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

Cold chain - Alarm testing of Blood Bank equipment

Quality Audit Preparation

Process:

Alarm testing of Blood Bank equipment
To include fridges, freezers, platelet incubators and FFP/cryoprecipitate thawers

Area:

Blood Bank

Issue Room

Auditees:

Any person within the Blood Transfusion Department

  • Biomedical Scientists
  • Medical Laboratory Assistants

Initial preparation:

Standard Operating Procedure for alarm testing, is it-

  • Comprehensible and specific
  • Appropriately authorised by designated personnel
  • Regularly reviewed
  • Linked to COSHH and Risk Assessments
  • Complete list of equipment for alarm testing
  • Official copy of document

Additional Evidence required:

  1. Training records and competency assessments/competency of trainers
  2. Document control
  3. Cold chain validation of laboratory equipment
  4. Appropriate SOPs
  5. Fridge/freezer/incubator calibration and service records
  6. Evidence of regular maintenance of equipment
  7. Evidence of temperature monitoring and appropriate documentation (? Temperature mapped equipment or calibrated probes – traceable to national standards)

Interviews/process:

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

Additional requirements:

  1. General housekeeping of the area
  2. Details of whom to contact in case of breakdown/alarm failure readily available
  3. Procedure for the event of major power failure – transfer of blood products to additional storage facilities and the subsequent validation process
  4. Documentation of equipment failure and action taken