The Retained Surgical Specimen,an Unappreciated Retained Foreign Object

Background

Over the past decade, there has been a concerted effort to reduce errors in healthcare, especially in surgery.^1,2 A retained foreign object (RFO) has been a constant, albeit rare, medical error with potential significant harm to the patient. ³ RFOs are considered preventable errors, and regulatory agencies have identified an RFO as a “never event,” ⁴ thus indicating an error in healthcare that should never happen. When such an event occurs, many states mandate that the event be reported to the local Agency for Healthcare Administration (AHCA) and the State's Medical Licensing Board prompting an investigation and potential disciplinary action against the hospital and surgeon. Put differently, it is expected that policies and procedures be in place to prevent an RFO from ever occurring.

Although nearly all hospitals have policies and procedures related to avoidance of RFOs, ⁵ there remains an as yet poorly characterized type of retained surgical object that warrants attention, the retained surgical specimen (RSS). A case study of an RSS is presented here, an explanation of the change in practice and paradigm shift that has created this new potential error, and a proposed solution. With this, it is hoped that all surgeons gain increased awareness of this error and embed in their hospital's existing policies and procedures a section that specifically addresses the RSS.

The Case

A patient underwent a laparoscopic antrectomy and gastrojejunostomy for the management of gastric antral vascular ectasia. Once the resection of the antrum had been completed, the specimen was tucked into the left upper quadrant while the gastrojejunostomy was completed. Once the gastrojejunostomy had been completed, an endoscopy was performed to visualize the anastomosis and test for leakage. With this, the team was quite pleased with the result and preparation was made to complete the operation. Sponge, needle, and instrument counts were completed; and once correct counts had been confirmed, trocars were removed, the wounds were closed, and the patient was awakened and transferred to the recovery room. The operating surgeon had performed the endoscopy and remained in the operating room throughout closure, but did not scrub back in to the case. The resident team commenced effecting the completion of the case while the attending surgeon completed paperwork and contacted the family. While dictating the operative report, the surgeon realized that the specimen had not been removed. The patient's family was immediately made aware, and the patient was instantaneously returned to the operating room from the recovery room. The laparoscope was reinserted, and the gastric antrum (RSS) was removed. The patient recovered uneventfully and was discharged from the hospital on postoperative day number 3.

This was deemed an RFO and reported to AHCA and the State Medical Licensing Board (SMLB). The State Medical Licensing Board found this to not fit the typical definition of an RFO and, therefore, managed this event as a deviation from the standard of care. Through the process of the SMLB investigating this event, it was identified that an RSS had never been presented before to this State's Medical Licensing Board, thus prompting the need to define this potential error as we are doing in this case report. Since the occurrence of this event and subsequent local and regional discussions about RSS, several other cases of an RSS have been informally reported to this author by various surgeons.

The Paradigm Shift

When performing an operation where a specimen is to be removed, one would typically remove the surgical specimen at the moment when the body part was disconnected from the body. There would be no reason to leave the specimen in the body cavity, and, in most cases, removing the specimen facilitates visualization of the operative field.

Laparoscopy has changed the practice of immediate removal of the resected body part, because removal of the specimen often requires enlarging a trocar site incision. If there is still a considerable or particularly complex portion of the operation to be laparoscopically completed (e.g., an anastomosis), then enlarging a trocar incision often results in leakage of air around the trocar, thereby compromising the integrity of the pneumoperitoneum and the laparoscopic operative field. In such a situation, one is left with a compromised view and difficult exposure during a critical portion of the operation, thereby exposing the patient to potential harm. In the case just outlined, had the specimen been removed when the resection of the antrum was complete, then visualization would have been compromised during the gastrojejunostomy, the most technically demanding part of the operation. Therefore, during laparoscopic surgery, the specimen is often positioned within the body cavity but away from the operative site and out of view of the surgical team until the entire procedure is complete. It may be hours later before the specimen is to be removed, during which time the surgical team is focused on the remainder of the operation. Without an explicit process to identify a specimen that has been “tucked,” it is at risk for being left behind.

The paradigm shift is leaving a specimen within the body until the end of a procedure, a sequence that is often critical when performing laparoscopic procedures where some sort of reconstruction is needed after the resection is complete. As more and more new laparoscopic procedures are introduced, each represents a potential new standard of care that should be defined and a process for specimen management effected.

The Solution

The surgical specimen should be included as a specifically identified and counted item for every operation. At the commencement of the procedure, preferably at the time of the time out (Table 1), it should be acknowledged to the team as to whether a surgical specimen is anticipated or not. If a specimen is anticipated, then it should be written on the count board along with needles, sponges, instruments, and any other items considered part of the sterile operative field.

At the time the body part is resected and becomes a surgical specimen, there should be a pause to identify the specimen and the plan for its management. If not being immediately removed, then it should be placed in a specimen retrieval bag with a long suture attached, and the bag tail brought out through one of the trocar incisions (preferably alongside the trocar rather than within the channel) and tagged with an instrument. This will provide a physical indicator that there is still a specimen in the body and prevent closure of that incision until it is removed.

At the completion of the operation, before incisions are closed, the surgical specimen should be included in the end-of-case count. The surgeon and team should specifically verbalize whether all specimens have been removed, and this should be documented in the operating room record by the surgical team.

The actions just outlined should be incorporated into any/all patient safety processes already in place in the operating room such as the WHO Surgical Safety Checklist. ⁶

Conclusion

An RSS is a new type of retained surgical object that is identical to any other RFO in its potential harm to a patient. As with RFOs, this is a preventable error. The surgical specimen should be fully incorporated into an institutions' RFO policies and procedures with explicit identification of whether a surgical specimen is going to be a part of the operation. The surgical specimen should then be included in all counts and processes currently adopted to prevent RFOs. If the institution uses a Surgical Safety Checklist, then this process should be incorporated into this checklist. Surgeon and administration awareness of this potential new problem is critical to the elimination of an RSS.