The American Society of Reproductive Medicine estimates that 12-15% of couples have trouble conceiving after one year of trying. Many of these couples turn to in vitro fertilization (IVF)—a technology responsible for 8 million births since its inception in 1978.
Despite the success of IVF, systemic issues at fertility clinics have exposed many patients to a great deal of financial, emotional and even physical harm. Properly addressing these shortcomings is crucial in protecting reproductive medicine.
In the United States, roughly 2% of all births are made possible through the use of IVF. The rapid expansion of IVF in the U.S. has occurred under inconsistent state laws and minimal regulations. Thousands of embryos have been lost in storage tank failures and other preventable incidents.
According to one report by The Washington Post, it is common for errors and accidents to go unreported in the fertility industry. Fertility clinics often self-enforce regulations and are not mandated to alert patients of mistakes.
Lack of Standardized Protocols
There are many areas within IVF that lack standardized protocols and oversight to help reduce negligence and outright misconduct. This regulatory gap needlessly puts patients at risk of significant harm.
One of the key areas where standardization is absent is how embryos are identified and labeled. For example, some clinics use handwritten tags while others use barcode systems.
This absence of standardized protocols has led to many errors and mix-ups and exposed fertility clinics to liability in the process. In one case, embryo labeling errors resulted in a class-action claim involving 93 IVF cycles.
Another area of concern is the lack of regulation and guidance on proper cryopreservation and storage practices. It is common for different fertility clinics to have different policies.
Wanda Ronner is a professor of obstetrics and gynecology at the University of Pennsylvania School of Medicine. She offered the following observation to The Atlantic. “We don’t even have independent, peer-reviewed research funded by the NIH to say, ‘What’s the most effective way to make sure the embryo is okay to transfer?’ or even ‘What temperature to freeze the embryos?’”(8)
Impact of Understaffing
All medical facilities need adequate levels of staff in order to ensure safety measures and procedures are being followed. This is particularly true for fertility clinics.
As emphasized by JBRA Assisted Reproduction, “The existing data indicate that an IVF laboratory need to have adequate staffing levels to perform the required daily duties, and to work in optimal conditions that are critical to assure a high quality service, as well as avoiding incidents and to provide the best outcomes.”
Understaffing at a fertility clinic can lead to increased workloads and longer hours for the staff that remain. This can affect every part of the IVF process.
Fertility clinic employees are more likely to make mistakes when they’re overworked or fatigued. When key procedures are undertaken by fewer people, this also puts pressure on existing staff to complete tasks more quickly.
In a recent case, two Bay Area couples have filed a lawsuit against Spring Fertility—accusing the provider of losing embryos during IVF transfers. An attorney for the couples alleges that the embryo loss was the result of understaffing, cutting costs and cutting corners.
Too much pressure can lead staff to begin taking shortcuts to save time. This creates an environment where embryos could get mislabeled, misplaced or otherwise mishandled.
Inadequate Training
Embryos are extremely delicate by their nature. Success during the IVF process is largely dependent on fertility clinic staff being properly trained for their assigned roles.
Several factors at fertility clinics can contribute to employees not being properly trained. One of these factors is burnout. Working under pressure is one of the most common driving factors related to employee burnout.
One study in MDPI found that one in every three professionals working in assisted reproduction experienced moderate-to-high levels of symptoms associated with burnout. Burnout can lead to high turnover rates.
As new people continuously rotate in, this contributes to a situation where there are fewer and fewer well-trained veteran providers. A lack of proper training is a known risk factor for adverse outcomes during IVF.
Flawed Processes
The diversity of methods used during IVF at various clinics has given room for flawed processes to contribute to mistakes. As discussed earlier, there is a lack of standardized methods for how embryos should be identified and labeled.
Several other laboratory practices, such as unclear communication or inconsistent labeling methods, may contribute to mix-ups and errors. Any breakdown in communication between key healthcare providers such as doctors, embryologists, lab staff, and nurses may allow preventable errors to occur.
Consider, for example, one embryo mix-up at the CHA Fertility Center in Los Angeles that allegedly resulted in a Korean woman giving birth to two young boys who were not of Asian descent. These mix-ups are nearly always preventable and tend to involve providers who fail to verify patient and embryo identities through proper labeling and clear communication.
Some clinics may fail to follow protocols related to screening embryos for genetic issues. Preimplantation genetic testing (PGT) can dramatically reduce the risk that a fertility clinic implants an embryo with undetected genetic anomalies.
Perhaps the most consequential flawed process at fertility clinics is limited error reporting and accountability in the event of a mistake. A lack of reporting makes it difficult for fertility clinics and outside parties to track and address recurring problems.
When fertility clinics don’t face any real consequences for serious mistakes, there is little incentive to address the systemic issues that contributed to those mistakes in the first place.
Solutions for Improved Oversight and Protocols
IVF patients face significant harm when fertility clinics fail to exercise due care. In order to better protect IVF patients, there is a great need to have improved oversight and protocols.
One measure that could make a big difference is mandatory standardized training. IVF clinic staff should be required to undergo specialized training in reproductive technology and embryology.
Stronger regulatory oversight can also help ensure that fertility clinics are complying with best practices. This is particularly important with respect to the handling, transfer and implantation of embryos.
The technology to prevent embryo mix-ups has been around for quite some time. But it is still common for fertility clinics to rely on hand labeling genetic materials. Errors can be largely eliminated if clinics are required to use RFID-tagged samples and barcode scanning to identify genetic materials.
Given that many errors during IVF involve understaffing, it is wise to develop and enforce minimum staff-to-patient ratios. This can help dramatically improve workload distribution while also reducing burnout.
Effective and clear communication among medical professionals is a necessity for reproductive medicine. Secure and centralized communication channels between all lab staff, embryologists, and physicians can reduce errors and improve patient outcomes.
At the end of the day, no amount of regulations can help improve IVF outcomes if errors are not properly documented and responsible parties are not being held accountable. The cornerstone of any comprehensive set of reforms must include comprehensive error reporting requirements and clear accountability.
These measures can go a long way toward improving trust in reproductive healthcare and help create better outcomes for all people and couples who wish to make use of IVF.
