Organ Transplantation Policies and Policy Reforms

1. Organ Transplantation Policies and Policy Reforms Catherine Alvarez, Rochelle Betton-Ford, Shelley Corp and Crystal Davis

2. “I am only one, but I am one. I cannot do everything, but I can do something. And I will not let what I cannot do interfere with what I can do.” ~Edward Everett Hale

3. Organ Procurement Facts • 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. • organ transplantation has evolved to the point where it is a safe and effective treatment . However, 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. • 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).

4. Our Position • Our position that the Dead Donor Rule should be upheld and maintained in order to maintain public trust in the organ-transplantation enterprise.

5. Statistics • 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. As well as 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.

6. History of Organ Procurement • In 1954, Massachusetts surgeon Joseph E. Murray performed the first successful kidney transplant between identical twins at Brigham and Women’s Hospital in Boston. • Although Dr. Murray’s surgery was a major breakthrough, it wasn’t a solution, as very few people have an identical twin they can rely on for organ donation (Watson, 2014). • In the late 1960’s , doctors utilized drugs to suppress the immune system of recipients and were able to perform transplants between nonrelatives and by the 1980’s 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.

7. The “Dead Donor Rule” • 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 patient’s 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.

8. Consent • First person authorization and advanced directives should be considered because these honor the wishes of the patient. • The Organ Procurement Organization (OPO) confirms that the healthcare team has assessed the patient’s competency and capacity to make withdrawal/support and other medical decisions. • The OPO must confirm that consent has been obtained for any DCD related procedures or drug administration that occur prior to patient death.

9. 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. • 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) • 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

10. Presumed Consent • US does not have presumed consent legislation • Presumed consent would almost certainly lead to an increase in rates of donation • ‘Opt-out’ 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

11. OHIO CASE • Ohio Case involved a 21 year old declared legally dead but was on artificial life support • Organs donated under court order over his family’s objections • Deceased wanted to be an organ and tissue donor when he applied for a driver’s license, 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 • Ohio law bars anyone other than the donor from amending or revoking an organ donation

12. Donation after Circulatory Determination of Death (DCD) • According to Steinbrook (2007) DCD is a donor who has suffered devastating and irreversible brain injury and may be near death • Donor does not meet formal brain death criteria • Donor is declared dead following irreversible cessations of circulatory and respiratory function • Cessation of functions is determined by an “absence of responsiveness; heart sounds, pulse and respiratory effort • Once the heart stops beating, blood ceases to circulate through the body resulting in loss of oxygen to the organs and causes immediate deterioration of the tissues (Night, 2007).

13. California Case • According to Night (2007) A transplant surgeon and his team were in the operating room before a Sierra Vista physician had arrived • Transplant surgeon ordered staff to administer sedatives and pain medication to donor to make sure patient did not suffer when life support was withdrawn • Cessation of cardiopulmonary function did not occur when donor was removed from the ventilator • Organs deteriorated beyond use • Transplant Surgeon was accused of hastening death of donor

14. California Case • The coroner ruled patient died from natural causes (Night, 2007) • According to Brande (2009) there were no policies in the state of California for DCD organ procurement • Standard practice provides a separation of duties between the transplant team and the care providers for the withdrawal of life-sustaining measures • California has since systemized a standard protocol for recovering organs using the DCD • Transplant Surgeon was acquitted (Brande, V. 2009).

16. Rules and Regulations • State laws • Federal laws • Federal regulations • The policies of the United Network of Organ Sharing (UNOS)

17. State and Federal Law • “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, p. 3). • Federal laws deal mainly with organ procurement, allocation and transportation of donor organs and tissues.

18. Federal Regulations • “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, p. 7).

19. Rules and Requirements United Network for Organ Sharing (UNOS) Controlled Donation after Circulatory Death (2.13) Protocol The OPTN policy 2.13 Requirements for Controlled Donation after Circulatory Death (DCD) Protocol define the necessary guidelines for hospitals that participate in organ donation. These policies will help OPOs and transplant hospitals develop necessary DCD protocols (UNOS, 2014). • 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.

20. 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. • 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.

21. 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. • IMPORTANT POLICY NOTICE. (2013, December 12). Retrieved from United Network for Organ Sharing: http://optn.transplant.hrsa.gov/contentdocuments/policy_notice_11-2013.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-highlights-controversy-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

22. References (con’t) • 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. • United Network for Organ Sharing. (2014). Retrieved from:http://www.unos.org/donation/ indexphp?topic=history • 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