The report, which we've embedded below, says that the hospital failed to maintain and inspect a liquid nitrogen storage container used for eggs and embryos, did not properly utilize alarms meant to alert staff that eggs and embryos in the storage tank were in danger, and used a "manual fill" technique with liquid nitrogen before the temperature rose.
From the survey:
Centers for Medicare and Medicaid Services was told in an interview with UH staff as part of the survey that remote alarms for liquid nitrogen containers were tested last March or April 2017, but UH failed to provide documented evidence of tests.
There was only one sole designated contact off-site in the event of an alarm. There should have been three, per the manufacturer's instructions.
Until the malfunction, the monitoring logs failed to indicate the amount of liquid in the storage tank or the presence or absence of vapors.
The report states that University Hospitals is now in compliance and deemed acceptable to meet applicable Medicare requirements after the state received “an acceptable plan of correction” from the hospital. The state conducted its revisit survey on April 24. ODH will no longer conduct monitoring surveys of the hospital, according to the report.
In the correction plan, University Hospitals will have four new liquid nitrogen tanks purchased for egg/embryo storage, a lab director will conduct weekly audits of compliance, and a quality control council will receive these results and “take any necessary action,” the report said.
A UH media relations strategist declined our request for an interview:
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 WEWS 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.