Chapter 40. Promoting a Culture of Safety
Laura T. Pizzi, Pharm.D.
Neil I. Goldfarb
David B. Nash, M.D., M.B.A.
Thomas Jefferson University School of Medicine and Office of Health Policy & Clinical Outcomes
Background
In a number of high hazard organizations, where the risk of error involves
dire consequences, leaders manage for safe, reliable performance. As a result,
the term High Reliability Organization has been coined to describe
organizations with exemplary track records of safety: aviation, chemical
manufacturing, shipping, nuclear power production, and the
military.1-10 This concept is rooted in the analyses of errors that
reveal organizational failures, along with technical failures (related to system
performance) and human limitations (related to human behavior).11
Theories about antecedents to accidents abound but major schools of thought
include Reason's belief that a number of latent factors embedded in
organizational systems can align and result in accidents,12-14 and
Rasmussen's approach to categorizing the different sources of error that
interact with latent factors to produce accidents.15-17 Another
school of thought, developed by Charles Perrow and first publicized shortly
after the Three Mile Island nuclear accident, Normal Accident
Theory,18,19 emphasizes the ever-present possibility of accidents
in organizations that exhibit complexity and "tight coupling" of processes and
the inevitability of accidents. Normal Accident Theory stands somewhat in
opposition to High Reliability Theory, which holds that accidents can be
prevented through organizational design and management. Scott Sagan's analysis
of the nuclear weapons industry, addressing the question of why there has never
been an 'accidental' nuclear war, represents a fascinating investigation of a
test case for these two schools of thought.20 Despite the obvious
apparent confirmation of the High Reliability Theory perspective (i.e.,
such an accident has thankfully never occurred), Sagan uncovers a surprising
amount of evidence that also seems to confirm the Normal Accident
perspective.
Regardless of the underlying theory, healthcare is vulnerable
to error. The application of safety promotion theories utilized to positive
effect in other high hazard organizations are being considered for healthcare,
where "accidents" tend to occur one person at a time instead of in sweeping
disasters.25
Attention to organizational issues of structure, strategy and culture may be
a promising direction for medicine. Although organizational elements are
intertwined and must be aligned for optimum performance26 this
chapter focuses on the culture component, especially "safety cultures."
Following a description of the prevailing models of culture and safety, we
review approaches that both medical and non-medical industries have used to
promote a culture of safety. On the medical side, the discussion is limited to
the Veterans Health Administration's comprehensive safety
initiative.27 On the non-medical side, specific methods other high
reliability industries have applied to promote a safety culture,4
including a behavior-based industry approach, are reported.28
Organizational Culture
Helmreich defines culture as "a complex framework of national,
organizational, and professional attitudes and values within which groups and
individuals function."29 Corporate culture is often referred to as
the glue that holds an organization together, and is therefore assumed to be a
contributor to organizational performance by socializing workers in a way that
increases commitment to the goals of the entity.4,30,31 As such, it
embodies the philosophy of senior leaders, which is translated into, and affects
the behaviors of employees.32 Although some schools of thought focus
on the role of leaders of an organization (board members and executives), others
note that middle management likely plays a substantial role as well, conveying
the culture to front-line workers in any organization, as evidenced by studies
of the effective use of total quality management.33 The power of
culture often goes unrecognized, since employees may assume that the dominant
paradigm is simply "the way we do things here."29
Safety Culture
While an exact definition of a safety culture does not exist, a
recurring theme in the literature is that organizations with effective safety
cultures share a constant commitment to safety as a top-level priority, which
permeates the entire organization. More concretely, noted components include: 1)
acknowledgment of the high risk, error-prone nature of an organization's
activities, 2) blame-free environment where individuals are able to report
errors or close calls without punishment, 3) expectation of collaboration across
ranks to seek solutions to vulnerabilities, and 4) willingness on the part of
the organization to direct resources to address safety
concerns.3,4,29,34-36 Based on extensive field work in multiple
organizations, Roberts et al have observed several common, cultural values in
reliability enhancing organizations: "interpersonal responsibility; person
centeredness; [co-workers] helpful and supportive of one another; friendly, open
sensitive personal relations; creativity; achieving goals, strong feelings of
credibility; strong feelings of interpersonal trust; and
resiliency."4
Culture Surveys
The aspect of organizational safety culture that may be visible
or measurable is sometimes referred to as the safety "climate," which includes
management systems, safety systems, and individual attitudes and
perceptions.32 Healthcare organizations are now adapting safety
culture and climate surveys from other industries to benchmark and identify
potential deficiencies in their unique safety culture. Kaiser Permanente, the
oldest and largest not-for-profit health maintenance organization in the United
States, has administered an executive attitudes and beliefs survey to identify
perceptions of patient safety for the purposes of planning and measurement
(written communication, February 2001, Suzanne Graham). The VA Palo Alto Patient
Safety Center of Inquiry and Stanford University's Center for Health
Policy/Center for Primary Care and Outcomes Research are conducting a patient
safety culture survey that builds on past work by Gaba and collaborators. The
survey includes items on production pressures and safety consequences, and draws
from several other sources (personal communication, June, 2001, Sara Singer).
Spath provides a checklist of elements that healthcare managers can use to
identify which cultural elements should be addressed in order to improve
safety37 (Table 40.1). Previous work in assessing organizational
culture effects on total quality management,38 and organizational
culture in high reliability organizations39 may also be pertinent to
efforts to measure culture and its consequences for patient safety.
Industries Outside Medicine
Promoting a culture of safety has historically been a priority for the
chemical, electrical, food processing, petroleum, plastic, and transportation
industries. Since the 1930s, safety managers within various industries have
recognized that most occupational injuries have a strong behavioral component, typically rooted in the safety culture.28 In
these settings, behavior analysis has been used as an approach to solving safety
problems. Behavioral analyses typically involve assessing upstream and
downstream behaviors associated with the problem, with further analysis as to
which behaviors may be modifiable. Once relevant behaviors are identified, a
behavior change intervention is implemented, and behavioral changes are
measured. Interventions are customized, and draw upon techniques of behavior
science, organizational development, safety science, and quality. Researchers
have shown associations between behavior-based safety programs and reduced rates
of accidents.
In an extensive field study of three organizations (nuclear
aircraft carriers, a nuclear power plant, and the federal agency responsible for
air traffic control) whose operations have the potential for widespread harm,
Roberts et al proposed several management processes that "cradle" a culture of
perfection.4 One process requires distributing decision making, while
having mechanisms that allow decisions to migrate up and down the chain of
command as circumstances develop. The mechanism for localizing decision making
is often extensive training, while the approach to moving decisions to higher
levels is based on management by exception when acceptable operation is in
question. Finally, these researchers suggest that both top-level managers and
local operators develop a deep understanding of their organizations, and use
this "big picture" perspective to provide intuitive judgments when situations
arise.
Practice
Description
Veterans Health Administration Approach
The Veterans Health Administration (VHA) has implemented a multifaceted
safety initiative, which was designed to build a culture of safety and address
system failures.27 The approach consists of 4 major elements: 1)
partnering with other safety-related organizations and affiliates to demonstrate
a public commitment by leadership, 2) establishing centers to direct safety
efforts, 3) improving reporting systems, and 4) providing incentives to
healthcare team members and division leaders. These tactics are detailed below.
In addition, several specific initiatives were implemented to address problems,
such as bar coding of medications (Subchapter 43.1) and use of computerized
medical records.
To demonstrate a public commitment to the importance of patient
safety, the VHA leadership founded the National Patient Safety
Partnership, along with several major health-related organizations (the
American Association of Medical Colleges, the American Hospital Association, the
American Medical Association, the American Nurses Association, and the Institute
for Healthcare Improvement). In addition, key senior management officials
sounded the safety message in congressional testimony.
The second part of the VHA's approach involved establishing
centers dedicated to the promotion of patient safety. The first of these was the
National Center for Patient Safety, which directs patient safety efforts
for the VHA at a national level. The Director of the Center oversees patient
safety efforts for the entire VHA health system and is a recognized authority.
Subsequently, four Patient Safety Centers for Inquiry were funded, which are
primarily responsible for safety-related research and development. Specifically,
the centers are responsible for identifying problems in the patient care
process, implementing corrective measures, and studying effects. Currently, one
of these centers is studying safety cultures in healthcare organizations.
Finally, the VHA's Virtual Learning Center contributes to the safety
initiative by allowing VHA facilities to share lessons learned. Additional
information, such as training, educational programs, alerts, and advisories are
planned.
The third major component of the VHA's initiative involves
incentives aimed at improving safety. There are two types of incentives
offered: 1) the "carrot," which is a monetary award of up to $5000 for
individuals and teams that develop approaches to improve safety issues; and 2)
the "stick," which is a performance expectation imposed on leaders to improve
patient safety. Leaders of the VHA's 22 regional networks must demonstrate
involvement in safety-promoting activities, or be subject to consequences,
including possible termination of employment. The primary objective of this
incentive is to align regional and national leaders' goals.
Last, the VHA has implemented a two-pronged system for
capturing adverse events. The first of these systems, the Patient Safety
Event Registry, mandates reporting of adverse events and "close calls"
occurring within the system. Before implementing the Patient Safety Event
Registry, regional review of event cases was sporadic. After implementation,
event data is systematically shared both regionally and nationally. The second
of the systems, the voluntary reporter identity system, was developed in
conjunction with the National Aeronautics and Space Administration, and allows
for anonymous event reporting. It is intended that the use of both reporting
systems will together provide a more comprehensive picture of safety management
than would be possible with one system alone.
Behavior-Based Safety Programs
Outside of medicine, the objective of behavior-based safety
interventions is to reduce incidents by managing at-risk behaviors of the
organization and work teams. An approach described by Krause and colleagues
consisted of safety assessments, steering committee formation, development of
checklists of well-specified critical behaviors related to safety, observer
training regarding the critical behaviors, observation and
feedback.28 These steps, somewhat analogous to aspects of crew
resource management training approaches (see Chapter 44), most likely reflect an
active safety culture. The Krause study assessed the effectiveness of behavioral
safety initiatives in reducing accidents in 229 facilities in various
industries, including chemical, electrical, food, plastic, petroleum,
transportation, service, and paper manufacturers.28 The study used an
interrupted time series design with the participating industrial sites. Event
rates after implementation of the behavioral program were compared with the
Occupational Safety and Health Administration (OSHA) recordable illness/injury
rates. Of the 229 participating sites, 73 provided necessary data (others were
excluded either because they failed to provide OSHA illness/injury rates or
results of the behavioral initiative). Compared with baseline, the behavioral
initiative resulted in an average 26% improvement in targeted safety behaviors
during the first year, which rose to 69% by the fifth year.
Prevalence and Severity of the Target Safety Problem
There is no known information about the prevalence of medical
error emanating from cultural/organizational problems in healthcare. Culture is
known to contribute to the occurrence of errors and accidents. Its contribution
relative to other causal factors is unknown, but likely to vary, depending on
the type of accident and work environment.3,7,29 The aviation
industry attributes its successful safety record in part to analysis of near
miss and accident reports (see Chapter 4).40-43 These types of
analyses are only possible if the culture supports reporting of errors. Culture
changes may, in fact, have their greatest impact on "underground" (unreported)
errors, which are extremely difficult to quantify.
Opportunities for Impact
Although no data from ongoing surveys has yet emerged to permit
us to accurately quantify safety culture penetration, we nonetheless speculate
based on anecdotal evidence that healthcare organizations have plenty of room
for improvement. A number of observers have noted large-scale obstacles to
promotion of safety culture within healthcare: a pervasive culture of
blame that impedes acknowledgment of error, and professional "silos"
that offer unique challenges to changing any universal aspect of healthcare,
including culture.44-46
Even before the Institute of Medicine's pivotal To Err is
Human report was delivered to the public, promoting a safety culture within
healthcare had received widespread attention. The Institute for Healthcare
Improvement's Web site features a report "Reducing Medical Errors and Improving
Patient Safety: Success Stories from the Front Lines of Medicine."47
It includes articles about the transformation of culture at the prestigious
Dana-Farber Cancer Institute after a highly publicized chemotherapy overdose in
1994, which resulted in the death of a patient. Another article in the same
series highlighted the major steps, including cultural change, as noted above,
taken by leaders of the nation's largest healthcare provider—the Veterans
Affairs Healthcare System—after fatal medical errors were reported by the
media.47
Comment
Measuring the impact of culture on safety-related outcomes is
challenging. Culture is a complex and abstract construct that must be inferred
from behaviors, and analysis often relies on self-reported data.29
Research continues to develop a working model of safety culture that permits
measurement of several connected concepts: individuals' perceptions and
attitudes about safety, individuals' observable safety behaviors, and an
organization's safety management system as evidenced by its policies and
management styles.35 The relative impact of each of these measures on
outcomes is another layer of ongoing research.
Although some data support the effectiveness of the entire VHA
initiative in improving safety, there are no direct data supporting the effect
of promoting a culture of safety. The use of incentives to reward
safety-promoting behavior and publicly demonstrating a commitment to safety are
approaches that could be applied in both large and small healthcare settings.
The VHA's reporting system will likely be watched, and potentially adapted by
large providers who have inconsistent and/or insufficient reporting of safety
problems at local, regional, and national levels.
The evidence presented by Krause provides compelling support
for the effectiveness of behavior-based safety programs in a wide range of
industrial settings. Although this exact approach has not been evaluated in
healthcare environments, its emphasis on promoting safety culture seems
applicable to patient care environments.
As noted in To Err is Human, researchers who have
studied organizations with a strong safety culture believe that it is "the most
critical underlying feature of their accomplishments."48 Although the
nature of the evidence is based on field studies and other methods not typical
of medical evidence, it is considered compelling by a number of experts from
organizational and other social sciences. At this point, promoting a culture of
safety remains surprisingly unexplored in healthcare settings, where the risks
of error are high. Further research in this area is warranted, though the
threshold for evidence may need a different yardstick than is typically applied
in medicine (Chapter 2).
Acknowledgments
The authors are grateful to Mr. Marcus Moore of Behavioral Science
Technology, Inc. for providing information related to industrial safety
programs. We would also like to thank Dr. Kasey Thompson, Director of the
American Society of Health-System Pharmacy's Center for Patient Safety, and Mr.
Mark Thomas, Director Of Pharmacy at Children's Hospital in Minneapolis for
their suggestions and insight on cultural safety issues.
Table 40.1. Checklist of elements that contribute to a patient-safe
environment
- All people acknowledge that top management provides essential patient
safety improvement leadership.
- The organization has clearly defined patient safety polices.
- All people can explain the organization's patient safety policies.
- All people are involved in developing patient safety goals, and everyone
can explain desired results and measures.
- All people are actively involved in identifying and resolving patient
safety concerns.
- All people can explain how their personal performance affects patient
safety.
- All people believe they have the necessary authority and resources to meet
their responsibilities for patient safety.
- Patient safety performance for all people is measured against goal,
clearly displayed, and rewarded.
- A comprehensive review of patient safety is conducted annually, and there
is a process in place that drives continuous improvement.
- Regular workplace hazard analyses are conducted to identify patient safety
improvement opportunities. The results are used to make changes in patient
care activities.
- All people are empowered to correct patient safety hazards as they are
identified.
- A comprehensive system exists for gathering information on patient safety
hazards. The system is positive, rewarding, and effective, and people use it.
- All people are fully aware of patient incident trends, causes, and means
of prevention.
- All injury-producing patient incidents and significant "near misses" are
investigated for root cause, with effective preventive actions taken.
- All people who operate patient care equipment are trained to recognize
maintenance needs and perform or request timely maintenance.
- All people know immediately how to respond to an emergency because of
effective planning, training, and drills.
- Facilities are fully equipped for emergencies; all necessary systems and
equipment are in place and regularly tested; and all people know how to use
equipment and communicate during emergencies.
- Ergonomics experts are provided when needed and are involved in patient
safety assessment and training.
- All supervisors/managers assist in patient safety workplace analyses,
ensure physical protections, reinforce training, enforce discipline, and can
explain how to provide safe patient care.
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