Is quality safety? Is safety quality? Clarity is a priority.

1. Is quality safety? Is safety quality?Clarity is a priority. Sam Sheps Karen Cardiff Department of Health Care and Epidemiology University of British Columbia Western Healthcare Improvement Network Conference Enhancing Patient Safety Across the Continuum Richmond, BC June 8, 2006

2. Why are we asking? In health care, quality and safety are most often talked about together, as if the concepts are the same, or at least, highly overlapping. System safety experts from other industries have thought about the same question, and we’ve discovered that they rarely refer to quality, in discussions about safety. Our research into the management and regulation of high-risk high reliability industries – aviation, nuclear power and rail – led us to think about the weakness in using the words interchangeably.

3. Brief history of efforts to understand the concepts ‘quality’ and ‘safety’ 1930’s to 60’s The fundamentals of good medical care (Lee and Jones, 1933) Hazards of modern diagnosis and therapy (Barr, 1955) Diseases of medical progress (Moser, 1956) The hazards of hospitalization (Schimmel, 1964) 2000 To err is human, building a safer health system (Institute of Medicine report. Kohn, Corrigan and Donaldson) 2001 Crossing the quality chasm: a new system for the 21st century (Committee on Quality of Health Care in America).

4. In health care…. At present, the words ‘quality’ and ‘safety’ are often used interchangeably (e.g. media, journals, educational initiatives, etc) The risk is that people responsible for governing, managing and providing health care may think these concepts mean the same thing.

5. Why do we think this is a problem? Conflating the concepts may implicitly create the belief that if you enhance quality, you are automatically managing safety. We think this assumption is wrong.

6. Familiar examples Quality of food versus the safety of food • Perfectly safe food that is unpalatable and unpleasant…quality attributes • Extremely tasty food that is contaminated Punctuality as a quality issue in the transportation sector • “If you are not on time you will lose a few customers, if you are not safe you will lose them all” (Bob Dodd, Qantas)

7. Even though people talk about improving ‘safety’, they may, in their directions and actions, actually be trying to do something to improve quality. Our central tenet is that in order to make progress on safety, it is important and necessary to separate the concepts, while not losing sight of the overlap.

8. Defining quality (Wikipedia) • Quality refers to the distinctive characteristics orproperties of a person, object, process or other thing. Such characteristics may enhance a subject's distinctiveness, or may denote some degree of achievement or excellence. • When used in relation to people, the term may also signify a personal character or trait. • When used in relation to management, the term may be easily defined as "reduction of variability" or "compliance with specifications".

9. Quality can be used as a tool of measurement, like metric or Fahrenheit, as it is used to judge both subjects that are esteemed as credible and agreeable as "high quality" and subjects that are viewed as confusing, offensive, unhelpful, or incredible as "low quality." But quality is also used as a positive word, as in the sense of "this is a quality chair." Its antonym can be perceived as poorness, incredibility, unhelpfulness, and a variety of other words that reflect the concept of having low quality. • ISO 9000 defines quality as "degree to which a set of inherent characteristics fulfils requirements".

10. Defining safety (Wikipedia) • Safety is the condition of being protected against physical, social, spiritual, financial, political, emotional, occupational, psychological or other types or consequences of failure, damage, error, accidents, harm or any other event. • Risk management is the art and science of identifying risks, determining how significant they are, deciding whether they are worth taking, and recommending measures to reduce or eliminate particular risks.

11. The key distinctions Quality is a characteristic of the system/organization • something the system has Safety is something that the system/organization does • it’s proactive Quality is an attribute that we try to enhance Creating safety is something we do to mitigate or prevent harm

12. Quality improvement • Embraces a philosophy of meeting or exceeding customer expectations through the continuous improvement of the processes or producing a good or service • Posits that the quality of goods and services depends foremost on the processes by which they are designed and delivered • Focuses on understanding, controlling, and improving work processes rather than correcting problems after they occur. • Assumes that uncontrolled variance in work processes is the primary case of quality problems.

13. ‘If you enhance quality you are managing safety’ Why do we think this premise is wrong? It’s based on what we have learned from other risk- critical high-reliability industries about making progress on safety.

14. Unlikely events….surprise In large, complex, dynamic, event driven organizations “one should expect that the unexpected will occur, that unimaginable interactions will develop, that accidents will happen” Scott Sagan, The limits of safety, 1993

15. “We live in a world of hazardous technologies and some risk of catastrophic accidents is therefore ever present. We try to keep these risks as low as possible, yet in recent years, the names of many social and environmental tragedies have been etched into our memory” Scott Sagan, The limits of safety, 1993

16. Accidents in technologically complex environments Chernobyl, the Exxon Valdez, the space shuttle Challenger, Bhopal, the Titanic and the Queen of the North Are accidents like these avoidable? Or, are these the predictable result of the widespread use of hazardous technologies and would they be addressed by quality improvement activity?

17. What creates safety and causes accidents in complex organizations? Two major schools of thought • High reliability theory • Normal accident theory

18. The ideas are rooted in the organizational theory literature • Different understandings of how organizations work • Different views on how best to analyze complex organizations Competing explanations • Proponents of each school of thought focus attention on a specific set of factors that they believe contributes to or decreases safety

19. High reliability theory “Optimistic” view Extremely safe operations are possible, even with extremely hazardous technologies, if appropriate organizational design and management techniques are followed. Scott Sagan, The limits of safety, 1993

20. Normal accidents theory “Pessimistic” view Serious accidents with complex high technology systems are inevitable. Scott Sagan, The limits of safety, 1993

21. High reliability theory Accidents can be prevented through good organizational design and management Safety is the priority organizational objective Redundancy enhances safety: duplication and overlap can make “a reliable system out of unreliable parts” Decentralized decision-making is needed to permit prompt and flexible field-level responses to surprises Normal accidents theory Accidents are inevitable in complex and tightly coupled systems. Safety is one of a number of competing objectives. Redundancy often causes accidents; it increases interactive complexity and opaqueness and encourages risk-taking. Organizational contradiction: decentralization is needed for complexity, but centralization is needed for tightly coupled systems. Contrasting views

22. High reliability theory A “culture of reliability” will enhance safety by encouraging uniform and appropriate responses by field-level operators. Continuous operations, training, and simulations can create and maintain high reliability operations. Trial and error learning from accidents can be effective, and can be supplemented by anticipation and simulations. Normal accidents theory A military model of intense discipline, socialization, and isolation is incompatible with democratic values. Organizations cannot train for unimagined, highly dangerous, or politically unpalatable operations. Denial of responsibility, faulty reporting, and reconstruction of history cripples learning efforts. Contrasting views

23. High reliability theory: The organization is a “rational” actor Organizations, properly designed and managed, can compensate for well-known human frailties High reliability hazardous organizations are “rational”  highly formalized structures and are oriented toward the achievement of clear and consistent goals (i.e. reliable and safe operations) Richard Scott, Organizations: Rational, natural and open systems, 1987

24. High reliability theory: Organizational characteristics and safety • Leadership safety objectives • The need for redundancy • Decentralization, culture and continuity • Organizational learning

25. Normal accident theory:The organization is not a “rational” actor Fits within the “natural open systems’ tradition – organizations actively pursue goals of narrow self-interest, e.g. security, survival, not just the official goals, such as profit, production or reliability. Organizations are seen as “open” i.e. constantly interacting with the outside environment, both influencing and being influenced by the broader social and political forces. Richard Scott, Organizations: Rational, natural and open systems, 1987 The “garbage can model” Cohen, March and Olsen, A garbage can model of organizational choice, 1986

26. Normal accidents theory: Organizational characteristics and safety • Structure, politics and accidents • Complex and linear interactions • Tight and loose coupling

27. What are the implications for health care? “Unlikely events”…adverse events can happen in what is thought of as an environment that is providing high quality care. e.g. transition care …the quality of the discharge planning process may be fine, but the nature of ‘transition’ itself creates the potential for unexpected events (that may threaten safety). Care may be considered high quality, but harm can still occur. Harm is an emergent characteristic of the system… ”The dangerous accidents lie in the system, not in the components” Charles Perrow, Normal accidents: Living with high-risk technologies, 1984

28. Creating quality involves ensuring an acceptable standard of care (hopefully, a predictable characteristic…you can guarantee quality). Quality is an attribute of a normally functioning system. Creating safety involves asking ‘what if’ …it anticipates what could go wrong (the unpredictable nature of safety…you cannot guarantee safety). Safety is linked to the capacity of a system to handle surprise or instability. Creating safety lies within the realm of dealing with things which haven’t happened yet, whereas creating quality involves doing something to enhance an ongoing process.

29. Quality focuses on the centre of distribution of care. Normal curve  move the whole curve to the right. Safety focuses on the tail of the distribution…you are trying to truncate the tail.

30. The normal curve

31. Different methods are used to investigate quality versus safety problems. This is another important reason to keep the concepts of quality and safety distinct.

32. Methods….guidelines, standards, patient satisfaction, outcomes Quality: compare characteristics/activities to evidence-based, and agreed upon, guidelines, standards; measure patient satisfaction and monitor and evaluate outcomes

33. Methods…incidents, adverse events, hindsight bias, and sensemaking Incidents/accidents: incidents and accidents in complex organizations are usually signs of trouble deeper within the system; however, a large portion of incidents and adverse events in health care are still attributed to human error…it is critical to understand why people did what they did, rather than judging them for doing what we now know (in retrospect) they should have done. It’s challenging to reconstruct the human contribution to incidents – the problem of hindsight bias. There are specific methods to mitigate the effects of hindsight bias.

34. Conclusions Quality and safety are distinct concepts. Quality is a characteristic of the system…you enhancequality. Safety is a set of activities that actively identifies risks and harms with the goal of preventing incidents and accidents. Good quality is necessary, but not sufficient, to ensure safety. Safety can be best developed on a foundation of quality, but can exist as a system property on it’s own. You don’t have a quality system without safety.

35. Safety management systems actively seek hazards as a core function – surveillance oriented, actively managing culture, monitoring it, and developing policies to encourage safety culture. The quality model can distort efforts at trying to achieve safety – you lose focus on safety if you conflate it with quality Personal communication with Bob Dodd, Qantas