, 229 Clotting factors. See Coagulation factors CMV (cytomegalovirus), 250
in neonates, 663 preventing with leukocyte reduction, 250, 663, 699-700 transmitted through transplantation, 784 CMV-reduced-risk products, 250, 597, 635, 663, 699-700 Coa/Cob, 355, 413, 428-429, 987 Coagulation monitoring hemostasis, 589-592, 681 in neonates, 656 normal test values for, 981, 982 Coagulation factors concentrates, 171, 176, 598-600 in Cryoprecipitated AHF, 206, 278, 594 half-lives of, 592, 593 in neonates, 656 normal values for, 982 in Plasma, 204, 205, 206, 278 in platelet components, 202, 203, 982 replacement of, 596 Coagulopathy in apheresis, 719-720 in blood donors, 149-150, 176, 177 diagnosis of, 589-592 in hemolytic transfusion reactions, 738 in massive transfusion, 749-751 plasma transfusions for, 589-593 Code of Federal Regulations (CFR), 1, 34, 87, 89 Codominant inheritance, 338, 340 Cold-acid elutions, 917-918 Cold agglutinin syndrome, 509-510 antibody detection in, 510 serologic findings in, 503, 509-510 specificity of autoantibodies in, 380, 464, 510 titration studies in, 923 Cold autoadsorption, 510, 920-921 Cold autoantibodies, 489 ABO discrepancies with, 372, 373, 509-510, 884 adsorption of, 489, 510, 920-921 in cold agglutinin syndrome, 380, 509-510 determining specificity of, 921-923 in mixed AIHA, 380, 511 in paroxysmal cold hemoglobinuria, 511 removing with warm saline washes, 889 in Rh testing, 406, 509 titration of, 923 use of sulfhydryl reagents with, 510, 890 in warm autoimmune hemolytic anemia, 502, 504 Cold-reactive alloantibodies, 372, 373, 443 Cold stress. See Hypothermia Collections, blood group, 432-433
1006
Colloid solutions, 572, 598 Colony-forming cell assays, 793-794 Colton system, 355, 413, 428-429, 987 Column agglutination technology, 450 Communications, emergency plans for, 111116, 120 Compartment syndrome, 149 Compatibility testing. See Pretransfusion testing Competency assessments, 7-8 Competitive ELISA, 311-312 Complement in acute transfusion reactions, 737-738 in autoimmune hemolytic anemia, 509 in positive DATs, 497, 503 role in immunity, 319-321 Complement receptor-1, 430-431 Complications. See Adverse reactions Complotype, 550 Computer crossmatch, 453 Computer systems alternative systems for, 20, 118 backup of, 18, 19, 118 in disaster plan, 118 management of, 19-20 security of, 19 validation of, 15 Concurrent audits, 765, 766, 769, 770-771, 771 Confidential unit exclusion, 153 Confidentiality of information, 19, 962 Consent for apheresis, 230 for blood donation, 141-142 for cord blood donation, 825-826 for transfusion, 617-618 Contacts list, in disaster planning, 111-112 Containers for aliquoting components, 650-651 for blood collection, 188, 189-190, 198, 827 for shipping dry shippers, 792, 833-834 labeling, 867 quality control intervals for, 39 temperature of, 198-199, 272, 832-834, 856, 868 validation of, 198-199, 285 Contamination fungal, 793, 853, 858, 859 between specimens, in PCR, 300 See also Bacterial contamination Continuity of Operations Plan, 108-120 Continuous-flow centrifuges, 708-709 Contraceptives, oral, in blood donors, 149 Contracts, 6-7, 9-10, 116 Control charts, 24, 32
Control process, 3 Controls autologous, 449, 454, 471-472, 474-475, 488-490 IgG-coated cells, 448 for Rh typing reagents, 405-406 Copper sulfate quality control of, 39, 965 in screening donors for anemia, 144-145, 939-940 Cord blood ABO/Rh typing on, 634, 637 antigen expression on, 481, 482 DAT testing on, 499, 634 See also HPC, Cord (HPC-C) Cordocentesis, 635, 641 Corneal transplants, 852-853 Corrected platelet count increment (CCI), 525, 583, 587-588 Corrective action, 26 Corticosteroids, 207, 232, 619 Cost collection, 432-433 Crawford phenotype, 398, 399 Creutzfeldt-Jakob disease (CJD), 262 and plasma derivatives, 598 screening donors for, 138, 140, 178 transmission through transplantation, 853, 859 Crohn disease, 717 Cromer system, 355, 413, 430, 988 Cross-out method, 470 Cross-reactive groups, 554 Crossing-over, gene, 344-346, 551-552 Crossmatch-to-transfusion ratios, 453 Crossmatching, 452-455 antiglobulin test in, 452-453 computer, 453 HLA (lymphocyte), 559, 563, 587 immediate-spin, 452, 897-898 in-vivo, 491, 578 interpretation of results, 453, 454, 455 in pediatric recipients, 457, 648-649 platelet components, 229, 527-528, 561, 587 in transfusion reaction evaluation, 735 Cryoprecipitate-reduced plasma, 204, 220, 275, 717, 718 Cryoprecipitated AHF, 206-207 ABO compatibility of, 447, 625, 657, 695 coagulation factors in, 206, 278, 594 dose of, 594 expiration of, 212, 275, 278 in HSCT transplantation, 697-698 indications for, 594-595 infusion rates for, 625
INDEX
1007
for pediatric patients, 652, 657-658, 663 pooled, 212, 281-282, 594, 954-955 preparation of, 206-207, 278, 953-954 quality control of, 220 storage of, 206, 212, 275, 278 thawing, 280, 954-955 transfusion of, 594-595 transportation and shipping of, 285 wet and dry, 206 Cryopreservation agents for, 208, 209, 210, 791 of HPCs, 790-791, 808, 831-832 of platelet components, 209-210 of Red Blood Cells, 208-209, 947-952 of tissue allografts, 851 Crystalloids, 572, 598, 718 Csa/Csb, 432-433 Culture assays, hematopoietic, 793-794 Cultures, microbial, 285, 736, 793 Current good manufacturing practice (cCMP), 1, 7, 8, 20, 271 Current good tissue practice (cGTP), 8, 20, 837 Customers, 6-7, 12 Cytapheresis, 714-715 Cytomegalovirus, 250 in neonates, 663 preventing with leukocyte reduction, 250, 663, 699-700 transmitted through transplantation, 784 Cytomegalovirus (CMV)-reduced-risk products, 250, 597, 635, 663, 699-700
D
D antigen, 394, 396-401 antibody to (anti-D) in HDFN, 632 and partial D, 400-401 passively acquired, 638-639 in tissue transplantation, 853 titrations of, 633, 935-937 and weak D, 400 clinical considerations for, 400-401 D and D-like epitopes on RHCE, 398, 399 D-negative, 393, 394, 398 D-positive, 396-398 Del, 397, 400 elevated D (deletion phenotypes), 398 in neonates, 634 partial D, 396, 397, 400-401, 407 in recipients, 400, 445, 447-448 weak D, 396-397 in donors, 400, 451 in prenatal patients, 637 in recipients, 400, 445, 447-448
DAT. See Direct antiglobulin test DAT-negative autoimmune hemolytic anemia, 508-509 Decontamination procedures, 52-53, 57-58 Deep vein thrombosis, in donors, 197 Deferasirox, 756-757 Deferiprone, 756, 757 Deferoxamine, 756 Deferrals. See Donor deferrals Deglycerolization, 209, 218, 280, 948-949, 951, 952 Del, 397, 400 Delayed transfusion reactions, 751-757 hemolytic, 321, 662, 732, 751-753 management of, 732-733 serologic, 752 Dendritic cells, 840 Dengue virus, 261 Density, of blood cells and components, 195 Derivatives, plasma, 262-263, 597-603 Design output, 3, 32 Designated donations, 153 Dexamethasone, 595 Dha, 429, 987 DHAR, 398, 399 Dia/Dib, 354, 412, 426, 986 DIC (disseminated intravascular coagulation), 738, 739-740 Diego system, 348, 354, 412, 425-426, 986 Digitonin acid elutions, 501 Dilution of percentage solutions, 872 of serum, 871-872 2,3-Diphosphoglycerate (2,3-DPG), 276, 575, 648 Diploid, defined, 330 Direct antiglobulin test (DAT), 497-501 false positive/negative results in, 446-447, 499 method for, 498, 905-906 positive test after HPC transplantation, 500, 788 in antibody identification, 472, 475, 487, 488-490 causes of, 497-498 in cold agglutinin syndrome, 503 drug-induced, 500, 512-516, 519-522 elution with, 500-501, 890-891, 917-920 evaluation of, 499-501 medical history in, 499-500 in mixed-type AIHA, 503, 511 in neonates, 634 in paroxysmal cold hemoglobinuria, 503, 511
1008
red cell testing with, 891-892 in warm autoimmune hemolytic anemia, 502, 503 in pretransfusion testing, 444, 449 principles of, 498-499 reagents for, 444, 498-499 specimens for, 498 in transfusion reaction evaluation, 498, 735 Directed donations, 153-154, 162 Disaster management, 103-131 for blood and transfusion services, 106-108 business operations planning in, 108-120 Continuity of Operations Plan in, 108-120 cycle of, 103-104 emergency management agencies in, 105106, 120-122 internet resources for, 136 lessons learned from recent disasters, 125, 126-131 planning team in, 108 regulatory issues in, 122-124 risk assessment in, 104-105 testing disaster plans, 124-125 Disinfectants to clean work surfaces, 52, 55 for venipuncture, 193-194, 258 Disposal of biohazardous waste, 57, 116-117 of chemical waste, 62-63 of radioactive waste, 66 Disposition of blood components, 286 Disseminated intravascular coagulation (DIC), 738, 739-740 Dithiothreitol (DTT) in differentiating IgG from IgM, 909-911 to disperse autoagglutination, 373, 510, 890 for inactivating blood group antigens, 476, 478, 485-486, 912-913 Diversion pouches, 188, 258 DMSO (dimethylsulfoxide), 210, 791, 792, 808, 836 DNA, 294-295, 300 DNA-based assays for genotyping, 306-307, 334 in antibody identification, 473 of fetus, 403, 633, 640 in relationship testing, 352 of Rh system, 403-404 for HLA antigens, 557-558, 565 for infectious diseases, 245-246 methods for, 296-307 for platelet antigens, 534 in pretransfusion testing, 450 Doa/Dob, 355, 412, 427-428, 987
Documents, 13, 16-19. See also Records Dolichos biflorus lectin, 367, 373, 889, 898 Dombrock system, 355, 412, 427-428, 987 DOMR, 427 Donath-Landsteiner test, 384, 511, 928 Donor deferrals for bleeding conditions or blood diseases, 149-150, 177 blood donation intervals for, 166-167, 168, 228-229, 231 for blood exposure, 169 for blood transfusions, 168 for bone, skin or dura mater grafts, 169, 177 for cancer, 148-149, 177 for clotting factor concentrates, 171, 175 developing criteria for, 138, 146-147, 148-152 during disasters, 107 for drugs taken by donor, 151-152, 164-165, 166, 175, 184, 229 for heart and lung conditions, 150-151, 177 for hemoglobin/hematocrit, 142, 144-145 for incarceration, 173 for infectious diseases, 140, 170-178 for needlesticks, 169 for piercings, 172 for pregnancy, 166 rates of, 143-144 for reactive infectious screening tests, 247, 248-249 records of, 137 requirements for, 160-162, 164-178 for sexual contacts, 170-171, 175 for tattoos, 172 for transplants, 168 for travel outside the US or Canada, 173174, 178 for vaccinations or shots, 167-168, 184 Donor History Questionnaire, 145-147, 180183 abbreviated, 152 effectiveness of, 147-148 historical perspective of, 138-140 regulations and standards for, 163-178 screening for infectious diseases in, 138140 Donor lymphocyte infusion (DLI), 783 Donor room, 56 Donor testing ABO and Rh, 369-370, 398, 400, 451 for blood group antigens, 451-452, 491-492 for cord blood donation, 826-827 for HPC transplantation, 783, 784 weak D, 400, 887-888 See also Infectious disease screening
INDEX
1009
Donors adverse reactions in, 20, 22, 196-197 age of, 141, 160 of apheresis RBCs, 160, 162, 168, 231 autologous, 154-155, 160-162, 250-251, 674 with bleeding conditions or blood diseases, 149-150, 176, 177 with cancer, 148-149, 177 consent of, 141-142, 230, 825-826 designated or directed, 153-154, 162 disabled, 142 donation intervals for, 160, 166-167, 168, 228-229, 231 donor history questionnaire for, 145-147, 152, 163-178, 180-183 educational materials for, 141-142, 165, 185-186 effect of disasters on, 108, 123 family members as, 492-493 frequent or repeat, 152 general health of, 164 hearing- or vision-impaired, 141 with heart and lung conditions, 150-151, 177 for hematopoietic transplantation, 782, 783-784 hemoglobin/hematocrit in, 142, 144-145, 161, 939-940 for HLA-matched platelets, 560-561 identification of, 140-141, 192 leukapheresis, 160, 166 on medications, 151-152, 164-165, 166, 184, 229 non-English-speaking, 141-142 notification of abnormal test results, 247 phlebotomy of, 192-194, 940-943 physical examination of, 142, 144-145, 160162 plasmapheresis, 160, 166, 230 plateletpheresis, 160, 162, 166, 228-229 postdonation instructions for, 152-153 postphlebotomy care of, 196 preparing for blood collection, 940-941 qualification requirements for, 160-178 with reactive screening tests, 246-250 records of, 140-141 registration of, 140-141 selection of, 137-155 sexual contacts of, 170-171, 175, 178 of tissue allografts, 849-850 of umbilical cord blood, 824-827 weight of, 142, 194, 230 L-dopa, 514 Dopamine hydrochloric acid, 739
Doppler ultrasonography, 634 Dosage effect, 335, 467, 481 Dosimeters, 64, 211 DOYA, 427, 987 2,3-DPG (2,3-diphosphoglycerate), 276, 575, 648 Drug-dependent platelet antibodies, 535-538, 587 Drug-induced immune hemolytic anemia, 512-516 antibodies in, 464, 512-515 classification of, 512-515 drugs associated with, 519-522 laboratory investigation of, 515-516, 929931 mechanisms of, 512 Drugs administered for leukapheresis, 232-233 antiplatelet agents, 151, 152, 166, 184, 229, 581 to assist coagulation function, 681 intravenous use of, 170, 171 platelet antibodies induced by, 535-538, 587 in positive DAT, 500, 512-516, 519-522 for preinfusion of HPCs, 809-810 pretransfusion medications, 619, 742, 745 regulations regarding, 87-88 removal of, in apheresis, 720 taken by donors, 151-152, 164-165, 166, 184, 229 Dry ice, 285, 867 Dry shippers, 792, 833-834 DSLK, 356, 404, 432, 988 DTT (dithiothreitol) in differentiating IgG from IgM, 909-911 to disperse autoagglutination, 373, 510, 890 for inactivating blood group antigens, 476, 478, 485-486, 912-913 Duclos, 356, 404, 432, 988 Duffy system, 421-423 antibodies, 412, 423, 989 antigens, 354, 421-423, 986 Duffy glycoprotein, 422, 423 and malaria, 423 phenotypes and genotypes, 422, 989 Dura mater transplants, 177 Dutasteride, 151, 184 Dysfibrinogenemias, 594
E
E/e antigens and antibodies, 401-403 phenotypes, 395 prevalence of, 391, 392 E-mail, 113
1010
Earlobe punctures, 144 ECMO (extracorporeal membrane oxygenation), 659-660 Education for disaster training, 124 donor, 141-142, 165, 185-186 patient, 618 for umbilical cord blood donation, 824-825 Electrical safety, 49-50 Electricity, emergency systems, 117 ELISA (enzyme-linked immunosorbent assay), 310-312, 538 Elutions, 479-480, 500-501 in autoimmune hemolytic anemias, 502, 503 methods for, 501, 917-920 acid elution, 501 cold-acid, 917-918 combined with adsorption, 480, 880881 digitonin-acid, 501 gentle-heat, 890-891 glycine-HCl/EDTA, 918-919 heat, 501, 919 Lui freeze thaw, 501, 919-920 Embolism, air, 678, 731, 751 Emergency Communications Plan, 111-116 Emergency equipment, 620-621 Emergency exits, 49 Emergency management. See Disaster management Emergency Management Agencies, 105-106, 114-115, 120-122 Emergency operations center, 120-121 Emergency release of blood, 214, 287-288, 457458, 577-578, 627 Emergency response plans, 45 for biohazards, 56-57 for chemical spills, 62 for electrical emergency, 50 for fires, 49 for radiation safety, 66 Emergency showers, 61 Employees. See Personnel Ena, 417 End-product test and inspection, 32 Engineering controls for biosafety, 51-52, 53-54, 55 for chemical safety, 61 for electrical safety, 50 for fire prevention, 49 general guidelines for, 45, 75 for radiation safety, 65 Engraftment, in HPC transplantation, 794, 810, 811
Enhancement media, 469, 488. See also specific reagents Enzyme-linked immunosorbent assay (ELISA), 310-312, 538 Enzymes in antibody identification, 449, 473, 476, 485-486 to confirm weak A and B antigens, 879-880 evaluating treated red cells, 903-904 ficin preparation, 902 one-stage procedure, 904-905 papain preparation, 902-903 standardization of procedures with, 903 two-stage procedure, 905 EPO (erythropoietin) in HPC transplantation, 692-693 in newborns and infants, 646-647 for preoperative anemia, 673 Equilibrium constant (Ko), 443 Equipment for apheresis, 228, 233-236, 708-709, 720 critical, 10 decontamination of, 52 emergency, 620-621 management of, 10-11, 13 personal protective, 45, 55, 73-74 quality control of alarm systems, 37, 967-969 automatic cell washers, 974-975 centrifuge calibration, 970-973 performance intervals for, 37-39 temperature monitoring systems, 272, 276 thermometers, 38, 965-967 for transfusions, 619-621 validation of, 15 Era/Erb, 433 Ergonomics, 43-44 Errors in ABO and Rh typing, 372, 406 companion, 734 fatalities due to, 622-623, 739 identification, 622-623, 734, 735, 739, 740 quarantine release, 251, 255 sources of, in antiglobulin test, 446-447 wrong blood in tube, 450-451, 455, 740 Erythroblastosis fetalis. See Hemolytic disease of the fetus and newborn Erythropoiesis, 646-647, 692 Erythropoietin (EPO), recombinant in HPC transplantation, 692-693 in newborns and infants, 646-647 for preoperative anemia, 673 Ethnic groups, differences in in ABO system, 990
INDEX
1011
in antibody identification, 464, 465-466, 486-487 in Duffy system, 421-422 in Kell system, 419-420 in Kidd system, 424 in Lutheran system, 417 in MNS system, 414 in Rh system, 391, 392, 394, 397, 398 Etretinate, 151, 184 Exchange transfusions, 653-655 for acute hemolytic transfusion reactions, 740 blood warmer for, 647 component choice for, 654 for hyperbilirubinemia, 653 intrauterine, 636 techniques for, 654-655 vascular access for, 654 volume of, 654 Exclusion in antibody identification, 470 in relationship testing, 352-353 Executive management, 5 Expiration, of components, 215-216, 273-275, 622 Exposure Control Plan, 50, 51 Extracorporeal membrane oxygenation (ECMO), 659-660 Extracorporeal photochemotherapy, 716 Eye washes, 75
F
Face shields, 74 Facilities alternate, during disasters, 110 clean rooms in, 42-43 design and workflow of, 42 ergonomic design of, 43-44 housekeeping in, 42 identification of, 215 licensure and registration of, 89-90 mobile sites, 43 quality management of, 5-6, 7, 12 regulatory agencies for, 41-42, 71-72 restricted areas in, 43 safety program of, 7, 12, 44-67 Factor VIIa, recombinant (rFVIIa), 599, 600, 697, 751 Factor VIII antibodies to, 599 concentrates, 596, 598-599 in Cryoprecipitated AHF, 206, 594 Factor IX complex concentrate, 599 Factor IX concentrates, 596, 599 Failure modes and effects analysis, 29
Failures, active and latent, 27 False-positive/-negative results in antiglobulin testing, 446-447 in Rh testing, 406-407 Family support plans, 119 Family trees, 337, 338 Fatalities during apheresis, 720 of blood donors, 20, 197 due to identification errors, 622-623, 739 due to transfusions, 20, 739, 756, 757 of employees, 47 related to medical devices, 91 reporting, 20, 47, 91, 197, 756, 757 Fatigue, in donors, 197 Fc receptors, 319, 320 FDA. See Food and Drug Administration Febrile nonhemolytic transfusion reactions, 729, 741-742 HLA antibodies in, 561, 742 in HPC transplant patients, 701 prevention of, 619, 742 Feldene, 151, 184, 229 Fenwal apheresis systems, 228, 233, 234, 235 Fetal and neonatal alloimmune thrombocytopenia, 639-641 Fetal hemoglobin (hemoglobin F), 979 Fetomaternal hemorrhage, 637-638, 933-935 Fetus genotyping, 403, 633, 640 transfusions in, 635-636 See also Hemolytic disease of the fetus and newborn Fever in HSCT patients, 701 transfusion-associated, 561, 729, 741-742, 751 FFP. See Fresh Frozen Plasma Fibrin clots, 372 Fibrin degradation products, 982 Fibrinogen abnormalities of, 594 in Cryoprecipitated AHF, 206, 594 normal values for, 982 Ficin, 473, 902. See also Enzymes Filters leukocyte-reduction, 208, 279, 623-624, 625 microaggregate, 623, 659 standard in-line, 623, 625, 659 Filtration devices, for apheresis, 709 Finasteride, 151, 184 Fingerstick samples, 144 Fire safety, 48-49 First aid, 47, 48
1012
Fish-bone diagrams, 27 Flow cytometry, 312-313 in CD34 analysis and enumeration, 793 in fluorescence-activated cell sorting, 787 in HLA antibody testing, 559, 563 to measure residual leukocytes, 208 in platelet antibody detection, 533-534, 536, 537 in red cell survival studies, 491 Fluids, replacement, in apheresis, 593, 717718 Fluorescence-activated cell sorting, 787 Fluorescent methods for nucleic acid analysis, 304-306 FMH (fetomaternal hemorrhage), 637-638, 933-935 Focal segmental glomerulosclerosis, 713-714 Food and Drug Administration (FDA) inspections by, 90-91 regulations of for biological products, 88-89 cGMP and cGTP, 1, 7, 8, 20, 271, 837 for donor eligibility, 138, 163-178 for drugs, 87-88 for emergencies, 122 for HPCs, 91-92, 837-838 for licensure and registration, 89-90 for medical devices, 88, 91 for recalls and withdrawals, 93 for tissues, 853-854, 855 reporting adverse events to, 20, 22, 91, 859 reporting fatalities to, 20, 91, 197, 756, 757 variances to requirements, 11 Forensic testing, 565 Forms, 17-18. See also Documents; Records Freeze-thaw elutions, 501, 919-920 Freezers, 37, 272, 969 Freezing cryoprotective agents for, 208, 209, 210, 791 Fresh Frozen Plasma, 203, 953 hematopoietic progenitor cells, 790-791, 808, 831-832 Platelets, 209-210 Red Blood Cells, 208-209, 947-952 Frequency, gene and allele, 349, 350-351 Fresenius AS104 apheresis system, 228, 235 Fresh Frozen Plasma (FFP), 203-204 ABO compatibility of, 447, 625, 656-657, 695 aliquoting, 656 coagulation factors in, 204, 278 collection by apheresis, 230-231 expiration of, 203, 204, 274-275, 278 jumbo units, 281 leukocyte content of, 577
leukocytes-reduced, 204, 208 in massive transfusion, 750 for pediatric patients, 652, 656-657, 663 preparation of, 199, 203, 276, 278, 953 quality control of, 220 as replacement fluid in apheresis, 593, 717, 718 storage of, 203-204, 274-275 thawing, 279-280 transfusion of, 593, 625 transportation and shipping of, 285 volume of, 204 Fuel, in disaster plan, 117-118 Fume hoods, 61 Fungal contamination of HPCs, 793 of tissue allografts, 853, 858, 859 Fy antigens, 354, 421-423, 986
G
G antigen, 401 G-CSF (granulocyte colony-stimulating factor) for HPC mobilization, 804-805, 806, 811 in leukapheresis, 207, 232-233, 596 side effects of, 804-805 G6PD deficiency, 741 Ge2/Ge3/Ge4, 355, 413, 429-430, 987 GEAT, 429 GEIS, 429, 987 Gene locus, 328 Genes, 328-330 of blood group systems, 331, 353, 354-356, 356, 989 frequencies, 350-351 of major histocompatibility complex, 548552 mapping, 353, 354-356, 356 mutation of, 335 nucleic acid structure in, 294-295 position effect, 347-348 silent or amorphic, 339, 341 suppressor or modifier, 347-348 syntenic, 345 Genetics alleles, 334-335 cell division, 330, 332, 333 chimerism, 356-357 crossing-over, 344-346, 551-552 gene interaction, 347-348 genes and chromosomes, 328-330, 331 genotype and phenotype, 334, 336 inheritance patterns, 337-348 linkage, 344-346 linkage disequilibrium, 346-347, 552
INDEX
1013
of major histocompatibility complex, 548552 Mendel's laws, 343-344 polymorphism, 335-336 population genetics, 348-351 position effect, 347 relationship testing, 351-353 X chromosome inactivation, 332-334 See also specific blood groups Genotype defined, 334 DNA-based typing, 306-307, 334 in antibody identification, 473 of fetus, 403, 633, 640 in relationship testing, 352 of Rh system, 403-404 frequencies of, 350-351 nomenclature for, 357-359 and phenotypes, 307, 336 GEPL, 429, 987 Gerbich system, 355, 413, 421, 429-430, 987 GETI, 429, 987 GIL antigen, 356, 432, 988 Gill system, 356, 413, 432, 988 Globoside collection, 355, 381, 382, 383, 413, 988 Gloves, 73-74 and latex allergy, 47-48 use in donor room, 56, 193 Glycerolization of red cells, 208-209, 947-951 Glycine-HCl/EDTA, 478, 892-893, 918-919 GM-CSF (granulocyte-macrophage colonystimulating factor), 804, 805 GMP (good manufacturing practice), 1, 7, 8, 20, 271 Goggles, safety, 74 Gonorrhea, in donors, 172 Grading test results, 445, 873-874 Graft failure, 787 Graft-vs-host disease (GVHD) acute and chronic, 783 efficacy of photopheresis in, 715-716 and graft-vs-leukemia effect, 782, 783 in HPC transplantation, 697-698, 780, 782, 783 transfusion-associated, 733, 753-754 HLA system in, 527, 561-562 in HPC transplant patients, 700 in neonates, 647 treatment and prevention of, 526-527, 754 Graft-vs-leukemia (tumor) effect, 782, 783, 813 Gram weight, 39 Grams stain, 736
Granulocyte colony-stimulating factor (GCSF) for HPC mobilization, 804-805, 806, 811 in leukapheresis, 207, 232-233, 596 side effects of, 804-805 Granulocyte-macrophage colony-stimulating factor (GM-CSF), 804, 805 Granulocytes, 207 ABO compatibility of, 233, 447, 597, 658 antigens and antibodies, 539-540, 746 apheresis collection of, 207, 228, 232-233, 278 CMV-reduced risk, 597 dose of, 658 expiration of, 274, 279 HLA-matched, 597 increasing yields of, 232-233, 595, 597 indications for, 595, 597, 658, 663 infusion of, 233, 625, 699 irradiation of, 233, 274, 597 laboratory testing of, 233, 286 preparation of, from whole blood, 207 quality control of, 221 storage of, 207, 233, 274, 279, 597 transportation and shipping of, 285 Growth factors, recombinant, 207, 232-233, 804-805, 806 Growth hormone, in donors, 151, 184 GTP (good tissue practice), 8, 20, 837 GVHD. See Graft-vs-host disease GVL (graft-vs-leukemia) effect, 782, 783, 813 Gya, 355, 427, 987
H
H system, 373-376 alloanti-H, 375, 413 autoanti-H, 375 autoanti-IH, 375, 922 biochemistry and genetics of, 355, 373, 374 Bombay phenotype, 365, 373, 375 H antigen, 364, 365, 373, 987 Para-Bombay phenotype, 375 saliva testing for soluble antigens, 881-883 transfusion practice for, 375-376 Haemonetics apheresis systems, 228, 233, 234, 235-236 Hand washing, 75 Haploid, defined, 332 Haplotype ancestral, 552, 565-566 defined, 346 of HLA system, 550, 551, 552 of Rh system, 390, 392
1014
Haptoglobin, 979 Hardy-Weinberg equilibrium, 350-351 Hazardous areas of facilities, 43 Hazardous materials biohazards, 50-58 chemicals, 58-63 classification of, 866-867 identification and communication of, 45 for biosafety, 51 for chemical safety, 60-61 for electrical safety, 50 for fire safety, 49 radioactive, 63-66 safety plan for, 44-45 shipping, 66, 865-867 waste management of, 57-58, 67 HBsAg (hepatitis B surface antigen), 139, 239, 255-256 HBV. See Hepatitis B virus HCT/Ps (human cells, tissue, and cellular and tissue-based products) biological product deviations of, 22 infectious disease testing on donors of, 251, 783, 784, 850 regulation of, 91-93, 837-838 See also Hematopoietic stem cell transplantation; Tissue transplantation HCV. See Hepatitis C virus HDFN. See Hemolytic disease of the fetus and newborn Health history questionnaires. See Donor history questionnaire Heart disease, in blood donors, 150-151, 177 Heart/lung transplants, 564-565 Heart transplants, 564-565 Heat elutions, 501, 890-891, 919 Heating blocks, 38 Hematocrit in blood donors, 142, 144-145, 161 of blood in exchange transfusions, 281, 654 in neonates, 659 normal values for, 979 preparing RBCs with known hematocrit, 281 of red cell components, 201 as transfusion threshold, 573-574, 692 Hematologic disorders, in blood donors, 149150 Hematoma, in donors, 197 Hematopoietic cultures, 793 Hematopoietic growth factors, 207, 232-233, 804-805, 806 Hematopoietic progenitor cells. See HPC entries
Hematopoietic stem cell transplantation (HSCT) ABO incompatible, 688-691, 787-790 bidirectional, 688, 690, 695 clinical outcomes and complications of, 690-691 major, 688, 689, 695, 788, 789, 790 minor, 688, 689-690, 695, 788, 789, 790 processing in, 788, 790 ABO typing discrepancies in, 372 adverse reactions to, 792, 808-809, 836-837 allogeneic, 687-688, 779, 780, 782, 783, 811812 autologous, 687, 779, 780, 783, 809-811 chimerism in, 370 clinical outcomes for, 813-814 and CMV, 699-700, 784 collection of products for, 784-785, 827-829 conditioning regimens for, 688, 780 cryopreservation of products in, 790-791, 808, 831-832 diseases treated with, 780, 781-782 donors for, 782, 783-784, 824-827 evaluation and QC of products in, 792-794, 831 graft failure and relapse in, 787 graft-vs-host disease after, 700, 780, 782, 783, 813-814 history of, in blood donors, 168 and HLA antibodies, 698-699 HLA matching in, 563, 782 irradiation of products in, 699 mobilization of HPCs in, 802-807 neutropenia in, 699 non-ABO red cell incompatible, 691 and platelet antibodies, 698 positive DAT after, 500 processing products in, 785-786, 788, 790, 808 regulation of, 91-93, 794, 837-838 sources of cells for, 687-688, 780, 812-814 standardization of care in, 701 standards for, 691-692, 794, 838 storage of products in, 790-792, 808, 831832 syngeneic, 779, 782, 811-812 thawing and infusion of products in, 792, 808-809, 834-837, 959-960 transfusion reactions after, 700-701 transfusion support for, 685, 692-698, 785 transportation and shipping products, 792, 832-833 xenogeneic, 779 Hemizygous, defined, 340
INDEX
1015
Hemochromatosis, in blood donors, 150 HemoCue, 145 Hemodilution, normovolemic, 678-679 Hemoglobin in blood donors, 142, 144-145, 161, 939-940 in infants, 646, 652-653, 659, 980 normal values for, 979, 980 physiology of, 569-571 in Red Blood Cells, 201 as transfusion threshold, 573-574, 577, 652653, 671-672, 692 Hemoglobin A2, 979 Hemoglobin F, 979 Hemoglobin S, 635, 656, 894-895 Hemoglobin substitutes, 578-579 Hemoglobinometers, 39 Hemoglobinopathies, in children, 661-663. See also Sickle cell disease Hemolysis in ABO testing, 369 in antiglobulin tests, 445 extravascular, 321, 502, 738 in hemolytic disease of the fetus and newborn, 632 intravascular, 321-322, 502, 737-738 nonimmune, 620, 720, 731, 740-741 passenger lymphocyte, 788 in patient samples, 441, 735 See also Hemolytic entries Hemolytic anemia autoimmune, 501-512 classification of, 502 cold agglutinin syndrome, 509-510 DAT-negative, 508-509 mixed-type, 380, 511 paroxysmal cold hemoglobinuria, 511512 serologic findings in, 503 transfusion in, 507-508, 511, 578 warm, 502, 503, 504-509 drug-induced immune, 512-516 hemolytic transfusion reactions, 737-740, 751-753 positive DAT in, 497, 499 See also Hemolytic disease of the fetus and newborn Hemolytic disease of the fetus and newborn (HDFN), 631-636 ABO, 639 alloimmunization in, 631-632 antibodies associated with, 412-413, 420, 485-486, 632, 633 antibody titers in, 480, 633, 907-909, 935937
blood selection in, 635-636 diagnosis and management of, 632-636 elutions in, 500 hemolysis in, 632 pathophysiology of, 631 preventing, 636-639 Rh testing in, 407, 632, 634, 637 Hemolytic transfusion reactions acute, 729, 737-740 antibodies associated with, 412-413, 485-486 clinical evaluation and management of, 728, 734 due to misidentification errors, 622-623 elutions in, 500 HLA antibodies in, 562 delayed, 321, 662, 732, 751-753 intravascular hemolysis in, 321-322 nonimmune, 731, 740-741 Hemolytic uremic syndrome, 713 Hemophilia in blood donors, 149, 171 factor replacement for, 596, 598-599 Hemorrhage fetomaternal, 637-638, 933-935 intracranial, 640-641 transfusion for, 571-574 Hemostasis during massive transfusion, 749-751 monitoring, 589-592, 681 in neonates, 65 normal test values for, 981, 982 Hemostatic agents, 676 Hemovigilance, 22, 727-728 Heparin, 152, 536-538, 717, 739, 869 Heparin-induced thrombocytopenia, 536-538, 588 Hepatitis B immune globulin, 47, 151, 184 Hepatitis B surface antigen (HBsAg), 139, 239, 255-256 Hepatitis B virus, 255-256 employee exposure to, 47 nucleic acid testing for, 246, 256 prevalence and incidence of, 139 prophylaxis for, 46-47 reactive donor screening tests for, 247, 248, 249 residual transfusion risk of, 251-253, 255 screening donors for, 138-139, 171, 176, 239, 244, 255-256 transmission through transplantation, 850, 853, 859 Hepatitis C virus, 256 employee exposure to, 47
1016
nucleic acid testing for, 245-246, 256 prevalence and incidence of, 139 reactive donor screening tests for, 247, 248, 249 residual transfusion risk of, 251-253, 256 screening donors for, 138-139, 171, 176, 244, 256 transmission through transplantation, 850, 853, 859 Hereditary hemochromatosis, 150, 548 Heredity, genetics of. See Genetics HES (hydroxyethyl starch), 232, 790, 791 Heterozygous, defined, 334 High-prevalence antigens 901 series, 433 antibodies to, 484, 486-487, 635-636 blood selection for, 492-493 High-titer, low-avidity antibodies, 481 Histocompatibility. See HLA system HIT (heparin-induced thrombocytopenia), 536-538, 588 HIV. See Human immunodeficiency virus Hives, 729, 742-743, 744 HLA alleles, 555-556 HLA antibodies detection of, 525-526, 559 in HPC transplant recipients, 698-699 management of, 732 in platelet refractoriness, 524, 525-528, 560561, 587 in TRALI, 561, 736, 746, 747 in transfusion reactions, 561, 562, 742 HLA antigens Bg, 434, 552-553, 562 Class I and Class II, 547, 552-554, 556-557 configuration of, 553-554 cross-reactive groups, 554 detection of, 557-559 nomenclature for, 554 permissive, 527 on platelets, 524 public, 555 splits, 554 HLA-B27, 566 HLA Matchmaker program, 560-561 HLA system biochemistry, tissue distribution and structure of, 552-557 biologic function of, 556 and chimerism, 561-562 disease associations with, 565-566 genetics of, 548-552 in graft-vs-host disease, 527, 561-562 importance of, 547-548
HLA typing cellular assays for, 559 crossmatching, 559, 563, 587 in diagnosis of TA-GVHD, 753, 754 in diagnosis of TRALI, 736 DNA-based assays for, 557-558, 565 in forensic testing, 565 of Granulocytes, 597 in HSCT, 698 lymphotoxicity assays for, 558-559 of Platelets, 526-527, 560-561, 587 in relationship testing, 565 in transplantation, 562-565, 698-699, 782 HNA (human neutrophil antigen), 539-540 Homolog, defined, 340 Homozygous, defined, 334 Hook effect, 312 HPA (human platelet antigen), 529-532 in fetal and neonatal alloimmune thrombocytopenia, 532, 639-640 in posttransfusion purpura, 532-533, 755 HPC, Apheresis [HPC(A)], 801-814 allogeneic, 811-812, 813-814 autologous, 809-811, 813 bacterial contamination of, 809 clinical use of, 809-812 cryopreservation and storage of, 808 discontinuing collection of, 803-804 and graft-vs-host disease, 813-814 mobilization of, 802-807 poor mobilizers of, 806-807 processing, 808 regulations regarding, 91-93 syngeneic, 811-812 thawing and infusion of, 808-809 transplantation outcomes of, 813-814 tumor contamination of, 810-811 venous access for collection of, 812 vs HPC-M and HPC-C grafts, 812-814 HPC, Cord [HPC(C)], 823-840 in cell expansion, 839 collection of ex-utero, 828-829 in-utero, 827-828 consent for collection of, 825-826 cryopreservation of, 829, 831-832 donor recruitment for, 824-825 donor testing, 826-827 health history and medical evaluation for, 826 in immunotherapy, 839-840 infusion of, 835-837 labeling, 833, 834 nonhematopoietic progenitor cells in, 840
INDEX
1017
processing, 829-832, 960-961 quality control of, 831 receipt of, for transplantation, 833-834 regulations and standards for, 91-93, 837838 shipping, 832-833 storing, 831-832 testing, 832 thawing and washing, 834-835 UCB banks, 824, 837-838 vs HPC-A or HPC-M grafts, 814, 824 HPC, Marrow [HPC(M)], 779-794 allogeneic, 780, 782, 783-784 autologous, 780, 783, 813 bioluminescence assays on, 794 buffy-coat preparations, 786 CD34 antigen on, 785, 786, 793 cell counts of, 792-793 cell enrichment, 786-787 clinical considerations for, 785 collection targets for, 784-785 colony-forming cell assays for, 793-794 cryopreservation of, 790-791 cytoplasmic aldehyde dehydrogenase in, 793 diseases treated with, 780, 781-782 donor databases for, 782 donor eligibility for, 783-784 engraftment of, 794 evaluation and quality control of, 792-794 and graft-vs-host disease, 780, 782, 783, 813-814 harvesting, 784, 812 histocompatibility of, 782 infectious disease testing of, 783, 784, 791 microbial cultures of, 793 mononuclear preparations, 786 processing, 785-787, 788, 790 red cell incompatibilities using, 787-790 red cell reduction in, 790 regulations for, 91-93, 794 standards for, 794 storing, 790-792 T-cell reduction of, 787 thawing and infusion of, 792 transfusions for donors of, 785 transplantation outcomes using, 813-814 transportation and shipping, 792 tumor cell detection in, 794 tumor cell purging in, 787 untested or infectious products, 791-792 viability assays of, 793 vs HPC-A or HPC-C grafts, 812-814 HSCT. See Hematopoietic stem cell transplantation
HTLV. See Human T-cell lymphotropic virus Human immunodeficiency virus (HIV), 254255 donor exposure to, 170-171, 175 educating donors about, 141, 185-186 employee exposure to, 47 nucleic acid testing for, 245-246, 254 prevalence and incidence of, 139 reactive donor screening tests for, 247, 248, 249 reporting new cases of, 859 residual transfusion risks for, 251-253, 254 screening donors for, 138, 139, 140, 240, 244, 254-255 transmission through transplantation, 850, 853, 859 Human neutrophil antigen (HNA), 539-540 Human platelet antigen (HPA), 529-532 in fetal and neonatal alloimmune thrombocytopenia, 532, 639-640 in HPC transplantation, 698 in posttransfusion purpura, 532-533, 755 Human resources, 7-9, 12, 119 Human T-cell lymphotropic virus (HTLV), 256-257 reactive donor screening tests for, 248, 249 screening donors for, 138, 244, 257 transmission through transplantation, 850, 859 Human urea transporter 11, 425 Hy antigen, 355, 427, 428, 987 Hydatid cyst fluid, 383, 477 Hydrops fetalis, 631 Hydroxyethyl starch (HES), 232, 790, 791 Hygiene, in disaster planning, 117 Hyperbilirubinemia, 653, 654 Hypercholesterolemia, 716 Hyperhemolytic syndrome, 662 Hyperkalemia, 627, 749 Hyperviscosity, 712-713 Hypocalcemia, 627, 718, 732, 749 Hypogammaglobulinemia, 372, 601, 720 Hypoglycemia, 654 Hypokalemia, 749 Hypomagnesemia, 718 Hypotension in apheresis, 719 associated with ACE inhibitors, 623 , 719, 731, 743, 744 deliberate, 679-680 in transfusion recipients, 738, 744 Hypothermia, 619-620, 647, 732, 751 Hypovolemia, 572, 598, 719
1018
I
I and i antigens and antibodies, 378-381 anti-I, 379-380, 413, 922 anti-i, 380, 922 anti-IH, 380 in cold agglutinin syndrome, 380, 464, 510 disease associations with, 380, 464 genetics of, 355, 378-379 ISBT nomenclature for, 988 phenotypes, 378 transfusion practice with, 380-381 IAT (indirect antiglobulin test), 444-445, 446447, 898-900 Identification of blood components labeling, 214-216, 221, 455, 457 prior to administration, 622-623 prior to issue, 621 of donors, 140-141, 192 of equipment, 11 errors in, 622-623, 734, 735, 739, 740 of personnel, 19 of persons issuing blood, 287, 457 of phlebotomists, 441 of problems and solutions, 26-29 of recipients, 287, 437, 438-441, 457, 618, 621, 622-623 of umbilical cord blood, 834 Ig. See Immunoglobulin entries Immediate-spin crossmatch, 452, 897-898 Immune thrombocytopenia (ITP), 150, 534535, 588, 641 Immunity afferent, 313-317 antibodies in, 317-319 antigen processing and presentation in, 313, 314 CD4+ T-cell activation in, 314-315 complement in, 319-321 efferent, 317-323 extravascular and intravascular hemolysis in, 321-322 Fc receptors in, 319, 320 helper T cells in, 316-317 immune diversity in, 315-316 in infants, 647 plasma cell generation of antibodies in, 315 Immunoglobulin(s), 317-319, 979, 981. See also specific immunoglobulins Immunoglobulin A, 318, 319 antibodies to, 736, 743-744, 745 deficiency of, 743-744, 745 normal values for, 979, 981 Immunoglobulin D, 979
Immunoglobulin E, 318, 319, 979 Immunoglobulin G, 318, 319 in autoimmune hemolytic anemias, 503 dissociation of, by chloroquine, 891-892 distinguishing from IgM, 909-911 in infants, 647 normal values for, 979, 981 serologic reactivity of, 443, 485-486 subgroups of, 318, 319 Immunoglobulin G-coated cells (check cells), 448 Immunoglobulin M, 318 in autoimmune hemolytic anemias, 503 cold-reactive autoagglutinins, 509-510, 511, 920-923 dispersing autoagglutination caused by, 373, 510, 890 distinguishing from IgG, 909-911 in infants, 647 in intravascular hemolysis, 321-322 normal values for, 979, 981 serologic reactivity of, 443, 485-486 in warm autoimmune hemolytic anemia, 504 Immunoglobulin products, 598, 600-602 Immunohematology reference laboratories, 490 Immunomagnetic cell separation, 787 Immunomodulation, transfusion-related (TRIM), 576 Immunotherapy, 839-840 In-vivo testing, 491, 578 Ina/Inb, 355, 413, 431, 988 Incarceration, history of, 173 Incidence, defined, 349 Incident Command System, 121-122 Incinerators, hospital/medical/infectious waste, 57-58 Incubation temperatures for, 476, 865 times for, 444, 476 Incubators, platelet, 37, 272 Independent assortment, 344 Independent segregation, 343-344 Indian system, 355, 413, 431, 988 Indirect antiglobulin test (IAT), 444-445, 446447, 898-900 Infants. See Neonates; Pediatric patients Infectious disease screening, 239-265 in apheresis donors, 229 approaches to, 241 of autologous donations, 250-251 for Babesia, 260-261 for bacterial contamination, 257-259
INDEX
1019
for chikungunya virus, 261 for cord blood donation, 826 for dengue virus, 261 in HCT/P donors, 251, 783, 784, 791 in health history assessment, 138-140 for hepatitis B virus, 255-256 for hepatitis C virus, 256 historical overview of, 138-140, 239-241, 242-243 for human immunodeficiency virus, 254255 for human T-cell lymphotropic virus, 256257 for immunocompromised recipients, 250 international variations in, 251 logistics of, 241, 245 for malaria, 261 nucleic acid testing, 245-246 for parvovirus B19, 262-263 for prions, 262 reactive test results in, 246-250 residual infectious risks of transfusion, 251254 serologic testing, 245 for syphilis, 257 in tissue transplantation, 850 for Trypanosoma cruzi, 260 in US blood banks, 244 for West Nile virus, 259 Infectious diseases safety precautions for, 50-58 transfusion-transmitted, 254-263 transmitted by plasma derivatives, 262-263 transmitted by tissue transplantation, 853, 858-859 See also Infectious disease screening Infectious substances labeling, 867 shipping, 865-867 waste, 57-58 INFI, 431, 988 Inflammatory bowel disease, 716-717 Information management, 13, 19-20 Infusion, of HPCs, 792, 808-809, 835-837, 959960 Infusion pumps, 620, 658 Infusion rates, 624, 625, 659 Infusion sets, 623-624, 659 Inheritance patterns, 337-348 aneuploidy, 341-342 autosomal codominant, 338, 340 autosomal dominant, 337, 339 autosomal recessive, 338-339, 341 crossing-over, 344-346, 551-552
gene interaction, 347-348 linkage, 344-346 linkage disequilibrium, 346-347, 552 of major histocompatibility complex, 550552 Mendels laws for, 343-344 pedigrees, 337, 338 position effect, 347-348 sex-linked, 339-341, 342-343 Inhibition tests, 477, 881-883, 911-912 Inhibitors, in PCR, 297, 299 INJA, 431, 988 Injuries, 47, 48, 52, 91 INR (international normalized ratio), 589, 590, 591, 592 Inspections of components, 202 before administration, 622 before release, 284-285, 457, 621 receiving into inventory, 284-285 in transfusion reaction evaluation, 736 external assessments, 25 FDA, 90-91 of incoming supplies, 10 of tissue grafts, 855-856 Insulin, bovine, in donors, 151, 184 Insurance, 111 Integrins, 532 Internal event report, 20, 21 International Normalized Ratio (INR), 589, 590, 591, 592 Intracranial hemorrhage, 640-641 Intrauterine transfusions, 635-636 Intravenous immune globulin (IVIG), 600-602 ABO discrepancies with, 372 adverse effects of, 601-602 in antibody identification problems, 464 applications of, 601-602 for fetal and neonatal immune thrombocytopenia, 640 in HDFN, 636 in platelet refractoriness, 588 positive DAT with, 500 Inventory, 108-109, 122-123, 286 Iron chelation therapy, 756-757 Iron overload, 662, 733, 756-757 Iron, supplemental, 145, 673-674 Irradiated products, 210-211, 280 expiration of, 273, 274, 280 Granulocytes, 233, 274, 597 in HPC transplantation, 699, 785 indications for, 526-527, 754, 755 for intrauterine transfusions, 635 for pediatric patients, 664
1020
platelet components, 211, 274, 526-527 potassium leak in, 648 quality control of, 211, 280 Red Blood Cells, 211, 273 storage of, 273, 274 ultraviolet B, 528, 560 Whole Blood, 273 Irradiators, blood, 38, 64, 65, 210-211, 280 ISBT (International Society of Blood Transfusion) 128 barcode labeling, 214, 216, 221 nomenclature for platelet antigens, 530-531 for red cell antigens, 357-359, 984-989 Ishikawa diagrams, 27 Isografts, 850 Isohemagglutinins, 364 Isotretinoin, 151, 184 Issuing blood, 287 delivering blood to patient area, 621-622 identification of recipient and component before, 455, 457, 621 policies and procedures for, 455, 457, 621622 reissue, 289, 622 from transfusion service, 287 in urgent situations, 214, 287-288, 457-458, 577-578, 627 ITP (immune thrombocytopenia), 150, 534535, 588, 641 IV solutions, 624 IVIG. See Intravenous immune globulin
biochemistry and genes of, 354, 418-419, 989 functional aspects of, 421 in HDFN, 420, 632, 633 Kmod, 412, 420 null phenotype (Ko), 412, 420 phenotypes of, 419, 989 position effect in, 347 Kernicterus, 632, 636, 653 Kidd system, 423-425 antibodies in, 412, 424-425 antigens in, 354, 423-424, 986, 989 in delayed transfusion reactions, 752 genetics of, 354, 989 inheritance patterns of, 340 Kidd glycoprotein, 424, 425 phenotypes of, 424, 989 in transfusion reactions, 424-425 Kidney transplantation, 563-564 Kleihauer-Betke acid-elution test, 637-638, 934-935 Kmod, 421 Kna/Knb, 355, 430-431, 988 Knops system, 355, 413, 430-431, 988 Kpa/Kpb/Kpc, 354, 418, 419, 985, 989 Ku (KEL5), 421 Kx system, 333-334, 343, 355, 413, 421, 987
L
Labels for aliquots, 651 for biohazardous materials, 51, 867 for blood components, 188, 214-216, 221, 286-287, 455, 457 for blood samples, 438-439, 441, 618 control of, 17 for hazardous chemicals, 60 ISBT 128 system for, 214, 216, 221 for pooled components, 212, 281 for reagents, 865 for shipments, 833, 866-867 for umbilical cord blood, 834 Laboratories, regulations for, 93-94, 96 Laboratory coats, 73 Landsteiner-Wiener blood group, 355, 389390, 413, 429, 987 Latex allergies, 47-48, 188, 189-190 Law of Independent Assortment, 344 Law of Independent Segregation, 343-344 LDL apheresis, 716 Lea/Leb, 354, 376-378, 412, 986, 989 Leadership, organizational, 5-6, 12, 112 LEAN, process improvement, 29 Lectins Dolichos biflorus, 367, 373, 888, 889
J
Jehovahs Witnesses, 671 Jka/Jkb/Jk3 antigens and antibodies, 354, 412, 423-425, 986, 989 Joa, 355, 427, 428, 987 Job descriptions, 7 John Milton Hagen system, 355, 413, 432, 988 Jsa/Jsb, 354, 420, 985 Just-in-time systems, 116
K
K/k antigens and antibodies, 354, 412, 418420, 985, 989 Karyotype, 329 KCAM, 431, 988 Kell system, 418-421 allele frequencies in, 350-351 antibodies of, 412, 420, 989 antigens of, 354, 419-420, 985, 989 association with Gerbich, 421
INDEX
1021
preparation and use of, 888-889 Ulex europaeus, 367, 373, 888, 889 Leishmaniasis, 173 Leukapheresis collection of Granulocytes by, 207, 235-236 donation intervals for, 160, 166-167 indications for, 714-715 instrumentation for, 228, 235-236 Leukemia cytapheresis for, 714-715 and G-CSF, 805 HPC transplantation for, 812, 813-814 platelet transfusions in, 579 Leukocyte-reduced components, 576 for children, 663-664 expiration of, 273, 274 Fresh Frozen Plasma, 204, 208 leukocyte content in, 576, 577 platelet components, 208, 211, 229, 528, 956-957 prestorage filtration, 207-208, 279, 945-946, 956-957 to prevent CMV infection, 250, 663, 699-700 quality control of, 218, 975-977 Red Blood Cells, 201, 207-208, 218, 273, 576, 945-946 to reduce alloimmunization, 528, 560, 587, 662 to reduce febrile nonhemolytic transfusion reactions, 701, 742 to reduce incidence of PTP, 755 storage of, 273, 274 Leukocyte reduction filters, 208, 279, 623-624, 625 Leukocytes in components, 577 normal values for, 979, 980 residual, 207-208, 576, 975-977 Lewis substance, 477 Lewis system, 376-378 antibodies of, 377-378, 412 antigens of, 354, 374, 376, 986, 989 biochemistry and synthesis of, 374, 376 disease associations with, 378 expression in children, 377 genetics of, 354, 376-377 phenotypes of, 376-377, 989 saliva testing for, 477, 881-883 transfusion practice with, 378 Licensure, of facilities, 89-90 Liley graphs, 634, 635 Linkage, 344-346 Linkage disequilibrium, 346-347, 552 Lipemic samples, 441
Liquid nitrogen for shipping, 792, 833 for storage, 791, 832 Liquid Plasma, 204, 275 LISS antibodies to ingredients in, 488 to enhance antigen-antibody reactions, 443, 448-449, 473, 899 and serum to red cell proportions, 443, 449 Liver, transplantation of, 564-565 LKE (Luke) antigen, 381, 384 Logistics, in disaster plan, 116 Look-back, 247, 248-249, 250, 859 Low-prevalence antigens, 433-434, 487 Low-volume units, 194-195, 201 Lsa, 429, 987 Lu antigens and antibodies. See Lutheran system Lui freeze thaw elution, 501, 920-921 Luke (LKE) antigen, 381, 384 Lung conditions, in blood donors, 150-151, 177 Lung injury. See Transfusion-related acute lung injury Lung transplants, 564-565 Lutheran system, 417-418 antibodies of, 412, 418 antigens of, 354, 417-418, 985 genetics of, 339, 341, 346, 347-348, 354 LWa/LWb, 355, 389, 429, 987 Lymphocyte crossmatching, 559 Lymphocytes natural killer cells, 839 passenger, 788 T regulatory cells, 839-840 Lymphocytotoxicity assays, 525-526, 557, 558559 Lyonization, 332-334
M
M antigen and antibodies, 354, 411, 412, 414416, 989 Magnesium, 718 MAIGA (monoclonal antibody immobilization of granulocyte antigens), 540 MAIPA (monoclonal antibody immobilization of platelet antigens), 534 Major histocompatibility complex, 547 in antigen processing and presentation, 313, 314 Class I, II, III molecules in, 552-554 genetics of, 548-552 Malaria, 261 and Duffy glycoprotein, 423
1022
and HLA type, 566 screening donors for, 138, 140, 173, 176, 261 Markers, defined, 327 Market withdrawals, 859 Marrow. See HPC, Marrow (HPC-M) Masks, 74 Massive transfusions complications of, 748-751 air embolism, 751 citrate toxicity, 749 coagulopathy, 749-751 hyper- and hypokalemia, 749 hypothermia, 751 component replacement in, 750-751 defined, 288, 458 Factor VIIa, recombinant, in, 751 pretransfusion testing in, 288, 458 Material safety data sheets, 60, 61 Materials management, 9-10, 12 Maximum surgical blood order schedules, 286, 991 MCA-PSV (middle cerebral artery peak systolic velocity), 634 McCa/McCb, 355, 430-431, 988 McLeod phenotype, 333-334, 343, 421 McLeod syndrome, 343, 421 2-ME (2-mercaptoethanol), 478, 510, 890 Mechanical hemolysis, 720, 741 Media, working with, 114, 115-116 Medical devices, regulations for, 88, 91 Medical history in antibody identification, 464 in blood donor selection, 145-147, 163-178 for cord blood donation, 826 in evaluation of positive DAT, 499-500 of recipients, 618 Medical waste, 57-58 Medications. See Drugs Meiosis, 330, 332 Membrane attack complex, 320-321 Mendels laws, 343-344 Mental health assistance, during disasters, 120 MER2 antigen, 432 2-mercaptoethanol (2-ME), 478, 510, 890 Mesenchymal stem cells, 840 Message mapping, 115 Messenger RNA, 295 Metabolic abnormalities, in infants, 647-648, 654 Methemoglobin, 979 -Methyldopa, 514 Methylene blue-treated plasma, 205-206, 264 Microaggregate filters, 623, 659
Microarray assays, 306, 312, 557-558, 559 Microfluorimetry, 208 Microhematocrit centrifuges, 39 Microhematocrit, spun, 145 Microlymphocytotoxicity tests, 525-526, 557, 558-559 Microplate test for ABO group, 877-878 for Rh type, 886-887 Microvascular bleeding, 750 Military service, donors in, 174 Mitosis, 330, 332 Mixed-field agglutination, 353, 370, 371, 433 Mixed leukocyte culture (MLC), 559 Mixed passive hemagglutination assay, 533 Mixed-type autoimmune hemolytic anemia, 380, 503, 511 MNS system, 411, 414-417 antibodies of, 412, 416-417, 477 antigens of, 354, 414, 416, 984, 989 effect of enzymes on, 414 genetics of, 354, 414, 416, 989 glycoproteins of, 414, 415, 416 linkage disequilibrium in, 346-347 linkage in, 346 nomenclature for, 984, 989 phenotypes of, 414, 989 SsU phenotype, 416 Mobile blood collection, 43, 198 Mobilization regimens of HPCs adhesion-blocking agents and cytokines, 805-806 chemotherapy, 802-804 combined growth factor and chemotherapy, 806 hematopoietic growth factors, 804-805 poor mobilizers, 806-807 Molecular typing. See DNA-based assays Monoclonal antibody immobilization of granulocyte antigens (MAIGA), 540 Monoclonal antibody-specific immobilization of platelet antigens (MAIPA), 534 Monoclonal reagents, 370, 398, 399, 406 Monocyte monolayer assay, 490-491 Mononuclear cell enrichment, 786 Mortality. See Fatalities Mozobil (AMD3100), 805-806, 807 Multiple sclerosis, 713 Multiplex nucleic acid amplification, 304 Multipotent stem cells, 840 Mur antigen, 417 Mutations, genetic, 335 Myeloma, IgM, 712-713
INDEX
1023
N
N antigen and antibodies, 354, 412, 414-416, 989 Nageotte hemocytometry, 208 Narcolepsy, 566 NAT. See Nucleic acid testing National Disaster Medical System, 106 National Incident Management System, 106 National Marrow Donor Program, 782 National Response Framework, 106 Natural killer (NK) cells, 839 Near-miss events, 26, 32 Needlesticks, 52, 169 Neonatal alloimmune neutropenia, 540 Neonatal alloimmune thrombocytopenia, 532, 639-641 Neonates (less than 4 months of age), 645-660 ABO and Rh typing in, 372, 457, 634, 637 ABO antigens and antibodies in, 365, 372, 648-649 alloimmune thrombocytopenia in, 532, 639-641 anemia in, 646 antibody screening in, 457 antigen variations in, 481, 482 autologous blood donation in, 155 blood volume in, 646, 983 compatibility testing in, 457, 648-650 direct antiglobulin testing in, 634 ECMO in, 659-660 erythropoietic response in, 646-647 hemoglobin in, 646, 652-653 hypothermia in, 647 immunologic status of, 647 Lewis antigens in, 377 metabolic problems in, 647-648 neutropenia in, 540, 597 normal laboratory values in, 980-981 plasma volume in, 983 polycythemia in, 659 red cell volume in, 983 size of, 645-646 transfusion-associated graft-vs-host disease in, 647 transfusions in, 648-660 administration of, 658-659 aliquots for, 282-284, 650-651 of Cryoprecipitated AHF, 652, 657-658 exchange, 636, 653-655 of Fresh Frozen Plasma, 652, 656-657 of Granulocytes, 658 indications for, 648, 649, 652-655 of platelet components, 655-656 of Red Blood Cells, 648-655
safety of additive solutions in, 651-652 vascular access for, 619, 654, 658 volumes for, 652 See also Hemolytic disease of the fetus and newborn Nerve injury, in donors, 197 Neutralization techniques, 477, 913-914 Neutropenia autoimmune, 540 granulocyte transfusions for, 595, 597, 663 in HPC transplant patients, 699 neonatal alloimmune, 540 Neutrophil antigens and antibodies, 539-540, 746 Nomenclature for blood group systems, 354-356, 357-359, 984-989 for granulocyte antigens, 539 for HLA system, 554, 555 of platelet antigens, 530-531 of Rh system, 390-393 Nonimmune hemolysis, 620, 720, 731, 740-741 Nonconformances biological product deviations, 20, 22, 93, 94 classification of, 22, 23 internal event reports, 20, 21 management of, 13, 20-22 Normovolemic hemodilution, 678-679 Notifications to donors, of reactive screening tests, 247 to recipients, of reactive donor tests, 247 Nucleated cell counts, 792-793 Nucleic acid analysis, 293-307 detection of amplification products in, 304306 for genotyping, 306-307, 334 in antibody identification, 473 of fetus, 403, 633, 640 in relationship testing, 352 of Rh system, 403-404 in HLA typing, 557-558, 565 hybridization-based methods in, 295-296 for infectious diseases, 245-246 isolation of nucleic acids in, 295 nucleic acid sequence-based amplification in, 302, 303 for platelet antigens, 534 polymerase chain reaction in, 296-305 in pretransfusion testing, 450 in relationship testing, 352 of single nucleotide polymorphisms, 306307 transcription-mediated amplification in, 302, 303
1024
Nucleic acid sequence-based amplification (NASBA), 302, 303 Nucleic acid testing (NAT), 245-246 in HBV testing, 256 in HCV testing, 256 in HIV testing, 254 in West Nile virus testing, 259 Nucleic acids, structure of, 294-295 Nutritional supplements, 151
Orientation program, 7, 124 Outpatients, 439
P
P antigen, 381-382, 384 P blood groups, 381-384 antibodies of, 382-384, 412 antigens of, 354, 381, 382, 985 autoanti-P, 384 biochemistry of, 381-382 disease associations with, 384, 464, 512 genetics of, 354 molecular biology of, 382 phenotypes of, 381 transfusion practice with, 384 P1 antigen, 381 P1 substance, 383, 477 P1PK, 354, 381, 412 Packaging biological materials, 865-867 PAD (preoperative autologous donation), 674 Paired donor exchange, 564 Pall eBDS system, 258 Panel reactive antibody (PRA), 526, 559, 560, 564 Panels, red cell, 467, 468, 469-471 Papain, 473, 902-903. See also Enzymes Para-Bombay phenotype, 375 Parentage testing, 351-353, 565 Pareto analysis, 28 Paroxysmal cold hemoglobinuria (PCH), 384, 466, 503, 511-512 Partial D, 396, 397, 400-401, 407 Partial thromboplastin time (PTT), 589, 681, 750, 981, 982 Parvovirus B19, 248, 262-263 Passenger lymphocyte hemolysis, 788 Paternity testing. See Relationship testing Pathogen reduction and inactivation methods, 205-206, 253, 263, 264, 597-598 Patient blood management, 671-681 acidosis in, 681 auditing in, 24-25, 672, 763-772 benchmarking in, 672 blood draws in, 673 deliberate hypotension in, 679-680 drug therapies in, 681 hemostatic agents in, 676 perioperative autotransfusion in, 674, 676679, 680 point-of-care monitoring in, 681 positioning in, 680 in preoperative anemia, 673-674 quality assurance measurement in, 672-673 routine surgical blood orders in, 286, 991
O
O alleles, 367 Oh (Bombay) phenotype, 365, 373, 375 Ok system, 355, 413, 431, 988 Oka, 355, 431, 988 Ola, 356, 404, 432, 988 Oligonucleotide probes, 557-558 Orders, physician auditing, 763-772 pretransfusion, 455, 618-619 routine surgical blood orders, 286, 991 sample form for, 776-777 verifying prior to transfusion, 622 Organ transplantation ABO compatibility in, 563, 564, 860 heart, 564-565 heart/lung, 564-565 history of, in blood donors, 168 HLA testing in, 563-565 kidney, 563-564 liver, 564-565 lung, 564-565 paired donor exchange, 564 positive DAT after, 500 procurement of organs for, 860 rejection of, 714 transfusion support for, 860 Organizations for biological product regulation, 88-89 for blood-related device regulation, 91 directory of, 992-993 for drug regulation, 87-88 for emergency management, 105-106, 122124, 136 for inspections, 90-91 for licensure and registration, 89-90 for managing recalls and withdrawals, 93, 94 for medical laboratory regulation, 93-94, 96 for quality system regulation, 1-2 for regulation of HPCs, 91-93 for safety, 41-42, 71-72, 994-995 structure of, 5-6, 12 See also specific organizations
INDEX
1025
single-unit transfusions in, 672 surgical techniques for minimizing blood loss, 675 temperature regulation in, 680-681 transfusion thresholds in, 671-672 PCR. See Polymerase chain reaction PEDI-PAK system, 650, 651 Pediatric patients (older than 4 months of age) ABO and Rh typing in, 372, 661 ABO antigens and antibodies in, 365, 372 antibody screening in, 661 autologous blood donation in, 155 compatibility testing in, 661 cytomegalovirus prevention in, 663 Lewis antigens in, 377 normal laboratory values in, 980-981 transfusions in, 660-663 aliquoting for small volumes, 282-284, 650-651 of CMV-reduced-risk components, 663 of Cryoprecipitated AHF, 652, 657, 663 of Fresh Frozen Plasma, 652, 657, 663 of Granulocytes, 658, 663 of irradiated components, 664 of leukocyte-reduced components, 663664 of platelet components, 652, 655, 663, 664 of Red Blood Cells, 652, 660-663 with sickle cell disease, 661-662 syringe infusion pumps for, 620 with thalassemia, 662-663 vascular access for, 619 of volume-reduced components, 664 of washed components, 664 See also Neonates Pedigrees, 337, 338 Peer review, 24, 763-772 PEG (polyethylene glycol) in antibody detection/identification, 449, 473, 899-900 use in adsorption, 927 Penicillin, 513-514, 515, 929 Peripheral blood progenitor cells. See HPC, Apheresis (HPC-A) Personal protective equipment, 45, 73-74 for biosafety, 55 for chemical safety, 61 gloves, 47-48, 56, 73-74 Personnel accidents and injuries in, 47, 48, 52 blood exposure in, 47, 55 competency assessment of, 7-8 disaster plans for, 118-120 essential, 119
hepatitis prophylaxis for, 46-47 identification of, 19 latex allergies in, 47-48 medical first aid and follow-up for, 47 orientation program for, 7 protective equipment for, 45, 55, 73-74 records, 19, 47 safety monitoring programs for, 47 selection of, 7 staffing plan, 8-9, 118-120, 123 training. See Training PF4 ELISA, 538 PF24. See Plasma Frozen Within 24 Hours After Phlebotomy pH, 443, 477, 482 pH meters, 38 Phenotype calculations for, 349, 492-493 defined, 334 distribution by ethnicity, 990 and genetic mutations, 335 and genotypes, 307, 335-336 nomenclature for, 357-359, 989 prevalence of, 349 rare, 465-466, 492-493 typing for autologous red cells, 472-473 donor units, 491-492 solid-phase assays for, 309-310 See also specific blood groups Phenotype-matching, 402-403, 451, 662, 717 Phlebotomy adverse reactions to, 196-197 care of donors after, 196 for collection of blood samples, 194, 441, 940-943 of donors, 192-194, 940-943 only as needed, 673 See also Blood collection Phosphate buffer, 873 Photopheresis, 715-716 Physical assessment of donors, 142, 144-145 of recipients, 621 Physiologic anemia of infancy, 646 Piercings, 172 Piperacillin, 513-514 Pipettes, recalibration of, 38 Pk antigen, 381, 382, 384 PlA1 (HPA-1) antigen, 529, 639 Plasma ABO compatibility of, 447, 625, 656-657, 693, 695
1026
aliquoting, 656 biochemical changes in storage of, 276, 278 coagulation factors in, 204, 205, 206, 278 collection by apheresis, 228, 230-231, 275 collection by sequestration, 679 expiration of, 203, 204, 274-275, 278 jumbo units, 281 leukocyte-reduced, 204 pathogen-inactivated, 205-206, 264 for pediatric patients, 652, 656-657, 663 preparation of, 200, 203, 276, 278, 953 for pretransfusion testing, 441, 463-464, 468 quality control of, 220 as replacement fluid in apheresis, 593, 706, 717, 718 storage of, 203-204, 274-275 thawing, 279-280 transportation and shipping of, 285 volume of, normal value, 983 See also specific plasma components; Plasma transfusion Plasma Cryoprecipitate Reduced, 204, 220, 275, 717, 718 Plasma D-dimers, 982 Plasma derivatives -antitrypsin, 603 activated protein C, 603 albumin, 598 antithrombin, 602-603 clotting factor concentrates, 598-599 Factor IX complex concentrate, 599 Factor VIIa, 600 intravenous immune globulin, 600-602 screening for parvovirus B19 in, 262-263 Plasma exchange. See Therapeutic plasma exchange Plasma Frozen Within 24 Hours After Phlebotomy, 204 coagulation factors in, 205, 593 preparation of, 199, 278 storage and expiration of, 275, 278 Plasma, Liquid, 204, 275 Plasma, Recovered (for manufacture), 205, 275 Plasma, solvent/detergent-treated, 206, 264 Plasma, Source, 230-231 Plasma, Thawed, 204, 205, 275, 278, 593 Plasma transfusions, 589-593 alternatives to, 679 dose and timing of, 592-593 in HPC transplantation, 697 infusion rate for, 625 in massive transfusion, 750 in pediatric patients, 656-657, 663 types of, 593
Plasmapheresis donation intervals for, 160, 166-167, 230 instrumentation for, 228, 233-234 manual, 230, 708 plasma transfusion in, 593 red cell losses in, 230 therapeutic plasma exchange adverse effects of, 718-720 in hemolytic disease of the fetus and newborn, 636 indications for, 709-714 instrumentation for, 708-709 volume exchange in, 708 Platelet agonists, 151, 152, 166, 184, 229, 581 Platelet antigens and antibodies, 523-538 ABO antigens on platelets, 523-524 autoantibodies, 534-535 detecting, 533-534, 535, 536, 537, 538 drug-induced antibodies, 535-538, 587 HLA antigens, 524, 560-561 in HPC transplantation, 698 platelet-specific antigens, 528-534, 639640, 698, 755 Platelet counts corrected platelet count increment, 525, 583, 587-588 normal values for, 979, 980 in plateletpheresis donors, 162, 229 posttransfusion platelet recovery, 525, 583 as transfusion threshold, 579-580, 655, 663, 694 Platelet disorders, 580-581. See also Thrombocytopenia Platelet factor 4 (PF4), 538 Platelet function, 681, 750 Platelet gel, 282, 588-589 Platelet incubators, 37, 272 Platelet PGD test, 258-259 Platelet-rich plasma (PRP), 199, 200, 202, 588589, 956 Platelet transfusions, 579-589 ABO compatibility of, 447, 523-524, 584-586 after HSCT transplantation, 693-694, 695 in hemolytic transfusion reactions, 740 in nonemergency settings, 625 in pediatric patients, 656, 663 alternatives to, 679 contraindications to, 588 dosage of, 581-583, 656, 696-697 in HPC transplantation, 693-697 indications for, 580-581, 655-656 infusion rates for, 625 in massive transfusion, 750 in pediatric patients, 640-641, 652, 655-656, 663
INDEX
1027
prophylactic vs. therapeutic, 579, 694 refractoriness to, 524-528 ABO compatibility in, 523-524 antibody specificity prediction method for, 527 causes of, 525-526 HLA antibodies in, 524, 525-528, 560561, 587, 732 HLA matched platelets for, 526-527, 560561 managing, 587-588 platelet crossmatching for, 527-258, 561, 587 preventing alloimmunization in, 528 Rh matching, 586 thresholds for, 579-580, 655, 663, 694, 696 unit type and age, 583-584 Plateletpheresis, 228-230 donation intervals for, 160, 166-167, 228-229 donor selection and monitoring in, 160, 162, 166, 228-229 instrumentation for, 228, 234 records of, 230 therapeutic, 715 yields from, 680 Platelets (whole-blood-derived), 202-203 agitation of, 272 aspirin-free, 152 bacterial contamination of, 258-259, 276, 284-285 biochemical changes during storage, 276, 583-584 coagulation factors in, 202, 203, 982 collection by sequestration, 679 compared to Apheresis Platelets, 584 cryopreservation of, 210 donors of, 152 expiration of, 211, 274, 281, 282, 284 inspection of, 289 irradiated, 211, 274, 528 Leukocytes Reduced, 208, 211, 274, 284, 528, 577, 956-957 pathogen reduction for, 264 pooled, 211-212, 274, 281 preparation of, 200-201, 202, 955-957 quality control of, 219 return and reissue of, 289 storage of, 202-203, 272, 274 transportation and shipping, 203, 285 volume-reduced, 212-213, 282, 586, 656, 664, 957-958 washed, 280, 664 Platelets, Apheresis agitation of, 272
aliquoting, 283-284 bacterial contamination of, 258-259, 276, 284-285 biochemical changes during storage, 276, 583-584 collection of, 228-229 compared to whole-blood-derived Platelets, 584 crossmatching, 527-528, 561, 587 cryopreservation of, 209-210, 220 donors of, 152, 160, 162, 228-229 expiration of, 274, 282 HLA-matched, 526-527, 560-561, 587 inspection of, 289 irradiated, 211, 274, 526-527, 528 laboratory testing of, 229 leukocyte content of, 577 Leukocytes Reduced, 229, 274, 528, 577 pathogen reduction for, 264 quality control of, 219, 220 return and reissue of, 289 storage of, 272, 274 transportation and shipping of, 285 volume-reduced, 212-213, 282, 586, 656, 957-958 washed, 280, 664 Plerixafor, 805-806, 807 Point-of-care testing, 681 Policies, 11, 16, 17-18 Polyagglutination, 370-371, 406, 888 Polycythemia, 659 Polyethylene glycol. See PEG Polymerase chain reaction (PCR), 296-302 in genotyping, 334, 633 in HLA typing, 557-558 oligonucleotide probes, 557-558 in platelet typing, 534 problems with, 297, 299-300 real-time, 304-306 reverse transcriptase, 300-302 sequence-based typing, 558 sequence-specific primers, 534, 557, 558 Polymorphism, 335-336, 351-352 Pooled components, 211-212, 280-282 Cryoprecipitated AHF, 212, 281-282, 594, 954-955 expiration of, 274, 281-282 labeling, 212 Platelets, 211-212, 274, 281 Reconstituted Red Cells, 281 Population genetics, 348-351 Position effect, 347-348 Positioning, surgical, 680 Posterior subcapsular cataract, 207
1028
Posttransfusion platelet recovery (PPR), 525, 583 Posttransfusion purpura (PTP), 532-533, 733, 754-756 Postzone effect, 308, 309 Potassium, 276, 627, 647-648, 749 PPE. See Personal protective equipment Pr antibodies, 510, 922 PRA (panel reactive antibody), 526, 559, 560, 564 Preadmission testing, 439 Pregnancy autologous blood donation during, 155 in blood donors, 166 in patient history, 441-442, 464 See also Prenatal studies Premature Infants in Need of Transfusion (PINT) study, 652-653 Premedication for HPC infusions, 809-810 for transfusions, 619, 742, 745 Prenatal studies amniotic fluid analysis, 634 antibody titration, 480, 633, 907-909, 935937 in fetal and neonatal immune thrombocytopenia, 640-641 fetal genotyping, 403, 633 serologic and molecular testing, 487, 632-634 Preoperative autologous donation (PAD), 674 PrepaCyte-CB, 831 Preservatives anticoagulant-preservative solutions, 188, 191, 216, 277, 827 reagent, antibodies to, 488 Press, working with, 114, 115-116 Pressure devices, 620 Pretransfusion testing, 437-459 AABB standards for, 438 ABO and Rh typing in, 445, 447-448 after non-group-specific transfusions, 288289, 458 antibody detection in, 448-450, 453-455 with autoantibodies, 504-505, 509-510 autologous control in, 449 and blood availability, 455 blood samples for, 438-442, 618 in cold agglutinin syndrome, 509-510 comparison with previous records, 450451 crossmatching, 452-455 donor testing in, 451 identification of recipients in, 438-441 interpretation of results, 453-455 in massive transfusions, 288, 458
orders for, 455, 456, 618-619 in pediatric recipients, 457, 648-650, 661 requests for transfusion, 437-438, 455, 456, 618, 776-777 selection of units in, 447, 451-452 serologic testing, principles of, 442-445 steps in, 438 tubeless methods for, 449-450 turnaround times for, 619 in urgent situations, 288, 457-458 Prevalence, of phenotypes, 349 Preventive action, 26 Prewarming technique, 489, 900-901 Primed lymphocyte typing (PLT), 559 Primers, PCR, 299-302 Prions, 262, 858 Probability values, in antibody identification, 470-471 Proband, 337 Problem identification and resolution, 26-29 Procedures, 11, 17-18, 22, 88-89 Process capability, 32 Process control, 3, 32 Process flow charts, 27, 28 Process improvement, 13, 25-29 Process management, 3-4, 11, 13, 14-16 Processes, 11, 14, 17-18 Production, principles of, 4 Proficiency testing, 25, 96 Propositus, 337 Prospective audits, 765, 765-766, 767-768, 770, 771 Protein analysis, 307-313 agglutination-based methods for, 307-309 enzyme-linked immunosorbent assay for, 310-312 flow cytometry for, 312-313 protein microarrays for, 312 solid-phase assays for, 309-310 Western blotting for, 312 Protein C, 603, 982 Protein microarrays, 312 Protein S, 982 Proteolytic enzymes. See Enzymes Prothrombin Complex Concentrate (PCC), 590, 599 Prothrombin time (PT), 589-590, 593, 681, 750, 981 Prozone effect, 308, 443 PRP (platelet-rich plasma), 199, 200, 202, 588589, 956 Pseudoautosomal, defined, 341 Pseudogenes, 548
INDEX
1029
PT (prothrombin time), 589-590, 593, 681, 750 PTP (posttransfusion purpura), 532-533, 733, 754-756 PTT (partial thromboplastin time), 589, 681, 750, 981, 982 Public antigens, 555 Pulmonary disease, in blood donors, 150-151, 177 Pulmonary edema, 719, 747, 748 Pulse, of donor, 161 Pumps, infusion, 620, 658 Pure red cell aplasia (PRCA), 689, 691
Q
Quad packs, 650 Qualification defined, 32 of personnel, 7 of suppliers, 9, 855, 856 Quality assurance, 1, 2, 33 Quality control, 15-16 of apheresis components, 975 of blood components, 217-221, 221 apheresis RBCs, 231-232 leukocyte-reduced components, 975977 Red Blood Cells, Deglycerolized, 952 of copper sulfate solution, 39, 965 defined, 2, 33 of equipment automatic cell washers, 974-975 centrifuge calibration, 970-973 freezer alarms, 37, 969 refrigerator alarms, 37, 967-969 temperature monitoring systems, 272, 276 thermometers, 38, 965-967 of HPCs, 792-794, 831 performance intervals for, 37-39 records of, 16 unacceptable results for, 16 Quality improvement, 3, 125 Quality indicators, 24, 33 Quality management systems, 1-30 components of, 12-13 customer focus, 6-7, 12 documents and records, 13, 16-19 equipment management, 10-11, 13 facilities, work environment and safety, 7, 12 human resources, 7-9, 12 information management, 13, 19-20 management of nonconforming events, 13, 20-22, 23
monitoring and assessment, 13, 23-25 organization and leadership, 5-6, 12 process improvement, 13, 25-29 process management, 11, 13, 14-16 quality concepts, 2-4 regulation of, 1-2, 34 suppliers and materials management, 9-10, 12 terminology of, 32-33 Quality oversight, 5-6, 8 Quality planning, 2-3, 4 Quality System Essentials, 2 Quarantine of collected blood, 213-214 of nonconforming products, 284-285, 286 of repeatedly reactive units, 247, 248-249, 250 of tissue allografts, 961-962 Quarantine release errors, 251, 255
R
Radiation safety, 63-66 Radios, 113 Raph system, 355, 413, 432, 988 Rare Donor Program, 492, 914-915 RBCs. See Red Blood Cells Rd antigen, 354, 427, 986 Reagents for ABO testing, 370 antibodies to components of, 370, 372, 487488 antiglobulin, 444, 467, 469, 498-499 bovine albumin, 448, 899 chloroquine diphosphate, 478, 891-892 contamination of, 406 DTT (dithiothreitol), 476 for elutions, 501, 917-920 enhancement media, 469, 488 enzymes, 449, 473, 476, 478, 902-905 glycine-HCl/EDTA, 478, 892-893 labeling, 865 LISS (low-ionic-strength saline), 448-449, 473, 899 monoclonal, 370, 398, 399, 406 PEG (polyethylene glycol), 449, 473, 899900 for phenotyping, 491-492 preparation of, 865, 869-871, 873, 888-889, 902-903 quality control intervals for, 39 red cells, 448, 466-467 for Rh testing, 398, 399, 405-406 sulfhydryl, 478, 890, 909-911, 912-913 ZZAP, 476, 478
1030
Real-time PCR (polymerase chain reaction), 304-306 Recalls, 93, 94, 859 Recipients ABO and Rh testing in, 369-370, 400, 445, 447-448 antibody detection in, 448-450 consent of, 617-618 crossmatching in, 452-455 disclosure of adverse outcomes to, 859 education of, 618 identification of, 287, 437, 438-441, 457, 621, 622-623 immunocompromised, 250 medical history of, 464 monitoring during transfusions, 624-625 phenotyping, 402-403, 472-473 records of, 450-451, 736 tracing (look-back), 247, 248-249, 250, 859 of unknown identity, 439, 441 weak D in, 400, 445, 447-448 Recombinant human erythropoietin (rHuEPO) in HPC transplantation, 692-693 in newborns and infants, 646-647 for preoperative anemia, 673 Recombination, 345 Reconstituted Red Blood Cells, 201, 281 Records altering, 18-19 apheresis, 230, 232 blood component, 457 checking before blood release, 286-287, 457, 621-622 comparing testing results to, 450-451 confidentiality of, 19 donor, 140-141 electronic, 18-19, 118 management of, 13, 16, 18-19 personnel, 19, 47 protection of, during disasters, 110-111, 118, 124 quality control, 16 storage of, 19 of tissue allografts, 857-858, 961-962 transfusion, 457, 626 of transfusion complications, 736 Recovered Plasma, 205, 275 Red Blood Cell transfusion, 571-579 ABO/Rh compatibility of, 447, 451, 575-576, 625, 694, 695 alternatives to, 674-679 in autoimmune hemolytic anemias, 507508, 511, 578
in emergency release, 214, 287-288, 457458, 577-578, 627 in exchange transfusion, 653-655 hemoglobin targets in, 577 in HPC transplantation, 692-693, 785 of incompatible units, 578 indications for, 571-579, 643, 644, 652-655 infusion rates for, 625, 659 intrauterine, 635-636 in massive transfusion, 288, 458, 748-751 non-group-specific, 288-289, 458-459 in pediatric patients, 648-655, 660-663 in red cell exchange, 717-718 Red Blood Cells aliquoting, 283, 650-651 bacterial contamination of, 259 biochemical changes of storage in, 276, 277, 575 cryopreservation of, 208-209, 947-952 expiration of, 201, 273-274 hemoglobin/hematocrit of, 201 inspecting, 202 irradiated, 211, 273 leukocyte content of, 577 low-volume or undercollected units, 194195, 201 pathogen reduction of, 264 phenotyping, 491-492, 662 preparation of, 199-200, 944-945 quality control of, 217-218 rare, 492-493 reconstituted, 201, 281 rejuvenated, 213, 273, 274, 284, 946-947 return and reissue of, 289 storage of, 273-274, 276, 482 substitutes for, 578-579 survival studies of, 491, 578, 735-736 transportation and shipping of, 285 washed, 218, 273, 280, 577, 664 Red Blood Cells, Apheresis, 231-232 collection of, 228, 235 donation requirements for, 160, 162, 168, 231 quality control of, 218, 231-232 records of, 232 storage and expiration of, 273 Red Blood Cells, Deglycerolized expiration of, 273, 280 leukocyte content of, 577 preparation of, 209, 280, 948-949, 951 quality control of, 218, 952 rejuvenated, 274 storage of, 273 Red Blood Cells, Frozen cryoprotective agents for, 208, 209
INDEX
1031
expiration of, 273 preparation of, 208-209, 947-952 rejuvenated, 274, 284 storage of, 273, 948 thawing and deglycerolizing, 280, 948-949, 951 transportation and shipping, 285 Red Blood Cells Leukocytes Reduced, 576 leukocyte content of, 201, 576, 577 preparing, 945-946 prestorage filtration, 207-208 quality control of, 218 storage and expiration of, 273 Red cell depletion, 790, 829, 830 Red cell exchange, 708, 714, 715, 717-718, 740 Red cell losses, in apheresis, 230 Red cell sedimentation, 790 Red cell substitutes, 578-579 Red cells normal values for, 979 preparation of 3% suspension, 872-873 separating autologous and transfused, 893895 volume of, normal value, 983 Reference laboratories, 490 Refractoriness to platelets, 524-528 ABO compatibility in, 523-524 antibody specificity prediction method for, 527 causes of, 525-526 HLA antibodies in, 524, 525-528, 560-561, 587, 732 HLA matched platelets for, 526-527, 560-561 managing, 587-588 platelet crossmatching for, 527-528, 561, 587 preventing alloimmunization in, 528 Refrigerators, 37, 272, 967-968 Regulatory issues, 87-96 for biological products, 88-89 for blood-related devices, 88, 91 for donor eligibility, 137-138, 163-178 for drugs, 87-88 for emergencies, 122-124 FDA inspections, 90-91 hospital regulations and accreditation, 95, 96 for HPCs, 91-93, 794, 837-838 licensure and registration, 89-90 medical laboratory laws and regulations, 93-94, 96 for quality systems, 1-2, 34 for radioactive materials, 64 recalls and withdrawals, 93, 94
for safety, 41-42, 64, 71-72 for shipping hazardous materials, 866-867 state and local regulations, 96 for tissue, 853-854 Reissuing blood products, 289, 622 Rejuvenated RBCs, 213, 273, 274, 284, 946-947 Rejuvesol, 284 Relationship testing, 351-353, 565 Relative risk, 566 Releasate, 282 Remedial action, 26 Renal failure, 713, 738 Reports of adverse events related to tissue grafts, 858, 859, 961-962, 963 facility quality, 26-27 of fatalities, 20, 47, 91, 197, 756, 757 of injuries, 47 internal event, 20, 21 Requests for transfusion, 437-438, 455, 456, 618, 776-777 Requirement, defined, 33 Respiratory distress in therapeutic apheresis, 718-719 in TRALI, 745-747 Restricted work areas, 43 Restriction fragment length polymorphism analysis (RFLP), 304 Reticulocyte counts, 979 Retrospective audits, 765, 767-768, 769, 771772, 772 Retrovirus Epidemiologic Donor Study, 147 Reverse transcriptase PCR, 300-302 RFLP (restriction fragment length polymorphism analysis), 304 Rg1/Rg2, 355, 429, 477, 911-912, 987 Rh Immune Globulin, 636-639 after non-group-specific transfusions, 289 antepartum administration of, 634, 636-638 in antibody identification problems, 464 development of, 390 dosage for, 637-638 in platelet transfusions, 586 positive DAT after, 500 postpartum administration of, 637-638 serology and mechanism of, 638-639 Rh system, 389-407 antibodies of, 405, 412, 492, 507 antigens of, 354, 390, 391, 394-403 C/c and E/e, 401-403 D antigen, 394, 396-401 G antigen, 401 prevalence of, 391-392 clinical considerations for, 400-401
1032
in component selection, 451, 492, 586 ethnic differences in, 391, 392, 394, 397, 398 genes and proteins of, 354, 393-394, 397, 989 genotypes, 394, 395 haplotypes in, 390, 392 history of, 389-390 in HPC transplantation, 698, 789 nonerythroid Rh glycoproteins, 404-405 phenotypes, 394, 395, 989 RhAG, 356, 404, 413, 432, 988 terminology for, 390-393, 985, 989 Rh testing of apheresis components, 229 with autoagglutinins, 406, 509 of blood components, 286, 451 for C, c, E, e antigens, 395 comparison with previous records, 450-451 controls for, 405-406 of cord blood, 634 for D antigen, 398-401, 403-404 discrepancies in, 400, 407, 509 of donors, 398, 400, 451 false-positive/-negative results in, 406-407 in HDFN, 407, 632, 634, 637 in multitransfused patients, 403 in pediatric patients, 407, 457, 634, 648-650, 661 phenotyping, 395, 492 in prenatal evaluation, 632 reagents for, 398, 399, 405-406 of recipients, 400, 445, 447-448 for sickle cell patients, 401-402, 404 slide test for, 885 in transfusion reaction evaluation, 735 tube test for, 885-886 for weak D, 400, 403-404, 445, 447-448, 637, 887-888 RhAG system, 356, 404, 413, 432, 988 RhBG, 404-405 RhCE, 393-394, 405 RhCG, 404-405 RhD, 393-394, 405 Rheopheresis, 709 Rhmod, 348 Rhnull, 348, 404 Risk assessment of hazards, 104-105, 108 Risk, relative, 566 RNA (ribonucleic acid), 295 RNA microarray hybridization, 306 Rodgers blood group. See Chido/Rodgers Root causes, of problems, 27-28 Rosette test, 637, 933-935 Rouleaux
in ABO discrepancies, 370, 372 in antibody detection/identification, 445, 488 in Rh typing, 406 saline replacement technique for, 373, 488, 901-902 Rule-out method, 470 Run charts, 24
S
S/s antigens and antibodies, 354, 414, 989 Safe work practices for biosafety, 55-56 for chemical safety, 61, 80-81 for electrical safety, 50 for fire prevention, 49 general guidelines for, 45, 75 for radiation safety, 65-66 Safety goggles, 74 Safety program, 44-67 accidents and injuries in, 47, 48, 52 biosafety in, 50-58, 77 chemical safety in, 58-63, 78-86 in disaster management, 110 electrical safety in, 49-50 emergency response plan in, 45 employee health services in, 46-48 engineering controls in, 45, 75 fire prevention in, 48-49 first aid and follow-up in, 47 hazard identification and communication in, 45 hepatitis prophylaxis in, 46-47 latex allergies in, 47-48 management controls in, 45, 46 personal protective equipment in, 45, 73-74 quality management of, 7, 12 radiation safety in, 63-66 regulations and recommendations for, 4142, 71-72 resources for information, 994-995 safe work practices in, 45, 75 safety officers in, 44, 58, 64 safety plan in, 44 shipping hazardous materials in, 66, 865867 training in, 45, 46 waste management in, 67 Saline replacement technique, 373, 488, 901902 Saliva Lewis substance in, 477, 881-883 testing for ABH antigens, 881-883 Samples, blood. See Blood samples
INDEX
1033
Sandwich ELISA, 310-311 SC1/SC2/SC3, 354, 412, 427, 986 SCAN (SC7), 427, 986 SCER (SC6), 427, 986 Scianna system, 354, 412, 427, 986 Scoring reactions, 445 SD (solvent/detergent-treated) plasma, 206, 264 Sda antigen, 433 agglutination pattern of antibody, 433, 445 neutralization of, 433, 477, 913-914 Secretors genetics of, 373, 374, 375, 376-377 linkage with Lutheran group, 346 saliva testing for, 881-883 Security, 110 Segments, of RBCs, 201-202 Selective absorption, 709, 716-717 Sensitization, 442-443 Sepax Cord Blood Processing System, 830-831 Sepsis neonatal, 597, 658 transfusion-associated, 731, 736, 741 Sequence-based typing (SBT), 558 Sequence-specific oligonucleotide probes (SSOP), 557-558 Sequence-specific primers (SSP), 534, 557, 558 Serologic testing principles, 442-442 Serotonin release assay (SRA), 538 Serum dilution procedure, 871-872 for pretransfusion testing, 441, 463-464, 466 proteins of, in typing discrepancies, 370, 373, 406 ratio to cells, in antibody identification, 476 Services, critical, 4, 9 Sewage disposal, in disaster plan, 118 Sex-linked inheritance, 339-343 Sexual contacts, of blood donors, 170-171, 175, 178 Sharps injuries, 52 Shelter, emergency, 119-120 Shipments container temperature during, 198-199, 272, 832-834, 856, 868 containers for, 39, 272, 285, 792, 832-833, 867 of frozen products, 285, 792, 833 of hazardous materials, 66, 865-867 of HPCs, 792, 832-833 labeling, 833, 867 packaging with dry ice, 285, 867 of samples, 66, 865-867 Shock, 738 Showers, emergency, 61
Sickle cell disease alloimmunization in, 402-403, 451, 662 in blood donors, 150 delayed transfusion reactions in, 662, 753 genotyping for, 404 in pediatric patients, 661-662 red cell exchange in, 715, 717 separation of transfused from autologous cells in, 472, 894 transfusion in, 402-403, 451, 661-662 Side effects. See Adverse reactions Signs, safety, 49, 51, 60, 61 Silent mutations, 335 Single nucleotide polymorphisms, 306-307 Six Sigma, 29 Skin appearance, in donors, 142, 161 Skin grafts, 169, 844, 851-852 Sl1/Sl2/Sl3, 355, 430-431, 988 Slide test for ABO group, 875-876 for Rh type, 885 Small intestine transplants, 564-565 Sodium citrate, 717, 718, 732, 749 Solid-phase red cell adherence (SPRCA) for detection of HLA antibodies, 559 for detection of platelet antibodies, 533 for phenotyping red cells, 309-310 for platelet crossmatching, 528 for pretransfusion testing, 449-450 Soluble antigens ABH, 881-883 Chido/Rodgers substance, 478, 911-912 HLA, 553 Lewis, 477, 881-883 P1 substance, 477 Sda substance, 433, 477, 913-914 testing for, 881-883 Solutions additive, 188, 192, 201, 277, 651-652 anticoagulant-preservative, 188, 191, 216, 277, 827 dilution of, 872 IV, 624 phosphate buffer, 873 preparation of, 865, 869-871, 873 Solvent/detergent-treated plasma (SD plasma), 206, 264 Source Plasma, 230-231 Specific gravity, of blood cells and components, 195 Specification, defined, 33 Spills blood, 56-57
1034
chemical, 62, 82-86 radioactive, 66 Splits, 554 Spokespersons, 115 SPRCA. See Solid-phase red cell adherence SRA (serotonin release assay), 538 SSOP (sequence-specific oligonucleotide probes), 557-558 SSP (sequence-specific primer), 534, 557, 558 Staffing, 8-9, 118-120, 123 Standard operating procedures. See Procedures Standard Precautions, 50-51, 55 Standards for biosafety, 50-51 for component quality control, 217-221 for donor eligibility, 137-138, 163-178 for HPC transplantation, 691-692, 794, 838 for performance improvement, 26 for pretransfusion testing, 438 for quality management, 1- 2 for tissue transplantation, 854 Staphylococcal protein A absorption, 716 STAR (SC5), 427, 986 Statistical tables for binomial distribution, 3536 Stem cells, 840. See also HPC entries Sterile connection devices, 38, 192, 193, 211, 650 Storage of biohazardous material, 55, 57 of blood components, 272-279 biochemical changes in, 276-279, 575, 583-584 Cryoprecipitated AHF, 206, 212, 275, 278 Granulocytes, 207, 233, 274, 279, 597 Plasma, 203-204, 274-275 Platelets, 202-203, 274 Red Blood Cell components, 273-274, 575, 948 red cell antigen deterioration with, 482 Whole Blood, 198, 273 of blood samples, 442 in disaster plan, 116 equipment for, 272, 276 of hazardous chemicals, 61 of HPCs, 790-792, 808, 831-832 liquid nitrogen, 791, 832 of records, 19 temperature for, 272, 273-275, 276, 865 of tissue grafts, 857, 859-860 Storage lesion of platelets, 276, 583-584 of red cells, 276, 277, 575
STR (short tandem repeat) analysis, 352 Stromal cells, 840 Subgroups of ABO system, 365-366, 367-368 in ABO discrepancies, 370, 372 testing for, 373, 879-881, 883 Sulfhydryl reagents, 478 to alter blood group antigens, 476, 478, 912913 applications for, 478 in dispersing autoagglutination, 510, 890 to distinguish IgM from IgG, 909-911 Suppliers management of, 9-10, 12 of tissues for transplantation, 854, 855, 856, 962-963 Supplies, critical, 9-10 Surgery acidosis in, 681 blood administration in, 627 blood loss in, 674, 675, 677 blood recovery in, 674, 676-678 component sequestration in, 679 deliberate hypotension in, 679-680 drugs to assist coagulation function in, 681 hemostatic agents for, 676 normovolemic hemodilution in, 678-679 operating room take-backs, 672-673 point-of-care testing in, 681 positioning in, 680 preoperative anemia, 673-674 preoperative autologous donation for, 674 routine blood orders for, 286, 991 temperature regulation in, 680-681 transfusion benchmarks for, 672 transfusion thresholds following, 573-574 Survey meters, for radiation monitoring, 65 Survival studies of red cells, 491, 578, 735-736 Syngeneic HPC transplantation, 779, 782, 811812 Syntenic genes, 345 Syphilis, 172, 244, 248, 249, 257, 850 Syringe aliquoting devices, 283, 284, 650-651 Syringe infusion pumps, 620, 658
T
T activation, 370-371 T-cell receptors, 314 T-cell reduction (depletion), 787 T cells CD4+, 314-315 helper, 316-317 in immunity, 314-316 regulatory, 839-840
INDEX
1035
TA-GVHD. See Transfusion-associated graftvs-host disease TACO (transfusion-associated circulatory overload), 731, 746, 747-748 Tattoos, 172 Tca/Tcb/Tcc, 355, 430, 988 Telephones, in disaster plan, 112-113, 118 Temperature of antibody reactivity, 443, 476, 485-486 of collected whole blood, 198 for component storage, 272-276, 865 of donor, 161 incubation, 476, 865 monitoring systems for, 272, 276, 868 in recipients, 621 regulation of, during surgery, 680-681 during shipments, 198-199, 272, 285, 832834, 856, 868 Teratogens, 151 Terminology for blood group systems, 354-356, 357-359, 984-989 of quality systems, 32-33 for Rh system, 390-393 Test results on component labels, 216 grading, 445, 873-874 Text messaging, 113 Thalassemia, 662-663 Thawed Plasma, 204, 205, 275, 278, 593 Thawing Cryoprecipitated AHF, 280, 954-955 devices for, 38 Fresh Frozen Plasma, 279-280 Frozen RBCs, 280, 948-949, 951 HPCs, 792, 808, 834-835 Therapeutic apheresis, 707-722 adverse effects of, 718-720, 722 anticoagulation in, 717 cytapheresis, 714-715 indications for, 709-717 modalities of, 708-709 patient evaluation in, 721, 722 photopheresis, 715-716 principles of, 707-708 replacement fluids in, 593, 717-718 rheopheresis, 709 selective absorption, 716-717 therapeutic plasma exchange, 709-714 vascular access in, 720, 722 Therapeutic plasma exchange (TPE) adverse effects of, 718-720 in hemolytic disease of the fetus and newborn, 636
indications for, 709-714 instrumentation for, 708-709 volume exchange in, 708 Thermal amplitude studies, 491, 509 Thermometers, 38, 272, 965-967 Thrombin, 282, 595 Thrombin time, normal value, 982 Thrombocytopathy, 580-581 Thrombocytopenia after HPC transplantation, 693-697 drug-induced, 535-538, 587 fetal and neonatal alloimmune, 532, 639641 heparin-induced, 536-538, 588 immune, 150, 534-535, 588, 641 management of, 585 in pediatric patients, 532, 639-641, 655-656 in plasmapheresis, 720 platelet transfusions in, 579-589 posttransfusion purpura, 532-533, 733, 754756 thrombotic thrombocytopenic purpura, 588, 713, 717, 718 Thrombocytosis, 715 Thromboelastograph analysis, 592 Thrombophilia, in blood donors, 149 Thrombosis, in blood donors, 149, 197 Thrombotic thrombocytopenic purpura (TTP), 588, 713, 717, 718 Ticlopidine, 151, 184, 229 Time, incubation, 444, 476 Timers, 38 Tissue collecting, 859 infectious disease testing of, 850 processing, 850-851 quarantine of, 961-962 recall of, 859 receipt, inspection and testing of, 855-856 regulations and standards for, 91-93, 853854 standard operating procedures for, 855 storage of, 857, 859-860 suppliers of, 854, 855, 856, 962-963 traceability and records of, 857-858, 961962 transporting, 856 See also Tissue transplantation Tissue antigens. See HLA antigens Tissue banks and distributors, 853 Tissue transplantation, 849-860 ABO compatibility in, 853 adverse events in, 858-859, 961-963 antibody development after, 853
1036
of autografts, 859-860 background of, 850 clinical uses for, 851-853 disease transmission through, 853 history of, in blood donors, 168, 177 hospital-based service for, 854-855 look-back investigations in, 859 organ transplantation, 860 oversight of, 854-855 regulations and standards for, 91-93, 853854 standard operating procedures for, 855 types of grafts for, 850 Titration of antibodies, 480-481 cold agglutinins, 923 maternal antibodies, 480, 633, 935-937 methods for, 907-909, 935-937 Traceability, of tissue allografts, 857-858 Training for biosafety, 51 for chemical safety, 58-59 for disasters, 119, 122, 124-125 for electrical safety, 49 FDA cGMP and cGTP, 8 for fire safety, 48 for general safety, 45, 46 for new employees, 7-8 for radiation safety, 65 Traits, 337. See also Inheritance patterns TRALI. See Transfusion-related acute lung injury Trans position, 347 Transcription-mediated amplification (TMA), 302, 303 Transfusion-associated circulatory overload (TACO), 731, 746, 747-748 Transfusion-associated graft-vs-host disease (TA-GVHD), 733, 753-754 HLA system in, 527, 561-562 in HPC transplant patients, 700 in neonates, 647 treatment and prevention of, 526-527, 754 Transfusion-associated sepsis, 731, 736, 741 Transfusion committee, 24-25 Transfusion reactions, 727-757 acute, 737-751 biovigilance programs in monitoring, 727-728 categories of, 729-733 clinical evaluation and management of, 728, 734 delayed, 751-757 in HSCT patients, 700-701 laboratory investigation of, 734-736 recognizing, 626, 728
records of, 736 reporting, 20, 22 signs and symptoms of, 728, 729-733 Transfusion-related acute lung injury (TRALI), 730, 745-747 differential diagnosis of, 745-746, 748 HLA antibodies in, 561, 746 laboratory evaluation of, 736 neutrophil antibodies in, 540, 746 Transfusion-related immunomodulation (TRIM), 576 Transfusion thresholds in pediatric patients, 652-653 for platelet transfusions, 579-580, 655, 663, 694, 696 for red cell transfusions, 573-574, 652-653, 671-672, 692 Transfusion-transmitted diseases, 254-263 by Babesia, 260-261 bacteria, 257-259, 731, 741 chikungunya virus, 261 dengue virus, 261 hepatitis B virus, 255-256 hepatitis C virus, 256 human immunodeficiency virus, 254-255 human T-cell lymphotropic virus, 256-257 malaria, 261 parvovirus B19, 262-263 prions, 262 safety precautions for, 50-58 syphilis, 257 by Trypanosoma cruzi, 260 West Nile virus, 259 Transfusions administration procedures for. See Blood administration alternatives to, 674-679 auditing, 24-25, 672, 763-772 chimerism after, 561-562 consent for, 617-618 of Cryoprecipitated AHF, 594-595, 657-658 during disasters, 107-108 documentation of, 626 exchange, 636, 653-655 fatalities due to, 20, 739, 756, 757 of Granulocytes, 233, 595, 597, 658 and HLA system, 560-562 in HPC transplantation, 692-698, 785 intrauterine, 635-636 massive, 288, 458, 748-751 in medical history, 168, 441-442, 464, 488489, 499 non-group-specific, 288-289, 458-459 in operating room and trauma, 627
INDEX
1037
in organ transplantation, 860 out-of-hospital, 627 in pediatric patients, 645-664 of Plasma, 589-593, 656-657 of plasma derivatives, 597-603 of platelet components, 579-589, 655-656 of Red Blood Cells, 571-579, 648-655 requests for, 437-438, 455, 456, 618, 776-777 selection of components for, 447, 451-452 single-unit, 672 in urgent situations, 287-288, 457-458, 577578, 627 of Whole Blood, 575 Transmissible spongiform encephalopathy, 262 Transplantation. See Hematopoietic stem cell transplantation; Organ transplantation; Tissue transplantation Transplantation antigens. See HLA antigens Transportation of blood components, 198-199, 272, 621 containers for, 39, 272, 285, 792, 867 in disaster plan, 116 of hazardous materials, 66, 856-867 of HPCs, 792, 832-833 labeling requirements, 833, 867 monitoring temperatures during, 198-199, 272, 833-834, 856, 868 packaging with dry ice, 285, 867 of samples, 66, 865-867 of tissue, 856 Trauma, blood administration in, 627 Travel, by blood donors, 173-174, 178, 261 Treponema pallidum, 257 Trypanosoma cruzi, 260 reactive donor screening for, 248, 249, 250 screening donors for, 244, 260 Tube test for ABO group, 876 for Rh type, 885-886 Tumor cell detection, 794 Tumor purging, 787, 810-811 Two-unit red cell collection, 160, 162, 168, 228, 231-232 Type and crossmatch, 455, 456 Type and hold, 455, 456 Type and screen, 455, 456
Uniforms, 73 Urea transporter-11, 425 Urgent release of blood, 287-288, 457-458, 577-578, 627 Urine examinations of, in transfusion reactions, 735 neutralization of Sda, 433, 477, 913-914 Urticaria (hives), 729, 742-743, 744 Utilities, in disaster plan, 117-118 Utilization of blood. See Blood utilization
V
Vaccines, 47, 151, 167-168, 184 Validation of computer systems, 15 definition of, 33 of equipment, 15 of processes, 14 of shipping containers, 198-199, 272, 285 statistical tables for, 35-36 of test methods, 14 validation plans, 14-15 Vapors, hazardous, 62, 63 Variant Creutzfeldt-Jakob disease (vCJD) and plasma derivatives, 598 screening donors for, 138, 140, 173, 174, 262 Vascular access for apheresis, 720, 722 for HPC, Apheresis collection, 812 in pediatric patients, 619, 654, 658 for transfusions, 619 Vasovagal reactions, 150, 196-197, 719, 743 Vector-borne diseases, 259-261 Vel antigen, 433 Venipuncture, 161, 192-194, 940-943 Verification, defined, 33 Viability assays for HPCs, 793 View boxes, 38 Virus inactivation, 263, 264, 597-598 Viruses donor screening for, 254-257, 259, 261 transmitted by tissue transplants, 850, 858, 859 transmitted by transfusion, 254-257, 259 Viscosity, plasma, 712-713, 979 Vital signs, 621, 626 Vitamin K, 590 VLAN (KEL25), 420, 985 Volume of blood administered in intrauterine transfusions, 636 administered in neonatal transfusions, 652 in exchange transfusions, 654
U
U antigen, 412, 416 Ulcerative colitis, 717 Ulex europaeus lectin, 367, 373, 888-889 Ultrasonography, 634 Ultraviolet B irradiation, 528, 560 Umbilical cord blood. See HPC, Cord (HPC-C)
1038
normal values for, 983 in pediatric patients, 646, 983 in whole blood collections, 160, 194-195, 216 Volume of plasma, 983 Volume of red cells, 983 Volume overload. See Transfusion-associated circulatory overload Volume-reduction of platelets, 212-213, 282, 586, 656, 664, 957-958 of umbilical cord blood, 829 von Willebrand disease, 149, 594-595, 596, 657-658 von Willebrand factor (vWF), 594 VONG (KEL28), 420, 985
W
Warfarin, 152, 590, 591 Warm autoantibodies, 489-490 adsorption of, 506-507, 924-927 alloantibodies with, 504-507 disease associations with, 464 mimicking alloantibodies, 506-507 in mixed-type autoimmune hemolytic anemia, 511 in phenotyping problems, 472-473 Rh testing with, 406 transfusion with, 507-508 in warm autoimmune hemolytic anemia, 502, 503, 504-508 Warm autoimmune hemolytic anemia (WAIHA), 502, 504-509 adsorption testing in, 505-507 autoantibody specificity in, 507 blood selection in, 507-508 Warm-reactive alloantibodies, 443 Warmers, blood, 38, 619-620, 647, 658, 741, 751 Washed components, 280 HPC, Cord, 834-835 for HPC transplant patients, 700 for pediatric patients, 648, 664 Platelets, 280, 664 Red Blood Cells, 218, 273, 280, 577, 664 Rejuvenated Red Blood Cells, 213, 274 Waste management, 67 biohazardous, 57-58 chemical, 62-63 disposal, 57 radioactive, 66 treating, 57-58 Water supply, in disaster plan, 117 Waterbaths, 38 WB. See Whole Blood
Wb (GE5), 429, 987 Weak D, 396-397 in donors, 400, 451 in prenatal patients, 637 in recipients, 400, 445, 447-448 testing for, 400, 445, 447-448, 887-888 Weight, donor, 142, 194, 230 WESa/WESb, 430, 988 West Nile virus, 259 nucleic acid testing for, 246, 259 reactive donor screening for, 248, 249, 250 screening donors for, 138, 244, 259 Western blotting, 312 White cells, 979, 980 Whole Blood (WB), 201 ABO compatibility of, 447, 575-576 biochemical changes during storage, 276, 277 donation intervals for, 160, 166-167 expiration of, 273 hematocrit of, 201 indications for, 575 irradiated, 273 leukocyte content of, 577 processing, 199-200 quality control of, 217 reconstituted, 201, 281 storage of, 273 transportation of, 198-199, 285 volume collected, 160 Wipe tests, 65 Withdrawals, 93, 94 Wka (K17), 420, 989 Work environment. See Facilities Work instructions, 17 Wra/Wrb, 348, 354, 412, 426, 986 Wristbands, patient, 439 Wrong blood in tube, 450-451, 455, 740
X
X chromosome inactivation, 332-334 Xenogeneic HPC transplantation, 779 Xenografts, 850 Xg system, 426-427 antibodies in, 412, 427 genes and antigens in, 354, 426-427, 986 inheritance pattern of, 333, 341-342 XK gene, 333, 343, 355, 421
Y-Z
Yka, 355, 430-431, 988 Yt system, 354, 412, 426, 986 Zygosity, 481. See also Dosage effect ZZAP, 476, 478, 510
Glossary of Abbreviations
AATB ACD ACE ACOG ADP AET AHF AHG AHTR AIDS AIHA ALDH ALT AML AMR ANH AORN APC aPTT ARDP AS ASFA ASHI ATP BCR BLA BPD BSA BSC BSL-1 CAP CAS CBER American Association of Tissue Banks acid-citrate-dextrose angiotensin-converting enzyme American College of Obstetricians and Gynecologists adenosine diphosphate 2-aminoethylisothiouronium antihemophilic factor antihuman globulin acute hemolytic transfusion reaction acquired immune deficiency syndrome autoimmune hemolytic anemia aldehyde dehydrogenase alanine aminotransferase acute myelogenous leukemia antibody-mediated rejection acute normovolemic hemodilution Association of periOperative Registered Nurses antigen-presenting cell activated partial thromboplastin time American Rare Donor Program additive solution American Society for Apheresis American Society for Histocompatibility and Immunogenetics adenosine triphosphate B-cell receptor biologics license application biological product deviation bovine serum albumin or body surface area biological safety cabinet Biosafety Level 1 College of American Pathologists cold agglutinin syndrome Center for Biologics Evaluation and Research CCI CD CDC cDNA CDRH CFR CFU CGD cGMP cGTP cGy CI CIDP CJD CLIA CLSI CML CMS CMV CNS CP2D CPD CPDA-1 CR CREG CRYO C/T CV DAF DAT DDAVP DHQ DHTR corrected count increment clusters of differentiation Centers for Disease Control and Prevention complementary deoxyribonucleic acid Center for Devices and Radiological Health Code of Federal Regulations colony-forming unit chronic granulomatous disease current good manufacturing practice current good tissue practice centiGray confidence interval chronic inflammatory demyelinating polyneuropathy Creutzfeldt-Jakob disease Clinical Laboratory Improvement Amendments Clinical and Laboratory Standards Institute chronic myelogenous leukemia Centers for Medicare and Medicaid Services cytomegalovirus central nervous system citrate-phosphate-dextrose-dextrose citrate-phosphate-dextrose citrate-phosphate-dextrose-adenine-1 complement receptor cross-reactive group cryoprecipitate (Cryoprecipitated AHF) crossmatch/transfusion coefficient of variation decay-accelerating factor direct antiglobulin test deamino-D-arginine vasopressin donor history questionnaire delayed hemolytic transfusion reaction
DIC DMSO DNA DOT 2,3-DPG DRG DSTR DTT EACA EBAA ECMO ECV EDTA EIA ELBW ELISA EMAs EPO FACT FcR FDA FFP FMH FNAIT FNHTR FTA-ABS G-CSF GalNAc GM-CSF GMP GPIa GPA GPB GPC GPD GTP GVHD Gy HAV HAZMAT Hb HBc
disseminated intravascular coagulation dimethylsulfoxide deoxyribonucleic acid (US) Department of Transportation 2,3-diphosphoglycerate diagnosis-related group delayed serologic transfusion reaction dithiothreitol epsilon aminocaproic acid Eye Bank Association of America extracorporeal membrane oxygenation extracorporeal volume ethylenediaminetetraacetic acid enzyme immunoassay extremely low birthweight enzyme-linked immunosorbent assay emergency management agencies erythropoietin Foundation for the Accreditation of Cellular Therapy Fc gamma receptor Food and Drug Administration Fresh Frozen Plasma fetomaternal hemorrhage fetal/neonatal alloimmune thrombocytopenia febrile nonhemolytic transfusion reaction fluorescent treponemal antibody absorption test granulocyte colony-stimulating factor N-acetylgalactosamine granulocyte-macrophage colonystimulating factor good manufacturing practice glycoprotein Ia glycophorin A glycophorin B glycophorin C glycophorin D good tissue practice graft-vs-host disease Gray hepatitis A virus hazardous material hemoglobin hepatitis B core antigen
HBsAg HBV Hct HCT/Ps HCV HDFN HES HHS HIT HIV HNA HPA HPC HPC(A) HPC(C) HPC(M) HSC HSCT HTLV-I HTR HUS IAT IATA ICAM-1 ID Ig IL-1 IL-1 IL-2 IM IND INR IRL IS ISBT ISO ITP IU IV IVIG LDH
hepatitis B surface antigen hepatitis B virus hematocrit human cells, tissues, and cellular and tissue-based products hepatitis C virus hemolytic disease of the fetus and newborn hydroxyethyl starch (US) Department of Health and Human Services heparin-induced thrombocytopenia human immunodeficiency virus human neutrophil antigen human platelet antigen hematopoietic progenitor cell HPCs from apheresis (HPC, Apheresis) HPCs from cord blood (HPC, Cord Blood) HPCs from marrow (HPC, Marrow) hematopoietic stem cell hematopoietic stem cell transplantation human T-cell lymphotropic virus, type I hemolytic transfusion reaction hemolytic uremic syndrome indirect antiglobulin test International Air Transport Association intercellular adhesion molecule-1 indentification or individual donation immunoglobulin interleukin-1 alpha interleukin-1 beta interleukin-2 intramuscular investigational new drug international normalized ratio immunohematology reference laboratory immediate spin International Society of Blood Transfusion International Organization for Standardization immune thrombocytopenia international unit intravenous intravenous immune globulin lactate dehydrogenase
LDL LISS LN2 LR MAC 2-ME MF MHC MNC MoAb MPHA mRNA MSDS MSM NAIT NAN NAT NHLBI NIH NIPA NK NMDP NRC NRF OSHA p PAD PBS PCH PCR PEG PF24 PPE PRA PRCA PRP PRT PT PTP PTT PVC QA
low-density lipoprotein low-ionic-strength saline liquid nitrogen leukocyte-reduced membrane attack complex 2-mercaptoethanol mixed field major histocompatibility complex mononuclear cell monoclonal antibody mixed passive hemagglutination assay messenger ribonucleic acid material safety data sheet males who have sex with other males neonatal alloimmune thrombocytopenia neonatal alloimmune neutropenia nucleic acid testing National Heart, Lung, and Blood Institute National Institutes of Health nonimmunologic protein adsorption natural killer National Marrow Donor Program Nuclear Regulatory Commission National Response Framework Occupational Safety and Health Administration probability preoperative autologous (blood) donation phosphate-buffered saline paroxysmal cold hemoglobinuria polymerase chain reaction polyethylene glycol Plasma Frozen Within 24 Hours After Phlebotomy personal protective equipment panel-reactive antibody pure red cell aplasia platelet-rich plasma pathogen reduction technology prothrombin time or proficiency testing posttransfusion purpura partial thromboplastin time polyvinyl chloride quality assessment or quality assurance
QC QSE RBCs RFLP rFVIIa Rh RHAG RhIG RIBA RIPA RNA RPR RT SCF SD SNP SOP SPRCA TA TACO TCR TMA TNCs TNF- TPE TPO TRALI TSE TTP UCB UDP UNOS USC vCJD VLBW vWD vWF WAIHA WB WBC WHO WNV
quality control Quality System Essential Red Blood Cells (blood donor unit) restriction fragment length polymorphism recombinant Factor VIIa Rhesus factor Rh-associated glycoprotein Rh Immune Globulin recombinant immunoblot assay radioimmunoprecipitation assay ribonucleic acid rapid plasma reagin (serologic test for syphilis) room temperature or reverse transcriptase stem cell factor standard deviation or solvent/detergent single nucleotide polymorphism standard operating procedure solid-phase red cell adherence transfusion-associated transfusion-associated circulatory overload T-cell receptor transcription-mediated amplification total nucleated cells tumor necrosis factor alpha therapeutic plasma exchange thrombopoietin transfusion-related acute lung injury transmissible spongiform encephalopathy thrombotic thrombocytopenic purpura umbilical cord blood uridine diphosphate United Network for Organ Sharing United States Code variant Creutzfeldt-Jakob disease very low birthweight von Willebrand disease von Willebrand factor warm autoimmune hemolytic anemia whole blood or Western blot white blood cell World Health Organization West Nile virus

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Technical Manual

John D. Roback, MD, PhD Emory University Hospital Atlanta, GA

Technical Manual Authors

Quality Management Systems: Theory and Practice . . . . . . . . . . 1

Facilities, Work Environment, and Safety. . . . . . . . . . . . . . . . . . . 41

AABB TECHNICAL MANUAL

Regulatory Issues in Blood Banking . . . . . . . . . . . . . . . . . . . . . . . . 87

Disaster Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

COL LEC TION

Allogeneic and Autologous Blood Donor Selection . . . . . . . . . 137

Blood Component Collection by Apheresis . . . . . . . . . . . . . . . . 227

Infectious Disease Screening. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 239

AABB TECHNICAL MANUAL

Storage, Monitoring, Pretransfusion Processing, and Distribution of Blood Components . . . . . . . . . . . . . . . . . . . . . 271

Molecular Biology and Immunology in Transfusion Medicine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

Blood Group Genetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327

The Rh System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389

404 404 405 405

Other Blood Groups. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 411

Pretransfusion Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 437

AABB TECHNICAL MANUAL

Identification of Antibodies to Red Cell Antigens . . . . . . . . . . . 463

The Positive Direct Antiglobulin Test and ImmuneMediated Hemolysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 497

Platelet and Granulocyte Antigens and Antibodies . . . . . . . . . 523

The HLA System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 547

CL INIC AL CONS IDE RA TION S TRA NS FU SION P RAC TIC E

Hemotherapy Decisions and Their Outcomes . . . . . . . . . . . . . 571

Administration of Blood Components . . . . . . . . . . . . . . . . . . . . 617

Perinatal Issues in Transfusion Practice . . . . . . . . . . . . . . . . . . . 631

Neonatal and Pediatric Transfusion Practice . . . . . . . . . . . . . . 645

Patient Blood Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 671

AABB TECHNICAL MANUAL

Transfusion Support for Hematopoietic Stem Cell Transplant Recipients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 687

Therapeutic Apheresis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 707

Noninfectious Complications of Blood Transfusion . . . . . . . . 727

Approaches to Blood Utilization Auditing . . . . . . . . . . . . . . . . . 763

Collecting and Processing Marrow Products for Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 779

Hematopoietic Progenitor Cells Collected by Apheresis. . . . . 801

Umbilical Cord Blood . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 823

AABB TECHNICAL MANUAL

Human Tissue Allografts and the Hospital Transfusion Service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 849

Methods Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 863 1. General Laboratory Methods. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 865

Red Cell Typing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 875

Antibody Detection, Identification, and Compatibility Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 897

AABB TECHNICAL MANUAL

Investigation of a Positive DAT . . . . . . . . . . . . . . . . . . . . . . . . . . . 917

Hemolytic Disease of the Fetus and Newborn. . . . . . . . . . . . . . 933

Blood Collection, Component Preparation, and Storage . . . . 939

953 954 955 957

Transplantation of Cells and Tissue. . . . . . . . . . . . . . . . . . . . . . . 959

Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 965

979 980 982 982 983 984

989 989 990 991 992 994

AABB TECHNICAL MANUAL

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AABB TECHNICAL MANUAL

AABB TECHNICAL MANUAL

AABB TECHNICAL MANUAL

AABB TECHNICAL MANUAL

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AABB TECHNICAL MANUAL