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 nonviable.
Initially, UH said 2,000 eggs and embryos were affected but late Monday 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.
The hospital earlier today said both human error and equipment failure could have caused the incident.
As for equipment failure, UH said it had known for weeks prior to the incident that the two cryofreezers, one that stored sperm, and one that stored eggs and embryos, were both malfunctioning and the hospital was taking steps to remedy those problems.
The temperature inside the tank climbed above the -196 Celsius threshold at which specimens needed to be stored before a fix could be made. 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.
UH wrote in a letter sent to patients via FedEX on March 26: “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.”
“We do not yet know if this fill process may explain the rise in temperature over the weekend,” the letter read.
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.
NBC reported Tuesday that the UH freezer might have come from a manufacturer in Michigan, Custom BioGenic Systems. The company did not return Plain Dealer requests for comment. Liu would not verify the manufacturer’s name.
UH had been working with the manufacturer of the tanks, 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 with 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 the 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 of the one in the embryology lab, UH said. On the Friday before the incident, liquid nitrogen was poured into the tank.
The tanks holding sperm and embryos were purchased when the lab opened in 2011, Liu said.
As for the possible human error, the remote alarm system on the tank, designed to alert employees to changes in temperature, was somehow turned off or deactivated. This meant that alerts that should have been sent to staff were never sent.
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.
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. There are about 25 employees who work at the facility, UH said.
As UH takes in new patients and performs new in vitro fertilization treatments for affected patients going forward, it is now splitting up eggs and embryos from each patient into separate tanks, Liu said.
The hospital has not disposed of any nonviable 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.
Jeremy and Kate Plants, patients in UH’s fertility program, said in an email to the Plain Dealer that UH’s latest letter and video statement were “totally horrifying to us.”
“We had accepted that our embryos were lost, but our hearts break for those who were holding on to hope that their embryos were still alive,” Jeremy Plants wrote.
The couple was childless but hoping for a family when Kate Plants learned she had ovarian cancer in 2015. She underwent treatment to harvest eggs, and wound up with five viable frozen embryos. All of them were ruined in the UH incident.
Jeremy Plants criticized UH for giving affected patients false hope for weeks, instead of helping them prepare for the worst. Jeremy Plants also pointed out that the hospital knew there were problems for weeks before this incident. “What were they thinking and why was nothing done before this disaster happened?” he wrote.
On Tuesday, 36 new plaintiffs came forward bringing the total number of plaintiffs to 57. There are 22 lawsuits that have been filed against UH over the incident.
Attorney Tom Merriman, who is representing patients affected by the UH incident, thinks every one of the victims should seek compensatory and punitive damages applicable to their losses in separate cases.
Punitive damages are awarded by a judge or a jury as retribution to the victim of a defendant’s “reckless or wanton conduct.” They are awarded in addition to damages to compensate the plaintiffs for their losses.
“It turns out everybody knew there were problems with this system. How do you leave that clinic unstaffed?” Merriman told the Plain Dealer. “They’re basically admitting that by Friday it wasn’t working, and they didn’t leave anybody there?”
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.
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.