CLEVELAND, Ohio — University Hospitals’ fertility clinic is under investigation by two accreditation organizations and the Ohio Department of Health after a storage tank malfunction potentially damaged thousands of embryos and eggs.
These groups are looking for answers as to what happened at UH’s Ahuja Medical Center in Beachwood. The eggs and embryos, according to officials, could be unviable for in vitro fertilization procedures. Several lawsuits have been filed against UH in Cuyahoga County Common Pleas Court, and more are expected. Since its initial statement, UH has declined to comment further.
A similar equipment malfunction recently hit a fertility clinic in San Francisco, but it is not clear if the two are related.
The findings may result in stricter guidelines for fertility labs across the country and could put UH’s accreditation in question.
The College of American Pathology, an international lab accreditation program based outside of Chicago, has launched an investigation into the fertility clinic equipment malfunction at UH.
CAP is drafting a letter to UH that outlines specific questions regarding the equipment malfunction, said Dr. Paul Bachner, advisor to the CAP accreditation committee. UH will have 10 days to respond and CAP may follow up with an on-site visit to the lab, Bachner said.
He declined to say whether UH had received the letter yet. CAP’s findings will not be made public.
UH could lose its accreditation with CAP if it is found to be out of compliance and doesn’t resolve the issues promptly, Bachner said. But, he added, “We cannot shut a lab down. We don’t have the authority to do that.”
Fertility labs want to keep their accreditation because patients look for that when deciding where to go for treatment, said Denise Driscoll, senior director, Accreditation & Regulatory Affairs for CAP.
The UH fertility lab passed a CAP inspection in 2016 and was due for another inspection this year. The San Francisco lab was found in compliance during its CAP inspection in 2017. Labs are inspected every two years.
In order to be accredited by CAP, labs must meet certain standards regarding the training and education of staff, facilities, equipment and other aspects.
The CAP checklist for inspecting fertility labs includes the following points:
- checks of incubator function are recorded each day
- written procedures for monitoring and maintaining adequate liquid nitrogen levels
- alarms monitored 24 hours a day either remotely or in the lab
- procedure for back-up refrigerators and freezers
It’s too soon to know what caused the freezer malfunction at UH, Driscoll said. CAP will take what it learns about the malfunction at UH and use it to make other labs safer, she said.
A team from the Ohio Department of Health investigated UH on Tuesday to determine if the hospital is in compliance with federal regulations for Medicare and Medicaid programs, wrote Russ Kennedy, of the department of health’s office of communications, in an email.
The Centers for Medicare and Medicaid Services asked the department to conduct the investigation, Kennedy wrote. The health department’s findings won’t be made public until they are given to UH and the release of public records is authorized, Kennedy said. It is not clear at this time what role CMS plays in fertilization coverage.
The Joint Commission, a nonprofit accrediting organization, certified Ahuja Medical Center’s fertility clinic’s embryo lab as part of the hospital’s overall accreditation in December 2016, according to the commission’s quality report on UH. The commission last performed an on-site survey of the hospital in January 2017.
The commission’s Office of Quality and Patient Safety “is aware of a patient safety concern” at Ahuja and “is currently reviewing the concern,” said Katie Looze Bronk, media and communications specialist for the commission.
When reviewing a concern, the commission can:
- make an unannounced or unscheduled on-site evaluation
- request a response to the safety concern
- review the concern during a routine accreditation survey in the near future
- add information about the concern to a database that tracks patient safety, quality issues and trends.
If an organization fails to address the concern, that could “potentially adversely affect an organization’s accreditation status,” the commission said.
While accreditation is voluntary, Dr. Nicholas Spirtos, who runs the Northeastern Ohio Fertility Center in Akron, said it’s risky for an organization not to seek accreditation.
“I guess you can get by without it but you’re taking a chance. It’s highly recommended you do all you can to protect the patients,” Spirtos said.
Spirtos has never heard of an incident like the one at UH in his 30 years as a reproductive endocrinology and infertility specialist. He expects the Society for Assisted Reproductive Technology, a professional organization for in vitro fertilization clinics, to come up with new quality control guidelines for alarm and tank monitoring in light of the malfunction at UH.
“If there was an issue, we want to make sure other programs don’t get too complacent,” said Spirtos, who has volunteered as an inspector for the College of American Pathologists, which accredits embryo labs. “I’m sure UH never had a problem before last week.”