Failure mode and effects analysis of witnessing protocols for ensuring traceability during PGD/PGS cycles

Danilo Cimadomo, Filippo Maria UbaldiaAntonio CapalboaRoberta Maggiulli, Catello Scarica, Stefania Romano, Cristina Poggiana, Daniela Zuccarello, Adriano Giancani, Alberto Vaiarelli, Laura Rienzi

 Reproductive BioMedicine Online Volume 33, Issue 3, September 2016, Pages 360–369


Preimplantation genetic diagnosis and aneuploidy testing (PGD/PGS) use is constantly growing in IVF, and embryo/biopsy traceability during the additional laboratory procedures needed is pivotal. An electronic witnessing system (EWS), which showed a significant value in decreasing mismatch occurrence and increasing detection possibilities during standard care IVF, still does not guarantee the same level of efficiency during PGD/PGS cycles. Specifically, EWS cannot follow single embryos throughout the procedure. This is however critical when an unambiguous diagnosis corresponds to each embryo. Failure Mode and Effects Analysis (FMEA) is a proactive method generally adopted to define tools ensuring safety along a procedure. Due to the implementation of a large quantitative PCR (qPCR)-based blastocyst stage PGD/PGS programme in our centre, and to evaluate the potential procedural risks, a FMEA was performed in September 2014. Forty-four failure modes were identified, among which six were given a moderate risk priority number (>15) (RPN; product of estimated occurrence, severity and detection). Specific corrective measures were then introduced and implemented, and a second evaluation performed six months later. The meticulous and careful application of such measures allowed the risks to be decreased along the whole protocol, by reducing their estimated occurrence and/or increasing detection possibilities.

Keywords: FMEA; misdiagnosis; mismatch; PGD; preimplantation genetic screening (PGS); traceability