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Leadership and patient safety culture
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Content
Leadership and Patient Safety Culture
by
Susan L. Montminy
Rossier School of Education
University of Southern California
A dissertation submitted to the faculty
in partial fulfillment of the requirements for the degree of
Doctor of Education
December 2021
© Copyright by Susan L. Montminy 2021
All Rights Reserved
The Committee for Susan L. Montminy certifies the approval of this Dissertation
Cathy Krop
Alexandra Wilcox
Emmy Min, Committee Chair
Rossier School of Education
University of Southern California
2021
iv
Abstract
It has been estimated that medical errors are the third highest-ranking cause of death in the
United States (Makary & Daniel, 2016). A patient safety culture has been touted for many years
as best practice to reduce medical error by several health care agencies (Joint Commission, 2016;
Emergency Care Resource Institute [ECRI], 2019; The National Patient Safety Foundation
[NPSF], 2015). While there is a general agreement of its importance, it has remained elusive for
many. This study sought to learn how strengthening leadership skills within a healthcare
organization could catalyze patient safety culture improvement. The research asked the following
to gain an appreciation for that question: How does a leader ensure consistency in policies,
practices, and protocols to create a patient safety culture? What attitudes, beliefs, and collective
efficacy are needed to produce a patient safety culture? What leadership characteristics are
needed to create a patient safety culture? The research participants were the employees who
make up the patient safety department in a large academic healthcare system. Information was
gathered to capture their view of leadership’s role in patient safety culture and to gain knowledge
relative to their individual experiences following a medical error. The study’s findings revealed a
need for alignment of senior leadership’s attitudes on patient safety, consistent leadership
approaches to patient safety principles, and consistently applied staff support following a
medical error. According to Kotter (1995), nothing undermines change more than behavior by
leaders that are inconsistent with their words.
v
Dedication
To my husband Brian and my sons Brian and Samuel. Family is everything.
To all hard-working and devoted healthcare professionals
vi
Acknowledgements
I have so many to thank for this accomplishment and humbly admit I could not have done
it without their never-ending support. To Cohort 14, we came together as strangers and are
leaving as lifelong friends. Who knew what life had in store for us when we began our journey
together in the summer of 2019? We not only helped each other survive the rigorous courses,
assignments, and dissertation process, we also helped each other survive the pandemic. At its
height when we were confined to our homes, two nights a week, we came together for a small
glimpse of normalcy in our upturned lives. We survived loved ones’ deaths, lost jobs, new jobs,
relocation, homeschooling, and bouts of illness. The bonds made during this time are forever.
To the professors who tirelessly imparted their wisdom throughout our years together,
pivoting when needed due to the unprecedented times in history we were encountering, I thank
you. I fondly recall Immersion I, a naive time when we could gather without social distancing,
hug, and dine together connected by a shared purpose; to achieve a doctoral degree from USC
and change a small piece of the world. I vividly recall Dr. Eric Canny telling us that we would
not be the same person when we graduate. He was so right.
To Dr. Emmy Min, my dissertation chair, I always felt you wanted me to succeed. Each
time you offered feedback, it was always delivered most respectfully. That was appreciated
more than you know. To my dissertation committee, Drs. Alexandra Wilcox and Cathy Krop,
thank you for taking the time to review my dissertation with such detail, the suggestions you
made truly enhanced the final product.
vii
To my husband Brian, from the moment we started dating and I was struggling to finish
school and become a registered nurse, your belief in me has never wavered. Over 30 years later,
it still carries me through dark times when I feel that I can’t go on. To my son Brian, for all of the
leadership talks we engaged in, these special moments reminded me how important the lessons I
was learning are. To my son Sam, for all of those times when I said, “I can’t do this”, and you
immediately responded, “Oh yes, you can!” This mattered more than you know. And to the rest
of my family members for your constant words of support and patient ear as I relentlessly talked
about school, I thank you.
And to all healthcare professionals, who tirelessly care for their patients, at times working
in the most difficult of conditions, I am so grateful for you. I hope that in some way, my work,
and the lessons learned in my research, can prevent even just one patient or healthcare
professional from harm. That is my passion and the reason I go to work each day.
viii
Table of Contents
Abstract .......................................................................................................................................... iv
Dedication ...................................................................................................................................... v
Acknowledgements ........................................................................................................................ vi
List of Tables ................................................................................................................................ xii
List of Figures .............................................................................................................................. xiii
Chapter One: Introduction .............................................................................................................. 1
Introduction to the Problem of Practice .............................................................................. 1
Study Context and Background .......................................................................................... 2
Organizational Goal and Mission ....................................................................................... 3
Stakeholder Groups for the Study ....................................................................................... 3
Overview of Methodological Framework ........................................................................... 4
Purpose of the Project and Research Questions .................................................................. 5
Definitions........................................................................................................................... 5
Organization of the Dissertation ......................................................................................... 6
Chapter Two: Literature Review .................................................................................................... 8
The Cost of Medical Errors................................................................................................. 8
To Err is Human: Medical Error ......................................................................................... 9
Patient Safety Culture ....................................................................................................... 10
Effective Leadership ......................................................................................................... 13
Theoretical Framework: Leadership through the Clark and Estes Lens ........................... 16
Summary ........................................................................................................................... 27
Chapter Three: Methodology ........................................................................................................ 28
Research Questions ........................................................................................................... 28
Overview of Design .......................................................................................................... 28
ix
Data Collection Methods .................................................................................................. 29
Research Setting................................................................................................................ 30
The Researcher.................................................................................................................. 31
Data Sources ..................................................................................................................... 34
Instrumentation ................................................................................................................. 35
Data Collection Procedures ............................................................................................... 36
Data Analysis Procedures ................................................................................................. 37
Ethics................................................................................................................................. 40
Limitations and Delimitations ........................................................................................... 41
Chapter Four: Findings ................................................................................................................. 43
Data Analysis .................................................................................................................... 44
Analysis through the Research Questions......................................................................... 49
Research Question 1 ......................................................................................................... 49
Research Question 2 ......................................................................................................... 57
Research Question 3 ......................................................................................................... 67
Summary ........................................................................................................................... 73
Chapter Five: Recommendations .................................................................................................. 74
Discussion of Findings ...................................................................................................... 75
The ADKAR Model .......................................................................................................... 80
Summary of Recommendations ........................................................................................ 86
Limitations and Delimitations ........................................................................................... 89
Strengths and Weaknesses of the Approach ..................................................................... 90
Recommendations for Future Research ............................................................................ 90
Conclusion ........................................................................................................................ 91
References ..................................................................................................................................... 93
x
Appendix A: Interview Protocol ................................................................................................. 109
Appendix B: Document Protocol ................................................................................................ 113
xi
List of Tables
Table 1 Summary of Key Components of a Patient Safety Culture ........................................... 936
Table 2 Knowledge Influences and Assessments for Analysis .................................................... 18
Table 3 Motivation Influences and Assessments for Analysis ..................................................... 21
Table 4 Organizational Influences and Assessments for Analysis ............................................... 22
Table 5 Data Collection Methods ................................................................................................. 30
Table 6 Participant Demographics ................................................................................................ 45
Table 7 Participant Years Working in the Patient Safety Field .................................................... 48
Table 8 Summary of Responses in Support of RQ1 ..................................................................... 55
Table 9 Knowledge Influences and Gaps ..................................................................................... 57
Table 10 Summary of Responses in Support of RQ2 ................................................................... 63
Table 11 Motivation Influences and Gaps ................................................................................... 67
Table 12 Summary of Responses to RQ3 Related to Leadership Characteristics ....................... 68
Table 13 Organizational Influences and Gaps ............................................................................. 73
Table 14 Knowledge Gaps and Recommendations ...................................................................... 76
Table 15 Motivation Gaps and Recommendations ....................................................................... 77
Table 16 Organizational Gaps and Recommendations ................................................................. 80
Table 17 Suggestions for Individual Action Framed in the ADKAR Model ............................... 86
xii
List of Figures
Figure 1 Leadership and Patient Safety Culture ........................................................................... 26
1
Chapter One: Introduction
Introduction to the Problem of Practice
Death certificates used to compile statistics have no method to recognize medical errors,
but if they did, it would be the third highest-ranking cause of death in the United States (Makary
& Daniel, 2016). The Institute of Medicine (IOM) first reported that 98,000 Americans were
dying each year due to medical errors (Wakefield, 2000). James (2013) estimated deaths
associated with medical errors to be more than 400,000 a year. Overall, two in five Americans
say they have either personally experienced a medical error or had a medical error occur in the
care of someone close to them (NORC at the University of Chicago, 2017).
Patients are not the only ones harmed by medical errors. Providers involved in medical
errors who experience emotional trauma are referred to as second victims. Research has shown
that 14-30% of healthcare providers who make medical errors report feelings of shame, anger,
and depression that can lead to burnout (Quillivan et al., 2016; Scott & McCoig, 2016).
Emotionally traumatized providers suffer anxiety and disturbed sleep and depending on the
severity of the error, impairment of their ability to take care of other patients (Harrison & Wu,
2017). In their survey of providers following a medical error, Edrees et al. (2011) reported the
majority felt emotional anguish. More recently, Harrison and Wu (2017) surveyed physicians
involved in a medical error; 76% reported personal and professional distress. The emotionally
heavy work of healthcare makes providers especially vulnerable to emotional turmoil following
medical errors (Scott & McCoig, 2016). Healthcare providers have received inadequate attention
after patient safety events, which further compromises patient safety (Edrees et al., 2011). The
problem of medical errors requires a continued examination to reduce patient and healthcare
provider harm.
2
Study Context and Background
A patient safety culture has been offered as a potential solution to medical errors. In
simple terms, patient safety culture is the extent to which an organization’s beliefs, values, and
norms support patient safety. It is a culture where errors are reported to allow for learning and
improvement and people are not punished for them (NPSF, 2015). Leaders who do not support
staff following medical errors and fail to act on reported safety vulnerabilities are inadequate to
create a patient safety culture (Joint Commission, 2017). As a practical strategy, creating a
patient safety culture seems simple, however, has remained elusive for many healthcare
organizations (Farokhzadian et al., 2018).
Schein (2004) posited that leaders communicate what is important to them by what they
pay attention to as well as what they don’t. Leadership interventions that promote individual and
teamwork behavior changes (Weaver et al., 2013) and focus on system improvement (Helo, &
Moulton, 2017) can advance the existing culture. Staff is more likely to learn from errors in
organizations with patient safety cultures and supportive leaders (Donaghy et al., 2018). When
leaders respond to errors in a non-punitive manner, there is an increased employee willingness to
report them and an associated reduction in second victim distress (Donaghy et al., 2018;
Quillivan et al., 2016). Further, leaders who promote nonjudgmental, open dialogue following a
medical error allow for ongoing learning opportunities (Quillivan et al., 2016). Leaders create a
patient safety culture by shaping staff behavior daily. The integration of a patient safety culture
cannot be achieved without the presence of thoughtful, transformational, authentic, and
committed leadership (Farokhzadian et al., 2018). A further understanding of what leadership
approaches are most effective to create this culture is critical to achieving meaningful
improvement (Weaver et al., 2013).
3
Organizational Goal and Mission
The research study took place in a healthcare system that will be referred to as Healthcare
System A (HSA). HSA is a complex academic healthcare system made up of five hospitals,
1,165 licensed beds, multiple clinics, inpatient and outpatient behavioral health centers, >15,000
employees, and a Level One Trauma Center. Their stated mission includes a commitment to
excellence and the provision of safe, high-quality, innovative care. In 2020, there were
approximately 50,000 patient discharges, 220,000 emergency department visits, 850,000
outpatient visits, 20,000 outpatient surgeries, 15,000 inpatient surgeries and 3,000 home health
care visits. HSA’s website affirms that the safety and well-being of their patients come first.
There is a declaration that staff monitor all aspects of patient safety and proactively identify
process failure points to prevent errors before they occur. The organization possesses a fully
staffed patient safety department and electronic medical error reporting system for prompt
follow-up on patient safety events across the system. HSA’s ultimate goal is safe patient care
delivery and systems to avoid medical errors and associated harm.
Stakeholder Groups for the Study
A stakeholder is considered to be a person with an interest or concern in something. The
study’s key stakeholders from this perspective are patients and providers. Each can experience
harm following a medical error. Applying a broader framework to understand a culture, one can
consider the organization itself as a key stakeholder. According to Clark and Estes (2008),
increasing knowledge, skills, and motivation are the keys to organizational success. Effective
leaders are positioned to effect change in all three of these dimensions. Leaders who know the
organization’s policies, are skilled in patient safety protocols and possess the capability to
motivate employees to achieve patient safety initiatives can change the culture one person or
4
team at a time. It is helpful to think of leaders as orchestral conductors, encouraging and
charismatically guiding their players, with the understanding that the music will be negatively
affected if all are not playing in sync.
To probe into the role of leadership at all levels of the organization, the stakeholders of
focus were those who make up the organization’s patient safety department. They include an
executive vice president, vice president, director, manager, and patient safety specialists. Each
was interviewed to achieve an understanding of the role leadership plays in the formation and
maintenance of patient safety cultures. They are well-positioned to provide insight into the topic
as they are often the first persons to respond to and investigate medical errors. In this capacity,
they observe leaders directly interacting with the staff who were involved in the medical error
and serve as the eyes and ears of the related error reporting and response activity.
Overview of Methodological Framework
The methodological approach for this research study is a qualitative interview process
based on a constructivist paradigm. This method was chosen due to the related ontological belief
in the presence of a socially constructed reality and the epistemological principle of subjectively
constructed meanings within specific contexts (Hinga, 2019). This lends itself well to the
examination of an organization’s culture (Hinga, 2019) with its collective presence of individual
and group perspectives. The study centered on interviews with the employees who make up the
patient safety department to develop an understanding of leaderships’ role in creating a patient
safety culture. An ethnographic stratagem was employed, grounding the interviews with those
leaders who are living the experience of supporting the development of a patient safety culture, a
single culture-sharing group. The semi-structured interviews were conducted virtually in the
leader’s natural setting. To ensure research dependability, all interviews were carried out in a
5
similar format, followed by data cataloging to their source to create an inventory of relevant
findings as the study unfolded. Artifacts and other documents about patient safety were reviewed
to further increase the study’s validity.
Purpose of the Project and Research Questions
The purpose of this study is to contribute to patient safety culture scholarship with a
focus on leadership and the achievement of a patient safety culture. This study sought to learn
how strengthening leadership skills within healthcare organizations could catalyze patient safety
culture improvement. The research asked the following to gain an appreciation for that question:
RQ1. How does a leader ensure consistency in policies, practices, and protocols to
create a patient safety culture?
RQ2. What attitudes, beliefs, and collective efficacy are needed to produce a patient
safety culture?
RQ3: What leadership characteristics are needed to create a patient safety culture?
Definitions
For this study, it is important to have a grounded understanding of several definitions that
inform it. They are as follows:
Authentic Leadership: a general desire to serve and lead from core values. Authentic leaders
establish trusting relationships, demonstrate self-discipline, and are passionate about their
mission (Northouse, 2016, p.197).
Leader: can include any of the following, a person who directly supervises work, creates policy,
or makes high-level organizational decisions. Examples: Senior-level leader, department
manager, supervisor.
Medical error: is “an unintended act (either of omission or commission), the failure of a planned
action to be completed as intended (an error of execution), the use of a wrong plan to achieve an
6
aim (an error of planning) or a deviation from the process of care that may or may not cause
harm to the patient” (Makaray & Daniel, 2016, p. 1).
Patient safety: “a discipline in the health care sector that applies safety science methods toward
the goal of achieving a trustworthy system of health care delivery. Patient safety is also an
attribute of health care systems; it minimizes the incidence and impact of and maximizes
recovery from, adverse events” (Emanuel et al., 2008, Defining Patient Safety, para. 12).
Patient safety event: is defined as “any type of healthcare-related error, mistake, or incident,
regardless of whether or not it results in patient harm” (Agency for Healthcare Research and
Quality [AHRQ], 2019, p. 2). This term is often alternated with medical errors in academic
literature. In this study, the term medical error will be used.
Second Victims: those who are involved in an event related to preventable medical error and feel
traumatized and personally responsible for the patient’s outcome (Scott, 2011).
Transformational leadership: is achieved by the specific actions of leaders. Leaders “take the
initiative in establishing and making a commitment to relationships with followers. This effort
includes the creation of formal, ongoing mechanisms that promote two-way communication and
the exchange of information and ideas. On an ongoing basis, leaders play a major role in
maintaining and nurturing the relationship with their followers” (Institute of Medicine [IOM],
2004, p. 4).
Organization of the Dissertation
Five chapters are used to organize this study. Chapter One offered the reader a
background into the concepts of medical error, healthcare provider emotional trauma, and patient
safety culture. The research methodology was introduced. Chapter Two will provide a review of
the literature surrounding patient safety culture as a potential solution to medical error and
7
reduced healthcare worker emotional trauma, and leadership’s role in moving change towards it.
This discussion will be encased in a gap analysis framework. Chapter Three will further describe
the research framework, detail knowledge, motivation, and organizational influences that were
examined, and outline the approach used for selecting interview participants, and collection of
related patient safety documents. Chapter Four will examine the research findings identified
through data collection and offer information on its outcomes. Chapter Five will propose
potential solutions for organizations struggling to achieve a patient safety culture and suggestions
for additional research into the operationalization of it.
8
Chapter Two: Review of the Literature
This chapter will begin with an overview of the cost of medical error followed by an
examination of the components of a patient safety culture. An analysis of leadership’s role in
patient safety culture creation with an emphasis on behaviors that have been positively
associated with a safe environment to report and learn from medical errors will follow. A
discussion of the elements of Clark and Estes’s gap analysis framework, that diagnoses the
human causes behind performance gaps (Clark & Estes, 2008) will provide a lens to examine the
principal role leadership plays in creating a patient safety culture. Transformational and authentic
leadership theory will be reviewed as potentially matched thoughtful approaches to create a
patient safety culture.
The Cost of Medical Errors
Recent reports indicate that medical errors may account for as many as 251,000 patient
deaths annually in the United States (Anderson & Abrahamson, 2017). Patients are not the only
ones hurt by medical errors; healthcare providers are harmed as well (Thomas et al., 2021).
Following their involvement in medical error, providers can experience anger, guilt, depression,
and in extreme cases, suicide (Thomas et al., 2021). In addition, there are associated financial
costs. The Betsy Lehman Center for Patient Safety, a Massachusetts-based advocacy group,
reported that 62,000 medical errors were responsible for over $617 million in excess healthcare
insurance claims in just one year (Palmer, 2019). In the United States, it is approximated that
400,000 hospitalized patients experience some type of preventable harm annually at a cost of
over $4 billion (Rodziewic et al., 2021). Despite this, less than 10 percent of medical errors are
reported (Anderson & Abrahamson, 2017). The reasons for non-reporting are myriad including
healthcare providers’ fear of punishment, job loss, disciplinary and legal action, and breach of
9
public trust (Thomas et al., 2021). Humans err, therefore, it is incumbent upon organizations to
create a patient safety culture where medical errors can be reported without fear.
To Err is Human: Medical Error
An important statement made in To Err Is Human, the groundbreaking report that is
premised to have started the patient safety movement is, “The status quo is not acceptable and
cannot be tolerated any longer” (IOM, 2000, Executive Summary, para. 13). This declaration
remains valid today; there is more work to be done to reduce instances of medical error, patient
harm, and healthcare provider distress. It is posited that medical errors are most often a
consequence of broken systems and inadequate processes, not individual or group recklessness
(IOM, 2000). It is therefore incumbent upon organizations to achieve a culture that avoids blame,
shame, and punishment following reported error and focuses on viable solutions to minimize risk
(Gandhi et al., 2016; Reason, 1998; Rodziewicz et al., 2020).
According to Scott and McCoig (2016), healthcare workers involved in medical errors
continually replay the moment they first realize something has gone wrong to gain clarity as to
why it happened. They internalize their distress and avoid help for fear of being stigmatized as
weak (Scott & McCoig, 2016). Engaging frontline staff in patient safety initiatives following
medical error and empowering them to take action to solve problems can decrease the likelihood
of second victim-related trauma (Ulrich & Kear, 2014). In their study to investigate the effect of
a patient safety culture on second victim reduction, Quillivan et al. (2016) found that a non-
punitive culture reduced distress when second victims felt supported by their organization. The
National Patient Safety Foundation’s (2015) report, Accelerating Patient Safety Improvement
Fifteen Years After To Err Is Human, declares teamwork and safety culture as critical factors to
achieve patient safety. Their stated vision to create a world where patients and those who care for
10
them are free from harm serves as a foundation to this research study (The National Patient
Safety Foundation, 2015).
Patient Safety Culture
Culture is the glue that bonds an organization, unites employees, and achieves desired
goals (Bolman & Deal, 2017). An organization’s culture is a created system of shared knowledge
and symbolic communication, behaviors, values, and assumptions (Berger, 2014). It is
accumulated learning that a group has acquired during its history that is then passed on to
newcomers (Schein, 1988). Culture includes tangible practices, protocols, structure, and safety
policies. The degree of cultural integration depends on several factors including how long the
organization has been in existence, the intensity of the group’s learning experiences, and the
strength and clarity of its leaders (Schein, 1988). Research does not universally subscribe to a
single definition of organizational culture, however, there is the relative agreement that it exists,
can be ambitious, malleable, unique to each organization, and is socially constructed through
group interactions (Bellot, 2011).
Following the release of the Institute of Medicine’s To Err is Human report, organizations
were encouraged to create a patient safety culture. It is understood that patient safety cultures
evolve gradually in response to past events and the character of the leadership (Reason, 1998).
They are difficult to develop and sustain, must be embraced as a core value of the organization
(Kaplan, 2017), and require consistent role modeling of safety behaviors in concert with
organizational controls (Reason, 1998). They are multilayered with organizational level and
social processes (Reiman et al., 2010). The social processes are the mechanisms that shape the
organizational dimensions and serve as a collective sense maker of reality (Reiman et al., 2010).
Leaders who role model safety behaviors in concert with organizational controls lead to a patient
11
safety culture built on honesty and organizational accountability (Reason, 1988). To better
understand the effect of a patient safety culture, Baines et al. (2015) reviewed greater than
16,000 patient health records and found a 45% decrease in preventable medical errors after its
implementation. In contrast, Kagan and Barnoy (2103) concluded that while a reported 64.7% of
nurses encounter medical errors on a daily or weekly basis, most would not report them without
an existing patient safety culture. Fear of punishment is real.
Employees who seek peer acceptance will observe and model existing safety behaviors to
gain it (O’Kelley, 2019). This acceptance is perceived as a reward and helps sustain the patient
safety culture (O’Kelley, 2019). The employee’s personal beliefs act as a philosophy that guides
their interactions with each other and their patients (Horwitz & Horwitz, 2017). In their study
that measured the effect of individual healthcare workers’ beliefs, values, and attitudes on patient
safety culture, Xuanyue et al. (2013) learned that an important nexus for getting staff to engage
in collaboration for improved and safer patient care delivery was to ensure that organizational,
individual, and group values were aligned. When employees believe their values are similar to
the organizations, top-quartile results across key quality patient care metrics were achieved
(Owens et al., 2017).
Leadership: Towards a Patient Safety Culture
Leaders create a patient safety culture with intent; informally built on a foundation of
shared goals and intrinsic beliefs. While culture is embedded in the beliefs of employees, one
must first understand the leaders’ beliefs to help create, change, and manage the organization’s
culture (Schein, 2016). In their study, Wang et al. (2014) measured nurses’ perceptions of patient
safety to determine if there was a connection between medical errors and patient safety culture.
Their study showed that employees who reported higher patient safety scores experienced lower
12
incidences of error and a shared perception of safety. In their study, Lee and Ko (2010) found
that organizations with leaders who focus on the enhancement of an individual’s self-efficacy
had high-quality nursing care and improved organizational performance. Leaders have the power
to influence individual beliefs and behaviors within their organization (Gandhi et al., 2016).
These collective individual interactions as part of everyday work reinforce the creation of a
healthcare team atmosphere (Lee & Ko, 2010). In this manner, leaders harness the power of the
people who represent their culture (Owens et al., 2017).
A leadership focus on employee basics is necessary to begin a culture change based on
trust. Buckingham and Coffman (1999) define employee basics as the provision of clearly stated
expectations, the necessary materials to complete work, praise for good work, caring leader, and
encouragement of continual development. Leaders have a prominent role in individual
development, leading to group cohesion (Goddard et al., 2016). Weaver et al. (2013) stated that
team training, communication, and executive leadership engagement with front-line staff are
effective interventions to improve the patient safety culture. In his study, Han (2018) surveyed
registered nurses who worked in a tertiary hospital. The results revealed that an organizational
atmosphere of cooperation led to continuous incentivization towards patient safety. When the
members of the organization trust their leader, there is a personal investment in patient safety
(Han, 2018). Employees who work in cultures based on trust are healthier and happier compared
with those working in low-trust cultures (Zak, 2017). An employee who is treated well will
demonstrate organizational citizenship (Whitener et al., 1998) and connect to patient safety
principles. Establishing an effective leadership style and set of behaviors is crucial to the
development of a patient safety culture.
13
Effective Leadership
Ulrich and Kear (2014) suggested an important part of patient safety culture is the
leadership engagement of frontline staff in patient safety initiatives. Employee engagement is
where there is a positive, work-related mindset with associated feelings of vigor, dedication, and
absorption in one's work (Daugherty et al., 2016). Several studies have examined this concept.
In their study, Kristensen et al. (2016) conducted leadership training with a focus on
coaching, change management, communication, motivation, development, and team leadership.
Frontline staff’s perceptions of patient safety culture were measured before and after the training.
The results revealed a documented improvement in staff’s attitude towards teamwork, safety
climate, job satisfaction, perception of management, and working conditions post leadership
training (Kristensen et al., 2016). In another study of employee engagement, results from the
Safety Attitudes Questionnaire survey administered by Johns Hopkins Hospital were analyzed.
The analysis revealed a moderate to strong positive correlation between employee engagement
and safety attitudes. While the analysis was somewhat limited in its ability to correlate causality,
it suggested an association between healthcare workers’ perceptions of safety culture and
engagement at work (Daugherty et al., 2016). In their cross-sectional study to measure
leadership’s effect on employee engagement and patient safety behaviors, Sexton et al. (2018)
surveyed 829 work settings to measure staff perception of leadership walk rounds as part of
patient safety culture. The results revealed staff with high levels of engagement when leadership
walk rounds were done on a routine basis. The walk rounds created a predictable ritual for
dialogue between leaders and healthcare employees with opportunities for employees to engage
in process improvement and a meaningful sense of efficacy when their ideas improved care
quality (Sexton et al., 2018). In yet another study, six large top-scoring acute care hospitals
14
showed consistent improvement in their AHRQ’s Hospital Survey on Patient Safety Culture
scores when leaders purposefully engaged in practices consistent with patient safety culture
(Campione, 2018).
Effective leadership is directly related to a blame-free patient safety work culture
(Murray et al., 2018). Framing errors as learning opportunities focus employees on developing
task proficiency and competence, creating an error management environment rather than an error
avoidance one (Maurer et al., 2017). Leadership characteristics such as behavioral consistency,
acting with integrity, the openness of communication, and demonstration of concern are
important to gain employee trust (Whitener et al., 1998). Recent research suggests that a kind,
compassionate, authentic, humble, and collaborative leader may be most effective within a
healthcare environment to change the organizational culture (Armstrong et al., 2019).
According to Northouse (2016), a century of research to identify desirable leadership
characteristics revealed central behaviors one should strive to possess to be perceived as an
effective leader. Those behaviors are intelligence, self-confidence, determination, integrity, and
sociability characteristics (Northouse, 2016, p. 26). Integrity in a leader can be described as a
general consistency among all elements of a person’s values, beliefs, words, and actions, how the
leader shows up each day (Moorman & Grover, 2009). The leader with integrity is consistent in
his or her words and their actions are deemed to be ethical by the follower (Moorman & Grover,
2009). In his research, Pincus (1986) studied the relationship between perceived job satisfaction
and organizational communication. The results revealed a leader's communication and personal
feedback to be major contributors to job satisfaction and leadership effectiveness (Pincus, 1986).
It has been determined that a good relationship with one's supervisor enhances the perceived
value among the staff of the organization’s investment in safety culture. The supervisor alone
15
cannot direct staff towards safe behaviors; they must rely on their ability to engage staff with a
strong commitment from senior leaders (Trinchero et al., 2019). Effective leadership towards a
patient safety culture is important at all levels of the organization. Table 1 provides a summary
of the literature supported key components of a patient safety culture covered in this section.
16
Table 1
Summary of Key Components of a Patient Safety Culture
(Joint Commission, 2016; ECRI, 2019; The National Patient Safety Foundation, 2015)
____________________________________________________________________________
Alignment with Mission:
The organization’s policies, procedures, beliefs, values, and norms support patient safety. Staff
collaborates for improved and safer patient care delivery. Organizational, individual, and group
values are aligned. Employees believe their values are similar to those held by the
organization.
Trust:
Members of the organization trust their leaders. Staff feels safe to self-report errors and near
misses. Leaders respond to errors in a non-punitive manner. Staff is not punished for reporting
or committing errors.
Learning Environment:
Errors are framed as learning opportunities. Staff learns from patient safety events to
continuously improve. Organizational leaders engage frontline staff in patient safety initiatives.
Staff Support:
Leaders promote nonjudgmental, open dialogue following a medical error. Staff receives
support following involvement in a medical error. Teamwork and supportive working
relationships lead to situational awareness for prompt recognition and reporting of identified
patient safety concerns.
___________________________________________________________________________
Theoretical Framework: Leadership through the Clark and Estes Lens
This research study utilized the Clark and Estes gap analysis framework (2008). Their
theory provided a lens to examine leadership’s effect on healthcare workers’ knowledge, (K),
motivation (M), and impact on the surrounding organizational (O) culture. Clark and Estes
(2008) suggest that even for people with top motivation, knowledge, and skills, ineffective
organizational processes can prevent goal achievement. Organizational leaders must therefore
align a patient safety culture with the core behaviors, policies, procedures, and communication
that relate to its collective concepts (Clark & Estes, 2008, p.112). Using this framework assisted
with the identification of barriers that might impact an organization’s ability to achieve a patient
safety culture.
17
Knowledge
The first of the three critical factors to examine during the gap analysis process is
people’s knowledge and skills, described as the how, when, what, why, where, and who of the
goal of establishing a patient safety culture. Clark and Estes (2008) posit that much of what
people know is unconscious, so new knowledge and skills must be learned in a way that will
allow for editing until they become automated. In contrast, conceptual thinking is conscious
decision-based knowledge. Most knowledge begins as conscious and transforms to the
unconscious (Clark & Estes, 2008, p. 74) when a comfort level is established.
Cognitive differences between experts and novices who have similar abilities are largely
influenced by deliberate practice (Clark & Estes, 1996, p. 2). When deliberate practice is denoted
by gradual increases in task difficulty and supportive feedback, it often results in exceptional
performance (Clark & Estes, 1996, p. 2). According to Clark and Estes (1996), most human
beings are capable of gaining declarative knowledge, information about why or what, and
procedural knowledge, information about how and when. Declarative knowledge is characterized
by its conscious quality and speed with which it can be learned and modified. Procedural
knowledge is distinguished by its unconscious, automated quality that makes it efficient to
express but difficult to change (Clark & Estes, 1996, p. 3).
People judge their capacity to face a challenge based on their perceptions of the
knowledge, skills, and strategies that are available to them (Locke, 1997). A group’s attainment
comes from shared knowledge and skills and interactive, synergistic dynamics of their
transactions. The locus of perceived collective efficacy is in the staff member’s minds and
together they act in a coordinated manner within a shared belief (Bandura, 2000). When the
organization’s goal of a safe place for patients to receive care is delivered by a trusted authority
18
with accompanying outlined individual and team expectations, value for that goal is enhanced.
Each team or individual whose performance might influence the outcome must fully understand
their role in achieving it (Clark & Estes, 2008). Leaders can serve as the connectors to guide
their employees towards knowledge mastery by promoting and practicing patient safety
principles, and adherence to patient safety-related policies and protocols. Table 2 outlines the
knowledge (K) influences and assessments associated with the study.
Table 2
Knowledge Influences and Assessments for Analysis
Stakeholder Goal
The goal of HSA is to create a culture where staff is knowledgeable of patient safety
principles, report unsafe systems and medical errors, and actively participate in patient safety
initiatives.
Assumed Knowledge
Influences
HSA’s staff need to know
the organization’s patient
safety-related principles.
Knowledge Type
Declarative (conceptual)
Knowledge Influence
Assessment
HSA’s patient safety
department staff members
were asked what components
make up a patient safety
culture and how they are
present in the organization.
HSA’s staff need to know
how to apply the patient
safety-related policies and
protocols that outline the
organization’s patient
safety principles.
Declarative (procedural)
HSA’s patient safety
department staff members
were asked how they see
patient safety-related policies
and protocols present in the
organization.
19
Motivation
The second of the three critical factors to examine during the analysis process is
motivation. Motivation influences an individual by opting and persisting towards a goal with an
accompanying mental effort investment to achieve it (Clark & Estes, 2008). Employees are
motivated by self-interest and their perceived value of the organizational goal of patient safety
culture (Clark & Estes, 2008). Healthy organizations understand their employees’ motivation and
successfully align their goals with them (Clark & Estes, 2008). Team-based organizations such
as healthcare benefit from a combination of individual motivation, feedback, and access to expert
skills. Team members must believe that each individual has all of the separate skills needed to
deliver safe patient care. There must be a balance between individual initiatives and
collaboration to effectively achieve results (Clark & Estes, 2008, p. 121). Teamwork and
supportive working relationships lead to situational awareness where healthcare workers pay
attention to what their peers are doing in a clear, objective manner with equal awareness that at
the same time, their peers are noticing their work (Maynard, 2012).
Clark and Estes (2008) opine that motivation is related to choice, persistence, and mental
effort. When these facets align, increased performance can be achieved (Clark and Estes, 2008,
pp. 80-81). Motivation at work results from one’s belief that they and their coworkers will be
successful. A team-oriented culture values collective efforts and works harder to achieve goals
(Clark and Estes, 2008, p. 84). Understanding the reasons for and benefits of the adoption of a
patient safety culture increases employees’ willingness to comply with its principles (Studer et
al., 2014). To effect change, individuals and groups have to share a vision and work cohesively.
According to social cognitive theory, people act as agents with perceived personal
efficacy that they can positively influence their life circumstances (Bandura, 2000). To fully
20
engage employees to adopt patient safety culture behaviors, leaders must motivate them to want
to make the necessary changes as individuals and to work as a team to achieve them. Collective
efficacy is the belief shared by a group regarding the abilities of its members to work together to
achieve goals. It can be understood as the intensity with which employees in a group imagine
they can solve problems and improve through joint efforts (Bandura, 2000). Collective efficacy
can only be attained with the belief that all members of the team can succeed (Bandura, 2000).
Great leaders recognize each person is motivated differently with their unique way of thinking
and relating to others (Buckingham & Coffman, 1999) and have the ability to orchestrate each
individual’s efforts, talents, and passion to move towards patient safety culture. Table 3 outlines
the study’s motivation (M) influences and assessments.
21
Table 3
Motivation Influences and Assessments for Analysis
Stakeholder Goal: The goal of HSA is to create a culture where staff is knowledgeable of
patient safety principles, report unsafe systems and medical errors, and actively participate in
patient safety initiatives.
__________________________________________________________________________
Assumed Motivation Influences
HSA staff need to believe that the
organization’s leaders are motivated to create
a patient safety culture and will help them get
there.
Motivation Influence Assessment
HSA’s patient safety department staff were
asked what behaviors leadership demonstrates
to motivate towards a patient safety culture.
HSA staff need to believe leaders will support
them following a medical error.
HSA’s patient safety department leaders were
asked to delineate the behaviors leaders
demonstrate following an employee report of
a medical error and how ideal leaders
motivate others towards a culture where
employees feel safe to report medical errors.
_____________________________________________________________________________
Organization
The final critical factor to examine during the gap analysis process is the organizational
environment, including tangible processes, resources, and procedures. Many organizations fail to
create change as a result of misaligned structures and processes with business goals (Clark &
Estes, 2008, P. 118). The organizational policies and procedures and leader’s behaviors and
attitudes need to agree to avoid employee confusion (Clark & Estes, 2009). The organization is
responsible to corroborate the practices, policies, and protocols to the patient safety mission.
To achieve a patient safety culture, the organization must ensure each leader possesses a
skill set to create group cohesion. Without it, employees will focus on individual career
advancement rather than the broader organizational goal of a patient safety culture. Upper-level
leadership candidly communicates their vision of a patient safety culture and accompanying
22
support in the form of policies, protocols, and associated behaviors. The vision must then be
continued by the lower-level management team framed in the language of the stakeholder group.
A leader cannot be effective by possessing culture-changing behaviors alone. They must work in
an organization that allows them to be effective; one with a motivating mission that helps focus
attention on initiatives that support the mission coupled with a strong vision of where the
organization is going. The mission creates an umbrella that encompasses everyone in the
organization, so all can work towards achieving a common goal (McDonald, 2007). The vision
describes the end of the journey (Taiwo et al., 2016). Table 4 depicts the study’s organizational
(O) influences and assessments.
Table 4
Organizational Influences and Assessments for Analysis
Stakeholder Goal: The goal of HSA is to create a culture where staff is knowledgeable of
patient safety principles, report unsafe systems and medical errors, and actively participate in
patient safety initiatives.
__________________________________________________________________________
Assumed Organizational Influence
The organization must ensure its leaders
possess a skill set to create group cohesion.
Organizational Influence Assessment
HSA’s patient safety department staff were
asked what role leadership plays in
maintaining a patient safety culture and what
it looks like when they see a leader adept at
creating group cohesion.
HSA staff need to believe the organization
will support them following a medical error.
HSA’s patient safety department leaders were
asked to describe what organization supports
are in place following an employee report of a
medical error.
___________________________________________________________________________
23
Transformational and Authentic Leadership
This study posits that strengthening existing leadership skills can assist with employee
engagement and mobilize patient safety culture improvement. Effective leadership development
is more about how than how much (Garman & Harris, 2011). The transformational leadership
style engages people to reach their fullest potential (Northouse, 2016, p. 162). Transformational
leaders create connections that raise levels of morality and motivation employing a change
process with charisma and vision at its core (Northouse, 2016, p. 161). Transformational leaders
demonstrate an interest in their subordinates’ personal and professional development. Armed
with the knowledge that employees watch leaders to see if their actions connect with their words
and adopt the leaders’ values as their own, transformational leaders behave in ways to instill
confidence and allow for personal identification with the leader and workgroup (Clark, 2013).
Transformational leaders possess the ability to communicate mission and vision to daily work in
a charismatic manner with inspirational motivation. In this way, high expectations are
communicated to followers through motivation with encouragement to become part of the
organizational mission. Transformational leaders create team spirit (Northouse, 2016, p.169).
They inspire trust and respect in their followers (Berger, 2014).
A transformational leadership approach is directly related to the development of cultures
with caring, collegial communication styles and associated employee safety to report a medical
error (McFadden et al., 2009). Transformational leaders communicate high expectations, inspire
followers to commit to a shared organizational vision, (Northouse, 2016, pp. 162-169), and
possess the ability to articulate a safe place for patients to receive care (Aguinis & Kraiger,
2009). The transformational leadership style enhances interpersonal relationships (Clarke, 2013)
that boosts a team’s collective efficacy (Chou et al., 2013). A similar leadership style, authentic
24
leadership, stimulates work environments where errors can be reported without fear. Authentic
leaders accept responsibility for their actions, do not blame others when they make a mistake
(Farnese et al., 2019), and serve as role models for equivalent behaviors. Authentic leaders lead
from their conviction to a mission-based cause (Gardner et al., 2011). This study opines that
these leadership styles are well suited to patient safety culture creation.
Bringing the Frameworks Together
This research study combined two theoretical frameworks to afford a comprehensive
examination of the problem. The first is the Clark and Estes K-M-O framework to direct the
focus to a leader’s impact on individual and group knowledge (K), motivation (M), and the role
of organizational (O) structure on culture formation. The second is transformational and
authentic leadership theories as leadership models for which to effect change.
The literature supports patient safety culture as an effective method to prevent or
minimize medical errors. The main features outlining a patient safety culture include a vision of
a safe place to deliver care, trust that punishment will not occur after committing an
unintentional medical error, the identification of medical error as a learning opportunity, and
post-error employee support and coaching. Lack of trust in the leader and organizational
response will inhibit error reporting and opportunities to learn will be lost. When employees trust
their leader and report without fear of punishment and shame, learning occurs and systems can
be fixed. Policies, protocols, and practices must be in alignment with the vision to effectively
embed the main principles the culture intends to create.
Several studies have supported the notion of a transformational leader as one who
possesses the characteristics to create the vision of patient safety. Their charismatic approach
delivers the message in a manner as to instill followers. They function as change agents, are
25
trusted, and have strong morals and values (Northouse, 2016, p. 190). Authentic leaders have
been identified as possessing several characteristics that also create a sense of trust. They hold a
moral dimension to do what is right and have confidence in their abilities to succeed and persist
when obstacles arise (Northouse, 2016, p. 204). Qualities from both seem efficacious in creating
a patient safety culture.
Figure 1 illustrates the interconnectedness between the research study’s key concepts. A
patient safety culture sits atop as the desired organizational goal. The arrows below demonstrate
a culture made up of tangible practices, policies, and protocols that are driven by the collective
attitudes and beliefs of all who make up the organization. The next tier consists of leaders at all
levels of the organization who must work in concert to align organizational structures with the
overarching goal of patient safety culture (Clark & Estes, 2008, p. 118). All leaders have the
responsibility to work with employees to affirm their confidence, capability, and self-efficacy to
deliver safe care. This leads to collective efficacy with members working together to achieve
goals and solve problems (Bandura, 2000). Collective efficacy fosters a groups’ motivational
commitment to their missions and performance accomplishments with the understanding that by
transforming their environmental circumstances, they can be producers of it as well (Bandura,
2000). These key concepts in connection can create a shared vision of patient safety with the
leader serving as the connector of all interrelated concepts.
26
Figure 1
Leadership and Patient Safety Culture
27
Summary
Patient safety culture is built on trust and a shared vision. To achieve this, the
organization’s decision-making body must ensure there is a cohesion of the practices, policies,
and protocols that make up the healthcare delivery system. These practices, policies, and
protocols are required to be in direct alignment with the principles that make up a patient safety
culture, specifically, a place where employees can safely report a medical error as opportunities
to learn, where they will be coached and supported following medical error, listened to when
sharing safety concerns and encouraged to work together to help shape system changes to avoid
a future error. In these circumstances, employees will embody and display the attitudes, beliefs,
and behaviors of a patient safety culture.
When leaders at all levels of the organization possess the characteristics that are best
suited to the creation of a patient safety culture, success is within reach. These leaders are
visionary, caring, moral, and trusting. They have a keen ability to impart the vision of a safe
place for patients to receive care and possess the skill set needed to develop a following to the
cause. Further, they are capable of individualizing each employee’s journey to aid in the gaining
of the necessary skills to deliver safe and effective care mindful of their unique needs to acquire
confidence in their capabilities. This approach will create a team environment and lead to
collective efficacy. Members who make up the healthcare team will be confident in their ability
to deliver safe patient care. Trust in each other will be a tangible part of the work environment.
28
Chapter Three: Methodology
The problem of practice associated with the study is preventable medical error with
resultant patient and healthcare provider harm. The study’s purpose was to advance patient safety
culture scholarship with a focus on leadership and the achievement of a patient safety culture to
reduce preventable medical errors. Clark and Estes’s gap analysis theory provided a lens to
examine leadership’s effect on healthcare workers’ knowledge (K), motivation (M), and impact
on the surrounding organizational (O) culture. Using this framework helped identify barriers that
may impact an organization’s ability to achieve the goal of a safe place for patients to receive
care and served as a spotlight to illuminate key concepts.
This chapter will begin with an outline of the research questions the study sought to
answer. An overview of the qualitative methodological design will follow. Primary data
collection methods will be shared to give the reader confidence in the findings. A description of
the research setting and participants will come next. The researcher’s positionality, ethical
stance, and potential biases will be accompanied by a summary of data sources, instrumentation,
and strategies to ensure validity and reliability. Data analysis approaches conclude the chapter.
Research Questions
RQ1. How does a leader ensure consistency in policies, practices, and protocols to
create a patient safety culture?
RQ2. What attitudes, beliefs, and collective efficacy are needed to produce a patient
safety culture?
RQ3: What leadership characteristics are needed to create a patient safety culture?
Overview of Design
Inquiry is any systematic process for uncovering data that can lead to new information
(Malloy, 2011). A purposeful exploration of the underlying research philosophy and system of
29
beliefs and assumptions on how knowledge is developed (Saunders, 2019) served as the starting
point for the study design. The study sought to understand and interpret social phenomena
holistically and naturally (Moore, 2019). A paradigm is a framework within which theories are
formed. It influences how one sees the world and shapes an understanding of how things are
connected (Aliyu, et al., 2015). The interpretive paradigm assumption encased the study’s view
with the knowledge that humans create meanings within social groups. An inductive approach,
with its data collecting methods to explore a phenomenon and connection to humanities, is well
informed by interpretivist philosophy.
Data Collection Methods
A qualitative approach to data collection was selected for this study because of its
effectiveness in gathering information that is in someone else’s mind (Merriam & Tisdell, 2016,
p. 108). Additionally, interviewing is necessary when the researcher is interested in an event that
occurred in the past (Merriam & Tisdell, p. 108, 2016). Thirdly, perception questions are best
answered using this method. The research participants are the employees who make up HSA’s
patient safety department. Information that is meaningful to them was gathered during the
interview process to capture their view of leadership’s role in patient safety culture and collective
efficacy, and to gain knowledge relative to their individual experiences following a medical
error. It is generally understood that information derived during an interview represents a
secondhand account as it is dependent upon the participant’s opinions and judgments;
observational data represents a firsthand encounter where the researcher can witness for
themselves what the interviewee has described to affirm or conflict with the interview data
(Merriam & Tisdell, 2016, p. 137). Although having data from both of these sources is desirable,
the COVID-19 pandemic restricted the ability to engage in direct observation; therefore, further
30
interview questions were incorporated into the interview protocol to provide similar data.
Internal documents, such as patient safety policies, and external information released to the
media that outlines the organization’s stance on patient safety, were examined. This review
helped to determine alignment and provided rich data to understand how the organization that
produced them thinks about their world (Bogdan & Biklen, 2007). Table 5 outlines the data
collection methods used in the study. Appendixes A and B provide the reader with the qualitative
interview and document review tools.
Table 5
Data Collection Methods
_________________________________________________________________________
RQ1: How does a leader
ensure consistency in policies,
practices, and protocols to
create a patient safety culture?
Interview
X
Document Review
X
RQ2: What attitudes, beliefs,
and collective efficacy are
needed to produce a patient
safety culture?
X
RQ3: What leadership
characteristics are needed to
create a patient safety culture?
X
_________________________________________________________________________
31
Research Setting
HSA’s patient-focused mission has remained steady over the years, with slight language
modifications only, and is based on the importance of the patient as the center of its work. In
social media forums, the organization commits to the respectful delivery of compassionate,
excellent care as its top priority. Visitors to the website learn that staff monitor all aspects of
patient safety and proactively identify potential failure points to prevent errors before they occur.
Having worked at HSA for 10 years, I possess an insider’s view of the organization. At the time
of my departure, the Patient Safety department, born from the commitment to achieve a patient
safety culture, was still in its infancy. It has now progressed to a fully staffed Patient Safety
department. The Patient Safety department’s employees have responsibility for medical error
investigation and response in all of the hospitals and outpatient treatment areas within HSA’s
complex healthcare system.
The Researcher
It has been more than 20 years since the IOM report, To Err is Human, was first released.
A proposition to create a patient safety culture as a potential solution quickly followed. The
attainment of a patient safety culture is complicated; there is much more to be learned. Grounded
theory is emic providing an insider's view of the people, groups, organizations, and cultures
being studied (Aliyu et. al., 2015). The challenge is to ensure I maintain an empathetic stance,
enter the social world of the research participants, and understand the world from their point of
view (Saunders, 2019) without bias.
In my experience as a registered nurse, Certified Healthcare Risk Manager, and Certified
Patient Safety Professional, a keen awareness of the importance of trust in creating a patient
safety culture was developed. Without it, fear of negative consequences prevents employees
32
from reporting errors and there is a resultant lost opportunity to learn. Tuck and Yang (2012)
refer to a theory of change as a belief or perspective about how a situation can be adjusted,
corrected, or improved. I believe that a change in organizational approach from a strict patient
safety focus to one inclusive of employee safety would fully embed a patient safety culture. This
will involve an “overturning of the existing state of affairs,” a radical change of perspective
(Saunders, 2019, p. 139).
Epistemology (theory of knowledge), ontology, and axiology address the “unspoken
assumptions that rest beneath the surface of the research” (Hinga, 2019, p. 1). According to
Lucian Leape (1998), the Chair of the Lucian Leape Institute at the National Patient Safety
Foundation, organizations that develop systems with the understanding that humans make errors
will reduce instances of medical error. I find this underpinning of a patient safety culture to be
valid and worthy of continued attention. Ontology refers to assumptions about the nature of
reality (Saunders, 2019, p. 133). An ontological assumption I possess is that organizations are
well-meaning and struggling to operationalize and maintain a patient safety culture. Axiology is
the branch of philosophy that studies values and ethics. The Hippocratic Oath to “First Do No
Harm” is one I believe in my core. It is a tenet that anchors my daily practice. I have been a
registered nurse since 1986 and firmly accept as true that most healthcare workers do not intend
to inflict harm on their patients. There is the trust that they go to work each day to do their best.
Healthcare is a highly risky and complicated work system; the potential for human error is high.
I, therefore, work under the premise that most of the time, it is the system that failed the
healthcare worker, not the healthcare worker that failed the patient. It is why I am so passionate
about the creation of a patient safety culture to minimize instances of medical error.
33
Research is all about unanswered questions, but it is also about unquestioned answers
(Wilson, 2008). This study possesses both. The three research questions remain unanswered and
anchor the study’s purpose. The unquestioned answer is patient safety culture itself. It has been
touted as a potential solution to medical error reduction but has remained elusive for many
organizations. In my role as a risk management professional, there is a direct witness of the pain
that medical error causes to patients, families, and the well-intended providers who commit the
error. The study design began with an awareness of this worldview at the onset. It will be my
goal to keep a balance between my story and how the research is focused. As Wilson (2008)
maintained, the more relationships a researcher maintains between themselves and their topic of
interest, the more fully they can understand its meaning (Wilson, 2008). It is from this
perspective that I entered the study with eyes wide open.
To address the potential for bias in data interpretation, the primary interview data was
looked at through a phenomenological lens, focusing on how the patient safety employees are
experiencing the patient safety culture, not how the researcher thinks it should be. The data was
coded to look for patterns and insights, described as “trees” (Merriam & Tisdell, 2016, pp. 207-
208). Once the patterns emerged, I stepped back and viewed them as a “forest” (Merriam &
Tisdell, 2016, p. 208) to determine if the patterns (trees) answered the research questions. Rather
than trying to eliminate existing biases, I continually monitored them through the lens of Clark
and Estes’s K-M-O’s theoretical framework.
I consider myself a seasoned interviewer in the healthcare risk management field for
more than 10 years. In this position, there is often a requirement to conduct interviews following
medical errors to identify systems gaps to avoid future occurrences. It requires an empathetic
approach and the ability to ask tough questions in a manner that will not further upset the already
34
traumatized healthcare worker. The risk manager also serves as a mediator for resolution
following errors with resultant patient harm. Active listening skills are key when meeting with
the family and patients who were harmed. I am confident in my abilities in the art of hearing
(Patton, 2002). The one thing that I remained mindful of, however, was body language as a
researcher to ensure neutrality was demonstrated even when what was heard was antithetical to
my own beliefs and values (Merriam & Tisdell, 2016, pp. 128-129).
Data Sources
Method 1
Method one involved semi-structured interviews with HSA’s patient safety employees.
Conducting the interviews in this format allowed for the discussion to include the topic of
interest to the researcher and additional insights the participant raised (Morgan, 2014).
Method 2
A document is an umbrella term that refers to the written, visual, digital, and physical
material that is relevant to the study’s topics (Merriam & Tisdell, 2016, p. 162), patient safety,
and avoidance of medical error. For purposes of this qualitative study, method two involved a
review of documents about patient safety to identify trends and look for consistency in policies,
practices, and protocols.
Participants
The interview participants included an executive vice president, vice president, director,
manager, and two out of four patient safety specialists from HSA’s Patient Safety department.
Patient safety employees are often the first persons to respond to and investigate medical errors.
In this capacity, they observe leaders directly interacting with the staff who were involved in the
medical error and serve as important observers of patient safety culture principles in action. This
35
purposeful sampling approach that allows for discovery and insight from a sample from which
the most can be learned (Merriam & Tisdell, 2016, p. 96), was employed to understand what
behaviors, attitudes, and beliefs patient safety employees relate to patient safety culture creation.
Instrumentation
The research methodology started with qualitative interviews. An ethnographic method,
with its focus on the culture and social regularities of everyday work life, (Merriam & Tisdell,
2016, p. 229) was used to ground the interviews with those leaders who are living the
experience, a single culture-sharing group. The study centered on these interviews to understand
leaderships’ effect on the achievement of collective efficacy towards a patient safety culture
through the K-M-O lens. The purpose of interviewing was to enter into their perspective (Patton,
2002). The interview protocol was made up of 11 questions. Each question had an additional
probe if a deeper dive was needed. The semi-structured interview technique allowed for greater
flexibility to logically order the questions based on the participant’s responses as well as the
freedom to add additional questions to delve into an area of researcher interest. The types of
questions that were asked included background, knowledge, sensory, and opinion. Knowledge
questions began the survey to gain factual information. Opinion questions followed to gather the
participants’ beliefs, values, and experiences within the patient safety arena. The protocol
concluded with sensory questions that allowed the researcher to enter into the sensory apparatus
of the respondent (Patton, 2002). The interview questions were intended to query patient safety
employees about their knowledge, observations, and opinions of what they perceive as best
leadership practices to create a patient safety culture. They were asked to describe the leadership
behaviors they have witnessed in support of patient safety culture development as well as those
36
that hinder it. The concepts of a safe environment to report medical errors and build strong teams
were also examined.
The research methodology continued with document review. This phase of the study
included an examination of organizational documents and public social media sites to look for
consistency with the information gleaned from the interviews. As the researcher, I served as the
data collection instrument and decided what was important and what to record (Johnson &
Christensen, 2015). These observations were an attempt to corroborate information gleaned
during the interview phase of the study including the context-rich questions to gather information
from the patient safety employee’s past observations in place of direct observations in the
leader’s setting, prohibited due to the COVID-19 pandemic.
Data Collection Procedures
The semi-structured interview protocol, with constructed questions that relate to the
research questions and accompanying probes to further explore participant responses, was
conducted virtually in the patient safety leader’s natural setting (Burkholder et al., 2019) in a
private area away from the hubbub of day-to-day activities. Each interview session was
scheduled for 60 minutes to complete in 45 minutes. The sessions were recorded using Zoom®
technology. There were notepads and pens to take minimal field notes available to enhance the
recording with observations on participant body language and other pertinent environmental cues
noted during the session. Following the interview, the video recording was transcribed for ease in
trend finding (Bogdan & Biklen, 2007). A system to manage the data including words and short
phrases considered to be salient to the research questions coding was employed to organize the
data (Merriam & Tisdell, 2016, p. 199).
37
Using a qualitative approach allowed for the research to evolve during the study as many
of the qualities that were explored during the interview portion of the study are constructs that
cannot be directly measured. As the researcher is the key instrument to data collection, it was
important to maintain empathic neutrality to ensure bias did not enter into what was being seen
and heard. After each interview, reflection on findings was critical to identify and remove bias
and maintain objectivity. Reflexivity has been identified as a core characteristic of good
qualitative research (Creswell & Creswell, 2018, p. 200).
Data Analysis Procedures
The phenomenological analysis sought to understand the basic structures of a
phenomenon. To prepare for the analysis process, phenomenological reduction led “the
researcher back to the experience of the participants” (Merriam & Tisdell, 2016, p. 227) and
encouraged the researcher to stay with the lived experience to get to its very essence. An even
more personalized approach to data analysis is for the researcher to include their experience as
part of the data, known as heuristic inquiry (Merriam & Tisdell, 2016). The study’s analysis was
founded on this approach.
The process of gathering and analyzing qualitative study data is inductive. Throughout,
the researcher makes sense of the information to answer the research questions that prompted the
study. The procedure involves data coding and categorizing to look for patterns representing the
kinds of things the participants are talking about. The researcher can find themselves moving
back and forth between the concrete and the abstract as the findings do not unveil in
chronological order (Malloy, 2021). The researcher’s positionality can still be present, even
when they are an outsider, or external to the environment (Malloy, 2021). Bringing in an
external auditor to review the analysis can ensure the researcher is engaged in active listening,
38
and not just putting their interpretation on the findings. It is touted to be helpful to have ongoing
data conversations (Malloy, 2021) as part of self-reflection and with colleagues to help uncover
potential blind spots early in the analysis. I committed to these activities and continually asked
what assumptions I might be bringing and how they might be shaping my definition of the data.
In contrast, being an insider can be helpful to allow for deep reflection on the key takeaways
(Malloy, 2021). It is part of who they are and results in a profound connection with the
participants and their reality. In this research study, I am both an outsider and an insider with a
shared passion for patient safety with the participants. During the data-gathering portion of the
study, Bogdan and Biklen (2007) suggest the researcher practice writing memos with comments
based on what the researcher observes, thinks, and feels. Throughout the analysis phase, I
actively engaged in memo writing to capture thoughts, feelings, and trepidations to provide
readers confidence in the findings.
The employed data analysis methods involved my imaginative and speculative
interpretations gleaned through qualitative interviews and document review (Gibbs, 2018). The
combination of these approaches was to seek alignment in organizational policies, practices, and
protocols and determine which leadership characteristics help to create patient safety culture
through collective efficacy to lead to shared attitudes and beliefs. This was to answer the
question “What is going on here?” allowing for a thick description as to what is happening
(Gibbs, 2018, pp. 5-6). As the researcher, I strived to represent the views of the participants as
accurately as possible to develop theory while collecting data to create new knowledge and
understanding. This came from the understanding that qualitative analysis is guided by pre-
existing concepts with the researcher as the data collecting instrument.
39
The interview questions were purposefully categorized into important components of the
study’s theoretical framework, K-M-O, and leadership theories. A review of the key portions of
the documents about patient safety set the groundwork for a basic understanding of how leaders
at the policy-setting level of the organization think. Data points were gleaned with grounded
theory-based coding, with its central focus on idea generation and theory development arising
from and supported by the data (Gibbs, 2018).
Validity and Reliability
In a qualitative study, validity equates to credibility, the truth of what the researcher is
trying to discover. Internal validity pertains to how well the research findings match reality. Data
does not speak for itself, there is always a translator of the reality involved (Merriam & Tisdell,
2016, p. 242). To achieve credibility, the study employed several strategies to improve
triangulation including, an increased length of time to complete the study, prolonged engagement
of participants, numbers of interviews conducted until saturation was achieved, and document
review to look for consistency in the organization’s practices, policies, protocols, attitudes, and
beliefs relative to patient safety principles (Lincoln & Guba, 1985). To assist the reader, the
study included consistency, trackability, and logic of the research design, data coding to match
research design and confirmability, detailed field notes, observations and interviews tracked to
their sources, and process notes including the researcher’s reflective conversations about
employed strategies (Lincoln & Guba, 1985).
Reliability or transferability is understood as the extent to which the findings can be
applied to other situations. Reliability in qualitative research can be problematic simply because
human behavior is not static. The more important question to ask, therefore, is whether the
results are consistent with the data collected (Merriam & Tisdell, 2016, p. 250). The study’s goal
40
for transferability is the utilization of thick descriptions to allow the reader to make an informed
decision regarding the usefulness of the findings for their purposes. The patient safety employees
are the primary instrument of data collection. Interpretations of their reality were accessed
through the interview protocol. Triangulation was used as a strategy to increase the validity of
the study with the knowledge that qualitative research can never truly capture truth. The study’s
original intent, following the interview portion of the study, was to include direct observation of
the leaders who have been identified as possessing characteristics that are conducive to a patient
safety culture. Time was going to be spent in their units to gather data on how they interact with
their staff in various forums, such as rounding and staff meetings. The observations were to be
used as confirmation of the data gleaned from the patient safety employees’ interviews. As this
was not possible, questions were added to the interview protocol to gather similar data.
Documents relating to patient safety were reviewed as evidence of leaders’ ideas of what
constitutes patient safety within the organization.
Ethics
From a constructivist viewpoint, it is premised that an understanding of people’s reality
within the workplace can be gained through individual stories and personal narratives (Lincoln &
Guba, 1985). It is therefore incumbent upon the researcher to create a safe environment for the
participants to tell their stories. They must trust that the researcher will maintain their
confidentiality and use the information drawn from their stories for patient safety improvement
purposes. Several techniques were employed to establish trust and rapport with the participants,
mindful that they are well-educated professionals who use data to affect change daily. The
consent process accordingly used this understanding to root the key discussion points that were
explored during the interviews. The consent discussion included specifics such as the sponsoring
41
organization, the rationale for the research, and the assurance that the responses would be kept
confidential. To ensure the interview derived rich information, the researcher strived to be
empathetic, neutral toward the content the interviewee was sharing, utilized gentle head nodding
and verbal “um-hms” to show interest, made sure the interviewee was doing most of the talking,
kept the interview focused and provided ample time for each question to be answered (Johnson
& Christensen, 2015). The participant’s time is valuable so in return, appreciation and
acknowledgment of how important their time was, and how reliant the research study was on
their input was offered (Glesne, 2011). The participants were informed at the onset of the study
that there are plans to publish the material.
Experiential knowledge, what the researcher’s background and identity bring to the
study, has often been seen as a bias to be eliminated from the design, rather than a valuable
component of it (Maxwell, 2013). An opposing view is for the researcher not to split their work
from their lives, and to use it to enrich the other. Subjectivity is something to capitalize on rather
than to exorcize (Maxwell, 2013), one should strive for critical subjectivity.
Limitations and Delimitations
The research design was carefully created to cull useful information, conform to ethical
norms, and attain credibility and reliability. In any study, however, there is the potential for
limitations. Several that may affect this study include the honesty of the participants, their
willingness to share information, and a restriction to enter the hospital for direct observation due
to the COVID-19 pandemic. To respond to these limitations and reduce their impact on the
research, I firmly committed to creating a safe space to allow for open and transparent discussion
during the interview process. The informed consent conversation preceding the interviews was
completed in a relaxed and unhurried manner so the participants had the opportunity to feel the
42
value of their input to the research, based on the shared commitment to patient safety. Here is
where my background enhanced the research. There was a shared passion, a career commitment
to the reduction of patient and healthcare worker harm.
43
Chapter Four: Findings
The purpose of this study was to evaluate the K-M-O influences present in HSA, an
academic healthcare system, with a focus on leadership and the achievement of a patient safety
culture. The study sought to discover how strengthening leadership skills within a healthcare
organization could further patient safety culture improvement. The following was asked to gain
an appreciation for that question:
RQ1. How does a leader ensure consistency in policies, practices, and protocols to
create a patient safety culture?
RQ2. What attitudes, beliefs, and collective efficacy are needed to produce a patient
safety culture?
RQ3: What leadership characteristics are needed to create a patient safety culture?
Assumed K-M-O influences and gaps were bred based on a review of the existing
literature, semi-structured interviews with members of HSA’s Patient Safety Department, and
document review of related practices, policies, protocols, and media presence. For purposes of
this research study, and in recognition of the small sample size, a gap will be considered to be
validated when the majority of participants, four out of six, respond in the affirmative. For
invalidated gaps, the measurement will remain the same, with at least four out of six respondents
providing evidence of the associated K-M-O assumption. Informed by these efforts, it was
assumed that HSA intended to strive for zero patient harm and develop a strong patient safety
culture to achieve that aim.
Chapter 4 begins with a description of participant demographics and is followed by
interview and document review results, presented in narrative and table format for easy
44
readability and understanding. The research study’s findings are organized in defined sections by
research question and the relevant K-M-O and leadership theory influences that informed them.
Data Analysis
Participating Stakeholders
The employees who compose HSA’s Patient Safety Department were the qualitative
interview’s participating stakeholders. Six out of the total of eight employees that make up the
department responded to the invitation to participate, including an Executive Vice President,
Vice President, Director, Manager, and two out of the four Patient Safety Specialists. All are
female and five out of six are registered nurses as outlined in Table 6. The participant
representation afforded a multi-level leadership view of the study’s topic, from those who set
policy, to those who ensure it is followed. To preserve the anonymity of the participants,
throughout this chapter, the Executive Vice President, Vice President, and Director will be
referred to as senior-level leaders (SL1, SL2, and SL3), and the Manager and two Patient Safety
Specialists will be referred to as management-level leaders (M1, M2, and M3). The
identification codes were randomly assigned with no connection to the hierarchy to further
protect their confidentiality.
45
Table 6
Participant Demographics
___________________________________________________________________________
Title Level Credentials
____________________________________________________________________________
Executive Vice President
Senior-level
Ph.D., RN
Vice President
Senior-level
Ph.D., Master Black Belt,
Certified Professional in
Healthcare Quality (CPHQ),
Fellow of the National
Association of Healthcare
Quality (FNAHQ)
Director
Manager
Patient Safety Specialist(s)
Senior-level
Management-level
Management-level
MS, RN, Certified
Professional in Healthcare
Quality (CPHQ)
RN, MS, Clinical Nurse
Leader (CNL), Board
Certified (BC)
RN, BSN, Legal Nurse
Consultant (LNC), Board
Certified (BC-Nursing
Informatics (NI), Certified
Professional in Healthcare
Information Management
Systems (CPHIMS)
RN, BSN, Nurse Executive
(NE)-Board Certified (BC)
At the onset of the interview, the participants were asked what led them to work in the
patient safety realm and how long they had been working in the patient safety field. These
questions were intended to establish their years of patient safety experience and provide the
reader with confidence in their acquired expertise to respond to the interview questions. This did
not lead to the simple black and white answer that was originally intended as a demographic
46
data point. Each participant, in various ways, struggled with the question and indicated that
patient safety had always been a part of their work, even before having an associated formal
title. It was hard for them to separate the two.
One senior-level leader (SL2) described that when she began doing work in quality, she
realized she “had the opportunity to not just impact one or two patients”, rather she could
“impact outcomes for patients at a much broader level.” She continued saying that “I think in
any nurse leadership role, it's always patient safety.” Another at the senior level (SL1) stated
that she thinks “the attractive part of working in patient safety is the ability to impact (...)
multiple patients.” A participant at the management level (M3) said, “Basically as a nurse
manager, your day is spent doing multiple things, but a lot of your focus is safety and quality,
taking care of your patients safely, giving your staff what they need to be safe.” Yet another at
the management level (M2) expanded on what a patient safety culture has always conveyed to
her:
That I'm somehow impacting better care, better communication, keeping a patient well
and whole, but yet making sure that the nurses and the providers aren't set up for
something to go wrong (...) [and I] haven't made it so difficult for the staff to do the right
thing, and to do a good job, and to feel good about what they're doing. (...) We speak for
the patient when the patient can't speak for themselves and that's why that's an honor as a
nurse (...) that patient is trusting me at the most vulnerable part of their life, and you
know, I owe that patient and their family, to keep them safe, to keep them home, and to
be their advocate when they can't advocate for themselves.
These participant quotes highlight their passion for the significance of a patient safety
culture. Impacting patient outcomes at a broad level, providing employee and patient safety, and
47
reducing medical errors were consistently threaded throughout. According to The Joint
Commission (2017), a strong patient safety culture is made up of productive individuals who are
engaged, learning, and collaborative. The patient safety participants demonstrate these
characteristics.
Without specifically being asked, two of the participants from the management level
(M2 and M3) shared details of their medical errors. One of the two (M2) revealed she will
never forget hers and said that she “didn’t wake up that morning to give a baby 10 times the
dosage of morphine” but the system set her up for failure. The second of the two (M3) said, “I
think every single one of us on our team could tell you a story about an error that we, you know,
something that happened in our career that we still remember to this day and that you know you
always have that defining moment that kind of makes you realize that you’re the last line of
defense to help your patient.”
Having personally experienced the importance of leader and organizational support
following a medical error served to be an important component of how these two management
level (M2 and M3) participants approach their work. Empathy for others in similar situations
was felt deeply. According to Scott and McCoig (2016), the most favorable outcome after a
provider’s involvement in a medical error is for them to be able to thrive. In this stage, the
provider has gained new insights and lifelong lessons in patient safety and can successfully
move forward in their career always asking what else they can do to promote patient safety
(Scott & McCoig, 2016). The two study participants who shared their medical error stories have
achieved this stage. The leadership response following their medical error confirmed for them
how important emotional support is for the involved employee. They have lived the experience
and felt the pain and realize this helps move employees towards healing.
48
Table 7 outlines the study participants’ answers to the interview question, “How long
have you been working in the patient safety field?” The column entitled Formal Role denotes
the number of years that participant has worked in a patient safety department, or possessed
patient safety tasks as an area of organizational responsibility. The column labeled Informal
Role is the number of years each participant mentioned that patient safety was an important
factor in their day-to-day patient care work. There are five leadership levels of employees
represented in this sample, and all struggled to answer this question.
Table 7
Participant years working in the patient safety field
Role
Years in a
Formal Role
Years in an
Informal Role
Quotation
Executive Vice
President,
Quality & Safety
5
25+
“You know, everything I’ve done in
leadership, I always translate to what
the impact is on the patient (...) what
impact does that have from a patient
safety, quality perspective”
Vice President,
Quality & Safety
20
30
“Back in the ’90s (...), you realized
you had to have programs that were
proactive in place or you would
never get a handle on what patient
safety culture was”
Director, Patient
Safety
15 15 “I’ve been in and out of patient
safety because of different you know
changes every fiscal year”
Manager, Patient
Safety
2 25 “There’s always patient safety in
every position”
Patient Safety
Specialist
4 months 16 “Patient safety in general, I would
say 16 years”
Patient Safety
Specialist
2 10+ “All throughout my career, I’ve been
able to worry about safety (sic)”
49
Analysis through the Research Questions
According to Clark and Estes (2008), increasing knowledge, skills, and motivation are
the keys to organizational success. Effective leaders are positioned to effect change in all three
of these dimensions. To begin the analysis process, the findings gleaned from the qualitative
semi-structured interviews were compared with the data found in the patient safety-related
documents. They provided descriptive information to verify what was heard in the interviews
and helped to advance new category development. All findings were then connected with
applicable patient safety literature and prior research. Relevant K-M-O assumptions and gaps are
included to further strengthen the analysis.
RQ 1: How does a leader ensure consistency in policies, practices, and protocols to create a
patient safety culture?
Several interview questions were asked to gain an appreciation for leadership approaches
to ensure consistency in policies, practices, and protocols in the quest for a patient safety culture.
Actively engaging with the data produced several main categories that answer this question.
They include the leadership’s responsibility to understand, communicate, and behave per the
patient safety-related policies, practices, and protocols. Direct quotes and connections to
organizational documents are included to provide validity for the findings in each of the
categories sections.
Leadership’s Responsibility to Understand
A senior leadership level participant (SL2) opined that culture creation begins with
leaders “who really see safety as a priority, from a value perspective (...) as part of an
organization that’s willing to invest the resources to drive it.” The data revealed it is not enough
to speak the patient safety language, the organization has the responsibility to put resources
50
behind it and ensure it possesses leaders who understand their role within it. Two examples of
the organization’s investment in resources emerged from the data analysis, an easy-to-use online
reporting system, and the creation of a patient safety department. HSA’s event reporting policy
includes the statement, “All staff is expected to report actual and potential safety events through
timely, objective, and respectful communication.” SL2 stated,
People at the front lines really [have to] own it and [be] willing to either report it or do
something about it all the way to the top level where the senior-most individual in the
organization is willing to accept responsibility and accountability for what’s happening.
Four out of six participants (SL1, SL2, SL3, M1) posited that each leader must develop
an understanding of patient safety issues in their area of responsibility through a data lens. This
includes reporting rates in each leader’s department that reveal consistent reporting as well as a
lack of reporting. SL3 added that it is a “statistical anomaly to think that you’re not going to be
making little errors, little mistakes, that for some people, they think are insignificant, but when
you start adding them up, [they are not].” Departments without error or near-miss reporting
would not be expected in an organization with a patient safety culture. SL1 presented executive
leadership rounds as an example of an additional method for leadership to gain an understanding
of what is going on in the organization outside of data. Leadership awareness and understanding
at all levels are key.
Five out of the six patient safety department members (SL1, SL2, SL3, M2, M3) assert
that leaders must be knowledgeable of the content within the organization’s patient safety-related
policies, protocols, and procedures to reduce variability in practice and use them to guide
practice. The decision algorithm, present in the organization’s Staff Responsibility for Safety
policy, entitled Just Culture Tool, was adopted to help evaluate employees involved in a medical
51
error to understand the contribution of human and system factors (National Patient Safety
Foundation, 2016). SL2 indicated that adopting a non-punitive approach while maintaining
mindfulness that “willful disregard of policy and procedure with no mitigating circumstances
will not be tolerated” is a necessary balance a leader must strive to maintain. Adoption of this
tool assists leaders to make this determination objectively.
All participants agreed that the written policies assist with the communication of
expectations, document the best practices to follow, and guide expectations and surrounding
behaviors for staff to follow. Said one participant at the management level (M2), they “eliminate
the gray” to hold staff accountable and is useful in medical error investigations to direct the
discussion. According to Dr. Don Berwick, former founder and Chief Executive Officer (CEO)
of the Institute for Healthcare Improvement (IHI) and former Administrator of the Centers for
Medicare and Medicaid Services (CMS), “Most serious errors are committed by competent,
caring people doing what other competent, caring people would do” (AHRQ, 2019, para. 12).
This understanding was noted in the totality of participant responses and is illustrative of the
leader’s responsibility to understand the organization’s policies, protocols, and procedures as a
basis to know what that competence is. In organizations with a strong patient safety culture,
decisions that affect safety are systematic and thorough. Leaders who practice by them, use
them to analyze systems, and coach staff to follow them lead to a learning culture that helps
implement reform when needed (Joint Commission, 2017).
Leadership’s Responsibility to Communicate
Patient safety must be communicated throughout the organization, with consistent
messaging in alignment with the associated policies, practices, and protocols. Several
participants commented on the importance of leadership’s adoption of multiple and creative
52
approaches to communicating patient safety as a priority. Four out of the six participants (SL1,
SL2, SL3, M3) iterate that communication should celebrate those who have reported near misses,
or other potentially hazardous situations on a routine basis during formal events, such as Patient
Safety Awareness week and new employee and manager orientation. Near miss reporting, before
a medical error has been committed, is the preferred method to examine a potentially faulty
system.
Two of the patient safety department’s senior-level leaders (SL1, SL3) stressed that when
a near-miss or medical error is reported, the communication loop should be closed so there is no
appearance of the report “falling into a black hole.” One of the two leaders (SL1) stated that the
person who takes the time to report deserves to know “that we actually look at every single event
and do something about it.” The second of the two (SL3) added that by providing feedback
following a report, the reporter feels “like they're participating in the (...) safety culture because
they're speaking up.” The black hole description was stated verbatim by these leaders (SL1, SL3)
and is an example of a practice that would lead to a reduction in error reporting. If employees do
not feel their reports are acted upon, there would be less incentive to report them. In their study,
Sexton et al. (2018) found employee engagement and participation in decision-making highest in
settings where leaders participate in active communication with their staff. Feedback to the
medical error or near-miss reporter to express appreciation and inform them of the positive
change that resulted from their submitted report emerged as instrumental to creating an
environment of consistent reporting and safety awareness.
While formal communication had its purpose, the patient safety specialists at the
management level (M1, M2, M3) stressed that communication should also promote awareness at
the unit level through the use of data, storyboards, and huddles. Huddles were defined as brief,
53
purposeful gatherings with management and employees to share patient safety-related concerns
and assess goals and anticipated challenges to achieve a comfort level of preparedness for the
shift. M3 said, “You know, huddles shouldn’t be about being talked at, it should be, you know,
more interactive” inspiring employees to interact with what is being expected of them rather than
being told what to do. According to M1, employees should be able to go to “their managers and
talk about something that they may have seen or a concern that they have” that will as M2
described, create a “learning environment.” By inviting the employee’s perspectives and seeking
feedback, the employees can feel more confident in their ability to respond to the potential
challenges that lie ahead. In their study, Horwitz and Horwitz (2017) found a positive correlation
between patient safety culture and structural empowerment, with structural empowerment
referring to staff’s ability to mobilize resources and achieve goals through access to information,
support, and resources (Moura et al., 2020). Huddles and other avenues of informal
communication at the unit level are the vehicles to provide that opportunity. The leader as a
communicator in both words and actions is crucial to the maintenance of a patient safety culture.
Leadership Commitment to Patient Safety Behaviors
Patient safety culture is developed with intent, however, tends to be informally created
among its members and built upon the foundation of mutual goals and behaviors. Role modeling
patient safety behaviors emerged through the data analysis process as an important element of
patient safety culture. Leaders must see small errors as opportunities for improvement and,
according to one senior-level participant (SL3), must “commit to doing everything they can so as
not to cause harm [and ensure that their staff view reporting as a] non-punitive, blameless
opportunity to tell us what they have seen.” Leaders are obliged to accept and hold staff
54
accountable to follow the policies, protocols, and practices that support patient safety. As one
management level participant (M3) commented,
I think so many people think that the only people that impact patient safety are the people
that have hands on the patient, which is far from the truth.” [Leaders have to create an
environment where staff feel safe to self-report and empower them to realize] they can
stop the line and question something [if it doesn’t feel right.]
At the senior level where policy is written, it was underscored that leaders must build
safety systems with double checks and forethought. They shouldn't allow for opportunities for
people to fall into a situation where they could make a mistake. The organization’s Quality and
Safety Improvement Plan documents its expectations of leaders, “Operational leaders from each
organizational department and service, share with senior leaders across the system the
responsibility to ensure optimal, high quality of patient care and/or service delivery within a safe
environment.” Table 8 is presented to summarize the key points gleaned from the collective
interviews that answer the first research question.
55
Table 8
Summary of responses in support of RQ1
They understand: They consistently follow policies, practices, and protocols and are
committed to being fully knowledgeable of their content. They use data and direct observation
to focus on individual areas of responsibility to lead to awareness and shine a light on areas of
opportunity for improvement within them.
They communicate: They get out of their office, are visible, and interact with staff to observe
and solidify patient safety behaviors according to the policies, practices, and protocols’
content. They communicate in creative and engaging ways to further the message that safety is
an organizational priority.
They exhibit patient safety behaviors: They communicate and behave in alignment with the
patient safety principles embedded in the related policies, practices, and protocols. They hold
staff accountable in a consistent, objective manner using the policies, practices, and protocols
as a guide and create safe environments to increase reporting of unsafe conditions and other
patient safety concerns.
Knowledge Influences and Gaps
The data analysis related to RQ1 was conducted through the Clark and Estes’s knowledge
lens. During the interview process, the patient safety staff members were asked what components
make up a patient safety culture and how they are present in the organization. They were also
asked how they see patient safety-related policies and protocols exhibited in the organization.
HSA’s Staff Responsibility for Safety policy has a stated purpose to
Establish a culture of safety characterized by an open atmosphere for reporting and
addressing safety risks, and by anticipating and preventing errors through careful
monitoring and timely re-design of internal patient care systems.
According to a participant at the management level (M3), everyone in your organization
“has to understand how they play a part in patient safety.” Leaders need to impart their
knowledge of the patient safety principles to get to a culture whereas M3 states “people feel
comfortable, they know that they have a say and that they understand how they impact patient
56
safety.” Further, as one senior-level leader (SL2) described, “I think the first thing is the leader
has to clearly articulate what the expectations are and set those expectations in a manner that can
be translated behaviorally.”
Safety culture has been described as an informed culture. It is one in which staff
understand and respect the hazards within the organization. As described by Reason (1998), it is
a culture where staff at all levels do not forget to be afraid. Leadership plays a pivotal role to
create an informed culture and is responsible to teach, role model, and coach to the patient safety
components to create it. They are the connectors to the policies, protocols, and procedures and
have a responsibility to ensure all on their team are knowledgeable and competent to carry out
the related actions. Table 9 presents the data analysis results with the knowledge influence, gap,
and supporting quotations that validate or invalidate it. As a reminder, gaps will be considered
validated or invalidated when at least four respondents provide evidence to support the finding.
57
Table 9
Knowledge Influences and Gaps
Stakeholder Goal
The goal of HSA is to create a culture where staff is knowledgeable of patient safety
principles, report unsafe systems and medical errors, and actively participate in patient safety
initiatives.
Assumed Knowledge
Influences
HSA’s staff need to know
the organization’s patient
safety-related principles.
Gap
Invalidated
Quote
SL1 “Employees have the ability to ask
questions about what’s shared with them (...)
from morning daily safety briefing”
SL2 “We just celebrated patient safety week
and (...) we had people sharing their good catch
stories”
M1 “They would mention it in huddles (...)
M3 “We review it in new employee
orientation, we review it in new manager
orientation”
HSA’s staff need to know
how to apply the patient
safety-related policies and
protocols that outline the
organization’s patient
safety principles.
Validated
SL1 “I’ve heard stories, you know not only
here, but in other organizations (...) you know,
someone makes a medical error, they feel so
bad, we don’t take care of them”
SL3 “I’ve seen leaders so bad that the people
that they’re leading are at odds with each
other”
M1 “They can get defensive sometimes, you
have to (...) remind them, this is not a blame”
M2 “I don’t feel the sameness”
RQ2: What attitudes, beliefs, and collective efficacy are needed to produce patient safety
culture?
Several interview questions were asked to better understand the role of attitudes, beliefs,
and collective efficacy on the production of a patient safety culture. Data align with the literature
on authentic and transformational leadership principles, specifically, the enhancement of
58
personal relationships in pursuit of collective efficacy, possession of strong morals and values,
and focus on authenticity and communication (Clarke, 2013; Institute of Medicine, 2004, p. 4;
Northouse, 2016, p. 190). A synopsis of the findings is presented in the three main areas
addressed in the research question; leadership attitudes, leadership beliefs, and leadership’s
ability to attain collective efficacy.
Leadership Attitudes
Leadership needs to demonstrate an attitude of humanness as it pertains to medical error.
Two participants, one from the senior level (SL3) and one from the management level (M3)
shared that leaders who tell stories with examples of their vulnerability, to elicit a response that,
“Oh my God, that could have been me” (SL3) and no one is “perfect” (M3) display an attitude of
connection. Many staff members are perplexed about who they can turn to for support and
guidance following medical error (Scott, 2011). When leaders share similar experiences that
happened to them, they open the door for others to do the same. These leaders present as role
models of the desired behaviors required to achieve a patient safety culture, namely, an
environment of nonjudgmental, open dialogue following a medical error (ECRI, 2019; Joint
Commission, 2016; The National Patient Safety Foundation, 2015).
Five of the six participants (SL1, SL2, SL3, M2, M3) impart that leaders must reveal an
attitude of caring and compassion after a medical error. The organization’s Event Reporting
System, Management, and Analysis policy support this construct with a reminder that involved
staff may need emotional support or formal referral to an employee assistance program. A
participant at the management level (M3) affirmed that the leader should take care of the
immediate safety needs of the patient while recognizing at the same time that the employee may
need support as well, specifically that “they need to be consoled, there's a lot of grief and a lot of
59
guilt that comes when, you know, an error is made.” Two of the senior-level participants (SL1,
SL2) iterated the importance for the leader to react to medical errors with consistency and apply
the just culture principles outlined in the Staff Responsibility for Safety policy or risk a hesitation
to come forward after a medical error. Said SL1, “we do have to educate leaders (...) to the
decision algorithm around what you do in response to reporting” and according to SL3,
“everybody has to come up with a standard way (...) of holding our employees accountable.” The
Staff responsibility for Safety policy includes a statement that there will be a “fair and just
response by balancing a non-punitive approach while holding all staff responsible” for safety
following a medical error.
Leadership plays a key role in a learning environment when an observation of behavior
that falls outside of the patient safety guidelines is made. When there is a witnessed deviation
from practices, policies, and protocols, in an organization with a patient safety culture, leaders
coach staff in a caring, empathetic manner, and as one senior-level leader (SL2) described, hold
people “answerable to the outcomes” by engaging in nonjudgmental conversation in real-time.
SL3 relayed a situation she observed that exemplifies this concept. It involved a nurse manager
who saw a nursing assistant bypass a step in the patient identification process who privately
pulled them aside for a coaching moment.
Hey, I just watched you and I'm sure (...) you believe you know this patient (...) our
expectation is that we double check (...) two identifiers, every patient, every time we
draw labs, and you know, let me just tell you why we do that, (...) we've had examples
across the organization where, in error, (...) we've sent the wrong blood down and you
know, we could be treating the wrong patient for something and really cause harm and I
watched this nursing assistant really get it, it was like, Oh, my goodness, I didn't even
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think that that could happen. But it was a very coaching, positive, collaborative and it
wasn't (...) beating the person up or berating them in a negative way and I said, wow this
is really great.
Employees who observe a consistent coaching style develop trust in their leaders and an
increased propensity to adhere to patient safety practices. In their cross-sectional survey
employing a convenience sample of 31 hospitals in Michigan, Sexton et al. (2018) found that the
percentage of respondents who worked in a hospital that engaged in routine leadership walk
rounds with real-time feedback had the strongest relationships with their leaders and high scores
for participation in decision-making and improvement readiness.
Leadership Beliefs
Leadership must hold the belief that all staff is accountable for patient safety. A senior-
level leader (SL2) indicated that following a medical error, leaders should be inquisitive and “as
gently as possible try to understand what was happening at the time” to prevent future
occurrences. They should gather facts, but be objective and neutral, ask to understand as one
senior-level leader (SL2) described, “not to chastise.” A leader at the management level (M2)
maintained that leaders should start by asking how they failed the employee and support them
through the investigation process, to move towards a nurtured, trusting relationship. She (M3)
added that following her error, her manager said “look how I failed you [and] that was the most
powerful way that he handled that event that’s made me the kind of nurse I am today.” The
organization’s beliefs, in sync with the Joint Commission (2017), find that leadership should
profess a fair and equitable measure of accountability for all. All six participants affirm the
importance of holding staff accountable for patient safety. This stance is documented in the
policy entitled, Staff Responsibility for Safety:
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All staff, regardless of their position, are responsible for: avoiding behaviors that may
cause risk or harm; reporting real or potential safety events using internal mechanisms;
practicing safely by following policies and procedures; making decisions that are aligned
with a culture of safety, and participating in activities which support and improve safety.
As noted by a participant at the senior level (SL2),
Just because we have words on a paper that say this is the way we do it, the policy by
itself isn't going to change the culture, it's how our leaders across the organization
evaluate behavior as compared to the policy, and coach, and make sure that people are
following [what's in it.]
Felt accountability, also known as simple accountability, is based on perceptions that
one’s decisions or actions will be evaluated by a salient audience and that rewards or sanctions
are contingent on this expected evaluation (Hall et al., 2017). Staff must believe that an account-
giving (explanation) might be required (Frink et al., 2008) following a decision. When feedback
is delivered consistently, staff will understand their roles and responsibilities and expect that
their actions will be evaluated accordingly. HSA clearly states in its mission, prominently
displayed on its public-facing website that all employees take ownership of their actions and the
consequences that may result from them.
Leadership’s Ability to Achieve Collective Efficacy
To move towards collective efficacy, leaders need to foster employee connections to
build trust within their teams to collectively move towards a patient safety culture. One senior-
level participant (SL1) stressed that to achieve that, leadership at all levels has to “play off each
other” and as a management-level participant (M3) described, “give consistent information.”
Another senior-level leader (SL3) averred that there are “inherent hierarchies within the
62
leadership food chain and that politics plays a part as you go up that hierarchy” and if there is
conflict, it can make it “extremely difficult for the “good leaders who work in middle
management or at other levels do the right thing for their (...) own teams.” Multiple levels of
leadership must be in alignment and communicate event reporting data according to a
management level leader (M3), “who can then sell it to their staff and get them to understand the
importance, how it relates specifically to their unit and to them” as a team. Three of the six
participants (SL2, SL3, M2) declared that staff needs to see leadership getting out and walking
around praising patient safety behaviors. According to PS1, effective leaders “find somebody
who has the leadership qualities (...), not like an official leader (...) one of their staff members to
champion” patient safety in their units. This further builds teamwork in support of patient safety.
There is always a leadership presence.
The leaders’ messaging also creates teamwork and according to one senior-level
participant (SL1) reminds “employees we are all in this together (...) they’re all our patients.”
According to another senior-level leader (SL2), an effective team “would have members who
feel like every other member of the team has their back” and begins with environments that
foster opportunities for colleagues to get to know each other, to find “shared interests outside of
the work environment (...) it kind of humanizes members of the team.” SL2 furthered that
effective leaders “encourage interaction and really constructive communication among members
of the work units [and] highlights accomplishments and successes among [them]”, identifies
areas of potential conflict, and encourages resolution which involves “basically pulling them
together and working it out and not letting things fester.” At the management level, M2 added
that successful leaders role model and encourage communication and collaboration between
disciplines, in further support of teamwork. Transformational leaders demonstrate a priority for
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safety through their behavior and develop trust within their teams that leads to enhanced
interpersonal relationships (Clarke, 2013). Team strengthening naturally follows. Table 10 is
presented to summarize the key points gleaned from this section that answer the second research
question.
Table 10
Summary of responses in support of RQ2
Attitudes: Leaders demonstrate humanness as it pertains to medical error. When they witness
a deviation from practices, policies, and protocols, leaders coach staff in an empathetic
manner. Leaders exhibit an attitude of compassion for their employees and provide emotional
support after a medical error has occurred.
Beliefs: Leadership believes all staff is accountable for patient safety. Leadership professes fair
and equitable measures of accountability for all. They understand, implement, role model, and
coach staff to patient safety culture components.
Collective Efficacy: Leaders foster employee connections to build trust within individual
teams. They help staff understand the importance of teamwork and how it relates specifically
to their departments. They encourage communication and collaboration between disciplines.
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Motivation Influences and Gaps
The data analysis related to RQ2 was conducted through Clark and Estes’s motivation
lens. During the interview process, the patient safety staff members were asked what behaviors
leadership demonstrates to motivate towards a patient safety culture. They were also asked to
delineate the behaviors leaders demonstrate following an employee report of a medical error and
how ideal leaders motivate towards a culture where employees feel safe to report medical errors.
While the policies, procedures, and protocols characterize a motivation to create a patient
safety culture, four study participants (SL2, SL3, M2, M3) observed inconsistency in leadership
behaviors to support it. One senior-level participant (SL2) shared “over my years in leadership, [I
have] experienced (...) managers who feel that they're going to look bad if their staff is reporting
things.” Another senior-level participant (SL3) indicated that physician leaders may be
disconnected from safety culture and doesn’t observe “fast-acting changes in the provider
mindset.” Another participant at the management level (M2) experienced resistance to a
suggested corrective action following a medical error and felt she has “to act one way at one
hospital” and “can speak freely and act another way at another hospital” Another management-
level participant (M3) indicated,
I think that’s where I see a lot of leaders falling short, is that you know they don’t want to
be punitive, they don’t want to blame somebody which I’m not saying we should blame a
person, sometimes it’s the systems issue, sometimes it’s the policy issue, but there are
times when staff doesn’t follow policy, and whether it is very blatant disregard or for a
knowledge deficit, I think that leaders need to do a deeper dive and I think that they need
to hold staff accountable, regardless of what the reason.
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All participants believe that at the highest levels of the organization, there is a genuine
commitment to a non-punitive culture following a medical error. As written in the policy, Staff
Responsibility for Safety, “Recognizing that human error does occur, HSA will promote a fair
and just response by balancing a non-punitive approach while holding all staff accountable for
embodying the fundamental responsibilities set forth.” The policy documents an expected
response following a patient safety event to include one or more of the following:
● “Consoling to provide emotional support, Employee Assistance, peer support
through available staff support programs
● Coaching to provide education, policy, and procedure review
● Corrective action to modify specific behaviors that were identified as a cause or
contributing factor in the safety event.”
There is observed inconsistency, however, in its application. As one senior-level leader
(SL3) has observed,
In [one department] you know, two times in a row because you've been caught making a
mistake or leaving out a step when you're supposed to be doing patient identification [you
lose your job] and then have the same thing happen four different times with a
completely different crew in [another department] and watch no one lose their job.
Charismatic leaders are positioned to motivate staff towards patient safety behaviors. As
a management-level leader (M1) shared, we have to remind them “that we’re all here for the
patient and remembering that, you know, there’s a patient in the bed and that patient could have
been our mom or dad.” While there is a communicated organizational drive to achieve zero
patient harm, there is inconsistent leadership motivation to fulfill it. The related consequences
are staff confusion and frustration. Table 11 presents the data analysis results with the motivation
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influence, gap, and supporting quotations to validate it. The reader is reminded that a validated
gap exists when at least four respondents provide evidence to support the finding.
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Table 11
Motivation Influences and Gaps
Stakeholder Goal
The goal of HSA is to create a culture where staff is knowledgeable of patient safety
principles, report unsafe systems and medical errors, and actively participate in patient safety
initiatives.
Assumed Motivation
Influences
HSA staff need to believe
that the organization’s
leaders are motivated to
create a patient safety
culture and will help them
get there.
Gap
Validated
Quote
SL1 “It’s almost impossible to get important
information to frontline staff.”
SL2 “I’d love to get to a point where every
single department and service gets updated
data on a regular basis about some of the
patient safety metrics.”
SL3 “It’s sad but we often resort to using the
hierarchical leadership chain to make
decisions that subject matter experts should
be doing.”
M1 “They start blaming each other and
constantly looking outward at what other
people they think (...) did wrong.”
M2 “feels like a partner in one hospital” and
“an appendage” in another.
HSA staff need to believe
leaders will support them
following a medical error.
Validated
SL1 “We don’t want employees to use event
reporting as a weapon”
SL2 “I do think we need to focus more on
frontline leadership management
development and support around how to
handle those situations and not come across
as punitive.”
SL3 “They get really upset when they find
out that we’re doing an investigation in their
areas.”
M1 “You could have the people who are very
negative about it.”
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RQ 3: What leadership characteristics are needed to create patient safety culture?
Several interview questions were asked to ascertain what leadership characteristics are
needed to create a patient safety culture. The findings reveal leaders who successfully create a
patient safety culture and accompanying learning environment can impact the organization’s
mission in a charismatic manner and build trust with their staff. In this environment, if an error is
made, employees expect to be supported and have the ability to learn from it. The participants
listing of individual characteristics gleaned through the interview process are categorized in
Table 12 by literature supported patient safety culture components, associated leadership styles,
and the patient safety professionals who identified the characteristics.
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Table 12
Summary of responses to RQ3 related to leadership characteristics
_________________________________________________________________________________
Category Leadership Characteristics Leadership Style Participants
__________________________________________________________________________________
Alignment with
Mission
Visionary gets people excited and
feeling good, good communicator,
ability to motivate, articulate
expectations in a manner that can be
translated behaviorally
Transformational,
Authentic
SL1, SL2, SL3, M2,
M3
Trust Draws people to them, they have a
presence, can connect with people,
transparent, honest, steps up and does
the right thing, shows interest in
employee’s personal life, empathetic,
warm, compassionate, fair and open-
minded, have to be seen, visible,
emotional intelligence
Transformational,
Authentic
SL1, SL2, SL3, M2,
M3
Learning
Environment
Can communicate why patient safety
is important, come from a real-world
bedside background, possesses
integrity, a role model of desired
behaviors, sense of accountability
Transformational,
Authentic
SL2, M1, M2, M3
Staff Support Supportive, willing to listen,
approachable, positivity, calmness
Transformational,
Authentic
SL1, SL2, SL3, M2
Patient safety culture is built on trust and a shared vision for patient safety; errors are
viewed as learning opportunities and staff is supported following adverse events and medical
error. HSA’s policies on patient safety outline leadership expectations, roles, responsibilities,
and processes surrounding medical error reporting and management of unexpected events.
Embedded in the organization’s policies is a statement outlining related staff support:
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Staff involved in a serious adverse event is sometimes understandably upset. Supervisors
should assess staff’s ability to continue working safely and make appropriate
arrangements for patient care. Involved staff may also need emotional support.
Changing from an organizational focus on patient safety to one of employee safety
having equal importance is supported by the literature as an important element of a patient safety
culture. According to Scott et al. (2016), staff involved in a medical error often desire emotional
first aid but are uncertain about whom to ask for support. Leaders must proactively anticipate this
need and initiate the conversation post medical error. Having an organizational foundation to
assist leaders with adequate resources to help with this conversation is imperative. Connection
and compassion for employees is a key leadership characteristic to create a patient safety culture.
A trusting relationship with one’s supervisor is ideally formed well before the incidence of
medical error.
Necessary leadership characteristics to maintain a patient safety culture are based on the
ability to behave in alignment with the mission, form trusting relationships, create learning
environments, and support staff. It starts with what SL3 described as the leader’s consistent
behaviors, where one can observe that “what they say and what they do match.” According to
SL1, leaders who are “visionary” and create excitement around the prospect of a safe place to
deliver patient care and are, as SL3 described, “empathic and open and inviting and
approachable” are positioned well to orchestrate a patient safety culture. Connection with staff
as shared by a participant at the management level (M1) is crucial, “we've had, you know, some
high up leadership that will go to the different units and talk with the nurses, and talk with the
staff, and [make] eye contact when they're walking through the hallways” and “it makes a big,
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big difference.” SL2 agrees and iterates “in order to be approachable (...) you go out and you’re
visible and you make eye contact.”
M1 stressed how vital it is to have patient safety messaging start at the top “from the
President down” adding if executive leadership is “engaged and visible” the better the chance of
employee engagement. According to SL3, a leader “has to be that person that’s like honey, not
like vinegar” who embodies patient safety and “always steps up and does the right thing. As M3
describes, “The leader has to be able to communicate to the staff (...) why patient safety is
important.” Patient safety culture cannot be achieved without the presence of leaders who
possess these character traits.
Organizational Influences and Gaps
The data analysis related to RQ3 was conducted through Clark and Estes’s organizational
lens with its associated responsibility to ensure its leaders are capable of creating a patient safety
culture built on trust and support. During the interview process, the patient safety staff members
were asked about HSA’s mission and what leadership characteristics help achieve a patient
safety culture to attain it.
HSA’s mission was deliberately created to be easy to remember. At the senior level, it
could be stated literally and at a deeper level, could be narrated. The newer members at the
management level of the Patient Safety Department could describe the concept but did not know
the exact language; M2 said “we’re all here to make a difference.” M3 added, “it’s part of our
quality priorities for taking care of our patients.” As SL2 shared “our aim from a patient safety
perspective is explicit about zero harm.” These statements are confirmed by HSA’s outward-
facing website with messaging that they continually strive for safe and compassionate patient
care.
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Data analysis reveals the organization possesses messaging, resources, and policy
language in support of patient safety, however, there is observed leadership behaviors contra to
its principles. Healthcare organizational leaders have “extraordinary power to influence
behaviors, beliefs, and practices” (Gandhi et al., 2016), but lack a road map to achieve it.
Leadership at all levels of the organization must work in concert to impart and role model patient
safety culture behaviors. According to the Joint Commission (2017), while policies, procedures,
and protocols are important, maintaining a safety culture requires leaders to visibly and
consistently support safety measures. Staff evaluate an organization mostly on what the leaders
do. As culture is created from the top-down and the bottom-up, a lack of group cohesion at the
senior level can confuse the organization’s members and thwart efforts to root patient safety into
the culture. Table 13 presents the data analysis results with the organizational influence, gap, and
supporting quotations to validate it. As a refresher, a validated gap exists when at least four
respondents provide evidence to support the finding.
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Table 13
Organizational Influences and Gaps
Stakeholder Goal
The goal of HSA is to create a culture where staff is knowledgeable of patient safety
principles, report unsafe systems and medical errors, and actively participate in patient safety
initiatives.
Assumed Organization
Influences
The organization must
ensure its leaders possess a
skill set to create group
cohesion.
Gap
Validated
Quote
SL2 “witnessing something that could potentially
cause patient harm and by the strategy of luck or
hope it did not and no action was taken, that’s
probably the most egregious thing I’ve seen.”
SL3 “not necessarily being developed to the
point, or having the skill set, the competencies,
and the personal characteristics that would make
a good leader puts marginal people in positions
(...) that create animosity.”
M2 “we’re going to do it our way and I’ve just
seen that fail and that’s very frustrating to me.”
M3 “I held my staff accountable but
unfortunately didn’t necessarily see my peers
doing the same thing.”
HSA staff need to believe
the organization will
support them following a
medical error.
Validated
M2 “I think more could be involved, I just think
you have to be very careful on, you know, how
that person is feeling.”
SL1 “In terms of applying the policies there’s
probably variability, you know, across leaders.”
SL2 “That’s the thing I worry about the most, the
after-effects in the impact of the clinician when a
mistake is made because we’re all human.”
SL3 I can “count probably on just a handful of
fingers how many residents [physicians in
training], those who are probably most likely to
do and make errors from non-experience” are
entering reports.
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Summary
The research study aimed to identify leadership characteristics, attitudes, and beliefs that
create a patient safety culture in alignment with the organization’s policies, practices, and
protocols. Conducting data analysis through the research questions revealed the importance of
leadership’s responsibility to understand, communicate, and behave per the patient safety-related
policies, practices, and protocols. The role of attitudes, beliefs, and collective efficacy on the
production of a patient safety culture was discussed with the emergence of the leader’s
humanness and vision as necessary to create connections and encourage medical error and near-
miss reporting. A light was shined on the importance of communication in the form of success
stories, within disciplines, at the unit level, through policies, procedures, and protocols, and
between all levels of leadership to impart a consistent approach to patient safety. Accountability
and responsibility was an important theme gleaned through the interviews and document review.
Clark and Estes K-M-O gap analysis framework was utilized to recognize potential areas
of improvement. Several noted areas for improvement include alignment of senior leadership’s
attitudes on patient safety and striving for consistent leadership approaches to patient safety
principles and staff support following a medical error. Chapter Five will outline these areas in
more detail.
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Chapter Five: Discussion
The purpose of this study is to contribute to patient safety culture scholarship with a
focus on leadership and the achievement of a patient safety culture. This study sought to learn
how strengthening leadership skills within a healthcare organization could catalyze patient safety
culture improvement. The research asked the following to gain an appreciation for that question:
RQ1. How does a leader ensure consistency in policies, practices, and protocols to
create a patient safety culture?
RQ2. What attitudes, beliefs, and collective efficacy are needed to produce a patient
safety culture?
RQ3: What leadership characteristics are needed to create a patient safety culture?
The study used Clark and Estes’s (2008) gap analysis framework. Using this framework
helped to identify barriers that might impact an organization’s ability to achieve a patient safety
culture. Document analysis and individual interviews were used to validate assumed knowledge,
motivation, and organization (K-M-O) influences of HSA’s existing patient safety culture. In this
chapter, recommendations will be offered as a means to address the validated K-M-O challenges
recognized in Chapter Four. Potential solutions will be proffered with the knowledge gleaned
through the study’s research questions. The recommended solutions will be framed by the
ADKAR model of change to provide a scaffolding for action and focus on individual leaders
within the organization. An important question to consider is, how can a leader be expected to
create a patient safety culture without an understanding of how to do it? Organizational change
can only happen when the individuals within them change. There must be an investment to
develop new skills of the individuals who create and sustain the new culture.
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Discussion of Findings
The study was held in an academic healthcare system with a focus on leadership and the
achievement of a patient safety culture. Data analysis through the K-M-O lens revealed several
gaps including the need for alignment of senior leadership’s attitudes on patient safety, consistent
leadership approaches to patient safety principles, and consistently applied staff support
following a medical error. Without leadership buy-in, organizational culture change cannot
occur. Leaders are orchestral conductors; when one section is not in sync or one individual is off-
key, the music is negatively affected and at times painful to listen to.
The recommendations for addressing the study’s identified K-M-O gaps are targeted at
HSA’s leadership. The organization has invested resources to forward a patient safety culture
including a medical error and near-miss reporting system and a fully staffed Patient Safety
Department. Patient safety principles are communicated to patients, employees, and visitors
through multiple and varied methods driven by the organization’s mission for zero harm. The
study’s document review revealed the presence of clearly stated, literature-supported
components and leadership practices necessary to create a patient safety culture. Despite these
efforts, the study participants report instances of observed leadership behaviors that are in direct
conflict with them. To successfully create a patient safety culture, cognitive, emotional, and
behavioral aspects of leadership dimensions must be considered. According to Kotter (1995),
nothing undermines change more than behavior by leaders that are inconsistent with their words.
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RQ1. How does a leader ensure consistency in policies, practices, and protocols to create a
patient safety culture?
Data analysis related to RQ1 was conducted through the Clark and Estes knowledge lens.
The assumed influences outlined in Table 9 did not reveal a gap in knowledge on the
components of patient safety culture included within the organization’s patient safety-related
policies and protocols, however, there was a validated gap noted on how they are applied. There
is an assumption that can be made that there may be a knowledge gap on the part of leadership in
how to carry out the behaviors reflected in the patient-safety related policies to achieve a patient
safety culture. A need for consistent leadership approaches that demonstrate patient safety
principles emerged as a pivotal area of focus through the study’s data analysis. Table 14 provides
an overview of the identified knowledge gap and recommendations to address it.
Table 14
Knowledge Gaps and Recommendations
Stakeholder Goal
The goal of HSA is to create a culture where staff is knowledgeable of patient safety
principles, report unsafe systems and medical errors, and actively participate in patient safety
initiatives.
Assumed Knowledge
Influence
HSA’s staff need to
know how to apply the
patient safety-related
policies and protocols
that outline the
organization’s patient
safety principles.
Gap
Staff are informed of and
held accountable to know the
organization’s patient safety-
related principles, policies,
protocols, and procedures,
however, leadership does not
consistently demonstrate the
behaviors that are outlined in
them.
Recommendation
Gather data from HSA’s leadership
team to identify the root cause of
the inconsistent behaviors. Use the
information to tailor individualized
education and coaching to achieve
consistency in practice.
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RQ2. What attitudes, beliefs, and collective efficacy are needed to produce a patient safety
culture?
Data analysis related to RQ2 was conducted through the Clark and Estes’s motivation
lens. The assumed influences presented in Table 10 validate that motivation gaps exist. There is
an observed inconsistency in leaderships’ provision of staff support following a medical error.
This finding affirms the need for alignment of senior leadership’s attitudes towards this key
patient safety culture component. Transformational and authentic leaders embrace the mission
and lead by example of how they live it (Clarke, 2013; Northouse, 2016, p. 190). Confusion can
occur when employees witness a mismatch between what is written in policy language and
leadership behavior, especially at the level of leadership who author the policy language. An
effective leader understands, communicates, and behaves in alignment with the patient safety-
related policies, procedures, protocols, and principles. Teams must share collective beliefs if they
are going to be successful, and it starts with the leader. Beliefs shape how organizations function
(Schneider, et al., 1996). Table 15 provides an overview of the identified motivation gaps and
recommendations to address them.
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Table 15
Motivation Gaps and Recommendations
Stakeholder Goal
The goal of HSA is to create a culture where staff is knowledgeable of patient safety
principles, report unsafe systems and medical errors, and actively participate in patient safety
initiatives.
Assumed Motivation
Influences
HSA staff need to believe
that the organization’s
leaders are motivated to
create a patient safety
culture and will help them
get there.
Gap
There are
inconsistent
leadership
approaches and
motivation to
support key
principles of
patient safety
culture.
Recommendations
Communicate to leadership the importance
of motivation towards a patient safety
culture.
Gather data from HSA’s leadership team to
identify the root cause of the inconsistent
behaviors. Use the information to tailor
individualized education and coaching to
achieve consistency in practice.
HSA staff need to believe
leaders will support them
following a medical error.
There are
inconsistent
leadership
approaches to
support staff
following a
medical error.
There is a brief mention of staff support in
several of the organization’s policies. Bring
this information to the forefront as part of
the policy’s purpose to impart that
employee safety is as important as patient
safety.
Survey staff who have been involved in a
medical error and use the information to
assess the current state of support services.
What works? What doesn’t?
Engage leadership in training sessions to
develop a skill set to empathetically respond
to employees who have been involved in a
medical error.
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RQ3: What leadership characteristics are needed to create a patient safety culture?
Data analysis related to RQ3 was conducted through the Clark and Estes organizational
lens. The assumed influences presented in Table 12 demonstrate organizational gaps. There was
an observed lack of group cohesion at the senior leadership level and inconsistency in employee
support following a medical error. The organization has demonstrated a purposeful commitment
and investment of resources to effectuate a patient safety culture. Additional resources devoted to
educational and mentoring opportunities for individual leaders to learn ways to effectively
embrace and live the mission statement to create a safe place for patients to receive and
employees to provide care will further embed the desired culture. Creating diversity in the
Patient Safety Department and the addition of medical staff members might further align
organizational efforts to achieve a patient safety culture. Several recommendations to address
HSA’s validated organizational gaps are summarized in Table 16. Further discussion on ways
that healthcare organizations can operationalize the recommendations framed in the ADKAR
model is submitted in the section that follows.
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Table 16
Organizational Gaps and Recommendations
Stakeholder Goal
The goal of HSA is to create a culture where staff is knowledgeable of patient safety
principles, report unsafe systems and medical errors, and actively participate in patient safety
initiatives.
Assumed Organization
Influences
The organization must
ensure its leaders possess a
skill set to create group
cohesion.
Gap
There are
inconsistently
demonstrated
leadership skills
to create group
cohesion
Recommendations
Develop leadership training and
mentoring sessions with a focus on
change management and collective
efficacy fundamentals. Include informal
leaders such as unit champions to advance
the efforts.
Diversify the Patient Safety Department
by adding medical staff members.
Create interview questions that focus on
the ideal leadership characteristics to
create a patient safety culture and hire
effective leaders to maintain it.
HSA staff need to believe
the organization will
support them following a
medical error.
There are
inconsistent
approaches to
employee support
following a
medical error.
Communicate the availability of
emotional support resources and support
for leaders for quick access following a
medical error.
Provide coaching and role modeling
opportunities for leaders to enhance their
skill set to ensure employees are well
supported following involvement in a
medical error.
The ADKAR model
ADKAR is the change model’s acronym to describe the outcomes an individual needs to
achieve before change can occur including awareness, desire, knowledge, ability, and
reinforcement. These five elements describe the natural order of how individuals experience
82
change. Awareness of the need to change stimulates a desire to make that change. Gaining a
desire to want the change propels an individual to seek knowledge of how to best achieve it. The
ability to apply what has been learned in the knowledge stage naturally follows and is solidified
with organizational reinforcement and support (Lawrence et al., 2017). Proceeding through this
process also prepares an individual for the inevitable barriers and resistance to change that may
present within themselves and their teams.
The ADKAR model has been described by Gilani (2018) as a tangible roadmap for
action. It is a simplified method that can help execute change and further root patient safety
culture into an organization. A direct focus on leadership, the people within the organization who
make things happen, would increase the odds of successful implementation and establish the
desired culture shift towards patient safety (Gilani et al., 2018). The model considers each person
as unique and allows for customization as one progresses through each of the five stages. It is
necessary to ensure leaders are armed with the skills they need to make change happen. Leaders
need coaching before they can effectively coach others. Leadership is the management of culture
(Schein, 2017).
Recommendations for Practice through the ADKAR model
Healthcare organizations expect that leaders will embed patient safety culture and
achieve collective efficacy within their teams and areas of responsibility. Successfully managing
staff members through this change requires a specialized knowledge base and skill set within all
levels of the organization. It cannot be assumed that leaders possess them; it would behoove
organizations to provide a supportive infrastructure to instill them.
The first stage in the ADKAR model is awareness. A key element in this stage is to
ensure that each individual fully understands the urgency surrounding the need for the change.
83
Reminding leaders of the harm that medical error causes patients and providers through various
communication platforms with the inclusion of statistics and stories, deemed to be a most
powerful way to get learners’ attention, could reawaken awareness to the reasons for
implementing a patient safety culture. In his book, A Leader’s Guide to Storytelling”, Denning
(2011, p. 58) posits that narratives enable staff to see the world differently and experience an
internal aha moment which in turn, connects them. In furtherance of the narrative, organizations
could invite employees who have been involved in medical error, second victims, to share their
personal stories. Patients who have been harmed by medical error could speak at patient safety-
related gatherings to engage leaders to act differently and at times contrary to their well-
established assumptions and practices (Denning, 2011, p. 259). People’s hearts and minds must
change in collaboration; putting a human face to the statistic associated with medical error would
help motivate the learner to effect change.
Once there is a clear awareness of the need for change, in the desire phase, the focus is
placed on instituting the intrinsic motivation of individual leaders. In their study, Lawrence et al.,
2017) found that the ADKAR model served as a prime infrastructure to design activities to
support managers through a major organizational change. They furthered that by understanding
how the model’s five elements affected individuals, successful changes were more likely to
occur for them as well as the rest of their team. This understanding also helped to foster plans
tailored to induce an individual’s willingness to accept the change (Lawrence et al., 2017).
Leaders must support and desire to change before they can successfully proceed to the
knowledge stage.
It can be understood that healthcare leaders know what constitutes a patient safety culture
as it has been touted for many years as best practice by several respected health care agencies
84
(Joint Commission, 2016; ECRI, 2019; The National Patient Safety Foundation, 2015). While
there is a general agreement of its importance as a patient safety approach, it has remained
elusive for many organizations. A proposed focus then is to switch from imparting knowledge to
the components of a patient safety culture to the motivation of and education to individual
leaders on how to be instrumental in the culture change processes towards achieving it. A
beneficial strategy would be to offer coaching and leadership training to those methods that
create trusted environments where employees feel safe to share patient safety concerns and
report a medical error. Research suggests that trust within an organization is a valuable resource
because it makes possible collaborative behaviors and cooperation to continually foster them
(Frink et al., 2008). The greater the trust among staff, the more effective the cooperative efforts
tend to be (Johnson et al., 2007). Education in an environment with trust at its base would allow
for effective peer learning without fear of embarrassment or punishment (Ngo, et al., 2018).
Reporting a medical error requires the reporter to make themselves vulnerable. Knowing that the
leader will act in their best interest and protect them from negative consequences will lead to a
willingness to report a medical error (Moorman & Grover, 2009) and provide an opportunity to
learn from it.
Once an individual emerges from the knowledge stage and proceeds to the ability stage,
the practice of their newly acquired skills with the opportunity for ongoing feedback and
coaching could propel the culture shift. Clear feedback on identified gaps with corrective
suggestions balanced with recognition for success will improve performance (Clark et al., 2008,
pp. 24-25). According to Wergin (2011), “learning and practice should always occur together in
a constant process of reflection, experimentation, and meaning-making.” In this manner,
learning becomes something that lives, breathes, and constantly evolves (Barley, 2012). When an
85
individual has an experience with the self, another person, and the world, there is a change “not
only in the self but also in the environment” (Rodgers, 2002). Feedback would be an evaluation
of the performance in context, not of the person (Nicol & MacFarlane-Dick, 2006). Without
feedback, errors persist and may even intensify because corrective actions were not taken at the
time it was needed (Morrison & Milliken, 2000). Simulation centers are offered as useful sites to
begin to practice these key skills before using them in the world.
The accountability relationship works when both parties are willing and capable
(Hentschke et al., 2004). The organization’s commitment to hold leadership accountable to
demonstrate patient safety principles and behaviors frame the last stage, reinforcement.
Reinforcement to ensure continued leadership competence of change management principles in
support of patient safety culture in each leader’s area of responsibility must continue or there is
an inherent risk of returning to old habits. Leaders should not assume that a change will never be
abandoned once implemented. Wong et al. (2019) used the ADKAR model to assist with
transitioning to a new model of care delivery. The reinforcement stage emerged as one of the
most important for team cohesiveness. Weekly team cohesion sessions to listen to struggles and
develop action plans to respond to them (Wong et al., 2019) were held to ensure the change did
not wane.
The ADKAR model applied simultaneously with organizational culture change methods
may further implant the patient safety principles outlined in HSA’s mission, policies, protocols,
and procedures to further strengthen the patient safety culture. Table 17 summarizes these
suggestions for individual action framed in the ADKAR model.
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Table 17
Suggestions for Individual Action Framed in the ADKAR Model
ADKAR stage Individual Action
Awareness: Understand the urgency for the
change
Share statistics and stories of the harm that
medical error causes.
Desire: Develop intrinsic motivation to want
the change
Foster plans to support individuals to accept
the change.
Knowledge: Attain knowledge of change
management principles
Offer coaching and leadership training to help
create trusted environments and gain
collective efficacy towards team building.
Action: Apply the newly acquired change
management and communication skills
Offer individual feedback and coaching to
develop competence.
Reinforcement: Maintain competence Check-in often to remove barriers to
maintaining competence.
Summary of Recommendations
Figure 1 affords a view of patient safety culture as the desired organizational goal
including tangible practices, policies, and protocols that are driven by the collective attitudes and
beliefs of all who make up the organization. The leader is the connector of all of the interrelated
concepts and is imperative for the successful implementation of a patient safety culture.
Utilizing Clark and Estes’s gap analysis theory revealed several opportunities for HSA to
ensure consistently practiced patient safety principles and help their leadership team
development to effectively serve as the connector of its concepts. Awareness of leadership
behaviors in conflict with patient safety principles and means to understand their causes when
they are witnessed will target the necessary action needed to close the gap. Skills development
for leaders to support employees following medical error with accompanying knowledge of
organizational programs and resources to refer them to will prepare leaders to respond
87
appropriately. Making employee safety more visible within existing patient safety policies will
demonstrate its equal importance. Change management essentials training and opportunity for
practice will further prepare leaders for their role as connectors. Bringing medical providers into
the patient safety department will increase physician participation in patient safety efforts. The
ADKAR model builds on these gaps and drills down to the individual level of the change
initiative. Attention is directed to the individual leader’s enhanced growth and development in
key patient safety behaviors to best position them to help their staff adapt to a patient safety
culture.
As with any program involving change, ongoing evaluation of its effectiveness is a
necessary component. Formative evaluation is well suited for this purpose with its openness to
learning and commitment to ongoing improvement at its core (Patton, 2017). An underpinning of
this type of evaluation is its requirement of mutual trust (Patton, 2017), similar to one of the
main patient safety culture components. Organizations would be well served to determine which
questions they will use to assess the program’s effectiveness before implementation. Several
examples for consideration include: Have reports of medical error and near-miss events
increased? How have participants received the training? Have patient safety culture survey
scores shown improvement?
Attention to the design of the leadership training is key to ensure it results in the desired
leadership behavior change towards patient safety culture creation. Learning is a
multidimensional process that results in a change in a person; motivation is the process whereby
goal-directed activity is instigated and sustained. Below are several recommendations to consider
when designing the training that incorporates both:
88
● Embed a message of praise to begin the training. Acknowledge the patient safety work
done thus far followed by a call to action for the need to continue the fight. The judicious
use of praise tied to effort and successful strategy can create a growth mindset and a
willingness to take on challenging tasks (American Psychological Association, 2015).
● Administer a pretest. Provide the answers so learners are cognizant of what they know
and where their knowledge gaps are. Activating prior knowledge allows learners to draw
on it more effectively (Ambrose et al., 2010). During the learning process, metacognition
guides the learning strategy. If learners know what they know and do not know, they can
focus on acquiring the knowledge they are lacking (Medina et al., 2017).
● Provide the learner with suggested opportunities to practice the measurement and culture
recognition skills often enough so they can be used with a fair degree of automaticity
(Mayer, 2011). In addition to the provision of resources, offer the ability to connect with
subject matter experts after the training when roadblocks are encountered.
● Allow learners to anticipate what might go wrong and equip them with the knowledge of
how to handle the potential problems. This is an effective strategy to promote knowledge
transfer (Grossman & Salas, 2011).
● Administer a test following the presentation. Taking a test on learned information renders
the information more likely to be remembered (Carpenter, 2012).
● Incorporate content to guide the leader to achieve collective efficacy. This can be gained
by facilitating progress towards goal attainment, giving constructive feedback to the
group, and generating social cohesion (Borgogni et al., 2011).
89
● Ask the learner to complete a training evaluation after the presentation. The results can
guide future presentations and document the return on investment for the training
(Aguinis & Kraiger, 2009).
Limitations and Delimitations
The limitations introduced after Chapter Three warrant an expanded discussion relative to
the COVID-19 pandemic. The original research study was modified to adapt to the restriction to
enter the healthcare facility. There were plans to spend time with the departmental and unit
leaders identified as possessing traits beneficial to a patient safety culture to observe how they
interact with staff in various forums, such as rounding and staff meetings. The observations were
to be used as confirmation of the data gleaned from the interviews with the patient safety
professionals and organizational documents relative to patient safety to further increase the
study’s validity. As this was not possible, similar information was gained through the interview
process with the creation of additional questions to position the participants as the eyes and ears
of the researcher.
The COVID-19 pandemic also interrupted the ability to hold face-to-face interviews with
the participants. While Zoom® technology served as a viable option, there was a recognized
missed opportunity to witness visual cues and other body languages that may have occurred
outside of the limited box view that might have led the researcher to expand upon through
additional probing. Using this platform also introduced a potential for technical issues to arise.
Two out of the six participant interviews had to be conducted without the benefit of video due to
technical difficulty. In hindsight, this could have impacted the ability to establish rapport and
create the comfortable environment the researcher was striving to achieve to gain rich
information.
90
Strengths and Weaknesses of the Approach
This study focused on one organization with already established efforts to create a patient
safety culture. This could be considered both a strength and a weakness. The strength relates to
the fact that the participants are knowledgeable about patient safety and positioned well to speak
with authority about the topic. The weakness is that it offered only one group’s experience within
a very large and complicated organization. Further research in smaller organizations, those
without established patient safety resources to attain patient safety culture, and other departments
outside of patient safety would be helpful to ascertain if different characteristics and approaches
to achieve it might emerge.
Recommendations for Future Research
Future researchers interested in this subject are encouraged to mimic the originally
intended research design and spend time observing leaders who are identified by peers as
effective change agents towards patient safety culture. These are the leaders who embody
effective leadership characteristics similar to those that emerged from the data analysis with
components of transformational and authentic leadership styles. These leaders are visionary with
an innate ability to get people excited about change and are capable of drawing people into their
vision. They are honest, transparent, and do the right thing. They are interested in their
employees’ lives and are warm and empathetic. They are good communicators and possess
integrity and a sense of accountability.
As shared by one participant at the management level, the importance of the informal
leader in patient safety culture development cannot be forgotten as one who is instrumental in
effecting change. The concept of an informal leader is worthy of additional exploration in future
studies. It would be intriguing to interview this key stakeholder group to hone in on those
91
informal leadership skills that would match the culture the organization is trying to maintain.
This would ensure further planting of the culture below the surface to become the new norm or
the way things are done around here as culture has often been described.
Another curious observation emerged in the medical leadership community. HSA’s
Patient Safety Department did not include anyone with a medical degree. It is possible that
having a provider as part of the department would encourage more physicians to report unsafe
practices and actively participate in solution development following a medical error. Questions
to focus future research in this area include: What patient safety-related training do physicians
get before beginning internships? Is it similar to the patient safety-related training that occurs in
nursing, laboratory, pharmacy, and other departments within the healthcare system? These and
other questions directed at this key stakeholder group could identify other gaps to focus on to
achieve a patient safety culture.
Conclusion
The ADKAR model of change complements Clark and Estes’s (2008) gap analysis
framework and provides a method to focus action on members of the organization’s leadership
team to address the identified gaps in K-M-O influences. Medical error harms patients, their
families, and the well-intended providers who commit them. A patient safety culture has
emerged as a suggested method to create a culture where employees feel safe to report errors and
near-miss errors with the confidence that their reports will be reviewed and acted upon. The
reports allow for learning to happen and present opportunities to improve systems. Creating a
patient safety culture requires thoughtful and transformational leaders who behave in concert
with the organization's policies, protocols, procedures, and alignment with patient safety culture
principles. According to the National Safety Foundation’s Lucian Leape Institute (2017), safety
92
needs to be embraced as a core value of an entire organization and as a moral and ethical
imperative in healthcare.
There has been much discussion within the patient safety literature regarding the
components of a patient safety culture and suggested actions to achieve it. Framing the actions
with a focus on the leaders who are the ones that orchestrate the changes in a change model that
applies to the individual is a new notion worthy of further exploration. By engaging all leaders in
the training with feedback, role modeling, and opportunities to practice the new skills, a
groundwork of accepted behaviors that support a patient safety culture will be embraced by all.
Leadership development should bring together a balance of “knowing (the acquisition of
information), doing (the application and practice of new skills), and being (the values, identity,
and purpose that animate leaders)” (Garvin, et al., 2011).
It has been more than 20 years since To Err is Human (2000), the groundbreaking report
that started the patient safety movement, encouraged organizations to achieve a patient safety
culture. At the time, it was estimated that 98,000 people a year were dying from medical errors
(Wakefield, 2000). More recently, deaths are estimated at more than 400,000 a year (James,
2013). The call to action put forth by the report was to remove the silence that surrounded
medical errors by not pointing fingers at caring health care professionals who make honest
errors. Humans err, therefore, it is incumbent upon organizations to continue the work to create a
patient safety culture where medical errors can be reported without fear. There is much more
work to be done to achieve that goal.
93
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Appendix A: Interview Protocol
Research Questions:
RQ1. How does a leader ensure consistency in policies, practices, and protocols to
create a patient safety culture?
RQ2. What attitudes, beliefs, and collective efficacy are needed to produce a patient
safety culture?
RQ3: What leadership characteristics are needed to create a patient safety culture?
Respondent Type:
Patient Safety leaders in an organization with a publicly stated commitment to patient safety.
They possess an appropriate lens to speak to the topic.
Definitions:
For purposes of this interview, a leader (L) can include any of the following, a person who
directly supervises work, creates policy, and/or makes high-level organizational decisions.
Examples: Senior-level leaders, department manager, supervisor
A patient safety culture (PSC) is when “people are held accountable for their behavior but are
not punished for human error. Errors are identified and reported to serve as opportunities for
learning and improvement and known or suspected risks are mitigated before harm occurs” (The
National Patient Safety Foundation, p. 11, 2015).
Introduction to the Interview:
Thank you for taking the time to meet with me today. I am here today to learn about your work
and experiences in patient safety. You will recall I sent an email describing the research study
before our meeting today. Do you have any questions about that? Do I have your consent to
proceed? Is it okay with you if I record our session? Please feel free to stop me at any time if
you have questions or if I am not being clear. It is important to me that you are comfortable
before we begin.
110
Interview Questions Potential Probes
RQ
Addressed
Key
Concept
Addressed
Q Type
(Patton)
1. Tell me about what led
you to work in the patient
safety realm.
Would you
elaborate on that?
N/A Establishing
credibility
Background
2. What is your
understanding of what
makes up a patient safety
culture?
Tell me more. 1 PSC Knowledge
3. How do those patient
safety components you
identified present in
HSA?
Can you give me an
example?
1 PSC Opinions
Observation
4. What role do policies
and protocols have in
creating a patient safety
culture?
How do you see
leaders
implementing the
policies and
protocols relating to
patient safety
culture?
1 PSC, L Opinions
5. What role does
leadership in HSA play
in maintaining a patient
safety culture?
I want to make sure
I understand what
you are saying. I
think it would help
if you told me more
about that.
1, 2 and 3 PSC, L Knowledge
111
6. When you see a leader
demonstrating patient
safety components if you
have, what does that look
like?
Put me in the room
with that leader.
What would I
witness?
1, 2 and 3 PSC, L Sensory
Observation
7. Imagine yourself as
that same leader
demonstrating best
patient safety culture
elements. They have just
learned that their
employee has made a
medical error and a
patient has been harmed.
What steps would they
take?
Then what? 1, 2 and 3 PSC, L Observation
8. If you could design the
ideal leader to develop a
culture where employees
feel safe to report
medical errors, what
characteristics would
they possess?
Put me in the room
with that leader
who has been
successfully
creating a culture
where employees
feel safe to report
medical errors.
What would I see?
1, 2 and 3 PSC, L Opinions
9. What role, if any, does
teamwork play as part of
the patient safety culture
at HSA?
How does the
leader develop an
environment of
teamwork?
3 L Knowledge
112
10. Imagine yourself as
that same leader
demonstrating best
patient safety culture
elements. What actions
would you witness the
leader take to ensure
teamwork is present?
Please provide
more specifics
relative to that
action.
3 L Observation
11. Is there anything that
I have not specifically
asked you about that you
think would be important
for me to know?
Explain why that is
important.
1, 2 and 3 PSC, L Conclusion
Conclusion to the Interview:
This information is so valuable. I am appreciative of your time and willingness to answer my
questions. Is there anything I didn’t ask about that you think is important for me to know? Do
you have any other questions for me before we conclude our time together? Okay then, thank
you so much.
Resources:
Patton, M. Q. (2002). Chapter 7: Qualitative Interviewing: In Qualitative research and
evaluation methods (3
rd
ed.) (p. 339-380). Thousand Oaks, CA: Sage
.
113
Appendix B: Document Protocol
Research Question:
RQ1. How does a leader ensure consistency in policies, practices, and protocols to create a
patient safety culture?
A document is an umbrella term that refers to the written, visual, digital, and physical material
that is relevant to the study’s topic (Merriam & Tisdell, p. 162, 2016), patient safety, and
avoidance of medical error. For purposes of this qualitative study, documents about patient
safety will be examined to identify trends and look for consistency in policies, practices, and
protocol.
Document Type Source Relevant Patient Safety terms
Resources:
Merriam, S. B., & Tisdell, E. J. (201). Qualitative research: A guide to design and
implementation (4
th
ed.). San Francisco, CA: Jossey-Bass.
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Montminy, Susan Leigh
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Core Title
Leadership and patient safety culture
School
Rossier School of Education
Degree
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Degree Program
Organizational Change and Leadership (On Line)
Degree Conferral Date
2021-12
Publication Date
11/24/2021
Defense Date
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