Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF
2015
Traceability of cells during IVF is a fundamental aspect of treatment, and involves
witnessingprotocols.
Failure modeand
effects analysis(FMEA) is a method of identifying real or potential breakdowns in processes, and allows strategies to mitigate risks to be developed. To examine the risks associated with
witnessingprotocols, an FMEA was carried out in a busy IVF centre, before and after implementation of an electronic
witnessingsystem (EWS). A multidisciplinary team was formed and moderated by human factors specialists. Possible causes of failures, and their potential effects, were identified and risk priority number (RPN) for each failure calculated. A second FMEA analysis was carried out after implementation of an EWS. The IVF team identified seven main process phases, 19 associated process steps and 32 possible failure modes. The highest RPN was 30, confirming the relatively low risk that mismatches may occur in IVF when a manual
witnessingsystem is used. The introduction of the EWS allowed a reduction in the moderate-risk failure mode by two-thirds (highest RPN = 10). In our experience, FMEA is effective in supporting multidisciplinary IVF groups to understand the
witnessing
process,
identifyingcritical steps and
planning changesin practice to enable safety to be enhanced.
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Correction
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