Tuesday, June 6, 1995

MICHELLE NICOLOSI; MARILYN KALFUS
THE ORANGE COUNTY REGISTER

Officials at UCI Medical Center have described the oversight of their world-renowned fertility clinic as "a gray area," but scientists at major teaching hospitals elsewhere say it should be clear as black and white:

University hospitals must take responsibility for what happens at clinics on campus. UCI Medical Center Director Mary Piccione and Dr. Thomas Garite, chairman of the OB/GYN department, have described UCI's monitoring of private practices at the Center for Reproductive Health as not particularly well-defined, according to a 16-page report by three University of California physicians investigating the clinic.

But the three physicians wrote that both the medical center and the department of obstetrics and gynecology were obligated to oversee the clinic because the clinic was located on campus and staffed by university employees.

Physicians at teaching hospitals elsewhere told The Orange County Register that following such safeguards is standard practice.

Dr. Joseph Gambone, director of the fertility center at the University of California, Los Angeles, said clinics at university hospitals typically undergo regular reviews of clinical practices.

"It would astound me that there wasn't any review," Gambone said.

"Some degree of oversight is critical," said Dr. Steven Ory, chief of fertility services at the Mayo Graduate School of Medicine and associate professor of Mayo Medical School.

Ory's fertility clinic undergoes a major review of clinical practices every four years and other intermittent reviews when adding new procedures to the clinical practice.

The Mayo fertility clinic's latest review was just last week: a review of the clinic's new anonymous oocyte and embryo donation program.

Ory said when a new program is set up, so is a review process.

"The clinical and scientific and ethical practices are reviewed by the institution and guidelines are established," he said. "I think that's the standard around the country."

Dr. Sam Wood, director of a large in-vitro fertilization program in San Diego, noted that whatever happens at a clinic is a reflection on the university.

For that reason, "I would be very surprised if there were any clinics located on a university campus that didn't receive careful oversight," said Wood, medical director of the Reproductive Sciences Center of the Palomar-Pomerado Health System.

"The gray area may come if a center is affiliated with a university or a health system and their office is off campus," he added.

The report on the University of California, Irvine, clinic was written by Dr. Stanley Korenman, associate dean at UCLA Medical Center; Dr. Mary C. Martin, director of the in-vitro fertilization program at the University of California, San Francisco; and Dr. Maureen Bocian, director of the Division of Human Genetics and Birth Defects at UCI Medical Center.

Among the findings in the report: Doctors at the UCI fertility clinic left consent forms and documents for tracking human eggs to be developed and instituted by their staff.

"The requirement for oversight is particularly relevant to this high technologic and sensitive area of medicine," the physicians wrote in the report.

But only after hospital workers blew the whistle on doctors at the UCI clinic did the medical center and the department of OB/GYN begin to oversee the practice, the report stated.

Biomedical ethicists agreed with scientists who said universities have an obligation to oversee what happens on their campuses even when the doctors in question are star practitioners.

"It may be `gray' in keeping tabs on lots of people doing lots of things," said Arthur Caplan, an ethicist at the University of Pennsyvania. "But it's technicolor as to who's responsible: Ultimately, it's the institution and the regents. It's not fuzzy."

"In retrospect, it's clear we should have had a higher level of oversight," said Dr. Sidney Golub, the university's executive vice chancellor.