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During a House Energy Committee hearing before the Congressional Recess, Rep. Kevin Mullin (D-CA) asked Chief of the Organ Transplant Branch at the U.S. Department of Health and Human Services Dr. Raymond Lynch about clarity surrounding organ procurement policies.
Transcript
00:00Gentleman yields. The chair now recognizes the gentleman, Mr. Mullen, for his five minutes of
00:05questioning. Thank you, Mr. Chair. Dr. Lynch, thank you for being here today. And Mr. Chair,
00:16thank you for calling this hearing to discuss such an important issue. Right now, there are
00:21over 100,000 Americans on the transplant waiting list, hoping to receive the phone call saying that
00:26they will finally be getting their transplant. While we must address flaws in this system, it is
00:32important to also recognize that it saves lives. Just last year, there were over 48,000 transplants
00:38in the U.S., the most ever, and that was made possible by over 24,000 unique donors. And yet,
00:45we still don't have enough donors. 13 people die every day waiting for an organ in the U.S.
00:51To reduce needless deaths, I believe that Congress must work to strengthen the public's trust
00:55in the transplant system. Donors need to trust that their selfless gift will be used wisely,
01:01not only by the dedicated medical teams performing life-saving transplants, but also by a federal
01:06government that prioritizes safety and conducts strong oversight. While I'm confident that many
01:12OPOs are highly committed to ensuring rigorous safety protocols, HRSA's investigation highlights
01:18some inconsistencies regarding how much authority is given to OPO staff during the organ donation process.
01:24In a medical setting, confusion can have heavy consequences. OPTN policy states that when
01:32evaluating whether the patient would be eligible for donation after cardiac death called DCD,
01:38quote, the primary health care team and the OPO must evaluate potential DCD donors to determine if
01:44the patient meets the OPO's criteria for DCD donation, end quote. Dr. Lynch, in your assessment,
01:51how is that collaboration, that collaborative evaluation supposed to happen? And is there
01:57a lack of clarity about this policy that needs to be addressed by OPTN or HRSA? And if so,
02:04what steps are being taken to provide that clarity?
02:12This is a public good. Transplant is a good thing. It is a focus for the federal government. Three successive
02:18administrations have worked to build our ability to deal with this, and we've enjoyed support from
02:24Congress in that role. The work that is done here, the collaboration between the OPO and the primary
02:30hospital, is one where the OPO is the driver. They are the one with whom the decision to proceed down a
02:36procurement pathway begins and ends. The hospital cannot force them to do that. The family cannot force them to
02:42do that. The OPO is the subject matter expert, and it is their call on what constitutes a
02:48potential organ donor.
02:51So I want to ensure that we aren't only reactively conducting oversight after a horrifying case and
02:59examples of those cases. Oversight over the transplant system needs to be forward-thinking
03:04and proactive. So, Dr. Lynch, are there any other strategies that HRSA is considering to improve
03:11the interaction between OPO staff and hospital staff and their respective roles on these DCD cases?
03:19So, there's two elements to that. The first is that, as you say, proactive is best here.
03:26Developing a true denominator for all these interactions is important. We know that over 1.1 million cases last
03:33year, an individual was referred to an OPO. Many of those individuals recovered. A referral was made,
03:38and the OPO opted not to proceed with evaluation. But HRSA's ability right now to know what happened
03:45at subsequent steps until somebody was an organ donor with what's called a UNOS ID is poor. We're
03:51improving that, and I think the best way to understand the utility of that is if you ask somebody,
03:56is air travel safe because there was an air disaster yesterday, you would want to know how many flights
04:01happened yesterday or last year to know if it's a single event or a common event. That is what we
04:07are doing here. In terms of providing the education and making sure that roles are understood and that
04:12the goals of care are collaborative, that is something that is an OPO's obligation to perform.
04:19They can do that in the abstract, so to speak, making sure that hospital staff are made aware. And then,
04:24when a potential donor patient is identified, they should have just-in-time training to go through what the
04:29steps that will follow are and to give everybody a clear understanding that if the patient status
04:35changes and they would not be considered a candidate, that the process should be halted or can at least
04:40be temporarily halted while that's investigated. I appreciate that. Thank you for your report and
04:47your continued work. Clear delineation of the roles of OPO's in hospitals is essential to avoid preventable
04:53harm to potential organ donors. Far too many people die each day waiting for an organ. It is critical that
04:59patients and their families have confidence in the decision to be an organ donor. A noble decision
05:04that can one day save a life. And with that, I yield back.

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