Best Practices for Cryogenic Storage Facilities Urgently Needed
We got some grim reminders this winter and spring about the importance of following the best practices in cryogenic storage. But 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.
So, whether you have one of the most typical small MVE or Taylor-Wharton aluminum dewers, or the giant steel tanks, or a whole bunch of them, you are running a bio-repository. In most cases, the management of these bio-repositories, typically in connection with an IVF clinic, is delegated to the embryologists and staff. These bio-repositories rarely have dedicated management or staff, and therefore don't quite get the attention they require.
Regardless of the size of the bio-repository, these cryogenic storage facilities, have to follow the same principles, and have to be seen holistically as a system. The questions should never be limited to why a tank failed, or why an alarm system failed. The basic assumption should be that tanks fail, and alarm systems fail. The key to survival, quite literally for all the cells and tissue stored, is systems design.
Designing the cryogenic storage system is not dependent on whether you have space for the best steel tanks or a bulk liquid nitrogen supply tank, or the fanciest automated monitoring and alarm system. In most cases, you can and must design a system that is based on your specific situation. Every system will have to address all the basic elements of a bio-repository: facility, emergency plans, equipment, inventory management, safety, monitoring, transportation and potentially even shipping. You can have the latest and greatest equipment, and still have an inadequate system design. Or you might have just a bunch of the little "mushroom" tanks with no auto-fill, no automatic alarm, but still run a great bio-repository, if you have designed your system well.
A quick look at ISBER's Best Practices, SART, ASRM, CAP, AABB and AATB reveal a lack of published standards specifically for cryogenic storage. It is important to note that the lack of public standards is not an excuse not to have designed your own cryogenic storage system. It can be done. That said, these organizations should invest resources in developing the standards and best practices, individually for their membership specifically, or joined for a national consensus task force.