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Clinical Risk reduction, safety and quality improving of Italian Healthcare System (SSN) services, is nowadays a National priority and Transfusion medicine is one of the most interesting intervention areas. Due to high complexity of transfusion process, characterized by various checks, analysis and handlings of blood assets, probability of human errors is the most dangerous. Infectious exposure and mismatch between patient and assigned blood component group are the most serious transfusion risks.
Recent international studies reveal that pre-analytical and clinical errors, which include incorrect ABO bedside testing and mistaken or missing patient identity check, represents about 80% of total adverse events (Ahrens, Pruss, et al., 2005). Particularly, “Acute Haemolytic Reaction” has deadly consequences in about 10% of cases (De Sanctis Lucentini, Marconi, et al., 2004). Statistical data of ABO-incompatible RBC transfusions incidence are relevant in different countries (rarely data are collected with standard procedures): Germany 1:36000; USA (New York) 1:38000; France 1:135207 (including autologous blood); Ireland 1:71428 (Ahrens, Pruss, et al., 2005).
Viral transmission has been reduced since the early ’90, thanks to the introduction of compulsory tests based on sierology and Nucleic Acid Amplification Technique (NAT). Estimates of the risk per unit of blood in the post-NAT era are approximately 1:1,900,000 for HIV and 1:1,600,000 for HCV (Goodnough 2003).
Error rate reduction is the key factor for service quality and safety enhancing.
A very important aspect for the success of the work consists in adopting the appropriate operational methodology for the analysis of the current and revised processes. In this field, the FMECA (Failure Modes and Effects Analysis Criticalities) is a valuable and tested tool, not only for the analysis of processes transfusion (Trucco, Cavallin 2010; Gianino, Finiguerra, et al., 2008) but also for the study of clinical risk in sensitive hospital areas (Coles 2006) and for the administration of drugs (Saizy-Callaert, Causse, et al., 2002).
Italian Hospitals are facing the need to update organizational processes, in order to contain operating costs, to increase efficiency level, and to improve service quality. Internal supply chain management is one of the main aspects: many Healthcare facilities have recently started to study systematically supply chain organization in order to detect criticalities and wastes.
An hospital supply chain includes handling and storage activities related to logistics assets and information flow management. In blood supply chain, logistic assets are test tubes, blood bags and paper or electronic supports that properly ensure the “vein to vein” traceability, starting from the acquisition of the donor's blood, till the transfusion. The study of blood supply chain aims to provide a proper service level to the patient, consistent with associated costs. “All hospital processes must be integrated organizing around the needs of the patient rather than being segregated in their respective functions that harbor them” (Nicholson 1995).
The issue of security in hospital ward procedures is worldwide topical. Currently hospital management trend is to use the latest technologies, complemented by a re-engineering of procedures, in order to increase control level and to minimize human error probability.
Nowadays in healthcare settings, particularly in transfusion medicine, traceability systems can be classified as follows:
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Systems based on traditional paper forms and registers, manually compiled.
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Bar-code technology based Systems.
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RFID technology based Systems.