Organ allocation rule ends in a hospital’s supsension
UNOS, liver foundation say system works
An apparent violation of federal organ transplantation procedures at St. Vincent Medical Center in Los Angeles and the subsequent voluntary suspension of transplants at the hospital have directed new scrutiny on the process by which donor organs are distributed in the United States.
The incident, which occurred in September 2003, involved the transplantation of a liver into a patient out of the order established by the national transplantation list maintained by United Network for Organ Sharing (UNOS), the agency that regulates transplantation centers in the United States. St. Vincent Medical Center’s initial investigation indicates that falsified data were subsequently submitted to UNOS.
Organ recipient was far down list
According to St. Vincent, a Saudi Arabian national sought treatment at the medical center, was placed on a waiting list for a liver transplant in early 2003, and sent home to Saudi Arabia to wait for a liver to become available. Later that year, a liver became available and he was at the top of the list of eligible recipients; however, he was in Saudi Arabia, not Los Angeles. He was not notified of the availability of the liver, and the liver was transplanted into another Saudi patient who was a patient at St. Vincent — only this patient was 52nd on the UNOS priority list of eligible recipients.
According to investigators, not only were 51 other patients, who were deemed more in need than the one who received the liver, passed over, but the transplant team falsified records for months afterward in an effort to make UNOS believe the intended man actually received the liver and was thriving. The transplant surgeon never informed the intended recipient that an organ had been available and used for another patient. When the intended recipient returned to the hospital four months later, he was told that his liver cancer had progressed to a terminal stage, and he died in early 2004.
UNOS urges strict compliance
Upon discovery of the alleged violation, St. Vincent voluntarily inactivated its liver transplant program, pending further investigation. The violation was discovered during a routine UNOS audit.
While St. Vincent’s program is inactive, its current liver transplant candidates were transferred to other local transplant programs, with no interruption to their allocation, according to a UNOS statement.
"The national transplant system is dependent upon the public’s trust in the equity of that system, and the willingness of the public to agree to donation," according to Francis L. Delmonico, MD, president of UNOS. "We want the general public — and especially those awaiting organ transplants — to know that there are policies and standards governing the equitable distribution of organs that must be adhered to throughout the country."
UNOS routinely audits all U.S. heart and liver transplant programs to assess compliance with federal laws and the policies of the Organ Procurement and Transplantation Network (OPTN), which is operated by UNOS under contract with the U.S. Department of Health and Human Services. The review process is designed to ensure that transplant candidates receive appropriate priority for suitable organ offers, thus creating an atmosphere of public trust to support organ donation.
"Any breach of integrity regarding established transplantation procedures is unacceptable," insists Gus Valdespino, president and chief executive officer of St. Vincent. "We are conducting a thorough investigation of this case to find out why and how this happened, and to make sure it never happens again. The patients of the St. Vincent Medical Center Liver Transplantation Program are our highest priority."
Richard Lopez, MD, director of St. Vincent’s liver transplant program, and Hector Ramos, MD, assistant director, were removed as directors of the program. Lopez resigned from the hospital. Ramos was serving as chair of the hospital’s bioethics committee at the time of the alleged violation; he has since stepped down from that post and left the liver transplant program. The temporary deactivation of the transplant program, Valdespino says, was necessitated by the loss of the surgeons.
The American Liver Foundation, dedicated to promoting liver wellness and advocating for liver disease and transplant patients, expressed concern over the events at St. Vincent, but insists the current system for procuring and allocating organs is a fair and equitable one.
"While there are many variables that contribute to one person’s ranking on any organ wait list, with liver transplants, simply put, the sickest patients are at the top of the list," according to Frederick G. Thompson, president and CEO of the American Liver Foundation. "Recent events in Los Angeles only strengthen our position that organs should go to the sickest patients, which is in keeping with the established national system."
According to UNOS, the demand for livers is projected to increase by more than 300% over the next decade due in part to the emerging impact of hepatitis B and C.
Sources
- Francis L. Delmonico, MD, president, United Network for Organ Sharing (UNOS). Address: 700 North 4th St., Richmond, VA 23219. Phone: (804) 782-4800.
- Gus Valdespino, president and chief executive officer, St. Vincent Medical Center, Los Angeles, CA. Phone: (213) 484-5551.
- American Liver Foundation, 75 Maiden Lane, Suite 603, New York, NY 10038. Phone: (800) GO-LIVER. Web site: www.liverfoundation.org.
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