UC to Tighten Control of 4 Remaining Clinics
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 composed 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 that 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-chairman 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 UCI 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 might 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 UCI clinic--Ricardo H. Asch, Jose P. Balmaceda and Sergio Stone--have denied any 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 has been outspoken regarding 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 UCI, were more pointed in 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 Board of 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.
Said UCI Chancellor Laurel L. Wilkening in a prepared statement, “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.”
The recommendations come less than a month after Sen. Tom Hayden (D-Santa Monica) proposed legislation that would 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 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 grant that their recommendations might not have short-circuited the UCI 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,” said Dr. Lo. “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 upon strengthening protocols for obtaining patient consent--a source of major controversy in the UCI scandal. At UCI, 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 such record keeping.
The task force urged that no clinic procedure be performed before the completion of written consent forms.
Further, the task force said, clinic workers other than doctors 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.”
Also, in an effort to safeguard procedures, the task force suggested broadening the ranks of those who can report possible wrongdoing. Under its plan, everyone from a lab worker to a social worker could file what was called an “incident report.”
“It’s almost like a whistle-blower’s protection,” Lo said. “We want to encourage anyone to come forward with suspicions so [they] can be dealt with before the situation gets out of hand.”
Other task force recommendations included: regular staff reviews of standards and oversight mechanisms, active membership in the professional society for fertility programs, and participation in the national College of American Pathologists laboratory certification program.
The task force report reaffirms some recommendations resulting from a UCI study completed in the spring of 1995 that changed procedures for oversight in all UCI medical departments, a UCI spokeswoman said.
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Fertility Safeguards
The University of California will enact a series recommendations from a 14-member panel intended to make it easier to report problems at the university’s remaining fertility clinics and ensure that patients are properly informed about procedures. The recommendations:
* Maintenance of quality-assurance programs and use of guidelines and oversight methods comparable to those used for other inpatient services such as surgery and blood banking.
* Membership in Society for Assisted Reproductive Technology and participation in SART reporting program. SART is a professional society that publishes annual data for assisted reproductive technology programs.
* Annual reports by program directors to department chair.
* Periodic reviews by program directors of issues including quality assurance, informed consent, annual reports.
* Maintenance of standards and oversight mechanisms comparable to those of other UC programs.
* Development of education and research activities to satisfy the overall UC mission in addition to providing clinic services.
Source: University of California
