Once again we can benefit from lessons learned in the most recent California Department of Public Health release of root cause analyses and plans of correction for serious events (CDPH 2013). Of the 10 cases in this most recent release, 2 involved wrong-site surgery and we think that many of the contributing factors are still commonplace occurrences at many other hospitals.
The first case involved removal of the wrong kidney (CDPH 4PPX11). An elderly man had suspected cancer involving the left kidney seen on a CT scan. However, when he was admitted for surgery the healthy kidney (right kidney) was removed rather than the left kidney. As we usually see in cases where errors lead to patient harm, there was a cascade of errors and contributing factors that led to the untoward outcome.
First, and foremost, was the fact that the CT scan images were not present in the OR. The CT scan had been performed at a hospital other than the one where the surgery was being performed and those images were not available either in hard copy or on the PACS system. Moreover, the reports of the CT scan were in the surgeon’s office and were not available in the OR.
We discussed in detail issues related to availability of images in the OR in our January 1, 2013 Patient Safety Tip of the Week “Don’t Throw Away Those View Boxes Yet”. We encourage you to read that since it had many insights into issues with images in the OR.
Remember, your surgical timeout procedure must include verification of correct patient (using multiple identifiers), the surgical procedure(s) to be done, the side or site of surgery, and must use multiple primary documentation sources in this process. Primary source materials include things like the H&P, the booking form, the consent form, and imaging studies. Yet we commonly see that failure to review imaging studies (or even the reports) occurs frequently.
In the January 1, 2013 column we noted that having all necessary images available in the OR is important for the surgeon but, frankly, may not help much in the verification process during the surgical timeout. That’s because all the other personnel in the room (nurses, surgical techs, CRNA’s and anesthesiologists) may not be able to interpret the images and thus might not appreciate which is the correct side to be operated on. In some images the most salient feature may, in fact, be an incidental finding and not relevant to the reason for which the surgery is being done. So from the standpoint of the verification during the surgical timeout you are probably better off having a copy of the radiology report and all parties should rely on that report as a primary source document for site verification.
We strongly recommend that you not schedule surgery until you (the hospital or ASC) have in hand copies of the H&P, the booking form, the consent form, and imaging studies. While you might provide a tentative date and time for surgery you must have a “drop dead” date on which you will cancel that tentatively scheduled slot if you have not received these items. Things like the H&P may need updating to meet regulatory time frames but you should have available at least the H&P from the office at the time the case was originally scheduled.
Our June 5, 2007 Patient Safety Tip of the Week “” noted that ambulatory surgery is particularly vulnerable to missing documents because those documents are usually in the surgeon’s office rather than at the hospital. That is why you need to be firm in your requirement for such documents before cases are scheduled.
Your surgeons may be unhappy with such requirements at the beginning and you may even incur the wrath of some patients when you cancel a tentative case in which the documents were not provided. But once they understand you mean business that will become a normal part of their workflow as well.
By the way, errors and miscommunications during the surgical booking and scheduling process are major contributors to wrong-site surgery. See our October 30, 2012 Patient Safety Tip of the Week “Surgical Scheduling Errors” for details and more recommendations about scheduling and booking.
A second major contributory factor was the fact that the patient said the surgery was to be on the right side. While Joint Commission and other regulators require involvement of the patient in the site verification process (and we concur with that) we have also seen numerous cases of wrong-site surgery in which the patient has incorrectly identified the site (in fact, in the wrong kidney case in our January 1, 2013 Patient Safety Tip of the Week “Don’t Throw Away Those View Boxes Yet” the patient also indicated the wrong side). So while the patient should be involved, you must still use all your primary source verification resources and don’t be overconfident with the patient’s identification of site.
A third contributory factor was the level of involvement of all members of the surgical team. The anesthesiologist stated that he did not ordinarily meet with the surgeon and go over the imaging studies and did not typically review test results (X-rays) “as it was not a standard of care”. Well, guess what – it is a standard of care to do verification using primary source documents and that includes radiology reports. So while the anesthesiologist need not be expert at interpretation of all radiology imaging, he/she must still look at reports to ensure that the site and laterality of the imaging finding correspond to the site and laterality identified by the H&P, consent, booking form, and site marking.
Another possible contributory factor was change in personnel. The circulating nurse was 10 minutes late so asked a second to interview the patient in the OR. In addition, the assistant surgeon originally scheduled to help on the case called in sick so a different assistant surgeon had to be called in. That assistant surgeon entered the OR after the initial incision had been made. It does not sound from the case description that a second time out occurred. Good practice dictates that whenever a second surgeon is not present for the time out, a second time out should take place.
The plan of corrections (POC) submitted by the hospital included revision of the Universal Protocol policy to specifically include language that all relevant images or studies be displayed and reviewed as part of the time out. They also developed a standardized checklist to ensure that relevant documentation, including any imaging studies or pathology reports, be available before the start of the procedure. And they added requests for such images or studies to the surgical scheduling process. The POC also included a plan for auditing for compliance with the image/report requirements.
The second case (CDPH ZGPR11) involved an initial incision made on wrong side for a planned left inguinal orchiectomy. Once again, multiple factors contributed. Apparently no surgical site marking was done. The surgeon went to see the patient pre-op but the anesthesiologist was with the patient and the surgeon did not return to mark the site. A pre-op nurse documented on the pre-op checklist that the site had been marked but, when interviewed, said she “assumed” the surgeon had marked the site. However, she also stated that she had not checked off “site initialed” on the Surgical Passport (a handoff tool with required items before a patient can be transferred to the OR). Though a time out was said to have taken place in the OR there was obviously no verification of the site marking and the surgeon had a nurse shave and prep the right inguinal region and he then made an initial small incision before the surgical team realized this was to be a left inguinal orchiectomy. The surgeon did promptly notify the patient and his wife immediately after the surgery of the error.
Also, though the H&P had noted that an ultrasound had documented the testicular lesion there was no indication as to whether the ultrasound image or report was present in the OR and used as part of the site verification process.
The real lesson here is, unfortunately, that in some OR’s corners are cut, assumptions made, and the degree of focus and participation in the time out is suboptimal. Though a checklist designed to prevent the patient from entering the OR without verification of all items had some items not checked, the patient was still moved to the OR. That is likely an example of “normalization of deviance” where successes despite problems lead to the acceptance of such problems and deviations as “normal” and therefore tolerable (akin to the Challenger disaster and described in our July 5, 2011 Patient Safety Tip of the Week “Sidney Dekker: Patient Safety. A Human Factors Approach”).
The time out obviously missed the fact that there was no surgical site marking. And though all participants apparently concurred that the procedure was to be a left inguinal orchiectomy, the surgeon proceeded to do an incision on the wrong inguinal region and no one immediately corrected him. Perhaps this was an example of “inattentional blindness” (see our February 7, 2012 Patient Safety Tip of the Week “Another Neuromuscular Blocking Agent Incident”). But suffice it to say that we often see OR’s in which some or all members of the surgical team go through the time out in a perfunctory manner. All members of the team should take an active role in the time out. It is not acceptable for any of them to simply nod their concurrence. Each should actively state all the elements of the verification process. We also like the “Minnesota Timeout” concept in which someone other than the surgeon leads the time out process. That helps prevent team members from simply agreeing with the surgeon.
The hospital’s plan of correction (POC) had lots of education about compliance with the Time Out process and the Passport (handoff) tool. But it also included direct observational audits.
While we are strong advocates of the observational audit (see our March 5, 2013 Patient Safety Tip of the Week “Underuitilized Safety Tools: The Observational Audit”) the presence of an “outside” observer in the OR often leads to behaviors other than the usual behavior. An alternative approach we’ve espoused on numerous occasions is using audio/video recording of OR cases. When such are used in a constructive, nonpunitive manner they can be very helpful in demonstrating team communication issues. They can also be extremely helpful in demonstrating how well the Time Out is being done.
Use of checklists has been very helpful in improving outcomes and reducing complications in surgery (see our Patient Safety Tips of the Week for September 23, 2008 “”, July 1, 2008 “ ”, and January 20, 2009 “ ”). However, the impact of checklists on wrong-site surgery remains difficult to quantify. And the case above illustrates some of the problems with compliance with checklists.
Two recent papers also highlight issues with compliance with checklists. One paper in press (Sparks 2013) demonstrates how poorly we might comply with the Surgical Safety Checklist. While participation in the checklist at a large tertiary teaching center improved to 94% over a year, accuracy of completion of the checklist was only 54% at one year. Though compliance with the “time out” portion of the checklist was better than other portions, the authors conclude that significant barriers remain and there is much room for improvement.
A second study (Aveling 2013) compared compliance with the WHO Surgical Safety Checklist between high- and low-income countries. Though it found considerably more difficulties with compliance in the low-income countries (for a variety of reasons but mostly lack of resources and cultural issues), it also identified issues even in high-income countries like the UK. While use and completeness of the checklists was high in the UK, “fidelity” was often problematic. The researchers found that sometimes staff was “distracted, dismissive, or absent” during checks. Full attention and focus were not always happening and sometimes the Sign In portion was done at the same time as the Time Out portion after the patient was already anesthetized. The study really focused on hierarchical influences and the culture of safety and teamwork.
The factors and circumstances that contribute to wrong-site surgery are manifold and complex. You’ve all put in place policies and procedures that you think will help avoid such incidents. But how closely does your organization follow those procedures? The “fidelity” of the “Time Out” or the “Sign In” or the pre-op huddle is critical. Most organizations really have little idea of how well those are done. We hope you’ll read some of our many previous columns relating to wrong-site surgery listed below.
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”
July 1, 2008 “ ”
January 20, 2009 “ ”
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”
December 6, 2010 “ ”
June 6, 2011 “Timeouts Outside the OR”
October 30, 2012 “Surgical Scheduling Errors”
January 1, 2013 “Don’t Throw Away Those View Boxes Yet”
August 27, 2013 “Lessons on Wrong-Site Surgery”
What’s New in the Patient Safety World columns:
July 2007 “ ”
August 2011 “New Wrong-Site Surgery Resources”
December 2011 “Novel Technique to Prevent Wrong Level Spine Surgery”
January 2013 “How Frequent are Surgical Never Events?”
CDPH (California Department of Public Health). CDPH Issues Penalties to Ten Hospitals. CDPH 2013 8/15/2013
CDPH (California Department of Public Health). Event ID ZGPR11
CDPH (California Department of Public Health). Event ID 4PPX11
Sparks EA, Wehbe-Janek H, Johnson RL, et al. Surgical Safety Checklist Compliance: A Job Done Poorly! Abstract presented at the American College of Surgeons 98th Annual Clinical Congress, Surgical Forum, Chicago, IL, 2012. Journal of the American College of Surgeons 2013; DOI: 10.1016/j.jamcollsurg.2013.07.393 published online 22 July 2013.
Aveling, EL, McCulloch P, Dixon-Woods M. A qualitative study comparing experiences of the Surgical Safety Checklist in hospitals in high and low-income countries. BMJ Open 2013; 16 Aug 2013 3:e003039 doi:10.1136/bmjopen-2013-003039
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