Alvarez, Betton-Ford, Corp, Davis

Law LDR650-OA Professor: Shanna Reed Organ Donation after Circulatory Determination of Death Catherine Alvarez, Rochelle Betton-Ford, Shelley Corp, Crystal Davis Siena Heights University

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According to the Organ Procurement and Transplantation Network (OPTN,2014) the waiting list of candidates for organs in the United States as of February 18, 2014 at 7:20 pm was 121, 260 people. Although, organ transplantation has evolved to the point where it is a safe and effective treatment there are many issues and underlying ethical principles associated with the procedure. The ethics of organ transplantation have been premised on the dead donor rule (DDR), which states that vital organs should be taken only from persons who are dead. Yet there are others that suggest certain living patients, such as those who are near death but on life support, should be allowed to donate their organs, and by doing so would benefit others and be consistent with their own interests (Truog, Miller and Halpern, 2013).In this white paper we will present our position that the Dead Donor Rule should be upheld and maintained in order to maintain public trust in the organ-transplantation enterprise. According to the National Institute of Health (2014) Organ donation takes healthy organs and tissues from one person for transplantation into another for the purpose of replacing organs that are damaged or missing. Experts say that the organs from one donor can save or help as many as fifty people. Organs that can be donated include internal organs such as kidneys, heart, liver, pancreas, intestines and lungs, skin, bone, bone marrow and corneas. People of all ages and backgrounds can be organ donors. Most organ and tissue donations occur after the donor has died. But some organs and tissues can be donated while the donor is alive. Scientists have long thought about the idea of replacing a diseased organ with a healthy one from a donor. The problem initially was that the human body is not receptive to foreign tissue. When tissue from a donor is placed inside the body of a recipient, the immune system sees it as a foreign invader and goes into battle mode (Watson, 2014). Eventually, scientists realized that the problem of rejection didnt occur when the organ donor and recipient were identical twins. The genetic

ORGAN DONATION similarity appeared to prevent the immune response. Massachusetts surgeon Joseph E. Murray used this concept to his advantage in 1954, when he accomplished the first successful kidney transplant between identical twins at Brigham and Womens Hospital in Boston. Although Dr. Murrays surgery was a major breakthrough, it wasnt a solution, as very few people have an identical twin they can rely on for organ donation (Watson, 2014). In the late 1960s , doctors utilized drugs to suppress the immune system of recipients and were able to perform transplants between nonrelatives. By the 1980s anti-rejection drugs had improved to the point where transplantation surgery became pretty routine and far less risky than it had been a few decades earlier. Survival rates rose. Allegiance to the DDR thus limits the procurement of transplantable organs by denying some patients the option to donate in situations in which death is imminent and donation is desired. The DDR has required physicians and society to develop the concept of brain death. Recovery of organs from a brain dead patient is considered acceptable if organ donation is

desired by the patient or by the surrogate on the patients behalf. More recently, to meet the ever growing need for transplantable organs, attention has turned to donors who are declared dead on the basis of the irreversible loss of circulatory function (Truog, Miller and Halpern, 2013) here again, there is a struggle with the need to declare death when organs are still viable for transplantation. This requirement has led to rules permitting organ procurement after the patient has been pulseless for at least 2 minutes. For many patients, circulatory function is not irreversibly lost within the two minutes-cardiopulmonary resuscitation could restore it. So, a compromise has been reached whereby organ procurement may begin before the loss of circulation is known to be irreversible, provided that clinicians wait long enough to have

ORGAN DONATION confidence that the heart will not restart on its own, and the patient or surrogate agrees that resuscitation will not be attempted (Gries et al, 2013) Consent First person authorization and advanced directives should be considered because these honor the wishes of the patient. According to Important Policy Notice (2013), Conditions involving a potential DCD donor being medically treated/supported in a conscious mental state shall require that the Organ Procurement Organization (OPO) confirms that the healthcare team has assessed the patients competency and capacity to make withdrawal/support and other medical decisions.

1. The OPO must confirm that consent has been obtained for any DCD related procedures or drug administration that occur prior to patient death. Authorization for DCD For the purpose of obtaining authorization for a DCD recovery, legal next of kin can include any of the following: 1. The patient who authorizes deceased donation 2. Persons defined by state/local laws to authorize organ donation. (pp. 32-33) When the Living, Deceased Don't Agree on Organ Donation (2013) stated, all 50 states and the District of Columbia have adopted the 2006 Revised Uniform Anatomical Gift Act (UAGA) or enacted similar legislation giving individuals the "First Person Authorization" (FPA) to consent to organ donation after death via a signed donor card or driver's license, or by enrollment in a donor registry. (para.1)

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Bramhall (2011) stated, the US does not have presumed consent legislation. A system of presumed consent would almost certainly lead to an increase in rates of donation but its introduction would be open to challenge. Presumed consent is alternatively known as an optout system and means that unless the deceased has expressed a wish in life not to be an organ donor then consent will be assumed. The current opt-in system of either registration on the organ signed donor card, driver's license, donor register or obtaining consent from the families is different from presumed consent. The ODOs around the US invest heavily in training of coordinators in consent processes that are very specific to families of potential organ donors. The coordinators in the US approach families to obtain consent and this has led to a significant increase in family consent rates (Bramhall, 2011). McCleskey stated (2013), a recent legal case in Ohio, involved a 21-year-old Columbus man who had been declared legally dead but was on artificial life support had his organs donated under court order over his familys objections. Elijah Smith said he wanted to be an organ and tissue donor when he applied for a drivers license in September, but the family was unaware of his wishes. Lifeline filed a complaint in the Franklin County Probate Court, seeking a court order to allow them to proceed with the removal and transplantation of Mr. Smiths organs. Ohio law bars anyone other than the donor from amending or revoking an organ donation. This case represents how difficult end-of-life decisions can be for the families (McCleskey, 2013). Donation after Circulatory Determination of Death (DCD) and the provision of End-of-Life Care According to Steinbrook (2007) a donor after cardiac death (DCD) is a donor who has suffered devastating and irreversible brain injury and may be near death, but does not meet formal brain death criteria. Extending the dead donor rule has resulted in the attempt to procure

ORGAN DONATION non-viable organs due to the prolonging of death determination (Troug, Miller, and Halpern, 2013), thus feeding the fear and distrust of doctors from the public only to believe that lives are ended prematurely for human body parts, creating an even longer list for future organ donors

(Truog, Miller and Halpern, 2013). While organs recovered from a donor after cardiac death has some degree of oxygen deprivation after the heart stops beating, tissues such as bone, skin, heart valves and corneas may be procured from a DCD within twenty-four hours after death (Gift of Life, 2014). The severe shortage of organs, and the growing wait for livers, has led to more widespread use of livers from donors not commonly used in the past. According to the Gift of Lifetime organization (2014) organ donations of mostly kidneys and livers have increased by as much as twenty-five percent, specifically in part to DCD. Provision of End-of-Life Care Some clinicians may refrain from participating in DCD because of the perceived conflict between fidelity to the dying patient and stewarding scarce medical resources for the benefit of patients in need of transplant (Gries, et al, (2012). To prevent such occurrences the United Network of Organ Sharing (UNOS) adopted a set of model elements that Organ Procurement Organizations (OPO) must include in their protocols for recovering organs using the donation after cardiac death procedure. The elements address the separation of duties of the transplant team from the care providers, specifying that no member of the transplant team shall be present for the withdrawal of life-sustaining measures, and that no member of the organ recovery team for organ procurement staff may participate in the guidance or administration of palliative care, or the declaration of death (Procter, 2012).

ORGAN DONATION Rules and Regulations The National Organ Transplant Act of 1984 called for an Organ Procurement and Transplantation Network (OPTN) to be created and run by a private, non-profit organization under federal contract (UNOS, 2014,). United Network for Organ Sharing (UNOS) was first awarded the national OPTN contract in 1986 by the U.S. Department of Health and Human Services and continues as the only organization ever to operate the OPTN (UNOS, 2014,

History). The OPTN is the national organization that coordinates, implements, and monitors the organ transplantation system as a whole (Crowe & Cohen, 2006). There are four kinds of rules that govern the distribution of transplantable organs, state laws, federal laws, federal regulations and the policies of the UNOS. State laws primarily cover the issues pertaining to the donation process such as the criteria for declaring death, the consent requirements of being a donor, the scope of public education programs, and the composition of donor registries (Crowe & Cohen, 2006). Federal laws deal mainly with organ procurement, allocation and transportation of donor organs and tissues. Federal regulations explains the framework of the OPTN and its relationship with its member organ procurement organizations (OPO) and transplant centers, this regulation is only a small portion of the policy that dictates the responsibility and action of the OPTN and its members (Crowe & Cohen, 2006). UNOS rules further define the functions of the OPTN, and describe the policies OPOs and transplant hospitals must follow in order to be members of the OPTN. While these rules, laws and regulations have done a good job of administering the process, policymakers on all levels are currently considering how to improve existing policy on organ transplantation. The OPTN policy 2.13 Requirements for Controlled Donation after Circulatory Death (DCD) Protocol define the necessary guidelines for hospitals that participate

ORGAN DONATION in organ donation. These policies will help OPOs and transplant hospitals develop necessary DCD protocols (UNOS, 2014). Conclusion

The US is facing a disproportion between the supply of donor organs and the demand for transplants. Some people feel Death after Circulatory Death which is declared in accordance with hospital policy and applicable under state and local statutes or regulation is the solution to increase the donor supply. Supporters for DCD feel that when people are near death they may want to help others by donating their organs. The ethical and legal foundation of organ donation has been based on the dead donor rule which states that the removal organs must not precede the death of the organ donor. The ethical and legal issue of DCD is the timing of death after patients have been removed from life support. Finally, we believe the Dead Donor Rule should be upheld and maintained in order to maintain public trust in the organ-transplantation.

ORGAN DONATION REFERENCES Bernat, J.L. (2008). Perspective: The Boundaries of Organ Donation after Circulatory Death. New England Journal of Medicine, 359, 669-671. doi:101056/NEJMp0804161 Beth Israel Deaconess Medical Center. (2013). Donor criteria standard and extended criteria Donors. Harvard Medical School Teaching Hospital. Retrieved February 18, 2014 from http://www.bidmc.org>...>WhereDoestheDeceasedDonorOrganComeFrom

Bramhall, S. (2011, May). Presumed consent for organ donation: a case against. Retrieved from National Center for Biotechnology Information: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3363073/ Cohen, E. Crowe, S. (2006, September). Organ Transplantation Policies and Policy Reforms. https://bioethicsarchive.georgetown.edu/pcbe/background/crowepaper.html Gift of Life. (2014). The gift of a lifetime: Understanding death before donation. Organ Transplants. Retrieved from www.organtransplants.org/understanding/death/Organ TissueTransplantationinAmerica. Gries, C. J., White, D. B., Truog, R. D., DuBois, J., Cosio, C. C., Dhanani, S., & Chan, K. M. (2013). Sharing Statement: Ethical and Policy considerations in organ donation after circulatory determination of death. American Journal respiratory Critical Care Medicine, 188(1), 103-109.

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IMPORTANT POLICY NOTICE. (2013, December 12). Retrieved from United Network for Organ 2013.pdf McCleskey, C. (2013, July 23). Legal Battle In Ohio Over Organ Donation Highlights Controversy Over Defining Death. Retrieved from Global Bioethics Initiative: http://globalbioethics.org/news/legal-battle-in-ohio-over-organ-donation-highlightscontroversy-over-defining-death/ National Institute of Health. (2014). Organ Donation. In Medline Plus. Retrieved February 18, 2014, from http://www.nlm.nih.gov/medlineplus/organdonation.html Night, S.S. (2017). Arrest of Transplant Surgeon Raises Concern Regarding Organ Donation After Cardiac Death Procedure. Retrieved February 18, 2014 from www.law.uh.edu/healthlaw/perspectives/2007/(SN)Organdon.pdf Procter, E. (2012) Collaboration between the specialties in provision of end-of-life care for all in the UK: reality or utopia. International Journal of Palliative Nursing 18 (7), 330-347. In Medline Plus. Retrieved February 18, 2014 from www.ncbi.nim.nih.gov/pub med/22885966. Steinbrook, R. (2007). Organ donation after cardiac death. New England Journal of Medicine. 357, 209-213. Retrieved from doi:10.1056/NETMp078066 Truog, R. D., Miller, F. G., & Halpern, S. D. (2013). The Dead-Donor Rule and the future of organ donation. New England Journal of Medicine, 369(14), 1287-1289. Sharing: http://optn.transplant.hrsa.gov/contentdocuments/policy_notice_11-

ORGAN DONATION United Network for Organ Sharing. (2014). Retrieved from:http://www.unos.org/donation/ indexphp?topic=history

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Watson, S. (2014). How Face Transplants work. In How Stuff Works. Retrieved February 18, 2014, from http://science.howstuffworks.com/life/human-biology/face-transplant1.htm When the living, deceased don't agree on organ donation. (2013, November 26). Retrieved from Science Daily: http://www.sciencedaily.com/releases/2013/11/131126092702.htm