Published by The Plain Dealer
March 27, 2018: Updated 6:01 PM; Posted 6:00 PM
By Ginger Christ and Julie Washington
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CLEVELAND, Ohio – University Hospitals was close to one day away from moving eggs and embryos to safety when a temperature fluctuation in a storage tank damaged them, rendering all 4,000 eggs and embryos in the hospital system’s care unviable.
Initially, UH said 2,000 eggs and embryos were affected but in the past day revised that number to include all the specimens and upped the number of patients involved to 950 from the original 700. UH first discovered the tank failure March 3-4.
“Our initial letter was a rough estimate of the number of eggs and the number of families that were affected. We were really intent on trying to notify the families involved, and so we were really focusing much of our time on that aspect as opposed to going way back in the inventory and doing a careful inventory,” Dr. James Liu, chairman of UH’s Department of OB/GYN, said during an interview today with The Plain Dealer.
UH for weeks had known that the two cryofreezers, where it stored sperm, eggs and embryos, were both malfunctioning and the hospital was taking steps to remedy those problems, Liu said. But it hadn’t yet completed that process when the temperature inside the tank climbed above the -196 Celsius threshold at which the specimens needed to be stored. UH is still investigating why there was a temperature fluctuation in the tank.
“I can’t say it any more plainly, we failed our fertility clinic patients. We are sorry. I am sorry. And we’re going to do everything we can to regain our patients’ trust,” UH CEO Tom Zenty said in a video UH uploaded to Facebook this afternoon.
The remote alarm system on the tank, designed to alert employees to changes in temperature, was turned off. This meant that alerts that should have been sent to staff were never sent.
“The liquid nitrogen levels in the tank were monitored and appeared to be appropriate on Friday and Saturday but we now suspect that may not have been the case,” UH wrote in a letter sent to patients via FedEx March 26. “We do not yet know if this fill process may explain the rise in temperature over the weekend.”
The hospital system first noticed issues with the tank in its andrology lab, where sperm is handled, and had successfully fixed that tank when the tank in the embryology lab failed, Liu said. At issue was the autofill valve on the tanks, which is how the freezers refill with the cooling agent liquid nitrogen. The valves on both tanks were stuck open.
UH had been working with the manufacturer of the tank, which Liu declined to name, to thaw the freezer and relocate the eggs and embryos to a new tank, as it had with the sperm in the other autofill freezer. Liu said UH was “about a day or so out” from transferring eggs and embryos to a loaner tank when the temperature fluctuation occurred.
While the autofill function was down, staff had been manually filling the storage tank for several weeks by connecting the tank to a line to a liquid nitrogen reserve tank, UH said in the March 26 letter. However, for several days prior to the March 3 weekend, staff could not manually fill the tank using a line because UH did not have liquid nitrogen tanks available in the embryology lab.
Staff instead had to manually fill the tank by pouring containers of liquid nitrogen from the andrology lab into the top, UH said. On the Friday before the incident, liquid nitrogen was poured into the tank.
Since the incident, UH has purchased new storage tanks with new alarms from a different vendor, Liu said. The new tanks are much smaller than the autofill tanks that malfunctioned and need to be manually filled with liquid nitrogen. Liu would not disclose the name of the new manufacturers.
UH put 24-hour surveillance on the tanks while it was switching to new alarm systems but did not have additional staff watching the tanks prior to March 3, even when it knew the freezers already had been malfunctioning, Liu said.
As UH takes in new patients and performs new in vitro fertilization treatments for affected patients, it is now splitting up eggs and embryos from each patient into different tanks, Liu said.
The fertility clinic is still operating and has been seeing both new and affected patients, he said. When asked if any of the fertility clinic’s employees had been disciplined, Liu said UH was still investigating the situation.
Zenty said UH is cooperating with the Ohio Department of Health; the College of American Pathologists, an accreditation organization; and other organizations to investigate what happened and also has engaged outside experts to help.
The tanks holding sperm and embryos were purchased when the lab opened in 2011, Liu said. The hospital has not disposed of any unviable embryos, Liu said. They will be held until patients decide what they want to do with them.
UH patients say they are devastated and frustrated by the loss of their embryos, which they regarded as potential future children. Some patients stored eggs and embryos prior to undergoing cancer treatments that would render them infertile.
About 57 lawsuits have been filed against UH.
UH’s fertility center is working to regain the public’s trust by instituting redundancy in its freezer systems and moving to a lower-tech setup, Liu said. He hopes that new guidelines for the fertility industry will result from UH’s investigation of what went wrong at its center.
“I don’t think there’s any other way to proceed,” he said.
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