To err is human, also in medically assisted reproduction: a cross-sectional study on error management practices†.

study questionHow do medically assisted reproduction (MAR) centres manage errors, and what are the practices for reporting adverse incidents and non-conformities to National Competent Authorities (NCA) and disclosing them to patients? SUMMARY ANSWER: The study reveals a diverse landscape of error management practices in MAR centres, with varying approaches to reporting and disclosure, emphasizing a mix of transparency and systematic management of non-conformities. WHAT IS KNOWN ALREADY: Previous studies have highlighted the critical nature of error management in MAR settings which are inherently susceptible to errors due to their complexity. Despite this recognition, comprehensive data on error management practices across different MAR centres have been limited. STUDY DESIGN, SIZE, DURATION: A cross-sectional study was set up to gather data on the current practice with regards to error management at MAR centres. Data were collected between 25 April and 25 May 2022. PARTICIPANTS/MATERIALS, SETTING,

methodsAn online survey was designed, using the online SurveyMonkey tool, to consist of 17 questions concerning three domains: error management in the MAR centre, reporting to NCA and disclosure of non-conformities to patients. The survey was distributed to professionals working in MAR centres through the ESHRE membership mailing list. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 464 replies were received and following exclusion of invalid results, the final dataset included the replies of 387 respondents. A majority, ∼71.6% of respondents, confirmed that both laboratory and clinical non-conformities are systematically recorded, predominantly using digital platforms. Mainly, all types of errors are recorded based on their severity, including near-misses. In terms of discussing incidents, about 85.8% of the centres reported that they regularly hold meetings to review them. However, practices varied considerably when it came to reporting non-conformities to the NCA and disclosing them to patients. Only 15.1% of respondents reported all types of incidents (major, moderate, and significant) to the NCA, while a significant portion, 65.6%, indicated that they report only major incidents. Concerning disclosure practices to patients, a majority (52%) stated that their centres always communicate incidents to patients, indicating a trend towards transparency in patient care. However, 11.7% of respondents mentioned that they do not disclose to patients, highlighting a gap in proactive patient communication in some centres. LIMITATIONS, REASONS FOR CAUTION: The study's sample may not be representative of all MAR centres, with a potential bias towards practices in countries with higher respondent rates (Spain, UK, Italy); also the possibility of having received multiple responses from the same centre could not be ruled out. Additionally, despite survey anonymity, there may be a tendency for respondents to provide socially desirable answers. WIDER IMPLICATIONS OF THE

findingsThese findings contribute to a broader understanding of error management in MAR centres worldwide, highlighting the need for standardized reporting systems and more transparent communication with patients. This study also underscores the importance of fostering a culture of safety and continuous learning from non-conformities in the MAR sector. STUDY FUNDING/COMPETING INTEREST(S): K.T. disclosed support for attending meetings and/or travel from Ferring, Cooper Surgical, Fujifilm, and Vitrolife group. K.R.-W. disclosed support from Radiumhemmets Forskningsfonder and The Swedish Cancer Society; grants from Swedish Research Council, Swedish Cancer Society, Swedish Childhood Cancer Fund, Radiumhemmets Forskningsfonder, Stockholm County Council FoU, Karolinska Institutet and IngaBritt och Arne Lundbergs Forskningsstiftelse; royalties; consulting fees from the Swedish Ministry of Health and Welfare; honoraria from Roche (for chairmanship and lectures), Pfizer (for chairmanship and lectures), Organon (lectures), and IBSA (Advisory Board for educational event); support for meetings and/or travel from Organon and Regionstockholm; participation at advisory boards for Merck and Ferring; receipt of equipment from Merck and Ferring. Z.V. disclosed research grants from ESHRE and Juhani Aaltonen Foundation; and support for meetings and/or travel from ESHRE. The other authors had no competing interests to disclose. TRIAL REGISTRATION NUMBER: N/A.