Measure Would Require License to Operate; Establish Third-Degree Offense for Violators
In an effort to prevent a repeat of tragedies in other states where thousands of embryos were lost, a measure sponsored by Assembly Democrats Pamela Lampitt, Raj Mukherji and Valerie Vainieri Huttle has been released by the Assembly Health and Senior Services committee.
The bill (A-4605) would require the New Jersey Department of Health (DOH) to regulate and license embryo storage facilities. The measure was prompted by disasters in California and Ohio where more than four thousand eggs and embryos were lost. In certain instances, the losses were caused by storage temperature fluctuations that were not properly monitored–an operational issue that could have been avoided. The bill looks to guard against similar operational mishaps as well as long-term power outages during natural disasters or catastrophic storage system failures.
“Families attempting to conceive face a number of physical and emotional challenges,” said Assemblywoman Lampitt (D-Burlington and Camden). “They put their hopes and dreams of conceiving into the embryos stored in these facilities. To have those dreams shattered due to a preventable operating failure is unimaginable.”
The proposed New Jersey legislation would prohibit the conduction, maintenance or operation of an embryo storage facility without a license granted by DOH. An embryo storage facility cryopreserves and stores human eggs, pre-embryos, and embryos for later use during in vitro fertilization, embryo transfer, gamete transfer, pronuclear stage transfer and zygote transfer, as well as other procedures performed to achieve a pregnancy or pregnancies. The facilities include a licensed health care provider that stores human eggs, pre-embryos, or embryos.
The bill also establishes a third degree crime for operating an embryo storage facility without a license or misrepresenting such licensure to consumers.
“Imagine the disappointment of all those in California and Ohio who unnecessarily lost their embryos,” said Assemblyman Mukherji (D-Hudson). “Couples grappling with infertility are faced with enough difficulties without hearing the devastating news that the facilities storing their embryos lost them in preventable incidents, because they weren’t following a uniform set of regulations. By requiring licensure of these facilities, enacting rules, and commencing onsite inspections, we can ensure that New Jersey couples planning IVF don’t suffer from the tragedies we’ve seen elsewhere and go on to realize the miracle of conceiving a child.”
As outlined in the bill, DOH would establish guidelines for storing and caring for human eggs, pre-embryos, and embryos by an embryo storage facility in accordance with:
(1) Standards ISO 9001 and ISO 20387 of the International Organization for Standardization;
(2) Standards for biorepositories established by the College of American Pathologists Biorepository Accreditation Program; and
(3) The U.S. Food and Drug Administration guidance on Current Good Tissue Practices.
The guidelines also cover the physical plant or facility and would be required to comply with state and local fire safety codes. They also would monitor the:
· Number of staff and qualifications staff members,
· Protection and safety of equipment use,
· Maintenance and confidentiality of records and information,
· Maintenance of accreditations and certifications
· Establishment of a quality management program, and
· Review and scope of internal audits.
Other safety protocols include on-site facility inspection by DOH who would be authorized to inspect and examine the physical facilities, documents and data during normal operating hours without prior notice.
“Infertility is an emotional, challenging issue with so many variables, factors, highs and lows,” said Assemblywoman Vainieri Huttle (D-Bergen). “This bill will help those struggling to conceive have confidence that their embryos are being stored in a facility that is authorized, regulated and properly maintained.”
The bill was introduced October 18, 2018. It now heads to the full Assembly for furthe review.