Introduction to SHOT Transfusion Safety Standards
The SHOT Transfusion Safety Standards have been produced to promote and ensure safe, effective transfusions by identifying risks, implementing strategies that create a safer environment for everyone involved, contributing to better patient outcomes, staff wellbeing and overall system safety.
It is important to recognise that local improvement plans must be identified and implemented to address any non-compliance with any of these standards to optimise transfusion safety. Compliance with these safety standards will be monitored by the relevant external regulatory bodies across UK, not by SHOT.
About SHOT
SHOT is the UK’s independent, professionally-led haemovigilance scheme analysing transfusion errors and reactions submitted annually since 1996 to identify areas for improvement to optimise safety. Haemovigilance reporting and learning from reports submitted contribute to improving patient safety. These reports provide a mechanism to identify risks so that all healthcare organisations can implement interventions to reduce these. Data from SHOT provide valuable information to identify hazards and worthwhile learning opportunities. SHOT collaborate and work closely with Medicines and Healthcare products Regulatory Agency (MHRA) as the regulators and other key transfusion stakeholders to enhance transfusion safety.
Why these standards have been produced
Serial Annual SHOT Reports indicate a worrying trend with >80% of reports related to avoidable errors. Recurring themes in analysed incidents include:
- Staffing issues, with shortages and mismatches with workload, inadequate skill mix, staff retention and recruitment challenges
- Gaps in staff knowledge with no protected training time, accelerated/abbreviated training programmes, poor awareness of the importance and application of human factors
- Inadequately resourced systems – lack of equipment or not fit for purpose
- IT issues: poor implementation, suboptimal staff training, no access to subject matter experts, overreliance on IT, complacency with alert fatigue/warning flags not heeded
- Poor communication within and between teams, especially during handovers
- Failure to listen to patients and families with missed opportunities for engagement
- Ineffective leadership and management, gaps in governance and suboptimal safety culture
To address risks and problems identified, SHOT have been producing recommendations to improve patient safety which are in the annual reports. Prioritisation and implementation of recommendations have been left to individual healthcare organisations, both NHS and independent ones. With limited resources and ongoing challenges, while some recommendations relating to immediate patient safety risks may be implemented, it remains variable with a lack of sustained long-term change and similar themes continuing to be evident in reports analysed year on year. Haemovigilance is an ongoing exercise, and while SHOT monitor the impact and extent of implementation of these recommendations, there is no effector arm for SHOT. Lack of effective implementation of these recommendations, clashing priorities and worsening healthcare challenges post pandemic means that the gaps identified and the recommendations to address them continue to be the same year on year.
The SHOT Transfusion Safety Standards have been produced to address the recurring trends identified from the submitted reports and to embed a proactive approach to enhance safety. Additional drivers for developing these safety standards include recommendations from the Infected Blood Inquiry report, Lord Darzi’s report from an independent investigation of the NHS in England and the Health Services Safety Investigations Body report released in September 2024 ‘Recommendations but no action: improving the effectiveness of quality and safety recommendations in healthcare’. Transfusion safety standards are intended to drive improvement actions to minimise risks, maintain reliability, ensure effectiveness of transfusions and optimise safety for all.
These SHOT Transfusion Safety Standards do not replace, but complement other regulatory or best practice recommendations such as the Blood Safety and Quality Regulations, British Society for Haematology guidelines, UK Transfusion Laboratory Collaborative (UKTLC) Standards and National Institute for Health and Care Excellence (NICE) Transfusion Quality Standards. These standards provide a framework for peer review/self-assessment, compliance check by regulatory organisations and/or national oversight. Where inspection against the SHOT Transfusion Safety Standards show deficiencies, organisations may be requested to demonstrate compliance with these other transfusion requirements.
Scope of the SHOT Transfusion Safety Standards
The standards cover all aspects of the SHOT 10 steps of the transfusion pathway. These include the key elements evident from serial Annual SHOT Reports relating to the clinical and laboratory aspects in healthcare systems that help ensure safe transfusions.
Effective implementation and use of these transfusion safety standards require the following:
- Healthcare leaders and managers to implement policies, processes, and practices to ensure the safe, appropriate, efficient, and effective use of blood components
- Clinicians and laboratory staff to ensure effective and appropriate use of blood components and participate in quality improvement activities, blood safety and quality systems
- Partnering with patients (guardians and carers) in decisions about their management and, if they receive blood components, they do so appropriately and safely
- Provision of adequate resources i.e., financial support, staffing and IT
The following key areas are covered in the SHOT Transfusion Safety Standards:
- Transfusion safety
- Transfusion information technology (IT) and equipment
- Supporting staff to work safely
- Staff education and training
- Safety culture
- Patients as safety partners
- Haemovigilance and risk management
- Governance
Explanation of terms used
Transfusion activities – includes direct patient care, laboratory, quality, regulatory, training, education, advice, IT support.
Blood components This refers to non-fractionated blood components issued by Blood Services (red cells, platelets, FFP, cryoprecipitate, granulocytes). Autologous (intraoperative cell salvage, pre- or post-operative using patients’ own blood) transfusions are also covered by this safety standard. Blood/plasma derived medicinal products are not covered here unless specifically included in SHOT definitions and reporting criteria (such as anti-D immunoglobulin and prothrombin complex concentrates).
Shared care – where a patient is treated/managed by different organisations or treating teams, or laboratory testing is performed by different organisations.
How should these SHOT Transfusion Safety Standards be used
It is important to recognise that local improvement plans must be identified and implemented to address any non-compliance with any of these standards to ensure optimal transfusion safety.
It is expected that compliance level against each of these standards can be recorded locally as either fully compliant/partially compliant or non-compliant with an action plan to address gaps when not fully compliant.
The following actions should be considered:
- Analysis to identify gaps in existing processes and practices against these standards to optimise compliance
- Drafting tangible action plans and prioritise actions based on risks to address gaps
- Monitor progress and benchmark to drive improvements
Feedback and queries
Please email [email protected] if you have any questions relating to these transfusion safety standards.