AABB Standards Compliance | Kintavo
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THE PROBLEM

AABB Assesses the System Around the BECS — the Part That Runs on Paper.

The BECS handles units and testing; AABB’s quality system essentials cover everything else: documents, training, equipment, suppliers, deviations, process improvement. In most transfusion services that layer runs on paper logs and spreadsheets — assessed every two years, reconciled the month before, and drifting the other twenty-three.

The deviation clock makes drift expensive: biological product deviations carry FDA reporting windows, and a paper intake process spends the window discovering what happened.

WHAT THE STANDARD REQUIRES

What AABB Standards and 21 CFR 606 Require From the Quality System

The AABB quality system essentials require controlled documents, qualified and competent personnel, validated processes and equipment, supplier qualification, deviation management with reporting, and records that trace every unit donor to recipient. 21 CFR 606 adds GMP for blood: records for each significant step (606.160), and biological product deviation reports to FDA (606.171) — with the clock defined.

Kintavo runs the essentials as daily workflows around your BECS: reagent QC signed at the bench, deviations with BPDR timelines enforced, equipment on schedule, and quality records born linked.

WHAT AUDITORS LOOK FOR
Reagent QC gaps — daily checks missing, or batch-signed after the fact.
BPDRs filed late because the deviation surfaced late.
Competency records lagging the techniques staff actually perform.
Equipment excursions with no documented product-impact assessment.
WHAT KINTAVO REPLACES
Reagent QC on paper logs → Daily QC signed at the bench, failures held
Deviations by memo → Structured events with BPDR clocks enforced
Equipment logs in binders → Schedules, alarms, and excursion events on the asset
Assessment prep as a project → Assessment-ready as the steady state
Records scattered across paper and systems → Quality records born linked for the lookback
CORE CAPABILITIES

The Quality System Essentials, Running.

Reagent QC & Lot Control
Antisera, cells, and kits qualified before use, daily QC with rules at entry, expiry enforced.
Deviation & BPDR Management
Structured intake, severity rules, product-impact assessment, and FDA reporting timelines tracked to filing.
Equipment & Alarm Events
Refrigerators, freezers, irradiators, cell washers — schedules enforced, excursions opening events with product review.
Competency per Technique
Crossmatch, antigen typing, apheresis — assessed on cycle, gating who can sign.
Document Control
SOPs current, medical director review on schedule, obsolete versions locked out.
Linked Quality Records
QC, equipment, deviation, and competency records linked as they are created — signed at every hop.
WHAT IT LOOKS LIKE IN PRACTICE

An AABB assessor samples the quality system: Tuesday’s reagent QC (signed at 6:04 a.m., one failed cell held before use), an equipment excursion (alarm event, product review, disposition signed), and a deviation from March (BPDR determination documented, filed on day 12 of 45). Then a records sample: each pull lands in seconds, signed and linked to its neighbors. The assessment closes early.

EVIDENCE, NOT CLAIMS

Records Born Linked.

Quality records link as they are created — so an investigation or assessment starts from connected, signed evidence rather than four filing systems.

Signed, timestamped quality records — linked as they are created
SHOWN WITH SAMPLE DATA. YOUR NUMBERS APPEAR THE DAY YOU CONNECT YOUR SYSTEM.

Covered as architecture — not configured after the fact.

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MODULES THAT CARRY THE LOAD
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WHO WORKS UNDER IT
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QUESTIONS & ANSWERS

AABB Standards FAQ

Does Kintavo replace our BECS?
No — the BECS remains the system of record for units and testing. Kintavo runs the AABB quality system around it and integrates via API.
How does Kintavo handle BPDR reporting windows?
Deviation intake captures the BPDR determination, and the reporting clock is tracked with escalation — the report drafts from the event record and files inside the window.
Does Kintavo cover cellular therapy standards?
Yes — the same quality system essentials apply, with chain-of-identity checkpoints and per-lot records for cellular products. Hoxworth Blood Center runs quality processes on the platform.
Can temperature excursions open events automatically?
Alarm integrations can open excursion events with the affected storage and product linked, routing product-impact review before disposition.

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