An unintended retained surgical item (RSI) is an item unintentionally left inside a patient (e.g., sponges, towels, device components, guide wires, needles, and instruments).1 Among never events, RSI is the most frequently reported to the Joint Commission.2 Surgical sponges are the most commonly reported retained item.3 According to the Joint Commission, the most common causes of RSIs include the absence of policies and procedures, and inadequate or incomplete staff education, and failure to comply with existing policies and procedures,4 as we see in this case.
NORCAL Group (now part of ProAssurance) closed claims involving an RSI often involve reporting of correct counts or completed surgeries, despite knowledge of an incorrect count. In this case, unresolved production pressure on overworked operating room staff led to inconsistent compliance with hospital sponge count policy.
Allegation
The patient sued all members of the surgical team and the hospital alleging that failure to comply with the hospital sponge count policy and failure to report noncompliance was negligent.
Case File
The surgeon had noticed operating room staff members were overworked, and they had complained directly to him about the situation on various occasions. As a result, they were not consistently complying with the hospital sponge count policy. The surgeon was aware of the noncompliance and was concerned that it was going to result in an RSI. Instead of bringing up the issue with the OR director, he relied on the sponge count he always kept in his head during surgeries. Unfortunately, in this case, the surgeon lost count when a surgery became unexpectedly complicated. He forgot he placed a lap pad in the patient’s abdomen. Because staff members were not maintaining an accurate sponge count, the lap pad was not noticed and sponge counts were documented as correct. After surgery, the patient experienced abdominal pain inconsistent with the healing process. Five days after the surgery, the lap pad was discovered and removed.
Discussion
There is a 10 to 15 percent chance that a sponge count will be incorrect.1 A vast majority of retained sponge cases involve documented correct counts, which means that in a certain number of cases — like this one — staff lost track or knew the count was off but failed to announce it.1 This failure might reflect a culture in which staff members do not feel empowered to report and pursue a potential RSI.4 A fragile system cannot sustain much pressure. This surgeon’s solution of taking on the responsibility for correct counts was not sustainable.
Because surgeons are responsible for their patients’ safety during surgery, this surgeon should have engaged administrators to relieve the production pressure causing the patient safety risk. Surgeons should also be invested in ensuring staff compliance with patient safety protocols as a risk management strategy. Although the counting process is primarily under the control of staff, surgeons are usually named as defendants in RSI lawsuits. This case took place in a jurisdiction in which the captain of the ship doctrine made the surgeon vicariously liable for staff negligence associated with the sponge count.
Risk Reduction Strategies
Consider the following strategies:5,6,7
Surgeons
- Lead team briefings and debriefings to allow surgical team members to raise concerns about the potential for an RSI.
- As part of a team briefing or time out, remind the team if the patient or procedure presents an increased risk for an RSI.
- Question and (if necessary) admonish staff members who are not counting surgical items pursuant to protocols.
- If staff continues to be noncompliant after requests, raise the issue with administrators.
- If production pressure is causing noncompliance, share this observation with administrators.
- Conduct a debriefing to confirm with staff that the counts are correct.
- Document the exchange in the operative note.
- Document the exchange in the operative note.
Staff
- When production pressure is affecting patient safety, approach managers or administrators to request changes in the situation.
- When a count should have been performed but was not, notify the surgeon and operating room supervisor, recommend a radiograph at the completion of the procedure, document why the count was not undertaken, and document the results of the radiograph.
Administrators
- Encourage and facilitate staff and surgeon reporting of staffing problems that increase the risk of RSI.
- Emphasize sharing RSI knowledge and information. Because the events are rare, it is important to use them for teaching purposes whenever possible to keep their potential occurrence in mind.
- Reinforce policies and discuss failures and successes through huddles, in-services, newsletters, and meetings.
- Communicate system improvements back to surgical teams that have reported patient safety issues.
This content originally appeared in Claims Rx, our claims-based learning publication available in the searchable Claims Rx Directory. Many releases are available for download and eligible insureds will find instructions for obtaining CME credit for select releases.
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References
1. The Joint Commission. Patient Safety Advisory Group. “Preventing Unintended Retained Foreign Objects.” Sentinel Event Alert, Issue 51, October 17, 2013.
2. Victoria M. Steelman, et al. “Retained Surgical Sponges: A Descriptive Study of 319 Occurrences and Contributing Factors from 2012 to 2017.” Patient Safety in Surgery. 12, 20 (2018). DOI: 10.1186/s13037-018-0166-0
3. The Joint Commission. “Sentinel Event Data: General Information & 2022 Q1, Q2 Update.”
4. Healthcare Risk Management Review. “What’s Left Behind .” (site not accessible at the time of publication)
5. Agency for Healthcare Research and Quality. “Improving Communication and Teamwork in the Surgical Environment Module: Facilitator Notes.” Page last reviewed May 2017.
6. World Health Organization. “Objective 7: The Team Will Prevent Inadvertent Retention of Instruments and Sponges in Surgical Wounds.” WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives.
7. NoThing Left Behind. Prevention of Retained Surgical Items. “All Providers.”