Cold chain – Laboratory storage
Quality Audit Preparation
Cold chain – laboratory storage
Stock Blood Bank in Blood Transfusion Laboratory
Blood Bank staff, including on-call staff
Consult the SOP for the process.
- Is the SOP in date? Is there a review date?
- Is the SOP clear and unambiguous?
- Is there an author, reviewer and authoriser?
- Is there a complete materials list?
- Are there any amendments or alterations to the SOP? Are these dated and signed? Is there a reason given for the alterations?
- Is there a Risk Assessment for the procedure?
- Are there training records available for the procedure?
- Have all staff been trained in the procedure?
Additional Evidence required:
- Data logger data (electronic/paper)
- Data logger calibration certificates
- Blood Bank Maintenance log sheet
- Blood Bank Alarms record sheet
- Downtime record sheet
- Staff training records
- SOP for Blood Bank Failure
- knowledge assessment
- objective evidence
- Evidence of appropriate stock rotation.
- Disposal methods for out-of-date products.
- Service contract.
- Evidence of documented investigation when temperature out of range/unexpected alarms.
- General Housekeeping.