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Patient Safety Primer

Adverse Events, Near Misses, and Errors | AHRQ Patient Safety Network

Last Updated: July 2016

Adverse Events, Near Misses, and Errors


Background
The concept of medical harm has existed since antiquity, famously discussed by
Hippocrates and passed on in the word iatrogenesis, from the Greek for originating
from a physician. The topic has received attention from notable physicians in the
centuries since. A paper in the New England Journal of Medicine in 1956 discussed
the topic of diseases of medical progress, and this paper evolved into a book that
used the phrase "iatrogenic disease" in its title.
One of the rst studies that sought to quantify the incidence of iatrogenic harm was
the Medical Insurance Feasibility Study, funded by the California Medical Association
and the California Hospital Association. This study, published in 1978, served as the
model for the subsequent landmark Harvard Medical Practice Study. The California
study had as its immediate goal "to obtain adequate information about patient
disabilities resulting from health care management." This study did not use the term
adverse event, but had as its focus the same idea, speci cally "adverse outcomes to
patients in the course of health care management," especially the subset of such
outcomes consisting of potentially compensable events, namely disabilities caused
by health care management. The California study reported 4.65 injuries to patients
per 100 hospitalizations. Subsequent studies have consistently found that 10%12%
of patients experience harm while hospitalized, with approximately half of these
events being considered preventable.

De nitions and Types of Patient Harm


Investigators in the Harvard Medical Practice Study de ned an adverse event as "an
injury that was caused by medical management (rather than the underlying disease)
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and that prolonged the hospitalization, produced a disability at the time of discharge,
or both." The Institute for Healthcare Improvement uses a similar de nition:
"unintended physical injury resulting from or contributed to by medical care
(including the absence of indicated medical treatment), that requires additional
monitoring, treatment, or hospitalization, or that results in death."
Adverse events may be preventable or nonpreventable. One de nition refers to
preventable adverse events as "avoidable by any means currently available unless
that means was not considered standard care." Preventable adverse events are
de ned as "care that fell below the standard expected of physicians in their
community." These adverse events were the focus of both the Medical Insurance
Feasibility Study and the Harvard Medical Practice Study. Examples of
nonpreventable adverse events and preventable adverse events from the Harvard
Medical Practice Study are provided in the Box.
Box. Example Adverse Event Cases From the Harvard Medical Practice Study
"Case 1: During angiography to evaluate coronary artery disease, a patient had an embolic cerebrovascular
accident. The angiography was indicated and was performed in standard fashion, and the patient was not
at high risk for a stroke. Although there was no substandard care, the stroke was probably the result of
medical management. The event was considered adverse but not due to negligence."
"Case 4: A middle-aged man had rectal bleeding. The patient's physician completed only a limited
sigmoidoscopy, which was negative. The patient had continued rectal bleeding but was reassured by the
physician. Twenty-two months later, after a 14-kg (30 lb) weight loss, he was admitted to a hospital for
evaluation. He was found to have colon cancer with metastases to the liver. The physicians who reviewed
his medical record judged that proper diagnostic management might have discovered the cancer when it
was still curable. They attributed the advanced disease to substandard medical care. The event was
considered adverse and due to negligence."

In addition to preventable adverse events, two other terms appear commonly in the
literature. Errors are de ned as "an act of commission (doing something wrong) or
omission (failing to do the right thing) leading to an undesirable outcome or
signi cant potential for such an outcome." The related Systems Approach Patient
Safety Primer discusses the relationship between errors and adverse events,
summarized in the Swiss Cheese Model of accident causation. A near miss is
de ned as "any event that could have had adverse consequences but did not and
was indistinguishable from fully edged adverse events in all but outcome." (Some
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studies use the related terms "potential adverse event" and "close call.") In a near
miss, an error was committed, but the patient did not experience clinical harm, either
through early detection or sheer luck. For example, consider a patient who is
admitted to the hospital and placed in a shared room. A nurse comes to administer
his medications, but inadvertently gives his pills to the other patient in the room. The
other patient recognizes that these are not his medications, does not take them, and
alerts the nurse so that the medications can be given to the correct patient. This
situation involved a high potential for harm, as a cognitively impaired or less aware
patient may have taken the incorrect medications.
A nal subcategory of adverse event is the ameliorable adverse event, a term rst
coined in a study of postdischarge of adverse events. Ameliorable adverse events are
those that are not preventable, but the severity of the injury "could have been
substantially reduced if different actions or procedures had been performed or
followed." For instance, a patient with a new diagnosis of heart failure is discharged
on furosemide (a diuretic) with a follow-up visit with a cardiologist in 4 weeks but no
instructions for earlier follow-up or laboratory tests. Ten days later, the patient
presents to the emergency department with acute kidney injury and critically low
potassium. These adverse effects of diuresis are not preventable in themselves, but
the severity could have been reduced by planning to have the patient come in for lab
testing within a week of discharge.

Controversies
Studies of the epidemiology of adverse events, such as a recent series of reports by
the Of ce of the Inspector General, use a two-stage record review process in which
patient charts are independently reviewed by two clinically experienced reviewers in
order to determine whether an adverse event occurred and if so, whether it was
preventable. It is important to note that even with highly trained reviewers, the level of
agreement between reviewers with regard to the presence of an adverse event is
usually only moderate. When an adverse event occurred, reviewers also may disagree
about whether the event was preventable.

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Designating an adverse event as preventable requires some judgment about the


degree to which the evidence supports speci c prevention strategies and the
feasibility of implementing these strategies. As the science of patient safety
advances, these judgments can change over time, such that more adverse events
become regarded as preventable. For instance, after publication of the seminal paper
on the central line bundle to prevent catheter-associated bloodstream infections,
reviewers participating in adverse event studies might have begun to judge all central
lineassociated bloodstream infections as preventable.

Current Context
In summary, adverse events refer to harm from medical care rather than an
underlying disease. Important subcategories of adverse events include:
Preventable adverse events: those that occurred due to error or failure to
apply an accepted strategy for prevention;
Ameliorable adverse events: events that, while not preventable, could have
been less harmful if care had been different;
Adverse events due to negligence: those that occurred due to care that falls
below the standards expected of clinicians in the community.
Two other terms de ne hazards to patients that do not result in harm:
Near miss: an unsafe situation that is indistinguishable from a preventable
adverse event except for the outcome. A patient is exposed to a hazardous
situation, but does not experience harm either through luck or early
detection.
Error: a broader term referring to any act of commission (doing something
wrong) or omission (failing to do the right thing) that exposes patients to a
potentially hazardous situation.

Editors Picks
PERSPECTIVE
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In Conversation with...Lucian Leape, MD


JOURNAL ARTICLE STUDY
Incidence and types of preventable adverse events in elderly patients: population based
review of medical records.
Thomas EJ, Brennan TA. BMJ. 2000;320:741-744.

JOURNAL ARTICLE COMMENTARY


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

JOURNAL ARTICLE STUDY


Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard
Medical Practice Study I.
Brennan TA, Leape LL, Laird NM, et al. N Engl J Med. 1991;324:370-376.

JOURNAL ARTICLE REVIEW


Diseases of medical progress.
Moser RH. N Engl J Med. 1956;255:606-614.

BOOK/REPORT
Adverse Events in Hospitals: National Incidence Among Medicare Bene ciaries.
Levinson DR. Washington, DC: US Department of Health and Human Services, Of ce of the Inspector General; November
2010. Report No. OEI-06-09-00090.

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