SHOT 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, please click here for our privacy notice, and click here for our ‘Fair processing statement – information for patients’.

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 provides 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.

SHOT Mission Statement

To improve patient safety in blood transfusion.

SHOT Aims

Improve standards of hospital transfusion practice
Educate users on transfusion hazards and their prevention
Aid production of clinical guidelines
Inform policy within the UK Blood Services
Inform national policy on transfusion safety within the UK
Inform Europe about transfusion safety in the UK

SHOT Objectives

Collect and analyse information on transfusion reactions and adverse events from all healthcare organisations in theUnited Kingdomthat are involved in the process of blood transfusion.
Provide authoritative data and recommendations based on these data, which are disseminated widely.
Investigate the contribution of deficiencies in the transfusion process to serious adverse patient outcomes.
Identify areas where laboratory and clinical practice need to be improved and make appropriate recommendations for changes that will improve outcomes for patients.
Provide and encourage education on all facets of transfusion safety and the management of transfusion reactions as relevant to all personnel involved in the blood transfusion process.
Undertake research, studies and audit in the area of transfusion safety, and this may be solely, collaboratively or by commission.

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) 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 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 Steering Group (SG) and the Working Expert Group (WEG).

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 theRoyalCollegesand other professional bodies. The Steering Group will always include

SHOT Medical Director (MD)
National Co-ordinator for Infectious Diseases
SHOT Operations Manager

Plus a representative from each of the following.

Health Protection Agency
Consultant specialist in Transfusion Microbiology
BCSH Transfusion Task Force
CMO’s National Blood Transfusion Committee (NBTC)
UKTransfusion Forum.

It is also desirable that membership of the Steering Group includes a representative of each of the following:

Institute of Biomedical Science
British Blood Transfusion Society
NHS Confederation
Royal College of Anaesthetists
Royal College of Pathologists
British Society for Haematology
Royal Collegeof Obstetricians and Gynaecologists
Royal College of Surgeons
Royal College of Physicians
Royal College ofNursing
Royal College of Midwives
Royal College of Paediatrics and Child Health
Intensive Care Society
College of Emergency Medicine
British Society of Gastroenterology
Faculty of Public Health
Defence Medical Services
Scottish Clinical Transfusion Advisory Committee
Clinical Advisory Group, Wales
Northern Ireland Regional Transfusion Committee
A lay member
Co-opted representatives from other groups as appropriate

As an NHS organisation, SHOT is obliged to apply financial guidelines from the NHS to potential claims from Steering Group members for expenses:

Members who are representing external bodies should receive their expenses from the organisation they represent.
All other members, except those employed by NHSBT, may reclaim expenses from SHOT directly.
NHSBT manage SHOT’s budget, therefore Steering Group members employed by NHSBT should claim from their own cost centre and may request a cross-charge to SHOT.

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 and former SHOT MDs may remain on the SG for an additional 2 years or until they retire with the agreement of the Group and may then become honorary members, retaining access to the SG area of website if they wish. A chair is elected from among the members. This appointment will be held for 3 years renewable for further 3 year terms, but with flexibility to act as an ex officio chair to allow some overlap with the incoming chair. To enable the chair to focus on chair duties, the Royal College/professional body represented by the chair may be requested to nominate another representative during the chair’s term of office.

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 inUKhaemovigilance

The SG may also convene working groups for specific functions as required and co-opt additional members as agreed.

SG minutes will be provided to all members of the SG and to the Department of Health for information.

Publications Sub-group

A publications group will be formed, which will be a sub-group of the Steering Group. The aim of this group will be to produce academic papers, using SHOT data, for submission to peer reviewed journals. The activity and membership of this

sub-group will be reviewed on a 3 yearly basis.

Working Expert Group

The WEG incorporates the concept of an Expert Panel and all members of the WEG are an integral part of the Steering Group. In addition to Steering Group meetings the WEG will meet on at least 4 further occasions (possibly some by teleconference) without the rest of the SG. Further ad hoc and sub-group meetings may be held as required.

Minutes of WEG meetings will be sent to 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 and in conjunction with the Publications Sub-group, 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 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 include the core SHOT team and other experts as appropriate, comprising at least:

2 Haematologists with clinical responsibility for transfusion
At least one each of hospital-based Transfusion Scientist and Transfusion Practitioner
At least one Blood Service Consultant
A representative from UK NEQAS Blood Transfusion Laboratory Practice
A member with expertise in paediatric transfusion medicine.
The SHOT National Co-ordinator for Infectious Diseases

It must be ensured that the expertise within the Group covers the main areas of SHOT reporting, so other members will be co-opted as required

As an NHS organisation, SHOT is obliged to apply financial guidelines from the NHS to potential claims from Steering Group members for expenses, which may be paid by SHOT:

Members employed within the Blood Services or within the NHS UK-wide, including devolved health services, should claim from their employers, who may reclaim it from SHOT via NHSBT.
NHSBT manage SHOT’s budget, therefore Steering Group members employed by NHSBT should claim from their own cost centre and may request a cross-charge to SHOT.

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.

5 Year SHOT Strategy 2020-2024

5 Year SHOT Strategy