Medical Errors James H. Paxton, MD, MBA Ilan Rubinfeld, MD, MBA, FACS Henry Ford Hospital Christine...

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Medical Errors

James H. Paxton, MD, MBA

Ilan Rubinfeld, MD, MBA, FACS

Henry Ford Hospital

Christine C. Toevs, MD, FACSCarilion Clinic

“. . . 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)

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

“To Err Is Human…”

Alexander Pope (1688-1744 CE)

Medical Errors - Objectives

• Terminology

• Active vs. latent errors

• Incidence

• Theories of error

• Disclosure of errors

• Legal considerations

• Conclusions

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

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 - 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

Medical Error - Aliases

• Adverse event (AE)

• Adverse outcome

• Medical mishap

• Unintended consequence

• Unplanned clinical occurrence

• Untoward incident

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.

• 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.”

Legal Definitions

Source: Black’s Law Dictionary. 7th ed. (1999)

Medical Error - Types

• Slip/Lapse

– Correct intervention, performed poorly

• Mistake

– Wrong intervention, proceeds as planned

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.

Latent Error - Examples

Active Error (Failure)

• Error with immediate adverse consequences

• Current responses tend to focus on active errors

Proximate (Seminal)Cause

Latent Errors

Active Error

Root Cause Analysis

“Every system is perfectly designed to produce exactly the result it gets”

Medical Error - Summary

(Active/Latent)ERROR

Slip/Lapse

Mistake

OmissionADVERSEEVENTS

PreventableAdverse Events

Negligence

Deviation from intended (correct) plan

Incorrect plan

Plan not attempted

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

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.

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.

• 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

Error - Comparison

Resident Self-Reporting

Wu AW et al. Do house officers learn from their mistakes? JAMA. 1991;265:2089-2094.

Procedural Complications (11%)

Communication (5%)

Evaluation (21%)

Errors in Diagnosis (33%)

Prescribing (29%)

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/

Sentinel Event - Statistics

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

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.

Adverse Drug Events (ADEs)

• 5.7% of all prescriptions filled include some error

• ADEs common with both inpatients & outpatients

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

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)

Unclear Abbreviations

Abbrev Intended Interpreted Better

µg Microgram Milligram mcg

o.d. or OD Daily Right eye Daily

TIW 3 X week TID 3 times a week

QD Daily QID Daily

or Every day

QOD Every other day QD or QID Every other day

U Units Zero units

Theory Chains of Error

• Aviation industry

• Small slips or lapses accumulate

• Average plane crash involves 6 different errors

Theory - “Swiss Cheese” Model

Source: Reason J. Human Error. New York: Cambridge University Press; 1990

Theory - HFACS Framework*

* Developed for US Navy and Marine Corps (2000)

Theory - Spectrum of Defense

Individual System

Device Improvements

Systemic Architecture

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.

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.”

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

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.

Disclosure - Barriers

• Emotional response to errors

• “Culture of blame”

• Lack of communication skills

Source: Leape LL. Error in medicine. JAMA. 1994;272:1851-1857.

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

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.

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.

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.

Mandatory Reporting - 2005

Source: http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=160854

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.

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

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.

“Be plainer with me – let me know thy trespass by its true visage”

William Shakespeare, “Winter’s Tale”

Patient injured

Claim filed

Case to trial

Court verdict

Verdict for plaintiff

Award designated

1.5%92-87%

8-13%93%

Insurance Info Inst. Hot topics and Insr Issues. Med Mal. Apr 2003Hiatt HH et al. A study of medical injury and medical malpractice. N Engl J Med. 1989;321:480-484.

Litigation Lottery?

Medical Malpractice Awards

Source: http://www.manhattan-institute.org/html/cjr_10.htm

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

Self Assessment

The following questions will provide a quick review of the important aspects of this module.

Complete Review

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Conclusion

• This ends the presentation.

Medical Errors James H. Paxton, MD, MBA Ilan Rubinfeld, MD, MBA, FACS Henry Ford Hospital Christine...

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