Case Study Donor Safety Concerns

In what one member said is a model for national debate, a state health department advisory panel on liver transplants discussed ways to ensure donor safety, ranging from informed consent to staffing ratios to follow-up studies.

"The donor is different than any other patient in the hospital because we have nothing to offer him except physical risk," said panel member Nancy Dubler, head of bioethics at Albert Einstein College of Medicine, echoing a theme that ran throughout the meeting in Manhattan yesterday.

State Health Commissioner Antonia Novello appointed the panel, called the Committee on Quality Improvements in Living Liver Donation, in March after issuing a report on the death of liver donor Michael Hurewitz, 57, Jan. 13 at Mount Sinai Hospital. Hurewitz died three days after donating part of his liver to his brother Adam, 54, chief of pulmonary and critical care medicine at Winthrop-University Hospital in Mineola. Novello noted not only problems specific to Hurewitz's care, but also lack of oversight among the five centers in the state that do live-donor liver transplants.

Wayne Osten, director of the Health Department's office of health systems management, said he expectsthat by the next meeting the panel will have draft recommendations that will be discussed, approved and ultimately presented to Novello. The panel, made up of transplant experts from New York and around the country, is scheduled to meet Oct. 24 in Albany.

A panel member, Dr. Francis Delmonico, head of the renal transplant program at Massachusetts General Hospital, said the state panel's actions "will have impact, no question" on a federal Health and Human Services advisory panel on transplantation grappling with the same issues. That panel is to meet in November. The state panel is charged with looking at ways to ensure the donor understands what the risks of a transplant are; ways to ensure the best care; and follow-up studies on what long-term health problems a donor might face.

The panel seemed to back a recommendation for an independent donor advocate team, including a doctor, social worker and transplant coordinator. The team's job would be to represent the donor's interests - even if that meant going against a potential donor's wish to give part of his liver.

Much of the debate on a donor's care in the hospital centered on which and how many doctors, nurses and other health care professionals need to be on site and responsible for a donor's care during and after surgery. Initially, Dr. Lewis Teperman, director of the liver transplant program at New York University Hospitals Center, presented his subcommittee's proposal for a 6-1 patients-to-nurse ratio, but that quickly was changed to a 4-1 ratio. Consensus on the ratio of surgeons and doctors-in-training to patients was less clear. There also was disagreement about what kind of unit donors should be taken to after the operation.

But all seemed to agree with the proposal that those who deal with donors should be credentialed to do so. There also was consensus that a donor with a complaint should be seen by someone within 30 minutes and a senior doctor notified. "Ultimately, the doctor is responsible; you have to have a different level of concern with a donor," Teperman said.

Another panel member, Dr. Jean Emond, chief of transplantation services at New York-Presbyterian Hospital, said that he hoped by the next meeting to have preliminary results of data gathered from previous liver donors about the impact of the surgery - the beginning of what he proposed would be long-term follow-up of donors.

New Rules on Liver Transplants
State emphasizes donor's protection

By Ridgely Ochs
STAFF WRITER

November 14, 2002

A New York advisory panel on liver transplants from living donors yesterday unanimously approved guidelines designed to protect the health of the donor - a move hailed by the state health commissioner as "likely to serve as a national model."

"No other state has looked at this issue in such depth," Health Commissioner Antonia Novello told the panel of transplant experts. "...These recommendations speak clearly that the health and safety of the donor must be the highest priority."

Next week, a federal Health and Human Services transplant advisory panel is scheduled to convene in Washington, and executive director Jack Kress said he expects the proposed national guidelines to mirror New York's on several points. The two groups have worked together "synergistically," said Kress, who has attended meetings of the state panel.

Dr. David Conti of Albany Medical Center, head of the state panel, said he believes the report "will restore confidence."

Novello appointed the group in March after issuing a scathing report on the events preceding the death of liver donor Michael Hurewitz, 57, who died Jan. 13 at The Mount Sinai Hospital in Manhattan. Hurewitz had donated a section of liver to his brother. The report detailed a lack of doctor and nursing care and raised questions about how well-informed such donors are about the potential impact of such a major, and fairly unstudied, operation. Two other donor deaths have been reported in the United States.

Novello said the guidelines will be forwarded to the new State Transplant Council, with members from the state's medical transplant centers, and then to the health department. Some parts are expected to become guidelines and others, enforceable regulations. Wayne Osten, director of the department's Office of Health Systems Management, said regulations would likely involve areas that could cost hospitals money - staffing requirements, for instance.

Specifically, the state panel called for:

An independent advocate team for the donor, consisting of a doctor, transplant coordinator, social worker and psychiatrist and/or ethicist. If the team decides the person is not a good candidate, the donation would not be permitted.

The donor and significant family members to be thoroughly informed of potential risks. The donor could change his or her mind at any point.

Two liver transplant surgeons to attend the donor, with a third in the recipient operating room.

Post-surgical staffing and routines that are spelled out, including one nurse per two patients in intensive care, and a 1-to-4 ratio thereafter on the transplant ward.

A data collection system has been instituted to track donors' long-term health.

Hurewitz's widow, Vickie, who has called for a moratorium on such operations, said she hoped to "ratchet up the discussion at the national level." Conti responded that a moratorium would "cost lives, not save lives."