Alternative Risk Transfer Programs

Frightening Times, Risky Conversations: Handling Disclosure Presented by

Susan Shepard, RN, MSN, CPHRM Director, Patient Safety Education

The Doctors Company

January 23-24, 2008 San Diego County Medical Society

We would like to disclose that

Susan Shepard has no financial interests in any organizations that have a direct interest in the subject matter of this CME presentation.

This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of OHIC Insurance Company and The Doctors Company. The OHIC Insurance Company is accredited by the ACCME to sponsor continuing medical education for physicians. The OHIC Insurance Company designates this educational activity for a maximum of 2.0 category 1 credits towards the AMA Physician’s Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity.

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Objectives After the presentation, the participant will be able to:  Describe three consequences of concealing an injurious medical error  Identify two ways in which error is defined and how they effect disclosure  Describe three considerations which should be reviewed and clarified prior to initiating a disclosure communication 3

Where Are We Now?  Admissions of liability prior to case review  Settlement on cases deemed defensible  Patients believing injury = negligence  Disclosures made on basis of  Individual opinion  Timing to meet physician’s need  Lack of perspective

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Launching The Doctors Company Program  Choice:  Join the current approach, or  Bring a new perspective to the problem

 Response:  Include lessons learned from claims, RM and litigation  Clarification by types of adverse outcomes

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Why a New Approach is Needed:  After many publications and presentations over the past 7 years, disclosure continues to be avoided and often mismanaged  National guidelines do not include the experience and contribution from RM, Claims and Med Mal Defense  Despite best intentions, current published recommendations have rendered the process more chaotic, not consistent

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The Political Climate Problem  Framing as ethical/moral prescription not open to debate or discussion  Advice provided from sectors that do not struggle with securing professional liability insurance coverage or NPDB reporting  Assertions that immediate disclosure including conjecture, near-misses, and information on how to sue will improve physician-patient relationships and decrease lawsuits—data LIMITED

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What Is Not Discussed  We have seen claims resulting from inaccurate, premature and inappropriate disclosures  Our old nemesis—gratuitous criticism of one provider by another—is now dressed up in Sunday clothes as “ethical duty to disclose”

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Apology Conveyed as Admission of Liability  “I made a negligent mistake that directly injured you”  Plaintiff does not need an expert witness  Defense of care becomes nearly impossible

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Clarification Needed:  Physicians ask “Is every bad outcome an error and is every error negligence?”  Current disclosure initiatives have avoided including any clarification about negligence.

Such clarification can add confidence to the process

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How Did We Get Here?

1. IOM report and definition of error 2. JCAHO communication standard 3. Veterans Administration Approach 4. A Patient Safety and Disclosure process that limited input from RM, Claims and Defense Bar

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1. IOM Definition of Error  “The failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim”

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2. JCAHO Standard Communication  Disclose “To patient and, when appropriate, family members when outcomes differ from those anticipated”

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A Workable Definition of Error  We looked to the National Quality Forum consensus report on Standardizing a Patient Safety Taxonomy  The NQF project was completed in partnership with AHRQ, the Department of Veterans Affairs, the California HealthCare Foundation and building from the JCAHO Patient Safety Event Taxonomy (PSET)

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Definition Problem Addressed:  NQF Definition “Error: Failure to perform a task satisfactorily against customary standards and the failure cannot be attributed to causes beyond the patient or providerâ€?

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Emerging Concerns  In Medical Errors and Medical Narcissism John Banja has a section on “Defining Medical Error: A Better Definition” and, after analysis he concludes that the definition of medical error he will use for the remainder of the book is--“An error is an unwarranted failure of action or judgment to accommodate the standard of care”

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Litigation Definition  Standard of care:  Prevailing practice; expert opinion  Evaluated based on what was known and done by the physician at the time care provided; not dependent on outcome.

 IOM and JCAHO language based on outcomes  Increasing appreciation that we need to return to a definition of error that does not presume all bad outcomes qualify

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3. The VA Lexington Strategy  Provide information on how to sue at first disclosure  Report everything including near-misses  This is required for improving safety  Their data show decreased litigation exposure  New England VA Presentation in 2000 and resulting claims

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Claims After Presentations  High-ranking M.D.-Admin “Get a lawyer”-now on plaintiff witness list  Failed sterilization procedure  New allergy case  Hindsight bias chest x-ray case

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Why Did We See Such Chaos?  Unclear definitions  Confused concepts  Advice offered from a sector functioning in a different set of circumstances  No input from Risk, Claims, Litigation

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The Federal Tort Claims Act Litigation related to medical care at the VA:  Government health care providers are protected from personal liability and being named in negligence actions  2 year SOL, bench trial, no punitive damages  No need to secure liability insurance  Minimal NPDB reporting  Pension benefits available to anyone who cannot return to work after medical injury

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Clarification Needed:  Current disclosure initiatives have avoided including any clarification about negligence.

Such clarification can add confidence to the process

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When Physicians Ask, “Are all bad outcomes errors and are all errors negligence?” and When clinicians and organizations believe there is an ethical obligation to disclose that “negligence” occurred or that they should advise the family to consult an attorney, then Clarifying the elements of negligence is helpful

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Negligence Duty to patient Breach in standard of care Proximate cause of Injury: clarifying terms and concepts

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Er ro r

Br ea SO ch in C

Ad o u ve tco rse m e

Clarifying Terms and Concepts

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Er ro r

Br ea SO ch in C

Ne gli inj ge ur nt y

Ad o u ve tco rse m e

Negligence

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Preliminary Classification 

Most cases, at early disclosure are: 

Medical or system error



Known risk/complication or unforeseeable event



New diagnosis of late-stage disease or unexplained change in patient status (challenge of avoiding hindsight and outcome bias)

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TDC Disclosure Premise  All communications following unexpected bad outcomes need to be compassionate and forthright  Apology after a medical error should have quality and content different from the communication after known risk/complication, unforeseeable, or unknown cause.

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Adverse Outcome

Event Recognition

Immediate Response

Objective Perspective Preliminary Classification

• Clinical response to medical event • Documentation of medical facts

• Preserve evidence for analysis • Review of medical facts with patient/family

Preliminary case review/report: patient safety, claims, colleague/expert

Known risk/complication or unforeseeable event

*Error affecting patient Unexplained change in patient status or new diagnosis of late-stage disease

Investigation Reviews

Sentinel event RCA Patient Safety Activity

Review and evaluation for preventability Informed consent process review Morbidity and Mortality Reviews • Sentinel Event – RCA • Internal/External Expert Reviews

Review Of Case with Patient/ Family

Disclosure • Event details • Effect of error • Apology • Future prevention • Ongoing support

*It is imperative to disclose patient injury due to error.

Concealment of this critical information not only violates the patient/family right to know, it also fuels punitive responses from judges and juries, increases the amounts of settlements and jury awards, and can extend the statute of limitations indefinitely.

Event Reclassification

• Case review with patient/family • Continuous care improvement • Review of informed consent

Case Review with Patient/Family • Findings of medical review/ investigation • Summary of case understanding

Matson Sewell 2/12/07 29

Care Evaluation  Standard of Care – prevailing practice  Evidence-based medical care: RCTs e.g., HRT  “Best Practice” e.g., Universal Protocol to avoid wrong surgery  Acceptable variations in practice

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Overview on Disclosure  It is difficult, often very painful communication  From my experience, common pitfall (test this through the wisdom of your own experience)  Keep it smaller, less formal, less administrative, more woven into the process of providing care  Larger, formal, structured meetings (every stakeholder demanding representation at the meeting) often backfires

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Who Needs What and When?

Need

A=Physician need to disclose B=Patient need to hear A

B

Time 32

Cases We Have Known (and Not Loved)  Failure to disclose injury due to error  Admission of liability when care was fine  Criticism of care by another specialty  Disclosure timing based on physician’s need  A disclosure “task force” scheduling a large, formal meeting with family on a no-liability case— don’t be surprised if they cancel, no-show or bring an attorney

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Failure to Disclose Injurious Error  Wrong side surgery lawsuit--2 year old undergoing uretal reimplantation  Prone position-disorientation  Radiology studies not displayed in OR

 Parents initially told problem also found on the other side  Surgeon had to acknowledge error and concealment  Resulting events at trial 34

If MD’s Remember Nothing Else: If Injurious Error is Concealed 

Statute of limitations extended indefinitely



Violates patient right to know, AMA ethical guidelines, Joint Commission standard on communication, increasing regulatory requirements—SB 1301 in effect 7-1-07 in California (other states)

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Punitive response from judge and jury

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Increases the settlement amount or jury award

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Inappropriate Admission of Liability  18 month old with chronic otitis media  Trial of sulfa medication  Extreme allergic reaction  Apology and admission of liability— “To make sure this doesn’t happen again…”  Family refusal to pay post-insurance balance and threat of lawsuit

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Criticism of Care by Another Specialty  6-year-old boy admitted for abdominal pain  Deteriorates and admitted to PICU  Aggressive M. D. disagreement  PICU attending insists on surgery  Surgeon waits 36 hours—bowel perforated  PICU attending: “ethical duty to disclose”  Surgery Case Review results 37

Disclosure Timing to Meet M.D. Needs  22-year-old man with open tib/fib fractures  Following ORIF surgery surgeon notified  Sterilization failure on instrument pack  Insisting on disclosing immediately  Wait for ID review: Pall filter left out  No viral contagion concerns  Already on broad spectrum antibiotics 38

Conveying Information Over Time  Newborn died--? due to adverse drug reaction  Hydralazine not available  ACE inhibitor-Enaprilat-2nd line med  Rapid renal deterioration and death  Autopsy and case review  Not preventable the first time  Preventable the next time--actions taken

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Considerations Prior to Disclosure 1. What facts are known so far?

2. What reviews/analyses pending? When will results be available?

3. Do we know the impact on the patient? Can we clarify further quickly?

4. Is this a facility-based occurrence that should be coordinated through facility channels?

5. Is the patient aware of a problem?

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Considerations (cont.)

6. Is one specialist trying to disclose a criticism of another specialist’s care? Any conflicts of interest? Objective reviews to rely on?

7. What will the disclosure content be? Apology? Speak the words aloud before meeting with family.

8. Who will be the ongoing contact person for patient/family follow up?

9. Any prevention strategies to share yet?

10. WHO, WHAT, WHEN, WHERE, WHY

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TDC Disclosure Premise  All communications following unexpected bad outcomes need to be compassionate and forthright  Apology after a medical error should have quality and content different from the communication after known risk/complication, unforeseeable, or unknown cause

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After Investigation and Review  A case initially thought to represent a known risk/complication is discovered to be an error  Postoperative infection – medication administration record review indicates antibiotics not administered as ordered

 Newly recognized facts can be disclosed to patient/family without referencing the privileged/protected process

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View Disclosure Resources on Website  TDC Disclosure Policy and Program for the outpatient setting where hospital resources unavailable  Case scenarios in the different categories and communication tips and examples  Johns Hopkins streaming video  MITSS Program  State-by-state “I’m Sorry” legislation overview

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What’s Our Goal?

We Don’t Want:  Patients caught in the crossfire of personal or specialty politics or strategizing  To frighten patients with incomplete information when we can quickly fill in the gaps  Patients to hear difficult information at the worst time and in the worst way

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We Do Want :  To respect patients’ autonomy and selfdetermination and recognize they need to be accurately and objectively informed about their condition and treatment choices  To add to their understanding as more information becomes available, not disclose/retract

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Disclosure Checklist  Do we know what happened? What reviews have occurred?  Is further information pending? When will it be available?  Do we know the impact on the patient? Can we clarify further?  Patient/family status/timing issues (when)  Who should do the disclosing? (Conflicts of interest, communication style, relationship with patient/family, other issues) 47

Disclosure Checklist (cont.)  What will the disclosure content be? (rehearse, keeping in mind QA, attorney-client privileged and employee considerations)  Further input needed prior to disclosure?

(Outside reviews? Ethics consult, claims manager, attorney, leadership, etc.)  Any external reporting requirements? Do we anticipate media exposure? Billing adjustments?  Identify ongoing contact person for patient/family  Prevention strategies we can share?

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Key Points  Disclosure is not a simple either/or  Culture does not change overnight  Patients can be hurt by clumsy disclosure-timing, review, content, wording and perspective make a huge difference  Coaching, mentoring, practice, review needed

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Resources On The Doctors Company Website  TDC Disclosure Policy and Program for the outpatient setting where hospital resources unavailable  Case scenarios in the different categories and communication tips and examples  Johns Hopkins streaming video  MITSS Program  State-by-state “I’m Sorry” legislation overview

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Objectives: After the presentation, the participant will be able to:  Identify the steps to take after an adverse outcome occurs in the office setting  Describe the situations not covered by The Doctors Company Disclosure Program  Identify the three categories of adverse events

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The Doctors Company Disclosure Program  Patients have a right to be informed  Physicians have a responsibility to provide accurate, timely information  The Doctors Company encourages its insured physicians to cooperate with institutional disclosure programs  Physicians are encouraged to seek guidance  Physicians have a responsibility to avoid gratuitous blame and unsubstantiated speculation.

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Disclosure in the Physician Office  Adverse event definition  The usual feelings and concerns  Patients want to know  Disclosure requires open, honest communication and genuine expression of concern or even apology

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Basic Components  Physician disclosure of the event  Physician acceptance of overall responsibility for the patient’s care  Empathizing with the patient  Discussion of future consequences of the injury  Explanation of what will be done to prevent this from happening again

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Events Covered Under The Doctors Company Program  Only in non-JCAHO accredited facilities  Physician office practice or group practice

 Specifically, not for hospital in-patients  Add outpatient adverse events, resulting in patient injury are included

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Situations Not Covered by These Guidelines  When there is a written demand for compensation  When there is an attorney representing the patient  When the state medical board has been notified  When the event occurred in a hospital or Joint Commission-accredited setting

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Physician’s Immediate Response 1. First priority is to provide immediate clinical care to prevent further harm 2. Preserve the evidence 3. Document the basic medical facts 4. Meet with the patient/family 

When its OK to say, “I don’t know.”

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Help That’s Available  Examples of empathetic statements

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Next Steps 1. Meeting with the patient/family 2. Express regret 3. Focus on the patient’s current condition, steps taken, changes in treatment plan 4. Assure the family 5. Provide contact information 6. Arrange follow-up meeting

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Next Steps for Insured Physicians 1.Call The Doctors Company regional patient safety/risk manager 2.The PS/RM will provide you with a complete disclosure protocol

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Different Types of Adverse Events and What to Do in Each Case 1. Medical and/or system error 2. Known risk/complication of unforeseeable event 3. Unexplained change in patient status or new diagnosis of late-stage disease

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Disclosure Scenarios

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Johns Hopkins Video on Disclosure

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sshepard@thedoctors.com (800) 421-2368 x 1134

Our Mission is to advance, protect, and reward the practice of good medicine.

For additional patient safety information‌ Please visit our web site at: www.thedoctors.com 64