Haemovigilance Scheme Research Articles

SHOT UK Collaborative Reviewing and Reforming IT Processes in Transfusion (SCRIPT) survey: Laboratory information management systems: Are we ready for digital transformation?

To understand the use, functionality and interoperability of laboratory information management systems (LIMS) in UK transfusion laboratories. LIMS are widely used to support safe transfusion practice. LIMS have the potential to reduce the risk of laboratory error using algorithms, flags and alerts that support compliance with best practice guidelines and regulatory standards. Reporting to Serious Hazards of Transfusion (SHOT), the United Kingdom (UK) haemovigilance scheme, has identified cases where the LIMS could have prevented errors but did not. Shared care of patients across different organisations and the development of pathology networks has raised challenges relating to interoperability of IT systems both within, and between, organisations. A survey was distributed to all SHOT-reporting organisations to understand the current state of LIMS in the UK, prevalence of expertise in transfusion IT, and barriers to progress. Survey questions covered LIMS interoperability with other IT systems used in the healthcare setting. A variety of LIMS and version numbers are in use in transfusion laboratories, LIMS are not always updated due to resource constraints. Respondents identified interoperability and improved functionality as the main requirements for transfusion safety. A nationally agreed set of minimum standards for transfusion LIMS is required for safe practice. Adequate resources, training and expertise should be provided to support the effective use and timely updates of LIMS. A single LIMS solution should be in place for transfusion laboratories working within a network and interoperability with other systems should be explored to further improve practice.

Guideline on the investigation and management of acute transfusion reactions.

Guideline on the investigation and management of acute transfusion reactions.

Management of Thrombosis in High-Risk Patients: Focus on Cancer-Associated Thrombosis

This symposium took place during the International Society on Thrombosis and Haemostasis (ISTH) Congress, 2022. Ajay Kakkar, Thrombosis Research Institute, London, UK, opened the symposium by highlighting the extent to which patients with cancer are affected by thrombotic disease. Subsequently, Mari Thomas, University College London, UK, described the current treatment options for patients with cancer-associated thrombosis (CAT). Thomas highlighted the current unmet needs faced by these patients, with the risk of bleeding continuing to be the main issue affecting anticoagulation treatment. Paula Bolton-Maggs, University of Manchester, UK, and UK Haemovigilance Scheme, Manchester, UK, gave an overview of Factor XI (FXI) inhibition and outlined why this factor is a potential attractive anticoagulation drug target. Multiple therapies targeting FXI are currently in development, with seven clinical trials published to date.1-7 Although there are some similarities between these agents, there are also many differences in terms of their administration route and frequency, the timing of onset of action, and methods of metabolism and excretion. Giancarlo Agnelli, University of Perugia, Italy, and Istituti Clinici Scientifici (ICS) Maugeri, Pavia-Milan, Italy, then described the importance of conducting clinical trials that are designed to address the unmet needs of patients with CAT. In particular, he highlighted the ongoing Phase III ASTER and MAGNOLIA studies that are aiming to demonstrate that the FXI inhibitor abelacimab is superior to standard of care treatments in terms of bleeding rates for patients with CAT, including those with gastrointestinal (GI) or genitourinary (GU) tumours. Concluding remarks were given by Gary Raskob, University of Oklahoma Health Sciences Center, Oklahoma City, USA, who re-emphasised the unmet needs in the treatment of CAT, and the promise that FXI inhibitors hold for the future.

Safe handovers: Safe patients-why good quality structured handovers in the transfusion laboratory are important.

Effective transfer of information relating to patient care is vital in healthcare. In the UK formal handover is an established and well reported process in the clinical setting but less so in transfusion laboratories. Blood transfusions occur within many hospital specialities and across clinical and laboratory staff shifts, making robust handover critical for safe practice. Failure to adequately transfer information relating to pending or ongoing provision of blood components during shift handover in the laboratory can have an adverse impact on patient care. To identify transfusion errors where laboratory handover was considered a contributory factor. Serious adverse events and reactions reported to the UK haemovigilance scheme, Serious Hazards of Transfusion (SHOT), involving handover in the transfusion laboratory were reviewed for a 6-year period. Laboratory incidents involving handover were mainly associated with incorrect blood component transfused-specific requirements not met (IBCT-SRNM) and delays in provision of blood components transfusion, with 16.6% of these cases involving major haemorrhage situations. Handover was found to be insufficient in most cases, no handover was completed in 29.5% of cases, inadequate written handover accounted for 14.8% cases, and inadequate verbal for 5.7% of cases. Poor handover can lead to laboratory errors, particularly delays in provision of blood components. Embedding effective handover processes in the laboratory and including handover time within the shift working pattern, may help reduce errors and ensure continuity of care. Handover should be considered a task that is built into laboratory routine practices, ensuring effective transfer of information and appropriate follow up actions are taken. SHOT have created a handover template which can be adopted in laboratories to formalise this process.

Missed irradiation of cellular blood components for vulnerable patients: Insights from 10 years of SHOT data.

BackgroundIrradiation of cellular blood components is recommended for patients at risk of transfusion‐associated graft‐vs‐host disease (TA‐GvHD). Prestorage leucodepletion (LD) of blood components is standard in the UK since 1999.Study Design and MethodsAnalysis of 10 years' reports from UK national hemovigilance scheme, Serious Hazards of Transfusion (2010‐2019), where patients failed to receive irradiated components when indicated according to British Society for Haematology guidelines (2011).ResultsThere were 956 incidents of failure to receive irradiated components all due to errors. One hundred and seventy two incidents were excluded from analysis, 125 of 172 (72.7%) because of missing essential information. No cases of TA‐GvHD were reported in this cohort. The 784 patients received 2809 components (number unknown for 67 incidents). Most failures occurred in patients treated with purine analogues (365) or alemtuzumab (69), or with a history of Hodgkin lymphoma (HL) (192). Together these make up 626 of 784 (79.9%). Poor communication is an important cause of errors.ConclusionLeucodepletion appears to reduce the risk for TA‐GvHD. None of 12 cases of TA‐GvHD reported to SHOT prior to introduction of LD occurred in patients with conditions recommended for irradiated components by current guidelines. Irradiation indefinitely for all stages of HL is not based on good evidence and is a difficult guideline to follow. Further research on long‐term immune function in HL is required. Variation between different national guidelines reflects the very limited evidence.

Staffing in hospital transfusion laboratories: UKTLC surveys show cause for concern.

To monitor minimum standards in hospital transfusion laboratories in relation to qualifications, training, competency and the use of information technology over time against published recommendations. The United Kingdom Transfusion Laboratory Collaborative was formed in 2006 with representatives from relevant organisations and has published standards for transfusion laboratory practice. The standards are set to ensure safe transfusion laboratory practice. Regular surveys are performed to see the extent to which laboratories are able to meet these standards and where any problems lie. An electronic survey is sent to hospital transfusion laboratories on a single mid-week day in the spring and is repeated every 2 years from 2011, to be completed by the lead in transfusion for the day. The questions cover staffing, training, funding and workload. Transfusion laboratories are having difficulty with staffing, particularly recruitment of suitably trained biomedical scientists, and with funding and time for training and education. Laboratory errors reported to the Serious Hazards of Transfusion haemovigilance scheme (SHOT) have not decreased with time, related to the under-resourced workforce. Problems in laboratory staffing and expertise in hospital transfusion laboratories need to be urgently addressed. The transfusion laboratory provides a key service to hospitals. The Blood Services in England and Wales are developing supportive strategies.

Obstetric intra-operative cell salvage: a review of an established cell salvage service with 1170 re-infused cases.

The use of cell salvage during caesarean section has been increasing steadily, although there are concerns relating to cost, a perceived risk of amniotic fluid embolism, and fetal red cell sensitisation. We present observational data from almost a decade of use of intra-operative cell salvage in obstetrics. By the end of this period, we set up cell salvage collection for >98% of all caesarean sections. From 2008 to 2017, 1170 women have had a re-infusion of cell salvaged blood with no clinical safety concerns; the median (IQR [range]) volume was 231 (154-306 [80-1690]) ml. During this time there has been a marked reduction in the number of women who were transfused allogeneic blood, as well as the amount of blood transfused. In total, 647 (55%) women have had alloimmunisation testing, with two positive cases. Quality control data indicate that the quality of blood processed from partial first bowls is no worse than that from full bowls. We discuss the costs of providing this service with regard to: staffing costs; single suction; leucodepletion filters; selectivity in the processing of collected blood; and the use of partial first bowls.

Are the 'rules' for times in set up and duration of red cell transfusion too strict?

To discover if any adverse clinical effects have been reported to the UK haemovigilance scheme, Serious Hazards of Transfusion (SHOT) relating to delays in set up of transfusion or extended transfusion time for red cell units. Current guidance for duration of transfusion is based on outdated studies that do not reflect current UK Blood Service practices. Recent evidence suggests that the '30-min rule' could be extended without adverse effects. Aggregated data from reports to SHOT covering a 5-year period (2010-2014) were reviewed in order to identify adverse clinical outcomes related to delay in set up of a red cell transfusion of more than 30 min after removal from cold storage, or total transfusion time of longer than 5 h. Five years of data from SHOT shows that there were no adverse clinical events related to delays in setting up transfusion or extended transfusion time between 2010 and 2014. There were a total of 382 reports which included 143 delays in set-up, and 239 episodes where transfusion took longer than 5 h. Delays in set up of transfusion and extended transfusion time did not result in any adverse clinical outcomes. Current guidance may be too stringent and lead to increased wastage.

The Example of the UK SHOT Haemovigilance System

SHOT (Serious Hazards of Transfusion scheme) is the UK’s National confidential haemovigilance system, and was set up in 1996. It is an independent, confidential, professionally led haemovigilance scheme. Initially the reporting was voluntary but now required by several professional bodies. SHOT publishes annual reports with recommendations and circulates to all relevant organizations including the 4 UK Blood services, Departments of Health in England, Wales, Scotland and Northern Ireland, all relevant professional bodies and reporting hospitals. Over the 17 years of reporting, the evidence gathered has prompted changes in transfusion practice from the selection and management of donors to changes in hospital practice, better education and training. Acute transfusion reactions and transfusion-associated circulatory overload carry the highest risk for morbidity and death. Greatest risk to patients remain errors in the process at the point of blood sampling, in the laboratory and at bedside administration. SHOT’s objectives are to use findings to improve standards of hospital transfusion practice, to educate users on transfusion hazards and prevention, to aid production of clinical guidelines in blood transfusion and to inform national policy on transfusion safety. MHRA is the UK competent authority to which serious adverse reactions and events have to be reported annually. Overall the most common adverse incidents are caused by errors, resulting in the transfusion of an incorrect component or one that does not meet the specific requirements of the patient (e.g. not irradiated or not appropriately antigen matched). TACO (transfusion associated circulatory overload) accounts for most deaths and major morbidity reported to SHOT but is overall underreported. Transfusions are not always given appropriately. This may be due to wrong haemoglobin results, failure to assess patients appropriately, or avoidable use of emergency O RhD negative units because of poor communication or planning. Review of cases of haemolytic transfusion reactions (HTR) shows that they are observed mainly in Sickle Cell Disease patients. HTR are associated with major morbidity (10/16 cases in sickle cell patients over 3 years) and death (a child in 2010). SCD patients are at particular risk of alloimmunization and this can be reduced by red cell phenotyping prior to the first transfusion followed by routine matching for at least the Rh and Kell groups. SHOT output data led over the time to the development of strategies to improve transfusion safety such as the implementation of guidelines for improving practice, implementation of the National Comparative Audit of Blood Transfusion programme, the publication of the Better blood transfusion initiatives and the establishment of The UK transfusion laboratory collaborative.

Bullet points from SHOT: key messages and recommendations from the Annual SHOT Report 2013.

Transfusion MedicineVolume 24, Issue 4 p. 197-203 CONFERENCE REPORT Bullet points from SHOT: key messages and recommendations from the Annual SHOT Report 2013 P. H. B. Bolton-Maggs, Corresponding Author P. H. B. Bolton-Maggs Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Manchester, UK Correspondence: Paula H. B. Bolton-Maggs, Medical Director, Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Plymouth Grove, Manchester M13 9LL, UK. Tel.: +44 (0)161 4234208; fax: +44(0)1614234395; e-mail: paula.bolton-maggs@nhsbt.nhs.ukSearch for more papers by this author P. H. B. Bolton-Maggs, Corresponding Author P. H. B. Bolton-Maggs Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Manchester, UK Correspondence: Paula H. B. Bolton-Maggs, Medical Director, Serious Hazards of Transfusion UK haemovigilance scheme, Manchester Blood Centre, Plymouth Grove, Manchester M13 9LL, UK. Tel.: +44 (0)161 4234208; fax: +44(0)1614234395; e-mail: paula.bolton-maggs@nhsbt.nhs.ukSearch for more papers by this author First published: 13 August 2014 https://doi.org/10.1111/tme.12142Citations: 22Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Citing Literature Volume24, Issue4August 2014Pages 197-203 RelatedInformation

BCSH guideline for the use of anti-D immunoglobulin for the prevention of haemolytic disease of the fetus and newborn.

BCSH guideline for the use of anti-D immunoglobulin for the prevention of haemolytic disease of the fetus and newborn.

Errors in anti‐D immunoglobulin administration: retrospective analysis of 15 years of reports to the UK confidential haemovigilance scheme

To highlight the errors associated with the use of anti-D immunoglobulin in RhD antigen-negative women, and their resultant clinical impact during and after pregnancy, and to suggest strategies to reduce these errors. Retrospective review of cumulative reporting to the UK confidential haemovigilance scheme, Serious Hazards of Transfusion (SHOT), between 1996 and 2011. Obstetric departments in the UK. Mothers who require anti-D immunoglobulin to prevent RhD sensitisation during pregnancy or after birth. Hospital transfusion teams reported adverse events to the SHOT database. Reported number of events and their causes, and morbidity and mortality associated with errors. In 15years of reporting, SHOT haemovigilance has shown a total of 1211 errors related to the administration of anti-D immunoglobulin, particularly regarding omission or late administration (157/249 or 63% reported in 2011). Anti-D immunoglobulin errors comprised 13.7% (249/1815) of all SHOT reports in 2011. Failure to recognise women who already have RhD sensitisation occurred in 19 cases, and was followed by suboptimal monitoring of the pregnancy. Nine of the infants suffered haemolytic disease of the fetus and newborn (HDFN): one resulted in neonatal death and three required red cell transfusion. Babies as well as their mothers remain at risk from avoidable errors. More active attention at national and local levels to further education and training, particularly for midwives, is an absolute necessity. We recommend the use of a SHOT-devised anti-D administration flowchart, adapted locally into a checklist, to help reduce errors.

Rational use of blood: how to do it?

Rational use of blood: how to do it?

Guidelines for pre‐transfusion compatibility procedures in blood transfusion laboratories

Guidelines for pre‐transfusion compatibility procedures in blood transfusion laboratories

What Has SHOT Told Us and What Are We Doing About It?

The UK haemovigilance scheme Serious Hazards of Transfusion (SHOT) has just issued its 7th report. Particpiation remains high, and is now actively encouraged by the Dept of Health. The main areas of concern over this period have been hospital errors, bacterial contamination, and more recently transfusion-related acute lung injury (TRALI). Post-transfusion purpura and transfusion-associated graft-versus-host disease, which were already uncommon, have virtually disappeared since universal leucocyte depletion in 1999. To minimise hospital errors, new guidelines for blood administration have been issued, and hospitals are trialling bar code equipment from patient wrists bands and blood fridges, which presents implementation challenges. SHOT is working with the new National Patient Safety Agency on further measures to reduce errors. Bacterial reduction is being approached in a stepwise manner, with new 2-stage donor arm cleansing being rolled out, and blood bag divert pouches now universal. Bacterial screening and pathogen reduction remain under consideration. Review of donors and components associated with TRALI cases showed a strong association between HLA- or HNA- positive female donors and ‘high plasma’ components (FFP and platelets). Therefore we are moving towards ‘male only’ FFP, and approach which requires neither donor testing or deferral. We have achieved 90% success so far, and some centres also use male plasma for suspension of buffy coat pools. Additional options for platelets including additive solution are being considered. Future haemovigilance data will assess the impact of these initiatives.

Ninety-six suspected transfusion related acute lung injury cases: Investigation findings and clinical outcome

Transfusion related acute lung injury (TRALI) is one of the complications of blood transfusion and can result in major morbidity or mortality. The diagnosis depends upon the application of strict clinical criteria defining acute lung injury (ALI) and a temporal relationship to blood transfusion. We present the clinical and immunogenetic findings of 96 suspected TRALI cases investigated between 1996 and 2004. During this time period the national haemovigilance scheme (UK) defined TRALI as a reaction occurring either during or within 24 h of blood transfusion. Using clinical, laboratory and post mortem evidence, 64/96 cases could be defined as TRALI in our series. Sensitive techniques were employed to screen for HLA class I, class II and granulocyte specific antibodies in donor serum. Donor derived antibodies were detected in 58/64 (90%) of cases. Recipient derived DNA or cells were not always available but incompatibility was confirmed by the presence of the cognate antigen on recipient leucocytes or by crossmatching in 47/64 (73%) of cases. Cases referred prior to 2001 were not tested for HLA class II antibodies. By applying strict clinical criteria and using sensitive techniques a white blood cell antibody mediated immunological pathophysiology can be implicated in the majority TRALI cases.

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

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). 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. 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. 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.

Setting Up the Hemovigilance Scheme in Ireland

SUMMARyThe international tragedy surrounding the infection of the blood supply by human immunodeficiency virus (HIV) in the 1980s, together with the recognition of the increasing morbidity associated with hepatitis C virus (HCV) and the accompanying paradigm shift in transfusion medicine led to the development of hemovigilance in a number of countries. In Ireland, the infection of women with HCV through anti‐D immunoglobulin, and hemophilia patients with HIV and HCV from factor concentrates, ensured that hemovigilance would be adopted as a high priority.The hemovigilance system in Ireland was launched in October 1999 under the National Haemovigilance Office (NHO). In the initial stages of development, the possibility of drawing on the experience of two well‐developed systems already in operation, SHOT and the French hemovigilance system, was a huge advantage. Reports are collected on an anonymous basis using similar, though not identical, categorization of incidents to the UK system. A key feature borrowed from the French hemovigilance scheme was the decision to appoint a Transfusion Safety Officer (TSO) in each hospital or group of smaller hospitals.The in‐depth analysis of individual incidents, coupled with the review of incidents showing common features, generates recommendations to improve transfusion practice. By drawing attention to a systemic approach to eliminating error rather than by promoting a blame culture, the hemovigilance scheme has the capacity, if implemented appropriately, to improve overall patient safety which extends well beyond the transfusion process itself.

Administration of blood transfusions to adults in general hospital settings: a review of the literature.

The Serious Hazards of Transfusion (SHOT) haemovigilance scheme for the United Kingdom and Republic of Ireland has clearly indicated that there are avoidable risks to which recipients of blood transfusion are exposed. Sometimes errors in practice have led to serious and even fatal consequences, particularly when a haemolytic response occurs due to an incompatible transfusion. Despite the risks, blood transfusion is an important and frequently life-saving therapy and its use in clinical practice is common. This paper discusses recently published national guidelines for the care of recipients of blood transfusion in the light of a review of the literature relevant to the administration of blood transfusions to adults in general hospital settings. Recommendations for practitioners, managers and teachers are offered in relation to preventing errors and to patient care associated with blood transfusion in the context of contemporary emphasis upon evidence based care.

Administration of blood transfusions to adults in general hospital settings: a review of the literature

• The Serious Hazards of Transfusion (SHOT) haemovigilance scheme for the United Kingdom and Republic of Ireland has clearly indicated that there are avoidable risks to which recipients of blood transfusion are exposed.• Sometimes errors in practice have led to serious and even fatal consequences, particularly when a haemolytic response occurs due to an incompatible transfusion.• Despite the risks, blood transfusion is an important and frequently life‐saving therapy and its use in clinical practice is common.• This paper discusses recently published national guidelines for the care of recipients of blood transfusion in the light of a review of the literature relevant to the administration of blood transfusions to adults in general hospital settings.• Recommendations for practitioners, managers and teachers are offered in relation to preventing errors and to patient care associated with blood transfusion in the context of contemporary emphasis upon evidence based care.