To retrieve and fertilize oocytes, and to generate embryos with the highest quality and potential to create a successful implantation, sophisticated equipment is needed. Moreover, our laboratories are staffed with highly trained professionals who maintain the highest level of quality assurance. This equipment needs a complex, and precisely scheduled quality control and assurance performed on a daily, weekly, or monthly schedule. This includes, but is not limited to, temperature and gas measurement, as well as pH in culture media. During the day, the functionally of incubators, work benches, microscopes, and liquid nitrogen tank used for the purpose of storage of cryopreserved oocytes, embryos or tissue can be monitored by the presenting staff. However, how would that be monitored after working hours? Even if no laboratory staff is present, quality assurance and safety of the oocytes and embryos has to be guaranteed. In the case of the FCI IVF Laboratory River North, it requires a process to monitor the functionality for 24 hours every single day. A sophisticated alarm system is attached to each incubator which monitors the water level as well as the correct gas concentration. If a deviation occurs, an alarm sound will ring, or in case it occurs at night, the system will dial into a defined list of phone numbers to inform the staff at home about an abnormality or malfunction, which then requires that a staff member comes into the lab to check on the malfunction of the equipment. An additional important factor is power control. Even at power loss, the equipment needs to work normally. To secure this, all equipment is connected to a power backup, which functionality will be tested twice per year.
Recently an Ohio fertility clinic experienced an equipment malfunction that resulted in potential damage to their cryo-stored eggs, embryos, and/or sperm. This situation affected more than 500 patients. As for our incubators, we have a 24 hour-7 day per week monitoring system, to which 30 liquid nitrogen tanks are connected. We feel that it is important to take a moment to reassure our patients that their precious egg, embryos, and sperm are safe with Fertility Centers of Illinois.
- We have 30 liquid nitrogen tanks on-site which currently store 30,000 + embryos.
- As a part of our daily quality check, we inspect the level of liquid nitrogen in our storage tanks. Once a week, we fill tanks to the top level.
- Liquid nitrogen is delivered twice a week to ensure we have the amount we need to keep tanks at the correct levels that are suitable for storage.
- We have 4 alarm systems attached to our tanks. In the event of an emergency when the lab is closed, the alarm alerts our staff remotely, and a trained staff member will respond to the laboratory at any hour.
- All alarm systems are connected to a back-up power source. This ensures that the alarm will not be shut off in the event of a power outage.
- Most importantly, our Embryology staff is on-site weekdays, weekends, and holidays, which allows us to monitor and confirm that all lab equipment is functioning properly.
Beyond the safety of our equipment, another important part is patient identification and the safety of the chain of custody. Each single step beginning at the oocyte retrieval, injecting sperm into an oocyte, transferring embryos, and finally freezing oocytes and /or embryos for cryopreservation and storage, there is a unique verification/ identification system in place. Our target for 2019 is to establish and to work with an electronic witness system, which will make the handling of oocytes, and embryos even safer. On top, the witness system has an integral part used to offer quality control in regards to what lot of media was used, what embryologist did which ICSI, transfer or cryopreservation of each patient. This will allow us to track each staff member in their work and outcome, and if necessary to retrain them for improvement.
Juergen Liebermann, Ph.D., HCLD, CC (ABB)
Director of Laboratories, Fertility Centers of Illinois