▶ 0:14:34The subcommittee on oversight and investigations will now come to order. The chair now recognizes himself for five minutes of an opening statement. Good morning and welcome to today's hearing entitled Ensuring Public Safety Oversight of the US Organ Procurement and Transplant System.
▶ 0:14:53I want to begin this hearing by saying that it is an honor to serve as a chairman of this subcommittee and I look forward to working on a bipartisan basis to shed light on many areas in need of oversight and reform. Just last year, 48,000 organ transplants were performed in the United States. Many of us know someone who is an organ donor or an organ recipient.
▶ 0:15:19That might be relatives, friends, neighbors, These procedures are often life-saving and in can extend an individual's life by years, if not by decades. While organ transplants are a relief to so many families, there's actually another side to the story that is equally important, and that is the story of the donors and their loved ones.
▶ 0:15:44In September of last year, this subcommittee held a hearing to conduct oversight of the organ transplant and procurement system, as well as implementation of the Securing the US Organ Procurement and Transplantation Network Act, which was signed into law in September of 2023. During that hearing, certain allegations came to light, raising concerns whether practices and procedures were putting patients safety at risk.
▶ 0:16:13Following the hearing, the Health Resources and Services Administration, known as HERSA, directed the Organ Procurement and Transplantation Network, or OPTN, to investigate the issue to better understand what transpired in one of these alleged incidents. HERSA also conducted its own investigation.
▶ 0:16:34The agency compiled a report that describes practices at the Organ Procurement Organization OPO, formerly known as the Kentucky Organ Donor Affiliates, Kota, but it is now known as the network for hope. The report also details the failures by the OPO and the OPTN to adequately recognize and respond to poor patient care and quality practices.
▶ 0:17:02HERSA then issued a corrective action plan to the OPN directing them to take specific actions to address the concerns that were identified in the reviews. I asked unanimous consent to enter Hersa's report dated March 24th, 2025 and Hersa's corrective action plan dated May 28th, 2025 into the hearing record. Without objection, so ordered.
▶ 0:17:28The report provided a detailed overview of HERS's investigation, including about what is referred to as the index case, OPN, the OPT contractor, and Kota, and finally Kota's organ procurement.
▶ 0:17:43In recent years, as part of the review of the cases beyond the index case, HERSA focused on the overall medical presentation and initial sub and subsequent neurologic status of patients, staff interactions with patients and families and primary medical teams and evidence of robust documentation and quality assurance procedures.
▶ 0:18:07Lastly, the report includes an appendic consisting of OPN's findings following the HERSA directed review. For every doctor, one of the most important tenants in the doctor patient relationship is above all do no harm. But what happened in these cases fractured the doctor patient relationship and saw patients subjected to pain and suffering that should never have occurred.
▶ 0:18:36As a member of Congress, we all swore an oath to protect the constitutional right to life afforded to each and every American. These incidents cannot be allowed to stand without strict investigation and oversight in the spirit of our constitutional oath.
▶ 0:18:54The federal government plays a critical role in ensuring the organizations tasked with administering and overseeing our nation's organ procurement and transplant operate safely, effectively, and in accordance with the law. Transparency is key to improving the system and repairing the public trust. This committee has and will continue to follow the facts so that we can restore trust and accountability within the system.
▶ 0:19:25I want to thank the witnesses from both panels for joining us today. I look forward to hearing from each of you about the challenges facing the organ procurement and transplant system, the ways that the system can be improved, and how we can ensure the safety of all patients who elect to be organ donors. I now recognize the ranking member of the subcommittee, Miss Clark, for her opening statement.
▶ 0:19:52Thank you very much, Mr. Chairman. I'd like to congratulate you on being named the new oversight and investigations chair. There's a great deal of important oversight to be done, including today's hearing. And I hope we can work together to shine a light on the problems across the broad jurisdiction of the committee and ensure that our government is working to improve the lives of Americans.
▶ 0:20:18Today's hearing is an important step toward improving confidence in America's organ donation system by confronting some of its problems headon. the Health Resources and Services Administration or HERSA and the entity that it oversees, the Organ Procurement and Transplantation Network or OPTN reacted to a troubling story that came to light during a hearing in this subcommittee last year.
▶ 0:20:46In that case, a patient in a Kentucky hospital had been identified as a likely donor and with the consent of his family began the various tests and procedures necessary to evaluate the viability of his organs for donation prior to his removal from life support.
▶ 0:21:08At numerous points throughout the process, both hospital staff and the staff from the organ procurement organization noted potential signs of consciousness and discomfort from the patient. Nevertheless, the process proceeded all the way to the point that the patient was in the operating room.
▶ 0:21:28At that point, however, the surgeon ultimately refused to operate, stating they felt the operation would be inhumane and The patient ultimately recovered and was later discharged from the hospital and is still alive today. As a result of this particular incident being raised at last year's hearing, a series of investigations took place.
▶ 0:21:52First, the Kentucky Oregon Procurement Organization, KOD, which is now a part of the network of hope, was ordered to conduct a self assessment and concluded that it was quote satisfied and confident confident in the donation process. End quote.
▶ 0:22:09The OPN initially accepted this conclusion, but Kota not providing any documents to substantiate Hersa then fortunately stepped in and required OPTN to press Kota for more information and conduct a broader analysis of Kota's practices in certain cases. OTPN's review quote noted as no major patient safety concerns based on their review end quote.
▶ 0:22:36Hersha also concluded its own parallel analysis and concluded that there was quote potentially serious and ongoing patient risk and fam, excuse me, and families as well as failure by the Kentucky OPO and the OTPN to adequately recognize and respond to poor patient care and quality practices. End quote.
▶ 0:23:03Herser's investigation identified 103 out of 351 examined cases that had quote concerning features. This is a stark warning. And what is concerning is not only the gravity of this warning, but the lack of urgency from the OPO and the OPN, both of which were content with the way things were being handled.
▶ 0:23:28In fact, instead of doing a serious assessment of the case, the Kentucky OPO retaliated against the whistleblower that brought the initial Kentucky case to light by pressuring the whistleblower's employer to fire them. This is reflective of a coverup culture, not a culture of concern for patients safety. New reporting from the New York Times over the weekend indicates that a case like that in Kentucky is not an isolated event.
▶ 0:23:55the that reporting sites 12 cases across nine states that all raise concerns about how OPOS's and donor hospitals are handling potential donors that are near death and might die from what is called circulatory death rather than brain death.
▶ 0:24:15As a follow-up to its investigation, HERSA has already directed the OP OPN board to take corrective action to make a series of policy and process improvements that may prevent future cases from occurring. This new reporting further demonstrates additional guidance and oversight is needed across the entire system.
▶ 0:24:40Hersa's recent actions are a positive step in the right direction and I thank the witnesses for their testimony today that we can better understand what is going wrong and how to fix it. I am also deeply grateful to my sister, Congresswoman Robin Kelly, the and the CBC Health Brain Trust Chairwoman and my fellow ENC member for her unwavering leadership in transforming the organ procurement system and championing
▶ 0:25:11the modernization of the organ procurement and trans transplantation network. with President Biden signing into law in September of 2023 the bipartisan securing the US Organ Procurement and Transplantation Network Act HR2544. Her tireless advocacy has paved the way for a more equitable, efficient, and lifesaving transport transplant system for all Americans.
▶ 0:25:41Organ donations save lives, but we won't have enough or organ donors if patients and their families do not have count confidence in the safety and sanctity of the process. Thank you, Mr. Chairman, and I yield back.
▶ 0:25:55Thank you. The chair now recognizes the chairman of the full committee, Mr. Guthrie, for five minutes for an opening
▶ 0:26:02Thank you, Mr. Chairman. I want to congratulate you on your hearing and your chairmanship of this great subcommittee. And Dr. Dun who's here is going to be vice is is the vice chair of the full committee and look forward for us all working together and I want to kind of set my perspective in the stage today. My mother passed away waiting on a liver. She had endstage liver failure and um so I've been there she was called once. So we're sitting at Vanderbilt Hospital and surgeon comes in and says I'm about to jump on a jet and fly to Chattanooga.
▶ 0:26:31And so you're sitting there with your family of hope and you've got the um thinking of the other family. there's another family in another hospital somewhere else who's having the opposite. Unfortunately, the the liver wasn't one that she could use and so that she didn't get called again. So, so we have to get this right. We have to have people I'm an organ donor. Uh I want to be an organ donor. I'm going to continue to be and hopefully everybody will continue because it really matters. It It's life.
▶ 0:26:59Um, but we have to address what's before us and so we can have confidence in the system and you know not having a hearing where we talk about this in the open. You have the New York Times article. You have all the other things out there. So we have to address this and we have to have it in a way that that we uh come to a conclusion that we're going to fix this so people can have confidence and have confidence in the system.
▶ 0:27:20And so we're looking at the HERSA report and and the the report obtained by the committee sheds new light on the challenges facing the organ procurement and transplant system and the Oregon procurement organization or the OPO that is subject for HERS's hearing hits close to home. Uh Chairman Joyce talked about it. It's it's a Kentucky uh situation and it's the now known as the network of hope following a recent merger.
▶ 0:27:44The report describes what happened to a Kentucky man who was an organ donor re registry known as the index case in this report. After his family consented organ donation, the Herser report details the critical failure to reassess that decision following developing circumstances.
▶ 0:28:01Specifically, hospital and OP staff documented improved neurological function at multiple points between the OPO uh was contacted and when the patient was in the operating room and an OPO coordinator even escalated statements of concern from hospital staff to the OPO's leadership.
▶ 0:28:17In a lot of the discussions that we've had about this case, a lot of times I've heard from several that the OPO is just not involved that this is completely hospital function, but the report seems to state otherwise that the person from the procurement was involved. Uh and and so I I'm not going to accept just to dismiss that it was all hospitals issue. It was it was both. And uh it was a actually the physician in the operating room. We finally just stopped uh this organ recovery process.
▶ 0:28:46But the report goes further beyond the index case. In fact, HERSA determined that of the 351 documented cases reviewed in this investigation, 103 or nearly 30% had concerning features. HERSA found concerning patterns that includes failures to recognize increased neurological function and patients who were previously identified as candidates for organ donation, failure to work collaborative with medical teams, and fail to safeguard decision-making or follow best practices.
▶ 0:29:14The numerous cases within report show a deeply concerning pattern and this is why we're having this oversight hearing today. We need to have an open and honest discussion about these failures and and Dr. Lynch is here. Hersa has a role and I think when we met you said we know Hersa has a role. You're a transplant surgeon. He says we're going to address it. We're going to fix it. We're going to build confidence in the system.
▶ 0:29:35Um we just need everybody here today and both panels to admit that we have issues we have to fix and not just point fingers. I think that's been a concern by some of us on on our side on on this side of the dis I think both sides of the aisle.
▶ 0:29:52uh as you saw the report in the Hurst report that the OPO on the index case just essentially said everything is working and we know everything's not working but we need everything to work and it starts by acknowledging that we have a role in the process of fixing this and so we need to admit we have issues we need to admit there are issues that need to be fixed and we need to come together and be constructive because I can tell you as a son of someone that we were praying was going to have an opportunity to have an extended life.
▶ 0:30:22Um just uh I've seen it and we and there are families out there today in the same situation we were in that are and we want people to donate. I'm not going to change my oan donor status. I'm going to give to whoever needs it if if if if the time comes that I'm I'm a donor. Uh hopefully that's not later rather than sooner. But but I want I'm confident that I want people to have the opportunity to have survive and live. But we don't need to not address this.
▶ 0:30:52We absolutely have to address it. So the family on the other side of the phone calls that we got can have confidence that their loved one is giving and giving in a way that I have a friend here from Bullet County uh Kentucky who has that with their son. Her son was an organ donor and someone lived people live today because of your Keegan, your dear son. And so thanks for being here and hopefully people will walk away today uh knowing we need to address issues but still confident that they can give life. So thank you and I will yield back.
▶ 0:31:21Thank you. The chair recognized the ranking member of the full committee, Mr. Palone, for five minutes of an opening statement.
▶ 0:31:27Thank you, Chairman Joyce. Today we're once again examining serious concerns that have been raised about our nation's organ donation system and what needs to be done to fix them. It's critical that the organ donation system continues to improve. Right now, there are over a 100,000 people waiting for an organ transplant. The decision of whether to donate life-saving or organs is a deeply personal and meaningful one.
▶ 0:31:51And we owe it to everyone involved to make sure the system is working smoothly and that there is respect for donors and their families throughout the process. And if we don't have that, then we won't have as many donors, obviously. And without donors, the waiting list for organs will only get longer. there'll be more suffering and death for those hoping for a transplant. So, I'm hopeful that today's hearing will help us conduct meaningful oversight and find ways to ensure that our organ procurement and donation system is one that donors and their families can trust.
▶ 0:32:18The Health Resources and Services Administration, Hersa, oversees the organ procurement and transplantation network or OPT and its members which include transplant hospitals, organ procurement organizations, labs, and medical and scientific organizations.
▶ 0:32:34This hearing focuses on findings and recommendations that were made by HERSA after investigating a specific incident in Kentucky and a series of other cases with similar features handled by the same organ procurement organizations which has since been merged into Networks for Hope. Sorry, I thought I had turned that off. Hurst's investigation and report revealed overly aggressive practices by the Kennedy Kentucky OPO that pose risk to patients.
▶ 0:33:01These findings should be caused for deep concern and immediate action. The experience of one patient in his family that was extensively covered in the report is deeply concerning. At numerous points prior to his near donation, signs that he should not have been considered an eligible donor were not acted upon by either the OPO or the hospital. Even more concerning, the Hurst investigation found similar examples of the OPO attempting to push forward with procurement of organs despite signs of cognitive function in the patients.
▶ 0:33:30Now, these procedures were all ultimately not completed, but the OPO's pressure tactics prolonged the process processes before they were stopped. When details of the incident in Kentucky were first reported, there were some key stakeholders who tried to downplay it before it was fully investigated, and some continue to do so even after seeing the results of hers's investigation. And I find this troubling and counterproductive. When there's a problem that affects people's lives, our responsibility is to face it and try to solve it, not sweep it under the rug.
▶ 0:34:00Yesterday, HHS announced it would take action against Network for Hope if it does not comply with certain accountability measures. And there's also new reporting from the New York Times over the weekend, describing numerous other cases from across the country where there were serious errors in the process of determining donation after circulatory death. In some cases, doctors found patients hearts still beating after they had started the procedure.
▶ 0:34:24Other healthc care providers described donation procedures being initiated prematurely or without a complete assessment of the patients cognitive condition. These are very disturbing cases and show why oversight of the donation system is necessary. Now, last Congress, we passed the bipartisan securing the US organ procurement and transplantation network act. This legislation created a foundation for the reforms that HERSA has been able to achieve and are still in progress.
▶ 0:34:50HERSA has used its new authorities and resources to strengthen its oversight over the OPTN, including by creating a new board of directors and beginning the transition to additional contractors, but there's a lot more work to do. We need to make sure that there are experienced and qualified staff to continue the work of improving the system and increasing accountability. Secretary Kennedy's massive staff cuts and reorganization plans at HHS will cause great harm to the services it provides to the American people.
▶ 0:35:19HHS has not been forthcoming about where the cuts are occurring and what programs may be harmed by this so-called reorganization. And committee Democrats will continue to push back against cuts at HERSA and across HHS. I just want everyone want to understand that with someone in charge like Secretary Kennedy who I really don't think has any idea what he's doing, it's hard to be concerned to be, you know, to be convinced that any reorganization could actually be uh, you know, productive or helpful.
▶ 0:35:49But in any case, we'll see. Improvements to the OPTN and increased oversight by HERSA have broad support from this committee and I hope we can continue to work together to ensure improvements that produce patient safety and create a culture of transparency and accountability and those changes will increase confidence in the system hopefully which in turn could increase organ donations that save the lives of others. So it's a very important hearing. I want to thank you Mr. Chairman. I yield back.
▶ 0:36:15That concludes member opening statements. The chair would like to remind members that pursuant to committee rules, all members written open in statements will be made part of the record. We want to thank our witnesses for being here today and taking the time to testify before the subcommittee. You will have the opportunity to give an opening statement followed by a round of questions from members. Our witness today is Dr. Dr.
▶ 0:36:39Raymond Lynch, chief organ transplant branch of HERSA and the division of the US Department of Health and Human Services. We appreciate you being here today, Dr. Lynch, and I look forward to hearing from you. You are aware that this committee is holding an oversight hearing and when doing so has the practice of taking the testimony under oath. Do you have any objection to testifying under oath?
▶ 0:37:03I do not.
▶ 0:37:04Seeing no objection, we will proceed. The chair advises that you are entitled to be advised by councel pursuant to house roles. Do you desire to be advised by councel during your testimony today?
▶ 0:37:16I do not.
▶ 0:37:18Seeing none, please rise and raise your right hand. Do you promise to tell the truth, the whole truth, and nothing but the truth? So help you God. Seeing the witness answered in the affirmative, you are now sworn in and under oath subject to the penalty set forth in title 18 section 101 of the United States Code. With that, we now recognize Dr. Lynch for five minutes to give your opening statement.
▶ 0:37:48Chairman Joyce, Ranking Member Clark, Chairman Griffith, members of the subcommittee, thank you for the opportunity to testify on behalf of the Health Resources and Services Administration or HERSA, an agency within the US Department of Health and Human Services. HERS's closer, sorry, want me to start over?
▶ 0:38:10Uh, Chairman Joyce, Ranking Member Clark, uh, Chairman Griffith, members of the subcommittee, thank you for the opportunity to testify on behalf of the Health Resources and Services Administration or HERSA, an agency within the US Department of Health and Human Services. HERSA's Division of Organ Transplantation oversees the Organ Procurement and Transplantation Network or OPTN, a public private partnership established by Congress to provide safe, fair, and consistent access to care across the United States.
▶ 0:38:39We thank Congress for the continued leadership on strengthening this mission. It was this committee that last year identified the safety concern we are here today to discuss. And it was through new resources and authorities provided by Congress in 2023 that we've been able to address this issue as well as others critical to the safety and welfare of all patients touched by the system. As you know, the OPN was established by passage of the National Organ Transplant Act or NOTA in 1984.
▶ 0:39:05The system includes transplant centers, labs, patient and family representatives, organ procurement organizations or OPOS who are the federally designated providers responsible for managing the process of deceased organ donor recovery. The OPN was designed to create rules for allocating or matching donated organs to transplant candidates. To create a safe, reliable framework for this, Congress empowered the OPN with oversight by HHS to establish policies for monitoring threats to patient safety or public health.
▶ 0:39:34Notice specified that only a single nonprofit contractor with expertise in transplant could support the OPTN and over the next four decades this role was held by one contractor the United Network for Organ Sharing or In the interim since the passage of NOA transplant has grown tremendously. Last year more than 48,000 patients received an organ. Advances in technology and practice have improved organ utilization and patient survival.
▶ 0:39:59Congress has continued to enhance transplant access with legal changes to support living donation among individuals with limited financial means and the HOPE act which allowed the use of organs from persons living with HIV. Despite these gains, transplant faces considerable challenges. More than a 100,000 individuals are currently on the wait list with many more unable to get even that far. Last year, more than 11,000 weightless patients died or became too sick to transplant.
▶ 0:40:25Hersa's ability to address these problems was limited by notice stipulation that only a single contractor could service the OPTN. The potential for structural conflicts of interest where the contractor is responsible for developing policies, assessing compliance, managing the finances, and reporting on the quality and impact of its work was compounded by having the OPTN board of directors also be the board of UNOS. As Congress has noted, this functionally reduced the OPN board's purview to issues that were amendable to the contractor.
▶ 0:40:55Hersa was further limited by an appropriations cap that left without adequate staff, technical expertise, and resources. As a whole, these statutory restrictions created an untransparent, ineffective, conflictridden monopoly that essentially avoided meaningful government oversight. In 2023, Congress passed the Securing the US OPTN Act, enabling HERSA to fundamentally transform its oversight through clarity on the status of the OPTN, increased appropriations, and the ability to employ multiple contractors.
▶ 0:41:23The same year, HERSA launched the OPTN modernization initiative. A major step in these advances was the spring special election to elect an independent and unconlicted board of directors. These and other improvements to OPTN governance will provide a more transparent, reliable, accountable, and safe system for patients. The commitment to improving patient safety is central to modernization. Historically, HERSA did not receive complete, consistent, or at times accurate information on safety problems.
▶ 0:41:53With the new law, Congress allowed HERSA to strengthen its oversight capacity by obtaining additional technical and subject matter expertise and support. In turn, HERSA has used these resources to create a multi-layered approach to preventing and addressing safety events. The impact of these changes cannot be overstated.
▶ 0:42:11In the legacy system, concerns of this type uh that we are here today to discuss could and did go undetected by the OPN or uncorrected by the OPTN instead of receiving the thorough review and response that we have provided in this case. As HERSA has stood up its new capabilities, we are grateful to those in the transplant community who have supported modernization.
▶ 0:42:33We're also grateful to Congress for recognizing that more than 80% of OPTN operations, including patient safety investigations, are supported by patient weightless registration fees. The temporary authority granted in this spring's continuing resolution allows HERSA instead of the contractor to collect these fees and is critical to good management and oversight of the OPN. We're hopeful that Congress will approve this on a permanent basis.
▶ 0:42:57We look forward to working with Congress to meet our shared goal of ensuring fair, safe, and reliable procurement and transplant care across the United States. I thank you for your testimony and we will now move to questioning. I will begin and recognize myself for five Dr.
▶ 0:43:20Lynch to better understand what occurred with the index case and how a DCD or donation after cardiac or circulatory death, how a case like that works. Is it fair to say that it is not a failure in a DCD case if the patient doesn't end up dying in the allotted time and the process is during the procuring of the organs if it is It's fair to say that the OPO has a duty to
▶ 0:43:50look for donors. Uh the prognosis, meaning uh planning whether or not an individual will expire within a time period that would allow for the recovery of their organs is imprecise. So in good faith cases, there will be uh instances where a patient has a withdrawal of care, is allowed to progress to a natural death, but that occurs over too long of a timeline to make the organs
▶ 0:44:12And you wouldn't consider that a failure, would you?
▶ 0:44:14I would not. However, it is a failure if at any point in the process leading up to the removal of the patient from life support and declaring that patient is deceased that the patient shows signs of improvement neurologic function such as signs of pain or fear. If you see a patient crying, if you see these kind of neurologic responses, the process should be immediately stopped. Do you agree? I agree.
▶ 0:44:44Or in another case, when a patient was awake and following commands, yet the OPO did not terminate the organ procurement process at the moment the patient exhibited that behavior. Is this how a DCD case should work? No, it is not. Why is that? So, in DCD, the appropriate initial and then the subsequent evaluation is key. identifying those individuals where the the injury to the brain is sufficient that they will not recover and allowing them to progress to a natural death.
▶ 0:45:15If over the course of the days between the OPO's initial assessment and when they ultimately go to the operating room, if they're improving, then it is unlikely that they're going to pass in that time frame and they're being un exposed unnecessarily to harm. So continued re-evaluation as the process continues has to be part of the process. Correct.
▶ 0:45:35We have seen continued reports of these concerning instances and an instance at times by both OPOS's and the OPTM board and its investigative arm that these cases do not represent a failure in the system.
▶ 0:45:50Based on your opinion as a transplant surgeon and now in your role of the treat as a chief of organ transplant brands of HERSA, can DCD continue to be done in a way that protects patients safety and honors the sacrifice of what these patients are
▶ 0:46:07Absolutely. So this is critical to to ensuring patients ability to have their wishes fulfilled. So, if you make that brave decision to be an organ donor and you can pass in a manner that you can be recovered safely as a DCD donor, you should be afforded that right. We're also relying on these organs to save the lives of other Americans. This is complex care. It's technically demanding, but it's knowable and fixable. This is something that can be done safely.
▶ 0:46:32As part of the investigation, HERSA analyzed information from over 350 unique cases of ANR patients or authorized not recovered. This means that the patients were considered for DCD recovery, but no organs were transplanted. The report continues that 103 of these cases or nearly 30% had concerning features. Could you explain what some of those features are and what the common themes are in these cases?
▶ 0:47:02So, HR's report and what we documented in our corrective action plan essentially identified four problems. There was the inability to perform a a good initial or subsequent neurologic exam and identify those individuals who were likely to uh progress. There was a poor pattern of collaboration and respect for the input from the primary medical team, the hospital providers.
▶ 0:47:24There was poor communication and treatment of families and then there was poor documentation of what was actually occurring with these patients in the OPO's records. Would you say that the issues occurring in these cases are more related to policies on how the situations are handled or personal errors or a lack of communication from team because there are multiple teams that are involved as this entire process continues.
▶ 0:47:49So this is as I said this is a technically demanding form of care. It involves good collaboration between the OPO and the hospital. But every area in the country has exactly one OPO. They are the only ones who can provide this care. It is within their scope to make those relationships, do the education for the hospital and provide that expertise and support to help them. I thank you for the clarity of your answers. I think it is important for this discussion.
▶ 0:48:16I now yield five minutes to the ranking member for her five minutes of questioning. Thank you, Mr. Chairman. I want to start by expressing appreciation for the extra oversight that HERSA has conducted here. Because of that work, we have some tangible findings and clear recommendations for process improvements. I'd like to talk through Hersa's process in investigating the Kentucky case. Dr.
▶ 0:48:42Lynch, has hersa ever directed the OT, excuse me, OPTN to initiate an investigation like it did last October regarding the Kentucky Oregon Procurement Organization.
▶ 0:48:55I should clarify, madame ranking member, that um this occurred before my time at HERSA started in October, but to my knowledge, I am unaware of any such uh
▶ 0:49:04Okay. So what has enabled Hersa to direct OPN to carry out more stringent oversight while also conducting its own parallel analysis? To be frank, it's the securing the US OPN act. It's the authority that Congress gave us, the ability to hire in expertise uh and to stand up a data anal analysis team to make sure that we can study these problems with the appropriate degree of rigor.
▶ 0:49:30So why did HERSA determine that this level of oversight was necessary over the Kentucky Oregon, excuse me, the Kentucky Oregon procurement organization?
▶ 0:49:41So the initial decision again preceded my uh individual time at HERSA, but it was a relatively easy uh decision to identify this on uh probing. The OPN contractor had sent a letter to the OPO asking for a detailed list of information. They got back a one-page letter telling them that there was no problem and that the OPO was satisfied and confident in the process that this patient had uh undergone. The OPN and its contractor then elected to close the case.
▶ 0:50:10The closing the case without reviewing the documents that you asked for is so inconceivable in a safety investigation that that uh made HERSA reassess this
▶ 0:50:20very well. The OPTN board of directors is also responsible for enforcing its policies among OPTN members which include OPOS's and transplant hospitals. Dr. Lynch, how does HERSA envision the role of the new OPTN board in conducting oversight and what changes should it make from the way things were handled previously? So the the vision for the OPTN is to provide that system level oversight.
▶ 0:50:49And to be clear, HERSA and other agencies within um HHS provide parallel lines of support and oversight for elements of this community. HERSA is the system. Um by the OPTN, we're able to manage the elements that are within the the transplant ecosystem, so to speak. The vision for this is that every patient who is touched by a member of the OPTN system should have their information knowable and their experiences, good or bad, should be uh the basis for subsequent policym and policy improvements.
▶ 0:51:20The findings of the report are deeply concerning and it's astonishing that no one appears to have thoroughly examined what happened in Kentucky for several years. The incident, including TJ Hoover, occurred in 2021, but there was no report of the case until 2024. Stronger oversight protocols of the OPTN and more transparency from OPOS's would uncover patient safety uh issues more quickly, enabling more time timely improvements. Dr.
▶ 0:51:49Lynch, how does Hersa plan to increase oversight of OPO specifically and improve visibility into outcomes for pre-donors as you mentioned in your testimony?
▶ 0:52:00So, it it is a multi-layered uh approach to this. The first is knowing the data um that every patient who's uh interacted with will have their information known to the government. Um and that's something called a ventilated patient form. in the case of the opios that we will know from the time of referral and first contact through either the successful recovery of organs or the end of the OPO's contact with that patient and then in the case where something adverse happens uh Hersa has already changed its practice so that instead of the report going to the OPN contractor
▶ 0:52:30and being triaged there reports can now come directly to the government for assessment and direction to the appropriate entities. So what triggers that when it comes directly to HERSA or is it that it goes to both?
▶ 0:52:43So there there are two ways in which a safety event can be reported. One is that it can be reported by the OPTN member itself through their secure portal. A broader way to do it is that anybody involved, anybody with access to an uh the internet can go to a public-f facing website and make a report to
▶ 0:53:00Very well. are the currently uh there are currently other hersled investigations underway that you're able to discuss.
▶ 0:53:09I would prefer not to discuss them in this setting, but there are investigations undergo are ongoing.
▶ 0:53:14And uh how does the Kentucky OPO investigation process inform inform HERSA uh will will approach its oversight and authority going forward? So the corrective action plan that HERSA released on May 28th is the first of its kind. Um this has parallels within other entities within HHS and the rest of the federal government. This is meant to immediately mitigate the circumstance at this OPO, but there's also a broader part to it.
▶ 0:53:42Part B addresses the entire system and we are confident that this pattern of care can be prevented in other opios.
▶ 0:53:49Very well, Mr. Chairman, I yield back.
▶ 0:53:51The general lady yields. The chair recognizes the chairman of the committee, Mr. Guthrie for his five minutes of questioning.
▶ 0:53:58Thanks. And thanks Dr. Lynch. Thanks for being here and thanks for your report. As I said in my opening statement, this is personal to me and I want people to be organ donors and I want uh people to have the ability to have that have a full life if they have the the access to organs, but we want to make sure everything is right and done correctly.
▶ 0:54:15And one of the things I think you said you weren't here at the beginning of this, but you didn't say, "Hey, I wasn't here, so it's not my responsibility at the time." Uh also you you didn't you when we had our meeting you didn't say well it's somebody else's issue not mine. You said Hersa has a role in this and you just got started with with uh Miss Clark. So what what have you what does Hersa need to do different to make more confidence in the system?
▶ 0:54:40So I'd like to begin by expressing my apologies for the care that was delivered to your constituents to the people of Kentucky. It's unacceptable and it's not something that HERSA is going to let stand. This was the impetus for our corrective action plan to make sure that this did not continue in Kentucky and that other OPOS's could learn uh by example. This is HERSA's responsibility. HERSA has this authority de delegated by the secretary and we intend to make sure that the OPTN and its contractors are able to fulfill this
▶ 0:55:10Okay. So thank you. So from your perspective or from Hersh's perspective, what more needs to be done by others including the hospitals, the OPOS's, OPT ends, all the different groups, what needs to be done differently?
▶ 0:55:21There's there's room for improvement by all parties. U but the central figure here is the OPO. So nobody proceeds to organ procurement without an OPO's involvement. The OPO is the subject matter expert in this and they are the ones who drive the process. They conduct the evaluation to identify and manage the donors and they are responsible for the uh identification of transplantable organs that will be offered out for
▶ 0:55:46So what do they need to do different to give more confidence to the system?
▶ 0:55:49So to we need better policy within the OPN to make sure that the these lapses in care are preventable. We don't need
▶ 0:55:57So what updated policies? What would you
▶ 0:55:59So right now there is as specified in the regulation there is attending to public health and uh patient safety. I think that we can speak definitively to improving DCD policy. This has been something that the OPTN board has discussed and other entities have discussed for years but no action has been taken. So, so those who are listening these means of the circulatory there's two types of
▶ 0:56:24could you explain the difference in in yes brain dead and and circulatory
▶ 0:56:28So the the manner of uh organ donation and procurement that most people are familiar with is brain death. That is where somebody is legally deceased. um their brain is not functioning um but their body is being maintained on uh ventilator and with medical support
▶ 0:56:42and that that that group which is a big group well there's a bigger unfortunately because of drug overdose a bigger group of the second but that group we're really not questioning today what's be what's being done with them are we
▶ 0:56:53there uh there hersa has ongoing work to make sure that all forms of organ donation and procurement are safe
▶ 0:56:59but brain dead is is not this is a different category
▶ 0:57:02the the case in Kentucky was donation after circulatory death or DCD. Historically, that was a less uh common pathway in the United States. Right now, it's about 50% of the organ donors
▶ 0:57:14and in our case, it's because of unfortunately drug overdoses or um so going to answer a lot of my questions. Do you believe that so you policies and procedures need to be updated? Um and we need to follow them obviously. So what I mean what specifically do you think in the Kentucky case would have were the O what was the OPO's responsibility in the Kentucky case and where do you think it failed?
▶ 0:57:37So some of this could have been corrected locally. So under CMS regulations which guide an OPO um they're required to have a quality department. Every OPO also has a medical director. Appropriate identification of of the donors, appropriate re-evaluation of their neurologic status would have prevented many of these errors. training and good hospital development meaning building that collaborative relationship and listening to the medical teams and the families would have prevented many of these.
▶ 0:58:05Okay. So will you commit to ensuring that uh there will be increased transparency from HERSA and if and when it identifies other issues with organ procurement and uh and so those who are responsible for implementation overseeing organ donations procurement and transplants can address these
▶ 0:58:21Commit to working together. Well, yeah, I think it's important that that as people are listening to this, there there is a distinct difference in the two. I know we need to make sure everything works, but someone who's brain dead versus circulatory death and and we need to and unfortunately the cases are rising with circulatory death. So, we need to make sure we have the procedures in place to make sure um someone is ready to donate before they they're the process moves forward. But you you have to prepare for it because you know they're going to die.
▶ 0:58:52That's that's that's the issue, isn't it? Is that if they're circulatory death, you remove the it that it's not brain dead. Once you remove the the the treatment, they they're passed. But circulatory death, when you remove the treatment because they're going to die anyway, then it takes a a little while. And that that's kind of the space we're worried about,
▶ 0:59:09There there is ongoing work. There has been work for many years to try and get better at predicting who will pass and in what time frame. It remains inexact, but however you're planning on predicting that, you need accurate information and that gets down to conducting a good neurologic exam and a good history on what is wrong with the
▶ 0:59:28Thank you. I yield back.
▶ 0:59:29The gentleman yields. The chair recognizes the ranking member of the entire committee, Mr. Palone, for his five minutes of questioning. Unlike our hearing last September, we have the benefit of HERSA in attendance as a witness and we have solid evidence-based examinations conducted by HERSA that's also directed the OPN to make a monitoring plan for the Kentucky organization that is the focus of its investigation and a systemwide policy on protocols to pause
▶ 0:59:59the organ procurement process when there are concerns about the patient's status. And these actions, I think, will better protect patients across the country during the pre-donor phase and increase confidence for wouldbe donors that their safety and interest will be addressed in the process. But Dr.
▶ 1:00:14Lynch, does the corrective action plan, which is now public, send a message to all OPOS's and relevant OPT members involved in patient care that OPT oversight is becoming stronger and what do you hope the impact of that shift will be on the culture at OPOS's and the OPTN? I have four questions though, so please be brief.
▶ 1:00:38Oh, your mic is not on. Mine wasn't either. Sorry.
▶ 1:00:41Um, I'd like to emphasize the vast majority of providers are doing this in good faith and every day they show up trying to do a good job. This shows that HERSA is doing the same and that we are committed to maintaining a safe environment and so if they see something that is wrong that they can plan for a future where we are doing that better.
▶ 1:00:57All right. And then what was it that you saw in your investigation that made you believe more safeguards were needed specifically for potential donations after circulatory death?
▶ 1:01:08The the primary problem in Kentucky related to them failing to re-evaluate their initial uh neurologic exam and failing to see that instead of somebody slowly getting worse or staying at a very low level of brain function that they were in many cases recovering.
▶ 1:01:24I see. Now, Hurst's report concludes that the Kentucky OPO disregarded or dismissed any indication that a patient who was identified as a potential donor would ultimately not be eligible for donation. And from the report, the OPA appears to have been determined to proceed with the donation protocol until it was forced to stop by a physician's refusal to do the procurement operation. And various hospital staff do not appear to have stepped in to stop the process either until the very end.
▶ 1:01:52And despite this, some organizations argue that discussing concerning cases like this openly leads to fewer donations and harm to the donation and transplant system. So, Dr. Lynch, I I I can't believe I'm asking you this because it seems absurd, but what is Hurst's response to criticism that identifying and discussing lapses in patient safety in the OPTN is harmful to the system? I mean, I don't agree with that, but go
▶ 1:02:18I'll keep it brief uh for your other questions. It's twofold. The first is that trust is earned. It's not to be expected. It's earned every day. Um and the second is that no system ever improved in the dark. We need to have good data. We need to show that we are paying attention. And and look, the bottom line is transparency is everything. You know, I mean, I've been here a long time and if you don't have transparency, ultimately you you know, things don't work. So, I I I totally agree with you.
▶ 1:02:48Last question though, you can take time on this. What are specific ways that improved oversight of the system will help restore confidence that the OPN is safe and effective and that people should be organ donors? You have almost two minutes to answer that one.
▶ 1:03:03So the again the the adequate collection of data um the OPOS's already collect these data um on the patients with whom they interact making sure that that's relayed to the government and that in turn is able to be used for analysis and for public uh use the OPTN already is a leading example of making all data that we have available to researchers and policy advocates adding in all the data on either end the individuals um with whom oos interact before they our organ donors
▶ 1:03:34and the individuals with whom transplant centers interact before they are on the wait list will help us to really understand the system and make sure that we're providing consistent good care.
▶ 1:03:44All right. Thank you. I I mean if the goal is trust in the system, there has to be consistent standards for all OPOS to avoid disperate treatment for patients based on where they live and receive care. And Hersa's corrective action plan I think is a step in that direction and the OPTN and OPO should welcome a constructive response from HERSA to prevent egregious incidents that put patients at risk. It's very important. So with that, Mr. Chairman, thank you. I yield back.
▶ 1:04:13The gentleman yields. The chair now recognizes the vice chairman of the committee, Mr. Balderson, for his five minutes of questioning.
▶ 1:04:22Thank you very much, Mr. Chairman, and congratulations, uh, Dr. Lynch. Thank you for being here today. Hersa's report details many instances where the neurological condition of patients were not thoroughly assessed. Can you provide a few examples of where you found that to be the case? The the initial one was what we are calling the index case.
▶ 1:04:45um that individual was showing increased signs of consciousness over the day preceding the organ recovery attempt and then throughout that day of the organ recovery attempt. Despite the OPO noting this in its own electronic medical record, they continued without deviation from the plan and went to the operating room with the intent of recovering his What changes to policy or procedures would you or have you recommended to ensure that patients are thoroughly evaluated prior to moving
▶ 1:05:15forward with procurement through DCD?
▶ 1:05:19So for DCD to be done in a safe way for any organ uh potential organ donor to be evaluated in a safe way we need to understand what is wrong with them and to what degree there is chemical uh manipulation of their neurologic status. By which I mean is this the the what we're seeing on a neurologic exam brain function or is it brain function and being sedated or paralyzed uh in order to you know accomplish other medical
▶ 1:05:45Thank you. Dr. Lynch, could you briefly describe what leads to variations in process and procedures related to DCD and hospitals and OPOS? So again the hospital providers have a role in this but they are dependent on the OPO as their subject matter expert. OPOS's have been have had established areas of care for many years.
▶ 1:06:09They have a responsibility to provide procurement care in every hospital in their area and so they all have hospital development uh divisions that are supposed to go out and provide education. That education can be in the abstract. A provider may not see somebody who could be an organ donor for many months.
▶ 1:06:25When a potential donor is identified by the OPO, they need to provide updated information and what we would term just in time training to make sure that there's a good expectation of the respective roles and the ability to reassess if this is a potential organ donor if the neurologic neurologic status changes.
▶ 1:06:43Thank you. And I'll follow up with that. You'd be interested some that how and how might this lead to different standards in patient care and occasionally patient outcomes in CDC So this is meant to provide consistent care to make sure that the imaginary lines or the the invisible lines um over which a patient may move within a state or across states don't affect the quality of neurologic care that they will receive in a hospital um and that they are able to to have equal access to being an organ donor
▶ 1:07:14if that is the path for them or to not being subject to that procurement process if it's not
▶ 1:07:19Thank you. Dr. Dr. Lynch, has Hersa ever recommended that an OPO be descertified?
▶ 1:07:26So, the decision to descertify an OPO actually rests with CMS, not with HERSA.
▶ 1:07:32Thank you. Has an OPO ever been
▶ 1:07:37Thank you, Mr. Chairman. I yield back my remaining time.
▶ 1:07:41The gentleman yields. The chair recognizes a gentle lady from Colorado, Miss Get for her five minutes of
▶ 1:07:48Thank you, Mr. chairman and congratulations on ascending to your new role. I know this subcommittee is in capable hands and um I want to say as someone who has been on this subcommittee my entire time in Congress, we've spent a lot of time over the years looking at the organ donation rules and practices. And um it's really shocking when something like this happens with all of the effort that Congress has put in and and I know agencies like yours as well.
▶ 1:08:17Um last year there were um more than 48,000 transplants performed in the United States, but right now there are more than 103,000 people on the national transplant waiting list. And tragically, as you know, Dr. Lynch, about 4700 patients die every year while waiting for organ donation. And so there's an incentive to find more organs.
▶ 1:08:45and and it's and it's a a you know it's a lifesaving thing if if it's appropriately done if the person wants to donate their organ and if in fact they're dead and in fact if if it qualifies that is that's something we all agree with and I'm hoping everyone on this subcommittee has checked yes for organ donation but it's horrifying to everybody to see some of these practices that are being used
▶ 1:09:15and um the New York Times has been in the last few weeks doing some very good investigative journalism around this practice of circulatory death uh certification and there was just an article um dated July 20th updated today in the New York Times about this practice. Mr. Chairman, I ask unanimous consent to put this re this article in the record. So, so what they talk about uh and and Dr.
▶ 1:09:46Lyn, you talked about it a little bit is the increase in the circulatory death process is is part of what has led to this problem because in a rush to get the organs then then then um many of the providers are saying that that this is putting um pressure on them to certify death when in fact the person may be even moving.
▶ 1:10:13Um, and I'm I'm wondering if you can talk about that just briefly.
▶ 1:10:18So, uh, to be clear, the certification of death is by the donor hospital, not by the OPO. Um, but with regard to what I believe your question is, is that is there increased um regulatory oversight in the the performance of OPOS's that they're required to perform similar to their peers? Is that leading to a rise in these events? Yeah, but that the hospitals feel that they're being pressured by the OPOS's to certify death.
▶ 1:10:45That's what's stated in these articles and by the investigations.
▶ 1:10:50So, my understanding of that article was that the the hospitals um some hospital staff were recorded as saying that the the opios were more present in their
▶ 1:10:59That's correct.
▶ 1:11:00Yeah. So, OPOS's are um recovering more organs than ever before and that is a multiffactorial thing. Some of it is related to increased oversight by CMS. Some of it is related to new technologies. Some of it's related to the ongoing opioid epidemic. Um the increased uh emphasis on performance in any area of medicine is never an excuse for non-compliance.
▶ 1:11:25That is correct. I I I want to ask you um about the structure because um the OPTN board has recently been restructured, but previously the board of directors of UNOS, which was the sole contractor, was also the board of directors. And you said in your written testimony that this governance structure, created a potential conflict of interest. And that's that's that goes to what I'm talking about.
▶ 1:11:52Um, and so I'm wondering if you can explain the conflicts of interest as we're trying to do this oversight over these new emerging trends.
▶ 1:12:01So, NOTA at its time was a wise piece of legislation, but over time it has shown uh its flaws. Um, NOTA basically told HHS to build a house for transplant and it said you can have one contractor and that contractor is your architect, your builder and your home inspector. Hersa was in the position of being across the street and wasn't able to directly oversee those functions.
▶ 1:12:24Um, having a contractor's board also be the board of the government entity, there's no way in which it will not affect the the objectivity of that board.
▶ 1:12:34It's almost a per se conflict of interest. Is that right?
▶ 1:12:36Yes. And so, so, uh, does Hersa have a written plan in place to make sure that we have continued safeguards against potential conflicts of interest and make sure this board remains truly independent going forward?
▶ 1:12:50Yes. So, uh, HERSA this spring um created a new uh, board of directors and that was done through a special nominating committee, what we called the transition nominating committee. They identified individuals who were volunteers coming forward from in within the community. They identified a list of criteria to screen them for potential conflicts of interest, including service on the board within the last 10 years during the the period of of most concern.
▶ 1:13:18And from within a group that passed that conflict check, uh the community elected a new board.
▶ 1:13:24Thank you. I yield back.
▶ 1:13:25Gentle lady yields. The chair recognizes a gentleman from Alabama, Mr. Palmer, for his five minutes of questioning. And as the former chairman, I u want to congratulate you on on um chairing the committee and I know it's going to function extremely well. Um Mr.
▶ 1:13:42Lynch, in your written testimony, I want to read something and I quote, "As Hersa was directing the OPTN to conduct the review of KYDA practices, an industry trade group, the Association of Organ Procurement Organizations, publicized an open letter characterizing the ongoing effort to improve patient safety through enhanced oversight as a misinformation conspiracy campaign and concluded it is time for it to stop." and it was signed by more than 20 of the
▶ 1:14:13UNO staff. Would that letter constitute an attempt to obstruct Hurst's investigation?
▶ 1:14:21Uh the legal definition of obstruct. I don't believe I would be the
▶ 1:14:25I'm not I I don't I'm not talking about a legal uh definition. It was it was concerning to HERSA that numerous high-ranking members of the contractor and members of the OPTN board did sign that and in the uh review committee that we directed the OPN to undertake, we asked that nobody who was a signer to that be a part.
▶ 1:14:45But but basically they were saying there's nothing to be seen here.
▶ 1:14:51That's correct.
▶ 1:14:52Okay. But that's not the first time you've had issues. Uh, your written testimony also notes that historically HERSA did not receive complete, consistent, and at times accurate information regarding patient safety and complaints and concerns raised by the OPTN members and other stakeholders. So, if there's any consistency here, it's a consistency in trying to u shield what they were actually doing.
▶ 1:15:18So, one of the problems with having a single contractor environment is that if it's responsible for devising the policies, anything that's happening that's out of compliance with the policies could be seen as a failure of that first process.
▶ 1:15:31But what I'm I'm not trying to necessarily throw people under the bus because I'm a an Oregon donor. It's on my driver's license and I realize the consequence of this. We had a lot of discussions about this before we ever had the hearing. But at the same time, we've got a responsibility to make sure that that people know that that this process will be conducted humanely, that it will be conducted legally, and that and that the people who are doing it have at at the very minimal the best interest of the of the individual donor
▶ 1:16:02and and the families that are involved. And from your own written testimony and from uh the report from HERSA, I mean there's multiple instances here where it appears that they were I I use the word obstruct clearly impeding an effort to to expose some major problems particularly in Kentucky. We are we have a plan which is already in place to prevent that in the future which includes making sure that
▶ 1:16:30I understand but what I'm trying to say is is that we're in we're we're trying to conduct an oversight hearing to reach uh to come up with some solutions which I think your efforts are excellent from what I've read and that's exactly what you're trying to do. But I think there's got to be some accountability. Uh there were clearly some some things that happened that that I I think could constitute euthanasia.
▶ 1:16:54I mean if if the patient's dying but they they take the patients organs before they die that that's euthanasia.
▶ 1:17:03When when we identify conduct that we find is at odds with the OPN contractor's duty we have notified them of the expectation to perform better. Well, again, as I we had this discussion before we had had this hearing, we want to make sure that that the American public knows that if they are willing to become an organ donor, they're going to be treated humanely and legally and that the family's wishes will be respected and that
▶ 1:17:34you're not going to have these horrible situations like we we've seen here in Kentucky and some other places, frankly. And my main concern is that you're able to to do your oversight uh function without interference from anyone. I I really am disappointed that that 20 people signed this letter, which to me constitutes obstruction of of a legitimate investigation, which the investigation uncovered some serious serious problems.
▶ 1:18:04And I just want to know if there's um any um consequences that anyone will be held responsible for uh for what for how they conducted this. And and going on reading through your your testimony, there are other examples where where you weren't given accurate information. I don't I won't say that that it was fraudulent, but it was clearly intended to um to not reach the conclusion that you needed to reach.
▶ 1:18:31So when we identify a deficiency, we do communicate that in the contracting
▶ 1:18:36But what are the consequences?
▶ 1:18:38Uh as a non-contracting expert, there is a a step-wise progression in noting a government contractor's ability to perform its functions effectively. The consequence that within is within my direct scope is that we do not take these things on faith. We are trying to make sure that this is something that the government has the accountability. We have now the resources to to get this done. So we double check the work.
▶ 1:19:03My time is expired. Mr. Chairman, I yield back.
▶ 1:19:05The gentleman yields. The chair recognizes a gentleman from New York, Mr. Tonko, for his five minutes of
▶ 1:19:11Thank you, Mr. Chair, and congratulations on your appointment. Look forward to working with you. And I thank you and Congresswoman Clark for hosting this hearing. Families of patients have to make agonizing decisions about the care of their loved ones under great stress. This is especially true when their loved one is on life support and may be nearing death.
▶ 1:19:29It is essential that the communication with families by hospital staff and OPOS's about the patients condition is indeed accurate and delivered appropriately so families can make well-informed decisions that respect the wishes of their loved one. Hersa's investigation identified a troubling record of the Kentucky OPO's communication with patient families. In one case, the OPO employee seeking consent to begin preparation for organ donation spoke with a patient's brother who had a cognitive impairment.
▶ 1:19:59This individual was described as, and I quote, childlike in case records. In a separate case, the OPO spoke with two family members who were quote clearly inebriated. So, Dr. Lynch, in your review, did you determine why the OPO would approach family members like those in these examples who are not in a position to make serious decisions like consent for organ donation?
▶ 1:20:24The records that we reviewed don't describe the motives of the individuals that did this. Um, but the inability to reconsider the options and to consider the humanity and the autonomy of these patients and their families is troubling. And were OPO employees responsible for seeking consent from families for organ donation trained to interact with families this way?
▶ 1:20:46That would be one of the core functions expected of the OPO.
▶ 1:20:49And what do you think needs to change so this doesn't keep happening? So, we have a corrective action plan in place um that includes the requirement that the OPO uh perform up-to-date uh education and setting expectations with the family with the uh health care team and in making sure that if at any point either the healthare team or the family has a concern that there is a pause in the process to allow for adjudication of
▶ 1:21:17Thank you. And this seems like a manipulative and overly aggressive strategy. The sister of the Kentucky patient has said that she was never told that her brother had started to wake up after she had given consent for donation. She says she only found out years later.
▶ 1:21:32So, doctor, the corrective action plan from HERSA directs the OPTN to develop systemwide policies for improving communication with families and empowering them along with medical teams and other involved stakeholders to request a pause in response to a patient's changing condition.
▶ 1:21:53Um, what are the gaps in patient family communication that you found in your So, this is, as you pointed out, one of the most horrible and challenging times in a family's life. Um, the events that lead to somebody becoming a potential organ donor are usually sudden and tragic.
▶ 1:22:12Interacting with a grieving family, helping them to to make educated decisions, providing compassionate and fair information and a complete uh sense of what the procurement process will look like. Those are skills. They are skills that some ops clearly perform better than others, but they are skills for which the OPO is responsible.
▶ 1:22:33Thank you. And why did Hersa conclude that the creation of a systemwide policy that includes a clear role for patient um was necessary and what do you hope will change after that policy is in One of the uh things that we have done with the new and unconlicted board that came in was to help them understand that the the greater uh system of patients than we normally hear from. And the new board on its first meeting heard from a family member who was a nurse of 25 years experience.
▶ 1:23:04Her sister was a kidney transplant recipient, but her nephew unfortunately had um suffered poor care from a different OPO, not from the OPO that we're here today discussing. making sure that we make clear to the OPTN to its members that this is something that matters that the you know to paraphrase a 100-year-old sentiment the key to the care of the patient is caring for the patient. Um those are the the key elements here.
▶ 1:23:30Thank you. And how will HERSA evaluate the effectiveness of the OPTN board's policy proposals and oversee compliance of the policies when they are established? As we move forward with this, we have several ongoing innovative areas of improving patient safety. Uh we are making sure that there is appropriate patient and family representation on these deliberative groups on these committees within the OPTN so that those perspectives can be honored. That's one of the key parts.
▶ 1:23:56Well, again, thank you. and the committee looks forward to receiving updates as the OPTN board and HERSA collaborate on clarifying this policy that will affirm the communication throughout the process leading up to planned organ donation that patient families are entitled to. So, it's obviously needed and your efforts are a step in the right direction and for that I thank you, Mr. Chair, I yield back.
▶ 1:24:17The gentleman yields. The chair recognizes a gentleman from Idaho, Mr. Fulture, for his five minutes of
▶ 1:24:23Thank you, Mr. Chairman. Mr. Lynch, thank you for being here today. Some of us have not been through this process personally and I I think that might be a blessing but at the same time that may also indicate that we're less familiar with some of the particulars that you're addressing here today. And I know that some of us have come back to you with the same general topic a time or two. And I'm probably no different.
▶ 1:24:49But I I want to frame this in a way that may open you up to make some comments that you haven't to some of the other questions and it has to do of course with the public safety responsibility that we have on the congressional side and just the public trust that that we want to try to foster.
▶ 1:25:07So, it's essential for for those of us here in the Congressional Panel to investigate and address situations that could result in harm to public safety, including improper practices in organ We're also sensitive, as has been pointed out, that this can have an impact on the public perception of the process.
▶ 1:25:26So in light of all of that, can you just take a moment and perhaps touch on some specific steps that Hersa can take to make sure that public trust is where it needs to be
▶ 1:25:43Public trust is earned and it is uh something that should not be expected in this process. We have an opt-in system. There are 170 million Americans who have made the brave choice that they would wish to be an organ donor. Um, we want to be able to reassure them that the care that they will get is safe, that the documentation of their status, their wishes, and their progress through the system is safe and complete. Um, that is being addressed through the the policy directive that we have.
▶ 1:26:11In cases where an individual identifies something that was adverse, we want to make sure that all those concerns are relayed to us and are able to be directed to the appropriate entities. That doesn't mean that every report we get is going to be substantiated, but they should all have their review.
▶ 1:26:29Thank you for that. In your written testimony, there was a quote that I I picked out there that I want to just uh refresh your memory on. Here's your quote and then I've got a question related to it. You said that HERSA aims to foster an environment where providers, patients, and families feel safe to report their concerns.
▶ 1:26:54And if an individual who has like me with very little or no experience with an organ donation system and got a concern and want to report that. Does Hersa have an easy to access navigate mechanism to report or to make a report?
▶ 1:27:16Yes. This spring we unveiled a new website OPN complaints OPN whistleblower. any any entry of words like that will bring you to a government website to make u such a complaint and then in the evaluation of those it's critical to have a denominator so to speak so getting those other data to know how often if a negative event happened how often is that occurring essentially creating a rate for it and so that's why getting a better data environment with a ventilated patient form is so
▶ 1:27:47deeply important
▶ 1:27:49with that Mr. Chairman, I'll just uh make the closing comment that um you know, some of the some of the things that we get involved with on this committee may not be in our real sphere of expertise, but it's also a reminder of just how important some of these components are. And in this one is truly uh impactful on life and death. So, thank you for what you do.
▶ 1:28:16uh and let's all just commit ourselves to trying to make the process better. With that, Mr. Chairman, I yield back.
▶ 1:28:23The gentleman yields. The chair recognizes a gentle lady from Massachusetts, Miss Strahan, for her five minutes of questioning.
▶ 1:28:30Thank you, Mr. Chairman, and thank you, Dr. Lynch, for testifying today. Everyone involved in organ donation and transplantation, from government organizations to clinicians to families, is trying to do the right thing. I believe that. Uh but what we're looking at today is a system in chaos. Too many adverse events are being reported, too many patients are being skipped on waiting lists, and too many donor cases raise deeply uh troubling questions.
▶ 1:28:59We're h we're hearing about people showing signs of consciousness during donation prep, patients being approached for consent while coming off of sedation, families feeling rushed, doctors feeling pressured. That's not how trust is built or maintained. And one way we can maintain trust is by ensuring the integrity and security of the decades of patient data that power this system, especially as we move away from a single vendor model.
▶ 1:29:30Dr. Lynch has hersa developed a plan to open up uh UNICE's technology systems to new contractors in a way that protects patient privacy and ensures continuity of care.
▶ 1:29:44So the plan for that is evolving as we continue to get new information and as our um our capacity to conduct oversight and safety reviews grows. I'm happy to hear that because it isn't just new vendors that will need UNOS's cooperation to modernize the OPTN. The federal government will also need unfettered access over the systems it paid for, starting with HERSA.
▶ 1:30:11It may surprise some to know that for years, HERSA has reportedly not had the power to fully review or access the computer systems that run the organ transplant network, including the code that makes matches and stores patient data. That means the government hasn't had a clear view into how the system works or where the risks are, which is especially concerning uh now as the system is being overhauled. So, Dr.
▶ 1:30:40Lynch, how is HERSA making sure it now has full access to the data and systems it needs to successfully carry out this transition?
▶ 1:30:48That also is it's an excellent question. Uh it's an ongoing area of work. So these are government data. These belong to the taxpayers who paid for it and the individual patient data and the information that's used to maintain the system should be available to the contractors. As we've moved into the multi- vendor environment, we've had what we call discovery contractors who vetted us with critical assessments of various elements of the system. Getting complete compliance from the legacy contractor is an ongoing area of work.
▶ 1:31:19Yes, we know that uh this transition is complex um but it's also necessary. For too long, one contractor has controlled the entire OPTN system including its data and its IT infrastructure. And now as new vendors are brought in to modernize the network, these are growing concerns that control um there are uh con growing concerns that control uh system code and data is being held hostage, potentially slowing down progress.
▶ 1:31:48Uh I'm especially troubled by the reports that UNOS may have even put a price tag on its systems, effectively a ransom uh that government must pay to access access taxpayerf funded technology. Dr. Lynch, to your knowledge, has ENOS ever obstructed or delayed government access to its technology or demanded compensation in order to turn over code and data? Yes,
▶ 1:32:16thank you for that brevity and honesty. I mean, at the end of the day, secure, uninterrupted access to OPTN's technology, especially code and data, isn't just a technical issue. It's a matter of trust, accountability, and patient safety, and that has to be non-negotiable. So, I thank you for your testimony, for your um for your help in us with our second panel, and uh I yield back. The gentle lady yields. The chair now recognizes a gentle lady from Tennessee, Dr.
▶ 1:32:46Harshburgger, for her five minutes of questioning.
▶ 1:32:49Thank you, Mr. Chairman, and thank you for being here, sir. Um, during a potential donor evaluation, an OPO must verify that death has been pronounced according to applicable local, state, and federal laws. Uh, are there any examples in the report where a time of death was not declared? The OPTN report did note one in which a fiveminute interval between the initial and subsequent uh time of death was not adequately uh observed.
▶ 1:33:17Just one then
▶ 1:33:18I believe so in the OPN report. Yeah.
▶ 1:33:21Uh Hersa mentions in the report that Kaida has retaliated against a congressional whistleblower. Could you explain um what occurred in that particular instance and are you aware of other instances in which a hospital, an OPO, OPTN, UNOS or anyone else that is part of the organ procurement and transplant ecosystem retaliated against someone who reported instances of
▶ 1:33:46So our awareness of that reported retaliation is based on media uh descri descriptions of it. Um that is not something that HERSA has direct knowledge of but it was described that a third party was pressured by the OPO um to uh withdraw their contract with that
▶ 1:34:05Okay. So third party um all right
▶ 1:34:10sorry I I realized I forgot to answer the second part of your question. um the chilling effect that instances like the the open letter um to which others have have made reference today, it really can't be underestimated.
▶ 1:34:24Um the sense that to criticize the system is to break the system or is to break faith with the uh leadership of the system has had a decided toll on individuals willingness to work on reform and to come forward when they have individual knowledge of an event.
▶ 1:34:42Absolutely. it will deter that from happening. U Hersa's report clearly states that a central tenant of DCD procurement is that until the patients pass, they remain under the care of the hospital's uh medical team. Can you provide any examples of cases where these lines may have been blurred?
▶ 1:35:02I'm sorry, could you repeat the very last point?
▶ 1:35:03Can you uh could you provide any example of cases where these lines may have been
▶ 1:35:09Sure. So, I think it's important to level set here. I apologize. I'll I'll use a little bit of time. Um, the OPO does not have the authority to to make patient care orders, but they do change what happens to these patients, and that is a standard part of DCD. If you imagine two twins who've had the same neurologic injury, one is pursued for organ procurement and the other isn't. They both get the same care at the end of their life in regard to what's supposed to happen to them. That is the ideal. But the one who is being followed as a potential donor has additional blood work done.
▶ 1:35:39They may have more invasive tests like a broncos broncoscopy where they have their lungs examined or a cardiac catheterization as the index patient in our review had happened. Those are not done for the care of that individual. They're done to evaluate the quality of those organs and opios commonly have what they call DCD order sets.
▶ 1:35:58We had numerous instances in our uh review where despite that being a good practice in terms of making sure that these organs can save the lives of others, the DCD order sets may have been forcing or giving hospital uh staff the sense that they were being forced to do things that they believed were unethical, unnecessary, or unwise. Well, I guess my question is why is that problematic? and is it considered a breach in protocol?
▶ 1:36:29So DCD suffers from a lack of good descriptive policies nationwide. We need to have consistency in this. We need to restore the public's trust in this because it is a safe way to to recover organs and to provide care for people who are at the end of their lives if it is done well.
▶ 1:36:47Yeah. Well, that's a risk uh to patient safety. uh in your opinion what aspects of DCT DCD procurement make this process
▶ 1:36:59So the death is a touchy subject for almost everybody and uh as opposed to the finality of somebody being legally brain dead. Yeah.
▶ 1:37:07Predicting that they will pass away in a time that is consistent with having their organs recovered. It is inexact and a good faith assessment can be wrong. But making a good faith assessment requires good data. So this can be fixed and and the trust restored by making sure that people are performing adequate exams.
▶ 1:37:26Okay. Thank you, sir. And Mr. Chairman, I yield back.
▶ 1:37:29The general lady yields. The chair recognizes a gentle woman from New York, Miss Alexandra Cortez.
▶ 1:37:35Thank 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's organ transplant system is responsible for saving so many lives and also for the loved ones of those um who have who have lost family members and friends to actually see their gifts live on in others.
▶ 1:38:05Um 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. Uh Dr. Lynch, can you briefly describe the circumstances in which most organ donations occur?
▶ 1:38:27So I 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. Um the way that this process works is that the OPO is the central figure in it.
▶ 1:38:43The 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.
▶ 1:39:01The OPO then facilitates getting adequate information about the donor, which means blood work, a 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
▶ 1:39:18Thank you. And it is often uh a patients 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. Um Dr. Dr. Lynch, can you explain a little bit further about what an organ procurement organization is for people who are learning what this how this system
▶ 1:39:46Sure. OPOS's are um a almost unique element of the American health care landscape. Um 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 um 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.
▶ 1:40:16Thank you. And um and in the way that this system is set up, there is currently only one organ procurement organization in any given reason and uh in any given region and uh which sometimes means that individuals may have little choice between OPOS. Uh Dr.
▶ 1:40:35Lynch, I have a report issued by your agency HERSA in March of this year and the report found cases where organ proc where the organ procurement system has at times not worked properly and patient safety was jeopardized.
▶ 1:40:50Now I think it's very important that uh in order to protect individuals and not to raise too much of an alarm by and large our Oregon 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. Um the report found cases where the Oregon procurement system has not worked properly and some of these do not appear to be isolated incidents.
▶ 1:41:18We do have a case of a woman in her 30s, which was reported just two days ago in the New York Times. In 2022, Danella Gyos 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 Danella started to improve, responding to touch and um and trying to move.
▶ 1:41:44Yet 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 Miss Gyos has actually made a full recovery. I would like to submit her statement to the record.
▶ 1:42:08Without objection, so ordered. Um, according to your rep to uh Hersa's report, um, there have been about a hundred uh, unique cases that had quote unquote concerning features. Now, that does not mean that they were all like, um, Danella Gayos's case, but Dr. Lynch. Um Hersa has investigated additional cases.
▶ 1:42:31Uh and um sorry has and the OPO was found to have um pressured the medical team to move forward with this. Um is that is that accurate? And if so, how many organ what would be the standards for an organ procurement organization to be on a path to descertification? And what would the line be for that? So, I'll start with the descertification decision would not rest with her hersa that would be within um CMS.
▶ 1:43:00Um I won't speak to Miss Ggo's case. Um there are numerous uh cases that have been reported to HERSA. We have ongoing reviews and we have made um referrals to partner agencies. Um the corrective action plan that we have for Kentucky as we are hearing about these other cases in other areas also includes a plan to make the OPN make this safe nationwide. and we believe that that will address the the type of error that you're describing.
▶ 1:43:26Great. Thank you very much.
▶ 1:43:28General lady yields. The chair recognizes a gentleman from Texas, Mr. Weber, for his five minutes of
▶ 1:43:34Thank you, Chairman. Uh Dr. Lynch, I guess I have to confess that I don't know a whole lot about you. Um background, college qualifications. Can you help us with that?
▶ 1:43:49Yes. Uh I joined HERSA in October of last year. Um prior to that I was an abdominal transplant surgeon. I'm board certified in surgery and uh I have I've been a doctor for 20 years.
▶ 1:44:02A board certified in abdominal surgery. Uh and I guess without going to too many of the details quote unquote there's but there's other organs. So is does that cover pretty much all?
▶ 1:44:16Sure. So my board certification is in general surgery um through the American Board of Surgery and then I did complete a further certification through the American Society of Transplant Surgeons.
▶ 1:44:25Okay. Now I guess what what colleges did you go to? Just curious.
▶ 1:44:31Uh I got my undergrad degree from Boston College. I got my medical degree and a master's in iminoiology from Yale University. And then I did my post-graduate um residency, my surgical training at the University of Michigan and my abdominal transplant fellowship at Emory University.
▶ 1:44:46Okay. Would you say that you have performed a number of transplants? Is it 20, 120 or what would you get?
▶ 1:44:54Hundreds. Two or 300.
▶ 1:44:57Uh more than that. I don't recall the exact number but more than that.
▶ 1:45:00Right. And so most all of them your with your background and with your expertise were for transplant.
▶ 1:45:07Uh after I finished my fellowship I focused on transplant surgery. Yes.
▶ 1:45:12And and how many years ago was that?
▶ 1:45:14I finished my fellowship in 2014.
▶ 1:45:162014. You're getting to be like me, an
▶ 1:45:20I don't believe I should comment on
▶ 1:45:23Well, you don't have as much gray hair as I do, so I I'll give you that. Um, well, let me let me get you, if you don't mind, to describe the events that led to the development of HERSA's HRSA's report dated March 24th to 25. How did and how did HERSA first become aware of these patient safety concerns?
▶ 1:45:43So, this specific concern was brought to HERSA's attention during a meeting or a hearing of this committee on September 11th of last year. Um the next day the OPTN contractor uh directed the OPO uh Kentucky Oregon donor uh associates agency to um respond with records.
▶ 1:46:04Um they responded on the 20th of September with a single page letter that disputed the uh substance of the report that was given to this committee but did not provide any of the records that were asked for by the OPN contractor. I believe four days later, the OPN and the contractor closed the case.
▶ 1:46:21Now, this was before my time at HERSA, but HERSA staff who were in attendance at that virtual call um were not satisfied that a thorough review had been done and directed the OPN and its contractor to reopen the case and actually review the records that had been requested.
▶ 1:46:38So, when did you go on get on board with
▶ 1:46:40Uh October 21st.
▶ 1:46:43Oh, so very recently. Okay. So, you said the call was made September 11th of last year. Uh, who made that call?
▶ 1:46:50Uh, there was an individual who provided a letter that was discussed in a hearing of this committee.
▶ 1:46:56Well, I guess without, you know, inv violating somebody's props or something, was that a patient or was it somebody who worked in the in the industry?
▶ 1:47:05It's been reported in the in the media. Um, it was an individual who was a former employee of that OPO who still worked in the transplant space. and is who still worked and it's still there today?
▶ 1:47:17No, they lost their employment.
▶ 1:47:20Okay. Um, if you went if you were notified of that, I think you gave the dates, but how long exactly what was the timeline? September and 11th. And when was it terminated again?
▶ 1:47:32Uh, so they received the single page letter on the 20th and they terminated it on the 24th.
▶ 1:47:38Thank you. Uh how many individuals were involved in actually developing that report?
▶ 1:47:45The the report that the the the letter that the OPO sent back
▶ 1:47:50and the response
▶ 1:47:52in their response I don't know
▶ 1:47:53you don't know
▶ 1:47:54the the OP
▶ 1:47:55who has oversight of that.
▶ 1:47:57Um so Hersa has oversight over the OPO and the or through the OPTN and that is why HERSA reopened that investigation.
▶ 1:48:05And who and Hersa has that oversight? uh it's authority delegated through the secretary to the uh associate
▶ 1:48:12and we would hope that that's a licensed position that has as much experience.
▶ 1:48:17So the associate administrator through the authorities that have been granted by the securing act has hired in a lot of expertise subject matter expertise data analytics expertise to assist with
▶ 1:48:28Okay, Mr. Chairman, I yield back.
▶ 1:48:30The gentleman yields. The chair now recognizes a gentleman, Mr. Mullen, for his five minutes of questioning. Thank you, Mr. Chair. Dr. Lynch, thank you for being here today. And uh Mr. Chair, thank you for calling this hearing to discuss such an important issue. Right now, there are over 100,000 Americans on the transplant waiting list, hoping to receive the phone call saying that they will finally be getting their transplant.
▶ 1:49:00While we must address flaws in this system, it is important to also recognize that it saves lives. Just last year, there were over 48,000 transplants in the US, the most ever. And that was made possible by over 24,000 unique donors. And yet, we still don't have enough donors. 13 people die every day waiting for an organ in the US. To reduce needless deaths, I believe that Congress must work to strengthen the public's trust in the transplant system.
▶ 1:49:28Donors need to trust that their selfless gift will be used wisely, not only by the dedicated medical teams performing life-saving transplants, but also by a federal government that prioritizes safety and conduct strong oversight. While I'm confident that many OPOs are highly committed to ensuring rigorous safety protocols, HERSA's investigation highlights some inconsistencies regarding how much authority is given to OPO staff during the organ donation process. In a medical setting, confusion can have heavy consequences.
▶ 1:49:59OPTN policy states that when evaluating whether the patient would be eligible for donation after cardiac death, called DCD, quote, "The primary health care team and the OPO must evaluate potential DCD donors to determine if the patient meets the OPO's criteria for DCD donation." End quote. Dr. Lynch, in your assessment, how is that collaboration, that collaborative evaluation supposed to happen?
▶ 1:50:27And is there a lack of clarity about this policy that needs to be addressed by the by OPTN or HERSA? And if so, what steps are being taken to to provide that clarity?
▶ 1:50:43This is a public good. Transplant is a good thing. It is a focus for the federal government. three successive administrations have worked to build our ability to deal with this and we've enjoyed u support from Congress in that role. The work that is done here, the collaboration between the OPO and the primary hospital is one where the OPO is the driver. They are the one with whom the decision to to proceed down a procurement pathway begins and ends. The hospital cannot force them to do that. The family cannot force them to do that.
▶ 1:51:13The OPO is the subject matter expert and it is their call on what constitutes a potential organ donor. So I want to uh ensure that we aren't only reactively conducting oversight after a a horrifying case and examples of those cases. Oversight over the transplant system needs to be forwardinking and proactive. So uh Dr. Dr.
▶ 1:51:37Lynch, are there any other strategies that HERSA is considering to improve the interaction between OPO staff and hospital staff and their respective roles on these DCD cases? So, um there's two elements to that. The first is that as you say, proactive is best here. Um developing a true denominator for all all these interactions is important. We know that over 1.1 million cases last year, an individual was referred to an OPO. Many of those individuals recovered.
▶ 1:52:07They were a referral was made and the OPO not opted not to proceed with evaluation. But HERSA's ability right now to know what happened at subsequent steps until somebody was an organ donor with what's called a UNO ID is poor. We're improving that. And I think the best way to understand that the utility of that is if you ask somebody is air travel safe because there was a an air disaster yesterday. You would want to know how many flights happened yesterday or last year to know if it's a single event or a common event.
▶ 1:52:36Uh that is what we are doing here in terms of providing the education and making sure that roles are understood and that the goals of care are collaborative. That is something that is an OPO's obligation um to perform. um they can do that in the abstract so to speak making sure that hospital staff are made aware and then when a potential donor patient is identified they should have just in time training to go through what the steps that we'll follow are and to give everybody a clear understanding that if the patient status changes and they
▶ 1:53:06would not be considered a candidate that the process should be halted or can at least be temporarily halted while that's
▶ 1:53:15I appreciate that. Thank you for your report and your continued work. Clear delineation of the roles of oposs and hospitals is essential to avoid preventable harm to potential organ donors. Far too many people die each day waiting for an organ. It is critical that patients and their families have confidence in the decision to be an organ donor. A noble decision that can one day save a life. And with that, I yield back. The gentleman yields. The chair recognizes a gentleman from Florida, Dr. Dunn, for his five minutes of questioning.
▶ 1:53:45Thank you very much, Mr. Chairman. uh and I want to thank you for holding this important hearing. Uh while I was practicing as a physician, I performed organ donation uh surgeries and transplants and drawing on my experience, I was shocked when uh reviewing the reports for this hearing. They're deeply disturbing.
▶ 1:54:04Uh transplant services depend on the generous donors that they m and they must have 100% trust in us uh in in all things on these donations. I was horrified by the findings and commit to working to ensure that these stories do not repeat. Dr. Lynch, I do want to first commend you for your work with HERSA uh and while compiling this investigation.
▶ 1:54:30Based on your testimony, I must say it seems that there was an effort by others uh to downplay the facts. Uh Hurst didn't let that happen, and I thank you for that. Has her been made aware of additional patient failures uh like those uh outlined in these reports? Thank you. I'd like to acknowledge the the division of transplant and the hersa uh and the secretary as a whole.
▶ 1:55:00This is a team sport and this has been one in which I believe everybody shares the goals and has shared the work in in generating reports like this. Um we are aware of other instances and in fact as we conducted our review of um the OPO in question here in Kentucky.
▶ 1:55:17They even after the September event that was um made aware they were made aware of in this hearing and after their merger with another OPO subsequent reporting came to us from individuals within the community identifying cases of concern. we did substantiate um cases of concern in that time period even during that that era.
▶ 1:55:38I trust her will investigate those as well and I and I appreciate your attention to these important investigations and reestablish public trust in all of us. Uh I remain concerned that the OPO responsible for the particular blatant failures uh we read about here today continues to operate even if under a new name.
▶ 1:56:00And I believe that HHS should consider all options to protect patients including considering descertifying OPOS with a record of failure in this regard. Finally, um uh perhaps HERSA uh or the OPOS's, whoever's in charge of making CMS makes these rules should consider uh the use of standard protocols for brain death. We always used brain death, not circulatory death.
▶ 1:56:28when I was in practice uh uh in all cases of drug um that seems to be the most common type of patient he gets confused in these situations with with uh circulatory death yes or no and and they're they're much more difficult people to or patients to understand. Is that is that a fair consideration? The determin of brain death, determination of brain death really does require a rigorous evaluation.
▶ 1:56:58And a layman's way of describing it is that nothing is wrong with the brain except that it's not working. The brain should be warm. The person can't be hypothermic. They can't be without oxygen. They can't have too low a blood pressure. That would make your or my brain not work well. And they can't be medicated or uh paralyzed so that we're not getting an accurate assessment of that. Those things are well described uh in you know consensus guidelines that are used as the basis for many state laws and they are uh
▶ 1:57:26Well that that was always the standard that we applied and and uh and I I have to say this circulatory death standard is uh it seems to be the thing confusing issue. So I I urge you to revisit that and with that Mr. Chairman I yield back. Thank you.
▶ 1:57:44The gentleman yields. The chair recognizes a gentle lady from Washington, Dr. Shrier, for her five minutes of questioning.
▶ 1:57:52Thank you, Mr. Chairman. Thank you, Ranking Member Clark. Thank you, Dr. Lynch, for being here today. And let me just say it is uh such a pleasure uh to see my friend John Joyce with Gavl in hand. And I want to say congratulations and thank you to you. Uh I would like to start today uh just by pointing out how incredible and what a blessing organ donation is. I don't want to lose sight of that um in all of this discussion.
▶ 1:58:20A a single donor can save by my count up to eight lives, can bring sight to the blind, can help burn victims, and so much more. and the families and individuals who make this noble decision to donate their organs to save others should be thanked and honored. And that's why it's so important uh to address the recent widely publicized donor safety concerns.
▶ 1:58:47And I just want to be really clear that what's been documented by the the HERSA report and the New York Times investigation is egregious and no patient or their family should ever have to worry about carelessness or recklessness or harm after making this very noble, selfless decision to help others. And that's why it's so important that we get these questions right today. The process of Oregon procurement and donation involves multiple parties.
▶ 1:59:16It's a pretty complex and integrated system. Healthc care providers, hospitals, organ procure procurement and transplantation networks, and HERSA, the Health Resources and Services Administration, all working together with this common goal of saving lives.
▶ 1:59:32And as we see the fast growth in organ donation in this country and the relatively new relatively new focus on donation after circulatory death, um I'm concerned that medical training and education may not be keeping pace with the often medically complex decisions and requirements for declaring circulatory death. And so Dr. Lynch, I just first wanted to touch on in really following up on Representative Mullen's question.
▶ 2:00:01What gaps are there in the training for providers involved in procurement procedures and those responsible for declaring death particularly if you could point out what could be done better to avoid errors.
▶ 2:00:15So an individual provider's familiarity with organ uh donation and procurement in general uh may vary and with DCD it may vary considerably. Um the failsafe here is that the OPO is the expert. The coordinators who go on site and the individuals to whom they report are the experts. They do this every day all year long and they have an established area in which they do it. So they should know the hospitals where they need to work um to provide extra support.
▶ 2:00:44One of the concerning aspects that HERSA found in its uh review was that these events appeared to be more frequent relative to the number of attempted uh donor recoveries in small hospitals. And that speaks to the quality of the education and support that was being provided. Um support can be a good thing, but it should never be mistaken for bullying or for telling somebody that this is just how it is.
▶ 2:01:09and the instances that we documented are concerning that those things may have been confused.
▶ 2:01:16I think it's a very interesting point to point out that it's in smaller community hospitals, not the trauma centers where you would get massive volumes and have a lot of experience with this. I I just wanted to point out in other areas of medicine um when I was practicing, you know, a woman comes in pregnant woman for delivery, there's a standard order sheet. you check boxes and make sure you haven't forget gotten anything.
▶ 2:01:39When you do hospital orders, we had a pneummonic that helped us remember not to forget fluids or not to forget checking blood pressures, those kinds of things. And so I'm wondering if um anybody's considering a just a procedural standard even the procedural pause that we take before operations happen because of some tragedies there and is used to prevent that. Is anybody working on a standard checklist?
▶ 2:02:05you know, check this many minutes later, check that many minutes later, make sure they're not on opioids, whatever it is to
▶ 2:02:11So, I I would agree with you. Many of my friends are in areas of medicine other than transplant. And this is perplexing to them because we appear to have skipped a generation relative to when I was in medical school, the Institute of Medicine, now what's called the National Academy of Science, Engineering, and Medicine, issued to as human showing that um you know, the preventable medical errors were causing unnecessary death.
▶ 2:02:33that led to a revolution in acknowledging error in um preventing it through increased data reporting, increased general and up totheminute education and things like the timeout. Um these things are knowable and fixable. This is care. This is safe. If it is practiced well, it is being practiced well in many areas of the country. HERSA's corrective action plan and directive to the OPN are to make sure that it is consistently safe across the country.
▶ 2:03:01Thank you very much and thank you for uh your contribution to hundreds of patients who are now alive because of your transplantations.
▶ 2:03:11The general lady yields. The gentleman from Georgia, Mr. Allen is recognized for his five minutes of questioning.
▶ 2:03:18I thank the chairman. Um Dr. Lynch, uh HRSA details several examples concerning interactions with patients, families, and obtaining consent from next of kin. One of these interactions, the report describes how OPO's staff proceeded with obtaining authorization from two family members despite witnessing the next of kin take psychoactive medication immediately prior to the discussion.
▶ 2:03:46Are there or should there be protocols in place that do not allow for consent if a family member or next of kin or under the influence? Uh, as a non-awyer, I'll speak in a in a generality, but I believe local, state, and federal laws address consent, and making sure that an individual has the capacity to do so involves their their mental state. Yes.
▶ 2:04:07Okay. Uh, there have been concerns about the risk of conflicts of interest in the organ procurement and transplant system, particularly as it relates to Ununice and OPTN. and your state testimony notes that Ununice was the only entity to hold the contract to support OPT for the past 40 years.
▶ 2:04:28As a result of that, the board of directors responsible for OPT governance was the same as the corporate board of unis which created a potential conflict of interest. What insights do you have into these potential conflicts of interest and what is being done to address those issues? So that was a source of strong concern that was noted by multiple congressional investigations.
▶ 2:04:51The lack of objectivity, the lack of independence for a board that feels that it has to answer to the OPN, the government entity, and also to the corporate entity, to the contractor. Um, so making sure that they were independent boards from each other and then making sure that the individuals who occupy that board had the best information and had a clear understanding of their obligations to the OPTN was a key part of the modernization initiative.
▶ 2:05:16With the authorities granted by the securing act in 2023, we were able to achieve that aim and we had a special election this spring. The new board has been sworn in on um July 1. And this election actually had un an unprecedented high level of turnout from within the community. So we believe there is excitement and enthusiasm for this.
▶ 2:05:35Good. Um while the report analyzes cases across KYDA's regional jurisdiction, HRSA's analysis found that there were disappro disappropriate gains in procurement in certain sectors. What kinds of trends did you see with organ procurement in smaller more rural hospitals? So we we found two trends in the smaller hospitals relative to larger ones.
▶ 2:05:59Um the first was that there were more uh cases that did not proceed um to the recovery of organs relative essentially the number of times they tried was lower and then in those cases where they did not um proceed to organ recovery there was a higher instance a higher rate of concerning findings in those smaller hospitals.
▶ 2:06:19For additional context, the report illustrates that there were proportionately more ANR cases per successful donor procurement at smaller hospitals and those with higher uh proportions of rural patients and that a higher fraction of the ANR cases at smaller hospitals and those with more rural population showed futures features of concern. Could you elaborate on those findings and what this means uh in the broader cont context of OPOS's?
▶ 2:06:50So again, that the the right to be an organ donor is recognized. This is something that if you've made that decision for care or your family makes that decision for care, it should be honored and it should be honored in a safe, consistent way. The small hospitals we believe did not receive adequate support from the OPO. Um, and that is based on a number of the features that we saw, specifically the interactions with uh staff.
▶ 2:07:14Good. Well, thank you so much. And with that, Mr. Chairman, I yield back.
▶ 2:07:18The gentleman yields. The chair recognizes a gentle lady from Indiana, Miss Hchin, for her five minutes of
▶ 2:07:25Thank you, Mr. Chairman, and congratulations on your chairmanship of this subcommittee. I'm grateful for the opportunity to weigh in on this extremely important topic. Every year, tens of thousands of lives are saved because individuals make the courageous and selfless decision to donate their organs. The reality is organ donation is rare. Only about 1% of people who register as a donor are eligible to donate their organs at the time of death. That's why we must treat every case with the utmost care, integrity, and accountability.
▶ 2:07:54When we fail to maintain rigorous oversight and ensure ethical practices, we risk eroding public confidence in the foundation of that system. Today's hearing not only touches on the safety of individual patients, but the sustainability of the organ donation system. HR's report lays out deeply troubling findings, particularly with respect to the actions of the Kentucky Organ Donor Affiliates or KYDA, now called the Network for Hope.
▶ 2:08:21These findings hit particularly close to home for me as the organization under investigation serves my hometown community of southern Indiana. The actions of KYDEA to repeatedly continue to pursue organ recovery despite multiple signs of neurological function is not just alarming. It's morally and clinically indefensible. We are talking here about vulnerable patients, rural patients struggling with drug addiction, grieving families facing impossible decisions.
▶ 2:08:52When the public places trust in our Oregon procurement organizations, that trust must be earned and honored. every single time. The fa failure to act upon clear signs of life, ignoring the pleading pressure uh by placed um by hospital staff and the absence of nonpartial accountability mechanisms raise serious questions about oversight and safeguards in the system. Dr. Lynch, your report makes it clear that existing protocols were not followed.
▶ 2:09:21Um why did the oversight framework in place fail before the incidents were reported? Um, and is it a broader systemic issue or is it um limited to uh KYDA?
▶ 2:09:38Unfortunately, it is not limited to KYDA. During the course of this investigation, we received concerns that were in areas served by other OPOS's.
▶ 2:09:46Um, the failure here is at multiple levels. So the OPO has a responsibility to conduct quality reviews and to conduct good oversight, to conduct good training of its staff to make sure that they know what to look for and to make sure that they feel empowered to stop the process. These are all important uh things at a local level. HER's oversight here is through the OPT on the system and the OPN and its contractor's review of this was poor. Um
▶ 2:10:14thank you. I'm I'm very concerned um that we wouldn't know about this had it not been necessarily for the whistleblower who um notified um that uh wrote a letter al to the committee alleging that a patient had been inaccurately pronounced brain dead and was pursued as an organ donor by KYDA. And per the report, the patient who was the victim of a drug overdose showed clear signs of life at multiple points, but KYDA senior staff directed that that the organ recovery proceed.
▶ 2:10:45Um, we would not necessarily know about the depths that this has gone at KYDA were it not for that whistleblower who was subsequently fired by a procurement agency. Is that your understanding?
▶ 2:10:56Yes. Um, so I'm concerned about uh what appears to be um, and I think some of your testimony today reflects this, that there is a an apparent conflict of interest in the oversight that HERSA is now working to correct. And I want to thank you for that. Um, on behalf of the constituents that I represent, but I I wanted to get your thoughts on, you know, we we talk about the ANRS that we know about uh, with respect to DCD procure procurements.
▶ 2:11:24How many DCD procurements were completed by KYDA during the HERSA review process? Do you know that?
▶ 2:11:31Uh I can't speak to I can't recall to be perfectly honest the exact number but it was um I believe that the ratio overall was about one one so on the order of 300 maybe. So, you can understand that I might be concerned that the ANRs are just the ones that we know about um and that some that were completed, they were followed through with despite the warning signs that may have been present with the ANRS.
▶ 2:11:56That's a a valid concern.
▶ 2:11:58Um well, I just want in in the remaining time I have um I know that that HERSA has asked OPT to uh report on within 30 days um some of their findings. Uh, have you received anything from OPTN at this point that met your your metric to develop and implement a 12-month uh monitoring plan for KYDA? Have they done
▶ 2:12:20Yes, we've started on that process and had meetings with them.
▶ 2:12:23Okay. They're supposed to issue that report um on how they are going to monitor it. Have they done that?
▶ 2:12:29There that is due at the end of this
▶ 2:12:31Okay. Um well, I I want to thank you for being here today. I look forward to us working together to improve accountability and transparency in our donation system. I remain concerned. It's clear there's a lot of work to be done to restore trust in the organ procurement network, particularly with respect to the troubling findings of KYDA. My last question with the time I have is um do you have concerns that KYDA is continuing uh under the current framework um given the concerns that that have been shared to the committee?
▶ 2:13:02We believe that the corrective action plan that we're putting into place will enable them to perform in a safe
▶ 2:13:07Thank you. I yield back.
▶ 2:13:09The general lady yields. The chair recognizes a gentleoman from Iowa, Dr. Miller Meeks, for her five minutes of
▶ 2:13:16Uh thank you very much uh Mr. Chairman, and I want to thank uh the witnesses of both panels for testifying before the subcommittee uh today. I probably have a unique perspective coming into this hearing. So, uh, first and foremost, uh, I was a newly, um, uh, newly made lieutenant at Walter Reed where having been an emergency room nurse, I was in a neurosurgical nurse, working on a floor that had comeosse patients, uh, brain dead patients and talking with family members,
▶ 2:13:46doing studies to ensure they were brain dead, and then talking to those family members about organ donation. Uh then I did that as an emergency room doctor uh serving on trauma doing a general surgery um res general surgery internship uh in a very busy hospital bear county hospital in San Antonio and then finally through my residency in opthalmology.
▶ 2:14:09So both as a nurse and as a physician have been in those very delicate conversations with family members determining first and foremost that their family member is in fact brain dead and may not um continue to have a viable life.
▶ 2:14:30And then as a physician and of opthalmologist doing visions saving coral transplant surgery on children on adults with chemical injury or heritable And so when I say that donation is only possible due to the public trust and the uh generosity of donor families I know that firsthand.
▶ 2:14:52And following the September 24th uh 2024 hearing and the subsequent story regarding Kucky's case in October, the Iowa donor network experienced a 78% increase in registry removal requests with 193 requests compared to the same time in the previous year in which we received 75 requests.
▶ 2:15:13And the sharp increase in registry removal requests following recent events clearly demonstrates how fragile this trust can be and how vital it is that we protect and restore it. And I know Dr. Lynch that that is also what you would like to do and I know that's what OPN and UNOS wants to do as So, I have a little bit different history than other people, and I haven't removed from my driver's license, nor has my husband, that we're donors, and that we want to donate
▶ 2:15:43and provide that life-saving or sight saving organ uh if we're healthy enough to do so to someone else, child or adult. And this is not a system that has been uh in place for a long time. I mean the system that I worked at as a nurse and a we didn't have the 2023 securing US organ procurement and transportation network, the OPTN network.
▶ 2:16:09So it's newly established and I think it's unfortunate that we are going through a process now where there will be as we learn from one another recommendations and processes that need to have to be changed. Dr. Dr. Lynch, can you detail how much of the funding has been allocated to date and where that funding has gone that has been provided to HERSA to improve the
▶ 2:16:36Sure. Um, thank you for your perspective. I we we share that in HERSA. Um this is something that we want the the public to feel that it is you know we are worthy of trust in the system and for those family members of individuals who have gone through the process we want them to be able to feel consolation and pride that their loved ones made that choice. Um so in terms of funding before the securing the US OPN act was limited u by statute at $7 million.
▶ 2:17:04I believe in the last year it was 23 million that we spent since the securing act. Um we have undertaken several tasks. Um from an operations perspective, the most important is that we now have not just one uh operations contractor, the legacy one. We have a new contractor AIRIR which is uh providing support to the board and that helps them to have independence from the rest of the the system.
▶ 2:17:30Uh we also conduct a lot of uh what we call discovery tasks or discovery contracts which are really to get external uh expert opinion and then from within that pull from the the community to understand all elements um logistics allocation policym communications I have a bill, the organ uh donation referral improvement act, which directs HHS to study and promote the widespread adoption of automated electronic referrals
▶ 2:18:00for or organ donation. However, HERSA could initiate this transition on its own. Are you familiar with automated referral and if so, have you worked with health systems and ops to further understand how it could be implemented on a wide scale?
▶ 2:18:14I'm familiar with the concept of automated donor referrals. I'm unfamiliar with with your piece of legislation. and I'd be happy to look at
▶ 2:18:21Thank you. I think uh further uh collaboration, working together, standards and processes in place will help restore the trust of the American people and uh organ donation, which is an extraordinarily valuable service that we do.
▶ 2:18:35The general lady yields. Dr. Lynch, thank you for your attention and thank you for your cander this morning. I do have just two brief follow-up questions. The report details instances in which patients are being evaluated after they have received seditives and paralytics.
▶ 2:18:53In one instance, the report notes, and I'm quoting, a lack of understanding or concern regarding the effects of medications on the patients neurologic status extended right up to the point of going into the operating room in preparation for for procurement of the organs for transplantation.
▶ 2:19:10Can you explain to us why it is so alarming that patients are being evaluated while they are under the influence of sedatives and paralytics right up to the point where a neurologic evaluation might be uh adversely affected.
▶ 2:19:25So it's an excellent question. The basis for this is making sure that we're actually understanding the neurologic injury or the remaining neurologic status of the patient. And so if you have somebody who is just sedated um and paralyzed, you're going to make an assessment of them that they may have no reflexes or that they may have a very depressed level of
▶ 2:19:46Would that be an adequate Would that be an adequate assessment?
▶ 2:19:49No. No. Are there protocols that need to be developed as far as as the progression of the evaluation right up to the time of procurement? Is there a an ability to assess what drugs can be effectively administered and what drugs should not be administered?
▶ 2:20:05Those are critical elements of HERSA's corrective action plan and system directive is to make sure that we understand um what the neurologic status is and that everybody involved is got a clear picture of the patient's real um situation and prognosis. Is there any uniformity with the current system where different sedatives or different uh medications prior to the procedures for the procurement are not utilized or shouldn't be utilized or recommendations that they be avoided.
▶ 2:20:35There are no set protocols or policies that apply across all OP all OPTN members. No,
▶ 2:20:42I thank you for the followup of question. I thank you again for being present here today. Seeing that there are no further members wishing to ask questions. I would ask our witnesses I would thank our witness again, Dr. Lynch, for being present here today. We will take a quick recess to allow the witness table to be set for the second We are in recess.
▶ 2:31:38the opport. Our witnesses today are Barry Massa, chief executive officer for the network for hope, Maren Bride, chief executive officer for United Network for Organ Sharing, Dr. Richard Formica, former president of organ procurement and transport transplantation network board of directors and John McGee, MD, president of organ procurement and transplantation network board of directors.
▶ 2:32:09We appreciate all of you being here and I look forward to hearing from you individually. You are aware that the committee is holding an oversight hearing and when doing so has had the practice of taking the testimony under oath. Do you have an objection to testifying under oath?
▶ 2:32:27Seeing no objections, we will proceed. The chair advises that you are entitled to be advised by councel pursuant to house roles. Do you desire to be advised by councel during your testimony today?
▶ 2:32:40Seeing none, please rise. Raise your right hand. Do you promise to tell the truth, the whole truth, and nothing but the truth? So help you, God. Seeing the witnesses answered in the affirmative, you are now sworn in and under oath. Subject to the penalty set forth in title 18, section 100001 of the United States Code. With that, we will now recognize Mr. NASA for five minutes to give an opening statement.
▶ 2:33:10Chairman Joyce, Chairman Guthrie, Ranking Member Clark, and Ranking Member Palone, and members of the subcommittee. Thank you. Thank you for inviting Network for Hope to testify at this hearing. My name is Barry Massa.
▶ 2:33:25I'm the CEO for Network for Hope, the federally designated organ procurement organization responsible for facilitating organ donation in Kentucky, parts of Ohio, West Virginia, and Network for Hope was formed in October of 2024 with a merger of Kentucky Organ Donor Affiliates and Life Center Organ Donor Network.
▶ 2:33:49I have had the privilege of dedicating the majority of my professional life to honoring the selfless and courageous individuals along with their families who give the gift of life to the more than 100,000 people currently waiting to receive a life-saving transplant. OPOS's play a vital and unique role. These community-based notfor-profits are exclusively designated to facilitate the deceased donation process.
▶ 2:34:18At Network for Hope, we recognize that organ donation and transplant system cannot succeed without public trust and that public trust must be earned. Every stakeholder in this complex ecosystem can and should always strive to be better and network for hope is no The work that we as OPOS's do can mean the difference in whether a family will be able to share another birthday with a loved one or have the opportunity to make more treasured
▶ 2:34:48memories with friends. None of this is lost on us. It is what drives us. There are a few points I want to make abundantly clear. OPOS do not provide health care. OPOS do not participate in the decision to withdraw life sustaining care. OPOS are not involved nor have any say in the declaration of a patient's death.
▶ 2:35:14Ops do not recover organs from living patients and ops only facilitate the organ recovery process from deceased patients. Since first receiving the March 2025 HERSA report just a few days ago, thanks to the actions taken by this committee, it is clear that the report's allegations and contents are serious and alarming, we are in the process of expeditiously reviewing the issues cited in the report
▶ 2:35:45and addressing the concerns raised therein. Let me be very clear about my next statement. Patient safety is at the forefront of everything that we do. I want to assure the subcommittee that Network for Hope will take any appropriate action necessary to continue to implement policies and procedures to continuously improve and be better and most importantly ensure and promote patient safety.
▶ 2:36:14You and the citizens we serve should expect nothing less. We also welcome oversight and share your goal of ensuring the highest standards in organ donation and transplantation. I'd like to introduce and recognize two individuals joining us today who have been personally impacted by organ donation.
▶ 2:36:35Sitting just behind me is Miss Adria Johnson, a mother organ donation advocate and the CEO of Metro United Way in Louisville, Kentucky. Her son KJ became a DCD donor in 20 at the age of His selfless choice directly saved three lives. His heart went to a man in his 30s and two mothers each received one of KJ's kidneys.
▶ 2:37:04Also with us today is Miss Shannon Atkins, also of Louisville, Kentucky. Three years after her eldest son, US Marine Sergeant Michael Atkins, was killed in action, Shannon's six-year-old son, Keegan, passed away. Shannon and her husband made the courageous decision to donate Keegan's organs. As an organ donor, Keegan saved the lives of four children and one adult.
▶ 2:37:32Andrea and Shannon have both turned unimaginable loss into miracles for others and their families and to continue and continue to advocate for organ donation and we are deeply grateful for their support. For myself, like many in our field, my passion for donation is very personal.
▶ 2:37:54Many years ago, even before joining Life Center, a close friend's daughter, Aubrey, received a double lung at just the age of 18 months old. Aubrey lived for another 18 months before unexpectedly passing away and upon her passing became an eye donor, the cornea donor.
▶ 2:38:13The stories like Aubrey's, KJ's, and Keegan's are what has driven me to advocate for all who are on the transplant list and to ensure OPOS's like Network for Hope can meet the growing need effectively and safely. Again, thank you for the opportunity to be here today. I look forward to continuing to work together collaboratively to improve the donation process. As Congressman Guthrie stated, we have to get this right.
▶ 2:38:43Thank you.
▶ 2:38:45Thank you, Mr. Massa, Dr. McBride, you are recognized for your fiveminute
▶ 2:38:51Good afternoon, Chairman Joyce, Ranking Member Clark, and members of the committee. My name is Dr. Moren McBride, and I am the CEO of UNOS. I am a PhD bio-statistician, and I have spent my career working to ensure more Americans are able to receive the gift of life. Thank you for inviting me to be here Organ donation and transplant is also my life's work.
▶ 2:39:16It's personal to me and my colleagues at UNOS, many of whom have been touched by organ donation or transplant. We go to work every day to support a system that is safe, fair, and effective for both donors and patients. We do that in a very specific way by supporting the nation's organ procurement and transplant network or OPN under contract with HERSA.
▶ 2:39:42Our work to support the OPN includes managing the national transplant weight list and organ matching system, providing support to the OPN volunteers during policy development and compliance oversight processes, and collecting and maintaining OPN data on behalf of HERSA.
▶ 2:40:00I'm incredibly proud that every day more than 100 life-saving transplants occur through the national network that UNOS supports and that our organization has played a role in giving more than 1 million Americans a second chance at To lead UNOS is to be reminded every day of the connection between life and death. Every transplant is a second chance and some are born from tragedy, a life cut short, a loved one gone.
▶ 2:40:30I've heard countless stories that broke my heart and stories that remind me of the true power of giving. Consider the experience of one of my colleagues at UNOS whose father passed away in 2023 at the age of 54. Walking alongside him to the operating room during his honor walk was the most difficult moment of her life. And yet she willingly shares his story to inspire others to become organ donors.
▶ 2:40:58Generous people like her father enabled more than 48,000 transplants last year. I also get to celebrate the milestones of other colleagues who are transplant recipients. They work at UNOS be because they feel compelled by their personal journey and our mission. They are living full lives thanks to the immeasurable gift of more time. It's important to understand that UNOS is only one stakeholder in a very complex system and when it comes to our support of the OPN.
▶ 2:41:29We work at the direction of HERSA. As we have seen, the system is not perfect and improvements do need to be made. The case in Kentucky shows that more work must be done to strengthen safeguards, promote patient safety reporting, and adopt more reforms. However, it's important to understand that UNOS had no direct role in the care ever provided to patients. We do not direct day-to-day operations at local hospitals.
▶ 2:41:56We do not work with families to secure organ donation or with hospitals to make donor referrals. We have no influence on patient care protocols. And we do not make determinations of death or direct medical decisions. But let me be clear. UNOS is here to work with all of you to make this system better. UNOS alone cannot make all the necessary changes to improve the system. But we are ready to collaborate.
▶ 2:42:23That's why today I call on Congress to require CMS and HERSA to work together to establish a no wrong door comprehensive patient safety reporting system. Any patient, family member, or health professional who has witnessed or experienced poor care should have a clear path for reporting their concerns.
▶ 2:42:43Since more than 95% of hospitals are not members of the OPTN, CMS and HERSA must work together to close the reporting UNOS remains deeply committed to working with Congress, HERSA, CMS, and the community to ensure that the system is safe, fair, and effective. In addition to the no wrongdoor reporting system, I recommend three more reforms.
▶ 2:43:11Implementing automated deceased donor referrals, mandating a national tracking system for donor organs, and migrating the OPTN computer system to the cloud. I've outlined these and other reforms in my written testimony. I did not become CEO to maintain the status quo. The organ and transplant system is founded on trust.
▶ 2:43:34To continue to earn and keep that trust, we must work collaboratively to improve the system that serves as a beacon of hope for patients and families across America. Thank you.
▶ 2:43:47Thank you, Dr. McBride. Dr. for Micah, you are recognized for your five
▶ 2:43:52Chairman Joyce, Ranking Member Clark, I appreciate the opportunity to provide testimony on this very important topic. My name is Rich Formica. I'm a kidney doctor who practices transplant medicine. I'm a professor and the director of transplant medicine at Yale University School of Medicine. However, today I'm testifying on my own behalf, not on behalf of Yale University and the views expressed on my own and not those of the university. I've also volunteered for the OPTN since 2008.
▶ 2:44:19The OPTN is composed of more than 450 volunteers who represent the entire transplant ecosystem, including physicians, surgeons, representatives of OPOS's, and most importantly, organ recipients, living donors, and deceased donor families. We all volunteer because we believe in the mission of transplantation, caring for patients with end organ failure, and particularly honoring the selfless gifts of deceased donors and their families.
▶ 2:44:46For the past 40 years, members of the transplant community have volunteered their time and expertise to the OPT. For the year from July 1, 2023 to June 30, 2024, the OPTN consisted of 459 individual volunteers filling 599 positions.
▶ 2:45:07A conservative estimate of the hours these volunteers contributed to the OPT that year is Over the years, these efforts have resulted in the United States having the highest organ donation and transplant rates and excellent patient outcomes. Over the past decade, these volunteer hours have positively contributed to the improvement in the nation's transplant system.
▶ 2:45:31Major policy achievements include the kidney allocation system of 2014, the simultaneous liver kidney allocation policy of 2017, the transplant c center's performance monitoring policy, the removal of donor service areas from the allocation of all organs, and the removal of race from the calculation of eGFR. These efforts have significantly improved both equity and fairness in the transplant system while allowing us to serve an everinccreasing number of patients.
▶ 2:45:59I would now like to take a few moments to address the issues we're discussing today. First, I think it's important to clarify the role of the OPN's authority to address incidents like the one we are discussing. In addition to its policy, development and organ allocation responsibilities, the OPN is responsible for overseeing transplant programs regarding their compliance with policy, transplant outcomes, and the safety of candidates on the weight list and recipients of solid organs.
▶ 2:46:27In addition, in collaboration with CMS, the OPN oversees performance and adherence to policy of OPOS's as well as the safety aspects of transporting and transplanting deceased donor organs into transplant recipients.
▶ 2:46:42The OPN OPN does not have oversight of donor hospitals and this limitation creates challenges when attempting to merge the OPN's role in overseeing the donation process with CMS's role in oversight of hospitals caring for patients who are being considered as potential donors after circulatory You know, while I as a physician uh have some strong opinions about medical care that is rendered to patients, when I'm acting in my role as an OPT representative, I don't have that oversight
▶ 2:47:13authority until the time of their death. They remain the care of the donor hospital and the physicians who treat them prior to death. The only policies that fall under the oversight of the OPT are those policies that govern OPO's data collection and recordkeeping responsibilities, restrictions on how the OPO staff can interact with families who are be considered or families whose family members are being considered as donors after circulatory death, timeout procedures, and explicitly stating that anyone
▶ 2:47:43participating in the organ recovery or transplant process may not be present during the time that withdrawal of care is initiated and death is declared. Therefore, when we were responding to the secretarial directive to review the charts of patients considered as potential DCD donors who did not pass away and therefore did not progress to donation at KDA KDYA, the OPN reviewed these cases based upon KDYA's adherence to OPN policy 2.15 and
▶ 2:48:13based upon the directions of HERSA, we did not review the index case. I think it's important to note that this was a unique review for the OPTN and we didn't have a precedent for it. It required setting up a new committee of volunteer reviewers to assess these documents, conducting the review of 35,000 pages of documents under a very compressed timeline and we had some restrictions on the experts who we could ask to participate in the review.
▶ 2:48:38However, I'm quite proud of the work that the committee did because despite the limitations, the recommendations that the board of directors made to the secretary are in essence the same concerns that were expressed by HERSA. I'd be happy to detail those in more detail later. Finally, for many years, the OPN has been focused on improving policy surrounding DCD donation. And a mere search of the OPT website can show you all the initiatives we've taken.
▶ 2:49:04And I personally feel as technology is advanced uh this is a topic that we have to address even more acutely. So thank you for the opportunity to testify and I look forward to answering any and all of your questions. Thank you.
▶ 2:49:17Thank you Dr. Formica. Dr. McGee, you are now uh available to uh present for five minutes.
▶ 2:49:23Thank you uh Chairman Guthrie, Chairman Joyce, Ranking Member Clark, and members of the committee. I also want to thank you for letting Dr. for Mike to exceed his time limit and give input. Thank you. I appreciate that. I know the regulations. Um members, thank you for the opportunity to speak today on behalf of the organ procurement transplantation network board. A little over three month three weeks ago, I was elected to serve as the volunteer president of the OPTN board of directors.
▶ 2:49:51While I may be new to the OPTN board, I've been a transplant surgeon for over 25 years. I entered this field because it embodies the endless potential of humanity and the best of health care in the United States. The guiding principles for our organs, our nation's donation and transplant system are respect for the life and dignity of the potential organ donors and transplant candidates.
▶ 2:50:16Respect for the autonomy of our donor heroes and their families to make decisions is first and foremost. Over my career, I've had the privilege of witnessing these principles in action. As a surgeon who has participated in many deceased donor procedures, I am always impacted by both the tragedy of sudden loss and the amazing altruism of donors and their loved ones. I'm also impressed by the teams present. The operating room team room can be intense and crowded.
▶ 2:50:46In my lived experience, staff from the donor hospital, OPO, and transplant team strive to work collaboratively with a deep reverence for our shared mission. Honor the donor's wishes to help save lives. As a surgeon who sees children and adults who can benefit from transplantation, I also understand the intense feelings of fear, hope, and uncertainty for the future.
▶ 2:51:12I welcome the members of this committee to observe these processes firsthand and I will be happy to facilitate this opportunity. I would also be happy to facilitate any interactions with the donor families and transplant recipients. I do want to take a moment to recognize any individuals or families who have experienced interactions with the donation process where there was any lack of respect for the dignity of donors and families. Trust is the foundation of our organ donation system.
▶ 2:51:43Each of each member of the donation and transplant community is a steward of our foundational principles. We both must acknowledge areas of improvement and necessary change. This is our path to ensuring that our system maintains trust while continuing growth and innovation. for our donors, our patients, and all those who may need us in the future. It is our obligation to commit to embracing complete transparency, accountability, and oversight.
▶ 2:52:10Over the last 40 years, donation and transplant professionals have evolved and innovated to serve our donors and our patients. Our systems and policies need to keep pace. I know we can do this. It is in this context that I decided to step forward for consideration to serve as the president of the OBTN board.
▶ 2:52:29The newly elected OPN board fully supports modernization efforts and commends Congress for its leadership in improving the system through the passage of the Securing the US OPT act as well as other legislation to help donors and families. working through the private public partnership that was established by NOTA in 1984 at a time I was in my first month of medical school and working with HERSA.
▶ 2:52:56The OP10 modernization effort has already completed considerable work to guide ongoing reform. As we move forward to improve our system, our donors and our patients need us to do so responsively. Responsibly. Disruption and recklessness can lead to unintended consequences. But above all, we must maintain trust in the system. Our goal is to constantly improve the system without losing the principles upon which it was built. We will do this by embracing transparency, accountability, and oversight.
▶ 2:53:26On behalf of the newly elected OPTN board, I look forward to working with you as partners in finding solutions necessary to honor the wishes and of of donors and saving more lives. Thank you. I want to thank all the witnesses for your testimony. We will now move to questioning. I will begin and recognize myself for five minutes. Mr.
▶ 2:53:49NASA, when looking at how your OPO handled the index case from the HERSA report, very simply, yes or no, do you still maintain the ascertation from your testimony that all of the relevant OPTN policy, regulations, statute, and rule were followed by KOD in the handling of the DCD case?
▶ 2:54:14My apologies. Thank you, Chairman Joyce, for your question. that case uh was very complex and during a very complex time. If you recall in 2021, we were in the midst of CO and I think that um impacted the communication that we had within our uh between our hospital and our team. And while I'm not using that as an excuse, I do think it added to the complexity of it.
▶ 2:54:41With that said, we we know that a successful donation experience happens when there is frequent communication and I think in that case and in this case that we're talking about the communication could have been vastly improved and if that communication wasn't where it should have been can you say yes or no was policy regulation statute and rule was that followed?
▶ 2:55:11the DCD process was followed. Yes, sir. But again, I think
▶ 2:55:16in light of the horrific pain and suffering that the index patient do you agree then if it was followed and what we have read about this case? Do you think that stricter standards need to be in place so that patient safety so that we never hear again about a patient suffering this horrific pain? We never want another experience like this as well and we are going to
▶ 2:55:42yes or no. Do you think that stricter standards should be in place?
▶ 2:55:46We are going to follow the recommendations of HERSA and we are glad they have more oversight to make sure that we restore the public trust.
▶ 2:55:56Mr. Massa, moving on. And we've heard this um from Dr. Lynch's testimony today. Did you or anyone in your organization play a role in retaliation against the incident reporter in the index case or according to the HERSA report was fired from another job in the organ transplant space following outreach from KOD just two days after this committee's hearing last year when the index case was first discussed?
▶ 2:56:26No sir, if if you look at the facts, I welcome every member of the subcommittee to look at the actual facts of that case or of that situation. Um there was no retaliation. If there was retaliation, that would not be tolerated within network for hope. As the individual who is now in charge of the OPO, have you looked into any possible retaliation against this retroactively looked at any retaliation against this or any other whistleblowers?
▶ 2:56:57I have. And what have you found?
▶ 2:57:00I found that in this case specifically that we're talking about, there was no retaliation. And I go back to the letters that we sent to this committee on December 17th and January 3rd in response to that.
▶ 2:57:15Will you commit to us that if there is any incident that it would occur in the future and it would be brought to the attention that there will be no real retaliation that you will work to make sure that those who bring these cases forward where someone is undergoing addition and moving forward in the transplant process and is not felt to be an appropriate candidate that there will be no efforts of retaliation against that individual.
▶ 2:57:42That is correct and I could tell you that we have a policy in place that not not only uh the expectation is to bring that forward but it says in the policy it is an obligation for anyone.
▶ 2:57:55Thank you for that commitment and thank you for that obligation. Dr. for Micah. It has been alleged that the OPN has a history of dismissing and downplaying serious allegations of risk to patient safety, like in oversight of the index case where you dismissed nearly proceedings with organ harvesting on a patient who ultimately was discharged from the hospital alive. And I'm quoting, you said, a nice story for the patient. Yes or no?
▶ 2:58:23Did the OPTN under your leadership adequately investigate and respond to all reported concerns?
▶ 2:58:31Chairman, I think this case highlights some of the challenges we face in the OPTN. I learned of this case after the MPSC had decided not to pursue that when HA instructed us to begin the larger In retrospect, had I heard about that sooner because I'm aware of the larger context of what's going on right now, I would have asked for a deeper
▶ 2:58:56So why did HERSA need to direct the OPTN to reopen their investigation of Kota and eventually issue a corrective action plan dictating how further action must be handled?
▶ 2:59:08I think that demonstrates the collaborative nature between the OPTN and HERSA, frankly. And I think that's why it works well.
▶ 2:59:13But if the safeguards were in place, would that have needed to occur? The OPTN is composed of volunteers who are also conducting their normal day jobs and we're facilitated by contractors that help provide the infrastructure around which we provide our work. As we've moved through the transition period, some of that fluid communication back and forth has taken some time to work out new pathways.
▶ 2:59:38But you have all talked about trust and now that trust has been violated. I think it's been fractured. Do you feel that that lack of communication that existed continues to exist today?
▶ 2:59:50I actually think it's getting better every day when you've moved from an environment where you have one contractor facilitating all the activities of the OPTN to multiple contractors now facilitating that. It takes some time to work out the pathway.
▶ 3:00:05I think it is clear to all of us on this committee, both sides of the aisle, that that communication needs to improve, that collaboration needs to improve, and that there needs to be the safety of the patients that ultimately guides whether or not they are viable candidates for those transplants that are so necessary for the health of so many Americans. I thank the panel for being here today. I now yield uh five minutes to the ranking member uh for her line of questioning.
▶ 3:00:36Thank you very much, Mr. Chairman. Uh this committee's bipartisan investigation has highlighted concerning reports highlighted that concerning reports have emerged that the organ donation system has become unsafe, inequitable, self-deing, and In addition to serving as the ranking member of the Oversight and Investigation Subcommittee for Energy and Commerce, I'm also the chair of the Congressional Black Caucus.
▶ 3:01:05I'm committed to ensuring that black Americans have equal access to life and death organ donation and transplant services. However, by all accounts, the US organ donation system is dangerously inequitable for black patients. UNOS is facing multiple lawsuits related to practices that discriminated against black patients, moving them further down the waiting list.
▶ 3:01:32And earlier this year, the New York Times ran a front page story titled, "Organ transplant system in chaos as waiting lists are ignored," which is detailed how organ contractors are systemically ignoring the organ transplant waiting list in order to preference hospitals serving wider and wealthier patient populations. The reporting was clear.
▶ 3:02:00Disregarding the list has worsened disparities. I want to be clear. Disregarding the list, a process that has become rampant under the OPN and UNOS, is a violation of basic trust and is killing vulnerable This committee is investigating systemic inequity in the organ donation system that has happened under UNOS's watch.
▶ 3:02:30So, Dr. McBride, I'm looking for a yes or no answer. Is UNOS currently being sued for racist practices which disadvantaged black patients on the kidney waiting list based on junk science, which assumes that they have more muscle mass? Thank you, Congresswoman.
▶ 3:02:52It is true that there are current lawsuits against UNOS in its role as the OPTN contractor for decisions that the OPN board made regarding organ allocation policy. Did at a past US, excuse me, at a past UNOS board meeting, uh, write, uh, excuse me, did a past UNUNIS board member write that black and rural Americans are less deserving of life-saving organ transplants
▶ 3:03:22because they are quote dumb for where they live.
▶ 3:03:29I am unable to comment on that, Congress. That's been what's been reported. And Dr. McBride, uh, the New York Times has written on chaos in the waiting list due to rampant skipping of the list, a practice which has exploded while UNOS has been the operations contractor for the OPT. Does the OPN's data indicate that this practice of weight list skipping in general harmed black patients?
▶ 3:04:00Thank you, Congresswoman. I would like to first clarify that UNOS's role is to support the OPTN and its policymaking and oversight decision-making process. UNOS does not make policies for the transplant community. We support the committees that are made up of volunteers from the community to uh implement those policy decisions. I 100% agree with you that skipping the list is not an acceptable practice and the OPN has been working very hard to address those problems.
▶ 3:04:29they have a number of um efforts that are underway to address that situation. Um unfortunately many of them have been paused but we are hope I would encourage um HERSA and the OPTN to resume that work so that this um issue can be addressed in a wholesome manner.
▶ 3:04:47Th this is um disturbing extremely disturbing you know we are talking life and death and I'm and I'm assuming that as a civil society we are seeing donors across the board from every community and we expect that recipients would be similarly reflected and so I think there's a lot of work to do here within this ecosystem system that
▶ 3:05:18has been created. And Mr. Chairman, my hope is that when you report back to us, all of this has been dealt with effectively, efficiently, so that again, the integrity of this meets the standards that all Americans from the work that you do on our behalf. With that, Mr. The chairman, I yield
▶ 3:05:48The gentle lady yields. The chair recognizes the chairman of the committee, Mr. Guthrie, for his five minutes of questioning.
▶ 3:05:54I thank you. Thank you all for being here. As I said earlier, this is very important to me and we we got to get this right. We absolutely have to get it right. So, Mr. Mass, obviously the Kentucky case is important to me as well. Um should be important to all of us.
▶ 3:06:07You know the response that KYDA I know that you came after that but the SP response in the report uh quote is the potential donor was treated on the Kentucky index case was treated following standard protocols for DCD the proper guardrails were in place and worked to the expectations policies and procedure for all regulatory agencies KYDA satisfied and confident in the donation process. Do you think that was an adequate response to the issue of that case? That seemed to be the the gist of the response back.
▶ 3:06:37Thank you, Congressman Guthrie for your As I mentioned before, we know that with any successful donation, it occurs with frequent And I think in this case especially given that it was very unique both the circumstances and the time that even further communication needed to be done on this case and I don't think that occurred on that case but when the process when the OPTN
▶ 3:07:07asked for KYDA to give them a response that's the that's that's the response
▶ 3:07:13of when they did an assessment of what happened that's their actual response. It's not this happened during the case or didn't. The response was everything essentially was fine.
▶ 3:07:22Well, again, I think on this particular case, um the process was followed. The process was followed, but there was a lot of unique things that could have been done better.
▶ 3:07:34Okay. So, thanks. And so, also it said
▶ 3:07:38the records provided to hers potentially. Okay. So, how does network of hope plan to address the issues identified in the report? Particularly the report says records provided to HERSA show potentially serious and ongoing risk to patients families as well as failures by KY and the OPT to adequately recognize and respond to poor patient care and quality practices.
▶ 3:08:00So that was in the report to you. I know that some have said that's the hospital situation but as it applies to OPT or or your network, how does how do you respond plan to respond to that? I guess
▶ 3:08:12as far as the uh things that we've put in place,
▶ 3:08:15it says uh failed to recognize uh poor patient care and quality practices. So, how are you responding to that? Are you changing your procedures for that or from the
▶ 3:08:24we have changed
▶ 3:08:25I know you just got it a week ago, but what I know you've had to digested it, but what is your first take on it? I know you haven't had a chance to
▶ 3:08:32We took these everything that was reported in that report very seriously and we have we are doing our own internal investigation into these cases. As you mentioned, we just got this report a few days ago, thanks to this committee. Um, but one thing in the report that's making it difficult is that the donor numbers being used in the report do not match the donor numbers that we provided.
▶ 3:08:57So, we're trying to do a crosswalk and we've asked for a crosswalk of that those donor numbers so we could get into the specifics that we have not yet received.
▶ 3:09:06Okay. But given that,
▶ 3:09:08we'll work with Dr. Lynch to make sure you get that. But given I mean the uh confidence in the system what what what is your assessment of what's going on today the confidence in the system that we can have
▶ 3:09:22well I think the changes that we have put in place with network for hope bring about more trust into the system we have devised a checklist for every nurse that is on a uh DCD case and we provide that to them in real time we did the Same thing with every attending physician, a checklist so that they know what their role is on the DCD donor as well as what the role of the hospital is as well as the role of the OPO.
▶ 3:09:53We also developed a 10-minute video that they that they can access through a QR code that literally goes from the very beginning of a DC DCD donor to the very end and everything that's expected in between.
▶ 3:10:08We've implemented hard stops so that during any part of the process we have huddles with everyone involved in the care and the treatment of that DCD donor so that if any concerns are raised they can raise those concerns at that time or at other times in the process. So I think we we've put together quite a bit of changes since that case and I think going forward we would never hear a case like that again.
▶ 3:10:37And and so there there just seemed to be some tone of in the report of several cases. I think about 30% of the case they looked at that had some issues. So not just the Kentucky index case but overall how are you plan to address it? Like I said, I want everybody to sign up to be an organ donor
▶ 3:10:53and and we want the same thing. And as I mentioned, we are putting in multiple changes in our processes so that these kind of things do not reoccur and we're still doing our investigation into those cases. But as I mentioned, we take this seriously and we're going to work with HERSA to implement the changes that they
▶ 3:11:11Thank you. Uh my time's expired. I'll yield back.
▶ 3:11:14The gentleman yields. The chair recognizes uh Miss Deette for her five minutes of questioning. Thank you very much, Mr. Chairman. Well, I I just want to reiterate all of us feel strongly that we u should support organ donation and that we should support a strong system. But I want to say it's sitting here today, it's been chilling to me to hear how you describe what has been happening in these very generic pabum terms.
▶ 3:11:41Uh saying things like it is time to accelerate improvements in our systems and policies, etc., etc. etc. After we have shifted more towards circulatory death for donation standards, we have seen an increase in these terrible stories of patients that have been repeated in the New York Times and other places of what people are going through and and this times or well well the the the incident that's forms
▶ 3:12:12the basis of this the the person was putting his knees to his chest. He was moaning. People are moaning. And and Kucky's the only one that the Times is investigating here. But Hersa in investigated se 350 cases in Kentucky. 73 instances should have stopped sooner. And 103 had concerning features.
▶ 3:12:37And that to me shows that Hersa was not convinced that those people were actually at a position where their organs should have been harvested. So, so I guess I'll say anything we can do to improve and to make sure this never happens again just not just in Kentucky but anywhere in this country, you've got our bipartisan agreement to do that because we keep thinking we fix this. So, I I have some questions about this.
▶ 3:13:05Last September, UNO sent the Kentucky OPO KOD and now Network for Hope a request for information on what happened. In response, all they got was a single page letter in which Kota provided zero requested information, disavowed any responsibility, and said, quote, "The proper guidelines were in place and worked." Unquote. After the letter was received, OPTN then deemed COD's response sufficient and closed their investigation.
▶ 3:13:36HERSA ordered them to reopen the investigation October 1st. So, Dr. For Mark, I I want to ask you, you were the president of OPTM when it sent the first request to Kota in September. Knowing what you know now, do you believe the initial response was sufficient? Yes or no?
▶ 3:13:54Okay. After Kota's incomplete response, did the OPT press Kota for the requested information before HERSA got involved?
▶ 3:14:03We did not. And how did you determine that the allegations against Kota were unfounded when they gave you so little information to work with?
▶ 3:14:12Congresswoman, I was not involved in that decision directly.
▶ 3:14:15So, you don't know?
▶ 3:14:16I I only know what I've heard through secondhand and I don't want to dis I don't feel I should discuss secondhand
▶ 3:14:23Is the person you heard it from still
▶ 3:14:28But I share your question.
▶ 3:14:29Well, I'm going to be following up with some questions about that. Now, once once Kota, as I said, once KOD finally provided the OPN with the initially requested information, the OPN's ensuing four-month investigation identified no no major concerns. But when Hersa did the unparallel in investigation, it found deeply damning information about this case.
▶ 3:14:55Hospital staff made clear they were uncomfortable with the amount of reflexes TJ Hoover was expressing and that quote this was euthanasia unquote. So Dr. Formica knowing now what you know do you stand by the OPTN's initial decision to close the case?
▶ 3:15:14I do not.
▶ 3:15:16Okay. Um, and knowing what we know now, do you stand by the OPTN's full report finding quote no major patient safety concerns unquote?
▶ 3:15:26Congressman, I do stand by that report because we conducted the report that we were requested to do based on OPM policy Now, I agree that HERSA's report and HERSA looked into this more detailed, which is they should do that. But from OPTN policy perspectives, we conducted the investigation.
▶ 3:15:49So, do you believe OPTN should have more robust policy perspectives so that it's not making these conclusions on an on a on a um obvious obvious serious error. As the past president of the OPTN, my opinion is this is a topic that needs much more thoughtful discussion about making policy. Doc
▶ 3:16:15Dr. McGee, you nodded your head when I said that. What
▶ 3:16:19I I believe in a system which you have used that word. It's a system. It's it's exists in the health care system. There's organ and transplantation system. There's OPTN and we're a sliver of that. So So we need a system. We need a robust process.
▶ 3:16:35Much more robust than we've got now.
▶ 3:16:37Yeah. And and the system may be robust enough, but the responsibilities aren't delineated enough. And I think that we need to work on that collaboration because this is not okay.
▶ 3:16:48Okay. Yeah. We can't keep making this mistake. People are dying and I yield
▶ 3:16:51The general lady yields. The chair recognizes the vice chairman of the committee, Mr. Balderson, for five minutes of questioning.
▶ 3:16:58Thank you, Mr. Chairman. Um Mr. Messa, let me start off with you. Your testimony notes that Kota and Network for Hope strongly deny these accusations. What accusations specifically does Network for Hope deny?
▶ 3:17:14I'm not sure which report is that? I'm
▶ 3:17:17So, the the accusations that have been out there, the Network for Hope uh has specifically said they deny these accusations. Um what I mean, are you referring to the same accusations? you've denied the accus accusations. What accusations are you denying?
▶ 3:17:34No, sir. I think that relates to the initial accusations with the uh index case that we talked about before and that that patient was initially said to be brain dead which that patient was never pronounced brain death and also it said that um there was organs recovered from that index case and that was not the case as well.
▶ 3:17:55Okay. Thank you. Um followup. You you mentioned to chairman Guthrie in viewing the report you were having difficulty matching cases with your records. Is it accurate to say Network for Hope has all the underlying documents that were provided to HERSA by you by your OPO for HERSA's review? We do.
▶ 3:18:16We do and we have we are doing our own extensive review but it would be helpful if we had their numbering system so we don't have to go back and guess which one it is and go through all 350 charts that we provided. Thank you. Um I'll move on to Dr. McBride. Um thank you. Your written testimony notes that the system is not without flaws. What flaws are you referring to?
▶ 3:18:45Well, I think every conversation we've had this morning indicates where there are opportunities for improvement. And as I suggested in my testimony, I think that one of the most concerning aspects of that indic index case was that it was not brought to this committee until 2024 when in fact it happened in 2021.
▶ 3:19:04And so if we create a more robust reporting system for patients to be able to take these instances when they feel like they have not been treated at well to a central um reporting system that can send the information to the appropriate oversight body. It can be acted on more quickly. It shouldn't take three years um before a family can take that to something.
▶ 3:19:28You know, when a family is going through this kind of devastating loss, they are not aware necessarily of EUNOS and the OPTN and HERSA and CMS. So that's why we need a system that is easy to understand for patients and for healthcare workers alike. You know, there were people in that hospital who had concerns. They didn't know where to take their concerns. So, let's fix that so these issues can be addressed more
▶ 3:19:53And you feel like we're in a better place with what we're going through moving forward. I think that would create a better place for sure.
▶ 3:20:03Did you you reported this to the OPL?
▶ 3:20:05do you I'm sorry. You report to the OPL.
▶ 3:20:09Uh we at UNOS learned of the case during the hearing at September and we reported the case to the MPSC and to HERSA the next day as as we were required to do.
▶ 3:20:19Okay. I I I apologize. um the past they stated that they reported to the OPO at OPO at the time uh the occurrences happened.
▶ 3:20:29Yeah. And I'm not familiar with what they might have reported to the OPO.
▶ 3:20:32Okay. I appreciate that. Thank you. Um Mr. Mass, I want to move back to you as my last question. I am coming back to you uh as network for hope engaged in any training and education for its staff to ensure the types of concerning family interactions detailed in HERSA report do not happen again.
▶ 3:20:51Yes sir, we are doing that as we speak. Our training has been ongoing and uh we have as I mentioned before implemented several changes especially as it relates to DCD donation and providing um not only to our staff but to the hospitals as well to make sure that everybody understands their role in this process because again as I mentioned communication is the key to making a success successful DCD
▶ 3:21:22donor and we have to get this Right.
▶ 3:21:25Would the gentleman yield his remaining time to me?
▶ 3:21:27Mr. Chairman, I yield.
▶ 3:21:29Mr. Massa, an additional question. You talked about the index case being unique. I think you've used that term two or three times. I'm perplexed by that because I view each donor case as being unique. And where's our where's our disconnect here? Donors go through and their families. And I don't think that anyone wants to think it's a cookie cutter donor case.
▶ 3:21:53So, what's so unique about the donor case in uh in the report that you've used that term two or three times here?
▶ 3:22:02Thank you, Chairman Joyce. When I'm using the word unique, I just think it's an unusual circumstance. Typically, we do not
▶ 3:22:11I want to use the word horrifying, but is that what you're equating unique with? This was a horrifying experience. It's not unique. Each case that comes forward, family members making this decision, it's a unique situation.
▶ 3:22:24The index case is a horrifying case. Do you agree?
▶ 3:22:28It was definitely um a case that we do not see every day. That is for sure.
▶ 3:22:33Well, I'm it's I hope you don't see this every day. Do you agree that this is a horrifying case? seeing somebody like that. Uh myself personally, yes, I think I would be
▶ 3:22:48I'll I'll yield back. The gentleman yields back and we recognize uh uh Dr. Harshburgger for her five minutes of questioning.
▶ 3:22:59Thank you, Mr. Chairman, and thank you to the witnesses here today. Uh Dr. McBride, your written testimony notes that the OPN makes policy decisions through its board of directors and
▶ 3:23:12and that UNOS is not the OPN. Later in your written testimony, however, you note that uh UNOS's board had to serve also serve as the OPN's board and that was uh the case until March 30th, 2024. Is that correct?
▶ 3:23:29Yes, that's correct.
▶ 3:23:29Okay. And while Hersa established an independent OPTN board in July of 24 and awarded the contract to support them to the American Institutes for Research in August of 24. Is it fair to say that UNOS is still helping to support the board and still supports the OPT in other ways?
▶ 3:23:47Yes, that is true. Uh Hersa has not yet modified our existing contract to remove the board support
▶ 3:23:54work for us.
▶ 3:23:55Okay. Thank you, ma'am. Dr. for Micah. Uh, how does the OPTN justify closing this case only two business days after receiving network for Hope's response despite not receiving the patient level materials or administrative documents
▶ 3:24:12Uh, Congresswoman, as I stated before, I don't think the case should have been closed after two days.
▶ 3:24:17Not going to defend that happening.
▶ 3:24:20Very good. Thank you, sir. I'll continue on with you. Uh in the corrective action plan dated May 28th, 2025, HERSA directed OPN to develop and implement a 12-month OPT MPSC monitoring plan for Kaida within 30 days? If so, what are the details of this plan? And have they had any impact uh so far? And if not,
▶ 3:24:44Congresswoman, that happened during the transition from myself to Dr. McGee. So, I started the process by setting up the committees to begin working on that, but I wouldn't comment on what's happened since since I'm no longer the president.
▶ 3:24:57Okay. Uh, Dr. McGee,
▶ 3:25:00what actions has network Well, go ahead and answer that question, then I'll go to my next one.
▶ 3:25:05Thank you. Um, the that work is ongoing. We're picking up where they left off. Some of this um, you know, this happened three years ago. discussion or events that happened in the past getting people focused on it can change things a lot independent of a change in a regulation. So we want to make sure the regulations, policies, anything match the right thing, but a lot of stuff I think has happened. I I think people feel more comfortable speaking out.
▶ 3:25:32I'm not sure changing the website to mp changing the website of the reporting for the bedside nurse whether it's hersa.gov or opt I'm not quite sure that has achieved its effect. It it it so we need to think about how to make sure they can do that. Well, sorry.
▶ 3:25:49Well, let me ask you the next question. What actions has Network for Hope taken to address the issues identified in Hz's report, whether that be actions directly uh related to the corrective action plan or actions that are separate and apart from the corrective action plan? Dr. McGee,
▶ 3:26:08did you hear that?
▶ 3:26:09I I was I thought you were talking
▶ 3:26:11You thought I was talking to Dr. for
▶ 3:26:13No, I thought you were talking to Doc, Mr. Massa. The the the corrective action plan for O the the Kentucky OPO that's due um that's been implemented. There's another report that's due on the 28th of this month.
▶ 3:26:27Okay. And this is um all the witnesses. Okay. Uh Hers's report notes that in a 2023 case, OPO staff uh proceeded with obtaining authorization from two family members despite witnessing the next token take psychoactive medication immediately prior to the consent discussion.
▶ 3:26:48OPO staff documented impairment on uh the part of both family members during the consent discussion as well as concerns from multiple hospital staff that the family were clearly inebriated and or high off of something. Are there adequate policies now and procedures in place to prevent these type of interactions from happening?
▶ 3:27:08Congresswoman Congresswoman, I could take that.
▶ 3:27:11And thank you for your question. Absolutely. And that is um we take that very very seriously. We have made changes in our training as well as in our policies to make sure that never happens again and if it does there will be some changes and disciplinary uh procedures taken.
▶ 3:27:31Yeah. Anybody else have any comments?
▶ 3:27:33Yes sir.
▶ 3:27:34Um the principles of informed consent are very straightforward and fear and and and and clear. uh one principle would be you cannot get incent consent from somebody that's under the influence. It is in that case though that shows a nuance that if I um gave what's called first person authorization or like my last will and testament that state that stands despite what somebody else would do. So in that case I would ask what how what was that? But you cannot get consent.
▶ 3:28:03You can't grant first person authorization or get consent if you're under the influence.
▶ 3:28:08Makes sense to me. Um, I guess this is to Dr. Formica. I have 30 seconds left. As doctors with experience in uh transplant medicine, this could go to Dr. McGee, too. Uh, what's your reaction to the idea of a patient being on sedatives and in some cases multiple sedatives while they're being assessed?
▶ 3:28:30I'm going to speak from the perspective of a doctor that doesn't care for those patients. So there may be nuances, but
▶ 3:28:37to me that sounds uh kind of frightening. I'll be honest with you. Um I think though to get you also made an important comment though about consent and you're 100% correct and that shows you some of the challenges of policy. OTTN policy says you must obtain consent. I I will be honest with you. I would presume that people would then behave like they were trained and obtain proper consent.
▶ 3:29:03And I would never think, at least on a first pass, that I would have to write a policy explicitly saying, "Oh, and by the way, they shouldn't be on site." I mean, that's hard for me to process based on my
▶ 3:29:14so I think I share your concern over
▶ 3:29:17If you don't put you cannot steal, then they're going to challenge you. It's crazy. Yes, sir.
▶ 3:29:24Um, that's a great question. And again, it's nuanced because patients that are suffering who the family and doctors are going to withdraw support of the
▶ 3:29:34goal one hurt nobody don't um prolong suffering. So we it's reasonable and appropriate to give pain medicines to people that are in pain. There's a a concept of double effect which is you can do things that are for the good even if they have some unintended consequences. And even sitting here today it's easy to think par That would be bad. But people that have had really bad lung injuries and have had a massive brain injury might be paralyzed.
▶ 3:30:03So their breathing works the m the breathing machine works better for them. Yeah. So that'd be again we just need to develop the rules. Yeah. And it depends on the diagnosis. Thank you so much.
▶ 3:30:13Well, thank you, Mr. Chairman. I yield
▶ 3:30:14The gentle lady yields. The chair recognizes a gentleman from New York, Mr. Tonka, for five minutes of
▶ 3:30:20Thank you, Mr. Chair. Uh Dr. Dr. Mica, in your testimony, you state that the nature of the OPTN review of Kota had no precedent. How did the OPTN or MPSC approach patient safety reviews in the past and what was different about this
▶ 3:30:38So that's a very important question. So in the context of the MPSC, there will be either an outcome results that are bad. So a program will be performing poorly. There could we've had many cases. I've been involved in two where there's been direct complaints about culture. Uh we've actually closed a program around that concept. Um but it's more focused on a specific event and a specific you know program or something that's a little more tangible.
▶ 3:31:06This review was um taken out of the MPSC. So we had to stand up a committee that didn't exist already. So we had to solicit volunteers to do that. try to populate them with the expertise. And then frankly the the volume was huge. It was 360 cases. It was 95 sets of protocols, documents, etc. It was over 35,000 pages of of material.
▶ 3:31:33And although the process began in September, I was only able to release that information to my volunteers on February the 6th to meet a February 28th deadline for a written report.
▶ 3:31:44Thank you. An enhanced approach to oversight of the OPN is a positive development and HERSA's review reached several troubling conclusions that I believe need to be addressed. HRSA's investigation observed a variation in level of care depending on the hospital in which they were being treated within Kota's service area, implying that Kota's management changes depending on on the surroundings.
▶ 3:32:11It should go without saying that OPOS's need to act responsibly with the patient's best interest in mind, no matter where that patient is being treated. So, Mr. Masa, can you tell me whether your opioid employees are supposed to apply different practices to potential donation after circulatory death processes depending on the hospital?
▶ 3:32:33No, sir. We have developed a checklist for every nurse that's involved on a DCD process as well as the attending physician that clearly states what the role of the OPO is at that time as well as that of the hospital. So they can know what to expect, what their role is during that DCD donor because as you mentioned u with an urban hospital maybe they have more experience with DCD donation but in a rural hospital they may not.
▶ 3:33:03So in real time on that case as we approach that case or we come on site for that case we are providing them with these documents that they could then see in real time so that they know what to expect and what duties that they have. And we also developed a 10-minute video that they can access through the QR code that again walks them through the process from beginning to end and in that 10 minutes goes over that DCD process. So we have developed that just for this case.
▶ 3:33:34Well, let me read from Hersa's report which presents data from your records that shows that Cotto's authorized not recovered cases where donation processes were started but organs were not procured are more prevalent at small and rural hospitals. HRS say uh indicates and I quote these trends suggest that patients may experience variable care from Kota depending on the hospital in which they are seen end quote. So Dr.
▶ 3:34:03Formica did the OPTN board run a similar analysis about cases like this comparing different hospital settings.
▶ 3:34:12No he did not.
▶ 3:34:14So Mr. Masa, your website states your OPO serves 7 million people and includes 188 hospitals. Is that correct?
▶ 3:34:23Yes, sir.
▶ 3:34:24The HRSA reports includes some complaints from hospital staff about their interactions with your OPO. So, Mr. Masa, how does network for hope address any complaints it receives from hospital staff?
▶ 3:34:38So, we take any complaint from a hospital very seriously. I myself get involved as well. We also have the ability for anybody in the hospital to provide a complaint or a concern through a QR code that would remain anonymous. Um because we want to make sure that we are getting that information because together and working together we can have process improvement.
▶ 3:35:05So we encourage people to do that and uh we welcome that.
▶ 3:35:09I had one other question. I'm running out of time from for Dr. McGee, which we'll get to the committee, but I hope the new OPTN board will give special attention to these situations. Rural communities of some of the nation's most vulnerable patients who often already face obstacles to health care. If opios are acting in a way that can put those patients at greater risk of mistreatment, that is simply unacceptable and certainly deserves far more scrutiny. And with that, Mr. Chair, I yield back.
▶ 3:35:38The gentleman yields. The chair recognizes a gentleman from Alabama, Mr. Palmer, for his five minutes of
▶ 3:35:44Thank you, Mr. Chairman. Thank the witnesses for being here. Mr. Mass, why were all the materials requested by the Network of Hope for the OTN uh membership and professional standards committee in the letter of September 12, 2024 not originally provided?
▶ 3:35:59Um, thank you for that question, sir. Um, initially that request was
▶ 3:36:05Why were they not provided? We're not We're not going to filibuster the time. Why were they not provided?
▶ 3:36:11That request was in regards to Mr. Hoover being a brain dead donor as well as organs being recovered. So, we provided the information that that was those were inaccurate. In addition, they asked for a summary which we provided.
▶ 3:36:26Um, Mr. Fora, your written testimony, you said that few recommendations that OPTN made are in essence the same as the concerns expressed by HERSA in their report. In your honest assessment, do you really believe that OPT10 and Hersa's findings were the same?
▶ 3:36:42I do. And that the concept of developing better protocols to identify who is a suitable donor.
▶ 3:36:49How do you justify closing case only two business days after receiving uh network for hopes response not receiving patient level materials or administrative documents requested?
▶ 3:37:00Oh, I'm congressman. I'm not congressman. I'm not justifying that. That was through the MPSC. that should not have happened. I was referring to the larger investigation that we did
▶ 3:37:10But in your written testimony, you also note that the UNO staff as the HERSA contractor supporting the OPT assisted OPTN's MPSC volunteers in their review. How did UNUNIS assist the NPSC in its
▶ 3:37:26Uh I'm not familiar with that in my written testimony.
▶ 3:37:29The reason I'm asking these questions is uh in Mr. Lynch's testimony, he points out that the Association of Organ Procurement Organizations publicized an open letter characterizing the ongoing effort to improve patient safety through enhanced oversight as misinformation a misinformation conspiracy campaign and concluded it is time to stop. Among the signatories to this letter were more than 20 UNO staff signing with their corporate affiliation. Uh M.
▶ 3:37:59Mc Dr. McBride, did you sign that Yes, I did.
▶ 3:38:05Um, Congressman, let me start off by saying that I disagree with the way that letter has been characterized.
▶ 3:38:11Well, it's been characterized by Hersa this way and it creates some serious concerns on our behalf. did you sign that letter?
▶ 3:38:22I did not.
▶ 3:38:23You did not. And you're president of of the UNOS board?
▶ 3:38:27No, I was
▶ 3:38:29No, you're president of OPTN. You didn't sign it. How about you, Dr.
▶ 3:38:34I did not see it. Sign it or see it.
▶ 3:38:36Okay. Dr. McBride, continuing in your why did you and 20 other uh UNO staff signed that letter? It it appears to me to be obstruction of of an inquiry.
▶ 3:38:52Congressman, I respectfully disagree with that assessment. I'm happy to provide the letter to this committee. Uh what I believe it asked for was an open dialogue between members of Congress, experts within the OPTN and HERSA to get to the bottom.
▶ 3:39:08The letter called it a misinformation conspiracy campaign.
▶ 3:39:11The letter referred to allegations that were hearsay.
▶ 3:39:14And you called it you said you called for it for it to stop. I called for hearsay to stop and I I called for the letter called for an open dialogue
▶ 3:39:23So you're saying that that the allegations that have been made in regard to um attempt to procure organs from from living donors is hearsay.
▶ 3:39:34The letter referred to the testimony at the hearing last September. I'm asking you, are you saying that the attempt to procure organs from a living donor is hearsay that that didn't
▶ 3:39:53No, I'm not saying that it didn't happen. I'm saying that the letter called for a stop to unfounded allegations and funos has always supported full open and fully transparent investigations and that has always been our position.
▶ 3:40:08You've created a situation here that I'm that I'm very concerned about and and we discussed this at length before this hearing about how this is going to impact the general public's decisions on whether or not to donate their organs. And I'm not satisfied with with what I've heard uh in the hearing thus far Uh this I I think this is extremely serious. I think there's uh there needs to be some serious reform.
▶ 3:40:37I thank uh the chairman for holding the hearing. But I I I just want to be very uh sensitive about the signals that this sends and and the fact and and I I I disagree with you. I think you you intent you intended to influence the outcome of HR's um research. I yield back.
▶ 3:41:01The gentleman yields. The chair recognizes a gentle lady from Massachusetts, Miss Tran, for five minutes of questions.
▶ 3:41:07Thank you, Mr. Chairman. There is no question that UNO's technology powers the OPTN. Uh, drop net for Donor Net, excuse me, for example, allows OPOS's to manage deceased donor data, launch match runs, and make organ offers to transplant hospitals. Dr. McBride, is it fair to say that the OPTN would not be possible without the technology systems that UNOS builds and maintains?
▶ 3:41:34Yes, that's correct.
▶ 3:41:35Thank you. So given the centrality of technology in the OPTN, it is vital that its systems are secure, reliable, and easy to use. Indeed, in recent years, many federal technologists with backgrounds in the private sector were dispatched to HERSA. Their mission was to inspect the code of the OPN to look for bugs, inefficiencies, and opportunities, and implement fixes.
▶ 3:42:00I imagine they expected to spend their time solving the gnarly problems plaguing the OPTN's technology systems. As it turned out, these missiondriven software engineers and data scientists struggled to even gain access to code and data styied by a resistant UNOS. This is unacceptable. If taxpayers fund a piece of technology, the federal government should own it. Full stop. Dr.
▶ 3:42:26McBride, do you believe the federal government is the rightful owner of the source code underlying the OPN and therefore should be able to freely inspect, develop, and share that code? Thank you, Congresswoman. Under our current contract with the OPTN, the contract clearly states that the contract that the computer system is owned by UNOS. This is a contract between HERSA and
▶ 3:42:50you you don't believe that the government should have the right to freely inspect that data that taxpayers
▶ 3:42:56I 100% agree that they should and they have. They came to our office this most recent December and were able to freely and openly look at our computer system. Well, according to an internal memo, uh government experts had never been able to inspect UNOS systems in the 30 plus years of the transplantation network's lifetime. Dr.
▶ 3:43:19McBride, your predecessor criticized that memo, contending that government officials could review the OPTN source code provided that they physically visit the UNOS office under strict supervision. Now, I'll be frank, that doesn't look like an open collaboration to me. It looks like chaperoning.
▶ 3:43:38To your knowledge, has UNOS ever obstructed or otherwise delayed government access to its technology, including by requiring HERSA engineers to physically visit ENOS facilities to view system code?
▶ 3:43:52I can't speak to what happened during my predecessor's term as CEO. I can tell you that HERSA has been welcomed into our office to look at our computer system. We have conversations with them
▶ 3:44:03twice a week about what was happening in the in the uh OPTN system. It is a very open collaborative process. maybe under your tenure there have been changes made. It's not what we've uh we understand to be true.
▶ 3:44:20Um, I was outraged at public reporting from 2022 that indicated HR's technology officials were told it would cost the government nearly $55 million to purchase UNOS's technology systems. So, begs the question, has UNOS ever set a price tag on government access to the technology or data techn or data technology that I must point out once again taxpayers paid for?
▶ 3:44:50And if so, what's that number?
▶ 3:44:52So the data in the OPTN computer system are completely available to HERSA and to anyone else who is
▶ 3:44:58without obstruction without delays.
▶ 3:45:00That's correct. you know, Mr. Chairman, the public record as well as Dr. Lynch's answers to me appear to contradict um the answer. I ask unanimous consent to enter into the record a Washington Post article detailing how UNOS told the government it would have to pay $55 million to acquire its technology should the OPT contract ever be opened.
▶ 3:45:26So ordered.
▶ 3:45:27Thank you. Here's the bottom line. I'm concerned UNOS is holding the organ transplantation system and its technology in particular hostage. UNOS has consistently shown resistance to federal efforts to modernize the technology and operationalize its data. We all have a role to play in changing the organ transplantation network for the better. No one, Congress included, should escape accountability and scrutiny.
▶ 3:45:57Um, I thank the chairman and I'll yield back.
▶ 3:46:01Gentle lady yields. The chair recognizes Mr. Allen for five minutes of questioning. Uh, thank you, Mr. Uh Dr. Famaka, uh HRSA's report notes that in most cases once authorization had been obtained and the coordinator's attention turned to uh peroperative logistics, there was scant subsequent recording of patients clinic condition. What are OPN's policies as it relates to data and recordkeeping?
▶ 3:46:33The OPN stipulates that OPOS's have to collect and retain data points. I would be not accurate if I tried to tell you what all those data points are. I think the the challenge from where I sit as a is having OPO staffers in a hospital of varying degrees of medical training. They're not physicians. Some are nurses and most are not.
▶ 3:47:00Doing physical exams, neurological exams, making assessments of patients. That makes me feel uneasy.
▶ 3:47:10Uh do you believe there should be more thorough records uh when assessing a patient's neurologic condition prior to recovery efforts? answering from the perspective of um physician in the hospital. Absolutely. That needs to be documented by the physicians that are caring for the patient because they're making life and death decisions to the degree to which an OPO would be documenting that finding taking it from the medical record.
▶ 3:47:40I think they should be doing that as well. Um I don't feel comfortable having an OPO making an assessment of that though. I think that must stay in the hands of the patients
▶ 3:47:51Okay. Thank you. U Mr. Massa, do you believe that network uh for hope has a culture that encourages the reporting of complaints or concerns historically and
▶ 3:48:04Yes, sir. Matter of fact, our policy states that not only do we encourage that, but you are obligated to do so. And if a complaint is they do not feel comfortable raising a complaint to a corporate compliance officer or their supervisor or a member of the executive team, they could do so anonymously through a QR code and they remain it's completely confidential of who that person is. And so again, we encourage people to do this.
▶ 3:48:35The OPOS's are required to provide organ donation data to transplant hospitals. they have agreements with what is included in this data lesson
▶ 3:48:46uh with the trans everything related to the donor in including any lab test uh their blood type um corologies HL testing um all the background related to the person's uh uniform um risk assessment uh as far as their background so there's a quite an extensive list of information provided to the transplant center before they accept a organ.
▶ 3:49:13What about complaints or incidents related to a potential donor? Would they be included in this data?
▶ 3:49:20Uh we actually provide a way for uh hospitals to pro to make a complaint and again we offer that ability to do it confidentially as well.
▶ 3:49:29Okay. All right. Great. Well, thank you and Mr. Chairman, I yield back.
▶ 3:49:34The gentleman yields. The chair recognizes a gentleoman from Washington, Dr. Shrier for five minutes of
▶ 3:49:42Thank you, Mr. Chairman, and thank you to our panel here today. Um, during the first panel, uh, with Dr. Lynch, uh, we talked about, well, first I just open by I want to say thank you to everybody involved in the organ transplantation space because it is such a blessing and such a lifesaver for so many people out there.
▶ 3:50:03And what I want is for this process to be safe and for the public to have full confidence that when they get that pink heart on their driver's license that I have, that my son has, um, and that when they make that decision, that altruistic decision to save somebody else's life, um, that it's going to be done responsibly and safely. And that's the whole point of of this hearing.
▶ 3:50:28And so one of the things that I asked about especially as a doc just thinking about how we function, how we prevent errors, knowing that that is a human uh risk. I asked Dr. Lynch, is there a checklist? We have a checklist when we admit somebody to the hospital so we don't forget something like to provide fluids. Uh we have a hospital for a list for labor and delivery to make sure that we don't overlook anything um with with labor and delivery.
▶ 3:50:58uh we have the the procedural pause before any operation to make sure everybody in the room is clear on what the what the the standards are. we have sepsis pathways and so I thought well is there a pathway for declaring circulatory death because that seems to be where these issues have come up and his answer was that the the OPOS the organ procurement organizations are really the experts in this and so I just wanted to pose this question to all four of you
▶ 3:51:29do you have the list what can you do to really guarantee no errors
▶ 3:51:36if you don't might I'll go first. Okay. Thank you. Uh thank you congressman or congresswoman for your question. I appreciate it. Um for us as I mentioned as the OPO we have developed these checklist uh specifically designed for nurses on a case as well as the attending physician to do exactly like you said in terms of going down the list making sure nothing is forgotten and making sure that they understand their role as well as the role of the OPO during those cases.
▶ 3:52:06Um we re OPOS's like I said in my uh initial uh testimony do not declare death. So that is relying upon a independent surgeon not involved in donation or transplantation to come in and pronounce death and as Dr. Fermica said in his testimony we are not even in the room at that time.
▶ 3:52:28So uh while OPOS's are the ones uh determining if a patient is suitable for a donation as far as uh determining death that is actually done by the physician and currently there really isn't any good tool to determine if a patient is going to die in that 90minute time frame.
▶ 3:52:49I mean it feels like that's the gap that your checklist is. Is this suitable? Does this person have hepatitis B that could be transmitted through transplantation? Is there CMV? It could be uh have we talked with the family? Have we gotten sign off?
▶ 3:53:06But the list that is really at the crux of this matter that we're discussing today is how do you not mess up when you're saying, "Okay, it's all right to go to the operating room." Do you have a list that says must not have had an opioid in x number of hours, must not have had, you know, any kind of any kind of sedative or paralytic for a certain amount of time. Where's where's that list?
▶ 3:53:32Can I take that? So, Congresswoman, I think your question is that is the question that needs to be resolved. And I was told when I was preparing for this that I should bring ideas. So from 20 years of working on the OPN, I'll tell you how I would like that fixed. The OP it crosses over two domains of responsibility. The OPN has responsibility and the donor hospital has responsibility and they're governed by different organizations.
▶ 3:53:59If there could be an ability to say that once a patient is identified as a potential protocols from the hospital side i.e. under CMS could be harmonized with protocols from the OPN side, meaning person OPTN and those individual patients that would fall under a standard set of protocols that would be agreed upon by people who are more knowledgeable than me on that topic, but then the OPT could get the donor hospital to do the things that needed to be happening and
▶ 3:54:29vice versa. And then there could be accountability. And I think that would be if you were to say one thing that could move us towards making people feel more confident in the system is we'd have one set of oversight. We'd have one set of protocols. We could work on those protocols and then we could act on those protocols and refine them as they go forward instead of refining one and then having to wait for the other one and back and forth.
▶ 3:54:51I think that would restore a lot of public confidence and uh I think it's just the smart and really should be a a standard thing to do to have everybody on board. Thank you. I appreciate your cander and I yield back.
▶ 3:55:04The gentle lady yields. The chair recognizes a gentleman from Florida, Dr. Dunn, for five minutes of questions.
▶ 3:55:10Thank you very much, Mr. Chair. Um, as a doctor, it pains me to read about the code patient in Kentucky. While being prepped for donation, obviously woke up and thrashy around felt terrified. Fortunately, one of the doctors performing a pre-donation procedure expressed his discomfort. Uh but the OPO who is president actually disagreed with him, shot him down, said the OP staffer notes indicate he was accusing him of euthanasia.
▶ 3:55:40Embarrassingly on the honor walk for this patient, the patient was regaining conscious and when he brought was brought in the operating room, he was actually curled up in a ball, his knees on his chest. Thank goodness for the doctor in the operating room. Uh this is a story that seems to me more fitting for a horror movie than a congressional hearing, frankly. Uh Mr. Massie, you're the CEO of Network for Hope. Less than a year ago, you merged with Kota.
▶ 3:56:07In what capacity does the former CEO of Kota serve in your organization?
▶ 3:56:13Uh the current the former CEO of uh Kentucky Organ Donor Affiliates currently serves as our COO. We made several changes in the COO. So, and you you have other code of organ operations staff perhaps surgeons still with you.
▶ 3:56:31They are, but not in their same role. Everybody in within the executive team took a much more
▶ 3:56:39I find it concerning that anyone involved in this misconduct uh is continuing to work with you in the field. Frankly, um, as a medical doctor, I find the recent increase in donations after circulatory death as opposed to brain death particularly concerning. We always use brain death as a as a criteria when uh when I was in the business. So, uh, and buried death confirmed by multiple physicians.
▶ 3:57:07I'm concerned that the current safeguards in the DCD process are simply not enough to secure uh secure patient safety. Um Dr. McBride, I'm under the impression that UNOS plays a role in encouraging patient uh organ procurement rather through uh through through the DCD type recover circulatory death. And I and I want Mr. Chairman I want to offer into record two two articles.
▶ 3:57:34The first says uh 26 OPOS's join new UNOSEled collaborative to increase DCD donor recoveries and that one's dated 21 April of 21. And uh the uh second one is UNO's using collaborative improvement model to increase DCD lung transplantation. I ask unanimous consent to have these placed into the record.
▶ 3:58:02So ordered. Thank you. Uh, I obtained these, by the way, through the wayback machine because they're no longer on your website. They've been taken down. It suggested that there was a reason you took them down. Was there, Dr. M?
▶ 3:58:17Thank you for the question, Congressman. Um, those reports refer to a collaborative work project that was done um in uh under the direction of HERSA and in partnership with the OPT.
▶ 3:58:28Okay. So, I just reclaim my time because we're running out, you know. Um last year's hearing on this subcommittee after that the association of your curban organ procurement uh penned a letter openly criticizing this congressional committee for advancing false misleading and unsupported allegations uh after reviewing and hearing all the data here today. Do you still agree with that?
▶ 3:58:55Congressman, I disagree with the way that letter has been characterized. I believe the letter actually called for an open conversation with Congress with experts in the organ donation.
▶ 3:59:05Let let me just say I think it's disturbing to me that uh that any that anyone would consider that congressional oversight which is a one of our jobs um is somehow damaging to public trust congressional oversight doesn't harm public trust. What happens to the public trust gets harmed when our trusted partners in organ procurement disregard process and put patients in danger? Several of you lectured us today on the importance of transplant surgery and transplant donors.
▶ 3:59:34I promise you, we understand the importance of uh transplantation doctors and lay people in Congress alike. But it's not right. It's not moral. It's not ethical to kill a patient who can potentially live and take their organs. And if America fears that your OPOS are doing that, you're going to lose your pool of donors. Simply, Americans should be confident that you are performing your own oversight. And we are too.
▶ 4:00:01I commit that we will continue to uh provide oversight and we will do everything in our power to make sure the bad actors in this field do not continue to behave this way. Thank you. I
▶ 4:00:13The gentleman yields. The general lady from Virginia, Miss McClone, is recognized for five minutes of
▶ 4:00:19Thank you, Chairman Joyce, and to Ranking Member Clark for convening this very important hearing. Um, our nation's organ procurement and transport transplantation system requires strong coordination between federal agencies, the organ procurement and transplant network, uh, organ procurement organizations and hospitals.
▶ 4:00:39Now, the current OPTN contractor, UNOS, uh, is based in my district, and over the years when I was a state legislator, I had a chance to visit their office several times and hear updates about the modernization process. These conversations have taught me that the the there's a very complex but critically important organ transplantation system in place that depends on having the public's trust.
▶ 4:01:08and we agree that there is always room for impro improvement to better protect patients while saving lives. Um, now while we are in this oversight hearing, I do want to highlight my bipartisan bill with Congressman Rob Whittmann, HR 330, the Oregon Donation Referral Improvement Act, that requires the Department of Human Services to uh study how automatic electronic donor referral systems can help eliminate barriers to successful organ transplantation.
▶ 4:01:39And this would be one step towards minimizing error and enhancing patient safety. And I appreciate today's discussion about uh other reforms and challenges that are needed. So I want to ask uh Dr. McBride uh in your testimony, you emphasize UNOS's role as a contractor supporting the OPT uh with four days decades of experience.
▶ 4:02:01From your perspective, what are the most important reforms uh that we need to make to improve the organ procurement and transplantation system to better protect patients while saving as many lives as possible?
▶ 4:02:14Thank you, Congresswoman, and thank you for the support of the automated donor referral bill. We really appreciate it. there are many reforms that we have um discussed and we have discussed some of them today. I think based on the topic of this hearing, the most important one is to create a reporting system where patients member members of the health care community can provide um information about potential wrongdoing for their loved one or their family member.
▶ 4:02:41Um the fact that it took three years for the index case as it's been referred to to come to light is unacceptable. And I hope that this Congress will push Hersa and CMS to create a system that can be available to all patients and families to make it easy for them to make these kinds of conversations um public so that it can be forwarded to the right oversight body to be addressed.
▶ 4:03:05Thank you. And I thought and I like Dr. Formica's uh words of wisdom that come with solutions. So I'm trying to give you all an opportunity to do that. Um but for Dr. McBride. Um, how can the OPTN improve oversight of OPOS to prevent the tragic situations that were discussed today?
▶ 4:03:22I think piggybacking off of Dr. Formica's comments, you know, there is a a split in the the oversight of the organ donation and transplant systems. So, CMS has oversight over hospitals and the OPN has oversight under HERSA of the um transplant hospitals, the OPOS's and the hystocompatibility labs. That split in oversight does leave room for communication gaps and opportunities for further improvement.
▶ 4:03:51So I do think consolidation of the entire transplant ecosystem under a single government over regulatory body could provide benefits to the transplant community.
▶ 4:04:00And are there any other resources or authorities that that we would need to provide to accomplish that?
▶ 4:04:06I believe Congress has the authority to do that.
▶ 4:04:08Okay. And um Dr. for Mike. I don't know if there's anything you'd like to add on to that.
▶ 4:04:13Yeah, I'll just echo that. As a as a program director, I prepare for an OBTN audit every three years and a CMS audit every five years, and they don't cover the same topics. So,
▶ 4:04:23Okay. And in the 55 seconds I have left, Dr. Massa or Dr. McGee, if there's anything else you would like to add on what you think Congress could do, either in your answer now or that you would like to provide on the record, I do want to give you all an opportunity. um and was probably going to have to be in writing on the record later.
▶ 4:04:41Um, I want to give each of you the opportunity from your perspective to say what uh changes need to be made and that recognizes the complexity of this this this process and how we have uh three different uh you know systems working together whether it's the hospital whether it's the um the procurement uh organization uh or or UNOS um and they all have different governing structures and and and different things in places
▶ 4:05:12and things fall through the cracks. So, if you could provide us uh from your perspective everything you think Congress needs to do to prevent these tragedies from happening, I'd appreciate
▶ 4:05:22Thank you. Back.
▶ 4:05:24The general lady yields. I'd like to note that as discussed in panel one that HERSA already has a system for individuals to report. With that, the chair recognizes a gentle lady from Iowa, Dr. Miller Meeks, for five minutes of questioning.
▶ 4:05:38Uh thank you, Mr. chairman and again I want to thank our witnesses. If you were here in the first panel uh you heard uh about my uh unique perspective in this matter but I'm going to repeat it. Uh so I started my uh career uh as a nurse. Uh uh my so after having done uh med surge nursing and emergency room nursing as a newly minted lieutenant station at Walter Reed, I was placed on a neurosurgery floor.
▶ 4:06:05Uh and we had a variety of patients uh patients who were comeomaosse from traumatic brain injury uh patients who had ruptured aneurysms uh strokes or hemorrhagic strokes. Uh and it was left to the nurse to have these very difficult conversations with family members whether or not to remove their family member from life support and how to navigate and support that family.
▶ 4:06:30And then the secondary conversation of whether they would be an or organ donor that held me very well as I went on to uh medicine and medical school and did emergency room trauma surgery. I did a general surgery internship even though I was going into opthalmology was on the transplant service. So again as the intern having these conversations with family members uh in a system that did not exist then as it does today.
▶ 4:06:58Um and very challenging to uh talk to family members about removing an individual from uh from life support uh that they're given all the medical knowledge that we had and a belief in God that uh they were not going to recover. Um and then to secondarily have um conversations about donating organs. We've certainly have progressed since then. You have u advanced directives. You have conversations with family.
▶ 4:07:26not enough uh on our license uh driver's license you can elect to donate um and then as an opthalmologist performing transplants for vision and I can tell you how grateful individuals are how parents are for their child who has an inherited disease and can't see uh to then see um adults who have uh traumatic injuries from chemicals alkali burns um before we had stem stem cells which we can now also transplant.
▶ 4:07:57Um, and then those with keraticonus or other inheritable eye diseases and to be part of that network of giving vision and in fact giving life. And that requires trust and it requires trust of those who donate, the family members who have to make that decision in the absence of consciousness for their loved one and then in those that receive organs knowing that they came from a place of appreciation, gratitude, and love.
▶ 4:08:25So there's a trust within this system that I think is extraordinarily important for all of us. Not a not a new concept. uh but this merging and um arrangement of the uh in September 2023 securing the US organ procurement and transplant transplantation network act when it was signed into to law is to help with this disparity of education uh communication involving p people so that
▶ 4:08:55there are more organs available to save life and to save vision and So I would just say having been uh in medicine and in this uh the first thing you want to do is admit you have a problem. You want to acknowledge that problem and you want to offer solutions. So Dr. McBride and Dr. uh Vermica I appreciate you offering solutions.
▶ 4:09:20I think what's imperative is that UNUNICE uh OPTN HERSA and CMS all come together and develop those standards. We know that if somebody is uh an uh an an addict and overdoses that brain function can be um can be altered by the medications that they may have been on or sedatives.
▶ 4:09:45and this delicate dance that we do and I call it a dance and it's the the wrong word but this conversation we have with families so that we can to help to continue that trust strongly support what you're doing but I'd like the commitment from all of you that you will work to have these conversations where there does not even need to be congressional action that you will work with HERSA CMS to bring this system together to have the appropriate standards and guidelines in place so
▶ 4:10:15that families, patients, and those who are transplanting and nurses working in that area have the assurance that that will occur. Dr. Ma,
▶ 4:10:26absolutely. And thank you for everything that you did in support of donation and making sure those people receive their second chance.
▶ 4:10:32Dr. McBride,
▶ 4:10:34absolutely. Thank you, Congresswoman, for everything.
▶ 4:10:36Dr. Forica,
▶ 4:10:37I agree with you completely. So,
▶ 4:10:39absolutely. And if we need more help, we're coming to you. Well, thank you and thank you for the suggestions that you gave us and recommendations that we can act upon. Thank you. I yield back.
▶ 4:10:48General lady yields. The chair recognizes the gentleoman from from Florida, Miss Kemik, for her five minutes of questioning.
▶ 4:10:56Thank you, Mr. Chairman. Thank you to our second panel of witnesses for appearing here today. Now, as everyone knows, this committee has been investigating corruption from Oregon contractors for more than a year. In fact, I was in the last hearing that we had on this and it was quite a contentious hearing. One issue that's pretty close to my heart is ensuring equal access for life-saving transplants for patients with disabilities.
▶ 4:11:20Just last month, the House passed a bipartisan bill that I was proud to lead alongside my friend and colleague Debbie Dingle to end organ transplant discrimination against individuals with disabilities. So, it is with total horror that I read a recent investigative report highlighting one of the most horrific cases of patient abuses. The New York Times detailed what happened to Misty Hawkins last year.
▶ 4:11:45She was a vibrant woman in Alabama who loved movies and dancing, but she also had a lifelong cognitive disability. After a tragic incident, Missy's mother agreed to organ donation. And I'm quoting from the report uh here about what happened next. quote, "A surgeon made an incision in her ch in her chest and sawed through her breast bone. Doctors discovered that her heart was still beating. She appeared to be breathing.
▶ 4:12:11They were slicing into Miss Hawkins while she was still alive." Now, this is not the first time that something like this has happened. In 2021, a doctor filed a case report about a woman with Down syndrome who was in an operating room being treated as an organ donor. During the harvesting of her organs, staff realized that her aortic and renal arteries were pumping and pulsing. In other words, she was not dead. The patient was given powerful drugs, fentanyl and uh larzazzipam.
▶ 4:12:42And then, according to the doctor filing the case report, 18 minutes after she was first pronounced dead, she was pronounced dead a second This is something that you would see in the movies, but unfortunately we're seeing real world examples of this today. So, I'm going to start with you, Mr. Formica. As a physi physician, I'm sure you are as horrified as I am.
▶ 4:13:12Were you invited to participate in the hearing on organ transplants last year?
▶ 4:13:17I was invited. Yes.
▶ 4:13:19Why did you not appear? I was given about 4 days notice and couldn't get away from my clinical responsibilities.
▶ 4:13:25I understand. Now, we discussed this back then, but I want to bring it to you now. H's report included two particularly damaging conclusions about the federal organ contractor assigned to Kentucky, including quote, "Its failure to recognize neurologic function inconsistent or unfavorable for organ donation and its failure to work collaboratively with patients primary medical teams.
▶ 4:13:48If there are reasons to believe that some organ contractors are failing to recognize neurologic function issues inconsistent with organ donation, in other words, the patients could never recover or they were not suitable for organ donation, then I'm even more concerned about what that means for care given to patients with disabilities. Are you tracking with me?
▶ 4:14:09Yeah, absolutely. I'm sure you're concerned about the patients
▶ 4:14:13and you're under oath. So I want you to very clearly detail if you have heard of other reports similar to this with the very basic failures that have been outlined in what I have said.
▶ 4:14:26The reports I've heard I've read that New York Times article I shared your I don't even know the verbs to put in there so I won't do that. Um I've heard from Hersa secondhand that there's other cases. I have never been given the primary data for those.
▶ 4:14:43Yeah. No really. We have not been given the We have not been given access to the primary cases. We were told that they were happening. I haven't seen them. I haven't seen the the only thing I know about the index case which we're discussing here is the HERSA report. I was the OPT was not given the data for that one. We were told not to review that case.
▶ 4:15:02And just just so we have this on the record, you recently you you have since left, but you were the president.
▶ 4:15:08I was the president up until June 30th.
▶ 4:15:10Okay. Now, you're aware of the bipartisan report from our friends in the Senate that found that the Miami OPO, for example, recovered organs from a donor before the donor's heart stopped and against the family's wishes.
▶ 4:15:25I've heard that case. Yes, I haven't
▶ 4:15:27You just said that you really hadn't.
▶ 4:15:28I I haven't seen primary data on that, Congresswoman. So, I've I've heard these cases. I can tell you that the Miami OPO has been under review with the OPTN and I the last my last act as a president with my board was to send a uh letter to the secretary asking for assistance in managing that case.
▶ 4:15:49But I mean the report is public. So I mean you're
▶ 4:15:53Congressman I I've heard these I know what you're saying. I've heard these cases but I don't have any primary data. I've been a spectator to those. I'm sure that brings the families of these individuals great comfort that you haven't seen primary data despite the fact that many of these reports are public record. I mean, this is this is outrageous that this is happening in the United States. This is the stuff that you hear in in in third world countries.
▶ 4:16:18I mean, it's clear that a 40-year experiment of letting organ contractors police themselves has left our most vulnerable neighbors um to endure unimaginable abuse and torture. So I I think it's clear that a lot more work has to be done here. Um while I appreciate your time here, I think many of the the answers uh have left us with a lot more uh questions than answers. So with that, my time is expired. Mr. Chairman, I yield.
▶ 4:16:42The general lady yields. In followup, Dr. Formica, didn't you serve on the MPSC? Wouldn't you have access to this information and this data?
▶ 4:16:51So MPSC members are assigned to different cases. So if a case comes in from say a transplant program, there may be three reviewers assigned to that case and they would not be assigned to look at other programs. I mean there's just so much work to be done that it's divied up and if you haven't seen if you're not assigned to the primary case, you just hear about it in discussion.
▶ 4:17:16Define for us. Uh as a physician, I've been in discussions. U but how would those discussions occur when you said you would hear them in discussion? Would they be case presentations that were presented at large? It's you're not the primary assigne for the case, but how were those discussions occurring? Uh to representative Kamik's point.
▶ 4:17:36Yes. So if you were uh and I don't recall the Florida case that you're discussing there because I was not I was on and off the MPSC for various times. So I don't recall that one. The a case would be presented with maybe three primary reviewers. it would be discussed from the data perspective. And then the the MPSC is actually composed of either 42 or 46 members. I'm not entirely sure the exact number.
▶ 4:18:02And then there would be an open discussion about we'd ask, you know, I'd ask a question. What did you find? They would answer that back, but we wouldn't necessarily see the primary data if you weren't the reviewers.
▶ 4:18:13Thank you for the explanation. Uh the gentle lady yields. The chair recognizes a gentleoman from Indiana, Miss Hchin, for 5 minutes of questioning.
▶ 4:18:22Thank you, Mr. Chairman. Thank you for the witnesses for being here. Mr. Massa, we've heard a lot during this hearing about some of the deeply concerning and frankly unacceptable incidents that have taken place over the last few years, particularly involving Network for Hope. I hope your presence on the panel today is an indication of Network for Hope's acknowledgment of previous shortcomings and your willingness to work together to improve our organ donation systems for both patients and OPOS.
▶ 4:18:51In addition to addressing the pattern of high-risk DCD procurement practices, HERSA's corrective action plan notes that the OPN within 12 80 days is to propose a requirement for the OPN to be informed of any requested or triggered pause in procurement efforts if there is a concern for unrecognized neurological improvement or potential for a patient to experience pain in the act of procuring organs.
▶ 4:19:18It notes that these pauses will be reviewed during monthly meetings. Mr. Massa, has Network for Hope implemented its own protocols to pause procurement in these cases?
▶ 4:19:30uh, first of all, thank you for your questions and your comments. We have we do have uh established huddles and hard stops during the donation process especially with DCD donors to make sure that everyone we get everybody on the health care team together um everybody involved in that DCD donor if there's any concerns they could address them at that time. There are multiple huddles during that process.
▶ 4:19:57Were those protocols in place before the uh HERSA report came out and and their recommendations? Were those protocols in
▶ 4:20:05They were.
▶ 4:20:06And why were they not followed?
▶ 4:20:08The huddles were followed. Yes.
▶ 4:20:11It's clear that in many cases uh they were not followed. Uh especially because I know you mentioned that the whistleblower who was allegedly not retaliated against uh spoke of at least one instance where the doctor uh suggested that the procedure stop. Um, has Network for Hope?
▶ 4:20:28Those were put in, just to correct me, those were put in place in after the
▶ 4:20:33Thank you. Why did Network for Hope not document drug overdose as the mechanism of death in nearly 75% of the cases reviewed by HERSA with evidence of patient drug intoxication?
▶ 4:20:44We saw that same report and um we are looking at all those and we have boosted our documentation process. We have additional training on documentation.
▶ 4:20:56The question, Mr. Massa, is why were those not documented?
▶ 4:20:59Those happened prior to the merger. I can't really speak to that, but since the merger, I can tell you our policy is more robust as it comes to
▶ 4:21:09Hersa points out in their corrective action plan that this suggests that there's a systemic concern regarding the treatment of potential DCD donors by KYDA staff. How do you explain that? Again, uh I can only address the things that occurred post merger, not
▶ 4:21:27when date was the merger, Mr. Massa,
▶ 4:21:29pardon me.
▶ 4:21:29When was the merger?
▶ 4:21:30October 1st of 2024.
▶ 4:21:33was the merger uh was the merger result of this uh this whistleblowers um uh and the uh findings from this committee. Was it a result of that?
▶ 4:21:43Not at all.
▶ 4:21:44It just followed that. I think
▶ 4:21:48September 11th, 2024 was the the hearing. It followed that, but it wasn't a result of that.
▶ 4:21:55No, ma'am.
▶ 4:21:56Okay. Um, given that at least 98 or or 30% nearly of the cases investigated in the HERSA report involved patients who were intoxicated with opioids, amphetamines, or cocaine, are there or should there be any special protocols in place for when a patient is intoxicated?
▶ 4:22:13Absolutely. and we have those policies in place now and we are going to abide by everything that the uh hersa recommended in their letter.
▶ 4:22:22Can you understand Mr. Massa the concern that we have for the public given the fact that uh the organization seemed to be uh and maybe this is not the case but they seem to be taking advantage of vulnerable families during their most difficult time. The HERSA report indicated a troubling lack of care and concern for patients uh who are potential uh potentially intoxicated uh by overdose as if their lives are less
▶ 4:22:48That is never the case. And yes, we do find those alarming and we as I mentioned I can't do anything about what happened prior to the merger. I can post merger and I can tell you those things are going to be rectified.
▶ 4:23:01Thank you very much. I hope today's hearing will bring clarity on how the failures have happened, what steps need to be taken place uh with HERSA, OPTN, the contractors so that we can ensure that these incidents never happen again. I thank you for your testimony today. I yield back.
▶ 4:23:18The general lady yields. Before we conclude this hearing, I want to take a brief moment to emphasize the importance of the work that this subcommittee is undertaking today. It is critical that the 170 million Americans who have made the selfless choice to register as organ donors and to give the ultimate gift to another person upon their death that they feel safe, that they feel protected in that decision to honor that commitment and that sacrifice, that pledge that
▶ 4:23:48these individuals have made that their loved ones that they must understand that we will fully investigate all claims that could cause fear. fear or mistrust in the decision that they have made and ensure that events that we have heard today would hopefully never occur today. A significant concern is from the HERSA report that there were 103 of the 351 examined cases with concerning features. These were not unique.
▶ 4:24:18These are horrific reports. That's a 30% occurrence rate. And it affirms the need for this subcommittee. It affirms the need for this investigation to occur. Seeing that there are no further members wishing to ask questions, I want to thank the witnesses for being here today. I ask unanimous consent to insert in the record the documents included on the staff document hearing list and without objection so order.
▶ 4:24:45Pursuant to committee roles, I remind members that they have 10 business days to submit additional requests for the record and I ask the witnesses to submit their responses again within 10 business days upon receipt of their questions. Members should request should submit their questions by the close of business on Tuesday, August 5th. Without objection, the subcommittee is adjourned.