INSIGHT: Achieving Zero Harm Through High Reliability in Health Care

“The single greatest impediment to error prevention in the medical industry is that we punish people for making mistakes.” — Lucian Leape

Introduction

Health care organization leaders and the health lawyers who advise them, both in-house and as outside counsel, have important roles to play as quality and safety champions who can advocate for zero patient harm. Understanding the concept of high reliability in health care, why it’s important to meeting longstanding health care quality and patient safety goals, and the resources available from The Joint Commission to implement its high reliability model for health care can help these organizations meet these goals.

The premise? If we want substantially better results in health care, we need a different approach to quality improvement. High reliability is that different approach. It’s not a one-time project. It is not a buzzword. It is about transforming health care organizations so that zero harm is the natural byproduct of the way patients are cared for every day.

High reliability in health care means “maintaining consistently high levels of safety and quality over time and across all health care services and settings (Chassin & Loeb, 2013).” This is a high bar to achieve in health care. Although many health care organizations have made high reliability and zero harm their goals, few (if any) have achieved this. The Joint Commission—a private, not-for-profit organization that develops safety and quality standards and evaluates thousands of health care organizations for compliance with these standards—knows of no one health care organization that has achieved such a high level of performance.

High Reliability Organizations

The overall goal of high reliability organizations is zero harm. Classic examples of high reliability organizations include commercial airlines, nuclear power plants, aircraft carriers, and even zoos. These organizations maintain extraordinarily high levels of quality and safety over long periods of time with no or extremely few adverse or harm events, despite operating in very hazardous conditions. (Chassin, 2018) In health care, high reliability means that care is consistently excellent and safe.

Weick and Sutcliffe describe high reliability organizations as having an environment of collective mindfulness where workers look for, report, and address small problems or unsafe conditions when they are easy to fix, and long before they pose a major hazard (Weick and Sutcliffe, 2007). Reason and Hobbs describe organizations that have a strong commitment to safety as being learning organizations. Learning organizations value errors and close calls which they regard as free lessons that lead to the identification and resolution of weaknesses in the systems and structures designed by the organization to prevent harm (Reason & Hobbs, 2003).

Zero Harm: An Aspirational Goal

The stellar safety records of high reliability organizations is in stark contrast to current conditions in health care. The Institute of Medicine’s 2000 report “To Err is Human,” pushed safety to the forefront of priorities for health care leaders. As a result of the focus on safety and quality, there have been remarkable improvements in patient safety, notably the reductions in a set of hospital acquired conditions in the United States between 2010 and 2014 (Agency for Healthcare Research and Quality, June 2018).

However, despite almost two decades of focus on safety and some important improvements, patients are still harmed in dishearteningly predictable ways: health care-associated infections, patient falls, wrong site surgeries, poor communication among care givers, and others. It seems clear that the current state of improvement in health care has fallen short of our expectations. We are not moving the needle far enough or fast enough. The widespread interest in adopting high reliability principles and practices and embedding these in the operations of health care organizations stems from industry-wide recognition that the current state is not good enough, and that we ought to try something else.

A High Reliability Model for Health Care

In its study of high reliability organizations, The Joint Commission found that there were no blueprints or roadmaps that health care organizations could use to guide their transformation to high reliability. To bridge this gap and translate high reliability principles to health care, Chassin and Loeb presented a framework for high reliability that is specific to health care. The High-Reliability Health Care Maturity Model (Maturity Model) has three foundational domains of change that are mutually reinforcing:

1. Leadership commitment to zero harm that is the necessary first step before widespread changes in systems, structures, behaviors, and outcomes can take place.
2. A fully functional safety culture where employees speak up to identify unsafe conditions motivated by their understanding that preventing harm is the priority.
3. Widespread deployment of Robust Process Improvement (RPI) tools such as Lean Six Sigma and change management, used by employees to eliminate unsafe conditions and address opportunities for improvement.

The Maturity Model has 14 components or areas of performance across the three domains, and four progression levels from Beginning, Developing, Advancing, to Approaching (Chassin & Loeb, 2013). The Maturity Model helps organizations determine where they are within the three high reliability domains, allowing an organization to move forward by focusing on their own performance areas that need the most attention.

The Three Domains of Change

Leadership commitment to zero harm is the first step before other changes begin. Yet, visible and active commitment to the goal of zero harm is not simple. Hospital leadership teams have found that aligning on a definition of high reliability that is relevant to their mission, stakeholders, staff, and patients is challenging. In addition, the idea that zero harm is possible, and even likely, if specific systems, structures, behaviors and practices are in place, continues to be controversial. Coleen Smith, director of High Reliability Initiatives at the Joint Commission’s Center for Transforming Healthcare, describes the belief and commitment to zero harm as a massive mindset shift that is the game changer for high reliability transformation in health care. The belief that zero harm is possible changes expectations, and leaders organize accordingly. Leaders make achievement of zero harm possible by providing the resources and expertise necessary to achieve the goal. This is where safety culture and RPI—the two other high reliability domains—fit into high reliability transformation.

Trust is the foundation of a safety culture, leading concerned employees to report unsafe events and identify opportunities for improvement. When leadership responds positively to these opportunities, employees are then further motivated to report, which results in more improvement and builds greater levels of trust (Chassin & Loeb, 2013).

There is growing understanding that the vast majority of errors that contribute to harm are the result of flawed systems and processes, rather than the irresponsible or negligent actions of individuals. Trust becomes stronger when an organization, through its leaders and its policies, shows its employees that it can distinguish blameless acts that are the products of system failure from reckless behavior, and that there are different consequences for each (Reason and Hobbs, 2003). However, errors and harmful events still lead to blame more often than not and individuals are punished for mistakes they may not have had control over compromising trust and employee engagement. A punitive culture is a dangerous culture. It erodes trust, inhibits reports of unsafe events, and hinders communication and collaboration, which are crucial for excellent patient care (Leonard & Frankel, 2011). Organizations with punitive cultures are not likely to learn from errors and adverse events, making it more likely for harm to reoccur.

The deployment of RPI is a powerful improvement mechanism that facilitates leadership’s drive to zero harm. Longstanding problems in health care, like sepsis, hospital-acquired pressure injuries, and others persist because they are complex and multi-factorial, resisting the one-size-fits-all “best practices” model. In contrast, RPI focuses on first finding an organization’s most significant factors that contribute to harm. These factors are unique to each individual organization. Then, targeted solutions are developed to address each factor to yield dramatic improvements. Lean Six Sigma provides data-driven problem solving, and change management harnesses the expertise of the people affected by the change so they are prepared to create, champion, and implement solutions. Because of these components, RPI has the breadth and sophistication to navigate complexity, leading to lasting and dramatic improvements.

While it is easy to measure concrete improvements in clinical, operational, and financial gains that result from the application of RPI, it is just as important to note the intangible benefits that RPI brings to a culture. The heart of successful RPI deployment is the ongoing training of employees and leaders in RPI methods and their application, with the expectation that RPI will become an organization’s common language and methodology for quality and improvement.

Staff who participate in RPI training programs are proud to be selected, which improves engagement and trust in the organization. The expertise of RPI practitioners deepens and improvement multiplies as they apply their skills to everyday work to benefit patients, colleagues, and the organization. Improvement is, in essence, about making the world a better place, inspiring joy, and engagement (Swensen, J Patient Safety, 2013).

Conclusion

As health care organizations pursue the goal of zero harm, it will be necessary to change their infrastructure to support the systems, processes, behaviors, and practices that make high reliability health care possible. Legal leadership and teams within health care can play an important role to advocate for systemic changes that will result in health care that is consistently excellent and safe.

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Lisa Diehl Vandecaveye is general counsel at The Joint Commission, in Oakbrook Terrace, Ill. She can be reached at lvandecaveye@jointcommission.org. Anne Marie Benedicto is vice president of the Joint Commission Center for Transforming Healthcare, also in Oakbrook Terrace. She can be reached at abenedicto@jointcommission.org.

To learn more about high reliability, including the Center’s related resources and tools, please visit centerfortransforminghealthcare.org.