Richard C. Boothman, JDThomas H. Gallagher, MD

Timothy B. McDonald, MD, JDEric J. Thomas, MD, MPH

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.

Topic Speaker Time

•Introduction, session overview•Transparency, safety, and quality: conceptual considerations

Gallagher 15 min

•Transparency and safety culture Thomas 15 min

•Promoting transparency at the institutional level

McDonald 15 min

•What now? Innovations to promote transparency at the institutional and national level

Boothman 15 min

•Discussion All 30 min

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

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.

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.

• 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

• 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

Event reporting◦ 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

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

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

• 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

• 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?

Transparency and safety culture: Eric Thomas

Innovative institutional transparency programs: Tim McDonald

Future developments in transparency: Rick Boothman

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.

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:

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.

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.

 

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Strongest item level predictor: caregivers feel comfortable speaking up if they perceive a problem with patient care.

Slide from Bryan Sexton

RN reports of Teamwork Climate and Subsequent RN Turnover

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Data from the University of Texas at Houston Memorial Hermann Center for Healthcare Quality and Safety

40% 43% 27% 23%

Red numbers indicate RN Turnover in that Quartile 3 years later

Improve teamwork climate by:

◦ SBAR training

◦ Briefings

◦ daily goals checklists

◦ shadowing other providers Hudson et al. Contemporary Critical Care 2009;7:

Courage…… and Leadership

Deal with the drivers of human behavior

Deal with the drivers of human behavior◦ Fear◦ Greed◦ Ego – soul◦ One we can leave out

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

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

Patient Care Medical Knowledge Practice-Based Learning & Improvement Interpersonal and Communication Skills Professionalism Systems-based Practices

Reporting Investigation Communication Apology with remediation Process and performance improvement Data tracking and analysis

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

Must report 5 unsafe conditions or “near misses per year”

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 CatastrophesGazoni et al. Anesth Analg.2008; 107: 591-600

Hold bills

West et al. JAMA. 2006 296(6): 1071-8.“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.

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

In a time of universal deceit, telling the truth becomes a

revolutionary act.

George Orwell

Habit #2: Begin with the End in Mind.

Stephen R. Covey

What do patients want?

What do patients deserve?

Truthful Explanation

Accountability

Apology and Compensation when warranted

What do caregivers want?

What do caregivers deserve?

Truthful Explanation

Reasonable Benchmark against which you judge their

actions

Support

What do hospitals want?

What do hospitals deserve?

Truthful Explanation

Opportunity to be Accountable

Opportunity to Improve

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

Triage

Intervention, Investigation, Stabilization

Referral for Action

Measurement to Gauge Improvement

Collection

Educate with Lessons Learned, Facilitate Improvements in Patient Safety, QI

Institutional Patient Safety

Concept

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)

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

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.

Was the care at issue “reasonable”?

Did the care adversely impact the patient’s outcome?

Assessment and Direction

Investigation and Analysis of Risk and Value

Medical Committee(3 months after notice)

Legal OfficeAssign to Counsel

Litigate

Claims CommitteeSettle or Trial?

Engage Patientand

Share Information

Agree no Claim

Agree to Disagree

Mistake/Injury

No Dialogue

Litigation

Settlement

← Pre Suit →

Medical Committee(3 months after notice)

Peer Review Clinical Quality Improvement

Educational Opportunities

Assessment and Direction

Investigation and Analysis of Risk and Value

Biggest Barrier:

Fear

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

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

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

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”

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

Gloria Steinem