Serious Hazards of Transfusion – Aims, Scope and Terms of Reference
Aims of SHOT
· To build an evidence base of transfusion hazards that improves patient safety by
· Providing authoritative information for use by policy making bodies
· Identifying areas of hospital transfusion practice where improvements can be made
· Supporting production of clinical guidelines
· Educating clinical users of blood
· To encourage all hospitals in the UK to participate actively in haemovigilance. Active participation means
· Fostering an open and fair culture.
· Reporting all transfusion related adverse reactions and events to SHOT and/or MHRA as appropriate
· Fully investigating all adverse reactions and events
· Instituting appropriate corrective and preventive action
· To make evidence based and targeted recommendations for improvements in transfusion practice
· To work collaboratively with other bodies with responsibility for transfusion safety i.e. Medicines and Healthcare products Regulatory Agency (MHRA), National Patient safety Agency (NPSA), the CMO’s National Blood Transfusion Committee (NBTC) of England and its counterparts in Scotland, Wales and Northern Ireland, UK Blood Transfusion Services
· To promote international haemovigilance by collaborative working within the European Haemovigilance Network and the International Society of Blood Transfusion Haemovigilance Working Party
Scope of SHOT
· SHOT encompasses all labile blood components issued by the four UK Blood Transfusion Services (the National Blood Service in England, the Scottish National Blood Transfusion Service, the Welsh Blood Service and the Northern Ireland Blood Transfusion Service). Adverse reactions and events related to viral inactivated fresh frozen plasma (FFP) (SD-FFP and MB-FFP) and adverse events (errors) related to administration (or failure of administration) of anti-D Ig are also included.
· SHOT does not receive reports of adverse reactions or events related to other fractionated blood products.
· Confidentiality of individual patients, donors and reporters is assured.
· Participation is voluntary, but strongly endorsed by the Department of Health ‘Better Blood Transfusion’ initiative that recognises the importance of active haemovigilance as part of the UK blood safety strategy.
· The Competent Authority for the Blood Safety and Quality Regulations 2005 is the Medicines and Healthcare products Regulatory Agency (MHRA).
· The UK Transfusion Forum provides funding and resources for SHOT.
· The National Blood Service ‘hosts’ SHOT and provides an infrastructure, i.e. IT, facilities, HR and Finance support.
· The National Medical Co-ordinator is employed by one of the UK Blood Services and is managerially accountable to the UK Forum through its Medical Director. It is essential for SHOT to retain autonomy for professional accountability and that this is independent of the UK Blood Services. For that reason, professional accountability is to the Steering Group through its chair.
· The National Co-ordinator for Transfusion Transmitted Infections is employed jointly by the HPA/NHSBT and is managerially accountable to the NBS Head of Transfusion Microbiology.
· The Steering Group provides professional ownership and strategic direction, monitors the performance of SHOT and is accountable to the UK Forum through the National Medical Co-ordinator for the use of resources and management of the budget.
· The Standing Working Group is responsible for operational matters and reports to the Steering Group.
· The Scheme Manager is responsible for ensuring the effective running of SHOT, in line with budgetary constraints, and is managerially accountable to the National Medical Co-ordinator.
· SHOT is affiliated to the Royal College of Pathologists.
SHOT Steering Group - Terms of Reference
· To be responsible for the professional ownership and strategic direction of the SHOT scheme. Its members will bring to the Steering Group the views of the professional body which they represent, and in turn seek endorsement from their professional body for major changes to the scheme.
· To promote and support SHOT recommendations and activities through their professional networks.
· To support and direct the activities of the SHOT team and Standing Working Group.
· To formulate recommendations based on SHOT findings and ensure that these are endorsed by and disseminated via professional bodies
· To undertake a programme of publications based on SHOT data in peer reviewed scientific journals
· To ensure integrity and confidentiality of the data
· To monitor and encourage participation
· To report to the UK Forum via the National Medical Co-ordinator
· May convene one or more Working Groups for specific functions as required.
· May co-opt additional members as agreed.
· Founding members (individuals involved in the setting up of SHOT) may be invited to remain on the Steering Group, normally for a further 2 years after the end of their term of office.
Membership and Organisation of Meetings
· The Steering Group will meet twice every year.
· Standing Working Group members will be invited to all Steering Group meetings.
· Membership of the Steering Group will consist of nominated representatives of Royal Colleges and professional bodies. The Steering Group will always include the National Co-ordinators, the Scheme Manager, a representative from each of the following: Health Protection Agency, British Committee for Standards in Haematology Transfusion Task Force, the CMO’s NBTC, and the UK Blood Transfusion Services The duration of membership of an individual member will normally be three years, renewable for further three year terms subject to agreement of the body which he/she represents.
· There will be a Chair elected from among the members. This appointment will be held for three years, renewable for further three year terms, but with flexibility to allow some overlap with the incoming Chair. The National Medical Co-ordinator will act as Secretary.
· The budget will be managed by the National Medical Co-ordinator who will provide regular financial reports to the Steering Group.
· Steering Group minutes will be provided to all members of the Standing Working Group and to the Department of Health for information.
SHOT Standing Working Group – Terms of Reference
· To develop an annual work programme for approval by the Steering Group, based on agreed strategic objectives.
· To advise the Steering Group on the functionality of the scheme and new initiatives, taking into account feedback from participants.
· To regularly review definitions and questionnaires and submit proposed changes to the Steering Group for approval.
· To support the National Medical Co-ordinator and Scheme Manager in the writing of the Annual Report, and submit drafts to the Steering Group.
· To cultivate links with haemovigilance schemes internationally.
· To submit all reports, publications and written media communications for approval to the Steering Group.
Membership and Organisation of Meetings
· The Standing Working Group will meet as necessary, but not less than four times a year. Meetings may be held by teleconference.
· The membership will be no more than eight, and will include at least two haematologists with clinical responsibility for transfusion, at least one hospital based transfusion scientist, at least one Specialist Practitioner of Transfusion, at least two blood service consultants, a representative from MHRA and a representative from UK NEQAS Blood Transfusion Laboratory Practice. A representative from NPSA will be co-opted. Duration of membership will normally be three years, renewable for three years.
· In addition the Chair of the Steering Group, the National Co-ordinators and Scheme Manager are members in their own right.
· The National Medical Co-ordinator will be the chair of the group and the Scheme Manager the secretary.
· Appointment of new members and renewal of terms of office must be approved by the Steering Group.
· The Standing Working Group may co-opt members if required, with Steering Group approval.
· Minutes of meetings will be sent to all Steering Group members.