1. 1 © 2007 TMIT Charles Denham Tom Gallagher Lee Taft Jennifer Dingman Gail Nielsen Informed Consent, End of Life Wishes, and Disclosure Safe Practices August 14, 2007

2. 2 © 2007 TMIT NQF Safe Practices for Better Healthcare: A Consensus Report 30 Safe Practices Criteria for Inclusion Specificity Benefit Evidence of Effectiveness Generalization Readiness

3. 3 © 2007 TMIT NQF Safe Practices Maintenance Committee Safe Practice 2006 Update Process SWOT analysis of each practice  Comprehensive literature search  Expert technical advisory support from more than 250 experts  Participation by The Joint Commission, CMS, and AHRQ  Input from hospitals and facility involved in 100,000 Lives Campaign  “Feedback from the Field” - Hospitals that reported publicly through The Leapfrog Group and TMIT National Research Test Bed

4. 4 © 2007 TMIT Harmonization – The Quality Choir

5. 5 © 2007 TMIT The Patient – Our Conductor

6. 6 © 2007 TMIT

7. 7 30 Safe Practices Organized into Functional Chapters  Creating and Sustaining a Culture of Safety (Chapter 2)  Informed Consent, Honoring Patient Wishes, and Disclosure (Chapter 3)  Matching Healthcare Needs with Service Delivery Capacity (Chapter 4)  Information Management and Continuity of Care (Chapter 5)  Medication Management (Chapter 6)  Prevention of Healthcare-Associated Infections (Chapter 7)  Condition- and Site-Specific Practices (Chapter 8)

8. 8 © 2007 TMIT Harmonization and Alignment  Harmonization of practices and specifications with national organization requirements and initiatives -The Joint Commission -CMS -AHRQ -IHI -Leapfrog Refinement  Extensive supporting evidence and references

9. 9 © 2007 TMIT Expansion  Implementation Approaches  New Horizons and Areas for Research  Outcomes, Structure, Process, and Patient-Centered Measures  Setting-specific applicability - Rural Hospitals - Children’s Hospitals - Specialty Hospitals  Relation of each Safe Practice to other relevant Practices

10. 10 © 2007 TMIT 27 Safe Practices required modification  23 Safe Practices included changes deemed material and will require vote 3 Safe Practices embedded into other related practices  Risk of Malnutrition  Use of Pneumatic Tourniquets  Medication Workspaces 3 new proposed Safe Practices  Medication Reconciliation  Direct Caregivers  Disclosure

11. 11 © 2007 TMIT All Rights Reserved Culture SP 1 Information Management & Continuity of Care Medication Management Healthcare-Assoc. Infections Condition- & Site-Specific Practices Consent & Disclosure Culture Workforce Consent & Disclosure 2007 NQF Report

12. 12 © 2006 TMIT Information Management & Continuity of Care Medication Management Healthcare-Associated Infections Condition- & Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp. + VAP Prevention Central V. Cath. BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med. Recon. Std. Med. Labeling & Pkg. High-Alert Meds. Unit-Dose Medications Evidence- Based Ref. Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas., F.B., & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject 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 Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure Consent & Disclosure 2007 NQF Report

13. 13 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital-Associated Infections Condition- & Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp. + VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med. Recon. Std. Med. Labeling & Pkg. High-Alert Meds. Unit-Dose Medications Evidence- Based Ref. Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas, F.B, & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject Nursing Workforce ICU Care Direct Caregivers Work Force CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care CHAPTER 2: Creating and Sustaining a Culture of Patient Safety Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life Sustaining Treatment Disclosure Consent & Disclosure CHAPTER 2: Creating and Sustaining a Culture of Patient Safety Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards 2007 NQF Report

14. 14 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital-Associated Infections Condition- & Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp. + VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med. Recon. Std. Med. Labeling & Pkg. High-Alert Meds Unit-Dose Medications Evidence- Based Ref. Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas., F.B., & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject Nursing Workforce ICU Care Direct Caregivers Work Force CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care CHAPTER 2: Creating and Sustaining a Culture of Patient Safety Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure Consent & Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure 2007 NQF Report

15. 15 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital-Associated Infections Condition- & Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp. + VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med. Recon. Std. Med. Labeling & Pkg High-Alert Meds Unit-Dose Medications Evidence- Based Ref. 2007 NQF Report Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas, F.B, & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject Nursing Workforce ICU Care Direct Caregivers Work Force CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care CHAPTER 2: Creating and Sustaining a Culture of Patient Safety Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life Sustaining Treatment Disclosure Consent & Disclosure CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care

16. 16 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital-Associated Infections Condition- & Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp. + VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med Recon. Std. Med Labeling & Pkg High Alert Meds Unit Dose Medications Evidence- Based Ref. Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas., F.B., & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject 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 Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure Consent & Disclosure CHAPTER 5: Information Management & Continuity of Care Critical Care Information Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Order Read-back Abbreviations 2007 NQF Report

17. 17 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital Acquired Infections Condition- & Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp. + VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med Recon. Std. Med Labeling & Pkg High Alert Meds Unit Dose Medications Evidence- Based Ref. Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas., F.B., & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject 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 Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure Consent & Disclosure CHAPTER 6: Medication Management Pharmacist Role Medication Reconciliation High-Alert Medications Standardized Medication Labeling & Packaging Unit-Dose Medications 2007 NQF Report

18. 18 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital Acquired Infections Condition & Site Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp +VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med Recon. Std. Med Labeling & Pkg High Alert Meds Unit Dose Medications Evidence- Based Ref. Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas., F.B, & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject 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 Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure Consent & Disclosure CHAPTER 7: Healthcare-Associated Infections Prevention of Aspiration and Ventilator- Associated Pneumonia, Hand Hygiene Influenza Prevention Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention 2007 NQF Report

19. 19 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital Acquired Infections Condition & Site Specific Practices Consent & Disclosure Wrong site Sx Prevention Peri-Op MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag Therapy Asp +VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med Recon. Std. Med Labeling & Pkg High Alert Meds Unit Dose Medications Evidence Based Ref. Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas., F.B., & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject 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 Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure Consent & Disclosure CHAPTER 8: Condition- or Site-Specific Practices Evidence-Based Referrals Anticoagulation Therapy DVT/VTE Prevention Pressure Ulcer Prevention Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Contrast Media-Induced Renal Failure Prevention 2007 NQF Report

20. 20 © 2006 TMIT Culture SP 1 Information Management & Continuity of Care Medication Management Hospital-Acquired Infections Condition- & Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Periop. MI Prevention Press. Ulcer Prevention DVT/VTE Prevention Anticoag. Therapy Asp. + VAP Prevention Central V. Cath BSI Prevention Sx Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Central Role Med. Recon. Std. Med. Labeling & Pkg. High-Alert Meds. Unit-Dose Medications Evidence- Based Ref. 2006 Proposed NQF Report Culture CPOE Order Read-back Abbreviations Discharge System Critical Care Info. Labeling Studies Culture Meas., F.B., & Interv. Structures & Systems ID Mitigation Risk & Hazards Team Training & Team Interv. CHAPTER 1: Background  Summary, and Set of Safe Practices CHAPTERS 2-8 : Practices By Subject 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 Leadership Structures & Systems Culture Measurement, Feedback and Interventions Teamwork Training and Team Interventions Identification and Mitigation of Risks and Hazards CHAPTER 5: Information Management & Continuity of Care Critical Care Information Order Read-back Labeling Studies Discharge Systems Safe Adoption of Integrated Clinical Systems including CPOE Abbreviations CHAPTER 6: Medication Management Medication Reconciliation Pharmacist Role Standardized Medication Labeling & Packaging High-Alert Medications Unit-Dose Medications CHAPTER 7: Hospital-Acquired Infections Prevention of Aspiration and Ventilator- Associated Pneumonia Central Venous Catheter-Related Blood Stream Infection Prevention Surgical Site Infection Prevention Hand Hygiene Influenza Prevention CHAPTER 8: Evidence-Based Referrals Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention Perioperative Myocardial Infarct/Ischemia Prevention Pressure Ulcer Prevention DVT/VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Informed Consent & Disclosure Informed Consent Life-Sustaining Treatment Disclosure Consent & Disclosure

21. 21 EXECUTIVE SUMMARY OVERVIEW 2004 Weight 2007 Weight CHAPTER 2: Creating and Sustaining A Culture of Patient Safety Practice Element 1: Leadership Structures and Systems 263 (Prior SP 1)* 300 SME 120 Practice Element 2: Culture Survey Measurement and Feedback 20 Practice Element 3 : Teamwork & Team interventions 40 Practice Element 4: Identification & Mitigation of Risks and Hazards 120 CHAPTER 3: Informed Consent and Disclosure Safe Practice 2: Informed Consent (Prior SP 10) 9 4 Safe Practice 3: Life-Sustaining Treatment (Prior SP 11) 12 4 Safe Practice 4: Disclosure NA 25 CHAPTER 4: Matching Healthcare Needs With Service Delivery Capacity Safe Practice 5: Nursing Workforce (Prior SP 3) 119100 Safe Practice 6: Direct Caregivers NA New 20 Safe Practice 7: ICU Care Leap 2 CHAPTER 5: Facilitating Information Transfer and Clear Communication Safe Practice 8: Critical Care Information ( Prior SP 9) 84 Safe Practice 9: Order Read-Back (Prior SP 6) 36 25 Safe Practice 10: Labeling Studies (Prior SP 13) 16 15 Safe Practice 11: Discharge Systems (Prior SP 8) 17 25 Safe Practice 12: Safe Adoption of CPOE Leap 1 Safe Practice 13 : Abbreviations (Prior SP 7) 17 15 CHAPTER 6: Improving Patient Safety Through Medication Management Safe Practice 14: Medication Reconciliation NA New 35 Safe Practice 15: Pharmacist Role (Prior SP 5) 32 Safe Practice 16: Standardizing Medication Labeling and Packaging (Prior SP 28) 22 20 Safe Practice 17: High-Alert Medications (Prior SP 29) 2120 Safe Practice 18: Unit-Dose Medications (Prior SP 30) 29 25 © 2006 CareLeaders Corp. EXECUTIVE SUMMARY OVERVIEW 2004 Weight 2007 Weight CHAPTER 7: Prevention of Healthcare-Associated Infections Safe Practice 19: Prevention of Aspiration and VAP (Prior SP 19) 2420 Safe Practice 20: CVC BSI Prevention (Prior SP 20) 3330 Safe Practice 21: Surgical Site Prevention (Prior SP 21) 3730 Safe Practice 22: Hand Hygiene (Prior SP 25 ) 3330 Safe Practice 23: Influenza Prevention (Prior SP 26) 1110 Chapter 8: Condition- and Site-Specific Practices Safe Practice 24: Evidence-Based Referrals Leap 3 Safe Practice 25: Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention (Prior SP 14) 3020 Safe Practice 26: Perioperative Myocardial Infarct/Ischemia Prevention (Prior SP 15) 2320 Safe Practice 27 : Pressure Ulcer Prevention (Prior SP 16) 2825 Safe Practice 28 : DVT/VTE Prevention (Prior SP 17) 2725 Safe Practice 29 : Anticoagulation Therapy (Prior SP 18) 3935 Safe Practice 30: Contrast Media-Induced Renal Failure Prevention (Prior SP 2 ) 1210 1000 Points Spread Over 30 Practices – 3 New & 3 Redefined

22. 22 EXECUTIVE SUMMARY OVERVIEW 2004 Weight 2007 Weight CHAPTER 2: Creating and Sustaining A Culture of Patient Safety Practice Element 1: Leadership Structures and Systems 263 (Prior SP 1)* 300 SME 120 Practice Element 2: Culture Survey Measurement and Feedback 20 Practice Element 3 : Teamwork & Team interventions 40 Practice Element 4: Identification & Mitigation of Risks and Hazards 120 CHAPTER 3: Informed Consent and Disclosure Safe Practice 2: Informed Consent (Prior SP 10) 9 4 Safe Practice 3: Life-Sustaining Treatment (Prior SP 11) 12 4 Safe Practice 4: Disclosure NA 25 CHAPTER 4: Matching Healthcare Needs With Service Delivery Capacity Safe Practice 5: Nursing Workforce (Prior SP 3) 119100 Safe Practice 6: Direct Caregivers NA New 20 Safe Practice 7: ICU Care Leap 2 CHAPTER 5: Facilitating Information Transfer and Clear Communication Safe Practice 8: Critical Care Information ( Prior SP 9) 84 Safe Practice 9: Order Read-Back (Prior SP 6) 36 25 Safe Practice 10: Labeling Studies (Prior SP 13) 16 15 Safe Practice 11: Discharge Systems (Prior SP 8) 17 25 Safe Practice 12: Safe Adoption of CPOE Leap 1 Safe Practice 13 : Abbreviations (Prior SP 7) 17 15 CHAPTER 6: Improving Patient Safety Through Medication Management Safe Practice 14: Medication Reconciliation NA New 35 Safe Practice 15: Pharmacist Role (Prior SP 5) 32 Safe Practice 16: Standardizing Medication Labeling and Packaging (Prior SP 28) 22 20 Safe Practice 17: High-Alert Medications (Prior SP 29) 2120 Safe Practice 18: Unit-Dose Medications (Prior SP 30) 29 25 © 2006 CareLeaders Corp. What went up or is new? Culture – 263 to 300 Disclosure – 25 Direct Care Giver - 20 Medication Reconciliation - 35 EXECUTIVE SUMMARY OVERVIEW 2004 Weight 2007 Weight CHAPTER 7: Prevention of Healthcare-Associated Infections Safe Practice 19: Prevention of Aspiration and VAP (Prior SP 19 ) 2420 Safe Practice 20: CVC BSI Prevention (Prior SP 20 ) 3330 Safe Practice 21: Surgical Site Prevention (Prior SP 21 ) 3730 Safe Practice 22: Hand Hygiene (Prior SP 25 ) 3330 Safe Practice 23: Influenza Prevention (Prior SP 26 ) 1110 Chapter 8: Condition- and Site-Specific Practices Safe Practice 24: Evidence-Based Referrals Leap 3 Safe Practice 25: Wrong-Site, Wrong Procedure, Wrong Person Surgery Prevention (Prior SP 14 ) 3020 Safe Practice 26: Perioperative Myocardial Infarct/Ischemia Prevention (Prior SP 15 ) 2320 Safe Practice 27 : Pressure Ulcer Prevention (Prior SP 16 ) 2825 Safe Practice 28 : DVT/VTE Prevention (Prior SP 17) 2725 Safe Practice 29 : Anticoagulation Therapy (Prior SP 18 ) 3935 Safe Practice 30: Contrast Media-Induced Renal Failure Prevention (Prior SP 22 ) 1210

23. 23 © 2006 TMIT 23 SP 2: Informed Consent PRACTICEADDITIONAL SPECIFICATIONS CHECKLIST Informed Consent: Ask each patient or legal surrogate to “teach back,” in his or her own words, key information about proposed treatments or procedures for which he or she is asked to provide informed consent. CRITICAL ELEMENTS: At a minimum, patients should be able to explain, in their everyday words: The diagnosis/health problem for which they need care. The name/type/general nature of the treatment, service, or procedure, including what receiving it will entail. The primary tasks, benefits, and alternatives. This practice includes all the following elements: Use of informed consent forms written at the 5 th grade level or lower, and in the primary language of the patient. Engage the patient, and, as appropriate, the family and other decision makers, in a dialogue about the nature and scope of the procedure covered in the consent form. Provide a qualified medical interpreter or reader to assist patients with limited English proficiency, limited health literacy, and visual or hearing impairments. Convey the risk associated with high-risk elective cardiac procedures and high-risk procedures with the strongest volume-outcomes relationship as defined in Safe Practice 24. Update 11_16_06

24. 24 © 2006 TMIT 24 SP 3: Life-Sustaining Treatment PRACTICEADDITIONAL SPECIFICATIONS CHECKLIST Life-Sustaining Treatment: Ensure that written documentation of the patient’s preferences for life-sustaining treatments is prominently displayed in his or her chart. CRITICAL ELEMENT: Organization policies, consistent with applicable law and regulation, should be in place and address patient preferences for life-sustaining treatment and withholding resuscitation. Update 11_16_06

25. 25 © 2006 TMIT 25 SP 4: Disclosure PRACTICEADDITIONAL SPECIFICATIONS CHECKLIST Disclosure: Following serious unanticipated outcomes, including those that are clearly caused by systems failure, the patient and, as appropriate, family should receive timely and transparent clear communication concerning what is known about the event. CRITICAL ELEMENTS: At a minimum, the types of serious unanticipated outcomes addressed include: Sentinel Events (Joint Commission) Serious Reportable Events (NQF) Any other unanticipated outcomes involving harm requiring substantial additional care (e.g., diagnostic tests/ therapeutic interventions or increased length of stay) or causing loss of limb or function lasting seven days or greater. Organizations must have formal processes for disclosing unanticipated outcomes and for reporting events to those responsible for patient safety, including external organizations, where applicable, and for identifying and mitigating risks and hazards. Governance and administrative leadership should ensure that such information is systematically used for performance improvement by the healthcare organization. Policies and procedures should incorporate continuous quality improvement techniques and provide for annual reviews and updates. Adherence to the practice and participation with the support system should be a requirement of credentialing of caregivers in the organization. Patient communication should include: The “Facts”: An explicit statement about what happened should include an explanation of why the event occurred and its preventability, to the extent it is known, and an explanation of the implications of the unanticipated outcome for the patient’s future health. Empathic communication of the facts regarding the outcome and its preventability based on skill in empathic communication techniques, the development and practice of which is supported in all healthcare organizations. An explicit and empathic expression of regret that the outcome was not as expected (e.g., “I am sorry that this has happened”). Commitment to investigate and prevent future occurrences by collecting the facts regarding the event and providing them to the organization’s patient safety leaders including those in governance positions. Feedback of results of the investigation, including whether or not it resulted from an error or systems failure, provided in sufficient detail to support informed decision-making by the patient. “Timeliness”: The initial conversation with the patient and/or family occurs within 24 hours whenever possible. There must be early and subsequent follow-up conversations, both to maintain the relationship and provide information as it becomes available. Such conversations are typically led by the patient’s responsible licensed independent practitioner. [Disclosure, cont] Update 11_16_06

26. 26 © 2006 TMIT 26 SP 4: Disclosure PRACTICEADDITIONAL SPECIFICATIONS CHECKLIST Disclosure: Following serious unanticipated outcomes, including those that are clearly caused by systems failure, the patient and, as appropriate, family should receive timely and transparent clear communication concerning what is known about the event. CRITICAL ELEMENTS, cont: Patient communication should include: Apology from the patient’s licensed independent practitioner, and/or an administrative leader, if the investigation reveals that the adverse outcome was clearly caused by unambiguous errors or systems failures. Emotional support for patients and their families by trained caregivers. Establishment and maintenance of a disclosure and improvement support system which should provide the following to caregivers and staff: Emotional support for caregivers and administrators involved in such events by trained caregivers in the immediate post-event period and often for weeks afterward. Education and skill building regarding the concepts, tools, and resources that produce optimal results for this practice centered on systems improvement rather than blame, with special emphasis on creating a just culture. 24-hour availability of advisory support to caregivers and staff to facilitate rapid response to serious unanticipated outcomes that includes “just in time” coaching and emotional support. Update 11_16_06

27. 27 Check all boxes that apply. In regard to disclosure of adverse events, our organization is: Aware of the performance improvement opportunity in that …  w ithin the last 12 months prior to submitting this survey, the organization has undertaken an educational initiative to make clinicians and administration aware of the frequency and severity of serious unanticipated events, how these were communicated to patients and families and has identified opportunities for improvement in this area, as documented by meeting minutes and attendance records.  Within the last 12 months, the organization has completed an enterprise-wide evaluation and performance improvement process of serious unanticipated events, completed a literature review to determine best practices, and has submitted a summary report to administration and governance with recommendations for measurable improvement targets for further action. Accountable to the issue of disclosure of adverse events as evidenced by…  our CEO, senior executives, risk management leaders, and quality improvement leaders being directly accountable through documented personal performance reviews or personal compensation incentives.  over the last 12 months prior to submission of this survey, the Patient Safety Officer or an Administrator who oversees organizational patient safety, or leader of risk management regularly reports performance metrics related to disclosure of events and lessons-learned to the CEO and board of trustees and is directly accountable to this area through documented performance reviews or compensation.  for the 12 months following submission of this survey, the organization has established a mechanism to make the Patient Safety Officer or an Administrator who oversees organizational patient safety, or leader of risk management regularly report performance metrics related to disclosure of events and lessons- learned to the CEO and board of trustees; such person or persons will be directly accountable for this area through documented performance reviews or compensation. Invested in our ability to deal with this issue of disclosure of adverse events by…  conducting staff education/knowledge transfer and/or skill development in this content area over the last 12 months, as evidenced by meeting minutes and attendance records.  formally allocating dedicated multidisciplinary human resources to disclosure education and systems, including dedicated staff time and budget allocation over the past 12 months, as evidenced by budget documentation.  establishing a formal disclosure support and performance improvement system to provide the following to caregivers and staff: emotional support for caregivers and administrators involved in such events by trained personnel in the immediate post-event period and often for weeks afterward. education and skill building regarding the concepts, tools, and resources that produce optimal results from this practice, centered on systems improvement rather than blame, with special emphasis on creating a just culture. 24-hour availability of advisory support to caregivers and staff to facilitate rapid response to serious unanticipated outcomes that includes ‘just in time’ coaching and emotional support. Taking action to address this area as evidenced by…  having in place policies and procedures regarding disclosure of systems failures or human errors that, at a minimum, address serious unanticipated outcomes including : a) Sentinel Events;** b) Serious Reportable Events; α or c) any other unanticipated outcomes involving harm requiring substantial additional care (such as diagnostic tests /therapeutic interventions or increased length of stay) or causing loss of limb or function lasting seven days or greater.  having in place formal processes and procedures for disclosing unanticipated outcomes and for reporting events to those responsible for patient safety, including external organizations where applicable and for identifying and mitigating risks and hazards.  governance and administrative leadership to ensure that such information is systematically used for performance improvement by the healthcare organization as well as internal communication policies and procedures that incorporate continuous quality improvement techniques and provide for annual reviews and updates as evidenced by regular documentation.  having completed a formal enterprise-wide performance improvement program (with regular performance measurement and tracking improvement activities having been done within the last 12 months) that addresses all elements of this Safe Practice including Additional Specifications.  patient communication polices which should include, or be characterized by… The “Facts” - an explicit statement about what happened should include an explanation of the implications of the unanticipated outcome for the patient’s future health, an explanation of why the event occurred and information about measures taken for its preventability Empathic communication of the “facts” is a skill that should be developed and practiced in healthcare organizations. An explicit and empathic expression of regret that the outcome was not as expected (e.g., “I am sorry that this has happened.”).  disclosure policies and procedures which include a commitment to investigate and prevent future occurrences by collecting the facts regarding the event and providing them to the organization’s patient safety leaders including those in governance positions.  a mechanism which is in place to assure that feedback of results of the investigations after events, including whether not it resulted from an error or systems failure is provided in sufficient detail to support informed decision-making by the patient.  disclosure polices which explicitly define that the initial conversation with the patient and/or family occurs within 24 hours whenever possible. Further that there must be early and subsequent follow-up conversations, both to maintain the relationship and provide information as it becomes available. LFG Questions: SP#4: Disclosure

28. 28 © 2007 TMIT

29. 29 Disclosing Unanticipated Outcomes to Patients Implementing the NQF Safe Practice Thomas H. Gallagher, MD University of Washington School of Medicine

30. 30 Accelerating Interest in Disclosure State laws re: disclosure, apology Growing experimentation with disclosure approaches –Healthcare organizations –Malpractice insurers New standards-NQF Increased emphasis on transparency in healthcare generally

31. 31 Disclosure Performance Gap Also Increasingly Evident Unanticipated outcomes often not disclosed When disclosure does take place, often falls short of meeting patient expectations Little prospective evidence exits regarding what disclosure strategies are effective Literature regarding disclosure’s impact on outcomes early in its development

32. 32

33. 33 Origins of the Disclosure Safe Practice Existing research base on disclosure –Patients desire disclosure –Healthcare workers endorse disclosure, little consensus re: core content of disclosure –Less disclosed when event unapparent to patient –Specialties approach disclosure differently –Impact of disclosure on outcomes Disclosure as patient-centered care –Risk management implications important, not dominant Critical role of transparency in patient safety

34. 34 Key Features of Disclosure Safe Practice Disclosure as bi-directional process Outlines process for disclosure Creates disclosure support system –Education for healthcare workers –Disclosure coaching –Support for healthcare workers, patients Integrates disclosure into patient safety Application of performance improve tools

35. 35 Scope of Proposed Policy “Serious unanticipated outcomes” –Joint Commission Sentinel Events –NQF Serious Reportable Events –Any other unanticipated outcome involving harm requiring substantial additional care or disability >7 days in duration Disclosure often appropriate for less severe events

36. 36 Content of Disclosure Empathic communication of the facts regarding the outcome and its preventability Expression of regret (all unanticipated outcomes) Commitment to investigate and prevent future occurrences

37. 37 “The Facts” Explicit statement about what happened Explanation of why event occurred and its preventability, to the extent known Explanation of the consequences of the unanticipated outcome for the patient’s future health

38. 38 Additional Content: Feedback of Results Results of investigation relevant to unanticipated outcome are communicated to patient, including whether the unanticipated outcome resulted from an error or system failure, in sufficient detail to support informed decision-making by patient.

39. 39 Apology Expression of regret appropriate for all unanticipated outcomes Apology when unanticipated outcome clearly caused by unambiguous error or system failure

40. 40 Institutional Disclosure Support System Emotional support for patients, families, healthcare workers Disclosure education/skill building Provide disclosure coaching 24/7/365

41. 41 Leading Disclosure Organizations Early, deep involvement of medical staff Tackling challenging disclosure issues –Acceptance of responsibility –Disclosure of events that patients were not aware of Training disclosure coaches Disclosure as team sport Tracking disclosure outcomes

42. 42 Challenges in disclosure education Social desirability bias is very strong –If unaddressed, education becomes disconnected from reality Mixed messages from risk managers Providing opportunities for practice, feedback

43. 43 Summary New Disclosure Safe Practice emphasizes transparency as core institutional value Articulates process, content of disclosure Describes disclosure support system Encourages application of performance improvement tools to disclosure process