IVF & COVID19 – Top 5 Things You Can Still do to Mitigate the Risk of Specimen Loss
As COVID-19 continues to rapidly expand, the IVF Industry is facing enormous challenges. From Protocols to Technology, IVFCRYO takes you through The top 5 "No-brainers" that you can still implement to reduce the risk of specimen loss.
As COVID-19 continues to rapidly expand, the IVF Industry is facing enormous challenges. Governments continue to escalate the social distancing requirements through business and city shutdowns. IVF authorities such as ASRM and ESHRE are providing guidance to stop certain functions of the IVF Industry. And ultimately, IVF clinics are now likely being forced to make the decisions on what services they will continue and what services they will halt to meet those requirements.
The one business function IVF Clinics cannot shut down is cryogenic preservation. Cryogenic storage and preservation is essential and does not stop regardless of the restrictions put in place.
If you are one of IVFCRYO’s clients, you are likely well prepared for such a scenario. For those that have not yet undergone the IVFCRYO consulting services, you may not be as well prepared for such a disaster scenario. However, there are some no-brainers that you can implement to ensure your clients’ specimens are safe and secure, even if your city or state decide to shut-down non-critical functions of your business.
#1: MAKE SURE YOU HAVE DISASTER PROTOCOLS IN PLACE, SPECIFICALLY FOR CRYOGENICS PRESERVATION FUNCTIONS
Many IVF clinics have elaborate lab policies and procedures in place to describe action plans for lab processes in the case of an emergency. However, many of those facilities lack specific policies and procedures dedicated to cryogenic storage.
THINGS TO QUICKLY DEFINE:
• WHO IS IN CHARGE OF CRYOGENIC STORAGE? Who is the one that will own responsibility of the storage tanks being filled and inspected? Who will own the responsibility of overseeing all critical functions are taking place in accordance with protocols? Who is that one person you trust more than anyone to ensure specimens are safely stored at all times?
• WHO IS RESPONBILE FOR PERFORMING QC FUNCTIONS to ensure storage tanks, liquid nitrogen supply cylinders, O2 monitors, ventilation and air exchange and such are functional and operating properly?
• HOW AND WHEN SHOULD CRITICAL EQIUPMENT UNDERGO QC? How often and at what interval will your staff physically inspect and ensure storage tanks are filled with liquid nitrogen.
• WHAT YOU WILL DO IF YOU RUN OUT OF SUPPLIES SUCH AS LIQUID NITORGEN? Make sure that you have back-up vendors in place. More about this later in the Top-5 list.
• WHAT WILL YOU DO WHEN STAFF ARE NOT ABLE TO MAKE IT INTO WORK? Whether they are ill, have family issues they need to attend to, are restricted by travel regulations enforced by government agencies, or simply cannot get in for a variety of other reasons, you must have a plan in place to ensure that your specimens are monitored and maintained.
#2: CONTACT YOUR CRITICAL VENDORS IMMEDIATELY
In emergency situations, vendors will prioritize their clients based on industry and amount of business you provide their company. From a pure business perspective, most IVF Clinic Facilities will be seen as low priority based on a pure business perspective. It is extremely important that you contact all of your critical vendors to remind them you are a healthcare facility that requires the use of critical supplies to protect irreplaceable medical specimens.
Specifically, regarding the fertility preservation and storage of your client’s reproductive tissue, it is important to reach out to your Liquid Nitrogen vendor to ensure they have you as a top priority healthcare facility. Although it may be too late to stockpile, requesting additional storage cylinders at in addition to your routine delivery may be obtainable.
Liquid Nitrogen is your most precious supply and absolutely needed to preserve your client’s reproductive tissue. Make sure your vendors know this and be prepared to pay a premium on supply.
#3 DEVELOP AN ON-CALL SCHEDULE
When I say “Develop an on-call procedure,” I mean you should develop a true on-call schedule with a rotation of staff, and not just one or two people on call continuously. Typically, one embryologist (or other staff member) acts as the on-call person at all times because they live close by or just because they are willing to take the responsibility. With this type of on-call system, it is inevitable that that staff member will eventually be delayed in their response or won’t show up at all due to travelling too far away, enjoying alcoholic beverages, or partaking in family functions such as parties or loud events that prevent them from hearing the notification of a phone call. Developing a true on-call system with a fair rotation, and on-call pay, will increase the probability that staff will show up when the time comes.
Not only is it important to create an on-call list, but it is necessary to train on the disaster SOP’s, how to respond to equipment failures, how to report them, when to escalate up the chain of command. Training is key and the more often you review your disaster plan and mimic real-life scenarios, the more your staff will be prepared to respond.
#4 UTILIZE CURRRENT TECHNOLOGY
It is likely too late to seek out new technology at this point to help monitor your equipment from remote locations in a way that will adequately help mitigate the risk of specimen loss. That being said, you probably have some good technology already available in your facility.
Things you can incorporate:
• Storage Tank temperature Monitoring Systems: You likely already have a monitoring system in place as it has become a very standard piece of equipment in the IVF Cryogenics Industry. Make sure you schedule for updated validation and annual PM to ensure you equipment is fully functional.
- Assuming you have remote access of your monitoring system, review monitoring temperature daily during through cloud access (or similar remote access application).
• Surveillance Equipment: Most of you likely have surveillance camera systems in your facility. When available, point them at your storage tanks and provide on-call staff with the ability to see via live stream. Even if they do not get an alarm, they can document that they viewed the video on a daily basis and at the specific time and even take screenshots. This is great documentation to create in a time of emergency to show QC checks even if your staff can’t go in to physically inspect.
• Auto-Fill Storage Tanks: If you have invested in auto-fill storage tanks, then you will certainly benefit in that the tanks will automatically fill with liquid nitrogen to the proper levels. Even thought is likely too late to purchase these, have them manufactured, delivered, and validated (all of which IVFCRYO can help with when the time comes), there are other things you can do to mimic this function.
- Physically inspect storage tanks, LN2 supply cylinders, and such twice a day (at the beginning of the day and at the end) and resolve any issues.
- Add top of Liquid nitrogen in storage tanks twice a day (in the morning at the beginning of the day and at the end of the day) to ensure the longest possible hold time should a tank failure ensue.
#5 DO NOT DEPEND SOLEY ON ELECTRONIC MONITORING AND/OR AUTOMATION
Yes, remote monitoring system and auto-fill storage tanks are amazing in helping us through our daily workload and being more efficient. However, technology is not an adequate alternative to the human element. That’s right, I said it…. Technology is fun, it is useful, and it pretty cool to show off, but it is only a tool in a toolbox to help mitigate the risk of specimen loss.
Nearly all failures in the past few years (as reporting through public knowledge) have two things in common.
- All had monitoring call-out systems in place
- All happened on a weekend or holiday
These two commonalities enforce the stance that technology and automation is useful, important, helpful, and very cool to have… and when it works well it is amazing. However, this type of technology and automation should be used as an early notification system and efficient at completing tasks.
A good overall system to mitigate the risk of tank failure, specimen loss, and legal liability will consist of specific policies and protocols for cryogenic storage and disaster planning. It will consist of excellent training on the protocols. And it will have the best technology available to perform monitoring, call out functions, and video surveillance. And they will also have the human element.
In my long history of experience working in the biorepository and healthcare industries, people are the most critical element of all. The human element must be configured into the complete quality system to mitigate risk.
Specifically when talking about how to manage your cryogenic storage during the COVID-19 crisis, it is critical that staff be present at least once a day to physically inspect the storage tanks for liquid nitrogen level, temperature, and signs/symptoms of vacuum loss to ensure those QC values fall withing the standard guidelines. It is also critical to daily monitor the liquid nitrogen supply cylinders to ensure they are not empty and have the proper level, that pressure is in the correct range (typically 20-40psi), and that liquid nitrogen supply is being exchanged and refilled with the supply vendor.
The human element is the last line of defense for all other failures. Write great procedures. Train your staff well. Then trust them to take care of business when the time comes.