5 years after the failure of the fertility clinic at the university hospital: looking back at the events leading up to and following the disaster

More than 4,000 eggs and embryos were destroyed, affecting approximately 950 patients. UH says the lawsuits have been settled and those affected have received free fertility treatment.

CLEVELAND. For hundreds of hopeful parents, this was one of the most devastating moments of their lives.

Five years ago, one of the cryocontainers in the university hospitals fertility laboratory at Ahuja Medical Center melted down, destroying thousands of eggs and embryos in storage and affecting almost a thousand patients.

On the same weekend as in Cleveland, another crisis occurred nationwide in San Francisco at the Pacific Fertility Center. Both cases resulted in dozens of lawsuits.

Chronology

IN end of February 2018UH lab workers only had a few days to move the eggs and embryos to a safety storage tank so they could fix the failed tank. On March, 3rdafter the staff left, the temperature in the tank began to rise, and the remote alarm designed to alert the embryologist on duty was deactivated.

When the staff returned March 4, they heard an internal alarm, but by then the damage had been done. Two days later on March, 6UH began sending out letters informing patients of what had happened.

The hospital independently reported the incident to federal regulators that oversee fertility clinics known as CLIA—Clinical Laboratory Improvement Amendments—which include members of the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and Centers for Disease Control and Prevention. On March 83News went public with the story, UH issued a public apology and offered free consultations and fertility services to those affected.

On March 12the first of dozens of lawsuits was filed against UH, and March 13 investigators from the Ohio Department of Health inspected the lab on behalf of CLIA. 26 March saw UH send a new letter to patients informing them that the entire tank had been compromised, destroying a total of 4,000 eggs and embryos and affecting 950 patients.

On 20 April, then UH CEO Tom Zenty sent out a memo to hospital staff outlining all the changes that had been made to the fertility clinic, urging staff to speak up and communicate any potential risks. Later 1st of MayCMS released a scathing nine-page report detailing its investigation into the outage.

As a result, UH loses the laboratory’s accreditation, but regains it after reporting system changes made to the protocol and the laboratory. These changes were many, but included the installation of a remote alarm system that would notify five people instead of one, and the introduction of new policies and procedures for inspections and preventive maintenance.

UH declined to participate in the WKYC interview on camera or show us the updated changes, but did make a statement.

“We appreciate the invitation for an interview, but this time we will respectfully decline it.

“Over the past five years, university hospitals have been committed to serving patients affected by the 2018 event. To this end, we have successfully resolved all claims and have successfully worked with hundreds of patients to provide fertility treatment services.

“It is equally important that UH has taken a number of security measures to prevent a similar incident in the future. Every day we strive to be a trusted healthcare partner for Northeast Ohio, and many families continue to turn to us for help with infertility.”

Although the lawsuits included non-disclosure agreements, the payments to those who sued were likely in the millions. A 2018 memo to employees indicated that the hospital had insurance to cover these costs and the fertility lab would not be affected. Today, the laboratory is still working and helping women become mothers.

Tank accidents in Cleveland and San Francisco have had an impact on reproductive clinics around the world. Many hospital systems have reviewed and upgraded their cryogenic storage procedures.

Experts would like reproductive medicine to be regulated at the federal level by the FDA or by a new agency like the UK’s Office of Human Fertilization and Embryology. They argue that oversight can help reduce medical risks, accidents, and ensure equal access to services.

In 2021, Democrats in the US House of Representatives introduced the Infertility Treatment and Care Access Act. This bill requires private health insurance plans to cover certain fertility treatments, such as in vitro treatments, if the plan also covers midwifery services, along with fertility preservation services, for individuals who are undergoing medically necessary treatments that could impair fertility. .

The proposal was submitted to the House Subcommittee on Health in September 2021, but no action was taken until the 117th Congress concluded its deliberations in January this year.

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