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Ladies and gentlemen, Good morning I’d like to thank the Ministry of Health and the director of the Russian Institute of Hematology and Transfusion, Professor Selevanov, for their kind invitation to participate in this Congress. Let me start with a short reference of the transfusion centre that I represent. The “Centre de Transfusió I Banc de Teixits” (CTBT from now on) is a public enterprise that manages and organizes blood donation, transfusion, analysis and processing in our sector, which represents approximately 60% of the territory of Catalunya ( it supplies a population of more than 3.5 million people ) . It also develops other activities: Tissue Bank and Cellullar Therapy, Cord Blood Bank integrated into the Netcord organization, Immunobiology laboratory for the diagnostic investigation and applications, Laboratory of molecular biology for the diagnosis of congenital diseases such as Hemophilia; finally, it has recently inaugurated the Josep Carreras Cellular Factory, where the processes of expansion and ex vivo production of the stem cells and in the near future of dendrytic cells and lymphocytes of cord blood ) will be carried out. Our centre is certified according to the ISO 9001:2000 regulations and at present we are heading to EFQM patterns of quality excellence. We work according to a management organization pattern in processes, which in our case are the following: 1- Blood processing, which includes the following services: promotion, donation, analysis (including PCR), Fractionation, Storage, Supply and Distribution to the hospitals of our area. 2- Transfusion 3- Immunohematology lab 4- Tissue Bank Each process is surveyed by a coordinator and the above-mentioned areas work interdependently. Furthermore we are linked to the University of Barcelona, UAB, with whom a number of post-grade courses, medical specialization training and masters are organized. We also work as a reference centre in our sector, supervising and evaluating the transfusional practice of the different blood deposits to which we provide with hemoderivates. Our centre was constituted as a public enterprise, independent from the Hematology service of the hospital in 1996, and by means of a series of merges with other Blood Banks, we make up a net of 7 centers spread along the 4 provinces of Catalunya, with the headquarters sited in Vall d’Hebron Hospital in Barcelona. Along 2003 we worked with 103,071 blood donors, 31,728 of whom were new ones. We have collected 134,352 whole blood donations and obtained 5,135 apheresis units. We collect approximately 75% of our blood donations in mobile units. To do so, we have organized 2055 campaigns, including 24 “blood donation marathons”, which are special collections of 12 hrs. non-stop, with a wide display of means and important cooperation of local authorities and media. They are joyful events where you mix blood donation together with music concerts, dance shows and raffles of presents offered by local traders. Special drinks and food can also be found. In Spain blood donation hasn’t been rewarded with money for more than 30 years and as promotional campaigning, education of population and economic resources to improve our infrastructure have allowed voluntary and altruistic donations, donation by relatives is almost anecdotal ( under 5% of donations ). We started the apheresis donations in the eighties, although at that time they were exceptional and the donor was usually a relative. 7 years ago we activated the plasmapheresis program, especially of groups AB and B ( of which we have surplus ), and less emphatically of group A. We usually used the Haemonetics PCS separator, which was later substituted by the Ultralite device, a revolutionary machine as it was portable due to its weight and measures. It led us to begin plasmapheresis outside the hospital area, in one of the provinces with the highest donation rate ( 50 donations per 1,000 inhabitants ), coinciding with blood donation campaigns in places of more than 10,000 inhabitants. For the few platelet apheresis carried out we used the Cobe-Spectra, an exceptional and still used device, but that obliges to two canal vein access (draw and return) with the resulting limitation in the donor selection and also a certain discomfort, both physical and psychological. Using a unique vein facilitates the incorporation of donors and makes it much more similar to a usual blood donation. At the beginning of 2000 the 4 centres that at the time were part of the CTBT started the platelet apheresis program aimed at blood donors with the adquisition of a number of cellular separators Cobe-Trima of Gambro BCT Company. This device brought many advantages to our organization as it made it possible to turn an important part of the plasmapheresis donors file into a plasma-platelet donors one, without objections from the volunteers. We simply told them that during approximately the same time that they were connected, they could donate two very valuable products, with the further advantage of a quick recovery. Shortly after that, we installed the MCS+ separators from Haemonetics, as compact as its predecessor Ultralite and with similar performances to Cobe-Trima. A source of platelet donors is the relatives, especially those of patients treated in the Services of Hematology, Oncology and Transplantation units, mainly the area of pediatric bone marrow. Transplanted children’s parents are probably one of the most sensitized groups. Doctors and nurses in charge of the patient cooperate giving info about the blood bank, although it is not widespread. From the transfusion centre we visit them regularly and we offer them info about apheresis and blood donation, but we always first find out about the patient’s state, suggesting their voluntary cooperation whenever they choose to do so, especially considering their emotional state. We insist on the fact that their donation is not aimed at their relative, but that it will be used to replace the stocks in the bank. They usually come up motivated and they themselves can help by promoting platelet donation among other relatives and friends. Although it is a useful cooperation, we don’t enhance it too much, we don’t put the relative under any pressure as the donation philosophy in our centre is for it to be voluntary and altruistic and we understand that trombopenic patients’relatives can feel obliged at least from the moral point of view. We simply inform them that we exist, where we are, our timetables and on how easy a platelet donation is. Our main goal is to use regular blood donors, with at least 10 donations (minimum 1 per year in the last 3 years) and preferably inhabitants of the same city in order to avoid long trips. We personally inform conventional blood donors, especially those that turn up to hospital Blood Banks, who are the ones already used to donating in the Hospital and not in the Mobile Units. We use the preliminary interview and medical examination for our doctors or nurses in charge of the donation area to explain what an apheresis donation is, the advantages for both donor and receiver, its utility and the guaranteed safety and confidentiality offered. We also tell them about the possibility of adverse effects, rare but possible, especially bruises and hematomas and possible mild paresthesias that easily disappear by drinking milk or calcium gluconate tablet administration. We inform them very clearly about the duration of the process ( app. 1hr.), but they have to bear in mind that they need alt least 1 hr and a half from their arrival till the moment they are ready to leave. They have free parking available in the same hospital. It’s important not to be in a hurry, to have an idea of the finishing time so that the period they remain in the Bank can be relaxed and comfortable. We offer them daily press, magazines and TV as an entertainment, but we remind them to bring their favorite music if they prefer so. They can even come with somebody else to chat or, why not, donate together. Sometimes they accept to cooperate at the very same moment, but in most cases we take down their personal data, evaluate the vein access, perform a platelet count taking advantage of the blood donation and we agree to call them 2 or 3 months later, as Spanish regulations establish a minimum period of 2 months after a whole blood donation. We have verified that the main success rate is achieved when we call before 6 months have gone by. It’s not worth insisting with those who agreed for apheresis donation but haven’t done it in one year. Almost all of them don’t turn up or make continuous excuses, which implies an untrustworthy file; therefore we reject them in order not to waste both time and money on the phone. We only keep those identified with a special phenotype, for instance donors with HPA-1 negative platelets. The donors’ answer has steadily improved, which has obliged the bank to widen its opening times, including Saturdays in some centers as the main problem has always been the short time availability due to the usual longworking hours among active population. The evolution of the apheresis program has been the following: Our experience shows that it is very important to contact personally with the donor and to call them approximately every two months to come back. All personal data is taken down in case it is useful: most suitable timetables for phone calls, personal information like job and address, medical or family issues told by them, possible problems along the donations, favorite device, etc. All these points are thought to make the them feel special and important for us, not simply one more anonymous donor. We are asking them to give us part of their scarce time and to agree to a donation that undoubtedly is more invasive than a conventional whole blood one. We have to obtain their confidence, not only professionally (which is obvious), but also from the point of view of the personal relationship. We try to work with a relatively stable staff to assist them as, in general, donors appreciate familiar faces. When vein damage occurs we ask for a second puncture if the other arm is suitable and, whenever possible, it is carried out by a different nurse. All the staff that assists the apheresis donors is specially trained to do it. They’ve followed special courses given by the technicians of the companies that supply with the equipment, both for the assembly and correct maintenance of the systems and the for the alarms that can happen during and after the process. The ones in charge of the Donation Service organize regular meetings and revise all protocols. In a pheresis there is always a medical doctor in charge who needn’t be a specialist in Hematology, but is trained in the use of separators and in solving the most common problems that arise. The donors are assisted by a professional nurse, who can be in charge of two of them simultaneously. At the beginning we only had one device per centre, so it was indispensable to make a previous appointment with a minimum gap of 1hr and a half between two donations to make sure that the donor didn’t have to wait. That was one more point in favour of personalized treatment as we avoided delays and made sure that the equipment would be ready in advance. Nowadays every donation service of our Blood Bank has a number of machines ( between 3 and 6 depending on the centre ), which allows us to be able to accept almost always spontaneous donors, those who turn up without previous appointments and who represent approximately 10 % of the platelet-apheresis carried out. Anyway, we keep on using the appointment system as it allows us to plan our logistics better, reinforce more crowded time frames with more staff and distribute the donors in the separator in advance according to their preference and their individual conditions. In this way we get to optimize the donation depending on the personal characteristics of volemia, number of platelets and types of veins. All along 2002 Cobe improved its new version 5.0 Accel. These advantages had significative after-effects on the donors’ comfort as the vein damages went down drastically due to the incorporation of a system of ramp between draw and return and viceversa and it also remarkably improved its productivity with a collection system of single stage. It made it possible for us to “accelerate” the obtention of double products of platelets in selected donors, which has optimized the processes and lowered the expenses because an equipment, a donation and one analysis provides the equivalent of two donations. In 2oo3 almost 10% of the processes carried out implied double products of platelets, which is a very satisfactory result considering we didn’t increase significantly the time of donation ( 1 hr. app. ) and that in Catalunya the average volemia per donor is around 4-5 liters and the platelet count-up is 220-240,000 per microliter. All along these years quantitative criteria have prevailed but we are not far from attaining a certain balance between offer and request of these very high-quality products. Our aim for the present year 2004 is to improve productivity, with higher collection rates and a lower number of units with performance under 3.0. We should do it by selecting donors more comprehensively and transferring low performance donors and AB group donors to the plasmapheresis donors file for our programme of quarantined plasma and definitely refusing those ones with little suitable vein accesses or those who, once they have been appointed repeatedly don’t turn up for donation. We have also intended to obtain 2,000 units of plasma for quarantine out of these units with a volume of at least 400 ml. That quarantine is set at least in 4 months and the units are delivered to the transfusion services after a new test carried out in the whatever kind of following donation. In order to do so we have started with the Cobe-Trima a protocol of plasma-reduced platelet concentrates, which has resulted in a collection of extra units of plasma with volume of 400 ml in 95 % of cases. Collected units of less than 400 ml. are sent to pharmaceutical industry to obtain by-products, mainly albumin, intravenous immunoglobulines and specific ones as anti-D, anti-hepatitis B, anti-tetanus, anti-RSV, anti-CMV. We also obtain VIII/vW factor, F IX, F VII, F XII, anti-thrombin, prothrombin complex, fibrinogen, alfa-1-antitripsin, C1-inhibitor, etc. We have in progress a pilot plan of plateletapheresis outside the Blood Bank. To do it we have adapted an elevated platform to one of the vans that allows us to transport 2 Cobe-Trima and small coulter for the cell count. We have carried it out in local hospitals and also in set out spaces to plateletpheresis and blood donation campaigns, such as libraries, exhibition lounges, social centres, etc. They’re very profitable ( they imply only one more nurse sent to the collection ) and very appreciated by donors of that kind of places because it means one more chance near them and decentralized from large reference hospitals. Our centre also owns a cellular separator Amicus of Baxter. It’s a wellsolved technically device, very well accepted by donors regarding comfort, but that requires a more complicated setting up of the disposable kit , which sometimes makes it difficult to perform the procedure in the donation lounge. We have also tested the Alyx platform, exclusively designed for RBC collection. It makes it possible to obtain twice as much concentrated of red cells in app. 30 min. and is well tolerated by donors. The needs of RBC concentrates in our community are quite thoroughly met, but it’s not the same with platelets, whose demand is steadily growing up. That’s why our experience in obtaining multicomponent is scarce although this is the step to take in the near future. On the other hand, we are steadily getting very dedicated donors whom we can gradually change the idea of donating a quick recovery product to a selective donation but more complete. It’s the selection process in those donors with hematocrit rates higher than 45% and especially belonging to negative Rh blood groups or with special phenotype. Many Blood Banks with apheresis programmes that include multicomponent products and organize their donors’ file looking for the highest optimization. To do so some of them design protocols and algorithms that ( even in an automatized way ) suggest the cellular separator, a programme option and kind of product to choose first of all. Treball AABB: automatització afèresis. Gràfics Our protocol follows very flexible guidelines in which we give priority to the donor’s comfort to set them as regular donors. This point is specially considered in the first donation so we try in the first process not to take more than 1 hr. As the donor gains confidence with the apheresis donation, we apply productivity criteria, trying to make every process highly profitable by lengthing its duration up to a maximum of 70-80 min. By doing so, we get twice as much product of platelets concentrates or an extra RBC unit. In outline, our selection policy is the following: we connect the donors preferably in Trima-Accel with plasma-reduced (PPC) protocol except: AB group donors: plasmapheresis of 600 ml with MCS+. If some of them are candidates to double product of platelets, we connect them to Trima-PPC platform with additive solution + plasma 400 ml. Donors with platelet count lower than 170.000: plasmapheresis of 600 ml unit, except donors with volemia higher than 5 liters that give with Trima. Donors with difficult vein access and platelets count higher than 180.000: we connect them to MCS+ device. Donors with volemia lower than 3.7 liters, give with conventional Trima-Accel Algoritme protocol CTBT We give priority to obtention of a platelet concentrate unit with performance equal or higher than 3.0. That’s why we have programmed machines with an estimated performance of 3.2 and 3.7 in order to get units with the real performance wished in more than 90% of cases. Secondly, we intend the obtention of plasma with a volume equal or higher than 400ml. In most procedures in order to get these two products together the chosen device is Trima-Accel plasma-reduced platform. Donors with less than 3.7 liters of volemia can rarely donate 1 unit of platelets and one of plasma higher than 400 ml, so if they have a platelet count over 200,000 they do conventional plateletapheresis and if the number is below they do a plasmapheresis because otherwise the performance is very poor. Our third priority is to avoid low performance units and those of ABO groups with little demand. Consequently, AB donors and those with low volemia or platelets count below 170,000 are derived to plasmapferesis programme with the MCS+ . According to our experience, it’s a very suitable separator for donors with little capacity vein accesses and for those with a high anxiety level. The centrifugation system in complete cycles seems to generate less discomfort among that kind of donors, but its productivity is remarkably inferior. Treball AABB productivitat MCS/Trima Anyway we always bear in mind the donor’s opinion about their preferences for a specific device, type of donation and its lengthin time. At last, but not the least, we especially appreciate the technical service that the companies that supply the equipments offer, both on speed and efficiency to solve technical problems as on their involvement in our results and opportunities of continuous improvement that they bring, being them by developing new versions of the device or with the design of more productive protocols. In this sense, the cooperation of Gambro BCT-Spain is impeccable. Thank you very much for your kind attention.