In November 1999, the Institute of Medicine (IOM) released its transformative report To Err Is Human, citing the deaths of thousands of patients each year in the United States from preventable medical errors. Since then, safety issues like alarm management and medical device interoperability have attracted scrupulous attention, and patient safety has become the watchword at many hospitals across the country. But has all this made patients any safer?
Last year, the National Patient Safety Foundation (NPSF) commissioned an expert panel led by Don Berwick, MD, and Kaveh Shojania, MD, to revisit the issue. The panel’s report, Free from Harm: Accelerating Patient Safety Improvement Fifteen Years After To Err Is Human, was published in December. Arguing that not nearly enough progress has been made over the past decade and a half in reducing hospital errors, it enumerated eight recommendations to achieve what the authors call “total systems safety,” including stronger leadership from hospital executives, a common set of safety metrics, increased research funding, and centralized, coordinated oversight of safety efforts.
Tejal Gandhi, MD, MPH, CPPS, may understand the challenges inherent in meeting these goals better than just about anyone. As president and chief executive officer of the NPSF and the NPSF Lucian Leape Institute, she convened the panel and oversaw drafting of the report. An ardent advocate for patient safety, she has previously served as the executive director of quality and safety at Brigham and Women’s Hospital and chief quality and safety officer at Partners Healthcare, both based in Boston. She is also an associate professor of medicine at Harvard Medical School. Gandhi recently spoke to 24×7 about healthcare’s slow progress in the patient safety arena, the intangible dimensions of patient harm, and what it will take to reach a more holistic approach to patient well-being.
24×7: How would you characterize the impact of To Err Is Human on the patient safety movement when it was released in 1999?
Gandhi: To Err Is Human was a landmark report that, for the first time, really brought the impact of medical errors and adverse events to the public’s attention. I would say for some time before that, a subset of health professionals had begun to recognize the toll of medical errors. Five years earlier, for example, Dr. Lucian Leape published a groundbreaking paper, “Error in Medicine,” in The Journal of the American Medical Association. And 2 years before the IOM report, in 1997, the National Patient Safety Foundation was founded.
But not everyone was on board with accepting the fact that big changes were needed in healthcare. To Err Is Human really helped put the problem into focus, by comparing the toll of hospital errors to other causes of death. It also directed health professionals to think more about systems, and how to create procedures and protocols that can help reduce human error.
24×7: How did NPSF decide it was time to assemble a panel for a follow-up report? In other words, why now?
Gandhi: We are now 15 years out since the IOM report, so it seemed to us to be a great time to assess progress in patient safety and try to focus efforts for the future, for the next 15 years or so.
24×7: What is the most important finding of Free from Harm, in your eyes?
Gandhi: To me, the most important recommendation is to ensure leaders create and sustain a safety culture. The panel of experts that convened to inform this report was in broad agreement about the challenges of culture change and the need to improve organizational culture in healthcare. As I wrote recently on the NPSF Web site, leaders and board members of healthcare organizations have extraordinary power to influence the culture. They really need to set the expectation that errors and near misses will be reported and investigated, that findings will be reported back to staff and patients, and that they will learn from these situations in order to prevent them from happening. They will not place blame on individuals for human error, but will institute structured and fair processes for addressing disruptive behavior. This is really so important to all of the other efforts around safety.
24×7: Free from Harm urges hospitals to move away from “reactive, piecemeal interventions” toward a “total systems approach” to safety. What does this mean, and what would this approach look like in practice?
Gandhi: As we describe in the report, a systems safety approach would mean making safety culture a constant priority of the leadership. It really requires everyone to be preoccupied with safety and the potential for human error and safety failures. It would look at safety in all settings, and it would consider harm, not just mortality. It requires organizations to put robust reporting systems into place and to create a culture that, as we say in the report, “encourages honesty, fosters learning, and balances individual and organizational accountability.”
24×7: Many facilities have already been working for years to tackle complex safety issues like clinical alarm management. What do they need to do differently to be more effective?
Gandhi: Again, I would say that leaders and boards need to really get involved in establishing goals, metrics, and the mechanisms to allow good reporting. And reports of adverse events need to be addressed, so that staff and patients have a good sense of what has been accomplished to prevent errors and promote safety, what still needs to be done, and any obstacles that remain. Leaders can empower their managers to act on safety risks, and managers can empower staff and make sure everyone is comfortable speaking up. Very often, teams can make significant progress by really exploring workflow and redesigning processes. Using proactive human factors and engineering approaches can help organizations better understand problems and design reliable and sustainable solutions.
24×7: The authors write, “Patient safety comprises more than just mortality; it also encompasses morbidity and more subtle forms of harm, such as loss of dignity and respect.” What are some examples of patient treatment that would violate this broader understanding of “safety”?
Gandhi: NPSF recently hosted a webcast with faculty from Beth Israel Deaconess Medical Center in Boston, a member of the Stand Up for Patient Safety program at NPSF. The Beth Israel team presented a webcast about their organization’s program to prevent emotional harm to patients, and they have written about their work as well. [Ed. note: The team’s article, “Emotional harm from disrespect: the neglected preventable harm,” was published in BMJ Quality & Safety in September 2015]. Patients who have experienced an adverse event often emphasize the impact of emotional harm even more so than physical harm. Examples can be anything from a covering physician giving very bad news to a patient or a patient witnessing another patient in crisis, instead of being moved to another area. Health professionals are under great pressure, and extremely busy, but we must take the time to treat patients as individuals, and as human beings.
24×7: Why has progress on safety issues been slower than anticipated?
Gandhi: Safety in healthcare is a relatively young field. We have had to build the knowledge base at the same time as we were trying to understand implementation science. There has also historically been less funding for patient safety than for other areas of health and medicine that impact broad populations. Healthcare is among the most complex fields as well, because every patient is different, the human body is so intricate. Healthcare leaders and organizations need to set priorities, so while you would expect patient safety to be very high on the prioritization list, sometimes it is hard to compete for limited dollars in an industry that functions on very slim margins.
Fundamentally, it still gets back to culture. There are too many organizations out there that do not encourage people to speak up about safety lapses, and too many healthcare workers fear punishment when they do make an error.
24×7: What is the role of organizations like ECRI Institute and The Joint Commission in these discussions?
Gandhi: We at NPSF believe that there is a role for anyone and everyone in helping to advance patient safety, and we’ve worked with both ECRI and The Joint Commission over the years on various projects. The new report specifies actions for various stakeholder groups. So, an example is in the area of creating centralized and coordinated oversight of patient safety, where an entity like ECRI can help by sharing data and best practices, as they do with their annual list of top technology hazards. Accrediting bodies such as The Joint Commission can set standards to require foundational education and training in safety science. We see a lot of opportunity for public-private partnerships, for example, in spreading innovation.
24×7: How did the panel arrive at its findings and recommendations?
Gandhi: The panel reviewed quite a lot of the literature on patient safety. We began to narrow things down through an informal survey of the panel members. We then met in person for a 2-day discussion, which included breakout sessions to dig deeper into certain areas. And that’s how we came up with the eight key recommendations.
24×7: Did any findings surprise you?
Gandhi: The strong desire for a central coordinated oversight approach. The panel understood this might be challenging but still felt it was important to include.
24×7: As the head of NPSF and a member of the investigatory panel, what was your role in the process?
Gandhi: My role was to recruit the cochairs and committee members, oversee the structure and format of the convening sessions, and then oversee the report writing and editing. My role was very hands-on, and we were very fortunate to have our distinguished cochairs, Drs. Don Berwick and Kaveh Shojania. They both brought very valuable experience and insight and were instrumental in forming the panel.
Tejal Gandhi is president and CEO of the National Patient Safety Foundation. For more information, contact chief editor Jenny Lower at [email protected].