The knowledgeable health reporter for the Boston Globe, Betsy Lehman, died from an overdose during chemotherapy. Willie King had the wrong leg amputated. Ben Kolb was eight years old when he died during ”minor" surgery due to a drug mix-up.1 These horrific cases that make the headlines are just the tip of the iceberg. Two large studies, one conducted in Colorado and Utah and the other in New York, found that adverse events occurred in 2.9 and 3.7 percent of hospitalizations, respectively.2 In Colorado and Utah hospitals, 6.6 percent of adverse events led to death, as compared with 13.6 percent in New York hospitals. In both of these studies, over half of these adverse events resulted from medical errors and could have been prevented. When extrapolated to the over 33.6 million admissions to U.S. hospitals in 1997,

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Read the Executive Summary of the IOM report and answer the following questions:

1. Why did this report spur an interest in quality management in the healthcare industry?

2. What can healthcare organizations do to reduce mistakes?

3. Think about the role of leadership, the climate, communications, skills, tools and procedures that can contribute to mistake-proofing healthcare.

Executive Summary
The knowledgeable health reporter for the Boston Globe, Betsy Lehman, died
from an overdose during chemotherapy. Willie King had the wrong leg
amputated. Ben Kolb was eight years old when he died during ”minor" surgery
due to a drug mix-up.1
These horrific cases that make the headlines are just the tip of the iceberg. Two
large studies, one conducted in Colorado and Utah and the other in New York,
found that adverse events occurred in 2.9 and 3.7 percent of hospitalizations,
respectively.2 In Colorado and Utah hospitals, 6.6 percent of adverse events led
to death, as compared with 13.6 percent in New York hospitals. In both of these
studies, over half of these adverse events resulted from medical errors and
could have been prevented.
When extrapolated to the over 33.6 million admissions to U.S. hospitals in 1997,
the results of the study in Colorado and Utah imply that at least 44,000
Americans die each year as a result of medical errors.3 The results of the New
York Study suggest the number may be as high as 98,000.4Even when using
the lower estimate, deaths due to medical errors exceed the number attributable
to the 8th-leading cause of death.5 More people die in a given year as a result of
medical errors than from motor vehicle accidents (43,458), breast cancer
(42,297), or AIDS (16,516).6
Total national costs (lost income, lost household production, disability and
health care costs) of preventable adverse events (medical errors resulting in
injury) are estimated to be between $17 billion and $29 billion, of which health
care costs represent over one-half.`7
In terms of lives lost, patient safety is as important an issue as worker safety.
Every year, over 6,000 Americans die from workplace injuries.8Medication errors
alone, occurring either in or out of the hospital, are estimated to account for over
7,000 deaths annually.9
Medication-related errors occur frequently in hospitals and although not all
result in actual harm, those that do, are costly. One recent study conducted at
two prestigious teaching hospitals, found that about two out of every 100
admissions experienced a preventable adverse drug event, resulting in average
increased hospital costs of $4,700 per admission or about $2.8 million annually
for a 700-bed teaching hospital.10 If these findings are generalizable, the
increased hospital costs alone of preventable adverse drug events affecting
inpatients are about $2 billion for the nation as a whole. These figures offer only a very modest estimate of the magnitude of the problem
since hospital patients represent only a small proportion of the total population
at risk, and direct hospital costs are only a fraction of total costs. More care and
increasingly complex care is provided in ambulatory settings. Outpatient
surgical centers, physician offices and clinics serve thousands of patients daily.
Home care requires patients and their families to use complicated equipment
and perform follow-up care. Retail pharmacies play a major role in filling
prescriptions for patients and educating them about their use. Other institutional
settings, such as nursing homes, provide a broad array of services to vulnerable
populations. Although many of the available studies have focused on the
hospital setting, medical errors present a problem in any setting, not just
hospitals.
Errors are also costly in terms of opportunity costs. Dollars spent on having to
repeat diagnostic tests or counteract adverse drug events are dollars
unavailable for other purposes. Purchasers and patients pay for errors when
insurance costs and copayments are inflated by services that would not have
been necessary had proper care been provided. It is impossible for the nation to
achieve the greatest value possible from the billions of dollars spent on medical
care if the care contains errors.
But not all the costs can be directly measured. Errors are also costly in terms of
loss of trust in the system by patients and diminished satisfaction by both
patients and health professionals. Patients who experience a longer hospital
stay or disability as a result of errors pay with physical and psychological
discomfort. Health care professionals pay with loss of morale and frustration at
not being able to provide the best care possible. Employers and society, in
general, pay in terms of lost worker productivity, reduced school attendance by
children, and lower levels of population health status.
Yet silence surrounds this issue. For the most part, consumers believe they are
protected. Media coverage has been limited to reporting of anecdotal cases.
Licensure and accreditation confer, in the eyes of the public, a "Good
Housekeeping Seal of Approval." Yet, licensing and accreditation processes
have focused only limited attention on the issue, and even these minimal efforts
have confronted some resistance from health care organizations and providers.
Providers also perceive the medical liability system as a serious impediment to
systematic efforts to uncover and learn from errors.11
The decentralized and fragmented nature of the health care delivery system
(some would say "nonsystem") also contributes to unsafe conditions for
patients, and serves as an impediment to efforts to improve safety. Even within hospitals and large medical groups, there are rigidly-defined areas of
specialization and influence. For example, when patients see multiple providers
in different settings, none of whom have access to complete information, it is
easier for something to go wrong than when care is better coordinated. At the
same time, the provision of care to patients by a collection of loosely affiliated
organizations and providers makes it difficult to implement improved clinical
information systems capable of providing timely access to complete patient
information. Unsafe care is one of the prices we pay for not having organized
systems of care with clear lines of accountability.
Lastly, the context in which health care is purchased further exacerbates these
problems. Group purchasers have made few demands for improvements in
safety.12 Most third party payment systems provide little incentive for a health
care organization to improve safety, nor do they recognize and reward safety or
quality.
The goal of this report is to break this cycle of inaction. The status quo is not
acceptable and cannot be tolerated any longer. Despite the cost pressures,
liability constraints, resistance to change and other seemingly insurmountable
barriers, it is simply not acceptable for patients to be harmed by the same health
care system that is supposed to offer healing and comfort. "First do no harm" is
an often quoted term from Hippocrates.13 Everyone working in health care is
familiar with the term. At a very minimum, the health system needs to offer that
assurance and security to the public.
A comprehensive approach to improving patient safety is needed. This
approach cannot focus on a single solution since there is no "magic bullet" that
will solve this problem, and indeed, no single recommendation in this report
should be considered as the answer. Rather, large, complex problems
require thoughtful, multifaceted responses. The combined goal of the
recommendations is for the external environment to create sufficient pressure to
make errors costly to health care organizations and providers, so they are
compelled to take action to improve safety. At the same time, there is a need to
enhance knowledge and tools to improve safety and break down legal and
cultural barriers that impede safety improvement. Given current knowledge
about the magnitude of the problem, the committee believes it would be
irresponsible to expect anything less than a 50 percent reduction in errors over
five years.
In this report, safety is defined as freedom from accidental injury. This definition
recognizes that this is the primary safety goal from the patient’s perspective. Error is defined as the failure of a planned action to be completed as intended or
the use of a wrong plan to achieve an aim. According to noted expert James
Reason, errors depend on two kinds of failures: either the correct action does
not proceed as intended (an error of execution) or the original intended action is
not correct (an error of planning).14 Errors can happen in all stages in the
process of care, from diagnosis, to treatment, to preventive care.
Not all errors result in harm. Errors that do result in injury are sometimes called
preventable adverse events. An adverse event is an injury resulting from a
medical intervention, or in other words, it is not due to the underlying condition
of the patient. While all adverse events result from medical management, not all
are preventable (i.e., not all are attributable to errors). For example, if a patient
has surgery and dies from pneumonia he or she got postoperatively, it is an
adverse event. If analysis of the case reveals that the patient got pneumonia
because of poor hand washing or instrument cleaning techniques by staff, the
adverse event was preventable (attributable to an error of execution). But the
analysis may conclude that no error occurred and the patient would be
presumed to have had a difficult surgery and recovery (not a preventable
adverse event).
Much can be learned from the analysis of errors. All adverse events resulting in
serious injury or death should be evaluated to assess whether improvements in
the delivery system can be made to reduce the likelihood of similar events
occurring in the future. Errors that do not result in harm also represent an
important opportunity to identify system improvements having the potential to
prevent adverse events. Preventing errors means designing the health care
system at all levels to make it safer. Building safety into processes of care is a
more effective way to reduce errors than blaming individuals (some experts,
such as Deming, believe improving processes is
the only way to improve quality15). The focus must shift from blaming
individuals for past errors to a focus on preventing future errors by designing
safety into the system. This does not mean that individuals can be careless.
People must still be vigilant and held responsible for their actions. But when an
error occurs, blaming an individual does little to make the system safer and
prevent someone else from committing the same error.
Health care is a decade or more behind other high-risk industries in its attention
to ensuring basic safety. Aviation has focused extensively on building safe
systems and has been doing so since World War II. Between 1990 and 1994,
the U.S. airline fatality rate was less than one-third the rate experienced in mid
century.16 In 1998, there were no deaths in the United States in commercial aviation. In health care, preventable injuries from care have been estimated to
affect between three to four percent of hospital patients.17 Although health care
may never achieve aviation’s impressive record, there is clearly room for
improvement.
To err is human, but errors can be prevented. Safety is a critical first step in
improving quality of care. The Harvard Medical Practice Study, a seminal
research study on this issue, was published almost ten years ago; other studies
have corroborated its findings. Yet few tangible actions to improve patient
safety can be found. Must we wait another decade to be safe in our health
system?
Recommendations The IOM Quality of Health Care in America Committee was formed in June 1998
to develop a strategy that will result in a threshold improvement in quality over
the next ten years. This report addresses issues related to patient safety, a
subset of overall quality-related concerns, and lays out a national agenda for
reducing errors in health care and improving patient safety. Although it is a
national agenda, many activities are aimed at prompting responses at the state
and local levels and within health care organizations and professional groups.
The committee believes that although there is still much to learn about the types
of errors committed in health care and why they occur, enough is known today
to recognize that a serious concern exists for patients. Whether a person is sick
or just trying to stay healthy, they should not have to worry about being harmed
by the health system itself. This report is a call to action to make health care
safer for patients.
The committee believes that a major force for improving patient safety
is the intrinsic motivation of health care providers, shaped by professional
ethics, norms and expectations. But the interaction between factors in the
external environment and factors inside health care organizations can also
prompt the changes needed to improve patient safety. Factors in the external
environment include availability of knowledge and tools to improve safety,
strong and visible professional leadership, legislative and regulatory initiatives,
and actions of purchasers and consumers to demand safety improvements.
Factors inside health care organizations include strong leadership for safety, an
organizational culture that encourages recognition and learning from errors, and
an effective patient safety program. In developing its recommendations, the committee seeks to strike a balance
between regulatory and market-based initiatives, and between the roles of
professionals and organizations. No single action represents a complete answer,
nor can any single group or sector offer a complete fix to the problem. However,
different groups can, and should, make significant contributions to the solution.
The committee recognizes that a number of groups are already working on
improving patient safety, such as the National Patient Safety Foundation and the
Anesthesia Patient Safety Foundation.
The recommendations contained in this report lay out a four-tiered approach:
• establishing a national focus to create leadership, research, tools and
protocols to enhance the knowledge base about safety;
• identifying and learning from errors through immediate and strong mandatory
reporting efforts, as well as the encouragement of voluntary efforts, both with
the aim of making sure the system continues to be made safer for patients;
• raising standards and expectations for improvements in safety through the
actions of oversight organizations, group purchasers, and professional groups;
and
• creating safety systems inside health care organizations through the
implementation of safe practices at the delivery level. This level is the ultimate
target of all the recommendations.

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