Your Patient Safety Survival Guide

by Gretchen LeFever Watson

  The bottom line is there are innumerable ways for minor errors to contribute to harmful off-the-mark procedures. This is precisely why the Joint Commission focuses on all off-the-mark procedures regardless of how minor they are in terms of their impact on patients. Healthcare leaders need to learn about as many as possible so they can search for patterns that warrant widespread attention.

  Too Common for Comfort

  You may think of surgery being performed on the wrong patient to be one of the most unlikely types of medical error. Indeed, the occurrence of these events is rare compared to the frequency of healthcare-associated infections and medication administration errors,9 but wrong-patient surgeries account for a substantial portion of off-the-mark procedures. A study based on hospital-based off-the-mark procedures for the state of Colorado identified twenty-five instances of wrong-patient operations over a six-year period.10

  Initially, these numbers might sound pretty good. However, they are more concerning than you may realize. For one thing, the lead author of the Colorado study considered the numbers to be low and misleading. Concurring with this assessment, a professor of surgery and public health at Johns Hopkins University said that catastrophic surgical errors are “a lot more common than the public thinks,” noting further:

  Each hospital, whether they publicly admit it or not, and whether or not it’s discoverable in a lawsuit, has an episode of wrong-site or wrong-patient surgery either every year or once every few years. Almost every surgeon has seen one.11

  Other research has documented anywhere between 1,300 and 4,000 off-the-mark procedures per year in US hospitals.12

  The American healthcare system began systematically studying the problem of off-the-mark surgeries in the mid to late 1990s when the Canadian Orthopedic Association and then American Academy of Orthopedic Surgeons endorsed educational campaigns to prevent such mishaps. Around the same time, in 1997, the American Academy of Orthopedic Surgeons launched a voluntary “Sign Your Site” campaign, which encouraged surgeons to initial or otherwise mark the patient’s body on the spot where the surgery was to occur. Nonetheless, this has not been a robust or popular area of patient safety research.

  The relatively few studies that have been conducted only focused on operating room surgeries, and many of these studies have been further restricted to include only wrong-side surgeries (rather than the broader group of wrong person, procedure, part/place procedures and surgeries). These limitations create artificially low prevalence estimates of hospital-based off-the-mark procedures and say nothing about the presumably more common problem of off-the-mark procedures that occur in freestanding surgical centers where, with increasing frequency, invasive procedures are performed.

  Regardless of the true prevalence of off-the-mark procedures, their occurrence in hospital and surgical centers is far too common for comfort. This is especially true considering that by 2004 surgeons were performing 230 million major surgeries per year. That figure amounts to one major surgery for every twenty-five human beings on the planet,13 with American surgeons performing more than fifty million operations annually and American patients undergoing an average of seven operations in their lifetime.14

  Where There’s Smoke, There’s Fire

  The most minor off-the-mark procedures can, and usually do, signal a more serious problem. In this sense, they are sentinel events that signal things are not right. They warn us to look out for signs of danger just as would a guard on a sentinel tower. They signal “where there’s smoke, there’s fire.”

  When the Joint Commission notices a pattern of reported events, it issues a Sentinel Event Alert. These alerts describe high-risk conditions and underlying causes that are common across the reported events. To date, the Joint Commission has issued fifty-four Sentinel Event Alerts to help healthcare organizations determine their need to design new or redesign existing processes to avoid never events or similar problems, including off-the-mark procedures (wrong-site surgeries) as a sentinel event.

  Without appreciation for the need to actively find and fix root causes of error (as opposed to incidentally discovering and fixing mistakes), it is easy to end up playing a game of whack-a-mole—a piecemeal or superficial attempt to solve a problem, resulting in only temporary or minor improvement. For example, this could amount to reprimanding or reassigning a surgical team member whose error contributed to an outcome involving patient harm, only to do so again with the new team member. Or, a whack-a-mole approach could entail repeatedly catching and addressing a scheduling error at the last minute in the preoperative area rather than finding a way to ensure that all the requisite information gets to the operating room scheduler in time to confirm all essential information. Falling short of finding and fixing the cause of the delayed paperwork leaves critical details to be attended to on the day of surgery and increases the likelihood of an off-the-mark procedure.

  You might think that a hospital would get to the root of the problem after a high-stakes failure like any of the off-the-mark cases discussed so far, but that is not necessarily the case. It is just so much easier to “see” what went wrong at the pointy end of care and then to overlook the blunt end issues that led to the error in the first place. Rather than viewing a failure as the smoke that signals a burning fire somewhere else, people have a tendency to conclude that mistakes represent isolated incidents that can be addressed through individual and/or idiosyncratic measures. But the Swiss Cheese Model discussed in chapter 2 makes clear that this is rarely the case. System failures—also known as blunt end factors—almost always precede human error at the pointy end of care.

  One Hospital, One Year, Three Off-the-Mark Brain Surgeries

  In 2007, a hospital was reported to have performed three brain surgeries on the wrong side of patients’ heads—all within the span of a year. One patient died; the others survived despite having had their skulls cut and brains unnecessarily exposed in an extra place. In one case, a nurse observed the mistake but didn’t speak up. In another, the nurse alerted the surgeon to lack of documentation about which side needed the operation, but the surgeon told her that he remembered which side was involved. The nurse questioned him again, but he insisted that he remembered correctly. So, she let it go. After these two cases, the hospital was ordered to make changes to prevent recurrences. But soon thereafter, a third case occurred. This prompted the state health department to dig deeper and discover that although the hospital had made some improvements within the operating room environment, these changes were insufficient. They had not spread to the rest of the hospital, leaving room for errors outside the operating room to contribute to the problem. The state’s Department of Health reprimanded the hospital and fined it $50,000, and the story hit the press.15

  Not long before these three off-the-mark procedures, surgeons at the same hospital operated on the wrong part of a child’s mouth during a cleft palate surgery. And five months before that, one of the hospital’s surgeons operated on the wrong finger of a patient. Although this story might have you thinking this happened in a third-rate hospital in rural America—you’d be wrong. These events happened at Rhode Island Hospital, a teaching hospital affiliated with the medical school at Brown University—an Ivy League institution—that is staffed by the best and brightest physicians. If it could happen there, it can happen anywhere.

  According to the Joint Commission, there was a sense among the surgeons at the hospital that “I’m very well trained. I’ve done this procedure one hundred times. It’s not going to happen to me.” In addition to the arrogance and overconfidence of the physicians, the hospital’s operating room nurses had become too timid to speak up and hold their ground when they saw safety issues. The end result was that the hospital had become a place where carelessness about small—though critical—details prevailed.16

  After its run on serious off-the-mark procedures, Rhode Island Hospital took more comprehensive action to minimize the chance of more errors. Bu
t what if the hospital had viewed its first off-the-mark surgery as an important “smoke signal” and diligently searched to find and fix the cause of the error? In all likelihood, none of the wrong brain surgeries would have occurred. This problem plays out more often than we care to think.

  Although communication breakdowns and scheduling glitches are common causes of off-the-mark procedures, the operating room milieu is a contributing factor in almost every case. It also has been well documented that nurses in hospitals across the country and abroad routinely experience physician arrogance, intimidation, and bullying. Consider this conversation that occurred in an operating room in October 2012.17

  Surgeon [Standing to the right of a patient under general anesthesia for hernia repair]:

  “Which side is the hernia?”

  Assisting surgeon: “I don’t know. I did not see the patient.”

  Surgeon: “Who saw the patient?”

  Assisting surgeon: “The house surgeon from the previous shift.”

  Surgeon: “What does it say in the notes and consent?”

  Assisting surgeon: “Hernia repair, obviously.”

  Surgeon [in anger]: “Obviously! But which bloody side?”

  There were a large group of people in that operation room: junior nurses and medical students and other staff. None of them will speak to the chief surgeon unless they are spoken to. Silence continued for a few moments.

  Surgeon [in exasperation]: “Does anybody know the side?”

  Medical student puts her hand up.

  Surgeon [very impatiently]: “Tell us. What are you waiting for?”

  Medical student: “I don’t know for sure, but I was standing on the right of the patient’s bed when I examined him and I had to reach out across to feel the hernia. So it must be on the left side.

  Surgeon: “Left it is then. Let us get this done.”

  The surgical team was lucky that day. The medical students had seen two other hernia preop patients the same day and fortunately they all had left groin hernias.18

  We know that simply telling nurses and other personnel to speak up for safety doesn’t work, but getting staff to speak up for safety is critically important to prevent safety mishaps. So, what can be done to prevent the continued accumulation of tragic off-the-mark stories?

  Actually, there already exists a straightforward strategy for expediting the sort of communication among surgical teams that is essential for creating a situation in which it is safe to speak up for safety. Remember, people often talk about attitude affecting performance, which is, indeed, true; however, as psychological research has shown, it is sometimes easier to act oneself into a new way of thinking than to think oneself into a new way of acting. Providing a specific behavioral script can help hardwire desirable habits, often serving as the turnkey to behavior change. Healthcare already has an effective tool in its arsenal that accomplishes this. It’s a checklist called the Universal Protocol.

  The Universal Protocol

  The Universal Protocol represents the culmination of work by the World Health Organization (WHO) to improve surgical safety. In 2002, in the face of worldwide evidence of substantial public health harm due to inadequate patient safety, the WHO assembly adopted a resolution urging countries to strengthen their monitoring of patient safety events. Two years later, it launched the World Health Alliance for Patient Safety, which brought together heads of agencies, policymakers, and patient advocacy groups from around the world. The purpose of this alliance is to concentrate actions around focused patient safety topics. In 2005, the alliance chose healthcare-associated infections as its Global Patient Safety Challenge, and in 2007 it chose surgical safety as its second Global Patient Safety Challenge.

  The World Health Alliance for Patient Safety selected Dr. Atul Gawande, a Harvard surgeon and popular writer, to lead the charge to improve surgical safety—an undertaking that involved experts from around the world who reviewed data and input from over fifty countries and over 280 million surgeries.19 In his book The Checklist Manifesto, Gawande details the public health and political process of creating the Universal Protocol.

  Through thoughtful testing and revising, the Universal Protocol became a meticulously crafted checklist. National and international groups have vetted the Universal Protocol for use in every operating room and venue where invasive procedures occur. This tool is a specific behavioral script that is believed to be capable of eliminating the majority (if not all) of off-the-mark procedures.20 The beauty of this checklist is that it has balanced brevity and effectiveness, taking as few as two minutes to complete and, yet, capturing the critical elements for eliminating off-the-mark procedures.

  The checklist is segmented into three distinct time-out processes—a preprocedure verification time-out, a site-marking time-out, and a preincision time-out. The first two time-outs occur with the active involvement of the patient (if possible) or the patient’s lay caregiver or advocate. First, the preprocedure verification time-out is performed. It creates the need to confirm the correct patient, procedure, and site (body part and place). This occurs before the patient receives any anesthesia—except under emergency surgery conditions when this is not feasible or when even minor delays could mean the difference between life and death.

  Second, the site verification time-out occurs. The licensed practitioner who is ultimately accountable for the procedure to be performed must mark the site of the surgery or procedure, obtaining confirmation from the patient. This process underscores the need for patients to be explicitly informed about the plan of their care. If, for example, a patient is eventually going to have both knees operated on but at different points in time, it can be critically important to understand which one is going to be addressed first. The surgeon could operate on the right knee but insert a left knee replacement part. You might think this is absurd, but it happens with too much regularity. When the patient’s body is marked to indicate the site of the procedure, the marking must be unambiguous and made with ink that is visible and durable throughout the procedure.21

  Then, after all preprocedure and site verification questions have been resolved, a third time-out is performed. This occurs prior to making the first cut. Other than the patient, who is often anesthetized by this point, the time-out must actively involve all members of the procedure team, including the person or persons performing the procedure, individuals providing anesthesia, the circulating nurse, and operating room technicians. In any hospital of reasonable size, it is fairly common for teams of clinicians who do not know each other to work together. For example, in the hospital where Gawande operates, there are forty-two operating rooms staffed by over one thousand nurses, technicians, residents, and physicians who rotate constantly. So team familiarity and collegiality cannot be taken for granted. Rather, a sense of team must be purposefully generated, even if it lasts only for the duration of a given procedure.

  We know from psychological research that people who do not know each other’s names generally do not work together nearly as well as those who do. Research has verified that the Universal Protocol’s process of having people introduce themselves by name and role prior to the initiation of a procedure dramatically increases the sense of teamwork among surgeons, anesthesiologists, and nurses.22 Anecdotal reports also confirm that this “team huddle” improves the likelihood that team members feel free to speak up for safety in the operating room environment. This seemingly simple behavioral routine of having team members introduce themselves before the procedure begins helps to overcome the silent disengagement that pervades many operating environments. This process minimizes the dangerous silo mentality of “that’s not my problem.”23

  Finally, all team members must agree they have identified the correct patient, correct procedure, and correct site. This preincision process explicitly invites—actually requires—everyone on the team to speak before the procedure begins.

  A Double-Edged K
nife and Its Double Standard

  Surgery is a high-stakes endeavor, and surgeons endure years of training and grueling schedules before they are granted the authority to brutally invade the human body, bringing it to the brink of death in the hopes of healing and curing their patients. The chutzpah and drive that surgeons possess (or develop) to sustain them through such arduous training emboldens them to initiate and oversee life-threatening procedures on a daily basis. At the same time, their brass necks can undermine their willingness to admit they are fallible and to own their mistakes. Introducing the use of the Universal Protocol will inevitably uncover errors. That is the exact point of the checklist.

  The Universal Protocol’s process, therefore, brings surgeons into direct contact with their own fallibility—an aspect of their humanness that they often fight to keep at bay. The brilliance of the Universal Protocol is that it uncovers errors in a manner that allows face-saving for every member of the surgical and procedural teams. By design, it provides the opportunity for minor human errors to be caught and addressed before they have an opportunity to contribute to devastating off-the-mark procedures. Because the checklist relies on a highly structured group process, it reinforces team effort and goes a long way toward overcoming the natural tendency to ascribe blame to a single person while also maintaining the surgeon’s status as the team leader. In so doing, the Universal Protocol serves as a powerful reminder that lots of little things go wrong before a big mistake happens. It makes explicit the steps that must be taken to avoid catastrophe and establishes the surgeon alone is not responsible for preventing off-the-mark procedures.