• Reprod. Biomed. Online · Sep 2016

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

    • Danilo Cimadomo, Filippo Maria Ubaldi, Antonio Capalbo, Roberta Maggiulli, Catello Scarica, Stefania Romano, Cristina Poggiana, Daniela Zuccarello, Adriano Giancani, Alberto Vaiarelli, and Laura Rienzi.
    • GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy; University of Rome, Sapienza, Dipartimento di Scienze Anatomiche, Istologiche, Medico-Legali e dell'Apparato Locomotore, Sezione Istologia ed Embriologia Medica, via A. Scarpa 16, Rome, Italy. Electronic address: cimadomo@generaroma.it.
    • Reprod. Biomed. Online. 2016 Sep 1; 33 (3): 360-9.

    AbstractPreimplantation 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. Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

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