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Objectives To estimate the number of actually Severe acute respiratory syndrome Coronavirus‐2 (SARS‐CoV‐2) infected blood donors applying a statistical forecasting model. Background Following the outbreak of the SARS‐CoV‐2 epidemic, a drop in blood donation has been observed. It is crucial to determine the actual number of potential SARS‐CoV‐2‐positive donors to define the measures and ensure adequate blood supply. Methods The cumulative incidence of SARS‐CoV‐2 positivity, calculated on the general population, was applied to the donor population by estimating the number of positive subjects. The calculation model was validated by the linear interpolation method. The number of blood units actually discarded based on post‐donation information was also taken into account. Results Three months after the outbreak, 5322 donors were estimated to be positive for SARS‐CoV‐2 and were therefore potentially excluded from donation. A total of units of blood components were discarded following post donation information. The estimated number of donors deceased (180) and the number of clinically recovered individuals in the same period was also considered. Conclusion This forecasting model can be used to obtain information on blood donors' involvement during future SARS‐CoV‐2 outbreaks, especially in case of changes concerning epidemiology, incidence by age bracket and geographical distribution and also for new outbreaks of emerging viruses.

We read with interest the International Forum recently published on Vox Sanguinis on the actions carried out from hospital transfusion services during the Coronavirus Disease 2019 (COVID‐19) [1]. The survey, to which 12 centers from around the world (included Italy) have joined, was structured on 9 questions assessing the changes in blood bank activities during COVID‐19 pandemia and including various technical aspects from pre‐transfusion testing to blood products storage and blood components utilization. Interestingly, the 9th question regarded the production of convalescent plasma (CP) [1]. The Italian participants answered that a number of protocols on CP are ongoing or planned in Italy and indicated as a reference the position paper of the Italian Society for Transfusion Medicine and Immunohematology (SIMTI) and the Italian Society for Haemapheresis and Cell Manipulation (SIdEM).

Purpose: To investigate the morphological changes of corneal epithelium and subbasal nerves by in vivo confocal microscopy in patients with ocular surface disease (OSD) treated with cord blood serum (CBS) eye drops. Methods: Twenty patients with OSD (mean age 61.1 ± 12.6 years) were included in this prospective 1-arm study and treated with CBS eye drops for 2 months. Corneal sensitivity, Schirmer test score, breakup time, subjective symptoms [Ocular Surface Disease Index (OSDI) and Visual Analogue Scale (VAS)], and corneal staining were evaluated before (T0) and after (T1) treatment. In vivo confocal microscopy analyzed giant epithelial cells, subbasal nerve number and tortuosity, neuromas, beading, and dendritic cells (DCs) in the central cornea. Results: OSDI, Visual Analogue Scale, and Oxford grading values significantly decreased at T1 versus T0 (respectively, 44.1 ± 18.9 vs. 74.2 ± 13.9; 3.7 ± 1.5 vs. 8.9 ± 0.9; and 2.4 ± 1.1 vs. 3.3 ± 1.3; P < 0.0001), whereas corneal sensitivity, Schirmer test score, and breakup time significantly increased (respectively, 49.5 ± 2.6 vs. 47.9 ± 2.9; 3.2 ± 2.0 vs. 2.4 ± 2.2; 4.6 ± 3.1 vs. 3.8 ± 2.1; P < 0.0001). Corneal nerve morphology improved at T1 versus T0 with a higher total nerve number (3.4 ± 1.6 vs. 2.5 ± 1.6 per frame) and lower tortuosity (3.0 ± 0.7 vs. 3.5 ± 0.6) (P < 0.01). The number of patients presenting with giant epithelial cells, beading, and neuromas decreased at T1. DC density did not change after treatment. The detection of neuromas and higher DC density at T0 were associated with greater OSDI reduction at T1 (P < 0.001). Conclusions: CBS eye drops significantly improved corneal nerve morphology and subjective symptoms in patients with severe OSD. The presence of neuromas and higher dendritic cell density at baseline were associated with greater reduction of discomfort symptoms after treatment.

The in vitro production of red blood cells and platelets is a groundbreaking technology that can—when optimized—surrogate for donated blood cells, in total or in part. Here we discuss questions that may arise when the technology is available, relative to safety issues (comprising both quantitative and qualitative parameters) and to ethics, an item often forgotten in the debates so far.

Le patologie emorragiche e trombotiche hanno una presentazione estremamente eterogenea e possono interessare un’ampia fetta di popolazione, come ad esempio nel caso dei pazienti che fanno uso di trattamenti antitrombotici. Il trattamento di queste condizioni richiede la disponibilita di specifiche indagini diagnostiche e della conoscenza clinica delle varie sindromi e del loro trattamento opportuno. Sono pertanto richieste, oltre a una qualificata esperienza clinica, specificita organizzative realizzabili solo in laboratori dedicati con la supervisione di personale esperto. Tale offerta diagnostica-terapeutica non e attualmente disponibile sul territorio nazionale se non in un numero limitato di ospedali di rilevanza nazionale. Sarebbe invece clinicamente molto rilevante per il singolo paziente, e verosimilmente cost-effective per l’insieme del SSN, che si attuasse una disponibilita uniformente distribuita nel territorio nazionale di strutture e/o persone esperte nel campo delle malattie emorragiche e trombotiche. Tale figura professionale non e contemplata dal corrente ordinamento accademico. Il presente documento, coordinato da SISET nel 2012 assieme alle principali societa scientifiche italiane interessate, identifica le conoscenze scientifiche, le competenze professionali e le funzioni all’interno del SSN richieste ad un esperto in emostasi e trombosi, graduate per livelli in funzione della complessita della struttura di appartenenza.

Donor history questionnaires for the determination of blood donor eligibility are a critical layer of blood safety. Early in the course of the AIDS epidemic in North America homosexual men with multiple partners were identified as one of the segments of the population with the highest risk of infection. Voluntary deferral of this group from blood donation led to a dramatic decrease in transfusion-transmitted HIV even before testing was introduced. In the early 1980s blood donors were deferred in England, the US and other nations, if they were ‘homosexual males with multiple partners’. After the implementation of HIV testing in 1985, the majority of the HIV-positive donors identified revealed ‘men having sex with men’ (MSM) behavior, leading the US Food and Drug Administration (FDA) to recommend indefinite deferral of all men who ‘have had sex with men, even once since 1977’; many other regulators and jurisdictions have enacted similar criteria. Three decades later, despite the recognition of other modes of transmission, MSM donors are still among the population segments with the highest prevalence and incidence of HIV in countries around the world. No other donor eligibility criterion has generated as much controversy or public discourse [1,2]. Proponents for change point out that in many countries other key components of blood safety such as donor testing and blood center process control have improved vastly, reducing the contribution of donor questioning to safety. Gay advocates in particular argue that donor selection policies based on MSM are discriminatory against gay and bisexual men in that they amount to a de facto permanent exclusion on the grounds of sexual preference, and are unfair, as other groups with similar risks of HIV infection are allowed to donate blood after shorter time-period deferrals designed to cover the seroconversion window. On the opposite side of the discussion, recipient advocacy groups and regulators are understandably adverse to any change that is not centered on improving safety. Recipient groups argue that they have suffered greatly due to transmission of HIV and HCV by transfusion, and they will be the bearers of any increase in risk that may result from policy changes. Because both MSM and recipients are vulnerable groups that have suffered in the past, the debate over possible changes in criteria has ethical, societal, and emotional dimensions not seen in discussions concerning other donor selection criteria. Of particular concern to blood operators is the prospect that young eligible donors may be dissuaded from donating blood to institutions that are perceived to act in a discriminatory and unfair fashion. This International Forum seeks to describe approaches to this issue and challenges to the status quo, in a snapshot in time. Since it is extremely difficult to obtaindatatoevaluatethepossibleimpactofpolicy changes made to address concerns expressed by advocacy groups, comparison of international practice is particularly valuable, since we may learn from approaches implemented in other jurisdictions. We received responses from 24 respondents representing countries on six continents. In most, but not all, the MSMpolicy isdetermined atthe national level. The following questions were asked of the respondents

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

BACKGROUND: Nucleic acid testing (NAT) for hepatitis C virus (HCV) and human immunodeficiency virus (HIV) has been implemented in several European countries and in the United States, while hepatitis B virus (HBV) NAT is still being questioned by opinions both in favor and against such an option, depending on the HBV endemicity, health care resources, and expected benefits. STUDY DESIGN AND METHODS: This survey was aimed to assess the NAT impact in improving the safety of blood supply in Italy, 6 years after implementation. The study involved 93 Italian transfusion centers and was carried out in 2001 through 2006. A total of 10,776,288 units were tested for the presence of HCV RNA, 7,932,430 for HIV RNA, and 3,405,497 for HBV DNA, respectively. RESULTS: Twenty-seven donations or 2.5 per million tested were HCV RNA–positive/anti-HCV–negative; 14 or 1.8 per million units tested were HIV RNA–positive/anti-HIV–negative; and 197 or 57.8 per million donations tested were HBV DNA–positive/hepatitis B surface antigen–negative. Of the latter, 8 (2.3/106) were collected from donors in the window phase of infection and 189 (55.5/106) from donors with occult HBV. Sixty-eight percent of the latter donors had hepatitis B surface antibody, 74.5 percent of whom with concentrations considered protective (≥10 mIU/mL). CONCLUSION: NAT implementation has improved blood safety by reducing the risk of entering 2.5 HCV and 1.8 HIV infectious units per million donations into the blood supply. The yield of NAT in detecting infectious blood before transfusion was higher for HBV than for HCV or HIV. However, the benefit of HBV NAT in terms of avoided HBV-related morbidity and mortality in blood recipients needs to be further evaluated.

Hemolytic uremic syndrome (HUS) is the life-threatenig sequela of intestinal infections by Shiga toxin (Stx)–producing Escherichia coli (STEC) in children. Human neutrophils specifically bind Stx through TLR4, the receptor of LPS. The binding could be considered protective (Stx sequestration) or harmful (toxin delivery to target organs). The amount of Stx on neutrophils is in equilibrium with the amount of Stx present in the gut, and it is also related to renal and neurologic symptoms. The TLR4-mediated interaction of LPS with innate immune cells is hampered by the well-known antibiotic polymyxin B. In this study, we show that the same antibiotic impairs the binding of Stx to neutrophils, also blocking their functional effects (release of CXCL8, formation of neutrophil/platelet aggregates) involved in HUS pathogenesis. Controls for contaminating LPS in Stx-induced neutrophil responses inhibited by polymyxin B were performed. Stx interact with human neutrophils through their A chain, since these leukocytes do not express globotriaosylceramide, the specific receptor for Stx B chains. Consistently, polymyxin B blocked the enzymatic activity of Stx1, Stx2, Stx1 A chain, and the analogous plant protein gelonin, whereas the antibiotic did not show any protective effect on Stx-induced cytotoxicity in globotriaosylceramide-expressing Raji cells. Antibiotic administration is not recommended in human STEC infections during the prodromal intestinal phase, and the toxicity of polymyxin B could further discourage its therapeutic use. However, nontoxic, nonbactericidal polymyxin derivatives have been developed and might be used in animal models of STEC infection to study their efficacy in preventing the onset of HUS during the systemic blood phase of Stx.

The use of human albumin is common in hepatology since international scientific societies support its administration to treat or prevent severe complications of cirrhosis, such as the prevention of post-paracentesis circulatory dysfunction after large-volume paracentesis and renal failure induced by spontaneous bacterial peritonitis, and the treatment of hepatorenal syndrome in association with vasoconstrictors. However, these indications are often disregarded, mainly because the high cost of human albumin leads health authorities and hospital administrations to restrict its use. On the other hand, physicians often prescribe human albumin in patients with advanced cirrhosis for indications that are not supported by solid scientific evidence and/or are still under investigation in clinical trials. In order to implement appropriate prescription of human albumin and to avoid its futile use, the Italian Association for the Study of the Liver (AISF) and the Italian Society of Transfusion Medicine and Immunohaematology (SIMTI) nominated a panel of experts, who reviewed the available clinical literature and produced practical clinical recommendations for the use of human albumin in patients with cirrhosis.

BACKGROUND: The main histopathological features of abdominal aortic aneurysm (AAA) are tissue proteolysis mediated by matrix metalloproteinases (MMPs) and inflammation. This study aimed at verifying the presence and contribution of mesenchymal stromal cells (MSCs) to aneurysmal tissue remodeling. METHODS AND RESULTS: MSCs were successfully isolated from the AAA wall of 12 male patients and were found to express mesenchymal and stemness markers. MMP-2/-9 are involved in AAA progression and their mRNA levels in AAA-MSCs resulted higher than healthy MSCs (cMSCs), especially MMP-9 (400-fold increased). Moreover, MMP-9 protein and activity were pronounced in AAA-MSCs. Immunomodulation was tested in AAA-MSCs after co-culture with activated peripheral blood mononuclear cells (PBMCs) and revealed a weak immunosuppressive action on PBMC proliferation (bromodeoxyuridine incorporation, flow cytometry assay), together with a reduced expression of anti-inflammatory molecules (HLA-G, IL-10) by AAA-MSCs compared to cMSCs. MMP-9 expression in AAA-MSCs was shown to be negatively modulated under the influence of cMSCs and exogenous IL-10. CONCLUSIONS: MSCs with stemness properties are niched in human AAA tissues and display a dysregulation of functional activities; that is, upregulation of MMP-9 and ineffective immunomodulatory capacity, which are crucial in the AAA progression; the possibility to modulate the increased MMP-9 expression by healthy MSCs and IL-10 suggests that novel therapeutic strategies are possible for slowing down AAA progression.

We evaluated the COBAS Ampliscreen hepatitis B virus (HBV) test using standards, seroconversion panels, consecutive donations, and samples from patients with abnormal alanine aminotransferase and chronic hepatitis C. Specificity was 100% and sensitivity was 20 IU/ml. In seroconversion panels, HBV DNA was detected up to 4 to 18 days before HBsAg, suggesting that this assay is useful in shortening the infectious window phase.

To determine why a significant proportion of birch pollen-sensitive patients do not have the oral allergy syndrome (OAS), possible predictive in vivo or in vitro tests for OAS were sought in a large retrospective and prospective follow-up study performed in 283 patients with clinical evidence of birch pollen hypersensitivity. OAS was associated with more severe respiratory symptoms and with higher birch-specific and total IgE levels; moreover, its onset was clearly related to duration of birch pollinosis. The prospective part of this study, performed in 63 patients without OAS, confirmed these findings and highlighted the very high negative predictive value of both skin prick tests with fresh foods and RAST with food allergens. This work suggests that about 15% of patients with birch pollen hypersensitivity are not prone to OAS and that their anti-birch IgE might be directed against determinants that do not crossreact with food allergens.

Objective To study type 1 and type 2 cytokine patterns in HIV-negative high-risk intravenous drug users (IVDU). Design We investigated interleukin (IL)-2, interferon (IFN)-gamma, IL-4, IL-6 and IL-10 production by phytohaemagglutinin (PHA)-stimulated and unstimulated peripheral blood mononuclear cell (PBMC) cultures from HIV-negative high-risk IVDU, HIV-negative controls and HIV-positive subjects. Methods Cytokine production was measured in supernatants using enzyme-linked immunosorbent assay (ELISA) in 10 HIV-negative high-risk IVDU, 25 HIV-negative controls, and 12 HIV-positive IVDU. We also determined spontaneous in vitro immunoglobulin (Ig) G and IgM production. Results HIV-negative high-risk IVDU showed increased IFN-gamma and decreased IL-4, IL-10 and IL-2, although the latter was not significant compared with HIV-negative controls. Further, HIV-negative high-risk IVDU had reduced IgG production and impaired IgM-IgG switch. Conclusions The reduced IL-2 and IL-4 production suggest an impaired CD4+ T-cell function in HIV-negative high-risk IVDU. The increased IFN-gamma production along with the decreased type 2 cytokine profile is consistent with the hypothesis that protective immunity against HIV may reside in type 1 responses and cell-mediated immunity.

The Italian Society of Transfusion Medicine and Immunohaematology (SIMTI) carried out a survey on the current use of anti-D immunoprophylaxis (IP) in Italy, on its ways of use and on the impact that it has had on decreasing haemolytic disease of the newborn (HDN), due to maternal-foetal incompatibility for the D antigen.The survey was carried out using a questionnaire prepared by the Working Group established for this purpose by the SIMTI. The questions were divided into five groups: the ways of carrying out IP, evaluation of foetal-maternal haemorrhage, serological tests after IP, the current incidence of HDN, and data on exchange transfusions.Data were obtained from 69 Transfusion Services (TS). Four of these give IP antenatally, whereas in the remaining cases IP is given after birth. Almost all the TS evaluate the amount of foetal-maternal haemorrhage in order to give additional doses of anti-D IgG, with the most widely used method being the Kleihauer-Betke test. Data were collected from 176,010 pregnancies: 18,639 were D-negative women, of whom 18,440 were not immunised. There were 136 cases of HDN with anti-D antibodies, and 39 of these required exchange transfusions (ET). Furthermore, there were 1,535 pregnant women with anti-A and/or anti-B IgG, which were clinically significant in 83 and required ET in 37. Finally, 40 women had antibodies, directly related to the pregnancy, against antigens other than D (in eight of these cases ET was necessary).The survey carried out by SIMTI was able to give a sufficiently full and accurate picture of current Italian practices concerning the use and ways of use of anti-D IP in pregnancy and the puerperum, as well as the incidence and characteristics of HDN. Furthermore, this survey was the basis for guidelines on the management of HDN, produced by SIMTI in collaboration with the Italian Society of Obstetricians and Gynaecologists.

The aim of this study was to analyze the role of HFE mutations in blood donors with iron parameters suggesting iron overload, taking into account the regional distribution of HFE mutations in Italy. We studied 5880 subjects undergoing evaluation for blood donation eligibility, from different areas of Italy. Abnormal iron parameters were defined as transferrin saturation (TS) 450% or 445% and serum ferritin (SF) 4300 or 4250mg/ml in males and females, respectively. Subjects with increased TS and/or SF were re-tested and typed for HFE mutations C282Y and H63D. A total of 548 individuals had increased iron parameters at first testing. In total, 179/548 were available for retesting, and in 109 increased TS and/or SF were confirmed. Increased TS was confirmed in 25 individuals, among whom three were C282Y homozygotes and six were compound heterozygotes for C282Y and H63D. Increased TS was more frequent in northern Italy than in southern regions. In individuals with increased TS and/ or SF, the frequency of C282Y and H63D was 0.13 and 0.21 in northern-Italy versus 0.05 and 0.45 in southern Italy (P ¼ 0.004 for H63D). Nine out of 10 individuals carrying hemochromatosis-associated genotypes (including compound heterozygosity for C282Y and H63D) originated from northern regions. Among controls, the allelic frequencies of C282Y and H63D were 0.037 and 0.16 in the northern regions and 0.015 and 0.16 in the southern regions. In conclusion, over one-third of individuals with persistently altered TS carried hemochromatosisassociated genotypes, confirming that a diagnostic approach based on TS and genotyping of selected cases may represent a viable screening procedure. The Hematology Journal (2003) 4, 436–440. doi:10.1038/sj.thj.6200324

We studied determinants of chronic inflammation and/or immune activation in plasma from patients in the transition from primary to early chronic HIV-1 infection. The following parameters were estimated in seven patients over time: plasma concentrations of soluble CD8 (sCD8), tumor necrosis factor alpha (TNF-alpha), soluble TNF receptor type II (sTNFRII), interleukin 6 (IL-6), soluble IL-6 receptor (slL6R). IL-10, transforming growth factor beta 1 (TGF-beta 1), along with CD4- and CD8-positive T cell counts, p24 antigenemia, and clinical evaluation. Results showed that concentrations of sCD8, TNF-alpha, and sTNFRII, and peripheral CD8-positive lymphocyte counts, were significantly increased in patients, compared to HIV-negative controls, and showed a trend toward normal values over time. Levels of IL6, sIL6R, IL-10, and TGF-beta 1 did not differ from those of controls and did not change over time, Heterogeneity was observed among the patients in terms of CD4-positive T cell depletion, levels of sCD8, concentrations of TNF-alpha/sTNFRII, and clinical outcome, These data indicate that in the transition phase from primary acute to chronic and asymptomatic infection the host immune activation in response to the virus is highly heterogeneous and that the sustained rise in TNF-alpha and its receptor may represent an important therapeutic target in early disease. The persistence of a state of chronic inflammation and/or immune activation could influence the progression of disease independently from CD4-positive T cell counts.

The complete lipoprotein profile is thought to give more information about the individual risk of coronary heart disease than total cholesterol alone. Although total cholesterol has a low sensitivity in the correct assessment of the risk of coronary heart disease, it may be of value in screening programs because of its low cost. In this study of 5,335 subjects, total cholesterol gave a different assessment of coronary heart disease risk (United States National Cholesterol Education Program guidelines) in 25% of subjects than the complete lipoprotein profile. Differences in risk assignment were mainly accounted for by high- and low-density lipoprotein-cholesterol (Friedewald equation). The calculated low-density lipoprotein-cholesterol was highly correlated with the value measured with a mixed ultracentrifugation and precipitation procedure. However, calculated values gave estimates of coronary heart disease risk which were 20% different from those from measure values. In 200 subjects in whom the lipoprotein profile was assessed three times in 1 year, the total cholesterol low-density lipoprotein-cholesterol varied by more than 30 mg/dl (0.78 mmol/l) in 52% and 50%, respectively, triglycerides by more than 30 mg/dl (0.34 mmol/l) in 75%, and high-density lipoprotein-cholesterol by more than 15 mg/dl (0.39 mmol/l) in 34%. Compared with the mean of the measurements, the single measurement of total cholesterol misclassified 48% of subjects, low-density lipoprotein-cholesterol 60%, high-density lipoprotein-cholesterol 12%, and 28%. We conclude that total cholesterol alone may be misleading in the assignment of coronary heart disease risk. Calculation of low-density lipoprotein-cholesterol, although less accurate than desirable, is the only way of evaluating this in clinical practice. Finally, repeated lipid measurements are required to assess coronary heart disease risk accurately.

Transfusion related acute lung injury (TRALI) is one of the most common causes of transfusion major morbidity and death. TRALI is still under-diagnosed and under-reported due to inadequate awareness among clinicians. According to expanded definition, TRALI can occur up to 72 hours of transfusion and in patients that have other risk factors for acute lung injury (ALI), i.e. sepsis, aspiration, near drowning, trauma, pneumonia, etc. In Croatia, the incidence of TRALI in Croatia is still unknown and has been only occasionally reported to date. To report on our initial experience with using a tool to improve clinical recognition and assessment of TRALI. A tool was developed as a web based application with the goal to collect evidence based knowledge about TRALI. Data from the cardiac surgery operating room and intensive care unit at Zagreb University Hospital Center were collected and analyzed during a six-month period (Jan-Jun 2009). In this prospective pilot cohort study, all transfused patients were closely observed for the development of ALI, including cardiopulmonary function, chest radiographs, arterial blood gases and central venous saturation within 72 hours of each transfusion, allowing for identification of patients with any grade of respiratory status worsening. Clinical suspicion of the probability of TRALI was made together by two anesthesiologists and one clinical transfusiologist. The informed consent form was signed by all patients and the study was approved by the hospital Ethics Committee. During the study period, 137 of 218 (63%) patients received transfusion of at least one type of blood component during their hospital stay and 17 (12%) developed ALI. Compared to transfused controls, ALI patients were more likely to have sepsis (37% vs. 22%) and massive transfusion (40% vs. 12%). Two of these 17 patients were verified as TRALI cases. Leukocyte antibodies were detected in two of these 17 patients (antibody-mediated TRALI). To our knowledge, this study was the first step in systematic assessment and recognition of TRALI among clinicians in Croatia. The ongoing multicenter, prospective study will allow us to collect more data in the near future and thus improve our clinical and transfusion practice.

Background. Collection of peripheral progenitor cells (PPC) by apheresis machine is generally considered a safe procedure. Data on adverse events in PPC harvesting are scarce. According to the new Croatian legislation on tissue banking (Act on Harvesting and Transplanting Human Body Parts for Therapeutic Purpose from April 2009), it is necessary to establish monitoring and reporting serious adverse reactions and events in the field and submit a report to the Ministry of Health and Social Welfare. Aim. To present our experience on adverse events in PPC harvesting, processing, storage and transplantation. Method. In this single-center retrospective study, the PPC collections done by Cobe Spectra apheresis machine during a 34-month period (2007-2009) were reviewed. Adverse events were subdivided into harvesting procedure-associated problems, patient- donor related side effects and PPC product related side effects, including serious and non-serious adverse events. Results. A total of 140 leukapheresis were performed in 99 patients. The patient-donor related side effects occurred in 64 (46%) leukapheresis procedures, all of them manifesting as paresthesias due to citrate toxicity. Paresthesias were treated by intravenous supplementation. Problems with venous access were recorded in approximately 20% of all leukapheresis procedures. During the additional processing of PPC products to decrease their volume, the package of two transfer bags (1.5%) were damaged and the products were inappropriate for use. Conclusions. Study results showed the patient-donor related problems to occur quite frequently, however, most of them were easily overcome.

The pre- and post-hemovigilance related interventions were compared according to the following: reports on adverse transfusion reactions and events, traceability of blood products, patient information on transfusion issues, audit and surveillance of transfusion practice. Data were collected from patient medical files, nursing files, blood transfusion prescriptions, patient interviews and other available documents (monitoring sheets, etc.). The measurement of improvement included an education package with guidelines for transfusion ; introduction of new hand-written blood component requests ; waste reduction policy ; education of nursing and medical staff ; review of routine blood ordering ; and consultation and rounds of transfused patients by a transfusiologist. All measurement packages were successfully carried out as planned. During the 2006-2008 period, a total of 23095 RBC units, 15911 platelet units, 8972 FFP units, and 529 cryoprecipitate units were issued, of which 16.8% of RBC, 7.6% of FFP and 9.3% of cryoprecipitate units were returned unused. HTS covered approximately 30% of the work per year. Out of the total number of blood product units, 72% of RBC, 56% of FFP and 48% of cryoprecipitate units were released by HTS. The percentage of returned units was greater for those released by CITM than for those issued by HTS (19% vs. 16% for RBC ; 15% vs. 1.6% for FFP, and 13% vs. 6% for cryoprecipitate units). The proportion of FFP units returned unused decreased from 11% in 2006 to 6% in 2008, and of cryoprecipitate units from 12% in 2006 to 8% in 2008. The policy of waste reduction resulted in 6% reduction in the cost of blood transfusion therapy. Reports on adverse transfusion reactions increased from 3 to 30 cases per year. Our experience showed that hemovigilance as a crucial step in patient safety is a useful tool in assessing and improving the quality of transfusion practice, thus pointing to the role of HTS in quality assurance of transfusion therapy. We have identified the need to improve the present transfusion practice (a high rate of inappropriate plasma utilization, questionable justification of cryoprecipitate administration, non-documented indications for blood component treatment, high rate of blood units returned unused, and under-reported adverse transfusion reactions). Proper education of medical and nursing staff combined with all other activities has resulted in a more appropriate use of blood products, to the benefit of our patients and resources. Improvement of transfusion practice involves not only the entire blood chain, but also the input from the hospital management team, active Hospital Transfusion Committee including all medical personnel, and accepting the concept of overall healthcare improvement.