title: Failure mode and effects analysis of witnessing protocols for ensuring traceability during PGD/PGS cycles.
abstract: 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.
authors.affiliation: 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.
authors.forename: Danilo
authors.initials: D
authors.lastname: Cimadomo
authors.affiliation: GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy; GENETYX Molecular Genetics Laboratory, via Fermi 1, Marostica, Italy.
authors.forename: Filippo Maria
authors.initials: FM
authors.lastname: Ubaldi
authors.affiliation: GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy; GENETYX Molecular Genetics Laboratory, via Fermi 1, Marostica, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Capalbo
authors.affiliation: GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Maggiulli
authors.affiliation: 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.
authors.forename: Catello
authors.initials: C
authors.lastname: Scarica
authors.affiliation: GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Romano
authors.affiliation: GENETYX Molecular Genetics Laboratory, via Fermi 1, Marostica, Italy.
authors.forename: Cristina
authors.initials: C
authors.lastname: Poggiana
authors.affiliation: GENETYX Molecular Genetics Laboratory, via Fermi 1, Marostica, Italy.
authors.forename: Daniela
authors.initials: D
authors.lastname: Zuccarello
authors.affiliation: GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy; GENETYX Molecular Genetics Laboratory, via Fermi 1, Marostica, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Giancani
authors.affiliation: GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Vaiarelli
authors.affiliation: GENERA centers for reproductive medicine, via G de Notaris 2/b, Rome, Italy; GENETYX Molecular Genetics Laboratory, via Fermi 1, Marostica, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Rienzi
mesh_terms: D002985:Clinical Protocols; D046149:Embryo Culture Techniques / Q000592:standards; D005307:Fertilization in Vitro; D006801:Humans; D010355:Patient Identification Systems; D019836:Preimplantation Diagnosis / Q000379:methods / Q000592:standards*; D013048:Specimen Handling / Q000379:methods / Q000592:standards*; D057188:Workflow
keywords: FMEA; PGD; misdiagnosis; mismatch; preimplantation genetic screening (PGS); traceability