Since July 2004, 646 wrong-site surgery events have been reported through the Pennsylvania Patient Safety Reporting System (PA-PSRS) and analyzed by the Pennsylvania Patient Safety Authority. Data collected through the fourth quarter of the 2014-2015 academic year marks 11 complete years of review and analysis. As noted in the Figure, steady progress was made in the number of events reported since the 2007-2008 academic year—the year the Authority’s Preventing Wrong-Site Surgery project began. However, throughout the 2014-2015 academic year, consistent regression was noted in the number of quarterly events reported as compared with the two previous years, with the exception of the first quarter. A total number of 58 events were reported in the most recent academic year, reflecting the highest number of events since 2009-2010.
Figure. Pennsylvania Patient Safety Authority Wrong-Site Surgery Reports by Academic Year
Twenty-one events were reported in the last quarter of the 2014-2015 academic year, the highest quarterly number of reported events since the first quarter of the 2008-2009 academic year (i.e., 27 quarters of data collection). Of the events reported from Pennsylvania operating rooms (ORs) this quarter, 23.8% (n = 5) accounted for wrong-site anesthesia blocks—one of which was administered by an anesthesiologist and the other four by surgeons. The other types of wrong-site surgery events were as follows: wrong-site procedures (23.8%, n = 5), three of which were wrong-site hand procedures involving a trigger finger release; misidentified spinal levels (23.8%, n = 5); wrong-side procedures (14.3%, n = 3); wrong-side ureteral stent placements (9.5%, n = 2); and a wrong-side pain management procedure (4.8%, n = 1).
The three most common types of wrong-site OR procedures reported through PA-PSRS since July 2004 continue to persist and account for more than 50% of events: anesthetic blocks by anesthesiologists and surgeons (27.4%, n= 177 of 646), wrong-level spinal procedures (12.7%, n = 82 of 646), and pain management procedures (11.1%, n = 72 of 646).
The reason for the observed regression is not clearly understood. Familiar mishaps and system failures continue to occur in all three phases of the Universal Protocol.1 To maximize its effectiveness and ensure the success of any wrong-site surgery program, it is essential that surgical teams (1) ensure that all preoperative documents are verified against the primary sources and (2) maintain situational awareness not only during the time-out but also throughout the procedure.2
An essential step in the preoperative verification and reconciliation process is confirming that all the patient documents (i.e., OR schedule, consent, and history and physical) align with the patient’s understanding of the procedure. The following scenario illustrates the potential outcome when this practice is overlooked:*
Patient arrived for a right transforaminal epidural steroid injection. Patient was asked where he was having pain. The patient used his left arm and pointed to the location on the patient's back. The physician then marked the patient’s back. The patient was brought to the procedure room and assisted to the prone position on the procedural table. The time-out was completed. The patient’s procedure started, and the appropriate spinal level was identified by fluoroscopy. The patient was injected at the appropriate spinal level at the site marking on the left side. Immediately following the injection, the patient stated that he felt symptoms from injection on the left but his pain was on his right side. The consent was then checked and noted that the patient’s pathology was noted to be on the right side.
Between 2007 and 2014, the Authority led three collaboration projects to help drive change in about 80 healthcare facilities. Through these collaborations and independent requests, the Authority has performed on-site consultations and observations of Pennsylvania ORs. Failure to visualize and reference the site mark in the prepped and draped field is a consistently observed deficiency that is relayed during team debriefing sessions. The following report is an example of such an observation:
Patient was having a left shoulder arthroscopy and a trigger finger release of the left ring finger. The correct surgical sites were marked with the patient’s approval, and a surgical time-out was performed prior to case. The shoulder procedure was done first. Once completed, the OR circulator reviewed the procedure and site to be done next for the trigger finger release. The surgeon started to make an incision on the left thumb in error. The circulator stopped the surgeon as soon as the incision was made. The incision was closed and the correct trigger finger release was performed.
Please visit the Authority’s website for the
full suite of wrong-site surgery prevention tools. The newest addition to the collection is the
Gap Analysis and Action Plan to Prevent Wrong-Site Surgery tool. This tool provides surgical teams with the opportunity to identify potential practice gaps as compared with the 21 evidenced-based best practices issued by the Authority.3
To request additional information about the Authority’s Preventing Wrong-Site Surgery program, including an on-site consultation, Pennsylvania hospitals and ambulatory surgical centers may contact their patient safety liaison.
* The details of the PA-PSRS event narratives in this article have been modified to preserve confidentiality.
Clarke JR. Wrong surgery: why does not the Universal Protocol solve the problem?
Am J Surg 2015 Jul;210(1):14.