Due to the recent news story out of California, we have been fielding many patient questions regarding our methods for ensuring the correct identity of your embryos. This question is foundational to your trust in Denver Fertility and we do not take that for granted. Each and every patient deserves the highest level of confidence that your carefully selected IVF laboratory is capable of safely handling your embryos. However, events such as these can truly shake you to your core.
Now, to be real, the highly-skilled embryologist is still human and human errors do occur. However, there is a fundamental difference between a typographical error that can be easily corrected and a misidentified embryo. Today, I want to detail the safeguards we have in place at Denver Fertility to make absolutely certain that the end results of our processes are error free 100% of the time. There is no acceptable level of error, irrespective of severity, in the IVF laboratory when the consequences can be so dire and permanent.
Though the cause of the recent tragedy has not been released, I think what has been most immediately reassuring to patients has been the sheer disbelief expressed by their embryologists that a mistake of this magnitude could happen in a laboratory with the most basic of standards. Over the past 41 years, our industry has evolved and implemented many levels of safeguards to prevent these exact issues. As a community, embryologists around the country are completely shocked.
In the United States, we have external oversite from multiple government agencies (CMS, FDA, CDC) that ensure we are following protocols which meet industry standards. CMS requires that High-complexity Clinical Laboratory Directors are board certified by the American Board of Bioanalysis. Directors and embryologists participate in national professional organizations and meetings. Those organizations provide current practice recommendations and continued education (ASRM, CRB). Additionally, most IVF laboratories voluntarily seek additional inspections from accreditation organizations, further raising the performance bar.
The gold standard for embryo identification is very much analogous to the chain-of-custody the police use to ensure evidence is admissible in court. At every step of the IVF process, two people observe as your sperm, egg, or embryo moves from one location to another. They are verbally agreeing at each point that two unique identifiers (your name and medical record number) on the original container match the following container. For each and every step, they assume this responsibility for the identity of your embryo. This is incredibly important and effective at ensuring that an individual human error is immediately caught and reconciled.
At Denver Fertility, we built our laboratory to exceed the gold standard! Not only do we follow the chain-of-custody protocol rigorously, but we have incorporated an electronic witnessing system (RI Witness). RI Witness provides an even higher level of confidence to our patients by tracking each sperm sample and embryo dish with individual RFID tags. These tags are assigned to your patient profile and will immediately sound an alarm should two unrelated containers be placed together at a workstation. Additionally, to track your frozen embryos, each cryo device is labeled with a RI Witness generated label containing a barcode programed with your RI Witness profile. With these improvements, it is a wonder that so few laboratories in the country have implemented electronic witness systems. Denver Fertility is proud to be an early adopter as we demonstrate the value we place on your peace of mind.
With these systems in place, our team can confidently reassure you that Denver Fertility will do everything in our power to ensure the identity of your embryos. The stresses of the IVF process should not be compounded by a lack of transparency. Should you have any further concerns, please do not hesitate to call 720-420-1570 or contact us.