1 © 2007 TMIT Charles Denham Tom Gallagher Lee Taft Jennifer Dingman Gail Nielsen Informed Consent,...

1© 2007 TMIT

Charles Denham Tom Gallagher

Lee TaftJennifer Dingman

Gail Nielsen

Informed Consent, End of Life Wishes, and Disclosure Safe Practices

August 14, 2007

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© 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© 2007 TMIT

Harmonization – The Quality Choir

5© 2007 TMIT

The Patient – Our Conductor

7© 2007 TMIT

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© 2007 TMIT

• Harmonization and AlignmentHarmonization of practices and specifications with

national organization requirements and initiatives- The Joint Commission- CMS- AHRQ- IHI- Leapfrog

• RefinementExtensive supporting evidence and references

9© 2007 TMIT

• Expansion Implementation ApproachesNew Horizons and Areas for ResearchOutcomes, Structure, Process, and Patient-Centered

MeasuresSetting-specific applicability

- Rural Hospitals- Children’s Hospitals- Specialty Hospitals

Relation of each Safe Practice to other relevant Practices

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© 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


2007 NQF Report

12© 2006 TMIT



Healthcare-Associated Infections



Wrong-siteSx Prevention

Periop. MIPrevention

Press. Ulcer Prevention

DVT/VTE Prevention

Anticoag. Therapy

Asp. + VAP Prevention

Central V. Cath.BSI Prevention

Sx Site Inf.Prevention

Contrast Media Use

Hand HygieneInfluenza

Prevention

PharmacistCentral Role

Med. Recon.

Std. Med. Labeling & Pkg.

High-AlertMeds.

Unit-DoseMedications

Evidence-Based Ref.

Culture

CPOE

OrderRead-back

Abbreviations Discharge

System

CriticalCare Info.

LabelingStudies

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 CareDirect

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


2007 NQF Report

13© 2006 TMIT

Culture SP 1



Hospital-Associated Infections






DVT/VTE Prevention

Anticoag. Therapy


Central V. CathBSI Prevention


Contrast Media Use


Prevention


Med. Recon.


High-AlertMeds.


Evidence-Based Ref.

Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies

Culture Meas,F.B, & Interv.

Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers

Work Force CHAPTER 4: Workforce• Nursing Workforce• Direct Caregivers• ICU Care













Informed Consent

Life Sustaining Treatment

Disclosure

CHAPTER 3: Informed Consent & Disclosure• Informed Consent• Life Sustaining Treatment• 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© 2006 TMIT

Culture SP 1









DVT/VTE Prevention

Anticoag. Therapy




Contrast Media Use


Prevention


Med. Recon.


High-AlertMeds


Evidence-Based Ref.

Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies


Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers














Informed Consent


Disclosure




2007 NQF Report

15© 2006 TMIT

Culture SP 1









DVT/VTE Prevention

Anticoag. Therapy




Contrast Media Use


Prevention


Med. Recon.

Std. Med. Labeling & Pkg

High-AlertMeds


Evidence-Based Ref.

2007 NQF Report Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies

Culture Meas,F.B, & Interv.

Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers














Informed Consent


Disclosure

CHAPTER 3: Informed Consent & Disclosure• Informed Consent• Life Sustaining Treatment• Disclosure


CHAPTER 4: Workforce• Nursing Workforce• Direct Caregivers• ICU Care

16© 2006 TMIT

Culture SP 1









DVT/VTE Prevention

Anticoag. Therapy




Contrast Media Use


Prevention


Med Recon.

Std. Med Labeling & Pkg

High AlertMeds

Unit DoseMedications

Evidence-Based Ref.

Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies


Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers







CHAPTER 6: Medication Management• Medication Reconciliation• Pharmacist Role• Standardized Medication Labeling & Packaging• High-Alert Medications• Unit Dose Medications


Associated Pneumonia • Central Venous Catheter Related Blood Stream





Informed 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© 2006 TMIT

Culture SP 1



Hospital Acquired Infections






DVT/VTE Prevention

Anticoag. Therapy




Contrast Media Use


Prevention


Med Recon.


High AlertMeds


Evidence-Based Ref.

Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies


Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers














Informed Consent


Disclosure



CHAPTER 6: Medication Management• Pharmacist Role• Medication Reconciliation• High-Alert Medications• Standardized Medication Labeling & Packaging• Unit-Dose Medications

2007 NQF Report

18© 2006 TMIT

Culture SP 1




Condition & Site Specific Practices





DVT/VTE Prevention

Anticoag. Therapy

Asp +VAP Prevention



Contrast Media Use


Prevention


Med Recon.


High AlertMeds


Evidence-Based Ref.

Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies

Culture Meas.,F.B, & Interv.

Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers














Informed 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© 2006 TMIT

Culture SP 1




Condition & Site Specific Practices


Wrong siteSx Prevention

Peri-Op MIPrevention


DVT/VTE Prevention

Anticoag Therapy

Asp +VAP Prevention



Contrast Media Use


Prevention


Med Recon.


High AlertMeds


EvidenceBased Ref.

Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies


Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers














Informed 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© 2006 TMIT

Culture SP 1



Hospital-Acquired Infections






DVT/VTE Prevention

Anticoag. Therapy




Contrast Media Use


Prevention


Med. Recon.


High-AlertMeds.


Evidence-Based Ref.

2006 Proposed NQF Report Culture

CPOE

OrderRead-back


System

CriticalCare Info.

LabelingStudies


Structures& Systems





Nursing Workforce

ICU CareDirect

Caregivers














Informed Consent


Disclosure



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) 119 100

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 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 32

Safe Practice 16: Standardizing Medication Labeling and Packaging (Prior SP 28)

22 20

Safe Practice 17: High-Alert Medications (Prior SP 29) 21 20

Safe Practice 18: Unit-Dose Medications (Prior SP 30) 29 25

© 2006 CareLeaders Corp.


2007 Weight

CHAPTER 7: Prevention of Healthcare-Associated Infections

Safe Practice 19: Prevention of Aspiration and VAP (Prior SP 19)

24 20

Safe Practice 20: CVC BSI Prevention (Prior SP 20) 33 30

Safe Practice 21: Surgical Site Prevention (Prior SP 21)

37 30

Safe Practice 22: Hand Hygiene (Prior SP 25 ) 33 30

Safe Practice 23: Influenza Prevention (Prior SP 26) 11 10

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) 30 20

Safe Practice 26: Perioperative Myocardial Infarct/Ischemia Prevention (Prior SP 15)

23 20

Safe Practice 27: Pressure Ulcer Prevention (Prior SP 16)

28 25

Safe Practice 28: DVT/VTE Prevention (Prior SP 17) 27 25

Safe Practice 29: Anticoagulation Therapy (Prior SP 18)

39 35

Safe Practice 30: Contrast Media-Induced Renal

Failure Prevention (Prior SP 2 )12 10

1000 Points Spread Over 30 Practices – 3 New & 3 Redefined

22


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) 119 100

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 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 32

Safe Practice 16: Standardizing Medication Labeling and Packaging (Prior SP 28)

22 20

Safe Practice 17: High-Alert Medications (Prior SP 29) 21 20

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


2007 Weight

CHAPTER 7: Prevention of Healthcare-Associated Infections

Safe Practice 19: Prevention of Aspiration and VAP (Prior SP 19 ) 24 20

Safe Practice 20: CVC BSI Prevention (Prior SP 20 ) 33 30

Safe Practice 21: Surgical Site Prevention (Prior SP 21 ) 37 30

Safe Practice 22: Hand Hygiene (Prior SP 25 ) 33 30

Safe Practice 23: Influenza Prevention (Prior SP 26 ) 11 10

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 ) 30 20

Safe Practice 26: Perioperative Myocardial Infarct/Ischemia Prevention (Prior SP 15 )

23 20

Safe Practice 27: Pressure Ulcer Prevention (Prior SP 16 ) 28 25

Safe Practice 28: DVT/VTE Prevention (Prior SP 17) 27 25

Safe Practice 29: Anticoagulation Therapy (Prior SP 18 ) 39 35

Safe Practice 30: Contrast Media-Induced Renal Failure

Prevention (Prior SP 22 )12 10

23

23© 2006 TMIT

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.

Update 11_16_06

24

24© 2006 TMIT

SP 3: Life-Sustaining Treatment


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

SP 4: Disclosure


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

SP 4: Disclosure


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

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 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

29

Disclosing Unanticipated Outcomes to Patients

Implementing the NQF Safe Practice

Thomas H. Gallagher, MDUniversity of Washington

School of Medicine

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

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

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

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

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

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

“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

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

Apology

• Expression of regret appropriate for all unanticipated outcomes

• Apology when unanticipated outcome clearly caused by unambiguous error or system failure

40

Institutional Disclosure Support System

• Emotional support for patients, families, healthcare workers

• Disclosure education/skill building

• Provide disclosure coaching 24/7/365

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

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

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

1 © 2007 TMIT Charles Denham Tom Gallagher Lee Taft Jennifer Dingman Gail Nielsen Informed Consent,...

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Transcript of 1 © 2007 TMIT Charles Denham Tom Gallagher Lee Taft Jennifer Dingman Gail Nielsen Informed Consent,...