Preparing for the inevitable: The death of a living liver donor

Authors


Address reprint requests to Teresa Diago Uso, M.D., Liver Transplant Program, Department of General Surgery, Cleveland Clinic, 9500 Euclid Avenue, Desk A100, Cleveland, OH 44195. E-mail: diagot@hotmail.com

Abstract

Living donor liver transplantation (LDLT) is associated with a low but finite and well-documented risk of donor morbidity and mortality, so organizations and individuals involved in this activity must accept the fact that a donor death is a question of when and not if. Studies in the field of crisis management show that preparing for the inevitable not only is critical in preparing institutions to better respond to catastrophic events but more importantly plays a crucial role in preventing them. This article describes the background of crisis management with specific reference to the death of a living liver donor and proposes a general framework that can be adopted by LDLT programs around the world. Liver Transpl 19:656–660, 2013. © 2013 AASLD.

Abbreviations
CEO

chief executive officer

CMP

crisis management plan

CMT

crisis management team

DAT

donor advocate team

LDLT

living donor liver transplantation

OPO

organ procurement organization

PR

public relations

UNOS

United Network for Organ Sharing

Living donor liver transplantation (LDLT) has evolved into a valuable tool for alleviating the organ shortage. It represents an important option for many patients who have little or no chance of receiving an organ from a deceased donor. However, LDLT is associated with a low but finite and well-documented risk of donor morbidity and mortality. We assert that a donor death is an inevitable event for LDLT programs. Deeming it inevitable implies that a donor death must be considered a question of when and not if. LDLT programs must have specific strategies in place to ensure that such a catastrophic event is carefully anticipated and managed properly in an ethically supportable way. The interests of multiple stakeholders, at times competing, must be given focused consideration and balanced appropriately.

It is important to note that the deaths of living liver donors have generated far more media coverage than the deaths of living kidney donors. Because liver donor deaths have been such a lightening rod and have attracted so much attention, organizations with LDLT programs need to be especially prepared.

ALL-HAZARDS APPROACH TO DISASTER PLANNING

Best practices for disaster planning dictate that an all-hazards approach provides the strongest basis for a successful response to critical events.[1] All-hazards planning is based on the concept that most disaster response functions are common to all disaster types, and unified planning provides the strongest foundation for an effective response.[2]

Disaster recovery and crisis management are 2 critical organizational functions. An airline company, a nuclear power plant, and a hospital with an active LDLT program are all organizations engaged in risky, high-profile activities. For these organizations, a failure to engage in comprehensive crisis planning can result in a loss of human life and serious harm to society and threaten the organization's reputation and a program's existence. There is extensive evidence in the literature that preparing for the inevitable is a crucial step in every successful organization. The inevitable must be learned to be viewed as a when event and not as an if event for the planning to be successful. Furthermore, these strategies are based on a very rigorous methodology that can be universally applied regardless of the sphere of operation of the organization.[1]

Several aspects of disaster preparedness and planning need emphasis. First and foremost, comprehensive disaster planning is strongly associated with a reduction and/or mitigation of catastrophic events. The less vulnerable an organization thinks that it is, the fewer crises it prepares for, and, as a result, the more vulnerable it becomes.[3]

Moreover, preparedness has been shown to be crucial in increasing the reliability of systems, in providing a sense of security, and in minimizing impromptu decision making during a disaster.[4] Organizations are better able to handle crises when they (1) have a crisis management plan (CMP) that is updated at least annually, (2) have a designated crisis management team (CMT), and (3) regularly conduct exercises to test the plans and teams.[4, 5]

Because every crisis may have many different specifics and variables, a CMP must be considered a flexible reference tool rather than a hard and fast blueprint. A CMP provides a list of the crisis team's key personnel, their contact information, their specific responsibilities, and a chain of command. One important subset of the CMP is a communication chain of all significant stakeholders (Fig. 1). Our CMP is just an example of a communication chain based on our institutional structure that can be adapted or expanded. It has been shown that a CMP saves time during a crisis by pre-assigning tasks, precollecting information, and serving as a reference source for the designated crisis team.[6]

Figure 1.

Communication procedure to implement in the event of an adverse LDLT outcome: the death of a healthy donor. All media interactions (proactive and reactive) will be handled by corporate communications.

APPLICATION TO LDLT PROGRAMS

From an organizational and leadership perspective, a few key points should be in place before an LDLT program is started.

To successfully emerge from a catastrophic event such as a living donor's death, the transplant program's leadership must have harmonious intra- and extra-organizational working relationships. Trying to simultaneously build last-minute lines of communication and relationships while managing a crisis is nearly impossible and can create a toxic mix when something goes terribly wrong. Building and establishing relationships and trust through routine and respectful communications between significant stakeholders inside and outside the transplant team (eg, organizational administration, risk management, quality, and safety personnel) is a prerequisite for any and all crisis management efforts.

Top institutional management must support and be integrally involved in the development of the disaster recovery planning process. Management should be responsible for coordinating the disaster recovery plan and ensuring its effectiveness within the organization. Adequate time and resources must be committed to the collaborative development and promulgation of an effective plan.

A planning committee should be appointed to oversee the development and implementation of the disaster recovery plan. Key committee members should include institution-wide physician and administrative leadership; core team medical and surgical leaders; and legal and risk management, media relations, and bioethics personnel. The chair of the committee should be appointed by the medical center's chief executive officer (CEO). This planning committee will develop the relevant policies and procedures and will most likely form the nucleus of the crisis team for actual program implementation.

THREE PHASES OF THE PLAN

Disaster planning and crisis management can be divided into 3 phases[4]: (1) the precrisis phase, (2) the crisis response phase, and (3) the postcrisis phase. What follows is a description of the essentials related to each phase.

Precrisis Phase: Prevention and Preparation

The precrisis phase focuses on prevention and preparation. Donor safety is prominent in this precrisis phase and includes preoperative, intraoperative, and postoperative elements. Because of their predominantly altruistic motivations and the liabilities and risks associated with the procedure, donors are not patients in the usual sense. Therefore, special protocols and paradigms for their care must be produced and published.

Ethical and pragmatic issues surround donor advocacy. For this reason, federal regulations require transplant programs to appoint an independent donor advocate to ensure the safe evaluation and protection of living donors.[7, 8] The goals of donor advocacy should include protocol development, education, medical and psychosocial evaluation, advocacy, support, and documentation throughout the assessment and donation process. This is best done if the independent advocate is surrounded by a team of professionals that includes bioethicists, physicians, surgeons, social workers, psychiatrists, and nurses; this committee is known as the donor advocate team (DAT).[9]

Optimal outcomes begin with prepared, educated, uncoerced, and motivated donors, and it is the responsibility and goal of the DAT to help donors reach this point.

At our institution, we view informed consent as both a process and a documentation event, and we feel that it is crucial to involve as much as possible family members and the power of attorney. The process is started before the initial visit, with the potential donor being given an informational booklet. This booklet provides a detailed guide to the process of donor evaluation, surgery, and aftercare. During the various consultations with physicians, nurse coordinators, social workers, and ethicists, the information in this booklet is reviewed and supplemented. The final step of the consent process includes a face-to-face consultation with the operating surgeon to review all risks, benefits, and alternatives, and this includes the disclosure of surgeon-specific, center-specific, and international outcomes data. This meeting is concluded with the surgeon's and patient's written attestation that the surgeon has presented this information and that the patient understands and wishes to proceed. On the surgical side, strict protocols regarding the quantity and quality of the donor liver remnant should be clear to, understood by, and accepted by all members of the LDLT team. A practical strategy aimed at ensuring that all resources and personnel are in place at the time of surgery is a final checklist review before the donation (2 days before the scheduled donation in our program) when the entire LDLT team assembles.

The routine use of perioperative checklists has been shown to substantially reduce morbidity and mortality, and they are rapidly becoming established standards of care.[10] We support their routine and rigorous use with the aims of improving standardization and teamwork and reducing the probability of error.

An additional safeguard is for the donor and the recipient to be seen on the day before surgery by predesignated transplant nurses and physicians to review and conclude that clinical conditions remain appropriate for both.

The surgery team for the donor operation should consist of at least 2 transplant surgeons with training and experience in accordance with United Network for Organ Sharing (UNOS) requirements. In addition, special liver transplant anesthesiologists and experienced operating room nurses should be involved. Lastly, during surgery, a living donor coordinator should provide donor family members with routine updates.

In the spirit of overarching safety, the donor should be admitted soon after the surgery to a unit (an intensive care unit, a step-down unit, a post–acute care unit, or the nursing floor) with the ability to continuously monitor vital parameters (eg, O2 saturation, electrocardiogram, urine output, Jackson-Pratt output, pain, and mental status) and with a low (1:1 or 1:2) nurse-to-patient ratio.

A surgical resident, fellow, or mid-level provider should be available and in the hospital at all times. A clearly delineated and written communications escalation protocol specifying contact information and the clinical chain of command (see the communication chart in the supporting information) should be in place to avoid any delay in communication. It is important to have a detailed and readily available protocol for several reasons: (1) it is a reference point for personnel not familiar with the care of living donor liver patients (eg, rotating resident physicians and new nurses); (2) it creates a standard and reproducible routine and minimizes mistakes, and (3) it is an indicator of the commitment of the program to donor care and safety. In our program, for example, the senior/chief resident surgeon in house is responsible for after-hours care of the donor patient.

Crisis Phase: When the Disaster Happens

Crisis response is what the CMT does and says after the disaster occurs. Guidelines for the initial crisis response include the following axioms: (1) be quick, (2) be accurate, and (3) be consistent.

Being quick requires operationalization of the CMP within 2 hours of the crisis. This expectation puts significant pressure on crisis managers to have a carefully crafted message ready in a brief period of time. Anticipation, preparation, and message templates (see the communication preparedness plan in the supporting information) will help to keep the response time within targeted limits. Crisis managers should have available templated messages that can easily be adapted to the specific circumstance of the crisis. Templates include statements by top management, news releases, and dark Web sites (prebuilt Web sites not accessible to the public that can be quickly turned on as needed during a crisis management situation). Both the Corporate Leadership Council[11] and the Business Roundtable[12] strongly recommend the use of templates. Taylor and Kent[13] found that having a crisis Web site is a best practice. On a practical level, to aid in anticipation, we notify the crisis team the day before each living donation procedure so that if something goes terribly wrong, they are not blindsided.

Being accurate is an important goal whenever an organization communicates with the public. An approach of speaking with 1 voice in a crisis is a way to maintain accuracy. Therefore, a key component of crisis team training is spokesperson training. An organizational spokesperson needs to be pre-assigned and pretrained; other members of the crisis team must also be trained and prepared to talk only in the event of a specific need and after approval from the CMT. Table 1 highlights best practices in initial crisis response.

Table 1. Initial Crisis Response Best Practices
1. Be quick and try to have an initial response within 2 hours.
2. Be accurate; double-check all facts.
3. Be consistent; the spokesperson needs key talking points.
4. Make safety the number 1 priority.
5. Use all available communication channels, including the Internet and intranets.
6. Provide expressions of concern/sympathy for the victims.
7. Target employees in communications.
8. Be ready to provide stress and trauma counseling to victims of the crisis and their families, including employees.

Being consistent includes maintaining control of the message, as facts emerge, to both internal and external audiences and making sure that only 1 message is being sent. The goal is to communicate 1 consistent message to the media, the donor's family, the medical community, current patients, and the general public. As facts emerge with time, the message needs to stay as consistent as possible. A copy of Cleveland Clinic's communication preparedness plan in the event of an adverse LDLT is included in the supporting information.

Postcrisis Phase: Addressing the Aftermath and Returning to Routine Practice

In the postcrisis phase, programmatic goals include addressing the consequences of the crisis and gradually returning the liver transplant program to routine practice without shortchanging the learning process. The crisis itself is no longer the focal point of attention but still requires attentiveness.

Timely and direct communication with the donor family is essential and will need immediate attention. This communication should take place in both an honest and empathic manner and be provided by the senior transplant leaders who are familiar with the facts of the surgery and the donor's death as known at the time and who can begin to answer the family's questions. The skills and competencies needed for these conversations are the same as those identified for disclosing bad news and expressing sympathy to patients and families in other clinical situations and settings.

By definition, the death of a liver donor is a sentinel event and must be reported to the Joint Commission, UNOS, and other regulatory agencies as required. As is appropriate for all sentinel events, a donor death should be subjected to a root-cause analysis so that causative factors and a remediation plan can be identified. The safety of future donors will be served if specific process and program improvements can be identified.

When and if to deactivate an LDLT program voluntarily or involuntarily (by the Centers for Medicare and Medicaid Services or UNOS) after a donor death is a complex issue. Although a root-cause analysis is critical and may take some time, the fate of other patients awaiting this lifesaving treatment hangs in the balance. The existence of a well-prepared crisis plan and team that can begin working immediately may well mitigate the need for inactivation or significantly shorten its duration.

Clinical and administrative staff associated with the donor's screening and approval process as well as the surgery itself can have significant emotional responses to a donor death. Transplant personnel can experience guilt and regret and second-guess their involvement in the living donation process more globally and/or in the specific case. Employee assistance programs, pastoral care providers, and social work counselors can be valuable organizational resources to address personnel's distress.

Reputational repair may be continued or initiated during this postcrisis phase. There will be important follow-up communication that is required. Crisis managers often promise to provide additional information during the crisis phase and must deliver on those informational promises or risk losing public trust. The organization needs to release updates on the identified and planned program improvements, corrective actions, and/or investigations of the crisis.

PERSONAL PERSPECTIVE: THE PRIMARY SURGEON

The sudden death of a patient is every surgeon's nightmare. Although always difficult, mortality is often easier to accept when the patient is a person with a serious condition that motivates the need for surgery rather than a person who is motivated by altruism as in the donation process. In contrast, the distress associated with the unexpected death of a donor can be overwhelming and disorienting.[14]

Moreover, most surgeons performing LDLT are natural leaders and, despite the mantra of when and not if, there is some sense that “it cannot happen to me.” A donor's death can temporarily weaken the surgeon's ability to lead and is always associated with severe emotional distress. It is, therefore, imperative that in the event of a donor death, the surgeon leader step back, receive grief counseling as needed, place trust in the crisis team, and let others within the organization do the leading. This stepping back and stepping away should be a clear directive in the written CMP and CMT. There must be no ambiguity regarding roles, responsibilities, and expectations, especially in the mind of the surgeon leader, who could make the situation worse if he or she remains intimately engaged in trying to lead the crisis management process.

CONCLUSION

No organization is immune from crises, so all organizations must prepare for them. Although crises begin as negatives and as threats to organizational activities, programs, and reputations, effective crisis management can minimize damages and losses and allow an organization to emerge stronger than before the crisis.

Is your organization prepared to handle the implications of a living donor death? Preparation for a crisis requires the collaboration of the entire institution. Through the process of organizing the crisis plan and developing the crisis team, there is an inherent raising of organizational consciousness about the real chance of such a disaster occurring. That new consciousness changes the way people think and behave and, in the end, provides a level of comfort that the crisis program is comprehensive, well planned, and staffed and that the impact of a crisis will be best mitigated. For those who work in the field of crisis management, it is no longer a question of whether a major disaster will strike any organization but only a matter of “when, how, and what form will it take, and who and how many will be affected.”[3] It is a question not of if but of when.

ACKNOWLEDGMENT

The authors thank Mary Kay Quinn, Amy Daneri, Samantha Miller, and the DAT for their expertise, dedication, and support of the Cleveland Clinic LDLT program.

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