Interventions involving a wrong site, wrong patient, or wrong procedure represent an unacceptable surgical complication. Although relatively rare, the results can be catastrophic for patients and physicians alike when wrong-site, wrong-patient surgeries occur. Several national organizations have released recommendations for hospitals and healthcare organizations to develop guidelines that ensure correct-patient, correct-site, and correct-procedure surgery. In 2004, the Joint Commission introduced a Universal Protocol for all accredited hospitals, ambulatory care facilities, and office-based surgical facilities. It consists of three distinct parts: 1) a pre-procedure verification, 2) a surgical-site marking, and 3) a “time-out” performed immediately before the surgical procedure.
“Despite the widespread implementation of the Universal Protocol in recent years, wrong-site surgery continues to pose a significant challenge to patient safety,” says Philip F. Stahel, MD, FACS. “We lack reliable data about the true incidence of wrong-patient and wrong-site operations largely because these confidential data may represent just the tip of the iceberg of the most severe occurrences.” In previously published studies, investigators have found that only about one-third of all wrong-site surgery cases result in legal action. It has also been estimated that the Joint Commission event database accounts for just 2% of all wrong-site procedures occurring in the United States.
A Common Problem Despite Improvement Efforts
In the October 2010 Archives of Surgery, Dr. Stahel and colleagues published an analysis of a prospective physician insurance database in Colorado, which contained more than 27,000 physician self-reported adverse occurrences between January 2002 and June 2008. Over the 6.5-year period, physicians reported 25 wrong-patient and 107 wrong-site procedures to a liability insurance database (Table 1). “Wrong-site, wrong-patient procedures are happening more often than suspected despite the efforts by national quality improvement campaigns,” says Dr. Stahel. “Surprisingly, the number of these occurrences remained consistent throughout the study period, which started prior to the Universal Protocol’s initiation and finished nearly 4 years after its implementation.”
“Wrong-site, wrong-patient procedures are happening more often than suspected despite the efforts by national quality improvement campaigns.”
In the study, wrong-patient incidents most commonly involved internists (24.0%), followed by family physicians/general practitioners, pathologists, urologists, obstetricians/gynecologists, and pediatricians (8.0% for each). Orthopedic surgeons accounted for 22.4% of wrong-site errors, followed by general surgeons at 16.8% and anesthesiologists at 12.1%. The predominant problems leading to wrong-site occurrences were errors in judgment (85.0%) and failure to perform a “time-out” (72.0%). Errors in diagnosis were a root cause for 56.0% of wrong-patient procedures and 12.1% of wrong-site procedures. A large proportion of cases failed to heed to one of the three components of the Universal Protocol.
Nonfatal harm was also common (Table 2). Serious harm occurred in 38 patients (35.5%) who were subjected to wrong-site procedures overall; five patients were seriously harmed by wrong-patient procedures (20.0%). The root cause of these errors was communication problems in all of the wrong-patient cases and 48.6% of the wrong-site cases. The only death associated with a wrong procedure in the study was a patient who died from acute respiratory failure after wrong-sided placement of a chest tube by an internist.
Interpreting the Data & Moving Forward
According to Dr. Stahel, the Joint Commission’s Universal Protocol can only be effective when it is adhered to by all members of the surgical team. “Our analysis showed that nonsurgical specialists were just as likely to cause significant injury from wrong-site errors as those in the procedural specialties. In order to achieve a zero-tolerance philosophy for these preventable incidents, it’s imperative that all specialists—surgical and nonsurgical—strictly adhere to the Universal Protocol,” says Dr. Stahel.
Dr. Stahel adds that the root cause may come from places other than the operating room (OR). For example, wrong dictation on which side of the patient needs to be treated or mixing up samples in a way that leads to the wrong patient being taken to surgery can have its root cause in the medical specialist’s or pathologist’s office. In other cases, internists may perform procedures outside the OR and may not adhere to the Universal Protocol.
“Greater efforts are needed to strive toward a culture of patient safety and raise awareness of the Universal Protocols to all physicians, not just those working in the OR,” Dr. Stahel says. “Following ‘time-out’ protocols and operative checklists is paramount to reducing the burden of wrong-site, wrong-patient procedures in the future. Using the ‘readbacks’—a strategy in which one surgeon or provider repeats exactly what the other surgeon or provider just said in order to avoid miscommunication—can be of help in the OR. So too can introducing the surgical team to each other prior to surgery. It can go a long way toward enhancing patient safety. It behooves everyone to take the time and effort required to adhere to patient safety protocols. We should remember that patients aren’t the only victims of these catastrophic events; physicians also bear the burden of these errors.”
Readings & Resources (click to view)
Stahel PF, Sabel AL, Victoroff MS, et al. Wrong-site and wrong-patient procedures in the universal protocol era: analysis of a prospective database of physician self-reported occurrences. Arch Surg. 2010;145:978-984. Available at: http://archsurg.ama-assn.org/cgi/content/full/145/10/978#AUTHINFO.
Stahel PF. Learning from aviation safety: a call for formal “readbacks” in surgery. Patient Saf Surg.2008;2:21.
Stahel PF, Mehler PS, Clarke TJ, Varnell J. The 5th anniversary of the “Universal Protocol”: pitfalls and pearls revisited. Patient Saf Surg. 2009;3:14.
Canale ST. Wrong-site surgery: a preventable complication. Clin Orthop Relat Res. 2005;433:26-29.