1. Linking Transparency, Patient Safety, and Quality of Care Innovative Institutional Programs and Future Directions
Richard C. Boothman, JD
Thomas H. Gallagher, MD
Timothy B. McDonald, MD, JD
Eric J. Thomas, MD, MPH

2. Session Objectives
Describe innovative institutional transparency efforts, including programs to promote reporting of adverse events and errors to institutions and disclosing these events to patients.
Describe the conceptual and practical linkages between event reporting, safety culture, and quality improvement.
Highlight future developments that could strengthen transparency and the link between transparency and quality at the institutional and national level.

3. Agenda Topic Speaker Time Introduction, session overview
Transparency, safety, and quality: conceptual considerations
Gallagher
15 min
Transparency and safety culture
Thomas
Promoting transparency at the institutional level
McDonald
What now? Innovations to promote transparency at the institutional and national level
Boothman
Discussion
All
30 min

4. Case
29 year-old healthy male cared for by PCP and local hospital for recurring epistaxis
After several months, referred to academic medical center ED—presented ill, with SOB, epistaxis, hemopytsis, low platelets.
CT scan shows large lung mass, thought to be tumor (less likely blood clot).
Bronchoscopy attempted, finds free blood in lungs.
Continued deterioration, recommendation for interventional radiology to embolize bleeding source

5. (Case continued)
IR attempts biopsy, retrieves only clot. Neoplasm still highest on differential.
While healthcare team is meeting, patient arrests and dies. Autopsy finds large PE with pulmonary hemorrhage.
Communication with family immediately after death is challenging-cultural barriers, uncertainty about what happened, sudden and unexpected demise of young patient.
Security called to remove distraught family—first time risk management becomes aware of event.

6. Follow-up disclosure meeting
One week later meeting held with 10 family members, unannounced trial lawyer, 5 physicians, 2 risk managers.
Clinical care thought to be reasonable; MD thought process shared with family.
Family perceptions addressed, misconceptions corrected.
Family could see shared grief.
Family’s anger heard, appropriate apologies made, lessons taken back to management for follow-up.

7. Transparency, safety, and quality
Transparency long recognized as key to safety culture and healthcare quality
Yet a decade after To Err Is Human, major gaps in transparency persist
Healthcare workers experience multiple mixed messages about transparency
No accountability around transparency
Limited transparency becomes path of least resistance
Missed opportunities to promote greater synergy among transparency practices

8. Practices in transparent healthcare organizations
Discuss events with colleagues, other team members
Formal event reporting
Disclose event to patient
Share lessons learned back with clinicians
Required external reporting
Optional external reporting
Standard quality measures
Extreme transparency
CEO blog
Other aspects of transparency
Clinical information (shared decision-making)
Price

9. How transparent are we? Event reporting Disclosure to patient
2009 AHRQ Patient Safety Culture survey-52% of staff reported no errors in the last 12 months
2005 Physician survey (n>2000)-65% unaware their hospital had an error reporting system
Disclosure to patient
Only 1/3 of harmful errors disclosed to patients
Those disclosures that do occur often go poorly
Feedback of lessons learned to clinicians
2005 Physician survey-18% of physicians agreed that current mechanisms to inform them about safety problems were adequate
Suggests shortcomings in our current approach to promoting transparency

10. Comparing Patient and Physician Ratings of Disclosure Quality

11. Transparency, accountability, and quality
Current paradigm
Culture of blame, shame, fear inhibit openness
Errors mostly represent system breakdowns
Greater openness promotes quality through event analysis, implementing prevention plans
Reality check
Errors mixture of individual and system breakdown
Transparency also promotes quality by encouraging low performers to improve and by deterrent effect
Performing poorly on report cards a potent stimulus
Accountability for transparency required
Current approaches to transparency not integrated

12. Are current approaches to transparency integrated?
Key transparency practices largely segregated by specialty
Nurses report events to institution
Physicians disclose events to patients
Most safety culture surveys measure event reporting but not disclosure attitudes or practices
Risk management and quality/safety programs often separated
Training usually addresses one transparency practice in isolation
Disclosure training rarely addresses event reporting to institution or communicating about events with colleagues

13. Are different transparency attitudes correlated?
2005 Physician survey
Physicians who strongly agreed that serious errors should be disclosed to patients twice as likely to strongly agree that serious errors should be reported to hospital
Similar relationship between MD support for disclosing minor errors to patients and reporting minor errors to hospital
Considerable anecdotal experience supports hypothesis that different transparency practices may be related

14. Implications of an integrated approach to transparency
What our are goals for transparency?
Are transparency’s deterrent, embarrassment effects good or bad?
Transparency is a skill, not just an attitude
Should training address reporting, communicating with colleagues, and disclosure in tandem?
Interprofessional implications
What are the real barriers to “speaking up?”
Will organizations adopt processes to ensure accountability around transparency?
Which of these will be publicly reported?
Will organizations compete on transparency?

15. Enhancing transparency, improving quality
Transparency and safety culture: Eric Thomas
Innovative institutional transparency programs: Tim McDonald
Future developments in transparency: Rick Boothman

16. Transparency and Safety Culture

17. Safety Climate
The culture in this ICU makes it easy to learn from the errors of others.
Medical errors are handled appropriately in this ICU.
I know the proper channels to direct questions regarding patient safety in this ICU.
I am encouraged by my colleagues to report any patient safety concerns I may have.
I receive appropriate feedback about my performance.
I would feel safe being treated here as a patient.
Sexton et al. BMC Health Services Research 2006;6:44.

18. Safety Climate Improve safety climate by:
improving incident report systems
executive walkrounds or safety rounds
increasing staff participation in RCAs and other efforts to learn from errors
Hudson et al. Contemporary Critical Care 2009;7:

19. Safety Climate Executive Walkrounds Study:
Randomized 24 clinical units to receive EWRs or usual patient safety activities and measured safety climate of nurses before and after the walkrounds
At baseline the experimental and control groups had similar safety climate scores
After the intervention, 72.9% of nurses in the walkrounds group reported a positive safety climate versus only 52.5% in the control group
Thomas et al. BMC Health Services Research 2005;5:28. For other data on walkrounds also see Frankel et al. Health Serv Res 2008;Jul 20:2.

20. Teamwork Climate
It is easy for personnel in this ICU to ask questions when there is something that they do not understand.
I have the support I need from other personnel to care for patients.
Nurse input is well received in this ICU.
In this ICU, it is difficult to speak up if I perceive a problem with patient care.
Disagreements in this ICU are resolved appropriately (i.e., not who is right, but what is best for the patient).
The physicians and nurses here work together as a well- coordinated team.
Sexton et al. BMC Health Services Research 2006;6:44.

21. Teamwork Climate and BSIs Across Michigan ICUs:
“No BSI” is > 5 consecutive months without BSI.
No BSI 21%
No BSI 31%
No BSI 44%
% of respondents within an ICU reporting good teamwork climate
Strongest item level predictor: caregivers feel comfortable speaking up if they perceive a problem with patient care.
Slide from Bryan Sexton

22. RN reports of Teamwork Climate and Subsequent RN Turnover
40% % % %
Red numbers indicate RN Turnover in that Quartile 3 years later
Data from the University of Texas at Houston Memorial Hermann Center for Healthcare Quality and Safety

23. Teamwork climate Improve teamwork climate by: SBAR training Briefings
daily goals checklists
shadowing other providers
Hudson et al. Contemporary Critical Care 2009;7:

24. Transparency and Safety Culture

25. Promoting Transparency at the Institutional Level

26. Condition Predicate to “Transparency”

27. Condition Predicate to “Transparency”
Courage…… and Leadership

28. How can we “encourage” institutions and care givers to be transparent?

29. How can we “encourage” institutions and care givers to be transparent?
Deal with the drivers of human behavior

30. How can we “encourage” institutions and care givers to be transparent?
Deal with the drivers of human behavior
Fear
Greed
Ego – soul
One we can leave out

31. How can we “encourage” institutions and care givers to be transparent?
Deal with the drivers of human behavior
Fear
Support structure–patients, families and providers
Education
Attack “truth to power” problems head-on
Greed
Financial incentives, disincentives for reporting
Tie to employment, privileges – OPPE, credentialing
Show the ROI – process improvements, claims
Ego – soul
Adopt principles of “just culture”
Handle occurrence reports with discretion
Focus on systems unless reckless, repetitive behavior

32. On the educational front: ACGME program director survey data
Most believe being transparent and honest is important
Future depends on resident physicians
Few feel competent
Little training
Lack of infrastructure in “real life”
Mixed messages from institutional leadership, insurers, risk management
Desire for clear articulated and approved principles

33. ACGME core competencies
Patient Care
Medical Knowledge
Practice-Based Learning & Improvement
Interpersonal and Communication Skills
Professionalism
Systems-based Practices

34. Elements of a “Transparent” Response to Adverse Event Process
Reporting
Investigation
Communication
Apology with remediation
Process and performance improvement
Data tracking and analysis

35. Elements of a “Transparent” Response to Adverse Event Process
Within the context of the Core Competencies
Reporting – all six competencies involved
Investigation – SBP & PBL & I
Communication – Professionalism and com skills
Apology with remediation - Professionalism
Process and performance improvement
Data tracking and analysis - PBL & I
All done in the context of institutional oversight

36. Resident Reporting
Must report 5 unsafe conditions or “near misses per year”

37. After reporting Degree of harm assessed If harm, investigation ensues
Must engage the family
RCA depending on severity
Consideration of “care for the care giver”
Life After Death: The Aftermath of Perioperative Catastrophes Gazoni et al. Anesth Analg.2008; 107:
Hold bills

38. Power of engaging families in the aftermath of a tragic event

39. Association of perceived medical errors with resident distress and empathy: a prospective longitudinal study
West et al. JAMA (6):
“Self-perceived medical errors are common among I.M. residents and are associated with substantial personal distress. Personal distress and decreased empathy are associated with increased odds of future errors…reciprocal cycle.” Must consider “care for the care giver” and methods to maintain trust between provider and patient/family.

40. Future possibilities and opportunities
Deal with the drivers of human behavior
Fear
Federal & state legislative changes
NPDB & State licensing
Greed
Personal asset protection if transparent
Ego – soul
Expanded adoption of “just culture”
Screening prior to medical school
Emotional intelligence assessment tools
Values drive behaviors which drive performance

41. In a time of universal deceit, telling the truth becomes a revolutionary act.
George Orwell

42. Habit #2: Begin with the End in Mind.
Stephen R. Covey

43. What do patients want? What do patients deserve?

44. Truthful Explanation

45. Accountability

46. Apology and Compensation when warranted

47. What do caregivers want? What do caregivers deserve?

48. Truthful Explanation

49. Reasonable Benchmark against which you judge their actions

50. Support

51. What do hospitals want? What do hospitals deserve?

52. Truthful Explanation

53. Opportunity to be Accountable

54. Opportunity to Improve

55. The very best risk management is to make no medical mistakes The next best is not to make the same mistake again “Deny and defend” and learning from mistakes are mutually exclusive

56. Institutional Patient Safety Concept
Collection
Institutional Patient Safety Concept
Triage
Intervention, Investigation, Stabilization
Referral for Action
Measurement to Gauge Improvement
Educate with Lessons Learned, Facilitate Improvements in Patient Safety, QI

57. Define “Disclosure” Communicating with patients/families/caregivers
Following unanticipated medical outcome
And telling them the truth (or as close to it as we can come after the fact)

58. When an explanation is needed, every day that passes further cements mistaken beliefs When an apology is truly owed, every day that passes results in a new injury

59. University of Michigan’s Claims Management Principles
We will compensate quickly and fairly when inappropriate medical care causes injury.
We will defend appropriate care vigorously.
We will reduce patient injuries (and claims) by learning from mistakes.

60. Key Questions: Was the care at issue “reasonable”?
Did the care adversely impact the patient’s outcome?

61. U of M Claims Management Model
Assessment
and Direction
Investigation and
Analysis of Risk and Value
Medical Committee
(3 months after notice)
← Pre Suit →
Legal Office
Assign to Counsel
Litigate
Agree to Disagree
Engage Patient
and
Share Information
Litigation
No Dialogue
Settlement
Mistake/Injury
Claims Committee
Settle or Trial?
Agree no Claim

62. Pre Suit Investigation
Assessment
and Direction
Investigation and
Analysis of Risk and Value
Medical Committee
(3 months after notice)
Clinical Quality Improvement
Peer Review
Educational Opportunities

63. Biggest Barrier:
Fear

64. The University of Michigan has two important advantages:
Caregivers are employees of health system/medical school
Alignment of culture, ethics, financial consequences
Caregivers are insulated from personal financial ruin
Still accountable, but freedom from imminent, catastrophic financial consequences enables transparency, adherence to principles, wider and longer view of patient safety imperatives

65. Fear leads to:
Provider/hospital’s abdication of responsibility to ask threshold question: what should my/our response be to this patient’s unanticipated outcome?
Fight or flight rules, cedes control over this critical issue to lawyers/courtroom
And freezes efforts to improve in deference to the legal system

66. Ten years from now . . . Information and honesty prevail
Incentives and penalties aligned to favor just response to patient and improve patient safety
Social safety net for patients so financial ruin is not main impetus for litigation
Protection for caregivers so financial ruin is not reason for deny and defend
Accountability (peer review), reasonable consequences based on “just culture” algorithm
Robust, widespread, compulsory data collection, sharing best practices, lessons learned and measurement of improvement

67. Litigation must change
Last resort (cooling off period, mediation, other ADR)
Elimination of opportunistic exploitation of weaknesses (runaway verdicts/caps, early evaluation of merit, affidavits of merit, junk science limits)
Favor full disclosure (federal civil procedure trend)
Experts are key (Australia’s “hot tubbing”, use of “masters”, elimination of charlatans)
Consideration of “health courts”

68. The truth will set you free. But first, it will piss you off.
Gloria Steinem