QQUUAALLIITTYY AASSSSUURRAANNCCEE IINN BBLLOOOODD BBAANNKKIINNGG AANNDD IITTSS CCLLIINNIICCAALL IIMMPPAACCTT DEVELOPMENTS IN HEMATOLOGY AND IMMUNOLOGY Already published in this series: Lijnen, H.R., Collen, D. and Verstraete, M., eds: Synthetic Substrates in Clinical Blood Coagulation Assays. 1980. ISBN 90-247-2409-0 Smit Sibinga, C.Th., Das, P.C. and Farfar, J.O., eds: Paediatrics and Blood Transfusion. 1982. ISBN 90-247-2619-0 Fabris, N., ed: Immunology and Ageing. 1982. ISBN 90-247-2640-9 Homstra, G.: Dietary Fats, Prostanoids and Arterial Thrombosis. 1982. ISBN 90-247-2667-0 Smit Sibinga, C.Th., Das, P.C. and Loghem, van J.J., eds: Blood Transfusion and Prob lems of Bleeding. 1982. ISBN 90-247-3058-9 Dormandy, J., ed: Red Cell Deformability and Filterability. 1983. ISBN 0-89838-578-4 Quality Assurance in Blood Banking and Its Clinical Impact Proceedings of the Seventh Annual Symposium on Blood Transfusion, Groningen 1982, organized by the Red Cross Blood Bank Groningen-Drenthe edited by C Th Smit Sibinga, P C Das Red Cross Blood Bank Groningen-Drenthe, The Netherlands H F Taswell Mayo Clinic Blood Bank, Rochester MN, USA 1984 MARTINUS NIJHOFF PUBLISHERS a member of the KLUWER ACADEMIC PUBLISHERS GROUP BOSTON / THE HAGUE / DORDRECHT / LANCASTER Distributors for the United States and Canada: Kluwer Boston, Inc., 190 Old Derby Street, Hingham, MA 02043, USA for all other countries: Kluwer Academic Publishers Group, Distribution Center, P.O.Box 322, 3300 AH Dordrecht, The Netherlands Library of Congress Cataloging in Publication Data Symposium on Blood Transfusion (7th : 1982 : Groningen, Netherlands) Quality assurance in blood banking and its clinical impact. (Developments in hematology and immunology) 1. Blood-banks--Quality control--Congresses. 2. Blood --Transfusion--Safety measures--Congresses. I. Smit Sibinga, C. Th. II. Das, P. C. III. Taswell, Howard F. IV. Stichting Rode Kruis Bloedbank GroningenjDrente. V. Title. VI. Series. RM172.S96 1982 362.1'784 83-23665 ISBN-13: 978-1-4612-9791-8 e-ISBN-13: 978-1-4613-2835-3 DOl: 10.1007/978-1-4613-2835-3 Copyright --- © 1984 by Martinus Nijhoff Publishers, Boston. Softcover reprint of the hardcover 1s t edition 1984 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, mechanical, photocopying, recording, or otherwise, without the prior written permission of the publishers, Martinus Nijhoff Publishers, 190 Old Derby Street, Hingham, MA 02043, USA. m TRAVENOL Acknowledgement This publication has been made possible through the support of Travenol, which is gratefully acknowledged. VII CONTENTS Invited speakers IX Foreword XI Opening address XV 1. Principles and organization of quality assurance International organization of quality assurance (J. Leikola) 3 A national framework of bloodtransfusion organization (J . W. Dorpema) 7 Bloodtransfusion practice in hospitals: A topic for quality assurance (A.F. Gasparie) 13 Discussion 21 II. Systems and procedures Principles and practices of quality control (F. Bonanni) 29 Blood bank standards and procedure manuals (P.J. Schmidt) 43 Administrative procedures and a machine-readable system to assure quality control within a blood bank (2. Smit, H. Smalbil, G.Th. Smit Sibinga) 55 Quality assurance of serological reagents (W.L. Marsh) 69 Quality control of equipment (R.E. Klein) 77 Quality control of blood components (C.Th. Smit Sibinga) 83 VIII Immunoglobulin production: Organization and quality control of source material (R.J. Crawford) 89 Bacterial surveyance in a blood bank (P.C. Das, C.Th. Smit Sibinga, J. Dankert) 95 Discussion 103 III. Personnel Job descriptions, competency testing and selection of personnel (H. v.d. Meulen) 115 Training programs for blood bank personnel (B. A. Myhre) 121 Continuous education in blood banking and bloodtrans fusion practice (S.R. Hollan) 129 Discussion l37 IV. Clinical efficacy Transfusion practice: Aspects of safety related to clinical efficacy (H. de Beus, C. Th. Smit Sibinga) 147 Transfusion reactions (K. Sintnicolaas) 157 Transmittable diseases and bloodt ransfusion (H. W. Reesink) 167 Platelet transfusion: Quality control (Ch.A. Schiffer) 177 Clinical efficacy and safety of Factor VIII concentrate (J-P. Allain) 187 The use of indium-labeled granulocytes to help assess the clinical efficacy of granulocyte transfusions (M. Clay, J.F. McCullough) 195 Discussion 213 V. Error Analysis Error analysis: Types of errors in the blood bank (H.F. Taswell, C.L. Sonnenberg) 227 Error analysis: Methods of detection, analysis and control (C.L. Sonnenberg, H.F. Taswell) 239 Discussion 247 IX INVITED SPEAKERS J-P. Allain - Centre National de Transfusion Sanguine, Paris, France H. de Beus - Wilhelmina Hospital, Assen, The Nether lands F. Bonanni - Travenol International Services Inc. , Brussels, Belgium A. F. Casparie - Weezenlanden Hospital, Zwolle, The Nether lands M. Clay - American Red Cross Blood Services, St. Paul, MN, USA R.J. Crawford - Glascow and West of Scotland Blood Trans fusion Service, Glasgow, UK P.C. Das - Red Cross Blood Bank Groningen-Drenthe, (moderator) Groningen, The Netherlands J.A. van der Does - Red Cross Blood Bank's Gravenhage, (moderator) The Netherlands J . W. Dorpema - State Control Laboratory, National Institute (moderator) of Health, Bilthoven, The Netherlands M.R. Halie - Dept. of International Medicine, University ( moderator) of Groningen, Groningen, The Netherlands A . M. Holburn - Blood Group Reference Laboratory, Oxford, (on behalf of WHO) UK S.R. Holan - National Institute of Haematology and Blood Transfusion, Budapest, Hungary R.E. Klein - National Committee on I & A, AABB, Arling (moderator) ton, VA, USA J. Leikola - League of Red Cross Societies, Geneva, Switzerland W.L. Marsh - The New York Blood Center, New York, NY, USA x H. van der Meulen - University of Groningen, Groningen, The Netherlands B.A. Myhre - University of California, Los Angeles, CA, (moderator) USA H . W. Reesink - Amsterdam Medical Centre, Amsterdam, The Netherlands Ch. A. Shiffer - University of Maryland Cancer Center, (moderator) Baltimore, MD, USA P.J. Schmidt - Southwest Florida Blood Bank, Tampa, FL, USA K. Sintnicolaas - Daniel den Hoed Clinic, Rotterdam, The Netherlands Z. Smit - Red Cross Blood Bank Groningen-Drenthe, Groningen, The Netherlands C.Th. Smit Sibinga - Red Cross Blood Bank Groningen-Drenthe, (moderator) Groningen, The Netherlands Ch.L. Sonnenberg - Mayo Clinic Blood Bank, Rochester, MN, (moderator) USA H. F. Taswell - Mayo Clinic Blood Bank, Rochester, MN, (chairman) USA XI FOREWORD THE PHILOSOPHY OF QUALITY ASSURANCE IN THE BLOOD BANK H. F. Taswell One year before this symposium, Cees Smit Sibinga and I began to discuss an approach to quality assurance in the blood bank which we felt would be both important and practical and could serve as the basis for the choice of subjects to be presented in the symposium. As an introduction to this book, I would like to outline our approach, the subjects chosen and the rationale behind our choice. What is the fundamental purpose of a blood bank and trans fusion service? Simply stated, the purpose of a blood bank and transfusion service and of a quality assurance program in blood banking is, for the one to provide and, the other to assure safe and effective transfusion therapy. This objective is in contrast to that of other clinical laboratories. The objective in a clinical chemistry laboratory is to produce accurate test results which will be meaningful to the clinician taking care of his patient. In most clinical laboratories, therefore, the goals of a quality assurance program are largely quantitative, that is, to assure accurate numerical test results. In contrast, in the blood bank, the goals of quality assurance are primarily qualitative, that is, to assure safe and effective transfusion. As a result, two somewhat different approaches to quality assurance are necessary. How are we to assure quality in the blood bank? Safe and effective transfusion can be achieved to a large degree by preven tion of error. Blood bank procedures are repetitive and relatively simple and straight forward. Since the morbidity and mortality associated with transfusion arises primarily from errors, one of the primary goals of quality assurance in the blood bank should be the prevention of errors. What is an error? An error can be defined for the purpose of this introduction as an "inadvertent or unauthorized deviation from standard procedure". If one accepts that errors are the primary cause of transfusion morbidity and mortality and that an error is a deviation from standard procedure, then the necessary elements of a quality assurance program in the blood bank are readily apparent. These same elements will provide both a means of error control and an efficient management system. What are the necessary elements? The first and most important element needed for a quality assurance program is a standardized