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CMS Officials Investigate Case Involving Four Transplant Recipients Who Contracted HIV, Hepatitis C From High-Risk Organ Donor

November 19, 2007

Health officials from CMS, which oversees organ procurement programs and hospitals in the U.S., are investigating the three hospitals involved in the case of four transplant recipients in the Chicago area who in January contracted HIV and hepatitis C from a high-risk organ donor, the AP/ reports (Tanner, AP/, 11/16).

According to officials at Gift of Hope Organ & Tissue Donor Network -- the organ procurement agency that tested and approved the organs for donation -- a screening questionnaire determined that the donor had engaged in high-risk behavior. However, tests for HIV, hepatitis and other conditions came back negative, indicating the donor most likely contracted the diseases in the last three weeks of his or her life, according to the Tribune. HIV-positive people can test HIV-negative for up to 22 days after contracting the virus because antibodies detected by the test are not yet present, and the latent period can be longer for hepatitis C, the Tribune reports.

Based on the test results, physicians at Northwestern Memorial Hospital, Rush University Medical Center and the University of Chicago Medical Center went ahead with the transplants, according to officials from the centers. Alison Smith, vice president for operations at Gift of Hope, said the agency "followed the right procedures" in testing the donor (Kaiser Daily HIV/AIDS Report, 11/14). The hospitals could face penalties or be expelled from Medicare participation if CMS finds any mishandling and the hospitals do not comply with corrective action demands, the AP/ reports.

Jan Tarantino, director of the division of continuing care providers at CMS, said Medicare officials usually contract with local authorities to investigate hospitals, but this time the agency sent officials to assist investigators from the state health department. "We're taking some extra steps ... because this is potentially a very serious situation," Tarantino said, adding, "We're looking at the circumstances surrounding the donor and the four recipients and checking to make sure that all the notifications" occurred (AP/, 11/16).

According to the Chicago Sun-Times, investigations by HHS' Health Resources and Services Administration, CDC and the Chicago Department of Public Health are under way.

Attorney for Organ Recipient Files Petition to Preserve, Supply Records Related to Case
Thomas Demetrio, an attorney for one of the organ recipients, filed a petition Thursday in Cook County, Ill., Circuit Court asking officials to prohibit the UC Medical Center and Gift of Hope from destroying or altering any records involved in the donation, the Sun-Times reports (Grossman, Chicago Sun-Times, 11/16). "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 (AP/, 11/16).

He also said that his client should have been told the organ came from a high-risk donor before the surgery was performed. "It's up to the patient ... to make the decision whether to incur the risk," Demetrio said, adding, "This was not a life or death situation." Tina Cheatham of HRSA said that while hospitals must be told the organ came from a high-risk patient, federal rules do not require physicians to inform patients about the donor. "Based on our initial review, it looks like all the protocols were followed" Cheatham said (Chicago Sun-Times, 11/16).

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