HospitalInspections.org

Based on interview and record review, the hospital failed to ensure surgical services were provided in accordance with professional standards of practice for one of 10 sampled patients (Patient 11). During Patient 11's surgery in 2014, the surgeon did not remove the paper backing from Seprafilm (a product used during surgery to prevent adhesions [bands of scar-like tissue that form between surfaces inside the body and cause them to stick together]). This failure resulted in Patient 11 having multiple small bowel obstructions (a blockage that prevents food and liquid from passing through the small intestine) and requiring surgery to correct her condition.

Findings:

Review of Patient 11's History and Physical (H&P), dated 4/2/14, indicated Patient 11 had symptomatic uterine fibroids (noncancerous growths in the uterus that cause symptoms including, but not limited to, heavy menstrual bleeding, pelvic pain, abdominal discomfort, and lower back pain). The H&P indicated Patient 11 wished to proceed with an abdominal myomectomy (a surgical procedure to remove uterine fibroids through an incision in the abdomen).

Review of Patient 11's Operative Report, dated 4/2/14, indicated an abdominal myomectomy was performed. The report indicated three fibroids were surgically removed from Patient 11's uterus. The report further indicated Seprafilm was placed over the surgical incisions.

Review of Patient 11's H&P, dated 9/30/24, indicated Patient 11 presented to the emergency room with abdominal pain and nausea. Patient 11 had a computerized tomography scan (CT scan, a procedure that produces images of the inside of the body), which revealed a small bowel obstruction. The H&P indicated Patient 11 had approximately six previous small bowel obstructions.

Review of Patient 11's Operative Report, dated 10/1/24, indicated that over the last 10 years, Patient 11 had multiple episodes of recurrent small bowel obstructions and elected to proceed with surgical exploration (surgery to inspect internal organs). The Operative Report indicated, "The patient had extremely dense adhesions of multiple segments of the small bowel to a retained sheet of material, which appeared similar to the packaging paper around Seprafilm. The sheet was densely wadded up between the posterior uterus [back part of the uterus] and multiple segments of small bowel with such adherence that small bowel was inseparable from this area along with significant surrounding inflammatory process [an immune response that causes redness and swelling]." According to the Operative Report, a segment of Patient 11's small bowel required suture repair and another segment of small bowel had to be resected (cut out). The Operative Report indicated a postoperative (after surgery) diagnosis of, "Multiple recurrent small bowel obstructions secondary to retained foreign body with dense adherence to multiple segments of small bowel."

An interview was conducted with the hospital's Chief Quality Officer (CQO) and Director of Risk Management (DRM) on 11/22/24 at 10:56 a.m. The CQO stated he thoroughly reviewed Patient 11's case. He explained that Seprafilm was meant to be left in the patient's body, but it had a paper backing that was supposed to be removed. The CQO and DRM confirmed that the surgeon who performed Patient 11's abdominal myomectomy in 2014 failed to remove the paper backing from the Seprafilm that was used during the surgery.

Review of the manufacturer's instructions printed on the back of the Seprafilm package indicated, "Apply Seprafilm and slide out bottom protective sheet, then remove entire sheet."

During an interview with the hospital's Director of Accreditation, Licensure, and Regulatory (DALR) on 11/25/24 at 3:22 p.m., the DALR confirmed the hospital's surgical department followed the guidelines of the Association of periOperative Registered Nurses (AORN).

Review of the AORN's undated guidelines titled "Retained Surgical Items" indicated, "Accurately accounting for items used during a surgical procedure is a primary responsibility of the surgeon and surgical first assistant." The guidelines further indicated, "The surgeon and surgical first assistant should maintain awareness of the location of items in the surgical wound during the course of the procedure."