1. 1 Welcome to the NQF Safe Practices for Better Healthcare 2009 Update Webinar: Creating Transparency, Openness, and Improved Safety (Safe Practices 5-8) Hosted by NQF and TMIT Attendee dial-in instructions: Toll-free Call-in number (US/Canada): 1-866-764-6260 (direct number, no code needed) To join the online webinar, go to: www.safetyleaders.org Online Access Password: Webinar1 (case-sensitive)

2. 2 Charles Denham, MD Chairman, TMIT; Co-chairman, NQF Safe Practices Consensus Committee; Chairman, Leapfrog Safe Practices Program Safe Practices Webinar October 22, 2009 Welcome and Safe Practice Overview Toll-free Call-in number: 1-866-764-6260

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5. 5 Panelists Peter Angood Charles Denham: Welcome and Safe Practice Overview Timothy McDonald: Looking Forward: Principles Applied Lucian Leape: Looking Back: Lessons Learned Peter Angood: The National Quality Forum Perspective Rebecca Martins: Opportunities for Patient and Family Involvement Rebecca Martins Lucian LeapeTimothy McDonald Toll-free Call-in number: 1-866-764-6260 Charles Denham

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9. 9 Practice Line-Up Changes: From 30 to 34 Practices Culture Practice Elements Broken Up into 4 Practices 2 Practices Discontinued 4 Medication Management Practices Combined into 1 2 Communication Practices Combined into 1 8 New Practices Added CMS Care Settings Defined Patient and Family Involvement Section Added Final Report: Format Structure Preserved Lightly Edited Text of Most Practices New Practices Updated References Corrections and Clarification Care Setting Clarification Using CMS Classification Measures To Be Considered (in formulation) Soft Copy Document Hyperlinks Crosswalk Tables Glossary Changes of 2006 Version to 2009 Update

10. 10 Toll-free Call-in number: 1-866-764-6260

11. 11 Harmonization – The Quality Choir Toll-free Call-in number: 1-866-764-6260

12. 12 Information Management and Continuity of Care Medication Management Healthcare-Associated Infections Condition- & Site-Specific Practices Consent & Disclosure Culture Workforce Consent and Disclosure Toll-free Call-in number: 1-866-764-6260

13. 13 CHAPTER 7: Hospital-Associated Infections Hand Hygiene Influenza Prevention Central Venous Catheter-Related Blood Stream Infection Prevention Surgical-Site Infection Prevention Care of the Ventilated Patient and VAP MDRO Prevention UTI Prevention Information Management and Continuity of Care Medication Management Healthcare-Associated Infections Condition-, Site-, and Risk-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy VAP Prevention Central V. Cath. BSI Prevention Sx-Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Systems Leadership: High-Alert, Std. Labeling/Pkg., and Unit-Dose Med. Recon. Culture CPOE Read-Back & Abbrev. Discharge System Patient Care Info. Labeling Studies Culture Meas., FB., and Interv. Structures and Systems ID and Mitigation Risk and Hazards Team Training and Team Interv. Nursing Workforce ICU Care Direct Caregivers Workforce CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care CHAPTER 2: Creating and Sustaining a Culture of Patient Safety (Separated into Practices]  Leadership Structures and Systems  Culture Measurement, Feedback, and Interventions  Teamwork Training and Team Interventions  Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management and Continuity of Care  Patient Care Information  Order Read-Back and Abbreviations  Labeling Studies  Discharge Systems  Safe Adoption of Integrated Clinical Systems including CPOE CHAPTER 6: Medication Management  Medication Reconciliation  Pharmacist Leadership Role Including: High-Alert Med. and Unit-Dose Standardized Medication Labeling and Packaging CHAPTER 8: Wrong-Site, Wrong-Procedure, Wrong-Person Surgery Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Organ Donation Glycemic Control Falls Prevention Pediatric Imaging Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent and Disclosure Informed Consent Life-Sustaining Treatment Disclosure Care of the Caregiver Consent and Disclosure 2009 NQF Report Care of Caregiver MDRO Prevention UTI Prevention Falls Prevention Organ Donation Glycemic Control New Material Changes No Material Changes Legend: Pediatric Imaging

14. 14 LEADERSHIP STRUCTURES and SYSTEMS Values Systems Structures Behaviors Outcomes Culture Measurement, Feedback, and Intervention Teamwork Training and Skill Building Identification and Mitigation of Risks and Hazards Leadership Structures and Systems Patients and Community NQF 34 Safe Practices

15. 15 Looking Forward: Principles Applied Timothy McDonald, MD, JD Chief Safety and Risk Officer for Health Affairs; Professor, Anesthesiology and Pediatrics, University of Illinois Safe Practices Webinar October 22, 2009 Toll-free Call-in number: 1-866-764-6260

16. 16 #5 Informed Consent #6 Life-Sustaining Treatment #7 Disclosure #8 Care of the Caregiver National Quality Forum Safe Practices Toll-free Call-in number: 1-866-764-6260

17. 17 #5 Informed Consent NQF SP #5 Toll-free Call-in number: 1-866-764-6260

18. 18 Only 24% of consent forms contained the four elements considered essential for informed consent. Designed more to protect institution than inform patient. Toll-free Call-in number: 1-866-764-6260 Background to Current Problem Arch Surg 2000; 135:26-33

19. 19 Average reading comprehension was 6 th grade; Educational materials – 11 th to 14 th grade; Informed consent written materials – written at college-level Toll-free Call-in number: 1-866-764-6260 Background to Current Problem J Fam Pract 1990; 31(5):533-8 The gap between patient reading comprehension and the readability of patient education materials. Davis, Crouch et al.

20. 20 Informed Consent: Safe Practice Statement Ask each patient or legal surrogate to “teach back,” in his or her own words, key information about the proposed treatments or procedures for which he or she is being asked to provide informed consent. NQF SP #5 Toll-free Call-in number: 1-866-764-6260

21. 21 Informed Consent: Additional Specifications - Informed consent documents for use with the patient should be written at or below the 5 th -grade level. - Shared decision-making: the patient and the family should be engaged in a dialogue about the nature and scope of the procedure. - A qualified medical interpreter or reader should be provided to assist patients with limited English proficiency, limited health literacy, and visual or hearing impairments. - The risk that is associated with high-risk elective cardiac procedures and high-risk procedures with the strongest volume-outcomes relationship should be conveyed. NQF SP #5 Toll-free Call-in number: 1-866-764-6260

22. 22 Full disclosure begins with the first visit to the caregiver’s office or with obtaining an informed consent Consider a random selection of patients for follow-up and assess degree of “recall” related to the informed consent process and “teach back” Future with computerized, internet-linked adult learning methodologies to engage patients and their families Informed Consent: Looking Forward Toll-free Call-in number: 1-866-764-6260

23. 23 NQF SP #6 Toll-free Call-in number: 1-866-764-6260 #6 Life-Sustaining Treatment

24. 24 NQF SP #6 Toll-free Call-in number: 1-866-764-6260 Life-Sustaining Treatment: The Problem The provision of unwanted end-of-life care is an adverse event that can be avoided by effective patient/provider collaboration In one study, 48% of patients with advance directives received mechanical ventilation against their wishes Fins JJ, Miller FG, Acres CA, et al. End-of-life decision-making in the hospital: current practice and future prospects. J Pain Symptom Manage 1999 Jan;17(1):6-15.

25. 25 NQF SP #6 Toll-free Call-in number: 1-866-764-6260 Life-Sustaining Treatment: Safe Practice Statement Ensure that written documentation of the patient’s preferences for life-sustaining treatments is prominently displayed in his or her chart. Additional specification: Organization policies, consistent with applicable law and regulation, should be in place that address patient preferences.

26. 26 A Not-Uncommon Ethical Dilemma Toll-free Call-in number: 1-866-764-6260 Elderly patient, with DNR order - GI suite for peg Peg for nutrition and pain management Is alert and conversant In error, patient over-sedated Patient becomes apneic Code called DNR form recognized Caregivers panic

27. 27 Ethical Principles Toll-free Call-in number: 1-866-764-6260 Beneficence Non-maleficence Patient autonomy Truth telling Ethical dilemmas – when principles conflict

28. 28 The Dilemma Toll-free Call-in number: 1-866-764-6260 Beneficence – put the tube in/give reversal Non-maleficence – put the tube in/give reversal Patient autonomy – do not resuscitate! Truth telling - ?

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30. 30 Life-Sustaining Treatment: Looking Forward Toll-free Call-in number: 1-866-764-6260 Should advance in parallel with informed consent Involves shared decision-making Can “force function” with documentation requirements Electronic medical record solutions

31. 31 NQF SP #7 Toll-free Call-in number: 1-866-764-6260 #7 Disclosure

32. 32 NQF SP #7 Toll-free Call-in number: 1-866-764-6260 Disclosure: The Problem We “deny and defend” We “shame and blame” We hide behind a “wall of silence” We fail to learn from our mistakes Patients and their insurers pay for our mistakes

33. 33 NQF SP #7 Toll-free Call-in number: 1-866-764-6260 Disclosure: Safe Practice Statement Following serious unanticipated outcomes, including those that are clearly caused by systems failures, the patient and, as appropriate, the family should receive timely, transparent, and clear communication concerning what is known about the event Disclosure: Additional Specifications - Support system, reporting, communication, apology, performance improvement, remedy

34. 34 Patient Harm? Inappropriate care? Yes No “Near misses” Activation of Crisis Management Team Hard-wiring NQF SP #7 A Comprehensive Approach to Adverse Patient Events Process Improvement Consider “Care for Caregiver” Error Investigation hold bills? Full Disclosure with Rapid Apology and Remedy Patient Communication Consult Service Data Base Unexpected Event reported to Safety/Risk Management

35. 35 Disclosure: Looking Forward Toll-free Call-in number: 1-866-764-6260 Full engagement of stakeholders - Patients and families - Caregivers - Administrators - Malpractice insurers - Health insurers - Legal community - A cultural transformation – the “Trojan horse”

36. 36 #8 Care of the Caregiver NQF SP #8 Toll-free Call-in number: 1-866-764-6260

37. 37 NQF SP #8 Toll-free Call-in number: 1-866-764-6260 Care of Caregiver: The Problem Caregivers are also hurt by medical error Can develop psychological impairment Impairment can lead to future errors Vicious cycle West CP, Huschka MM, Novotny PJ, et al. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study. JAMA 2006 Sep 6;296(9):1071-8.

38. 38 NQF SP #8 Toll-free Call-in number: 1-866-764-6260 Care of the Caregiver: Safe Practice Statement Following serious unintentional harm due to systems failures and/or errors that resulted from human performance failures - the involved caregivers should receive timely and systematic care: treatment that is just, respect, compassion, supportive medical care, and the opportunity to fully participate in event investigation and risk identification and mitigation activities that will prevent future events.

39. 39 Patient Harm? Inappropriate care? Yes No “Near misses” Activation of Crisis Management Team Hard-wiring NQF SP #8 A Comprehensive Approach to Adverse Patient Events Process Improvement Consider “Care for Caregiver” Error Investigation hold bills? Full Disclosure with Rapid Apology and Remedy Patient Communication Consult Service Data Base Unexpected Event reported to Safety/Risk Management

40. 40 Care of Caregiver: Looking Forward Toll-free Call-in number: 1-866-764-6260 Rapid response teams for patients, caregivers Psychological support for all Ongoing support and assessment Implementation of “just culture” concepts

41. 41 Looking Back: Lessons Learned Lucian Leape, MD Chair, Lucian Leape Institute; Adjunct Professor of Health Policy, Harvard School of Public Health Safe Practices Webinar October 22, 2009 Toll-free Call-in number: 1-866-764-6260

42. 42 1. Know what happened 2. Receive an apology 3. Be assured the hospital is doing all it can to prevent a recurrence Making Disclosure Happen: What Do Patients Want? Toll-free Call-in number: 1-866-764-6260

43. 43 1. It is very difficult for anyone to apologize - No one likes to admit guilt and apologize - It’s even harder in the medical encounter 2. Medical injury is very different from the other reasons people apologize 3. Many of us lack the skills for delivering bad news Why Are Disclosure and Apology So Difficult? Toll-free Call-in number: 1-866-764-6260

44. 44 4.It is very difficult for doctors to accept failure 5.The sense of shame and guilt can be overpowering 6.Fear of consequences: - Loss of patient’s trust, respect - Loss of colleagues’ respect - Risk of being sued Toll-free Call-in number: 1-866-764-6260 Why Are Disclosure and Apology So Difficult?

45. 45 Our fear of being sued overpowers our sense of responsibility to the patient and our recognition of the patient’s need for full, open, honest disclosure. We Have Serious Hang-ups About Being Open and Apologizing Toll-free Call-in number: 1-866-764-6260

46. 46 Framing apology as a liability issue sabotages the needs of both the patient and the doctor for healing Withholding information and not apologizing for our mistakes makes a difficult situation infinitely worse Bad Advice from Lawyers Toll-free Call-in number: 1-866-764-6260

47. 47 Myth: If you tell the patient what happened or apologize, he is more likely to sue, and it will be used against you in court Reality: Patients are much less likely to sue if you level with them - Plaintiff lawyer experience - Evidence: VA, U. Mich, COPIC The Malpractice Myth Toll-free Call-in number: 1-866-764-6260

48. 48 1999:136 2003: 81 2000: 122 2004: 91 2001: 121 2005: 85 2002: 88 2006: 61 2008: 14 The Malpractice Myth Toll-free Call-in number: 1-866-764-6260

49. 49 University of Michigan Toll-free Call-in number: 1-866-764-6260

50. 50 The Experience with Transparency Toll-free Call-in number: 1-866-764-6260 University of Michigan Hospitals University of Illinois Medical Center at Chicago Kaiser Permanente (CA) Children’s Hospital & Clinics of Minnesota Johns Hopkins Hospital Catholic Healthcare West Physicians Reimbursement Fund (CA) COPIC (CO)

51. 51 He/She also has an emotional wound - Shame, guilt, and fear can be profound We ignore it, give no support We ask him/her to lie The Doctor is the Second Victim Toll-free Call-in number: 1-866-764-6260

52. 52 An Effective Disclosure Program Toll-free Call-in number: 1-866-764-6260 Board and leadership establish a clear policy Training and support Hospital shares responsibility with doctor Prospective compensation for patient’s expenses Patient support – continuing after discharge

53. 53 The Power of Apology Toll-free Call-in number: 1-866-764-6260 For the patient: It begins the healing process Helps to restore the patient’s dignity and self-respect Begins to restore trust Provides assurance that patient is not at fault Shows that you also suffer

54. 54 Toll-free Call-in number: 1-866-764-6260 The Power of Apology For the doctor: Gives expression to the normal empathic concern we have for the harmed patient Begins to relieve guilt and shame Begins to restore the emotional balance Makes forgiveness possible (but not inevitable)

55. 55 www.macoalition.org

56. 56 The National Quality Forum Perspective Peter B. Angood, MD, FRCS(C), FACS, FCCM Senior Advisor, Patient Safety, National Quality Forum Safe Practices Webinar October 22, 2009 Toll-free Call-in number: 1-866-764-6260

57. 57 Top 5 Issues for CEOs Toll-free Call-in number: 1-866-764-6260 1.Safety and Quality 2.Revenue Enhancement 3.Capital Enhancement 4.Technology Investment 5.Medical Staff Development Cejka & Solucient

58. 58 Barriers to Patient Safety Toll-free Call-in number: 1-866-764-6260 29 Overall; Top 7 are: - Competing priorities for scarce resources - Lack of resources - Availability & cost of PS technology - Resistance to change - Culture of blame - Lack of senior leadership understanding and involvement with PS - Negative culture that permits cover-ups Atkins & Cole 2005 (Delphi - Texas A&M)

59. 59 Today, one in four Americans is a member of a racial or ethnic minority group; by 2070, it will be one in two. A much higher percentage of Americans under the age of 50 are members of minority groups than those over 50 - there may be important cultural differences between older patients and the people who provide services to them. In the future, the population over 65—the heaviest users of healthcare—will be far more diverse, and the majority of them will be women. Of the “oldest old” (those over 85) — 70%will be women. Changing USA Demographics Toll-free Call-in number: 1-866-764-6260

60. 60 More than one in ten Americans were born in another country and are more likely to come from non-English- speaking cultures. Literacy is not a given; 10 million Americans cannot read in any language, and 40 million cannot read English at a 5th-grade level. AMA estimates that 90 million Americans do not understand what they are told by their providers. Changing USA Demographics Toll-free Call-in number: 1-866-764-6260

61. 61 “The communications gap between the abilities of ordinary citizens, and especially those with low health literacy or low English proficiency, and the skills required to comprehend everyday healthcare information must be narrowed.” Communication is the Cornerstone of Patient Safety Toll-free Call-in number: 1-866-764-6260

62. 62 Make effective communications an organizational priority to protect the safety of patients Address patients’ communication needs across the continuum of care Pursue policy changes that promote improved practitioner-patient communications To That End: Toll-free Call-in number: 1-866-764-6260

63. 63 © 1997, Russell Consulting, Inc. Used with permission. Cultural (values, beliefs, and norms) Behavioral (what groups and individuals do) Infrastructure (management systems, measurements, and rewards) Physical (processes, tools, and structures) Most difficult Long term Ability to influence or change Durability of the change Easiest Short term The Four Levels of Every Organization

64. 64 The Nature of Change* * Leading Change Training, Jeff and Linda Russell, 2003 Change is the disruption of the status quo A break in the continuities that represent the steady stream of our lives. Change and the forces of change introduce disruptions Diminishes one’s personal and organizational capacities to envision himself beyond today and into the future. The path of change is unpredictable… Where’s this coming from? How will it affect me? What’s going to happen? When will this end?

65. 65 * Leading Change Training, Jeff and Linda Russell, 2003 What are Your Tasks… as a Change Leader?

66. 66 Diffusion of Innovations Definition: The process by which an innovation is communicated through certain channels over time among members of a social system. It is a special type of communication concerned with the spread of messages that are perceived as new ideas. Five attributes: - Relative advantage - Compatibility - Complexity - Trialability - Observability E. Rogers

67. 67 Opportunities for Patient and Family Involvement Rebecca Martins Founder, www.voice4patients.comwww.voice4patients.com Safe Practices Webinar October 22, 2009

68. 68 Toll-free Call-in number: 1-866-764-6260

69. 69 Toll-free Call-in number: 1-866-764-6260

70. 70 Upcoming Safe Practices Webinars  November 19 – Healthier Communication and Safe Information Management (Safe Practices 12-16)  December 17 – Optimizing a Workforce for Optimal Safe Care (Safe Practices 9-11)