Abstract
Although minimized by expert evaluation, operative technique, and postoperative care, the extremely low risk of perioperative mortality following living kidney or liver donation will never be eliminated. Furthermore, anticipation of poor donor outcome may simultaneously be a source of anxiety for physicians and programs, and also be a circumstance for which they are unprepared. We conducted a national survey of U.S. transplant surgeons to understand experiences with and systemic preparedness for the event of a living donor death. Respondents represented 87 unique transplant programs (71 kidney and 16 liver donor programs). Perioperative deaths were rare, as expected. Although most respondents (N=57, 64% of total respondents; 88% of liver programs) reported being moderately to extremely concerned about a future living donor death at their institution, only 30 (33% of total program respondents) had a written plan available in the case of such an event. 63% of programs would find guidance and recommendations useful. To help address this gap, the American Society of Transplantation Live Donor Community of Practice (AST LDCOP) developed Living Donor Crisis Management Plan Talking Points suitable to guide crisis plan development at transplant programs.
INTRODUCTION
Living donor transplantation is an important treatment option for patients with end-stage organ disease, accounting for nearly 33% of the kidney transplants and approximately 5% of the liver transplants performed annually in the United States (1). In the context of a severe organ shortage, living donor transplantation presents an opportunity to expand access to life-saving organs. The post-operative risk of mortality for living organ donors is extremely low; however, it is not nonexistent. Living kidney donors face a 90-day mortality risk of 3.1 deaths per 10,000 donors; living liver donors face a risk of 15–20 deaths per 10,000 donors (2–4). Living donor deaths are tragic and devastating, not only for the decedent’s family and loved ones but also for the transplant recipient, clinical team, and transplant program (5–9).
The transplant community must ensure the risk of mortality for living organ donors, who undergo a major surgical procedure for the sole medical benefit of another individual, is as low as possible (10). All living donor deaths occurring within 2 years post-donation must be reported via the Patient Safety Portal in UNet within 72 hours (11). An immediate communication occurs with Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) staff, Health Resources and Services Administration (HRSA) representatives, and the Chair and Vice Chair of the Members and Professional Standards Committee (MPSC) of the OPTN to evaluate the case and make a determination regarding immediate risk to patient safety. A confidential peer review is conducted, with findings presented to the MPSC for further peer review (12). Following a living donor death, OPTN/ UNOS recommends that living donor transplant programs voluntarily suspend surgical activities to review related procedures and protocols (6, 8, 13–15).
Community-wide discussion about these tragic events has been limited, with minimal opportunity to share lessons learned, although there have been calls for this communication for years (16). An example of the benefits of shared community discussion is the mid-2000s dialogue about use of nontransfixing hem-o-lok clips in laparoscopic donor nephrectomy, and the resulting recommendation to discontinue such use (17–19). Since then, while both living liver and kidney donor deaths have occurred, there is a paucity of published information regarding transplant programs’ experience, practice, and policy related to response to and management of living donor deaths (20). This information is critical to developing effective materials to support and guide patient families and transplant programs (21, 22).
In 2014, Miller et al encouraged living liver donor programs build contingency plans for catastrophe. They argued that delineating quality care practices in a ‘pre-crisis phase’ as part of a crisis management plan emphasizes their import, and readies program spokespeople in the event of a catastrophe. During the crisis, they encouraged consideration of stakeholders’ interests and delineation of key personnel responsibilities, a defined chain of command, and a harmonious approach to teamwork. Miller et al. offered the personal recommendation that the primary surgeon step back from leading primary response. Specific action items post- crisis were proposed, with key roles defined (24).
The American Society of Transplantation Live Donor Community of Practice (AST LDCOP) convened a Living Donor Mortality workgroup in 2017, composed of multidisciplinary experts in living donation clinical care, transplant program management, and outcomes research, with the goal of improving community-wide and program-specific preparedness in the event of a living donor catastrophe. Specifically, the workgroup investigated and sought to corroborate publicly available data regarding living donor deaths, reviewed the current literature, and conducted a national survey of transplant providers to ascertain experiences with living donor deaths,program-specific policies, and attitudes about preparedness. The workgroup reviewed literature on living donor program crisis management plans, and conducted community outreach to compile individual transplant program crisis management plans so as to identify essential components. Here we provide survey results and a set of Living Donor Crisis Management Plan Talking Points to support preparation, appropriate response, and communication in the event of a living donor death or catastrophe. This manuscript is a work product of the AST LDCOP and has been reviewed by the AST LDCOP Executive Committee, and the AST Education Committee on behalf of the AST Board of Directors.
METHODS
Study population and survey distribution
Contact information for survey distribution was assembled through the public American Society of Transplant Surgeons (ASTS) member and community database. To the best of our ability, we cleaned the list to include surgeon members. The web-based survey was hosted by Qualtrics (Qualtrics, Provo, UT) and distributed to 1,055 ASTS surgeon members between July 21, 2018 and September 18, 2018. Respondents were contacted up to 4 times via email. The Johns Hopkins School of Medicine Institutional Review Board approved the survey study (IRB00181477-PI: MLH). Informed consent was presumed upon completion of the survey.
Survey design
The survey length ranged from 9 to 17 questions depending on participant responses. The survey was designed by the AST LDCOP Living Donor Mortality Workgroup and was pilot tested by two transplant nephrologists, two transplant surgeons, a transplant social worker, and two transplant researchers.
Review of program-specific contingency plans
Program-specfic contingency plans for review in this project were solicited through posting on the AST LDCOP, Kidney-Pancreas COP, Transplant Administrators COP listservs, and through email communication by the work group. Seven program-specific contingency plans were submitted; two workgroup members (REH,DGM) compiled and synthesized content themes.
Statistical analysis
Descriptive analysis was performed using Stata 15.0/MP for Linux (College Station, Texas). Confidence intervals are reported as per the method of Louis and Zeger (23).
RESULTS
Study Population
Of 1,055 living donor transplant surgeons contacted, 119 responded to the survey. We aimed to capture one response per program and used the following hierarchy to select answers for analysis when there were multiple responses per program: 1) survey completeness, 2) response from a Program Director, and 3) random selection. The majority (N=76) of respondents worked primarily in living kidney donation; 17 worked primarily in living liver donation. Respondents represented 87 unique transplant programs (71 kidney and 16 liver donor programs), with 6 missing program affiliation. 44 respondents described themselves as their institution’s Living Donor Kidney Program Director; 9 described themselves as their institution’sLiving Donor Liver Program Director. Respondents reported a median annual living donor kidney transplant volume of 30 (interquartile range [IQR]: 20–60; range: 6–175) and a median annual living donor liver transplant volume of 15 (IQR: 10–15; range: 2–25), came from a broad geographic swathe, and represented both urban and rural programs.
Transplant program experience with living donor deaths
Among kidney program respondents, most(74.3%, N=55) reported no living kidney donor deaths within 2 years of donation. Among 19 respondents who reported at least 1 living kidney donor death at their program, most (89.5%, N=17) reported a single event. Attributed causes of death are found in Table 1. Living donor deaths were attributed to suicide or psychological issues (26.3%, N=5), accidents/trauma unrelated to donation (15.8%%, N=3), medical or surgical complications unrelated to donation (10.5%N=2), and surgical complications (31.6%%, N=6). Cause of death was unknown or not reported for 3 donors (15.8%). The 6 deaths attributed to surgical complications occurred within 24 hours (50.0%, N=3),between 24 hours to 1 week (33.3%, N=2), or between 1 week to 1 month post-donation (16.7%, N=1). The remaining donor deaths were equally distributed between 3 months to 1 year (31.6%, N=6) and between 1 to 2 years post-donation (36.8%, N=7). Timing of death was not reported for 2 deaths (10.5%).
Table 1.
Timing and Primary Attributable Cause of Living Kidney and Liver Donor Deaths
| Timing of death | Primary attributable cause(s) of death | |
|---|---|---|
| Kidney donors | Within 24 hours | |
| Bleeding (surgical) + Other medical | ||
| 24 hours to 1 week | ||
| Other medical: Unknown | ||
| 1 week to 1 month | Other surgical: pulmonary embolus | |
| 3 months to 1 year | ||
| Other surgical + Other medical: Overdose on psych meds 6 months post donation | ||
| > 1 year | ||
| Other surgical: Bowel injury and perforation Cardiac (medical) + Other medical: unknown | ||
| Liver donors | Intraoperative | Bleeding (surgical) |
| 24 hours to 1 week | Other medical: respiratory arrest 2° over sedation |
Attributable cause of death categories were defined by AST LDCOP Workgroup Consensus
Among liver program respondents, most (86.7%, N=13) reported no living liver donor deaths within two years of donation. Two respondents (13.3%) reported 1 liver donor death at their transplant program. These deaths were attributed to surgical bleeding and respiratory arrest due to over-sedation and occurred intraoperatively and between 24 hours to 1 week post-donation, respectively.
Concern about and preparedness for future living donor deaths
Among kidney program respondents, 18 (24.3%) reported being extremely concerned about future living kidney donor deaths at their institution; 25 (33.8%) were moderately concerned; 23 (31.1%) were slightly concerned; and 8 (10.8%) were not concerned. Among liver program respondents, 6 (37.5%) reported being extremely concerned about future living liver donor deaths; 8 (50.0%) were moderately concerned; and 2 (12.5%) were slightly concerned (Figure 1). Respondents who reported at least 1 living donor death at their center were not more or less likely to report concern about future living donor deaths. Most respondents (N=59, 68%) reported their institution did not have a written “contingency” or “disaster” plan in the case of a living donor death.
Figure 1.
Concern About and Preparedness for Future Living Donor Deaths
Development of the AST LDCOP Living Donor Crisis Management Plan Talking Points
Interestingly, although Miller et al published crisis management plan recommendations in 2014 and a majority of survey respondents were concerned about future living donor deaths, only a minority of survey respondent programs had a crisis management plan. We aimed to synthesize available models and simplify the task of crisis plan development for other programs. We identified key plan elements from the foundational frame built by Miller et al. and from crisis management plans submitted by survey respondents. We offer these as seasoned donor clinicians and researchers, absent regulatory guidance, as a frame for discussion and a spur to action rather than as a prescriptive guideline.
Crisis management plans: examples and synthesis
Of the 30 respondents reporting crisis management plans, 7 shared their institution’s written plan. Each had a slightly different purpose and scope; some described high-level concepts whereas others provided granular steps and action plans. All described senior hospital/ institutional leadership participation, and the role of a crisis management team (CMT). Some defined CMT roles, responsibilities, and chain of command; some were clear in aiming for rapid, consistent, accurate messaging and even offered scripted templates for use with media. All addressed coping with crisis aftermath: managing consequences with the goal of gradually returning the program to active practice. This included patient and family communication and support, team communication and support, mandated reporting, root cause analysis, and temporary deactivation of the program.
Several recommendations offered by Miller et al. had not been widely incorporated in submitted crisis management plans. Only 2 plans identified ‘pre-crisis’ protocols. In addition, few of the submitted plans acknowledged potential ethical dilemmas and/or conflicts within the team and the larger hospital system. Few described how to communicate updates. None recommended annual review.
Several submitted crisis management plans had components beyond those described by Miller et al. These included: defining catastrophic events, procedures for corrective action planning, recommendations for communicating with the recipient and recipient care team, and the role of the Independent Living Donor Advocate (ILDA) in donor family communication. Plans offered differing recommendations for the role of the donor surgeon: one recommended the donor surgeon communicate with the donor’s family but otherwise be removed from crisis management leadership; another removed the operating surgeon from clinical care for a defined period.
Building from Miller et al’s framework, and integrating elements from individual crisis management plans received from transplant programs, our work group built an outline of talking points to guide individual programs’ Living Donor Crisis Management Plan development.
AST LDCOP Crisis Management Plan: Talking Points
The Living Donor Crisis Management Plan Talking Points (Figure 2) may help programs target discussion and build a frame to identify key players, steps, and topics. We offer structure and rationale, and have intentionally refrained from granular guidance or a fill-in template, as we assert that elements girding donor safety and guiding communication strategies will vary by program and by setting.
Figure 2.
Living Donor Crisis Management Plan Talking Points
Introduction
The Crisis Management Plan Introduction provides a statement of purpose and defines scope. Goals should include clarifying roles, building communication plans, and defining action steps over three phases: pre-crisis, crisis, and post-crisis. An inclusive method of plan development should be utilized and described, so as to promote team participation and institutional buy-in and should include senior institutional leaderhip. Any crisis management plan should acknowledge that in the event of a donor crisis there may be competing needs between stakeholders regarding response and message delivery internally and externally; the crisis management plan aims to provide clarity and minimize conflict. The need for disclosure while protecting the program and its personnel must be recognized as potentially requiring modification of standard team roles. “Donor crisis events” (which might include crises in additional to donor mortality) and UNOS reporting criteria should be defined (11). The Plan should have a scheduled review every 3–5 years.
Pre-crisis: Fundamentals of safety that help prevent donor catastrophe
Donor safety and advocacy practices aimed at effective prevention should be at the forefront of any plan. This serves the dual benefit of highlighting processes that prevent crisis and providing grounding language about transplant program donor care practices. Description of “pre-crisis” donor safety fundamentals should be tailored to the individual transplant programs’ protocols, but might include: donor advocacy to support informed consent process, peri-operative checklists, delineated and robust staffing and monitoring procedures, and a communication escalation protocol, with a defined chain of command (26,25).
Crisis Phase
Delineation of team roles and communication tasks during crisis is paramount. The primary goal is to plan for quick, accurate and consistent communication to internal and external stakeholders (27). The crisis management team should be identified, with defined roles, a chain of command including senior institutional leadership, and a communication pathway. The ILDA should be invited to participate. We recommend templated messages, and a trained spokesperson. We also recommend removal of the donor primary surgeon from managing the crisis on an institutional or team-based level, with the understanding that the surgeon may be integral to initial donor family communication (28).
Post-crisis
The “post-crisis” phase addresses long-term programmatic consequences and aims for a gradual return to normal activities. We support designating clinicians to communicate with the family of the donor and the recipient (28). We suggest a communication plan for the clinical care team, including provision of supportive care, and a schedule for crisis management team meetings. Program leaders should coordinate the mandated reporting to the Joint Commission and UNOS, a temporary deactivation of the program in cases in which the donor’s death was within 90 days of surgery or has ties to the surgery event, a root cause analysis and accompanying corrective action planning. We recommend a plan to follow through on promises to release updates as available to the public or to affected families.
DISCUSSION
Members of the workgroup sought to understand how transplant programs experience and respond to living donor deaths. Not surprisingly, most survey respondents had not experienced a living donor death within the reportable 2 years post- donation. Although the majority of survey respondents reported at least moderate concern about a potential future living donor death, only a minority of programs surveyed had written crisis management plans.
We acknowledge limits to this survey, including a not-unanticipated low response rate, and a discipline-specific perspective. The survey aimed to glimpse the current state to guide workgroup efforts, and define our strength-of-purpose; it did not entail multiple pleas for responses. We limited the survey to surgeons to reduce duplicative program responses. In addition, it is possible that respondents are not representative of all US programs, and may be somewhat more likely to be concerned about donor deaths than non-respondents. Respondents included those from a wide range of programs, including those with small and large volumes, private and academic, and with a broad geographic range.
We also acknowledge several barriers to programs building crisis management plans. First, the process may feel burdensome: living donor death is a low-likelihood problem and therefore the task can become a low priority. Second, we wonder if conceiving of a living donor death causes teams discomfort. We hope the Talking Points herein reduce barriers, spur team member discussion, & facilitate individual program Crisis Management Plan construction. Furthermore, crisis management planning could be applicable to broader severe donor complications beyond deaths following living organ donation.
Publically available data regarding living donor deaths is scarce, both on incidence and on what may be contributing factors. Although reporting is required under OPTN/UNOS Policy 18.6, the substance of these reports, subsequent review and actions by the MPSC, and resultant changes in individual program practice/policy are protected by Peer Review confidentiality guidelines (11, 29). Disincentives for programs to share details about living donor deaths may include liability concerns, fear of public scrutiny, and potential negative effects on patient referral networks.
We hope the transplant community can begin to create a non-punitive and transparent climate in which to learn from the – thankfully rare—instances of living donor death. A 2002 living liver donor death had a profound effect on the liver transplant comunitiy, triggering a decrease in US living liver donor cases in the years to follow, and leading to the introduction of the independent living donor advocate. Ideally, cases with catastrophic outcome could be discussed (anonymized to patient and program) so that care and process improvements could occur. Examining these cases in the aggregate would highlight any trends in causation.
CONCLUSION
Protection of living donor safety is the hallmark of all OPTN/UNOS living donor programs and is a key strategic priority for the national transplant system. Effective crisis management is essential for the thankfully rare circumstance of a living donor catastrophe, including: systems for communicating with donor & recipient families, support for transplant team members, a process for program accountability and recovery, and public messaging.
ACKNOWLEDGEMENTS
The authors thank the AST LDCOP Executive Committee, the AST Education Committee, and the AST Board of Directors for support of the LDCOP workgroup, and review and feedback of the manuscript. We also thank members of the AST LDCOP, Kidney-Pancreas COP, Transplant Administrators COP listservs and colleagues for sharing program-specfic disaster plans. Funding for this study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) grant numbers K01DK114388–01 (PI: Henderson). The analyses described here are the responsibility of the authors alone and do not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products or organizations imply endorsement by the U.S. Government.
The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Abbreviations:
- OPTN
Organ Procurement and Transplantation Network
- UNOS
United Network for Organ Sharing
- AST
American Society of Transplantation
- LDCOP
Live Donor Community of Practice
- HRSA
Health Resources and Services Administration
- MPSC
Members and Professional Standards Committee
- CMT
Crisis Management Team
- ILDA
Independent Living Donor Advocate
Appendix
Footnotes
DISCLOSURE
The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation. The authors are volunteer members of the American Society of Transplantation Living Donor Community of Practice.
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