Concerns About Medical Errors
The IOMís release
of To Err is Human brought medical errors and patient safety
the attention it has long needed but never had. The information
presented in the report is not new. Indeed, many studies, some as
early as the 1960s, showed that patients were frequently injured
by the same medical care that was intended to help them (Schimmel,
1964). While evidence of medical error has existed for some
time, the report succeeded in capturing the publicís attention by
revealing the magnitude of this pervasive problem and presenting
it in a uniquely compelling fashion. The IOM estimates that medical
errors cause between 44,000 and 98,000 deaths annually in the United
States. Using the more conservative figure, medical errors rank
as the eighth leading cause of death, killing more Americans than
motor vehicle accidents, breast cancer, or AIDS. In addition to
this extraordinary human toll, medical errors result in annual costs
of $17 to $29 billion in the United States (Institute
of Medicine, 1999). Additionally, fear of becoming a victim
of medical error may lead patients to delay obtaining potentially
beneficial medical care, which may allow their illnesses to worsen.
harm as a result of receiving health care is a growing concern for
the American public. Front-page articles in newspapers, television
exposes, and cover stories in magazine have provided the stark details
of the latest and most dramatic examples of medical errors. Until
recently, the perception of medical errors among health care providers
and the public has been shaped by these anecdotes, and remedies
have focused on fixing blame on individual providers, including
health plans, hospitals, doctors, pharmacists, nurses, and other
caregivers. That approach, however, has proven ineffective in addressing
patient safety, as documented by the ongoing problems noted in the
IOM report. The IOMís recommended alternative approaches and other
ways in which the Federal agencies can work to reduce medical errors
are described in this report.
The lack of
standardized nomenclature and a universal taxonomy for medical errors
complicates the development of a response to the issues outlined
in the IOM report. A number of definitions have been applied to
medical errors and patient safety. In To Err is Human, the
IOM adopted the following definition:
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.
In an effort
to thoroughly consider all of the relevant issues related to medical
errors, the QuIC expanded of the IOM definition, as follows:
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. Errors
can include problems in practice, products, procedures, and systems.
acknowledgment of the broad scope of errors reflected in this definition
respects the responsibilities and capabilities of the Government
agencies and departments contributing to this report. The term "patient
safety" as used here applies to initiatives designed to prevent
adverse outcomes from medical errors. The enhancement of patient
safety encompasses three complementary activities: preventing errors,
making errors visible, and mitigating the effects of errors.
It is critical
to recognize that not all bad outcomes for patients are due to medical
errors. Patients may not be cured of their disease or disability
despite the fact that they are provided the very best of care. Additionally,
not all adverse events that are the result of medical care are,
in fact, errors. An adverse event is defined broadly as an injury
that was caused by medical management and that resulted in measurable
disability (Leape, 1991). Some
adverse events, termed "unpreventable adverse events,"
result from a complication that cannot be prevented given the current
state of knowledge. Many drugs, even when used appropriately, have
a chance of side effects, such as nausea from an antibiotic. The
occurrence of nausea would be an adverse event, but it would not
be considered a medical error to have given the antibiotic if the
patient had an infection that was expected to respond to the chosen
antibiotic. Medical errors are adverse events that are preventable
with our current state of medical knowledge. Figure
1 (16 KB) shows this set of possible outcomes of medical care.
In this report,
the consideration of errors is broadened beyond preventable adverse
events that lead to actual patient harm to include "near misses,"
sometimes know as "close calls." A "near miss"
is an event or situation that could have resulted in an accident,
injury, or illness, but did not, either by chance or through timely
intervention. Experience in other industries, including aviation,
manufacturing, and nuclear energy, demonstrates that there is as
much to learn from close calls as there is from incidents leading
to actual harm.
It is also important
to situate medical errors within the broader context of problems
in health care quality. These can be classified under three categories:
overuse (the service is unlikely to have net benefit), underuse
(a potentially beneficial service is withheld), and misuse (a service
is inappropriately used) (Chassin,
1998). The majority of medical errors fall into the category
of misuse, but some problems with overuse (e.g., when an unnecessary
therapy is prescribed, leading to harm) or underuse (e.g., when
an error in diagnosis leads to the failure to apply timely treatment)
blur these distinctions. These are related quality problems and
may be addressed, in part, by using some of the same approaches.
In some cases, however, distinct approaches may be required. That
is why the IOM has chosen to deal with the issue of errors separately
in its report and plans to issue future reports on underuse and
overuse quality problems. Our report will also focus exclusively
on errors. Nevertheless, the QuIC participants recognize that the
improvements made in patient safety will lay the foundation for,
and may encourage, other quality improvements.
for Thinking About Errors
There are many
possible ways to categorize medical errors, but no universally accepted
taxonomy. Classifications have included:
- Type of health
care service provided (e.g., classification of medication errors
by the National Coordinating Council for Medication Error Reporting
of the resulting injury (e.g., sentinel events, defined as "any
unexpected occurrence involving death or serious physical or psychological
injury" by the Joint Commission on Accreditation of Healthcare
- Legal definition
(e.g., errors resulting from negligence [Institute
of Medicine, 1999]).
- Type of setting
(e.g., outpatient clinic, intensive care unit).
- Type of individual
involved (e.g., physician, nurse, patient).
the current variety of classifications is the understanding that
different types of medical errors are likely to require different
solutions and preventive measures. A single approach to error reduction
will fail because it does not account for important differences
in types of errors. For example, for the Food and Drug Administration
(FDA), product risk category may be a crucial dimension for shaping
regulatory policy, but a health care provider may see this dimension
as a minor consideration in shaping its error-control methods.
classification of errors would need to be well suited to the purpose
to which it is being applied, but there is no single classification
system that could be successfully applied to the full set of IOM
recommendations being addressed by the QuIC. A framework for reporting
may include considerations of the level of reporting (Federal versus
State versus organizational), the reasons for which the reporting
is being done (learning versus accountability), or the level of
injury (near-miss versus minor versus severe). A framework for developing
a research agenda may require more focus on the populations involved,
available data, and research tools that can be applied to the problem.
The experience with the Aviation Safety Reporting System (ASRS),
which relies on narrative reporting without a formal framework,
demonstrates that rigorous classification may not be necessary at
all for some purposes.
The QuIC recommends
that the framework for analysis of errors in health care include
considerations of how to measure and improve patient safety. As
a result, the framework will evolve with each of the initiatives
outlined in this report, and the development of classifications
to deal with specific purposes will be part of the ongoing work
of the QuIC in addressing the IOM recommendations.
As noted in
the IOM report, health care is "a decade or more behind other
high-risk industries in its attention to ensuring basic safety"
(Institute of Medicine, 1999; p. 4).
Other sectors of the economy have made remarkable progress in error
reduction and safety assurance during the latter part of the 20th
century, much of which is attributable to industryís attention to
quality management and improvement. In 1986, Motorola instituted
a strategy called "Six-Sigma Quality," whose name refers
to the Greek letter used to represent standard deviation from the
mean of any normally distributed curve (Chassin,
1998). A company which has six-sigma quality experiences only
3.4 defects or errors per million products or events. This is the
equivalent of seeing only one misspelled word in about six typical
mystery novels or one fumble in 1,600 football games.
six-sigma quality strategy, Motorola, General Electric, and others
have substantially reduced their error rates. These companies have
systems in place to monitor and report errors and defects so that
proper action can be taken, and it is no surprise that these companies
are the leaders in their respective industries. Although originally
devised for reducing defects in manufacturing plants, the application
of the six-sigma quality approach has provided benefits to service
industries as well (Chassin, 1998).
Service industries have used the six-sigma strategy to analyze,
for example, the number of customer complaints that go unanswered
after 2 days (per million complaints) or the excess waiting time
over 5 minutes a customer encounters before being served (per million
In another example,
the aviation industry has adopted quality improvement, safety assurance,
and error reduction as its core mission. Currently, airline safety
is operating at a five-sigma level (Chassin,
1998). The Federal Aviation Administration (FAA) strategic plan
targets a further 80 percent reduction in the airline accident death
rate, which would place it close to the six-sigma level. The cornerstone
of the FAAís safety initiative has been the ASRS, which was established
in 1975. Although the ASRS is funded by the FAA, it is administered
by the National Aeronautics and Space Administration (NASA). Many
believe that this separation of control over the reporting function
to improve safety from the enforcement function is a critical factor
in its success. It gives credibility and a sense of safety to the
system in the eyes of the many users, particularly those being asked
to report their errors and near misses. The ASRS is a vital link
between those who observe or experience errors and defects and investigators
who have the ability to research and disseminate information regarding
these errors. In January 2000 the President signed an executive
order providing further protections to reporters under the aviation
safety system to enhance information collection. The aviation community
(as well as nuclear power and the military communities) has demonstrated
the importance of looking critically at human factors and interface
design practices in preventing accidents and increasing operating
efficiency (Rouse, Kober, and Mavor,
A review of
the experience in non-health-care industries offers some lessons
that may be applicable to reducing medical errors. Characteristics
of error-reducing industries include:
- Not tolerating
high error rates, and setting ambitious targets for error reduction
tracking mechanisms that expose errors.
- Relying on
the abundant reports of errors and "near misses."
investigating errors, including a root causes analysis.
to error reduction a systems approach that embraces a wide array
of human factors, technical, and organizational remedies.
on systems solutions that do not seek to find individual
fault and blame.
the organizational culture so that it enhances safety and error
adequate resources to error prevention initiatives and the development
of the knowledge base to support them.
that solutions often come from unexpected sources, "out of
the box" thinking, and new combinations of disciplines (e.g.,
human factors psychology with aeronautical engineering).
The QuIC, in
reviewing the IOM report as well as these experiences in other industries,
has concluded that there is no single "magic bullet" approach
to reducing errors, but there is a generalizable approach (that
includes the strategies listed above) which, when applied vigorously,
is likely to yield favorable outcomes.
of Health Care Errors
of it sponsored by AHRQís predecessor, the Agency for Health Care
Policy and Research, documents that the rate of health care errors
is far higher than the error rate in other industries. In one study
of intensive care units, the correct action was taken 99.0 percent
of the time, translating to 1.7 errors per day. One out of five
of these errors was serious and/or potentially fatal. If performance
levels even substantially better than those found in the ICU (for
example, 99.9%, a 10-fold reduction in errors) were applied to the
airline and banking industries, it would still equate to two dangerous
landings per day at OíHare International Airport and 32,000 checks
deducted from the wrong account per hour (Leape,
1994). In these industries, such error rates would not be tolerated.
shares a number of characteristics with these other industries.
They all rely on systems which include the interaction of humans
and technology to perform a number of functions leading to an outcome
(e.g., a safe transcontinental flight, a check correctly deducted
from the right account, a patientís recovery from breast cancer).
However, health care is distinct in its complexity. For example,
a patient in an intensive care unit is the recipient of an average
of 178 different activities performed per day that rely on the interaction
of monitoring, treatment, and support systems (Leape,
1994). One observer noted that many medical errors can be attributed
to the simple fact that the knowledge base to effectively and safely
deliver health care exceeds the storage capacity of the human brain
and fragmented nature of the American health care industry contributes
to the problem of errors, and will make it a challenge to institute
the kind of comprehensive strategy to reduce errors and increase
patient safety that the IOM recommends in its report. The work of
federally-sponsored researchers such as Lucian Leape and David Bates
has illustrated the importance of focusing on the systems of health
care delivery in efforts to reduce medical errors. Prescription
and delivery of medications provides a dramatic example. It requires
the successful completion of at least five interdependent steps:
ordering, transcribing, dispensing, delivering, and administering.
Inattention to system design leads to numerous opportunities for
error in any one of these steps. One study on adverse drug events
showed that 78 percent of adverse drug events were due to system
failures (Leape, 1995).
factors are also a distinct challenge in addressing medical errors.
Within many hospitals, departments are only loosely linked, and
communications between primary care doctors and medical specialists
are notoriously poor. As a result, information on problems, as well
as improved practices to reduce errors and enhance safety, in one
department or one facility do not migrate quickly to others. The
variety of settings in which health care is provided (including
hospitals, nursing homes, clinics, ambulatory surgery centers, private
offices, and patientsí homes) and the transitions of patients and
providers among them provide additional challenges.
Errors may be
particularly difficult to recognize in health care because variations
in an individualís response to treatment is expected. In addition,
medical professionals may not recognize that a particular product
or procedure may have contributed to or caused the problem because
the patient is already ill, the product is not expected to work
perfectly at all times, or the event appears unrelated to the product
or procedure. Lack of recognition of a serviceís role in adverse
events reduces reporting of the association and the opportunity
to learn from previous experiences with the product. Because medical
errors usually affect only a single patient at a time, they are
treated as isolated incidents, and little public attention is drawn
to these problems when compared with aviation or nuclear power accidents.
Health care errors are also underreported due to liability and confidentiality
concerns. These factors explain, in part, the ongoing "invisibility"
of medical errors despite the existence of research which has documented
their high prevalence.
Organizational and Professional Culture
complexity of health care delivery systems is one of the factors
distinguishing health care from other industries, the professional
culture may pose an even greater challenge than does complexityto
improving patient safety. The "naming, blaming, and shaming"
approach to dealing with errors has hindered medical error reduction,
yet it is the most commonly used approach to addressing errors in
health care. In fact, this traditional approach has proven counterproductiveit
has driven the patient safety problem underground, leading to an
implicit "conspiracy of silence" where problems and close
calls are not discussed due to fear of reprisal (Koop,
events have existed since the beginning of organized medical practice,
but may not have been recognized at the time of their occurrence.
Bloodletting and toxic "therapies," such as mercurials,
led to premature deaths, but these deaths were seen as a reflection
of the patientís underlying illness rather than of harmful practice.
To some extent, that culture still persists in health care. Although
advances in medical technology and knowledge have eliminated these
historic practices, errors and mistakes continue to occur at an
unacceptably high rate in the delivery of health care. Contrary
to popular expectations, doctors, nurses, and other health care
professionals are inherently fallibleas are all humans.
The IOM report
notes that the majority of medical errors today are not produced
by negligence, lack of education, or lack of training. Rather, errors
occur in our health care systems due to poor systems design and
organizational factors, much as in any other industry. Health care
workers are placed in systems and settings where errors are bound
to happen. That is, the systems are designed to achieve a particular
set of goals, but inadvertently produce a certain level of errors.
For example, health care workers are sometimes expected to work
24-hour shifts to ensure patients are cared for and have some continuity
of care, although it is known that overwork and fatigue lead to
decreased mental concentration and alertness. These caregivers are
expected to function in an environment that is not ergonomically
designed for optimal work performance. They are expected to rely
on their memories and deliver safe care without substantial investments
in information technology or even the simple application of checklists.
They often deliver care through a set of complex processes, although
industry has shown that the probability of performing a task perfectly
decreases as the number of steps in the process increases. Finally,
they are expected to work in a climate where one error, even if
not preventable, may mean a catastrophe or the end of a career.
By not improving
the systems in which medicine is practiced, the health care industry
as a whole has not advocated a culture of safety and is not well
organized to tackle the challenge of improving patient safety. Only
when the entire industry is able to make patient safety and the
reduction of medical errors its first priority will errors in medical
practice be reduced.
errors epidemic is a global problem. The United Kingdom, for example,
has had some well-publicized difficulties with pediatric surgery
outcomes in Bristol. British authorities estimate that 40,000 hospitalized
patients die annually as a result of errors, which translates to
a 3.7 percent overall rate of errors. The Australian Review of Professional
Indemnity Arrangements for Health Care Professionals (Commonwealth
Department of Human Services and Health, 1995) also found error
to be a serious cause of morbidity and mortality. Australia, the
United Kingdom, and Sweden are among the countries that have begun
to address this issue. The British Ministry of Health is in the
process of making funds available to researchers to investigate
medical errors, and is re-engineering its clinical governance programs
to provide mechanisms to improve patient safety. Australia has included
medical errors as part of its focus on quality, and is initiating
a national system for error reduction with enhanced reporting mechanisms.
However, efforts to actually translate the limited research available
into practice are still at an early stage, at best. Approaches are
likely to vary across nations because of differences in health care
organization, attitudes toward regulation, and views on patient
information and confidentiality. The evidence informing those approaches,
however, is likely to be more universal. As a global leader, the
United States has a responsibility to the many countries that do
not have the resources to devote to the study of this issue.
of Medical Errors
Errors and other
adverse events occur regularly in health care settings, but the
causes, frequency, severity, preventability, and impact of these
events on patient outcomes are not completely understood. A few
studies have found an alarmingly high prevalence of adverse events
and medical errors in some hospitals. In two large studies of hospital
admissions, one in New York using 1984 data and another in Colorado
and Utah using 1992 data, the proportions of admissions in which
there were adverse events (defined as injuries caused by medical
management) were 2.9 and 3.7 percent, respectively (Leape,
1991; Gawande, 1999). In the
New York study, errors (defined as avoidable "mistakes in performance
or thought") were determined to have caused more than half
of the adverse events. However, the absence of standardized definitions
of medical error, the lack of coordination and integration of systems
to report and monitor errors, and the difficulty in distinguishing
preventable errors from currently unavoidable adverse events hamper
our understanding of this problem. It is unlikely that we can ever
know the precise frequency with which errors occur in health care
settings because we must rely on people to recognize that errors
were made, to distinguish them from bad outcomes of appropriate
treatment, and then to report them.
Events and Medical Products Use or Misuse
injuries and deaths from pharmaceutical drugs are a growing problem
that, according to some studies, represents a leading cause of death
and patient harm in the United States (American
Hospital Association, 1999; Centers
for Disease Control and Prevention, 1999; Leape,
1991). Although the methods used to measure the rate of errors
associated with the use of drugs have significant limitations, researchers
have estimated that more than 50 percent of prescriptions are used
incorrectly (Porter and Jick, 1977).
Problems related to the use of pharmaceutical drugs account for
nearly 10 percent of all hospital admissions, and significantly
contribute to increased morbidity and mortality in the United States
In the Harvard
Medical Practices Study of adverse medical events (Leape,
1991), which was based on 30,195 randomly selected records from
51 hospitals in New York State, the researchers found that drug
complications represented 19 percent of all adverse events. The
researchers concluded that 58 percent of injuries and deaths due
to drug reactions were preventable, and 27.6 percent of such complications
were due to negligence. According to this study, antimicrobial drugs
were the class of agents most commonly associated with adverse drug
events. Misuse of antimicrobial drugs not only exposes individual
patients to an increased risk of a poor treatment outcome, but also
leads to the emergence and spread of drug-resistant microorganisms,
which may place other patients and health care workers at risk of
problem of medication errors has drawn considerable public attention,
since all such errors are preventable. Medication errorsmistakes
in writing prescriptions, dispensing or administering drugsare
a subset of the larger category of errors involving drugs. In a
caseĖcontrol study covering a 4-year period at a single hospital,
it was determined that there was an almost 2-fold increase in the
risk of death attributable to such errors. In the previously cited
Harvard Medical Practice Study, 19.4 percent of all disabling adverse
events were caused by drugs, of which 45 percent were due to medication
errors. In that study, 30 percent of those with drug-related injuries
to drug-related injuries and deaths that occur in hospitals, information
is available indicating that preventable, drug-related injuries
are also occur at a high frequency among out-patients. In a study
of 1,000 ambulatory patients drawn from a community, office-based
medical practice (Burnum, 1976),
the researchers noted side effects from drugs in 42 patients (4.2
percent), including 23 who experienced preventable side effects.
Well-understood drugĖdrug interactions are preventable, but there
is evidence that physicians do not routinely screen for them, even
when a patientís medication history is readily available. In a study
of 424 randomly selected visits to a hospital emergency department
(Beers, 1990), 47 percent of visits
resulted in the patient receiving a prescription for a medication.
In 10 percent of these instances, the new medication could potentially
harm the patient due to an avoidable drug-drug interaction. In all
of these cases, a medication history had been recorded and available
to the prescribing physicians.
Thus, it can
be seen that preventable and avoidable injuries due to drugs constitute
a significant public health concern. The increasing use of drugs,
the growing fragmentation of health care delivery, and the competing
demands of an overburdened health care delivery system will, undoubtedly,
accentuate these problems.
to Prevent Errors
Measurement and Performance Improvement Systems. In the past
decade, health care facilities and health plans have placed an increasing
emphasis on improving health care quality. The impetus has come,
at least in part, from patients, purchasers, accreditation agencies,
and regulators determined to obtain the best value for the Nationís
health care dollars. Today, virtually all health care organizations
have programs to measure and/or improve health care quality.
and health plans collect and monitor data relevant to specific events
(e.g., patient falls, failure to appropriately administer beta-blockers
after myocardial infarction) or health outcomes (e.g., anesthesia
mortality, length of stay after total hip replacement), which may
or may not reflect medical errors. Hospitals commonly use these
data for performance measurement or continuous quality improvement.
Decisions about what will be monitored are usually based on the
nature, severity, and importance of perceived problems at the local
level, the feasibility of accessing data and formulating a response,
and related incentives (e.g., meeting standards required for accreditation,
anticipated cost-savings). Similarly, some hospital departments
(e.g., pharmacy, nursing) use performance measurement to target
treatment errors and other adverse events.
measurement and quality improvement programs are less common and
often less extensive outside of acute-care hospitals. Programs in
risk management as well as more recently developed programs in what
has been called "disease management" or "outcomes
management," although aimed at improving health outcomes, generally
have not specifically included error reduction in their scope. Occupational
health or employee health programs, in addressing risks to health
care workers, may also impact patient safety and quality of care.
Overall, the degree to which these local programs address medical
errors or other preventable adverse events and, more importantly,
the extent to which they motivate changes that improve the overall
heath status of patients, are not known. Part of the research agenda
will be to see if market forces favor those health care organizations
that improve patient safety.
infection prevention and control provide long-standing and successful
examples of health care programs specifically designed to prevent
adverse health events. These programs have been shown to reduce
morbidity and mortality due to health care-associated infections.
For this reason, infection control programs are mandated as a condition
of accreditation for health care facilities. In hospitals, accreditation
standards require a minimum number of trained infection control
personnel and delineate specific program components. Such programs
usually include ongoing monitoring (surveillance) of infection rates
by trained infection control personnel using standardized case definitions,
analysis of data with adjustment for facility and patient characteristics
known to affect risk, comparison of local rates to aggregate benchmark
data, prompt feedback of infection rates and trends to providers
and decisionmakers, and targeted interventions that address specifically
identified problems. This approach parallels that used in industrial
continuous quality improvement programs and in industrial quality
control. In nonhospital facilities, accreditation standards are
less rigorous, and the composition and quality of infection control
program is variable.
National Programs. Some regional and national external reporting
systems to monitor errors and adverse health events already exist.
FDA operates systems monitoring adverse events associated with drugs,
medical devices, vaccines (co-managed with CDC), and blood and blood
products. CDCís NNIS monitors health care-associated infections. Some
State health agencies (e.g., those of New York, Massachusetts, Florida)
also monitor targeted health events. Nongovernmental agencies (e.g.,
JCAHO and the U.S. Pharmacopeia, through their Sentinel Events and
Medication Errors Reporting Programs, respectively) also operate error
programs motivate local efforts to recognize and address problems,
provide norms to which local efforts can be compared, and identify
emerging problems (e.g., adverse drug events or manufacturing errors)
that may require governmental or other system-wide response. For
example, reported errors related to medical products can lead the
FDA to require changes in package inserts and promotional materials,
modifications in product packaging, and widespread dissemination
of information through letters to health professionals and published
systems have little or no enforcement authority to assure that reporting
of errors is occurring consistently and completely. A recent report
from the Department of Health and Human Serviceís (DHHS) Inspector
General found that there is widespread underreporting to FDA's drug
adverse event reporting system, despite the fact that more than
270,000 incidents are reported annually. In addition, even though
these programssome of which may be considered mandatorymay
promise the opportunity to report errors and near-misses confidentially,
those who submit reports (e.g., clinicians and hospitals) have expressed
concern about their legal vulnerability in these reporting systems.
Another reason for low rates of reporting in some systems is that
information on how to prevent similar errors in the future is not
fed back to the reporters. Therefore, these reporters see little
benefit in completing and submitting reports.
of Programs to Prevent Medical Errors
strikingly high incidence of medical errors documented in the IOM
report, and the difficulties in obtaining reports on errors and
near misses, there are remarkable examples of successful efforts
to improve patient safety. Surgical anesthesia, which once had an
error rate of 25 to 50 per million patients, reduced its error rate
nearly 7-fold. (Orkin, 1993). The
first step in reducing surgical anesthesia error rates was the collection
of data that permitted a systems analysis of errors, rather than
a hunt for "responsible" individuals. Through teamwork,
practice guidelines, automation, procedure simplification, and standardization
of many functions, anesthesiologists demonstrated that a properly
designed system can either prevent mistakes or prevent mistakes
from doing harm.
of success is the advances in patient safety that have been achieved
in the Department of Veterans Affairs (VA), through its Veterans
Health Administration. For instance, a hand-held, wireless bar-coding
system was introduced into VA and has reduced medication errors
by 70 percent at relatively low cost (Gebhart,
1999). It is particularly interesting that this approach was
adopted from a completely different industryfrom observation
of how Avis checked in returned rental cars. Similar behavioral
and cultural changes must occur in other segments of the health
care industry in order to address the patient safety issue fully.
agencies have learned that the creation of a comprehensive knowledge
base, rich in textual description of all aspects of errors occurrence,
must be developed if preventive efforts are to be targeted and effective.
One hopeful sign has been the development of private-sector organizations,
such as the National Patient Safety Foundation (NPSF), the National
Coordinating Council for Medication Error Reporting and Prevention,
and JCAHO, which are promoting research and improvement initiatives
focused on systems approaches to error reduction.
health field has demonstrated that human factors engineering can
identify ergonomic concepts to prevent injuries to both patients
and workers. Examples include curving the design of hallway corners
to reduce the risk of injury from collisions, using mechanical lifts
to prevent patient falls and employee back injuries, and reducing
the number of scheduled work hours in a rotating shift to minimize
the likelihood of errors resulting from fatigue and sleep deprivation.
of Existing Programs
prevention systems need to be built on a foundation of locally directed
and managed programs within health care organizations, complemented
by coordinated, external support and guidance from Federal, State,
and nongovernmental agencies and organizations. Within this framework,
a comprehensive approach to error reduction would require specifically
designated personnel working in or consulting with each health care
and monitor the occurrence of errors in targeted patient populations
at greatest risk, and understand their root causes, especially
those that are preventable.
interpret, and disseminate data to clinicians and other stakeholders.
error reduction strategies based on reanalysis and reworking of
health care systems.
- As necessary,
call upon experts with clinical, epidemiologic, and management
training and experience for technical support and to conduct on-site
the impact of these programs on patient safety.
A number of
factors reduce the effectiveness of existing programs to prevent
medical errors. Performance measurement and improvement programs
within health care organizations do not directly address the problem
of medical errors. Programs that have been specifically developed
to prevent medical errors often operate in isolation. In addition,
programs such as infection control and employee health and safety
typically receive low priorities within health care centers.
Efforts by external
organizations to monitor errors also face limitations. A number
of different programs exist to detect adverse health events, although
no one system is designed to detect the full scope of medical errors.
systems, such as the National Notifiable Diseases Surveillance Systemin
which health care providers and laboratories report incident cases
of diseases (mostly infectious) to the State health departmentwhile
broad in scope and coverage, are often hampered by collection of
incomplete data. Each State determines the diseases that are reportable,
resulting in some differences across States. Furthermore, health
care providers must remember which diseases are reportable, and
take the time to report them.
on the other hand, means soliciting case reports in a timely manner
directly from potential reporting sources. Examples of this type
of reporting include HIV/AIDS reporting, in which CDC provides funding
to State and local health departments to support the surveillance
process. These active surveillance systems provide more complete
and accurate information, but are expensive to implement and maintain.
Systems designed to hold organization or individual accountable
for bad outcomes are commonly limited by underreporting of adverse
improvement programs within health care organizations could be enhanced
or adapted to address errors, obstacles remain. The more serious
- Lack of awareness
that a problem exists.
- A traditional
medical culture of individual responsibility and blame.
- The lack
of protection from legal discovery and liability, which causes
errors to be concealed.
- The primitive
state of medical information systems, which hampers efficient
and timely information collection and analysis.
allocation of resources for quality improvement and error prevention
throughout the health care system.
knowledge about the frequency, cause and impact of errors, as
well as about evidence of effective methods for error prevention.
- Lack of understanding
of systems-based approaches to error reduction (such as those
used in aviation safety or manufacturing) and the perceived difficulty
of adapting those approaches to the health care sector.
There are even
greater barriers to error reduction in nonhospital settings, where
the general absence of organized surveillance systems and lack of
adequate personnel hinder local data collection, feedback, and improvement.
Lack of awareness.
As stated earlier, the existence of medical errors has been
known for some time. However, the fact that there has been very
little success in reducing errors suggests that a general lack of
awareness or alarm about errors is a factor in this failure. The
awareness of the problem of medical errors and any subsequent solutions
must be improved, not only among physicians, nurses, pharmacists,
dentists, and other health care providers, but also among patients,
policymakers, and the many other stakeholders of the health care
to partnership. The punitive and pejorative connotations of
"error" as the object of investigation pose a potential
barrier to the unfettered cooperation and collaboration of health
care providers in establishing and managing effective error control
programs. A cultural change needs to occur that will enable health
care providers and leaders, as well as the public, to talk about
errors and recognize that they are, in large measure, a result of
faulty systems and faulty system design, not of individual failures.
A system which supports learning from errors is dependent upon
reporting, but fear of reprisal or legal action will dissuade many
potential reporters. Assurances that the identity of reporters will
be masked or never collected at all have been shown to enhance reporting
in other industries (e.g., the ASRS). Disclosure of the individuals
or organizations involved in an incident could also discourage reporting.
There will remain instances, however, where criminal or negligent
acts demand appropriate disclosure. The legal issues surrounding
patient safety will have to be examined carefully to determine the
best mechanisms to promote learning from errors while protecting
systems and technical problems. To be practical, error prevention
will need to rely on sophisticated management and clinical information
systems, both as sources of data on adverse events and as a component
of interventions to reduce errors, such as through the adoption
of computer-based decision-support for health care providers. However,
information systems in most health care organizations are neither
sufficiently integrated nor flexible enough to serve either of these
purposes. Technical support and research into information system
desifgn will be required to address this problem.
structural concerns. Although considerable cost savings could
be realized by effective reduction in medical errors, instituting
such programs will require a substantial initial investment. In
addition, the relative autonomy of departments within some health
care institutions is a potential barrier to rapid organizational
change and the adoption of new models and procedures needed to prevent
in knowledge and understanding. The epidemiology of errors is
not well understood. Standardized definitions of errors and adverse
events need to be developed and the methods of collecting meaningful
data require further study. Research is needed to help distinguish
between adverse events due to errors, unavoidable consequences of
treatment, and complications caused by a patientís underlying disease.
The current paucity of fundamental and applied research on medical
errors limits the tool kit of effective interventions that can enhance
Lack of appropriate
collaboration among disciplines. Because of the nature of medical
errors, an effective response requires an integration of efforts
across traditional occupational and scientific boundaries. The nature
of the patient safety challenge requires synergy among scientific
and technical disciplines, from human factors psychology to product
design and delivery. This collaboration is needed at all stages
of the effort to reduce errors and enhance patient safetyfrom
research on its causes and remedies to implementation and partnership
in its reduction and elimination. The response to medical errors
by the health care system is hindered by the traditional focus of
single disciplines on individual providers or on products, and even
by poorly coordinated efforts among Government agencies and with
the private sector.
to apply a coherent strategy. The variety of medical errors
and the multidimensional nature of the patient safety challenge
demand a variety of approaches for improvement. Experience from
other industries demonstrates, however, that successful interventions
to address different types of errors can consistently result from
the application of a coherent strategy that includes intolerance
of high rates of error, development of tracking mechanisms, root
cause analysis, the application of innovative resources and relationships
to address the problem, and an institutional devotion to error prevention.
The QuIC concludes
that systems designed to facilitate quality improvement through
error reduction can generate effective, useful reporting if those
individuals who report are assured of confidentiality, protected
from legal liability resulting from the report, provided with timely
feedback on data from the system, and are not unduly burdened by
the effort involved in reporting.
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