Pediatr Radiol (2008) 38 (Suppl 4):S685-S689

DOI 10.1007/s00247-008-0882-l

Fundamentals of a patient safety program

Karen S. Frush
Received: 1 April 2008 /Accepted: 8 April 2008 / Published online: 23 September 2008 '
Springer-Verlag 2008

Abstract Thousands of people are injured or die from medical errors and adverse events each year, despite being cared
for by hard-working, intelligent and well-intended health care professionals, working in the highly complex and highrisk environment of the American health care system. Patient safety leaders have described a need for health care
organizations to make error prevention a major strategic objective while at the same time recognizing the importance of
transforming the traditional health care culture. In response, comprehensive patient safety programs have been
developed with the aim of reducing medical eiTors and adverse events and acting as a catalyst in the development of a
culture of safety. Components of these programs are described, with an emphasis on strategies to improve pediatric
patient safety. Physicians, as leaders of the health care team, have a unique opportunity to foster the culture and
commitment required to address the underlying systems causes of medical error and harm.
Keywords Patient safety Medical error Adverse event Culture of safety Just culture Teamwork
Communication Disclosure Transparency
Introduction
Nearly a decade has passed since the Institute of Medicine report on medical errors was published in November 1999,
revealing the humbling reality that thousands of people are injured or die from medical errors in U.S. hospitals each
year while seeking care from health care professionals they trust [1]. Physicians and nurses - highly trained, dedicated
and hard-working individuals - began to understand that the health care system has become so highly complex and
high-risk that they, as human beings, cannot be vigilant or careful enough to prevent all errors from occurring. The
system has to be re-designed in such a way as to intercept human errors and prevent harm to patients. Lucian Leape and
other national leaders in patient safety have described a need for health care organizations to make error prevention a
major strategic objective while at the same time recognizing the importance of transforming the traditional health care
culture from a culture of blame to a culture of accountability in an environment of organizational learning.
During the last few years, many hospitals and health care organizations have established patient safety programs
to provide an infrastructure for efforts to identify and reduce medical errors and adverse events and to act as a catalyst
in the development of a culture of safety. Examples of such programs will be described. Additionally, specific strategies
to improve pediatric patient safety will be reviewed, because children have unique physiologic and developmental
needs that put them at higher risk of errors and adverse events. This material is intended to complement the perspective
of a patient safety officer (see J. Shook, Reflections of a patient safety officer in this issue of Pediatric Radiology).
Patient safety programs
The delivery of safe, reliable care is no accident. Rather, through an approach based on human factors and reliability
science, hospitals and health care systems must design safety into the system in such a way as to lead to improved risk
identification and mitigation and, ultimately, prevention of harm. When considered in this way, it becomes obvious that
patient safety cannot be mandated from executive leadership but requires the active involvement of patient safety
champions at all levels of the organization. It is important for the executive team and the Board to acknowledge patient
safety as a priority, for senior leaders and middle managers to provide training and support for front line providers, and
for local multidisciplinary care teams to have the knowledge and tools needed to develop and implement strategies to
reduce risk. The concept of a comprehensive unit-based safety program (CUSP) has been described [2], and activities
included in local programs vary. At many hospitals, local teams conduct patient safety rounds in conjunction with their
organizations executives and hold regularly scheduled meetings during which patient safety data are reviewed and
patient safety concerns discussed. Improvement priorities are established and plans to resolve issues are developed and
executed. Each teams activities are monitored and reported through the performance improvement infrastructure at
their organization, up to middle management, senior leadership, and ultimately the governing body of the organization.
Whatever the structure of the patient safety program, the primary goal is to facilitate the delivery of reliable care in a
safe environment, through a focus on risk-reduction strategies and culture.

Identifying and mitigating errors to prevent patient harm

In 2003, the National Quality Forum (NQF) endorsed 30 safe practices that should be universally implemented in
clinical care settings to reduce the risk of error and resultant harm to patients (Table 1) [3], A second report was
published in 2006, adding to the practices endorsed in 2003 and updating them with current evidence, expanded
implementation approaches, and measures for assessing implementation of the practices. The first safe practice is
composed of four elements, one of which suggests that health care organizations must systematically identify and
mitigate patient safety risks and hazards with an integrated approach in order to continuously drive down preventable
patient harm. Identification and mitigation efforts should include proactive and real-time strategies, as well as
retrospective review of adverse events.
One example of a proactive risk identification strategy is safety walk-rounds [4]. During these rounds, clinicians,
administrators and executive leaders visit with front line staff and even patients to ask, Whats the next thing that will
hurt a patient in this area/unit? Concerns are documented and entered into a database, so that when solutions are
developed and implemented, this information can be fed back to those individuals who raised the concern. The action
of closing the loop helps to establish a culture of safety, as the individuals who report concerns recognize they play an
important role in helping to re-design the system to improve safety.
A commonly used retrospective method to mitigate risk is the root cause analysis, which is conducted following
sentinel events and near-misses. This analysis must be a robust process in order to identify true causative factors of
adverse events, develop and implement improvement strategies, and measure/monitor progress, again providing
feedback to clinicians involved and sharing lessons learned broadly throughout the organization.
Table 1 National

Quality Forum: 30 safe practices for better health care.

Practice 1
Create and sustain a health care culture of safety.
Element 1: Leadership structures and systems must be established to ensure that there is organization-wide awareness of patient safety performance gaps, that there is direct
accountability of leaders for those gaps, that an adequate investment is made in performance improvement abilities, and that actions are taken to assure the safe care of every
patient served.
Element 2: Health care organizations must measure their culture, provide feedback to the leadership and staff, and undertake interventions that will reduce patient safety risk.
Element 3: Health care organizations must establish a proactive, systematic, and organization-wide approach to developing team-based care through teamwork training, skill
building, and team led performance improvement interventions that reduce preventable harm to patients.
Element 4: Health care organizations must systematically identify and mitigate patient safety risks and hazards with an integrated approach in order to continuously drive down
preventable patient harm.

National Quality Forum (NQF), Safe Practices for Better Healthcare: 2006 Update. A Consensus Report,
Washington, DC, NQF; 2007 [3

Root causes, or causative factors, can include environmental factors, equipment issues and human factors. A good
example of human factors is a case involving a medication error in the Emergency Department: a young infant was
brought to the Emergency Department in the middle of the night with fever and rash. After evaluation, the physician
was concerned about bacterial infection and ordered a dose of an antibiotic to be given. This particular night shift was
very busy; the physician was interrupted multiple times while writing the order, and the mathematical equation used to
determine the appropriate dose for the infants weight was miscalculated. Though the nurse checked the math, she got
the same (wrong) answer, and administered 10 times the amount of medication that should have been given. Evidence
suggests that this is not rare, and pediatric medication error rates are higher than rates in adults, due to several factors
including lack of unit dosing (so that medication doses have to be calculated for each child) [5]. Further, because of a
lack of standard formulations for pediatric medicines, nurses must frequently convert the dose that has been ordered (in
milligrams) to an amount of liquid to be given (intravenously or by mouth) to children, and this has been shown to be
an error-ridden process [6],
When conducting a root cause analysis, it is important to identify strategies to improve the system while
acknowledging the limits and fallibility of health care providers who are sometimes set up to make errors by the very
complexity of the system in which they work. In the historical model of culpability, clinicians were often blamed for
mistakes (such as a calculation error) leading to adverse events, or made to feel incompetent or careless, hi a culture of
safety, the human limits of individual providers are acknowledged, and the system is re-designed by improving faulty
processes and conditions that lead to human mistakes. Individuals are not blamed, yet held accountable for their
behavioral choices.

Creating a culture of safety

Lucian Leape and others have described the traditional health care culture as punitive, or a culture of blame. It is
critically important to recognize, when considering transition to a culture of safety, that the transition is not to a
blameless culture; rather, it is to a culture in which health care professionals are held accountable for their behavioral
choices. This is best described by the Just Culture contextual model [7].
The Just Culture model describes three behavioral choices to be considered when reviewing the actions of a clinician
at the time of an adverse event: a simple mistake, risk-taking behavior, and blatant reckless behavior. When applying
the principles of Just Culture to the case study described above, one should ask this question: would three
peers of the provider who made an error be likely to make the same error? It is easy to imagine that other providers
could make the same math mistake if working in such a chaotic environment, with numerous distractions, in the middle
of the night. The appropriate response to a simple human (math) error, according to Just Culture principles, is to
console the individual involved, and change the system to make it easier to do the right thing; i.e. provide precalculated medication doses so that physicians and nurses dont have to do math in the middle of the night in a busy
clinical setting.
An example of risk-taking behavior might be to administer a medication to a patient in the ED after identifying him
by room number (i.e. pain medicine for the patient in room 20), rather than double-checking the patients name and
ID band. Though the nurse has no intent of harming the patient, an adverse drag event could result from his or her
decision to bypass a basic safety rule. This behavior requires coaching and limit-setting, while reckless behavior (i.e.
coming to work intoxicated) would require administrative consequences. The Just Culture model helps provide
guidance when trying to transition from a traditional punitive culture, or culture of blame, to a culture of accountability
and organizational learning.
As important as transitioning from a punitive culture to a Just Culture is the need to improve communication and
teamwork behaviors among health care professionals. In recent years, patient safety advocates, health care leaders and
regulatory agencies have come to understand how critically important effective communication and teamwork are in
the delivery of high-quality, safe patient care. For example, communication failures are among the most common
causes of sentinel events reported to the Joint Commission [8], accounting for nearly two-thirds of these cases. The
complexity of medical care, coupled with the inherent limitations of human performance, make it critically important
that clinicians have standardized communication tools, create an environment of psychological safety in which
individuals feel comfortable to speak up and express concerns, and share common critical language to alert team
members to unsafe situations.
There is a growing body of evidence to suggest that effective teamwork behavior is essential to safe patient care [9,
10]. Effective leaders articulate clear goals, make decisions through collective input of team members, empower
members to speak up and challenge, when appropriate, and actively promote and facilitate good teamwork [11].
Physicians are commonly the designated leaders of health care teams and, as such, they play a pivotal role in team
performance. Consider, for example, the role of the surgeon in the operating room. If the surgeon enters the operating
room and sets a tone of mutual respect by
actively inviting each team member to participate (for example, addressing each team member by name and asking
them to speak up if they see anything unsafe), nurses and technicians are much more likely to speak up if they are
concerned. In the traditional, autonomous culture of health care, nurses have been hesitant to speak up, fearing they
might be ridiculed or yelled at by the surgeon. Too often, procedure-related errors occur (including wrong-site
surgeries) even while a member of the care team is aware of the error but is unable to communicate it to the physician.
In a culture of safety, teamwork extends beyond the traditional health care provider and includes patients and
families as active participants in their care. In the current health care system, efforts and initiatives to improve safety
and prevent patient harm are often developed by health care providers and hospital administrators, sometimes reacting
publicly to sentinel events. Patients, the consumers of health care and those most knowledgeable about their own needs,
have not traditionally been invited to participate in health care improvement efforts. As noted by Susan Sheridan,
president of Consumers Advancing Patient Safety: Historically, patients have had little opportunity to contribute their
wisdom or perspective back to the health care system or voice their aspirations in the efforts to improve patient safety
[12], Patient safety improvement efforts require a collaborative approach, as Sheridan continues: Improving patient
safety is a global challenge ... and calls for robust, integrated participation of providers, health care leaders, government
agencies, regulators, professional organizations and ... patients. There is a recent appreciation and respect for patient
participation in the creation of a safer health care system acknowledging that patients are key and even necessary in
identifying patient safety issues, advocating for change and designing and implementing solutions [12].
Some hospitals and health care organizations have established formal committees or councils to augment
communication between patients and health care providers and to facilitate their active involvement as members of
health system and hospital committees, achieving a more patient-centric focus. The Dana Farber Patient Advisory
Council is a model program, providing an example of true patient-provider partnership in care delivery [13].

Disclosure of medical errors and unanticipated outcomes

One of the hardest things physicians and patient safety leaders must do is to meet with patients and families who have
suffered a significant preventable injury while receiving care. This might also be the most meaningful thing we can do,
for when a sincere apology and transparent disclosure of the facts of the case are offered to patients and families, both
clinicians and patients are less likely to feel abandoned. These conversations are not easy, and education and training
related to appropriate disclosure at the time of a medical error or unanticipated outcome is an essential component of a
comprehensive patient safety program.
Information technology
Many efforts to improve patient safety and prevent harm to patients are enabled by innovative technological advance ments, including information technology (IT). IT safety initiatives that have been shown to improve patient safety
include computerized physician order entry (CPOE), an electronic system that replaces hand-written physician orders
to improve order accuracy and provides order advisers to guide prescribing decisions [14]. There has been some
concern that implementation of a CPOE system designed for adults might lead to unexpected errors in children [15],
but other systems that have been customized to the needs of children have shown good promise.
Computerized Safety Reporting Systems that are easily accessible by all faculty and employees throughout a hospital
or health care facility can help facilitate the reporting (anonymous, if desired) of safety concerns and events. This is
important in efforts to change culture, in addition to identify risk so that preventive strategies can be developed and
implemented.
Computerized Adverse Drug Event Surveillance Systems (ADE-S) provide computerized chart review, using
triggers, to identify potential adverse drug events in real time, allowing an opportunity for proactive risk mitigation and
prevention of harm [16].
Measuring and monitoring progress
Efforts to improve patient safety (i.e. prevent harm) must be measured, and results must be shared with care providers
in a meaningful way. National metrics have been developed, including the AHRQ Patient Safety Indicators [17]. Other
outcomes that can be measured include hospital acquired infections (MRSA, surgical site infections, urinary tract
infections and central line-associated blood stream infections), patient falls with injury and adverse drug events.
In addition to monitoring outcomes measures, it is important to measure culture, which can be done through
the use of surveys and observational assessments. Several survey tools are accessible to health care leaders and
providers [18, 19]. Instruments to assess teamwork behaviors continue to be refined [20], As recommended by the
National Quality Forums safe practice #1: health care organizations must measure their culture, provide feedback to
the leadership and staff, and undertake interventions that will reduce patient safety risk [3].
Conclusion
As well as we think we generally do in providing care, we must recognize that the current health care system and its
historical punitive culture must be transformed. This will require relentless commitment on the part of all health care
providers, administrators, executive leaders, and patients and families. As physicians, we are often the designated
leaders of the health care team. As leaders, we have a unique opportunity to foster the culture and commitment required
to address the underlying systems causes of medical error and harm.
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