SHOT’s Terms of Reference
SHOT (Serious Hazards of Transfusion) is the United Kingdom’s independent, professionally led, confidential enquiry into the serious hazards of transfusion.
Purpose of SHOT
SHOT collects information on transfusion reactions and adverse events from all healthcare organisations in the United Kingdom that are involved in the process of blood transfusion.
SHOT investigates the contribution of deficiencies in the transfusion process to serious adverse patient outcomes.
SHOT identifies areas where laboratory and clinical practice need to be improved and makes appropriate recommendations for changes that will improve outcomes for patients.
SHOT providers authoritative data to inform policy in blood transfusion.
SHOT supports the production of clinical guidelines in blood transfusion.
SHOT undertakes research, studies and audit in the area of transfusion safety, and this may be solely, collaboratively or by commission.
SHOT provides and encourages education on all facets of transfusion safety and the management of transfusion reactions as relevant to all personnel involved in the blood transfusion process.
Scope of SHOT
SHOT encompasses all labile blood components issued by the 4 UK Blood Transfusion Services (NHS Blood & Transplant, Scottish National Blood Transfusion Service, Welsh Blood Service and Northern Ireland Blood Transfusion Service), the Ministry of Defence and the Blood Services in the Crown Dependencies. Reactions and events related to all forms of autologous transfusion, including cell salvage, are included.
Adverse reactions and events related to virus inactivated fresh frozen plasma (FFP) (solvent detergent (SD-FFP) and methylene-blue treated (MB-FFP)) and adverse events (errors) related to administration (or failure of administration) of anti-D Ig (immunoglobulin) are also included.
New types of components regularly become available and SHOT will undertake to collect adverse events on all or any of these which are considered by the SG to be within the scope of SHOT.
SHOT does not receive reports of adverse reactions or events related to other fractionated blood products e.g. coagulation factors, albumin, IVIg etc.
Confidentiality of patients and donors is assured.
Relationship to other bodies
SHOT aims to work collaboratively with other bodies with responsibility for transfusion safety e.g. Medicines and Healthcare products Regulatory Agency (MHRA), the National Patient Safety Agency (NPSA), the CMO’s National Blood Transfusion Committee (NBTC) of England and its counterparts in Scotland, Wales and Northern Ireland, the 4 UK Blood Transfusion Services, the Department of Health Blood Policy Unit and the Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO).
The Competent Authority for the Blood Safety and Quality Regulations UK (2005) is the Medicines and Healthcare products Regulatory Agency (MHRA).
SHOT aims to promote international haemovigilance by collaborative working within the European Haemovigilance Network (soon to become the International Haemovigilance Network), the International Society of Blood Transfusion (via its haemovigilance working party), and the European Commission via its Competent Authorities Haemovigilance Sub Committee.
SHOT has reciprocal representation on the British Committee for Standards in Haematology (BCSH) Transfusion Task Force.
SHOT Structure and Funding
SHOT is funded by the 4 UK Blood Services via the UK Transfusion Forum.
NHSBT currently ‘hosts’ SHOT and provides resources such as office space, and services such as IT, human resources and finance support.
SHOT consists of the SHOT office team, the Working Expert Group (WEG) and the Steering Group (SG).
Steering Group
The Steering Group (SG) provides professional ownership and strategic direction, monitors the performance of SHOT and is accountable to the UK Forum through the Medical Director for the use of resources and management of the budget. Membership of the Steering Group will consist of nominated representatives of the Royal Colleges and other professional bodies. The Steering Group will always include the Medical Director, National Co-ordinator for Transfusion Transmitted Infections, the Operations Manager, and a representative from each of the following: Health Protection Agency, a Consultant specialist in Transfusion Microbiology, BCSH Transfusion Task Force, the CMO’s National Blood Transfusion Committee (NBTC), and the UK Blood Transfusion Forum.
It is also desirable that membership of the Steering Group includes a representative of each of the following: the Institute of Biomedical Science, the NHS Confederation, Royal College of Anaesthetists, the Royal College of Pathologists, the British Society for Haematology, the Royal College of Obstetricians and Gynaecologists, the Royal College of Surgeons, the Royal College of Nursing and the Royal College of Midwives, the Intensive Care Society, the Royal College of Emergency Medicine, the British Society of Gastroenterology, the Faculty of Public Health, and a co-opted representative from the National Patient Safety Agency and MHRA. The Steering Group should also include a lay member.
The duration of membership of an individual member will normally be 3 years renewable for further 3 year terms subject to agreement with the body which he/she represents. Founder members may remain on the SG for an additional 2 years with the agreement of the Group, and retiring members will be invited to stay for a maximum of 2 years beyond retirement. A chair is elected from among the members. This appointment will be held at 3 years renewable for further 3 year terms, but with flexibility to allow some overlap with the incoming chair. The Medical Director acts as secretary for the Steering Group.
The Steering Group meets face to face twice every year.
The Steering Group will also incorporate the Working Expert Group (WEG).
Members of the SG will bring to the meeting the views of the professional body which they represent and in turn seek endorsement from their professional body of major initiatives of the SHOT scheme. The WEG will develop some themes for each SG meeting and the SG will bring items and ideas for strategic development from their own professional bodies.
The SG will also be responsible for:
- Formulating the recommendations based on SHOT findings and ensuring that these are endorsed and disseminated via professional bodies
- Promoting and supporting SHOT recommendations and activities through their professional networks
- Ensuring the integrity and confidentiality of the data
- Monitoring and encouraging participation in UK haemovigilance
The SG may also convene working groups for specific functions as required and co-opt additional members as agreed.
Founder members (individuals involved in the setting up of SHOT) may be invited to remain on the SG normally for a further two years after the end of their term of office.
SG minutes will be provided to all members of the SG and to the Department of Health for information.
Working Expert Group
This replaces the previous Standing Working Group.
The WEG incorporates the concept of an Expert Panel and all members of WEG will also be members of the Steering Group therefore meeting face to face twice per year at the full Steering Group meeting. In addition the WEG will meet face to face on a further two occasions without the rest of the SG. The WEG will have a teleconference 4/6 weeks before the main SG meeting. The WEG therefore will meet 6 times per year, twice by telecon, twice on their own and twice with the rest of the SG. Minutes of all WEG meetings will be sent to all SG members.
The WEG is responsible for:
- Analysing the data that have been reported to SHOT and for writing the annual SHOT report.
- Developing an annual work programme to be approved by the SG based on agreed strategic objectives.
- Advising the SG on the functionality of the scheme and any new initiatives in development.
- In addition to the production of the annual data, members of the WEG will, together with members of the SHOT office team, produce papers for publication in scientific journals, on behalf of the SG.
- The WEG will initiate research, studies and audits alone and in collaboration with other bodies some of which may be task and finish and some of which will be ongoing projects.
- The WEG will be responsible for ensuring that all data produced by SHOT is published and disseminated appropriately to fulfil the stated purpose of SHOT in improving the safety of the transfusion process and standards of hospital transfusion practice.
- The WEG will regularly review definitions and questionnaires and submit proposed changes to the Steering Group for endorsement.
The WEG membership will be no more than 10 and will include at least 2 Haematologists with clinical responsibility of transfusion, at least one hospital based Transfusion Scientist and Transfusion Practitioner, a Blood Service Consultant, a representative from UK NEQAS Blood Transfusion Laboratory Practice and a member with expertise in paediatric medicine. It must be ensured that the expertise within the Group covers the main areas of SHOT reporting.
The SG chair and all members of the SHOT office team, namely the Medical Director, the Operations Manager, the Research Analyst, the Laboratory Incidents Specialist and the Clinical Incidents Specialist, will be members of the WEG in their own right. The SHOT Transfusion Liaison Practitioner (joint post with Hospital Liaison) and the National Co-ordinator for Transfusion Transmitted Infections will also be members of the WEG in their own right.
The Medical Director will be the chair of the group and the secretary, one of the other members of the SHOT office team (the Operations Manager, the Research Analyst, the Laboratory Incidents Specialist or the Clinical Incidents Specialist.)
The election of new members and renewal of terms of office will be approved by the Steering Group.
The WEG may co-opt members as required with SG approval.
SHOT office team
This comprises the Medical Director, the Operations Manager, the Research Analyst, the Laboratory Incidents Specialist, the Clinical Incidents Specialist, the Transfusion Liaison Practitioner, and two Information Officers.
The day to day management of SHOT is undertaken by the Medical Director and the Operations Manager (see organogram). The SHOT office team will publish a regular newsletter.
Accountability
The Medical Director of SHOT is employed by one of the UK Blood Services and is managerially accountable to the UK Forum. It is essential for SHOT to retain autonomy for professional accountability and that it is independent of the UK Blood Services. For that reason professional accountability of the Medical Director is to the Steering Group through its Chair.
The National Co-ordinator for Transfusion Transmitted Infections is employed jointly by the HPA and the NHSBT and is managerially accountable to the Consultant in Epidemiology and Health Protection at the HPA.
SHOT is affiliated to the Royal College of Pathologists.