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1 donor, missteps, 3 infected patients

By Chelsea Conaboy
Globe Staff / December 23, 2011
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A child contracted hepatitis C through a blood vessel transplanted in September at Children’s Hospital Boston from an infected donor who was not known to have the disease. Two people in Kentucky who received kidneys from the same donor were also infected, the Centers for Disease Control and Prevention reported yesterday.

The agency traced the transmission in Massachusetts to a testing error at an unnamed tissue bank and delayed communication between the Kentucky transplant center and public health officials.

Such transmission through transplants is rare, and, in this case, the infections were “entirely preventable,’’ said Dr. Matthew J. Kuehnert, director of the Office of Blood, Organ, and Other Tissue Safety at the CDC.

His office released its investigation yesterday and called for improved testing and a more centralized system for tracking tissues and organs and notifying transplant surgeons of problems.

“It’s all done the old-fashioned way with phone calls and letters and e-mails,’’ Kuehnert said.

That had consequences in this case. Eleven days passed between the first kidney recipient in Kentucky testing positive for hepatitis C and notification of Kuehnert’s office on Sept. 29. Meanwhile, three days earlier, surgeons at Children’s Hospital Boston unknowingly used an infected piece of tissue to repair a malformation of a child’s heart. The child’s name was not disclosed because of patient confidentiality.

Six weeks later, the child tested positive for hepatitis C, a chronic illness that can, over time, lead to liver scarring or cancer or require a liver transplant. The child is not showing symptoms, said hospital spokesman Robert Graham.

“The patient received counseling and a care plan that includes an evaluation every three months,’’ he said, in an e-mail. “Children’s will continue to focus on providing care to our patient affected by this unfortunate situation.’’

It is suspected that about 1 percent of all organ donations are associated with disease transmission, Kuehnert said. Less is known about transmission through tissue transplants. The last confirmed tissue transmission, also of hepatitis C, was reported in 2002 in Oregon.

Most tissues, particularly those from muscle or bone, are treated with radiation or chemicals that greatly reduce the risk of infection. More sensitive heart tissue, such as the vessel used in the Boston transplant, typically is treated only with antibiotics.

As many as 100 body parts may be taken from a single donor: the liver, kidneys, and lungs, as well as tissues such as bone, skin, and heart valves.

Two federal agencies regulate tissues and organs. Organs are collected and distributed by the nonprofit United Network for Organ Sharing, which has regional affiliates and is regulated by the Health Resources and Services Administration.

Tissue banks, some of which are for-profit and contract with hospitals, are overseen by the Food and Drug Administration. While most are accredited by the American Association of Tissue Banks, there is no central body tracking tissues.

In addition, the more than 1 million tissue transplants each year occur across many more medical specialties, making them harder to monitor.

Communication between the two networks is minimal, said Kuehnert, and they have no protocol for sharing information about donor infections.

The donor in this case was a middle-aged man in Kentucky who died in March after an all-terrain vehicle incident. While he had a history of substance abuse, his father told hospital officials that he had no known history of intravenous drug use, a risk factor for hepatitis C, the report said. The donor received blood transfusions during his hospital stay.

Kuehnert said it is likely that his infection occurred shortly before his death because antibody tests, which look for an immune response to infections, were negative for both the organs and tissue. Only tissue is required to have more sensitive nucleic acid testing, which looks for presence of a virus itself.

According to the report, a worker at an unnamed tissue bank incorrectly read a test in March, marking the donor’s tissue as negative for hepatitis C. In fact, it had tested positive, and the error was only discovered in a follow-up investigation.

Graham said the erroneous nucleic acid test was not conducted by Children’s Hospital Boston, which is a registered tissue bank. He declined to answer further questions about the case.

A 41-year-old man and a 46-year-old woman received the donor’s kidneys that month at Jewish Hospital in Louisville. Another man, who already had hepatitis C, received the donor’s liver.

Federal regulations require that organ transplant centers report diseases suspected to have come from a donor to a national online reporting system within 24 hours.

It is left up to the physician to decide when an infection may be tied to the donor, and reporting practices vary, said Shandie Covington, senior patient safety specialist at the United Network for Organ Sharing, which manages the system.

On Sept. 19 and Sept. 22, tests showed that the kidney recipients had been infected with the virus, according to the CDC report. But the transplant center did not report the transmission until Sept. 28. The information made it to the CDC a day later.

Dr. Michael Marvin, director of the transplant program at Jewish Hospital, said the patients were being treated by different doctors, and it took several days to get the test results for the second patient.

He said the doctors did not immediately recognize the infections as being from the donor. Once the physicians realized they had two infected patients, they filed a report the same day, he said.

“Hindsight, of course, is 20/20,’’ but such donor infections are rare, he said. The CDC’s Kuehnert was careful not to assign blame to Jewish Hospital.

“The fact that they recognized it at all is something that most transplant centers don’t do,’’ he said.

Still, Kuehnert said, the country needs a computerized tracking system for organ and tissue donations, similar to the barcoding of blood products, so information about possible infections can be disseminated more quickly.

He and Dr. Jay Fishman of Massachusetts General Hospital created a prototype tagging system in a pilot program used for about five years until it lost funding in 2009. Launching it nationally will take money and collaboration across the medical fields, the two said.

Kuehnert’s office also has called for organs to be screened regularly with the more sensitive nucleic acid tests. The CDC has been collecting public comments on that measure this fall, with some pushback from people concerned that that change will be costly or slow the availability of organs.

Fishman, director of the transplant infectious disease program at Mass. General, said the new tests should not affect supply. The current testing structure is working, he said, “but the reality is that the safety could be enhanced by using more sophisticated testing in a more uniform way.’’

In addition to the heart vessel and organs, 43 pieces of musculoskeletal tissue were taken from the Kentucky donor, and 15 were implanted in patients across the country before the tissue was recalled. By last week, federal officials had confirmed that 14 of those recipients did not have hepatitis C.

Chelsea Conaboy can be reached at cconaboy@boston.com. Follow her on Twitter @cconaboy.

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