Despite sustained improvements in deceased organ donation rates in Canada, the gap between patients on the transplant waitlist and available organs persists.1 As a result, patients continue to die on, or be withdrawn due to deteriorating health, from the transplant waitlist.2 Deceased organ donation is predicated on timely identification and referral (IDR) of potential organ donors, as failure to perform this first, critical step jeopardizes the downstream donation process (Figure).3,4,5 Furthermore, in Canada, five provinces (BC, MB, ON, NS, AB) have legislated mandatory referral/consideration of deceased donors to ensure IDR. In addition to untimely or missed IDR, missed donation opportunities (MDO) can occur at every step along the donation pathway. Missed donation opportunities are safety events where best or expected practice has not occurred.

Figure
figure 1

Sequence of care in deceased donation. Reproduced and adapted with permission from Figure 2: Sequence of care in deceased donation in relation to notification and referral. Zavalkoff S, Shemie SD, Grimshaw JM, et al. Potential organ donor identification and system accountability: expert guidance from a Canadian consensus conference. Can J Anesth 2019; 66: 432–47. https://doi.org/10.1007/s12630-018-1252-6

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The 2016 Potential Organ Donor Identification and System Accountability expert guidance advanced missed IDR as a preventable harm to both patients on the transplant list, who are denied access to lifesaving organs, and to families and patients at the end of life (EOL), who are denied the opportunity to donate.3 Currently, the Canadian organ donation and transplantation (ODT) system is unable to quantify this preventable harm, nor plan and monitor improvement initiatives to reduce it. Our objective was to determine the national rate of donor IDR, estimate the number of MDO from missed IDR, and quantify the consequential preventable harm to Canadians patients and their families at EOL and on the transplant waitlist.

Methods

The Research Institute of the McGill University Health Centre, in collaboration with Canadian Blood Services, consulted with all eleven Canadian provincial organ donation organizations (ODOs) to complete the study. The study was granted an exemption letter for ethics review by The McGill University Health Centre Research Ethics Board as a quality improvement project.

Survey and interview development

The survey and interview guide were designed using the methodology of Burns et al.6 The research team first generated an exhaustive list of themes based on the existing literature. Themes were then drafted as survey and interview questions and divided into domains of potential donor audit practices, procedures and resources, and operational definitions. Potential survey and interview questions were then circulated to expert consultants (donor coordinators and donor physicians) for feedback. The research team and an experienced deceased donor coordinator reduced the list of potential survey questions to a target of 25 or fewer.7 Our team then determined whether each item should be 1) retained, 2) retained with edits, 3) excluded, or 4) retained and moved to the interview guide.

Prior to data collection, two donor coordinators provided feedback on ease of survey completion, flow, clarity, relevance, completeness, face validity, content validity, redundancy, and time for completion. We revised the survey based on the provided feedback. The survey was created and hosted on the Interceptum (Acquiro Systems, Inc., Gatineau, QC, Canada) platform. The final survey had 21 questions.

Survey administration

Each ODO was invited to participate in the study as part of a larger environmental scan. A member of the research team established a point of contact and introduced the project. Subsequently, each ODO was emailed a cover letter with a link to an electronic survey. Up to three weekly reminders were sent after the initial invitation.

Interviews

After survey submission, the research coordinator booked a one-hour telephone interview with each ODO representative to clarify and complete submitted survey responses. Interviews were recorded for transcription with verbal consent. Data were entered and summarized in a spreadsheet. No patient level data were collected, nor did we collect information about tissue donation.

The structured interview guide included questions about donor audit objectives, frequency, scope (hospital sites and patient inclusion and exclusion criteria), methodology of data collection, human and other resources required to conduct donor audits (including training, standard operating procedures, policies), and outcomes reporting and feedback processes including accountability structures. In addition, we sought to collect any missing data from the survey.

We collected ODO operational definitions for the following terms: potential, identified, referred, missed referral, eligible, approached, consented, and nonutilized donors. We obtained available aggregate rates for IDR, consent, and approach from the calendar years 2016, 2017, and 2018. These years were chosen as this research was initiated in 2019 but was delayed due to the COVID-19 pandemic. We accepted each ODO’s local definition of a potential, eligible, approached, and consented donor. We also asked each ODO to describe how they calculated these rates based on their operational definitions and assessed whether the calculation aligned with the method outlined in Table 1. When it did not, we collaborated with the ODO to complete the calculations using their raw data. If we could not harmonize ODO data with calculations in Table 1, the data were not included. In the absence of national agreed upon definitions and metrics, we based Table 1 on work developed by the Canadian Deceased Donation Data Working Group.8

Table 1 Donor metrics
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Calculation of preventable harm

We considered preventable harm to both potential organ donors and their families (i.e., depriving the opportunity to donate) and to patients on the transplant waitlist (i.e., depriving access to a lifesaving/life-enhancing transplant). Missed IDR patients are those who met the ODO trigger for referral but were not referred. Missed eligible IDR patients are missed IDR patients whom the ODO deemed suitable for approach (Table 1). We calculated the mean IDR, approach, and consent rates along with the 95% confidence interval. To estimate preventable harm, we applied the ODO’s annual proportion of donors who were eligible for approach (for referred donors) to the ODO’s number of nonreferred donors (missed IDR). Two ODOs directly provided the proportion of referred patients who were eligible for approach. For the other two ODOs, we used the denominator of their approach rate as a surrogate for the number of potential donors who were medically eligible for approach. The other seven ODOs were unable to provide sufficient data to estimate the metrics of interest and were not included in the analysis.

We considered missed eligible IDR as patients who were harmed at EOL, as they were denied the opportunity to consider donation by not being referred. Next, we applied the ODO’s actual approach and consent rates for the corresponding year, and used an average of three organs per donor,1 to estimate the number of missed transplants. While a deceased organ donor may provide up to eight organs, three is the average number a donor in Canada provides.1 This final number of missed transplants was then equated with the number of patients on the transplant waitlist who were harmed by missed IDR. When applied to the provincial population of the four ODOs included in this analysis, we calculated this as missed referrals per million population (PMP).9,10 The denominator of PMP is the traditional metric for deceased donation, living donation, and transplantation rates and which allow interjurisdictional comparison. Analysis was carried out with Microsoft Excel (Microsoft Corporation, Redmond, WA, USA) and Stata (StataCorp, College Station, TX, USA).

Results

Three ODOs provided definitions and metrics that aligned with those defined in Table 1. One ODO’s raw data allowed the necessary data to be sourced. Together, these four ODOs provided data that could be harmonized to calculate mean IDR, approach, and consent rates for 2016–2018 (Table 2). Both potential donors after neurologic and circulatory determination of death were included. Data were de-identified to maintain each ODO’s confidentiality.

Table 2 Mean identification and referral, approach, and consent rates (2016–2018)
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Annually, there were 75–105 missed IDR safety events in four provinces where patients who met the ODO’s clinical referral triggers were not referred. Of these, 63–76 were theoretically eligible to be approached for donation (3.6–4.5 PMP),10 and having not been IDR, suffered preventable harm at the EOL by not being offered the opportunity to donate. By applying each ODO’s actual approach and consent rates for the corresponding year, the theoretical number of missed consented donors was 37–41 (2.4 donor PMP). The corresponding theoretical number of missed transplants was 111–123 annually (6.4–7.3 transplants PMP), and assuming three transplants per donor,1 this represents preventable harm to a total of 354 waitlisted transplant patients between 2016 and 2018 (Table 3).

Table 3 Preventable harm from missed donor identification and referral
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Interpretation

We requested data on donation metrics from all Canadian ODOs. Given the lack of national consistency in conducting donor audits, only four ODOs could provide data to estimate preventable harm. Annually, 63–76 missed eligible IDR patients were harmed at the EOL by being denied the opportunity to donate. There were 37–41 MDO (2.4 donors PMP annually) due to missed IDR once the ODO’s actual approach and consent rates were applied. This resulted in an estimated 111–123 patients on the transplant waitlist potentially harmed each year of the study by being denied a lifesaving or life-enhancing transplant (6.4–7.3 transplants PMP).

These estimations of harm are significant when considered in the context of Canada’s deceased ODT system metrics. In 2018, 4,351 patients were on the transplant waitlist and 223 patients died waiting. Given the rare scenario that allows for organ donation, in addition to these figures, the reported MDO from missed IDR are substantial. In 2018, there were 20.3 donors PMP,1 so 2.4 missed donors PMP represents an unrealized increase of 12%. In addition, 7.3 missed transplants PMP represents a nearly 10% unrealized increase from the 2018 rate of 76.3 transplants PMP.1 The potential harm of missed IDR is likely more significant than estimated, given calculations were only based on four ODO.

Missed and untimely IDR has been described previously in Canada and internationally. The ACCORD project found that 35% of patients in Europe who died of devastating brain injury were never referred.11 The Alberta death audit found that 18% of brain death cases were not referred.12 Timely referrals entail calling the ODO when EOL conversations are planned and/or conducted to ensure sufficient time for the donation process. Untimely referral compromises the donation process by not allowing time for donor assessment, mobilizing resources, and a well-planned approach. Krmpotic et al. reported only 66% of medically suitable potential donors in Ontario had timely referrals before withdrawal of life-sustaining measures (WLSM), resulting in 251 MDOs over two years.13 Singh et al. found the most common reason for not approaching a patient with donor potential in Ontario was referrals made at the time of or after WLSM.14 Organ donation organization A in our study showed an improved IDR rate and a decline in approach rate for the three years reviewed, likely explained by untimely referrals. Missed and untimely referrals of potential donors are particularly problematic from the emergency department (ED). In the UK, Empson et al. described that 53% of potential donors failed to be referred even though 16% of these were on the donation registry.15 A systematic review showed that up to 86% of patients after neurologic determination of death and 75% of donors after circulatory determination of death were not referred from the ED.16 Finally, an Ontario ED donor audit found ten postmortem referrals that potentially would have increased the hospital’s donation rate, had they been referred.17 While the problem of IDR has been broadly described, our study is unique in quantifying its downstream preventable harm as a safety event.

Traditionally, we recognize safety events that cause direct harm to patients like a medication error or wrong-site surgery. In many jurisdictions, we are obligated to disclose such events to the patients.18 When a potential organ donor is not IDR this causes downstream, but disconnected, harm to a vulnerable patient awaiting transplant. There is no official accountability for this safety event; no disclosure is required. Offering donation is recommended as a standard part of high quality EOL care.3,5,19,20,21,22 Moreover, it is essential we respect people’s dying wishes which they may have registered or expressed to family. When standards for management of sepsis or myocardial infarction are not respected in clinical care, these are considered safety events. The same approach currently does not apply to guidelines advising routine and timely IDR of potential deceased organ donors.

The lack of available data from ODOs in our study is itself an important finding. The fact that only four of eleven ODOs could provide the requested data highlights Canada’s need for a national, standardized approach to donor audits including definitions, a minimal data set, and metrics. This would allow measurement and reporting of the disconnected, downstream harm of MDOs including missed or untimely donor IDR. It would also facilitate goal setting, planning, and evaluation of quality improvement interventions.5

We acknowledge there are limitations to our study. While the lack of available data from all ODOs highlights a weakness of the Canadian ODT system, it also represents a limitation of this work. It is likely that the unmeasured harm from missed IDR is greater than reported, as our conclusions are only based on data from four ODOs. While the approach and consent rates are based on the ODOs actual rates during those years, we have made assumptions about the utilization rates and the number of organs each donor would yield. Since not all theoretically consented donors may actualize, this is a source of potential overestimation. Furthermore, ODO definitions and reporting metrics were misaligned. For example, the definition of approach (e.g., inclusive of health care provider approach vs ODO-only approach) varied by ODO, and thus the approach rate may differ. Referral rates may be impacted by a lack of standard referral criteria across jurisdictions. We attempted to mitigate these limitations by clarifying our understanding of these nuances through telephone interviews and by sourcing raw ODO data when required. In addition, data presented are a combination of both neurologic and circulatory determination of death which does not allow us to comment on specific referral patterns by donation type. We also did not weigh our results by provincial population size.

Conclusions

Missed identification and referral of potential organ donors causes harm by denying both the opportunity to donate at end of life and access to lifesaving or life-enhancing organs to vulnerable patients awaiting transplant. This safety event and its consequential preventable harm is unmeasured and unrecognized, so there is no accountability or disclosure of these patient safety events. Future work is needed to standardize the definition of a potential donor, clinical referral triggers, and the reporting of missed donor identification and referral to allow for accurate measurement and reporting of these patient safety events and to facilitate accountability mechanisms.