1. Program Information

2. Medical Errors James H. Paxton, MD, MBA Ilan Rubinfeld, MD, MBA, FACS
Henry Ford Hospital
Christine C. Toevs, MD, FACS Carilion Clinic

3. “I would give great praise to the physician whose mistakes are small for perfect accuracy is seldom to be seen” – Hippocrates ( BCE)
“Grant me the courage to realize my daily mistakes so that tomorrow I shall be able to see and understand in a better light what I could not comprehend in the dim light of yesterday” – Rabbi Moshe ben Maimon (aka Maimonides, CE)
“. . . even admitting to the full extent the great value of the hospital improvements in recent years, a vast deal of the suffering, and some at least of the mortality, in these establishments is avoidable.” – Florence Nightingale ( CE)

4. “To Err Is Human…”
Alexander Pope ( CE)

5. Medical Errors - Objectives
Terminology
Active vs. latent errors
Incidence
Theories of error
Disclosure of errors
Legal considerations
Conclusions

6. Common Non-Medical Definitions
Error: a misconception resulting from incorrect information (e.g., “she was quick to point out my errors”)
Mistake: a wrong action attributable to bad judgment, ignorance, or inattention (e.g., "he made a bad mistake“)
Erroneousness: inadvertent incorrectness
Error: a departure from what is ethically acceptable
Error: an incorrect statement (e.g., "the book was full of errors“)
Error (Computer Science): the occurrence of an incorrect result produced by a computer
Mistake: a wrong action attributable to bad judgment, ignorance, or inattention (e.g., "he made a bad mistake“)
Erroneousness: inadvertent incorrectness

7. Medical Error - Definitions
Medical Error (ME)
Failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim
Near Miss
An event or situation that could have resulted in an accident, injury, or illness but did not.
Medical Error (ME)
Failure of a planned action to be completed as intended or use of a wrong plan to achieve an aim
Can include problems in practice, products, procedures, and systems
Can lead to a near miss or preventable adverse event
Near Miss
An event or situation that could have resulted in an accident, injury, or illness but did not, either by chance or through timely intervention

8. Medical Error - Categories
A: No error, but potential for error
B: Error caught before med reached patient
C: Med reached patient; no harm
D: Increased monitoring; no harm
E: Temporary harm requiring intervention
F: Temporary harm requiring hospitalization
G: Permanent harm
H: Near death
I: Death

9. Medical Error - Aliases
Adverse event (AE)
Adverse outcome
Medical mishap
Unintended consequence
Unplanned clinical occurrence
Untoward incident
Adverse event (AE)
Adverse outcome
Medical mishap
Unintended consequence
Unplanned clinical occurrence
Untoward incident
Therapeutic misadventure
Bad call
Peritherapeutic accident
Sentinel event
Iatrogenic injury
Hospital-acquired complication

10. Adverse Event - Definition
Adverse Event (AE)
Injury caused by medical management resulting in measurable disability, not due to underlying illness
Types of AEs
Preventable = due to error
Unpreventable
Adverse Event (AE)
Injury caused by medical management resulting in measurable disability, not due to underlying illness
Types of AEs
Preventable = due to error
Negligence [legal term] = medical malpractice
Unpreventable
Cannot be prevented, given the state of current medical knowledge
Source: To Err is Human: Building a Safer Health System. Washington, DC: Institute of Medicine, 1999.

11. Legal Definitions Negligence Malpractice
“The failure to exercise the standard of care that a reasonably prudent person would have exercised in a similar situation.”
Malpractice
“An instance of negligence or incompetence on the part of a professional.”
Negligence
“The failure to exercise the standard of care that a reasonably prudent person would have exercised in a similar situation.”
“Does NOT include conduct that is intentionally, wantonly, or willfully disregardful of others’ rights.”
Malpractice
“An instance of negligence or incompetence on the part of a professional.”
“In order to succeed in a malpractice claim, the plaintiff must also prove proximate cause and damages.”
Source: Black’s Law Dictionary. 7th ed. (1999)

12. Medical Error - Types Slip/Lapse
Correct intervention, performed poorly
Mistake
Wrong intervention, proceeds as planned
Slip/Lapse
Correct intervention, performed poorly
“Error of Execution”
Slips are observable (external), lapses are not (internal)
Mistake
Wrong intervention, proceeds as planned
“Error of Planning”

13. Latent Error (Condition)
Systemic conditions conducive to the generation of active errors
Human errors
Latent errors may be hidden in computers or layers of management
Source: To Err is Human: Building a Safer Health System. Washington, DC:
Institute of Medicine, 1999.
Systemic conditions conducive to the generation of active errors, often following long periods of dormancy
“One of the greatest contributors to accidents in any industry, including health care, is human error. However, saying that an accident is due to human error is not the same as assigning blame because most human errors are induced by system failures.”
“Latent errors are difficult for the people working in the system to see since they may be hidden in computers or layers of management and people become accustomed to working around the problem.”

14. Latent Error - Examples
The reason that “blame and train” does not work is that there are underlying latent conditions that set you up to fail again: error-conducive situations or accidents waiting to happen (like this child with a full water glass). I won’t solve the problem by punishing her, but I have to look at how to solve the error-conducive situation.

15. Active Error (Failure)
Error with immediate adverse consequences
Current responses tend to focus on active errors
Source: To Err is Human: Building a Safer Health System. Washington, DC: Institute of Medicine, 1999.
Error with immediate adverse consequences, often a manifestation of latent errors within the system
“Current responses tend to focus on active errors. This is not always an effective way to make systems safer. If latent failures remain unaddressed, their accumulation actually makes the system more prone to future failure. Discovering and fixing latent failures and decreasing their duration are likely to have a greater effect on building safer systems than efforts to minimize errors at the point at which they occur.”

16. Active Error Latent Errors Proximate (Seminal) Cause
Root Cause Analysis
“Every system is perfectly designed to produce exactly the result it gets”
Root Cause Analysis: Pioneered by aviation/nuclear power generation. Process for “getting to the root of the problem.” Goal: redesign organization and processes for risk reduction (examples: CPOE to avoid dosage errors, name problems)
Systems: “every system is perfectly designed to produce exactly the result it gets.“ AEs are built into systems.
If you don’t change the underlying conditions that set up this error, the error will reproduce itself elsewhere, perhaps by someone else or manifested in a different way.
Goal: Look for common causes of errors; identify system problems and potential improvements, action plan, measurement strategy

17. Medical Error - Summary
Deviation from intended (correct) plan
(Active/Latent)
ERROR
ADVERSE
EVENTS
Preventable
Adverse Events
Incorrect plan
Slip/Lapse
Mistake
Negligence
Active Error: Erroneous decisions and actions that have immediate impact on system state.
Slips: Unintended deviations from the intended plan. You know what the right thing to do is, but you accidentally do something else.
Accidentally pour orange juice on your breakfast cereal; give bupropion instead of buspirone
Fatigue, distraction, multiple tasks
Mistakes: You accidentally do the wrong thing because of poor judgment, education deficiency, incomplete information.
Not being able to program the VCR; ordering an antibiotic without knowing that the patient is allergic to it; thinking the patient has pneumonia when he/she has CHF
Omissions:
Forgetting something important; DVT prophylaxis; an important medication
AEs: Injury caused by treatment resulting in prolongation of hospital stay or measurable disability at discharge.
AEs that are NOT preventable: e.g., neutropenia after chemotherapy or other predictable reactions to medications
Preventable AEs: 70% (from Brenna TA 1991, Harvard Medical Practice Study)
Negligence: physician-patient relationship is primary determinant of malpractice suits.
Omission
Plan not attempted

18. Medical Error - Incidence
Estimated 44,000-98,000 patients die from medical errors annually in the US
8th leading cause of death in the US
Medical errors are costly
Source: To Err is Human: Building a Safer Health System. Washington, DC: Institute of Medicine, 1999.
Estimated 44,000-98,000 patients die from medical errors annually in the US
8th leading cause of death in the US
Motor vehicle crashes = 43,458/year
Breast cancer = 42,297/year
AIDS = 16,516/year
Medical errors are costly
Preventable AEs : $17-$29 billion/year in US

19. Medical Error - Incidence
Harvard Medical Practice Study
Retrospective study, (30,121 records) 51 NY hospitals
3.7% of all patients experienced an adverse event (AE)
58% of AEs preventable
2.6% resulted in permanent disability
13.6% resulted in patient death
Harvard Medical Practice Study
Retrospective study, reviewing 30,121 patient records from 51 hospitals in State of New York during 1984
3.7% of all patients experienced an adverse event (AE); Drug (19%), wound infections (14%), technical (13%); 58% of AEs preventable
27.6% of AEs were due to negligence
17.0% of surgical AEs,
37.2% of nonsurgical AEs
2.6% resulted in permanent disability
13.6% resulted in patient death
Brennan TA et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study. Qual Saf Health Care. 1991;13:

20. Medical Error - Incidence
Critical Care Safety Study
1-year observational study (391 patients)
223 “serious errors” (SEs) without AEs were detected (~150/1,000 patient-days)
79 patients (20.2%) experienced 120 AEs (~81/1,000 patient-days)
11% of SEs and 13% of AEs were potentially life-threatening
61% of all SEs were medication errors
53% of all SEs involved slip/lapse; rather than knowledge deficit
Prospective 1-year observational study at academic tertiary-care urban hospital, including 391 patients with 420 MICU or CICU admissions over 1,490 patient-days
223 “serious errors” (SEs) without AEs were detected (~150/1,000 patient-days)
79 patients (20.2%) experienced 120 AEs (~81/1,000 patient-days); 66 (55%) were unpreventable; 54 (45%) were preventable (~36/1,000 patient-days)
11% of SEs and 13% of AEs were potentially life-threatening
61% of all SEs were medication errors
53% of all SEs involved slip/lapse; rather than knowledge deficit
Rothschild JM et al. The critical care safety study: the incidence and nature of adverse events and serious medical errors in intensive care. Crit Care Med. 2005;33:

21. Error - Comparison Virginia Commonwealth University Study
Retrospective study of all post-surgical complications over a 14-year period
2.7% of post-surgical patients experienced (and 0.13% of patients died from) a medical error
McGuire HH et al. Measuring and managing quality of surgery:
statistical vs incidental approaches. Arch Surg. 1992;127:
With 97.3% accuracy, there would be:
54 unsafe plane landings at Chicago’s O’Hare Airport daily
432,000 pieces of mail lost by US Postal Service daily
21 million checks deducted from the wrong bank account daily

22. Resident Self-Reporting
Errors in Diagnosis (33%)
Procedural Complications (11%)
Wu AW, Folkman S, McPhee SJ, Lo B. Do house officers learn from their mistakes? JAMA. 1991;265: Available at:
Communication (5%)
Prescribing (29%)
Evaluation (21%)
Wu AW et al. Do house officers learn from their mistakes? JAMA. 1991;265:

23. Sentinel Event - JCAHO
Definition = an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Such events are called sentinel because they signal the need for immediate investigation and response.
Definition = an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called sentinel because they signal the need for immediate investigation and response.

24. Sentinel Event - Statistics
Source:

25. Sentinel Event - Statistics
Source:

26. Sentinel Event - Statistics
Source:

27. Sentinel Event - Statistics
Source:

28. Adverse Drug Events (ADEs)
5.7% of all prescriptions filled include some error
ADEs common with both inpatients & outpatients
Sources:
Bates DW et al. Effect of computerized physician order entry and a team intervention on prevention of serious medication errors. JAMA. 1998;280:
Gandhi TK et al. Adverse drug events in ambulatory care. N Engl J Med. 2003;348:
5.7% of all prescriptions filled include some error this results in 770,000 drug-related injuries/year in US. ADEs common with both inpatients & outpatients; 2-7% of hospitalized patients will experience an ADE. 25% are preventable and 25% of ambulatory patients will experience an ADE of which 40% are preventable.

29. Medication Errors - Question
In which stage of the medication order cycle are mistakes most likely to occur?
Ordering the medication
Transcribing the medication order
Filling or dispensing the medication order
Administering the medication

30. Medication Errors - Answer
When?
56% at stage of ordering
6% from transcribing order
34% at administration
What?
Dose (28%)
Route (18%)
Documentation error (14%)
No or wrong date (12%)
Frequency (9.4%)
Other (18.6%)
Rx Written
Rx Transcribed
Med Dispensed
Med Administered
(Physician)
(Clinical Secretary)
(Pharmacist)
(Nurse)

31. Unclear Abbreviations
Intended
Interpreted
Better µg
Microgram
Milligram
mcg
o.d. or OD
Daily
Right eye
TIW
3 X week
TID
3 times a week QD
QID
or Every day
QOD
Every other day
QD or QID U
Units
Zero
units

32. Theory Chains of Error Aviation industry
Small slips or lapses accumulate
Average plane crash involves 6 different errors
Aviation industry
Small slips or lapses accumulate
Average plane crash involves 6 different errors
Recognizing one error sufficient to avert tragedy
Multiple people at multiple stages involved
Failure to recognize/respond to “gut feelings”
“Something’s not going the way it usually does”

33. Theory - “Swiss Cheese” Model
Source: Reason J. Human Error. New York: Cambridge University Press; 1990

34. Theory - HFACS Framework*
* Developed for US Navy and Marine Corps (2000)

35. Theory - Spectrum of Defense
Individual
System

36. Device Improvements

37. Systemic Architecture

38. AMA Code of Medical Ethics Council on Ethical and Judicial Affairs (1997)
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.

39. American College of Physicians Ethics Manual (1998)
“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.”
“Although medical errors do not necessarily constitute improper, negligent, or unethical behavior, failures to disclose them are all three.”

40. Disclosure - Components
Full Disclosure
What the error was, how it contributed to the injury
Regret that patient suffered because of error
Reason for error
How future recurrences will be prevented
Non-Disclosure
Event regrettable, but “things happen”
Vague, nebulous explanations
No plan for prevention
Read slide first.
You’ll see excerpts of the text from the dialogues on Figure 1 on your handout.
So we have a total of 8 different conditions, but each person only sees one error/outcome scenario and one associated dialogue.

41. Disclosure - Barriers Unsure of what to report/disclose
Fear of litigation
Discomfort with discussing such issues
Concern that information will harm relationship
Sources:
Gallagher TH et al. JAMA. 2003;289:
Robinson AR, et al. Arch Intern Med. 2002;162:
Wu AW et al. JAMA. 1991;265:
Unsure of what to report/disclose - May not understand legal/institutional definitions of “error”
Fear of litigation - Concern about consequences of admitting fault
Discomfort with discussing such issues - Physician may avoid explicitly stating that an error has been made
Concern that information will harm relationship - May believe disclosure degrades patient’s trust in the physician
Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients' and physicians' attitudes regarding the disclosure of medical errors. JAMA. 2003;289: Available at:
Robinson AR, Hohmann KB, Rifkin JI, et al. Physician and public opinions on quality of health care and the problem of medical errors. Arch Intern Med. 2002;162: Available at:
Wu AW, Folkman S, McPhee SJ, Lo B. Do house officers learn from their mistakes? JAMA. 1991;265: Available at:

42. Disclosure - Barriers Emotional response to errors “Culture of blame”
Lack of communication skills
Source: Leape LL. Error in medicine. JAMA. 1994;272:
Emotional response to errors
Disappointment about failing to meet personal standards
May include physical symptoms (insomnia, anxiety, difficulty concentrating)
“Culture of blame”
Mistakes are unacceptable, result of personal failure
“Only incompetent docs make mistakes”
Human nature (“someone is at fault”)
Reinforced by legal system (“someone must pay”)
Lack of communication skills

43. Disclosure - Why?
Preserves (and often strengthens) the doctor-patient relationship
Helps to establish a “Culture of Responsibility”
More easily defendable from a legal viewpoint
Gives others evidence of latent errors that may be corrected (thereby preventing future errors)
Improves your own emotional well-being
Can be important to your patient’s future health care
Preserves (and often strengthens) the doctor-patient relationship
Better to hear from you, now, than from another, later!
Can provide patient/family with closure
Helps to establish a “Culture of Responsibility”
More easily defendable from a legal viewpoint
Gives others evidence of latent errors that may be corrected (thereby preventing future errors)
Improves your own emotional well-being
Can be important to your patient’s future health care

44. Disclosure - How?
Notify your professional insurer and seek assistance from those who might help you with disclosure (e.g., unit director, risk manager)
Don't wait for the patient to ask – take the lead
Outline plan of care to rectify harm/prevent recurrence
Offer to get prompt second opinions when appropriate
Offer a family meeting, with lawyers present if desired
Source: Hébert PC, et al. Bioethics for clinicians: 23. Disclosure of medical error. CMAJ. 2001;164:

45. Disclosure - How? Always document important discussions
Offer the option of follow-up meetings
Be prepared for strong emotions
Accept responsibility, but avoid attributions of blame
Apologies and expressions of sorrow are appropriate
Source: Hébert PC, et al. Bioethics for clinicians: 23. Disclosure of medical error. CMAJ. 2001;164:

46. Medical Error - Reporting
Institutional, state, and federal health boards encourage voluntary reporting of “unanticipated outcomes”
Evidence suggests 20% or less are reported
Only 1/3 of patients surveyed said that a healthcare professional disclosed error or apologized for error
Only 23 states in the US have some form of mandatory error reporting, most without protection from risk of lawsuit
Blendon RJ, DesRoches CM, Brodie M, et al. Views of practicing physicians and the public on medical errors. N Engl J Med. 2002;347: Available at:
Source: Blendon RJ et al. Views of practicing physicians and the
public on medical errors. N Engl J Med. 2002;347:

47. Mandatory Reporting
    
Source:

48. Litigation - Statistics
Litigation is a painful, tiresome experience for both sides
Injuries are usually SEVERE
>70% against emergency docs, surgeons, OB-GYNs
Even in the “litigious” United States, odds of being sued for negligent event are less than 1 in 50
Sources:
Lown B. The Lost Art of Healing; Practicing Compassion in Medicine. New York: Ballantine; 1999.
Hiatt HH et al. A study of medical injury and medical malpractice. N Engl J Med. 1989;321:
Litigation is a painful, tiresome experience for both sides
Injuries are usually SEVERE
52% anatomic deformity or death
20% emotional impairment
>70% against emergency docs, surgeons, OB-GYNs
Even in the “litigious” United States, odds of being sued for negligent event are less than 1 in 50

49. Litigation - Why? “Original injury is not enough”
Prime concern: perceived lack of caring
3 reasons for litigation
Lack of communication, dishonesty, patient ignored
Over 1/3 would have abandoned litigation if provided an explanation and an apology
“Original injury is not enough”
Prime concern: perceived lack of caring
3 reasons for litigation
Altruism – “protect others”
Expose the truth
Financial restitution (least important)
Lack of communication, dishonesty, patient ignored
Over 1/3 would have abandoned litigation if provided an explanation and an apology
“Be plainer with me – let me know thy trespass by its true visage”
William Shakespeare, “Winter’s Tale”
Source: Lown B. The Lost Art of Healing; Practicing Compassion in Medicine. New York: Ballantine; 1999.
Vincent C et al. Why do people sue doctors? Lancet. 1994;343:

50. Litigation Lottery? Award designated Verdict for plaintiff 19%
Just what are patients getting out of the medical malpractice process for their “frivolous” claims? Is the US liability system really working on behalf of injured patients?
Only 1.5% of injured individuals file a claim.
Only 8%-13% of cases filed go to trial.
Only 6.7% of trials receive court verdicts (others thrown out in favor of defense).
Only 19% of verdicts in favor of plaintiff and award designated.
Then, only % (3 of 10,000,000) of all reported medical injuries result in any type of verdict in favor of the patient.
14x as many negligent acts as successful claims.
Hiatt HH et al. A study of medical injury and medical malpractice. N Engl J Med. 1989;321:
Only 30% of claims settled in patients’ favor (doesn’t necessitate a payment).
57–70% of claims result in no payment.
PIAA, 1987
Patient injured
Claim filed
Case to trial
Court verdict
Verdict for plaintiff
Award designated
98.5%
1.5%
92-87%
8-13%
93% 7%
81%
19%
Insurance Info Inst. Hot topics and Insr Issues. Med Mal. Apr 2003
Hiatt HH et al. A study of medical injury and medical malpractice. N Engl J Med. 1989;321:

51. Medical Malpractice Awards
Source:

52. Conclusions Adverse event ≠ error, but many AEs are preventable
Individual mistakes are a SYMPTOM of the problem
Don’t perpetuate the “Culture of Blame”
Ask for help when you need it
Good communication is essential to ME prevention
Disclosure is the standard of care
Adverse event ≠ error, but many AEs are preventable
Individual mistakes are a SYMPTOM of the problem
Active errors result from systemic errors
Human nature is immutable, but systems are not
Don’t perpetuate the “Culture of Blame”
To err is human…to forgive divine
Learn from your mistakes and the mistakes of others
Ask for help when you need it
Good communication is essential to the prevention of MEs
Disclosure is the standard of care

53. Self Assessment
The following questions will provide a quick review of the important aspects of this module.
Complete Review
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54. Medical Errors

55. Conclusion
This ends the presentation.