00:00Minutes to the ranking member for her five minutes of questioning.
00:04Thank you, Mr. Chairman. I want to start by expressing appreciation for the extra oversight
00:10that HRSA has conducted here. Because of that work, we have some tangible findings and clear
00:16recommendations for process improvements. I'd like to talk through HRSA's process in investigating
00:22the Kentucky case. Dr. Lynch, has HRSA ever directed the OPTN to initiate an investigation
00:30like it did last October regarding the Kentucky Organ Procurement Organization?
00:37I should clarify, Madam Ranking Member, that this occurred before my time at HRSA started in October,
00:42but to my knowledge, I am unaware of any such direction. Okay, so what has enabled HRSA to
00:48direct OPTN to carry out more stringent oversight while also conducting its own parallel analysis?
00:56To be frank, it's the Securing the U.S. OPTN Act. It's the authority that Congress gave us,
01:01the ability to hire in expertise and to stand up a data and analysis team to make sure that
01:08we can study these problems with the appropriate degree of rigor. So why did HRSA determine that
01:14this level of oversight was necessary over the Kentucky Organ, excuse me, the Kentucky Organ
01:20Procurement Organization? So the initial decision, again, preceded my individual time at HRSA, but it
01:27was a relatively easy decision to identify this. On probing, the OPTN contractor had sent a letter to the
01:35OPO asking for a detailed list of information. They got back a one-page letter telling them that there was no
01:41problem, and that the OPO was satisfied and confident in the process that this patient had
01:46undergone. The OPTN and its contractor then elected to close the case. Closing the case without reviewing
01:53the documents that you asked for is so inconceivable in a safety investigation that that made HRSA reassess
02:01this. Very well. The OPTN Board of Directors is also responsible for enforcing its policies among OPTN
02:10members, which include OPOs and transplant hospitals. Dr. Lynch, how does HRSA envision the role of the new
02:18OPTN Board in conducting oversight, and what changes should it make from the way things were handled
02:25previously? So the the vision for the OPTN is to provide that system level oversight. And to be clear, HRSA and
02:32other agencies within HHS provide parallel lines of support and oversight for elements of this community. HRSA is the
02:40system. By the OPTN, we're able to manage the elements that are within the the transplant ecosystem, so to speak. The
02:48vision for this is that every patient who is touched by a member of the OPTN system should have their
02:53information knowable, and their experiences, good or bad, should be the basis for subsequent policy making
02:59and policy improvements. The findings of the report are deeply concerning, and it's astonishing that no
03:05one appears to have thoroughly examined what happened in Kentucky for several years. The incident, including
03:12T.J. Hoover, occurred in 2021, but there was no report of the case until 2024. Stronger oversight
03:20protocols of the OPTN and more transparency from OPOs would uncover patient safety issues more quickly,
03:28enabling more timely improvements. Dr. Lynch, how does HRSA plan to increase oversight of OPOs specifically
03:36and improve visibility into outcomes for pre-donors, as you mentioned in your testimony?
03:41So it is a multi-layered approach to this. The first is knowing the data that every patient who's
03:48interacted with will have their information known to the government. That's something called the
03:52ventilated patient form in the case of the OPOs that we will know from the time of referral and first
03:57contact through either the successful recovery of organs or the end of the OPO's contact with that
04:02patient. And then in the case where something adverse happens, HRSA has already changed its practice so
04:09that instead of the report going to the OPTN contractor and being triaged there, reports can now come
04:14directly to the government for assessment and direction to the appropriate entities.
04:19So what triggers that when it comes directly to HRSA or is it that it goes to both?
04:25So there are two ways in which a safety event can be reported. One is that it can be reported by the
04:30OPTN member itself through their secure portal. A broader way to do it is that anybody involved, anybody with access to
04:36the internet, can go to a public-facing website and make a report to HRSA.
04:42Very well. Are there currently other HRSA-led investigations underway that you're able to discuss?
04:50I would prefer not to discuss them in this setting, but there are investigations ongoing.
04:55And how does the Kentucky OPO investigation process inform HRSA will approach its oversight
05:06and authority going forward? So the corrective action plan that HRSA released on May 28th is the
05:11first of its kind. This has parallels within other entities within HHS and the rest of the federal
05:17government. This is meant to immediately mitigate the circumstance at this OPO. But there's also a broader
05:23part to it. Part B addresses the entire system and we are confident that this pattern of care can be
05:29prevented in other OPOs. Very well. Mr. Chairman, I yield back. The general lady yields. The chair recognizes
05:35the chairman of the committee. Mr.
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