Ten years of hemovigilance reports of transfusion-related acute lung injury in the United Kingdom and the impact of preferential use of male donor plasma.

BACKGROUND AND METHODS: From 1996 through 2006, 195 cases were reported as transfusion-related acute lung injury (TRALI) to the Serious Hazards of Transfusion scheme and from 1999 onward classified by probability, using clinical features and HLA and/or HNA typing. From late 2003, the National Blood Service provided 80 to 90 percent of fresh-frozen plasma (FFP) and plasma for platelet (PLT) pools from male donors. RESULTS: Forty-nine percent of reports were highly likely/probable TRALI, and 51 percent possible/unlikely. Of 96 investigations, donor antibodies recognizing recipient antigens were found in 73 cases (65%), with HLA Class I in 25 of those (40%), HLA Class II antibodies in 38 (62%), and granulocyte antibodies in 12 (17%). A review in 2003 revealed that the TRALI risk/component was 6.9 times higher for FFP and 8.2 times higher for PLTs than for red blood cells, and that in donors of implicated FFP/PLTs, white blood cell antibodies were found 3.6 times more often than by chance (p

Serious hazards of transfusion: a decade of hemovigilance in the UK.

The Serious Hazards of Transfusion (SHOT) scheme is a UK-wide, independent, professionally led hemovigilance system focused on learning from adverse events. SHOT was established in 1996 as a confidential reporting system for significant transfusion-related events, building an evidence base to support blood safety policy decisions, clinical guidelines, clinician education, and improvements in transfusion practice. Recommendations are formulated by an independent steering group drawn from medical royal colleges and professional bodies. Ten years after its inception, SHOT has analyzed 2630 transfusion safety events, published 8 annual reports with recommendations, and presented data nationally and internationally. These recommendations have underpinned key initiatives, in particular the UK Department of Health "Better Blood Transfusion" strategy. SHOT has encouraged open reporting of adverse events and "near-misses" in a supportive, learning culture, vigilance in hospital transfusion practice, and evaluation of information technology to support this process. The importance of education and training has been emphasized. Detailed analysis of events has identified weaknesses in the transfusion chain. A collaborative initiative between SHOT, the Chief Medical Officer for England's National Blood Transfusion Committee, and the National Patient Safety Agency aims to reduce ABO-incompatible transfusions by improving bedside practice. Cumulative SHOT data have documented the decline in transfusion-related graft vs host disease after implementation of leucodepletion and have highlighted transfusion-related acute lung injury and bacterial contamination of platelets as important causes of death and morbidity. The UK blood services have developed strategies to reduce these risks. Future SHOT data will evaluate the success of these and other blood safety improvements.

6 Years of shot reporting--its influence on UK blood safety.

Recognition of the importance of systematic surveillance of adverse effects of transfusion has led to the development of haemovigilance schemes [Faber JC. Haemovigilance around the world. Vox Sang 2002;83(suppl.1):71], of which the Serious Hazards of Transfusion (SHOT) scheme, launched in 1996, was one of the first. Over 90% of UK hospitals now participate in the scheme; in 6 years of reporting, SHOT analysed 1630 events of which 64% were errors in the transfusion process, leading to 193 instances of ABO incompatible transfusion. Transfusion related acute lung injury, bacterial contamination of platelets and transfusion-associated graft-versus-host disease were also identified as important preventable causes of mortality and morbidity. Data from SHOT has provided evidence to support the development of blood safety strategies in the UK.

The impact of universal leukodepletion of the blood supply on hemovigilance reports of posttransfusion purpura and transfusion-associated graft-versus-host disease.

BACKGROUND: The pathogenesis of posttransfusion purpura (PTP) and transfusion-associated graft-versus-host disease (TA-GVHD) involves patient exposure to donor platelets (PLTs) and T lymphocytes, respectively, which are removed during blood component leukodepletion (LD). STUDY DESIGN AND METHODS: Reports of PTP and TA-GVHD to the UK hemovigilance scheme Serious Hazards of Transfusion (SHOT) from 1996 to 2005 were compared before and after implementation of universal LD during 1999. RESULTS: There were 45 reports of PTP, with a mean of 10.3 per year before universal LD and 2.3 per year afterward (p < 0.001). All patients had received red cells, but before universal LD, only 1 of 31 (3%) cases had also received PLTs, compared to 8 of 14 (57%) afterward (p < 0.001). Thirty-four cases (76%) had human platelet antigen (HPA)-1a antibodies, whereas 11 had antibodies to other HPA specificities, only 1 of which occurred after LD. Two cases reported before LD also had heparin-dependent PLT antibodies. There were 13 reports of TA-GVHD, all fatal, of which only 2 cases of undiagnosed immunodeficiency met current UK criteria for irradiated components. Eight others had one or more risk factors: B-cell malignancy (6), steroids (1), fresh blood (1), and donor-recipient HLA haplotype share (4). Eleven cases were due to non-LD and 2 to LD components (p < 0.001). No cases have been reported since 2001. In an additional 405 cases, nonirradiated components were transfused in error to high-risk recipients, mainly on fludarabine, but none developed TA-GVHD. CONCLUSIONS: These findings suggest that universal LD has further reduced the already low risk of TA-GVHD in immunocompetent recipients and has altered the profile of PTP cases.

Errors in transfusion medicine.

In the past two decades, health services in the developed world have directed much resource toward improving the safety of the blood supply. Blood is collected, tested, and processed within a carefully controlled environment, and quality is assured by rigorous donor selection procedures and increasingly sensitive and sophisticated testing for transfusion-transmitted pathogens. Additional safety strategies implemented by some blood services include leukocyte reduction, bacterial screening, and pathogen inactivation. Thus, the transfusion chain from the donor to the point of issue from the blood center is highly regulated and secure, and transfusion-transmitted infection is an increasingly rare event.

Reducing adverse events in blood transfusion.

Against a background of ever increasing expenditure on blood safety, less attention has been paid to improving the safety of the transfusion chain within hospitals. Based on reports to the Serious Hazards of Transfusion (SHOT scheme) between 1996 and 2003, the risk of an error occurring during transfusion of a blood component is estimated at 1:16 500, an ABO incompatible transfusion at 1:100 000 and the risk of death as a result of an 'incorrect blood component transfused' (IBCT) is around 1:1 500 000. There are opportunities for error at a number of critical points in the transfusion chain, starting with the decision to transfuse, prescription and request, patient sampling, pretransfusion testing and finally the collection of the component from the blood refrigerator and administration to the patient, consistently the commonest error in successive SHOT reports. Successive 'Better Blood Transfusion' initiatives and the 2003 Annual Report of the Chief Medical Officer for England have drawn welcome attention to the importance of safe and appropriate transfusion and the National Patient Safety Agency has now set a target of reducing the number of ABO incompatible transfusions by 50% over 3-5 years.