New Directions in Safety Research: Lessons for Patient Safety

EIP/OPSQuality 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.

"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

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

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

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

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 Evaluation—three areas where Human Engineering contributes to Human Systems Integration.

Application Domains

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

Nuclear Safety Research

Reactor Physics, Materials Systems Behaviour Human factor, culture of safety Waste Management Issue of Public Concern in Safetyas much technical as it is political Nuclear safety research = public

confidence

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

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

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.)

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

Normal Accident Theory (NAT)

"In some technological systems accidents and inevitable or normal"

Two dimensions:

1. Interactive complexity

2. Loose/Tightly coupled system

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

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

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

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

Organizational Information Theory

Information Environment Information Equivocality Cycles of Communication

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

Math and Computer Sciences

Risk Measuring and Management Information

working with uncertainty

aggregation of information

computerisation of information Theories of accidents

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

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

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

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 to

pics

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.

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!

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

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

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