Assessment and management of the risk of SARS-CoV-2 infection in an IVF laboratory: a failure mode and effect analysis (FMEA)

Maggiulli, Roberta; Giancani, Adriano; Fabozzi, Gemma; Dovere, Lisa; Tacconi, Luisa; Amendola, Mariagiulia; Cimadomo, Danilo; Ubaldi, Filippo Maria; Rienzi, Laura

RESEARCH QUESTION: To identify corrective measures aimed at reducing the risk of aerosol-mediated viral infection within an IVF laboratory. DESIGN: A Failure Modes and Effect Analysis (FMEA) was conducted by a multidisciplinary IVF team. A schematic representation of new protocols and procedures adopted during COVID-19 emergency has been defined, including directives about the behavior to adopt when entering the clinic and the laboratory, in case of face-to-face contact with patients and between staff members. Lastly, the risk of cross-contamination between samples belonging to different patients during cell handling and manipulation has been also evaluated. Potential failure modes for each phase have been analyzed, focusing on possible sources of error. Risk priority numbers have been calculated as products of Occurrence x Severity x Detection scores. RESULTS: Except for cell-cell contamination, which has been considered highly unlikely, failure modes during Patient-Staff, Staff-Staff and Staff-Cell interactions were estimated at moderate-high risk of infection. The main corrective measures entailed precautionary logistic measures, the implementation of additional personal protective equipment (PPE), and changes in setting the IVF laboratory and scheduling the daily routine. Some IVF procedures were also revised mainly aiming at increasing staff's awareness and caution during pandemic. CONCLUSIONS: Standard IVF laboratory protocols are insufficient to face a virus whose transmission is aerosol-mediated. The measures outlined in this FMEA should thus be considered not only facing this pandemic but also for the future to be able to manage promptly any aerosol-mediated virus infection, whose impact on the management of an IVF laboratory might be less severe than COVID-19 although not completely negligible (i.e. staff reduction and patient health at the time of IVF procedure).