Abstract
Unintentionally Retained Foreign Objects (URFO) are an uncommon, but significant type of patient harm. Retained surgical specimens are new entities that accompanied the surge of minimally invasive surgery (MIS). Despite being rare sentinel events, they are associated with increased morbidity, healthcare cost, and liability. We present a case of a retained surgical specimen, identified after surgical closure but before patient extubation, thanks to routine utilization of end-of-procedure checklists.
Background
An unintentionally retained foreign object (URFO), is an object that is retained after skin closure has occurred following an invasive or surgical procedure.1,2 Retained surgical specimens is an uncommon type of URFO that first appeared in the literature with expanding use of minimally invasive surgery (MIS). 3 They are considered sentinel events regardless of whether they caused patient harm, as an additional major procedure is often required to resolve the condition. 4 Based on a recent voluntary report to the Joint Commission, retained surgical specimens represent 1.9% (6/308) of the unintentionally retained foreign objects (URFO), with the remainder of the URFOs being equipment used in the surgical procedure—packing, surgical instruments, catheters and drains, needles and blades and implants. 5 All reported cases of retained surgical specimens occurred during minimally invasive, laparoscopic surgical abdominal procedures, with colon (n = 2) and gallbladder (n = 2) specimens being the most common, followed by stomach (n = 1), and ovary (n = 1). 5 Retained surgical specimens require reporting to state and national healthcare authorities, and are subject to internal review and monitoring of hospital policies. They generally result in additional healthcare-related cost, morbidity, and professional liability. We present the first reported case of a retained surgical specimen after robotic colorectal surgery, aiming at increasing surgeons’ awareness and education on pitfalls and risk factors that are associated with this sentinel event. In addition, safety measures granting timely identification of the error and rapid correction without further patient harm, will be discussed.
Case
A patient with medically refractory ulcerative colitis, who already underwent robotic total abdominal colectomy and end ileostomy four months prior, presented for his second stage procedure, consisting of a robot-assisted completion proctectomy with creation of ileal J-pouch anal anastomosis. The case commenced with taking down the prior ileostomy, creating the stapled J-pouch, and securing the anvil of the circular stapler within the pouch. This was performed extra-corporeally by pulling the bowel through the ileostomy site. The pouch was then re-introduced into the abdomen, and the robot was docked. The proctectomy was then performed, and the dissection was carried down to the pelvic floor. The rectum was transected using the robotic stapler, and the specimen was placed in the left lower quadrant, out of the surgeon's field of view. The ileal pouch-anal anastomosis was then performed and a leak test was done. Hemostasis was ensured, the ports were extracted, and fascia and skin suture-closed. The operation was relatively uneventful. At the conclusion of the case and per our usual protocol, a surgeon signature was required on the pathology sheet. At that moment, the team realized that the specimen had not been retrieved from the abdominal cavity. The skin had been closed, but the patient was still intubated at that time. The skin was re-prepped, draped, and the left lower quadrant port site reopened to remove the surgical specimen. The patient had an uncomplicated postoperative recovery and was discharged home on post-operative day 5.
Discussion
The Joint Commission report many risk factors for retained surgical objects, most notably human factors, surgeon and staff competence, communication, and non-compliance with policies. 2 Other relevant risk factors described in the literature include emergency surgical procedure, elevated body mass index, estimated blood loss greater than 500 mL, and involvement of two or more surgical teams.1,6 In the case described above, human factor, as well as lack of communication between the members of the surgical team regarding the extraction of the surgical specimen, played a role in the unintentional retained specimen. In addition to human factors, the robotic technique may be associated with a higher risk of sentinel events as the surgical team is working far away from the sterile operative field—in our case both the attending and chief resident were at the robotic consoles, and a junior resident at bedside. Moreover, the range of view is usually limited to 1 quadrant or 1 space at a time (for example the pelvis), compared to open surgery which allows a much wider range of the entire abdominal cavity. It is not infrequent that the surgeon would try to improve exposure by clearing the working space and moving organs and bowel out of the range of view. In the case described above, the specimen was removed out of the pelvis and out of the surgeon's field of vision, to allow a good pelvic exposure. This step would never be needed in open surgery as the specimen could be immediately extracted. In laparoscopic or robotic surgery, the specimen is frequently left inside the abdominal cavity and then extracted at a later time, often immediately before closure. This played a major role leading to the retained specimen. Despite the number of pitfalls that occurred, a multilayer control system represented by the institutional Surgical Safety Checklist (to ensure a post-procedure debrief about specimens), allowed for a timely identification and resolution of the error, with minimal increase in operative time and no increased morbidity from the rescue procedure.
Suggested solutions
Several interventions could be implemented in different phases of the operation to avoid a retained surgical specimen. The “time-out” before incision is made, with the presence of the attending surgeon in the room, using either institution-specific checklists, or the WHO Surgical Safety Checklist, 7 has been shown to improve patient safety and decrease health costs. 8 Discussing the number and nature of expected specimens with the entire team, including circulating nurses, scrub techs, and the anesthesia team at the beginning of the case can help prime the all members of the team to expect a specimen and speak up when is not received before wound closure.
During the procedure, distractions, specifically phone calls, pagers, loud music, conversations should be minimized. This allows surgeons and staff to have their full attention aimed at the different steps of the operation. In regards to specimen extraction, with the widespread adoption of laparoscopic and robotic surgery, the immediate removal of the specimen when detached from all surrounding structures is often not feasible, due to the frequent need for extending one of the incisions, resulting in loss of pneumoperitoneum which is necessary to the completion of the operation. The specimen is therefore often extracted at the end of the case before closure, which leaves room for errors and possible retention of the specimen. The use of an endo-catch bag with a long string brought out and anchored to one of the ports, can help bring attention to the specimen during port removal. Similarly, a long suture can be placed through the specimen and brough out through one of the ports. Another communication tool can include the use of a dry erase board note as reminder for the team. A note can be made when the specimen is detached but still in the abdominal cavity, the same way as a note is made when a laparotomy sponge or towel is placed in the abdomen during open surgery, as a reminder to remove it before the end of the case. Another informal technique has been suggested whereby the surgeon clamps a surgical instrument to their gown as another physical reminder to remove a towel, sponge, (or in this case a specimen) to avoid an URFO.
Furthermore, an end-of-procedure “sign out/debriefing” with checklists that include surgical specimens at the same time as the instrument count, would provide an additional safety layer to prevent this sentinel event. 9 In this setting, intraoperative RFID tagging (radio frequency identification) of the specimen and use of an RFID reader to confirm collection and retrieval of the specimen, is another solution that might be implemented in the future. Of note, debriefing and RFID would need to occur before the incisions are closed to prevent the URFO. Finally, when performing lengthy robotic surgeries, safety can be improved with the use of a “second time-out” with an additional checklist run at three to 4 h after the start of the procedure. 10
Conclusion
Despite retained surgical specimens being a rare occurrence, associated harm and the need for an additional rescue procedure warrants implementation of multilayer safety checklists, improved communication and surgical team education/training. Our case shows how implementation of end-of-operation checklists including surgical specimen during the debrief, prevented a later discovery of the retained surgical specimen and allowed for a timely identification and resolution of the error, without adding undue harm and morbidity to the initially planned procedure. The addition of simple straightforward maneuvers and tactics can prevent even a rare sentinel event from occurring.
Footnotes
Acknowledgments
We would like to thank the participating patient, the nursing and surgical staff for patient care, and the reviewers for insightful comments. All Authors equally contributed to the writing and of the manuscript and approved the final draft. There was no financial support for the research, authorship and/or publication of this article.
Declaration of conflicting interests
Dr Atallah, Dr Safar, Dr Simioni and Dr Fransman have no relevant interest to disclose. Dr Haut reports research funding from The Patient-Centered Outcomes Research Institute (PCORI), the Agency for Healthcare Research and Quality (AHRQ), the NIH/NHLBI, the DOD/Army Medical Research Acquisition Activity, and the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). Dr Haut receives royalties from Lippincott, Williams, Wilkins for a book—“Avoiding Common ICU Errors.” Dr Haut was a paid speaker for the Vizient Hospital Improvement Innovation Network (HIIN) VTE Prevention Acceleration Network. None of the remaining Authors declared potential conflict of interest with respect to the research, authorship and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship and/or publication of this article.
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