Patient Safety Systems (PS)

Quality and Safety in Laboratories

The quality of care and the safety of patients are core values of The Joint Commission
accreditation process. This is a commitment The Joint Commission has made to
patients, families, health care practitioners, staff, and laboratory leaders.
The ultimate purpose of The Joint Commission’s accreditation process is to enhance
quality of care and patient safety. Each accreditation requirement, the survey process,
the Sentinel Event Policy, and other Joint Commission policies and initiatives are
designed to help laboratories reduce variation, reduce risk, and improve quality.
Laboratories should have an integrated approach to patient safety so that safe patient
care can be provided for every patient in every care setting and service.
Laboratories are complex environments that depend on strong leadership to support an
integrated patient safety system that includes the following:
■ Safety culture
■ Validated methods to improve processes and systems
■ Standardized ways for interdisciplinary teams to communicate and collaborate
■ Safely integrated technologies
In an integrated patient safety system, staff and leaders work together to eliminate
complacency, promote collective mindfulness, treat each other with respect and
compassion, and learn from patient safety events, including close calls and other system
failures that have not yet led to patient harm. Sidebar 1 defines these and other key
terms.

Sidebar 1. Key Terms

■ patient safety event An event, incident, or condition that could have resulted or
did result in harm to a patient.
■ adverse event A patient safety event that resulted in harm to a patient. Adverse
events should prompt notification of organization leaders, investigation, and
corrective actions. An adverse event may or may not result from an error.
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Sidebar 1. (continued)

■ sentinel event* A sentinel event is a patient safety event (not primarily related
to the natural course of the patient’s illness or underlying condition) that reaches
a patient and results in death, severe harm (regardless of duration of harm), or
permanent harm (regardless of severity of harm). Sentinel events are a
subcategory of adverse events.
■ close call A patient safety event that did not cause harm but posed a risk of
harm. Also called near miss or good catch.
■ hazardous condition A circumstance (other than a patient’s own disease
process or condition) that increases the probability of an adverse event. Also
called unsafe condition.

Quality and safety in laboratories are inextricably linked. Quality, as defined by the
Institute of Medicine, is the degree to which health services for individuals and
populations increase the likelihood of desired health outcomes and are consistent with
current professional knowledge.1 It is achieved when processes and results meet or exceed
the needs and desires of the people it serves.2,3 Those needs and desires include safety.
The components of a quality management system should include the following:
■ Ensuring reliable processes
■ Decreasing variation and defects (waste)
■ Focusing on achieving positive measurable outcomes
■ Using evidence to ensure that a service is satisfactory
Patient safety emerges as a central aim of quality. Patient safety, as defined by the World
Health Organization, is the prevention of errors and adverse effects to patients that are
associated with health care. Safety is what patients, families, staff, and the public expect
from Joint Commission–accredited laboratories. While patient safety events may not be
completely eliminated, the goal is always zero harm (that is, reducing harm to patients).
Joint Commission–accredited laboratories should be continually focused on eliminating
systems failures and human errors that may cause harm to patients, families, and staff.

*
For a list of specific patient safety events that are also considered sentinel events, see the “Sentinel
Event Policy” (SE) chapter in E-dition® or the Comprehensive Accreditation Manual.

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Goals of This Chapter

This “Patient Safety Systems” (PS) chapter provides laboratories with a proactive
approach to maintaining or redesigning a patient-centered system that aims to improve
quality of care and patient safety, an approach that aligns with the Joint Commission’s
mission and its standards.
The Joint Commission partners with accredited laboratories to improve their ability to
protect patients. The first obligation of health care is to “do no harm.” Therefore, this
chapter focuses on the following three guiding principles:
1. Aligning existing Joint Commission standards with daily work to engage patients and
staff throughout the health care system, at all times, on reducing harm.
2. Assisting laboratories to become learning organizations by advancing knowledge,
skills, and competence of staff and patients by recommending methods that will
improve quality and safety processes.
3. Encouraging and recommending proactive quality and patient safety methods that
will increase accountability, trust, and knowledge while reducing the impact of fear
and blame.
It informs and educates laboratories about the importance and structure of an integrated
patient safety system and helps staff understand the relationship between Joint
Commission accreditation and patient safety. It offers approaches and methods that may
be adapted by any organization that aims to increase the reliability and transparency of
its complex systems while removing the risk of patient harm.
The PS chapter refers to specific Joint Commission standards, describing how existing
requirements can be applied to achieve improved patient safety. It does not contain
any new requirements. Standards cited in this chapter are formatted with the standard
number in boldface type (for example, “Standard RI.01.01.01”) and are accompanied by
language that summarizes the standard. For the full text of a standard and its element(s)
of performance (EP), please reference E-dition or the Comprehensive Accreditation
Manual.
Throughout this chapter, we will do the following:
■ Discuss how laboratories can develop into learning organizations
■ Identify the role leaders have to establish a safety culture and ensure staff
accountability
■ Explain how laboratories can continually evaluate the status and progress of their
patient safety systems

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■ Describe how laboratories can work to prevent patient safety events with proactive
risk assessments
■ Highlight the critical component of patient activation and engagement in a patient
safety system
■ Provide a framework to guide laboratory leaders as they work to improve patient
safety in their laboratories

Becoming a Learning Organization

The need for sustainable improvement in patient safety and the quality of care has never
been greater. One of the fundamental steps to achieving and sustaining this
improvement is to become a learning organization. A learning organization is one in
which people learn continuously, thereby enhancing their capabilities to create and
innovate.4 Learning organizations uphold five principles:
1. Team learning
2. Shared visions and goals
3. A shared mental model (that is, similar ways of thinking)
4. Individual commitment to lifelong learning
5. Systems thinking4
In a learning organization, patient safety events are seen as opportunities for learning
and improvement.5 Therefore, leaders in learning organizations adopt a transparent,
nonpunitive approach to reporting so that the organization can report to learn and can
collectively learn from patient safety events. In order to become a learning organization,
a laboratory must have a fair and just safety culture, a strong reporting system, and a
commitment to put that data to work by driving improvement. Each of these require
the support and encouragement of laboratory leaders.
Leaders, staff, and patients in a learning organization realize that every patient safety
event (from close calls to events that cause major harm to patients) must be reported and
investigated.5-9 It is impossible to determine if there are practical prevention or mitigation
countermeasures available for a patient safety event without first doing an event analysis.
An event analysis will identify systems-level vulnerabilities and weaknesses and the
possible remedial or corrective actions that can be implemented. When patient safety
events are continuously reported, experts within the laboratory can define the problem,
complete a comprehensive systematic analysis, identify solutions, achieve sustainable
results, and disseminate the changes or lessons learned to the rest of the laboratory.5-9 In a
learning organization, the laboratory provides staff with information regarding improve-

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ments based on reported concerns. This helps foster trust that encourages further
reporting. (See the “Sentinel Event Policy” [SE] chapter for more about comprehensive
systematic analyses.)

The Role of Leaders in Patient Safety

Laboratory leaders provide the foundation for an effective patient safety system by
doing the following:10
■ Promoting learning
■ Motivating staff to uphold a fair and just safety culture
■ Providing a transparent environment in which quality measures and learnings about
patient harm events are freely shared with staff
■ Modeling professional behavior
■ Addressing intimidating behavior that might undermine the safety culture
■ Providing the resources and training necessary to take on improvement initiatives
For these reasons, many of the standards that are focused on the laboratory’s patient
safety system appear in the Joint Commission’s Leadership (LD) standards, including
Standard LD.03.01.01 (which focuses on having a culture of safety).
Without the support of laboratory leaders, laboratorywide changes and improvement
initiatives are difficult to achieve. Leadership engagement in patient safety and quality
initiatives is imperative because 75% to 80% of all initiatives that require people to
change their behaviors fail in the absence of leadership managing the change.5 Thus,
leadership should take on a long-term commitment to transform the laboratory.11

Safety Culture
A strong safety culture is an essential component of a successful patient safety system
and is a crucial starting point for laboratories striving to become learning organizations.
In a strong safety culture, the laboratory has an unrelenting commitment to safety and
to do no harm. Among the most critical responsibilities of laboratory leaders is to
establish and maintain a strong safety culture within their laboratory. The Joint
Commission’s standards address safety culture in Standard LD.03.01.01, which requires
leaders to create and maintain a culture of safety and quality throughout the laboratory.
The safety culture of a laboratory is the product of individual and group beliefs, values,
attitudes, perceptions, competencies, and patterns of behavior that determine the
laboratory’s commitment to quality and patient safety. Laboratories that have a robust

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safety culture are characterized by communications founded on mutual trust, by shared

perceptions of the importance of safety, and by confidence in the efficacy of preventive
measures.12 Laboratories will have varying levels of safety culture, but all should be
working toward a safety culture that has the following qualities:
■ Staff and leaders that value transparency, accountability, and mutual respect.5
■ Safety as everyone’s first priority.5
■ Behaviors that undermine a culture of safety are not acceptable, and thus are
reported to laboratory leadership by staff, patients, and families for the purpose of
fostering risk reduction.5,11,13
■ Collective mindfulness is present, wherein staff realize that systems always have the
potential to fail and staff are focused on finding hazardous conditions or close calls
at early stages before a patient may be harmed.11 Staff do not view close calls as
evidence that the system prevented an error but rather as evidence that the system
needs to be further improved to prevent any defects.11,14
■ Staff who do not deny or cover up errors but rather want to report errors to learn
from mistakes and improve the system flaws that contribute to or enable patient
safety events.7 Staff know that their leaders will focus not on blaming those involved
in errors but on the systems issues that contributed to or enabled the patient safety
event.7,15
■ By reporting and learning from patient safety events, staff create a learning
organization.
A safety culture operates effectively when the laboratory fosters a cycle of trust,
reporting, and improvement.11,16 In laboratories that have a strong safety culture, health
care staff trust their coworkers and leaders to support them when they identify and
report a patient safety event.11 When trust is established, staff are more likely to report
patient safety events, and laboratories can use these reports to inform their improvement
efforts. In the trust-report-improve cycle, leaders foster trust, which enables staff to
report, which enables the laboratory to improve.11 In turn, staff see that their reporting
contributes to actual improvement, which bolsters their trust. Thus, the trust-report-
improve cycle reinforces itself.11 (See Figure 1.)

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Figure 1. The Trust-Report-Improve Cycle.

In the trust-report-improve cycle, trust promotes reporting, which leads to improve-

ment, which in turn fosters trust.
Leaders and staff need to address intimidating or unprofessional behaviors within the
laboratory, so as not to inhibit others from reporting safety concerns.17 Leaders should
both educate staff and hold them accountable for professional behavior. This includes
the adoption and promotion of a code of conduct that defines acceptable behavior as
well as behaviors that undermine a culture of safety. The Joint Commission’s Standard
LD.03.01.01, EP 4, requires that leaders develop such a code.
Intimidating and disrespectful behaviors disrupt the culture of safety and prevent
collaboration, communication, and teamwork, which is required for safe and highly
reliable patient care.18 Disrespect is not limited to outbursts of anger that humiliate a
member of the health care team; it can manifest in many forms, including the
following:5,13,18
■ Inappropriate words (profane, insulting, intimidating, demeaning, humiliating, or
abusive language)
■ Shaming others for negative outcomes
■ Unjustified negative comments or complaints about another staff member’s care
■ Refusal to comply with known and generally accepted practice standards, which
may prevent other staff from delivering quality care

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■ Not working collaboratively or cooperatively with other members of the interdisci-

plinary team
■ Creating rigid or inflexible barriers to requests for assistance or cooperation
■ Not returning pages or calls promptly
These issues are still occurring in laboratories nationwide. Of 1,047 respondents to a
2021 survey by the Institute for Safe Medication Practices (ISMP), 79% reported
personally experiencing disrespectful behaviors during the previous year. In addition,
60% reported witnessing disrespectful behaviors.19 The respondents included nurses,
physicians, pharmacists, and quality/risk management personnel.
Approximately half (51%) of the respondents had asked colleagues to help interpret a
medication order or validate its safety to avoid interacting with a particular prescriber.19
Moreover, 27% said they were aware of a medication error during the previous year in
which behavior that undermines a culture of safety was a contributing factor. Nearly
200 events were described, many of which involved high-alert medications (e.g.,
neuromuscular blocking agents, anticoagulants, insulin, chemotherapy) and led to
significant delays in care and/or adverse events.
Of the respondents who indicated that their organizations had clearly defined an
effective process for handling disagreements with the safety of an order, only 41% said
that the process for handling disagreements allows them to bypass a typical chain of
command, if necessary.19 While these data are specific to medication safety, their lessons
are broadly applicable: Behaviors that undermine a culture of safety have an adverse
effect on quality and patient safety.

A Fair and Just Safety Culture

A fair and just safety culture is needed for staff to trust that they can report patient
safety events without being treated punitively.3,9 In order to accomplish this, laboratories
should provide and encourage the use of a standardized reporting process for staff to
report patient safety events. This is also built into the Joint Commission’s standards at
Standard LD.03.09.01, EP 3, which requires leaders to provide and encourage the use of
systems for blame-free reporting of a system or process failure or the results of proactive
risk assessments. Reporting enables both proactive and reactive risk reduction. Proactive
risk reduction solves problems before patients are harmed, and reactive risk reduction
attempts to prevent the recurrence of problems that have already caused patient harm.11,16

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A fair and just culture takes into account that individuals are human, fallible, and
capable of mistakes, and that they work in systems that are often flawed. In the most
basic terms, a fair and just culture holds individuals accountable for their actions but
does not punish individuals for issues attributed to flawed systems or processes.15,19,20
Standard LD.03.09.01, EP 3, requires that staff are held accountable for their
responsibilities.
It is important to note that for some actions for which an individual is accountable, the
individual should be held culpable and some disciplinary action may then be necessary.
(See Sidebar 2, below, for a discussion of tools that can help leaders determine a fair and
just response to a patient safety event.) However, staff should never be punished or
ostracized for reporting the event, close call, hazardous condition, or concern.

Sidebar 2. Assessing Staff Accountability

The aim of a safety culture is not a “blame-free” culture but one that balances
organization learning with individual accountability. To achieve this, it is essential
that leaders assess errors and patterns of behavior in a consistent manner, with the
goal of eliminating behaviors that undermine a culture of safety. There has to exist
within the laboratory a clear, equitable, and transparent process for recognizing and
separating the blameless errors that fallible humans make daily from the unsafe or
reckless acts that are blameworthy.1–10

Numerous sources (see references below) are available to assist a laboratory in

creating a formal decision process to determine what events should be considered
blameworthy and require individual discipline in addition to systems-level corrective
actions. The use of a formal process reinforces the culture of safety and
demonstrates the laboratory’s commitment to transparency and fairness.

Reaching a determination of staff accountability requires an initial investigation into

the patient safety event to identify contributing factors. The use of the Incident
Decision Tree (adapted by the United Kingdom’s National Patient Safety Agency
from James Reason’s culpability matrix) or another formal decision process can help
make determinations of culpability more transparent and fair.5

References
1. The Joint Commission. Behaviors that undermine a culture of safety. Sentinel
Event Alert, No. 40, Jul 9, 2008. Accessed Jan 10, 2024. https://www.
jointcommission.org/resources/patient-safety-topics/sentinel-event/sentinel-
event-alert-newsletters/sentinel-event-alert-issue-40-behaviors-that-undermine-
a-culture-of-safety/
continued on next page

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Sidebar 2. (continued)

2. The Joint Commission. The essential role of leadership in developing a safety

culture. Sentinel Event Alert. Mar 1, 2017. Accessed Jan 10, 2024. https://www.
jointcommission.org/-/media/tjc/documents/resources/patient-safety-topics/sen-
tinel-event/sea-57-safety-culture-and-leadership-final2.pdf
3. Marx D. How building a ‘just culture’ helps an organization learn from errors. OR
Manager. 2003 May;19(5):1, 14–15, 20.
4. Reason J, Hobbs A. Managing Maintenance Error. Farnham, Surrey, United
Kingdom: Ashgate Publishing, 2003.
5. Vincent C. Patient Safety, 2nd ed. Hoboken, NJ: Wiley-Blackwell, 2010.
6. National Patient Safety Agency. Incident Decision Tree. Accessed Jan 10,
2024. https://www.ahrq.gov/downloads/pub/advances/vol4/meadows.pdf
7. Bagian JP, et al. Developing and deploying a patient safety program in a large
health care delivery system: You can’t fix what you don’t know about. Jt Com J
Qual Patient Saf. 2001 Oct;27(10):522–532.
8. National Patient Safety Foundation. RCA2: Improving Root Cause Analyses and
Actions to Prevent Harm. Jun 16, 2015. Accessed Jan 10, 2024. https://www.
ashp.org/-/media/assets/policy-guidelines/docs/endorsed-documents/en-
dorsed-documents-improving-root-cause-analyses-actions-prevent-harm.ashx
9. The Joint Commission. Video: Building Your Safety Culture: A Job for Leaders.
Chassin M. April 27, 2017. Accessed Jan 10, 2024. https://www.jointcommis-
sion.org/resources/news-and-multimedia/video-resources/president-and-ceo-
discusses-safety-cultures/
10. The Joint Commission. Take 5: Building a Strong Safety Culture - A Job For
Leaders. Benedicto A. May 10, 2017. Accessed Jan 10, 2024. https://www.
jointcommission.org/resources/news-and-multimedia/podcasts/#
q=Building%20a%20Strong%20Safety%20Culture

Data Use and Reporting Systems

An effective culture of safety is evidenced by a robust reporting system and use of
measurement to improve. When laboratories adopt a transparent, nonpunitive approach
to reports of patient safety events or other concerns, the laboratory begins reporting to
learn—and to learn collectively from adverse events, close calls, and hazardous
conditions. While this section focuses on data from reported patient safety events, it is
but one type of data among many that should be collected and used to drive
improvement.

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When there is continuous reporting for adverse events, close calls, and hazardous
conditions, the laboratory can analyze the events, change the process or system to
improve safety, and disseminate the changes or lessons learned to the rest of the
laboratory.21–25
A number of standards relate to the reporting of safety information, including
Performance Improvement (PI) Standard PI.01.01.01, which requires laboratories to
collect data to monitor their performance, and Standard LD.03.02.01, which requires
laboratories to use data and information to guide decisions and to understand variation
in the performance of processes supporting safety and quality.
Laboratories can engage frontline staff in internal reporting in a number of ways,
including the following:
■ Create a nonpunitive approach to patient safety event reporting
■ Educate staff on and encourage them to identify patient safety events that should be
reported
■ Provide timely feedback regarding actions taken on reported patient safety events

Effective Use of Data

Collecting Data
When laboratories collect data or measure staff compliance with evidence-based care
processes or patient outcomes, they can manage and improve those processes or
outcomes and, ultimately, improve patient safety. The effective use of data enables
laboratories to identify problems, prioritize issues, develop solutions, and track
performance to determine success.10 Objective data can be used to support decisions as
well as to influence people to change their behaviors and to comply with evidence-based
care guidelines.10,23
The Joint Commission and the Centers for Medicare & Medicaid Services (CMS) both
require laboratories to collect and use data related to certain patient care outcomes and
patient harm events. Some key Joint Commission standards related to data collection
and use require laboratories to do the following:
■ Collect information to monitor conditions in the environment (Standard
EC.04.01.01)
■ Identify risks for acquiring and transmitting infections (Standard IC.01.03.01)
■ Use data and information to guide decisions and to understand variation in the
performance of processes supporting safety and quality (Standard LD.03.02.01)

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■ Manage safety issues (Standard LD.03.09.01)

■ Collect data to monitor their performance (Standard PI.01.01.01)
■ Improve performance on an ongoing basis (Standard PI.03.01.01)
Analyzing Data
Effective data analysis can enable a laboratory to “diagnose” problems within its system
similar to the way one would diagnose a patient’s illness based on symptoms, health
history, and other factors. Turning data into information is a critical competency of a
learning organization and of effective management of change. When the right data are
collected and appropriate analytic techniques are applied, it enables the laboratory to
monitor the performance of a system, detect variation, and identify opportunities to
improve. This can help the laboratory not only understand the current performance of
laboratory systems but also can help it predict its performance going forward.24
Analyzing data with tools such as run charts, statistical process control (SPC) charts, and
capability charts helps a laboratory determine what has occurred in a system and
provides clues as to why the system responded as it did.24 Table 1, following, describes
and compares examples of these tools.

Table 1. Defining and Comparing Analytical Tools

Tool What It Is When to Use It

Run Chart A data chart, plotted in time ■ When the organization needs to
order, used to show the per- identify changes and variation within
formance of a process over
a process
time. It shows both positive and
■ When the organization needs a
negative patterns, trends, and
variation in a process. simple and straightforward analysis of
a process
■ As a precursor to an SPC chart

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An advanced data chart, plotted

Statistical Process in time order, used to show the
Control (SPC) performance and stability of a ■ When the organization needs to de-
Chart process over time. The chart
includes a center line (process termine if a process is stable, to
mean) and upper and lower identify variation within a process, or
control limits (process vari- find indicators of why the variation
ation), based on the data plot- occurred
ted, that show both positive and ■ When the organization needs a more
negative patterns, trends, and
detailed and in-depth analysis of a
variation in a process. Action is
taken when a point goes be- process
yond a control limit or points
form a pattern or trend.
Capability Chart A chart used to assess the ■ When the organization needs to de-
capability of a process to meet termine whether a process will func-
specifications based on the
tion as expected, according to specifi-
voice of the customer. The
chart shows upper and/or lower cations (requirements or targets)
specifications (that is, customer ■ When the organization needs to de-
requirements or targets). termine how capable their process is
for meeting customer specifications
(requirements or target)

Using Data to Drive Improvement

After data has been turned into information, leadership should ensure the following (per
the requirements shown):26–28
■ Information is presented in a clear manner (Standard LD.03.04.01)
■ Information is shared with the appropriate groups throughout the laboratory (from
the front line to the board) (Standard LD.03.04.01)
■ Opportunities for improvement and actions to be taken are communicated
(Standards LD.03.05.01, LD.03.07.01)
■ Improvements are celebrated or recognized

A Proactive Approach to Preventing Harm

Proactive risk reduction prevents harm before it reaches the patient. By engaging in
proactive risk reduction, a laboratory can correct process problems to reduce the
likelihood of experiencing adverse events. Additional benefits of a proactive approach to
patient safety include increased likelihood of the following:
■ Identification of actionable common causes
■ Avoidance of unintended consequences
■ Identification of commonalities across departments/services/units
■ Identification of system solutions

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In a proactive risk assessment the laboratory evaluates a process to see how it could
potentially fail, to understand the consequences of such a failure, and to identify parts of
the process that need improvement. A proactive risk assessment increases understanding
within the laboratory about the complexities of process design and management—and
what could happen if the process fails.
The Joint Commission addresses proactive risk assessments at Standard LD.03.09.01,
which recommends using the results of proactive risk assessments to improve safety.
Laboratories working to become learning organizations are encouraged to exceed this
requirement by constantly working to proactively identify risk.
When conducting a proactive risk assessment, laboratories should prioritize high-risk,
high-frequency areas. Areas of risk are identified from internal sources such as ongoing
monitoring of the environment, results of previous proactive risk assessments, and
results of data collection activities. Risk assessment tools should be accessed from
credible external sources such as nationally recognized risk assessment tools and peer
review literature.
Hazardous (or unsafe) conditions also provide an opportunity for a laboratory to take a
proactive approach to reduce harm. Laboratories benefit from identifying hazardous
conditions while designing any new process that could impact patient safety. A
hazardous condition is defined as any circumstance that increases the probability of a
patient safety event. A hazardous condition may be the result of a human error or
violation, may be a design flaw in a system or process, or may arise in a system or process
in changing circumstances.† A proactive approach to such conditions should include an
analysis of the systems and processes in which the hazardous condition is found, with a
focus on the climate that preceded the hazardous condition.
A proactive approach to hazardous conditions should include an analysis of the related
systems and processes, including the following aspects:29

†
Human errors are typically skills based, decision based, or knowledge based, whereas violations could
be either routine or exceptional (intentional or negligent). Routine violations tend to include habitual
“bending of the rules,” often enabled by management. A routine violation may break established rules
or policies, and yet be a common practice within an organization. An exceptional violation is a willful
behavior outside the norm that is not condoned by management, engaged in by others, nor part of the
individual’s usual behavior. Source: Diller T, et al. The human factors analysis classification system
(HFACS) applied to health care. Am J Med Qual. 2014 May–Jun;29(3)181–190.

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■ Preconditions. Examples include hazardous (or unsafe) conditions in the environ-

ment of care (such as noise, clutter, wet floors, and so forth), inadequate staffing
levels (inability to effectively monitor, observe, and provide care, treatment, or
services to patients).
■ Supervisory influences. Examples include inadequate supervision, unsafe oper-
ations, failure to address a known problem, authorization of activities that are
known to be hazardous.
■ Organization influences. Examples include inadequate staffing, organization
culture, lack of strategic risk assessment.

Tools for Conducting a Proactive Risk Assessment

A number of tools are available to help laboratories conduct a proactive risk assessment.
One of the best known of these tools is the Failure Modes and Effects Analysis (FMEA).
An FMEA is used to prospectively examine how failures could occur during high-risk
processes and, ultimately, how to prevent them. The FMEA asks “What if?” to explore
what could happen if a failure occurs at particular steps in a process.30
Other tools to consider using for a proactive risk assessment include the following:
■ Institute for Safe Medication Practices Medication Safety Self Assessment®.
Available for various health care settings, these tools are designed to help reduce
medication errors. Visit https://www.ismp.org/selfassessments/default.asp for more
information.
■ Contingency diagram: The contingency diagram uses brainstorming to generate a
list of problems that could arise from a process. Visit https://digital.ahrq.gov/
health-it-tools-and-resources/evaluation-resources/workflow-assessment-health-it-
toolkit/all-workflow-tools/contingency-diagram for more information.
■ Potential problem analysis (PPA) is a systematic method for determining what
could go wrong in a plan under development, rating problem causes according to
their likelihood of occurrence and the severity of their consequences. Visit https://
digital.ahrq.gov/health-it-tools-and-resources/evaluation-resources/workflow-assess-
ment-health-it-toolkit/all-workflow-tools/potential-problem-analysis.
■ Process decision program chart (PDPC) provides a systematic means of finding
errors with a plan while it is being created. After potential issues are found,
preventive measures are developed, allowing the problems to either be avoided or a
contingency plan to be in place should the error occur. Visit https://digital.ahrq.
gov/health-it-tools-and-resources/evaluation-resources/workflow-assessment-health-
it-toolkit/all-workflow-tools/process-decision-program-chart for more information.

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Sidebar 3 lists strategies for conducting an effective proactive risk assessment, no matter
the strategy chosen.

Sidebar 3. Strategies for an Effective Risk

Assessment

Regardless of the method chosen for conducting a proactive risk assessment, it

should address the following points:
■ Promote a blame-free reporting culture and provide a reporting system to
support it.
■ Describe the chosen process (for example, through the use of a flowchart).
■ Identify ways in which the process could break down or fail to perform its
desired function, which are often referred to as “failure modes.”
■ Identify the possible effects that a breakdown or failure of the process could
have on patients and the seriousness of the possible effects.
■ Prioritize the potential process breakdowns or failures.
■ Determine why the prioritized breakdowns or failures could occur, which may
involve performing a hypothetical root cause analysis.
■ Design or redesign the process and/or underlying systems to minimize the risk
of the effects on patients.
■ Test and implement the newly designed or redesigned process.
■ Monitor the effectiveness of the newly designed or redesigned process.

Encouraging Patient Activation

To achieve the best outcomes, patients and families must be more actively engaged in
decisions about their health care and must have broader access to information and
support. Patient activation is inextricably intertwined with patient safety. Activated
patients are less likely to experience harm and unnecessary hospital readmissions.
Patients who are less activated suffer poorer health outcomes and are less likely to follow
their physician’s or other licensed practitioner’s advice.31,32
A patient-centered approach to care can help laboratories assess and enhance patient
activation. Achieving this requires leadership engagement in the effort to establish
patient-centered care as a top priority throughout the laboratory. This includes adopting
the following principles:33
■ Patient safety guides all decision making.
■ Patients and families are partners at every level of care.

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■ Patient- and family-centered care is verifiable, rewarded, and celebrated.

■ The physician or other licensed practitioner responsible for the patient’s care, or the
physician’s or other licensed practitioner’s designee, discloses to the patient and
family any unanticipated outcomes of care, treatment, and services.
■ Transparent communication when harm occurs. Although Joint Commission
standards do not require apology, evidence suggests that patients benefit—and are
less likely to pursue litigation—when physicians disclose harm, express sympathy,
and apologize.34
■ Staffing levels are sufficient, and staff has the necessary tools and skills.
■ The laboratory has a focus on measurement, learning, and improvement.
■ Staff must be fully engaged in patient- and family-centered care as demonstrated by
their skills, knowledge, and competence in compassionate communication.
Laboratories can adopt a number of strategies to support and improve patient
activation, including promoting culture change, adopting transitional care models, and
leveraging health information technology capabilities.33

Beyond Accreditation: The Joint

Commission Is Your Patient Safety Partner
To assist laboratories on their journey toward creating highly reliable patient safety
systems, The Joint Commission provides many resources, including the following:
■ Office of Quality and Patient Safety: An internal Joint Commission department
that offers laboratories guidance and support when an organization experiences a
sentinel event or when a safety event is reported that may require analysis or
improvement work. The Office of Quality and Patient Safety assesses the
thoroughness and credibility of a laboratory’s comprehensive systematic analysis as
well as the action plan to help the laboratory prevent the hazardous or unsafe
conditions from occurring again. (See the “Sentinel Event Policy” [SE] chapter for
more information.)
■ Standards Interpretation Group: An internal Joint Commission department that
helps laboratories with their questions about Joint Commission standards. First,
laboratories can see if other laboratories have had similar questions by accessing the
Standards FAQs at https://www.jointcommission.org/standards/standard-faqs/. If
you do not find an answer in the FAQs, laboratories can submit questions about
standards to the Standards Interpretation Group by clicking on a link to complete
an online submission form.

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■ National Patient Safety Goals: The Joint Commission gathers information about
emerging patient safety issues from widely recognized experts and stakeholders to
create the National Patient Safety Goals® (NPSG), which are tailored for each
accreditation program. These goals focus on significant problems in health care
safety and specific actions to prevent them. For a list of the current NPSG, go to
the NPSG chapter in E-dition or the Comprehensive Accreditation Manual or http:/
/www.jointcommission.org/standards_information/npsgs.
■ Sentinel Event Alert: The Joint Commission’s periodic alerts with timely infor-
mation about similar, frequently reported sentinel events, including root causes,
applicable Joint Commission requirements, and suggested actions to prevent a
particular sentinel event. (For archives of previously published Sentinel Event Alerts,
go to https://www.jointcommission.org/resources/sentinel-event/sentinel-event-
alert-newsletters/.)
■ Quick Safety: Quick Safety is a periodic newsletter that outlines an incident, topic,
or trend in health care that could compromise patient safety. (For more
information, visit https://www.jointcommission.org/resources/news-and-multime-
dia/newsletters/newsletters/quick-safety/.)
■ Joint Commission Resources: A Joint Commission not-for-profit affiliate that
produces books and periodicals, holds conferences, provides consulting services, and
develops software products for accreditation and survey readiness. (For more
information, visit http://www.jcrinc.com.)
■ Webinars and podcasts: The Joint Commission and its affiliate, Joint Commission
Resources, offer free and fee-based webinars and podcasts on various accreditation
and patient safety topics.
■ Speak Up™ program: The Joint Commission’s campaign to educate patients about
health care processes and potential safety issues and encourage them to speak up
whenever they have questions or concerns about their safety. For more information
and patient education resources, go to http://www.jointcommission.org/speakup.
■ Joint Commission patient safety web portals: Through The Joint Commission
website (at http://www.jointcommission.org/toc.aspx), laboratories can access web
portals with a repository of resources on the following topics:
❏ Zero Harm
❏ Emergency Management
❏ Health Care Workforce Safety and Well-Being
❏ Infection Prevention and Control
❏ Suicide Prevention
❏ Workplace Violence Prevention

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