The media has forgotten the reality of regulations for the fertility world. Dr. Jessica Scotchie addresses the misconceptions and shares just how careful we are with your embryos.
As a fertility specialist, there are two nightmare scenarios that keep me up at night. The first, is that all of the cryopreservation storage tanks for embryos and eggs lose power and we lose everything (TRM has excellent safeguards against that). The second, is that we accidentally implant the wrong embryos into a patient.
That second scenario is the ongoing reality of an in vitro fertilization (IVF) clinic in California. The story has been everywhere lately and truly is a terrible tragedy for all involved. However, the story seems to have run away with the idea that fertility clinics are unsafe, reckless and unregulated. This could not be further from the truth.
I want to address some of these misconceptions and accusations as well as provide a little information on TRM’s own protocols to protect our patients from accidents like the one in California.
Are fertility clinics regulated?
Some news sites have claimed otherwise, but yes! Fertility clinics have some of the most rigorous standards in the industry. From the CDC to CLIA to CAP, we have plenty of organizations – with plenty of acronyms – that regulate fertility clinics.
These regulations and organizations are voluntary
This means that each clinic may choose not to follow these standards. Anyone searching for a fertility clinic should ask about the regulations they hold themselves to. Selecting a clinic that voluntarily subjects its laboratory to rigorous testing and yearly audits by some of these organizations, demonstrates that the clinic is willing to go the extra mile to ensure the highest patient care.
Tennessee Reproductive Medicine reports to and follows the regulations of the organizations listed below.
Centers for Disease Control and Prevention (CDC)
The CDC is the nation’s health protection agency, meaning it protects the health of the American people through critical science and health information. While we may think of the CDC handling disease outbreaks, it also monitors fertility clinics.
The CDC ensures that there are solid protocols in place, such as chain of custody, testing procedures and operating standards. The agency performs yearly audits on fertility clinics, with site visits. This auditing ensures that we have clear, consistent protocols we follow for every patient.
Clinical Laboratory Improvement Amendments (CLIA)
The CLIA regulates approximately 260,000 laboratory entities in the United States and ensures quality lab testing. Started in 1988, the CLIA does not regulate just IVF laboratories but all labs (except research) that perform testing on humans.
College of American Pathologists (CAP)
For more than 70 years, the CAP has been an international leader in medicine. The Accreditation Committee of the College of American Pathologists ensures the highest standard of care for all laboratory patients. Inspectors check all the laboratory’s records and procedures for the preceding two years. They go on to examine lab staff qualifications, facilities, safety programs and overall management.
Tennessee Reproductive Medicine’s laboratory has been awarded this accreditation. Our lab is one of more than 8,000 CAP-accredited facilities in the world. The federal government recognizes the CAP Laboratory Accreditation Program as being equal to or more stringent than the government’s own inspection program.
Society for Assisted Reproductive Technology (SART)
SART sets the standards for infertility care and represents the majority of the assisted reproductive technology clinics in the U.S. Clinics can choose to be a member of SART or not. The organization sets the standards that all members must follow and requires members to report birth outcomes and advertise those outcomes honestly.
Many insurance companies only provide coverage at fertility clinics that are SART members.
Our IVF protocols, your peace of mind
In addition to submitting our laboratory and office to auditing and adhering to the regulations of the above organizations, TRM has a secure protocol to ensure mix-ups do not happen. Below is a brief description of some of our guidelines for the chain of custody in the embryology laboratory.
Embryos/oocytes from retrieval to cryopreservation
- Embryologist talks to the patient before the egg retrieval to confirm name, date of birth and treatment plan.
- Once patient is brought into the procedure room, there is a “time out” to verify that it is the correct patient.
- All dishes and incubator spaces are labeled with the patient’s name and date of birth.
- The embryologist never has more than one patient’s embryos out of the incubator at the same time.
- All dishes are checked and matched with incubator door label before placing them back into the incubator.
- Cryopreservation straws are labeled with a handwritten name plus a printed label that states patient’s name, date of birth, date of cryopreservation, age of embryo, and quality.
- Each cane (a tube) that holds the patient’s frozen embryos/oocytes is labeled with a colored tab that states the name of the patient and date of cryopreservation.
- The embryo cryopreservation sheet contains the patient’s information plus cryopreservation time and date. Embryo number, embryo grade, color of the straw, the color of the cane label, and the tank location where the embryos are stored are also on this sheet.
Thawing frozen embryos/oocytes
- Before removing embryos/oocytes from liquid nitrogen storage into smaller dewars (tanks), patient’s chart is checked for tank location.
- Embryos/oocytes are removed from storage tanks and the cane label is matched to the name and freeze date in the patient’s chart.
- Before thawing begins, the label on the cryopreservation straw is checked and information also matched to patient’s chart.
- Thawed embryos/oocytes are moved into pre-labeled dishes and placed into labeled incubators.
- Before the embryo transfer the patient is shown the straw that the embryo came from and signs a consent showing the number of embryos thawed and the number remaining in storage.
- At the time of the transfer the embryologist reads the information on the dish out loud saying, “My dish says Jane Doe 1/2/85 and we are transferring 1 embryo.” Before proceeding the embryologist must hear the physician and patient say “we agree.”
So, an IVF mix-up? Not likely
While what happened in California is unconscionable and a truly terrible tragedy, remember that this is the outlier. According to the CDC, 1.7% of all infants born in the U.S. are conceived each year through assisted reproductive technologies.
Much like shark attacks or being struck by lightning, the chances of this type of mix-up happening are minimal. Human error does occur, and we can never fully remove that from the IVF process. However, it is incredibly unlikely that this will happen. Don’t let the sensationalism of some media outlets scare you into believing fertility specialists do not care about you or your potential family.
It’s why we do what we do, and we want to do it right.