QAP Cold chain - alarm testing
Quality Audit Preparation
Alarm testing of Blood Bank equipment
To include fridges, freezers, platelet incubators and FFP/cryoprecipitate thawers
Any person within the Blood Transfusion Department
- Biomedical Scientists
- Medical Laboratory Assistants
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:
- Training records and competency assessments/competency of trainers
- Document control
- Cold chain validation of laboratory equipment
- Appropriate SOPs
- Fridge/freezer/incubator calibration and service records
- Evidence of regular maintenance of equipment
- Evidence of temperature monitoring and appropriate documentation (? Temperature mapped equipment or calibrated probes – traceable to national standards)
- Observation
- Questions
- Knowledge assessment
- Objective evidence
- General housekeeping of the area
- Details of whom to contact in case of breakdown/alarm failure readily available
- Procedure for the event of major power failure – transfer of blood products to additional storage facilities and the subsequent validation process
- Documentation of equipment failure and action taken
