A CASE STUDY SERIES WHERE IT ALL WENT WRONG & What You Need to learn from others mistakes
Like the famous Swiss cheese that Wisconsin is known for, the informed consent process for surgical procedures has many holes. This case study reviews the findings from the Wisconsin Examining Board, exposing a broken chain of events, but it also spotlights opportunities to avoid this type of medical error by using electronic consent technologies.
In 2015, Wisconsin Examining Board published a case outlining an incident where UW-Madison's Obstetrics and Gynecology Department’s paper-based informed consent process contained a series of errors, a gaffe that serves as the basis for this review. For 20 years, Access has provided patient electronic signature solutions, and we have seen a number of paper-based errors occur at hospitals. However, in this case, there were a multitude of breakdowns in the process that all began with a patient requesting ta simple change to surgery. This routine and minor change served as the initial domino in a chain reaction of errors in the surgical procedural consent process resulting in serious complications and failures in the system. These failures placed the hospital, the physician, and the patient at avoidable risk and caused an unnecessary secondary follow-up procedure for the patient.
A Play-by-Play of What Happened
On October 2, 2014, a patient met with her OBGYN in the physician’s office outside of the hospital to discuss undergoing a total vaginal hysterectomy (TVH). The EHR for WU-Madison and the Physician Clinic were on separate and nonintegrated platforms, which is not uncommon for large integrated delivery networks with independent physicians. After some discussion, the physician and patient agreed to schedule the TVH without the removal of her ovaries. At the time of scheduling, the Physician Clinic EMR scheduler sent a record to the health systems central scheduling via fax. The patient and her surgeon agreed upon an order at the clinic that was faxed to the hospital, along with an order for the procedure, where it was received by the central scheduling department.
Two days later, on October 6, 2014, the OBGYN and patient discussed the options available to the patient, which included keeping her ovaries or having them removed as part of the procedure. Taking the physician’s advice to keep her ovaries, the patient signed a paper consent for bilateral salpingectomy (fallopian tube removal ONLY).
Later in the day, with a change of heart, the patient called back and spoke with the surgeon. She stated that she would like a full hysterectomy with ovary removal. The Surgeon made a handwritten change on the paper consent form by adding the terminology, "bilateral salpingoophorectomy (ovary + fallopian tube removal)”, The physician failed to cross out or redact the terminology for the previously agreed-to procedure for bilateral salpingectomy (fallopian tube removal). With this change, a clinic RN placed a note in the clinic EMR to read that the patient had added bilateral oophorectomy (removal of ovaries), but this change in the surgeon’s EMR was not relayed to the hospital’s EMR because of a lack of integration.
The day of surgery, October 26, 2014, the surgeon entered the preoperative orders into the hospital’s EMR.
Checkpoint 1: The board in the pre-surgical area and in the hospital EHR, upon review, showed “total vaginal hysterectomy, bilateral salpingectomy.”
Checkpoint 2: The patient arrived at the hospital and followed normal protocol. The surgeon again reviewed the procedure with the patient in the pre-operative area to ensure that the patient was fully informed. The patient agreed to a "total vaginal hysterectomy and right labial polyp excision.”
Checkpoint 3: Prior to the procedure, the surgeon opened another window on his computer to review the patient’s progress notes from October 2 with the surgical team, which existed in the Clinic EHR.
Checkpoint 4: During the pre-induction timeouts, the surgeon read the procedures given by a nurse on a “pink-slip” and from the hospitals EHR which read, “total vaginal hysterectomy, bilateral salpingectomy and labial excision.” Everyone in the OR agreed that this was the procedure to be performed.
Four known checkpoints with multiple clinicians and the patient were involved in the review process. Additionally, although separate, this patient information resided in two dependable EHRs and had a clinical team board review. How did things go so terribly wrong?
Where Did It All Go Wrong?
As planned, the physician/surgeon performed the procedure. After the procedure and while in recovery, the patient inquired if her ovaries had been removed, reflecting her pre-procedure intent. They had not. The surgeon was called in to correct the procedure via an immediate surgery to remove her ovaries as well. What happened? Where was the breakdown?
There were four different complications in this timeline that contributed to the overall breakdown, and there is one clear solution that could have ensured the correct procedure. Do you know what it is?
If you think you know what it is, email us here and we’ll give you and your team a shoutout in the next blog!
Stay tuned for next week, where we will examine how the impact of Scanning Consents Post-Surgery played in this incident at WU-Madison.