Surgical Never Event - Retained Needle

An unintended retained surgical item (RSI) is an item unintentionally left inside a patient (e.g., sponges, towels, device components, guidewires, needles, and instruments).¹ Among surgical never events, RSI is the most frequently reported to the Joint Commission.² According to the Joint Commission, the most common causes of RSIs include the absence of policies and procedures, failure to comply with existing policies and procedures, and inadequate or incomplete staff education.³ 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. The following case illustrates an example of how and why RSIs occur.

Allegation

Closing the surgery with an incorrect needle count was negligent.

Case File

Following surgery, while the surgeon was in the process of closing, the needle count was completed. The surgical tech reported that they were missing one needle. While other members of the surgical team searched locations where the needle could have become lost (e.g., the sterile field, floor, drapes, trash can, etc.), the surgeon finished closing, confident that he had not lost a needle inside the patient. The surgeon then ordered a bedside x-ray to determine whether the needle was still inside of the patient. Both the surgeon and radiologist were unable to locate the needle on the images. The surgeon did not mention the incorrect needle count or the efforts to locate the needle in the operative report, nor did he mention the incorrect count to the patient. About a year later, a CT scan revealed a 16 mm needle at the location of the surgery.

Discussion

Patients being closed prior to the count being completed, or when a count is incorrect due to the assumption that the missing item is outside of the patient, are recurring issues in NORCAL RSI closed claims. This case was complicated by both issues. The surgeon would later explain that the needle counts were frequently incorrect at this hospital, and the missing needles were usually found in the trash or in the sterile field, hidden in the drapes. This surgeon’s experience was not unique. Research indicates that incorrect count false alarms occur frequently.⁴ Unfortunately, false alarms can result in the members of the surgical team attaching less importance than appropriate to incorrect counts.

Experts believed that the standard of care required the surgeon to obtain an x-ray and wait for the radiologist’s interpretation before concluding the operation. The fact that no needle was visible on the film did not absolve the surgeon from the requirement to comply with the standard of care. Some experts questioned whether the surgeon had adequately advised the x-ray tech of what he was trying to find and where it might be located. Furthermore, the mere fact that the needle was left inside the patient, that the surgical tech and scrub nurse followed their protocols, and that the surgeon failed to document either the incorrect count or efforts undertaken to locate it further complicated the surgeon’s defense.

Risk Reduction Strategies

Consider the following strategies:^1,4,5

Surgeon

• Stop the procedure when an incorrect count is announced and follow incorrect-count protocols.
• Do not let assumptions of a counting mistake affect efforts to locate the missing item.
• Do not get so far along in the closing process that it affects your judgment about conducting an adequate search inside the patient.
• Pay attention to the counting process.
• Support team members in their efforts to comply with counting policies.
  • If you treat count policies and protocols as low value, others on the surgical team will be less likely to exert the time and effort necessary to fulfill their duties.
• Adequately describe all locations of the procedure and the missing object to the tech doing a bedside radiograph following an incorrect count.
• Document efforts to find a missing surgical item. If the item cannot be found, the documentation is evidence that actions were consistent with policies and procedures, the standard of care, and clinical guidelines. A record of an incorrect count may also alert subsequent clinicians to a retained item that is the cause of a patient’s symptoms.

Staff

• Use a white board during surgery to show counts. It can improve team awareness and foster shared responsibility.
• Clearly communicate the result of the counts to the surgeon.
• At the end of the procedure ask questions or raise concerns related to any risk of retained items.

Administrators

• Describe the protocol to follow in case of a count discrepancy.
• Utilize an incorrect final count report form.
• Require documentation of the names and positions of everyone on the team and who performs the counts.
• Require documentation of the results of counts and actions taken when count discrepancies occur.
• Include space on counting forms to describe efforts to recover the missing item and recommendations for the next level of care.

Resources

The Joint Commission. Sentinel Event Alert: Preventing Unintended Retained Foreign Objects. (2013)

World Health Organization (WHO). WHO Guidelines for Safe Surgery. “Objective 7: The Team Will Prevent Inadvertent Retention of Instruments and Sponges in Surgical Wounds.” (2009)

American College of Surgeons. “Revised Statement on the Prevention of Unintentionally Retained Surgical Items After Surgery.” (2016)

NoThing Left Behind: A National Surgical Patient Safety Project to Prevent Retained Surgical Items

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. Healthcare Risk Management Review. “What’s Left Behind .” (site not accessible at the time of publication)

4. Stanislaw P.A. Stawicki, et al. “Retained Surgical Items: A Problem Yet To Be Solved.” Journal of the American College of Surgeons. 2013 Jan;216(1):15-22. DOI: 10.1016/j.jamcollsurg.2012.08.026

5. NoThing Left Behind. Prevention of Retained Surgical Items. “All Providers.”