Operational Impact Group – Update Report
The following information was supplied to the MHRA Blood Consultative Committee (BCC)
Some SABRE access problems are still being encountered where reporters are using non-broadband connections or old versions of Internet Explorer. The SABRE Helpdesk can be contacted for advice on resolving these or other SABRE issues. Work is ongoing with the SHOT interface and this should be completed and working very soon. The folders application for organising work will soon be implemented. Also, the ability for users to search for incidents will be available. The Frequently Asked Questions (FAQ) has been updated.
Statistics end of December 2006.
||MHRA & SHOT
|| includes 107 sent to MHRA only, but subsequently copied to SHOT or non-SHOT reportable
SABRE reports submitted by Country:-
||Serious Adverse Reactions
||Serious Adverse Events
SAEs : Reporting issues
- incorrect storage in clinical area
- special requirements not requested by prescriber
- incorrect unit collected from issue fridge by non BB staff
- wrong sample/labelling in clinical area
- bedside blood administration practice
SAEs : Reporting issues
- wrongly categorised on SABRE form
- responsibility for correction before submission of figures to EU
- “whole blood collection” does not mean phlebotomy of patients
- “apheresis” does not mean an event relating to an apheresis platelet pack
- “testing of donations” does not mean testing of patient samples
- “processing” does not mean incorrect selection of processed component e.g irradiated
- “distribution”…needs clarification. Does it mean carrying around hospital by non BB staff
The definition for non “serious” reactions is still not clear and this needs further clarification. Currently only excluding those reports where transfusion continues or finishes uninterrupted.
BCC Adverse Events sub-group
“A sub committee will be set up under the auspices of the Blood Consultative Committee. This will review any detailed operational issues relating to SABRE. It will also discuss any technical points related to the reporting of serious adverse reactions and events. This will be a primary focus for discussions between the MHRA and SHOT.”
Update on Inspections
- 54 inspections completed, including the 6 previously assigned as compliant.
- 1 site voluntarily agreed to “cease and desist”, following a critical Quality Systems deficiency
- 1 site has a critical deficiency – traceability
- 1 site has a critical deficiency – poorly controlled site relocation
- The previously observed trend in common major deficiencies (QMS, validation, equipment maintenance, documentation, traceability and controlled temperature storage) has continued.
- Three sites, with the critical deficiencies, have been referred for possible Regulatory Action following the Critical findings.
The Blood Compliance Report template was reviewed by the Blood Inspectors in light of experiences from the first round of assessments, and inspection findings.
Changes were made to:
- Improve guidance to sites
- Provide improved structure and detail to questions
- Address areas of weakness identified during inspections, to assist sites in achieving compliance with BSQR
- Questions re-structured to more effectively assess common areas of deficiency identified during site inspections.
- References are provided to BSQR 2005, EU Directives and EU GMP, to assist sites in understanding the requirements, enabling them to best demonstrate their compliance.
- Greater detail required in responses.
- References to applicable site SOPs required.
This new version is available on the MHRA website.
A critical finding is either:
- Where evidence is found of patient harm or a serious potential for patient harm.
- A significant deficiency from the Blood Safety and Quality regulations and Good Practices
What happens when one is found?
- Firstly the inspector will stop the inspection and inform the bank Management that it is believed that a deficiency is likely to be classified as critical.
- The inspector will then work with the bank to try to establish evidence for the critical findings or hopefully to mitigate the criticality of the findings (at this point the Agenda will no longer be followed).
- At the end of the inspection the Inspector will hold the usual closeout meeting and will confirm that a deficiency or deficiencies are classified as critical (it is a good idea for senior Management to be represented at this meeting).
- At the close out meeting the Bank Management can offer to voluntarily suspend operations effected by the critical finding
After the inspection
- The Inspector will refer the inspection to a group called the “Inspection Action Group (IAG).
- They will review the Inspectors findings and will decide whether they agree that the finding is critical.
- Then what actions will be taken next (this will take into account any commitments made by the Bank at the close out meeting or post inspection).
What actions can be taken?
Depending on the response from the Bank Management, IAG can decide on a number of actions:
- Keep a watching brief on the case but take no immediate action.
- Recommend notice to suspend the Bank authorisation with respect to specific elements of the bank process.
- Recommend full suspension of the bank authorisation.
- All actions will take into account the likely risk of the bank continuing to supply against the risk caused by the deficiency
The blood bank corrective action plan will be monitored by the IAG and the initial Inspector. This will usually be followed by a repeat inspection to ensure effective implementation of the actions committed to and then closure of the inspection.
Examples of critical deficiencies raised:
- Lack of a traceability system
- Issuing of incorrect blood type
- Failure to control significant changes such that the Bank can no longer assure the quality of the components issued.
This list is not exhaustive. Critical deficiencies are based on an assessment of risk to public health at the time of inspection, and may be affected by other contributing factors.
Temperature settings and monitoring
Looking in detail at 12 Inspections
- 8 “Major” observations
- 2 “Other” observations
Deficiencies can be broken down to issues with:
- Temperature Limits
- Equipment management
- Documented records
- Alarms set at 2 to 8°C, not the required 4°C +/- 2°C
- Alarm set at 1.5°C contrary to the required lower storage condition of 2°C.
- Access to change the limits in the monitoring system is not controlled.
- The temperature monitoring of the laboratory…… indicates that the required storage conditions for the room (ie. 18 to 25°C) is not maintained. This is unacceptable for the platelets which are required to be at 22°C +/- 2°C but are agitated in the open laboratory with no controls.
- Alarm challenged through opening the fridge door and witnessing the temperature rise. No audible alarm occurred. The Digital display read 15°C; the BMS record was in excess of 8°C.
- The theatre fridge alarm was challenged during the inspection and failed to result in an audible alarm.
- At the time of the inspection it was not possible to confirm the alarm conditions for the Theatre fridge.
- The buzzer on the Theatre fridge has been silenced.
- The alarm for the Ward / Theatre fridge was set off and no response was obtained from the switch board within approximately 10 to 15 minutes
- There is currently no programme / schedule for planned maintenance / calibration.
- The blood storage fridges are not temperature mapped or calibrated.
- The calibration records for the fridges / freezer do not state the accuracy to which the calibration is carried out.
- The Calibration certificates for the fridges have not been reviewed / signed by a member of the laboratory staff to ensure that any potential issues have been identified and addressed – For example the most recent Calibration certificate for the Ward / Theatre fridge showed a 0.8°C difference pre and post calibration.
- The Calibration of the Blood Bank fridges is to an uncertainty of +/- 3°C.
- Various laboratory documents give the upper limit for the blood storage as 8°C.
- Display chart for the blood bank showed a trace of 6.5°C to 7°C for the week of the inspection. This is outside the required 2 – 6°C limit. Charts since this time have been reviewed and approved without the excursion being noticed.
- The records for the back up fridge had the ink fail from 5 Aug to week starting 2 Oct. There was no link to a laboratory incident, there was no assessment as to the suitability of the storage at this time for the Blood components.
- The temperature chart records for the blood stock fridge appeared to be missing for 30 May to 6 Jun 06 and dual sets of data appeared to be present with no explanation for 15 / 17 Jun and 6 / 7 Jul 06.
The Expectation of the inspectors are:
- Meet the temperature storage requirements - 4°C +/- 2°C or 22°C +/- 2°C
- Know what your Alarms are set at and why – Challenge them periodically (with an increase in temperature where possible). Document this.
- Annual maintenance / Calibration
- Temperature map all blood storage fridges
- Calibration (to at least +/-0.5 °C)
- Review the Calibration certificate – be able to trace calibration of testing equipment to National Standard
- Address any non conformances (ie. Record, investigate and assess the impact)
- Review the temperature record charts – sign and date to show who checked them – investigate any non conformances