Indiana Patient Safety Center

1. Indiana Patient Safety Center Betsy Lee, RN, MSPH April 11, 2007

2. Session Topics • Update on state and national events • Indiana’s first annual serious event report • Proposed state legislation • National legislation and reporting requirements • Indiana Patient Safety Center • Needs assessment • Statewide culture survey • Educational activities and inter-professional course • IHI 5 Million Lives Campaign • Regional coalitions • Leadership for safety

3. HeightenedPublic Awareness: 1999 IOM Report • Faulty systems, processes, and conditions that leadto mistakes • Not bad people,bad systems • Loss of trust in thehealth care system • Culture that impedes open discussion of errors and steps to prevent them

4. National Organizations involved in Patient Safety • JCAHO: Joint Commission on Accreditation of Healthcare Organizations • CMS: Centers for Medicare & Medicaid Services • IHI: Institute for Healthcare Improvement • AHRQ: Agency for Healthcare Research &Quality • The Leapfrog Group

5. Adverse Event Public Reporting • At least 24 other states report adverse events, in aggregate • Minnesota has released three annual hospital specific reports related to NQF events • Indiana is the second to report hospital-specific results related to NQF events • Pennsylvania has recently released statewide data from their database – not hospital-specific

6. Indiana’s Rule • Governor Daniels: Executive Order 05-10 • Based on National Quality Forum’s 27 Serious Reportable Adverse Events • Effective January 1, 2006 • Applies to hospitals, ambulatory surgery centers, birthing centers and abortion clinics • Linked to ongoing regulatory requirement for hospital quality assessment and improvement • Electronic data reports to ISDH required

7. Indiana’s Rule • 6 months to determine if event is reportable • 15 days to report • Name of hospital, type of event, quarter of year • March 2007 - Interim 2006 tally of highly preventable serious adverse events in hospitals, surgery centers, birthing centers, and abortion clinics • Final report will be on web site in July 2007

8. Why? • To stimulate patient safety initiatives • To promote shared learning • To help consumers think about kinds of questions to ask doctors, nurses, etc. • To enlist patients and families as partners in preventing harm Not to be tool for punishing providers

9. Context • Over 600,000 hospital surgeries • Over 700,000 admissions • Nearly 3 million ER visits • About 14 million outpatient visits

10. Indiana’s First Annual Report: Results • 287 total facilities impacted (includes 139 hospitals and 137 ASCs) • 77 reports • 72 from hospitals • 5 from ambulatory surgery centers • Each facility has a page on-line with numbers of each type of event reported (zeros included) • 36 hospitals and 5 ASCs reported at least one event

11. Most frequently reported events • Stage 3 or 4 pressure ulcers (23 or 29% of reports) • Retained foreign object (21 - 27.3%) • Wrong site surgery (9 - 11.7%) • Death or serious disability from medication error (6 - 7.8%)

12. Comparison to Minnesota

13. Right questions • What led to the event? • What is the hospital doing to prevent future events?

14. How do errors happen? • Most errors result from system failures or processes inadequately designed to prevent highly educated, dedicated workforce from inadvertently causing harm.

15. James Reason: Swiss Cheese Model of Human Error BMJ 2000;320:768-770

16. Human Error (Reason) • Active failures: unsafe acts committed by people who are in direct contact with patients – slips, lapses, fumbles, mistakes, procedural violations • Latent conditions: inevitable “resident pathogens” within the system. They arise from decisions made by designers, builders, procedure writers, and top management – system characteristics that translate into error provoking conditions OR holes or weaknesses in the system

17. Human Error (Reason) • “ Blunt end” – Management and organizational infrastructure • “Sharp end” – direct caregivers

18. Complex Adaptive Systems • Characteristic of embedded CAS’s • Importance of diversity • Nonlinear – possibility for a small change to have a large impact • Distributed control vs. centralized control – “self organization” • Importance of structure, process, and patterns • Focus on relationships From: Edgeware: Lessons From Complexity Science for Health Care Leaders, by Brenda Zimmerman, Curt Lindberg, and Paul Plsek, 1998, Dallas, TX: VHA Inc.

19. Work in Complex Adaptive Systems (Woods, et. al, 1994) Management and Development Organizations Goals Conflicts Obstacles Hazards Data Behaviors Resources and Constraints Adapt Anticipate Accommodate React Cope Coordinating Knowledge Mindset Goals Existing and escalating situations

20. Report, Learn, and Fix Blaming or punishing a caregiver will not fix a system problem, and another patient could be harmed by the same high-risk process.

21. Promoting Just Cultures • “Just cultures” recognize that individual providers should not be held accountable for systems for which they have no control • Contrasts with “blame-free cultures” in that “just cultures” do not tolerate conscious disregard of clear risks to patients or gross negligence • “Just cultures” recognize that competent professionals make mistakes and acknowledge that even competent providers will develop unhealthy norms (shortcuts, work arounds) within their complex systems

22. Adverse Event Report: Conversation with Community • Chance for regional coalitions to emphasize how they are working together to prevent harm • Opportunity to inform patients and families about what they can do to prevent harm (e.g. medication lists, asking questions of caregivers, hand washing, etc.)

23. Key messages One patient harmed is one too many. We regret that any patient has suffered while in our care.

24. Key messages Our staff strives to provide a safe care environment. We are not only committed to learning why a serious event happened and how we can prevent its recurrence; we are working to build safe and reliable systems that reduce the chance for harm.

25. Apology and Disclosure • Massachusetts Coalition for the Prevention of Medical Errors and the Harvard hospitals • When Things Go Wrong: • http://www.macoalition.org/documents/respondingToAdverseEvents.pdf

26. What To Do If An Event Occurs…. • Acknowledge the event: tell the patient and family what happened – leave the “how” and “why” for later • Take responsibility: e.g. “Our systems broke down. We’re going to find out what happened and do everything we can to see that it doesn’t happen again.” • Apologize – primary caregiver should express regret http://www.macoalition.org/documents/respondingToAdverseEvents.pdf

27. What To Do If An Event Occurs….(cont.) • Explain what will be done to prevent future events - focus on efforts to build safe and reliable systems that reduce the chance for harm. • Support the caregiver(s) – they are victims, too. • Provide a contact name and number for patients and families to call http://www.macoalition.org/documents/respondingToAdverseEvents.pdf

28. Leapfrog Patient Safety Emphasis • Leapfrog survey incorporates NQF Safe Practices • Expanding list of Indiana hospitals on survey target list • Policy related to NQF “never events” • Apology • Reporting to state, JCAHO, PSO • Root cause analysis • Waiver of charges for costs associated with event (CMS considering similar actions)

29. National Patient Safety and Quality Improvement Act of 2005 • Enacted in summer 2005 • Creates a system for: • Analyzing quality and safety issues • Improving the quality and safety of health care services • Secretary of HHS will develop a process to certify PSOs & create a national network of patient safety information

30. PSO Data Exchange Model Confidential and Privileged Quality & Safety Issues, Questions and Data Patient Safety Organization Providers Analysis of Data and Guidance Concerning Quality & Safety Issues

31. Indiana Patient Safety CenterPartners • Indiana Hospital&Health Association • Indiana University School of Medicine, Center for Health Services and Outcomes Research • Purdue University Regenstrief Center for Healthcare Engineering • Indiana State Medical Association • Health Care Excel

32. Indiana Patient Safety Center Mission: To facilitate the development of safe and reliable health care systems that prevent harm to patients.

33. Functions of the Indiana Patient Safety Center Inform policy decisions Disseminate best practices Educate/ collaborate on clinical topics Foster just cultures & learning climates Use data to identify systems issues Conduct research to study impact Integrate safety into curriculum

34. IPSC Key Start-Up Activities: Fall 2006-Spring 2007 • Needs Assessment survey – August 2006 • Safety Culture survey • Educational session: • Mandatory serious event reporting – October 2006 • Campaign Launch meeting – January 16, 2007 • IHHA Leadership Conference – May 31-June 1 (Allan Frankel and Michael Leonard – Leadership, Culture, and Team Behaviors)

35. IHHA Member Needs assessment Chief Executive Officers NEEDS ASSESSMENT Patient Safety Reps Key Physicians Chief Nursing Officers

36. Needs Assessment Summary • Conducted by the Indiana Patient Safety Center on-line in August 2006 using Survey Monkey application • Analyzed by the Indiana University School of Medicine Center for Health Services and Outcomes Research

37. Needs Assessment Response • 302 responses from 135 of 167 IHHA member hospitals • 72 Chief Executive Officers • 53 Chief Medical Officers • 80 Chief Nursing Executives • 97 Patient Safety Officers or reps

38. Key Findings • High level of CEO interest in submitting voluntary reports of adverse events and near misses to the Indiana Patient Safety Center if it becomes a federally certified Patient Safety Organization • Strong support for conducting statewide employee safety survey using a common methodology

39. Top Clinical Education Needs • Medication error prevention • Infection prevention • Rapid response to patient decline • Falls prevention • Operating room safety

40. Top System Support Needs • Engaging front line staff in safety improvements • Communicating evidence-based safety strategies • Leadership strategies to create a culture of safety • Spreading safety changes

41. Statewide Safety culture survey • Survey instrument (AHRQ) • Web-based front-end to measure employee/physician perception of the culture of safety • Currently conducting survey administrator training through April • Recommending that Indiana hospitals conduct culture survey to establish baseline by the end of May 2007

42. IPSC Educational Activities – Determined by Needs Assessment • Multidisciplinary education on communication, complex systems, and safety culture • Tools training (e.g. Improvement Methods, Root Cause Analysis, “lean” techniques, and FMEA) • Mandatory Reporting of Serious Adverse Events (key strategies to reduce harm and strategies for responding to public reporting) • Clinical safety topics • Inter-professional safety class pilot (IUPUI) • Patient Safety Institute (planned for Fall ’07)

43. Inter-professional course • 27 students (CNS, MHA, MPH, Med school, patient safety officers) • Topics: • Complex adaptive systems • Reliability and HROs • Tools and methods • Communication tools • Reducing harm in high risk areas • Spread of evidence-based practices

44. IPSC Community Building • Create linkages to and alignment with key stakeholders • Connect with regional workgroups and coalitions to foster collaborative efforts (e.g. Indianapolis Coalition for Patient Safety) • Partner with colleges and universities to integrate safety principles into curriculum and provide technical assistance to regions • Website – www.indianapatientsafety.org

45. IPSC Data Collection & Analysis • Conduct and analyze statewide safety culture/climate surveys • Evaluate voluntary reporting system for adverse events and close calls • Identify & disseminate lessons & best practices across settings and conditions/problems • Analyze clinical and process improvement interventions to improve patient safety • Distribute written alerts and advisories

46. IPSC PSO Planning • Awaiting regulations from the federal Agency for Healthcare Research and Quality (AHRQ) describing how PSOs will be certified • Regulations will guide new corporate structure and reporting specifications

47. Emerging State Safety Network • Goal to link to Purdue RCHE Healthcare TAP faculty and clinical faculty to new regional coalitions for technical assistance, research support, and education • Building lists of interested parties • Encouraging regional safety coalitions • Eager to link nurses into the IPSC to represent front line staff, leaders and educators

48. Selected Regional Coalition Activities • Standardized colors for arm bands • Standardized correct site surgery policies • Standardized unsafe abbreviations lists • Collaboration around IHI Campaign interventions • Regular meetings of clinical experts and leaders

49. Indiana Campaign Statistics (as of 03/22/07) • 128 of 162 total Indiana hospitals enrolled (79%) • 116 of 125 short term acute hospitals enrolled (93%)

50. New IHI Campaign – Protecting 5 Million Lives from Harm • Reduce surgical complications • Prevent harm from high alert medications • Prevent methicillin resistant staph. aureus (MRSA) • Reduce readmissions from congestive heart failure • Prevent pressure ulcers • Get Boards on board • Plus six interventions from 100K Lives