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    Steve Brewer
    Steve Brewer, MBA, CMPE, FACHE

    While the concept of providing safe patient care is traced back to Hippocrates’ “first, do no harm” more than 2,000 years ago, it wasn’t until the 1990s that patient safety gained visibility as a strategic imperative.1 Since the 1999 To Err Is Human report by the Institute of Medicine, patient safety has evolved into a diverse and complex field within healthcare.2

    Providing a safe care environment touches on all facets of healthcare. Because of the depth and breadth of the patient safety field, organizations can struggle with focusing resources and establishing priorities.3 Developing a strong culture of safety at all levels of an organization should be the first step toward delivering highly reliable patient care.

    Tenets for advancing a patient safety culture

    Leadership commitment: Effective and engaged leadership sets the vision and explains why delivering safe patient care is critical for healthcare systems.4 Leadership engagement includes a strong connection to the governing board, as well as the CEO, and other senior leaders demonstrating the importance of patient safety.5 Organizational leaders, working together with physicians and staff, are essential in establishing a highly reliable care environment.6 Examples of integrating patient safety at all levels of leadership include the CEO participating in patient safety trainings, senior leadership integrating safety into their performance goals and front-line supervisors deploying best practices within their departments.

    Fostering psychological safety

    Organizational leaders are also instrumental in developing a safety culture by ensuring all employees feel safe in pointing out areas for improvement or flawed practices that can lead to patient harm. The Institute for Healthcare Improvement (IHI) describes this as psychological safety.7 Leaders who understand psychological safety foster an environment in which employees feel comfortable asking questions, seeking feedback, allowing for diverse opinions and making suggestions without fear of criticism or being made to feel incompetent. Organizations that encourage this open communication in an accepting environment have high levels of employee and clinician engagement in reducing errors and providing safe care.8

    Principles of highly reliable organizations

    Learning from other businesses with significant risk for harm and functioning in highly complex and stressful environments such as the nuclear and airline industries, healthcare systems can adopt certain principles in striving to be highly reliable organizations (HROs).9 HROs have demonstrated an ability to create highly effective safety cultures and adopt methods to continuously learn from near misses, errors and process reviews to achieve nearly failure-free performance.10 Effective health systems have developed highly effective safety cultures by incorporating the following characteristics of HROs:

    • Preoccupation with failure. Healthcare leaders understand that processes in complex environments are subject to failure and that clinicians and staff must be fully aware and committed to reducing errors and preventing harm.11 This preoccupation with failure translates into a hyperfocus on not only causes of actual errors but also treating near misses as red flags to be addressed as a means to proactively avoid causing patient harm.
    • Reluctance to simplify. HROs foster a culture whereby simple explanations or tolerating the notion that there will always be some level of failure is not acceptable. Leaders and staff refuse to accept variations as the norm and strive toward zero-error performance.12
    • Sensitivity to operations. Operations and workflows can impact reliability at all levels of an organization.13 Thus, organizations should continuously monitor how day-to-day occurrences affect the delivery of highly reliable care. In HROs, everyone is encouraged to continuously call out situations that can deter from a safe practice, which leads to a heightened awareness of potentially harmful situations. This mindful awareness points to how subtle variations in operations can significantly impact the delivery of safe care.14
    • Commitment to resilience. When an error happens, organizations with a highly reliable safety culture act quickly to minimize harm and prevent future occurrences. Resiliency includes a focus on a just culture in which mistakes are not met with an assumption of incompetence but rather an opportunity to review process and look for contributing system factors.15 By fostering a non-blame culture, physicians and staff are more open to reporting errors and working together to improve processes.16
    • Deference to expertise. This characteristic is the acknowledgment that those closest to the work are integral in developing safe workflows and must be included in the planning for process development.17 Healthcare organizations recognize this as a principal foundation and seek out those with the most relevant knowledge and experience to engage them in development of safe, highly reliable practices regardless of their formal role or title.18

    Integrating continuous process improvement methods

    Another foundation in building a safety culture is integrating a systematic and structured approach to continuous process improvement with the overarching goal of achieving optimal quality outcomes. Continuous improvement sciences draw from the fields of psychology, engineering, management and statistical process controls. Translating these into the healthcare setting can be challenging; however, there are some basic frameworks to facilitate simple yet effective structures for integrating process improvements in advancing a culture of safety at all levels.19

    Change management

    At its core, effective change management can be described as a systematic approach that helps people understand, accept and implement changes to achieve a desired result.20 A basic element of change management is to explain the “why” a change is needed and to include those most closely affected in the improvement planning.21 This is a critical first step in developing a culture that reliably delivers safe and effective care.

    Plan-Do-Study-Act model

    The Plan-Do-Study-Act (PDSA) model provides a solid framework on which to build a common vision and method for approaching continuous improvement.22 Following the PDSA model entails planning for change; putting the change into action; studying the results; and acting accordingly to refine, plan and implement the next improvement cycle. The IHI, along with others in the field, have supplemented the PDSA model with three basic questions:23

    • What is the organization or team trying to accomplish?
    • How will they know that a change will be an improvement?  
    • What change will result in improvement? 

    Integrating these three questions into the PDSA cycle can provide additional context and clarity when pursuing continuous improvement efforts.

    Process improvement tools

    Understanding why change is needed and filtering ideas through the PDSA improvement model can help organizations move toward a culture of patient safety, but these concepts alone are not enough for high reliability. HROs systematically embed tools and techniques in Lean and Six Sigma throughout the organization.24

    Lean is a process improvement method that focuses on removing waste, streamlining processes and improving efficiency. Six Sigma focuses on statistical process controls and techniques to minimize variation and to ensure highly reliable performance. Lean and Six Sigma are used in tandem by many organizations as primary techniques to systematically measure, test and implement changes for better clinical processes and outcomes.25 By using well-established Lean and Six Sigma tools, organizations also ensure that a common language for process improvement is understood at all levels. Having this common terminology for continuous improvement is vital for an aligned and effective improvement culture.26


    Achieving an HRO and delivering near-perfect care with zero harm is a lofty goal. This notion is often met with some resistance by those within healthcare who believe that medicine, while based in science, has too many variables to ensure zero errors and that some level of harm is unavoidable. However, as the field of patient safety has accelerated since the Institute of Medicine report on medical errors in the 1990s, significant progress has been made in reducing mistakes and providing safer care to patients. By adopting the key elements of engaged leadership, fostering environments for open dialogue at all levels and instituting effective process improvement methods, healthcare will continue to build cultures focused on reliably delivering safe and effective care to individuals and the communities they serve.


    1. Wachter RM, Gupta K. Understanding patient safety, 3rd edition. 2018. New York: McGraw-Hill Education.
    2. Nash DB, Clark J, Skoufalos A, Horowitz M., eds. Health care quality: The clinician’s primer. 2012. Tampa, Fla.: American College of Physician Executives.
    3. Chassin M, Loeb J. “High reliability health care: Getting there from here.” The Millbank Quarterly, 91, 459-490. Available from:
    4. Benedicto AM. “Engaging all employees in efforts to achieve high reliability.” Frontiers of Health Services Management, 2017, 33(4), 33-40.
    5. Chassin, Loeb.
    6. Weaver R. “Seeking high reliability in primary care: Leadership, tools, and organization.” Health Care Management Review, 40, 183-192.
    7. Frankel A, Haraden C, Federico F, Lenoci-Edwards J. “A framework for safe, reliable, and effective care.” White paper, Institute for Healthcare Improvement and Safe and Reliable Healthcare. Available from:
    8. Cawley PJ, Scheurer DB. “Achieving high reliability through cultural mindfulness.” Frontiers of Health Services Management, 33(4), 3-15.
    9. Burroughs J. (Ed.). Essential operational components for high performing healthcare enterprises. 2018. Chicago: Health Administration Press.
    10. Federico F. “Is your organization highly reliable?” Healthcare Executive. January 2018;33(1):76-79. Available from:
    11. Bondurant P, Nielsen-Farrell J, Armstrong L. “The journey to high reliability in the NICU.” Journal of Perinatal Nursing, April/June 2015;29, 170-178.
    12. Federico.
    13. Bondurant, et al.
    14. Cawley, Scheurer.
    15. Miller RG, Scott SD, Hirschinger LE. “Improving patient safety: The intersection of safety culture, clinician and staff support, and patient safety organizations.” White paper. Available from:
    16. Ibid.
    17. Cawley, Scheurer.
    18. Bondurant, et al.
    19. Frankel, et al.
    20. Chassin, Loeb.
    21. Bondurant, et al.
    22. Wachter, Gupta.
    23. Frankel, et al.
    24. Wachter, Gupta.
    25. Frankel, et al.
    26. Bondurant, et al.

    Steve Brewer

    Written By

    Steve Brewer, MBA, CMPE, FACHE

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