Hello, and welcome to the session of the 51st Critical Care Congress of Society of Critical Care in Medicine. Today, we're going to be talking about the laws and ethics of organ donation. I'm Dr. Paul Chestovich. I'm a trauma and critical care surgeon at UNLV School of Medicine in Las Vegas, Nevada. I'm also the associate medical director of the Nevada Donor Network. Main disclosure, as the associate medical director, I do receive compensation from them, but I've received no compensation specifically for this presentation, and I have no other relevant financial relationships. Our objectives for this talk, first of all, we're going to talk about the general ethical principles and how they apply to organ donation, review major legislation pertinent to organ donation, specifically the Universal Anatomical Gift Act and its history and scope, discuss regulations governing organ procurement organizations, review ethical considerations for donation after cardiac death, and also a summary of best actions for physicians regarding organ donation. First of all, a couple of limitations. When we talk about laws and ethics, this is going to be restricted to deceased donor donation. We're not going to be talking about the ethics of living donor donation. Additionally, we will not talk about any international laws. We will restrict the discussion to laws in the United States. The major ethical principles, which apply to all medical ethics, and this is going to be the framework for the discussion on organ donation. These I'm sure we've heard of before, the first of which, of course, is beneficence, which means broadly to help, non-maleficence, which means to do no harm, autonomy, which means to make decisions for oneself, and finally, justice, which is that medical care should be fair, equitable, and appropriate. We're going to refer back to these periodically throughout this talk. The first point to talk about is what's called the dead donor rule. This is not a legal statute. It's not anything that's ever been passed or is in laws, either federal or state, but it is a widely held belief among the organ transplant community. Simply put, it means that organs for transplant should only be removed from a patient who has been declared deceased. This reflects a very long-held belief that it is unethical to kill somebody in order to save the life of another person, and this is consistent with one of the ethical principles we just talked about of non-maleficence. There's a key distinction in terminology regarding the permission to do something in health care. Ordinarily, for treatments, we obtain consent from patients, which is legal permission for something to happen. However, in organ donation, the terminology is slightly different where we obtain authorization. Now, this is a similar term. It involves granting legal permission to perform an act. But for organ donation, the authorization term is used, whereas in normal medical care for providing treatment or a procedure, the term consent is used. One of the most important laws to know is the Uniform Determination of Death Act. And in essence, this delineates the two ways that a person can be declared deceased. The first of which is irreversible cessation of circulatory and respiratory functions. This is the way that the vast majority of patients are declared deceased, which is lack of any heart or lung function. The second way, though, is irreversible cessation of all functions of the brain, including the brain stem. And from a legal perspective, both of these methods are considered equivalent. So when a patient is declared brain dead, they are declared legally deceased. Now, the Uniform Anatomical Gift Act is the primary set of laws that governs organ donation. And this is the most important set of laws to really know about. This is a uniform act from the National Conference of Commissioners of Uniform Laws, which in essence is a group of legislators and law writers who get together and they try to write legislation that has commonality from state to state. And then they set it up for individual states to take it through their own legislative process and pass it. There's three iterations of this law. The first one came out in 1968, and this was in response to the first heart transplant. The goal was to establish uniformity between states with regards to organ donation. In 1987, a new version came along, and this had uniform consent. It bans organ sale, simplified authorization, and also identified potential donors in the hospital. Many states passed this one, but several did not. And then the newest version came out in 2006. This involves first-person authorization. It honors donors' wishes over families, and it made the laws more uniform between states. Currently throughout the United States, most states have passed the 2006 version. There's a few exceptions. Washington, D.C. still has the 1968 version. New York City still has 1987, and Pennsylvania also has 1987. Some states have passed the law but have added specific revisions for their own state. So while the law is pretty consistent, there are some minor variations. There's a few key provisions to know about with the Uniform Anatomical Gift Act, or as just the GIFT Act as we'll refer it. First of all, it bans the sale of organs. It also has first-person authorization, and this is one of the single most important components of understanding a person's right to be an organ donor, whereas it supports an individual's right to be or not be an organ donor. It also allows family members to make the decision to donate on a donor's behalf if there's been no prior designation. It also prevents hospitals from withdrawing support from a potential organ donor during the evaluation period when that patient is being checked out to see if they could be a donor. It also prevents a DNR declaration from precluding a patient from being an organ donor. So if a patient indicates that they are a donor, they're on a registry, but they also have a DNR, the DNR does not mean that that patient is immediately removed from life support. It also establishes standards for organ donor registries. It gives OPOs the privilege to enter hospitals and evaluate potential donors. It also requires hospitals to notify OPOs of patients within certain clinical criteria that they could be organ donors, and these are also known as clinical triggers. An example would be a patient with a brain injury who's on a ventilator or a patient's family inquires about organ donation. There are two primary pathways to obtain organ donation authorization specified by the GIFT Act. The first of which is the individual indicates they would like to be an organ donor before their death, and this is generally done so on a donor registry or a driver's license. The second way is through a surrogate, and this is where if an individual has not indicated one way or the other, then that surrogate, generally the next of kin, can authorize organ donation on the donor's behalf. It's important to note that the GIFT Act specifies that if an individual has indicated one way or the other, that that individual's decision is honored. So if an individual has stated through a registry or an advanced directive that they wish to be an organ donor, then that should be honored. Similarly, if somebody has indicated they do not wish to be an organ donor through an advanced directive, then that decision should be honored as well. But if they have not made the decision one way or the other, then the surrogate can make the decision on their behalf. Now it's very important to know your own state's laws. They are pretty consistent from state to state, but there are some subtle differences, and so it's important throughout the United States to consult your own state's individual statutes. This is actually Nevada's, which is the state I live in, and this is what it looks like. We are Nevada Revised Statute 451. The heading for this is dead bodies, and this is the exact wording that is in our legislature. This is just a small piece of it, but it's all available generally online. So in whatever state you're in, if you are involved in organ donation, I think it's important to read what is there and know what your state's laws are. Additionally, HIPAA, which obviously we all know quite well, the Health Insurance Portability and Accountability Act of 1996. Broadly, this protects patient health information. It prevents healthcare organizations from disclosing protected health information. But it's important to know that OPOs are covered under exception for the purpose of organ and tissue donation, and that is that uses and disclosures for cadaveric organ, eye, or tissue donation purposes. So whenever an OPO is So whenever OPO representatives are in a hospital and they are evaluating a patient, they are entitled to access that patient's private health information for the purpose of organ donation. Donation after cardiac death. There is a key distinction here from brain dead donation. Now, as we talked about earlier with the dead donor rule, organ donation can only occur after patient is deceased. Now, in brain death, the patient is declared deceased when the organ donation process and workup starts. They are already legally dead. They already legally have been issued a death certificate. Now, donation after cardiac death is a bit different. This is a patient who is still alive. Generally, they have an unsurvivable injury, and they're determined to be terminal. And that's when the donation workup begins. And the idea is that that patient would be taken to the operating room where they would undergo comfort care, and then after expiration, they could undergo organ donation. This brings up some very unique ethical considerations that are unique to donation after cardiac death. Because often with DCD, there's going to be decisions regarding end-of-life care. It's tremendously important that these decisions should be completely separate from any decisions about organ donation. This is consistent with the dead donor rule, whereas organs are only removed if the patient is deceased. And this is, again, consistent with non-maleficence. Now, what if during end-of-life discussion, a patient surrogate inquires about the possibility of organ donation? If this comes up, the best thing to do is to refer any questions to the organ procurement organization serving your hospital. The reason is because this allows you to maintain a clear division between the end-of-life facilitation and discussion, and any discussions about organ donation. Remember, it is a CMS requirement that physicians should not discuss organ donation with patients and families. This all should be left to the OPO. This allows a clear distinction between any discussions about donating organs, and any discussions about end-of-life care. We're going to talk about two brief ethical dilemmas that may come up. The first one is that there's a patient who suffers a motor vehicle crash and has a severe head injury. This patient is resuscitated, but they are a GCS3T. They have no brainstem reflexes. The pupils are fixed and dilated. The patient's wife arrives and states the patient is a DNR. So what should be done in this case? Well, the patient should be kept stable to first verify the advanced directive and also check organ donor registries. If the advanced directive states the patient does not want to donate organs, they cannot donate, and this is consistent with first-person authorization. However, if the patient is in fact a registered donor, they should be kept stable. The GIFT Act supports keeping potential donors on life support despite having an active DNR for sufficient time to reconcile this conflict. Some patients in their advanced directive may have stated that they cannot or do not want to be an organ donor, and if this is the case, then this should be respected and followed. However, if it's not specified and the patient is a DNR, but they are a registered donor, then they can still donate. The second one is a patient who suffers a major stroke and is declared brain dead. There is no family present. The patient is not a registered donor in your state. The hospital contacts you and they want to remove the patient from life support immediately because this patient is deceased. So what should be done? Well, in this case, the OPO should be provided sufficient time to check other state registries and attempt to identify a surrogate decision maker for the patient, and the patient should be kept stable during this period. Now, a common question that should be allowed. Now, this is not specified in state statutes, but the best thing to do is to use good judgment and allow a reasonable amount of time to check other state registries and attempt to identify a decision maker. At the beginning of the talk, I briefly mentioned the four main principles of medical ethics. The first, of course, is autonomy, and this is going to be consistent with the laws of organ donation, which is first-person authorization. So this reflects a patient's right to determine if they wish to donate organs or if they wish to not donate organs. Beneficence, there is legislative goal to help as many patients as possible, and that really is the goal of the GIFT Act to facilitate the potential organ donation and allow as many patients as possible to donate if that's their choice. Now, the GIFT Act does not require that you allow as many patients as possible to donate if that's their choice. Non-maleficence, laws only apply to donation after death. This is consistent with the dead donor rule, and the goal here is to do no harm. Finally, justice. The GIFT Act also states it is illegal to sell organs, and organs are distributed through allocation policies and UNOS. So what is the physician's role with regard to organ donation? First and foremost, know and uphold the ethical principles. Second, preserve the option for organ donation if that's the patient's choice. Next, let patients and families decide what their wishes are, and with whatever their wish is regarding organ donation, it's a physician's job to support and facilitate that decision. Thank you for your attention.

Dr. Paul Chestovich

trauma and critical care surgeon

laws and ethics

organ donation

United States