Over the past few weeks, we have covered how a single paper-based informed consent process experienced failures at every possible turn, and today we are going to cover the single failsafe that it all came down to. There are several lessons to learn about what not to do in this particular paper-based informed consent calamity, but there is one lesson that stands supreme in the category of "lessons to learn."
OTHer blogs in this series
What All Went Wrong: A Quick Recap
At the University of Wisconsin Medical Center, a female patient spent time meeting with her specialist regarding the possible removal of portions of her reproductive organs. The patient and her doctor discussed the removal of her uterus and/or both of her ovaries. Ultimately, the patient and her doctor decided it would be best to only remove her uterus. A surgical course of action was defined and mutually agreed upon, and the gears were set in motion to make the procedure a reality. This entailed obtaining the patient's signature on a paper-based informed consent form that outlined the surgical procedure in technical detail. The patient signed the document, and it was faxed over to the hospital from the doctor’s office, along with all the documentation required to schedule the procedure. These documents were not submitted electronically, as the doctor’s office was not only physically disconnected from the hospital, but also disconnected in terms of technology. In other words, the doctor’s office and the hospital were using different EHR systems that at the time did not integrate.
Everything was working as it should until the patient had a change of heart and called the doctor’s office back. After leaving the appointment with her doctor she decided that in addition to removing the uterus, it was in her best interest to also remove both of her ovaries during surgery. This request was noted by the doctor, and he altered the paper-based informed consent form by simply writing the new procedure on the already-signed document. He did not cross out the previous procedure.
Unfortunately, the new documents that reflected the change in procedure were not sent over to the hospital from the doctor’s office. The lack of EHR integration ensured that the revised paper-based informed consent, along with electronic notes inside the doctor's EHR, did not find their way to the patient's chart at the hospital. Because the entire surgical team was using outdated information on the day of surgery, the incorrect procedure was performed on the patient. Once the error was caught by the patient in the recovery room, she was immediately wheeled back into the operating room where the remainder of the correct procedure was completed.
The Final Failsafe & Unjust Patient Burden
There is one failsafe that could have prevented the domino effect of errors that occurred in this situation. On the day of the surgery, when the patient was being prepared for surgery, the surgeon met with the patient, completed paper-based informed consent in hand, and he reviewed the procedure with the patient. If the patient had caught on that the doctor was talking about the incorrect procedure, and spoken up, then all of this could have been avoided. Unfortunately, an error occurred here that happens all too often at hospitals, and it has to do with the language of the procedure being presented in plain-spoken, approachable terms that the patient can understand.
In this situation, the surgeon described the procedure in very specific and technical medical terminology that was not meant to be understood by anyone without professional medical training. Specifically, the patient was told that they would undergo a " bilateral salpingectomy," but the correct procedure was actually called a "bilateral salpingoophorectomy," a minor difference which included the removal of the ovaries.
Naturally, the patient did not catch the difference. All other errors aside, if the procedure had been presented to the patient in plain language, this whole mess could have been avoided. However, expecting the patient to be the last bastion of hope that an error like this would not occur is plain wrong.
In the end, there are many takeaways to be gathered from this unfortunate surgical error at UW Medical Center, but perhaps chief among them is to alter the procedure content on your informed consents to be in plain spoken language so the patient knows what surgical procedure they are about to undergo. Of all the complicated processes that hospitals encounter, this is one relatively simple change that could pay dividends in terms of ensuring the best outcomes for your patients, as well as ensuring that your doctors and hospital are not hobbled by the morale-crushing experience of a serious medical malpractice claim.