Promoting Best Practices in Assisted Human Reproduction.

Objectives: Assisted human reproduction (AHR) is a complex process of clinical, laboratory, and organizational activities that involve risk and safety. The regulation of the Canadian fertility industry is a mix of federal and provincial/territorial responsibility. Oversight of care is fragmented as patients, donors, and surrogates may each live in different jurisdictions. The Canadian Medical Protective Association (CMPA) undertook a retrospective analysis of CMPA medico-legal data to identify the contributing factors to medico-legal risks for Canadian physicians providing AHR services.

Methods: Experienced CMPA medical analysts, reviewed information from closed cases. A previously reported medical coding methodology was applied to a 5-year retrospective descriptive analysis of CMPA cases closed between 2015 and 2019, involving physicians caring for patients with infertility seeking AHR. Class action legal cases were excluded. All contributing factors were analyzed using the CMPA Contributing Factor Framework. Cases were de-identified and reported at the aggregate level for analysis to ensure confidentiality for both patients and health care providers.

Results: There were 860 gynaecology cases with comprehensive information and peer expert review. Of these, 43 cases involved patients seeking AHR. Due to the small sample size, the results presented are for descriptive purposes only. AHR cases had an unfavourable outcome for the physician in 29 cases. Diagnostic error was noted in 10 cases. The most common patient allegations were related to a breakdown in communication. Peer experts were critical of patient care in 34 cases. These were divided among provider, team, and system factors.

Conclusions: Diagnostic error was the most common clinical concern. Deficient clinical decision-making and communication breakdown with the patient contributed to these errors. Enhanced clinical decision-making, through heightened situational awareness, strengthened diagnostic test follow-up, and improved communication with the health care team may reduce medico-legal complaints related to AHR and improve patient safety.