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Details released from the investigation into University Hospitals fertility failure

University Hospitals has made significant changes to its fertility center after it lost accreditation from the Centers for Medicare and Medicaid Services.

New details have been released on the steps University Hospitals has taken to prevent another fertility failure.

The hospital has made significant changes after it lost accreditation from the Centers for Medicare and Medicaid Services.

It was after an investigation by the CMS, the Ohio Department of Health, and the College of American Pathologists. What they found was disturbing to say the least. But the hospital took action and has since been re-accredited.

"The fact that they knew of problems long before March is even more of a tragedy for our clients," said attorney Paul Grieco of Landskroner Grieco Merriman.

Grieco was referring to a nine page scathing report from the Centers for Medicare and Medicaid Services, or CMS, which detailed their investigation into the failures at University Hospitals Fertility Clinic dating back to January.

The report found out the following:

  • UH failed to ensure that the liquid nitrogen tank, that lost the thousands of eggs and embryos, was inspected and maintained.
  • That there was no documented evidence as to why the designated contact person wasn’t notified when an alarm went off signaling problems with the tank
  • And that there was only one contact person for the tank when an alarm went off versus three.

These were all steps recommended by the tanks manufacturer in their instruction manual.

And it was those findings that caused the hospital to lose its accreditation with the CMS.

"In January they were aware of the problems with temperature fluctuations which they never disclosed to patients and haven't disclosed to public as of yet,” said Grieco.

But shortly after the government's report, the hospital made significant changes and the

CMS rescinded its termination decision.

Some of UH's changes included:

  • Permanently removing the storage tank where the eggs and embryos were lost.
  • Installing a remote alarm system which would notify five different people instead of one.
  • And implementing new policy and procedures to perform checks and preventative maintenance.

UH also sent me this written statement which reads in part, "The hospital has hired additional staff to assist in the transition to the new equipment and processes. And that It will continue to make changes to help ensure that an event such as this doesn't happen again."

"In all fairness the hospital took responsibility and took steps to fix it,” I said to attorney Grieco.

Grieco, whose firm represents 150 clients affected by the fertility failure says it's too little too late.

"Without the investigation and investigators going in and holding them accountable, this information likely would not have come out," he said.

MORE | Judge grants motion by University Hospitals to consolidate lawsuits over fertility clinic failure

On Tuesday we learned the Custom Biogenics, the company that manufactured the storage tank in question, tried to quash a subpoena by plaintiffs in the case, who were requesting information from the company.

A judge ruled against them. They have until June 1st to respond.

Below is the full statement from University Hospitals:

Danielle,

We’re going to decline the interview because of the pending litigation involving the fertility clinic. We appreciate the opportunity to be part of the WKYC story and we want to emphasize several points that have been the focus of our efforts.

  • Patients have been our first, and are our ongoing, priority.
  • We have cooperated fully with the Centers for Medicare & Medicaid Services (CMS), the Ohio Department of Health (ODH) and the College of American Pathologists (CAP) in their reviews.
  • While we investigate why this happened, we also have been taking action to improve our operations at the fertility clinic, including upgrading equipment at the lab with new tanks, alarms and remote monitoring. We hired additional embryologists, nurses and support staff to assist in the transition to the new equipment and processes. We will continue to make changes that we think will provide the best care for our patients.

We strive to make sure we provide the services needed by our patients and, in this situation, to help ensure that an event such as this doesn’t happen again. As we learn more, we plan to share what we have learned from this event with other fertility clinics to take care in this area to a new and higher level.

George Stamatis

Sr. Media Relations Strategist

The below documents detail the findings by the Centers for Medicare and Medicaid and response actions by University Hospitals.

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