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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 UHs 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. 

Jake Anderson, a founder of Fertility IQ, a website that provides assessments of fertility doctors and clinics, noted that both the Cleveland and San Francisco clinics are large, reputable, subject to oversight, and they both quickly acknowledged the failures publicly. But he said he worried about smaller, private clinics that have no affiliation with a university or hospital and whether some would be less inclined to disclose a problem. If this happens in other places that are private, people would take this to the grave and they would never breathe a word of this, Mr. Anderson said. To think that only the well-run places that have boards and clinical oversight — theyre the only ones having this problem? I believe the opposite.

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 UHs accreditation in question.

A change in freezing technology in recent years has made things easier. The previous technique, slow freezing, could create ice crystals, which could damage the eggs when they were thawed, said Dr. Randi Goldman, a clinical instructor of reproductive endocrinology and infertility at Harvard and Brigham and Womens. Several years ago, clinics began using a process called vitrification, in which the temperature of the eggs in the liquid nitrogen is dropped so quickly that they are frozen truly in a matter of a second, Dr. Goldman said. Eggs frozen by that method are less vulnerable to damage when thawed.

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.

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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.

The failure of systems used to store frozen eggs and embryos at two fertility clinics has rattled people who count on such clinics to help them realize their hopes of having children. But the breakdowns at clinics in Cleveland and San Francisco, each apparently involving the temperature or level of liquid nitrogen in one storage tank, have damaged at least some eggs and embryos belonging to potentially hundreds of people.

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He declined to say whether UH had received the letter yet. CAPs findings will not be made public.

Mr. Anderson recommends asking the clinics fertilization rate — if its below 70 percent, its a nonstarter, he said — and its embryo conversion rate, the percentage of fertilized eggs that become embryos. Below 40 percent you should walk out the door; 40 to 50 percent — thats a stay, theyre competent. Above 50 percent, he said, is pretty spectacular.

UH could lose its accreditation with CAP if it is found to be out of compliance and doesnt resolve the issues promptly, Bachner said. But, he added, “We cannot shut a lab down. We dont have the authority to do that.”

Its unclear. Egg freezing has grown sharply. Its up from 475 women in 2009 to 6,207 women in 2015, according to the most recent data from the Society of Assisted Reproductive Technology. But while more than 20,000 American women have had their eggs frozen, the vast majority (an estimated 85 percent or more) have not had their eggs thawed, the first step toward creating a healthy embryo.

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.

On March 12, the law firm Peiffer Rosca Wolf Abdullah Carr & Kane, which has handled a number cases involving embryo loss and related issues pertaining to fertility clinics, filed suit in Cuyahoga County Common Pleas Court on behalf of a Pennsylvania couple and 700 other patients affected by University Hospitals faulty freezer, the report said.

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 couple called the UH fertility clinic March 5 to begin the implantation procedure using their frozen embryos. Later that day, UH informed the couple that their embryos had been destroyed by the tissue storage bank temperature fluctuations over the preceding two days, the publication said.

The CAP checklist for inspecting fertility labs includes the following points:

Partner Adam Wolf said he expects multiple lawsuits to be filed in the UH case. PRW has received calls from at least 12 patients affected by a similar accident at a San Francisco fertility clinic, and looking for legal representation, Wolf said in a March 12 conference call.

Its 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.

In the days after the freezer malfunctioned, a proposed class action lawsuit was filed March 11 on behalf of Amber and Elliott Ash, who lost two embryos stored there. The Ashes are represented by the law firm DiCello Levitt & Casey, based in Chicago and Cleveland.

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 healths office of communications, in an email.

The Centers for Medicare and Medicaid Services asked the department to conduct the investigation, Kennedy wrote. The health departments findings wont 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.

It is named in honor of Monte Ahuja, the Indian American board chairman of University Hospitals, his wife Usha and their family, who donated $30 million towards Vision 2010: The UH Difference.

The Joint Commission, a nonprofit accrediting organization, certified Ahuja Medical Centers fertility clinics embryo lab as part of the hospitals overall accreditation in December 2016, according to the commissions quality report on UH. The commission last performed an on-site survey of the hospital in January 2017.

These lawsuits send the message that accidents like the one at UH are unacceptable, Wolf said. There has been no discussion of a settlement with UH yet, he said, according to the report.

The commissions 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.  

Beachwood, Ohio-based University Hospitals Ahuja Medical Centers Fertility Clinic will put in place increased security after a freezer malfunctioned, affecting some embryos.

If an organization fails to address the concern, that could “potentially adversely affect an organizations accreditation status,” the commission said.

While accreditation is voluntary, Dr. Nicholas Spirtos, who runs the Northeastern Ohio Fertility Center in Akron, said its risky for an organization not to seek accreditation.

“I guess you can get by without it but youre taking a chance. Its 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 dont get too complacent,” said Spirtos, who has volunteered as an inspector for the College of American Pathologists, which accredits embryo labs. “Im sure UH never had a problem before last week.”

After a cryogenic tank like the one in this file photo lost a great deal of liquid nitrogen, a fertility clinic began the process of determining the damage to stored embryos and eggs. Lluis Gene/AFP/Getty Images hide caption

After a cryogenic tank like the one in this file photo lost a great deal of liquid nitrogen, a fertility clinic began the process of determining the damage to stored embryos and eggs.

A San Francisco fertility clinic says that a problem with the liquid nitrogen in one of its storage tanks may have damaged thousands of frozen eggs and embryos, triggering calls and letters to more than 400 concerned patients of the Pacific Fertility Center.

The nitrogen level in one tank fell very low, according to Dr. Carl Herbert, the fertility clinics president. Herbert told ABC News that an “emergency filling” immediately took place, and that the tanks contents were then transferred to a fully functioning tank.

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