[Blood transfusion and supply chain management safety]. / Transfusion sanguine : la sécurité de la chaîne.

The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments.

Residual risk and retrospective analysis of transfusion-transmitted bacterial infection reported by the French National Hemovigilance Network from 2000 to 2008.

BACKGROUND: Regarding blood safety, transfusion-transmitted bacterial infection (TTBI) remains the most frequent infectious risk. The incidence of these episodes needs to be assessed and updated frequently to accurately manage this risk. STUDY DESIGN AND METHODS: TTBIs were reported by the French network of local correspondents in each hospital and blood center. The regional coordinator managed the investigation. A multidisciplinary expert group from the French National Agency of Medicine and Health Products Safety (ANSM) analyzed each TTBI according to a standardized scale of imputability and severity. Only cases with likely or certain imputability are reported in this study. RESULTS: In France, 18.0 × 10(6) red blood cell (RBC) products, 1.94 × 10(6) platelet concentrates (PCs), and 2.44 × 10(6) fresh-frozen plasma units were transfused throughout 2000 to 2008. The incidence of TTBI was 2.45, 24.7, and 0.39 per million blood components (BCs), PCs, and RBCs, respectively. For PCs, the incidences of severe (vital threat or death) and fatal TTBI were 13.4 and 5.14 per million, respectively. PCs were responsible for 87% of TTBIs. A total of 66.7% of the implicated bacteria were Gram positive, most of them belonging to the normal skin flora. A total of 33.3% of the other implicated bacteria were Gram negative. CONCLUSION: The French hemovigilance system provides an accurate estimate of the TTBI incidence during a period with diversion and improving skin disinfection but without bacterial detection screening. This tool would be able to evaluate further additional safety procedures like bacterial screening and pathogen reduction technology.

Transfusion-related acute lung injury: reports to the French Hemovigilance Network 2007 through 2008.

BACKGROUND: Transfusion-related acute lung injury (TRALI) is a major cause of transfusion-related mortality and morbidity. Epidemiologic studies using data from national transfusion schemes can help achieve a better understanding of TRALI incidence. STUDY DESIGN AND METHODS: A multidisciplinary working group analyzed TRALI cases extracted from the French Hemovigilance Network Database (2007-2008). All notified cases were reviewed for diagnosis. Those meeting the Canadian Consensus Conference criteria for TRALI were classified according to imputability to transfusion and clinical severity. Patient data (clinical characteristics, number and types of products transfused, and serology results) were obtained. RESULTS: There were 62 TRALI cases and 23 possible TRALI cases during the 2-year period. An immune-mediated mechanism was identified in 30 of 50 TRALI cases with complete serology. TRALI was considered to be the cause of death in 7.1% of patients and might have contributed to death in an additional 9.4% of TRALI or possible TRALI patients. Occurrence ranked high in obstetrics (15%), after surgery (34%), and in hematologic malignancies (21%). Single-donor high-plasma-volume components were involved in half of the cases where the implicated blood product could be determined and carried the highest risk per component (1:31,000 for single-donor fresh-frozen plasma units and apheresis platelet [PLT] concentrates, and 1:173,000 for red blood cells). No incident could be definitively related to the transfusion of solvent/detergent-treated pooled plasma (>200,000 units transfused), nor to pooled PLT concentrates. CONCLUSION: The proportion of TRALI cases related to plasma-rich components was lower than previously described.

Epidemiology of Transfusion Related Acute Lung Injury in France: Preliminary Results.

SUMMARY: The French Hemovigilance Network has been established in 1994 and records all adverse events associated with the transfusion of a labile blood products (LBP) regardless of their severity. From 1994 to 2006 35,423,172 LBP were issued, 85,812 adverse transfusion reactions notified, and 139 cases of transfusion related acute lung injury (TRALI) observed. The LBP most at risk is fresh frozen plasma (FFP), followed by platelets concentrates (PC) and packed red cells (PRC). However, because the use of FFP is not frequent in France, it only accounts for about 10% of TRALI, whereas PRC and PC are involved in the remaining cases. In no case, pooled FFP treated with solvent-detergent were involved. Patients' profiles are peculiar with a high disease burden. Therefore, targeting a prevention policy only on FFP would result in a marginal reduction of TRALI in France.

French Haemovigilance Data on Platelet Transfusion.

SUMMARY: The Agence Française de Securite Sanitaire des Produits de Santé (Afssaps; French Health Products Safety Agency) is responsible, through its hemovigilance unit, for the organization and the functioning of the national hemovigilance network. In accordance with the French law, it receives all data on adverse transfusion reactions regardless of their severity. With the aim of evaluating the tolerance of two kinds of labile blood products (LBP), pooled platelet concentrates (PP) and apheresis platelet concentrates (APC), we screened the French national database from January 1, 2000 to December 31, 2006. We observed that the number of transfusion incident reports is more than twice as high with APC (8.61:1,000 LBP) than with PP (4.21:1,000 LBP). The difference between these two ratios is statistically significant as shown by chi-square test (e = 21.00 with α = 5%). The risk to suffer adverse reactions of any type, except for alloimmunization, is higher with APC, and the major type of diagnosis related to APC is allergic reaction (1:200 APC issued) even if those allergic reactions are rarely serious. The new French National Hemovigilance Commission should impel a working group evaluating this topic and above all the impact of additive solutions which have been used since 2005 to put forward preventives measures.