Comments

UC San Diego Health Center for Transplantation | 03/20/2024

UCSD Center for Transplantation (CASD) appreciates the effort the OPO’s Committee put forward in the proposal to Clarify Requirements for Pronouncement of Death as well as the opportunity to comment. We generally agree and support the proposal as written but want to emphasize our hesitation in being overly prescriptive absent engagement with other medical and ethical societies. One member of the team added that separation between treating team and procuring team needs to be emphasized, the more prescriptive in managing potential donors that we become, the more opportunity for unintentional influence on the primary team's management may arise and we should avoid any such opportunity.

Infinite Legacy | 03/19/2024

Infinite Legacy supports the changes for providing clear requirements and guidelines. The OPO Committee should consider a guidance document for proactive auditing so that OPOs are prepared for future UNOS site visits. OPTN policies should contain clear language regarding a declaring physician and physicians who consult during OPO management to address any perceived conflicts of interest. Any language regarding who might pronounce death that might have an actual or perceived conflict of interest would need to be very clear.

Mid-America Transplant | 03/19/2024

Mid-America Transplant (MT) appreciates the opportunity to provide feedback to the OPTN regarding Pronouncement of Death. As a high-performing organ procurement organization (OPO), MT is committed to its mission of saving lives through excellence in organ and tissue donation, and we are grateful for OPTN’s efforts to improve the organ transplant system.
MT is committed to conducting its operations as an organ procurement organization with the highest level of integrity. Therefore, MT supports the OPTN’s proposed policy language change. To ensure that there is no actual or apparent conflict of interest or impropriety, physicians or other hospital team members who may declare death of a potential deceased donor should not be involved in any aspect of the organ recovery procedure or transplantation. We do not believe these changes will impact patient or donor care. Further, we believe this change may increase public trust around declaration of death of potential organ donors, as it will more clearly separate roles.

Region 10 | 03/19/2024

8 strongly support, 12 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. An attendee noted that there is a need for clarification for those who declare death to ensure that they do not have conflicts of interest due to their OPO relationship.

Region 9 | 03/19/2024

4 strongly support, 6 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 6 | 03/19/2024

2 strongly support, 11 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

This proposal was not discussed during the meeting, but attendees were able to submit comments. One attendee commented that this is an opportunity to review current policy and provide updates re: utilizing family readiness assessments and the importance of providing information to families during the end-of-life decision making process that meets their individual needs.

UW Health Organ and Tissue Donation | 03/18/2024

This provides clarifying easy-to-follow language and streamlines the declaration of death, which seems an important concept given the current landscape and debates surrounding death declaration. UW Organ and Tissue Donation supports this proposal and we find it easy to follow and clear in language.

NATCO | 03/18/2024

NATCO supports updating the requirements for Pronouncement of Death and Conflicts of Interest Policies. We believe that this will not only increase the pool of those that can declare death for donation, but also reinforce that any individuals involved with declaration of death cannot be involved with the donation or transplant process. The concern is that OPO’s are contracting with Physicians to work on their behalf as Medical Directors and that when they are not functioning in this capacity may be called to pronounce death in the hospital setting. NATCO agrees that it must be clear that these individuals cannot participate in the donation process or recovery of organs. This has been deemed as too broad to monitor without clarity for potential policy violations.
Pronouncement of death in brain dead and DCD patients must be consistent and clear . Consistent terminology, pronouncement in place of declaration, should be utilized nationally. Pronouncement must follow the donor hospital policy as well as national regulations/guidelines on pronouncing death.
NATCO feels there is no concern that these changes will impact patient or donor care. The only ethical consideration is making sure that the policy clearly states pronouncing providers do not participate in the donation and transplant process. The proposed policy changes areclear enough to beunderstood by medical professionals that provide on-call support for OPO’s. As for public trust, the general public is not versed on the intricacies of pronouncement of death, so we agree that this will likely not affect the public in any way.

OPTN Ethics Committee | 03/18/2024

The OPTN Ethics Committee thanks the OPTN Organ Procurement Organization for their development of this proposal and the opportunity to provide feedback. The Committee supports this proposal, and notes that more clarity regarding the policy changes proposed and their impact may be helpful. Members appreciated the desire to reduce conflicts of interest or the perception of conflicts of interest, as public trust is paramount in donation and transplantation. A member noted that it may be helpful to suggest that OPOs work with donor hospitals to make changes to their internal policies for matters outside of OPTN jurisdiction related to this issue. 

Region 7 | 03/18/2024

7 strongly support, 7 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose 

This was not discussed during the meeting, but attendees were able to submit comments with their sentiment. One attendee noted their strong support for the clear language in the proposal. Another attendee added that this policy will help maintain public trust with the transplantation community. The proposal does acknowledge the issue and requires transplant programs and OPOs to address the issue.

OPTN Liver & Intestinal Organ Transplantation Committee | 03/18/2024

The OPTN Liver Intestinal Organ Transplantation Committee thanks the OPTN Organ Procurement Organizations Committee for their efforts on the Clarify Requirements for Pronouncement of Death proposal.

The Committee supports this proposal and highlights their appreciation for the clarity and usage of straightforward language. 

Region 1 | 03/18/2024

3 strongly support, 8 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose 

This proposal was not discussed during the meeting, but attendees were able to submit comments. A member noted the proposal does not address the circumstance of an OPO Medical Director advising an OPO on donor screening and/or management of a donor and also being the physician declaring death. This is not prohibited by the Uniform Anatomical Gift Act and is not a direct conflict, but could be perceived as a potential conflict of interest. Another member shared that their hospital’s cardiac intensive care nursing staff did not have the requirements of DCD pronouncement of death readily available to them at the time of a patient's DCD organ donation. The member strongly endorses clarifying these requirements and enhancing accessibility to staff who are exposed to the pronouncement of death for donors.

American Society of Transplant Surgeons | 03/18/2024

Attachment

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Region 5 | 03/15/2024

12 strongly support, 22 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose 

Region 5 supports this proposal and commented that there is a need for a standard procedure and protocol for transparency and consistency purposes. There was significant support for standardizing the processes, and providing clear requirements and guidelines, surrounding the pronouncement of death in DCD donors. There was support for clarifying both policies and having consistent language especially when referencing pronouncement of death. An attendee supports a simple clarification that ensures separation of duties. A member commented that in DCD situations, many physicians are uncomfortable with the five-minute time period between initial determination of death and the second confirmation, which is time of death. They explained that they personally have seen many physicians strongly express frustrations that an outside team, who are not their academic peers, request them to veer against their own personal practice for determination of death. To prevent this conflict, they suggested the committee draft clear guidelines that are standardized nationally and that can be clearly incorporated into a hospital's own DCD internal protocol.

American Society of Transplantation | 03/15/2024

The American Society of Transplantation (AST) supports the proposal, “Clarify Requirements for Pronouncement of Death.” This is a helpful clarification to ensure OPTN policy is consistent with current terminology and practices while maintaining the clear separation between the healthcare provider who declares a donor’s death and the subsequent recovery and transplant of that donor’s organs. The two sections in the policy (2.14.A and 2.15.G) are now duplicative and could be combined into one.

The National Catholic Bioethics Center | 03/15/2024

Thank you for the opportunity provide comment to the Organ Procurement and Transplantation Network (OPTN) on Public Comment Proposal: Clarify Requirements for Pronouncement of Death. The National Catholic Bioethics Center (NCBC) supports efforts by the OPTN to increase public trust in the organ/tissue transplantation process. Recent examples include increasing equity in kidney transplantation by adjusting geographical factors for organ allocation and strengthening transparency and accountability by collaborating with the US Department of Health and Human Services on the Organ Procurement and Transplantation Network Modernization Initiative (Organ Procurement and Transplantation Network, “Two-Year Monitoring Report Continues to Show Improvements in Equity in Access to Kidney Transplants for Several Key Population,” new release, July 6, 2023, https://optn.transplant.hrsa.gov/news/two-year-monitoring-report-continues-to-show-improvements-in-equity-in-access-to-kidney-transplants-for-several-key-populations/; and Health Resources and Services Administration, “HRSA Announces Organ Procurement and Transplantation Network Modernization Initiative,” new release, March 22, 2023, https://www.hrsa.gov/about/news/press-releases/organ-procurement-transplantation-network-modernization-initiative). However, despite its contribution to this work, the OPTN’s current proposal on the pronouncement of death does not sufficiently promote the patient-donor’s integral human good, on which public trust in organ/tissue transplantation is premised. To achieve this goal, the policies, practices, and procedures of the OPTN, organ transplantation organizations (OPOs), and hospitals related to conflicts of interest and pronouncement of death must explicitly affirm the following (without prejudice to other OPTN policies): The donor must be dead before his or her organs/tissues are procured. The patient’s living will or advance directive and the free and informed consent of surrogates and families for organ/tissue donation must be respected. Health care team members’ professional judgment when determining whether and how to pronounce death must be guaranteed, when that judgment is consistent with scientific standards indicating irreversible cessation of circulatory and respiratory functions or irreversible cessation of all functions of the entire brain.

The NCBC is a nonprofit research and educational institute committed to applying the moral teachings of the Catholic Church to ethical issues arising in health care and the life sciences. The NCBC serves numerous health care agencies in their development and analysis of policies and protocols, including protocols for implementing OPTN policies on organ/tissue donation and transplantation that comply with the Ethical and Religious Directives for Catholic Health Care Services. The NCBC has thirteen hundred members throughout the United States. Furthermore, the NCBC provides consultations to hundreds of institutions and individuals seeking its opinion on the appropriate application of Catholic moral teaching in the delivery of health care, including organ/tissue procurement and transplantation.

The NCBC supports the OPTN’s proposal to update Policy 2.14.A Conflicts of Interest and Policy 2.15.G Pronouncement of Death to clarify that “donor hospital healthcare professionals who declare the death of a potential deceased donor cannot be involved in any aspect of the organ recovery procedure or transplantation of that donor’s organs” (Organ Procurement and Transplantation Network, Organ Procurement Organization Committee, Public Comment Proposal: Clarifying Requirements for Pronouncement of Death (Richmond, VA: United Network for Organ Sharing, 2024), 2) This revision can help remove potential conflicts of interest between health care professionals’ primary duty to their patients and the obligations they have assumed as representatives of an OPO. In turn, this can increase public trust in the pronouncement of death. However, this criterion of independence is not sufficient to maintain ethical integrity and consequent public trust. Too narrow a focus on this source of conflict can obscure other factors “during patient care and potential donor evaluation, which could compromise the examination of the donor” (Organ Procurement Organization Committee, Clarifying Requirements for Pronouncement of Death, 4), such as the perception that physicians sometimes pressure family members to consent to organ/tissue donation (Nancy Kentish-Barnes et al., “Grief Symptoms in Relatives Who Experienced Organ Donation Requests in the ICU,” American Journal of Respiratory and Critical Care Medicine 198.6 (September 15, 2018): 751–758, doi: 10.1164/rccm.201709-1899OC).

Despite the noble goal of savings lives by increasing the number of organs available for transplantations, overly aggressive organ procurement practices can irreparably harm public trust, which is premised less on avoiding conflicts of interest, ensuring consistent policies, and clarifying the roles of health care team members than on guaranteeing an organ/tissue transplantation process that protects human dignity and promotes solidarity and subsidiarity. Moreover, ethical criteria must guide all technological development. Consequently, in addition to the proposed revisions, and without prejudice to other policies (see, for example, Policy 2.14.E Deceased Donor Authorization Requirement, Policy 2.15.D Consent for DCD, and Policy 2.15.E Authorization for DCD), we urge the OPTN to explicitly affirm the following principles in 2.14.A Conflicts of Interest and 2.15.G Pronouncement of Death.

All hospital and OPO practices and procedures for the pronouncement of death must ensure that the donor is truly dead before vital organs/tissues may be taken and that the act of organ/tissue procurement does not result in the death of the donor (US Conference of Catholic Bishops (USCCB), Ethical and Religious Directives for Catholic Health Care Services, 6th ed. (Washington, DC: USCCB, 2018), no. 64; see also no. 60). These practices and procedures must be governed by the precautionary principle to preclude “the slightest suspicion of arbitration [arbitrariness]” (Benedict XVI, Address to Participants at an International Congress Organized by the Pontifical Academy for Life (November 7, 2008), https://www.vatican.va/content/benedict-xvi/en/speeches/2008/november/documents/hf_ben-xvi_spe_20081107_acdlife.html). This duty is entailed by the sanctity of life and the dignity of the patient. Respect for these principles—which are grounded in the human person’s openness to relationality and “unrepeatable and inviolable uniqueness” (Pontifical Council for Justice and Peace (PCJP), Compendium of the Social Doctrine of the Church (Vatican City: Libreria Editrice Vaticana, 2004), nos. 130-131)—requires us to remember that the donor is, first and foremost, a patient who has entered into a healing relationship with the health care team, whose primary responsibility is to use their “professional competence most effectively to maintain or restore the patient’s health” (USCCB, Ethical and Religious Directives, part 3, introduction). At the end of life, this includes the recognition that “the task of medicine is to care even when it cannot cure” (USCCB, Ethical and Religious Directives, part 5, introduction). This healing relationship is guided by the principle of solidarity, “a firm and persevering determination to commit oneself to the . . . good of all and of each individual, because we are all really responsible for all” (PCJP, Compendium of Social Doctrine, no. 133, emphasis original, quoting John Paul II, Sollicitudo rei socialis (December 30, 1987), no. 38, emphasis added). The patient is an end in himself or herself and, therefore, must not be “manipulated for ends that are foreign to his own development” (PCJP, Compendium of Social Doctrine, no. 193).

OPO representatives and health care team members must obtain free and informed consent from the patient or, if the patient is no longer competent, the surrogate or family for organ/tissue procurement, acting consistently with the known will of the patient. The patient’s or surrogate’s decision should be respected, whether it be in favor of or against organ/tissue donation. Fundamentally, this principle obtains its force from the right and duty of the patient to direct his or her own medical treatment and, in matters of organ donation, to make a truly free gift of self. The health care team and the family “have no separate or independent right where the patient is concerned” (Pius XII, “The Prolongation of Life: An Address to an International Congress of Anesthesiologists, November 24, 1954,” trans. the National Catholic Welfare Conference News Service and the editors of The Pope Speaks, National Catholic Bioethics Quarterly 9.2 (Summer 2009): 329, 331, doi: 10.5840/ncbq20099259), and the family is “in a position to know best the patient’s wishes” (USCCB, Ethical and Religious Directives, no. 25). This hierarchy is guided by the principle of subsidiarity, according to which a higher-level social authority cannot take from a lower-level group those choices that its members are able to make.

Health care team members must be authorized to exercise their professional judgment on whether a pronouncement of death should be made and on how death should be determined, in a specific situation for a specific patient, provided this meets all requirements of law, hospital policy, and medical standards for pronouncing death. However, this does not mean the health care team can violate patient consent, conduct testing without consent when such testing may harm the patient (e.g., apnea test), or apply any techniques that are designed to cause or ensure brain death after declaration of circulatory death, such as extracorporeal interval support for organ retrieval with occlusion of blood vessels to the brain. The privilege and authority of the professional-patient relationship must be protected to ensure the patient’s “dignity and essential place” in the practice of medicine. This relationship of solidarity, which is sensitive to the patient’s dignity and, through subsidiarity, to his or her values and goals, is possible only among those in a healing relationship, not with a hospital or OPO, their administrators, or their policies. The public’s trust in the medical community is based not only on the latter’s technical expertise but perhaps even more so on the confidence that, when a person is seriously ill, he can enter an “interpersonal relationship” with an individual “who encounters him in order to support and care for him, thus adopting a sincere attitude of ‘compassion’” (Pontifical Council for Pastoral Assistance to Health Care Workers, New Charter for Health Care Workers, English ed., trans. The National Catholic Bioethics Center (Philadelphia: National Catholic Bioethics Center, 2017), no. 4).

Maintaining trust in the organ/tissue transplantation process, especially regarding the pronouncement of death, will be impossible without first demonstrating respect for the sanctity of each human life, which may not be superseded by either the benefits to society of contemporary organ/tissue transplantation or the clinical, technological, and organizational demands of transplantation programs. The principles of dignity, solidarity, and subsidiarity—which originate in the natural law and are knowable by reason, irrespective of a person’s values—make an indispensable contribution to this work. At stake is whether vulnerable patients may be compromised in the process of procuring vital organs to save the lives of others.

Joseph Meaney, PhD, President, The National Catholic Bioethics Center

Michelle K. Stanford, MD, President, The Catholic Medical Association

Leo Zanchettin, Chair, Board of Directors, The National Catholic Partnership on Disability

Association of Organ Procurement Organizations | 03/14/2024

AOPO appreciates the opportunity to comment on the OPTN Organ Procurement Organization Committee’s proposal, Clarify Requirements for Pronouncement of Death. Public trust in the organ donation and transplant process is critical to achieving OPOs’ lifesaving mission. Ensuring that (i) death is declared in accordance with law, regulation, and hospital policy, and (ii) by a healthcare provider without interest in the outcome, regardless of whether death is declared through neurologic or circulatory criteria, is paramount to that public trust.

AOPO commends the Committee for its work in maintaining the public trust through changes to the Conflict of Interest and Death Declaration Policies. OPOs understand their obligations regarding death declaration in the donation process and are committed to ensuring that death is declared in accordance with law and by individuals who do not have an interest in the outcome of the declaration. AOPO supports clarifying the policy language to ensure the policy is consistent with state law regarding who may pronounce death and contemplates that licensed healthcare professionals other than physicians may make the pronouncement under applicable state laws.

While the proposed policy changes make clear that a healthcare provider who pronounces death for a potential donor may not participate in the recovery of organs and/or transplantation of organs from the potential donor, the policy changes do not address whether a healthcare provider who has consulted with the OPO during the assessment of medical suitability or donor management for the potential donor is permitted to also serve as the pronouncing provider. AOPO recommends that the Committee address that circumstance and provide guidance to avoid any perceived conflicts of interest with limited hospital resources. The guidance should protect against conflicts of interest and provide alternative mechanisms to absolute prohibition when hospital resources for pronouncing death are limited and may require that a provider who offers services to the OPO must pronounce death to avoid loss of organs.

Anonymous | 03/14/2024

Support

Gift of Life Michigan | 03/14/2024

We appreciate the OPTN Organ Procurement Organization (OPO) Committee’s work to clarify requirements for pronouncement of death via modifications to OPTN Policy 2.14.A and 2.15.G. We agree with the Committee that these small wording changes refine the expectations and realities that providers in donor hospitals have multiple roles that sometimes position them close to donor situations, but not always. The clarifications proposed address those situations and allow realistic flexibility for pronouncement.

Gift of Life Michigan also recommends that the Committee address circumstances and provide guidance of any perceived conflicts of interest when hospital resources are limited. The guidance should allow for donor hospitals and OPOs to develop appropriate hospital-specific policies to protect against conflicts of interest but do not impose an absolute prohibition when hospital resources for pronouncing death are limited and may require that a provider who offers services to the OPO (but is not part of the recovery or transplant team) must pronounce death to avoid loss of organs.

The Committee asked whether this proposal would help increase or maintain the public trust in the declaration of death of potential donors. We are aware that some people are wary of the organ donation process because they believe patient care might be compromised in favor of donation. While we are aware no evidence exists to support that notion, we encourage an additional layer of adherence to this policy by auditing declarations of death to verify no perceived or real conflicts of interest exist. The Committee could strengthen its advice to “evaluate [OPOs’] internal policies and procedures to account for this policy change” by adding a suggestion to check effectiveness and compliance with the changes through an auditing process. We also wonder whether the Committee could broaden or change its recommendation that “transplant hospitals” similarly evaluate their policies to the more inclusive “donor hospitals”, since declaration policies should exist in all hospitals, not just transplant hospitals.

Region 3 | 03/11/2024

5 strongly support, 11 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/09/2024

This proposal is not pertinent to ASHI or its members.

OPTN Vascularized Composite Allograft Transplantation Committee | 03/08/2024

The OPTN Vascularized Composite Allograft Committee thanks the OPTN Organ Procurement Organization Committee for the opportunity to provide feedback on this proposal. The Committee supports this proposal, noting their appreciation for how straightforward and clear the proposal is. 

Region 8 | 03/05/2024

4 strongly support, 10 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose

In support of this proposal, an attendee commented that as the transplant community utilizes more DCD options there is a need to clarify pronouncement of death. Another commented that this is well documented in literature.

Region 2 | 02/29/2024

7 strongly support, 12 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose

Region 11 | 02/29/2024

6 strongly support, 11 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose 

This proposal was not discussed during the meeting, but attendees were able to submit comments. The region supports this proposal. A member pointed out the need to emphasize that this proposal does not change the existing definitions of death but is a clarification on the role of the individual who pronounces death. An attendee strongly supported the proposal because of the importance of aligning policy with the current practices of health care providers and OPOs.  

UAMS | 02/27/2024

After evaluation of the proposal for changes to OPTN policies regarding Requirements for Pronouncement of Death, we believe creating clearer guidelines will have a positive impact on our patient population and transplant center. It is necessary to create clear and concise guidelines that allow for little variation to ensure there is a set practice in place. This protects our physicians and healthcare team by ensuring the same process is practiced in all situations in case there is ever a question regarding the quality of care provided by our team.

Region 4 | 02/26/2024

2 strongly support, 8 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose

Anonymous | 02/22/2024

I believe there should be a standard set of practices for pronouncement of death that does not vary between centers based on an ethical assessment of the options available for defining death.

Anonymous | 02/21/2024

This is a good update to clarify the two policies. Having consistent language between policies, especially when referencing pronouncement of death, is very important. It is also crucial to be able to determine if a violation occurred, and have straightforward and clear guidelines to follow.

Déboralis Ramos | 01/31/2024

Strongly Support

Anonymous | 01/30/2024

With transplant stigmas being that the doctors will not save you if you are an organ donor it may be a good foundation to have cut and dry requirements to check off.