Fertility clinic failure raises questions about oversight

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CLEVELAND - With human lives on the line, fertility clinics like the one at University Hospitals face little government oversight.

There are no federal or state regulations for embryology in Ohio, but instead, some fertility clinics voluntarily seek accreditation.

University Hospitals passed inspection by the College of American Pathologists in 2016, but representatives from the organization returned on March 21 for an inspection. It’s investigating after a storage tank failure likely ruined more than 4,000 eggs and embryos.

CAP has strict requirements for accreditation, including daily checks of tanks and monitoring of liquid nitrogen levels, alarms that are monitored 24 hours a day, and a plan in place for emergency backup storage.

A spokesperson said CAP is still awaiting more information from UH before acting.

The Joint Commission, which accredits Ahuja Medical Center and University Hospitals overall, is evaluating next steps, according to a spokesperson for the organization.

On Tuesday, nearly 1,000 families received letters from University Hospitals revealing additional details about the storage tank problem.

The letter revealed that a remote alarm system on the tank was turned off, the tank hadn’t been working properly for weeks, and staff had not yet moved eggs and embryos to a new tank.

The “loaner” tank still needed to be decontaminated and prepared, according to Dr. James Liu, Chairman of the UH Department of OB/GYN.

“We were thinking the liquid nitrogen levels had sufficient reserve for several days, and therefore it was not a concern raised with regards to that,” Liu said.

While no state agency is charged with regulating fertility clinics, the Ohio Department of Health is investigating whether the clinic complied with federal requirements for participation in Medicare and Medicaid on behalf of the Centers for Medicare and Medicaid Services.

The U.S. Food and Drug Administration only regulates tanks marketed and labeled for use in assisted reproduction technology procedures. A spokesperson said the agency has no record of any tanks that are labeled for that purpose. So, tanks remain unregulated, even though they are routinely used to store eggs and embryos.

“Many of the labs have their own protocols, although they're very similar in some respects, but there is no overall umbrella organization that formally provides guidelines,” Liu said.

Liu stopped short of calling for more regulations, citing the hospital’s ongoing internal investigation into the incident.

“Our aim really is to, once we do have the findings, to fix those findings, build in redundancies, and hopefully be able to give this information to our professional societies and establish some guidelines for how we should implement these long-term storage facilities,” Liu said.

A spokesperson for one of those professional societies, The American Society for Reproductive Medicine, said it is gathering information to determine if there are urgent recommendations it needs to provide its members.

**Continuing coverage, here**

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