CHICAGO - Federal officials are investigating what three hospitals knew and told four organ transplant patients about a high-risk donor who infected them with HIV and hepatitis.
The investigation's new phase involves the federal Centers for Medicare and Medicaid Services, which oversees organ procurement programs and hospitals nationwide.
The stakes are high: If the agency finds any mishandling and the hospitals don't comply with any demands for corrective action, the hospitals could face penalties. The worst would be being ousted from Medicare participation, meaning a loss of crucial federal revenue.
The case disclosed this week is the first known instance of HIV transmission through organ transplants since 1986, and the first time HIV and hepatitis have been spread simultaneously from one donor to transplant recipients, public health officials say.
While Medicare officials generally contract with local authorities to investigate hospitals, this time the agency has sent officials to Chicago to assist investigators from Illinois' Department of Public Health, said Jan Tarantino, director of the agency's division of continuing care providers.
"We're taking some extra steps... because this is potentially a very serious situation," she said Thursday.
Hospital and public health officials have called the case a tragedy, but emphasize that the risk of getting any disease from transplanted organs is less than 0.01 per cent.
Tarantino said officials from her agency last week visited the Elmhurst group that procured the organs, Gift of Hope Organ & Tissue Donor Network. This week they started questioning authorities at the three hospitals, Northwestern Memorial Hospital, Rush University Medical Centre and the University of Chicago Medical Centre.
"We're looking at the circumstances surrounding the donor and the four recipients and checking to make sure that all the notifications" took place, Tarantino said.
None of the hospitals has said publicly what patients were told, citing doctor-patient confidentiality. They also have declined to identify the donor, the patients and what organs they received, citing privacy concerns.
Gift of Hope officials have said they followed proper procedures before the January transplants by notifying all three hospitals that the donor had engaged in high-risk behaviors.
Attorney Thomas Demetrio filed a petition Thursday in Cook County Circuit Court on behalf of an infected female patient, asking officials to keep the University of Chicago and Gift of Hope from destroying or altering any records involving the donation.
The patient received a kidney transplant at the University of Chicago Hospitals on Jan. 9, Demetrio said in a statement.
Gift of Hope and the University of Chicago both knew the kidney donor was high-risk and did not inform the patient, according to the petition.
"It is imperative that we secure any and all records and information pertaining to this transplant surgery and the kidney donor in order to properly protect the legal rights and interests of our client," Demetrio said.
Federal guidelines say patients are supposed to be notified about the possibility of HIV infection from a high-risk donor even if tests show the donor doesn't have the virus.
Standard tests for HIV and hepatitis antibodies showed the donor didn't have those diseases. Authorities say the donor probably acquired the infections a few weeks before death, too soon for the tests to detect antibodies.
A newer, costlier test that is not widely available can detect the virus earlier but wasn't done in this case. That has led public health officials to press for more widespread use of the newer test.
"Hopefully in the future it can be the norm," said Dr. Susan Gerber, chief medical officer for Chicago's Department of Public Health.
Gerber said her office is working with the federal Centers for Disease Control and Prevention, "trying to find out what happened." That includes examining the circumstances surrounding when the patients were first tested for HIV.
CDC guidelines recommend testing three months after transplants from high-risk donors. But the University of Chicago said the patients didn't learn they were infected until tests within the past few weeks, prompted by a blood test one of them underwent during an evaluation for a new transplant.
The CDC's Dr. Matt Kuehnert said Thursday his agency has not sent anyone to Chicago but is doing laboratory testing on blood samples from the donor and patients to determine how responsive the virus is to anti-HIV drugs, which will help doctors determine the best treatment.
