CLEVELAND — For hundreds of hopeful parents, it was one of the most devastating moments of their lives.
Five years ago, one of the cryo tanks in University Hospitals' fertility lab at Ahuja Medical Center melted down, destroying thousands of eggs and embryos in storage and impacting nearly a thousand patients.
The very same weekend it happened in Cleveland, another meltdown occurred across the country in San Francisco at Pacific Fertility Center. Both cases launched dozens of lawsuits.
The Timeline
In late February 2018, UH lab workers were just days away from moving the eggs and embryos into a spare tank for safety so they could fix the one that was malfunctioning. On March 3, after staff members left, the tank temperature began to rise, and a remote alarm designed to alert the embryologist on call was deactivated.
When staff returned March 4, they heard the inside alarm, but by then, the damage was done. Two days later, on March 6, UH began sending letters informing patients what happened.
The hospital self-reported the incident to federal regulators that monitor fertility clinics known as CLIA — Clinical Laboratory Improvement Amendments — made up of members of the Food and Drug Administration, Centers for Medicare and Medicaid Services, and Centers for Disease Control and Prevention. On March 8, 3News broke the story to the public, with UH issuing a public apology and offering free counseling and fertility services to those impacted.
On March 12, the first of dozens of lawsuits were filed against UH, and on March 13 investigators from the Ohio Department of Health inspected the lab on behalf of CLIA. March 26 saw UH sending a new letter to patients revealing the entire tank was compromised, destroying a total of 4,000 eggs and embryos while impacting 950 patients.
On April 20, then-UH CEO Tom Zenty sent a memo to hospital employees outlining all the changes that have been made to the fertility clinic, encouraging employees to speak up and report any potential risks. Later on May 1, CMS issued a scathing nine-page report detailing its investigation into the failure.
As a result, UH loses its lab accreditation, but regained it after reporting the system changes made to protocol and the lab. Those changes were numerous, but included installing a remote alarm system which would notify five people instead of just one as well as implementing new policies and procedures to perform checks and preventative maintenance.
UH declined to participate in an on-camera interview with WKYC or show us the updated changes, but did issue a statement.
"We appreciate the invitation for an interview, but at this time we will respectfully decline.
"Over the past five years, University Hospitals sought to serve those patients impacted by the 2018 event. To that end, we successfully resolved all claims and successfully worked with hundreds of patients to provide fertility services.
"Equally important, UH implemented a number of safety steps to prevent a similar incident in the future. Every day, we strive to be Northeast Ohio’s trusted health care partner, and many families continue to turn to us for fertility care."
While the lawsuits included non-disclosure agreements, it's likely the payout for those who sued was in the millions. A memo to employees in 2018 indicated the hospital had insurance to cover those expenditures and it would not impact the fertility lab. Today, the lab is still operating and helping women become mothers.
The Cleveland and San Francisco tank failures had a ripple effect globally in reproductive clinics. Many hospital systems revisited and revamped their cryo storage procedures.
Experts would like to see reproductive medicine federally regulated by the FDA or a new agency similar to the United Kingdom's Human Fertilization and Embryology Authority. Oversight, they argue, may help mitigate medical risks, accidents and give equal access to services.
In 2021, Democrats in the U.S. House of Representatives introduced the Access to Infertility Treatment and Care Act. This bill would require private health insurance plans to cover specified infertility treatments such as in vitro if the plan also covers obstetrical services, along with fertility preservation services for individuals who undergo medically necessary treatment that may cause impairment of fertility.
The proposal was referred to the House Subcommittee on Health in September of 2021, but no action was taken prior to the 117th Congress concluding its business this past January.