The loss of 4,000 eggs and embryos at the University Hospitals Fertility Clinic in suburban Cleveland in March was, according to a preliminary investigation, largely preventable. The Ohio Department of Health found the facility had issues with record keeping of temperatures and liquid nitrogen levels in its cryotanks and had only one designated point of contact for problems related to the tanks.
Ohio state Sen. Joe Schiavoni (D) is working on legislation he hopes will help prevent such disasters in the future and introduce penalties for fertility clinics that violate the new safeguards.
In a phone interview this week, he said the bill would incorporate recommendations from various stakeholders with whom he and his staff have been meeting, including the American Society of Reproductive Medicine; College of American Pathologists; and RESOLVE, which represents patients around the country; as well as University Hospitals.
Schiavoni, a father of a 5-year-old and 4-year-old, said he was moved to action when he heard from families affected by the tragedy. In one case, the father had passed away since the embryos were put in storage. In another case, a woman had cancer and was unable to produce more eggs.
“For many families there is no second go-round here,” he said. “I can't imagine going through that.”
When he and his staff started looking into what happened at University Hospitals, he said, they found “a lot of holes.”
Assisted reproduction is largely self-regulated in the United States, in sharp contrast to the United Kingdom, Sweden and other countries where governments keep detailed data and conduct regular monitoring of clinics. The fertility industry has argued this is sufficient. Many lawmakers have historically not been eager to jump into the field because of fears that whatever they do will get caught up in the inflammatory politics of conception and abortion.
Some states do have laws regarding surrogacy. Several are debating “personhood” amendments that give embryos the same rights as people. Utah in 2015 passed a law that gives adults 18 and older who were conceived from donors access to the medical histories of their biological parents. Arizona earlier this year passed a bill that determines what happens to embryos in custody disputes.
But legislation that attempts to create oversight and accountability of the day-to-day operations of fertility clinics are rare.
Schiavoni is aware of these sensitivities and emphasizes the bill focuses only on cryostorage and does not attempt to regulate reproduction in any other way. His legislation is important, because it is one of the first attempts to try to create detailed rules governing how clinics operate, what they must report to the state — and to provide strong consequences for those that do not comply.
“I’ve been pretty clear in my political views that protect a woman’s right to choose. I try to not get into this conversation when it comes to the protection of these embryos and eggs, but it is part of the conversation. Some of the victims I talk to feel like they lost a child. And I have to respect that’s a feeling they have,” he said.
Among the key aspects of the bill, which he is planning to introduce when the legislature meets next, which could be as early as this month, are that clinics must have 24-hour monitoring by a person on site at all times, that clinics store multiple samples from one person in different tanks, that all employees have training in handling liquid nitrogen.
Clinics would also be required to report any movement of tissues or cells — including any transfer as the result of an emergency. If any material is damaged or destroyed, they must report it to the patient no later than 24 hours later. They would also be required to report any compromise of storage to their accreditation agency.
Penalties for violations would initially be fines, and after a certain number of issues a clinic would no longer be able to operate in the state.
The University Hospitals Cleveland Medical Center said in a statement that it is "conducting a detailed examination of every aspect of this event." Meanwhile, it has taken numerous steps to enhance its operations and equipment and has provided additional training to its employees.
"State Sen. Schiavoni contacted University Hospitals for our perspective on the proposed legislation regarding fertility centers. We appreciated the opportunity to share our thoughts regarding the legislation with the Senator and his staff and look forward to working with him," George Stamatis, a UH media representative, wrote.
This post has been updated.
Correction: A previous version of this post erroneously referred to one of the groups consulted about Ohio State Sen. Joe Schiavoni's bill about embryo storage. It is the College of American Pathologists, not the American College of Pathology.