L.A., CA., USA: Hospital Halts Organ Program

St. Vincent center in L.A. says a patient, 52nd on liver transplant list, got improper priority and the action was covered up.

"St. Vincent Medical Center, one of the largest organ transplantation centers in the state, has suspended its liver program after discovering that its doctors improperly arranged for a transplant to a Saudi national using an organ that should have gone to a much higher priority patient at another hospital, officials said."

"Hospital staff members then falsified documents several times to cover up the alleged maneuver, pretending that the transplant was for a patient who was near the top of the regional waiting list, hospital President and Chief Executive Gus Valdespino confirmed Monday.
The transplant took place in September 2003 and was paid for by the Royal Embassy of Saudi Arabia. But Valdespino said the problem was discovered only this month when officials were responding to routine questions from auditors at the United Network for Organ Sharing, the nonprofit group that administers the national transplant system.

The patient who received the successful transplant was actually 52nd on the list, which covers much of Southern California and takes into account such factors as who is sickest and who has been waiting longest.

A patient at UCLA Medical Center was entitled to receive the organ and St. Vincent should have declined it, Valdespino said.

Transplant directors and ethicists from across the country say what is alleged to have happened at St. Vincent is a sin in organ transplantation, which is heavily regulated by a procurement network, as well as state and federal officials, to maintain integrity and fairness in the process.
The idea of moving one patient above another for other than medical reasons is 'totally unconscionable,' said Dr. Douglas Hanto, chief of the transplant division at Beth Israel Deaconess Medical Center in Boston. 'It's wrong unequivocally.'

The hospital, west of downtown Los Angeles, notified the state Department of Health Services about the line-jumping problem Monday, and agency spokeswoman Lea Brooks said inspectors would immediately investigate.

St. Vincent officials said that Dr. Richard R. Lopez Jr., director of the liver transplant program, and Dr. Hector C. Ramos, the assistant director, no longer were affiliated with the program. They declined to say whether the doctors had been terminated from those positions.

An attorney for Ramos said her client had done nothing wrong. A lawyer for Lopez said he did not have enough information to comment.

Suspending the program means that 75 patients on the waiting list for livers may have to seek care at other hospitals, possibly delaying their chances for a life-saving transplant. Patients who need livers typically suffer from end-stage liver failure, cirrhosis and other liver and metabolic diseases. The liver filters medications and toxins in the body and metabolizes carbohydrates, fats and proteins.

The Royal Embassy of Saudi Arabia paid the $339,000 cost for the transplant and hospital stay, which is 25% to 30% higher than what the hospital would typically be paid for the procedure by insurance companies and government programs, Valdespino said. A lawyer for Ramos, who was paid separately for his services, said he believed that the patient was an impoverished Bedouin and that the doctor didn't know if he would be compensated.

Patients without insurance, such as those from foreign countries, pay a higher rate than those whose health plans have negotiated steep discounts with the hospital.

The St. Vincent liver transplant program, which was created in 1995, has performed 184 transplants, according to data from the national organ network, including 22 last year. The hospital is in the process of contacting the 75 patients on its waiting list about the program's suspension.

The organ transplantation system in the United States strives to ensure that organs get to those who can benefit most from them.

Before placing a patient on a transplant waiting list, a hospital runs tests and assesses the patient's physical and mental health. The patient is not ranked at first, but instead is placed in a pool of potential recipients.

When an organ becomes available, after a donor dies, the patients are then ranked. A regional transplant coordinator tries to find someone who matches the donor's blood type, and also factors in medical urgency, waiting time and the geographical distance between the donor and the recipient.

The selected patient must be healthy enough to undergo major surgery and be willing to receive the transplant immediately.

The national organ network has said that no more than 5% of organs should go to foreign nationals, and indeed the actual percentage is much lower. However, data show that the liver transplant program at St. Vincent provided about 8% of its organs to foreign nationals. Overall, less than 5% of the hospital's organs go to citizens of other countries.

The scenario described by St. Vincent officials violated national standards in several respects. According to Valdespino, this is what happened:

On Sept. 8, 2003, the hospital was notified by the regional organ procurement agency that a liver was available for transplant into a Saudi patient, whom Valdespino referred to as Patient A. That patient, however, was out of town.

The transplant team then should have notified the regional agency that the patient was unavailable so that the liver could have been sent to the patient at UCLA Medical Center, who was next on the list.

Instead, St. Vincent transplanted the liver into a different Saudi national patient, whom Valdespino called Patient B. Although the patient had been hospitalized since Aug. 6, he was 52nd on the regional list.

The next morning, a data analyst at St. Vincent notified the national organ network that Patient B should be removed from the waiting list because he had just received a liver — a correct description of what had occurred.

Hours later, however, the analyst retracted his correspondence and requested that Patient B be put back on the waiting list. A form later sent to the national organ network, bearing the signature stamp of surgeon Lopez, stated that, 'In the process of training someone to enter data into the … system, there was an error in removing the patient from the wait list. The problem has been addressed and corrected.'

In October 2003, St. Vincent notified the organ network that Patient B wanted to be removed from the waiting list because he was transferring to a center in Europe.

Because the organ was incorrectly labeled as going to Patient A, he was removed from the waiting list. Valdespino said he does not know what happened to that patient or what his condition is now.

The hospital did not identify patients A or B. The identity of the UCLA patient and his or her condition also was unknown.

Valdespino, who started at the hospital in February 2004, said St. Vincent has discovered several more instances in which staff fabricated documentation. In six-month and one-year follow-up reports, the hospital identified Patient B as Patient A. Hospital staff also digitally altered the pathology report on Patient B's removed organ to indicate that it had been taken from Patient A.

Valdespino did not identify which employee or employees he believed had participated in the falsification.

A lawyer for Ramos, the program's assistant director, said her client did nothing wrong and was terminated by the hospital when he would not resign. 'Dr. Ramos was not involved in the falsification of records,' said his lawyer, Evelina M. Serafini. 'He intends to fight this to clear his name of any implication of fraud. He was simply not involved in that.'

UCLA said it had not been informed that the problem involved one of its patients, just that the St. Vincent program had been suspended and that UCLA may have to take some of its patients, spokeswoman Roxanne Moster said.

Valdespino said his staff has launched an investigation of St. Vincent's entire transplant program, which also includes kidneys and hearts, to determine if other misallocations of organs took place. 'We have not found anything yet,' he said.

The allegations at St. Vincent are among the most serious facing the organ transplantation network since claims in 1995 that baseball Hall of Famer Mickey Mantle received a liver for which he should not have been eligible. The national organ network looked into the allegations and determined that the organ was appropriately allocated to him.

The network was also called upon to justify why a 17-year-old girl was incorrectly given organs of the wrong blood type in 2003 at Duke University Medical Center and then why she received a second heart-lung transplant when her condition was deteriorating. She subsequently died.

'Having a system that the public views as equitable and views as worthy of their trust and their investment is really critical to serving the needs of 90,000 people that need transplants,' said Dr. Mark Fox, associate director of the Oklahoma Bioethics Center and a former chairman of the United Network on Organ Sharing's ethics committee. 'I feel pretty comfortable that this is not a widespread problem.'

Fox said St. Vincent seemed to be 'reacting in a responsible way' by suspending its program.

Tom Mone, chief executive of OneLegacy, the regional organ procurement agency for Southern California, said he hoped that the effects of the St. Vincent suspension won't cause potential donors or families to withhold their consent.

'In many years, we have had no prior allegations of such improprieties,' he said. 'It shouldn't have any impact on people's sense of confidence in the system.'

Valdespino agrees. He said his hospital has created a toll-free number for patients awaiting transplants to receive information: (866) 478-8462.

'We're not attempting to run and hide,' he said. 'We're not attempting to rationalize. We have a responsibility to restore the reputation of this program.'"

Sources:
Los Angeles Times, LATimes.com
Article by Charles Ornstein, Times Staff Writer