1. © Crown copyright 2005 Safeguarding public health Blood Bank Inspections Common Deficiencies Stephen Grayson Medicines Inspector, GMP July 2008

2. Slide 2 1 st July 2008 Stephen Grayson © Crown copyright 2005 Crown copyright 2005 The materials featured within these MHRA presentation notes and delegate pack are subject to Crown copyright protection for this event. Any other copy or use of Crown copyright materials featured in this presentation, in any form or medium, is subject to prior approval of the MHRA which has Delegated Authority from Her Majesty's Stationery Office (HMSO) to administer Crown copyright for MHRA originated material. Applications should be in writing, clearly stating the proposed use/reuse of the information, and should be sent to the MHRA at the following address: Conference and Education Function, 16 th Floor, MHRA, 1 Nine Elms Lane, London SW8 5NQ. Fax 020 7084 3522 or e-mail speakers@mhra.gsi.gov.uk. You may not sell or resell any information reproduced to any third party without prior agreement. The permission to reproduce Crown copyright protected material does not extend to any material in this pack which is subject to a separate licence or is the copyright of a third party. Authorisation to reproduce such material must be obtained from the copyright holders concerned.

3. Slide 3 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

4. Slide 4 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

5. Slide 5 1 st July 2008 Stephen Grayson © Crown copyright 2005 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

6. Slide 6 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

7. Slide 7 1 st July 2008 Stephen Grayson © Crown copyright 2005 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

8. Slide 8 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

9. Slide 9 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

10. Slide 10 1 st July 2008 Stephen Grayson © Crown copyright 2005 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. Traceability Deficiencies

11. Slide 11 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

12. Slide 12 1 st July 2008 Stephen Grayson © Crown copyright 2005 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 Storage Deficiencies

13. Slide 13 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

14. Slide 14 1 st July 2008 Stephen Grayson © Crown copyright 2005 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.

15. Slide 15 1 st July 2008 Stephen Grayson © Crown copyright 2005 Thank You Questions ?