1. Disclosing Medical Error to Patients
Konrad C. Nau, MD,FAAFP,CPE
Professor and Chair, Department of Family Medicine
WVU Health Sciences Center-Eastern Division

2. Objectives Review the incidence of error
Explore the obligation of error disclosure
Discuss the evidence about physician and patient expectations of error disclosure
Enumerate the risks & benefits of medical error disclosure
Learn an effective method of disclosing medical error to patients

3. Patient Safety vocabulary
Medical Error
Failure of a planned action to be completed as intended
Use of a wrong plan to achieve an aim.
Adverse Event
Injury that results from medical care
Not a part of the natural disease process

4. Medical Errors & Adverse Events
Non-preventable
Medical Errors AE
Near
Miss
Preventable AE
Serious Medical Errors

5. Error Happens
The commitment of medical errors is “ an inevitable accompaniment of the human condition”
Lucian Leape JAMA 1994
Medicine is a “probabilistic science”
Complex systems of care

6. Location of Medical Care/Error

7. Incidence of Medical Error
Intensive Care Units
20% of ICU pts had an Adverse Event
45% were preventable
13% were life threatening or fatal
15 serious errors/100 patient-days
11% potentially life threatening
61% occurred during execution of medication treatments
Slips and lapses were most common reason
Crit Care Med Aug;33(8):
Crit Care Med Aug;33(8):
The Critical Care Safety Study: The incidence and nature of adverse events and serious medical errors in intensive care. Rothschild JM, Landrigan CP, Cronin JW, Kaushal R, Lockley SW, Burdick E, Stone PH, Lilly CM, Katz JT, Czeisler CA, Bates DW. Divisions of General Internal Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA. OBJECTIVE: Critically ill patients require high-intensity care and may be at especially high risk of iatrogenic injury because they are severely ill. We sought to study the incidence and nature of adverse events and serious errors in the critical care setting. DESIGN: We conducted a prospective 1-year observational study. Incidents were collected with use of a multifaceted approach including direct continuous observation. Two physicians independently assessed incident type, severity, and preventability as well as systems-related and individual performance failures. SETTING: Academic, tertiary-care urban hospital. PATIENTS: Medical intensive care unit and coronary care unit patients. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcomes of interest were the incidence and rates of adverse events and serious errors per 1000 patient-days. A total of 391 patients with 420 unit admissions were studied during 1490 patient-days. We found 120 adverse events in 79 patients (20.2%), including 66 (55%) nonpreventable and 54 (45%) preventable adverse events as well as 223 serious errors. The rates per 1000 patient-days for all adverse events, preventable adverse events, and serious errors were 80.5, 36.2, and 149.7, respectively. Among adverse events, 13% (16/120) were life-threatening or fatal; and among serious errors, 11% (24/223) were potentially life-threatening. Most serious medical errors occurred during the ordering or execution of treatments, especially medications (61%; 170/277). Performance level failures were most commonly slips and lapses (53%; 148/277), rather than rule-based or knowledge-based mistakes. CONCLUSIONS: Adverse events and serious errors involving critically ill patients were common and often potentially life-threatening. Although many types of errors were identified, failure to carry out intended treatment correctly was the leading category.

8. Incidence of Medical Error
Hospitals
3.7% of admissions experience iatrogenic AE
28% of AE due to negligence
14% of AE lead to death
N Engl J Med Feb 7;324(6):370-6.
6.5 Adverse Drug Events/100 admissions
Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Division of General Medicine, Brigham and Women's Hospital, Boston, MA BACKGROUND. As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. METHODS. We reviewed 30,121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. RESULTS. Adverse events occurred in 3.7 percent of the hospitalizations (95 percent confidence interval, 3.2 to 4.2), and 27.6 percent of the adverse events were due to negligence (95 percent confidence interval, 22.5 to 32.6). Although 70.5 percent of the adverse events gave rise to disability lasting less than six months, 2.6 percent caused permanently disabling injuries and 13.6 percent led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi 2 = 21.04, P less than ). Using weighted totals, we estimated that among the 2,671,863 patients discharged from New York hospitals in 1984 there were 98,609 adverse events and 27,179 adverse events involving negligence. Rates of adverse events rose with age (P less than ). The percentage of adverse events due to negligence was markedly higher among the elderly (P less than 0.01). There were significant differences in rates of adverse events among categories of clinical specialties (P less than ), but no differences in the percentage due to negligence. CONCLUSIONS. There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

9. Incidence of Medical Error
Ambulatory clinics
Medline/Embase review
Medical error in 5 – 80 /100,000 visits
Mostly diagnosis and treatment related
Prescription errors identified in 11% of all prescriptions
Mostly dose related
Fam Pract Jun;20(3):231-6
1: Fam Pract Jun;20(3):231-6.Related Articles, Links   The frequency and nature of medical error in primary care: understanding the diversity across studies. Sandars J, Esmail A. School of Primary Care, University of Manchester, Walmer Street, Manchester M14 5NP, UK. BACKGROUND: The identification and reduction of medical error has become a major priority for all health care providers, including primary care. Understanding the frequency and nature of medical error in primary care is a first step in developing a policy to reduce harm and improve patient safety. There has been scant research into this area. OBJECTIVES: This review had two objectives; first, to identify the frequency and nature of error in primary care, and, secondly, to consider the possible causes for the diversity in the stated rates and nature of error in primary care. METHODS: Literature searches of English language studies identified in the National Patient Safety Foundation bibliography database, in Medline and in Embase were carried out. Studies that were relevant to the purpose of the study were included. Additional information was obtained from a specialist medico-legal database. RESULTS: Studies identified that medical error occurs between five and 80 times per consultations, mainly related to the processes involved in diagnosis and treatment. Prescribing and prescription errors have been identified to occur in up to 11% of all prescriptions, mainly related to errors in dose. There are a wide variety of definitions and methods used to identify the frequency and nature of medical error. Incident reporting, systematic identification and medico-legal databases reveal differing aspects, and there are additional perspectives obtained from GPs, primary health care workers and patients. CONCLUSION: An understanding of the true frequency and nature of medical error is complicated by the different definitions and methods used in the studies. Further research is warranted to understand the complex nature and causes of such errors that occur in primary care so that appropriate policy decisions to improve patient safety can be made.

10. Incidence of Medical Error
Ambulatory clinics
Risk management database study
8 academic clinics over 5.5 years
3.7 reported Adverse Events / 100,000 visits
23% caused permanent disabling injury
3% caused death
83% were preventable
J Fam Pract Jul;45(1):40-6.
J Fam Pract Jul;45(1):40-6.Related Articles, Links Comment in:
J Fam Pract Jul;45(1):38-9.
Adverse events in primary care identified from a risk-management database. Fischer G, Fetters MD, Munro AP, Goldman EB. University of Rochester, New York, USA. BACKGROUND: The inevitability of adverse events in medicine arises from human fallibility, negligent care, limits of medical knowledge, risks inherent in medical practice, and biological variability among individuals. A better understanding of the nature and causes of adverse events is necessary to reduce their occurrence and limit their harm. This study describes adverse events identified from a risk-management database that occurred in an out-patient primary care setting. METHODS: Incident reports filed with the risk-management office of an academic medical center between January 1, 1991, and June 30, 1996, by eight primary health care clinics affiliated with the center were eligible for the study. Two independent reviewers assessed the incidents to determine whether there were adverse medical events. Incidents classified as adverse events were analyzed to determine the cause, potential preventability, and outcome. RESULTS: The prevalence of adverse events was 3.7 per 100,000 clinic visits over a period of 5 1/2 years. Twenty-nine of 35 (83%) adverse events were due to medical errors and were considered preventable. The causes of the adverse events included 9 diagnostic errors (26%), 11 treatment errors (31%), and 9 other errors (26%). Of the adverse events attributed to medical errors, 4 (14%) resulted in a permanent, disabling injury and 1 (3%) resulted in a death. CONCLUSIONS: Serious adverse events appear to occur infrequently in primary care outpatient practice, although these data probably underestimate the overall prevalence. To reduce or prevent the occurrence of adverse events in primary care, better systems for recognizing and tracking them and for assessing their causes are needed.

11. Personal Experience of Medical Error
Harvard School of Public Health,2002,
Medical Errors: Practicing Physician & Public Views

12. Medical Error Perception
Harvard School of Public Health,2002,
Medical Errors: Practicing Physician & Public Views

13. Disclosure of Medical Error

14. Obligation for Error Disclosure
“The man is a doctor….Where else but in medicine do you find men and women who never admit a mistake? Who talk more than they listen, and feel entitled to withhold crucial information?”
Marjorie Williams
Washington Post, December 2003
Commentary on Howard Dean, MD and his US Presidential bid.

15. Sources for Obligation of Error Disclosure
AMA Code of Medical Ethics
American College of Physician’s Ethics Manual
Consequentialist Theory
Deontological Theory or Principalism

16. AMA Code of Medical Ethics
When a patient experiences significant medical complications that may have resulted from the physician’s mistake or judgment:
the physician is ethically required to inform the patient of all the facts necessary to ensure understanding of what has occurred,
so as to enable the patient to make informed decisions regarding future medical care
Council on Ethical and Judicial Affairs. (1997)

17. American College of Physicians
“physicians should disclose to patients information about procedural or judgment errors made during care
if such information is material to the patient’s well-being “
ACP Ethics Manual (1998)

18. American College of Physicians
Although medical errors do not necessarily constitute improper, negligent, or unethical behavior,
failure to disclose them are all three.
ACP Ethics Manual (Annals Int Med 1998) 
Ritchie JH, Davies SC (BMJ 1995)

19. AMA & ACP Ethics
Professional groups clearly mandate disclosure of “significant” medical error
Unclear about obligation to disclose “minor errors”
Minor = errors without material consequence to patient’s well being.

20. Consequentialist Theory
Supports behavior that maximizes net good
Requires specifying harms and benefits to a specifically identified moral group
Problem: multiple moral groups are involved in medical error
Patient
Physician
Nurse
Hospital Administration
Consiconsequentialism, argues that some overall ranking of goods always determines what one ought to do
Considderation of benefits for moral groups other than the patient are generally, but not always, considered inappropriate.

21. Consequentialist Theory
Medical Error Case:
During a weekend checkout mixup, Resident A
mistakenly orders laxative for Patient X, instead
of Patient Y. Patient X has several diarrhea stools
during the night.
Rosner, Arch Int Med 2000.
Patient: Reassured no new disease starting, diarrhea will stop soon. Could lose confidence in doc/nurse/hospital. Could become distressed and seek more competent providers.
Doc/Nurses: don’t want to enter as ADE and have it count against them. Fear patients trust will undermine their larger therapy plan.
Hospital: could represent an opportunity for a FMEA or Root Cause Analysis about weekend “hand offs”
What do you disclose (and to whom) on morning rounds?

22. Deontological Theory or Principalism
Deontological theories hold that some rights must not be violated even if it would produce the most overall good.
Principles in Tension
Principle of Patient Autonomy
Freedom to choose
Informed Consent principle
Principle of Non-maleficence
Legal/ethical term for “Do no harm”
Similar to medical term “primum non nocere”
Deon = obligation
Deontology = theory of duties

23. "Primum non nocere" “First do no harm” (Latin)
Roman physician Galen
Introduced to US and British medicine in 1860
“As to disease make a habit of two things — to help, or at least to do no harm. The art consists in three things - the disease, the patient, and the physician.”
Hippocrates in Epidemics, Book 1
Not in the Hippocratic Oath

24. Medical Error: Pt Autonomy & "Primum non nocere"
Did the error harm the patient ?
Significant / serious
Minor
Will disclosure promote patient autonomy?
Empowered to make therapy or provider choices
Will disclosure of the error harm the patient ?
Emotional distress
Erode patient trust

25. Error Disclosure: Physicians
Physicians generally feel they SHOULD disclose medical error (iatrogenic incident)
70% of European Intensivists (Vincent,1998)
80% of MSIV and Residents (Sorokin,2005)
71% of Emergency Physicians (Hobgood,2005)
___% of Family Physicians (Gallagher,2003)
1: Acad Emerg Med Apr;13(4): Epub 2006 Mar 10.Related Articles, Links
  Medical error identification, disclosure, and reporting: do emergency medicine provider groups differ? Hobgood C, Weiner B, Tamayo-Sarver JH. Department of Emergency Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. OBJECTIVES: To determine if the three types of emergency medicine providers--physicians, nurses, and out-of-hospital providers (emergency medical technicians [EMTs])--differ in their identification, disclosure, and reporting of medical error. METHODS: A convenience sample of providers in an academic emergency department evaluated ten case vignettes that represented two error types (medication and cognitive) and three severity levels. For each vignette, providers were asked the following: 1) Is this an error? 2) Would you tell the patient? 3) Would you report this to a hospital committee? To assess differences in identification, disclosure, and reporting by provider type, error type, and error severity, the authors constructed three-way tables with the nonparametric Somers' D clustered on participant. To assess the contribution of disclosure instruction and environmental variables, fixed-effects regression stratified by provider type was used. RESULTS: Of the 116 providers who were eligible, 103 (40 physicians, 26 nurses, and 35 EMTs) had complete data. Physicians were more likely to classify an event as an error (78%) than nurses (71%; p = 0.04) or EMTs (68%; p < 0.01). Nurses were less likely to disclose an error to the patient (59%) than physicians (71%; p = 0.04). Physicians were the least likely to report the error (54%) compared with nurses (68%; p = 0.02) or EMTs (78%; p < 0.01). For all provider and error types, identification, disclosure, and reporting increased with increasing severity. CONCLUSIONS: Improving patient safety hinges on the ability of health care providers to accurately identify, disclose, and report medical errors. Interventions must account for differences in error identification, disclosure, and reporting by provider type.

26. Error Disclosure: Physicians
But……
Fewer Physicians actually DO or WOULD disclose an iatrogenic incident
30% in general (Rosner,2000)
32% of European Intensivists tell patients/families (Vincent,1998)
24% of House Officers tell patients (Wu, 1997)
54% of House Officers tell attendings (Wu, 1997)

27. Error Disclosure: Patients
Most Patients Desire Disclosure
76% of Emergency Dept patients (Hobgood,2002)
98% of California Internal Medicine pts (Witman,1996)
98.8% of New England Health Plan pts (Mazor,004)
99% of parents of North Carolina Pediatric pts (Hobgood,2005)
Acad Emerg Med Nov;9(11): Related Articles, Links
Medical errors-what and when: what do patients want to know? Hobgood C, Peck CR, Gilbert B, Chappell K, Zou B. Department of Emergency Medicine, UNC School of Medicine, Chapel Hill, NC 27599, USA. OBJECTIVES: 1) To determine how and when emergency department (ED) patients and their families wish to learn of health care errors. 2) To assess the error threshold this population believes should trigger reporting to government agencies, state medical boards, and hospital patient safety committees. 3) To evaluate the role patients and families believe medical educators should play in this process. METHODS: A 12-item survey was administered to a convenience sample of ED patients and families during evaluation in a tertiary care academic ED. Results were tabulated and data were reported as percentages. Statistical significance was analyzed using the chi-square test. RESULTS: 258 surveys were returned (80%). A majority of respondents wished to be informed immediately of any medical error (76%) and to have full disclosure of the error's extent (88%). An overwhelming majority of respondents endorse reporting of errors to government agencies (92%), state medical boards (97%), and hospital committees (99%). Most respondents believe medical educators should focus on teaching students to be honest and compassionate (38%) or on how to tell patients about mistakes (25%). The frequency of hospital admission or physician visits per year had no impact on any response pattern (ns with chi(2) test). CONCLUSIONS: Regardless of health care utilization, a majority of respondents want full disclosure of medical error and wish to be informed of error immediately upon its detection. Respondents support reporting of errors to government agencies, the state medical board, and hospital committees focused on patient safety. Teaching physicians error disclosure techniques, honesty, and compassion were endorsed as a priority for educators who teach error management.

28. Error Disclosure: Patients
Harvard School of Public Health,2002,
Medical Errors: Practicing Physician & Public Views

29. Effects of Non-Disclosure
When patients learn of error from someone other than physician they feel:
Anger
Bitterness
Betrayal
Sense of humiliation
Loss of trust
Suspicion of cover-up

30. The Disclosure & Apology Gap
Disclosure and Apology
Only occurs 30% of the time
Most doctors feel they
should disclose error.
Nearly all patients want
to be told about errors

31. Apology Disclosure Apology Ethical obligation Informed Consent
Truth Telling
Involves telling what happened
Apology
Therapeutic obligation
Allows patient healing
Allows doctor healing
Allows patient to recognize our humanity
Involves expressing you are sorry

32. Apology Case: Physician orders penicillin for patient
allergic to amoxil and patient has anaphylaxis
requiring ICU treatment.
3 apologies : what do they really say ?
“I’m sorry that you had to go through that reaction.”
“I’m sorry I ordered the penicillin, but I was up all night and I guess I was tired.”
“I’m sorry I ordered the penicillin that we know you are allergic to.”
I’m sorry that this happened to you. Lacks remorse and acceptance of responsibility.
An apology statement should never include the word “but”..it dilutes the value of the apolgy and sounds like fingerpointing.
Clear expression of remorse and acceptance of responsibility.

33. Why the Disclosure Gap Apology is hard to do
Medical errors are often complex
Lack of physician training in this special communication skill
Fear of loss of reputation
Fear of causing emotional damage to the patient
Fear of increasing liability/lawsuits

34. The Process of Disclosing Medical Error to Patients

35. Western Cultural Expectations in Errors (Berlinger & Wu ,J Med Ethics 2005)
Confession
Full disclosure to the patient
Repentance
Apologize
What will be done to prevent recurrence
Forgiveness
Physicians need to forgive themselves so that learning from the incident and healing can begin.
Foundation laid for possible future patient forgiveness of the physician.
The Judeo Christian traditions of Confession,Repentance, and Forgiveness are embedded ibto the cultural fabric of many in the US.

36. What Patients Desire After Medical Error
What happened ?
Full immediate disclosure
Apology
Sincere remorse
Medical +/- financial compensation
How will patient get through this
What is being done to prevent future errors?
Sense that their tragedy may help others

37. Error Disclosure Process
Prepare for the meeting
Disclose the Error
Apologize
Establish a medical +/- fiscal plan
Outline how future similar errors will be prevented

38. 1. Prepare for the Disclosure
Get your facts straight
Discuss significant errors with colleagues who can assist you (Risk Mgr., VPMA)
Notify your liability carrier
Set the scene
Private
Give patient option for support to be present
Interruption free

39. 2. Disclose the Error DO Maintain “open body language”
First fire a warning shot.
Simply state the error in layman’s terms.
Stop talking…and let the patient react.
Answer the patient’s questions
Touch patient -“hands - elbows area”

40. 2. Disclose the Error DO NOT Adopt “closed body posture”
Use medical jargon
Forget to BE QUIET
Get defensive about questions
Guess at facts you are not absolutely certain about
Inappropriately touch the patient by patting on the head or shoulder

41. 3. Apology DO Make a sincere apology Take responsibility DO NOT
Make excuses. “I’m sorry, but………”
Finger point
Blame others

42. 4. Establish medical +/- fiscal plan
How will the harm be treated
Empower the patient
Choice for second opinion/consultant
Possible transfer of care may be entertained
Financial Plan
May come in later conversations
How will medical bills from this incident be handled
Will there be a negotiated payment for “injury”
Open the door for another meeting
Financial promises should only be made by the people who can make them happen. Don’t promise “no charges” etc. unless the hospital and involved parties are all willing and committed to doing so. Risk Managers and hospital or clinic administration should be very involved in this process with the physician.

43. 5. How will future errors be prevented
Gives patients a sense that someone else might be helped as result of their tragedy
Will you be doing a Root Cause Analysis ?
Give them a sense of timeframe for your actions

44. Medical Disclosure BENEFITS RISKS
Makes the process more “human” for physician and patient
May reduce needless litigation for mal-outcome and minor errors
RISKS
Patient will suspect “cover-up” if disclosure facts are not complete and truthful.
You may feel disappointed if you don’t prevent litigation in gross negligence that results in death or major disability.

45. Optimal Role of your Organization
Set an institutional expectation that patients are entitled to disclosure and apology
Train staff in communicating about adverse events
Develop support systems
For the injured patient
For the “the second victims of medical error” (the professionals who contributed to the error)

46. Conclusion “The most fruitful lesson is the conquest of
one’s own error.
Whoever refuses to admit error may be a great scholar but he is not a great learner.
Whoever is ashamed of error will struggle against recognizing and admitting it, which means that he struggles against his greatest inward gain.”
Goethe, Maxims and Reflections