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The International Haemovigilance Network (IHN) defines haemovigilance as 'a set of surveillance procedures covering the whole transfusion chain (from the collection of blood and its components to the follow-up of recipients), intended to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile blood products, and to prevent their occurrence or recurrence'. IHN, the International Society of Blood Transfusion and World Health Organization work together to support both developing and established haemovigilance systems. Haemovigilance systems provide valuable data on a range of adverse events related to blood donation and clinical transfusion, from donor syncopal events to transfusion-transmitted infections, immunological complications and the impact of human errors. Harmonised definitions for most adverse reactions have been developed and validated internationally. Definitions of pulmonary complications are again under review. Haemovigilance data have resulted in changes in policy, products and practice, and can complement and inform clinical audit and research, leading to improved blood donor safety, optimised product use and better clinical outcomes after transfusion. However, more work is needed. Not all countries have haemovigilance systems in place. More robust data and careful analysis are required to improve the understanding of the causes, occurrence and clinical outcomes of these events. Wider dissemination of results will facilitate health policy development internationally, and implementation of haemovigilance recommendations will support further important progress in blood safety.

Background Norway has no overview of the number of patients who are transfused, their age and gender distribution or reasons for transfusion. We wished to investigate which patient groups received blood at Sorlandet Hospital in 2010-2011, and to test a method of electronic data linkage from treatment systems, with a view to further monitoring of blood consumption. Material and method Data from all patients treated in somatic departments at Sorlandet Hospital in the period from 1 January 2010 to 31 December 2011 were linked to data from the blood bank with the aid of the system 'Forskning i sykehus'. SPSS version 23.0 was used for the statistical analyses. Results A total of 19 108 red blood cells and platelet concentrates were transfused to 3 967 patients, with the same number of units for both genders. Patients older than 60 years accounted for 79 % of the total blood consumption. Patients in the main diagnostic group neoplasms had the most transfusion episodes, followed by the diagnostic groups injuries, diseases of the digestive system and diseases of the blood. In cases of primary and secondary hip prostheses, 33.8 % and 65.6 % of the patients received blood, respectively. For caesarean section the figure was 8.9 %. Interpretation Our data are comparable to data from other countries. The method is suitable for assessing and monitoring transfusion practice. It could also be used by other health trusts and to collect national data after all blood components and parameters such as haemoglobin, blood group and transfusion complications are included.

International survey on NAT testing of blood donations : expanding implementation and yield from 1999 to 2009.

H. W. Reesink, C. P. Engelfriet, G. Henn, W. R. Mayr, G. Delage, F. Bernier, T. Krusius, A. Assal, P. Gallian, C. Corbi, P. Morel, B. David, P. De Micco, H. Murokawa, H. Yugi, S. Hino, K. Tadokoro, O. Flesland, E. Brojer, M. Oe towska, G. Olim, F. Nascimento, H. Goncalves, L. Castro, M. Morais, S. L. Stezinar, M. Alvarez, S. Sauleda, R. Gonzalez, C. Niederhauser, M. Stolz, J.-P. Allain, S. Owusu-Ofori, R. Eglin, S. Stramer, M. Busch, D. M. Strong, J. Epstein, R. Biswas

Important current issues in transfusion medicine in Norway are discussed. Current patient legislation specifically defines blood donors as patients, and blood and blood products are defined as drugs. Donor selection is controversial, especially deferral of all persons born in, or having lived for more than one year in areas with high prevalence of infections that are transmitted by blood. The threshold for becoming a blood donor is high, but registered donors donate frequently, e.g. 2,4 whole blood donations per year on average. Some blood banks have specialized in multicomponent aphereis technology, in particular collection of two units of red cells.

The establishment of the Norwegian Fractionation Project (Project) was of major importance in preserving national self-sufficiency when plasma, cryoprecipitate and small batch factor IX-concentrates were replaced by virus inactivated products in the last part of the 1980s. Fractionation was performed abroad by contract with Octapharma after tenders on the European market. All Norwegian blood banks (>50) participated in the Project. Total yearly production was 50–60 tons of mainly recovered plasma. From 1993 solvent detergent (SD) treated plasma has replaced other plasma for transfusion. The blood banks paid for the fractionation and/or viral inactivation process, while the plasma remained the property of the blood banks and the final products were returned to the blood banks. The Project sold surplus products to other Norwegian blood banks and the majority of the coagulation factor concentrates to The Institute of Haemophilia and Rikshospitalet University Hospital. Both plasma and blood bank quality was improved by the Project. Clinical experience with the products has been satisfactory and self-sufficiency has been achieved for all major plasma proteins and SD plasma, but a surplus exceeding 3 years consumption of albumin has accumulated due to decreasing clinical use. The Project has secured high yields of the fractionated products and the net income from the produced products is NOK 1115 (140 € or US$) per litre plasma. An increasing surplus of albumin and the possibility of significant sales abroad of currently not fractionated IVIgG, could lead to a reorganisation of the Project from that of a co-ordinator to a national plasma handling unit. This unit could buy the plasma from the blood banks and have the plasma fractionated by contract after tender, before selling the products back for cost recovery. The small blood banks could produce plasma for products for the Norwegian market, while surplus products from the larger blood banks which are certified for delivery of plasma for fractionation of products to be consumed in the European Community, could be sold on the international market.

Background In 2007, previous syphilis infection was diagnosed in a blood donor who had given blood regularly for 15 years. This was discovered when the donor was tested for syphilis, as a new donor in another blood bank. The time of infection is unknown. An expert group, set up by The Norwegian Directorate of Health, was commissioned to evaluate the risk of syphilis transmission through blood products in Norway. Material and methods The expert group based its evaluation on the epidemiology of syphilis, risk of infection and properties of the syphilis bacterium, especially in relation to blood donation. Specific information about the actual incident, made available by the Norwegian Directorate of Health, was also evaluated. Results Of 54 blood recipients 21 were alive and 18 (86 %) were tested for syphilis, all with a negative result. For 11 deceased the hospital records were studied without discovering signs of syphilis infection. Interpretation The risk of transfusion-transmitted syphilis is low for several reasons: The prevalence of syphilis in the population is low, a compulsory interview and completion of a questionnaire before donation in Norway excludes patients who are ill or at risk of being infected; the proportion of fresh blood donations is very low and syphilis bacteria die quickly during normal storage conditions for blood. An incidental infection is symptomatic and easily treated by antibiotics. The expert group recommends to not start syphilis testing of each blood donor but to continue the present routine testing of new donors.

This commentary deals briefly with various topics discussed in the recent annual course in Transfusion Medicine, organized by the Norwegian Red Cross Blood Programme.

Most parous women have progenitor cells of offspring origin in their peripheral blood for various time periods after giving birth [1,2]. Artlett and colleagues have shown a rate of microchimerism in parous women of 28% [3]. Postpartum women may be microchimeric to offspring hematopoietic cells up to 27 years [1]. However, little is known about the effects of microchimerism in a normal person, but the appearance and persistence of allogeneic white blood cells in a recipient after transplantation, transfusion, or pregnancy has the potential for far-reaching biologic ramification [4]. Microchimerism and HLA-relationships of host and non-host cells may be involved in autoimmune disease [2]. On the other hand, it has been suggested that cellular microchimerism is a physiologic phenomenon in parous women [5]. Starzl et al. described the development of tolerance in five patients who received kidney allografts

In Norway, 55 hospitals collect blood and there are 62 hospital associated laboratories that issue blood. All of the blood banks in Norway have performed universal leukodepletion of cellular blood components since 2001. Approximately 200,000 whole blood donations are performed per year and approximately 250,000 blood components are transfused. Blood components are considered as pharmaceutical products and blood banks are audited by the Norwegian Medicines Agency. The Council of Europe defines the term Hemovigilance as ‘‘the detection, gathering and analysis of information regarding untoward and unexpected effects of blood transfusion’’. Although a system for reporting transfusion reactions has been in use in Norway during the last years, it is well known that transfusion reactions are not systematically reported. Most European countries have implemented, or are just about to implement a hemovigilance system, mainly as ‘‘hybrids’’ of the two main hemovigilance models, the

The purpose of a haemovigilance system is to identify complications related to transfusion or blood donation, analyze them and learn in order to avoid complications in the future. The Norwegian Haemovigilance System (Troll) started as a voluntary, professionally led reporting system in 2004. In 2007 haemovigilance became an authority task, according to the EU blood directive, and reporting of serious adverse reactions and serious adverse events became mandatory. The Norwegian Directorate of Health became responsible for the system and asked The Norwegian Knowledge Centre for the Health Services to run it. Results from the first eight years of reporting are presented. A total of 2607 transfusion complications or incorrect blood component transfused (IBCT) have been reported (127 per 100,000 transfusions). Most transfusion reactions are mild. The most frequently reported are febrile non-hemolytic and mild allergic reactions. Serious adverse reactions such as anaphylaxis, TRALI and hemolytic transfusion reactions occur, but are rare. One incident of bacterial transmission and four incidents of viral transmission have been reported, among them one case of HCV transmission. No incidents of transmission of HIV or hepatitis B have been reported. IBCT was reported 168 times. Our data are comparable with data from other countries. Recommendations from the haemovigilance system are included in local and national guidelines. Increased knowledge of haemovigilance among physicians and nurses can lead to improved transfusion safety. It is safe to receive blood in Norway, but serious adverse reactions do occur. Our reporting system seems to be well accepted. We have not yet been able to document any change of practice that has lead to a reduction in the number of complications.

H. W. Reesink, S. Panzer, C. A. Gonzalez, N. Lena, P. Muntaabski, S. Gimbatti, E. Wood, M. Lambermont, V. Deneys, D. Sondag, T. Alport, D. Towns, D. Devine, P. Turek, M.-K. Auvinen, T. Koski, C. K. Lin, C. K. Lee, W. C. Tsoi, E. Lawlor, G. Grazzini, V. Piccinini, L. Catalano, S. Pupella, H. Kato, S. Takamoto, H. Okazaki, I. Hamaguchi, J. C. Wiersum-Osselton, A. J. W. van Tilborgh, P. Y. Zijlker-Jansen, K. M. Mangundap, M. R. Schipperus, D. Dinesh, P. Flanagan, O. Flesland, C. T. Steinsvag, A. Espinosa, M. Letowska, A. Rosiek, J. Antoniewicz-Papis, E. Lachert, M. B. C. Koh, R. Alcantara, M. Corral Alonso & E. Muniz-Diaz

Prophylactic anti-D is a very safe and effective therapy for the suppression of anti-D immunization and thus prevention of haemolytic disease of the foetus and newborn. However, migration from countries with low health standards and substantial cuts in public health expenses have increased the incidence of anti-D immunization in many "developed" countries. Therefore, this forum focuses on prenatal monitoring standards and treatment strategies in pregnancies with anti-D alloimmunization. The following questions were addressed, and a response was obtained from 12 centres, mainly from Europe.

The International Forum of Vox Sanguinis is meant to obtain information concerning important and ⁄or controversial subjects of transfusion medicine. Transfusiontransmitted malaria is severe and often fatal. The measures taken to prevent it in non-endemic areas have been successful, although cases still occur occasionally. However, the number of immigrants from and travellers to endemic areas has increased considerably and is still increasing. Furthermore, new tests have been developed to detect plasmodium antibodies and are used for selected group of donors in various blood centres. Also, tests to detect plasmodium antigens and nucleic acid amplification testing (NAT) for parasite DNA have been developed. It seemed therefore of interest to evaluate the preventive measures taken at present in non-endemic areas. To obtain the relevant information, the following questions were sent to transfusion services.

Quality assurance of the donor questionnaire and the donor interview must ensure that all relevant questions about donor eligibility are answered and documented in a reliable format. The use of the self explanatory, electronic donor information tool [EDIT], not only provided a harmonized and standardised system of quality assurance but also saved time and can be easily modified as guidelines change. This brief report highlights the principles of this tool and some of its potential benefits, as experienced over the 3 years since its introduction in Norway.

International audience

Purpose of review Donor selection and viral screening methods combined with pathogen reduction have increased the safety of pooled plasma to a level which makes reintroduction of ABO-universal plasma an important option. Recent findings Solvent detergent-treated pooled plasma has proved to be well suited for the production of pathogen-reduced ABO-universal plasma. One such product, Bioplasma FDP, was licensed in South Africa in 1994 and has since 1996 been in successful clinical use. A clinical study with this product and two studies with the European product, Uniplas, have confirmed the efficacy and safety of pathogen-reduced ABO-universal plasma. Summary Pooling of plasma enables the production of ABO-universal plasma. Pathogen reduction with solvent detergent eliminates lipid-enveloped viruses, whereas neutralizing antibodies in the plasma pool and nucleic acid amplification testing ensures the safety for recognized nonlipid-enveloped viruses. Pooling also eliminates transfusion-associated acute lung injury (the leading cause of plasma transfusion-related death), reduces immunologic/allergic adverse events by 60-80% and standardizes plasma protein content. Thus, in addition to ABO compatibility, pathogen-reduced ABO-universal plasma has important supplementary benefits that improve the product's cost-effectiveness.

Udgivelsesdato: 2008-Apr

Haemovigilance is defined as the collection of information on complications of transfusion, the analysis of the data, and suggestions for improvement in the transfusion service. A national haemovigilance system is of value in identifying possible areas in need of improvement in the national transfusion system. Haemovigilance becomes even more important if the system is used to compare the situation in one country with the situation in other countries, e.g. if the countries differ significantly in products used. The current study focuses on immunological transfusion complications, especially TRALI, as published in haemovigilance reports from Denmark, Norway, Sweden and the UK.In Norway immunological transfusion reactions occurred 96.7 times per 100 000 red cell (RBC) transfusion, 231.1 times per 100 000 thrombocyte (Trc) concentrate transfusion and five times per 100.000 transfusions of solvent detergent treated plasma (SD plasma). Denmark and the UK have similar rates of transfusion reactions to RBC and fresh frozen plasma (FFP), but quite different for Trc (0.5 vs. 4.9 per 100 000). In 49% of reported TRALI the causative product is FFP, but no case of TRALI after SD plasma transfusion has been reported.When considering all reports for immunological complications in Norway, the most striking is the very small number of reports related to SD plasma. Comparing data from Denmark and the UK shows a big difference in reactions caused by thrombocyte concentrates that may reflect different production methods in the two countries. TRALI is most often caused by FFP, but has never been reported after SD plasma transfusion. Heamovigilance data can be valuable in choosing the safest products available.

During 2005 Norwegian Transfusion Medicine has faced some new problems, sought new solutions and gained strength. Interactions with the public and the health authorities have been important issues for consideration, which are discussed below.

Background . Transferrin receptor mediates cellular uptake of iron, and the expression on cells reflects iron needs and erythropoietic activity. The results of measuring transferrin receptor in serum (sTfR) in blood donors are presented. Study design and methods . Haemoglobin, serum-ferritin and sTfR were measured in 172 female and 174 male donors that had donated whole blood six or more times during the previous 3 years and in 96 female and 56 male new donors. Results . Haemoglobin and sTfR were not significant different in new and repeat donors. New donors had significantly higher s-ferritin than repeat donors. Twenty donors had a Hb above the low limit for normal, but below the determined cut-off for donation. Only three of these had high sTfR and/or low serum-ferritin. Hence, of the total 492 donors 3.5% were below the Hb cut-off, but having Hb, s-ferritin and sTfR within normal ranges. 11.6% of new female donors belonged in this category. Conclusion . STfR is better than s-ferritin as a screening for iron deficiency. Most donors with low tissue iron neither have high sTfR, nor anaemia. There is probably no need to have a separate, higher than the lower normal range, requirement for Hb in donors. STfR measurements are probably most valuable in a setting where most donors are repeat donors.

In a prospective study of 16,756 consecutive blood donors, we found 54 donors (0.3%) to be anti-hepatitis C virus (HCV)-positive by a first-generation enzyme-linked immunosorbent assay. After retesting, 18 donors were confirmed positive or indeterminate by a second-generation recombinant immunoblot assay. Sixteen of these donors were found positive by a second-generation enzyme-linked immunosorbent assay, and 15 of these were positive by HCV polymerase chain reaction with two primer sets. Nine donors (50%) had a history of drug abuse. In 15 donors found positive by a second-generation enzyme-linked immunoblot assay liver biopsy specimens were taken after at least 6 months' follow-up. In all except one hepatitis C RNA-negative donor, histologic abnormalities were observed, even when alanine aminotransferase (ALAT) levels were continuously normal or only moderately elevated. The abnormalities were less pronounced in these donors (n = 5) than in donors with ALAT levels increased more than twice the upper normal limit (p0.05). In conclusion, we found the proportion of previous drug abusers in anti-HCV-positive blood donors to be high. We confirm that the presence of anti-HCV (second generation) usually, and HCV-RNA always, seems to indicate ongoing infection--also when ALAT levels are normal. Our study further suggests that low-activity hepatitis, evaluated by ALAT levels, may indicate a milder disease.