Serious Safety Events:
What does a Manager do?
David Gourley, RRT, MHA, FAARC
Executive Director of Regulatory
Affairs
Chilton Hospital
Pompton Plains, New Jersey
Serious Safety Events
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Overview of serious safety events
Incident reporting
Incident investigation
Root cause analysis
Culture of safety
Second victim
Overview of serious safety events
• Serious reportable event (National Quality
Forum)
• Never event (Agency for Healthcare Quality and
Research)
• Sentinel event (The Joint Commission)
Serious reportable event
Preventing adverse events in healthcare is central to the
National Quality Forum’s (NQF) patient safety efforts.
To ensure that all patients are protected from injury while
receiving care, NQF has developed and endorsed a set of
Serious Reportable Events (SREs). This set is a
compilation of serious, largely preventable, and harmful
clinical events, designed to help the healthcare field assess,
measure, and report performance in providing safe care.
National Quality Forum
Never Events
• Established by National Quality Forum
• Spearheaded by IOM report “To Err is Human”
• Originally 27 serious reportable events,
expanded to 29
• Considered “largely preventable”
• Incorporated into 26 states and DC into patient
safety programs
• Established to facilitate uniform and comparable
public reporting
• Drive national improvements in patient safety
Never Events
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2 million events annually
90,000 deaths annually
$5.7 billion in additional healthcare costs
$29 billion in associated costs (additional
healthcare expenses, lost work, lost income,
disability)
Never Events
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Care management events
Environmental events
Product or device events
Surgery-related events
Patient protection events
Sentinel Events
An unexpected occurrence involving death or serious
physical or psychological injury, or the risk
thereof. Serious injury specifically includes loss of limb or
function. The phrase, "or the risk thereof" includes any
process variation for which a recurrence would carry a
significant chance of a serious adverse outcome. Such
events are called "sentinel" because they signal the need
for immediate investigation and response.
The Joint Commission
Respiratory serious safety events
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Ventilator-related death
Intubation complication
Medical gas mix-up
Critical value not reported
Stage IV pressure ulcer from BiPAP mask
Tubing misconnection
Home care oxygen fire
Alarm safety issue
Incident Reporting
• Majority of events are not reported through
hospital incident reporting systems
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Estimated 86% not reported
Staff misperception of patient harm
Staff reluctance to report
Nurses most often report events
• OIG estimates 27% of in-patients experienced at
least one adverse event or temporary harm
Incident Reporting
TYPE OF SYSTEM
# OF
HOSPITALS
WITH
SYSTEM
General incident reporting system
189
Specialized incident reporting system
132
Infection tracking
98
Pharmacy or medication error tracking
43
Patient complaint tracking
40
Security issues
14
Harm to staff
7
Regulatory compliance
4
EVENT CATEGORY
% OF ALL
EVENTS
Events Captured by Incident Reporting systems
14%
Events Not Captured by Incident Reporting Systems
86%
Event was not reported:
Staff did not perceive event as reportable because:
62%
Event was not caused by a perceptible error
12%
Event was an expected outcome or side effect
12%
Event caused little harm and/or harm was ameliorated
11%
Event was not on hospital’s mandatory reporting list
9%
Event occurs frequently in hospitals
8%
Event symptoms became apparent after discharge
5%
Event occurred in patient with a history of similar events
4%
No reason given for why staff did not perceive event as reportable
2%
Event was not reported although event type is commonly reported
25%
Investigation and analysis
of clinical incidents
• Cursory investigation identifies only immediate
and obvious deviations in practice
• Hospital-wide clinical risk management offers
detached investigation of serious events
• Investigations often focus on actions and
omissions of individual clinicians and not
background of events
• Fundamental cause usually systemic features
Steps in Incident Investigation
• Secure the area and preserve evidence
• Notify Risk Management/Human Resources
(injuries, loss of life, criminal acts)
▫ External reporting (law enforcement, regulatory
agencies)
• Gather information about area before, during,
and after incident
▫ Visit and inspect incident site
Steps in Incident Investigation
• Gather information about area before, during,
and after incident (cont.)
▫ Identify and interview key healthcare workers,
patients, and witnesses
▫ Photograph/sketch pertinent aspects of site
▫ Collect physical evidence
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Position of injured patient/worker
PPE
Position of equipment
Evidence of equipment tampering
Steps in Incident Investigation
• Gather information about area before, during,
and after incident (cont.)
▫ Collect physical evidence (cont.)
 Materials being used at scene
 Condition of environment
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Lighting
Noise level
Smoke, dust, fumes, vapor
Odor
Housekeeping, maintenance, sanitation conditions
Steps in Incident Investigation
• Gather information about area before, during,
and after incident (cont.)
▫ Collect physical evidence (cont.)
 Background information
 Employee records (license, certification, orientation,
competency, performance evaluations)
 Equipment records (maintenance and service records,
operators manuals)
 Policies and procedures
 Previous incident reports
 Material safety data sheets (MSDS), if applicable
Steps in Incident Investigation
• Analyze facts, determine root cause and
contributing factors
• Report findings and make recommendations for
corrective actions
• Develop plan to evaluate effectiveness of
corrective actions
• Alter corrective actions as determined by
ongoing monitoring
Scope of Root Cause Analysis (RCA)
• Behavioral assessment
process
• Physical assessment process
• Patient identification
process
• Patient observation
procedures
• Care planning process
• Continuum of care
• Staffing levels
• Orientation and training of
staff
• Competency assessment
• Supervision of staff
Scope of Root Cause Analysis (RCA)
• Communication with
patient/family
• Communication among staff
members
• Availability of information
• Adequacy of technological
support
• Equipment maintenance/
management
• Physical environment
• Security systems and
processes
• Control of medications
(storage/ access)
• Labeling of medications
Framework of contributing factors
• Patient factors
▫ Condition (complexity/seriousness)
▫ Language and communication
▫ Personality and social factors
• Task factors
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Task design and clarity of structure
Availability and use of protocols
Availability and accuracy of test results
Decision-making aids
Framework of contributing factors
• Individual staff factors
▫ Knowledge and skills
▫ Competence
▫ Physical and mental health
• Team factors
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Verbal communication
Written communication
Supervision and seeking help
Team structure (congruence,
consistency, leadership)
Framework of contributing factors
• Work environmental factors
▫ Staffing levels and skill mix
▫ Workload and shift patterns
▫ Design, availability, and maintenance of
equipment
▫ Administrative and managerial support
▫ Environment
▫ Time delays
Framework of contributing factors
• Organizational and management factors
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Financial resources and constraints
Organizational structure
Policies, procedures, standards, and goals
Safety culture and priorities
• Institutional factors
▫ Economic and regulatory context
▫ Links with external organizations
Interviews with staff
• Setting the scene
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Private setting, away from incident scene
Supportive and understanding
Not judgmental or confrontational
One interviewer, another person documenting
• Establish chronology
▫ Establish role of staff member in incident
▫ Establish chronology of events as staff saw them
Interviews with staff (cont.)
• Identifying care delivery problems
▫ Explain concept to staff member
▫ Ask staff member to identify main care delivery
problem as they see them (do not assign blame)
▫ Identify acts and omissions made by staff
▫ Identify breakdowns in clinical process (deviations
from practice)
• Identify contributing factors
Building a Culture of Safety
• Recognize that people are human and will make
mistakes
• Systems are designed to catch mistakes before
they become errors
• The need to review “near misses” to further
reduce opportunities for error
Building a Culture of Safety
• Leadership driven – must guide every decision
• Acknowledge that our systems are most likely to
cause errors, not our people
• No healthcare decision is removed from patient
safety
• Need to recognize and correct at-risk behavior
Building a Culture of Safety
ERROR
Preventing errors from being
made in the first place
Detecting and reversing
error before it causes harm
Repairing or minimizing
the damage caused by
errors that cannot be
prevented or reversed
ADVERSE
EVENT
Building a Culture of Safety
“The single greatest impediment to
error prevention in the
medical industry
is that we punish people
for making mistakes.”
Dr. Lucian Leape
Professor, Harvard School of Public Health
Testimony before Congress on
Health Care Quality Improvement
Building a Culture of Safety
• Human error -inadvertent action; inadvertently
doing other that what should have been done; slip,
lapse, mistake.
• At-risk behavior –behavioral choice that increases
risk where risk is not recognized or is mistakenly
believed to be justified.
• Reckless behavior -behavioral choice to
consciously disregard a substantial and
unjustifiable risk.
“Second Victim”
• Caregivers and staff involved in medical errors
that harm patients
• Staff can sustain complex psychological harm
• Healthcare practitioners repeatedly exposed to
emotional turmoil
• Equivalent to post-traumatic stress disorder
• Staff feel sadness, fear, anger, shame, panic,
horror, apprehension
• Effective support needed for practitioners
“Second Victim”
• Five rights of second victims: T R U S T
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Treatment that is just
Respect
Understanding and compassion
Supportive care
Transparency and opportunity to contribute
Serious Safety Events:
What Does a Manager Do?