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Three get hepatitis from Kentucky donor-Organs and tissue had been tested
  9:25 PM, Dec. 22, 2011

Louisville Courier-Journal

Two Kentucky adults and a Massachusetts child contracted hepatitis C through transplants from an infected organ and tissue donor from Kentucky who initially tested negative for the disease, the U.S. Centers for Disease Control and Prevention reported Thursday.

CDC officials say the case raises questions about the adequacy of organ and tissue testing and the need for a real-time notification of problems to prevent further use of organs and tissue after recipients develop infections.

"I think there's a lot of things that could have been done better in this event. But I don't think there's one thing that could be pointed to - a person or an institution," Dr. Matthew Kuehnert, director of the CDC's Office of Blood, Organ and Other Tissue Safety, said in an interview. "I think this happens a lot and we don't know about it."

Kuehnert said diseases are transmitted in about 1 percent of organ transplants. In 2010, 28,262 transplants were done, a vast majority from deceased donors, according to the Organ Procurement and Transplantation Network.

The CDC's report says the unidentified donor's organs initially tested negative for the disease after he died in an all-terrain vehicle accident in March. He had a history of schizophrenia, substance abuse and a five-month incarceration about 10 years before his death, the report says, but he had no known history of intravenous drug use or other hepatitis risk factors, his father said at the time the organs were taken.

But the report says further investigation revealed that the father had limited contact with his son in the year before his death.

Two kidneys and the donor's liver were transplanted into three recipients at Jewish Hospital. The kidney recipients tested negative for hepatitis C before the transplant, while the liver recipient had previously been diagnosed with hepatitis.

But the kidney recipients both tested positive in September.

A 41-year-old man who received one of the donor's kidneys was tested Sept. 19, and the results came back positive the next day, said Dr. Michael Marvin, chief of transplantation at the University of Louisville and at Jewish Hospital. But he said doctors didn't immediately suspect the organ had caused the disease because the man was a health care worker, another risk factor for the condition.

The CDC report said the second kidney recipient, a 46-year-old woman, "was positive Sept. 21." But Marvin said his understanding is the test was administered on Sept. 21, although he has no records because it was done on an outpatient basis at another facility - the U of L Division of Nephrology, which could not be reached for comment Thursday.

Marvin said Jewish Hospital learned of the positive test Sept. 28 and immediately notified the organ procurement organization, Kentucky Organ Donor Affiliates, suspecting hepatitis C was related to the transplant.

"As soon as the center got the results that the second recipient had tested positive, KODA was notified," Marvin said. "It was within a couple of hours."

The policy of the United Network for Organ Sharing, the nonprofit organization that operates the Organ Procurement and Transplantation Network under contract with the federal government, is that the transplant center must notify the organ procurement organization by phone and provide available documentation within 24 hours of the concern.

Shandie Covington, senior patient safety specialist for UNOS, said "there is a certain degree of medical judgment" when it comes to deciding whether an infection or other problem is linked to a transplant.

"The transplant center that suspects potential transmission should not wait for all medical documentation that may eventually be available, but must inform the host OPO (Organ Procurement Organization) and/or the OPTN (Organ Procurement and Transplantation Network) Patient Safety System ... as soon as possible to all other centers that received organs from the same donor," UNOS policy says.

The CDC report says on Sept. 29, the OPO notified the tissue bank - which was not identified in the report - of the disease transmission to the organ recipients. The tissue bank informed health care facilities, the report said, and a voluntary recall was started on Sept. 30. KODA said it was the organ procurement organization involved.

The report said the tissue bank had distributed 43 musculoskeletal grafts and one cardiopulmonary patch from the donor to health care facilities. The patch went to a child in Boston Sept. 26 - just a couple of days before Jewish Hospital said it first notified KODA. The child developed hepatitis.

The CDC's Kuehnert acknowledged that initial testing of the donor was not ideal. An antibody test was negative on both organ and tissue donor screening. But the tissue bank performed an antibody test on the donor's serum that was negative and a nucleic acid test that was positive, but misread as negative, according to the CDC report.

Jenny Miller Jones, director of education for KODA, said her organization "abided by all protocol with regard to testing the donor. But the tests at that time came back negative." Jones pointed out that the Organ Procurement and Transplantation Network only requires antibody testing for solid organ donation. "If changes are made, KODA will certainly adhere to them," Jones said.

Kuehnert said if nucleic acid testing - which research shows shortens the time between infection and detection - had been used, these cases could have been avoided.

The U.S. Public Health Service recently drafted guidelines that recommend all organ donors have nucleic acid testing, "regardless of risk status," the CDC report says in an editorial note. "Even if test results are not available at the time of transplantation, results still can be used afterward to guide recipient evaluation and treatment."

The note continues: "The events in this report demonstrate the importance of timely communication once a transplant transmission is suspected and the difficulty of tracking tissue to the patient or provider level should a potential transmission be recognized after tissue has been distributed."

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