LPCH’s Most Excellent Adventure Transitioning to High Reliability

1. LPCH’s Most Excellent Adventure Transitioning to High Reliability Paul Sharek, MD, MPH Assistant Professor of Pediatrics, Stanford University Medical Director of Quality Management Chief Clinical Patient Safety Officer Vice President of Quality, Safety, and Outcomes Management Lucile Packard Children’s Hospital

2. Opening Remarks • Thank you for the invitation! • Honor to come to Children’s Hospital of Philadelphia! • Worked with Annette Bollig (and others at CHOP) for years, as well as knowing Ron Karen since residency

3. The Basics • Learning objectives • Understand the rationale for the patient safety imperative • Review concepts of reliability science • Translate high reliability constructs into practical improvement strategies • Take home messages • Harm occurs at high frequency in children’s hospitals • Traditional quality improvement strategies will only move us to patient safety mediocrity • Translating high reliability concepts into health care will be challenging, but will move us into ultrasafe care

4. Why should we care about patient safety? • Institute of Medicine report (1999) • Data is flat out disturbing • 44,000-120,000 deaths/yr in US hosp (est) • 7,000 deaths/yr from medication errors in US (est) • Compared to 45,000 deaths in car accidents • Costly (LOS, malpractice) • Lay press/public (credibility) • Joint Commission • Medical systems increasingly complex • Problem ain’t going away

5. Background(Bare with me just a little…)

6. Adverse Medical Event (AE) • Adverse Event (AE) - An injury, large or small, caused by the use (including non-use) of a drug, test, or medical treatment. This may be as harmless as a drug rash or as serious as death. (modified from IHI definition of an adverse drug event or ADE.)

7. Harm vs. Error (IHI) • “Error”: concept of preventability, process-focused • “Adverse event”: harm, outcome focused • Relationship between errors and adverse events Adverse Events Errors

8. Pediatrics: ADE Rates with Trigger Tool Takata, Mason, Taketomo, Logsdon, Sharek. Pediatrics April 2008 960 Pediatric Inpatients; 11.1 ADEs per 100 admissions; 22x more ADEs than incident reports 12% of 95 “neonatal patients” (< 30 days old) had an Adverse Drug Event

9. 74 Adverse Events per 100 admissions 56% of all Adverse Events “Preventable” Adverse Events in the NICU setting are substantially higher than previously described. Many events resulted in permanent harm, and the majority were classified as preventable…

10. Total Patient Count: 734 Total Triggers: 2,816 Total # AEs identified: 1,488 Total Number of Patients with Adverse Events: 455 (62%) 91% of patients with an AE Identified with a Trigger (=416/455) Number of patients with multiple (> 1) Unique AEs: 245 (33%) Average LOS: 7.1 Days Average AEs over all Patients: 2.03/patient Average AEs in patients with adverse events: 3.27 / patient Overall # AEs per 100 pt. Days= 28.6 Average AEs per Trigger (Positive Predictive Value of any given trigger): 0.444 Average Triggers per Patient: 3.84 Mean Time for Chart Reviews: 24.7 minutes (per reviewer) PICU Trigger Tool Trial: Preliminary Results

11. Average Rate Per Exposure of Catastrophes and Associated Deaths Per Activity (“Reliability”)Amalberti, et al. Ann Intern Med.2005;142:756-764

12. Strategies to Address Adverse Events • Practical-Target top offenders • Rational and Logical • I contend that this is like being on call, putting out fires… • Will get you to 10-2 or 10-3 level of reliability • Results not impressive nationally…

13. Are we better off 5 years after IOM???JAMA. 2005 May 18;293:2384-90 “…Although these efforts are affecting safety at the margin, their overall impact is hard to see in national statistics”

14. Strategies to Address Adverse Events • Practical-Target top offenders • Rational and Logical • I contend that this is like being on call, putting out fires… • Will get you to 10-2 or 10-3 level of reliability • Stretch your mind…To really address pt safety, to make a huge impact on patient safety • …shift in philosophy • …paradigm shift • Look to other complex high risk industries who have done this well

15. What do you call an organization/industry that is complex and risky…But very safe? High Reliability Organization

16. Definition: High Reliability (IHI) • Failure free operation over time from the perspective of the patient. • Reliability Index: • Unstable process: Failure in greater than 20% of opportunities • 10-1: 1 or 2 failures out of 10 opportunities • 10-2: 1 failure or less out of 100 opportunities • 10-3: 1 failure or less out of 1,000 opportunities • 10-4: 1 failure or less out of 10,000 opportunities • 10-5: 1 failures or less out of 100,000 opportunities • 10-6: 1 failures or less out of 1,000,000 opportunities

17. Average Rate Per Exposure of Catastrophes and Associated Deaths Per Activity (“Reliability”)Amalberti, et al. Ann Intern Med.2005;142:756-764

18. Reliability Science • Principles used to • Examine complex systems and processes • Calculate overall reliability • Develop mechanisms to compensate for limits of human ability • Adopting these principles-increase likelihood that the system will perform it’s intended functions reliably. In healthcare: • Help providers minimize defects in care • Increase consistency in care • Improve patient outcomes

19. Highly Reliable OrganizationsCharacteristics (Attributes) Karl E. Weick, PhD Organizational Psychologist University of Michigan

20. Attributes of High Reliability Organizations: Weick 1. Preoccupation with failure 2. Reluctance to simplify interpretations 3. Sensitivity to operations 4. Commitment to resilience 5. Deference to expertise Weick, et al. Research in Organizational Behavior. 1999;21:81-123Weick, Managing the Unexpected: Assuring High Performance in an Age of Complexity, Jossey Bass 2001

21. Attributes of High Reliability Organizations: Weick • 1. Preoccupation with failure • Small failures are as important as large failures • Avoid complacency: • Success breeds confidence in a single way of doing things and generates complacency • Ex. “My patient has never had a Potassium overdose, so why should I change?” • Success narrows perceptions • Worry about normalization of unexpected events

22. Attributes of High Reliability Organizations: Weick • 2. Reluctance to simplify interpretations • Closer attention to context leads to more differentiation of worldviews and mindsets • Look for the root cause, not the obvious cause • Ex. Dumb resident wrote a 10-fold overdose • Root Cause: “dumb” resident was up all night, in ED with seizing kid, called for verbal order, …

23. Attributes of High Reliability Organizations: Weick • 2. Reluctance to simplify interpretations • Differentiation (diverse viewpoints) brings a varied picture of potential consequences  better precautions and responses to early warning signs. • Over dependency on insiders leads to simplification • Ex. Inbreeding at LPCH/Stanford leads to “The Packard Way…”

24. Attributes of High Reliability Organizations: Weick • 3. Sensitivity to operations • Attentive to the front line where the real work gets done • Authority moves toward expertise: • Role of RNs • Role of Clinical MDs, PNPs • Role of Parents • Make continuous adjustments that prevent errors from accumulating and enlarging based upon reporting from operations, not the “master plan”

25. Attributes of High Reliability Organizations: Weick • 4. Commitment to resilience • Develop capabilities to detect, contain, and bounce back from those inevitable errors that are part of an indeterminate world • Ex. Trigger tools (and automation) • A focus on intelligent reaction, improvisation • Correct errors before they worsen and cause more serious harm • Ex. “stop the line”

26. Attributes of High Reliability Organizations: Weick • 5. Deference to expertise • Decisions are made on the front line, and authority migrates to the people with the most expertise, regardless of their rank • Avoidance of the structure of deference to the powerful, coercive, or senior

27. Mindfulness: Weick “Together these five processes produce a collective state of mindfulness. To be mindful is to have an enhanced ability to discover and correct errors that could escalate into a crisis.”

28. Rene Amalberti, MD, PhDCognitive Science Department, Bretigny-sur-Orge, FranceAmelberti et al. Ann Intern Med 2005;142:756-764 …the most important difference among industries…lies in their willingness to abandon historical and cultural precedent and beliefs that are linked to performance and autonomy, in a constant drive toward a culture of safety…

29. How do you translate all of this theoretic garbage? A few ideas from Paul…

30. Leadership “Patient first” mantra Organizational clarity Mission statement Goals/incentives aligned Human factors integration Fatigue, staffing ratios, labels Culture “patients first”, collegiality, communication, reporting Simulation Prepare in advance for high risk situations Zero defect philosophy Defects in care not accepted as inevitable Stop the line Responsibility to stop dangerous processes and fix Systems thinking Systems and processes drive outcomes Standardization Checklists, boarding passes, order sets Data driven Data driven and evidenced based decision making Technology: Tools for supporting ideal processes Paul’s Practical Solutions to Move Toward High Reliability in Healthcare

31. Leadership “Patient first” mantra Organizational clarity Mission statement Goals/incentives aligned Human factors integration Fatigue, staffing ratios, labels Culture “patients first”, collegiality, communication, reporting Simulation Prepare in advance for high risk situations Zero defect philosophy Defects in care not accepted as inevitable Stop the line Responsibility to stop dangerous processes and fix Systems thinking Systems and processes drive outcomes Standardization Checklists, boarding passes, order sets Data driven Data driven and evidenced based decision making Technology: Tools for supporting ideal processes Transitioning Toward High Reliability: the LPCH Experience

32. Example 1: Transitioning to High Reliability @ LPCHOperationalizing Simulation

33. How do we do it at LPCH?:What is CAPE (Center for Advanced Pediatric Education)? • a physical space at LPCH equipped to simulate any pediatric or obstetric healthcare environment • real working medical equipment • realistic human patient simulators • AV gear to record and play back all events occurring during scenarios

34. NeoSim, SimTrans Neonatal OB Sim, FetalSim, Sim DR PediSim, Pediatric Office Emergencies Disclosing Unanticipated Consequences, Delivering Bad News, Perinatal Counseling NALS/PALS … CAPE: program development since 1995

35. Patient Safety Oversight CommitteeLPCH Patient Safety Oversight Committee “P-SOC”

36. Taking the plunge… • Membership of P-SOC recommend “operationalizing simulation at LPCH” • Partnership with Risk Management • Self insured • Invest in simulation • Recommendation: “construct a 3-5 year strategic plan to transition from traditional didactic educational model to an active, simulation based model”

37. Moving Closer to High Reliability: The “Circle of Safety” @ LPCH drills @ LPCH care of real patients Senior leadership, Risk Quality/Patient safety dept dedicated time @ CAPE

38. Operationalization: Step 1 1. Multi-disciplinary team training (NICU + OB) in Delivery Room 2. ECMO simulation (initiating/changing circuits) 3. Interpersonal communication in stressful situations

39. Leadership “Patient first” mantra Organizational clarity Mission statement Goals/incentives aligned Human factors integration Fatigue, staffing ratios, labels Culture “patients first”, collegiality, communication, reporting Simulation Prepare in advance for high risk situations Zero defect philosophy Defects in care not accepted as inevitable Stop the line Responsibility to stop dangerous processes and fix Systems thinking Systems and processes drive outcomes Standardization Checklists, boarding passes, order sets Data driven Data driven and evidenced based decision making Technology: Tools for supporting ideal processes Paul’s Practical Solutions to Move Toward High Reliability in Healthcare

40. Example 2: Transitioning to High Reliability @ LPCHRapid Response Team Implementation

41. Prelude: Literature at the Time of Addressing Codes Outside of ICU • 6 to 8 hour period of escalating instability that precedes nearly every cardiopulmonary arrest • Many causative physiological processes prior to an arrest are treatable • Post-cardiac arrest survival • 24 hour survival: 33%*-36%** • Survival to discharge: 24***-27%* • 1 year survival: 15%*, ** *Reis, et al. Pediatrics.2002;109:200-209 **Nadkarni et al. JAMA.2006;295:50-57 ***Young et al. Annals of Emerg Med. 1999;33:195-205

42. Chapter 4 of our tale…“Panic in Palo Alto: The Hero Gets Desperate”

43. New Literature Emerging …Medical Emergency Team coincident with a reduction of cardiac arrest and mortality…

44. Results: Codes Outside of the ICU:Absolute Number

45. Results: Codes Outside of ICU:Rate (per 1000 pt days) P < 0.01 Decrease of 71%

46. Mortality Rate-Housewide 34 kids lives saved in 19 mo! 18% reduction p < 0.01

47. Our Contribution to the Literature

48. Leadership “Patient first” mantra Organizational clarity Mission statement Goals/incentives aligned Human factors integration Fatigue, staffing ratios, labels Culture “patients first”, collegiality, communication, reporting Simulation Prepare in advance for high risk situations Zero defect philosophy Defects in care not accepted as inevitable Stop the line Responsibility to stop dangerous processes and fix Systems thinking Systems and processes drive outcomes Standardization Checklists, boarding passes, order sets Data driven Data driven and evidenced based decision making Technology: Tools for supporting ideal processes Paul’s Practical Solutions to Move Toward High Reliability in Healthcare

49. Example 3: Transitioning to High Reliability at LPCHTransparency

50. Transparency of outcomes: Internal Performance Information Flow Medical Board Governing Board Environment of Care Committee Quality Service and Safety Committee OR Committee Critical Care Committee Patient Safety Committee LPCH Infection Quality Control Committee Code Committee Improvement Committee Patient Safety Oversight Committee Care Improvement Committee Faculty Practice Org Pharmacy and Quality Committee Therapeutics Committee Patient Progression Committee Sanctioned Projects Patient Care QI Committee