1. How Safe Are We? Frank Federico

2. Safety and Quality Safety as a dimension of quality IOM STEEP – Safe – Timely – Effective – Efficient – Patient-centered

3. What should we measure? Errors Harm resulting from errors Incidents that have been deemed to be preventable

4. What is being measured? Errors – Incident/voluntary reports – Observation Preventable harm – Infections – Pressure ulcers All harm – IHI Global Trigger Tool

5. Accepting the Harm Burden Adverse Event/Harm and Errors – “Error” definition bears upon concept of preventability and human mistake – “Adverse event” describes harm to the patient regardless of error and is often system-based – Relationship between errors and adverse events: Errors Adverse Events Mortality

6. What else? Process measures Culture of the organization Staff injuries

7. Incident Reports Voluntary reports of incidents – Mostly errors – Most by nurses Dependent on – Knowledge that an error was made – The time to report – Ease of reporting – Culture of safety – Expanding the scope of what is reported to include harm

8. What percent of medical errors actually lead to harm ? 3.7% of patients experienced adverse events; 58% due to error (Harvard Medical Practice Study, 1991) 2.99% of reported medication errors (41,296) led to harm (Med Marx 2000 Report; NCC MERP data) 5% of reported medication errors (>11,000) in perioperative settings led to harm US Pharmacopiea 3/5/07

9. Voluntary Reporting “We found that less than 4% of all adverse drug events involving use of rescue drugs were reported.” Schade, Am J Med Qual. 2006 Sep-Oct;21(5):335-41 Studies of medical services suggest that only 1.5% of all adverse events result in an incident report. O'Neil A,. Ann Intern Med 1993;119:370-376)

10. Copyright ©2007 BMJ Publishing Group Ltd. Olsen, S. et al. Qual Saf Health Care 2007;16:40-44 Incidents Detected by Three Methods

11. Hospital Acquired Conditions Infections Pressure Ulcers Falls with Harm Adverse Drug Events What about all other types of harm?

12. Serious Reportable Events Surgical or Invasive Procedure events Product or Device events Patient Protection events Care Management events Environmental events Radiologic events Potential Criminal events http://www.qualityforum.org/Topics/SREs/Serious_Reportable_Events.aspx

13. Safety Culture Surveys Assess the attitudes of staff Determine the strengths and weaknesses of a safety program Strongly influenced by the most recent event Requires significant response rate to be valuable Variation within areas of the organization Variation among different layers of the organization

14. You are the leader of the organization… ….what would you like to know? Do you feel safe? Do you believe that your organization is safe?

16. S+P=O Avedis Donabedian

17. Structure, Process, Outcomes Structures – Hiring system – Learning system – Committees to review events – Competency assessments – Sustainability models

18. Structure, Process, Outcomes Processes – Processes that support evidence-based care – Reliably implemented and followed

19. Structure, Process, Outcomes Outcomes – Reduction in harm – Effective outcomes

20. There is no single measure of safety, but early warning signals can be valuable and should be maintained and heeded. A promise to learn– a commitment to act Improving the Safety of Patients in England National Advisory Group on the Safety of Patients in England

22. Perhaps We Should Be Proactive Reliability of processes Sensitivity to operations – Walkrounds – Patient Safety Officers – Meetings, handovers, rounds – Day-to-day conversations – Patient involvement Briefings and safety huddles

23. Situational Awareness in Healthcare Perception: Each huddle participant to systematically report on patients on their unit who they thought may deteriorate in the near future and label them as ‘watchers’ Comprehension: asking senior nurses and physician leads to coach charge nurses on how to integrate their perceptions into an informal severity of illness assessment Projection: training the clinicians on how to use the information to facilitate prediction and planning for at-risk patients

24. Horsens, Denmark

25. Safety Cases High risk situations must present with evidence of safety before can undertake a hazardous operation A safety case is a ‘documented body of evidence that provides a convincing and valid argument that a system is adequately safe for a given application in a given environment’.* * Bishop P and Bloomfield RE. 1999. A methodology for safety case development. In: Redmill F and Anderson T (eds.) Industrial Perspectives of Safety-Critical Systems: Proceedings of the Sixth Safety-critical Systems Symposium, Feb 1998, Birmingham, UK. Springer; 1998.

26. Summary Safety is a dynamic non-event Measuring safety and measuring harm are not the same Different measures exist – Each has advantages and disadvantages We must learn how safe we have been, how safe we are now, and how safe we expect to be.

27. Questions and Comments