New Directions in Safety Research: Lessons for Patient Safety

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New Directions in Safety Research Lessons for
Patient Safety

• EIP/OPS
• Quality and Patient Safety Team,
• Varavikova E.A., MD, PhD, MPH

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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"

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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)

• 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

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Current Problems in Aviation Safety
research/practice

• 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

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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 nuclear-powered 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)

• 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 Evaluationthree areas where
  Human Engineering contributes to Human Systems
  Integration.
• Application Domains

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NASA- Systems Safety Research Branch focus on
Human Factors

• Aviation Performance Measuring System
• Aviation Safety Reporting System
• Aviation Safety Monitoring and Modeling
• Cognitive Performance in Aviation Training and
  Operations

• Distributed Team Decision-Making
• Emergency and Abnormal Situations Study
• Fatigue Countermeasures Group
• Performance Data Analysis and Reporting System

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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

• 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

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Swiss Cheese Model of accident causation (Jim
Reason)

• 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.)

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Organizational aspects of safety in sociology,
implication to high-tech, complex systems (1)

• High Reliability Organizations (HRO)
• "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

• Normal Accident Theory (NAT)
• "In some technological systems accidents and
  inevitable or normal"
• Two dimensions
• 1. Interactive complexity
• 2. Loose/Tightly coupled system

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NAT VS HRO

• System Accident can NOT be foreseen or prevented
  engineering solutions to improve safety
  redundancy
• Solutions
• - Reduce unnecessary complexity
• - Design for monitoring
• Trade off how much risk is acceptable to
  achieve basic goals, other then safety

• 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)
• Design for Organizational change

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NAT limitations HRO

• Unnecessary pessimistic in effectively dealing
  with problems in organization of safety critical
  systems

• Uncertainty of the complex systems (innovative
  technical, organizational or social)
• Extensive use of Redundancy
• Reliability VS Safety

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Alternative to NAT and HRO systems approach

• 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

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Organizational Information Theory

• Information Environment
• Information Equivocality
• Cycles of Communication

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Theory of Naturalistic Decision Making (real-life
contexts, incl. Emergencies)

• 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

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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

• 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

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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

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Simulation

• 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.

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Safety Research

• Hazard
• Risk
• Information
• Engineering and design
• Tools, techniques, and metrics
• Human Factors
• Management

• Complexity systems (system analysis uncertainty
  social engineering)
• Organization change
• Education and training
• Modelling
• Relationship to other topics

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How Safe is the Safety paradigm?

• 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.
• 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.
• 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.
• Both effects and side effects of current
  initiatives need careful rigorous evaluation to
  achieve evidence based safety in health systems.

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Approach to Improve safety

• Error Reporting and Analysis
• Quality Improvement strategies
• Education and training
• Technologic Approaches
• Communication Improvement

• 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!

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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

• 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