Kosten durch fehlerhafte oder unzureichend validierte Testergebnisse

Definition

Australian guidance mandates that all in‑house assays and modified standard methods undergo validation, and all commercial assays must have their performance verified in situ, with records of these diagnostic activities kept for accreditation.[5] ISO 15189-based policies emphasise that validation reports must include raw data, performance characteristics and evidence that methods are fit for purpose, with ongoing re‑verification when performance criteria are not met or when methods change.[1][5] In practice, many labs still manage validation and result‑validation checks through spreadsheets, manual calculations and ad‑hoc documentation, which increases the chance that method performance issues are missed until clinicians notice discordant results. When this happens, the lab must conduct investigations, recall affected results, repeat tests and sometimes provide financial concessions to clients or absorb the cost of additional sample collections. Based on common quality-management experience, even a single significant validation failure on a high‑volume assay (e.g. a miscalibrated analyzer) can lead to 500–2,000 results requiring review or repetition, at a direct internal cost of approximately AUD 20–60 per repeated episode (staff time, consumables, overhead), implying AUD 10,000–120,000 of rework for the event. Logic-based approximation for a mid‑size Australian pathology lab that experiences several smaller-scale validation or QC issues per year suggests an annualised cost of around AUD 50,000–150,000 in rework, staff overtime, consumables and reputational remediation attributable to quality failures that robust, automated validation and rule‑based result release could prevent or reduce.

Why This Matters

The Pitch: Medical laboratories in Australia 🇦🇺 waste an estimated AUD 50,000–150,000 per year on repeat testing, investigation and lost productivity caused by insufficiently standardised validation and result-checking. Automating method validation documentation, delta checks and rule‑based result release reduces rework and risk.

Affected Stakeholders

Laboratory Director, Quality Manager, Section Supervisors (Chemistry, Haematology, Microbiology), Method Validation Scientists, Pathologists, Client Relationship Managers

Related Business Risks