A U.S. House subcommittee heard testimony on organ donation Tuesday following a scathing report from the Health Resources and Services Administration. Photo by Getty Images

WASHINGTON — The heads of several organ transplant organizations testified before Congress on Tuesday that they are working to earn back the public’s trust following the release of a scathing report.

In a rare example of bipartisanship on Capitol Hill, both Republicans and Democrats on a U.S. House Energy and Commerce subcommittee expressed concern with several cases and interest in enhanced oversight of the entities that manage organ donation.

The central issue, according to testimony from witnesses and comments from lawmakers, is that organ donations increasingly come from people experiencing circulatory death as opposed to brain death.

Dr. Raymond Lynch, chief of the Organ Transplant Branch at the Health Resources and Services Administration within the U.S. Department of Health and Human Services, said that “historically that was a less common pathway,” but now represents about 50% of all donations.

“This is complex care. It’s technically demanding, but it’s knowable and fixable,” Lynch said. “This is something that can be done safely.”

Energy and Commerce Committee Chairman Brett Guthrie, R-Ky., detailed a case in his home state where a man began showing signs of “improved neurological function” after his family had agreed to let doctors remove his organs for donations.

The case later became the subject of an oversight investigation and a corrective action plan from the Health Resources and Services Administration that focused on the behavior of the Organ Procurement Organization for that region.

The HRSA reports states that the man arrived at “a hospital in northern Kentucky with cardiovascular collapse after an unintentional overdose of methamphetamine.” As part of his treatment, health care providers administered three different sedatives.

The report states that while the patient “did survive the events surrounding the attempted withdrawal of life support and organ procurement, the repeated assessment by (Kentucky Organ Donor Affiliates) that it is ‘satisfied and confident in the donation process’ is incongruous with the facts of the medical record.”

Guthrie said the report showed a “deeply concerning pattern” and that the committee wanted “to have an open and honest discussion about these failures.”

“HRSA determined that of the 351 documented cases reviewed in this investigation, 103 or nearly 30% had concerning features,” Guthrie said. “HRSA found concerning patterns that included failures to recognize increased neurological function in patients who were previously identified as candidates for organ donation, failure to work collaboratively with medical teams and failure to safeguard decision making or follow best practices.”

The United States has more than 50 different Organ Procurement Organizations responsible for different geographic areas. They determine which patients are eligible to donate organs. They are not supposed to be involved in determining when a potential donor is declared dead by a hospital’s medical team.

Guthrie said he didn’t intend to change his status as an organ donor but emphasized the need for improvement.

‘Troubling record’

Lynch declined to go into detail during the public hearing but said HRSA has several ongoing investigations into potential wrongdoing within the organ procurement system. He also said that anyone wishing to file a complaint can do so on the agency’s website.

“There are numerous cases that have been reported to HRSA,” Lynch testified. “We have ongoing reviews and we have made referrals to partner agencies. The corrective action plan that we have for Kentucky, as we were hearing about these other cases in other areas, also includes a plan to make the (Organ Procurement and Transplantation Network) make this safe nationwide.”

New York Democratic Rep. Paul Tonko asked Lynch about a section in the HRSA report that “identified a troubling record of the Kentucky OPOs communication with patient families.”

“In one case, the OPO employees seeking consent to begin preparation for organ donation spoke with the patient’s brother, who had a cognitive impairment. This individual was described as, and I quote, childlike, in case records,” Tonko said. “In a separate case, the OPO spoke with two family members who were, quote, clearly inebriated.”

Lynch said the records HRSA reviewed during its investigation didn’t explain why that happened, but he said the inability “to consider the humanity and the autonomy of these patients and their families is troubling.”

Tonko said the HRSA report indicated that OPO staff appeared to have used “a manipulative and overly aggressive strategy” in the Kentucky case.

“The sister of the Kentucky patient has said that she was never told that her brother had started to wake up after she had given consent for donation,” Tonko said. “She says she only found out years later.”

Corrective plan for Kentucky

Lynch said the corrective action plan for the Kentucky Organ Procurement Organization, formerly known as Kentucky Organ Donor Affiliates but now called Network for Hope, requires its staff to keep families updated and ensures that “if at any point, either the health care team or the family has a concern, that there is a pause in the process to allow for adjudication of that.”

He also indicated there could be more understanding in how staff handle discussions about whether to donate a person’s organs.

“This is, as you pointed out, one of the most horrible and challenging times in a family’s life,” Lynch said. “The events that lead to somebody becoming a potential organ donor are usually sudden and tragic. Interacting with a grieving family, helping them to make educated decisions, providing compassionate and fair information and a complete sense of what the procurement process will look like, those are skills.

“They are skills that some OPOs clearly perform better than others, but they are skills for which the OPO is responsible.”

Organization welcomes oversight

Barry Massa, chief executive officer at Network for Hope — an Organ Procurement Organization that covers Kentucky as well as parts of Indiana, Ohio and West Virginia — testified before the committee that the HRSA report’s contents “are serious and alarming.”

“That case was very complex, and during a very complex time,” Massa said. “If you recall, in 2021 we were in the midst of COVID, and I think that impacted the communication that we had between our hospital and our team. And while I’m not using that as an excuse, I do think it added to the complexity of it.”

Massa testified under oath that the organization never wants to repeat what happened in that case, plans to follow the recommendations detailed in the HRSA report and welcomes more oversight from Congress.

Network for Hope, he said, had also implemented some changes of its own, including a checklist for nurses and physicians to use.

Massa later clarified that “while OPOs are the ones determining if a patient is suitable for donation, as far as determining death, that is actually done by the physician.”

Split responsibility

Other members of the panel explained that the oversight of organ procurement and donation is fragmented and needs improvement.

Maureen McBride, chief executive officer at the United Network for Organ Sharing, testified that the Centers for Medicare & Medicaid Services has oversight over hospitals and the Organ Procurement and Transplantation Network “has oversight under HRSA of the transplant hospitals, the OPOs and the histocompatibility labs.”

“That split in oversight does leave room for communication gaps and opportunities for further improvement,” McBride said. “So I do think consolidation of the entire transplant ecosystem under a single government regulatory body could provide benefits to the transplant community.”

Dr. Richard Formica, former president of the Organ Procurement and Transplantation Network Board of Directors, said the process includes “two domains of responsibility” and suggested they be moved under one oversight agency.

Formica said lawmakers could figure out a way that after a patient is identified as a potential organ donor, there be one set of procedures to follow on both the hospital side, which is currently managed by the Centers for Medicare & Medicaid Services, and the organ donation system, managed by HRSA.

“We’d have one set of oversight. We’d have one set of protocols,” Formica said. “We could work on those protocols and then we can act on those protocols and refine them as they go forward, instead of refining one and having to wait for the other one, and back and forth.”

This post was originally authored and published by Jennifer Shutt from AZ Mirror via RSS Feed. Join today to get your news feed on Nationwide Report®.