Serious Adverse Blood Reactions & Events (SABRE)

Report serious adverse events (SAE) and serious adverse reactions (SAR) related to blood and blood components

This system is for:

  • blood establishments
  • hospital blood banks / facilities

This is MHRA’s secure and confidential online reporting system.

 

 

As a registered reporter, your online ‘workspace’ has a searchable library of all your reports. You can:

  • save draft reports
  • review submitted reports
  • submit a confirmation report once your local investigation has been completed.

SABRE does not replace your local reporting arrangements.

Enquiries and help
Contact us by email sabre@mhra.gsi.gov.uk or by telephone on 020 3080 7336.

You should always report SAEs and SARs via SABRE.
If SABRE is temporarily unavailable and the report is urgent, contact us on telephone 020 3080 7080 for guidance on how to report.

Guidance
'User guide for mandatory haemovigilance reporting in the UKPDF file (opens in new window) (634Kb)' is our guidance on reporting SAEs and SARs.
This incorporates current advice from the European Commission working group on a common approach to the definition of reportable incidents as set out in the relevant EU directives and UK regulations.

SHOT (Serious Hazards Of Transfusion)
Reporting to SHOT (external link) is done through a SABRE report.

A number of blood safety initiatives depend on continuity of SHOT data for monitoring and evaluation and it is therefore vital that hospitals keep reporting to SHOT.

The CMO for England recommends that all hospitals make SHOT reports.

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.

Enquiries for SHOT
Email: shot@nhsbt.nhs.uk
Telephone: 0161 423 4208

Joint statement from the MHRA and SHOT
SHOT and the MHRA  produced a joint statementPDF file (opens in new window) (54Kb) about our plans to work together to find ways to clarify, simplify and rationalise haemovigilance reporting in the UK.
 

Report on the UK Regulation of Blood Safety and Quality 2005 - 2010

We published this reportPDF file (opens in new window) (1231Kb) in March 2012, presenting haemovigilance data collected by SABRE.

It reviews reporting patterns and trends, summarises common findings by MHRA inspectors and provides guidance to support adverse incident investigation.


Page last modified: 13 October 2014