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

Cold chain – Issue fridges / satellite fridges

Quality Audit Preparation

Process:

Cold chain – issue fridges / satellite fridges

Area:

Blood bank issue fridge and all areas with satellite blood fridges

Auditees:

Any person involved in the process of stocking, issuing or returning blood back to stock. This may include:

  • Blood Bank staff (BMS or MLA)
  • On-Call staff
  • Porters
  • Nurses
  • ODPs

Initial preparation:

SOP for the process, is it:

  • Specific
  • In date
  • Appropriately signed / authorised by an authorised signatory
  • Lists issue fridges / satellite fridges and their locations
  • Official copy
  • Cross-referenced with COSHH register and risk assessments
  • Regularly reviewed

Additional Evidence required:

  1. Temperature mapping performed
  2. Continuous temperature monitoring
  3. Storage of temperature monitoring records
  4. Calibrated probes (traceable to national UKAS standards)
  5. Alarm system tested
  6. Training records and competency assessment / competency of trainers
  7. Document control

Interviews/process:

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

Additional requirements:

  1. General housekeeping of areas.
  2. Evidence of investigation of “out of temperature” incidents.
  3. Evidence of reporting unexpected fridge failures to the MHRA via SABRE website.
  4. Evidence unused blood is returned to stock.
  5. Evidence that “time expired blood” is removed from the fridge before midnight on the day of expiry.
  6. Evidence that failure to remove time expired blood is reported to the MHRA via the SABRE website.