Your Patient Safety Survival Guide

by Gretchen LeFever Watson

  If the best clinicians, scientists, regulators, and policymakers working in tandem haven’t been able to solve this problem, why should anyone expect the solution to depend on getting the public involved? After all, we are talking about a vexing problem that occurs during the course of complex clinical care within an industry that operates at a rapid pace, under the toll of extensive regulation, and in the midst of a constantly changing knowledge base. So, you might wonder, why complicate the problem by getting the public involved?

  The truth is that the public cannot solve the patient safety crisis on its own any more than hospitals can. Radically improving patient safety will require meaningful collaboration—a true partnership—among providers and patients and between hospitals and the communities they serve. Such collaboration must be the norm; it must not remain a lofty ideal or the exception to the rule. And waiting until patients are hospitalized, or about to be hospitalized, to prepare them for their roles and responsibilities for safe care amounts to too little too late.

  The Evolution of Patient Safety Training, 1900–2000

  For over one hundred years, beginning in the early 1900s and long before the term “patient safety” ever came into vogue, surgeons and anesthesiologists routinely learned from patient safety events. They participated in what they called morbidity and mortality, or M&M, conferences. These regularly scheduled hospital-based conferences were considered a place where physicians could freely discuss unexpectedly bad outcomes with trusted colleagues. Eventually, the Accreditation Council for Graduate Medical Education and other physician residency programs mandated that M&M conferences become part of physician training. As these conferences became a more integral part of physician training, M&M cases were often selected for presentation based on their instructive value for residents rather than the ability to improve an understanding of medical mistakes.

  Besides M&M conferences no longer being a dependable source of patient safety education per se, medicine has been slow to incorporate the field’s accumulating knowledge into its textbooks and medical school curricula.17 With the exponential growth of medical science, it has been challenging to fit the newly emerging body of patient safety knowledge into established clinical courses. While there are massive efforts underway to strengthen patient safety education in medical schools and to improve continuing education standards for physicians, the reality is that physician sensitivity to the topic of patient safety is not yet universally viewed as an essential aspect of physician selection, training, or evaluation.18

  By default, a lot of patient safety education has been relegated to on-the-job training. Once physicians graduate and enter the workforce, it is not necessarily easy for them to learn about the science and practice of patient safety. With pressing needs to remain current on rapidly evolving topics of clinical care, most physicians choose to travel to conferences related to their clinical specialties rather than on patient safety. So, in-house patient safety training is of paramount importance. Yet many hospitals routinely exempt physicians from such training. A stated reason has been that because most of their physicians function as independent practitioners rather than hospital employees, hospital administrators cannot require them to participate in hospital training. Exempting physicians is unfortunate because physicians are regarded as team leaders.

  With physicians at the top of the medical hierarchy, how they are educated about patient safety has a major influence over what gets incorporated into academic training programs for nurses, pharmacists, and allied health professionals. When doctors are not prepared to support hospital safety initiatives, nurses and other staff will not take them seriously, or at least they won’t for long.

  During the course of a consulting engagement with a large and highly respected urban hospital, physicians refused to join in-house safety training sessions alongside nurses and other staff members. Whatever length of time was necessary to cover the topic with employees, the physicians felt they could learn the material faster. My colleagues and I did not necessarily agree; in fact, some of us strongly believed in the value of cross-disciplinary training. Nonetheless, we seized an opportunity to arrange for a notable safety expert to provide a brief, free, and physician-only seminar on patient safety at the hospital. The seminar was specifically designed for physicians. In spite of the recruiting efforts by the hospital’s department that oversaw safety and quality work, only a handful of doctors showed up for the training. Just like parenting programs that seem to attract the most competent parents rather than those most in need of guidance, the physicians who attended the seminar were already recognized as notable in-house patient safety champions.

  Birth of the Patient Safety Movement, 1995–2005

  For centuries, the magnitude of preventable deaths was underappreciated and underreported. This changed in an “instant” with the publication of the now legendary report by the National Academies of Science’s Institute of Medicine, aptly titled To Err Is Human.19 Release of this report marked a turning point in medical history. It was the first time that the field of medicine disclosed to the public the extent to which hospital patients are needlessly harmed in the process of receiving care and the industry’s lack of a systematic approach to prevent such harm.20

  The considerable press associated with the release of the report is commonly marked as the start of the patient safety movement. Dr. Lucian Leape, the physician who conducted one of the two large-scale studies on which To Err Is Human was based and who is now recognized as the father of the academic field of patient safety, has noted that crucial events preceded the media frenzy over the report. In 1995, for example, a number of egregious patient safety events made front-page news; the attorney for the American Medical Association “prodded” the organization to form a group of stakeholders to promote patient safety; and the head of the Veteran’s Administration decided to make safety a system priority.21 But the media’s focus on the report and the federal government’s response to it set other critical actions in motion.

  Most significantly, the release of To Err Is Human removed the medical profession’s own blinders to the magnitude of preventable hospital deaths. Before the report was released, preventable fatalities simply had not been regularly tallied or publicized. Thus, individual doctors and nurses had no way of knowing how the isolated errors that they or their colleagues witnessed or experienced added up on a hospital, community, or national scale. Over the last fifteen years, however, the field of patient safety has been advancing its knowledge of healthcare-induced harm and how to prevent it. But far too many healthcare professionals and patients still know far too little about how they contribute to the problem or what they can do to solve it.

  In spite of the initial and strong backlash from some quarters suggesting that To Err Is Human overestimated the magnitude of the problem (a criticism that with the benefit of hindsight was clearly proved wrong), the federal government set a national goal of reducing the number of preventable healthcare-induced deaths by 50 percent between 2000 and 2005. In 2001, Congress appropriated $50 million for patient safety research. As a result, for the first time in modern medicine studying patient safety became a legitimate pursuit, and journals were created for the purpose of establishing repositories of knowledge about patient safety.

  Existing and newly formed patient safety-oriented organizations began buzzing with passionate focus and activity directed toward improving patient outcomes, including the US Agency for Healthcare Research and Quality and the Joint Commission (the largest hospital and healthcare accrediting agency in the United States), as well as major nonprofit organizations such as the Institute for Healthcare Improvement and National Patient Safety Forum—all of which continue to play a vital role in advancing safe patient care.

  For somewhat different reasons, leaders of Fortune 500 companies and other large public and private purchasers of healthcare benefits weighed in on To Err Is Human. They were distraught over paying for healthcare coverage
for their employees when such coverage might actually lead to harm. It was particularly concerning to them that they had no way to determine which hospitals or healthcare plans were more likely to be associated with bad outcomes for their employees and high costs to their businesses. By the end of 2000, these leaders coalesced to form what is known as The Leapfrog Group.

  To this day, The Leapfrog Group is a powerful consumer-oriented consortium of businesses with a mission to trigger giant leaps forward in healthcare safety and quality. Leapfrog continues to press the envelope with respect to hospital transparency and public reporting of patient safety and quality metrics, making it easier for businesses and individuals to be more informed when choosing their healthcare providers. As summed up by Leapfrog’s president and CEO, Leah Binder (who repeatedly has been listed among the top fifty professionals who positively impact healthcare), “I run an organization . . . with a membership of highly impatient business leaders fed up with problems of injuries, accidents, and errors in hospitals.”22

  And so, within months of To Err Is Human going public, the patient safety movement was born.

  Safety Culture Work in American Hospitals, 2005–2010

  Five years into the movement, American hospitals had invested a great amount of effort and capital to improve patient safety. Nearly every healthcare worker, regardless of his or her professional background, had become aware of the patient safety crisis. By 2005, nobody doubted that the patient safety crisis was every bit as real as first suggested by To Err Is Human. The walls of silence and denial had come crumbling down. But by 2005, it was also clear that healthcare had not achieved—or even come close to achieving—its goal of reducing preventable deaths by 50 percent on a national level. In fact, there was no evidence of widespread improvement. There simply had been no downshift in the magnitude of the crisis.23 While leaders of the movement were stressed by the lack of obvious progress, they had laid important groundwork for future success.

  When I joined the field in 2007, hospital safety efforts were intense and intensifying. Healthcare leaders had already turned to nuclear power engineers and aviation psychologists for help because these industries experienced fewer than one in a million safety disasters. Healthcare wanted to be like commercial aviation and nuclear power—industries that had figured out how to minimize safety disasters while maintaining high-volume, high-risk operations. High reliability organizations, or HROs, are business entities that are reliably safe despite their inherently high-risk, high-volume endeavors. Drawing on the lessons learned by safety experts working with HRO companies, healthcare policymakers, leaders, and consultants agreed on the components that were essential to building a culture of safety in hospitals.

  Dominant consultancy organizations marketed fundamental HRO concepts to hospitals around the country. First and foremost, they considered (and still consider) it essential that hospital leaders view safety as a core value. Adopting safety as a core value means that safety is a precondition for the delivery of clinical care and that safety cannot be compromised to the service of productivity or other potentially competing priorities. As a natural extension of holding safety as a core value, hospitals followed a three-step process of setting clear expectations for safe behavior, educating staff about such behavioral expectations, and building accountability around adherence to established expectations.24 To model themselves after high-risk industries with stellar safety records, hospitals also recognized the need to develop programs to investigate serious safety events for the purpose of finding and fixing their root causes. The strongest programs began sharing the lessons they learned about errors and serious mishaps with employees throughout their hospitals and broader healthcare systems. Some even started to post stories of patient safety events that had transpired in their facilities on websites for the public to see.

  Between 2005 and 2010, hospital-based safety culture programs proliferated, and it wasn’t long before almost every hospital worker was familiar with the term safety culture and at least a few HRO concepts. However, by 2010, American hospitals still had not come close to achieving HRO status. While safety culture work had fostered incredibly important breakthroughs in narrowly defined clinical issues, such as ways to eliminate infections associated with specific medical procedures, the country’s overall rate of preventable hospital deaths had not declined. In spite of astounding dedication by hospital leaders around the country, ten years into the movement patient safety leaders were disheartened to report that—yet again—there was no sign of general improvement.25

  Healthcare is distinctly different from industries that have achieved HRO status. Healthcare centers on people, and people are dynamic beings whose behavior cannot be controlled to the same degree as equipment (airplanes), physical structures (power plants), or materials (chemicals). While safety culture work wasn’t producing the level of results that healthcare was looking for on a national level, the industry thought (and many proclaimed) that standardizing clinical operations through the use of technology could lead to radical improvements in patient safety. Then along came the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.

  Health Information Technology Hype and Hope, 2009–2013

  The HITECH Act refers to federal legislation that included $19.2 billion to stimulate a digital revolution in the healthcare industry by promoting rapid adoption of electronic health records in hospitals and clinics across the nation. Through Medicaid and Medicare resources, the federal government offered financial incentives for hospitals and medical practices that were early adopters of electronic health records and levied financial penalties for those who did not make measurable progress by specific target dates.

  The HITECH legislation and its associated stimulus funding and policies infused the patient safety movement with a dose of hope; and, once again, hospitals responded in a commendable fashion. Even in spite of trepidations about the logistics and costs of implementing electronic health record systems, hospitals (and outpatient clinics) rapidly began implementing electronic health records in ways that had a meaningful impact on patient care. Whereas only 12 percent of acute care hospitals had even a basic electronic health record system in place in 2008, as of May 2014, 94 percent had a system in place that met federal certification requirements.26

  This digital revolution contributed to seismic improvements in the way health information was captured, stored, and retrieved from patient records. Nonetheless, the use of electronic health records did not lessen the overall magnitude of the patient safety crisis.27 In fact, it quickly became apparent that these systems created new opportunities for error while controlling for known sources of error. Furthermore, in the rush to implement these systems, too little attention was paid to the human side of safety, including the human interface with technology.28

  From 2010 to 2013, I served as one of the country’s five regional leaders for the HITECH consortium of community colleges that was charged with developing and implementing new programs to prepare a workforce to support the use of electronic health records. To my dismay, none of my four counterparts had any notable expertise in patient safety. Likewise, none of the program directors or managers of the community colleges within my thirteen-state HITECH region did either. I was concerned about the fact that the HITECH workforce initiative was flooding the market with newly minted electronic health record professionals with minimal training on patient safety. And I thought it would be irresponsible to not use some portion of the $16 million HITECH grant I was directing to deliver patient safety education to those who were designing and overseeing electronic health record training and educational programs.

  Fortunately, HITECH grant officers allowed a portion of the federal funding to be used to host a national conference on the topic of patient safety in the digital era. Conference attendees were impressed with the dynamic keynote talks delivered by Leah Binder (Leapfrog president and CEO) and David Classen, MD (renowned health infor
mation technology innovator). But few, if any, conference participants consequently strengthened the patient safety component of their programs. Like medical schools, it seemed community colleges were leaving much of the necessary education about patient safety to on-the-job training.

  In spite of past and current disappointments and limitations of electronic health record systems and the ways in which they are (and are not) used, they are here to stay. As eloquently explained in The Digital Doctor by physician Robert Wachter, one of the field’s champions and examiners of reform, this is a good thing.29 While working with numerous hospitals during their transitions from paper to digital systems, I never encountered a professional who did not eventually—if not immediately—see the value of electronic health record systems.

  Temporary Disillusionment, 2013–2015

  By 2013, the Joint Commission’s president and chief executive officer and its executive vice president publicly admitted defeat in their effort to stem the tide of patient safety events. They lamented that in the wake of safety culture work and the adoption of electronic health record systems, hospitals were suffering from project fatigue. They noted that no hospital had managed to successfully adapt the science of safety to the business of healthcare. They declared the performance of American hospitals to be predictably unreliable and unsafe and that no amount of regulation could make them safe.30 It is an extraordinary day when leaders of the most significant healthcare regulatory body assert that more regulation will not solve the problem at hand. So it is not shocking that by 2013, there was blog chatter about the patient safety movement flickering out.31

  To make matters worse, the following year, the patient safety movement was rocked by its first scandal. The scandal centered on Dr. Charles Denham, the man who had been a darling of the movement, with connections to people in high places from Hollywood to the White House; the man who produced a slick video about the importance of patient safety that his consulting firm provided free of charge to hospitals around the country; the man who, after suddenly appearing on the scene from left field, managed to position himself as a board member or chair of several major patient safety organizations and as the editor of the Journal of Patient Safety. In 2014, it was discovered that Denham was under federal investigation for having accepted over $11 million from CareFusion, a company that manufactured safety-related products, apparently to infiltrate the field and use his position of authority to lobby for policies that directly advantaged CareFusion. The government settled the case with a $40 million payment by CareFusion and a $1 million payment by Denham. The settlement precludes the public from ever knowing details of the case. Denham never admitted to the charges, but he did dupe a lot of people.