America's Healthcare Transformation: Strategies and Innovations

Innovations

I

PATIENT SAFETY AND QUALITY

CHAPTER 1

Organizing Performance Management to Support High-Reliability Healthcare

Erin S. DuPree

Mark R. Chassin

Abstract

Quality and safety problems abound in healthcare despite intensive efforts across the industry to eradicate them. To rectify these problems, healthcare organizations are beginning to adopt lessons from organizations in so-called high-reliability industries. These high-reliability organizations (HROs) routinely produce stellar safety records despite operating under extremely hazardous conditions. This chapter discusses the concept of high reliability and its goal of zero harm, briefly describes a pathway that healthcare organizations might follow to pursue this goal, and focuses on how performance management can best be structured to support a high-reliability journey in healthcare.

Healthcare is complex, depends heavily on human behaviors, and is subject to unexpected occurrences at every level from the individual patient to the organizational and system levels, making it inherently unsafe. Problems such as wrong site surgeries and healthcare-associated infections persist in healthcare despite widespread attention to improvement¹ in the years following reports from the Institute of Medicine (IOM), especially To Err Is Human² and Crossing the Quality Chasm.³ One study updated the estimated number of deaths from error-related injuries published by the IOM in 1999 from 98,000 per year to 210,000–400,000 per year, with serious harm events ranging from 10 to 20 times the number of deaths.⁴

This level of harm is foreign to high-reliability organizations (HROs), which include nuclear power plants, commercial air carriers, military aircraft carriers, and even zoos and theme parks. Weick and Sutcliffe describe these organizations as managing unexpected events through five processes: (1) preoccupation with failure, (2) sensitivity to operations, and (3) reluctance to simplify; and when errors occur (4) commitment to resilience and (5) deference to expertise. These processes enable organizations to contain errors and prevent harm.⁵ Together these processes create a state of collective mindfulness in which workers look for and report unsafe conditions before harm occurs and when these problems can be more easily fixed. These industries thus learn continuously and strive for zero harm. For example, from 1990 through 2001, U.S. commercial aviation had a death rate of 13.9 deaths per million flights. From 2002 to 2013, however, that death rate plummeted by a remarkable 90% to 1.4 deaths per million flights, even though the average annual number of flights increased by 12%.⁶ This may demonstrate how HROs are never satisfied with their current level of safety.

Interest has been growing in the methods used in other industries and how they might be applied to clinical safety and quality issues⁷ within healthcare to ensure reliability for every patient, every time. Reliability in healthcare is failure-free operation from the patient’s viewpoint. First and foremost, it is safe care, and it is effective, timely, accessible, efficient, and patient centered. Healthcare is far from highly reliable even with routine safety practices such as hand hygiene, which does not occur 60% of the time.⁸ Yet there is no guidance in the high-reliability literature about how to get from low to high reliability. A roadmap has been developed at the Joint Commission, taking what has been learned from high-reliability organizations, the accreditation surveys of thousands of organizations, and some hospitals that have started to adapt high-reliability principles. The first step toward high reliability in healthcare is a leadership commitment to zero harm. The second major change for healthcare is the incorporation of safety culture principles and practices throughout the organization. A leadership commitment to zero harm and a culture of safety are essential components of HROs. Healthcare, though, requires a third component: the adoption of highly robust performance improvement methodologies. This is absent from the high-reliability literature because these industries do not have key safety processes that fail most of the time. Performance improvement methodologies originated in manufacturing industries and have evolved over time. Individual companies and healthcare organizations have seen dramatic improvements with business processes and billions of dollars saved using performance improvement methodologies.⁹–¹¹ Again, healthcare must take lessons from other industries to address the magnitude of errors and harm currently present today.

LEADERSHIP COMMITMENT

Moving toward high reliability requires a healthcare organization to adopt the long-term aim of zero harm starting with the board of trustees or directors of the healthcare organization and its chief executive officer (CEO). This commitment leads to a change in investment strategies and leadership behaviors. The board is responsible for financial performance and the quality of care delivered to the community: clinical outcomes, accessibility, patient experience, and productivity. Because board members are typically community leaders who are more comfortable with finances than clinical information, the CEO must ensure the board has ongoing education regarding the organization’s clinical performance. Adopting the goal of zero harm is critical, because a main principle of healthcare is First, do no harm; this clearly and succinctly establishes the long-term vision necessary for leadership alignment. Leadership includes the board and CEO, senior management, and nursing and physician leaders. The vision of zero harm creates a burning platform, a place around which everyone can rally, leading to profound inspiration and respect for the work in which front line workers are engaged every day. The leaders’ attitudes, beliefs, and behaviors, especially the CEO’s, are central to the changes in organizational culture.

SAFETY CULTURE

A culture of safety has three central attributes: trust, reporting, and improvement.¹² Front line workers trust their peers and management to routinely recognize and report errors and unsafe conditions. Trust is established through the elimination of intimidating behaviors, fixing problems that have been reported, implementing improvements, and communicating the improvements consistently and broadly. Visible, meaningful improvements strengthen trust and reporting and create a positive reinforcing cycle (Figure 1.1). Holding everyone accountable for consistent adherence to safe practices is another critical ingredient for trust. Healthcare organizations often punish staff for blameless acts while failing to implement equitable disciplinary procedures across disciplines and departments, a failure that leads to confusion around accountability and diminished trust. Workers fail to report because they are afraid that the errors will end up in their personnel files.¹³ Many physicians continue to work largely as independent craftsmen, claiming their own approach to patient care without accountability to the care team or system that supports the diagnosis and treatment plan.¹⁴ If physicians who bring in high revenues are allowed to misbehave, then workers see the priority of leadership as production over safety. Nurses still eat their young, also contributing to the pervasive issues with behavior and accountability in healthcare.¹⁵

FIGURE 1.1   Safety Culture. Adapted from Reason J, Hobbs A.¹²

High-reliability organizations recognize that errors and harm are always possible and seek to continuously learn and improve. Humility on the part of healthcare leaders is required so they can understand that the vast majority of adverse events are the result of system or management failures, not individual failures. Even with the elimination of harm and system failures, organizations do not arrive at high reliability. Organizations continuously learn and strive to deliver better care. Creating an infrastructure for performance improvement provides an organization with the cultural underpinnings—the foundation—to be a high-reliability organization.

IMPROVEMENT: SIX SIGMA, LEAN, AND THE IMPORTANCE OF CHANGE MANAGEMENT

Modern quality improvement methods were developed initially in manufacturing industries in the decades after World War II by W. Edwards Deming and others. Deming combined statistical process control with transformational change for superior performance, or what has become known as operational excellence.¹⁶ Dramatic results in performance are evident in diverse companies such as General Electric, Motorola, and Toyota,⁹ which have embraced process improvement methods. These effective process improvement approaches based on Deming’s management principles have not been incorporated effectively into healthcare delivery. Healthcare organizations too often look to external agencies to create their quality agenda and strategy, instead of leading from within and determining strategic objectives from their own analysis of the needs of the patients and communities they serve. Quality strategies are typically produced in reaction to the ever-growing list of federal and state requirements and public demands, leading to project fatigue throughout the industry.

The performance improvement infrastructure is a critical component to the creation of a high-reliability organization in healthcare. In the 1970s, Motorola, a company at the leading edge of industrial America, recognized it had a quality problem and adopted Deming’s postulate that a focus on quality decreases cost while increasing customer satisfaction; this ran counter to the prevailing focus on cost, which can lead to decreased quality and eventually increased costs and decreased customer satisfaction. Variation was linked to defects and waste: eliminate the variation and quality will increase, costs will decrease, and customer satisfaction will increase. Motorola assembled the problem-solving methodology of DMAIC—that is, define, measure, analyze, improve, and control (Figure 1.2). This alignment with the scientific method addressed variation and became known as Six Sigma, or zero defects. Sigma is the symbol for standard deviation in statistics, and standard deviation levels help us understand how much the process deviates from perfection. The higher the sigma level, the less variation there is and the better the process is. Today, Six Sigma emphasizes a structured organizational approach to competency-based deployment so that the entire workforce is trained and the methodology becomes the way the organization does its work. Six Sigma has become a philosophy of management that emphasizes the importance of understanding factors critical to quality and customer expectations through the measurement and analysis of data, the implementation of solutions designed to improve processes to affect the most statistically significant sources of variation, and sustaining these solutions. With billions of dollars of documented savings in individual companies, Six Sigma has proven to be the most effective process-improvement method in history.¹⁷

FIGURE 1.2   DMAIC (Define, Measure, Analyze, Improve, and Control), A problem-solving methodology

The lean concept also evolved in the Japanese automotive industry as an integrated system of principles, practices, tools and techniques focused on increasing customer value, improving work flows throughout the value stream, and reducing waste.¹⁸ Rather than organizing work processes to accommodate physicians and nurses, lean in the healthcare industry stresses the need to make the patient—the customer—the starting point for all process design, with all subsequent decisions guided by the notion of narrowing all actions to only those the patient deems valuable. Occurrences that patients do not perceive as valuable include waiting to be seen and getting hospital-associated infections. This not only includes lost lives and resources but also lost human potential, which could be applied more usefully to providing better care if waste and defects were eliminated.¹⁹ Lean emphasizes operational change driven by the front line staff who best understand the processes, recurrent errors, and unsafe conditions that need to be improved, which results in profound respect for the front line staff. However, lean is weak on organizational infrastructure, deployment plans, analytical tools, and control.²⁰

Combining lean approaches with Six Sigma leads to an expanded breadth of application and enables an organization to benefit from both types of improvement, depending on the nature of the problem. Six Sigma is the best method for chronic, complex problems when solutions are not known; lean tends to work best with problems that have known solutions that are not being implemented, enabling rapid improvements with minimal data collection.

Many quality improvement initiatives fail or are not sustained because of a lack of acceptance and accountability. Change management is a set of actions supported by a tool set that is used to address these aspects of improvement by providing guidance at every stage of performance to everyone at every level. The tools increase the exposure and participation of staff and leadership in shaping new solutions and interventions; this increases the speed in which a proposed change is adapted and accepted, reinforces its effectiveness, and strengthens sustainability. The tools facilitate employees’ ability to improve processes by engaging them in managing and directing the constant change that is inherent in any dynamic business environment, especially healthcare.

A blend of Six Sigma, lean, and change management emphasize data-driven problem solving to understand the root causes for performance failure, removing waste from processes, and recognizing and harnessing the needs and strengths of the people who will implement and sustain the required changes. Collectively called Robust Process Improvement® (RPI®), these methods build on the strengths of prior methodologies and offer a systematic approach to dissecting complex safety problems; this can help guide an organization to deploy focused, highly effective solutions.²¹ The tools from one or two methods and toolboxes are not adequate to address the layers of complex issues in healthcare today: Countless deep problems in healthcare require RPI.

RPI strategies, methods, and training programs have been used effectively to improve business processes as well as patient-centered processes and outcomes (Figure 1.3).¹,¹¹,²¹ These results emphasize the importance of developing a measurement system that will lead to targeted solution development and reliably assess whether the solution actually leads to improvement. The link to overall organizational strategy, patient-centered definition of problems, inclusion of change management, and data-driven approach to analysis leads to changing processes critical to system performance. To date, although there is a growing awareness of lean and Six Sigma, much of the diffusion in healthcare has been inconsistent and thus limited in effectiveness: isolated consulting engagements, a brief leadership introduction to the concepts, or dependency on a specific organization leader who has brought enthusiasm to the topic. Increasing improvement capacity is the basis for transforming individual healthcare organizations and the delivery system at large.

FIGURE 1.3   RPI improves patient-centered processes and outcomes. Reproduced from Chassin MR, Loeb JM.¹

HOW TO BUILD AN RPI PROGRAM THAT LASTS

A consistent approach to improvement across an entire organization is needed in order to effectively move toward an organization’s vision, mission, and strategic imperatives. If a consistent approach is not part of the organizational culture, then transformation and sustainability will remain elusive. A commitment to performance improvement is aligned with patient interests, organizational reputation, employee engagement, and a favorable return on investment. For example, the Mayo Clinic has documented a 5:1 return on its investment in effective performance improvement methods.²² Patients, providers, insurers, and employers all benefit. Companies such as General Electric, BD, Cardinal, and Eli Lilly have shown how to embed a program into an organization, yet these successes cannot be imported directly from Fortune 500 companies.¹¹ Implementation of performance improvement methodology can fail for many reasons, including a lack of financial or human resources, poor training, project selection that is not tied to strategic imperatives, and a lack of leadership.²³ To ensure that the methodology becomes the way the organization does its work and becomes part of its culture, leadership commitment and support to the ongoing investment of financial and human capital are critical.

A board-level commitment to implementation of a performance improvement methodology ensures that it will be more than a flavor of the month type of initiative. It enables performance improvement to not be dependent on one person or department. Ongoing education of the board in quality principles, RPI tools, and its role in providing that oversight is a necessary component to ensure that the commitment is sustained. Keeping the board abreast of the progress and results of strategic projects and organizational change is critical to successful integration. A financial commitment enables the senior management team to invest in effective training and develop the internal capacity over time to train management and staff across the organization in the tenets of improvement and to avoid costly consultants who helicopter in and out of an organization.

The CEO’s role is to create and foster an environment that sets the stage for success. He or she must signal by committing time and energy that implementing RPI is a principal organizational priority. The CEO must educate the board and also align senior managers around an understanding of RPI: what it is, why the organization will benefit from it, and how the organization will operationalize the training, methods, and spread of the methodology. Management alignment on the importance of training is necessary because training can take up to 25% of a staff member’s time over many months. If management does not see the training as important, then staff members will not have the time or support from their supervisors to do the work necessary to complete the training.

Getting the buy in of the chief financial officer (CFO) is critical because he or she will want to see a return on the investment. The CFO should lead efforts to track the costs of training and validate the financial results of any improvement initiative. The head of human resources is also important to sustaining improvement in the organization because completion of RPI training and the use of improvement methods and tools are incorporated over time into staff development and performance expectations. Performance expectations of leaders and managers should include goals for spreading RPI in their areas of responsibility.

The clinical leadership (e.g., chief medical officer, chief quality officer, vice president of medical affairs, and chief nursing officer) have the responsibility of promoting the program, working with leaders to identify trainees, and operationalizing training time and support for large groups of workers across the organization. Their alignment with the program is essential. They often take the brunt of dealing with influential resisters and need the explicit support of the board, CEO, and CFO to do their jobs.

Project selection, or the right work, is critical to the success of RPI in an organization. Initiatives should be tied to issues of strategic importance. For example, the Red Cross Hospital in Beverwijk, Netherlands, realized that the projects they worked on were not necessarily always strategic or did not have significant drivers aligned with the organization’s business. The hospital lacked a systematic process for project management and tracking, and projects were often not completed. Management adopted Six Sigma to overcome these challenges to improvement.²³

Measuring the results of the RPI program allows for adjustments and midcourse corrections when necessary. The return on investment, progress spreading across the entire organization, staff knowledge, and the use of RPI are all indicators that can be tracked over time to measure how well RPI is being implemented. RPI integration in an organization is a strategic goal in and of itself, the progress of which is reported to the board.

To embed the management philosophy and methodology throughout the organization, the training must go beyond a few select individuals or just the quality department: Limited expertise leads to limited results in improvement. To transform to a learning and improvement culture, everyone must be trained at a level appropriate to their positions so that RPI becomes the way work is done in the organization. This internal capacity allows management and staff to speak the same language and work across silos to achieve organizational objectives. The knowledge and skills gained empower front line staff to identify and act on opportunities to improve.

The creation of multiple levels of training allows opportunities for all staff to participate. RPI training includes courses for leadership, RPI experts, change leaders, full-time trainers and mentors, and foundational tools and concepts. Training starts with leadership. Leaders learn how to be role models for behavior, providing motivation and support, and accepting specific program and project responsibilities. Leaders are taught how to select staff and projects for training. Leaders also learn the critically important task of embedding the program in their organization. An early objective is to create a group of internal experts and trainers.

The most talented formal and informal leaders across the organization are selected to become the organization’s RPI experts (e.g., green belts, black belts). The training for green belts can take up to 25% of their time over 6 to 12 months. Typically, several teams of green belt trainees are trained at once, with each team drawn from different parts of the organization. The teams work on projects as they learn the tools; this allows each team of 3 to 5 trainees to see how RPI works for a variety of initiatives. This approach also fosters cross-departmental communication and breaks down internal silos. Once they have been trained, the green belts remain embedded throughout the organization to facilitate and lead ongoing improvement initiatives.

A few select green belts undergo additional training to become black belts. Once trained and certified as black belts, these individuals spend 100% of their time on organization-wide strategic initiatives. A few black belts and change leaders undergo even more advanced training to become full-time RPI trainers and mentors for the organization: master black belts and master change leaders. This group will become the critical mass of trainers who can facilitate spread of the methodology and capacity across the organization.

The importance of change management cannot be underestimated. Accepting solutions and being accountable for change are usually the most difficult aspects of implementing, sustaining, and spreading improvement. Staff throughout the organization are trained as change leaders. These individuals are trained only in change management tools and techniques, ensuring that change is thoughtful and managed to support continuous improvement. In addition to the change leaders, everyone in the organization incorporates change management tools as part of daily work. The tools are used to ensure that meetings are purposeful and run efficiently with clear accountability for decisions made and work to be done. When discussions lead to differing opinions and ideas even when decisions must be made, change management tools can help achieve consensus. When conflicts arise across the organization, change agents facilitate meetings to work through the issues and move forward.

The rest of the workforce is trained in the principles and basic tools of RPI (yellow belts) so workers understand the language, execute small-scale process improvements in their work area, and participate in larger organizational initiatives. This is the introductory, or foundational, level of training. All three toolkits (lean, Six Sigma, and change management) are introduced and a project is completed using some of the tools. Participants do not need to learn in-depth statistical analysis for this level of training but do learn meaningful ways to present data and the practicality of statistical process control in the early detection and prevention of problems rather than inspecting problems.

To be sustainable, the integration of performance improvement management and methodology requires substantial change and ongoing employee engagement. Programs and infrastructure need to be developed to ensure trainee skills are used and maintained after the initial training. RPI training and projects should be a consistent presence in the employee newsletter. Celebrations at the close of projects and annual fairs can keep implementation fun and rewarding. The CEO must visibly champion and recognize those individuals who undergo training and use improvement methodology in their work. The CEO can include the progress of the RPI program and project results in town halls, daily meetings, and board reports, as well as when speaking with external stakeholders.

A fundamental shift in healthcare quality from a top-down, externally driven process that tells providers what to do to a blend of top-down and bottoms-up approaches is critical for the transformation to high reliability in healthcare. Front line caregivers are in a unique position to address the fundamental barriers to improving clinical care: Only they fully understand how complex the work is and the strengths and weaknesses of the electronic health record; they are also the ones involved in high-risk communication processes. Leadership commitment and clear strategic direction allows and empowers front line providers who are trained in robust improvement methods to identify variations in care and develop interventions that ensure safe, excellent care. Without improved knowledge and skills, clinical teams have only limited abilities to innovate and effectively improve local processes. RPI is an approach to performance and organizational culture change that enables transformation. Much of healthcare improvement today rests in the hands of leaders to take the initiative to learn about performance methodologies and increase improvement capacity within their own organizations. Leadership commitment to performance improvement management and methodology is essential to high reliability in