There must be an internal incident reporting system within the Trust to highlight local problems.
A report of all serious adverse reactions, serious adverse events and near misses, both MHRA/SHOT reportable and non MHRA/SHOT reportable, relating to transfusion should be prepared at regular intervals and presented to the Hospital Transfusion Team (HTT), Hospital Transfusion Committee (HTC), Clinical Governance Committee, Clinical Risk Management Team, as appropriate, according to local organisation.
Guidance on Clinical Governance can be found at www.hcsu.org.uk
The Transfusion Practitioner, the HTT or HTC must address recurring problems or omissions in the transfusion process highlighted by adverse events. Any changes necessary or problem areas highlighted must be fed back to the users. This may be incorporated in the Trust Training Program, Clinical Audit and/or Clinical Governance meetings.
SHOT (Serious Hazards of Transfusion) provides a yearly analysis of serious adverse events related to blood transfusion. The Annual report and summary documents are available on the SHOT website.
The SHOT website (www.shotuk.org) also contains a Toolkit/Resources section which contains:
- Root Cause Analysis guide
- Standards for Investigation
- Leaflets - Lessons for Clinical Staff, Lessons for Laboratory Staff
SHOT produce two leaflets:
- - SHOT for children
- - SHOT in obstetrics
These are available at www.shotuk.org/toolkit&resources.htm
SHOT data can be used to inform policy, improve standards and educate users on transfusion hazards and their prevention.
Examples of methods of feedback within Trusts are available from the HoT Special Interest Group via www.bbts.org.uk
Reporting of Serious Adverse Reactions and Serious Adverse Events
Reporting of all serious adverse reactions and serious adverse events to the Competent Authority is mandatory, in order to comply with UK legislation and EU Directives.
Copies of the UK legislation and EU Directives can accessed via:
UKBTS Document Library / EU Directives & Regulations
The Department of Health has designated the MHRA (Medicines and Healthcare products Regulatory Agency) as the UK Competent Authority. To facilitate reporting the MHRA has developed SABRE (Serious Adverse Blood Reactions and Events), an online reporting system that allows drafting, editing, saving and submission of notification and subsequent confirmation of blood related adverse events and reactions. This is a single reporting system allowing Blood Establishments and Blood Banks / Hospital Transfusion Teams to meet not only their regulatory obligations but also to report to SHOT electronically.
Although SABRE provides a single reporting point for both MHRA and SHOT, the reporter is also able to choose to submit a report to only one organisation. Reports can be made in confidence; a SHOT only report cannot be viewed by the MHRA. Similarly, the user must specify if MHRA reports are to be made available to SHOT for review. Information reported using SABRE that is shared with SHOT continues to remain anonymised.
Tracking and Trending of Incidents
It is important for any organisation to be able to ‘track and trend’ adverse incidents as part of the risk management process.
Reporting and looking at incidents in isolation is not enough to detect ‘drift’ and minor deviation from procedures and protocols, which may eventually lead to a critical safety breach.If the same type of incident is being continually reported it should flag up to the organisation that the corrective action and preventative actions (CAPA) system used to deal with a previous incident may not be robust and the preventive action could not be considered to be effective.
Tracking is required to ensure that incidents are being investigated and discussed in a timely manner, that appropriate learning points and corrective actions are considered and applied and that no untoward risks are being ignored or forgotten.
SABRE can be accessed via the SHOT website:www.shotuk.org
SHOT reporting is linked to standards of good practice:
SHOT Near Miss Reporting Pilot 2008
The SHOT definition of Near Miss has been modified in light of comments from a workshop that took place in November 2006. The revised definition is "any error which, if undetected, could result in the determination of a wrong blood group or transfusion of an incorrect component, but was recognised before transfusion took place".
The transfusion process can be divided into three stages and there are some barriers already in place to prevent errors at each phase:-
The Pre-testing phase, where an erroneous request/sample may be rejected, cancelled or amended prior to testing in the Transfusion Laboratory
The Testing phase, where a sample / processing / selection error is detected by the Transfusion Laboratory quality system
The Collection and Administration phase, where collection / transport / storage / identification errors are detected before the patient actually receives the component
Phase 1 of the pilot is looking exclusively at sample errors and the barriers in place to prevent these samples entering the testing process.
If you have any queries or would like more information about this pilot, please contact Tony Davies, Transfusion Liaison Practitoner, firstname.lastname@example.org
Pilot of adverse event reporting for intra and postoperative cell salvage
SHOT in conjunction with the UK Cell Salvage Action Group are collecting reports on incidents which occur in either intraoperative or postoperative cell salvage systems.
The following adverse events are being collected:
- Abandoned procedures due to operator error (incorrect assembly, non IV solutions, incorrect anticoagulant, collection time exceeded)
- Abandoned procedures due to machine failure ( clotted lines/reservoirs, )
- Adverse clinical events (PE, coagulopathy etc)
For further information please contact the SHOT office on 0161 423 4208, by email:
SHOT@nhsbt.nhs.uk or at www.shotuk.org.