3. Advancing Patient Safety: A Snapshot History  Tort Reform Efforts (1975-96)  Willie King/Rolando Sanchez case (1995)  Betsy Lehman Case (1995-96)  104th Congress (“Contract with America”) (1995-96)  Anesthesia Patient Safety Foundation (1985)  Leape’s Error in Medicine article (JAMA 1991)  Ben Kolb case (1995)  First Annenberg conference (1996)  VA implementation efforts & NPSF (1997)  IOM1 Report (1999) -- a new plateau  IOM2 Report (2001) -- milestone or miss (or both)?

4. What is a Safety Culture? How Do We Build it? Problem - No Precedents in Health Care Solution? Look at High Reliability Service Organizations in other fields HRO’s are engineered to deliver consistently Good Outcomes in Complex & Dynamic Environments

5. How Did Other Fields Achieve High Reliability? HRO Key Attributes…  Reporting Cultures  Flexibility in Operation  Perceived to be Just  Engaged in and dedicated to Learning

6. Advancing Patient Safety: Three Fronts of Engagement The Challenges…  Transforming the External Environment Fostering a New Understanding of Accountability  Transforming the Internal Environment Growing Internal Cultures that Honor Safety & Deliver High Reliability Service  More Effectively Managing Knowledge Capturing Safety Information & Converting it to Practical Tools

7. Growing a Safety Culture: Knowledge Sources Health Care Research Systems Analysis, Engineering & Design Cognitive Psychology Human Factors/Ergonomics Sociology & Organizational Behavior Lessons Learned from other Industries Quality Improvement Complexity Theory

8. Growing a Safety Culture: The Stakeholders Consumers The Clinician/Patient/Family Team Health Care Administrators Makers & Purchasers of Medical Products Educators Employers, Payors & Managed Care Orgs Legislators/Regulators/Lawyers Media

9. The Patient Safety Paradox We have… New Technological “Miracles” Pushing Health Care Forward Ability to Treat Ever Sicker Populations

10. The Patient Safety Paradox But we also have… Increased Process Complexity Escalating Change Information Overload Increased Expectations for Perfect Outcomes New Patient Vulnerabilities

11. The Accountability Paradigm The “Old Look” Clinicians are Supposed to be Infallible Bad Things Happen Only when People Make Mistakes People/Organizations that Fail are Bad Blame & Punishment Sufficiently Motivate Carefulness

12. The Accountability Paradigm The “New Look” Risk of Failure is Inherent in Complex Systems Risk is always Emerging Latent Risk is not Foreseeable People are Fallible…No Matter How Hard They Try Not to Be Systems are Fallible Alert, Well-trained Clinicians are Crucial

13. To Err is Human (1999) The IOM Call to Action  Create a National Center for Patient Safety  Establish Mandatory Reporting via State Agencies to Ensure Accountability  Encourage External Voluntary Reporting  Pass Legislation for “Peer Review” Protection of External Reporting Programs  Raise Standards & Expectations for Safety Through the Actions of Oversight Organizations, Purchasers, Professional Groups, etc.  Implement Proven Medication Practices by Creating Safety Systems Inside Health Care Organizations

14. Patient Safety Key Concepts The Buzz Words...

15. Growing a Safety Culture The Buzz Words 1.Patient Safety As a “Core Value” 2. “Human Factors” Engineering 3.“Errors” vs. “Recovery” vs. “Adverse Events” 4.“Near Misses” = “Near Hits” = “Close Calls”

16. Growing Safety Cultures The Buzz Words 5.“Swiss Cheese” Model of Complex System Performance 6.“Latent Failure” 7.“Hindsight Bias” 8.“Blunt End vs. Sharp End”

17. Swiss Cheese Model Modified from Reason, 1991 © 1991, James Reason Triggers DEFENSES Accident Regulatory Narrowness Incomplete Procedures Mixed Messages Production Pressures Responsibility Shifting Inadequate Training Attention Distractions Deferred Maintenance Clumsy Technology LATENT FAILURES Goal Conflicts and Double Binds The World

18. Modified from Richard I. Cook, MD (1997) Hindsight Bias

19. Sharp and Blunt Ends Errors and Expertise Monitored Process Organizations, Institutions, Policies, Procedures, Regulations Resources and Constraints Practitioner Knowledge Focus of Attention Goals Modified from Woods, et al., 1994

20. Sharp and Blunt Ends The Sharp End Consumers Media, Legislators, Regulators, Lawyers, Accreditors, Educators Resources and Constraints Health Care Organizations Administrators Clinicians, Families, Patients Pr. Buyers Modified from Woods, et al., 1994 Employers/Payors & Product Makers

21. Advancing Patient Safety: Legislative Action in 2001? Federal Health Legislation Priorities pre-IOM2 “Safe Harbor” Reporting Protection Nursing Shortage Interventions Patient Bill of Rights Increased Funding for AHRQ Remedies for the Uninsured?

22. Advancing Patient Safety: What Have the States Done? Post-IOM1 Legislation Introduced.. Fifteen states (eleven referencing IOM Report) Forty-five bills Eight enacted -- FL, MA(2), MO, NY, SD, WA(2) Ten pending Three tabled for later consideration

23. Advancing Patient Safety: What Have the States Done? State Legislation Themes... Whistle-blower protection Adequate nurse staffing Increasing info to consumers Establishing government supported patient safety centers Expanded error reporting

24. Advancing Patient Safety: New Regulations and Standards Florida ruling on Medicare access to adverse event info Expanded PRO activity New JCAHO standards Increased oversight/training in ambulatory care Multifaceted AHRQ activities

25. Advancing Patient Safety: Employer/Purchaser Initiatives Leapfrog Group Initiatives Computerized medication/order entry Intensivists in the ICU High volume centers WBGH focus on medication management VA initiatives on bar coding, etc.

26. IOM2: Crossing the Quality Chasm A New Health System for the 21st Century So, Does IOM2 mark a change in direction? Reinforcement of the course set by IOM1? A different call to action? And, who’s listening? Who’s opposing?

27. IOM2: Crossing the Quality Chasm A New Health System for the 21st Century Six Aims -- Health Care should be: Safe - No unintended injuries Effective - Based on evidence Patient-Centered Timely - No harmful delays Efficient - Waste avoided Equitable - No variance in quality

28. IOM2: Crossing the Quality Chasm A New Health System for the 21st Century 13 Recommendations/4 Themes: Vision Redesign of the delivery system Building organizational supports for change Environmental changes

29. IOM2: Crossing the Quality Chasm A New Health System for the 21st Century Vision: Adopt Explicit Goal to Improve Quality Every HCO Pursues the 6 Aims Congress to provide funds for establishing and evaluating progress in achieving 6 Aims

30. IOM2: Crossing the Quality Chasm A New Health System for the 21st Century Delivery System Redesign: Every stakeholder follows same basic rules & works together AHRQ identifies 15 conditions and makes progress in 5 years Congress establishes $1 billion HC Quality Innovation Fund

31. IOM2: Crossing the Quality Chasm A New Health System for the 21st Century Building Organizational Support for change : AHRQ convenes workshops to promote state-of-art change DHHS supports effort to make knowledge more accessible National commitment to infrastructure improvement

32. IOM2: Crossing the Quality Chasm A New Health System for the 21st Century Environmental Changes : Purchasers remove barriers that impede quality improvement AHRQ and HCFA explore options for better alignment Clinician education re-examined Legal & regulatory reform studied

33. Advancing Patient Safety: Is the Media Helping or Hurting? Philadelphia Enquirer Series (Spring 2000) Chicago Tribune Series on Nurses (Summer 2000) Florida Ambulatory Care Stories (Summer/Fall 2000) Minneapolis Children’s Hospitals Challenges “Public Relations” Apologies

34. Growing a Safety Culture in Medicine -- The Road Map Progress through alignment…  Based on Core Values (First Do No Harm)  Focused on Delivery Process Redesign  Supported by state-of-art knowledge management infrastructure  Encouraged by payment incentives  Not discouraged by legal or regulatory threats  Advanced by cooperation among all stakeholders

35. Advancing Patient Safety: A Lesson from Aviation “One reason that an incident reporting system worked in aviation...was that the entire aviation community -- essentially all of the stakeholders, including air passengers -- were involved in the process from the beginning and became advocates for the reporting system (as well as severe, but constructive, critics).” Charles E. Billings, MD, Editorial Arch Pathol Lab Med 1998, 121:214-215