New Directions in Safety
Research: Lessons for
Patient Safety
EIP/OPS
Quality and Patient Safety Team,
Varavikova E.A., MD, PhD, MPH
Outline
To describe current tendencies in safety
research
 To emphasise multiplicity of the safety
research field
 To draw attention to the need for research
in validation, evaluation of impact and in
evidence based studies.
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"To Err is Human: Building a
Safer Health System" 1999
"…health care is a decade or
more behind other high risk
industries in its attention to
ensuring basic safety"
High Hazard Industries:
Aviation
 Nuclear power
 Space Travel
 Petrochemical Processing
 Rail transport
 Maritime industries
 Defence
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Aviation Safety and security
program (NASA)
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Aircraft self-protection and Preservation
(due to abnormal operations and system failures)
 Hostile Act Intervention and protection
 Human Error Avoidance
 Environmental Hazards Awareness and
Mitigation
 System Vulnerability Discovery and
Management
Current Problems in Aviation
Safety research/practice:
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Air-traffic control – changing patterns in
commercial aviation have increased the number
of connecting flights
"Near misses and error rates have been
mounting steadily in the last few years, and
system not paying attention to it" Perrow, 2003
Preventing catastrophic failure costs $
Not only for high profile upgrades
Better Management, Monitoring & Maintenance
NAVY
The Navy is one Institution, instilling a
culture that urges everyone on a ship
to be aware and report things that are
awry, no matter how inconsequential.
 The results include more then 127
million miles travelled by nuclearpowered ships and submarines with
no reactor accidents and a low rate of
problems on aircraft carriers
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The Human Systems
Information Analysis Center
(Human Systems IAC, DoD)
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Human Systems Integration (HSI) manpower,
personnel, training; health hazards; safety factors;
medical factors; personnel (or human) survivability
factors; and habitability considerations into the
system acquisition process.
Information Resources
Methods, Models, Tools & Techniques Analysis,
Design, and Test and Evaluation—three areas where
Human Engineering contributes to Human Systems
Integration.
Application Domains
NASA- Systems Safety
Research Branch focus on
Human Factors
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Aviation Performance
Measuring System
Aviation Safety
Reporting System
Aviation Safety
Monitoring and
Modeling
Cognitive Performance
in Aviation Training and
Operations
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Distributed Team
Decision-Making
Emergency and Abnormal
Situations Study
Fatigue Countermeasures
Group
Performance Data
Analysis and Reporting
System
Nuclear Safety Research
Reactor Physics, Materials
 Systems Behaviour
 Human factor, culture of safety
 Waste Management
 Issue of Public Concern in Safety
as much technical as it is political
Nuclear safety research = public
confidence
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The Safety Culture Goal
The term Safety Culture was introduced
after Chernobyl disaster:
Safety culture is that assembly of
characteristics and attitudes in organization
and individuals which establishes that, as
an overriding priority, nuclear plant safety
issues receive the attention warranted by
their significance
Estimates of the time needed for change
between 5 and 15 years
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Shell - "Hearts and minds"
change programme
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Change process to bring lasting
improvements in Health safety and
Environment Performance
Hearts and Minds – the goal is to
develop a programme in which the entire
workforce would become intrinsically
motivated for safety
Safety culture is a goal
Tools for behavioural and organizational
change
Swiss Cheese Model of
accident causation (Jim
Reason)
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Layers of defences (barriers) between hazards and
unwanted outcomes. Accident happened if all holes lined up
and there were long-lasting underlying conditions
(inappropriate policies, resources etc.)
Organizational aspects of safety in
sociology, implication to high-tech,
complex systems (1)
Normal Accident Theory
(NAT)
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"In some technological
systems accidents and
inevitable or normal"
Two dimensions:
1. Interactive
complexity
2. Loose/Tightly
coupled system
High Reliability Organizations
(HRO)
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"The subset of hazardous
organizations that enjoy a
record of high safety over a
long period of time"
Measure of HRO – accident
rate
Drive for technical
predictability (and stable
technical process)
Complete technical
knowledge
Standard system safety and
industrial safety approaches
NAT
VS

System Accident can NOT be
foreseen or prevented –
engineering solutions to
improve safety = redundancy
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Solutions:
- Reduce unnecessary
complexity
- Design for monitoring
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Trade off : how much risk is
acceptable to achieve basic
goals, other then safety
HRO
Organizational change can
improve safety no matter how
complex is organization
Solutions: 5 elements
(process auditing, reward system,
quality assurance, risk
management, command and
control)
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Design for Organizational change
NAT
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limitations
Unnecessary
pessimistic in
effectively dealing
with problems in
organization of
safety critical
systems
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HRO
Uncertainty of the
complex systems
(innovative
technical,
organizational or
social)
Extensive use of
Redundancy
Reliability VS
Safety
Alternative to NAT and HRO
systems approach
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Identifying the system safety constrains necessary
to prevent accidents;
Designing the system to enforce the constraints,
including understanding how the safety
constraints could be violated and building in
protection against these dysfunctional (unsafe)
behaviours
Determine how changes in the process over time
could increase risk. Define metrics and value
forms of performance auditing
Organizational Information
Theory
 Information
Environment
 Information Equivocality
 Cycles of Communication
Theory of Naturalistic Decision
Making (real-life contexts, incl.
Emergencies)
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Belong to Human Factors theories
Specific decision theories:
Image, Recognition Prime Decision, Explanation
Based, Lens Model, Dominance Search
 Applicability to the given problem
 Possible sources of error,
strengths/weaknesses
Decision support system (DSS) and testing the
hypothesis
Math and Computer
Sciences
Risk Measuring and Management
 Information
working with uncertainty
aggregation of information
computerisation of information
 Theories of accidents
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Cognitive System
Engineering
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Systematic Model for Driver-In- Control
Achieving goals of purpose and safety
Allow to account for the dynamics that are
unattainable by structural models.
Study cycles of decision making in a
constant safety framework
Research on OIT and
Learning
Information systems can support
organizational learning processes
such as knowledge acquisition,
information distribution,
information interpretation, and
organizational memory.
Many aspects of learning require
further research by organization
scientists and information systems
researchers
Simulation
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Simulation allows the user to predict and optimize
system and component performance.
The Simulation Module uses Monte Carlo simulation
techniques to predict component and system
performance.
The Simulation Module models inspected components
with un-revealed failures and preventive and corrective
policies
System parameters include predicted unavailability,
number of expected system failures, unreliability and
required spares levels.
Safety Research
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Hazard
Risk
Information
Engineering and
design
Tools, techniques, and
metrics
Human Factors
Management
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Complexity systems
(system analysis;
uncertainty; social +
engineering)
Organization change
Education and training
Modelling
Relationship to other
topics
How Safe is the Safety
paradigm?
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Developed countries have all engaged in safety initiatives
such as patient safety agencies, adverse event reporting and
learning systems, and the use of safety performance
indicators.
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The benefits of such programmatic efforts are assumed, but
it is still unclear how effective these multiple initiatives are.
Furthermore, little attention has been paid to their potential
side effects.
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These shortcomings which can exacerbate the initial safety
and health problems should be anticipated and guarded
against from the outset, especially as these initiatives can
become accountability tools.
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Both effects and side effects of current initiatives need
careful rigorous evaluation to achieve evidence based safety
in health systems.
Approach to Improve safety
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Error Reporting and
Analysis
Quality Improvement
strategies
Education and training
Technologic
Approaches
Communication
Improvement
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Culture of safety
Legal and policy
approaches
Human factors
engineering
Logistical Approaches
Teamwork
Specialization of care
NB! Research in soft
and hard ware and
education & training
in both!
Safety topics and practices
for PS (1)
Incident Reporting
 Root cause analysis
 Computerized physician order entry
and decision support as a means of
reducing medical errors
 Automated medication dispensing
systems
 Bar coding technology to avoid
misidentification errors
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Safety topics and practices
for PS (2)
Aviation-style preoperative checklists
for anaesthesia equipment
 Promoting a "culture of safety"
 Crew resource management (team
work training and crisis response,
aviation)
 Simulators as a training tool
 Human factors theory in the design of
medical devices and alarms
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Lessons Learned
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Systematic approach prevailing in research for
the complex systems
Theories NA and HRO needs more
assessment
Research on implementation is not less
important
Evaluation before implementation
Patient Safety Research = Public Confidence
and trust in Health Care