🔰Rep. AOC Addresses U.S. Organ Donation System at Oversight _ Investigations Subcommittee Hearing

Thank you so much, Mr. Chairman. The ability to transplant an organ from one person to another is one of the great successes of modern medicine, and the United States' organ transplant system is responsible for saving so many lives and also for the loved ones of those who have lost family members and friends to actually see their gifts live on in others. And because organ transplants do save lives, the system we have in the United States needs to work well, and there are so many people responsible for ensuring that it does. Dr. Lynch, can you briefly describe the circumstances in which most organ donations occur? So I agree with your sentiments completely. This is a public good. This is something that restores hope to individuals who have suffered loss, in the case of the donor families, and it literally restores life to people on the wait list. The way that this process works is that the OPO is the central figure in it. The OPO staff are supposed to show up to a hospital, identify individuals who are neurologically injured, either if they're already brain-dead or if they're progressing in that fashion, or if they're not brain-dead or not believed to be progressing that way, if they have a poor prognosis and the family is considering moving towards end-of-life care. The OPO then facilitates getting adequate information about the donor, which means blood work, history and physical, and in some cases invasive tests. And then they facilitate the operation where other parties, usually staff from transplant centers, come to that donor hospital and recover the organ. Thank you. And it is often a patient's loved ones and their family or friends that often have to make this difficult decision. And as you mentioned, the individuals who often help them make those decisions are from OPOs, or organ procurement organizations. Dr. Lynch, can you explain a little bit further about what an organ procurement organization is for people who are learning how this system works? Sure. OPOs are an almost unique element of the American healthcare landscape. They serve two different populations. They serve those patients who are the potential donors, and they serve the potential recipients with the organs that they recover. They also have a unique situation in that they are made whole on their costs completely by the federal government. They also have a situation where the patients with whom they interact are at their most vulnerable. They're neurologically injured or deceased, so they're not going to speak up about the care that they receive. Thank you. And in the way that this system is set up, there is currently only one organ procurement organization in any given region, which sometimes means that individuals may have little choice between OPOs. Dr. Lynch, I have a report issued by your agency HRSA in March of this year. And the report found cases where the organ procurement system has at times not worked properly and patient safety was jeopardized. Now I think it's very important that in order to protect individuals and not to raise too much of an alarm, by and large our organ procurement system works well. But we also want to protect the integrity of that system and ensure that we investigate any situations where a question may be raised. The report found cases where the organ procurement system has not worked properly. And some of these do not appear to be isolated incidents. We do have a case of a woman in her 30s, which was reported just two days ago in the New York Times. In 2022, Daniela Gallegos was hospitalized and went into a coma. Doctors thought that she would not survive. And her family agreed to donate her organs. However, it seemed that Daniela started to improve responding to touch and trying to move. Yet the organ procurement organization serving her area pushed towards surgery for organ removal and donation anyway. However, and the system did work, thankfully, hospital staff refused to move forward with the procedure. And Ms. Gallegos has actually made a full recovery. I would like to submit her statement to the record. Without objection, so ordered. According to HRSA's report, there have been about 100 unique cases that had quote, unquote concerning features. Now that does not mean that they were all like Daniela Gallegos' case. But Dr. Lynch, HRSA has investigated additional cases and the OPO was found to have pressured the medical team to move forward with this. Is that accurate? And if so, what would be the standards for an organ procurement organization to be on a path to decertification? And what would the line be for that? So I'll start with the decertification decision would not rest with HRSA. That would be within CMS. I won't speak to Ms. Gallegos' case. There are numerous cases that have been reported to HRSA. We have ongoing reviews and we have made referrals to partner agencies. The corrective action plan that we have for Kentucky, as we were hearing about these other cases in other areas, also includes a plan to make the OPTN make this safe nationwide. And we believe that that will address the type of area that you're describing. Great. Thank you very much.