Failure to identify retained foreign object
by Laura Hale Brockway, ELS, Vice President, Marketing, and
Tamara Vasquez, Risk Management Representative
Presentation
On May 7, a 30-year-old woman came to a local hospital in premature labor. An examination revealed that she was in active labor and had experienced spontaneous rupture of membranes at 33 weeks, five days gestation. The fetus was in the breech presentation with cord prolapse.
Physician action
Ob-gyn A performed an emergency cesarean delivery. The patient experienced severe hemorrhaging and required multiple transfusions. Because of the hemorrhaging, Ob-gyn A performed a hysterectomy with removal of the left fallopian tube and ovary. Intraoperative cystoscopy revealed intact ureters, good urine output, and good “jet” on the ureters bilaterally.
Because this was an emergency procedure, initial sponge and lap counts were not done. At the end of the procedure, Ob-gyn A ordered a kidney, ureter, and bladder (KUB) x-ray. The KUB was completed at 4:32 p.m. Ob-gyn A looked at the film and closed the patient’s incision. The surgical case record showed that the procedure ended at 4:45 p.m.
A second KUB was completed at 5:04 p.m. Ob-gyn A’s order for this KUB stated the reason for the study was “incorrect count.” The patient was transferred to the ICU.
Both KUB studies were interpreted by Radiologist A, who dictated a report at 5:47 p.m. The history section of the radiology report indicated “incorrect count.” Radiologist A’s final impression was “1. Nonspecific bowel gas pattern. 2. At least 2 surgical drains noted in the pelvis and postsurgical findings with multiple clips left pelvis. Please correlate clinically. 3. No comparisons available.”
The patient was discharged on May 11. She was re-admitted on May 18 with pain, swelling, and redness in the lower abdomen. She had a necrotic wound, approximately 8 cm in depth by 21 cm in length. The next day, she underwent surgical wound debridement and wound vacuum placement. She was given IV antibiotics and was discharged on May 24.
On June 4, the patient was re-admitted for wound infection and dehiscence. Ob-gyn A performed wound debridement and attempted a secondary closure. He was unable to approximate the edges because of the patient’s habitus and shape. Ob-gyn A documented that he would refer the patient to a plastic surgeon for closure.
The patient’s wound complications continued. Six weeks later, a CT scan of the abdomen was interpreted by Radiologist B. The impression was:
“1. Abnormal CT examination. 2. There appears to be a large phlegmon or abscess in the left hemipelvis extending from the left pelvic sidewall to the apex of the vaginal cuff. The phlegmon consists of heterogenous soft tissue attenuation, contrast enhancement with a central cavity measuring 4 x 3 x 2 cm in diameter containing heterogenous attenuation and numerous gas locules. 3. There is left-sided hydronephrosis and dilatation of the left ureter to the level of the true pelvic brim and left pelvic phlegmon. Extrinsic mass effect upon the ureter or involvement of the ureter is suspected. Note is made of symmetrical renal cortical medullary enhancement, the left kidney enhances to a lesser degree than the right.”
Ob-gyn A referred the patient to Urologist A, who performed a cystoscopy, left retrograde pyelogram, and vaginoscopy. The results showed that the patient had a significant deviation of the bladder to the left with intrinsic mass effect pushing on the posterior lateral left side of the bladder pushing up on the left trigone and ureter. She had severe medialization of the ureter associated with a radio-opaque structure within the pelvis. Urologist A took a scout KUB and believed there was a radio-opaque mass.
Ob-gyn A performed a laparotomy for a pelvic mass on August 3. A general surgeon was called to assist due to inflammation in the surgical field. A foreign object — a gauze sponge retained from her prior surgery — was isolated and removed from the iliac vessels, the ureter, and the sigmoid colon. The pathology report described the object as a piece of gauze approximately 32 x 7 cm. There was tissue attached to the gauze.
Over the next three years, the patient was treated with multiple procedures and surgeries, including placement of a ureteral stent, ureteral reimplantation, colostomy, and colostomy take down. She was also treated for several wound infections and has reduced function in her left kidney.
Allegations
A lawsuit was filed against Radiologist A. The allegations were failure to properly interpret and identify the foreign object in the KUB taken on May 7, and failure to perform additional testing to rule out a foreign object in the patient’s abdomen.
Lawsuits were also filed against Ob-gyn A and the hospital.
Legal implications
The plaintiff’s radiology expert stated that Radiologist A did not meet the standard of care in this case. He failed to diagnose the retained sponge and failed to qualify the exam as limited by image quality or body habitus. According to this expert, if the purpose of the KUB was to rule out a retained foreign object, it was incumbent on Radiologist A to adjust the contrast and brightness of the image to search for it. He could also have requested non-portable follow-up films.
Defense radiology consultants conducted blind reviews of the KUB taken at 5:04 p.m. on May 7.
All but one of the reviewers described seeing a radio-opaque foreign body in the film. These radiologists also stated that based on the request for the KUB — “incorrect count” — they would have recommended repeat imaging or a CT scan.
Radiologist A testified that had someone called him — either Ob-gyn A or operating room (OR) personnel — and told him there was a missing sponge, he likely would have recognized it. Because of the manner in which the films were obtained and that the patient had been closed, he had a low suspicion when he reviewed the film. He also commented that he reviewed a “busy” image with various surgical clips and drains.
Communication issues complicated the defense of this case. Radiologist A did not contact Ob-gyn A with the request to clinically correlate what was seen in the KUB, though hospital policy required physician-to-physician contact in this situation. Ob-gyn A did not indicate what was missing as a result of the “incorrect count” on the order for the second KUB. Hospital policy also required OR staff to contact Radiologist A with a description of what was missing. This was not done. Better communication between everyone involved may have changed the outcome in this case.
Disposition
This case was settled on behalf of Radiologist A. The hospital also settled their case with the plaintiff. The outcome of the case against Ob-gyn A is unknown.
Risk management considerations
The primary injury in this case was caused by a retained surgical sponge; the communication breakdown between Ob-gyn A, the Radiologist, and the surgical staff also contributed to the delay in diagnosing the foreign object and severity of the injury to the patient.
The emergency nature of the cesarean delivery prevented an initial sponge and lap count. The Association of Surgical Technologists recommends that in the event of a stat emergency procedure, a sponge count be performed upon closure, and an x-ray taken to confirm the absence of foreign bodies in the patient. (1)
In the event of a wrong count, the surgical team is responsible for resolving the count. A visual search must be conducted, and the surgeon may explore the abdomen or cavity. If not found, an intraoperative x-ray should be taken and read by a radiologist before closing a patient’s surgical wound and being taken out of the operating room. (1)
The American College of Radiology’s “ACR Practice Guideline for Communication of Diagnostic Imaging Findings offers guidelines — not rules or requirements — for creating a diagnostic imaging report. Two guidelines would apply to this case:
- Clinical issues: “The report should address or answer any specific clinical questions. If there are factors that prevent answering the clinical question, these should be stated explicitly.”
- Impression (conclusion or diagnosis): “Follow-up or additional diagnostic studies to clarify or confirm the impression should be suggested when appropriate.” (2)
Ob-gyn A ordered and reviewed the initial KUB and closed the patient’s incision. A second KUB was ordered shortly after the first with the indication of “incorrect count.” The radiologist was not provided the information from Ob-gyn A or the first KUB to look for a retained sponge or a foreign object. The second KUB order/history simply stated, “incorrect count.”
The ACR also states, “there is a reciprocal duty of information exchange . . . a request for imaging should include relevant clinical information, including pertinent signs and symptoms. In addition, including a specific question to be answered can be helpful. Such information helps tailor the most appropriate imaging study to the clinical scenario and enhances the clinical relevance of the report, thus promoting optimal patient care.” (2)
The hospital policy required physician-to-physician communication when there was an incorrect count, allowing the surgeon to clarify what object is being looked for and for the radiologist to report their reading. In this case, no physician-to-physician communication occurred.
Sources
- Association of Surgical Technologists. Recommended Standard of Practice for Counts. Available at https://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/Standard%20Counts.pdf. Accessed May 30, 2023.
- American College of Radiology. ACR Practice Parameter for Communication of Diagnostic Imaging Findings. Revised 2020. Available https://www.acr.org/-/media/acr/files/practice-parameters/communicationdiag.pdf. Accessed May 30, 2023.
Laura Brockway can be reached at laura-brockway@tmlt.org.
Tamara Vasquez can be reached at tamara-vasquez@tmlt.org.