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Safeguarding public health
Blood Bank Inspections
Common Deficiencies
Stephen Grayson
Medicines Inspector, GMP
July 2008
© Crown copyright 2005
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Stephen Grayson
Slide 2
1st July 2008
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Quality Systems Deficiencies
•
The Quality Management System remains insufficiently resourced,
and was not fit for purpose in all areas. At the time of inspection, the
operation of the Quality Management System was reliant upon one
person taking responsibility for a significant number of functions. A
number of systems placed inappropriate reliance upon personal
historical knowledge, rather than using a robust, documented
approach.
•
A number of GMP deficiencies and Regulatory Non-compliances have
not been adequately addressed, despite their identification during the
previous MHRA inspection.
Stephen Grayson
Slide 3
1st July 2008
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Quality Systems Deficiencies
•
-
The Quality system was deficient in that:
There was no Validation procedure
There was no Change Control procedure
There was no Corrective and Preventative action procedure
There was no procedure to describe how to perform internal recalls,
and the external recall procedure was not easily accessible.
•
Many core quality system procedures had been absent until just prior
to the inspection. The number of records available for review to
demonstrate compliance was subsequently very limited.
•
The self inspection system does not effectively ensure compliance
with the BSQR’s and EU GMP, as evidenced by the large number of
significant deviations reported during this inspection.
Stephen Grayson
Slide 4
1st July 2008
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Recall / Notification of SAE and SAR
Deficiencies
•
An SAE/SAR may be notified to the laboratory >48hrs after the event
due to delays inherent in the hospital incident reporting system, thus
investigations and remedial actions, including the potential recall of
other implicated components, can be significantly delayed.
•
A Trust Incident report relating to transfusion reaction raised one year
prior to the inspection had not been progressed or reported to SABRE.
•
There was no requirement within the procedures to periodically
challenge the recall system to ensure that it is accurate, efficient and
verifiable for the withdrawal from distribution of blood or blood
components
Stephen Grayson
Slide 5
1st July 2008
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Validation and Change Control
Deficiencies
•
Validation is not routinely performed for critical system changes, for
example no validation or qualification work was performed following
the software upgrade on the Laboratory Information System.
•
The Change Control system was ineffective as evidenced by the
introduction of the Laboratory Information System where the system
did not identify the requirement for SOP’s and training to be completed
prior to the go live date.
•
Interfaces between the computerised systems were not validated
•
The new laboratory information system was not appropriate for use in
the blood bank as evidenced by the large number of manual
workarounds embedded, e.g. electronic issue.
Stephen Grayson
Slide 6
1st July 2008
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Training System Deficiencies
•
Task-based training (to each SOP) was found to be incomplete; some
SOPs were noted to have no record of staff training at all. The
laboratory cannot therefore demonstrate staff awareness of relevant
procedures. A significant number of SOP training records were dated
immediately prior to the inspection, despite the SOPs having become
effective 7 months earlier.
•
Training responsibilities for the single Transfusion Practitioner (SPoT)
included over 3000 personnel. This is considered to be an inadequate
resource for this function.
•
The recently appointed laboratory deputy has not received
appropriate training due to stated operational issues
Stephen Grayson
Slide 7
1st July 2008
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Training System Deficiencies
•
Several examples were observed where training could not
be demonstrated to key quality system and operational
procedures.
•
Not all ancillary staff had been trained (e.g. porters), and
systems for ensuring that all such personnel are trained do
not exist.
•
It was noted on several occasions that procedures and
schedules were not being complied with.
Stephen Grayson
Slide 8
1st July 2008
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Documentation Deficiencies
•
The record retention policy was not formally stated and therefore it
was unclear whether electronic or paper records were to be held for
the period required by the Blood Safety and Quality regulations, as
amended.
•
Procedures within the laboratory did not reflect the use of current
equipment, and were lacking in that insufficient instruction was
available.
•
There were many examples of procedures observed that had not been
reviewed in accordance with the specified review dates.
•
Poor documentation practice was observed in several areas with
missing entries, correction fluid use, deletions / corrections,
overwriting and pencil being used extensively on GMP documents.
•
Unstable Thermographic / pressure temperature chart paper was in
use on one satellite blood bank inspected. The unstable nature of the
recording medium was demonstrated with charts approximately 2
years old being barely readable.
Stephen Grayson
Slide 9
1st July 2008
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Traceability Deficiencies
•
100% vein to vein traceability is not performed. Reported traceability
figures are from an audit of ca.1% of component issues, which
cannot in their own right be positively confirmed as transfused.
•
The blood ledger forms returned to the blood bank from the wards
do not positively identify whether defined units have been
transfused.
•
Auto-fating of components is used extensively
•
No procedure was available to describe the traceability system, and
up to 2 weeks before the inspection all issued units were auto-fated
as transfused if not returned to the laboratory.
Stephen Grayson
Slide 10
1st July 2008
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Traceability Deficiencies
• The traceability figures quoted were on a mass balance basis rather
than a positive confirmation of transfusion for each unit issued from the
blood bank.
• Three of the sample of Transfusion Prescription and Record Sheets
reviewed showed components as transfused, though no patient details
(i.e. name, date of birth, etc.) were recorded on the form by ward staff. It
was therefore unclear which patient had received the blood component
and thus vein to vein traceability could not be assured.
Stephen Grayson
Slide 11
1st July 2008
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Storage Deficiencies
•
Routine maintenance (e.g. cleaning & defrosting) was not
performed on any controlled temperature storage facilities.
Possible mould growth and heavy soiling were observed within the
Stock refrigerator.
•
Temperature charts were not reviewed by the laboratory. Evidence
was observed where the Stock refrigerator (storage requirements
2°C to 6°C) had recorded a temperature of -5°C on the chart for 2
years without being addressed.
•
An incident had not been raised to record the stock fridge
temperature excursion to approximately 20°C for 5 to 6 hours. It
was therefore unclear if blood components had been stored at the
appropriate temperature during this period
Stephen Grayson
Slide 12
1st July 2008
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Storage Deficiencies
• During the inspection, the remote alarms linked to both the Ward and
Main fridges were activated (tested). On neither occasion did the
switchboard notify the transfusion laboratory of the alarm (contrary to
the stated procedure).
• The freezer was exhibiting two divergent temperatures simultaneously
on the chart (-26°C) and the digital display (-34°C). The true
temperature could not be established. The alarm was not active as the
key switch was incorrectly set and the key left on the unit enabling
unauthorised changing of the setting.
• There was a thick build up of ice on the interior of the freezer such that
product cases were partially entrapped. Routine maintenance
operations were not performed as required by the relevant procedure.
• The platelet incubator did not have a record of its temperature as no
chart was fitted, and no other suitable device was available. The unit
had a single transient digital display only.
Stephen Grayson
Slide 13
1st July 2008
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Maintenance Deficiencies
•
No formal system was in place to ensure that planned preventative
maintenance was completed at the required intervals, and that
operations during this maintenance procedure were completed to
specification. In addition, items were not formally reviewed and
authorised for use following these operations.
•
There was a lack of good housekeeping within the laboratory and
surrounding areas with a heavy dust and dirt layer visible at high level.
•
PPM for the centrifuge was recorded as being performed by the
Medical Physics department, however the operations performed as
part of this PPM were not stated, and no references to engineers
calibrated equipment, and certificates to show compliance were
available.
•
The control of basic housekeeping duties within the laboratory was
very poor with dust balls on top of the refrigerators, dirty floors,
unclean equipment, and blood soiling in sinks.
Stephen Grayson
Slide 14
1st July 2008
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Thank You
Questions ?
Stephen Grayson
Slide 15
1st July 2008
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