Why Now
The fertility industry has seen some very critical issues over the past few years regarding cryogenic storage and the importance of following the best practices. While these events were perhaps larger in scale and happened very close to each other, these types of events happen every year. They might be smaller in scale and not grab national headlines, but the impact on individuals storing their own tissue or cells is equally devastating. The legal and financial consequences to the institutions are equally severe, not to mention the impact on the reputation of the IVF clinics and their physicians. These incidents have also spurred lawmakers to come up with their own, often ill-advised solution to rectify the perceived problem, such as a current bill in Ohio.
Through our work with fertility companies such as California Cryobank and Donor Egg Bank, we came to witness and observe the challenges that IVF clinics face with providing cryogenic storage of the gametes for their patients.
It is with this background and experience we have realized that we can, and must help the industry as a whole to improve. There are no clear, specific guidelines, best practices or standards for the management of reproductive tissue storage, so we will commit to creating those guidelines for the IVF clinics, and help them implement them. With the backing and support from a team of industry veterans with decades of cryogenic storage facility experience, we will be able to help the IVF bio-repositories, what ever their size, to follow the best practices, taking into consideration their own resource limitations.
While the storage revenue for the clinics may seem like "found money", in reality, it carries a heavy burden of potential liability, without adequate attention to the storage system as a whole. Every system will have to address all the basic elements of a bio-repository: facility, emergency plans, equipment, monitoring, inventory management, safety, staff training, and transportation. We can help by putting together a comprehensive assessment of the system for the management, make recommendations to bridge the gaps, help implement the recommendations by developing SOPs, and training the staff to perform the processes properly, and we can maintain the system with regular check-ins, competency assessments and continued education.