Abstract
Despite being recognized as a preventable serious adverse event more than a century ago, Unintentionally Retained Foreign Objects (URFOs) continue to occur. They, in fact, remain the second most common Sentinel Event (SE) reported to The Joint Commission (TJC)
Introduction and background
In 1882, the first unintentionally retained foreign object (URFO), (a piece of sponge left in the abdomen) was reported, causing peritonitis and subsequently death. 1 Despite being recognized as a preventable event more than a century ago, URFOs continue to occur, and they remain the second most common Sentinel Event (SE) reported to The Joint Commission.2,3 Cima and Newman, in a very thorough historical review, concluded that despite efforts to understand and reduce the occurrence of retained items, available data suggests that the problem remains unresolved. 4
Because URFOs are preventable Sentinel Events (SE), it is very surprising that they continue to occur. Given a recent flurry of URFOs in our institution, we examined their root causes via multiple root cause analyses (RCA) and compared their root causes to the root causes of URFOs cited in the literature. We were eager to understand whether there was anything unusual in our URFOs and we could create appropriate action plans to eliminate them.
Cases
A large private Hospital located in the South of Brazil (Porto Alegre, Rio Grande do Sul) experienced four cases of URFOs from March 9, 2021, to March 4, 2022, after many years. The Quality and Patient Safety team performed detailed RCAs for each case that outlined contributing factors and listed action plans. A team from Johns Hopkins Medicine International independently reviewed each RCA to familiarize themselves with the cases in order to be of assistance in developing an optimal and realistic plan. Next, the two teams together discussed each case and agreed on the following points.
All four cases involved women (aged 34, 41, 57, and 68). Three cases occurred in the Operating Room (OR), and one case occurred in Labor & Delivery. All four cases involved the abdomen. The URFO was a sponge in two cases, a retractor wrapped in a surgical pad in one case, and a surgical specimen in one case. The URFO was discovered outside the OR in all cases (in two cases the patient was in the Recovery Room, and in two cases, the patient was in the ward). The URFO was discovered because of persistent abdominal pain in two cases, a missing surgical specimen (1 case), and because of a delayed report of count discrepancy (1 case). (Table 1)
Demographics and general information.
Our review found several contributing factors. There was no count before wound closing in three cases. In two of these cases, the operating team felt “confident” enough to override the written policy about sponge counting. In one case, during the procedure, there was a change of the surgical technician without an associated handover. In another case, there were two surgical teams involved. In the fourth case characterized by major intraoperative bleeding, the count was reported as correct. Inexperienced nursing staff linked to a dramatic 40% turnover during the pandemic was an important contributing factor. Interpersonal communication was found to be less than optimal in all cases. Upon review, the policy regarding the counting of sponges/instruments and the disposal of surgical specimens was found unclear.
The harm due to the URFOs consisted of a second procedure to remove the URFO and a prolonged stay.
The team recommended several action plans to address the above-mentioned contributing factors. (Table 2).
Contributing factors and action plans.
Earliest identified root causes of URFOS
In 1884, Dr Wilson discussed the first series of retained foreign bodies and offered a list of recommendations to prevent their occurrence. He stressed the importance of collaboration within a small team, careful counting sponges and instruments used in the operation, need to maintain a record of the count, and need to perform a tally at the closure of the operation. He stressed parsimony in the use of assistants, instruments, and sponges. He also emphasized the accountability of the surgeon, who should do “his own sponging and should always have a fixed number in use, should never allow a sponge to be divided during an operation and should use as few as possible,” certifying the count at the end. 5
In 1901, Schachner discussing a series of 155 URFOs events, recognized that distraction and disruption of a routine (such as when the surgeon is facing an intraoperative disaster due to overwhelming hemorrhage or is forced to make significant changes in the intraoperative plan) represent important risk factors. 6 Schachner recommended that: a) critically important counting responsibility be clearly assigned to two nurses “before and at the close of the operation,” b) aids be used in localizing the pads or the instruments inside the abdominal cavity “Tapes or threads attached to pads and instruments” c) use of small sponges be discouraged, and d) parsimony be used in the utensils. He also highlighted the critical role of watchfulness. “After all, we are forced to the conclusion that the real factor in the avoidance of this accident is the recognition of system, simplicity, and watchfulness to the most exacting degree. At the bottom of most of these accidents, we find diverted attention, a defective system, or a dangerous degree of complexity”.
URFOs’ root causes identified by TJC
Nowadays, besides sponges, URFOs include, in declining order: instruments, catheters, drains, needles, blades, packing, implants, specimens, and other items that add more complexity to the surgical procedure. Lastly, URFOs may occur during orthopedic and minimally invasive surgery, as in our first case. 3
The majority of the 319 events involving a retained sponge reported to The Joint Commission occurred in the OR (64.1%), Labor and Delivery (L&D) (32.7%), Interventional Radiology (IR), and Cardiac Catheterization (CC) (3.3%). Again, the authors confirmed that by far the most common locations for a retained sponge were the abdomen (50.2%) and vagina (23.9%), followed by the chest (8.5%), breast (4.6%), throat (1.9%), and intracranial compartment (0.7%). Of interest, the recognition of a URFO usually occurred more commonly after discharge (49.4%), than in OR (16.5%), or the immediate post-op period (34.2%). While the most common harm was a delayed stay (63.9%), severe temporary harm (14.7%), and death (0.3%) also occurred. Contributing factors included human factors at 29.2%; (credentialing 30%, orientation 22.5%, competency 11.7%), leadership at 27.6%, (non-compliance 52%, poor policy 32.7%, culture 7%), and communication at 23.1%; (with physician 46.3%, staff 27.8%). Healthcare Failure Mode and Effects Analysis (HFMEA) documented 57 different causes grouped as distraction in 21%, multitasking in 18%, and Emergency in 18%. The most unexpected and stunning discovery, however, was that in 80.6% of events, the count was reported as correct
URFOs’ root causes: Our results
Our review confirmed that, by and large, the characteristics of our cases matched those reported by the Joint Commission.
All our four cases involved women (aged 34, 41, 57, and 68). As in the report of TJC, the operating room (OR) was the most common place of occurrence (3 cases), followed by Labor & Delivery (one case). All four cases involved the abdomen. As in the report of TJC, a sponge was the most common URFO. The URFO was a sponge in two cases, a retractor wrapped in a pad in one case, and a surgical specimen in one case. Differently from the report by TJC where half of the URFOs were discovered after discharge, in our series all the URFOs were discovered before discharge from the hospital. URFO was discovered outside the OR in all four cases. Two cases were recognized in the Recovery Room because of missing surgical specimen (case 3), and late report of count discrepancy (case 1). Two cases were recognized in the ward because of persistent abdominal pain (cases 2 & 4). (Table 1)
Our review found several contributing factors. Firstly, the critically important counting responsibility was not clearly assigned and aggravated by the nursing staff's inexperience. While in the TJC report, the sponge count was performed in 77.4% (n = 247 of 319) of cases, in our series, the count was only performed in 25% of the cases (case 2 with major intraoperative bleeding), yet the count was incorrectly reported as correct. In the TJC report when the count was performed, it was reported as being correct 80.6% (n = 199 of 247) of the time.
In two of our cases, the operating team felt “confident” enough to override the written policy about sponge counting. In these two cases, the failure to assign responsibility for conducting the count was both an individual provider failure and a teamwork failure.
In case 3, there were two surgical teams (gynecology and urology) involved, and the policy regarding handling of surgical specimen was not clear. In case 4, during the procedure, there was a shift of the surgical technician without handoff. Team communication was found to be less than optimal in all cases.
In all cases, a contributing factor was the lack of clear assignment of the critically important counting responsibility probably linked to the stress and inexperience of the nursing staff, due to a dramatic 40% turnover in this department during the pandemic. Upon review, the policy itself regarding the counting/disposal of surgical specimens was found not to be clear.
Recommendations made by TJC
The Joint Commission recommends the following to prevent URFOs:
To control Human Factors, TJC recommends to:
Optimize staff education by providing team training, reminding staff about the risks of URFOs recommending risk-reduction strategies, and assessing the competency of personnel. Address disruptive behavior. Minimize distractions and interruptions. Account for objects inserted in the wound. Methodically explore the surgical site prior to closure. Verify integrity of objects upon removal. Prioritize a culture of safety. Conduct a proactive risk assessment and implement policies and procedures based on the risk assessment. Celebrate successes, but also encourage reporting of near misses. Verbally acknowledging the removal of objects. Discussing removal of objects during standardized debriefing after procedures. Discussing the need for packing removal during handoff. Documenting verification of removal and integrity of objects.
To control factors associated with Leadership, TJC recommends that healthcare institutions do the following:
To control Communication factors, TJC recommendations include
3
:
Our action plans (Table 2)
To deal with our surge of URFOs we chose to implement a multipronged approach that includes the following:
To control leadership factors
Standardization and clarification of the sponge counting protocol prior to wound closure.
Standardization of procedure for shift change or double surgical team involvement.
Assignment of counting responsibility to two nurses and addition of the name of the nurse in charge to the Safe Surgery checklist.
To control human factors
Education of the new nurses about the OR procedures with a recurrent survey of the staff to make sure they are aware of the policies.
Engagement and education of the independent practitioners admitting their patients to the hospital.
Monitoring of the compliance to the counting prior to wound closure both by electronic auditing and by in-person secret shopper from Quality.
Shared accountability of the above Key Performance Indicator (KPI) by making everyone (nurses, physicians, and quality team) the owner of safety and by creating a triumvirate consisting of Chief OR Physician, Chief OR Nurse, and Chief of Quality reporting directly to the CMO, CNO, and CEO.
Triggering performance of expedited RCA and implementation of corrective actions if failure to comply occurs.
Root Causes varied slightly between cases. A stricter correlation between patient-specific contributing factors and improvement plans shows how each factor was addressed (Table 3).
Correlation between patient-specific root causes and corresponding action plans.
Discussion
Despite the many interventions to increase safety in the OR, we seem to be failing to reduce/eliminate this type of sentinel event. 7 Prevention is critical to enhance the safety we offer to our patients and to address the significant economic consequences of a URFO linked to increased morbidity, and the usually associated prolonged stay. It is calculated that in the US, a URFO event generates additional healthcare costs averaging $70,767/case. This does not include liability settlements related to URFO, estimated at $150,000 per patient. 8 In Brazil, the costs of adverse events in hospitals are still being evaluated, but it is an issue that is growing between administrators and health insurance.
We believe that the spike in the occurrence of four URFOs in a 12-month period after many years of having no URFOs, at our own institution, is one frightening effect of the pandemic. The RCA process revealed that a major contributing factor was the absence of formal counting of sponges and instruments in three cases and an incorrect count in the fourth case. This happened because of a combination of the nurses’ inexperience and overconfidence in the surgical team. As mentioned earlier, a very high proportion of the nurses was new, young, and inexperienced due to a dramatic 40% turnover caused by COVID-19.
We believe that when searching for the root causes of SEs, we cannot ignore these and other mitigating factors such as long working hours, understaffing, inability to spend sufficient time with the patient, and increased workload to meet operational targets. We, therefore, concur with O’Neill that health care institutions need to re-assess their incentives and eliminate the perverse ones. 9
It is also undeniable that the development and maintenance of a safety culture also demand the reaffirmation of personal accountability: a safe and just culture recognizes that the failure to follow clear rules in the face of well-functioning systems is a violation. 10 As it was stressed in his original report, Wilson reminded us of the primary accountability of the surgeon, who should do “his own sponging and should always have a fixed number in use, should never allow a sponge to be divided during an operation and should use as few as possible,” certifying the count at the end. 5 This personal responsibility was declined in two of our cases in which a “confident” surgeon chose to skip the count.
The presence in the OR of a hierarchical, mixed-gender clinical team prone to conflict ranging from constructive differences of opinion to discord and distraction is an underlying threat that can ultimately jeopardize patient safety.
11
The hierarchical nature of the OR team, discouraging the lower-ranked individual from speaking up explain why the team did not object to skipping the count when the surgeon was “confident” that counting could be skipped. Furthermore, a similar deference to authority is likely to operate even more during stressful moments, when a complication has occurred. This happened in our case 2, characterized by major intraoperative bleeding, it is easy to imagine in these circumstances how reporting a missing sponge to the distressed surgeon could be difficult. This type of behavior could possibly explain why in a recent study; the count was reported as correct in 80.6% of URFOs events
A study from Australia confirmed the power relationships between members of the surgical team and the complexity of striking a balance between organizational policy and professional judgment. 12
It is expected that physicians, especially surgeons, would resist the idea of receiving coaching due to social and peer expectations related to identity. However, coaching is proven helpful by providing a safe space that allows physicians to practice vulnerability without the pressures of professional norms. 13
Another factor creating an environment conducive to human errors is the difficulty of caregivers to engage colleagues or patients with empathy, given the fact that the system frequently creates expectations that play a role in impeding individual efforts to be aligned with values. Long working hours, understaffing, inability to spend sufficient time with the patient, and increased workload to meet operational targets negatively influence individual behavior. This multitude of stressors has caused a burnout epidemic among healthcare providers (HCPs), only aggravated by the pandemic. 14
If we want our healthcare providers to be empathetic and compassionate, we should not only focus on the individual professional but also include healthcare institutions and systems. It would be prudent to reward professionals for focusing on the person. Processing patients quickly might meet operational targets, but it is the antithesis of empathy and compassion. 15 Furthermore, in the OR, processing patients quickly to meet operational targets is likely to interfere with the needed pause to carefully count specimens, sponges and instruments, and other foreign bodies used during the surgery.
We also believe that one powerful step to mitigate the problem is to mandate the sponge/instrument/specimen count not at the end of the surgery, but before wound closure. We respectfully believe that this should become a standard also adopted by TJC.
Conclusions
URFOs have been described and tackled for more than a century. Despite the efforts to understand and reduce the occurrence of retained items, available data suggests that the problem remains unresolved. 4 They remain, after falls, the most common sentinel event voluntarily reported to The Joint Commission (TJC).
A combination of factors explains the persistent occurrence of URFOs. Poor communication and not enough individual and collective responsibility are leading the list. Improving the safety culture in the OR will require strengthening the OR social fabric, enabling staff to speak up, mapping skills, deferring to expertise, and exercising more empathy and compassion for others coupled with performing regular drills to strengthen the needed skills of the staff.
Leadership should revisit operational targets that negatively influence individual behavior. Long working hours, understaffing, inability to spend sufficient time with the patient, and increased workload are important systemic contributing factors dramatically augmented during the pandemic that beg to be addressed.
Limitations
As with all uncommon events, it is difficult to “prove” that the intervention reduced or eliminated the adverse event of interest.
Footnotes
Declaration of conflicting interests
The author(s) declared no potential conflicts 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.
