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

Cold chain - Packing transport boxes with red cells for distribution outside the hospital

Quality Audit Preparation

Process:

Packing transport boxes with red cells for distribution outside the hospital

Area:

Blood Bank

Issue fridge

Auditees:

Any person involved in the process this may include:

  • Blood Bank staff BMS or MLA
  • On Call staff
  • Porters

Initial preparation:

SOP for the process is it:

  • Specific
  • In date
  • Appropriately signed/authorised by an authorised signatory
  • Complete equipment list
  • Official copy
  • Links to COSHH / Risk assessments
  • Regularly reviewed
     

SLA with Satellite hospitals clinics etc

  • In date
  • Signed
  • Covers reporting SAE and SARs, traceability, cold chain requirements
  • Training requirements
     

SLA with transport companies

  • In date
  • Signed
  • Training requirements

Additional Evidence required:

  1. Validation of transport boxes
  2. Manual handling training
  3. Training records and competency assessments/competency of trainers
  4. Document control
  5. Calibration certificates for data loggers (in date)

Interviews/process:

  1. Observation
  2. Questions
  3. Knowledge assessment
  4. Objective evidence

Additional requirements:

  1. General housekeeping of the area
  2. Freezer calibration/ handling frozen packages, evidence that any out of specifications are fully investigated
  3. Storage issues
  4. Regular maintenance of freezer/evidence of temperature monitoring/ temperature mapped freezer?/ calibrated probes (traceable to national standards)
  5. Alarms formerly tested
  6. Segregation in freezer (first in / first out)
  7. Disposal of out of date products