SHOT Annual Report 2009 - Serious Hazards of Transfusion

2. SHOT – The UK Haemovigilance Scheme
SHOT, established in 1996, is the UK’s professionally led haemovigilance scheme for the reporting of transfusion-related
adverse events and reactions.
SHOT’s goal is to improve transfusion safety by haemovigilance. Through the involvement of the Royal Colleges and
other professional bodies, the UK blood services and the four departments of health, the annual SHOT report provides
authoritative data and evidence-based recommendations, for use by policy making bodies to:
a) improve patient safety through the improvement of standards of hospital transfusion practice;
b) aid in the production of clinical guidelines for the use of blood components;
c) educate users on transfusion hazards and their prevention;
d) identify new trends or patterns in adverse incidents which can be influenced by new safety interventions or
further assessed by research and audit.
SHOT reports are entered by reporters onto a live database, designed in collaboration with Dendrite Clinical Systems
and implemented on 4 th January 2010. This is accessed via the front pages of the SABRE (Serious Adverse Blood
Reactions and Events) online system, developed and shared with MHRA.
SHOT is regarded as the international ‘gold standard’ in haemovigilance and a model to other countries worldwide in
the establishment of haemovigilance systems.
SHOT is integrated into the International Haemovigilance Network (IHN), which seeks to improve and standardise
haemovigilance practice, allows for benchmarking between countries, shares good practice, and offers support and
resource for nations developing haemovigilance for the first time.
SHOT annual reports, presentations at annual educational symposia and all other publications are available on its
website: www.shotuk.org.
Legal requirement for haemovigilance data
The MHRA was appointed as the Competent Authority to implement the EU Blood Safety Directive 1 and the Blood Safety
and Quality Regulations (BSQR) 2005, 2 the UK transposition of the EU Directive, on behalf of the Secretary of State. In
its regulatory role, the MHRA emphasises the place of the quality management system (QMS) in blood establishments
and hospital transfusion laboratories, and its legislative remit extends to the point where the transfusion laboratory
responsibility ends.
The BSQR require that serious adverse events (SAEs) and serious adverse reactions (SARs) related to blood and blood
components are reported to the Competent Authority for annual submission to the European Union (EU). A relatively
small part of the overall remit of MHRA in relation to the BSQR is to collect headline figures for transfusion-related
adverse events and reactions.
Thus, since 8 th November 2005, all suspected SARs and SAEs relating to the quality and safety of blood and blood
components must be reported to the MHRA. Reports are submitted to the MHRA through the statutory SABRE online
reporting system. MHRA data are not available prior to 2005 as the BSQR and SABRE only came into being in 2005.
The SHOT report is published annually in June or July to coincide with the requirement under the BSQR 2005 for the
annualised UK haemovigilance data to be sent to the EU Commission. MHRA is responsible for collating their SAR and
SAE reports, and the Adverse Events subgroup of the MHRA’s Blood Consultative Committee (chaired by the SHOT
Medical Director) then conducts a reconciliation between SHOT and MHRA figures before the data for the EU are finally
submitted.
2. SHOT – The UK Haemovigilance Scheme
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