1 © 2010 TMIT NQF-Endorsed ® Safe Practices for Better Healthcare Safe Practice 7 Disclosure Chapter 3: Improving Patient Safety Through Informed Consent, Life-Sustaining Treatment, Disclosure, and Care of the Caregiver

© 2006 HCC, Inc. CD XX 2 © 2010 TMIT Slide Deck Overview Slide Set Includes:  Section 1: NQF-Endorsed ® Safe Practices for Better Healthcare Overview  Section 2: Harmonization Partners  Section 3:The Problem  Section 4: Practice Specifications  Section 5: Example Implementation Approaches  Section 6: Front-line Resources

3 © 2010 TMIT NQF-Endorsed ® Safe Practices for Better Healthcare Overview Safe Practice 7 Disclosure Chapter 3: Improving Patient Safety Through Informed Consent, Life-Sustaining Treatment, Disclosure, and Care of the Caregiver

4 © 2010 TMIT 2010 NQF Safe Practices for Better Healthcare: A Consensus Report 34 Safe Practices Criteria for Inclusion Specificity Benefit Evidence of Effectiveness Generalization Readiness

5 © 2010 TMIT Culture SP NQF Report

CHAPTER 7: Healthcare-Associated Infections Hand Hygiene Influenza Prevention Central Line-Associated Blood Stream Infection Prevention Surgical-Site Infection Prevention Daily Care of the Ventilated Patient MDRO Prevention Catheter-Associated UTI Prevention Information Management and Continuity of Care Medication Management Healthcare-Associated Infections Condition- and Site-Specific Practices Consent & Disclosure Wrong-site Sx Prevention Press. Ulcer Prevention VTE Prevention Anticoag. Therapy VAP Prevention Central Line-Assoc. BSI Prevention Sx-Site Inf. Prevention Contrast Media Use Hand Hygiene Influenza Prevention Pharmacist Leadership Structures and Systems Med. Recon. Culture CPOE Read-Back & Abbrev. Discharge Systems Patient Care Info. Labeling Diag. Studies Culture Meas., FB., and Interv. Structures and Systems Risk and Hazards Team Training and Skill Bldg. Nursing Workforce ICU Care Direct Caregivers Workforce CHAPTER 4: Workforce Nursing Workforce Direct Caregivers ICU Care CHAPTER 2: Creating and Sustaining a Culture of Safety (Separated into Practices]  Culture of Safety Leadership Structures and Systems  Culture Measurement, Feedback, and Intervention  Teamwork Training and Skill Building  Risks and Hazards CHAPTER 5: Information Management and Continuity of Care  Patient Care Information  Order Read-Back and Abbreviations  Labeling Diagnostic Studies  Discharge Systems  Safe Adoption of Computerized Prescriber Order Entry CHAPTER 6: Medication Management  Medication Reconciliation  Pharmacist Leadership Structures and Systems CHAPTER 8: Condition- and Site-Specific Practices Wrong-Site, Wrong-Procedure, Wrong-Person Surgery Prevention Pressure Ulcer Prevention VTE Prevention Anticoagulation Therapy Contrast Media-Induced Renal Failure Prevention Organ Donation Glycemic Control Falls Prevention Pediatric Imaging Informed Consent Life-Sustaining Treatment Disclosure CHAPTER 3: Consent and Disclosure Informed Consent Life-Sustaining Treatment Disclosure Care of the Caregiver Consent and Disclosure Care of Caregiver MDRO Prevention UTI Prevention Falls Prevention Organ Donation Glycemic Control Pediatric Imaging

7 © 2010 TMIT Harmonization Partners Safe Practice 7 Disclosure Chapter 3: Improving Patient Safety Through Informed Consent, Life-Sustaining Treatment, Disclosure, and Care of the Caregiver

8 © 2010 TMIT Harmonization – The Quality Choir

9 © 2010 TMIT The Patient – Our Conductor

© 2006 HCC, Inc. CD XX 10 © 2010 TMIT The Objective Disclosure  Provide open and clear communication with patients and their families about serious unanticipated outcomes that is supported by systems that foster transparency and performance improvement to reduce preventable harm

11 © 2010 TMIT The Problem Safe Practice 7 Disclosure Chapter 3: Improving Patient Safety Through Informed Consent, Life-Sustaining Treatment, Disclosure, and Care of the Caregiver

© 2006 HCC, Inc. CD XX 12 © 2010 TMIT The Problem

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© 2006 HCC, Inc. CD XX 16 © 2010 TMIT The Problem Frequency  40% of the American public have reported a medical error in their own care or a family member’s care  Research has shown that disclosure happens once in every four harmful events [Blendon, N Engl J Med 2002 Dec 12;347(24): ; Denham, J Patient Saf 2006 Dec;2(4):225-32; Sheridan, J Patient Saf 2008 Mar;4(1):18-26]

© 2006 HCC, Inc. CD XX 17 © 2010 TMIT The Problem Severity  When medical errors occur clinicians often overlook disclosure in fear of the implications of liability  Dr. Leape points out that serious preventable harm causes emotional trauma for patients and families  The patient-doctor relationship suffers when the truth is not openly discussed [Leape, Physician Exec Mar-Apr;32(2):16-8; Gallagher, Arch Intern Med 2006 Aug 14-28;166(15): ; Gallagher, Arch Intern Med 2006 Aug 14-28;166(15): ; Denham, J Patient Saf 2006 Sep;2(3):162-70; Denham, J Patient Saf 2008 Jun;4(2):119-23]

© 2006 HCC, Inc. CD XX 18 © 2010 TMIT The Problem Preventability  Implement full disclosure programs that include the caregiver, who acknowledges the error, takes responsibility, and apologizes  The process of disclosure must include the concerned caregivers  Organizations must provide the necessary support systems to assist patients and caregivers throughout the process [Leape, Physician Exec Mar-Apr;32(2):16-8; Liang, Qual Saf Health Care 2002 Mar; 11(1):64-8. Iedema, Int J Qual Health Care 2008 Dec;20(6):421-32; Gallagher, JAMA 2009 Aug 12;302(6):669-77; Holden, BMJ 2009 Feb 10;338:b520; Denham, J Patient Saf 2007 Jun;3(2):107-19]

© 2006 HCC, Inc. CD XX 19 © 2010 TMIT The Problem Cost Impact  The Lexington Veterans Affairs Medical Center reported an average settlement payout of $82K less than the national Department of Veterans Affairs average, due to their disclosure policy  University of Michigan experienced $2 million annual savings from a full disclosure program [Kraman, Jt Comm J Qual Improv 2002 Dec;28(12):646-50; Boothman, Annual Meeting of Greater New York Hospital Association, May 13, 2005; Clinton, N Engl J Med 2006 May 25;354(21):2205-8; Wojcieszak, Jt Comm J Qual Patient Saf 2006 Jun;32(6):344-50]

20 © 2010 TMIT Practice Specifications Safe Practice 7 Disclosure Chapter 3: Improving Patient Safety Through Informed Consent, Life-Sustaining Treatment, Disclosure, and Care of the Caregiver

© 2006 HCC, Inc. CD XX 21 © 2010 TMIT Additional Specifications

© 2006 HCC, Inc. CD XX 22 © 2010 TMIT Safe Practice Statement Disclosure  Following serious unanticipated outcomes, including those that are clearly caused by systems failures, the patient and, as appropriate, the family should receive timely, transparent, and clear communication concerning what is known about the event [MCPME, When Things Go Wrong: Responding to Adverse Events, 2006; Gallagher, J Patient Saf 2007 Sept;3(3):158-65; UMich, Patient Safety Toolkit – Disclosure Chapter, 2009; Institute for Healthcare Improvement, Communication with Patients and Families after an Adverse Event. IHI Improvement Map, 2009]

© 2006 HCC, Inc. CD XX 23 © 2010 TMIT Additional Specifications  Serious unanticipated outcomes include sentinel events, serious reportable events, and outcomes requiring substantial additional care  Create formal processes for disclosing unanticipated outcomes and for reporting events to those responsible for patient safety  Policies should incorporate continuous quality improvement techniques and provide for annual reviews and updates  Adherence to the practice and participation with the support system are expected [TJC, J Health Serv Res Policy 2008 Oct;13(4):227-32, 2009; NQF, Serious Reportable Events in Healthcare: A Consensus Report, 2002; JCR, 2010 Comprehensive Accreditation Manual: CAMH for Hospitals: The Official Handbook, 2010; Kussman, Disclosure of adverse events to patients, 2008]

© 2006 HCC, Inc. CD XX 24 © 2010 TMIT Additional Specifications  Patient communication should include sharing facts, showing empathy and regret, commitment to investigate, feedback, timeliness, possible licensed independent practitioners or administrative leader apology, patient support, and disclosure  Implement a procedure to ensure that all LIPs are provided with a detailed description of the organization’s program for responding to adverse events [Fein, J Gen Intern Med 2007 Jun;22(6):755-61; Holden, BMJ 2009 Feb 10;338:b520; Iedema, Int J Qual Health Care 2008 Dec;20 (6):421-32; McDonnell, Ann Intern Med 2008 Dec 2;149(11):811-6; HBQI, Healthcare Benchmarks Qual Improv 2008 Sep/;15(9):94-6; Frankel, Health Serv Res 2006 Aug;41(4 Pt 2): ; Sorensen, J Health Serv Res Policy 2008 Oct:13(4):227-32; Gallagher, Chest 2009 Sep;136(3): ; Keller, WMJ 2009 Feb;108(1):27-9; Shannon, Jt Comm J Qual Patient Saf 2009 Jan;35(1):5-12]

© 2006 HCC, Inc. CD XX 25 © 2010 TMIT Additional Specifications  Implement a process that will provide information to a Patient Safety Organization that would protect confidential information  Create a process that will allow waiving of billing in the case of systemic or human error [Agency for Healthcare Research and Quality, Legislation and Regulations: Patient Safety and Quality Improvement Act of 2005 (the Patient Safety Act): An Overview; Public Law , Patient Safety and Quality Improvement Act of 2005; Boothman, Journal of Health & Life Sciences Law 2009 Jan;2(2):125-59; McDonald, Qual Saf Health Care [In press], 2009]

26 © 2010 TMIT Example Implementation Approaches Safe Practice 7 Disclosure Chapter 3: Improving Patient Safety Through Informed Consent, Life-Sustaining Treatment, Disclosure, and Care of the Caregiver

© 2006 HCC, Inc. CD XX 27 © 2010 TMIT Example Implementation Approaches

© 2006 HCC, Inc. CD XX 28 © 2010 TMIT Example Implementation Approaches  Implement policies and procedures that incorporate critical practice elements and provide healthcare workers with disclosure education and “just-in-time” coaching  Establish processes and systems to comply with this practice through the collaborative work of governing boards, senior administrative leaders, medical staff, and risk management leaders  Start with simple processes, basic educational strategies, and clear engagement tactics that incorporate the practice into existing meetings to ensure it becomes a part of the way an organization operates [Camiré, CMAJ 2009 Apr 28;180(9):936-43; Gunderson, An International Journal 2009; 21(3):229-32]

© 2006 HCC, Inc. CD XX 29 © 2010 TMIT Example Implementation Approaches Strategies of Progressive Organizations  Some organizations are experimenting with policies that involve disclosing a broader range of unanticipated outcomes  High-performing organizations are tracking waived costs generated because of adverse events and are allocating accountabilities to departments and care providers  Leading academic organizations are teaching disclosure to nursing and medical students [McDonald, "Full Disclosure" and Residency Education, 2008; White, Acad Med 2008 Mar;83(3):250-6; McDonald, Responding to Patient Safety Incidents: The Seven Pillars, 2009; Shannon, Jt Comm J Qual Patient Saf 2009 Jan;35(1):5-12]

30 © 2010 TMIT Front-line Resources Safe Practice 7 Disclosure Chapter 3: Improving Patient Safety Through Informed Consent, Life-Sustaining Treatment, Disclosure, and Care of the Caregiver

31 © 2010 TMIT

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© 2006 HCC, Inc. CD XX 34 © 2010 TMIT NQF & TMIT National Webinar Series Creating Transparency, Openness, and Improved Safety (Safe Practices 5-8)  Timothy McDonald, MD, JD – Topic: Looking Forward: Principles Applied  Lucian Leape, MD – Topic: Looking Back: Lessons Learned  Peter B. Angood, MD, FRCS(C), FACS, FCCM – Topic: The National Quality Forum Perspective  Becky Martins – Discussion: Opportunities for Patient and Family Involvement  Go to: (October 22, 2009)

© 2006 HCC, Inc. CD XX 35 © 2010 TMIT TMIT National Webinar Series Consent, End of Life, and Disclosure (Safe Practices 2-4)  Thomas H. Gallagher, MD  Lee Taft, JD  Jennifer Dingman  Gail Nielsen, BSHCS, FAHRA, RTR  Go to: (August 14, 2007)