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Approach to the Analysis
of Medical Errors
Erin DuPree*
Key Pearls
• A just culture is critical to developing an organization that relies on
front line workers (nurses and physicians) to report errors.
• The Swiss cheese model illustrates how a series of weaknesses in
organizational defenses leads to adverse outcomes.
• Root cause analysis is a performance improvement tool that can be
used to systematically look at organizational weaknesses that contribute to an adverse outcome.
• Patient disclosure is an important aspect of medical errors that
requires planning and effective communication skills.
In the 21st century, healthcare is a complex endeavor. The processes of
healthcare can and should be designed to anticipate and mitigate human
errors, and ensure that they occur in the way they are intended. In 2000,
The Institute of Medicine report “To Err Is Human,” asserted that the
problem with medical errors is not bad people in healthcare — it is that good
people are working in bad systems that need to be made safer. The report
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*Mount Sinai Medical Center, New York, NY, USA.
https://avxhm.se/blogs/hill0
concluded that 44,000–98,000 people die from medical errors in inpatient
settings each year.
1
Dr. James Reason, a Professor of Psychology who has published
extensively on the nature of human error, describes error as circumstances
in which planned actions fail to achieve the desired outcome.
2
Providing
healthcare will always involve humans in the decision-making and care
delivery, yet as humans, we will make errors. Systems must be created to
prevent or catch the inevitable human errors before they result in harm.
There is no universally agreed upon definition of error and thus there
are many ways in which errors may be classified. Rasmussen defines levels of human performance,
3
which Reason used to develop an intentional
taxonomy for errors.
2
This approach looks at the underlying psychology
leading to the error by asking,
1. “ Was there a prior intention to act?”
2. If intended, did the actions go as planned? If the actions did not go as
intended, then these are slips or skill-based errors. Slips tend to
occur in automatic skill-based activities like grabbing ointment
instead of toothpaste when one intends to brush his teeth. In health-
care, an example is an experienced nurse administering the wrong
medication by picking up the wrong syringe.
3. Were the actions intended and did they achieve the desired outcome? If
not, then this is a failure in planning. This is a more complex error than
making slips. These are mistakes and are either rule- or knowledge-
based. Rules are attained through training and experience and lead to
expertise. A rule-based activity would be following a treatment proto-
col. If a person is time-constrained and working in the service of
production, the person may simply forget a step. This is a lapse, or a
rule-based error, which is typically not visible. Knowledge-based mis-
takes occur when clinicians encounter a new situation and have to think
on their feet. This requires laborious conscious effort and is highly error
prone and subject to biases. These turn up in complex processes, such
as prescribing the wrong medication because of inadequate knowledge
about the drug of choice and are also seen in diagnostic errors.
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E. DuPree
Errors can also be classified in other ways, such as through the actions
(e.g. omissions); the task at hand (e.g. surgery); context (e.g. fatigue, distraction); and outcomes (e.g. near-misses, risky behaviors, incidents,
accidents).
Accountability
A just culture, a key component of a safety culture, has fairness as the
backbone for understanding errors, with a balance between individual
accountability and systems thinking.
4
The person model is based on the
assumption that the person who makes an error has certain characteristics
under his or her control and therefore is to blame for the errors made.
From this perspective, error reduction is focused on “doing better,”
retraining, discipline, and suspension. The legal perspective on error and
medical negligence are built on personal responsibility. This is a narrow
view that does not incorporate the vast systems in which healthcare workers perform. The systems model looks at the interplay between individuals and systems when analyzing errors and human behavior.
5
Errors in this
light are not as much individual fallibility as they are consequences of the
working environment. The United Kingdom Decision Error Tree is a useful tool for assessing individual accountability when analyzing errors in
an incident (see Fig. 1).
6
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Approach to the Analysis of Medical Errors
Fig. 1. Error accountability questions. (Adapted from Reason J, 1997.6)
https://avxhm.se/blogs/hill0
1. Was there malicious intent? Did the individual intentionally cause harm?
2. Was the person knowingly impaired?
3. Were safe operating procedures knowingly violated?
4. Did the individual make a mistake someone of similar training and
experience would make?
5. Is there a history of unsafe acts with this individual?
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E. DuPree
Fig. 2. Swiss cheese model: How defenses, barriers and safeguards may be penetrated
by an accident trajectory. (Adapted from Reason J, 2000.
5
)
Causal Factors of Error (Swiss cheese model)
James Reason distinguishes active failures which are errors and violations by people at the front lines and latent conditions which are the organizational processes that are hidden and become obvious only when they
combine with other failures to breach the defenses that typically prevent
an adverse event. He developed the “Swiss cheese model” to illustrate
how organizational accidents are a compilation of multiple, smaller failures leading up to the actual event (see Fig. 2).
2,5
Each slice of Swiss
cheese represents a defense, or barrier, against a particular hazard in the
system. The defenses in healthcare can include effective hiring protocols,
training, adequate supervision, communication, equipment maintenance,
staffing ratios and proper working environments. When there are weaknesses in a defense, such as inadequate supervision of trainees, then that
failure can line up with other weaknesses and active failures at the front
lines to lead to an adverse event. Organizations need to be able to identify
the “holes” or weaknesses in accident investigations (e.g. root cause
analyses) or ideally, before such incidents occur.
Reporting
Safety reporting systems in healthcare are based on systems in other
industries such as aviation, and is often referred to as incident reporting.
Anything that worries frontline healthcare workers about the care provided should be reported. Near miss reporting gives warnings of potential
catastrophes and enables a preventative approach. The key components of
an effective event reporting system include:
• A supportive environment for reporting that protects the privacy of
staff who reports.
• The ability to report by a broad range of personnel.
• Summaries that are dispersed in a timely manner.
• A structured mechanism to review reports and develop action plans.
Reporting systems do not have to be limited to a single organization; for
instance, the United Kingdom’s National Patient Safety Agency and the
MEDMARX system in the US maintain national reporting systems.
Event reports are a passive form of surveillance for unsafe conditions,
in contrast to active methods such as direct observation, and typically only
capture a small percentage of events. Event reporting systems are underutilized by providers due to concerns about their own performance
reports, lack of feedback, time involved in submitting a report, and lack
of understanding about what to report.
7
Therefore, event reports typically
provide only a snapshot of organizational vulnerabilities. It is important
for an organization to have an infrastructure in place to deal with the
analysis and follow up of events rather than encouraging reporting for its
own sake.
Root Cause Analysis
Root cause analysis (RCA) is an invaluable and powerful performance
improvement tool to evaluate the underlying causes in adverse events and
prevent future harm by eliminating latent errors. It is typically conducted
reactively, in response to an adverse event. It identifies changes that could
be made in organizational systems and processes through redesign in
order to improve the reliability of the process, for achieving the intended
result.
8
The product of a root causes analysis is an improvement plan that
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Approach to the Analysis of Medical Errors
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identifies risk reduction strategies along with plans for measuring the
effectiveness of those strategies.
To conduct a root causes analysis, a team must be organized that
includes:
• Front line staff familiar with the processes.
• Subject matter experts.
• Representatives from departments under review.
• Organizational leaders.
• Others familiar with the RCA process.
The team defines what happened by creating a detailed timeline. The next
step is to identify how the event occurred (through identification of active
errors at the front line) and then why it occurred (through systematic identification and analysis of latent errors). The team can use brainstorming;
cause-and-effect diagrams (see “Process Improvement” chapter for more
details); and literature review to determine why the event occurred. This
requires repeatedly digging deeper by asking “ why?” and when answered,
asking “why?” again.
The root causes of the event are identified and a corrective action plan
is developed to reduce the risk of the event occurring again. Quick fix
interim changes are put in place to protect patients. The corrective action
plan must identify the strategies that an organization intends to implement
to reduce the risk of recurrence and the measurement that will be undertaken to assess the effectiveness of those strategies. People closely
involved in the processes should participate in developing the improvement strategies to ensure that the plan is realistic and possible to implement. Oversight and responsibility for implementation and monitoring of
each specific improvement item should be assigned to an individual. If
incorporating system-wide changes, pilot-testing the changes prior to
widespread implementation are advisable. Report the results of implementation and monitoring to institutional quality committees and ultimately to the governing board of the hospital.
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E. DuPree
Disclosure
Patient disclosure is important in the medical error process as patients
have specific information needs after an adverse event, including:
• Acknowledgement
• Information about why it happened
• How it will be prevented
• An apology
Since 2001, The Joint Commission patient safety standards require the
disclosure of certain “unanticipated outcomes of care.” Healthcare
professionals worry about the risks of disclosure, including litigation.
A clinician’s disclosure of an error may be admissible in a malpractice
lawsuit. In 2008, only eight US states explicitly prohibited “admissions
of fault” from being used as evidence at trial, although the majority
of states exclude “expressions of sympathy” from being used as
evidence.
9
Effective disclosure can be facilitated by planning ahead (review the
record, determine who will speak with the patient/family, be mindful of
cultural and language differences); factual documentation of the conversation in the medical record; arranging for next steps (e.g. future discussions as necessary); and understanding what to expect from patients and
families (the need to express their feelings and strong emotions). When
disclosing, defend the actions of the staff and institution when care was
reasonable and appropriate, and accept responsibility on behalf of the
institution when the hospital was clearly at fault. It is important to do so
after discussion with risk management personnel. Explain clearly the
known facts in layperson’s language and invite questions and participation. The patient’s reaction will often depend on how the information is
disclosed. Effective disclosure communication can lead to improved
patient outcomes and ultimately improved patient satisfaction which in
some cases can reduce the cost associated with medical malpractice
claims.
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References
1. Kohn LT, Corrigan JM, Donaldson MS (Institute of Medicine). (2005)
To Err is Human: Building a Safer Health System. National Academy
Press, Washington, DC.
2. Reason J. (1990) Human error. Cambridge University Press, New
York.
3. Rasmussen J. (1983) Skill, rules and knowledge; signals, signs, and
symbols and other distinctions in human performance models. IEEE
Trans Syst Man Cyberneti 13(3): 257–266.
4. Marx D. (1999) Maintenance Error Causation. Federal Aviation
Authority Office of Aviation Medicine, Washington, DC.
5. Reason J. (2002) Human error: Models and management. BMJ. 320:
768–770.
6. Reason J. (1997) Managing the Risk of Organizational Accidents.
Ashgate, Aldershot, Hampshire, England.
7. Evans SM, Berry JG, et al. (2006) Attitudes and barriers to incident
reporting: A collaborative hospital study. Qual Saf Health Care 15:
39–43
8. The Joint Commission Sentinel Event Policy and Procedures (updated
July 2007). Available at http://www.jointcommission.org/NR/
rdonlyres/F84F9DC6-A5DA-490F-A91F-A9FCE26347C4/0/SE_
chapter_ july07.pdf
9. Agency for Healthcare Research and Quality (AHRQ). Accessed at:
http://psnet.ahrq.gov/primer.aspx?primerID=2.
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E. DuPree
Process Improvement Tools
Ira S. Nash*
Key Pearls
• Measuring the quality of care is a necessary prerequisite for improv-
ing it.
• Quality can be assessed by evaluating structure, process and outcome.
• Improving outcomes requires changing processes.
• Successful process improvement requires a methodical data-driven
approach.
• Process maps, Pareto charts, and fishbone diagrams are specific tools
that facilitate understanding of processes.
Introduction
One of the most important developments in medicine over the last decade
has been the emergence of the “quality movement” — the focus on assessing and improving the quality of healthcare. The 2000 publication of the
Institute of Medicine report, To Err is Human,
1
exposed the quality deficiencies in medical care in the United States, and transformed the understanding
of the public and medical professionals alike. The follow-up report, Crossing
the Quality Chasm,
2
laid out a path for fixing these deficiencies. This chap-
ter reviews methods and tools for making progress along that path.
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Chapter
*Mount Sinai Medical Center, New York, NY, USA.
https://avxhm.se/blogs/hill0