Report on the UK Regulation of Blood Safety and Quality 2005 - 2010
The MHRA Haemovigilance Team has prepared a report to share data collated from our Serious Adverse Blood Reactions and Events (SABRE) system. The report presents haemovigilance data for the period from 8 November 2005 (when the current regulations were introduced) to 31 December 2010. Download the report (1231Kb).
In addition to a first review of UK haemovigilance reporting patterns and trends, this document also summarises common findings by MHRA inspectors and provides guidance to support adverse incident investigation.
Our aim is to highlight areas in which improvements may be made to existing blood safety and quality standards, so the report contains highlighted learning points which we hope will be of assistance.
The MHRA and SHOT recently issued a joint statement outlining their commitment to closer collaboration in order to simplify haemovigilance reporting in the UK. A review of 2011 SABRE reporting data will therefore be provided in the forthcoming SHOT annual report to be published in July, 2012.
Joint statement from the MHRA and SHOT
SHOT and the MHRA have produced a joint statement (54Kb) about our plans to work together to find ways to clarify, simplify and rationalise haemovigilance reporting in the UK.
This statement is also available on the SHOT website at www.shotuk.org (external link).
Reporting serious adverse events and serious adverse reactions related to blood and blood components
The UK Blood Safety and Quality Regulations 2005 and the EU Blood Safety Directive require that serious adverse events and serious adverse reactions related to blood and blood components are reported to the MHRA, the UK Competent Authority for blood safety.
From these web-pages Blood Establishments, Blood Banks/Hospital Transfusion Teams can Register and Log In to use the MHRA’s secure and confidential online reporting system. This system allows reporters electronically to submit reports of serious adverse event or serious adverse reaction directly to the MHRA.
This new reporting system is known as SABRE – Serious Adverse Blood Reactions & Events.
Feedback direct to us: email@example.com
Once registered and logged In, healthcare and blood service staff are able to draft and submit initial notifications and subsequent confirmations of adverse events and adverse reactions.
Registered reporters also have access to an online ‘Workspace’ containing a searchable library of all their reports. Reporters will be able to save draft reports, review submitted reports, and submit a confirmation report once their local investigation has been completed.
SABRE does not replace existing local reporting arrangements. If an adverse event or reaction would previously have been reported to local management or to a blood establishment, those arrangements should continue. If information on an event or reaction would previously have been passed to SHOT (see below) that too should continue.
We have updated guidance for blood banks and blood establishments reporting serious adverse events and reactions under the UK Blood Safety and Quality Regulations. This incorporates current advice from the European Commission Working Group on a common approach to the definition of reportable incidents as set out in both the relevant EU Directives and UK Regulations.
Please remember to archive your copies of the original guidance: ‘SABRE - a User Guide’ and ‘Background and Advice on Reporting Serious Adverse Events and Serious Adverse Reactions’.
Enquiries and help
The new online reporting system has been designed to be very simple to use, and incorporates comprehensive online helptext at all stages. However, if at any time reporters require advice or assistance beyond the helptext and guidance documents, staff in the MHRA Adverse Incident Centre will be available to provide assistance.
Enquiries may be made either by email firstname.lastname@example.org or by telephone 020 3080 7336
Reports of Serious Adverse Events and Serious Adverse Reactions should only be submitted via SABRE. Other means of submission should only be considered if SABRE is temporarily unavailable and the report is urgent. In such cases the MHRA Adverse Incident Centre should be contacted for guidance on how to report.
Access to the SHOT reporting system is prompted by your SABRE report.
Reporting to SHOT remains voluntary, but is required for compliance with HSC/2002/009 'Better Blood Transfusion' and is a standard for the Clinical Negligence Scheme for Trusts in England. Active participation in SHOT by all hospitals was recommended by the CMO for England in his 2003 Annual report. A number of blood safety initiatives depend on continuity of SHOT data for monitoring and evaluation and it is therefore vital that hospitals use the SABRE system to continue to report to SHOT.
Enquiries for SHOT may be made either by email email@example.com or by telephone 0161 423 4208.