1. Accountability after Medical Injury: Recent Developments and Future Directions Thomas H. Gallagher, MD Professor of Medicine, Bioethics & Humanities Director, UW Medicine Center for Scholarship in Patient Care Quality & Safety Director, Program in Hospital Medicine University of Washington

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3. The Accountability Gap Fear of unpredictable, punitive response chills provider reporting of adverse events Hampers efforts to learn, prevent recurrence System does not serve patients’ needs Information Acceptance of responsibility Timely compensation Prevention of recurrences System stresses providers financially and emotionally

4. Where’s the Patient? 4 Only modest efforts to involve families as partners in preventing and resolving injuries Reform debates heavily driven by providers’ and insurers’ concerns Little understanding of what accountability actually means to patients

5. What Would an Accountable System Look Like? Healthcare institutions and providers: Recognize that event has occurred Disclose it effectively to the patient Proactively make the patient whole Learn from what happened In a healthcare delivery environment that: Prospectively monitors quality of care Identifies unsafe providers and employs effective remediation Spreads learning across institutions In a legal/regulatory environment that supports providers in “doing the right thing”

6. Recent Developments The disclosure gap persists CRPs LSAE disclosure Communicating with patients about other healthcare workers’ errors Collective Accountability

8. COPIC 3Rs program for disclosure and compensation, 2007-2009 837 Events 445 patient surveys (55% response rate) 705 physician surveys (84% response rate) Quality of Actual Disclosures

9. Patient Assessment Physician Assessment Extremely serious (I might have died) 31%7% Very Serious (permanent injury)25% Somewhat serious (injury that resolved) 28%61% Not at all serious3%6% Event Severity

10. Quality of Disclosure

11. Two CRP Models Goal: Reimburse out-of-pocket expenses for minor injuries without regard to fault Examples: COPIC Insurance, West Virginia Mutual Insurance Co., ProMutual Group Reimbursement Model Goal: Expedite settlement of incidents involving substandard care Examples: University of Michigan Health System, University of Illinois at Chicago, Stanford University Medical Indemnity Trust Early Settlement Model

12. The Appeal of Institution-Led Reform No need for legislation Can be led by physician champions and other insiders More palatable to patient and attorney organizations Can be tailored to local institutional culture Governed by market forces

13. The CRP Approach Catches On First wave: Lexington VA Early Settlement Programs: University of Michigan UIC Stanford Reimbursement programs: COPIC Coverys West Virginia Mutual Second wave: HealthPact partners (Washington) NYC hospitals Massachusetts Alliance for Communication and Resolution following Medical Injury (MACRMI) 10 Illinois hospitals University of Texas Ascension Health

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15. How Are LSAEs Different? Like individual adverse events Type, cause, severity vary widely Strong patient expectations for disclosure, learning Unlike individual adverse events By definition, involve multiple patients (sometimes thousands) Hard to keep quiet High potential for negative impact on reputation of organization Responding appropriately is highly resource intensive Many represent near misses Don’t know which patients are affected until investigation complete Primary harm may be anxiety caused by disclosure itself

16. How Can Institutions Effectively Link Disclosure Strategy with LSAE type? LSAE with low potential for harm Primarily mailed disclosure LSAE with high potential for harm Primarily direct, in-person disclosure However… Patient perception of severity of harm can vary dramatically from that of the institution When media gets involved, they essentially provide written disclosure to entire community For high harm event, this alerts potential LSAE recipients before institution can contact them directly Part of how patients judge LSAE is by watching how institution handles notification, response Tsunami of anxious patients calling institution after seeing media report can overwhelm based laid plans for response

17. Matching Disclosure Content and Nature of LSAE The “ick factor” Contaminated endoscopes Duke hydraulic fluid case Greater specificity about exactly what happened, plans for preventing recurrences can persuade patients, public that institution has responded appropriately But feels to some institutions like admission of liability Blame is natural reaction to adverse events, increases absent evidence of robust response Benefits of public partnership in response with external entities (public health, CDC)

18. How Proactive Should the Media Strategy Be? Assume media coverage of LSAE is inevitable The more proactive the strategy, the better Provide press release, prep organizational leaders and external partners to talk to media Best media strategy will not lead to positive story, just one that is less negative, not as visible, and goes away quickly Almost impossible to recover from combination of LSAE plus botched disclosure/ “cover-up”

20. Should I Talk to Involved Clinician? Discuss what happened, what to say to patient Easier said than done Fear of how colleague will react Strong cultural norms around loyalty, solidarity, tattling Reluctance to acquire unfavorable reputation, or disrupt are relationships Power differentials Dependence on colleagues for referrals Some clinicians use chart to document concern without confronting colleague

21. Maybe My Institution Could Help Clinicians worry that reporting event to institution could trigger unpredictable, potentially punitive response Or that no action will be taken Clinicians may have different malpractice insurers Many clinicians work in small practices without ready access to institutional resources

22. What Should I Say To The Patient? Concerns about destroying patient trust in colleague Fear of triggering litigation Subjecting colleague to conversation with angry patient is one thing Subjecting colleague to potential lawsuit is much more worrisome Unclear how state apology/disclosure laws apply No evidence regarding how to disclose other clinicians’ error without triggering claim

23. What happens currently? When faced with another healthcare workers’ error, most providers Hesitate to discuss event with the involved provider, especially when at outside institution Worry that reporting event to institution could trigger punitive, unpredictable cascade Are reluctant to tell the patient If event mentioned at all, vague language used and patient left to “connect the dots”

24. Key Principles Patients and families come first Explore, don’t ignore Institutions should lead

25. Patients and Families Come First Concern about collegial relationships do not obviate patient’s right to know what happened Patients and families should not have to dig for information Patients and families will need financial help after serious error Can’t access compensation without knowing what happened The tort system is dysfunctional and may not treat physicians fairly Yet professionalism calls on physicians to put the patient’s needs first When disclosure is ethically required, fact that it is difficult should not stand in the way

26. Explore, Don’t Ignore Before talking to patient about potential error involving colleague, first obligation is to obtain the facts Patient’s interests are not served by speculation Colleagues deserve chance to correct misconceptions, participate in disclosure Strengthened commitment to exploring potential errors with colleagues is needed

27. Institutional support Disclosure coaches Role modeling by senior colleagues Formal venues to address quality concerns M&M, peer review Informal approaches Curbside consultation with risk/quality expert Ensure that relevant QI/peer review protections in place

28. Why Does the Bad Apple Model Persist? Check the mirror Blame feels good “I wouldn’t/couldn’t/can’t see myself doing that” Competence is not binary Exists on spectrum across and within individuals Who are the bad apples? Physicians who can’t or won’t learn from mistakes

29. Collective Accountability Transparency with each other, patient is shared professional responsibility Need to share, act on information together Requires that we turn towards, not away from colleagues involved in potential error

30. What Does Accountability Look Like? After medical injury Meet needs of affected patient Demonstrated learning