WASHINGTON (AP) 鈥 The U.S. is developing new safeguards for the organ transplant system after a government investigation found a Kentucky group continued preparations for organ donation by some patients who showed signs of life, officials told Congress Tuesday.
While the organ removals were canceled, near misses that some lawmakers called horrifying should never happen. A House subcommittee asked how to repair trust in the transplant network for potential organ donors and families -- some of whom have after these cases were publicized.
鈥淲e have to get this right,鈥 said Rep. Brett Guthrie, a Kentucky Republican who chairs the Energy and Commerce Committee and whose mother died waiting for a liver transplant.
鈥淗opefully people will walk away today knowing we need to address issues but still confident that they can give life,鈥 Guthrie said, adding that he will remain a registered organ donor.
The hearing came after a federal investigation began last fall into allegations that a Kentucky donation group pressured a hospital in 2021 to proceed with plans to withdraw life support and retrieve organs from a man despite signs that he might be waking up from his drug overdose. That surgery never happened after a doctor noticed him moving and moaning while being transported to the operating room 鈥 and the man survived.
Lawmakers stressed most organ donations proceed appropriately and save tens of thousands of lives a year. But the federal probe 鈥 concluded in March but only made public ahead of Tuesday鈥檚 hearing -- cited a 鈥渃oncerning pattern of risk鈥 in dozens of other cases involving the Kentucky group's initial planning to recover someone's organs.
The report said some should have been stopped or reassessed earlier, and mostly involved small or rural hospitals with less experience in caring for potential organ donors.
The Kentucky organ procurement organization, or OPO, has made changes and the national transplant network is working on additional steps. But notably absent Tuesday was any testimony from hospitals 鈥 whose doctors must independently determine a patient is dead before donation groups are allowed to retrieve organs.
Here's a look at how the nation's transplant system works.
There鈥檚 a dire need for organ donation
More than 100,000 people are on the and about 13 a day die waiting, according to the Organ Procurement and Transplantation Network.
Only about 1% of deaths occur in a way that allows someone to even be considered . Most people declared dead in a hospital will quickly be transferred to a funeral home or morgue instead.
How the U.S. organ transplant system is set up
Several groups are involved in every transplant: the hospital caring for someone dead or dying; the 55 OPOs that coordinate recovery of organs and help match them to patients on the waiting list; and transplant centers that decide if an organ is the right fit for their patients.
Adding to the complexity, two government agencies 鈥 HRSA, the Health Resources and Services Administration, and the Centers for Medicare and Medicaid Services 鈥 share regulatory oversight of different parts of the donation and transplant process.
How deceased donation works
Most organ donors are brain-dead 鈥 when testing determines someone has no brain function after a catastrophic injury. The body is left on a ventilator to support the organs until they can be retrieved.
But increasingly organs are donated after circulatory death, called DCD 鈥 when people die because their heart stops. It usually happens when doctors determine someone has a nonsurvivable injury and the family withdraws life support.
Donation groups don鈥檛 provide hands-on patient care
Hospitals are required to alert their area OPO to every potential donor who is declared brain-dead or once the decision to withdraw life support is made. The OPOs by law can't participate in that decision and "we are not even in the room at that time,鈥 said Barry Massa of Kentucky's Network for Hope.
During the following days of preparation, hospital employees continue caring for the patient 鈥 while the donation team talks with the family about the process, gathers hospital records showing the patient is eligible, requests tests of organ quality, and make arrangements with transplant centers to use them.
Once the hospital withdraws life support and the heart stops beating there鈥檚 a mandatory wait 鈥 five minutes 鈥 to be sure it won鈥檛 restart. When the doctor declares death, the organ retrieval process can begin.
Organs are only considered usable if death occurs relatively quickly, usually up to about two hours. Sometimes that takes much longer and thus the organs can鈥檛 be used 鈥 and HRSA鈥檚 Dr. Raymond Lynch told Congress that doesn鈥檛 necessarily mean anything was done wrong. Still, he said HRSA is investigating reports of possible mistakes elsewhere.
鈥淭his is a technically demanding form of care鈥 that requires 鈥済ood collaboration between the OPO and the hospital,鈥 he said.
What happens next
At issue is how doctors are sure when it鈥檚 time to withdraw life support from a dying patient 鈥 and the delicate balance of how OPOs interact with hospital staff in preparing for donation once death occurs.
In May, HRSA quietly ordered the U.S. transplant network to oversee improvements at the Kentucky OPO and to develop new national policies making clear that anyone 鈥 family, hospital staff or organ donation staff 鈥 can call for a pause in donation preparations any time there are concerns about the patient鈥檚 eligibility.
Lynch said the government now wants more proactive collaboration from OPOs to give hospital staff 鈥渁 clear understanding鈥 of when to at least temporarily halt and reevaluate a potential donor if their health status changes.
Kentucky's Massa said his group only received HRSA鈥檚 reports this week 鈥 but that after learning about last fall鈥檚 allegations, it made some changes. Massa said every hospital doctor and nurse now gets a checklist on caring for potential donors and how to pause when concerns are raised 鈥 and anyone can anonymously report complaints.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute鈥檚 Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
