Event Reporting,
Disclosure, Sentinel
Events & Mock RCA –
Grand Rounds
Eva M. Satori, B.A., CPHRM, FASHRM
Manager, Risk Services
April 2, 2015
Objectives
• What Events should be reported in online Event Reporting
System (ERS)
• Definition of Sentinel Events
• Disclosure of Adverse Events
• Definition Root Cause Analysis (RCA)
• Mock RCA
2
Definitions
• Event (incident, occurrence, notification):
– Any unanticipated event that is not consistent with the routine care of a particular
patient and/or the routine operation of the facility. An event may be a potential or
actual adverse event that involves a patient, guest, employee, volunteer, student or
physician.
• Sentinel Event:
– An unexpected event involving death or serious physical injury or psychological injury or
the risk thereof. Serious injury includes loss of limb or function. The phrase “or risk
thereof” includes any process variation for which the recurrence would carry significant
chance of serious adverse outcome.
• Disclosure:
– Information regarding the results of a diagnostic test, medical treatment or surgical
intervention communicated to the patient, family and/or surrogate.
• Root Cause Analysis (RCA):
– Is a process intended to help organizations delve deeper into processes (not people).
3
Event Reporting
4
Event Reporting
•
An event/incident is any unanticipated
event or any potential event that is not
consistent with the routine care of a
particular patient and/or routine
operation of the facility.
– Be timely
– Be factual
– Provide details
– You may submit anonymously but it is
always best if your name is provided for
follow up
– Inform Attending MD, Program Directors
or Chiefs
– Safe Harbor provision – report event
within 48 hours in which employee
involved.
5
Event Reporting
6
What happens to Event Reports?
• Categorized and Routed to the involved
Department/Director/Manager/Medical Staff
• Investigated and reviewed
• Improvement activities and follow up plans
• Serious events are quickly escalated to leadership for review
and consideration of RCA.
7
Examples of Events to be report in Event Reporting
System (ERS)
• Missed diagnosis or misdiagnosis
• Procedure or test done on wrong patient
• Reactions/complications to a medical test
• Patient death or serious injury associated with unsafe administration
of blood products
• Hospital incurred trauma, injury or infection
• Patient or guest suicide or suicide attempt
• Death or permanent loss of function from a hospital acquired injury
•
See “Think Pink handout” examples for further examples.
8
TOTAL SJHMC ERS FY13 & FY14
9
SJHMC FY14 TOP 10 CATEGORIES
Mislabeled specimen
25
13
73
Skin/Wound: HAPU
20
Unexpected clin event
Accidental fall
62
Medication/IV:
Infilitration/extravasation
100
12
11
Equipment/Device:
Disconnection/dislodged
Fall: Anticipated physiological
AMA
79
Skin/Wound: Skin tear/laceration
73
Equipment/Device: malfunction
10
SJHMC 1st QUARTER FY15 TOP 10 CATEGORIES
40
47
180
Other: unexpected clinical event
54
Skin/Wound: HAPU
Fall: Accidental fall
Other: AMA
54
Medication/IV: other
Other: Elopement
83
58
Complaint: Service
Perinatal: vaginal
Tests/Tx: mislabeled specimens
Tests/Tx: delays
80
95
92
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Sentinel Events
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What is a Sentinel Event?
• The Joint Commission (TJC) adopted a formal Sentinel Event
Policy in 1996 to help hospitals that experience serious adverse
events, improve safety and learn from those sentinel events.
• Definition of Sentinel Event:
– Death
– Permanent Harm
– Severe Temporary Harm (critical, potentially life-threatening harm lasting
for a limited time with no permanent residual, but requires transfer to
higher level of care/monitoring for a prolonged period of time, transfer to
higher level of care for a life-threatening condition, or additional major
surgery, procedure, or treatment to resolve the condition.)
13
What is a Sentinel Event? (cont)
• An event is also considered sentinel if it is one of the following:
– Suicide of any patient receiving care, treatment, and services in a staffed
around-the-clock care setting or within 72 hours of discharge, including
from a hospital’s ED
– Unanticipated death of a full-term infant
– Discharge of an infant to the wrong family
– Abduction of any patient receiving care, treatment, and services
– Any elopement (that is, unauthorized departure) of a patient from a
staffed around-the-clock care setting (including the ED), leading to a death,
permanent harm, or severe temporary harm to the patient
– Hemolytic transfusion reaction involving administration of blood or blood
products having major blood group incompatibilities (ABO, Rh, other blood
groups)
14
What is a Sentinel Event? (cont)
– Rape, assault (leading to death, permanent harm, or severe temporary harm),
or homicide of a staff member, licensed independent practitioner, guest, or
vendor while on site at the hospital
– Invasive procedure, including surgery, on the wrong patient, at the wrong site,
or that is the wrong (unintended) procedure
– Unintended retention of a foreign object in a patient after an invasive
procedure, including surgery
– Severe neonatal hyperbilirubenemia (bilirubin >30 milligrams/deciliter)
– Prolonged fluroscopy with cumulative dose >1,500 rads to a single field or any
delivery of radiotherapy to the wrong body region or >25% above the planned
radiotherapy dose
– Fire, flame, or unanticipated smoke, heat or flashes occurring during an
episode of patient care
– Any intrapartum (related to the birth process) maternal death or severe
maternal morbidity
15
Disclosure
16
Disclosure
• Patients and their families will be informed about outcomes of
treatment, including those that differ significantly from anticipated
outcomes.
• The attending physician will lead the disclosure discussion. A
representative from the hospital/Nursing, and Risk Manager will be
present.
• Provide a factual explanation of the event and the impact on the
patient’s treatment.
• A commitment to investigate the event in order to prevent like
occurrences.
• Resources available to support and comfort the patient, family
and/or surrogate.
• An apology or other expression of sympathy.
17
Disclosure – documentation in medical record
• Documentation in the medical record, should be completed by
the physician or other designated individual participating in the
disclosure and should contain:
– A full description of facts of the event, without conjecture as to the cause
or attribution of fault/blame.
– Detailed disclosure discussions with the patient, family and/or surrogate.
– Identity of any interpreter used during the disclosure.
– Any follow-up discussions with the patient, family and/or surrogate.
– Complete an event report (if one not already completed). Do not refer to
the event report in the patient’s medical record.
18
May I apologize?
• Arizona Apology Law ARS 12-2605 (2005)
– In any civil action that is brought against a health care provider…any
statement…expression apology…made by a health care provider…to the
patient…that relates to discomfort, pain, suffering, injury, or death of the
patient as a result of the unanticipated outcome of medical care is
inadmissible as evidence of an admission of liability.
19
Root Cause Analysis
(RCA)
20
Root Cause Analysis (RCA)
• Per The Joint Commission (TJC) and St. Joseph’s policy, an RCA is to
be completed within 45 days of the event.
•
Is a process for identifying the basic and causal factor(s) that underlying
variation in performance, including the occurrence or possible occurrence of a
sentinel event.
Focuses primarily on systems and processes, not individual performance.
Addresses the appropriate elements from TJC “Minimum Scope of Review of
RCA”.
Set ground-rules:
•
•
•
•
Safe, blame-free, protected
•
Structured retrospective analysis of events
•
Multidisciplinary
•
Focus on systems and processes, not individual performance
•
Identify and implement improvement actions to prevent recurrence
21
Root Cause Analysis (RCA) (cont)
• The Joint Commission (TJC) expects hospitals to identify and respond
appropriate to all sentinel events:
•
A formalized team response that stabilizes the patient, discloses the event to the
patient and family, and provides support for the family as well as staff involved.
•
Notification of hospital leadership.
•
Immediate investigation.
•
Completion of a comprehensive systematic analysis for identifying the causal and
contributory factors.
•
Corrective actions.
•
Timeline for implementation of corrective actions.
•
Systemic improvement.
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RCA process
• Start the investigation
• Gather data (e.g. staff involved, create a timeline)
• Analyze the data
• Identify root causes
– A determination of the human and other factors most directly associated with
the sentinel event and the process(es) and systems related to its occurrence;
– Analysis of the underlying systems and processes through a series of “WHY?”
questions to determine where redesign might reduce risk;
– Identification of risk points and their potential contributions to this type of
event
• Create recommendations
• Complete investigation and follow up on results
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RCA Action Plan
• RCA action plan addressing the identified root causes, will
identify the strategies than an organization intends to
implement to reduce the risk of similar events occurring in the
future. An appropriate action plan should demonstrate the
following:
– Identify changes that can be implemented to reduce risk, or formulates a
rationale for not undertaking such changes.
– Address responsibility for implementation, oversight, pilot testing as
appropriate, timelines, and strategies for measuring the effectiveness of
the actions.
24
RCA – Common Pitfalls and Strategies to Avoid them
• Common Pitfalls
• Guiding Principles
– Insufficient Organizational Support
– Embrace Organizational Learning
– Reliance on the “Old View”
– Address Root Causes
– Hindsight Bias
– Focus on “Work as Done”
– Emphasis on “Work as Written”
– See Perspective of Staff
– Failure to Reach True Root Causes
– Get into the Mindset
– Root Causes Unaddressed
– Delve Deeply
– Insufficient Follow-Up, monitoring
– Develop Leading Indicators
25
MOCK RCA
• Patient RW
– 64 YO male with new onset seizure-like activity with right hemiplegia,
altered mental status
– After consulting neurology, decided to get MRI with LP; MRI performed
under general anesthesia due to deteriorating mental status
– MRI results inconclusive, so LP performed while patient still under general
anesthesia
– Neurology reviews the MRI and adds additional recommendations which
are text to the Medicine intern
– Next AM, patient RW is told that the LP studies looked normal. He hadn’t
realized the LP was even performed and is angry about this fact.
– Neurology recommends additional LP to complete studies which weren’t
done.
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MOCK RCA (cont)
• Was there an error in RW’s care?
– How would you classify the error(s)?
• Was there an adverse event?
– If so, was it preventable?
• Should an Event Report be completed?
– If so, by whom?
27
Most Frequently Identified Root Causes of Sentinel
Events Reviewed by The Joint Commission by Year
The majority of events have multiple root causes
(Please refer to subcategories listed on slides 5-7)
2013 (N=887)
Jan to Jun 2014
(N=394)
Human Factors
614
Human Factors
635
Human Factors
290
Leadership
Communication
557
532
Communication
Leadership
563
547
Leadership
Communication
269
248
Assessment
482
Assessment
505
Assessment
208
Information Management
203
Information Management
155
Physical Environment
53
Physical Environment
150
Physical Environment
138
Care Planning
38
Continuum of Care
95
Care Planning
103
Information Management
36
Operative Care
93
Continuum of Care
97
Continuum of Care
33
Medication Use
91
Medication Use
77
Operative Care
29
Care Planning
81
Operative Care
76
Health information technologyrelated
27
The reporting of most sentinel events to The Joint Commission is voluntary and represents only
a small proportion of actual events. Therefore, these root cause data are not an epidemiologic
data set and no conclusions should be drawn about the actual relative frequency of root causes
or trends in root causes over time.
Office of Quality Monitoring 28
© Copyright, The Joint Commission
2012 (N=901)
Resources
•
Think Pink handout Sample Reportable Events (revised 11/18/14)
•
AZ Service Area Policy Event Reporting Policy 2.011/10025.1 (effective 9/1/14)
•
Dignity Health Patient Safety Event Reporting and Management Policy 100.5.006 (effective 6/26/14)
•
St. Joseph’s Sentinel Event Identification/Investigation Policy 10027 (effective 12/27/06; last reviewed
8/1/12)
•
Comprehensive Accreditation Manual for Hospitals (CAMH) (1/2015)
•
Dignity Health Patient Safety Disclosure of Unanticipated or Adverse Outcome to Patients/Families
(6/26/14)
•
St. Joseph’s Medical Staff Disclosure Policy (10/17/14)
•
Getting the Most out of RCAs (ECRI 2/10/15)
•
Root Cause Analysis: How Incident Reports Lead to Improvements & Mock RCA (Matt Russell, M.D.,
Glenn Rosenbluth, M.D. UCSF 2014)
•
What I Learned About Adverse Events from Captain Sully: It’s Not What You Think (Marjorie Podraza
Stiegler, M.D. JAMA 1/27/15)
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Thank You!
Eva M. Satori, B.A., CPHRM, FASHRM
Manager Risk Services
602.406.6937 office
602.746.4069 pager
818.207.6535 cell