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• W4321459260 abstract "In 2022, the United Kingdom's Serious Hazards of Transfusion (SHOT) programme celebrated its 25th anniversary [1]. SHOT is not the first haemovigilance system internationally (the first national programme was established in Japan in 1993), but it is one of the best known and most influential. In this Commentary, we summarize some of SHOT's achievements and consider what we can all learn from their experience and findings that will help us into the future. Different definitions of haemovigilance exist, but all capture its broad scope (incorporating blood donor, product and transfusion recipient issues), its centrality to quality management and the importance of the systematic collection, analysis and reporting of robust data to improve blood systems, clinical practice and donor and patient outcomes [2, 3]. Haemovigilance itself has evolved from an initial focus on transfusion-transmitted infections (particularly HIV and hepatitis), which was the impetus for establishment of haemovigilance programmes in many parts of the world, to a much broader approach, as health systems have evolved over recent decades, and in response to lessons learned from haemovigilance itself. Haemovigilance links closely with national blood policy development, with patient blood management and with changes in blood product manufacturing. It also serves as a foundation for research efforts by identifying areas of unmet need and as a mechanism to measure the effects of changes as they are introduced [4]. Many gaps and challenges still exist. For example, evidence-based or consensus definitions for some important complications of donation or transfusion are still lacking or do not align well with the clinical picture—such as for some post-transfusion cardiopulmonary reactions. Frequently, data are incomplete or denominators unavailable, limiting analysis and comparison over time and between systems. Most haemovigilance systems struggle with availability of sufficient resources (people, tools and systems) to do their work effectively. Recommendations are often not taken up into policy or implemented into practice. In this context, it is worth briefly examining some of SHOT's achievements, and what we can all learn, from SHOT's experience. Firstly, let us consider some key elements of governance and structure. SHOT's professional independence enables it to conduct its activities and provide its reports freely and impartially. There is a demonstrated commitment to openness, transparency and reporting of findings, while not identifying or blaming individuals or organizations. Participation is high (see below) and is now professionally mandated. SHOT is affiliated to the UK Royal College of Pathologists (RCPath) and has established links with the UK Health Security Agency Epidemiology Unit (for transfusion-transmitted infection reporting and analysis) and the Medicines and Healthcare products Regulatory Agency (regarding product-focused safety issues). SHOT is managed by a small multidisciplinary team and supported by a wider expert group (see below). There are clear operational and reporting lines, and the programme has recruited (and retained) staff with relevant experience, including from both hospital and blood centre backgrounds and with data management expertise. Sustained funding from the four UK blood services (National Health Service Blood and Transplant [NHSBT, England], Northern Ireland Blood Transfusion Service, Scottish National Blood Transfusion Service and the Welsh Blood Service) has been secured. Some administrative functions are handled by NHSBT, permitting the SHOT team to focus on core activities. One of SHOT's strengths is the close collaboration with, and broad input from, across the professional spectrum (biomedical scientists, nurses, clinicians who prescribe transfusions, representatives of specialist colleges and societies) along with the UK blood services, clinical and laboratory transfusion experts, regulators and health safety experts. Very importantly, lay members, representing the voices of the broader community, have a seat at this table as members of the SHOT Steering Group. Founding members and former directors contribute corporate memory and ongoing advice in honorary roles. SHOT's Working Expert Group provides specialist input to targeted analyses, such as events affecting specific patient groups (e.g., paediatrics or patients with haemoglobin disorders) or settings (such as the emergency department) or specific blood products (such as the use of RhD immunoglobulin in pregnancy). They also serve as liaison with their specialties to provide input and disseminate messages from SHOT. Next, let us consider some of SHOT's activities and outputs. From 169 reports in 1996, more than 4000 cases were reported in 2021 from across the United Kingdom, both from the public (all NHS Trusts/Health Boards submitted at least one report) and private (non-NHS) sectors. Although participation has been very high for years, and is now professionally mandated, this is the first time that complete 100% national participation has been documented [1]. This is important because it gives confidence that SHOT's findings are truly representative of a national picture and that participation is valued and recognized as contributing to practice improvement. As is clear from its name, SHOT analyses reports of serious hazards of transfusion. There are different schools of thought on the ideal scope of haemovigilance reporting, with some systems including all cases of all severity, aiming to ensure a comprehensive picture of all adverse reactions and incidents. This can certainly be helpful in understanding the breadth and scale of potential clinical and procedural complications, as well as ensuring that cases that otherwise might have been missed are not. Many of the contributing factors are similar too, of course, whether serious or minor in consequence; however, this approach also creates a huge workload of cases for investigation that can distract from other, more clinically relevant events, which are SHOT's priorities. ‘Near-miss’ events are also an opportunity to learn, as many of the same factors contribute to these cases as those that result in patient harm; near misses are reportable to SHOT and account for a substantial proportion of cases. Transfusion is a complex process with many steps and interdependencies [1, 5]. SHOT has documented and analysed how human errors and inadequate systems can contribute to both near-miss events and actual incidents, with consequences ranging from no harm to fatal outcomes for patients, and major impact (psychologically and professionally) on staff and other participants. The importance of a safety culture, and a learning culture, to identify and address hazards, is emphasized. SHOT promotes a combined Safety-I and Safety-II approach and recently introduced SHOT-ACE: Acknowledging Continuing Excellence in Transfusion. Recognizing errors and identifying improvement actions to prevent recurrence is the primary focus when incidents are investigated, typical of a Safety-I approach. Safety-II, a more proactive approach, seeks to understand the ability of healthcare staff to adapt to problems and pressures, and considers organizational resilience. It focuses on productivity and ensuring the best possible outcomes. Combining Safety-I and Safety-II approaches helps provide a more holistic understanding of the underlying reasons for errors and procedural violations. Reporting and studying success augment learning, enhance patient outcomes and experience through quality improvement work, and positively impact workplace resilience and culture. The Annual SHOT Report is essential reading for those interested in haemovigilance and the ‘gold standard’ for haemovigilance reports internationally [1]. The effort necessary to compile, analyse, draft, edit and present the annual report—245 pages in 2021—cannot be underestimated, but neither can the value of this rigorous and up-to-date document, written for a broad readership and with concrete recommendations for action to stakeholders. A series of chapters presents analyses of incidents from the past year and relevant cumulative data. De-identified clinical vignettes engage the reader and are highly useful for teaching purposes. Donor haemovigilance data are provided by UK blood service representatives. Sections focus on high-risk areas for attention or topics of interest, and recommendations are framed in a clear, positive and practical way, indicating parties responsible for action. Annual SHOT symposia are open to all interested parties and supported by multiple professional organizations. Some have been collaborations with the International Haemovigilance Network, and for these, International Society of Blood Transfusion (ISBT) has provided ISBT Academy support to enable participants from low- and middle-income countries to attend, resulting in even greater international engagement. The symposia have an educational focus and include reviews of SHOT data and key themes from the annual reports, along with guest speakers and discussions. A communications expert participates in the meeting and distils important points into visual and written messages for wide distribution. SHOT regularly contributes to educational and professional activities, including through regional transfusion committee meetings, RCPath and other collaborative events, and peer-reviewed publications. SHOT's comprehensive website and social media presence help raise awareness of activities and findings. SHOT contributed to the ISBT-World Health Organization project to curate haemovigilance tools and resources and make these readily available to facilitate strengthening haemovigilance activities worldwide. These will be continuously updated and expanded to provide a comprehensive library of resources [2]. So, in summary, important messages from SHOT's 25-year experience are about being inclusive, collaborative and open to sharing resources and findings, with a focus on learning and practice improvement. It is also clear that haemovigilance takes time: SHOT is still making many of the same recommendations it has been making since the initial report in 1996, and many problems that prompted the establishment of haemovigilance programmes are still with us. However, much progress has been made in both understanding and improving transfusion safety, and SHOT has been a major contributor to this effort, across the United Kingdom and around the world. Congratulations to SHOT on this important anniversary—and to everyone working in haemovigilance internationally. This work is vital and must continue. The authors acknowledge Dr Shruthi Narayan, Serious Hazards of Transfusion Medical Director, for helpful discussions. E.M.W. wrote the first draft of the manuscript. All authors reviewed and edited the manuscript. Open access publishing facilitated by Monash University, as part of the Wiley - Monash University agreement via the Council of Australian University Librarians. The authors received no specific funding for this work. No conflict of interest is identified by the authors. Data sharing is not applicable to this article as no new data were created or analysed in this study." @default.
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• W4321459260 date "2023-02-20" @default.
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• W4321459260 title "Haemovigilance: Giving it our best <scp>SHOT</scp>!" @default.
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