2. End-of-life issues
21. Revising the Uniform Anatomical Gift Act - the role of physicians in shaping legislation
Gail A. Van Norman and Michael DeVita
In Pennsylvania, a man lies in critical condition. He has indicated in his living will that he would not want his life maintained “on machines.” He has a do-not-resuscitate (DNR) order. He has also designated on his driver’s license that he wishes to be an organ donor. His physicians are prevented from discussing of palliative care options by a new state law based on the new Uniform Anatomical Gift Act (2006). The new law prioritizes management of potential organ donors to promote organ viability, even if it compromises palliative care. According to the new law, the family may not intervene when, despite his DNR order, the patient is resuscitated from a hypotensive arrest and mechanical ventilation is continued. After evaluation for organ donation, he is taken to an operating room for withdrawal of life-sustaining treatment. Shortly thereafter he dies and his organs are procured for transplantation.
In Washington State, an anesthesiologist who is unaware of these events discovers that adoption of a state law based on the new UAGA (2006) is about to pass out of committee in the state senate and will likely be signed by the governor. She is troubled by several problems with the legislation, one of which is that it would permit organ procurement agencies to override a patient’s living will and continue or even initiate life-sustaining treatments to promote organ viability, without the agreement of the patient or the patient’s surrogate decision-makers.
The original Uniform Anatomical Gift Act (UAGA) is model legislation for states to emulate, and to promote uniform laws among states. It was enacted in 1968 and revised in 1987, assuring patients of their rights to donate their organs for transplantation after death. More than 40 years later, organ transplantation is a fixture in modern health care in developed countries. But controversies in organ transplantation persist: particularly those involving rights of donors versus the needs of recipients, the balance between end-of-life (EOL) care and preservation of transplantable organs, and concerns for vulnerable populations who may experience either barriers to organ donation or, alternatively, become the victims of rules that do not fairly recognize their rights and desires to refuse organ donation.
The original version of the 2006 revision of the UAGA and its consequences is an object lesson in how well-meaning experts unintentionally crossed critical ethical boundaries in their desire to improve organ donation. It is also a story of how legislative actions can profoundly affect clinical practice in anesthesiology, and an illustration that clinical practitioners have important roles to play in promoting ethical legislation. A revised version of the UAGA 2006 has now been adopted in most of the US, but the story still serves to remind us that our ethical responsibilities do not end at the hospital doors, but include a duty to help shape healthcare legislation.
The 1987 revision of the original UAGA never achieved national ratification and was only adopted by 26 states.1 Organ donation and transplantation often transcends state boundaries, and the US needed uniform rules for organ donation and transplantation that could be adopted in all 50 states. In addition, despite a seemingly clear mandate in the first UAGA to protect the rights of persons to donate organs, the decisions of donors to make their organs available were often being treated by physicians and families as though they were merely suggestions rather than formal mandates. It is still common for donors’ wishes to be countermanded once they have died or can no longer speak for themselves, because of family objections to organ donation.2 Some physicians are reluctant to proceed with organ donation over family objections, even when the donor’s wishes are clear – in part out of fear of litigation, in part due to uncertainty about legal obligations. This is occurring while demand for transplantable organs far outstrips supply, and loss of organs from willing donors because of objections of third parties is perceived as a barrier to increasing organ availability.
The UAGA (2006) sought to accomplish several explicit goals set forth in the preamble, among them: (1) to address the critical organ shortage by providing additional ways to make donations; (2) to strengthen language barring others from overriding a donor’s decision to donate organs; (3) to broaden opportunities for organ donation by expanding the definition of persons who could agree to donate a patient’s organs when the patient could not do so for him or herself to non-family members, such as “an adult who exhibited special care and concern for the decedent;” (4) to provide an explicit way for persons who did not wish to donate organs to refuse to do so; and (5) to expand the number of transplantable organs by promoting processes biased toward preserving organ viability.1
Respect for patient autonomy
A major flaw in the UAGA revision was the manner in which it dealt with conflicts between provisions of living wills and procedures to promote organ donation. UAGA 2006 permitted, even required, institution of measures to “ensure the medical suitability of the organ for transplantation,” stating that “therapy may not be withheld or withdrawn from the prospective donor, unless the declaration [of a desire to be an organ donor] expressly provides to the contrary.”1 The National Conference of Commissioners on Uniform State Laws (NCCUSL) assumed that organ donors always want to prioritize organ donation over other EOL decisions, although they had no empiric evidence for this presumption. There is evidence that the major concerns of patients at the EOL are control over the timing and location of death, relief of symptoms including pain, dyspnea, anxiety and depression, avoidance of a prolonged death, and preservation of therapeutic options including withdrawal of life-sustaining measures and terminal sedation.3 The lack of basis for prioritizing organ donation ahead of other EOL concerns led to criticism of the original UAGA 2006.4 Critics of the original UAGA 2006 point out that, even if a majority of dying patients would agree to suspend their living wills in order to become donors, the ethical principle of respect for autonomy demands that we respect the rights of patients who do not agree, and are seeking EOL care that conforms with different goals. Thus a more flexible approach would be warranted.
The UAGA (2006) provided that once a person had designated that they are an organ donor, there were only limited ways in which their wishes could be countermanded. The donor could rescind their agreement by executing a new legal document of recission, they could destroy the original document agreeing to organ donation, or they could provide verbal rescission of the agreement to donate. Each of these measures required two witnesses, one of whom “could not be an interested party,” such as a family member or transplantation representative.1 These provisions were intended to promote respect for the wishes of donors, but they failed to adequately respect the autonomy of persons whose wishes regarding organ donation change with time and circumstance. They also failed to take into account practical aspects of EOL decision-making. Donors may lack the opportunity or be unable to execute new legal documents as EOL approaches and they become incapacitated. Many depend on family members to represent them in medical decision making when they are unable to make or express decisions for themselves. Legal and ethical principles in surrogate decision-making have traditionally recognized the legitimate role of family, since they presumably share common elements of culture, upbringing, values, and religious beliefs. And there may be no non-family members present when a last-minute rescission is expressed by a dying patient. Without the presence of such a “disinterested party,” late changes of heart would not necessarily be followed under the new law.
Respect for patient autonomy requires that patients be fully informed about implications that organ donation may have for other aspects of EOL care. UAGA 2006 required no such discussion, even though in its original form, its mandates clearly could be interpreted to say that EOL decisions to forgo life-saving interventions must be rescinded, and measures to promote organ viability must be initiated if a patient states that they want to be an organ donor. It is reasonable to assume that most patients do not understand that their EOL preferences and organ donation decisions impact each other, although the model law assumed that the potential conflict is understood and this prioritization has been made when an organ donor designation is created. A common way in which many people express their interest in becoming organ donors is to sign a statement on the back of their driver’s license, where there is no opportunity for “informed consent” about how that signature could potentially alter their other options for EOL care.
The principle of beneficence
The NCCUSL intended to assure patients who wished to donate organs that their desires would be carried out at EOL. By resolving ambiguities in favor or organ donation, they also hoped to increase the supply of organs for transplantation. However their approach fostered an either-or process instead of a collaborative decision making process. Organ donation is an important part of EOL planning that should be honored by physicians and family.
Organ donation may provide meaning for patients and families at EOL. On the other hand, unwanted resuscitation can cause physical suffering for the patient, and has emotional implications for families. The balance of benefits and harms for dying patients is complex, with highly individual considerations. An absolute solution that fits the needs of all patients and is of sufficient moral accountability in all cases is probably impossible to legislate. Instead, it is better for it to rest in the dialogue between patients, their families, and their physicians.
The principle of nonmaleficence
The UAGA (2006) sought to end a potential harm to organ donors – the risk that their wishes, even if clear, might be rescinded at EOL and their gift not accepted or honored. But the model statute failed to recognize two important things about dying patients. The first is that donors can and do sometimes change their minds at EOL, when they may be both vulnerable and have limited capacity to express their change of heart.5 Meaningful EOL care involves managing and facilitating – not hindering – a wide array of decisions to meet the changing needs and wishes of dying patients. The second is that patients may truly have conflicting desires as EOL approaches: the desire to donate viable organs, and the desire to forgo life-sustaining interventions that would make such a donation possible. These seemingly conflicting goals may not be entirely resolvable. We propose that consideration of organ donation is an important component of good EOL care, but that organ donation does not trump EOL care. Society and physicians have generally chosen in circumstances where a clear resolution of conflicting goals is not obvious, to “err” on the side of asking the patient or their surrogate decision-makers to clarify their priorities, since the goal of care is to promote beneficence and nonmaleficence first and foremost for the patient, and not for third parties such as organ procurement agencies, transplant teams and organ recipients.
The principle of justice; fair distribution of burdens and benefits
Principles of justice require that equal persons be treated equally. The NCCUSL based their resolution of conflicting EOL decisions in favor of organ donation on the fact that often donor wishes are ignored even if there is no conflict about EOL management. The most common situation is after death determination using neurological criteria where the wishes of up to 20% of potential donors are ignored.6Nevertheless, when there emerges a situation where EOL care and organ donation have to be prioritized, there is not evidence to support that most dying patients would prefer one or the other priority.
By not creating clearer processes to firmly establish that in the setting of needed EOL care a patient did or did not want to be an organ donor, the model law had the potential to disproportionately harm vulnerable populations. Economically disadvantaged patients, minority populations, and those who do not speak English as a first language are least likely to be informed about such procedures, or to have means to carry them out. Organ distribution in the US is already known to suffer from imbalance: minority patients are less likely to receive vital organs than Caucasian men, for example.7 The concern, accurate or otherwise, is that the organ donation “system” takes organs from the poor, and unfairly benefits the wealthy. It is one of the reasons cited for why organ donation from minority populations remains low.8 Legislation that even has the appearance of unfairly treating vulnerable populations may foster mistrust in the transplant system, and therefore could adversely affect future organ donations.
Several factors likely contributed to the fact that original UAGA 2006 got so far, even being enacted in eighteen states, before the flaws became obvious. First, of all the numerous “stakeholders” identified by the NCCUSL in its preamble to UAGA 2006 did not include any physician group traditionally associated with end of life care in the intensive care unit, such as the American Academy of Hospice and Palliative Medicine, or the Society of Critical Care Medicine.1 Physician specialists in end-of-life have a critical understanding of complex end-of-life issues, and are arguably the most important physicians to involve in any discussions surrounding medical issues at end-of-life. Second, the implementation of the legislation was poorly publicized, both nationally and locally. Many physicians involved in organ transplantation were unaware that UAGA was being revised. In Washington State there had been no widespread public announcement of the adoption of the legislation. Indeed, the witnesses at Senate hearings were for the most part organ transplant recipients and representatives of the local organ procurement network. As a result, the committee members were under informed and perhaps not well positioned to assess unintended consequences of the wording of the UAGA.
Ethical obligations in promoting healthcare legislation
Physician advocacy for patient rights is not only the responsibility of a few politically interested parties; patient advocacy is a founding principle in medical practice, and is a specific duty of every physician in practice. Such advocacy can take many forms; from supporting individual patients in their endeavors to seek health benefits owed to them, to developing and advocating for positive changes in health care legislation.
Physician professional organizations acknowledge that ethical obligations of physicians extend beyond those between individual doctors and patients. The AMA’s “principles of medical ethics” states that, “A physician shall respect the law and also recognize a responsibility to seek changes in those requirements which are contrary to the best interests of the patient.”9 The AMA Code of Medical Ethics goes on to say that: “Whenever engaging in advocacy efforts, physicians must ensure that the health of patients is not jeopardized and that patient care is not compromised.”10 When doctors engage in legislative efforts, they are therefore obliged to look at all of the benefits and harms that might result from such rules.
The AMA Principles of Medical Ethics form a foundation upon which the American Society of Anesthesiologist basis its own Guidelines for Ethical Practice of Anesthesiology, first adopted in 1992, and reconfirmed in 2008.11 Anesthesiologists who recognize special concerns in health care legislation and who have special knowledge to inform lawmakers should step forward when needed to help assure that laws and regulations do not result in unintended negative outcomes for patients.
The end of the story and Its “morals”
The case summarized at the beginning of this chapter was reported by Drs DeVita and Caplan in 2007 in the Annals of Internal Medicine.4 It was their intention to point out the flaws in UAGA 2006 with regard to end-of-life care for dying patients, flaws in the NCCUSL process and its consequences, and to promote passage of significantly amended UAGA model legislation in its place. The “revised” UAGA 2006 (the “New Section 21”) was proposed by the NCCUSL and contained patient-centered rather than organ-centered resolution when conflicts between living wills and donation declarations occurred.1 DeVita and Caplan further suggested that states that had passed the original UAGA 2006 should amend their legislation to include this critical change.4
In Washington State, the anesthesiologist partnered with a community opinion leader to contact and inform state legislators about flaws in the legislation which was based on the original UAGA 2006. They placed an editorial in a local leading newspaper, urging voters to contact their legislators.12 The anesthesiologist solicited letters to the legislators from national opinion leaders in anesthesiology and critical care who supported amending the legislation. She then met with the governor’s legislative aide on healthcare issues and urged that the governor not sign the legislation until it was amended to contain the revised wording of Section 21. Despite strong opposition from the local organ procurement agency, the bill was placed on hold for one year until more informed discussion could occur. A revised UAGA 2006 was ultimately passed, containing the critical amendment protecting patient rights and options regarding EOL care.
• Laws can significantly impact individual patient care. Without input from physicians of all involved specialties, including anesthesiology, legislators may inadvertently create rules and regulations that lead to unintended negative consequences for patients.
• Anesthesiologists have ethical duties to understand legislation that may affect their patients, to publicize concerns, and to press for legislation that adequately and protects the rights of all patients.
• Decisions regarding organ donation are critical in EOL planning, and when patient wishes produce contradictory instructions, physicians have a duty whenever possible to discuss and resolve those contradictions with the patient or their legal surrogates. Such resolutions should represent the patient’s priorities with regard to his or her own healthcare, and should not be guided exclusively by the interests of third parties, such as organ procurement agencies.
• Legislative change requires the actions of just a few knowledgeable persons. Individual physicians should not be discouraged from trying to effect positive change when misinformation or lack of debate may lead to the adoption of flawed regulations or laws that are detrimental to patient care.
1* National Conference of Commissioners on Uniform State Laws. (2006). Revised Uniform Anatomical Gift Act with Prefatory Note and Comments. South Carolina; National Conference of Commissioners on Uniform State Laws.
2* Christmas, A.B., Burris, G.W., Bogart, T.A., and Sing, R.F. (2008). Organ donation: family members not honoring patient wishes. J Trauma, 65(5), 1095–7.
3* Truog, R., Cist, A.F.M., Brackett, S.E., et al. (2001). Recommendations for end-of-life care in the intensive care unit: The Ethics Committee of the Society of Critical Care Medicine. Crit Care Med, 29,2332–48.
4* DeVita, M. and Caplan, A. (2007). Caring for organs or for patients? Ethical concerns about the Uniform Anatomical Gift Act (2006). Ann Int Med, 147, 876–9.
5* Ditto, P.H., Jacobson, J.A., Smucker, W.D., et al. (2006). Context changes choices: a prospective study of the effects of hospitalization on life-sustaining treatment preferences. Med Decis Making, 26,313–22.
6* Barber, K., Falvey, S., Hamilton, C., et al. (2006). Potential for organ donation in the United Kingdom: audit of intensive care records. BMJ, 332, 1124–7.
7* Siminoff, L.A., Burant, C.J. and Ibrahim, S.A. (2006). Racial disparities in preferences and perceptions regarding organ donation. J Gen Intern Med, 21, 995–1000.
8* Siminoff, L.A. and Sturm, C.M.S. (2000). African-American reluctance to donate: beliefs and attitudes aobut organ donation and implications for policy. Kennedy Inst Ethics J, 10, 59–74.
9* American Medical Association. (2001). Principles of Medical Ethics. American Medical Association, Chicago, IL.
10* American Medical Association. (2004) AMA Code of Medical Ethics, Opinion 9.025. American Medical Association, Chicago, IL.
11* American Society of Anesthesiologists. (2008). Guidelines for the Ethical Practice of Anesthesiology. Adopted 2003; amended 2008). American Society of Anesthesiologists, Highland Park, IL.
12* Van Norman, G, and Brown, S. (2007). Organ donation a personal decision. Opinion, The Seattle Post Intelligencer, March 20.
Beacuhamp, T. and Childress, J.F. (2009) Justice. In Principles of Biomedical Ethics, 6th edn. New York, NY: Oxford University Press.