WASHINGTON – The United States is implementing new measures to enhance safety within the organ transplant system after a government investigation revealed that a Kentucky group proceeded with preparations for organ donation from some patients who were exhibiting signs of life, officials reported to Congress on Tuesday.

Although the organ removals were ultimately halted, these close calls, deemed alarming by some lawmakers, must be permanently prevented. A House subcommittee inquired about rebuilding trust in the transplant network among prospective donors and their families—many of whom have withdrawn from donor lists after these incidents came to light.

“We have to get this right,” stated Rep. Brett Guthrie, a Kentucky Republican and chair of the Energy and Commerce Committee, who has a personal connection as his mother passed away waiting for a liver transplant.

“Hopefully people will walk away today knowing we need to address issues but still confident that they can give life,” 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 — and the man survived.

Lawmakers stressed most organ donations proceed appropriately and save tens of thousands of lives a year. But the federal probe – concluded in March but only made public ahead of Tuesday’s hearing — cited a “concerning pattern of risk” 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 – 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’s a dire need for organ donation

More than 100,000 people are on the U.S. transplant list 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 for organ donation. 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 — HRSA, the Health Resources and Services Administration, and the Centers for Medicare and Medicaid Services — share regulatory oversight of different parts of the donation and transplant process.

How deceased donation works

Most organ donors are brain-dead – 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 – 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’t 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,” said Barry Massa of Kentucky’s Network for Hope.

During the following days of preparation, hospital employees continue caring for the patient – 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’s a mandatory wait – five minutes – to be sure it won’t 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’t be used – and HRSA’s Dr. Raymond Lynch told Congress that doesn’t necessarily mean anything was done wrong. Still, he said HRSA is investigating reports of possible mistakes elsewhere.

“This is a technically demanding form of care” that requires “good collaboration between the OPO and the hospital,” he said.

What happens next

At issue is how doctors are sure when it’s time to withdraw life support from a dying patient — 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 – family, hospital staff or organ donation staff – can call for a pause in donation preparations any time there are concerns about the patient’s eligibility.

Lynch said the government now wants more proactive collaboration from OPOs to give hospital staff “a clear understanding” 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’s reports this week – but that after learning about last fall’s 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 — and anyone can anonymously report complaints.

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