EXECUTIVE SUMMARY
Wrong-site surgery continues despite efforts to stop this sentinel event. Risk managers should ensure continued diligence in prevention efforts.
- A culture of safety is essential to reducing the risk.
- Wrong-site surgeries are underreported.
- Time out procedures must be strictly followed.
Despite many years of intense education and attention to prevention efforts, wrong-site surgery is on the rise. Hospitals and health systems must make sure their wrong-site prevention efforts have not weakened.
In 2021, 85 wrong-site surgeries were reported, according to the latest sentinel event data from The Joint Commission (TJC). That figure is up from 68 in 2020, and 52 in 2019. TJC notes reporting is voluntary and the figure may not represent the actual number of wrong-site surgeries. Many patient safety groups consider wrong-site surgery to be underreported.1
A review of 9,744 paid malpractice claims with surgical never events reported to the National Practitioner Data Bank (NPDB) revealed wrong procedure, wrong-site surgery, and wrong-patient surgery were the second most commonly occurring category, with retained foreign objects the first. Investigators noted wrong-procedure surgery was associated with a mean liability payment of $232,035. Wrong-site surgery was associated with a mean liability payment of $127,159, and wrong-patient surgery with a mean liability payment of $109,648.2
In one recent example, the Connecticut Medical Examining Board issued a $5,000 fine and a reprimand to an orthopedic surgeon who operated on the wrong knee of a patient in 2018. The board found the surgeon failed to follow the pre-incision protocol and failed to independently verify the site of the operation.3
Scheduling Can Be an Issue
Preventing wrong-site surgery requires continued vigilance, says Tammy Williams, MSN, RN, CPPS, program director with the Vizient Patient Safety Organization (PSO) in Irving, TX. Vizient works with healthcare organizations to improve safety and quality.
Prevention of wrong-site events requires attention to several areas within the healthcare system, addressing the issue both before the day of surgery, in preoperative holding, and immediately before operating.
“Common issues tied to these events include scheduling and documentation problems, as well as issues during the time-out process,” Williams says. “We see three important opportunities for improvement: culture, scheduling, and time out.” A strong culture of safety is the foundation for avoiding these and other sentinel events, she says.
Scheduling requires coordination between the operating room, physician offices, and other departments. Those interactions all pose a risk of error. Electronic scheduling systems can help reduce the risk, but physician offices that are not directly affiliated with the hospital may have trouble with interoperability. For that reason, some surgeries are scheduled on paper, which Williams says can introduce the possibility of incomplete information and the use of abbreviations that might be unclear or misunderstood.
“A key recommendation for years has been to not accept verbal bookings because they present a high risk,” Williams notes. “There also can be issues around key clinical documents having incorrect information in them, so there must be processes and barriers to catch those errors. These can be checks prior to the day of surgery and the pre-procedure verification, which includes cross-checks between the different documents, and means that most errors will be caught prior to the day of surgery.”
Time Outs Must Be Consistent
The time-out process in the operating room is the last chance to catch errors, so it must always be performed carefully, Williams says. The team must take the time to review documentation and confirm all necessary elements, including the patient identification and procedure, before beginning the surgery.
“It is really critical that the entire surgical team participates in the time-out process, and it is very important that there not be variation in the process across surgical teams in the organization,” Williams explains. “Any work that can be done to hardwire that time-out process into the culture is valuable.”
Some hospitals have created prevention efforts that include video monitoring of the time-out process, Williams says. The video can be monitored in real time and reviewed after surgery to identify any opportunities for improvement.
Wrong-site surgery data indicate 46% are near misses, says Ellen Flynn, RN, MBA, JD, principal leader of the Vizient PSO. A near miss on a wrong-site surgery is a valuable opportunity to study the processes that led to that moment — both the processes that allowed an error to creep in and the processes that caught it.
“Embrace those near misses and dig deep to understand why they occurred and how they can be prevented. Let staff know that those near misses are being studied and used to improve safety in the organization,” Flynn explains. “Staff must feel that they can speak up, voice a concern, escalate, and stop the line when needed.”
Never Events
Wrong-site surgery must be a “never event,” says Ehsan Natour, MD, PhD, a cardiothoracic surgeon in Maastricht, Limburg, Netherlands.
“If a problem or a complication is rare, we usually don’t focus on it, we mostly think it will not happen to us,” Natour says. “Studies demonstrate that experienced surgeons are more involved than the younger colleagues. This has to do with the hierarchical system in patient care.”
Wrong-site surgeries are a failure of the system, not of the individual, Natour explains. “There are clear implications to face this problem. When all members of the caring team became owners of the process and are allowed and empowered to identify and [call] out any deviation noticed from the protocol, a culture of patient safety is secured,” he says. “This will reduce the wrong-site surgery.”
Natour suggests addressing these factors before intervention and before anesthesia, with participation of the patient:
- Before the intervention, conduct a time-out involving all team members.
- Are all documents available? Verify patient, procedure, and site.
- Is the surgical site marked and verified? This should be confirmed immediately before the procedure by the responsible surgeon and by team members. If possible, the patient should confirm the correct site.
- Once the equipment, personnel, and all documentation are available and confirmed through all members, only then may the procedure start.
- Reduce stress throughout the procedure.
“Those steps secure a multiple independent check, detect discrepancies during the whole procedure, and provide an excellent prevention of wrong-site surgery,” Natour says. “Participating in the ownership together with the patient creates proactive involvement of every single member of the team instead of a routine check-off of the steps.”
Duplicate records also can contribute to wrong-site surgery, says Gregg Church, president of 4medica, a Marina Del Rey, CA-based company that provides data management services to hospitals and health systems. Some hospitals use two different record systems because interoperability issues or legacy systems cannot be updated, resulting in duplicate records for the same patient that might not be consistent.
“The care team may have to figure out which information resides in which repository, which just increases the risk of an error or omission that can lead to wrong-site surgery,” Church explains. “We also see data overlay, which is the worst, when the data from multiple patients gets comingled. We hear it all the time because there are so many different systems where medical records exist.”
REFERENCES
- The Joint Commission. General information & 2021 update. 2021.
- Mehtsun WT, Ibrahim AM, Diener-West M, et al. Surgical never events in the United States. Surgery 2013;153:465-472.
- Backus L. Connecticut surgeon fined after operating on the wrong knee of a patient. Hartford Courant. Feb. 15, 2022.
SOURCES
- Gregg Church, President, 4medica, Marina Del Rey, CA. Phone: (424) 289-2531. Email: [email protected].
- Ellen Flynn, RN, MBA, JD, Principal, Vizient Patient Safety Organization, Irving, TX. Email: [email protected].
- Ehsan Natour, Cardiothoracic Surgeon, Maastricht, Limburg, Netherlands. Email: [email protected].
- Tammy Williams, MSN, RN, CPPS, Program Director, Vizient Patient Safety Organization, Irving, TX. Email: [email protected].
Despite many years of intense education and attention to prevention efforts, wrong-site surgery is on the rise. Hospitals and health systems must make sure their wrong-site prevention efforts have not weakened.
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