History of Quality Improvement and Patient
SafetyReferencesImages Slides 3,4: "To Err is Human" book cover,
Kohn LT, Corrigan JM and Donaldson MS, (eds). "To Err Is Human:
Building a Safer Health System" Committee on Quality of Health Care
in America, Institute of Medicine, Washington DC: National
Academies Press, 1999. Source Name: Image used with permission from
National Academies Press. Slides 5,6: "Crossing Quality Chasm" book
cover, Committee on Quality of Health Care in America, Institute of
Medicine. Crossing the Quality Chasm: A New Health System for the
21st Century, Washington, DC: National Academy Press, 2001. Source
Name: Image used with permission from National Academies Press.
Slide 7: Bust of Hippocrates, Available from:
http://en.wikipedia.org/wiki/File:Hippocrates_rubens.jpg Source
Name: Wikipedia Commons/Courtesy National Library of Medicine
Slides 8, 11, 18: Clip Art, Available from: Microsoft clips online
Source Name: Used with permission from Microsoft
*Health IT Workforce Curriculum Version 3.0/Spring 2012 History
of Health Information Technology in the U.S. History of Quality
Improvement and Patient Safety
Welcome to History of Health IT in the U.S., History of Quality
Improvement and Patient Safety. This lecture covers the history of
the Quality Improvement and Patient Safety movements in the United
States. The focus of the presentation it to familiarize the student
with some key milestones in the patient safety movement that have
contributed to the present national policies related to health
information technology.*The Objectives for this unit, History of
Quality Improvement and Patient Safety are to:1. Describe
conditions and notable publications concerning patient safety and
quality improvement from 1959 to the present.2. Describe the
background to the Institute of Medicine reports on Patient Safety3.
Summarize the main findings from several Institute of Medicine
reports on quality, patient safety, and health information
technology (HIT).4. Describe various ways in which HIT has evolved
to improve quality or enhance patient safety.
*The history of the patient safety movement in the US goes back
many decades. Before we review some of the historical milestones,
it is important to introduce a series of reports published by the
Institute of Medicine (or IOM). The two reports I am about to
describe are by no means the beginning of the safety and quality
movements in this country. However, they are among the most
important developments in how and why health IT and patient safety
have grown intertwined.The first IOM report was released in late
1999 and titled To Err is Human.
*The report generated significant media attention because it
shockingly suggested that up to 98,000 people die every year due to
medical errors. Such errors included medication errors, surgical
errors, or other errors such as failing to correctly diagnose a
patients condition.
More importantly, the IOM report laid out a compelling argument
that most errors in medicine are the result of a poorly designed
system that, generally speaking-- well-intentioned clinicians are
forced to work in.
Some characteristics of the error-prone system in which doctors
and nurses work include excessively long hours, sleep deprived
training programs, a culture in medicine that does not support open
communication, an over-reliance on memory, and the lack of use of
information systems that can reduce errors by eliminating the
reliance on faulty handwriting, and making information more readily
available for medical decision making.
Ironically, the report even with it its shocking statistics did
not present any new data. Instead, it compiled the results of
previous studies stemming from the work of researchers including
those working on a project known as the Harvard Medical Practice
Study. When the report was released, some critics argued that the
statistics were inflated. Since then, the general consensus among
experts is that the statistics are accurate, or even, possibly, an
underestimation.
*Two years after the first IOM report was released, the
Institute of Medicine released a second report entitled Crossing
the Quality Chasm. This report made several important contributions
to the national quality movement.
First, it defined quality of care as including 6 main
components. The first, patient safety, was defined as freedom from
unnecessary injury, such as that which is associated with medical
errors. The second and third components of quality were
effectiveness and efficiency. Effectiveness refers to care that is
evidence-based, while efficiency refers to care processes that are
not wasteful of resources.
The fourth component of quality was timeliness. If care is to be
high quality, it must be provided in a timely fashion. Next, was
patient-centeredness. Traditionally, healthcare has been provided
in such a way that the comforts and needs of medical personnel
typically were more important than those of the patients. The IOM
report strongly suggested that high quality care must take into
consideration the needs of the patient. These needs can include
religious, spiritual, emotional, cultural, physical and other
needs.
Lastly, the final component of quality of care is equitable
access. If our healthcare system is to become high-quality,
everyone must be treated equitably. Clearly there are many racial,
gender, geographic, and other disparities that must be addressed
before achieving the 21st century health system outlined in the
report.
*Secondly, the report suggested (as its title reveals) that
where we are right now compared to where we should be with respect
to quality is not a gap but a chasm.
Lastly, the report said that Health IT plays an important role
in addressing quality concerns across all six components of
quality.
*Now that weve mentioned the landmark IOM reports, it is
important to state that patient safety has been part of medicine
for thousands of years. Ever since the time of Hippocrates, an
ancient Greek physician widely considered the father of modern
medicine, physicians would take an oath, now known as the
Hippocratic oath, that includes the phrase First, do no harm.
*And while many other milestones in the intervening years can be
discussed, in more modern times, the medical profession started
talking about patient safety issues in the form of a book entitled
Diseases of Medical Progress: A study of Iatrogenic Disease
published by Robert Moser. Iatrogenic diseases are adverse
conditions caused by interacting with the health care system.
Hospital-acquired infections would be an example of iatrogenic
disease. An otherwise uninfected person, by virtue of being in a
hospital for an unrelated issue contracts an infection due to being
exposed in the hospital environment to a bug.
The book described ways in which modern medicine was
inadvertently exposing patients to these types of injuries and
began to describe ways to address these issues.
*In the 80s and 90s, a series of high-profile patient deaths due
to medical errors kept patient safety in the headlines.
One of those deaths was Libby Zion, daughter of a well-known
journalist, who died in 1984 at the age of 18 likely due to the
care of overworked sleep-deprived physicians.
The second death was Betsy Lehman, a Boston Globe health news
reporter who died in 1994 from an overdose of chemotherapy a
situation which was clearly a preventable medical error.
Both deaths occurred at well-known, highly respected, medical
centers further suggesting that these types of errors can occur
anywhere.
*In 1990, psychologist and author Dr. James Reason published a
book entitled Human Error, that shed light on the contribution of
human fallibility to performance. In the book, Reason distinguished
between errors that occur because of the way our brains are wired,
and those that occur because of the type of situations that humans
work in. These situations, called latent conditions exacerbate the
imperfections of how human minds work, frequently resulting in
predictable levels of error.
The book was important because it later was used by the
Institute of Medicine reports as an explanatory framework for why
so many errors occur in our health care system.
*By 1991, the Harvard Medical Practice Studies were complete.
Previously, we mentioned that the Harvard Medical Practice Study
was the source of many of the IOM reports shocking statistics. As
it turns out, the Harvard Medical Practice Study really had two
main components and is referred to in the plural. The studies
actually focused on malpractice issues and not medical errors per
se.Specifically, the researchers at Harvard were interested in
studying medical injury and malpractice litigation- so they
collected data to estimate the frequency at which injuries caused
by medical management (or mis-management) were the result of
negligence or substandard care. After combing through over 30,000
records, they concluded that harm to patients occurred in about
3.7% of hospitalizations- but only about a quarter of this harm was
due to negligence. This was clear evidence that just because
something bad happened to a patient- that didnt mean that the
doctor responsible should be sued. In fact, in the majority of
cases, negligence was not a contributing factor. Remember, these
studies were completed in 1991. It wasnt until 1999 when the
Institute of Medicine released their first report that the public
became widely aware of these statistics.
*One of the authors of the Harvard Medical Practice Studies, a
pediatrician by the name of Lucian Leape, published an important
commentary in the prestigious Journal of the American Medical
Association (or JAMA).
In this article, Dr. Leape outlined the system-related issues
that contribute to the high adverse event rate in medicine.
Incidentally, all of these system issues were later reiterated in
the IOM reports. Dr. Leape concluded his commentary with a
discussion of how errors can be prevented which included such
activities as: reducing reliance on memory, and improving access to
information so that doctors arent forced to make decisions on
incomplete data. These and other points paved the way for why
health IT is a vital component of improving the healthcare
system.
*By the late 1990s the first IOM report which we have already
discussed in detail was published. As previously mentioned, the
second IOM report was published two years later. I am including
these reports in the timeline so that you can see when in history
they occurred.
*But in the intervening year between the two influential IOM
reports, a group by the name Leapfrog was established.
The launching of the Leapfrog group was significant because this
organization was a conglomerate of large fortune 500 companies.
Collectively, these companies buy health insurance for their
employees who represent a sizeable proportion of Americans. By
forming Leapfrog, these companies wanted to leverage their
collective purchasing power to influence quality of care for the
better. To do so, Leapfrog announced that they would only work with
health companies and hospitals who are making leaps forward with
respect to implementing solutions that reduced errors. Among the
first set of criteria which Leapfrog began tracking, was the
expectation that hospitals make progress toward implementing
Computerized Physician Order Entry systems (or CPOE).
This was the first concerted effort, using market forces, to
encourage hospitals to engage in activities believed to improve
quality which included adopting Health IT.
*One of the many recommendations of the first IOM report was to
establish a federal agency that can coordinate and stimulate the
growing patient safety and quality movement.
In response to this recommendation, Congress established the
Agency for Healthcare Research and Quality (or AHRQ) (pronounced
ARK)) by re-organizing and re-focusing a previous agency with a
related, but different, focus. Within the new AHRQ, the Center for
Quality Improvement and Patient Safety was also established.
Overall, the agency became the worlds largest funder of patient
safety research, and the Center went on to stimulate scientific
breakthroughs in our understanding on how health IT impacts quality
and patient safety.
*By the early 2000s the number of activities surrounding the
intersections of patient safety and health IT became too numerous
to list. But in 2002, another milestone worth discussing occurred
when the Joint Commission, which accredits hospitals, released the
first set of National Patient Safety Goals.
This was an important milestone because it represented a shift
in mentality regarding how accreditation of hospitals was viewed.
Traditionally, the purpose of accreditation is to help assure a
certain level of quality among organizations deemed worthy.
However, rather than focusing on outcomes, accreditation
traditionally focused on documentation of readiness to perform at a
certain level rather than a focus on processes in the system that
can assure a certain level of performance. The National Patient
Safety Goals were a deliberate attempt at focusing on hospital
processes and systems that are critical to quality and safety. This
caused many hospitals to begin thinking about system issues
(similar to the recommendations of the IOM) in an effort to improve
quality.
*By 2004, the concepts of patient safety and health IT began
regularly being addressed by the highest levels of policy makers in
the US. Several state-of-the-union addresses by both President
Clinton and then President Bush specifically outlined a vision for
improving quality in the US health care system with the use of
Health IT. In 2004, President Bush had outlined a vision that
within 10 years, our country should be completely transitioned to
electronic health records. Soon thereafter, he established the
Office of the National Coordinator for Health IT with a director
who was going to serve as our countrys first Health IT czar.*While
the Office of the National Coordinator for Health IT has been
coordinating various IT programs since 2004. It wasnt until 2009
that the Health IT czar was given significantly more oomph.
With the passage of the HITECH Act, which was part of the
stimulus package of 2009, many health IT related changes were
enacted. Changes is a bit of a misnomer, because the health IT
vision, in many ways, was already articulated by President Bush in
2004. By changes, I mean specific strategies to accomplish the goal
of complete electronic health record adoption by 2014.
*To help accomplish this goal, the HITECH Act makes available
monetary incentives for physicians and hospitals who adopt
electronic health records. The important element, especially in the
context of this lecture, is that the unprecedented bonus payments
for adopting EHRs are not simply for adopting the technology.
To get the money, providers must adopt EHRs and demonstrate that
they are meaningfully using the technology. In order to demonstrate
meaningful use, EHR systems need to have certain patient safety and
quality-enhancing functionalities built-in. These functionalities
include electronic prescribing, health information exchange, and
other features that the IOM reports, and other researchers that are
part of the patient safety movement, have been advocating for
years.
*In a sense, the HITECH Act is the culmination of efforts of the
patient safety, the quality of care, and the health IT movements.
In the years to come, we will begin noticing major changes as a
result of this occurrence.
*Lastly, in late 2011, the IOM released another report entitled
Health IT and Patient Safety: Building Safer Systems for Better
Care. In this report, the ongoing potential for HIT (pronounced
H-I-T) systems to potentially cause harm was acknowledged and it
was recommended that the nation have a better way of tracking
unintended consequences of HIT adoption.
One of the main recommendations was to create a new federal
agency that will be responsible for conducting investigations of
HIT safety issues and developing recommendations to providers and
HIT vendors. The report also stated that vendors should be required
to report adverse events associated with their products.
Previously, there had been talks that an agency such as the Food
and Drug Administration that already oversees medical devices
should also oversee HIT products. However, the IOM report
recommended that a new agency, specializing in HIT, have this
responsibility.
The Federal government will now decide how it will act upon the
recommendations of the IOM. Either way, it seems likely that HIT
products will be scrutinized and monitored for safety on an
on-going basis.
*This concludes History of Quality Improvement and Patient
Safety.
In summary, this lecture covered the history of the Quality
Improvement and Patient Safety movements in the United States.
Students should be familiar with some key milestones in the patient
safety movement that have contributed to the present national
policies related to health information technology.
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