Several articles in the past couple months have pointed out wrong-site surgery continues to occur and offer some useful insights into contributing factors.
A study using self-reported adverse events from a Colorado physicians’ malpractice insurance database (Stahel 2010) highlights the continued occurrence of wrong-patient and wrong-site occurrences but also has some interesting revelations. Over a 6 ½ year period they found 25 cases of wrong-patient procedures and 107 cases of wrong-site procedures, with patient harm occurring in 20% and 36% respectively.
Root cause analyses were available on most cases. Not surprisingly, errors in communication were highly prevalent in both categories, though more frequent in the wrong-patient cases. On the other hand, errors in judgment were much more common in the wrong-site cases. Failures in the time-out process were significant in the wrong-site cases but not the wrong-patient cases.
Perhaps the most revealing finding in the study was the contributory roles played by physicians in specialties “outside” the OR, i.e. physicians other than surgeons and anesthesiologists. We’ve long known that wrong-site procedures outside the OR are frequent (in our Patient Safety Tip of the Week November 25, 2008 “” we noted that chest tubes inserted on the wrong side was the most frequent wrong-site occurrence in New York State in the past). But the Stahel paper notes how often events such as mislabeling pathology specimens, mixups in medical records or imaging studies or lab reports contributed to the adverse events even inside the OR. The study highlights the importance of the “time-out” in multiple venues of patient care where correct identification of patients and clinical information is critical. While we have always advocated time-outs prior to any invasive procedure (eg. thoracenteses, paracenteses, lumbar punctures, etc.), the same sort of diligence should be applied in places like the pathology lab. See our Patient Safety Tips of the Week for October 9, 2007 “ “ where we discussed pathology specimens being mixed up and November 16, 2010 “ ” for examples of vulnerable laboratory processes.
It has long been recognized that multiple surgeries are a risk factor for wrong-site surgery. A recent case at Yale-New Haven Hospital (Bailey 2010) illustrates how such cases can happen. A motor vehicle accident victim had fractures of the right ankle and pelvis and was taken to the OR for surgery on the right ankle. Two surgical residents discussing the case also noted the left leg was internally rotated and shorter than the right leg so decided that a skeletal traction pin should be applied to the left leg. However, after surgery on the right ankle was completed, the skeletal traction pin was applied mistakenly to the right leg. The investigation determined that no second timeout had occurred prior to the second procedure. Yale-New Haven’s protocol apparently required a second timeout only when a surgeon (or surgical team) performing the second procedure was not present during the initial timeout. They apparently subsequently modified their protocol to require a second timeout any time a second procedure is to be done, regardless of whether there have been changes in the surgical team or not.
A second case (Knight 2010) illustrates why verification of all clinical information during a timeout, not just verification of the site marking, is critical. In this case, a permanent marker was used to place an arrow, smiling face, and surgeon’s initials on the correct leg of a 2-year old undergoing femur surgery. However, when the patient arrived in the OR, there were markings on both legs (see photos in the article). It appears that the positioning of the legs had resulted in transfer of some of the marking to the other leg. Fortunately, the correct site was verified from clinical notes, the consent form, and imaging studies.
A third case received the most attention since it was published in the New England Journal of Medicine (Ring 2010). We applaud the surgeon involved in the case and the Massachusetts General Hospital for giving public attention to this case so that valuable lessons would be shared with the greater medical community. A patient scheduled for a trigger finger release instead received carpal tunnel release surgery. The root cause analysis demonstrated the typical cascade of events we usually see in cases with adverse outcomes, including communication errors, time pressures, distractions of multiple personnel, and failures to adhere to best-practice protocols.
The surgeon had several surgical cases scheduled that day, 3 major cases and then 3 he admittedly considered “minor” cases. The first two “minor” cases were carpal tunnel releases and the last case was the patient scheduled to have the trigger finger release. (Note that we’ve considered multiple “simple” surgeries to be as high or higher a risk for errors as a single complicated case. This is especially so in specialties where many cases typically get scheduled consecutively, for example ophthalmology or ENT. The larger number of patients involved, often with multiple charts and multiple imaging studies, increases the opportunity for mixups and the added time pressures may lead to shortcuts and workarounds.) Though the first “minor” case went well, the patient had some concerns about the injection of anesthetic that required additional time for the surgeon with that patient. The surgeon also was called away to translate for the preoperative preparation of the patient involved in the incident (she spoke Spanish, no interpreter was available, and the surgeon spoke Spanish). The surgeon noted that a nurse had marked the arm on which the surgery was planned (apparently hospital protocol at the time allowed nurses to mark the site). The surgeon then returned to perform uneventful surgery on the second case. But the last (third) case was moved to another room because several other cases in the OR were running late. The latter change also resulted in a change in OR personnel so that the nurse who had performed the preoperative evaluation was no longer involved in the case. Because of that delay, the surgeon also went to perform a consultation elsewhere and then also had to further console patient #1 about the anesthetic injection issue. As the last case was being prepared for in the OR, a nurse had to search for a tourniquet and fell behind on her documentation. The site marking was washed off by the preparation of the arm with soap, alcohol and providone-iodine. The surgeon spoke to the patient in Spanish. The nurse mistakenly thought this was the timeout. Hence, no formal timeout took place. There was also a nursing change mid-procedure. The surgeon performed a carpal tunnel release and only recognized the error about 15 minutes later while dictating the op report.
Once the error was recognized, the response was prompt and appropriate, with disclosure and apology (see our June 22, 2010 Patient Safety Tip of the Week “Disclosure and Apology: How to Do It” and our November 2010 What’s New in the Patient Safety World column “ ”). The hospital did its root casue analysis and made multiple system changes. Nursing is no longer responsible for marking the surgical site (that is the responsibility of the surgeon) and alcohol-based solutions that might erase the ink are no longer allowed. The timeout process was improved to meet the Join Commission’s updated Universal Protocol and educational sessions for all staff made it clear the timeout verification process is an active rather than passive one and should involve the patient where possible. Importantly, the nurse may not give the scalpel to the surgeon until the timeout has been completed. The culture of safety means the entire team is responsible and the verification and Universal Protocol need to be followed, with surgeons taking the lead.
Finally, the Pennsylvania Patient Safety Authority has continued to provide its valuable contributions to help avoid wrong-site surgery. You’ll recall the PPSA has been providing quarterly updates on wrong-site surgery now for several years. They continue to see about a case per week reported despite all the knowledge we have accumulated for preventing wrong-site surgery. This month in their quarterly update on wrong-site surgery they provide several principles and supporting evidence for each.
First, the correct site of the procedure should be specified at the time the case is scheduled. See our August 2010 What’s New in the Patient Safety World column “Surgical Case Listing Accuracy” for a discussion on the current pitfalls in that process. PPSA notes that about 5% of wrong-site surgeries involve errors in the scheduling process. The next two principles involve ensuring that the correct operation and site be indicated on the history & physical and the informed consent, respectively. And the next one is that everyone involved should review the information on the schedule/booking, H&P, informed consent, and any other reports with the diagnosis and that any discrepancies need to be reconciled with the surgeon.
Another principle, which we consider very important, is that the surgeon have any supporting information uniquely available in the office notes at the surgical facility on the day of surgery. Our June 5, 2007 Patient Safety Tip of the Week “Patient Safety in Ambulatoy Surgery” noted that the quality of the medical records is often not as good in ambulatory settings. The “facility” medical record is often scant and the physician often brings in his/her office notes that are “unofficial” as far as the facility is concerned. Often critical information is in the physician office record and never appears in the facility medical record. It is therefore incumbent upon the facility and entire team to ensure the adequacy of the medical record and all documentation prior to the procedure.
The next principle is that all the information that should be used to support the correct patient, operation, and site, including the patient’s or family’s verbal understanding, should be verified by the nurse and surgeon before the patient enters the OR.
The principle that 2 unique patient identifiers are required in all cases is, of course, a Joint Commission requirement. Note in the Stahel paper noted above there were cases of wrong patient surgery involving patients who had identical first and last names.
This next principle is also very important: any discrepancies must be resolved by the surgeon, based on primary sources of information, prior to the patient entering the OR. We’ve seen or heard of several cases where discrepancies were resolved based on the surgeon’s “memory” where that memory turned out to be wrong.
Several principles related to site marking follow, including marking with the intials of the surgeon and marking done in conjunction with verification of all supporting information plus the alert patient’s (or family’s) understanding, and verified also by the circulating nurse on moving the patient into the OR.
The next several principles apply to the timeout and are mentioned in the NEJM case above: verification procedure should be an active one rather than a passive one and all potentially distracting noncritical activities be suspended during the timeout and verification procedure. It is critical that all questions during the timeout verification procedure be phrased in a manner that requires and active answer. Never should you assume that no answer means concurrence. And all involved should be verifying that they are verifying information from relevant documents, not just second-hand information. And the site marking needs to be clearly visible in the prepped, draped field during the timeout. And all this must take place in an environment where all staff are encouraged to speak up and voice any concerns. If there are any concerns, the surgeon must resolve those concerns based on primary sources of information to the satisfaction of all team members.
The principle that separate timeouts be performed for separate procedures, including anesthetic blocks, with the person performing that procedure was noted earlier and needs to apply to all procedures, not just ones performed by different providers.
It’s humbling when wrong-site surgery can occur at some of our most respected hospitals. But these occurrences make it clear that we must have both a culture of safety and specific system interventions in place to ensure that such events do not occur in our organizations. We highly recommend that you read the whole PPSA article and take the principles outlined in the PPSA quarterly update, put them in a checklist format, and use that checklist to perform random audits on cases at your facility. Note that requires someone physically being present to observe some portions of the entire workflow or you have the means of video recording of portions of that workflow, such as the timeout occurring in the OR itself. That is critical to understanding whether the timeouts are truly performed in an active, rather than passive, format and that all staff involved truly feel empowered to stop a procedure at any time they have any concerns or discomfort.
Some of our prior columns related to wrong-site surgery:
Patient Safety Tip of the Week columns:
September 23, 2008 “”
June 5, 2007 “ ”
March 11, 2008 “Lessons from Ophthalmology”
September 14, 2010 “ ”
November 25, 2008 “Wrong-Site Neurosurgery”
January 19, 2010 “Timeouts and Safe Surgery”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
What’s New in the Patient Safety World columns:
July 2007 “ ”
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(10): 978-984
Bailey M. Doctor Operates On Wrong Leg. New Haven Independent November 2, 2010
Knight DMA, Wedge JH. Marking the operative site: a lesson learned.
CMAJ 2010 182: E799.
Ring DC, Herndon JH, Meyer GS. Case Records of the Massachusetts General Hospital.
Case 34-2010 — A 65-Year-Old Woman with an Incorrect Operation on the Left Hand. N Engl J Med 2010; 363:1950-1957
Pennsylvania Patient Safety Authority. Quarterly Update: The Evidence Base for Best Practices for Preventing Wrong-Site Surgery. Pa Patient Saf Advis 2010 Dec;7(4):151-4.