UC Imposes New Safeguards at Fertility Clinics

OAKLAND —  The University of California on Monday ordered tighter controls over its four remaining fertility clinics to prevent a repeat of a scandal that shut down UC Irvine’s once-prestigious clinic last summer.

UC President Richard C. Atkinson authorized the swift enactment of a series of recommendations from a 14-member task force made up of medical, legal and ethical experts. Chief among the task force’s wide-ranging recommendations were measures to make it easier to report wrongdoing and to ensure fertility patients are properly informed of medical procedures.

“At UCI, the problem was there was no close reporting relationship to either the department or to the hospital’s administrator,” said Dr. Bernard Lo, task force co-chair and director of medical ethics at UC San Francisco. “We hope that these will reassure the public, whose trust has been shaken.”

The task force was convened in July 1995 after allegations surfaced that three UC Irvine doctors stole the eggs and embryos of scores of women and gave them to other patients, as well as engaged in research and financial fraud. UC officials acknowledge that more than 70 women may have been victimized by egg and embryo misappropriation, and have said that at least seven live births have resulted from misappropriated eggs and embryos.

The report’s 21 recommendations include:

* Establishing clearer lines of reporting and oversight.

* Requiring annual reports to department heads.

* Holding attending physicians responsible for obtaining written consent from patients.

The physicians who ran the UC Irvine clinic--Ricardo H. Asch, Jose P. Balmaceda and Sergio Stone--have denied deliberate wrongdoing. Asch has moved to Mexico City, Balmaceda is practicing in Santiago, Chile, and Stone remains in Orange County. The three are the subject of at least seven investigations, although no charges have been filed against them.

Critics who applauded UC’s recommendations nevertheless questioned why the measures weren’t developed sooner.

“No pun intended, but this isn’t brain surgery,” said Lt. Gov. Gray Davis, who as a UC regent also has been outspoken of the university’s management of the scandal. “There’s nothing revolutionary or extraordinary about the suggestions, and it’s a little shocking that they have not been in place from the outset.”

Others, such as Orange attorney Melanie Blum, who represents 17 plaintiffs among the 40 lawsuits filed against Asch and UC Irvine, were more pointed in the attacks on UC officials.

“What? Now a warning and recommendations?” Blum said. “What is this? Now you’re going to start thinking about consent forms? Am I missing something here?”

The recommendations, part of a 41-page report to be presented to the UC Regents on Thursday in San Francisco, will be quickly instituted at fertility clinics at UC Davis, UC San Diego, UC San Francisco and UCLA, officials said.

“If there is any positive result to come out of the tragedy of the alleged actions of the Center for Reproductive Health doctors, it will be that it serves as a wake-up call for doctors, universities, [and] hospitals,” said UC Irvine Chancellor Laurel L. Wilkening in a prepared statement.

The recommendations come less than a month after state Sen. Tom Hayden (D-Santa Monica) proposed legislation to make it a felony to transfer or implant human eggs or embryos without the informed consent of both donor and recipient.

“It’s promising to see that UC has proposed some reforms,” said Stephanie Rubin, a Hayden aide. “I agree that some systemic reforms and oversight must take place at UC medical centers [so they will] care more about patients than their prestige and profits.”

But Rubin seemed to doubt whether the UC recommendations will address what Hayden regards as the root problem of university operation of lucrative clinics.

“There’s an inherent conflict between the university that’s making money from these medical enterprises and also supposed to be overseeing them,” she said. “Whether [these recommendations] get to the heart of that conflict remains to be seen.”

Even task force members concede that their recommendations might not have short-circuited the UC Irvine fertility scandal. But, add task force members, the new guidelines should reduce the likelihood of a repeat incident.

“No one can guarantee what people do no matter how many rules or laws you have,” Lo said. “But if these guidelines were in place it would have become much clearer, much sooner that something was wrong.”

A key issue addressed in the report centered on strengthening protocols for obtaining patient consent--a source of major controversy in the UC Irvine scandal. At the university, no clear records were kept regarding patient consent for egg and embryo transfers, leaving university officials and Asch pointing fingers at each other over who was responsible for record keeping.

The task force urged that no clinic procedure be performed without first securing a written consent form. Further, the task force said, other clinic workers such as nurses should verify that patient consent has been given.

This task force proposal drew almost uniform praise.

“There’s no question that requiring written consent will prevent misappropriation of eggs and embryos,” Davis said. “And if it doesn’t, it will certainly identify the culprit. This way doctors can’t say, ‘I didn’t do anything.’ You’ll have their written consent this time.”