12/27/18 - Schiavoni Bill to Regulate Cryostorage Facility Operations Introduced in Ohio on 12/10/18
S.B. No. 344, legislation that would regulate fertility treatment cryopreservation facilities in the state of Ohio, was introduced by Ohio State Senator Joe Schiavoni (D-33rd District) in the Ohio State General Assembly on December 10, 2018. While the bill was introduced, it was not assigned to committee, and was introduced in the 2017-2018 legislative session, which ends on December 28, 2018.
Therefore, the bill will have to be reintroduced during the 2019-2020 General Assembly for further action.
Key provisions of the bill, as introduced, include:
- A requirement that at least one qualified member of the cryostorage facility’s personnel must reside at a location from which that individual is able to arrive at the cryostorage facility in not more than twenty-five (25) minutes. [CRB was able to convince Senator Schiavoni to drop his original requirement that facilities be staffed with qualified onsite personnel 24/7.]
- Alarms and function checks of alarms are required of all facilities. In addition, there are requirements for system validations and recordkeeping requirements.
- A requirement to maintain at least one of the following: at least one cryostorage tank with capacity equal to the largest tank in use at the facility; or, available space in other tanks at least equal to the space used by all samples stored in the largest tank in use at the facility.
- A requirement to maintain a contract with another entity for the provision of a backup cryostorage tank to be delivered to the facility no later than 48 hours after a tank in use at the facility ceases to function properly.
- Requirements for how and when client depositors will be notified of an issue involving their stored reproductive tissue(s).
- Provisions for various fines for violations involving failure of the facility to meet required elements of the legislation.
CRB’s Legislative Committee was actively engaged with Senator Schiavoni’s staff as the legislation was drafted. Although the bill, as introduced, does not include all of CRB’s suggestions, it does include many of CRB’s recommendations.
While this is state legislation, its effects may go well beyond Ohio, as other state and federal regulators are closely monitoring the content and status of the bill.
To view S.B. No. 344, click here.
7/12/2018 - Ohio State Senator Joe Schiavoni Proposes Bill Regulating Fertility Clinics
In the wake of the March 2018 cryotank failure at University Hospitals’ fertility clinic at Ahuja Medical Center, Beachwood, Ohio, State Senator Joe Schiavoni (D-33rd District) is drafting legislation that would create guidelines and establish penalties for fertility clinics to prevent future incidents like the March 2018 freezer failure.
The University Hospitals cryotank failure resulted in irreversible damage to 4,000 frozen eggs and embryos and affected 950 patients.
According to recent news reports, the proposed bill could require oversight of fertility clinics by the state or an organization such as CAP and the establishment of emergency procedures. The proposed bill would also require:
- Onsite, around-the-clock tank monitoring
- Splitting up samples from one person across different tanks
- Training all employees to handle liquid nitrogen
- Clinic reporting if tissues or cells are moved, including emergency relocations
- Patient notification within 24 hours if damage occurs
- Clinics to notify their accreditation agency regarding any storage compromises
Violations would result in fines, and clinics with multiple issues could be forced to close.
The bill has not yet been introduced, but Senator Schiavoni is meeting with stakeholders with plans to include recommendations from the College of American Pathologists (CAP), American Society of Reproductive Medicine (ASRM), RESOLVE, University Hospitals and other interested parties. The CRB Board considers the CRB an "interested party."
While the legislation is at the state level and in the early stages of drafting, it could easily have an impact on a national level. CRB is following this issue closely and will keep you updated as developments occur.