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

Cold chain – Laboratory storage

Quality Audit Preparation

Process:

Cold chain – laboratory storage

Area:

Stock Blood Bank in Blood Transfusion Laboratory

Auditees:

Blood Bank staff, including on-call staff

Initial preparation:

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:

  1. Data logger data (electronic/paper)
  2. Data logger calibration certificates
  3. Blood Bank Maintenance log sheet
  4. Blood Bank Alarms record sheet
  5. Downtime record sheet
  6. Staff training records
  7. SOP for Blood Bank Failure

Interviews/process:

  1. observation
  2. questions
  3. knowledge assessment
  4. objective evidence

Additional requirements:

  1. Evidence of appropriate stock rotation.
  2. Disposal methods for out-of-date products.
  3. Service contract.
  4. Evidence of documented investigation when temperature out of range/unexpected alarms.
  5. General Housekeeping.