JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee

Major Non Compliances Listing

For the full listing with details download 'Deficiencies arising from blood bank inspections' (pdf - 78KB)

Summary and approximate collation from list of major non compliances found by MHRA inspectors in hospital blood banks

First 27 inspections

Change control - 13 mentions

  • No formal procedure
  • Not used when plan to move lab/facility
  • Training and validation required

Corrective actions for quality incidents - 14 mentions

  • Not documented
  • Not completed or closed
  • Not done in timely fashion
  • Why original training was ineffective not documented

Self inspection schedule - 12 mentions

  • Not maintained
  • Not present at all
  • No SOP for internal audit

QI logging - 9 mentions

  • Severity not documented
  • No procedure at all
  • Those falling outside Trust QI not documented
  • Process deviations not documented
  • Tracking and trending incidents not done
  • Events not logged that should be

Customer complaint procedure - 10 mentions

  • Not present
  • Not linked to QI system
  • Not a formal system
  • Needs QIF (quality improvement form)

Validation procedures - 15 mentions

  • No procedure
  • No master plan
  • No SOP
  • No preventive maintenance schedule
  • No IT upgrade validation
  • Transport boxes not validated

Out of spec results review - 2 mentions

  • Not done

Recall procedure - 8 mentions

  • Not done
  • Not formal
  • No internal recall procedure
  • No quarantine of units procedure

QMS not developed yet - 3 mentions

SLAs with other hospitals - 10 mentions

  • Not there
  • Specific responsibility eg traceability/HV not there
  • AE notification from other hospitals
  • Responsibility for cold chain

Haemovigilance - 6 mentions

  • Must state informing MHRA in SOP
  • SOP for SABRE reporting
  • Track and trend actions

Document control - 23 mentions

  • No system present
  • Illegible hand written changes (4)
  • SOPs amended but found with same version number
  • Uncontrolled aide memoirs everywhere (4)
  • Poor security of master copies
  • Masters not signed off
  • Docs not reviewed annually
  • Old versions still in use some VERY old

SOPs not present - examples

  • Sample labeling acceptance
  • G&S on Autovue
  • Failure of lab controls
  • Manual system if equipment failure
  • Stock receipt
  • Exceptional issue if non compatible
  • Emergency issue
  • Equipment validation
  • Process validation
  • Change control
  • Antibody panel interpretation on Autovue
  • Cold chain – maintenance of
  • Use of transport boxes for components
  • Prevention of transcription errors from Autovue
  • Interpretation of groups and screens
  • Labelling and issue of components
  • Receipt of test kits and testing them
  • Labeling of reagents, dating etc

GMP awareness training - 6 mentions

  • Not done

Incomplete training records - 12 mentions

  • No record of GMP training
  • No Good Practice Training
  • Not everyone trained
  • Non transfusion staff not trained/documented
  • No procedural based records
  • No training policy
  • No update training
  • No competency assessment

IT related problems - 15 mentions

  • System/SOP to grant/remove access to system
  • External access to engineers
  • Training of staff in key functions
  • Upgrade training
  • Validation of IT system
  • Validation of upgrades
  • Incomplete migration of legacy data
  • Emergency issue function
  • Incompatible issue

System to ensure only trained staff collect blood - 1 mention

Traceability - 4 mentions

  • No system – still “presumed transfused”
  • Only 75% units fated

Fridges - 8 mentions

  • Fridge temp not set at 2-6oC (1.5 or 6.5)
  • Fridge alarm not working/not audible/turned off
  • No cleaning records of main/ satellite fridges
  • No temp mapping done in main/satellite fridges
  • No preventive maintenance schedule
  • Inadequate /incomplete temp monitoring
  • Alarm delay switched on when probe in fluid buffer

Albumin - 2 mentions

  • Stored in the light
  • Not stored in temp controlled area

Blood transport boxes - 3 mentions

  • Not validated
  • No SOP for use
  • Not part of SLAs with other hospitals

Platelet agitator - 2 mentions

  • Not temp controlled
  • Wrong temp setting

Premises

  • Cramped and over crowded - 2 mentions
  • Windows and doors propped open - 2 mentions
  • Room temp too hot/not monitored - 2 mentions
  • Corrosion/damp/dirt/damage/holes - 4 mentions