The growing importance of informed consent documentation
You don’t have to look any further than your news feed to see how advances in embryology have shifted the focus of IVF conversations from the expertise of the physician to the delicate work of the IVF lab. And it’s not just REIs and patients who are talking.
Legal and medical scholars publishing papers decrying the lack of laboratory regulation offer valuable insights to both lawyers and laboratories. While personal injury attorneys heedlessly blogging on “common IVF errors” and “reproductive negligence” compete with the legitimate educational materials provided by physicians and erode trust between physicians and patients. And then there is the media.
“Heartbreak, anxiety, lawsuits: The egg-freezing disaster a year later” - NBCNEWS.COM
“What happens when Reproductive Tech Like IVF Goes Awry?” - Wired.com
As a science, IVF is a remarkably safe and successful way to assist patients who need help conceiving. Advances in embryology and technology have made it even more so. But the IVF laboratory is also becoming progressively complex. Bringing with it, increased risk of human and systems error and intense public and legal scrutiny.
Practice vulnerability to lab error
According to Dr. Steven Katz of REI Protect, “A lab error is four times more likely in today’s current REI arena than a physician incident. And that number is probably conservative. Knowing that, and knowing how little most malpractice insurance carriers understand about the subspecialty, I feel safe saying that If an REI group was able to choose only one type of coverage for their REI practice, I would urge them to choose IVF lab coverage over Physician malpractice coverage.”
Dr. Katz is not alone in his concerns. Nor is he the first to sound the alarm. A University of Texas School of Medicine study published in Fertility and Sterility in 2012 reviewed “PGD Litigation Against IVF Facilities in the Face of New Technology”. The study’s authors concluded that “Facilities offering PGD services expose themselves to a new realm of liability in which damage awards can easily exceed the limits of a facility’s insurance policy. Competent laboratory personnel and proper informed consent–with particular care to inform patients of the inherent inaccuracies of PGD–are crucial in helping deter liability.”
Fast forward eight years to where we are today and it’s easy to see why Dr. Katz and his colleagues are advising practices to reexamine their informed consent process and review their malpractice coverage to make sure a) that they’ve accounted for what happens behind the doors of the lab, and b) that insurance carriers are properly categorizing the practice’s risk.
“Competent laboratory personnel and proper informed consent–with particular care to inform patients of the inherent inaccuracies of PGD–are crucial in helping deter liability.”
Accidents and errors will happen, sometimes even despite following strict safety protocols. In the case of IVF lab accidents or testing errors, it’s not a stretch to think that legal claims against a practice or lab could be filed years, even decades after a patient has been treated. If you were faced with a claim, how confident are you that your staff could recall specific details or that physician notes would provide a reasonable defense?
Would you be able to recall whether you explained the risks of a lab accident clearly and completely to a patient whose embryos were frozen six years? Will your notes alone prove that?
Are you sure?
Room for improvement
Protecting your patients and your practice requires that your informed consent and risk mitigation efforts accurately reflect changing laboratory advancements. Educational materials should prepare patients to carefully evaluate the potential success and risks inherent in both physician and lab procedures accurately, completely, and in plain language to facilitate truly informed consent.
A 2015 study of REI claims published by Gerard Letterie in the Journal of Assisted Reproduction and Genetics found that “Cases involving misdiagnosis and lack of informed consent accounted for the largest settlement awards; while cases related to lab error and mishandling of gametes or embryos accounted for the highest frequency of claims settled.
Letterie further concluded that “these observations offer the opportunity to evaluate areas for improvement and root cause analysis and suggest that claims frequency could be reduced by adjustment of practice patterns in these two areas.”
“Cases involving misdiagnosis and lack of informed consent accounted for the largest settlement awards; while cases related to lab error and mishandling of gametes or embryos accounted for the highest frequency of claims settled.”
Understanding the risks
When adverse outcomes occur, distraught patients, at times encouraged by their attorneys, will need to assign fault. It’s just human nature. But according to Dr. Katz, that need is amplified when patients feel that they were not made aware of the risks.
“If there is a bad outcome and a patient did not even understand that a bad outcome was possible, you can lose the necessary trust and goodwill between the physician and the patient that make it possible to mitigate a claim. To avoid this situation, practices must have clear communication upfront and an instrument of informed consent that records a patient’s understanding and acceptance of the stated risks.”
Interpretation of informed consent
Dr. Katz further cautions that informed consent should never be viewed as a perfunctory practice to either the patient or the clinic. That the attention a practice gives to the entire informed consent process influences how patients view and recall providing their consent.
When counseling REI Protect clients, he advises them to focus on both the delivery and the interpretation of informed consent.
“It is not enough to merely repeat statistics from testing companies during a consultation or quote laboratory risks in the clinical language of a twelve-page consent form. Practices must protect their patients and themselves by providing clear, well-documented, accurate information about lab and testing errors and risks, leaving no room for conjecture on behalf of the patient or the insurance carrier.”
“Practices must protect their patients and themselves by providing clear, well-documented, accurate information about lab and testing errors and risks, leaving no room for conjecture on behalf of the patient or the insurance carrier.”
As IVF has gained popular acceptance as a viable means of conception and the weight of responsibility has shifted from the physician to the lab, it’s not uncommon to hear the perspective that the responsibility of decision making has also shifted— from the physician to the patient.
Dr. Katz asserts that the responsibility for decision making has and should always be with the patient. That the physician is there in an advisory role to help the patient understand the decisions before them. Those decisions include both clinical and laboratory procedures. This is why staying current with informed consent is so fundamental to REI practice,” adds Dr. Katz.
Mitigate Risk with EngagedMD
"When the patient has more accountability—when they fully understand the procedure being performed and they’ve chosen that procedure, then informed consent is present. The EngagedMD platform, in addition to strengthening claims defense because of the documentation, ensures that patients understand the risks of procedures and make choices they’re most comfortable with. I can think of no better definition of informed consent.”