Tuesday, January 1, 2008

U.S. regulators join HIV transplant probe

U.S. regulators join HIV transplant probe
CHICAGO (Reuters) - The Centers for Medicare and MedicaidServices has joined an investigation into how four Chicagotransplant recipients contracted HIV and hepatitis C from asingle organ donor, U.S. officials said on Friday.
CMS, a federal agency that regulates organ procurement, ischecking whether three Chicago hospitals fully informedtransplant recipients that the organ donor was at high risk ofbeing infected with the human immunodeficiency virus, whichcauses AIDS.
A Chicago attorney has asked the Cook County Circuit Courtto order one hospital to preserve all records related to itsorgan donation procedures.
Thomas Demetrio said his client, one of the organrecipients, was not told the kidney she received was from ahigh-risk donor until this week.
Tests of the organs initially showed them to be free ofinfection, but a more sophisticated test done later detectedHIV and hepatitis C, health officials said.
"We are still doing an investigation of the organprocurement organization and we also are looking at thehospitals to make sure information was shared with both thetransplant programs and the recipients," said Jan Tarantino,director of the division of continuing care providers at CMS, apart of the U.S. Department of Health and Human Services.
SERIOUS SITUATION
"This is a serious situation," Tarantino said in atelephone interview.
Typically, CMS contracts with the state health department,but she said CMS has sent its own investigator to accompanystate officials. "We've never gotten a report of this beforeand the consequences are very serious for the patientsinvolved," she said.
Hospital officials have confirmed that two patients fromthe University of Chicago Medical Center, one from NorthwesternMemorial Hospital and one at Rush University Medical Centertested positive for HIV and hepatitis C.
If the hospitals are found to have violated procedures,they could face sanctions and ultimately could be dropped fromparticipation in Medicare, Tarantino said.
The U.S. Centers for Disease Control and Prevention hassaid the cases mark the first incidence of HIV infectioncontracted from organ donation since 1986.
Dave Bosch of the Gift of Hope Organ and Tissue DonorNetwork, the regional organ procurement agency that handled thedonor organs, this week confirmed the organs came from ahigh-risk donor. He said standard tests failed to pick up theinfections, likely because they occurred within three weeks ofthe donor's death -- too soon for the tests to detect.
Demetrio said in a telephone interview his client, a womanin her early 30s, had been on the transplant list for more thanfive years before receiving a kidney from the University ofChicago Medical Center. "Right now she's a wreck. She's stillin shock," he said.
Demetrio said his client had been undergoing kidneydialysis and could have waited for another organ.
A University of Chicago Medical Center spokesman confirmedthat the hospital received a petition from Cook County CircuitCourt and said the hospital will provide necessary records withthe patient's consent.
A spokeswoman for Rush said the hospital has been contactedby CMS and is cooperating with the investigation.
Bosch said about 9 percent of the 22,000 organ transplantsin the United States involve high-risk organs.(Editing by Will Dunham and Vicki Allen)

No comments: