Transcripts For CSPAN3 Health Care Providers Testify On Organ Donation Transplant System 20220916

The finance committee will come to order. The last place anybody wants to hear about gross mismanagement and incompetence is in the business of saving lives. That is precisely at unfortunately with the finance committee needs to discuss today. This mornings hearing is an update on the investigation senator, grassley and i, along with senator young have been conducting for more than 2. 5 years. It examines a network of dozens of organizations with the demand to organ transplant and a group that oversees and coordinates them. The United Network for organ sharing. We have reviewed 100 thousand of their documents, totaling more than half a million pages. Before i get to specific findings, i want to frame what we have learned as simply as possible. Already Many Americans are dying needlessly becauseuno and many of the transplant organizations it oversees are failing and seem uninterested in improving. The existing alphabet soup of acronyms and organizations, i will start out with a bitter background. It was named the organ procurement and Transplantation Network. Someone needed to management that system for the whole country so the government thought to contract an organization to run it. Unos was the only bidder for that contract. The contract has come up for bid seven other times. Unos has won all seven. Todays network, unos is made up of nearly 400 members including 252 transplant centers and 57 regional organizations known as oregon oregon procurement organizations. A family city and a family city in hospital room, thinking about donating a loved ones organs is not have a choice of opos. Those are the important terms to remember here. When a kidney is donated in another state and these to get to another state, that is where the opos come in. As our investigation shows, unos is doing this job poorly. Three years errors are shockingly common. Between 2010 and 2020, more than 1100 errors were filed complaints were filed by a few and others. In a number of cases, opos failed to complete a number of tests for things like blood disease and more. He found one person died after being transplanted with lungs that were marked with the wrong blood type. Similar blood type errors have happened many times. Some had to have organs removed after transplant. Another person was told he would likely die within three years after an opo of supplied him with a heart of a person who died from a billing it tomorrow. Unos did not do any disciplinary action. In further, another patient contracted cancer and an opo sound the case for months. Between 2008 and 2015, 229 organ transplant patients received about organs and more than a quarter of them died. He found 53 complaints between 2010 and 2020, as well as evidence that this was just the tip of the iceberg. In some cases, couriers missed a flight. In others, the orchids were abandoned at airports and some were never picked up. Any of these failures reserve to billiards resulted in organs being discarded. It is reasonable to assume that many of these are going unreported. Organ transplant professionals repeatedly told the finance committee that the unos complaint process was a black hole. A complaint with in and unos went quiet. And vesta gave an disciplinary measures really amount to much more than a slap on the wrist. Only one time has unos recommended that an opo lose their certification. The bottom line is the failures we uncovered cost lives. Thousands of organs donated each year wind up discarded including one in four kidneys. According to federal data, roughly 6000 americans die every year while waiting for an organ transplant. This kind of mismanagement has a disproportionate impact on minority americans. Africanamericans for example have a greater need for kidney transplants than some other demographic groups. The center for medicare and Medicaid Services recently issued new statements for new standards for opo performance and more than a third are failing to meet them. They are failing to increase supply of lifesaving available for transplant. Another area of the committees investigation has examined the i. T. , Information Technology of unos to run the transplant network. The system is outdated, mismanaged, and insecure. Easing such decrepit data to run the transplant late network put Sensitive Data at risk and there is no solution in sight. In a report issued last year, titled lives are at stake, the u. S. Concluded that unos does not have the Technical Capability. If you looked at the data between unos and many of the day the nations opos, i would wager the vast majority are hardworking, good people doing their best to save lives. The glaring issues uncovered in our investigation stems from failures at the top. Leadership failures. Our investigation is ongoing and it is clear the system needs reforming. Youre going to continue investigating unos and opos and policies that need changing at the federal level. This is not a partisan effort. Everybody wants this system to work with as few errors as possible. I want to command centers grassley, cardin and young. The three of them have been working very closely with us. This is a thoroughly bipartisan interest. I want to thank senator grassley, and senator cardin and senator thune. We are going to have lots of members interested in this. I see senator warren as well and i want to think ever witnessed panel for joining the community the committee today. Today we want to discuss about the u. S. Organ procurement and Transplantation Network. And the Government Contractor overseeing this program, the United Network for organ sharing. In 1984, Congress Passed the National Organ transplant act, a bill cosponsored by the late senator warren hatch, a friend of mine and a former chairman of this committee. A few years later in 1998, the federal government contracted with the United Network for organ sharing to oversee the Transplantation Network. The network performs three critical functions on behalf of the federal government. Policymaking, technology delivery, and oversight of member compliance with its policies and its procedures. However, more than a decade now, government watchdogs and the media have questioned the advocacy of the networks oversight. That is because of multiple reports of fraud, waste, abuse, criminality, deadly Patient Safety, and failure to recover organs. Some have even observed the network is 15 times more likely to lose, damage or mishandle any organ in transit and a Passenger Airline losing its luggage. I have written about all these issues and more, going way back to 2005. Sadly, the federal government has only recently begun to take action. As a result, thousands of organs go to waste each year, resulting in lives lost, and billions of dollars wasted. This system is even worse for people of caller color who are less likely to get on the waitlist and less likely to find a match. At least amongst themselves, the Networks Senior leadership admits these facts. One officials response to these concerns was that this is just that real americans are dumb and should be moved somewhere else to obtain lifesaving treatment. Of course, that attitude is totally unacceptable. Now, a bit more about the investigation into the network. In february 2020, this committee sent a net a letter to the network, questing information and data on its oversight of the transplantation organization. We found that there is a huge variability in how well Organ Procurement Organizations, known as opo, are serving their communities. According to the senate for medicare and Medicaid Services, as many as 2257 opos are feeling outcome and performance metrics. This variability has negative consequences for the Transplantation Network and causes transplant hospitals to have fewer organs from patients on the waitlist. We also found that the network has broken governments systems that fail to hold the members accountable for reoccurring Patient Safety issues. As i said, once again, when i started looking into this in 2006, network acts like the fox guarding the chicken house. Instead of a trustworthy and independent oversight body that holds its members accountable. As such, transportation failures , abo blood type testing, and allocation errors are common occurrences at underperforming opos. Mr. Chairman, it is about time into very timely that we hold the steering. Congress has waited too long to fix a broken system. We must sit insist upon accountability moving forward. S patients lives are at stake. Thank you very much senator grassley. As noted in my statement, im very glad we had senator young here as well. Senator young, senator grassley and senator cardin and myself have been at this for a long time. The committee has made a number of important findings during this inquiry. We believe it is in the publics best and truest to see these results. I ask our committee to submit all this memo and all documents in this memo to be submitted into the record. Let me introduce our guests. Mr. Sheppard is the chief executive officer of the unos. His Organization Currently holds the government contract for organ procurement and Transplantation Network. He has been in this role since 2012. Prior to joining unos, he served 15 years with the virginia government. The ceo for the Organ Procurement Organization located in st. Louis, missouri is also here. She turned her career as an organ procurement coordinator. In 2016, became the president and ceo overseeing the organizations operations including partnership for more than 120 hospitals and transplant centers located throughout missouri, arkansas, and Southern Illinois. This is a position he has held since january 2020. He began his civilian career in organ transportation in icu. I was a staff nurse in st. Louis, missouri in 1985 and has over 30 Years Experience in the transplant community. The transplant centers around the country and is also had a distinguished military career. Calvin henry is on the Patient Affairs committee in 2012. He received a double transplant in the hospital after being diagnosed with an untreatable lung disease considered to be a terminal illness. He was a successful Lung Transplant recipient and runs marathons. Mr. Henry has a professional background in Health Information and also volunteered as a patient mentor for a local transplant center in georgia. He connects those on the transport list with educational resources. Mr. Henry is urging immediate reforms in the transfer system that he entered into the records. Before he begins the statement, i ask for unanimous consent to do so. Dr. Jamie locke is at the university of alabama birmingham where she is a professor in the chief of the division of transplantation among other positions. She graduated from Duke University and completed her medical degree at Carolina University and her surgical residency at johns hopkins. We want to thank all our guest for their participation and we will begin with mr. Brian sheppard. Thank you mr. Chairman and members of the committee. Thank you for inviting me to discuss our organ by nation and transplant system and the role of the unos and our communitys ongoing efforts to increase transplantation. My name is Brian Sheppard and i am the ceo of unos, the nonprofit which holds the federal contract to serve as the working donation and transplant network. I have seen up close the power of Organ Donation and transplant, the thing and sustaining the families of organ donors and restoring the fire into transplant recipients. Unos worked with transplant hospitals, opos and patients to address the most important issues and we leverage experts in the field to continually improve the National System. Convene a community of diverse professionals and patients, sometimes with very strongly held opinions and leverage the diversity of opinions into a system that provides the rate as possible benefit to patients within transplant. All of the individuals on this panel with me have served on or lead at least one committee and two of them have served on the board of directors. Their opinions and insights have helped shape the system we have today. I look forward to having a conversation about that system. A system that just to mark its ninth consecutive record saving year of transplants and surpassed 41,000 transplants in 2021. A total never before received in a single year by the u. S. Or any other country. Transplantation on that scale would have been hard to imagine in 1984 when Congress Passed the National Organ transplant act. It has been an honor to serve the nation for over three decades. He also realized that unos is not the final word in Organ Donation. We are part of an multifaceted agency that includes multiple federal agencies and important roles for the cdc, the fda and nih and more. Consistent with the medical recommendations and best practices in health care quality, the opt and creates a role of peer monitoring and Quality Improvement. It complements but is different from the regulatory certification and oversight role rented to cmf to support their role. Unos is bounded by the optn contract and focus on those on developing equitable policy, and offering matters to patients through safe and secure modern technology and continuing to improve performance through peer review. Our work is closely overseen by herself Service Members on all our board of directors. That is a community that unos is so proud to be a part of. We have made rapid and remarkable changes in the past few years alone changes that have expanded equitable access. Increase priorities for the sickest nations, reduce disparities between races, ethnicities and geographies but there is always more to do. Are over 100 thousand americans waiting for an organ as we speak. Even as a 115 patients are successfully transplanted every day, another 17 die waiting. We cannot rest until every patient who needs a transplant is able to get one. By building on the success of our National System and ongoing efforts, we can get around that vision and when we do, our work saves life. They are prepared to work with any legislator to provide information or serve as a resource. If you again for inviting me to discuss the status of transplant and donation and i look forward to taking actions. Thank you mr. Shepherd. Misses mrs. Brockmeyer. I am the ceo of transplant serving missouri, Southern Illinois and eastern arkansas. At our organization, we followed the ethers of every donor, every time. Our team is committed to giving donors and their family they care they deserve while stewarding their gifts to patients desperately need. We depend on the broader National Transplant system as administered by unos to accomplish this work and need to urgently address Patient Safety. Each organ loss has a consequence to the thousands of patients waiting for a transplant. Furthermore, a discarded organ fails to honor the heroic gift from a selfless donor and compounds the family sense of loss. Unos lacks urgency and accountability around identifying and remediating the criminal loss of organs and are not required to publicly report adverse events when patients are harmed, organs are lost or the quality of patient care is deemed unsafe. Unos does not require clinical training, licensure or certification standards for opo delivered critical patient care. In this environment, who is looking out for the patient . Was being held accountable for patient care . No opo has actually ever been decertified regardless of its performance or safety record. Unos has failed to align its efforts to ensure Patient Safety and this has created tragic and deadly consequences. You must update our Technology System there. As opos, we are required to work with unos Donor Network every day. Donor net is slow to use and is hard to function when every minute counts. Opo transplant center staff are not empowered with the right information when time is critical. I have served in leadership roles on the opo committee and Committee Members and Industry Leaders voice repeated request to improve donor net. The consistent response was unos i. T. Did not have the bandwidth. The limitation of the unos Technology Eyes delaying and denying transplant to patients dying on the waitlist. Poor Technology Impacts the disturbingly high katie discard rate in the u. S. Are one in four kidneys never makes it to a patient for transplantation. Critical time is lost due to the inefficiency of donor net. Of course, an available organ should be offered to a patient in list sequence but far too much of the matching, particularly on older donors and orders are typically hard to place, are less due to the individual opos and transplant centers to find each other. Midamerican transplants have identified surgeons who have excepted kidneys that have been repeatedly turned down. These are life saving options for those patients. In may 2022, of those patients was number 18,222. Relying on donor net alone, the kitty would never have been placed and the chance to save a life would have been wasted. When an opo goes out of sequence to replace a organ that otherwise would have been thrown away, unos requires an estimation but when organs are discarded, unos remains silent. From 20182020, i served as a board number for the optn which automatically assigns membership to the unos board. This experience showed me that at times unos is not aligned with the fundamental vision of a lifesaving transplant for everyone in need. Board members are often kept in the dark about critical matters and are marginalized, particularly if they express you views that differ from unos. Small calls are conducted prior to board meetings to explore voting intentions. If the barber was not aligned with the opinion of unos leadership, followup calls were initiated. Fellow members felt pressure to vote with unos leadership. I am for the committee that those who speak out against this are not penalized. Patients deserve a system that works on their behalf. To protect patients, i urge congress and the administration to separate the optn functions into different contracts so that patients can be , to immediately separate opt and contractors and workers. Your immediate action on this matter will save lives. Thank you very much misses ms. Brockmeier. Next is barry friedman. I am honored to provide testimony on the state of organ transplant policy in the u. S. I testimony reflects 30 years of health care and transplant experience and my direct leadership involvement in organ sharing and the Organ Procurement Transplant Networks. A currently service the executive director of the Advent Health transplant and institute, of the busiest centers in the u. S. , having performed nearly 5000 transplants. I take very seriously my duties to the families and patients who entrust us with the gift of life for Organ Transplants. It is our duty to be good stewards of these organs, or the faith of these families and the help of our communities. Families in need have no other option but to trust the organ Transportation System in place. This is filled many patients due to the lack of oversight and accountability. Approximately 23 of katies from deceased donors of kidn eys from deceased donors are discarded. It is our responsibility to address this issue. Organ transplantation is a process of federally donated opo. Currently, they develop their own relationships with careers and rely on airlines, charter flights, Ground Transportation and federal agencies to facilitate transportation. In many cases, organs must connect from one flight to another, the Airline Personnel responsible for transfers. There is no consistent way of tracking these lifesaving organs. The transplant community promoted the use of gps tracking, organ shipments, and unos piloted an organ tracking system. This was not dependable so we opted out and are working with a company that uses less expensive, Higher Quality trackers and commodity shipments in real time. There is currently no requirement for opos to use tracking systems. Data availability and transparency are your key to improving organ procurement and unos has not proven capable in providing this function. Opt and optn has interoperability challenges and lags behind other technology prop forms. This contributes to a fractured flow of information between opos , donor hospitals and transplant programs. I believe there is conflict of interest related to the management of i. T. Functions by unos, as the i. T. Tools they offer come with additional costs , despite these being essential for the safety and management of organs. Unos is not effectively screening organ donors so they can be quickly directed to transplant programs. Unos has centers voluntarily opt out of certain organs via a filtering process. As a result, opos wasted valuable time making organ offers to centers that will never accept them. Time wasted equal to prolonged time and organs not placed, resulting in lost organ transplant opportunities. This creates a vicious cycle that disadvantages patients on the waitlist. Due to the limited expertise that unos has in the placement of organs, it would be best if they were no longer responsible for the development of organ placement practices. The unos policymaking process lacks transparency. Currently optn Board Members can serve as the Board Members of unos which creates a conflict of interest that contribute to the lack of transparency. Unos committees are formed in a vacuum. There is no call for nominations and no data shared with the transplant community to explain the rationale behind decisions that create policy change. A perfect example was recently during a kitty kidney allocation change. This committee that was created created an an equitable distribution of organs. The committee was instrumental in creating this policy which resulted in a high kidney discard rate which also caused increased costs and challenges with transportation. Most importantly, in this equation, we are jeopardizing the trust of our most precious resource. Organ donors and their families and the recipients of those who receive the the organs. The challenges i detailed to you are fixable and we to reempower the unos membership and increase Patient Advocacy representation within the policymaking process. You can implement interoperable technology, increase transparency, a doctoral gps tracking of organs and improve organ offers with the placement of from the strategies and reduce organ discard rates. We applaud the Senate Finance committee for listening and learning and thank you for providing the u. S. The opportunity to fix stellar communication from. For organ patients. Thank you mr. Friedman. Next we are going to have mr. Calvin henry who i believe is going to be testifying virtually. Mr. Henry, are you out there in cyberspace . I am. Wonderful, but will like to hear from you. Good afternoon. My name is calvin henry and i serve on a Affairs Committee as a region three representative for the southeastern u. S. And the u. S. Territories of the Virgin Islands and puerto rico. I am also a double Lung Transplant recipient of 9. 5 years and i spent much of that time as a dedicated patient advocate, and organ trips placated in recipients, Organ Donation and a strong proponent for improvements and transparency throughout the organ procurement and transportation process. It is a privilege to be invited here today to share my thoughts. Let mr. A bit about my experience navigating the transportation the transportation experience. 15 years ago, i was informed my only option for survival was to receive a double Lung Transplant. I was told i was unlikely to receive one and i should just begin making endoflife preparations. In several years after that diagnosis come on three separate luke occasions, i nearly lost my life due to the adverse effects of a disease. I was also diagnosed with a serious and disqualifying disorder for transplant. Rejection i received from that program launched an solo effort. Without the assistance of any organization to locate and other program that would take me on as a patient. The specific circumstances of my own experience a be unique but the constant difficulties in accessing transplant services are all too common. I was fortunate that i had the means, including access to good insurance, that allowed me to travel to another state to receive care. That is not always the case. My studies highlight the disparities and an equitable access to transplant services that disproportionately harm black people and people of color who do not have the resources to access transplant circumstances. This committee has previously highlighted that working donation failures are urgent issues across the board. The numbers for kidney for hispanic americans, black americans and native americans are far worse than white americans. Also no black people and people of caller are less likely to receive transplants. Researchers also documented that often black families have received this trip different treatment from opos. As they former Surgeon General noted, the of opo resources means opos to not respond to all donation cases are properly train and support their frontline staff. The impact is not surprisingly, it falls disproportionately on families of color. The studies show the u. S. May be recovering as few as 28,000 organs each year. According to the chief of transplant who testified that the house of treatment at vanderbilt who testified at the House Oversight Committee Last year, there would be no waiting list for livers, hearts, or lungs in three years and the kidney would be dramatically reduced. The leaders, of several of my colleagues on the optn committee asked me to submit a letter which is in my full written testament. Among those messages to you are the following, any apathetic culture and Bad Technology have caused patients to languish incomplete and Incorrect Information and lead people to die everyday on the list. Unos eunice leadership. We have to grasp at the obsolete failure that unos operates on transplant and to acknowledge much less effectively serve patients who are waiting and dying on the organ waitlist. We ask that you ensure that federal government makes the fast approaching contract in the cycle competitive. For the First Time Since the original optn contract was awarded in 1986, and we import you to ensure that unos does not hold patients hostage in the process. I urge you all to act and ensure that we make better use of the organs that are donated, to ensure they help equity issues with black americans and that people of caller are addressed and Technology Issues causing patients harm our remedy. I thank you for your time. Mr. Henry, thank you for your participating. I also want to note that he has asked that a letter from the Patient Affairs committee, urging immediate reforms in the triplet system, be entered into the record. Mr. Henry and colleagues, that has been done. For jamie locke is next. My name is dr. Jamie locke and i am the director of transplantation surgery at the university of alabama in birmingham. We currently have 1022 patients waitlisted for kidneys, the majority self identify as africanamerican or black. Transportation was always supposed to be about the patient but the system we operate now has almost a complete lack of ownership or whether it is getting recovered organs matched or more. These are governments own contractors. I patients and constituents need to rachel. We know thousands of kidneys are recovered and discarded every year and thousands more are never recovered at all. This increased since the most recent allocation change as the new system increase complexity. To date, you notice unos has shown no willingness to change. Imagine having a medication you need to lift being thrown away simply because someone took too long to get it to you. For life quite literally in a trashcan. Organs are no different, they have shelf lives and are measured in hours. Discarded organs and transplantation errors may sound abstract but let me make this role for you. In 2014, i received a kidney that arrived frozen. The intended recipient was synthesized, meeting difficulty matched. The only thing we could do was tell the waiting place should the waiting patient at the kitty had to be thrown into the trash. In 2017, i received a kitty that arrived in a box that appeared to have higher marks. The box was squished and the container had been ruptured. We are lucky and able to salvage the kitty for transplant kidney for transplant but why should luck paint play a role . Since then, i have received others had to be discarded due to handling issues or transplantation errors. One week was particularly occult. In one week, i received for four kidneys that had all errors because of two others arrived to me blue, meaning they had not been flushed. Opacity at unos means we do not know how often things like this have happened and there is no nothing in place to address the errors so they do not keep happening. All i know is i received four kidneys that cannot be used. What was particularly heartbreaking was two of these were for africanamerican or black women, women who had been pregnant multiple times are harder to match, contributing to both gender and racial disparities. This is a very real example of how constraint of organs disproportionately hurt women and women of color who are more likely to have multiple pregnancies. I know others have spoken out and more still want to speak up. Please know every person i have talked to who has spoken up about system failures has told me they happen punished in some way through both micro and macro aggression. The highest levels of leadership within unos is an insular club that has turned its back on patients by ignoring their own unconscious biases and patients behind closed doors. We need reform now. I am asking for your help on behalf of my patients. Immediately separate the optn from any of the boards of any contractors. Ring in rural experts to ensure our patients are served by the best of the best bring in real experts to ensure our patients are served by the best of the best. Improve policy, technology, and logistics. And sure patients are safe by holding all contracts accountable to public reporting and immediate redressing of problems. Final and critical point is i cannot tell you how disturbing it was to read of how unos has held the transplant system hostage. Unos has at times even threaten to walk away and continue operating without a contract despite the fact it would be illegal. To bring anything to jeopardize patients, even threatening to walk away, violates health care. It is called patient abandonment. You cannot threaten to do that. I would lose my medical license. If it is true that unos has started to walk away or not cooperate with a transition to a new contract, but that would make them responsible for not saving lives. Please realize that every day that passes with these feeling systems in place means more of our neighbors will die. I patients need the senate to act. Thank you all. These are terrible accounts that you have just given us dr. Locke. The idea that kidneys have arrived arrived with higher marks. The reprisal of those speaks the truth about the inefficiencies and gaps and quality with risk inequality with respect to the services. This is a wakeup call and you deliver this powerfully. We start with this question. And number of you referred to the issue of recovered organs being discarded. Obviously, the purpose of the transplant were network is too much organs with patients who need them. Unfortunately, one in seven organs recovered by any Organ Procurement Organization is not transplanted. That rate is increasing and has been since 2018. For kidneys, the most needed organ, it is even worse. One in four discovered discarded kidneys. A vesely, there are instances where an organ cannot be transplanted through legitimate medical reasons. But in the course of this finance investigation, we discovered an endless number of cases where organs are discarded because of errors from opos. In several cases, they were delayed or lost on their way to a transplant center. In another case, a heart was discarded because an opo had a policy disagreement with a hospital. In another case, an opo through two kidneys in the trash, immediately after recovering them. Mr. Henry, let me start with you. We have over 90,000 people waiting for a kidney transport in this country get to one in four are not being transplanted. My question to you, mr. Henry, you have been a patient advocate and have spoken eloquently today. How does this high discard rate and the practices that are being documented, how does this affect the publics willingness to donate when they hear this . My first hearing, about this inexcusable recovery rate is it is absolutely heartbreaking. We talk about the fact that a little over 90,000 kidney candidates are on the waiting list and 106,000 total organ recipients. As an advocate, i am tasked to go out to the community, which i willingly do because organ donors save lives. I willingly and eagerly advocate for Organ Donation. When you hear about the high nonuse rate, we think or ask for donations but the individual and the opos and unos you are in charge and are supposed to be stewards of ensuring efficient recovery do not seem to be doing the job necessary. Again, it is absolutely heartbreaking. Mr. Shepherd, week out this tremendous sacrifice by donors and families. All the time, money, and effort and recovered organs are not being transplanted into patients who need them. Is it acceptable that 25 of kidneys are being discarded . Is that ok with you . No senator, absolutely not. You find that never to be entirely too high and think every missed opportunity for transplant is tragedy. Why are they to hide what are you doing about it . There are any number of reasons that organs would not be used. There are specific operational events at opos and i think your research and review of the mpse file shows you that. I think a much larger number are simply deemed not a viable for transplant by the centers that they are being offered to. Of the things that unos is doing and just adopted a new metric for our evaluation at transplant centers is this year we have adopted a metric to measure transplant centers on their organ acceptance rate. In the past we have measured them on their post transplant success rate, how long did their patients last now we will also be measuring translate hospitals on whether or not they are accepting organs at annex a double rate. Do you think that is the heart of the problem, ms. Brockmeier . Dr. Shepherd says you have high transplant rates because organ centers are refusing them for any reason. I would like your thoughts. There are at times when i would discover that a potential donor might have had cancer so those obviously could not allocated for transplantation. On occasion, that does happen. But the cumbersome nests of the technology by which we can identify the best homes for those kidneys certainly complicates and compounds the discard rate. That, to me, is the heart of the problem. Yes, there are medical instances where it is warranted. You said that and i said that and that is the consensus. A heart of the problem is the system does not work and is way too cumbersome and inefficient. We have to turn this around. Senator grassley . I would like to have any one or two of you that can answer this question. You heard me in my opening comments refer to the fact that the system does not seem to be fair to racial minorities or People Living in Rural Communities so what are your efforts underway to understand the root causes and help make decisions fair to patients on the waiting list . Explain the factors that result in the disparity for minorities and rural populations navy process and how can the federal government address the problem . If we have to be involved in addressing it. One of the most important things we do not currently do is account for Disease Burden in terms of examining our waiting list. We have no way of knowing if we are actually serving the correct people or if they are actually making it to the waiting list. This ease burden is important because it not only identifies the individuals i need in need but also speaks to supply. Areas of high rates of Kidney Disease are going to have much lower supply and also are predominantly consistent of africanamerican or black individuals. If we want to make a truly equitable organ system, have to get more organs to those areas are there are higher Disease Burdens. The other thing is we have to have more focus on how we approach donor families to make sure that we have cultural competence apart of ever opo and how they approach families to ensure that we are not marginalizing minority families with regard to the Organ Donation process. Mr. Shepherd, unos has a responsibility to conduct oversight of membership. There is little indication that your organization is capable of doing it. In fact, this Committee Found that less than 40 of all Patient Safety cases are referred to the membership of professional Standards Committee which is responsible for moderate turning member compliance foot for monitoring member compliance with the Transportation Network policy and procedures. How does unos staff determine what cases are referred to this committee . Thank you, senator. Unos staff refers cases to be mpse, the pure committee. Our statute requires us to use peer review to do the Quality Improvement work we do. Our staff uses a rubric approved by the Peer Committee. The Peer Committee has given them a set of guidance rules to say these are the type of cases we would like to see and the type of cases that when you evaluate them do not need to be referred to the committee. Our staff do not make the judgments independently. All of those staff decisions, as to whether a case meets the mpse rubric for referral, are reviewed in a group of the member quality staff including the chief medical officer. With the committees findings in mind, should your organization reevaluate its oversight efforts so more cases are referred to the committee . If you disagree, why not . What are these things that our conversation with your staff has one of the things that our staff has led to is that the Current Committee might not be aware of some of the issues past committees have made in explaining the rubric. Now, we go over the rubric so each committee can endorse, amend or otherwise alter the description of what type of cases they would like to see and not simply rely on what a Pass Committee has decided. Mr. Friedman, in 2021, the u. S. Digital Service Found that the unos cannot properly modernize its i. T. System and its core systems are fragile. This is concerning, especially since the organization is the only Government Contractor responsible for making transplants possible. Can you give us an example of a time when unoss Technology Cost and hampered Patient Safety events . Generally, do you think Advent Health is getting the best value with regard to the Services Offered by unos . Senator grassley, i believe the i. T. System i agree with you that the i. T. System is fractured. Let me travel more time. Senator grassley, i agree with you that the i. T. System is fractured. There are situations where organs are not offered in a timely manner. I. T. System that unos currently utilizes does not allow transplant centers easily the opportunities to turn down organs or ensure that the right organ is going to the right patient. They also believe with the i. T. Technology as i stated, monitoring organs and organ placement, when i was in the military, i did medical airlift. My cruise out of Scott Air Force base knew where i was earl dwight with my patient i was worldwide with my patient. I kidney cannot even get a i cannot even get a kidney 20 miles away from my transplant center to me without unos thinking it is farther away. This is deplorable and needs to be fixed. Thank you senator grassley. Senator cardin . Thank you mr. Chairman. We thank you for your leadership and i want to thank our Witnesses Today. Our Committee Report verifies our fears that the system today is clearly broken. Our Witnesses Today have reinforced that view. That is a tragedy that needs to be corrected. Unless you have transparency, unless you have accountability, there is no way that you can correct a system. If those that want to report a problem are retaliated against, this makes the matter much, much worse. We have the chance involved to accomplish that and we have the chance to do that. I am hearing about numerous receipts mistakes of harvesting and preparations and matching and transportation. If you do not have timely knowledge of those errors, you cannot correct those errors. From what i can tell, most of these errors are being hidden rather than acted upon and changed. So, all of us are involved in buying products are attractive and we are amazed how we can see every step of the process. The technology is why the utilized. Mr. Shepherd, let me ask you about the technology you are using. According to our reports, your system has crashed on several several occasions when your system is down, you cannot do a match so time is lost. We are seeing all these challenges. Is there a financial poem as to why you cannot update the technology . Is there a reason why we cannot get what much better performance on vital organs being trapped tract or master . What is the poem here . The problem here . The optn system is highly reliable. We are audited annually. My information had 17 every day there is loss of life isnt it . That is the total amount of time. The system isnt down 17 days a year. The system has never been down for a day. To my knowledge. I have not been on since 1999. There was an event that was longer than an hour and that was three hours. But the total time since 1999 you are satisfied with your technology . You are satisfied with your tracking systems and you think everything is ok . We attempt three million times a day to hack into the database and we successfully repel them all. We are never satisfied with our technology. We do maintain 99. 9 we disagree with the u. S. Is analysis of our system. I understand that you have restrictions by law that you should not have to change the laws but the system is working right. I have heard so many example here of mistakes that need to be corrected. Whether they are testing mistakes, whether there whether they are shipping mistakes, and they are not being corrected. Why arent you proactive in working with does if laws need to be changed so we can get a higher sufficiency on making these organs available . We would be happy to work with the committee and anyone who is interested in legislation that would improve the safety of the system. We work directly in a pure review process with op owes and transplant hospitals for an incident and many of our incidents, nearly half of our incidents reviewed by our committee are selfreported. Selfreported should be. That is a good thing. Who retaliates against people who are making, you mention intimidation factors about making reports. Can you enlighten us to what is happening out there. . I have personally had people come up to me and made comments, i submitted a letter related to some of the other emails that were unsealed that disparaged our population in the United States and i submitted that letter along with other colleagues region three and had two different Board Members approached me and suggested that i should not have done that and that was inappropriate. So it makes it very challenging. That is just one example. I have other colleagues who feel they have been blocked from being on committees and other things and we have all been silenced at our region meetings on more than one occasion when we have spoken up about what we think is not appropriate. We have been told that is something you cannot vote on, you cannot present data, only they control the data that can be presented. We are members of the opt in and the purpose of those meetings is to be able to have representation and have dialogue about what we think is going well and what is not going well. It is incredibly prescribed and we are routinely silenced. Thank you for coming forward i appreciate it. Thank you senator cornyn. I also want to note all of the notes mistakes being taken which i believe its a pretty serious to keep them subpoenaed. The number of nature of safety events, this whole portion senator cornyn is talking about with dealing with the state is very much on point and i think my colleague for raising it. Next in order of appearance will be senator portman. Thank you, mr. Chairman. Mr. Chairman i have got to follow on some of the questions that senator raise. According to information obtained by the committee, a seven year. , at least 249 transplant recipients have developed it have developed diseases from infected organs and have died. One of those cases was in ohio. The recipient came for a routine followup and was informed he accidentally received a transplant form a transplant from a donor with cancer. Tragically it was not on the initial report. That the recipient had a three week. Where they didnt even know that the donor had a brain tumor and it was on the pap apology report and was not available for some reason. This recipient has now been told he is likely to die within three years. There are four chairman in the and they all do work. We need to make sure the lives are not lost and we dont have tragic situations like this one due to testing failures. Can you tell us, mr. Shepherd what more we can do to ensure there are these 2800 ohioans that do not receive organs that are infected . Yes, thank you. You knows has created in the opt in which also creates in addition to the Peer Review Committee which is studying the specific techniques, specific operations that may need to be improved or changes that a transport that a transplant hospital might need to make, actually reviews transmissions, ensures rapid communication between op owes and all the recipient transplant hospitals so if one transplant hospital were to find they received an infected organ, there is a quick communication chain back to the rest of the organs that were recovered from that donor. And we continue, that committee routinely provides guidance. You said earlier there is no regulation of these op owes. There are a lot of great ones that stabilize every day. There is a monitoring of this and information provided. There is no assurance these best practices would be followed, even upon disease. Is that true . If you are asking from being a opo the peer review does not have authority. You dont have the ability to require them to do things. A lot that comes out in this says we should automate the data entries for their Health Care Records and we should be automated right now. Updating information manually accounts for human error. Do you agree with that . We absolutely agree data should be data entry should be automated. Does opt in require that . Opt in does not require the use of api. It could be the difference in life and death from Cyber Attacks. Do you believe you are protected from Cyber Attacks . We never are satisfied with our protection from Cyber Attacks but we know we are potentially to be hacked into more than 3 million times a day and have not yet been successfully hacked. We continually update those connections on a daily basis. That is a very beneficial service. Other commercially available factors, there is not a single requirement to use a particular system. The 20 discard rate has a lot to do with transporting organs and a lot to do what tracking is a part of the problem. In one report, organs or 15 times more likely to be lost or damaged then your luggage when taken to an airport. Is that possible . I havent seen that number. I would certainly be surprised. That came out of this report. You talked about the app you are developing to offer transport options. Is this cap operational . It has been fully you rise by our organs to fully utilized by our organs since her oregon center. Would you plan to make the network safer from Cyber Attacks by using automation . Is there a plan to do that question mark is there a plan to do that . Yes. I didnt mean to leave you out. We have some questions to record for you all. I thank you for holding this hearing for the committee. Thank you mr. Chairman. Next is senator warren. Thank you, mr. Chairman. In the United States and people need an organ transplant, their lives are in the hands of one federal contractor that our government calls to run the entire National Organ donation program. Today the system is run by you not which got its contract back in 1986. It is the only industry that has ever been awarded or even bid for this federal contract. It is response will for seeing that overseeing opos. Some opos are a disaster. Never collecting organs that could have been donated. Without competition, the organ transplant system over all has become a dangerous mess. Right now, you knows is 15 times more likely to lose or damage an organ in transit as an airline is to lose or damage your luggage. That is a pretty terrible record. Mr. Chairman, you are the ceo of unos and you have document these problems. In the 36 years that they have had the contract to run our National Organ system, and how many times have they declared its op oh what opo members . Two times. It has run for past three decades and has received at least 249 recipients have developed diseases from infected organs after transplants. At least 70 people have died from those transplants and you have looked the other way when one of your members was a part of an illegal kick next game that eventually sent an opo executive to prison. 36 years, a list of problems, kickback scheme and yet it is only twice declared one of its members not in Good Standing. A designation that is so toothless that it doesnt even require the opo deposits operations. Let me get one other piece of data out here. Mr. Shepherd, how many times has it put an opo on probation . Is not a large number. It is three. This is sitting on your hands while people die. They have been allowed to look the other way because it is never safe in competition. Finally, the federal agencies that awards your contract is now heading into this contracting cycle that stakeholders have said we must break up the monopoly for the first time ever. Based on the prospect of accountability in the past, has demanded tens of millions of dollars to hand the Technology System that gets developed with taxpayer funding. It has even threatened to walk away and refused to continue to operate the operating the organ system without a contract. Can you attest that they will not in anyway attempt to hijack the United States transplant system during a transition to future contractors . It will never make an attempt to take any action that will harm patients. The discussion that comes to light in the u. S. Ts was our attempt to assure her show that to assure we would not turn away from patient even if paperwork youre not going to walk away and turn the system off . You are also not going to demand millions of dollars developed for taxpayer transplants . Approximately 10 of this budget is taxpayerfunded. The rest of that is paid by hospitals when they list patients. The government has not over the years paid for the software. So you are still planning to get millions of dollars for the system . That is what you want to do . Sell it back to the government if you dont get this contract . The contract allows to purchase we have an obvious i will be clear, you should lose this contract. You should not be allowed anywhere near the organ transplant system in this country. If you try to interfere with the process of turning the contract over to someone who can actually do the job, you should be held accountable for that. There are a whole lot of reforms that are needed in this system, but this is a good place to start. Patients and families deserve better than they are getting right now from eunice. Thank you mr. Chairman. Patients and families deserve better. Senator young. For many years i have taken an active personal interest in the Organ Donation system. A very good i had a very good friend, i served with him in the u. S. Marine corps. His name is david mcfarlane. I have gotten to know his wife, jennifer, we call him gunny mcfarlane. I reconnected with gunny mcfarland when i moved back to indiana after service in the marines. He died waiting on a heart. That was a really powerful experience for me. When i was elected to the u. S. House rep is iterative, resolved to do whatever i could to bring more organs into the system. Hate to find out there was seemingly very little i could do. I scrutinized a an existing system that was highly opaque. That is really frustrating to a lot of americans. In recent years, as some of my colleagues have indicated, there have been a number of complaints submitted to knows. Less than 14 of those were referred for an additional claims resulted in probation. A very impressive record of success, a low record of probation. My strong suspicion is whether these complaints are indeed valid and should result in probation. 2, these complex of lead to a member not in Good Standing. There are allegations ranging from illegal Financial Arrangements to testing failures resulting in patient deaths. Im going to ask for a real short explanation. Mr. Shepherd maybe mr. Shepherd you can provide it. The reason would be, the primary tool for you knows is the peer review process. It calls for us to be the confidential coaching in contrast to the regulatory and financial oversight rules that cns provides. Ok. And yet we still have a large gap between the need for organs and the number of organs brought forth. It doesnt seem like we are awarding success. It doesnt seem like we are Holding People accountable for falling short of success. Once the opos designated night and good standard not in Good Standing, it is toothless. Indicate war me what penalties or sanctions are actually placed on an opo when they are designated not in Good Standing. The statute does not give any options for certification like that. The you know statute doesnt give us the ability. It is toothless in that sense . It is designed to be by regulation and contract and improvement contract in contrast to the oversight by a federal agency. What corrective actions must occur for the opo to get back in Good Standing . And member not in Good Standing is generally in an environment where multiple things of gone wrong, there seems to be not an incident where an organization with a strong culture would cover from incident. More systemic issues would be expanded. Is there a review process to in to ensure members are complying with rules . Members go through monthly meetings with the committee for usually two or three years to come off of that standing. All opos are reviewed annually. The American People would expect the system to perform. I would like to return to donna organs that are lost or delayed and transport. To what extent does track the standing of organs at any time . It is not track organs and transit. We provide a service they can use to use gps service on some of these commercially available products. How does it plans operate organ if you dont have 100 visibility into where they are at any time . The gps products that we offer and other people offer are valuable that you help in the delivery of kidneys. Only kidneys that traveled by a company. I think the gps trackers are valuable and that is why you see more use that. My son can order a pair of shoes or a toy and get a pretty good sense of where it is at any. Of time. At any period of time. This is lifesaving. It seems like that ought to be locked in. We will continue. I know the chairman and Ranking Member have made this a real priority. My colleagues, many of them have doubted the importance of this issue for some time. They are beginning to get energized and animated about it. I am encouraged about that. We will keep fighting on behalf of our constituents. Thank you, chairman. Thank you for your participation. I just want to make a point that is clear for the record. Mr. Shepherd has said twice, with respect to this whole question of the power to decertify and opo that cns has the power to do it. It also has the power to decertify qualification under the opn rule. That has been done only once. I wanted to say that with respect to making sure the committee has got what is really going on with the certifying opos. Mr. Shepherd, before going to the other stuff, i would like to ask procedurally, according to the committee staff, you were not cooperative. Records were not given. That after a committee issued a subpoena on february the third, on those continued to withhold relevant information without recognizing federal etc. Final information was given with reductions. Reductions are not a patient. It was a senior opio employee. Why was you knows refusing to respond and why were you hiding information from the committee . We explained because of the peer protection of the evaluation process it required a subpoena to open that box. The subpoena was given and you continue to withhold information from the committee . What happened there . The Hospital Administrator is not someone to be redacted. The patient needs to be redacted. Why were you redacting senior opo employees . The fool participation in our interview process was what we believed to a full understanding of the event. We asked if redacting the service would help them understand how it worked in these events. They said no and we submitted documents that were unredacted. Next, you mentioned the transport system. You mentioned earlier continuous improvement, Quality Improvement. I had a lot of patients who died on transplant because of organs. I had a lot of patients who were black with renal failure and couldnt get transplant. The remarks of your work member, are particularly insulting to the patients for whom i cared for for many years. I have a sense of indignation that dr. Locke shares my indignation. I do not know if i i do not know if you are allowed or will continue. It is amazing such prejudice. My louisiana opo tells me they asked you knows for a tracker. That they didnt hear back. That they didnt hear trackers. Seven weeks later they get an organ, a kidney. They ship it. It gets lost in transit and eventually it expires. If this is a Quality Improvement process and they are relying upon you, they say their emails were not being answered. What kind of breakdown do we have in the system where emails are not getting lost in transplant. Im not aware of that situation it is disturbing. I know the leadership of the opio. This at the emailed the organization twice. Dr. Locke has this incident in her testimony. So it was known outside of louisiana. It just seems like a failure of an organization. Ok. What case would you make for them to have continued contracted cms toward . What would give us confidence that there will be a change in direction whether there is a responsiveness to emails, i need a tracker, and the obvious failure when the tracker doesnt, the patient is lost in the patient doesnt get there translate. What case could you make . By making the transplant and donation community, wherever you understood we have a unique understanding of how Organ Transplants work. I dont understand the particular situation and i find that is as troubling as you do. But i also think there is a long track record of promoting increases in transplantation in equitable transportation. We have an equity tracker that says once listed, african and rural patients are transplanted at similar rates as other patients. It is the weightless that it is the equity challenge. There are things we can improve and we do every day i do think it is a Strong Organization that has served patients well. We heard a lot of testimony today that suggest that is not the case. With that i yield. Thank you very much. It is a very important question. I am going to walk everyone through what we have turned up with respect to transportation organs. This is a major focus of the committees investigation. We asked about it. Unos told us, it does not collect transportation data on systematic basis. That strikes me as a showstopper kind of response. Unos does not track donated organs arriving at transplanted centers. How in the world can we give people confidence if the organization that runs this, it turns out unos tracks the shipments they handle themselves, even in this very small sample, dozens of organs are thrown away each year after transportation. Unos it is the other 96 of shipments that are just as bad because they dont ask. Unos has not made any policies on safe organ transportation. And opios are not required to report these issues. When complaints about transportation failures are made, unos does not reply. So, dr. Locke, you have been outspoken about this whole area, with respect to the deficiencies in unoss operations. Tell us a bit more about organ transplant programs and what your response has been when you hover ordered problems with transportation you have reported problems with transportation. People have described we have about a 25 if you look at numbers last year, it would be about 8000 kidneys. I think in some ways these are the victims of an entrenched allocation of rhythm algorithms that are organ a. Organil. It would result in more efficient placement of kidneys. This would decrease time. It reflects the failure of transportation logistics. If you take the organ center, they have a very rigid system for assigning flights and lack either and ability order interest in thinking outside of the box. For example, there are no direct flights from california to birmingham, alabama. Instead of looking for a flight from San Francisco to atlanta, understanding a carrier could pick it up from atlanta and drive two hours. Someone sets it on us on a flight from sfo to atlanta and allowed to go to cargo hold overnight where it is literally rotting. Where putting extra time on it. Lets make sure everyone gets this. You say you have seen instances of something being put in cargo hold when it is very likely to rot . That is correct. If the kidney arrives after 10 00 p. M. At the Atlanta Airport it goes to cargo hold. We discovered that and made calls to the airlines ourselves and after several calls the airlines were mortified, not understanding that was what was happening and had their manager meet our courier. We were able to get the kidney out of cargo hold. This went on before we figured out what was happening. Essentially, they flight in. It sits in cargo hold and comes out the next morning to catch the next flight. Instead thinking outside the box, instead of getting to atlanta, it is drivable to birmingham. That sounds way too logical for what unos is often up to. Please go ahead. So, from our perspective, one of the things we really want to understand is why have we not engaged experts and applied mathematics to optimize our matching algorithms and organ placement . Why havent we engaged experts in logistics around transportation . I think of the faa. What a remarkable entity. The fact that every day thousands of flights across the u. S. Are in the air at the same time and dont crash into each other. They know exactly where given plane is. It happens almost seamlessly every day. We should be able to do the same thing or our transplant system for our organs. As i said, miss brockmeier, unos has developed this organ tracking system. Do you all use it . Im curious what you think of it . Thank you for the question. Senator, we did use a participant in the beta pilot through unos and made the decision to not move forward using their product. Why was that . Part of the issues were Service Related issues, the lack of the interconnectivity we wanted to be able to facilitate more expedited visual tracking for the organ. Was a tracking technology lowquality . Yes. I have additional questions but my time is up. Senator grassley. Ok. Mr. Shepherd, in your testimony you highlighted how people work on the Organ Transplant Networks 40 committee come from dashboards commit he come from all comes from and how effectively the system works to protect patients. Yet, the way you describe these people and the peer review process in the documents you provided to the committee was very different. I would like to enter into the record to emails that you wrote. Here is how you describe the principal transplant Oversight Committee in one of your emails produced to the committee. You said, allowing the committee to fill these jobs increases communities beliefs in the validity of the document. You go on to say, it is like putting your kids artwork up at home, evaluate because of how it was created, rather than value it because of how it was created rather than how it was done. We persuade ourselves that it was well done anyway. In email you describe the Organ Transplant Network that you are in charge of as nothing more than and i quote, an overgrown homeowners association. Now, when you compare the Organ Transplant Network you oversee to an overgrown homeowners association, doesnt that call into question the effectiveness of the oversight and government processes of organ transplant system that you are saying works so well . Senator, i dont recall those particular emails or the context. They are yours. I assume they are. They are yours, mr. Shepherd. And they are central to your beliefs, as you try to tell us everything is hunky dory. You wrote a bunch of emo psycho 180 degrees in the you wrote a bunch of emails that go 180 degrees in the other direction. Let me turn to the issue with respect to Information Technology. The principal function of unos is to manage the electronic database, to keep track of Organ Donations and match them to people on the transfer want waiting list. The technology that is used here is woefully out of date. Government report entitled lives are at stake, the governments role in modernizing the obt and confirms that unos lacks capabilities to monetize their system which the Current System requires. Instead of a modern integrated cloudbased sickness system, unos requires manual information updates at every stage. Unos computers have crashed for a total of 17 days, with one, february 2021 outage lasting three hours. Mr. Shepherd say said improving the system to industry standards was not a priority for unos. Because it is not like air traffic control. Mr. Henry, i think you are still with us. We are glad that you are. These organs are very perishable to somebody who received a lifesaving transplant. My guess is you believe every minute counts when youre on the transplant waiting list. Yes. Absolutely. Like everyone else, we have read the reports. We have read the Washington Post reports from earlier this week. The it services obviously have been inadequate for quite some time on Patient Services committee, our leadership has voiced their concerns about the i. T. Systems for quite some time, without much of a response. Mr. Henry, how long have you been voicing their concerns about how i dated the i. T. Systems are outdated the i. T. Systems are . Im speaking about Patient Affairs leadership. I have been recently appointed as a representative for the Patient Affairs committee this year. So, as far i read through a lot of the emails and Background Information and spoken with leadership of the committee about these issues including the i. T. Services. That is what i am referring to as far as our concerns about the i. T. Systems being voiced, but not addressed. You are correct, senator wyden. Every minute counts, every Second Counts when we hear about downtown downtime as a i. T. Issue. Those are lives that are lost, patients dying, while i. T. Systems are down. So, again, heartbreaking issues that we feel should be addressed. Again, because you are on the front lines, tell us your experiences with unos systems. Lets talk for example about Something Like donor net. Why has that not been modernized . The response, that we were provided with the Committee Day i was chairing. I asked about improvements, if there was bandwidth that the i. T. Department would address. You did not have Current Technology . I cannot say what started the response. But that was the response. Bandwidth, that is a priority. Your technology is not uptodate. Ok. Lets go opio failure rates. Again, like everywhere in our society there are performers that do well and some that do not. A range of organs is massive. The highperforming opio successfully recovered in transplant, as the poorly performing opios. After several years of how to improve the opios, medicare and Medicaid Services adopted a raw performance standards. When measured against the standards more than one third of the 57 opio are failing. Not one or 2, 22. A lot of people in community oppose the ruling, including unos. When you see the large number of opios that are failing to me to the standard, i guess you can understand why. Your op oh is not one of them. You think your measure is a step in the right direction for holding opos accountable. Our organization went on the record early on in strong support of the proposed metrics. While they may not be perfect it was an improvement over what we had here today. The metrics are designed in such a way that everyone can accomplish them. We can all be here one performers. It takes a dedicated performer step. To ensure your opo is ready to respond every time the phone rings to make sure all the organs are recovered. Lets talk for a moment about the boards that are supposed to be overseeing these. It looks to me that there is a serious conflict of interest here. I will send this, perhaps he would like to get to this as well. The Organ Procurement Transplant Network which is the formal title of the Organ Network that operates under federal contract, administered by hhs and unos which is the contractor that operates the network and controls about the information of the network has the same board of directors despite this the efforts of the government to separate them. That means the people who look out for the best interest of unos, multimillion dollar nonprofit are same people who look out for interest in the entire Organ Transplant Network. That sure sounds like a conflict to me. Unos claims two boards must be the same. That is their claim. Weve got to be the same. Theres no need for the board to be independent of the Government Contractor that runs it. Why shouldnt the network have an independent board . An independent board that can make its own judgments about whether the contractor is performing adequately . Your thoughts . Yes, i think there should be an independent board. I think the division of the responsibilities of the board and by the inherent ways that they are structured do pose a conflicts. It would be like if you had an organization that was a supporting organization, you would want to hold it accountable for its performance. The current structure limits that opportunity. Mr. Friedman . Chairman, they changed the board complexity for opos requiring non transplant individuals. The same thing can be employed here as well. As we make organ allocation changes, people win and people lose. What we have done in this country through the efforts of this board is allow has allowed individuals to express their opinions at the board level and the executive board level that were based more towards their own individual needs. This has to change. That is why i continuously, at our region three meetings, continually recommend that we separate that out and allow the membership of unos. This is a membership driven organization to bring us up to speed so we have transparency and that we regain the trust of our providers, our hospitals, our opos, the patients and the donor families. We cannot lose that trust. I support you as the chairman of this to enact that immediately. That can be part of the contract. We are just trying to determine if we have any senators on. The way. Let me ask our republican colleagues. We do. We do not. Thank you for your participation. We are very pleased that a strong advocate of patients is here. Lets let senator casey get settled, we will go to him for his questions. Ive got a couple of other areas that we need to look at, briefly. Senator casey . Mr. Chairman thanks so much. I wanted to start by thanking you for the hearing and for the work that you and the Ranking Member have donei n conducting this simple done in conducting this important investigation. This is a subject area that doesnt get nearly enough attention in washington and not so in the context of this hearing and the work that was done by this committee and staff. All of their good work should be held up for commendation. I also want to say i know im late for the hearing. I may have missed some of the engagement and some of the answers to questions. If my questions are redundant or duplicate of i apologize for that. Ive come to this issue, not just in the context of a public official and a member of a committee, but also in a very personal way. My father was the beneficiary of a double organ transplant in june of 1993, harding lover. Now many heart and liver. Not many 61 euros at the time a 61yearolds at the time had were beneficiaries of that transplant. I was told he was one of only there have been only six in the nation at that point. Four of those six were dead. So his chances were not great. But thankfully, he came through it. And was able to live seven more years almost to the day. We were blessed and fortunate. About 100 separate things had to go right for him enough to die before receiving that double organ transplant. Transplantation. We were grateful for that. But, i wanted to focus on the last two recommendations that call for both transparency and accountability. For chain of custody entranced on of organs chain of custody and transport of organs. We know americans are anxiously awaiting for these lifechanging operations and waiting for that call to save the life of a family member. I wanted to start with dr. Locke. In terms of both the transparency and accountability, how would both improve transplant system . I think it would result in more lives saved. If think about the three areas that youre supposed to oversee. Greater transparency around policy would lead us to address gender disparity and liver allocation sooner. In 2002, the model for liver was introduced. When you do create we knew that created gender disparities in allocation. One of the measures incorporated into males is not reflecting does not reflect kidney functions and women. It is this year we finally updated that to address that, 20 years later. That was a policy example that should have been addressed sooner. If you think about transportation. I gave an example a minute ago. Having a unos organ center that is more flexible in their ability to figure out logistics. Instead of thinking of trying to get a kidney from San Francisco to birmingham and only looking at flights i get you to birmingham and having the kidney go from San Francisco to atlanta and getting there so late that it gets in cargo get stuck in cargo load and is literally rotting until i can get into a plane the next day. As the surgeon, getting that kidney and having to make the decision, can i use this, is it going to be ok, is there too much time, am i going to put the patient at risk or should i go for it . Versus having the ability to get the kidney to atlanta, having a courier drive and pick it up to birmingham and save 12 hours of call time. Those things matter. If you think about i. T. , something as simple as having a system where we can easily put in unacceptable. This was a debate for many years. For context, we list unacceptable antigens to list better matched kidneys. We have a high probability that there will be a good tissue match. That took forever. We couldnt really get our unacceptable antigens and. People get offered kidneys that are not going to be a match and you have to get through all of those before you can get to the person that they really should go to. Those are simple examples. If we can have transparency and accountability around those kinds of things, we can save more lives. Thanks very much. Thats compelling. For those of us who are concerned about the work of a Committee Like the finance committee being done, report and investigation, study is only as good as the implementation of it. I turn to you mr. Shepherd just having heard from dr. Locke about the benefits of both increasing accountability and transparency. What you commit to implementing you may have been asked this, and may be redundant would you commit to implementing the bipartisan recommendations with regard to both transparency and it can ability when it comes to Organ Transplantation . We are always looking for ways to improve the process. I look forward to receiving receiving the committees look forward to receiving the committees recommendations. I hope that part of the followup of the work of the committee, the engagement with you and others, we live in a world where we can use technology and all of the innovations that our economy presents to virtually have instantaneous retrieval of goods. Everything from ordering food to groceries, goods online, the idea that we cant have in place some of the practices and procedures and pathways to move organs faster. I hope that would be something that would be the subject of history as opposed to where we are headed in the future. I look forward to talking to more about it. Mr. Chairman, thanks for your time. Im over. I appreciate the work you have done. Thank you. The committee has a great interest in these topics as well. I need to make another correction. Something mr. Shepherd said, we will get close to wrapping up, unless any of the senators are here serving on the committee. Mr. Shepherd told senator warren that only 10 of unos funds come from taxpayer money and the rest comes from fees paid by transplant centers. But the fact that medicare is the largest payer of the fees, for kidneys. We are talking about inefficiency that puts patients at risk. And taxpayer dollars are used to cover some of these practices. We have been added for a couple of hours. This has certainly been an ominous portrayal that you all have heard about with organs, tire tracks left. Weve heard about organs left behind to spoil in airports. We have heard about reprisals against people who try to speak the truth about what is going on. Weve heard about the culture of secrecy that dominates unos. We got emails that mr. Shepherd ridiculed employees, that he says he counts on. We also have gone through some of the details, with respect to the Transportation System and probably the best way i would describe it, its not even a system, just sounds like confusing at best. We hear testimony from Witnesses Today. And certainly according to witnesses representing opos transplant centers, patients. There are Serious Problems in the organ procurement transplant system and it is not keeping up with demand for organs. Patients die every day while they wait. The committee is going to continue its investigation. We have already looked at over 1100 safety complaints filed with unos. They provide example of patient deaths and near misses after people have been selected from the list for transplant. One third of the nations organ procurement nations failed to meet the minimum standards set out by the agency that certified them to operate. One in four kidneys are covered for transplant never transplanted. The federal experts on Information Technology said that the network i. T. Systems are not up to the task and that unos, the contractor that operates them simply doesnt have the Technical Capability to update them. The testimony from unos, which is the organization that has run this for decades is unrepentant. You have not heard anything resembling it at all. We heard the smith over the last decade. We should have done it but we are going to get it fixed soon. According to mr. Shepherd things have never been better. That is really what we have heard today. We have the contract, claims mr. Shepherd, we are doing fine, our people should be satisfied with it. The patient and the families and the physician basically are sending a different message. The situation is dire. The organization responsible for fixing it says there really isnt anything to fix. So, we have certainly found in our investigation, thus far, theres a lot to fix. We will continue the investigation. The committee will be looking more closely at the role of federal agencies, the center for medicare and Medicaid Services. They are charged with overseeing the system. We will be looking at that. And federal contract that unos has had for decades is up for renewal. This is an opportunity to fix things. On this committee, in a bipartisan way, we are determined not to miss this opportunity to get this fixed. Thanks, senator grassley, senator young, for their interest. They have been working on the committee for a long time. It is not a partisan issue. It is a national issue. As we have touched on, repeatedly over the afternoon. Patients waiting for organs and families of donors deserve better. We are going to stay added until they get those fixes. Let me also note, procedurally, that members have 14 days to submit any questions or statements for the record. I want to think our witnesses, mr. Henry thank our witnesses, mr. Henry was been out there giving us good information, cyberspace for their patients. Meeting is adjourned. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap. Org]