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

Recall procedure

Quality Audit Preparation

Process:

Recall procedure- internal and external

Area:

Blood bank, and areas with issue or satellite fridges

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
  • Official copy
  • Cross-referenced with COSHH register and risk assessments
  • Regularly reviewed

Additional Evidence required:

  1. Documentation of product recall from an external supplier
  2. Documentation of reason for internal product recall
  3. Evidence of product quarantine and return to external supplier
  4. Training records and competency assessment / competency of trainers
  5. Document control

Interviews/process:

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

Additional requirements:

  1. General housekeeping of area.
  2. Designated “quarantine area” for blood or blood products.
  3. Record of transfusion if product transfused prior to recall.
  4. Reporting to MHRA via SABRE website of transfusion of recalled products