Cic edizioni internazionali
Current Trends in Clinical Embryology

Traceability in IVF depends on each of us

Original Article, 1 - 7
doi: 10.11138/cce/2017.4.1.001
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Abstract
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Introduction: in IVF, one of the worst irreversible clinical risks is to obtain a pregnancy from an embryo produced from wrong gametes.
Each infertility clinic, and in particular IVF lab, must create and apply rigorous procedures of traceability to avoid mismatch.
We assessed the risk of patient/gamete/embryo traceability failure from gametes donation to processing, storage and distribution of embryos in a routine IVF protocol.
Material and Methods: the failure mode and effect analysis (FMEA) and critical analysis (FMECA) of each phase and under-phase of patient/gamete/embryo traceability in a routine IVF protocol, were performed by an internal multidisciplinary team.
Results: after critical analysis, the risk priority number score decreased from 8.1 to 3.8.
There was no relevant risk of cell mismatch.
Improvements were made to ensure the traceability of in vitro treatment and to avoid patient data cancellation on sperm collection container. Active witnessing was also implemented.
Conclusion: the FMEA/FMECA methodology is an effective way to proactively assess the risk of traceability failure in IVF. Procedures can always be improved. The efficacy of patient/gamete/embryo traceability depends on each operator in the IVF unit. Each operator
must be aware of their own role and responsibility in the traceability process.

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