To prepare:
Review the summary of “To Err Is Human” presented in the Plawecki and Amrhein article found in this week’s Learning Resources.
Consider the following statement:
“The most significant barrier to improving patient safety identified in “To Err Is Human”is a “lack of awareness of the extent to which errors occur daily in all health care settings and organizations (Wakefield, 2008).”
Review “The Quality Chasm Series: Implications for Nursing” focusing on Table 3: “Simple Rules for the 21st Century Health Care System.” Consider your current organization or one with which you are familiar. Reflect on one of the rules where the “current rule” is still in operation in the organization and consider another instance in which the organization has effectively transitioned to the new rule.
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Post your thoughts on how the development of information technology has helped address the concerns about patient safety raised in the “To Err Is Human” report. Summarize how informatics has assisted in improving health care safety in your organization and areas where growth is still needed.
Clearing the Err
Reporting Serious Adverse Events and “Never Events” in Today’s Health Care System
Lawrence H. Plawecki, RN, JD, LLM; and David W. Amrhein, MD
Absent an infinitesimal percentage, most Americans seek health care services due to a legitimate health issue. Fundamental within this relationship
is the understanding that health care professionals will do everything within
their power and expertise to alleviate the suffering of each patient they
treat. Unfortunately, preventable medical errors do occur, and the in-
© iStockphoto.com/ Ireneusz Skorupa
Abstract
nocent patient is left to suffer. In 1999, the Institute of Medicine
released To Err Is Human: Building A Safer Health System, the
first mainstream publication calling for a change in the
culture of health care and the eradication of preventable medical errors. In the 10 years since its publication, federal and state governments and agencies
have been proactive in attempting to meet the
recommendations originally proposed in To Err Is
Human. This article will review what has been accomplished in this time frame.
About the Authors
Mr. Plawecki is Registered Nurse,
Rehabilitation Hospital of Indiana, Indianapolis, and Dr. Amrhein is Resident
Physician, Family Practice Medicine, Ball
Memorial Hospital, Muncie, Indiana.
The authors disclose that they have no
significant financial interests in any product or class of products discussed directly
or indirectly in this activity, including
research support.
Address correspondence to Lawrence
H. Plawecki, RN, JD, LLM, Registered Nurse, Rehabilitation Hospital of
Indiana, 4141 Shore Drive, Indianapolis,
IN 46254; e-mail: Lawrence.plawecki@
gmail.com.
doi:10.3928/00989134-20091016-01
26
“I
’ve made a mistake.” This
simple statement, or its mere
thought, is enough to strike fear
within the most experienced and
knowledgeable of health care professionals. No matter how many
times a procedure has been done or
a medication administered, there is
always the likelihood of preventable error. Each year, the public
is reminded of the potential for
mistakes as the media report medical
horror stories where, for example,
unknowing patients have surgery
performed on the wrong body part,
a wrong medication administered,
or a foreign object errantly left
inside their bodies. These reports
highlight the biggest fear of health
care workers—their own fallibility.
Through carelessness, assumption,
overt act, or omission, the health
care professional can easily err
and cause harm to the patient. In
addition to the pain caused to the
patient, health care providers also
understand the devastating impact
that such errors can wreak on their
own personal and professional lives.
The purpose of this article is to
JOGNonline.com
discuss the trend in today’s health
care systems toward the reporting
of serious adverse events or “never
events,” as well as the impact—both
impending and current—on the role
of geriatric nurses.
Refocusing and
Rebuilding a Safe Health
Care System
In November 1999, the Institute of Medicine (IOM) released a
profound call to action for everyone
involved in the health care community. This statement, entitled To Err
Is Human: Building A Safer Health
System, began with a grim statistic,
estimating that between 44,000 and
98,000 people died per year from
preventable medical errors as hospital patients. The IOM (1999) report
defined medical error as the use of a
wrong plan of action to achieve an
aim or the planned action’s failure
to be completed as intended. In
economic terms, these errors were
estimated to cost between $17 billion
and $29 billion per year across the
country (IOM, 1999). These financial
estimates include the costs of lost
income, lost household productivity,
and the cost of the additional health
care necessitated by the errors (IOM,
1999). The more specific recommendations posited by the IOM (1999)
for the prevention of medical errors
are discussed below.
The IOM (1999) report recommended a four-tiered approach to
achieve a better safety record:
l Establishing a national focus
to create leadership, research,
tools, and protocols to enhance the
knowledge base about safety.
l Identifying and learning from
errors by developing a nationwide
public mandatory reporting system
and by encouraging health care
organizations and practitioners to
develop and participate in voluntary
reporting systems.
l Raising performance standards
and expectations for improvements in
safety through the actions of oversight
organizations, professional groups,
and purchasers of health care.
l Implementing safety systems
in health care organizations to ensure
safe practices at the delivery level.
As a result of these broad recommendations, state and federal
governments, agencies, and health
care institutions were given notice
about the increased focus on the
prevention of medical errors and,
consequently, the improved safety
of the patient receiving treatment.
During the 5 years following the
IOM (1999) report, progress began
to be made.
In 2001, the U.S. Congress appropriated an annual budget of $50
million for patient safety research
(Leape & Berwick, 2005). From
this appropriation, the Agency for
Healthcare Research and Quality
(AHRQ) was codified as the federal
agency to oversee patient safety and
its improvement (Leape & Berwick,
2005). AHRQ became an important
player in the new patient safety
movement by evaluating health care
practices to determine effectiveness,
educating health care institutions
about how to best report errors and
adverse events, and creating a roadmap of evidence-based best practices
(Leape & Berwick, 2005).
Using the roadmap created
by AHRQ, the National Quality Forum (NQF) (2007) created a
list of 27 serious reportable events,
Journal of Gerontological Nursing • Vol. 35, No. 11, 2009
also referred to as never events,
which were offered as the basis
for a potential national reporting
system chronicling patient safety.
The serious reportable events may
be divided into six separate categories, including surgical events,
product or device events, patient
protection events, care management
events, environmental events, and
criminal events (NQF, 2007). For
the purposes of this article, however,
the individual events will not be discussed, as the focus is to remain on
the implementation and evolution of
patient safety standards.
In 2005, the American Medical Association (AMA) released
a report by Leape and Berwick
detailing the effects of the original IOM publication. The AMA
report, while admitting there had
been little measurable effect after
the release of the IOM report and
that no comprehensive nationwide
system for monitoring had been
put into existence, discussed how
the focus of patient care had shifted
from fixing blame to implementing a
culture of safety (Leape & Berwick,
2005). This alone can be considered
an impressive feat in today’s increasingly litigious society. Furthermore,
Leape and Berwick (2005) identified
the four areas the health care system
needed to advance in the following 5
years to facilitate the transition to a
patient safety focus.
First, Leape and Berwick (2005)
recommended the implementation
of electronic medical records. It is
argued that this implementation, although a substantial initial cost, will
save the facility and pay for itself
due to the decrease in charges of adverse events and increase in efficien-
27
cy of staff. Second, as more methods
are implemented, newer and safer
practices will be proven. The final
two advancements named in the
IOM (1999) recommendations can
be met as newly learned information
is disseminated through the health
care system and, ultimately, training of health care workers continues
to evolve and improve. Last, health
care professionals should then be
able to admit mistakes, apologize,
and improve communication with
patients, as it has been found that
full disclosure of a mistake does not
increase the risk of a lawsuit being
filed (Leape & Berwick, 2005).
Where are we now?
As the tenth year following To Err
is Human (IOM, 1999) is drawing
to a close, health care professionals can readily see and appreciate
the changes being made to improve
patient safety and their own practice.
An inexhaustive list comparing several states, their attempts to improve
patient safety, and new federal guidelines are discussed below.
Minnesota
In 2003, Minnesota became the
first state to adopt a never events
law (Minnesota Department of
Health, 2008). Initially, this law
required Minnesota’s hospitals,
regional treatment centers, and freestanding outpatient surgical centers
to report these never events to the
Minnesota Department of Health
(2009). These events were then
reported to the public by the Minnesota Department of Health (2008)
on an annual basis. In 2005, however, an amended law took effect,
requiring Minnesota hospitals to report the occurrence of a never event
publicly, to the Minnesota Hospital
Association’s web-based Patient
Safety Registry (Dotseth, 2004).
In addition, Minnesota Statutes
§144.7065 (2005) requires applicable
facilities to investigate each reported
event, report the underlying cause
of each event, and take corrective
28
action to prevent the recurrence of
such an event. Lastly, an annual report required by Minnesota Statutes
§144.7069 (2005) is published by the
Minnesota Department of Health,
thereby providing a forum for hospitals to share information and learn
from each other’s errors.
New Jersey
In 2004, the State of New Jersey
put into effect The Patient Safety
Act, requiring every health care
facility licensed by the New Jersey
Department of Health and Senior
Services (2008) to report serious
preventable adverse events. Specifically, the law required hospitals
to report these events to the New
Jersey Department of Health and
Senior Services (Patterson, 2009).
Interestingly, the law keeps hospital-specific information confidential
after its release, leaving consumers
uninformed about where the never
events actually occurred; however,
unlike other states, the law requires
immediate disclosure of medical
errors to patients who were harmed
by them (Patterson, 2009).
Connecticut
Also in 2004, the State of Connecticut adopted into law Public Act
No. 04-164: An Act Concerning the
Quality of Health Care, a combination of NQF and state-specific
reportable events. Originally, Connecticut only required facilities to
report injuries associated with or
caused by medical management that
resulted in measurable disability
or death, thereby allowing nonlethal and less catastrophic errors to
remain confidential from the public;
however, after review, the law was
amended to require the disclosure
of the never events as proposed
by NQF (Public Act No. 04-164,
2004). Both hospitals and outpatient
surgical facilities are required to report such events to the state Department of Public Health; however, the
disclosure of the reports is restricted
(Public Act No. 04-164, 2004).
Illinois
On January 1, 2008, Illinois
became the fourth state to require
the public reporting of never events
with the implementation of the Illinois Adverse Health Care Events
Reporting Law of 2005. Initially,
this mandatory reporting law, the
Hospital Assessment Act of 2005,
required ambulatory surgical centers
and hospitals to report these events
to the Illinois Department of Public
Health (Illinois Hospital Association, 2008). In addition, it should be
noted that only the published annual
report is available publicly. Further,
any findings, corrective action plans,
and records are unavailable to the
public and are not discoverable or
admissible at law (Illinois Hospital
Association, 2008).
California
The State of California began the
implementation of a law, effective
in 2007, mandating that general
acute care hospitals, special hospitals, and acute psychiatric hospitals
report the occurrence of one of
their statutorily defined adverse
events to the California Department of Public Health (California
Health and Safety Code §1279.1 et
seq., 2008). Interestingly, California has two unique provisions to
its medical error reporting system.
First, reporting is required of an
event or series of events that causes
the serious disability or death
or a patient, visitor, or personnel (California Health and Safety
Code §1279.1 et seq., 2008). This
requirement is an expansion of
whom to include within the definition of adverse event. Second, the
requirements call for the patient to
be notified within 24 hours of the
discovery of the error (California
Health and Safety Code §1279.1 et
seq., 2008). This second feature creates several potential and currently
unresolved issues, including how
the patient should be informed of
the error, who should inform the
patient of such an error, and how
JOGNonline.com
this information will be communicated and later analyzed by the
California Department of Public
Health.
Geriatric Patient Populations
Of specific interest to professional nurses practicing with
geriatric patients in skilled nursing, long-term care, extended care,
assisted living, or other facilities
recognized by the individual state,
is the current incantation of the
state’s existing law. For example,
in the NQF (2007) update, only
New Jersey, Oregon, and Wyoming
appear to have laws in place that
specifically address the locations
begun shifting from that of assigning blame and determining liability
to the promotion of safety and
prevention of error. As the focus
of the practice of medicine shifts
more from diagnosis and treatment
to screening and prevention, so too
does the practice of nursing. As
this continues, nurses must always
strive to learn and implement the
most current best practices while
remaining knowledgeable of their
state’s applicable laws and federal
guidelines. The changing landscape
of nursing and health care presents
an especially difficult challenge for
those providing care to geriatric
patients who are not located in acute
The changing landscape of nursing and health care
presents an especially difficult challenge for those
providing care to geriatric patients who are not located in
acute care settings.
most often associated with geriatric
care.
Furthermore, on May 18, 2006,
the Centers for Medicare & Medicaid
Services (CMS) spoke for the first
time about never events. In this statement, CMS reported it was investigating ways for Medicare to reduce
or eliminate the occurrence of these
events. CMS provided its plan on
April 14, 2008, when it announced
that Medicare will cease payment for
eight specific kinds of never events.
Since releasing these statements,
CMS has extended this policy of
nonpayment from inpatient hospital
services to both service of nonfacility
providers, including physicians, and
to outpatient services. Frequent updating and research will be required
as the focus of today’s health care
system changes.
Conclusion
Nursing is one of the most
dynamic and ever-changing professions in health care. In a relatively
short time, the focus of nursing has
care settings. Only by researching
the current law and forecasting state
and federal trends will nurses be
able to provide the best and safest
care for their patients while limiting
personal risk and liability. Unfortunately, errors will probably never
be eradicated, but with education
and care, nurses will be able to focus
their practice on the most important
aspect in health care—the patient.
References
California Health and Safety Code § 1279.1 et
seq. (2008). Retrieved from the California
Board of Nursing website: http://www.
rn.ca.gov/pdfs/regulations/npr-b-58.pdf
Centers for Medicare & Medicaid Services.
(2006, May 18). Eliminating serious, preventable, and costly medical errors–Never
events. Retrieved from http://www.
cms.hhs.gov/apps/media/press/release.
asp?Counter=1863
Centers for Medicare & Medicaid Services.
(2008, April 14). CMS proposes to expand
quality program for hospital inpatient services in FY 2009. Retrieved from http://
www.cms.hhs.gov/apps/media/press/
release.asp?Counter=3041
Connecticut Public Act No. 04-164: An act
concerning the quality of health care
(2004). Retrieved from http://www.
Journal of Gerontological Nursing • Vol. 35, No. 11, 2009
cga.ct.gov/2004/act/Pa/2004PA-00164R00SB-00566-PA.htm
Dotseth, M. (2004). The reporting of adverse
events in health care: Minnesota’s law. Retrieved from the Minnesota Department of
Health website: http://www.health.state.
mn.us/patientsafety/ae/lawoverview.pdf
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leg.mn/bin/getpub.php?pubtype=STAT_
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section=144.7065&image.x=11&image.
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Retrieved from the AARP Bulletin Today
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articles/public_disclosure.html
