AABB 35th edition · Effective April 1, 2026
Review your blood storage monitoring evidence.
2026 Blood Bank Audit Readiness Checklist
Use this checklist to locate evidence, identify gaps and assign follow-up actions.
About this preparation checklist
This Qualified Controls worksheet supports a focused monitoring evidence review. Use your current licensed standards and approved procedures to determine applicable requirements. AABB edition and effective date · AABB significant changes

Set the scope
What are you reviewing?
Start with one site, storage activity or equipment group. These details appear in your downloaded plan.
Area 1 of 6
Monitoring Coverage & Control
Choose the evidence status for each prompt. You can return to any area.
What evidence could help?
Asset register, approved limits or SOP, probe-placement study, temporary-storage qualification and validation for the defined storage duration (AABB 5.1.9.3.2). Use examples that fit your approved process.
Capture the follow-up
Add one shared record location or note for this area. If a prompt does not apply, identify it and explain why.
Area 2 of 6
Alarm & Escalation
Choose the evidence status for each prompt. You can return to any area.
What evidence could help?
On-call roster, escalation procedure, approved alarm settings, end-to-end notification test record. Use examples that fit your approved process.
Capture the follow-up
Add one shared record location or note for this area. If a prompt does not apply, identify it and explain why.
Area 3 of 6
Documentation & Data Integrity
Choose the evidence status for each prompt. You can return to any area.
What evidence could help?
Temperature export with asset ID and time zone, access-role list, change history, retention and retrieval procedure. Use examples that fit your approved process.
Capture the follow-up
Add one shared record location or note for this area. If a prompt does not apply, identify it and explain why.
Area 4 of 6
Calibration & Traceability
Choose the evidence status for each prompt. You can return to any area.
What evidence could help?
Device/probe register, calibration certificate, interval rationale, out-of-tolerance review procedure. Use examples that fit your approved process.
Capture the follow-up
Add one shared record location or note for this area. If a prompt does not apply, identify it and explain why.
Area 5 of 6
Infrastructure & Reliability
Choose the evidence status for each prompt. You can return to any area.
What evidence could help?
Dependency map, risk-based technology and communications checks at defined intervals (AABB 3.7), backup procedure, recovery-test evidence. Use examples that fit your approved process.
Capture the follow-up
Add one shared record location or note for this area. If a prompt does not apply, identify it and explain why.
Area 6 of 6
Excursion Preparedness
Choose the evidence status for each prompt. You can return to any area.
What evidence could help?
Current excursion SOP, event timeline, evaluation of potentially involved equipment when the cause is uncertain (AABB 3.5.4.1), inventory review and closure evidence. Use examples that fit your approved process.
Capture the follow-up
Add one shared record location or note for this area. If a prompt does not apply, identify it and explain why.
Review all 24 prompts to unlock your follow-up plan.
Your follow-up plan
Get your follow-up plan.
Enter your details to view your evidence review and download the editable PDF.
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Your working review
Turn evidence gaps into next steps.
These counts describe your worksheet entries. They do not measure compliance or establish an audit-readiness score.
PDF counts and follow-up text reflect your entries at download. Editing PDF fields does not recalculate them.
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