Registration numbers have not significantly changed since last year. 25 sites yet to report but these are very small hospitals (< 1000 units / year) or facilities.
Notes that there are twice as many SAEs as SARs and the number of excluded reports is declining year on year, (most of these are clinical incidents or involve prescription of anti-D).
Reporters are good at notifying but close out in a timely manner is more problematic.
- Notification – as soon as known.
- If unable to complete within 30 days you are asked to keep the SABRE team informed.
The number of SAE reports for 2010 is 930.
In the category of other these are mostly comprised of:
- IBCT (missing special requirements).
- Component labelling errors.
- Pre-transfusion testing errors.
- Expired components available for transfusion.
- Data entry errors.
Future plans for SABRE team:
- Feedback to reporters and incident trend analysis. This will include input from inspectors with common inspection findings.
- Informal site visits and provide local trend analysis.
- Sessions at Regional Transfusion Meetings.
- Enhanced collaboration with MHRA inspectors with development of risk based signalling from SABRE to inspectors.
- Obtaining comparative data from Europe.
Blood Compliance Report
New excel based templates for both HBBs and facilities. Documents will be published on MHRA site by 25 March and for submission by 30 April 2011.
- Similar to the HBB version but shorter and no free text responses.
- Similar to 2010 with data validation prompts to ensure correct type of response.
- Format improvements.
- No risk score formulae in stakeholder version.
- New pre-transfusion testing section incorporating E1.
- The MHRA will be able to see links to summaries of previous assessments and SABRE information.
The following graphs are based on the top 10 deficiencies by % of those raised in critical and major deficiencies
Data from 38 inspections completed.
New categories noted in the top 10 are:
- Self inspection.
- Computerised document control (This is not normally a fault of the system but in how the system is managed and used).
New categories noted for BEA.
- Complaints and Recall.
- Process validation.
- Maintenance of equipment.
- Quality Management
The Coalition Government’s Regulatory Agenda for Better Regulation. In order to ensure optimum use of resources, a number of hospital blood banks initially identified as 'higher risk' during the 2010/2011 BCR assessment process were asked to provide additional information for assessment, before a decision to perform an inspection was made. The purpose of this was to assess to what degree the individual blood banks were taking responsibility for issues identified in the compliance report and a detailed CAPA was requested to demonstrate how the level of risk identified was being mitigated.
The BCR assessment process for 2011/2012 is expected to follow the same approach. As in previous years, the BCR report template has been further enhanced and will be available shortly on the MHRA website. BCR submissions will be assessed by a trained team of GMP Inspectors and both 'higher risk' and 'control' sites will be identified for a more detailed review. At this point, depending on any mitigating factors, the sites will either be inspected or further information and associated CAPA plans requested before a decision to inspect is taken, thus encouraging sites to take greater responsibility for their own compliance. The actual number of blood banks that will be inspected in 2011/2012 is unknown at this point and will depend on the number of sites identified for detailed review and the quality of responses received from requests for further information. This approach ensures that compliance is verified in a robust and efficient manner that maximises resources and is consistent with the Agency and wider Government initiatives for Better Regulation.
A copy of the presentation will be available in due course.
FAQs on EI
Several questions have been raised in response to the MHRA guidance paper on EI. The answers to these questions will be placed on the MHRA website in the next few weeks.
Head of QA and RC