LEADING CRYO-SAFETY STANDARDS

LEADING CRYO-SAFETY STANDARDS

At Spring Fertility, we’ve rigorously evaluated our cryotank safeguards and protocols. As the leader in fertility options in the Bay Area, we continually monitor and upgrade our technology to minimize risks to our patients. We thoughtfully employ the most advanced technology and well-tested standard operating procedures to deliver the safest environment for your eggs, embryos and sperm.

In the interest of transparency, we want to share with you some details regarding the redundant safeguards that we employ to keep your precious eggs and embryos safe.

Some key background information:

  • Cryopreserved cells are stored in/around liquid nitrogen.
  • Liquid nitrogen is the key ingredient to maintain cells at a temperature compatible with cryopreservation: minus 135˚C to minus 196˚C.
  • Liquid nitrogen is extremely stable and effective at maintaining the viability of the eggs and embryos for decades without changes.
  • Storage in liquid nitrogen does not require electricity to maintain their temperature.

 

At the core of our systems is a dedicated team of embryologists, critical to the implementation and execution of these systems. We are fortunate to have brilliant embryologists, dedicated lab assistants and committed, passionate leadership by Dr. Sergio Vaccari, our American Board of Bioanalysis certified High Complexity Lab Director. Below is an outline of our systems and redundancy. We are “CAP certified” with zero deficiencies.

Core Tank infrastructure to ensure sufficient liquid nitrogen

  • Cryotanks: Spring uses state-of-the-art storage tanks designed around the needs for embryo and egg storage.
  • We use the most advanced technology “Vapor” tanks filled with liquid nitrogen. These tanks can hold their temperature if unopened for more than 30 days without refilling. We keep tanks filled and replenished daily with the maximum permittable level of liquid nitrogen.
  • All cryotanks are kept filled with liquid nitrogen and replenished daily, using an “intelligent,” pressure sensing automatic filling system called “Cryowiz.”
  • In addition to keeping our tanks full at all times, we maintain two backup “filling” tanks. At least one is kept full at all times.
  • Our cryoroom and backup tanks are secured to reinforced steel to comply with CA earthquake requirements.
  • In the event of a power outage, we have a 16,000lb 50kVA Uninterruptable Power Supply (“a data-center grade” backup battery system) to support all critical lab equipment, including tank monitors.

 

Maintenance

  • Our lab is newly built using the highest quality equipment and preventive servicing is performed annually.
  • Maintenance: We close our lab for one full week every year to conduct a deep cleaning & preventative maintenance of all equipment including tanks.

 

Monitoring and Alerts – We employ multiple independent systems:

  • Storage tank alarms: Our tanks have an on-board computer alarm with audible and data port for local and transmitted alerts that call four manager’s cell phones 24 hours/day. Alarms sound if:
    • Liquid Nitrogen levels are too low (we maintain 36” and the alert sounds at 20”)
    • Too much time is required to fill the tank (implying an empty refill tank or other potential problems)
    • Temperatures fall below -150˚C (Cells are stable and without cellular activity as long as temperatures remain below -135˚C, but we maintain levels at -196˚C and are alerted at -150˚C
  • Visual and Physical inspection
  • Our cryoroom is purposefully adjacent to our lab and acts as a vestibule for entering the lab. This means we pass by and visually inspect the cryotanks every day we are open.
  • Spring operates 7 days a week so there is daily visual inspection of our cryotanks.
  • In addition to daily visual inspection, physical inspections are conducted and documented 3 times per week.
  • Secondary Alert system
    • We have a separate monitoring system as a backup to the built-in temperature system in our cryotanks.
      • One probe is submerged in liquid nitrogen so will be @ -196˚C as long as liquid nitrogen levels are above our threshold.
      • A second surface temperature probe w/ ambient temp sensor. This alerts if room temperature changes, suggesting a possible external malfunction or breach in the vacuum surrounding the tanks.
      • This secondary monitoring system also has a separate battery power backup and uses cellular network (rather than internet which is used by the cryotank monitors). This system is therefore independent of our backup power AND internet connection.
    • Tertiary monitoring
      • Oxygen deprivation sensors in the cryoroom also alert audibly, visually if oxygen levels drop, indicating a potential liquid nitrogen leak (causing oxygen displacement).

 

Security

  • A card reader security access system only permits access by physicians and lab personnel (and tracks who entered).
  • Video surveillance allows remotely viewing and listening to sounds coming from the cryotank storage area and records all footage for 10 days.
  • Our building has 24-hour concierge security, 365 days a year.

 

Certifications and Accreditations

Spring Fertility’s lab and personnel are regularly reviewed and certified by the following agencies and organizations:

  • College of American Pathologists (CAP)
  • American Society of Reproductive Medicine (ASRM)
  • Clinical Laboratory Improvement Amendment (CLIA)
  • High-complexity Clinical Lab Director (HCLD), by American Board of Bioanalysis (ABB)
  • California Department of Health (CDH)
  • San Francisco Department of Health (DPH)
  • The Food & Drug Administration (FDA) regulates use of donor eggs and sperm

 

We realize this may be overwhelming. Spring Fertility has a large window into our lab because transparency is important to us. Your comfort, safety and outcomes are our highest priority, as is your peace of mind.

As always, we are available to answer your questions. If you have further questions, please do not hesitate to contact us.

Sincerely,

The Spring Fertility Family

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