Introduction: Adequate legislation and accountability frameworks are key components of high performing deceased donation systems. In 2021, the province of Nova Scotia, Canada, became the first jurisdiction in North America to enact deemed consent legislation. This was accompanied by government provision of frontline financial resources to support further development of program infrastructure, including implementation of means to evaluate system performance.
Method: To quantitatively evaluate system performance before and after the legislative change, the provincial organ donation program, in collaboration with other key stakeholders, used an iterative design process to develop a Potential Donor Audit tool and electronic database for referral intake and manual performance audits. Retrospective chart reviews of patients in the calendar year prior to legislative change (2020) were conducted to pilot and revise the tool and evaluate missed potential donation opportunities.
Results: The Nova Scotia tool was piloted on 1028 patient deaths, with limited medical record documentation of several fields including: religion (66%), ethnicity (2.8%), and gender (0%), referrals to the medical examiner (45.2%) and regional tissue bank (4.8%). Coding of free text entries for “cause of death” resulted in creation of 17 drop down categories. In total, 518 (50.4%) met clinical triggers for referral to the organ donation program; only 72 were referred (86.1% missed referral rate). Only 244 (54.7%) of 446 non-referred patients had a documented reason for non-referral. Of 163 patients meeting the Nova Scotia definition of a potential donor, 53 (32.5%) were referred, yielding 110 missed potential donors. Of these, only 6 (5.5%) had documentation of a donation discussion with next-of-kin. Reasons for non-approach were only documented in 30 (28.8%) the remaining 104 missed potential donors. Consent rates for referred patients reached 71.7% (n=38 of 53 next-of-kin approaches); reasons for next-of-kin decline were documented for all remaining patients. The actualized donation rate reported by Canadian Blood Services in 2020 was 29.9 donors per million population (n=34 donors).
Conclusion: We documented a high rate of missed referral and missed potential donors in Nova Scotia in the year prior to enactment of mandatory referral and deemed consent legislation. This information supports the decision of the Nova Scotia ODP to intentionally broaden clinical criteria for referral to shift responsibility of identifying medically suitable potential donors from bedside clinicians to organ donation specialists and develop targeted educational initiatives related to these changes. Furthermore, piloting the potential donor audit tool as a part of an iterative development process was useful for creation of a data dictionary, variable modification, and workflow changes in the electronic database, yielding a tool that may be useful for other jurisdictional audits, contribution to national donor audits, and novel research programs.