Practice of Medicine

Claims Lesson

Time-Out Procedure Fails - Patient Gets an Unwanted Bilateral Oophorectomy

November 26, 2013

The Case

The nurse practitioner (NP) saw the patient for her annual GYN examination. The patient had a five-year history of heavy menstrual cycles. At this visit she complained of severe, progressive dysmenorrhea over the past four months, not relieved by Tylenol, and accompanied by menstrual migraines. The patient further reported using up to five overnight super pads and passing half-dollar sized clots. The NP ordered an ultrasound, CBC and TSH, and gave the patient an appointment to follow up with the OB/GYN physician.

Two weeks later, the patient was seen by the OB/GYN who discussed the test results. The ultrasound revealed an endometrial thickness of 1.4 cm. An endometrial biopsy revealed early secretory endometrium. The patient's sonohystogram ruled out intracavitary lesions. The physician counseled the patient on several options, including hormonal regulation, endometrial ablation and hysterectomy. He discussed the benefits and risks of removing the ovaries. The patient mentioned that she was unsure about keeping her ovaries secondary to her history of menstrual migraines that could continue post hysterectomy. She advised her physician that she would call him back with her decision.

Two weeks later, the patient called back, clarifying her request for a hysterectomy only. The staff did not bring this call to the physician's attention, nor was it documented, but the informed consent form the patient had previously signed reflected "laparoscopic-assisted vaginal hysterectomy" and was not changed.

During the week of this patient's surgery, the physician had three other patients undergoing hysterectomies who had changed their minds about oophorectomy at different points in the preoperative process - one at her preoperative visit, another by telephone, and one the morning of surgery. The physician thought that this patient was one of these three, remembering her indecisiveness regarding the removal of her ovaries.

So, during the surgical time-out, the physician ignored the procedure, "laparoscopic-assisted vaginal hysterectomy," as written on the informed consent form, and ignored the circulating nurse's procedure call-out. The staff attempted to respond to the discrepancy but the physician overruled them. The physician insisted the patient had changed her mind, and also wanted a bilateral salpingo-oophorectomy (BSO). Thus, the patient's ovaries were removed in error. During the procedure, the patient also sustained an intraoperative cystotomy, a known complication, which the physician immediately recognized. Urology was consulted and the repair was performed vaginally while the patient was still under anesthesia. The patient required one week bladder rest with Foley catheter without incident or post-operative sequelae. Post-operatively the physician discussed both the procedural error and the bladder injury with patient and her husband, admitting responsibility for both.

Allegation

Plaintiff alleged the physician negligently removed the patient's ovaries and fallopian tubes, putting the patient into early menopause with full symptoms (12 years prematurely), and injured the patient's bladder during the procedure.

Disposition

The case was settled for a large amount of money on behalf of the insured OB/GYN physician and his practice.

Risk Management Commentary

Despite intense efforts to prevent wrong-site surgery (this includes wrong patient, wrong part and wrong procedure), the Joint Commission Center for Transforming Healthcare (the Commission) reports the adverse event "that should never happen" occurs about 40 times a week nationwide.In 2010, wrong site surgery was the third most common sentinel event reported, and it was the most common sentinel event reported between 2004 and 2010.1

In an independent study, Stahel et al reported that among operations on the wrong part of the body, 85% were due to errors in judgment and 72% were due to not performing a "time-out" as required by protocols introduced by The Joint Commission.2

In June 2011, the Commission announced the preliminary results of a project it conducted with eight hospitals and ambulatory surgery centers. The facilities found that problems with scheduling and preoperative/holding processes, as well as ineffective communication and distractions in the operating room, contributed to increasing the risk for wrong-site surgery. A "time-out" without full participation by all key people in the operating room was identified as another contributing factor that increased risk.3

Based on these and other findings from the study, the Commission has developed a tool that may help facilities discover the flaws in their processes that can lead to irreversible or life-threatening mistakes. Recommended checkpoints to eliminate these adverse events are being pilot tested to prove their effectiveness in different types and sizes of facilities, and other care settings. The Commission has data to demonstrate whether the solutions can be sustained at a 90% or greater compliance rate.

With the Commission's "Targeted Solutions Tool," facilities should be able to follow some very simple sets of instructions with an electronic application available through every organization's secure electronic connection with The Joint Commission. The tool measures each organization's risk at each point in the process - the time of scheduling, in the pre-op area and in the operating room.4

Clearly, the public will no longer tolerate injuries involving wrong site, wrong person or wrong procedure surgery and is forcing action through state agencies and other regulatory bodies. There are solutions to preventing this type of medical error. The center's Targeted Solutions Tool is available to all Joint Commission-accredited facilities at a href="http://www.centerfortransforminghealthcare.org/tst.aspx">http://www.centerfortransforminghealthcare.org/tst.aspx.

Reference:

1. The Joint Commission, jointcommission.org, Joint Commission Online, Dec. 1, 2010.

2. Stahel PF, Sabel AL, Victoroff MS et al "Wrong-Site and Wrong-Patient Procedures in the Universal Protocol Era: Analysis of a Prospective Database of Physician Self-report Occurrences" Arch Surg, 2010; 145 (100):978-984.

3. "Joint Commission Targets Wrong-Site Surgery," ModernHealthcare.com; Maureen McKinney; posted June 29, 2011.

4. "Joint Commission Unveils Wrong-Site Surgery Prevention Tool," Cheryl Clark, HealthLeadersMedia.com, July 5, 2011.

Disclaimer

The information provided in this resource does not constitute legal, medical or any other professional advice, nor does it establish a standard of care. This resource has been created as an aid to you in your practice. The ultimate decision on how to use the information provided rests solely with you, the PolicyOwner.