Efficiency of plasmapheresis: a comparison of three Italian Centres

Background. In order to support the economic and financial sustainability of the Italian health system, there is a need to define technically and economically efficient strategies that assure the self-sufficient apheretic production of plasma. Material and methods. Process and product costs at the Casa del Donatore (CD) in Bologna were determined on the basis of costing models used at Verona's Inter-hospital Department of Transfusional Medicine (IDTM) by academics from the University of Turin and those used at the Marche Regional IDTM by academics from Marche Polytechnic University. During the first phase, data was collected concerning donors, biological screening tests, the number of units produced/discarded, the materials used (individual pharmacy codes and related final expenditure), human resources (number, professional status, time involved, the number of activities per day, percentage productivity), equipment, and general costs. During the second phase, direct costs were verified and the costs common to the units produced were attributed using the functional principle. Results. The overall cost of a litre of plasma collected by means of apherisis (about \u20ac 280) was similar at the three centres, but there were differences in their cost structures that could be attributed to organisational choices, economic factors and/or structural variables. Plasmapheresis accounts for 24% of the plasma collected in Marche and the CD, but 17% of that collected in Verona, whereas the donation index is lower in the CD (1.8) than in the other two centres (2.2). The annual donor screening tests are substantially similar, but there are some differences in their timing (at the time of screening candidate donors or at the time of first donation). There are also some differences in the use of tests that are not required by law but are carried out in order to protect donors and recipients. The working times in three centres are similar, but personnel costs vary because of their different retribution policies. Discussion. Comparing the cost determinants at each centre made it possible to highlight changes that each can make in order to improve efficiency, and may lay the basis for doing the same in other organisational contexts

Adverse reactions to blood donations: the READ project

Background. In 2006 in Italy 2,404,267 donations of blood components were made by 1,539,454 donors; approximately 55% of the donations were collected directly by Transfusion Structures (TS), while about 45% were collected in Donation Centres managed by Associations and Federations of Donors. The aim of the READ (Rilevamento Eventi Avversi alla Donazione) project is to create a network of TS to test a standardised system for monitoring adverse events (AE) related to blood donations. Materials and methods. Shared, standardised data collection forms, compatible with the forms produced by the ISBT-EHN, were prepared. Two types of form were used: (i) a form to collect data on single events (READ 1), to be used at the individual collection sites; (ii) a form for processing the data collected by each TS (READ 2). Results. Between February and August 2008 six TS collected data related to the donation of 89,332 units of blood. Overall, 523 AE were recorded. The AE occurred in 0.59% of the donations. The mean duration of the symptoms was 17 minutes. Fifteen percent of the symptoms were related to the venipuncture (mainly haematomas) and 77% to vasovagal AE. The AE were defined severe (grade C) in 47 cases. The donations in which AE were recorded were completed in 81% of the cases; 59% of the AE did not require treatment. Three donors were monitored briefly (for less than 4 hours) in hospital. Conclusions. The use of standardised forms enabled the collection of data that could be analysed. Some problems related to the performance of the haemovigilance programme did, however, emerge: (i) organisational problems, (ii) limited sensitivity, (iii) inadequate training, and (iv) poorly defined responsibilities. These problems must be resolved at various levels: local, regional and national. \ua9 SIMTI Servizi Srl

Impact of blood source and component manufacturing on neurotrophin content and in vitro cell wound healing

none7noBackground: We evaluated neurotrophin (NF) levels and their impact on in vitro cell wound healing in eye drops from differently prepared blood sources (cord blood [CB], and peripheral blood [PB]) in the same donor, to avoid intrasubject biological variability. Materials and methods: Twenty healthy adult donor PB samples, and twenty CB samples acquired at the time of delivery were processed to obtain serum (S), platelet-rich plasma (PRP), platelet-poor plasma (PPP), and S retrieved from PRP after activation with Ca-gluconate (PRP-R). The levels of brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), glial-derived neurotrophic factor (GDNF), fibroblast growth factor (FGF), and epidermal growth factor (EGF) were assessed with a Luminex xMAP (Luminex Corporation), and by using multikine kits from R&D system, and were statistically analysed in the eight different preparations. The impact of S, PRP, PPP, PRP-R from both sources on a cell line responding to NF supplementation (MIO-M1, UCL Institute of Ophthalmology, London, UK) was tested with a scratch wound assay, and analysed by IncuCyte S3 equipment. Results: All the preparations from CB showed higher NF levels, except for BDNF where no difference was found as compared to PB. PRP showed higher NF levels with respect to S, PPP and PRP-R in this decreasing order. Younger donors in PB contributed with higher NF levels. The scratch assay showed different cell migration results, with a complete wound closure only recorded with the supplementation of CB-S, and a progressive reduction by using PRP, PRP-R, and PPP from both sources. Discussion: Protocols of preparation and choice of blood source determine different NF levels in the final products. The therapeutic use of a natural neurotrophin pool from blood sources might have a clinical impact in several different settings. Efforts are needed to standardise the manufacturing and the product content in order to establish and modulate the posology of the final supplementation.openValente, Sabrina; Curti, Nico; Giampieri, Enrico; Randi, Vanda; Donadei, Chiara; Buzzi, Marina; Versura, PieraValente, Sabrina; Curti, Nico; Giampieri, Enrico; Randi, Vanda; Donadei, Chiara; Buzzi, Marina; Versura, Pier

West Nile virus in Italy: a further threat to blood safety, a further challenge to the blood system

This report describes the epidemiology of WNV in an heavily populated area where this infection appeared recently in horses and humans. In particular, the implementation of a strategy for assuring the safety of blood donation is described. An epidemiological surveillance system directed at the rapid detection of WNV has been established since the last decade in Italy, due to the high diffusion of mosquitoes vectors. This system is based on the monitoring of sentinel animals located in different areas of the country. The data obtained from this activity indicated a possible circulation of WNV in the flat area of the lower Po river valley during the summer of 2008. In September 2008 the first cases of WNV related diseases in horses from this area were confirmed by laboratory investigations at the National Veterinary Reference Centre for exotic disease. Based on these data a surveillance for the human meningo-encephalitis was established. On September 20th 2008, the Laboratory of the Regional Reference Centre for Microbiological Emergency (CRREM), in Bologna, reported the first case of neuro-invasive WNV disease in a female patient living in a small village located in the middle of the area where the horses infection have been reported. This patient suffered from sudden onset of meningo-encephalitis and a specific IgM and IgG response to WNV was identified. Up to mid November 2008, two additional cases of WNV neuro-invasive disease have been identified by CRREM. All these cases have been further confirmed by the National Reference Laboratory for Arboviruses in Rome. As of November 14th 2008, the total number of horses that showed the presence of a specific antibody response to WNV was 354, with 21 animals also positive for viral RNA by RT-PCR. These epidemiological data prompted for the immediate necessity of a system to assess the safety of blood donations harvested in the area of WNV diffusion, that accounts for a total at risk population of about 1.8 millions subjects. Based on guidelines from the National Blood Centre, a nucleic acid amplification test (NAAT) based and CE marked method, (PROCLEIX West Nile Virus, Chiron) was chosen a screening technique by the CRREM in Bologna. Due to the high number of samples, including plasma specimens from donors patients for solid organs and tissues (> 200) that need to be tested per day, this methods has been performed by using the PROCLEIX TIGRIS automated system. Since the beginning of the automated screening testing (October 10th, 2008) more than 6000 plasma samples from blood and organs/tissues donors have been evaluated, with a mean daily number of samples tested of 204. Up to November 15th no positive samples among the blood or organ donors were detected. The use of the automated \u201cwalk-away\u201d instrumentation allowed the release of results within 6 hours from the arrival of the samples and required only one unit of personnel to perform the test. In addition, the results have been reported in a time schedule that fit the requirements for solid organ donation in six cases. The screening activity for the safety assessment of blood and organ donations is presently scheduled until November 30th, due to the seasonal decline of the vectors activity. A plan of activities for the next season is currently under development. The screening season will be from May 1st to November 30th and the activation would be dependent on the results of a seroprevalence studies that has been undertaken by CRREM on a 11.000 blood donors population from the WNV affected area. The identification of the exact sero-prevalence ratio and the geographical distribution of the seropositive population would be extremely useful in order to define the WNV NAAT screening activity for the next vector season

Detection of Specific Antibodies against Toscana Virus among Blood Donors in Northeastern Italy and Correlation with Sand Fly Abundance in 2014

Toscana virus (TOSV) is a Phlebovirus transmitted by phlebotomine sand flies and is an important etiological agent of summer meningitis in the Mediterranean basin. Since TOSV infection is often asymptomatic, we evaluated the seroprevalence in blood donors (BDs) in the Bologna and Ferrara provinces (Northeastern Italy)—the areas with the highest and lowest numbers of TOSV neuroinvasive cases in the region, respectively. A total of 1208 serum samples from BDs were collected in April–June 2014 and evaluated for the presence of specific TOSV-IgG by ELISA. The IgG-reactive samples were confirmed by indirect immunofluorescence assay (IIF) and by microneutralization test (MN). Serum samples were defined as positive for anti-TOSV IgG when reactive by ELISA and by at least one second-level test; TOSV seroprevalence was 6.8% in the Bologna province, while no circulation of TOSV was detected in the Ferrara province. Sand fly abundance in 2014 was also estimated by a geographic information system using a generalized linear model applied to a series of explanatory variables. TOSV seroprevalence rate was strongly associated with the sand fly abundance index in each municipality, pointing out the strong association between sand fly abundance and human exposure to TOSV