Ahuja Medical Center. Credit: Google Street View
Following a failure at University Hospitals fertility clinic that destroyed the eggs and embryos of more than 900 patients, the system has replaced lab equipment and implemented new protocols to prevent further malfunctions.
CEO Thomas Zenty sent to employees a memo, obtained by Healthcare Finance, that lab equipment has been changed including tanks, alarms and remote monitoring and a review of all temperature-regulated storage systems at all facilities has been conducted. A plan for monitoring those areas is in the works, Zenty added.
Zenty said the UH system has cooperated with the Centers for Medicare and Medicaid Services, the Ohio Department of Health and the College of American Pathologists in their reviews and he believes they will meet the requirements to maintain their Medicare certification and CAP accreditation at the UH Fertility Clinic.
"We will learn from our experience and share the best practices we expect to develop to enhance fertility programs everywhere," Zenty wrote.
In early March that one of the liquid nitrogen-filled tanks holding the frozen eggs and embryos of clinic patients malfunctioned, causing the temperature in the tank to rise to a level that destroyed the eggs and embryos inside.
Originally the system reported that roughly 2,000 eggs and embryos were destroyed by the temperature fluctuation. In a letter dated late March, the system said that number destroyed was actually double that, at 4,000. About 950 patients were affected.
The letter stated that remote alarm system on the tank that was supposed to be turned on so as to alert system staff of any issues in the tank, was in fact off at the time of the incident. The letter stated that the system was unaware of when the alarm was turned off, but that it had remained off the entire weekend including the Saturday night when the fluctuation occurred, such that alarms that should have been triggered by the rise in tank temperature were never sent and the temperature in the tank went unchecked. The letter said UH was still seeking answers.
It also said that the tank in question needed preventative maintenance as the mechanism which automatically fills the tank with liquid nitrogen had not been working properly, and UH had been working with the manufacturer to correct it, which first required transferring all the specimens to a different tank. That process was supposed to take several weeks and had technically begun, though no specimens had yet been transferred from the original tank. With the autofill function not working, staff had been filling the tank manually. The system said that the day before and the day of the malfunction, levels appeared to be appropriate but it suspected that in fact, they were not.
Dozens of lawsuits have erupted as a result of the tank malfunction. This week, a local report numbered them at "more than 40" with roughly 70 plaintiffs. A Cuyahoga County Court has ordered that the lawsuits filed against University Hospitals' fertility clinic be combined into a single case. The judge did so saying that the suits are "substantially the same."
UH declined to comment on the cost of replacing all the equipment.