UH fertility clinic tanks unregulated, hospital isn't required to federally report failure

CLEVELAND - It's been nearly a week since a medical misstep in the University Hospitals' fertility clinic had devastating consequences for hundreds of families and News 5 continues to dig deeper into the regulations of reproductive labs.

When it comes to regulations you may be surprised by what is regulated, or what isn't.

Liquid nitrogen keeps fertility storage tanks at the right temperature - more than 300 degrees below zero. Something regarding one of those tanks/storage facilities was behind the malfunction at University Hospital that changed the future for hundreds of local families. 

"My heart truly goes out to the parents of the people who were supposed to be having transfers this week, because the embryos were unthawed and lost and some of them, that was their only shot," UH Fertility patient Marlo Emch said. 

But who was keeping watch? News 5 found that the tanks, or storage containers, containing those delicate embryos and eggs aren't federally regulated. 

When something goes wrong, there is no required federal reporting of an incident. 


Here's everything we know about the University Hospitals fertility storage malfunction

News 5 also found procedures across fertility hospitals are different.

In Tucson, a doctor said they don't keep all of a patient's eggs or embryos in one place.

"You wouldn't want to have all of your eggs in one tank that could be devastated if something were to happen," said Dr. Timothy Gelety with the Arizona Center for Reproductive Endocrinology and Infertility.

He also said they have an employee checking nitrogen levels at their clinic every day. 

"They have to be maintained," Dr. Gelety said.

Another fertility doctor in Denver agreed. 

"With sensors, with alarms and daily inspection of the freezing units? The idea this failure would occur seems odd," Dr. William Schoolcraft said. 

But University Hospitals will not share their procedures. 

"There's never been a similar error," Dr. William Schoolcraft said. 

News 5 also found that the labs don't have to be accredited. A federal statute requires most labs across the country to have accreditation, but there's no requirement for reproductive labs. 

University Hospitals elects accreditation, and both accreditation boards — The College of American Pathologists and The Joint Commission — are now investigating the incident and University Hospitals' compliance.

RELATED: Another accreditation agency investigating University Hospitals after fertility clinic malfunction

The FDA oversees the registration of medical devices. News 5 has made several requests for information on the devices used in University Hospitals fertility clinics, and we have been told they will not disclose that information and that it has to come from the hospital.

Our University Hospitals interview requests today, and every other day, have been denied. 


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