Program Information

1. Program Information

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

3. “I would give great praise to the physician whose mistakes are small for perfect accuracy is seldom to be seen” – Hippocrates (470 - 410 BCE) “. . . 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 (1820-1910 CE) “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, 1135-1204 CE)

4. “To Err Is Human…” Alexander Pope (1688-1744 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

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.

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

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 Source: To Err is Human: Building a Safer Health System. Washington, DC: Institute of Medicine, 1999.

11. Legal Definitions • Negligence • “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.” Source: Black’s Law Dictionary. 7th ed. (1999)

12. Medical Error - Types • Slip/Lapse • Correct intervention, performed poorly • Mistake • Wrong intervention, proceeds as planned

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.

14. Latent Error - Examples

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.

16. Active Error Active Error Proximate (Seminal) Cause Active Error Root Cause Analysis “Every system is perfectly designed to produce exactly the result it gets” Latent Errors

17. Deviation from intended (correct) plan Incorrect plan Medical Error - Summary (Active/Latent) ERROR ADVERSE EVENTS Preventable Adverse Events Slip/Lapse Mistake Negligence 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.

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 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;13:145-152.

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 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;33:1694-1700.

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;127:733-737. • 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%) Communication (5%) Prescribing (29%) Evaluation (21%) Wu AW et al.Do house officers learn from their mistakes? JAMA. 1991;265:2089-2094.

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. http://www.jointcommission.org/SentinelEvents/Statistics/

24. Sentinel Event - Statistics Source: http://www.jointcommission.org/SentinelEvents/Statistics/

25. Sentinel Event - Statistics Source: http://www.jointcommission.org/SentinelEvents/Statistics/

26. Sentinel Event - Statistics Source: http://www.jointcommission.org/SentinelEvents/Statistics/

27. Sentinel Event - Statistics Source: http://www.jointcommission.org/SentinelEvents/Statistics/

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;280:1311-1316. Gandhi TK et al. Adverse drug events in ambulatory care. N Engl J Med. 2003;348:1556-1564.

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. RxWritten (Physician) RxTranscribed (Clinical Secretary) Med Dispensed (Pharmacist) Med Administered (Nurse) Medication Errors - Answer • When? • 56% at stage ofordering • 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%)

31. Unclear Abbreviations

32. Theory Chains of Error • Aviation industry • Small slips or lapses accumulate • Average plane crash involves 6 different errors

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

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

35. Theory - Spectrum of Defense Individual System

36. Device Improvements

37. Systemic Architecture

38. AMA Code of Medical EthicsCouncil 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

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;289:1001-1007. Robinson AR, et al. Arch Intern Med. 2002;162:2186-2190. Wu AW et al. JAMA. 1991;265:2089-2094.

42. Disclosure - Barriers • Emotional response to errors • “Culture of blame” • Lack of communication skills Source: Leape LL. Error in medicine. JAMA. 1994;272:1851-1857.

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

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;164:509-513.

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;164:509-513.

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 Source: Blendon RJ et al.Views of practicing physicians and the public on medical errors. N Engl J Med. 2002;347:1933-1940.

47. Mandatory Reporting - 2005 Source: http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=160854

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;321:480-484.

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 “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;343:1609-1613.

50. Award designated Verdict for plaintiff 19% Court verdict 81% 7% Case to trial 93% 8-13% Claim filed 92-87% 1.5% Patient injured 98.5% Litigation Lottery? 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;321:480-484.