Dr. Douglas E. Paull, acting chief officer of the Department of Veterans Affairs’ National Center for Patient Safety (NCPS), is good at offering examples, real and hypothetical, that illustrate the many ways things can go wrong in a health care setting – while also demonstrating the value of his center’s work. “Let’s say there is a nurse taking care of a sick patient in an intensive care unit,” he said. The nurse wants to flush the patient’s intravascular catheter with a blood thinner, heparin, a routine procedure, and he/she finds two vials in the cabinet: one a relatively weak solution, and another that’s considerably stronger. The nurse wants to use the weaker one. “But the two vials in the cabinet look nearly identical,” Paull said. “They both have a blue label on them. They both have a similar cap. Yes, there’s writing in a small font that spells out the concentration. It’s clearly there. And yes, the unit has policies and rules for checking medicine. But that nurse is a little fatigued. Maybe it’s his or her second shift. Maybe they’ve been taking care of several sick patients. Maybe they’re distracted for just a moment. And maybe they flush the line with the wrong medicine.”

In 1999, when the Institute of Medicine (IOM, now the National Academy of Medicine) published “To Err is Human: Building a Safer Health System,” the report was a wake-up call for health care organizations and professionals. Between 3 and 3.5 percent of patients admitted to U.S. health care facilities suffered an adverse event during their stay, the report reads, and more than half these events were preventable. This meant that avoidable adverse events in health care were a leading cause of death in the United States.

The NCPS is world famous for designing these two processes for answering questions – What happened and why? What might happen and why? – that seem deceptively simple, but are anything but simple in health care settings.

A year earlier, in 1999, the Department of Veterans Affairs (VA) had established the NCPS to lead patient safety efforts throughout its health care system, the Veterans Health Administration (VHA). Located in Ann Arbor, Michigan, with a field office in White River Junction, Vermont, the NCPS, with a staff of about 60 people, leverages its expertise and works to improve patient safety in every facility that treats American veterans.

Since NCPS’ inception, its patient safety experts have studied the principles of what are known as high-reliability organizations (HROs), such as the aviation and nuclear power industries, where daily operations are a matter of life and death – and where mistakes are exceedingly rare. Today, Paull said, the center’s tools for analysis and outreach help embed these principles, some of which may surprise outsiders, in VHA facilities. For example, leaders within the most effective HROs are engaged and sensitive to what’s going on at the front lines – they want to discover bad news and fix what caused it, rather than hide from it – and defer to others not because of their title, but because they have the skills and knowledge to solve problems. For all the talk of “accountability” in the working world, HROs often have a different way of establishing it: They don’t target the “who” – the people who make mistakes – but the “why.” The “whys” are key to beginning the process of making sure a mistake isn’t repeated, and that a more resilient and “fault-tolerant” health care organization results.

In the 1970s, Paull said, when the aviation industry began to study itself and discover the reasons for plane crashes, it found these reasons went far beyond mechanical failures; they extended to cockpits and control towers. “It was the conversations that weren’t happening, the lack of communication, the lack of planning or situational awareness or interaction. It was the things that weren’t said. In any health care organization, communication is one of the most common contributing factors [to mistakes]. When something bad is happening, usually somebody knows about it, and yet there is something that prevents them sometimes from speaking up about their concern. We’re really talking about creating a culture of safety.”

 

Tools for Protecting Patients: Discovering the “Why”

The programs and initiatives offered by NCPS are aimed at creating this culture. In Paull’s example of the nurse who mistakenly used the wrong concentration of heparin to flush a patient’s catheter, a response favored by some people would be to discipline the nurse, even fire her, especially if the patient were harmed. This, however, would do nothing to assure such a mistake didn’t happen again. The center’s most proximate tool for preventing recurrent harm is the Root Cause Analysis (RCA), a team approach involving professionals from the appropriate disciplines who meet to find out what happened and why; to make sure it doesn’t happen again; and to follow up by measuring whether corrective actions have made a difference.

RCA teams develop flow diagrams of the events that occurred prior to an adverse event. “That tells you what happened,” Paull said. “But then we start to ask the deeper questions, the whys. We’ve developed what we call a causal statement.” The causal statement must be precise – it can’t simply state, for example, that a person didn’t follow policy. “You have to ask why didn’t they follow policy,” said Paull. “Did they even know there was a policy? Were they trained in that policy? When was their training? Maybe the training was three years ago. Do they have recurrent training? Is anybody providing oversight? … When you start to frame these causal statements you find out that for most things that go wrong, there are multiple contributing factors. In fact, we probably shouldn’t call it Root Cause Analysis, because there is very seldom, in my opinion almost never, a single root cause.” The example of the nurse and the blood thinner, if explored by an RCA team, might discover issues associated with staffing, fatigue, or an ill-timed distraction. “And of course, there are two look-alike medications, so that’s a big problem. Why isn’t one a different color – or why aren’t they otherwise separated? Anyone in a hurry might have picked the wrong one.”

This isn’t to say the organization is completely blind to blameworthy acts that cause harm. Criminal or deliberately unsafe acts – such as a surgeon willfully ignoring a mandatory “time out” between procedures – are subject to disciplinary action in the VHA, as in any other health care setting.

RCAs are used not only to examine adverse events, but also close calls or near misses – mistakes that were caught and corrected before they could cause harm. They occur much more often than adverse events, and addressing mistakes in this way not only results in a safer system, but also focuses the attention of everyone involved on continually identifying and correcting potential problems.

An RCA is, by definition, reactive in nature; it happens after an adverse event or a close call has occurred. The center’s primary tool for proactively analyzing new procedures or medical devices is a process called Healthcare Failure Mode and Effects Analysis (HFMEA), a risk-assessment method adapted from the engineering profession. It’s a more technical process, involving a bigger team than an RCA, but it’s a useful tool for gaming out the consequences of proposed changes to the health care environment – say, the introduction of a new or updated electronic health record. “Imagine the unintended consequences of introducing staff to a completely new software program,” Paull said. “All kinds of things could happen. So instead of just introducing it, we do things like HFMEA to look at the process. Where are the potential failure points, where are the hazards? And then we can start to prevent those things from happening during a pre-implementation phase.”

 

An Organizational Culture of Safety

The NCPS is world famous for designing these two processes for answering questions – What happened and why? What might happen and why? – that seem deceptively simple, but are anything but simple in health care settings. The RCA and the HFMEA are the backbone of the center’s work, but they are far from comprising all that NCPS does. The staff in Ann Arbor and White River Junction aren’t just a bunch of health care nerds, crunching numbers in cubicles. They are, like Paull, passionately dedicated to protecting veteran patients from harm. They work to spread the gospel of patient safety to every corner of the VHA, and beyond – and their work has measurably improved outcomes within the VHA.

The center’s outreach to VHA medical professionals takes many forms. The Daily Plan®, a patient-centered document template designed by NCPS staff, is a means of prompting communication between patients and providers. Each month, more than 75,000 veterans use this document to review with their providers what they can expect on a specific day of hospitalization – medications, tests, imaging orders, and future appointments, for example – as a way of identifying and preventing potential errors. Through its web-based Patient Safety Assessment Tool (PSAT), which allows VHA managers and staff to conduct a detailed assessment of their patient safety program according to guidelines and best practices, and the Patient Safety Centers of Inquiry, which develop and disseminate relevant innovations (such as new protocols for reducing hospital-acquired infections), NCPS teams up with frontline providers to enact HRO principles.

The NCPS sometimes aims its expertise at a specific problem. The leading category of adverse events in the RCAs submitted to the NCPS’ internal, confidential patient safety reporting system, for example, is patient falls. In response, NCPS created the Falls Toolkit, an online package of resources that helps facilities design their own comprehensive fall prevention programs. Still one of the most frequently downloaded items on the NCPS website, the Falls Toolkit has helped reduce major fall-related injuries in VHA facilities.

Two other NCPS programs reach back to the earliest stages of medical education. The center has worked with leaders at VA medical centers and their affiliated university schools of medicine to create patient safety curricula for faculty development and resident education, and since 2002, dozens of workshops, customized to fit the needs of host facilities, have been conducted for thousands of faculty and residents across the nation.

Another program, first implemented in 2007, has helped to substantially reduce the number of suicides completed by inpatients at VHA mental health facilities. NCPS designed and distributed the Mental Health Environment of Care Checklist as a tool for these facilities to survey and recognize environmental hazards – items or conditions in patients’ rooms and living areas – that could increase the likelihood of a completed suicide. The checklist was deployed throughout VHA’s inpatient facilities, and a follow-up review of RCA data from 2000 to 2015 found that after its 2007 introduction, the completed suicide rate dropped 82 percent at these facilities.

In keeping with the center’s emphasis on proactive measures, many of its initiatives focus on instilling a culture of safety in the emerging generation of health care professionals through education and training. Thousands of VA personnel nationwide have received training though the NCPS’ Clinical Team Training (CTT) program, which improves patient safety by facilitating clear, timely communication among multidisciplinary teams. Modeled after the aviation industry’s crew resource management training, CTT has demonstrated measurable improvements in patient safety outcomes, including fewer medication errors, surgical mortality, hospital-acquired pressure ulcers, and “failure to rescue events” among groups trained in CTT methods.

Two other NCPS programs reach back to the earliest stages of medical education. The center has worked with leaders at VA medical centers and their affiliated university schools of medicine to create patient safety curricula for faculty development and resident education, and since 2002, dozens of workshops, customized to fit the needs of host facilities, have been conducted for thousands of faculty and residents across the nation. In partnership with the VA’s Office of Academic Affiliations (OAA), NCPS offers a one-year fellowship in patient safety to applicants from both clinical and non-clinical disciplines. Another NCPS/OAA collaboration offers chief residents a one-year program of learning and teaching about quality and patient safety while improving safety at their home facilities. Today, more than 80 Chief Residents in Quality and Patient Safety are learning and leading at more than 55 VA facilities.

The effects of this work are accumulating not only throughout the VHA, Paull said, but also throughout American medicine. “There aren’t enough people on faculty in the United States who have expertise in quality and safety, who know how to do a root-cause analysis, how to create control charts, how to use that data,” he said. “I’m meeting young people who were Chief Residents in Quality and Safety 10 years ago, and now they’re assistant chiefs of staff. They’re making decisions for our nation’s veterans. They’re teaching junior residents. So we’re forming an army of patient safety leaders, and each of them is creating an army – and by the way, 70 percent of all U.S. physicians and nurses train at VA facilities in their lifetime. So we’re getting to most of the people in the country who will be taking care of you and me. We’re force-multiplying.”

This article was first published in the Veterans Affairs & Military Medicine 2018 Spring edition publication.