“The thing itself speaks” or more often translated as “the thing speaks for itself” signifying that further details are unnecessary and the proof of the case is self-evident. This legal principle directly applies to wrong-site surgery and, as eloquently outlined in a recent article from the Annals of Surgery, Vol 246 #3 9/2007 by Clarke, MD, et. al., we still are not “getting surgery right.”

According to the Patient Safety Authority of the Commonwealth of Pennsylvania, an actual adverse event or near miss of a wrong-site surgery occurs every other day in Pennsylvania. In a 30- month time period (June 2004 – December 2006) the Authority received 427 “near misses” and serious events of wrong-site surgeries. Of those, 253 were “near misses” or did not reach the patient. Of those events that reached the patient in the operating room, 69% were wrong side surgeries, 14% were wrong body part surgeries, 9% were wrong procedures, and 8% were wrong patient. The most common sites where the wrong-site occurred were extremities, eyes and spine. Orthopedic and ophthalmologic procedures were the most common for wrong-site surgeries.

In July 2004, as part of the Joint Commissions Universal Protocol for Preventing Wrong-Site, Wrong Procedure and Wrong Person Surgery, the “time-out” was launched, which requires verification of the correct patient, correct procedure and correct site before any surgery begins. However, it is surprising since the Joint Commission launched its universal protocol, there has been a sustained increase, not decrease, in the number of report cases of wrong-site surgeries. While some of the rise may be due to increased reporting, the fact remains that the incidence and frequency of this problem is not decreasing.

Also of concern, of the “Sentinel Events” reported to the Joint Commission, wrong-site surgery continues to remain #1, accounting for 13.2% of all Sentinel Events.

As reported in the 9/2007 Annals of Surgery article, wrong-site surgery will occur about once a year in a 300-bed hospital. Surgeons working on symmetrical structures have a 1 in 4 chance of being involved in wrong-site surgery during their careers.

The National Quality Forum (NQF) includes wrong-site surgery events on its list of Serious Reportable Events, commonly referred to as “never events.” Several states use that list as the basis for reporting patient safety problems. In some states (e.g. Minnesota) these reports are made public. Florida, has taken the issue one step further, having imposed fines and disciplinary actions against surgeons for doing wrong-site surgery. As of July 2006, they had disciplined 45 physicians; 3 had been fined $20,000 each.

In spite of a concerted effort and development of a robust “Universal Protocol” for all invasive procedures to prevent wrong-site surgery, Lancaster General Hospital is not immune to this medical error; of concern, our numbers have not decreased, since institution of our “time-out,” or “surgical pause,” as part of our Universal Protocol throughout the LG system. Root cause analyses have been conducted on every instance of wrong-site surgery, including all invasive procedures, and of some measure of comfort, the Universal Protocol, as written, has never been found to be a root cause of an event. What has become quite clear, however, is failure on the part of all members of the care team to follow the Universal Protocol precisely, consistently, each and every time. Our policy states that the scalpel or instrument will not touch the patient until the completion of the “surgical pause or time-out” by all members of the surgical or procedural team, immediately prior to initiating the surgery or procedure.

Through our root cause analyses, we have discovered that the “Universal Protocol” is being interpreted and conducted in a wide variety of fashion by the various members of the surgical or procedural teams. It appears that this process can take place any where from 20 minutes to immediately prior to the initiation of the surgery or procedure and, in some instances, takes place in a “rolling fashion,” rather than with all members of the team “huddled,” immediately prior to the onset of the procedure or surgery.

To tighten and clarify the Universal Protocol across the LG system, the circulating surgical nurse has been designated as “the referee” for all procedures taking place within a surgical suite (and like counterpart in other procedural areas), whereas “play will not commence until the referee blows the whistle,” which, in the case of surgery or invasive procedures, will not take place until the “time-out/surgical pause” has taken place, immediately prior to the procedure. In contrast to football, where failure to follow the referee’s signal merely results in a 5 yard “false-start” penalty, failure to heed the referee’s signal during the performance of an invasive procedure or surgery (as we have unfortunately learned at Lancaster General Hospital) may result in wrong-site surgery, which all of us concur should be a “never event” and occurrence of same will always follow under the category of res ipsa loquitur.

To ensure that all members of invasive procedural and surgical teams are following the same play book, a video (illustrating the proper performance of a “surgical pause/time-out”) is in the process of being developed, which will be shown on a continuous basis in all areas where the majority of surgery and invasive procedures occur, in addition to having all members of the Medical and Dental Staff, who perform invasive procedures or surgery, signing off on having viewed this video. The same holds true for all nursing personnel, surgical techs, and other ancillary staff involved in the performance of invasive procedures or surgery.

It is our intention to completely eliminate wrong-site surgery at Lancaster General Hospital, as this is not a medical risk that any patient must accept. In addition, CMS will no longer reimburse hospitals for the care provided in cases where wrong-site surgery occurred. Therefore, always wait for the referee’s whistle before starting the play.