Preventing Surgical Never Events - Case Studies and Best Practices

Never event was coined in 2001 to describe medical errors that should never happen. The National Quality Forum (NQF) now lists 29 types of never events¹ (also referred to as “serious reportable events” by NQF and “sentinel events” by The Joint Commission). The linked case studies address examples of surgical adverse incidents that would be considered never events: retained surgical items, surgical fires, and wrong-site surgery.

According to the Agency for Healthcare Research and Quality (AHRQ) Patient Safety Network, “although individual events are uncommon, on a population basis, many patients still experience these serious errors.” They go on to cite a 2013 study that estimated “more than 4000 surgical never events occur yearly in the United States.”¹

Despite a concerted effort in the healthcare community to completely eradicate surgical never events, they have remained a persistent problem. Part of the reason they persist may have something to do with their low frequency, which may cause surgical team members to relax vigilance. Analysis of closed claims from NORCAL Group (now part of ProAssurance) reveals that many of these surgical events occurred because members of the surgical team were not complying with the safety measures in place to prevent them. For example: time outs did not occur; surgical sponge count or fire safety protocols were not followed; checklists were not used; or checklist tasks were completed with incorrect information. In some cases, obviously incorrect statements were made during time outs and other perioperative briefings, but either no one on the team noticed or no one felt compelled to speak up. In this way and others, failure to communicate during the perioperative period may contribute to surgical never events.

Research indicates that up to 80 percent of patient injuries in the surgical environment involve communication failures.² Communication can be defined narrowly or broadly as it applies to surgical patient safety and risk management. Defined narrowly, communication is limited to what is said between members of the surgical team during the perioperative period. But the concept of communication is much broader when considered from a risk management and patient safety perspective. In addition to what is said, communication encompasses what is perceived and understood. Surgeons communicate their commitment to patient welfare through leading by example when it comes to patient safety protocols such as surgical time outs and participating in surgical item counts and surgical fire prevention.

Communication includes what is entered into the medical record for the benefit of subsequent clinicians. It includes marking the surgical site, which communicates to anyone who sees it that “this is where the incision goes.” Importantly, healthcare entities communicate elements of their systems approach to patient safety and risk management through policies and protocols. Each aspect of communication requires attention to avoid a surgical never event.

In most NORCAL closed claims involving surgical never events, it was difficult to find experts who would testify that surgical team members involved in these events met the standard of care. Liability essentially attached to anyone involved when one of these events occurred. Consequently for the defendants, litigation often primarily focused on apportioning fault among the members of the surgical team. Despite the almost certain liability, however, surgical team members can minimize patient injury, mitigate damages, and reduce malpractice risk when one of these events occurs. This could include, for example, quickly responding to and adequately treating injuries, appropriately informing the patient of the event, and appropriately documenting it.

It is beyond the scope of this article to discuss all of the patient safety or risk management strategies available to prevent surgical never events. Therefore, after the communication-focused risk-reduction strategies below are links to various guidelines and resources that cover other components of a complete program to prevent these events.

Perioperative Communication Strategies

Different aspects of the surgical environment can interfere with communication between surgical team members; for example, background noise interferes with hearing and masks muffle speech, prohibit lip reading, and make visual cues harder to see.² Additionally, hierarchical barriers and production pressure can discourage discussion. Briefings, debriefings, and checklists can provide clarity and structure to communication.

The following discussion is primarily adapted from the Agency for Healthcare Research and Quality’s (AHRQ) “Improving Communication and Teamwork in the Surgical Environment Module: Facilitator Notes,” where you can find the complete slide presentation, facilitator guide, and material use guide.

Team Briefings and Time Outs

Successful pre-surgical team briefings and time outs can accomplish a variety of objectives that increase the clarity and effectiveness of communication by, for example, creating a sense of teamwork while establishing leadership, fostering collaboration, empowering staff to speak up if they perceive a problem, setting a shared vision for the surgery, and increasing situational awareness.^2,3 Surgeons should lead team briefings and time outs.² Effective briefings and time outs include several critical elements:²

• The team members introduce themselves.
• The surgeon shares the operative plan, including any changes to the plan that may have occurred and any anticipated difficulties.
• The anesthesiologist shares the anesthesia plan and any anticipated difficulties.
• The nurse and scrub technician share potential equipment or other concerns and confirm that the medications present are correct and labeled.
• The team verifies and affirms the patient’s identity, correct site, and correct procedure.
• The surgeon encourages anyone on the team to express concerns; for example, by asking, “Does anybody have any concerns? If you see something that concerns you during this case, please speak up.”

AHRQ’s short video provides an example of a basic team briefing.

Surgical Checklist

A surgical checklist can also improve communication. Checklists are used by the entire team and should require everyone to stop at designated points during the perioperative period during which time patient safety reviews are conducted. Different individuals usually conduct different portions of the checklist. Checklists are meant to be read, preferably from a poster on the wall, and should never be memorized, to avoid cognitive errors.²

Various organizations provide surgical safety checklists and implementation guidance, including:

• Association of periOperative Registered Nurses (AORN): “AORN Comprehensive Surgical Checklist”
• World Health Organization (WHO): “Surgical Safety Checklist”
• Canadian Patient Safety Institute: “Surgical Safety Checklist”

Debriefing

A debriefing is a discussion among team members after surgery. It should ideally occur after all the counts have been completed and before the patient is transferred to the recovery area. During the debriefing the team confirms critical information and discusses what went well and what could have gone better. Effective debriefings include verification of surgical item counts and discussion of incorrect counts, a review of the procedure performed to ensure that the procedure is documented consistently, read-back of the patient’s name on specimen labels, equipment issues encountered, near misses, or other problems identified (including concerns for the patient’s recovery and management) that should be passed on to the patient’s subsequent care team.²

AHRQ’s short video provides an example of a basic team debriefing.

Unintended Retained Surgical Items

An unintended retained surgical item (RSI) is an item unintentionally left inside a patient (e.g., sponges, towels, device components, guidewires, needles, and instruments).⁴ RSI is the sentinel event most frequently reported to the Joint Commission.⁵ Surgical sponges are the most commonly reported retained item.⁶ Certain factors appear to increase the risk of an RSI, including obesity, urgency, long surgery duration, unexpected events, multiple surgical procedures, and multiple surgical teams or multiple staff turnovers during the procedure.⁷ 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.⁷ NORCAL closed claims involving RSIs often involve reporting of correct counts or completed surgeries despite knowledge of an incorrect count. The following case studies illustrate how and why RSIs occur.

Surgical Never Event Case Studies: Unintended Retained Surgical Items

• Case Study: Retained Surgical Towel
• Case Study: Retained Cautery Tip
• Case Study: Retained Lap Pad
• Case Study: Retained Needle

Surgical Fires

Surgical fires occur in a wide variety of medical settings, from solo practices to large hospitals. Surgical fire prevention depends mostly on fire risk awareness and communication among the members of the surgical team. Any team member can prevent or contribute to a surgical fire because elements of the fire triangle — air (oxygen), fuel (prepping solution, drapes, patient skin), and ignition source (electrosurgical units) — are generally overseen by different members of the surgical team. Therefore, all team members should think about how their actions might complete the fire triangle and should communicate with other team members about fire risk status throughout the surgery. Consider how the various surgical team members could have prevented the fires in the following case studies.

Surgical Never Event Case Studies: Surgical Fires

• Case Study: Electrocautery Ignites Supplemental Oxygen
• Case Study: Electrocautery Ignites Alcohol-Based Surgical Prep
• Case Study: Electrocautery Ignites Aerosolized Anesthetic

Wrong-Site Surgery

Wrong-site surgery incidents are usually due to multiple processes that combine to cause the event as opposed to one specific error. As with the other never events discussed in this article and the linked case studies, a range of risk reduction strategies are necessary to prevent wrong-site surgery. Site marking has reduced wrong-site surgery, but has not eradicated it. The Joint Commission recommends, and studies indicate that, active communication and shared responsibility among surgical team members — including time outs; team briefings; and checklists to verify correct patient, site, and procedure — can further reduce the incidence of wrong-site surgery.⁸ In the following case, the site was marked correctly, but other protocols were overlooked. Consider what the surgical team members could have done to prevent the error.

Surgical Never Event Case Study: Wrong-Site Surgery

• Case Study: Surgery on the Wrong Knee

Preventing surgical never events depends on excellent communication among all members of the surgical team. Excellence is unlikely to occur without policies, protocols, communication strategies and tools, and training that allows members of the surgical team to practice effective communication among themselves. With patient safety organizations like the ECRI Institute, the Joint Commission, and the Pennsylvania Patient Safety Authority asserting that most surgical never events are preventable, it can be difficult to convince jurors that these events occurred in the absence of negligence.

The nature of surgery makes it unlikely that one person will be responsible for a patient’s injury due to a never event. In many closed claims, however, various members of the surgical team will argue that they are not responsible for the patient’s injury because the standard of care allowed them to remain passive. This attitude is problematic from both a patient safety and risk management perspective. In most claims arising from a surgical never event, everyone on the surgical team shares liability and, consequently, will share in the settlement or verdict amount paid to the patient. But, most importantly, everyone on the surgical team has a duty to protect patient safety. This effort may require the anesthesiologist to attempt to stop the surgeon from firing an electrocautery unit in an oxygen-rich environment; the surgeon to demand the scrub tech count a particular item; and the circulating nurse to attempt to stop the surgeon from starting surgery before the final time out occurs. Anyone on the surgical team can cause or prevent a never event.

References

1. Patient Safety Network. “Patient Safety Primer: Never Events.” Agency for Healthcare Research and Quality. September 7, 2019.

2. Agency for Healthcare Research and Quality. “Improving Communication and Teamwork in the Surgical Environment Module: Facilitator Notes.” Page last reviewed May 2017.

3. Carlos A. Pellegrini. “Time-Outs and Their Role in Improving Safety and Quality in Surgery.” Bulletin of the American College of Surgeons. June 1, 2017.

4. The Joint Commission. Patient Safety Advisory Group. “Preventing Unintended Retained Foreign Objects.” Sentinel Event Alert, Issue 51, October 17, 2013.

5. 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

6. The Joint Commission. “Sentinel Event Data: General Information & 2022 Q1, Q2 Update.”

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

8. Arvid Steinar Haugen, et al. “A Survey of Surgical Team Members’ Perceptions of Near Misses and Attitudes Towards Time Out Protocols. BMC Surgery. 2013;13:46. DOI: 10.1186/1471-2482-13-46