Informed Consent, End of Life Wishes, and
Disclosure Safe Practices
Charles Denham
Tom Gallagher
Lee Taft
Jennifer Dingman
Gail Nielsen
August 14, 2007
© 2007 TMIT
1
NQF Safe Practices for Better Healthcare:
A Consensus Report
• 30 Safe Practices
Criteria for Inclusion
• Specificity
• Benefit
• Evidence of
Effectiveness
• Generalization
• Readiness
© 2007 TMIT
2
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
© 2007 TMIT
3
Harmonization – The Quality Choir
© 2007 TMIT
4
The Patient – Our Conductor
© 2007 TMIT
5
© 2007 TMIT
6
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)
© 2007 TMIT
7
• 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
© 2007 TMIT
8
• 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
© 2007 TMIT
9
• 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
© 2007 TMIT
10
Culture SP 1
Culture
2007 NQF Report
Consent & Disclosure
Consent & Disclosure
Workforce
Information Management &
Continuity of Care
Medication Management
Healthcare-Assoc. Infections
Condition- &
Site-Specific Practices
© 2007 TMIT All Rights Reserved
11
Culture
2007 NQF Report
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
ID Mitigation
Risk & Hazards
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Labeling
Studies
Order
Read-back
Discharge
System
CPOE
Abbreviations
Medication Management
Med. Recon.
Pharmacist
Central Role
High-Alert
Meds.
Std. Med.
Labeling & Pkg.
Unit-Dose
Medications
Healthcare-Associated Infections
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath.
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
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
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
12
DVT/VTE
Prevention
Contrast
Media Use
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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 VentilatorAssociated 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
Culture
2007Culture
NQFSPReport
1
Structures
& Systems
Team Training
& Team Interv.
Culture Meas,
F.B, & Interv.
ID Mitigation
Risk & Hazards
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 2: Creating and Sustaining a Culture of Patient Safety
• Leadership StructuresConsent
& Systems
Disclosure
Consent &&Disclosure
• Culture Measurement, Feedback and Interventions
• Teamwork Training and Team Interventions
• Identification and Mitigation
of Risks and Hazards
Work Force
CHAPTERS 2-8 :
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Informed
Consent
Life Sustaining
Treatment
Disclosure
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Labeling
Studies
Order
Read-back
Discharge
System
CPOE
Abbreviations
Medication Management
Med. Recon.
Pharmacist
Central Role
High-Alert
Meds.
Std. Med.
Labeling & Pkg.
Unit-Dose
Medications
Hospital-Associated Infections
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
13
DVT/VTE
Prevention
Contrast
Media Use
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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 VentilatorAssociated 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
Culture
2007Culture
NQFSPReport
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
ID Mitigation
Risk & Hazards
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
CHAPTERS 2-8 :
Practices By Subject
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
Life Sustaining
Treatment
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
Work Force
• Life-Sustaining Treatment
• Disclosure
Nursing
Workforce
Disclosure
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Labeling
Studies
Order
Read-back
Discharge
System
CPOE
Abbreviations
Medication Management
Med. Recon.
Pharmacist
Central Role
High-Alert
Meds
Std. Med.
Labeling & Pkg.
Unit-Dose
Medications
Hospital-Associated Infections
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
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
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
14
DVT/VTE
Prevention
Contrast
Media Use
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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 VentilatorAssociated 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
Culture
2007Culture
NQFSPReport
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
ID Mitigation
Risk & Hazards
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
CHAPTERS 2-8 :
Practices By Subject
Team Training
& Team Interv.
Culture Meas,
F.B, & Interv.
Life Sustaining
Treatment
Disclosure
Work Force
CHAPTER 4: Workforce
• Nursing Workforce
• Direct
Caregivers
Information
Management & Continuity of Care
• ICU Care
Nursing
Workforce
Direct
Caregivers
Critical
Care Info.
Labeling
Studies
ICU Care
Order
Read-back
Discharge
System
CPOE
Abbreviations
Medication Management
Med. Recon.
Pharmacist
Central Role
High-Alert
Meds
Std. Med.
Labeling & Pkg
Unit-Dose
Medications
Hospital-Associated Infections
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
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
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
15
DVT/VTE
Prevention
Contrast
Media Use
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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 VentilatorAssociated 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
Culture
2007Culture
NQFSPReport
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
ID Mitigation
Risk & Hazards
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
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
CHAPTER 5: Information Management & Continuity of Care
• Critical Care Information
Information Management & Continuity of Care
• Labeling Studies
• Discharge Systems
• Safe Adoption of Integrated Clinical Systems including
Medication Management
CPOE
.
• Order Read-back
• Abbreviations
Critical
Care Info.
Labeling
Studies
ICU Care
Order
Read-back
Discharge
System
CPOE
Abbreviations
Med Recon
Pharmacist
Central Role
High Alert
Meds
Std. Med
Labeling & Pkg
Unit Dose
Medications
Hospital-Associated Infections
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
16
DVT/VTE
Prevention
Contrast
Media Use
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 VentilatorAssociated 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
Culture
2007Culture
NQFSPReport
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
ID Mitigation
Risk & Hazards
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
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Order
Read-back
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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
• Pharmacist Role
Medication Management
• Medication Reconciliation
.
• High-Alert Medications
• Standardized Medication Labeling & Packaging
• Unit-Dose Medications
Hospital Acquired Infections
Labeling
Studies
Discharge
System
CPOE
Abbreviations
Med Recon
Pharmacist
Central Role
High Alert
Meds
Std. Med
Labeling & Pkg
Unit Dose
Medications
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
17
DVT/VTE
Prevention
Contrast
Media Use
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 VentilatorAssociated 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
Culture
2007Culture
NQFSPReport
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B, & Interv.
ID Mitigation
Risk & Hazards
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
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Labeling
Studies
Order
Read-back
Discharge
System
CPOE
Abbreviations
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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 7: Healthcare-Associated
Infections
Medication Management
• Prevention of Aspiration and
Ventilator.
Associated Pneumonia,
• Hand Hygiene
Hospital Acquired Infections
• Influenza Prevention
• Central Venous Catheter-Related Blood Stream
Infection Prevention
• Surgical Site Infection
Prevention
Condition & Site Specific Practices
Med Recon
Pharmacist
Central Role
High Alert
Meds
Std. Med
Labeling & Pkg
Unit Dose
Medications
Asp +VAP
Prevention
Hand Hygiene
Influenza
Prevention
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
Central V. Cath
BSI Prevention
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
18
Sx Site Inf.
Prevention
DVT/VTE
Prevention
Contrast
Media Use
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 VentilatorAssociated 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
Culture
2007Culture
NQFSPReport
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
ID Mitigation
Risk & Hazards
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
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Labeling
Studies
Order
Read-back
Discharge
System
CPOE
Abbreviations
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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 8: ConditionSite-Specific Practices
Medicationor
Management
• Evidence-Based Referrals .
• Anticoagulation Therapy
• DVT/VTE Prevention
Hospital Acquired Infections
• Pressure Ulcer Prevention
• Wrong-Site, Wrong Procedure, Wrong Person
Surgery Prevention
• Perioperative Condition
Myocardial
Infarct/Ischemia
& Site Specific
Practices
Prevention
• Contrast Media-Induced Renal Failure Prevention
Med Recon
Pharmacist
Central Role
High Alert
Meds
Std. Med
Labeling & Pkg
Unit Dose
Medications
Asp +VAP
Prevention
Hand Hygiene
Influenza
Prevention
Evidence
Based Ref.
Press. Ulcer
Prevention
© 2006 TMIT
Central V. Cath
BSI Prevention
Anticoag
Therapy
Wrong site
Sx Prevention
Peri-Op MI
Prevention
19
Sx Site Inf.
Prevention
DVT/VTE
Prevention
Contrast
Media Use
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 VentilatorAssociated 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
Culture
2006 Proposed
Report
Culture SPNQF
1
CHAPTER 1: Background
 Summary, and Set of
Safe Practices
Structures
& Systems
Team Training
& Team Interv.
Culture Meas.,
F.B., & Interv.
ID Mitigation
Risk & Hazards
Consent&&Disclosure
Disclosure
Consent
Informed
Consent
Life-Sustaining
Treatment
Disclosure
Workforce
CHAPTERS 2-8 :
Practices By Subject
Nursing
Workforce
Direct
Caregivers
ICU Care
Information Management & Continuity of Care
Critical
Care Info.
Labeling
Studies
Order
Read-back
Discharge
System
CPOE
Abbreviations
Medication Management
Med. Recon.
Pharmacist
Central Role
High-Alert
Meds.
Std. Med.
Labeling & Pkg.
Unit-Dose
Medications
Hospital-Acquired Infections
Asp. + VAP
Prevention
Hand Hygiene
Influenza
Prevention
Central V. Cath
BSI Prevention
Sx Site Inf.
Prevention
Condition- & Site-Specific Practices
EvidenceBased Ref.
Press. Ulcer
Prevention
© 2006 TMIT
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
Anticoag.
Therapy
Wrong-site
Sx Prevention
Periop. MI
Prevention
20
DVT/VTE
Prevention
Contrast
Media Use
CHAPTER 3: Informed Consent & Disclosure
• Informed Consent
• Life-Sustaining Treatment
• Disclosure
CHAPTER 4: Workforce
• Nursing Workforce
• Direct Caregivers
• ICU Care
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 VentilatorAssociated 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
Weight
2007
Weight
263
120
2004
EXECUTIVE SUMMARY OVERVIEW
CHAPTER 2: Creating and Sustaining A Culture of Patient Safety
Practice Element 1: Leadership Structures and Systems
Practice Element 2: Culture Survey Measurement and
(Prior
SP 1)*
Feedback
Practice Element 3: Teamwork & Team interventions
300
SME
Practice Element 4: Identification & Mitigation of Risks and
20
1000 Points Spread Over 30
Practices – 3 New & 3 Redefined
40
120
Hazards
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
Weight
24
20
33
30
37
30
Safe Practice 22: Hand Hygiene (Prior SP 25 )
33
30
11
10
VAP (Prior SP 19)
119
100
Safe Practice 6: Direct Caregivers
NA New
20
Safe Practice 7: ICU Care
Leap 2
Safe Practice 20: CVC BSI Prevention
(Prior SP 20)
Safe Practice 21: Surgical Site Prevention
(Prior
SP 21)
CHAPTER 5: Facilitating Information Transfer and Clear Communication
84
84
Safe Practice 23: Influenza Prevention
Safe Practice 9: Order Read-Back (Prior SP 6)
36
25
Chapter 8: Condition- and Site-Specific Practices
Safe Practice 10: Labeling Studies (Prior SP 13)
16
15
Safe Practice 24: Evidence-Based Referrals
Safe Practice 11: Discharge Systems (Prior SP 8)
17
25
Safe Practice 25: Wrong-Site, Wrong Procedure,
Safe Practice 8: Critical Care Information
( Prior SP 9)
(Prior SP 26)
Leap 3
30
20
23
20
(Prior
28
25
(Prior SP 17)
27
25
39
35
12
10
Wrong Person Surgery Prevention (Prior SP 14)
Leap 1
Safe Practice 12: Safe Adoption of CPOE
Safe Practice 13: Abbreviations
(Prior SP 7)
17
15
Safe Practice 26: Perioperative Myocardial
Infarct/Ischemia Prevention (Prior SP 15)
CHAPTER 6: Improving Patient Safety Through Medication Management
Safe Practice 27: Pressure Ulcer Prevention
NA New
35
Safe Practice 15: Pharmacist Role (Prior SP 5)
32
32
Safe Practice 28: DVT/VTE Prevention
Safe Practice 16: Standardizing Medication Labeling and
22
20
Safe Practice 29: Anticoagulation Therapy (Prior
Safe Practice 14: Medication Reconciliation
Packaging (Prior SP 28)
Safe Practice 17: High-Alert Medications
SP 16)
SP 18)
(Prior SP 29)
21
20
Safe Practice 30: Contrast Media-Induced Renal
Failure Prevention (Prior SP 2 )
Safe Practice 18: Unit-Dose Medications
© 2006 CareLeaders Corp.
2007
Weight
CHAPTER 7: Prevention of Healthcare-Associated Infections
Safe Practice 19: Prevention of Aspiration and
CHAPTER 4: Matching Healthcare Needs With Service Delivery Capacity
Safe Practice 5: Nursing Workforce (Prior SP 3)
2004
EXECUTIVE SUMMARY OVERVIEW
(Prior SP 30)
29
25
21
Weight
2007
Weight
263
120
2004
EXECUTIVE SUMMARY OVERVIEW
What went up or is new?




CHAPTER 2: Creating and Sustaining A Culture of Patient Safety
Practice Element 1: Leadership Structures and Systems
Practice Element 2: Culture Survey Measurement and
(Prior
SP 1)*
Feedback
Practice Element 3: Teamwork & Team interventions
300
SME
Practice Element 4: Identification & Mitigation of Risks and
20
40
120
Hazards
Culture – 263 to 300
Disclosure – 25
Direct Care Giver - 20
Medication Reconciliation - 35
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
Weight
2007
Weight
24
20
33
30
37
30
33
30
11
10
2004
EXECUTIVE SUMMARY OVERVIEW
CHAPTER 7: Prevention of Healthcare-Associated Infections
Safe Practice 19: Prevention of Aspiration and VAP (Prior SP
19 )
CHAPTER 4: Matching Healthcare Needs With Service Delivery Capacity
Safe Practice 20: CVC BSI Prevention
Safe Practice 5: Nursing Workforce (Prior SP 3)
119
100
Safe Practice 6: Direct Caregivers
NA New
20
Safe Practice 7: ICU Care
Leap 2
Safe Practice 21: Surgical Site Prevention
(Prior SP 21 )
Safe Practice 22: Hand Hygiene (Prior SP 25 )
CHAPTER 5: Facilitating Information Transfer and Clear Communication
Safe Practice 8: Critical Care Information
(Prior SP 20 )
Safe Practice 23: Influenza Prevention
(Prior SP 26 )
84
84
Safe Practice 9: Order Read-Back (Prior SP 6)
36
25
Safe Practice 10: Labeling Studies (Prior SP 13)
16
15
Safe Practice 24: Evidence-Based Referrals
Safe Practice 11: Discharge Systems (Prior SP 8)
17
25
Safe Practice 25: Wrong-Site, Wrong Procedure, Wrong
( Prior SP 9)
Chapter 8: Condition- and Site-Specific Practices
30
20
23
20
Safe Practice 27: Pressure Ulcer Prevention (Prior SP 16 )
28
25
Safe Practice 28: DVT/VTE Prevention
27
25
39
35
12
10
Person Surgery Prevention (Prior SP 14 )
Leap 1
Safe Practice 12: Safe Adoption of CPOE
Safe Practice 13: Abbreviations
(Prior SP 7)
17
15
NA New
35
Safe Practice 15: Pharmacist Role (Prior SP 5)
32
32
Safe Practice 16: Standardizing Medication Labeling and
22
Safe Practice 14: Medication Reconciliation
Packaging (Prior SP 28)
Safe Practice 18: Unit-Dose Medications
© 2006 CareLeaders Corp.
(Prior SP 29)
(Prior SP 30)
21
29
Safe Practice 26: Perioperative Myocardial Infarct/Ischemia
Prevention (Prior SP 15 )
CHAPTER 6: Improving Patient Safety Through Medication Management
Safe Practice 17: High-Alert Medications
Leap 3
20
20
25
(Prior SP 17)
Safe Practice 29: Anticoagulation Therapy (Prior SP 18 )
Safe Practice 30: Contrast Media-Induced Renal Failure
Prevention (Prior SP 22 )
22
Update 11_16_06
SP 2: Informed Consent
PRACTICE
ADDITIONAL 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 5th 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.
23
© 2006 TMIT
23
Update 11_16_06
SP 3: Life-Sustaining Treatment
PRACTICE
ADDITIONAL 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.
24
© 2006 TMIT
24
Update 11_16_06
SP 4: Disclosure
PRACTICE
ADDITIONAL SPECIFICATIONS CHECKLIST
CRITICAL ELEMENTS:
 At a minimum, the types of serious unanticipated outcomes addressed include:
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.
© 2006 TMIT
 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]
25
25
Update 11_16_06
SP 4: Disclosure
PRACTICE
ADDITIONAL 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.
26
© 2006 TMIT
26
LFG Questions: SP#4: Disclosure
Check all boxes that apply.
In regard to disclosure of adverse events, our organization is:
Aware of the performance improvement opportunity in that …
 within 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 lessonslearned 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.
27
© 2007 TMIT
28
Disclosing Unanticipated Outcomes
to Patients
Implementing the NQF Safe Practice
Thomas H. Gallagher, MD
University of Washington
School of Medicine
29
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
30
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
31
32
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
33
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
34
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
35
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
36
“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
37
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.
38
Apology
• Expression of regret appropriate for all
unanticipated outcomes
• Apology when unanticipated outcome
clearly caused by unambiguous error or
system failure
39
Institutional Disclosure
Support System
• Emotional support for patients, families,
healthcare workers
• Disclosure education/skill building
• Provide disclosure coaching 24/7/365
40
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
41
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
42
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
43