This book is the only published literature that comprehensively discusses all aspects of transfusion of transmissible diseases, the facts and the fiction. It is of paramount importance to all involved in the vein to vein chain of transfusion medicine.

Session I addresses the basic blood safety aspects including the need for quality management, rational donor screening and the risks of blood transfusion for prenatal developmental toxicity.

Session II addresses the gamma of transmissible infectious agents from bacteria through parasites and tick-borne agents to prions and the risks associated with xeno-transplantation and xenozoonoses

Session III sheds new light on NAT technology for detection of viral DNA and RNA, the cost-effectiveness of the alternatives to allogeneic blood transfusion. To what extent are genetic defects in stem cell genomic structures transmissible through transplantation and does questioning potential donors make any sense?

Session IV addresses the preventive aspects on the future of transfusion medicine. Quantitative real-time PCR for Parvo B19 and advances in bacterial detection technology. The advancement from theory to practice of pathogen inactivation technology based on destruction of nucleic acids in cellular structures. Finally, a plea is made for co-operation and collaboration on a global scale, changing the pars pro toto phenomenon (the ships that pass in the night) for a totum pro parte, a true joining of forces to create a global network for blood safety and structured blood supply systems.

Transmissible Diseases and Blood Transfusion is an important reference for all hematologists and researchers involved in transfusion medicine.

th It is a great pleasure for me to open the jubilee 25 International Symposium on Blood Transfusion here in Groningen. This symposium is co-sponsored by the World Health Organization and is being held under the auspices of the ISBT and the Secretary General of the Council of Europe, Mr Walter Schwimmer. The patronage was granted with great pleasure for several reasons. First of all, Dutch experts are very active in our Committees and have largely contributed in developing the Council of Europe principles in the blood area. Secondly, the Council of Europe is active today in the area of blood transfusion due to a tragic event, which occurred in 1953 in the Netherlands; following a flooding many of the blood products given for assistance' could not be used due to incompatibilities and differences in labelling. Some words to present the Council of Europe since the organisation is sometimes confused with institutions ofthe European Union: The organisation has been founded in 1949 to establish the principles of democracy and rule of law all over Europe. Since 1989, the year of the fall of the Berlin wall and the opening up of the iron curtain, these principles could be extended to the countries of Central and Eastern Europe. Today this makes the Council of Europe the only pan-European organisation with 41 Member States thus representing more than 750 million people.

380 years ago, in the year 1614, Ubbo Emmius transplanted the gene ofscience from Ostfriesland into the education genome ofthe city ofGroningen as devel oped by Regnerus Praedinius. He thereby founded the University ofGroningen. It is with great pleasure that the Faculty of Medicine as one of the founding faculties ofour University, welcomes you to this 19th International Symposium ofBloodTransfusion, whichwill coverthe themeofHereditaryDiseasesandtheir relation to Transfusion Medicine, where cell expansion, gene transfer and gene therapy are the read thread. Since the earlydays there has beena specificand sincere interest in inborn errors ofmetabolism and hereditarydisorders. This interest has resulted in a structured research, diagnostic and counselling facilities, and therapeuticapproaches where various disciplines within our faculty work closely together with groups from related faculties of the University of Groningen, as well as other national and international scientific institutions. The field of inborn errors, genetic abnormalities and mutations, and hereditary diseases covers a broad gamma of extremely interesting and exciting scientific aspects, whichrangefrom clearphysicalaberrationstomolecularanalysisofgenes and genomes, coding areas and amino acid sequences. It is intriguing to realise that the balance of life seemingly depends on the position or presence of one single molecule as a part ofthe total complex ofgenetic information in the cell."

Cytokines are cellular growth factors which also provide communication between cells and their milieu. This clearly is an exciting area in modern medicine that will have significant impact on various facets of transfusion. Erythropoietin therapy stimulates red cell production while thrombopoietin seems to positively affect megakaryopoiesis and can be an added armamentarium for the thrombocytopenic patient. Using haematnopoietic growth factors, stem cells could be mobilized early to the peripheral blood for collection and subsequent transplantation into haemato-oncology patients instead of bone marrow transplantation. Using a cocktail of cytokines in cell culture, stem cells could be expanded and selected for therapy. Cytokines and growth factors can even be modified, which may lead to successful gene therapy in malignancies, including solid tumour vaccines. However, the presence of cytokines in certain blood products could have biological effects following transfusion, although its clinical relevance needs to be ascertained. There is much potential for the use of cytokines in the treatment of infections. Early diagnostic methods are now available to monitor their levels and relevance. It is likely that cytokines will increasingly play a role in therapy and could develop our fundamental knowledge about the development of T-cells. An ethical dilemma remains, however, regarding the use of cytokines in healthy donors for harvesting suitable specific cells. Longer clinical observation will be necessary to gather the necessary information. Cytokines and growth factors in blood transfusion was the theme of the 21st International Symposium in Blood Transfusion, where twenty clinicians and scientists, experts in their own fields, were invited to update the above information. Their findings are presented in four sections in this volume: Fundamental aspects - cytokines in development of T-cells, growth factors in haematopoiesis, growth factor receptors and signal transduction, cytokine response in platelet and whole blood transfusions. Function, production and diagnosis &endash; laboratory diagnostics of cytokines and growth factors, cytokines in blood components, cytokines and growth factors in cell expansions, cytokines for genetic modification towards gene therapy, progenitor cells from healthy donors. Application in clinical medicine &endash; clinical relevance of cytokines in transfusion products, cytokines and growth factors in solid tumours, gene therapy in malignancies, vaccine strategies inducing T-cell immunity against tumours, cytokines in the treatment of infections, thrombopoietin and megakaryopoiesis. Future potential use in transfusion medicine &endash; erythropoietin, immunotherapy, ethical aspects of the use of cytokines and growth factors in donors, potential of cytokines and growth factors in transfusion medicine.

With this symposium the Red Cross Blood Bank Groningen-Drenthe affirms its well known reputation as an organizer of symposia of high standard and quality. Several important aspects of bloodbanking have been discussed in the past. The Blood Bank here is a specialist in its own field. Administrative processes in respect of the donor, information processes, the preparation of the blood and the laboratory process are automatized. New developments in these fields are undeway that you will certainly identify and investigate. I do hope that you will come to conclusions from which we can learn and get better results. As general manager of the Development and Investments Company for the Northern Netherlands - NOM - for several reasons I am very much interested in the outcome of this symposium. In the first place I am proud that the Red Cross Blood Bank Groningen Drenthe is doing its utmost to be excellent in regard of research, education and bloodprocessing. In being so, the Blood Bank can produce spinn-offs for healthservices and the related industry."

In transfusion medicine the scientific fundamentals of immunology have had a considerable clinical impact. Transfusion may suppress the immunity but some patients could suffer disadvantages including GvHD, alloimmunisation and possible cancer, where white cells (WBC) play pivotal roles in this phenomenon, presenting antigens and producing cytokines. A clinical application of this practice is LAK-cells targeted against cancer. MHC on the WBC may provide additional immunological modulations through series of secondary messengers. Thus reduction of WBC in the blood and bone marrow may be advantageous for patients. On the other hand, sharing a part of MHC or making the transplanted white cells anergic by storage may be even more advantageous for patients. CMV infection could mimic part of this MHC. UV radiation is effective in the inactivation of the WBC although filters are easy means for such removal. However, their accurate quantification requires flow cytometry that has considerable potential application in blood transfusions. Idiotypic antibody could play an important role in platelet theory. However, the potential infection risks in transfusion like HIV and HCV remain, but application of molecular biological methods like PCR or RT/PCR has great potentials in detection of infectious diseases, transplantation and genetic disorders. Immuno affinity purified concentrates, like factor IX and protein C, could reduce patients' immune functions, where in the future protein C could be derived from transgenic animals. Advances are sure to emerge through adoptive immunotherapy and gene therapies are exciting prospects when genes transferred into lymphocytes could be used to correct cell mediated immune deficiency, as in ADA.

As a clinical discipline blood transfusion encompasses enormous vista, vary ing from biotechnology to molecular biology, from plasma products, cell biology and growth factors to interleukines. Growth of knowledge in this field has been rapid, and expertise is now required to be mastered and renewed in translating these ideas for patient care. Various types of cells could be harvested - progenitor stem cells derived from bone marrow or from circulating blood as a source for transplants; in the hemostatic armoury platelets could be used prophylactically; granulocytes and mononuclear cells are available for treatment of infections or immune modulations. However, their therapeutic use carries potential complications including graft versus host disease and CMV-infection. Prevention of such complications by irradiation and by removal of immunocompetent leukocytes are important issues. Thus, production of such therapeutic materials ought to address the issues at the earliest, to eliminate those problems while adhering to the con cept of high quality; the impact of storing platelets for longer periods by using improved plastic containers or storing almost indefinitely in frozen state should be explored. Rapid progress in cell culture techniques and bio technology have enriched the transfusion medicine armoury with lympho kines, interferons and cell colony growth factors which have great potentials for enhancement of basic knowledge as well as considerable therapeutic applications in patients."

This book is composed of four major sections: The perception of risk, where authorities from the field of environmental psychology and risk analysis describe the backgrounds and mechanisms of cognitive behavior and the effects of emotional and publicity factors on perception and acceptance of risk. The management of infection-defined risk, the core of public and political anxiety. Here the book illustrates how safe the current blood supply has become over the past decade in at least the majority of industrialized countries in the world. The management of immune-defined risks has been the Cinderella of blood transfusion and transfusion medicine up till now. Risk management in clinical practice: optimal versus maximal is the section where the real virtue of reality comes to life through valuable contributors by authors from the field of clinical blood banking, heavily involved consumers organizations (WFH), the Cochrane Institute of Medical Sciences and National Health Services Center for reviews and dissemination, and international policy makers and regulative bodies like the Council of Europe and the European Commission. When the reader is first confronted with a poem illustrating the reality of virtue, written by one of the editors noted for his talent in anecdotal medical poetry, the scene is set for the virtue of reality in the management of risk in blood transfusion.

Transfusion medicine is an excellent way for the healthy community to help the sick. However, service providers and patients have much to gain from the establishment of guidelines concerning when and how it is used. An important first step would be to introduce informed consent for transfusion recipients. Discussions with blood banks and assessment of clinical demand would also be necessary, taking into account the needs of patients and physicians, and the availability of products. Unfortunately, the efficacy and safety of transfusion products can be difficult to ascertain. Furthermore, although major advances have been made in safety, the risks of giving and receiving blood are still seen as high. It is vital to learn what underlies that perception and how to counter it. The policies and protocols used to establish surgical criteria for blood transfusions should be explored. Finally, clinical audits can help evaluate the risk: benefit ratio of transfusion; they may be carried out by hospital transfusion committees but are likely to be more successful with the support of national and international legislative and regulatory bodies. The implementation of appropriate initiatives now will improve the outlook for the future of transfusion medicine, perhaps with ex-vivo expanded haemopoietic cell therapy as the next milestone. All these key points and controversies are explored in this book, which paints a broad picture of the current status and future trends in transfusion medicine.

The international symposia on blood transfusion in Groningen have taken place without interruption since 1976. Each year Dr. Smit-Sibinga and his team have not only organized a meeting on timely topics in blood transfusion, but also succeeded in attracting prominent chairmen and speakers. The subject of the 24th Symposium was Molecular Biology in Blood Transfusion and it was chaired by Dr. Harvey G. Klein, National Institutes of Health, USA. In this book of proceedings an extraordinary range of subjects is covered, including diagnostic aspects, virology, quality control, cell and protein processing as well as a section on new horizons in clinical medicine.

The provocative title stems from the recent International Blood Transfusion Symposium in Groningen, The Netherlands held under the auspicies of the World Health Organization (WHO), International Society of Blood Transfusion (ISBT) and Council of Europe (CoE). Transfusion medicine is a new discipline which has a wide remit. As defined recently, transfusion medicine deals with that part of the healthcare system which undertakes appropriate provision and use of human blood resources; transfusion practice is therefore a collective activity linking the blood donor with the patient. Transfusion medicine occupies areas in which it is deemed to be important or even essential that medical practitioners contribute to this bridging process. The broad issues and complex practices are presented in the masterly Introduction by the WHO's Assistant Director General with emphasis on education and multidisciplinary facets involving transfusion medicine. The challenging subjects are dealt in great details with a wealth of personal experience by 24 experts from the U.K., France, The Netherlands, U.S.A., Australia, Germany, Sweden, WHO and the Council of Europe. This is a comprehensive yet concise state of the art presentation involving donor and delivery system, ethics and legal elements, effects of modern techniques, importance of management and the future directions in this new economic environment. The book has been divided into four sections which discuss both the facts and the fiction.

With great pleasure I welcome you to the City of Groningen. In more than one way there is cause for celebration. Today marks the third lustrum of the annual international sympo sium on blood transfusion, organized by the Rode Kruis Bloedbank Groningen-Drenthe. In my opinion it has been a remarkable initiative of the Bloedbank, to start organizing a scientific conference, as it did, in 1976. It meant, among others, that in case of success the initiative would grow to be an annual item on the international congress calen der. It also meant that a possible third lustrum would coincide with the celebration of the 950th anniversary of the City of Groningen. I am happy to note that the initiative has been successful: over the past fourteen years the Rode Kruis Bloedbank Groningen-Drenthe has succeeded in organizing an annual symposium on blood transfusion, with a different theme each year, and with an average attendance of 250 participants from some 26 countries world-wide. The platform created with the special formula of the symposium, for science and industry, has been well balanced and beneficial to both. Mr. Chairman, ladies and gentlemen, I like to compliment the organizers with the success that they have attained. Allow me to men tion the name of just one person, in whom I like to thank everyone who has been involved in creating the annual Bloedbank-symposia: my warm congratulations to Dr. Smit Sibinga and his staff."

Proceedings of the Tenth Annual Symposium on Blood Transfusion, Groningen 1985, organized by the Red Cross Blood Bank Groningen-Drenthe

Welcome to the City of Groningen, the center of the North of the Netherlands. Groningen is proud of the long lasting tradition of scientific symposia organised by the Sanquin Blood Bank. These Sanquin International Symposia on Blood Transfusion have become a true traditional event in Groningen, marking the early academic year and have contributed to the specific reputation of Groningen and its University in the scientific field of Transfusion Medicine. The growing tradition has also contributed to initiatives of both University, Province and the City of Groningen to bring science and industry together - BioMedCity Groningen. Such repu- tion does not just happen, but is the result of creative and scientific leadership, of vision and an open mind, to explore in a team spirit horizons. Groningen is particularly proud of this reputation thanks to its leadership, the Sanquin Blood Bank North-East. This year in particular the theme chosen some two years ago is extremely timely as it illustrates the activities and scientific interest of an integrated team which includes our regional Sanquin Blood Bank North-East and fits in the City initiatives within the concept of BioMedCity, Groningen.

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."

The practice of transfusing blood started at the bedside but over the last few decades blood transfusion has become more and more a laboratory directed discipline. The emphasis on serology and laboratory controlled measures has made blood transfusion safer and more effective, but laboratory and clinical aspects of the discipline have tended to become increasingly separated. As a result of this separation clinical developments in blood transfusion may not have derived full benefit from the knowledge accrued in blood transfusion services. Over the last five years the Red Cross Blood Bank Groningen-Drenthe has organised yearly symposia with a clinical theme in order to bring blood banks and clinicians closer together. Many of the recent major advances in clinical medicine have been based on developments in blood transfusion practice. This is certainly true for paediatric medicine. For instance, in paediatric oncology, including leukemia, cell separator programmes have made available new forms of support. Further, blood component therapy has provided an effective means of control in some of the bleeding disorders of children. Some of these topics are discussed in this symposium dealing with intensive care. Haemolytic disease of the newborn and exchange transfusion are other aspec.ts of intensive care. Our purpose in dealing with them was twofold.

The first International Meeting on Apheresis was held in Dyon in 1984. At the congress it became clear that both the technical and therapeutic sides developed very rapidly and it appeared fruitful to bring together the investigators of the different countries working in the areas. At that time immunology had come to pervade many clinical specialities, and hemapheresis, especially plasmapheresis was considered a therapeutic tool in many immunological diseases which hitherto had proved to be fatal. New methods to identify certain antibodies and circulating immune complexes in the serum and the possibilities to remove them from the blood by several techniques (filtration, centrifugation, immunoabsorp tion) led to an almost uncontrolled use of plasma exchange in a variety of diseases. Since then the technical possibilities of this technique were further recognized, as was the impact of immunology on many diseases, and the possibilities to collect specific components for therapeutic pur poses. But also we became aware of the limited contributions of anec dotal data on successes or failures of apheresis as adjuvant treatment. Therefore international prospective studies were initiated to make critical assessment possible of apheresis in various diseases."

Transfusion medicine provides an excellent bridge connecting the healthy community donors with the patient's needs at the bedside; the dominant philosophy has been on patient care and science, but it is now realised that blood banks manufacture increasing amounts of blood components to administer to patients -- a role analogous to manufacturing functions. The concept of Good Manufacturing Practice (GMP) is therefore relatively new. While quality has always been important, the impact of GMP, Total Quality Management (TQM) and Quality Assurance (QA) will be profound. As the regulatory agencies, like the FDA in the U.S.A. and the EEC Commission in Europe, increase their enforcement activities, doctors, technical experts and managers will have to face many issues of quality assurance including documentation, validation, audit system, regulatory laws, licensing, teaching and training of staff and their job descriptions, standards, processing facilities, procedure validations, automation, record keeping, internal and external quality control of products and their release. The expansion of this philosophy to include Good Clinical Practice (GCP) is an even greater challenge demanding consensus therapy protocols and quality management of transfusion through auditing by the hospital transfusion committees. Such comprehensive plans will profoundly affect the financial and organisational structure of blood transfusion in the future.

The theme of this 14th International Symposium on Blood Transfusion is closely related to the work and scientific contributions of the Dutch cryobiology pioneer Dr. Herman W. Krijnen of the Dutch Red Cross Central Laboratory. Dr. Krijnen was known and respected in the national and interna tional blood transfusion community as an extremely competent scientist and a beloved and admired colleague. Dr. Krijnen was intentionally honoured with the invitation to open this symposium on cryopreservation and low temperature biology in blood transfusion and be the guest of honour at this event. Unfortunately, Dr. Krijnen suddenly died on the first of June 1989. In honour and mem ory of Dr. Krijnen this symposium will therefore be dedicated to him. Since the lOth International Symposium on Blood Transfusion in 1985 highlighted the theme of "Future developments in blood banking," major changes have occurred in the blood banking world. Most of these changes were forced upon the Blood Banks by the fear of spreading AIDS through contaminated donations. This not only led to the wide spread testing of blood, but also to a more appropriate counselling of the community and the blood donors in specific. Additionally, virus inacti vation techniques were introduced for those components derived from multiple donations and intended for a regular transfusion in haemophi lia patients and others."

Currently blood is a volatile issue. The safety of blood and the quantification of transfusion risks have been dominant themes that have stimulated the development of alternative approaches in this rapidly developing area. In clinical medicine conventional blood and its components are used in supportive therapies dependent on the choice of apparent uncritical trigger factors. A compounding factor is depth of prospective clinical trials for evidence. Such trials in critical care areas would be of enormous value, not only in recording adverse effects and under-transfusion, but also indicating the value of decision analysis and cost-effectiveness in transfusion practice. Alternative approaches include the use of cytokines, growth factors, humanised monoclonal antibodies, recombinant plasma factors, and buffy coat derived natural human interferons. These are being increasingly implemented in the clinic. Solutions for oxygen transport are being developed and fibrinogen coated microcapsules are being investigated for thrombocytopenia. In surgical patients, various crystalloid and colloid combinations are explored as volume replacements. To avoid allogeneic transfusions, beneficial blood saving methods include various strategies, such as autologous deposits, normovolemic haemodilution and various agents including aprotinin, tranecamic acid, desmopressin and erythropoietin, but their use in hospital shows considerable variations. That umbilical cord blood could be a significant source of allogeneic stem cells in related and unrelated transplantation is illustrated by the increasing number of cord blood banks in Europe and elsewhere. Future blood resources are likely to face several challenges: immediate challenges relate to increased regulatory and political oversights; intermediate solutions would offer some improvements in public health and alleviate public fear but probably not address the economic challenges thrust upon the medical care system. As we approach the year 2000, the major concerns about transfusion medicine remain its logistics, safety and effectiveness. This theme is presented in the proceedings of the 22nd International Symposium on Blood Transfusion, developed in 21 up-to-date topics, collected and discussed in four sections. This book will be of timely value to students, professionals and all others interested or involved in the field of transfusion medicine, whether clinical or related.

This symposium is devoted to Biotechnology in Blood Transfusion; there are 22 experts discussing the state of the art in the application of monoclonal anti bodies, recombinant DNA technologies and heterologous expression systems to the improvement and sometimes replacement of blood products, charac terization of blood constituents, and the effect of these developments on blood transfusion procedures. Ten and maybe five years ago the title of a symposium such as this would have been Biosciences in blood transfusion, informing what basic developments in molecular biology, biochemistry and human physiology might pertain to blood transfusion in the distant future. That future is getting closer, and not only one is interested in basic developments in immunology, recognition and identification of viral and bacterial components and products, tissue and blood bloodgroup blood group typing, typing, but also in the potential application of these developments and their economic perspectives. That is what biotechnology is all alI about: basic science telIs tells us where and how we might look for new technologies, and the development of such tech nologies is only possible if there is a perspective for improvement in quality, safety, acceptance or performance to cost ratio."

Proceedings of the Eighth Annual Symposium on Blood Transfusion, Groningen 1983, organized by the Red Cross Blood Bank Groningen-Drenthe

th It is a great pleasure for me to open the jubilee 25 International Symposium on Blood Transfusion here in Groningen. This symposium is co-sponsored by the World Health Organization and is being held under the auspices of the ISBT and the Secretary General of the Council of Europe, Mr Walter Schwimmer. The patronage was granted with great pleasure for several reasons. First of all, Dutch experts are very active in our Committees and have largely contributed in developing the Council of Europe principles in the blood area. Secondly, the Council of Europe is active today in the area of blood transfusion due to a tragic event, which occurred in 1953 in the Netherlands; following a flooding many of the blood products given for assistance' could not be used due to incompatibilities and differences in labelling. Some words to present the Council of Europe since the organisation is sometimes confused with institutions ofthe European Union: The organisation has been founded in 1949 to establish the principles of democracy and rule of law all over Europe. Since 1989, the year of the fall of the Berlin wall and the opening up of the iron curtain, these principles could be extended to the countries of Central and Eastern Europe. Today this makes the Council of Europe the only pan-European organisation with 41 Member States thus representing more than 750 million people.

The provocative title stems from the recent International Blood Transfusion Symposium in Groningen, The Netherlands held under the auspicies of the World Health Organization (WHO), International Society of Blood Transfusion (ISBT) and Council of Europe (CoE). Transfusion medicine is a new discipline which has a wide remit. As defined recently, transfusion medicine deals with that part of the healthcare system which undertakes appropriate provision and use of human blood resources; transfusion practice is therefore a collective activity linking the blood donor with the patient. Transfusion medicine occupies areas in which it is deemed to be important or even essential that medical practitioners contribute to this bridging process. The broad issues and complex practices are presented in the masterly Introduction by the WHO's Assistant Director General with emphasis on education and multidisciplinary facets involving transfusion medicine. The challenging subjects are dealt in great details with a wealth of personal experience by 24 experts from the U.K., France, The Netherlands, U.S.A., Australia, Germany, Sweden, WHO and the Council of Europe.This is a comprehensive yet concise state of the art presentation involving donor and delivery system, ethics and legal elements, effects of modern techniques, importance of management and the future directions in this new economic environment. The book has been divided into four sections which discuss both the facts and the fiction.

Transfusion medicine provides an excellent bridge connecting the healthy community donors with the patient's needs at the bedside; the dominant philosophy has been on patient care and science, but it is now realised that blood banks manufacture increasing amounts of blood components to administer to patients -- a role analogous to manufacturing functions. The concept of Good Manufacturing Practice (GMP) is therefore relatively new. While quality has always been important, the impact of GMP, Total Quality Management (TQM) and Quality Assurance (QA) will be profound. As the regulatory agencies, like the FDA in the U.S.A. and the EEC Commission in Europe, increase their enforcement activities, doctors, technical experts and managers will have to face many issues of quality assurance including documentation, validation, audit system, regulatory laws, licensing, teaching and training of staff and their job descriptions, standards, processing facilities, procedure validations, automation, record keeping, internal and external quality control of products and their release.The expansion of this philosophy to include Good Clinical Practice (GCP) is an even greater challenge demanding consensus therapy protocols and quality management of transfusion through auditing by the hospital transfusion committees. Such comprehensive plans will profoundly affect the financial and organisational structure of blood transfusion in the future.