The landscape of medicolegal risk is constantly evolving in fertility. What trends should your clinic consider as you update your risk mitigation plans?

We asked this question of our panelists in a recent fireside chat, which featured Dr. Gilbert Mottla of Shady Grove Fertility, Allison Burrows of VIOS Fertility Institute and Kindbody, and Dr. Steven Katz, CEO of REI Protect. Here are some of their top tips and insights on mitigating risk for your clinic.

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Informed consent processes

While keeping an up-to-date and efficient informed consent process may seem daunting or hard to prioritize, our experts suggest templates from ASRM and SART to start and constantly evolving to meet current needs. In fact, our experts suggest updating consent documents approximately every 6 months due to the frequently changing guidelines, recommendations, and updates in the fertility space. 

“We make somewhat frequent updates. We always try to keep up on [our consents] and make sure that we’re considering those updates whenever we’re presenting these documents and information to the patients. We meet routinely and we talk about this at least every month.” - Allison Burrows

Three components of an action plan to mitigate risk with informed consent 

When it comes to risk mitigation within the medical space, there’s a lot to consider. To start creating a reliable action plan, Dr. Mottla identifies three primary components to ensure patients truly have informed consent:

• Patient education
• Patient signed declination
• Physician documentation

The legally and ethically binding duty to meet these components has likely always been on your clinic’s radar. However, we find that many clinics have an opportunity to revisit these more frequently to meet the constantly evolving standard of care. We asked our panelists for their insights on this continually changing and important standard.

“To the best of our ability, we have to educate the patients so we feel comfortable that they have informed consent. Years ago, the concept was that the doctor gave them informed consent. I think the standard of care is now for the doctor to really feel, understand, and document that patients have informed consent.” - Dr. Katz

How to ensure patient understanding

You can present information to your patients, but how do you ensure – and, importantly, document – that they understand? It’s important to have a mechanism in place.

“We have an obligation to educate at this point... that’s the standard of care in 2022. And that’s a high standard that we have to meet. And it has to be documented, or else it didn’t happen.” - Dr. Mottla

For example, EngagedMD documents patient education through patient knowledge checkpoints that ask questions on the assigned fertility content a patient has viewed. Whatever processes your clinic uses in patient education, ensure the patient’s understanding of their treatments and fertility journey is documented.

This is particularly important in areas where there is variability in test results and outcomes. Clarity not only helps protect the patient from potential emotional stress, but can also protect your practice from litigation. 

Meeting education and informed consent standards for genetic testing

Some additional tips on meeting today’s standard of care in high-risk areas like genetic testing include:

• Set patient expectations for third parties                                               Involving third parties adds a new layer of variables regarding education and informed consent. Burrows emphasizes the importance of setting the expectation of third party embryologists as a vital part of the patient journey.
• Tandem testing 
  Consistency is pivotal in ensuring the accuracy of tests and procedures. When possible and applicable, our panelists advise that partners be tested at the same time and by the same lab.
• Mandatory genetic counseling to assess risks when needed
  In cases of uncertainty, specifically in reference to risk associated with Therapeutic Donor Insemination (TDI) embryos in which a female is positive for something that was not available for sperm donor testing when the embryos were created, Dr. Mottla suggests requiring patients to undergo genetic counseling.

Laboratory Risks

As the field continues to advance, we’ve seen risk moving from the clinical side of fertility to the lab. This creates a need for up-to-date and well-synchronized processes for laboratory protocols. For more information on how a clinic can be vulnerable to lab error, read Dr. Katz’ concerns and advice in this post addressing the high-risk world of ART.

“A claim is six times more likely to occur in the laboratory these days than in the practice.” - Dr. Katz

Dr. Katz goes on to note some sources of lab risks:

• Mislabeling Events

• 
  This is one of the most pressing lab risks, and must be dealt with delicately.
• Loss of Gametes
  Through simple but common lab accidents, labs often see loss of gametes through human error. Embryologists may accidentally lodge or drop dishes, while transporting them within the lab.
• Cryopreservation Laws
  From tank failures to professional negligence, cryopreservation losses are infamous within the fertility community. Labs must pay careful attention to the levels of liquid nitrogen in the tank and must be diligent and proactive in managing lab equipment. Dr. Katz recommends ensuring a backup generator is functioning and capable of supplying power to incubators in the case of a power outage.

Dr. Mottla notes the role physicians and non-lab staff play in lab risks through miscommunications. For example, a patient may express sex selection preference to a nurse who inputs  the information as a chart note. That chart note may not be communicated to the physician or put onto any lab identifying form. Ultimately, the  lab may select the wrong embryo, not knowing the patient’s preference. While the error happened in the lab, its source was a miscommunication on a clinical level.

Verification and witnessing are more areas of vulnerability for lab risks. Dr. Mottla recommends a double verification system at the clinical and laboratory level. This process calls for a 4-person witnessing and verification system, with both a physician and nurse at the clinic level and two lab members at the laboratory level, jointly verifying and witnessing procedures.

With an increase in genetic testing developments comes an increase in lab procedures. This can, in part, account for the shift in risk management to focus on lab error. As developments continue to be made, we must continue to analyze the risks associated with them.

How the future of fertility genetics will introduce risk

When asked about the future of genetics with regards to introduction of new risks, our panelists predicted continued advances. It can be easy to overlook the fact that genetics is still a very young field,

 continuously undergoing new research and developments. Specifically, our panelists anticipate: 

• Accuracy increases in testing
• Less invasiveness

In light of how far the fertility industry has come in the past ten years, as outlined in the New York Times’ article 10 Years of Fertility Advances,  it’s likely that the future of genetics will continue to see exciting new developments. This can be a double–edged sword regarding risk for your clinic. While new advancements lead to increased precision and lower technical error, new technology poses risk associated with outdated resources, staff training needs, and new system challenges. 

Next steps for your clinic

In making the most of our panelists’ advice, we recommend you watch and share the rest of the Risk Mitigation chat with your clinic.

Looking toward next steps in risk mitigation that you could start today, our panelists recommend:

• If your clinic has been doing something the same way for years, change it – modernizing your processes and consents is essential
• Initiate routine check-ins with your team to ensure synchronized processes and patient dialogues
• Look toward up-to-date resources to inform patients and document their understanding

EngagedMD’s eLearn and eSign platforms help your clinic mitigate risk by properly educating patients, documenting patient understanding, and safely storing signatures and forms. Connect with our team to learn more about how you can use the tools to mitigate risk for your clinic.

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