Donation physicians are specialists with a focus and enhanced expertise in organ and tissue donation and have been recognized internationally as a key contributor to improving organ and tissue donation services. In 2011, Canadian Blood Services, in collaboration with the Canadian Critical Care Society, explored the role of donation physicians during a forum of key stakeholders.1 The consensus at this forum was that donation physicians should be introduced in Canada, and subsequently programs have been implemented in several provinces. They usually work in collaboration with nurse donor coordinators and organ donation organizations and their role can include donor care, program administration, education, training, performance measures, quality improvement, and advocacy. Responsibilities vary according to region. In some cases, they act as local champions and in others, they are directly involved in the clinical care of potential donors.
During the 2011 forum, there were preliminary discussions about anticipated ethical challenges that have also been identified in response to the publication of the report proceedings2 and by deceased donation leaders in the field. These professionals are generally intensive care unit (ICU) physicians who must manage the dual obligation of caring for dying patients and their families while providing donation care. This situation gives rise to inevitable ethical challenges and actual, potential or perceived conflicts of interest. It is recognized that conflicts of interest are not implicitly unethical, but ethics should inform their management.
An ethics guide provides a framework to promote ethical decision-making in situations where a single, unifying recommendation is not possible. Although many guidelines for donation systems include some guidance,3,4 these documents generally focus on broader ethical issues within organ donation. This highlights the need for an ethics guide to advise on mechanisms to mitigate conflicts that may arise and support hospital leaders and donation physicians in preserving their duty of care, protecting the interests of dying patients, and fulfilling best practices for organ and tissue donation. It is important to provide practical guidance to donation physicians and the organizations that sponsor them on how to manage the complex tensions at the intersection of dying, death, and organ donation. The intent was not to dictate clinical practices for donation physicians but to serve as a guide for ethical conduct, recognizing the need for flexibility to adapt to regional and individual circumstances. Although this report is intended to inform donation physician practices, it is recognized that the recommendations may have applicability to other professionals (eg, physicians in intensive care, emergency medicine, neurology, neurosurgery, pulmonology) who may also participate in the end-of-life care of potential donors in various clinical settings.
A forum was held February 23 to 24, 2015, in British Columbia in conjunction with the Whistler Canadian Critical Care Conference, according to the process developed by the Steering Committee (see Appendix 1, SDC,http://links.lww.com/TP/B411), who met regularly for 8 months before developing the agenda, the process and the supportive background documents for the workshop. Background documents included a literature review and environmental scan on practices related to donation physicians,5 roles and responsibilities of donation physicians in the Canada and the status of implementation in the various provinces.
The forum was attended by ethicists and clinicians (including practicing donation physicians) and representatives of professional associations, including the Canadian Critical Care Society and the Canadian Medical Association. Discussions focused on the deceased donation process (donation after circulatory or neurological determination of death, DCD, donation after neurological determination of death) and ethical practices were understood to be situated within the current Canadian legal standard. Donation physicians' roles included hospital and region-based donation leads, organ donation organization (ODO) medical directors, and senior ODO administrators who may continue to provide care in the ICU. The forum started with several presentations to set context and provide information, followed by a discussion of the benefits of donation physicians and the value they provide to patients, families, health care professionals, and the health care system. The participants built consensus around practical clinical scenarios and challenge questions related to 4 broad and interrelated themes: communication with families; inter-professional conflicts; donation-specific clinical practices; performance metrics, resources and remuneration. After the forum, the discussions and recommendations were collated and summarized, reflecting the consensus view of the group. A draft report was developed, finalized by the Steering Committee and subsequently distributed to the forum participants for comment and to confirm faithfulness to the forum process. The final report was approved by the Steering Committee. The full report including background documents, clinical scenarios, challenge questions, considerations, recommendations, outstanding questions and research agendas is also available subsequent to this publication.
The following principles form the basis to the recommendations and guide deceased donation practices.
- The donation physician should seek to maintain patient, family, and public trust while facilitating the opportunity to donate.
- Health care professionals and related health care system policies and practices should respect the wishes of those patients who want to donate organs after their death.
- Notwithstanding the donation physician’s multiple roles, the primary duty is for the treatment and high quality end-of-life care of the patient.
- End-of-life care should be provided in response to patient needs and applied consistently regardless of the intention or consent to donate.
- End-of-life care must not be compromised for the purpose of enhancing the likelihood of actualizing donation.
- The ‘dead donor rule’ applies to all forms of deceased donation: nonpaired vital organs can be retrieved only from patients who are determined to be dead.
- Those donation physicians who are involved with organ allocation decisions or transplant procedures should distance themselves from donation proceedings and donation discussion with families
Participants acknowledged that a guide on ethics will need to accommodate the unique needs of regions, programs and health care professionals. Although the complete separation of roles related to donation is preferable, this may not always be possible due to variations in the donation physician role based on geographical location, resources, specialist scheduling, etc.
BENEFITS OF THE DONATION PHYSICIAN ROLE
Participants identified common key benefits of the DP role that may improve donation practices and the ethical conduct of donor care:
- Normalization of the donation process within hospitals
- Enhanced separation between end-of-life decision-making and deceased donation
- Support for other health care professionals involved in donation
- Improved compliance with leading practices
- Quality improvement and minimization of errors in the process of donation and death determination
- Improved communication with families and health care professionals involved in ICU care, donation and transplantation
- Enhancement of the actualization of donor potential and intention
- Participation in donation medicine research
Communication With Families—Role Disclosure
The circumstances leading up to a decision concerning donation often involve traumatic injury or sudden onset of tragic illness. Given extremes of emotional distress, the capacity of families for rational decision-making during this period may be compromised. As such, communication with families during end-of-life care must be performed sensitively and ethically, according to leading practices.6
Disclosure must take into account the context of the situation, the nature of the physician’s relationship with the patient, and the goals of the patient’s care. Questions to consider include: Is the patient’s condition survivable? Is the patient a candidate for donation? Has an NDD declaration or WLST decision been made? What is the donation physician role in care for this patient?
- Actual, potential or perceived conflicts of interest that arise in the course of the donation physician's professional duties and activities should be identified, disclosed and resolved in the best interest of the patient.
- Disclosure is context specific and depends on the donation physician's role, the circumstances, and the relationship with the patient and family. Disclosure is not necessary if it has no bearing on the situation or the relationship with the family.
During disclosure conversations, the donation physician should explain:
- If the physician, as most responsible physician (MRP), has been treating the patient, he/she should disclose his/her role as a donation physician once donation conversations begin with the family. The disclosure should be made regardless of whether the donation physician role is clinical or administrative.
- Donation physician who have an active role in allocation of transplantable organs should disclose this fact.
Institutions are encouraged to develop policies concerning when and how disclosure should be conducted.
- Why the disclosure is being made
- Why the system exists as it is (separation of roles)
- How both roles (intensivist/donation physician) are complementary
- Which role the disclosing physician is playing now and what their involvement would be in future, with or without donation.
Communication With Families—Consent for Donation
As part of their role, donation physicians will be involved, either directly or indirectly, in conversations with families about donation. Ethical challenges emerge when there are conflicts between (i) patient wishes and family wishes and (ii) family wishes, staff sensitivities and societal need (ie, the need for organs). Canadian leading practice guidelines for approaching the family for donation conversations have been developed6 and provide guidance for navigating these situations. The key goal is to ensure that the family has an opportunity to make an informed decision that would be comparable to one made if they were not in a crisis and that they would not regret at a later date.
- 5. The donation physician, in collaboration and consultation with the donor coordinator and hospital staff, should provide the opportunity for families to make informed decisions. Reasons for family reluctance to donate can be explored and medical, religious, or cultural misinformation or misconceptions should be addressed.
- 6. In cases of initial refusal, it is acceptable to reapproach for donation if the patient has previously registered intent to donate, if new information becomes available, if the family misunderstands the information, or if there have been previous conversations by untrained staff that have provided incorrect information.
- 7. If reapproaching is warranted, the donation physician should communicate with health care professionals involved in the patient’s care to make sure the reason for reapproaching the family is understood.
- 8. The donation physician should facilitate the reapproach with an emphasis on gaining clarity and ensuring informed decision-making rather than reversing the initial decision. Any revisiting of the subject of donation with a family should focus on the quality of the process rather than the outcome.
- 9. In cases where consent is withdrawn, the donation physician should debrief with the donor coordinator and staff to identify the underlying causes, work to improve processes and communication, and remove barriers for future opportunities.
Interprofessional Conflicts—Challenges to Dual Roles
The diversity of experience, knowledge, and perspectives among health care professionals in relation to deceased donation may lead to disagreements concerning the best course of action and tensions among members of the hospital staff. Other health care professionals may be concerned about dual responsibilities between patient care and donation. Donation physicians may find themselves involved in these conflicts and may be required to play a mediating role to help resolve these situations. Donation physicians must work to reassure staff that these real or perceived conflicts are being managed appropriately, in the interest of the patient and family.
- 10. Donation physicians should build institutional trust by openly engaging with staff about their role. The donation physician should be transparent about potential conflicts of interest and discuss with staff their strategy for addressing these potential conflicts. Objectivity, transparency, and open communication will help reduce perception of conflict and mitigate the effects of real conflict of interest with respect to the dual roles of donation physician and MRP.
- 11. If concerns of bias persist, the donation physician should seek a collaborative solution. This should involve consensus-building with the health care team based on a discussion of the facts of the case, the published literature, and hospital policies. If the donation physician is the MRP, he or she should seek a second opinion or transfer care to another physician when a conflict of interest cannot be managed. If a potential donor and recipient are receiving care in the same unit (potentially with the same MRP), every effort should be made to separate responsibility and accountability to avoid conflict.
- 12. A system should be implemented to provide ongoing quality assurance and to mediate in cases of conflict. This system may include:
- A regular review of cases in coordination with the ODO
- Debriefs of staff and physicians to learn from conflicts and improve practice
- An independent body or ombudsman appointed to mediate conflicts and adjudicate in cases of complaints
- An escalation process to resolve cases quickly, so that patient care is not jeopardized and donation opportunities are not lost
Interprofessional Conflicts—Conscientious Objection
Some health care professionals may conscientiously object to certain practices or types of donation. The donation physician must balance the benefit of providing the opportunity of donation for patients with the individual rights of health care professionals not to participate directly in the donation process.
- 13. The donation physician should work to remove barriers to donation. In cases of conscientious objection, the donation physician should:
- Offer respectful and sensitive education on the national, ethical, legal and professional framework that donation operates within to allay concerns if possible
- Where conscientious objection remains, ensure alternative access to donation services such that family and patient wishes are not compromised
- 14. Hospitals should have a plan or process for addressing conscientious objection. This may involve:
- Transfer of care to another physician
- Transfer of the patient to another facility
- 15. When a conscious patient with terminal disease and unbearable burden (eg, amyotrophic lateral sclerosis) is able to give informed consent for withdrawal of life-sustaining therapies and donation directly, without requiring a substitute decision maker, the health care system and professionals should honour the patient’s right to autonomy while preserving the integrity of the process. This may involve:
- Discussing with other health care providers the difference between active euthanasia and withdrawal of life sustaining therapies (the latter of which is currently standard practice in the ICU at the end‐of‐life). Ethics consultation may also helpful.
- With patient's permission provided, discussing the patient's wishes with the family, to support them in being comfortable with the patient’s decision
- In cases of disagreement between the most responsible physician of the potential donor and the transplant team (who have no role in the management of the potential donor), the donation physician should help facilitate communication and education to address disagreements to fulfill the donor's wishes.
Donation-Specific Clinical Practices—Minimizing Errors in Donation Practices
The donation physician has an important role as a steward of the donation process, ensuring that the process by which donation occurs reflects evidence-based leading practices. Donation physicians must be seen as a trusted resource on the topic of donation care and protocols, and a clinical expert in end-of-life care.
- 16. Institutions would benefit from policies that clearly delineate which physicians should be permitted to make determinations of death. These policies should consider:
- The relationship of the physician with potential recipients
- Hospital hierarchy (ie, resident acting as second for his/her attending)
- Availability of staff
- Expertise of available staff
- 17. If the donation physician is acting as MRP for the patient, it is acceptable to perform the first examination for a determination of death. Any risk of bias is mitigated by the requirement for the second confirming determination as required by law.
- 18. The donation physician can assist and advise during end-of-life care, including acting as the second physician in the determination of death. The benefits brought by the expertise of the donation physician outweigh the risk of perceived conflict. Perceived conflict can be managed through transparency and formal policies.
- 19. If concerns of bias are expressed by other health care professionals, the donation physician should seek the opinion of a third party.
- 20. If the donation physician has responsibilities regarding allocation of organs for transplantation or a direct leadership role in transplantation, he/she must not be involved in making end-of-life care decisions or death determinations of potential donors.
- 21. The donation physician should use instances of disagreement or misalignment of views as learning opportunities to enhance health care professionals’ knowledge and improve the quality of the process around end‐of‐life care and donation
- 22. In the case of errors associated with the donation process, the donation physician should facilitate debriefing of the team and perform a root cause analysis of the error. The goal should be education and quality improvement without focusing on blame.
- 23. There is a duty to report errors in the donation process or death determination to the family. The donation physician should contact the initial physician and coordinate with the health care team to plan the disclosure to the family. The most appropriate person to make the disclosure depends on the specific context, such as who the current most responsible physician is, what the prognosis upon re‐evaluation is, and what the next steps in the patient’s care are.
Donation-Specific Clinical Practices—Neuroprognostication and Decisions on WLST
Neuroprognostication and decisions to withdraw life-sustaining therapy may result in potential for disagreement among the care team. Disagreements or differing perspectives on prognosis are not uncommon in ICU care and are not specific to donation. If the donation physician is the MRP and involved in decision-making, it is possible that other health care professionals may perceive that the donation physician is placing donation interests ahead of those of the patient.
- 24. Neuroprognostication and end-of-life decisions should be made before and separate from donation considerations.
- 25. If the MRP is also a donation physician, and if the clinical decision making is called into question, the donation physician should discuss with colleagues and request another medical opinion.
- 26. Until a consensus decision has been made, it may be beneficial for the donation physician and/or organ donation coordinator to not be involved in the process.
- 27. If consensus on prognosis or course of action cannot be achieved among the medical team, the donation physician should advocate for a waiting period (24-72 hours) to confirm diagnostics and prognosis.
- 28. The hospital should have policies on end-of-life prognostication and withdrawal of life-sustaining therapies. These policies should clearly outline the role of the donation physician by:
- Acknowledging and supporting the donation physician as a trusted advisor with expertise in prognostication, process, and procedures
- Providing clarity on the role the donation physician plays in the process, thereby reducing the potential for perceived bias
- Assisting with culture change in the organization to normalize the role of the donation physician
- 29. The donation physician should be aware of early considerations for donation before the point when neuroprognostication decisions have been made. The role of the donation physician should be to reiterate appropriate timing of donation considerations and temper enthusiasm of other less experienced practitioners to help minimize any potential conflicts of interest and/or confusion about patient end-of-life care.
Donation-Specific Clinical Practices—Provision of End-of-Life and Comfort Care for DCD
During end-of-life care, physicians may be subject to pressure from family or other health care professionals concerning the type and extent of comfort care a dying patient receives. These pressures may include the family’s desire to relieve suffering, hasten death or actualize donation in a scenario that is not suitable, or it may result from frustration and impatience from the transplant-procurement team if the patient does not progress to donation.
- 30. The donation physician should act in an advisory capacity to the MRP and should not direct or interfere with management decisions concerning end-of-life care. If the MRP is on service as the donation physician at the same time, role disclosure should be ensured and/or second opinions should be considered (see also recommendation 11).
- 31. The donation physician must be aware of the potential for covert and overt pressures from family members and staff. The donation physician should support other health care professionals in acknowledging these pressures and adhering to leading practices.
- 32. The donation physician or MRP should not engage in, or condone, the following practices:
- Withholding appropriate analgesia/sedation for fear of perceptions about expediting death
- Providing analgesia/sedation that may expedite death as its primary aim (notwithstanding impending legislation on physician assisted death)
- Providing analgesia/sedation intended to hasten death to ensure the patient’s/family’s wishes for donation are realized.
- 33. The donation physician should seek congruence among the family, the MRP, and others involved in the patient’s care concerning the goals of treatment and symptom control.
- 34. The donation physician should act as an intermediary between the transplant team and most responsible physician to help protect the most responsible physician from pressure that may influence end‐of‐life care.
- 35. Institutions, as well as patients and family, will benefit from policies and protocols around end‐of‐life care and withdrawal of life‐sustaining therapies, to be used in all situations, not just for patients who may be involved in donation.
Donation-Specific Clinical Practices—Preserving the Opportunity to Donate
Performing medically nonbeneficial treatments to patients to preserve the opportunity to donate presents many ethical challenges and questions. If the donor has expressed their wish to be a donor, and medical treatment will not save their life, then their best interests are served by fulfilling their wishes. Where interventions may potentially cause harm, then risks and benefits and purpose (if strictly for donation) need to be discussed between the MRP, the treating team, and the family. The donation physician's role should be in engaging the relevant parties to explore solutions that avoid or minimize harm to the patient while preserving the opportunity to donate.
- 36. Where donation wishes have been expressed by the patient or through the family, interventions to preserve the opportunity to donate and enhance graft and recipient outcomes should be considered to be in the best interest of the patient.
- 37. Premortem interventions should be discussed with family and the health care team, indicating the purpose, benefits, and risks.
- 38. The transplant team can only advise on the implications of any donor management decision, not seek to alter that decision. In situations of disagreement between the transplant team and the donor care team, the donation physician should liaise between the 2 groups to clarify facts, discuss risks and benefits, and propose alternatives to try to come to a mutually beneficial solution that honors the intention to donate.
Performance Metrics, Resources, and Remuneration—Funding of Donation Physicians
Measuring the success of donation physician programs, as well as the competence of individual donation physicians, presents several challenges. Poorly designed or implemented compensation and measurement strategies carry a risk of unintended consequences. For example, rewarding based on consent rate or absolute donor number may incentivize physicians to push donation in inappropriate cases. It is, therefore, important that the remuneration and measurement structure is designed such that it favours the ethical conduct of donation physicians.
- 39. Compensation for donation physicians should not be predicated on donation rate or donor numbers; rather, measurement should focus on:
- Reduction of missed donation opportunities through appropriate donor identification, referrals, family approaches and conversations
- Improved quality of donation related processes including local policy and procedures
- Improved family and health care professional satisfaction with the donation process
- Education, training, and research activities
- Identification and resolution of local barriers to donation
Performance Metrics, Resources, and Remuneration—Conflict of Interest
Donation physicians, as experts in organ donation, have a role in sharing their expertise through research, knowledge translation, and education. They also can offer a valuable perspective to transplant societies or corporations working in the donation and transplantation field. However, in some cases, this may present actual, potential or perceived conflicts of interest related to personal advancement or financial gain, or result in bias in professional decision‐making.
- 40. Guidelines exist for the medical profession in managing conflicts of interest related to education and research, and should be followed by donation physicians.7
- 41. Donation physicians can participate in committees/societies/boards dealing with transplantation as they can bring valuable insight from the clinical/donation perspective.
- 42. Donation physicians should be transparent and disclose any relevant conflicts related to research and educational activities.
- 43. Honoraria, when they exist, should be modest and proportional to the work being performed.
- 44. The donation physician has an important role in developing new knowledge to advance understanding in donation and transplantation. The sponsoring organization should support the academic freedom of the role. Opinions and research data should not be suppressed even when contrary to the prevailing views and processes of the organization.
- 45. The donation physicians should present a balanced view based on evidence‐based leading practices. It is permissible to present a challenging, innovative, or controversial view to generate discussion and provoke thought but these should be clearly defined as such.
Performance Metrics, Resources, and Remuneration—Access to ICU and OR
Although acknowledging the requirement of the hospital to manage many priorities and patients, participants felt that the donation physician could advocate for increased access for potential donors. Patients waiting for organs are less visible to front line ICU hospital staff but the health care system should strive to fulfil their needs. Recognizing and minimizing “moral distance” through awareness and education can be part of the donation physician’s responsibilities.
- 46. The donation physician should advocate on behalf of donation and explore options to improve access to ICU and OR.
The authors gratefully acknowledge the collaboration of the Canadian Medical Association and the Canadian Critical Care Society. The authors would like to especially thank the process consultation by Strachan-Tomlinson and Associates and the writing assistance of Chris Cochrane as recorder. The authors would like to acknowledge the participation of Dr. Greg Grant, who requested not to be included in the participant list.
Donation Physician Ethics Guide Meeting Participants
Ms. Amber Appleby Provincial Operations Director, British Columbia Transplant Vancouver, British Columbia.
Dr. Stephen D. Beed (Canadian Critical Care Society Representative) Medical Director, Critical Care Organ Donation Program QEII Health Science Centre, Halifax, Nova Scotia Professor, Faculty of Medicine, Dalhousie University.
Dr. Dale Gardiner UK Consultant in Adult Intensive Care Medicine, Nottingham University Hospitals, UK Deputy National Clinical Lead for Organ Donation, NHSBT.
Ms. Rebecca Greenberg Bioethicist, The Hospital for Sick Children Toronto, Ontario.
Dr. Michael Hartwick Intensivist and Palliative Care Physician, The Ottawa Hospital Regional Medical Lead, Trillium Gift of Life Network, Ontario Assistant Professor, Faculty of Medicine, University of Ottawa.
Dr. Laura Hawryluck Associate Professor Critical Care, Physician Lead, CCRT Toronto Western Hospital Corporate Chair, Acute Resuscitation Committee, University Health Network.
Dr. George Isac Medical Director, Organ Donation (VGH), BC Transplant Medical Director ICU, Vancouver General Hospital Clinical Associate Professor, Faculty of Medicine, University of British Columbia.
Dr. Bashir Jiwani Director, Ethics Services, Fraser Health Authority Surrey, British Columbia.
Dr. Jim Kutsogiannis Professor, Faculty of Medicine and Dentistry, University of Alberta Medical Director of the Neurosciences Intensive Care Unit, University of Alberta Hospital Medical Director, Human Organ Procurement Exchange Program of Northern Alberta, Edmonton.
Dr. Brendan Leier Clinical Assistant Professor John Dossetor Health Ethics Center, Edmonton, Alberta.
Dr. Jean‐François Lizé Assistant Medical Director, Transplant Québec Pulmonologist‐Intensivist, Centre hospitalier de l'Université de Montréal Chief of ICU, Hôpital Notre –Dame, Montreal.
Ms. Janet MacLean Vice President, Clinical Affairs Trillium Gift of Life Network, Toronto, Ontario.
Dr. Adrian Robertson Medical Director, Transplant Manitoba Gift of Life Program, Manitoba Intensivist, Winnipeg Regional Health Authority Assistant Professor of Medicine, University of Manitoba, Winnipeg Health Sciences Centre.
Dr. David Unger Clinical Associate, St. Paul’s Hospital HIV Service Clinical Assistant Professor, School of Population and Public Health, UBC Director of Ethics, Providence Health Care Ethics Consultant, BC Transplant.
Ms. Kim Werestiuk Manager, GD4/Transplant Clinic/Adult Kidney Transplant Program Gift of Life, Organ Donor Organization of Manitoba Winnipeg, Manitoba.
Prof. Linda Wright Director of Bioethics, Joint Centre of Bioethics & University Heath Network, Toronto, Ontario.
Ms. Kimberly Young Director, Donation and Transplantation, Canadian Blood Services, Edmonton, Alberta.