A MESSAGE FROM OUR MEDICAL DIRECTOR, DR. ERIC WIDRA, ABOUT SGF’S SAFETY AND QUALITY ASSURANCE STANDARDS:
All of us in the fertility community have been alarmed and saddened by the media reports of the wrong embryos being transferred by a clinic in California. While none of us know the details of this case, the story goes directly to the worst fears of all of us—patients and providers alike. At SGF we spend enormous time and energy to ensure that such an error cannot occur in our facilities. This includes ongoing re-evaluation of the processes outlined below, as well as the use of outside consultants to evaluate our procedures for identification and tracking of patient material—embryos, eggs, and sperm.
Identity and Custody at SGF
Every patient at SGF is identified in our systems by name and a unique identification number, the MPI. As our patients will attest, any transfer of material requires additional identifiers: date of birth, and, if available, social security number. Before accepting material or performing a procedure involving sperm or eggs, the patient’s identification must be confirmed with photo ID.
Whenever our lab staff accepts or processes fresh or cryopreserved patient material, there must be an unbroken chain of custody from the patient to the center and confirmation of correct identity by TWO lab staff. In the case of embryo transfer, there is a THIRD confirmation of identification by the physician performing the procedure.
All sperm, eggs, and embryos are assigned a specific location within the cryostorage system, and identifiers are permanently affixed to the vials containing the material.
If there were ever a discrepancy in any of the above checks, we would not proceed with insemination, fertilization of eggs, or transfer of embryos.
Our hearts go out to those suffering from this apparent error. We will remain vigilant in ensuring the safety and accuracy of our systems.
KEEPING YOUR EMBRYOS AND EGGS SAFE
Many wonder how their embryos and eggs are kept safe during the process of freezing and throughout an indefinite amount of time spent in storage. At Shady Grove Fertility, we take all appropriate preventive safety precautions for frozen embryos and eggs to preserve and protect them so that they are available to you when you decide to start or grow your family.
EXPERTISE INSIDE SGF LABORATORIES
Shady Grove Fertility, home to the largest freestanding in vitro fertilization (IVF) lab in its headquarters location in Rockville, MD, along with four other world-class laboratories in Chesterbrook, PA, Towson, MD, Atlanta, GA, and Fairfax, VA, continues to meet and exceed quality standards when it comes to patient care and operations.
The laboratories are operated under the distinct leadership of nationally and internationally known Jim Graham, laboratories director, and Michael J. Tucker, BSc Comb Hons, Ph.D., FIBiol, HCLD, director of IVF and embryology laboratories. One of the most important aspects of well-run laboratories is quality control. Our protocols and the extensive training required of our laboratory staff ensure the upmost quality with zero margin for error.
Behind each piece of equipment is an embryologist. The principal functions of these specially trained staff are to verify the identification of individual patient specimens, carefully handle sperm, eggs, and embryos and to guarantee appropriate distribution of all materials.
All staff involved in the handling of sperm, eggs, and embryos must follow what is known as a Chain of Custody protocol. Chain of custody refers to the way each specimen is identified during every step of the process to ensure the integrity of each patient’s specimens. Shady Grove Fertility’s chain of custody protocol requires that two embryologists verify the identification of samples at each stage of the process to ensure, for example, that the correct sperm is paired with the correct eggs. Patients also take an active role in the protocol when they are asked to verify their identification verbally at several points.
Because of our commitment to these procedures, Shady Grove Fertility has never had an incorrect identification in our almost 29-year history. Making sure the right sperm ends up with the right eggs or that the right embryo is transferred to the right patient is the absolute most important thing to our Practice.
SGF never compromises when it comes to maintaining the highest quality and safety standards. The dedicated professionals who work within SGF’s labs partner with SGF clinicians in the completion of over 15,000 fresh in vitro fertilization (IVF) cycles a year, not including an equal number of ovulation induction and intrauterine insemination (IUI) cycles annually.
FREEZING TECHNOLOGY AND STORAGE PROTOCOLS
SGF keeps eggs and embryos stored in liquid nitrogen versus vapor. Liquid nitrogen is more expensive but maintains a more stable lower temperature for long-term storage. Each tank is regularly monitored and alarmed 24/7 with numerous and redundant fail safes in place to ensure the temperature of the environment is kept at the ideal level. In the event of a natural disaster or other catastrophe preventing access to the tanks, or to additional liquid nitrogen, the tanks will maintain their temperature for 6 weeks with no risk to the contents. The tanks can also be evacuated from the building in less than 1 hour, should that need arise.
At SGF, we also alarm our tanks for any change that could indicate a problem. Each tank must communicate daily with the alarm system. If the communication does not occur, the system alerts lab personnel in ample time to address the problem before it has any impact on the contents. We believe that this is the safest and most effective system available and are 100% confident in our ability to care for our patients’ gametes and embryos.
SGF’s embryology laboratories are filled with state-of-the-art incubators, microscopes, and highly skilled technicians to ensure patient’s sensitive eggs have the best chance of growing into healthy embryos.
The equipment within the laboratories is another aspect of what really sets the Shady Grove Fertility laboratory apart from any other. At our largest laboratory in Rockville, the embryology laboratory is ISO-certified Level 1000 clean rooms. This means that the space within the laboratory is so clean, it has less than 1,000 particles per cubic meter. To put this in perspective, the environment outside has over 35,000,000 particles per cubic meter. The filtered air within the entire laboratory is replaced 30 times per hour. Air re-entering the laboratory is filtered through both HEPA filtration for particulates and carbon filters for volatile organic compounds (VOCs). This prevents nearly all contaminates from interrupting the growth of embryos.
Embryos are developed and cultured in one of SGF’s incubators, which act as artificial wombs. The environment within each incubator is carefully controlled; the temperature is set to a constant 98.6 degrees Fahrenheit, and the incubator interior is kept dark to further emulate the womb environment.
Several of the procedures within the embryology department take place under one of the laboratory’s inverted microscopes. These microscopes allow light from above the Petri dish to illuminate down through the sample into the lenses located at the bottom of the microscope. Each microscope magnifies up to 400 times and provides high resolution views of the sperm, eggs, and embryos, allowing embryologist to make precise movements when doing procedures.
SAFETY PRECAUTIONS / LAB SECURITY
Shady Grove Fertility has been a part of many nationwide protocol changes to better ensure the safety of all of the frozen eggs and embryos stored and used here. Should a known, highly-damaging event be predicted to take place, we have partners further in-land who would safely house all of our patients’ eggs and embryos should it be needed. Luckily, this hasn’t happened in our almost 29-year history. Our first route of protection would be at one of our five laboratories located in Chesterbrook, PA; Towson, MD; Rockville, MD; Fairfax, VA; or Atlanta, GA.
To learn more about safety precautions for frozen embryos or eggs at Shady Grove Fertility, call 1-877-411-9292 to speak with one of our New Patient Liaisons.