Disclosing Medical Errors: 2008 and Beyond

Wendy Levinson, MDProfessor of MedicineUniversity of Toronto

Goals

1. To describe physicians’ attitudes and experience re disclosure.

2. To describe changing regulatory and legal environment in North America.

3. To anticipate changes over the next five years.

Patient Attitudes Regarding Disclosure of Errors

• Want full information about error: What happened? How? Consequences and management?

• Prevention of future errors

• Apology

• Fear professionals hiding information

JAMA 2003

Physician Attitudes in US & Canada

• Survey of 4,500 physicians; 63% response

• Canada national sample; US Washington and Missouri

• Content a) attitudes b) sample scenarios c) Impact of errors on physicians

Arch Intern Med 2006

General Attitudes About Patient Safety

Statement % Agree Country Difference

Specialty Difference

“Medical errors are one of the most serious problems in health care.”

64% - -

“Medical errors are usually caused by failures of care delivery systems, not the failure individuals.”

50% - *(lower in surgery)

“Disclosing a SERIOUS error would make it less likely that the patient would sue me.”

66% agree - *(lower in surgery)

General Attitudes About Disclosure

Statement % Agree Country Difference

Specialty Difference

“NEAR MISSES should be disclosed to patients.” 35% *

(lower in US)*

(lower in surgery)

“MINOR errors should be disclosed to patients.” 78% - -

“SERIOUS errors should be disclosed to patients.” 98% - -

What Would They Disclose?

• 42% use the word “error”; 56% “adverse event”

• 50% provide specific details (13% only if asked)

• 61% express regret; 31% apologize

• Few describe future error prevention plans

• Less likely to disclose information if error is not apparent

Disclosure Experiences of Physicians

• 58% had disclosed a serious error

• 85% satisfied with most recent disclosure conversation

• 74% reported a positive effect on the relationship

Have Errors Impacted Your Life?

Residents Attendings

Your job satisfaction 34.6% 42.1%

Your confidence in your ability as a physician

45.4% 47.2%

Your professional reputation

11.9% 12.6%

Your anxiety about future errors

64.9% 60.5%

Your ability to sleep 24.3% 40.3%

Criteria for Judging Disclosure

• Explanation of medical facts

• Honesty and truthfulness

• Empathy

• Apology

• Prevention of future errors

JAMA 2003

Wrong Side Breast Surgery

● Mrs. Jones is a 48 year old woman on which you

performed a left lumpectomy and axillary dissection for

a malignant lesion

● The final pathology specimen is benign. You realize

that you made a mistake labeling the biopsy

specimens and operated on the wrong breast

● You are about to meet with Mrs. Jones two weeks

post-operative

Surgeons scores on individual items

Error case Explanation Honesty Empathy PreventionGeneral

Communication skills

Wrong-side lumpectomy (n=20)

4.15 4.13 3.65 2.30 4.00

Retained surgical sponge (n=20)

4.20 3.88 3.83 1.75 4.08

Hyperkalemia-induced arrhythmia (n=20)

3.93 3.85 3.58 2.40 3.78

Surgery 2005

Bottom Line in 2006

• Physicians still uncertain of how open to be

• Worried about malpractice

• Don’t have specific training

• High degree in interest in disclosure

Development of Standards

• 2001: Joint Commission standard on disclosure of “unanticipated outcomes”

• 2006: Harvard Hospitals publish “When Things Go Wrong”

• 2006: NQF Safe Practice

NEJM 2007

Key Elements of the Safe PracticeContent to be disclosed to patient

• Provide facts about the event• Presence of error or system failure, if known• Results of event analysis to support informed

decision making by the patient

• Express regret for unanticipated outcome

• Give formal apology if unanticipated outcome caused by error or system failure

Key Elements of the Safe PracticeInstitutional requirements

• Integrate disclosure, patient-safety, and risk management activities

• Establish disclosure support system• Disclosure education• Ensure disclosure coaching is available • Provide emotional support for health care workers,

administrators, patients, and families

• Use performance-improvement tools to track and enhance disclosure

Why is Safe Practice a Big Step Forward?

• Frames disclosure as a safety and improvement issue

• Recognizes challenging conversation and provides support

• Includes expression of apology

• Encourages performance improvement and tracking

Legal Context

• Standards for disclosure vs. concern about increase in malpractice

• Legal system designed to assign fault

“Apology Laws”

• 35 states have “Apology Laws”

• 26 protect expression of remorse• 6 remorse plus explanation• 4 disclosure plus apology (includes admission of

fault)

• 9 states have laws that mandate disclosure of serious unanticipated outcomes

Impact on malpractice?

T. Gallagher, personal communication

Prominent Disclosure Programs

• VA (Lexington)

• U of Michigan – reported decrease in claims and costs

• COPIC in Colorado

Key Elements for COPIC’s 3R’s Program

Key Features:• Disclosure linked to no-fault compensation for patient’s

out-of-pocket expenses (up to $30,000)• Disclosure training for physicians• Exclusion criteria: death, clear negligence, attorney

involvement, complaint to state board, written demand for payment

• Disclosure coaching for physician and case management for patient provided by 3R’s administrators

• Payments not reportable to National Practitioner Data Bank

Summary

1. Evolving legal environment.

2. Experiments report no impact or a decrease in malpractice claims and costs.

3. Very little evaluation of these new disclosure programs.

2008 and Beyond

1. Training programs for physicians and other health professionals

• Standardized patients for practice and feedback

2008 and Beyond

2. Institutional supports as outlined in the “Safe Practice”

2008 and Beyond

3. Evidence of Impact• Patient safety improvements• Process of care• Patient satisfaction and trust• Malpractice

2008 and Beyond

4. Change in culture over time from blame and shame to transparency and quality improvement

References

1. Gallagher TH, Studdert D, Levinson W. Disclosing harmful medical errors to patients: recent developments and future direction. N Engl J Med. 2007 356 (26): 2713-2719.

2. Gallagher TH, Waterman MD, Garbutt JM, Krygiel JM, Chan DK, Dunagan WC, Fraser VJ, Levinson W. United States and Canadian physician’s attitudes and experiences regarding disclosing errors to patients. Arch Intern Med, August 2006;166:1605-11.

3. Gallagher TH, Waterman A, Weikal R, Flum D, Levinson W, Fraser V, Waterman B. Choosing your words carefully: How physicians would disclose harmful medical errors to patients. Arch of Intern Med 2006; 166(15):1585-93.

4. Chan DK, Gallagher TH, Reznick R, Levinson W. How surgeons disclose medical errors to patients: a study using standardized patients. Surgery 2005;138(5):851-58.

5. Gallagher T, Waterman AD, Ebers AG, Fraser V, Levinson W. Patients’ and Physicians’ Attitudes Regarding the Disclosure of Medical Errors. JAMA 2003;289(8):1001-07.