Patient Safety Officer Training Course:

Incident Reporting & Investigation

Incident Reporting & Investigation

Objectives:

• To understand the importance of identifying, surfacing,

and reporting the incidents that occur in the healthcare
facility
• To know the various types of incidents and classifications
• To present a scenario of a safety event and how it was
analyzed and recommendations given
Incident Reporting & Investigation

Important Component of a Safety Program:

• Established reporting systems

• Proactive risk reduction tools
• Organizational data to help identify concerns
• Procedures for responding to a sentinel event
• Training and education programs
Incident Reporting & Investigation

Reports of harms & errors:

• required for systems learning
• information gathered is used by leadership to promote
safety-generating attitudes
• direct feedback to front-liners regarding actions taken and
be intimately involved in brining learning opportunities
forward
• an essential component of a high-reliability organization
Incident Reporting & Investigation

Purpose of Reporting System:

• Primary:
 to support a culture of open communication &
transparency
 to promote the concept that everyone is an important
contributor to improvements in quality and safety
• Secondary:
 help identify major system flaws or problem
individuals by collecting data on events and contributing
factors
Incident Reporting & Investigation

Report Errors, Near Misses, Hazardous Conditions

Characteristics of a Good Reporting System

• System is nonpunitive
• Examines both errors and near misses
• Offers variety of ways to report
• Provides learning opportunities
• Contains feedback mechanisms
Incident Reporting & Investigation

Types of Incidents:
Adverse Event – an unanticipated, undesirable, or
potentially dangerous occurrence in a healthcare
organization
Near Miss Event – any process variation that did not affect
an outcome but for which a recurrence carries a significant
chance of a serious adverse outcome
Sentinel Event – an unanticipated occurrence involving
death or major permanent loss of function
Incident Reporting & Investigation

Types of Reporting Systems:

•Confidential Reporting System – works best in large
organizations
•Anonymous Reporting System – limited value because
root causes cannot be elicited; does not promote
transparency
•Open System – allows for follow-up & fosters open
discussion; individuals are given a voice and encouraged to
influence change; but must be supported by clear
accountability principles
Incident Reporting & Investigation

Open System
• Works well in healthcare institutions
• Promotes positive cultural change
• Able to gather data helpful in improving systems
• Must be supported by clearly delineated accountability
principles
 Sentinel Events

What is a Sentinel Event?

• An unexpected occurrence involving death or serious

physical or psychological injury, or the risk thereof
• Not all sentinel events occur because of an error, and
not all errors result in sentinel events
 Sentinel Events

Examples of a Sentinel Event

• Fatal fall
• Abduction of any individual receiving care
• Wrong-site or wrong-person surgery
 Sentinel Events

Examples of a Sentinel Event (continued)

• Infection-related death
• Suicide within 72 hours of discharge
• Foreign object left in body after surgery
 Sentinel Events

Examples of a Sentinel Event (continued)

• Unanticipated death of a full-term infant

• Transfusion of the wrong blood type
• Fire-related death
Incident Reporting & Investigation

Voluntary versus Mandatory Reporting:

• technically all reporting systems are voluntary
• Mandatory reporting:
• sanctions imposed with failure to report
• mandatory reporting may undermine the idea of
appropriate accountability and transparency
•Best associated with requirement to report outside the
organization (national or local government initiated)
Incident Reporting & Investigation

Creating a Successful Reporting System:

• must be clearly delineated, leadership supported, easy to
use and robustly used to capture the necessary information
• mechanism of feedback - given to source of report
• Communicate to the whole organization information
regarding issue and action through a high-visibility vehicle
• a poorly supported reporting system is worse than no
reporting system at all as it will undermine the credibility of
leadership
Incident Reporting & Investigation

What to look for in an investigation:

• look at the system first, not the person
•Communication failures and breakdown
•Working conditions, environmental or staffing issues
•Trends related to medication errors, procedures, access
and patient flow
•Hand-off areas (endorsements from one area to the other)
Incident Reporting & Investigation

“All to often in the past the immediate response to an error

has been to blame the member of the staff involved and
ignore the underlying causes. The evidence tells us that
often when things go wrong, the causes can be traced back
to the systems. An automatic decision to blame and
suspend staff makes it more likely that errors will be
covered up and that the right lessons will not be learned.”
- Sue Osborne, NPSA
Incident Reporting & Investigation

Incident Decision Tree:

• developed by the National Patient Safety Agency (NPSA) to
help decision makers determine a fair and consistent course
of action to take with staff involved in a safety incident
• Based of Professor James Reason’s “Decision Culpability
Tree” currently used by the aviation industry
 NCC MERP

• National Coordinating Council for Medication

Error and Prevention
• Mission: maximize safe medication use and
increase awareness of medication errors
through open communication, increased
reporting and promotion of medication error
prevention strategies
• Standardized reporting and categories for
medication errors and outcome
Wrong Surgery Incident Investigation

Right? Left? Neither!

 Objectives

At the conclusion of this educational activity,

participants should be able to:
• Appreciate the role of Reason's Swiss Cheese
Model in medical errors
• Understand the process of analyzing a single
error
• Provide suggestions for remediation

23
 Case: Right? Left? Neither!
A 79-year-old woman presented to an after-hours
clinic with a 1-week history of diarrhea and
progressive weakness. Due to signs of
dehydration, the patient was directly admitted to
the hospital. Past medical history was notable for
stroke with residual left-sided hemiparesis,
hypertension, coronary artery disease with
ischemic cardiomyopathy, peptic ulcer disease,
asthma, and obesity.

24
 Case: Right? Left? Neither!
Two weeks prior to this admission, she had
developed right ankle and foot pain and had
been evaluated in the emergency department
(ED) of another hospital. The family was told of a
possible fracture and a splint was applied. She
was instructed to follow up with an orthopedist
as soon as possible. Due to transportation
difficulties, the patient was not seen in follow up.

25
 Case: Right? Left? Neither!
On physical exam, she was afebrile, appeared weak,
and had a left-sided hemiparesis. The right ankle and
foot was in the same splint from 2 weeks earlier.
When examined, the ankle had a normal range of
motion with no localized tenderness. A stool
specimen collected in the ED was subsequently
positive for Clostridium difficile toxin. At admission, a
signed release of information was faxed to the other
hospital to obtain records of the recent ED visit for
the ankle and foot injury.

26
 Case: Right? Left? Neither!

The family requested an orthopedic consultation to

expedite work-up. Outside records of the previous ED
visit did not arrive promptly, so another x-ray was
taken of the right foot and ankle. This x-ray was read
by the radiologist as showing a right ankle
trimalleolar fracture and dislocation. The consulting
orthopedist reviewed the x-ray report then briefly
examined the patient. Surgery was recommended
and discussed with family, and consent was
obtained.

27
 Case: Right? Left? Neither!

The next morning, the patient was taken to

the OR and spinal anesthesia was
administered. The orthopedist scrubbed and
was preparing to operate. The ankle x-ray was
on the view box in the OR. Prior to making an
incision, the orthopedist reviewed the x-ray
and was shocked to notice that it was a left
ankle x-ray showing a trimalleolar fracture.

28
 Trimalleolar Fracture

29
 Case: Right? Left? Neither!
A prompt examination of both of the patient's
ankles under anesthesia did not demonstrate
any clinical evidence of fracture or dislocation.
The x-ray was clearly labeled as belonging to
the patient. Stat x-rays of both ankles were
taken in the OR. The left ankle was intact and
the right showed an intact ankle with a
healing fracture of the fifth metatarsal bone.

30
 Case: Right? Left? Neither!
During the ensuing confusion, one of the OR
technicians recalled that another patient had
undergone an Operative Reduction-Internal
Fixation (ORIF) of a left ankle trimalleolar
fracture 2 days prior. It was later confirmed that
the x-ray showing the left ankle trimalleolar
fracture was mislabeled by date and belonged
to the other patient who already had surgery.

31
 Mechanisms of Adverse Events

• A single mistake, if it is serious enough, may

cause harm by itself
• Organizational accidents—many smaller
errors may occur, no one of which alone is
severe enough to cause harm but in
combination they become toxic

32 Reason J. Aldershot, United Kingdom: Ashgate Publishing Ltd; 1997.

 "Swiss Cheese Model" of Error

• Synthesizing the work of psychologists,

accident experts, and organizational
sociologists, Reason provides a conceptual
framework that delineates how errors made
by individuals interact with system defects in
complex organizations to cause harm.

33 Reason J. Aldershot, United Kingdom: Ashgate Publishing Ltd; 1997.

 Swiss Cheese Holes Line Up

34
 "Swiss Cheese Model"

• Hospitals put defenses into place to prevent

errors from doing harm
– Training programs; safety protocols, policies, and
procedures; computerized decision support tools
• Every layer of defense has weaknesses
• Adverse events occur only when all the
defenses around a particular situation have
been circumvented by many errors

35 Reason J. BMJ. 2000;320:768-770.

 Case Analysis

• Which of the two causal pathways was

involved?
– Single error versus Swiss cheese
• If Swiss cheese pathway was causative, which
defenses failed to prevent harm?
• What remedial action might be called for?

36
 First Error: Communication
• Two weeks prior to admission, staff in the emergency
department (ED) who diagnosed the non-displaced
metatarsal fracture failed to communicate this
diagnosis clearly and unambiguously to the patient
and her family
• The ED physician who examined the patient and
found a normal right ankle failed to communicate his
or her findings to the physician responsible for
admitting the patient or to the consulting orthopedic
surgeon

37
 Second Error: Follow-up

• If the ED physician ordered the repeat foot

radiographs, he or she erred further in not
personally reviewing the films
• If the patient was admitted to an internist or
other primary care physician, that physician
also erred in not examining the patient and
her x-rays

38
 Third Error: Mislabeled X-Ray

• Initially, an erroneous report on the patient

was generated showing a right trimalleolar
fracture with dislocation
• Initial erroneous report also identified the
wrong side, labeling trimalleolar fracture as
right instead of left

39
 Fourth Error: Individual Error

• The orthopedist failed to elicit or to discover

the history of the patient's previous diagnosis
or treatment
• The orthopedist "briefly examined the
patient"
• Surgery recommended on basis of incomplete
evaluation

40
 Fifth Error: Failure to Comply
with Universal Protocol
• A preoperative verification process to ensure
that all studies and records are available,
have been reviewed, and are consistent
• Marking the operative site
• A "time out" to conduct a final verification of
the correct patient, procedure, and site prior
to starting the procedure

41 JCAHO.
 Sixth Error: Teamwork Failure
• Teamwork failed in the
operating room
– No team members
observed that the
patient's ankle appeared
normal
– No one questioned
whether the procedure
should continue

42
 What Went Right?
• The patient was spared unnecessary surgery
at the last moment when the orthopedist
discovered that the presumptive diagnosis
was wrong
• The surgeon reviewed x-rays in OR after
finally recognizing that the ankle he or she
was "preparing to operate" on did not appear
to have a trimalleolar fracture/dislocation

43
 Individual Error or Swiss Cheese?
• The failure of the orthopedist to perform an
adequate History & PE - most serious error
• Second-most serious error was mislabeling of the
ankle x-ray
• Many other individuals, including the staff in the first
ED, the second ED physician, the admitting physician,
and the OR staff had opportunity to stop this
sequence of errors
• Only when all the defenses surrounding this patient
failed did she experience the harm of unnecessary
spinal anesthesia
44
 In This Case: Swiss Cheese

45
 Case (cont.): Right? Left? Neither!
Spinal anesthesia was reversed, and the
patient was returned to her room and did not
have any consequences. The family received
full disclosure and an apology. By discharge, a
faxed copy of ED records from the outside
hospital had been received. Included was an
x-ray report describing a non-displaced, fifth
metatarsal fracture of the right foot.

46
 Near Miss or Adverse Event?
• While some might call this case a "near miss" or
close call—a situation that could have led to an
adverse event but did not—it is more appropriate
to call this case an adverse event
• This patient was subjected to spinal anesthesia for
no reason; although risks are low, spinal
anesthesia is occasionally associated with severe
risks such as cardiac arrest and neurological
complications

47 Horlocker TT. Anesthesiol Clin North America. 2000;18:461-485.

 Remedial Actions
• Review process of identifying and labeling
radiographs
• Implement Universal Protocol in all operating
rooms
• Develop formal protocol to delineate precisely
how responsibility for care is handed off from
ED to admitting physicians and consultants
• Perform peer review of orthopedist's actions

48
 Take-Home Points
• Reason's Swiss Cheese Model, in which multiple
errors combine to create major adverse events
because of inadequate defenses, explains many
adverse events in health care
• Analysis of adverse events should focus on
discovering which defenses failed and bolstering them
• To prevent wrong-site/wrong-patient procedures,
hospitals should implement the Universal Protocol

49
 References

• The presentation was based on the May

2006 AHRQ WebM&M Spotlight Case
• Frankel, A. 2004. “Adverse Event &
Potential Event Reporting Systems”.
Achieving Safe & Reliable Healthcare: 139-
152.

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