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.

A Customized Tool of Incident Reporting for the Detection of Nonconformances at a Single IVF Center: Development, Application, and Efficacy

“…There is not enough openness about the discussion of unwanted events, thus limiting our ability to learn from each other's mistakes. In fact, the use of tools for risk analysis in IVF is poorly documented and focuses on proactive tool applications whose versatility is well acknowledged [ 5 , 13 , 27 , 28 ]. To the best of our knowledge, this study showed for the first time the feasibility of a reactive tool for risk analysis of IVF processes, as it uncovers those nonadverse events that may potentially account for the final safety of care given.…”

Failure modes and effects analysis for testicular sperm extraction management process

“…In fact, a partial loss of reproductive cells due to an incorrect management of biopsies could negatively impact reproductive chances of TESE patients. From this perspective, human witnessing was also considered essential to reduce some risks like incomplete crosscheck, involuntary automaticity and control omission (Cimadomo et al, ; de los Santos & Ruiz, ; Rienzi et al, , ; Toft & Mascie‐Taylor, ). To minimise these dangers, the FMEA team clearly defined essential the timing of witnessing (during and at the end of the procedure).…”

Traceability Management of Systemsof Systems: A Systematic Reviewin the Assisted Reproduction Domain

“…Usefulness of a quality system in reproduction [24] A novel embryo identification system by direct tagging of mouse embryos using silicon-based barcodes [25] Direct embryo tagging and identification system by attachment of biofunctionalized polysilicon barcodes to the zona pellucida of mouse embryos [26] Barcode tagging of human oocytes and embryos to prevent mix-ups in assisted reproduction technologies [27] Traceability of human sperm samples by direct tagging with polysilicon microbarcodes [28] Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF [29] Revised guidelines for good practices in IVF laboratories [30] Application of failure mode and effect analysis in an assisted reproduction technology laboratory [31] Failure mode an affects analysis of witnessing protocols of ensuring traceability during PGD/PGS cycles [32] Electronic witness system in IVF-patients perspective [33] Quality management in the IVF laboratory: Witnessing [34] Comprehensive protocol of traceability during IVF: The result of a multicentre failure mode and effect analysis [35] Different barcodes codification for embryo microlabeling [36] Development of a security system for assisted reproductive technology (ART) [37] Measuring human error in the IVF laboratory using an electronic witnessing system [38]…”