Summary of Recent MHRA Inspections in the East of England – Common Themes

1. Summary of Recent MHRA Inspections in the East of England – Common Themes East of England RTC Lisa Haythornthwaite NSC TADG Chair February 2013

2. Recent MHRA Inspections in the East of England 4 Hospitals were all inspected in October/November 2012 Three out of the four hospitals had the same inspector Stephen Grayson. The other was inspected by Richard Funnell. None of the hospitals inspected received a critical non-conformance but 3 out of the 4 received one major each. Overview

3. Major – Deviations.This was separated into four subsections, all linked to chronic staff shortages by the inspector. Delay in recording/no timescales Delay in closing (clinical source of delay) Inconsistent quality of RCA Inappropriate classification of some deviations Other No formal capacity plan Internal recalls well hidden! Analyser solutions topped up Validation failures noted but sign off not explained (rr/capacity) Comments LIMS upgrade for manual entry of blood group – Action plan in place Central database being set up for C & A competencies Inspector was willing to change date of inspection Recent MHRA Inspections in the East of England Key Findings for 1 Hospital

4. Recent MHRA Inspections in the East of England Major – Traceability Failed to meet statutory requirement of 100% Other QMS – Deviations (early assessment/insufficient detail/RCA), recall, change control, documentation (deletions/doc control) No Trust staff blood collection competencies Management of computerised systems – no formal merging process, lack of senior control, back-up location, reinstall, periodic requalification, no SLA Laboratory activities – Equipment (centrifuges), reagents, QC, result editing, issuing components (line clearance) Mapping of temperature controlled storage devices – No protocol/acceptance criteria, routine monitoring probe not referenced, maximum thermocouple error not specified/end determination of unit status Comments Site to provide traceability data on a quarterly basis Site to provide a PAS merging procedure of inspector to review Key Findings for 2 Hospital

5. Major – Traceability Failed to meet statutory requirement of 100% Other QMS – Deviations (early assessment/insufficient detail/RCA), recalls, change control, OOH competency – No QMS content Merging (no training records, unmerging, no senior review), database management, IT SLA provision Laboratory activities – premises (lab/cold room), sample labelling, sample bar coding, reagent storage, temperature monitoring (hourly intervals), equipment (centrifuges), QC failure, temperature mapping (no protocol/acceptance criteria/conclusions) Comments Significant recent document review & audit activity Site to provide quarterly traceability data indefinitely Key Findings for 3 Hospital Recent MHRA Inspections in the East of England

6. Major – None Other Premises Completeness of QMS (change control review) GMP/Documentation (deletions) Collection of blood (via laboratory) Inspector was unwilling to change date of inspection even though Transfusion Manager was off sick Recent MHRA Inspections in the East of England Key Findings for 4 Hospital

7. Recent MHRA Inspections in the East of England Inspector One – SG - Common Findings • QMS - change control review post go live, documentation • Deviation – early assessment, formal RCA, insufficient detail, recall • Traceability – need >99% • QC - Failures • Centrifuges – procedures/settings • Merging (lack of senior control, training, procedure) • IT - SLA’s, disaster recovery, back-ups • Temperature mapping – No protocol and no final conclusion • Pre-transfusion testing

8. Recent MHRA Inspections in the East of England Inspector Two - RF • QMS • Deviations (timely & consistent reporting) • Validation (analysers!!) • Pre-transfusion testing, particularly electronic issue, automation and manual edit • IT • Traceability • Training and competency assessment (Trust/Lab) • Temperature mapping & monitoring

9. Recent MHRA Inspections in the East of England Conclusions • Inspector styles observed • Generic GMP themes • Expect recent MHRA guidance/hot topics • Find out why you are being inspected • End inspection report ‘almost’ in standards format – useful • Consider external contractor to map temperature controlled storages devices • Higher standards achieved