From: Reuters
Published November 16, 2007 02:42 PM

U.S. regulators join HIV transplant probe

By Julie Steenhuysen

CHICAGO (Reuters) - The Centers for Medicare and Medicaid Services has joined an investigation into how four Chicago transplant recipients contracted HIV and hepatitis C from a single organ donor, U.S. officials said on Friday.

CMS, a federal agency that regulates organ procurement, is checking whether three Chicago hospitals fully informed transplant recipients that the organ donor was at high risk of being infected with the human immunodeficiency virus, which causes AIDS.

A Chicago attorney has asked the Cook County Circuit Court to order one hospital to preserve all records related to its organ donation procedures.

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Thomas Demetrio said his client, one of the organ recipients, was not told the kidney she received was from a high-risk donor until this week.

Tests of the organs initially showed them to be free of infection, but a more sophisticated test done later detected HIV and hepatitis C, health officials said.

"We are still doing an investigation of the organ procurement organization and we also are looking at the hospitals to make sure information was shared with both the transplant programs and the recipients," said Jan Tarantino, director of the division of continuing care providers at CMS, a part of the U.S. Department of Health and Human Services.

SERIOUS SITUATION

"This is a serious situation," Tarantino said in a telephone interview.

Typically, CMS contracts with the state health department, but she said CMS has sent its own investigator to accompany state officials. "We've never gotten a report of this before and the consequences are very serious for the patients involved," she said.

Hospital officials have confirmed that two patients from the University of Chicago Medical Center, one from Northwestern Memorial Hospital and one at Rush University Medical Center tested positive for HIV and hepatitis C.

If the hospitals are found to have violated procedures, they could face sanctions and ultimately could be dropped from participation in Medicare, Tarantino said.

The U.S. Centers for Disease Control and Prevention has said the cases mark the first incidence of HIV infection contracted from organ donation since 1986.

Dave Bosch of the Gift of Hope Organ and Tissue Donor Network, the regional organ procurement agency that handled the donor organs, this week confirmed the organs came from a high-risk donor. He said standard tests failed to pick up the infections, likely because they occurred within three weeks of the donor's death -- too soon for the tests to detect.

Demetrio said in a telephone interview his client, a woman in her early 30s, had been on the transplant list for more than five years before receiving a kidney from the University of Chicago Medical Center. "Right now she's a wreck. She's still in shock," he said.

Demetrio said his client had been undergoing kidney dialysis and could have waited for another organ.

A University of Chicago Medical Center spokesman confirmed that the hospital received a petition from Cook County Circuit Court and said the hospital will provide necessary records with the patient's consent.

A spokeswoman for Rush said the hospital has been contacted by CMS and is cooperating with the investigation.

Bosch said about 9 percent of the 22,000 organ transplants in the United States involve high-risk organs.

(Editing by Will Dunham and Vicki Allen)

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