On-site federal probe of UPMC transplant programs completed

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On-site federal probe of UPMC transplant programs completed
Sean D Hamill Pittsburgh Post-Gazette

The on-site portion of a federal investigation into UPMC's living donor kidney and liver transplant programs has been completed, officials said Friday, following a case in which a kidney infected with hepatitis C was wrongly transplanted into a patient.

Don McLeod, spokesman for the Centers for Medicare and Medicaid Services (CMS), said the team made up of Pennsylvania Department of Health employees, under contract with CMS, finished the two-day, on-site investigation Thursday.

Final results of the investigation won't be known for some time, as long as a month or two, said health department spokeswoman Brandi Hunter-Davenport.

UPMC spokeswoman Jennifer Yates confirmed CMS made its visit but said she had no other comment.

The United Network for Organ Sharing, the agency that oversees the nation's organ donations for the federal government, is also conducting an investigation into the medical error, but it is not clear if that investigation is complete.

An UNOS spokeswoman declined to comment.

On May 6, UPMC told CMS as well as UNOS that it had detected the error in the kidney transplant and was voluntarily and temporarily shutting down its living donor kidney program.

It was a living kidney transplant between a woman and a man who are a couple, sources have told the Pittsburgh Post-Gazette. The woman did not know she was hepatitis C positive, and she was tested, but the test results were somehow missed by people on the transplant team, and the transplant went forward.

Then, on May 9, when UPMC officials discussed the case with the U.S. Health Resources and Services Administration, they mutually decided to shut down the living donor liver program, too, because staff members who evaluate patients -- and who missed the test result -- are the same for liver and kidney transplants.

On May 11, Elizabeth Concordia, UPMC's executive vice president, briefed board members of the hospital system on the incident.

She told them, according to one board member, that the positive test result for hepatitis C was missed by two people on the transplant team during a dozen steps in the process.

UPMC later suspended a nurse and demoted a surgeon for their role in the medical error.

When the case first became public, UPMC said it hoped it would be able to restart its program within weeks, not months. But it is still not clear when UPMC will restart its program.

Over the last month, though, the shutdown affected relatively few cases.

In that time, Ms. Yates said, UPMC has postponed three previously scheduled live kidney donation transplants because of the shutdown, and one other case was postponed because the recipient became ill. There were no living donor liver transplants scheduled over the last month.

Because of the shutdown, potentially other living donor kidney transplants were never done because UPMC also had to pull its list of living donors and possible recipients from the working lists of several organizations that set up matched paired kidney exchanges.

Under matched pair exchanges, someone who needs a kidney and a friend or family member who wants to donate one of their kidneys but who isn't a physical match (through blood types, antigens and other factors) both get put on national lists that seek to find both a donor and a recipient who are matches.

The exchanges have grown enormously in the last five years, rising from just 74 paired exchange transplants in 2006 to 422 cases last year, according to UNOS.

In February, UPMC participated in its first large matched pair exchange chain, in which 16 recipients got kidneys from 16 donors (one each at UPMC) in a nationwide chain that involved 12 transplant centers in nine states.

Garet Hil, founder and president of the National Kidney Registry in Babylon, N.Y., which organized the 32-person chain, said that shortly after UPMC announced it was shutting down its living donor kidney program, it pulled its patients from his organization's list.

"They're not in play now, but they can be reactivated in five minutes," he said.

Because the computers that find the potential matches from the thousands of donors and recipients on the list are constantly running new computations, including adding new donors and recipients daily, it is impossible to say if any chains were affected by UPMC pulling its list.

"We look forward to them coming back on line because they're such a great center," Mr. Hil said.

News of the error at UPMC spurred other area transplant centers to take a closer look at their own procedures.

"When this came out, the surgical services here began to look at the same issues in our hospital," said Mohan Ramkumar, kidney transplant program medical director at VA Pittsburgh Healthcare. "They haven't made any changes yet. But this [case at UPMC] is obviously human error, so we always want to prevent human errors if we can."

Ngoc Thai, director of Allegheny General Hospital's center for abdominal transplantation, which includes kidney transplants, said his hospital also reviewed its processes in the wake of the UPMC case.

"As a result, we further formalized our documentation, adding an extra layer of checks-and-balances" for pre-surgical review of patients, Dr. Thai said.

Dr. Thai said instead of the normal two-paper checklists that AGH uses to review important facts about a patient before surgery -- including whether a test for hepatitis C has been checked -- AGH will now use a third checklist.

AGH may have also recently seen an additional fallout from the UPMC case.

Dr. Thai said that last week four potential transplant patients who had begun pre-surgery testing at UPMC decided to move their cases over to AGH.

"We don't know why," he said. "But it is very unusual."

Sean D. Hamill: shamill@post-gazette.com or 412-263-2579.