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PREVENTABLE ADVERSE
EVENTS
Jassin M. Jouria, MD
Dr. Jassin M. Jouria is a medical doctor, professor of
academic medicine, and medical author. He graduated
from Ross University School of Medicine and has
completed his clinical clerkship training in various
teaching hospitals throughout New York, including
King’s County Hospital Center and Brookdale Medical
Center, among others. Dr. Jouria has passed all USMLE
medical board exams, and has served as a test prep
tutor and instructor for Kaplan. He has developed several medical courses and curricula for
a variety of educational institutions. Dr. Jouria has also served on multiple levels in the
academic field including faculty member and Department Chair. Dr. Jouria continues to
serves as a Subject Matter Expert for several continuing education organizations covering
multiple basic medical sciences. He has also developed several continuing medical education
courses covering various topics in clinical medicine. Recently, Dr. Jouria has been contracted
by the University of Miami/Jackson Memorial Hospital’s Department of Surgery to develop
an e-module training series for trauma patient management. Dr. Jouria is currently
authoring an academic textbook on Human Anatomy & Physiology.
ABSTRACT
Despite increased advances in healthcare initiatives, in particular as it
relates to standard organizational safety practices, failures continue to result
in serious reportable medical or diagnostic errors. Health organizations
focused on acute care and outpatient services are continuously confronted
by material and human barriers to effective health team participation and
accountability to meet the growing demands in healthcare, including
professional practice education, data collection and reporting. The definitions
of patient safety are discussed in detail and the classification of various
types of medication and diagnostic errors, which are both preventable and
not. There will be an emphasis on the different recommendations and
methods on how to improve the major problems in healthcare.
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Continuing Nursing Education Course Planners
William A. Cook, PhD, Director, Douglas Lawrence, MA, Webmaster,
Susan DePasquale, MSN, FPMHNP-BC, Lead Nurse Planner
Policy Statement
This activity has been planned and implemented in accordance with the
policies of NurseCe4Less.com and the continuing nursing education
requirements of the American Nurses Credentialing Center's Commission on
Accreditation for registered nurses. It is the policy of NurseCe4Less.com to
ensure objectivity, transparency, and best practice in clinical education for
all continuing nursing education (CNE) activities.
Continuing Education Credit Designation
This educational activity is credited for 4.5 hours. Nurses may only claim
credit commensurate with the credit awarded for completion of this course
activity.
Statement of Learning Need
Knowledge of preventable medical errors includes being informed of
guidelines of healthcare that prevent patient harm during medical treatment
and nursing care. Nursing standards and professionalism require ongoing
education and implementation of patient safety standards.
Course Purpose
To provide nurses and health team associates with current and up to date
knowledge about preventable medical errors.
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Target Audience
Advanced Practice Registered Nurses and Registered Nurses
(Interdisciplinary Health Team Members, including Vocational Nurses and
Medical Assistants may obtain a Certificate of Completion)
Course Author & Planning Team Conflict of Interest Disclosures
Jassin M. Jouria, MD, William S. Cook, PhD, Douglas Lawrence, MA
Susan DePasquale, MSN, FPMHNP-BC – all have no disclosures
Acknowledgement of Commercial Support
There is no commercial support for this course.
Activity Review Information
Reviewed by Susan DePasquale, MSN, FPMHNP-BC
Release Date: 3/15/2016
Termination Date: 3/15/2019
Please take time to complete a self-assessment of knowledge, on
page 4, sample questions before reading the article.
Opportunity to complete a self-assessment of knowledge learned
will be provided at the end of the course.
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1.
The data on preventable events has not shown that:
a. Incidence study categories are problematic for staff.
b. Preventable events should be a learning focus.
c. Near misses are an important, complex category, based on harm
potential and proximity to patients.
d. Staff agree on events that caused or had potential for severe harm.
2.
True or False. In acute care, 24/7 shifting simultaneous service
of the medical or hospital team can lead to high-risk
complications that can happen.
a. True
b. False
3.
The data on preventable events has not shown that:
a. two-way exchange of information was lacking.
b. staff not on good terms or uncomfortable with each other.
c. long absences from work and/or being new in a setting
d. all of the above
4.
The most common missed or delayed diagnoses have been:
a. urinary tract infection
b. pulmonary embolism
c. drug reaction and overdose
d. answers b and c above
5.
True or False. Blood donor or organ transplant incompatibility is
a preventable adverse event.
a. True
b. False
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Introduction
Professional roles are evolving in medicine and nursing with quality at the
center of health system reform and trends to promote safe outcomes. This
study will discuss the definitions of patient safety in detail and the
classification of various types of medication and diagnostic errors, which are
both preventable and not. There will be an emphasis on the different
recommendations and methods on how to improve the major problems in
healthcare.
Patient safety in healthcare improvement and quality involves a wide range
of activities to meet ever-increasing demands, which involves multiple
stakeholders focused on healthcare safety, efficiency, and ethical outcomes.
Healthcare in the United States and countries represented by the World
Health Organization (WHO) are actively engaged in health reform processes
to improve health care quality initiatives. The terms “adverse medical
event”, “adverse medical outcome” or “medical error” are used in the lay
press, scientific literature and mainly the web – to explain the cause or
result of an injury to a patient because of a medical intervention, and not
just any underlying medical illness. Ultimately, a preventable adverse event
occurs unintentionally to a patient from any kind of healthcare
management.1
Most adverse outcomes are due to failures traced to the healthcare delivery
system as well as human error. Some adverse events occur due to
unforeseen safety risks or as a result of new emerging technologies;
whereas, others occur due to system failures such as poor communication,
poor documentation, poor staffing or mismanagement of resources that lead
to errors. Errors can also happen due to lack of necessary education to
support health professional skills or knowledge base, or may result due to
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fatigue, stress, or inability to keep up with the demands and flow of the
healthcare system.1
Patient Safety Definitions
Patient safety during a patient’s course of care in a hospital or clinic setting
has become a very important issue in healthcare delivery today. There are
numerous studies that reveal unsafe practices with devastating outcomes
occur in healthcare, and health organizations and providers have not
appropriately addressed approximately 50% of various types of adverse
events shown to be preventable.2 Other studies have discussed solutions to
improve patient safety by focusing on organizational team functions and
their culture of safety, which is defined by the healthcare organization as the
result of individual and group values, competencies, attitudes and behavior.
These are the ones that influence patient safety.2
In order to achieve a positive safety environment, the organization should
first evaluate their current culture on patient safety. Most positive safety
culture organizations are bounded with openness and trust and values of the
importance of safety.2 One of the biggest reasons why there are threats to
patient safety is due to understaffing, most especially when it comes to
nurses. It was researched that Dutch hospitals have shortages in operating
room personnel, which is just about 23% of the population in the
Netherlands, since this is “not the most satisfying or popular job” for
nurses.13
Other reasons have been studied and reported. In Canada, clinic medical
providers who participated in a research study revealed four major types of
self-reported medical errors or incidents as the following: documentation
(41.4%), medication (29.7%), clinical administration (18.7%) and clinical
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process (17.5%). It shows that medication has the largest percentage of
threat for the health of the patient.17
Triage is also one of the threats to patient safety, but this is hardly noticed
nor documented in any adverse effect studies. According to Smits et al., it
was reported that there are approximately 9 out of 27 incidents (33%)
identified in record review of primary care patients that were related to
triage. The telephone triage nurses in Norway correctly classified 82% of
acute and 74% of urgent cases based on written documents. Based on this
study, it was determined that nurses and physicians themselves perceive
triage as a major threat to patient safety. Triaging patients for appointment
is a difficult task that needs to be carefully analyzed and balanced. There
should be regular trainings in triage as well as clear communication between
physicians and nurses about triage processes in order to avoid medical
errors.17
In order to promote patient safety in a primary care setting, identification of
the most common types of errors should be prioritized first. There are
different researchers who have studied different types of methodologies just
to identify these errors; and, some approaches included reviewing medical
reports from doctors, interviewing adult patients, doing observational
prospective studies, and reviewing malpractice cases in hospitals. These
different methodologies are the reasons for difficulty in comparing the rates
of errors or even adverse events.
Despite obstacles identified with the different methodologies, similar error
categories and events have been identified to provide a classified system.
According to one study, the following are the number of events reported:29
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
117 errors for 15 physicians in 83 visits across 7 offices over 3 half
day sessions

221 incidents from interviews with 38 patients asking them to recall
events that occurred at any time in the past

344 incidents from 42 physicians over 20 weeks

940 incidents over 2 weeks across 10 practices

805 incidents occurring between October 1993 and June 1995 from
324 physicians

5,921 incidents from claims data for over a 15-year period

1,223 incidents from 4 articles published 1995-2002
Types Of Errors Causing Adverse Events
There are different types of errors that cause adverse events; and in one
research it shows that the most common type of adverse event was caused
by therapeutic error (34.2%, range 4-49%), followed by diagnostic error
(19.1%, 12-41%) and operative adverse event (18.4%, 7-47%).
Therapeutic error means that a diagnosis has been made but an appropriate
therapeutic response was either not ordered or not delivered. Diagnostic
error indicates either failure to make a diagnosis or to do so in a timely
manner or the failure to make a correct diagnosis from provided information.
Operative adverse events occurred more in the peri-operative period but this
also includes those occurring during the actual procedure.37
The literature has little information in terms on what types of patient safety
events the health care professionals or health care setting should focus or
agree upon. There are diverse ways to focus attention on safer outcomes in
terms of learning strategies, and creating change and improvement; and,
there is no concise universal definition of what constitutes a medical error.
In fact, the way front-line health care providers or managers understand and
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categorize different types of errors, adverse events and near misses and the
kinds of events believed to be valuable for learning are not well
understood.50
There are focus groups that may be utilized by a health organization to
research how people in different healthcare settings understand the concepts
of the different types of Patient Safety Events (PSEs) to gather knowledge
and learning. Generally, a short questionnaire is developed by the focus
group and mailed to each study participant for investigation and validation.
In one such focus group, health care staff along with their managers divided
adverse events into simple categories of major and minor events, and based
upon harm or harm potential.
Four themes surmounted from the gathered data, and are as follows:50
1. Incidence study categories are problematic for those working in
organizations.
2. Preventable events should be the focus for learning.
3. Near misses are an important but complex category, differentiated based
on harm potential and proximity to patients.
4. Staff disagrees on whether events causing severe harm or events with
harm potential are most valuable for learning.
Misconception of patient safety terminology can lead to confusion for health
care providers, creating barriers to needed reflection on a range of different
PSEs for additional knowledge on ways to reduce harm and, ultimately,
improve patient safety at the point of care.50 One study explored how frontline providers and managers categorized different types of errors, adverse
events and near misses (collectively referred to here as patient safety
events, or PSEs) with a focus on the kinds of events useful to a range of
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healthcare professionals. By learning, it involves processes of identifying
PSEs, analyzing their causes and taking corrective action to reduce the
reoccurrence of similar events. The researchers were able to examine how
front-line providers and managers categorize PSEs and their reasons for
doing so, as outlined below:50
1. Firstly, organizations that intend to learn from PSEs will be presented
with bigger opportunities, given past studies reporting on the incidence
of adverse events among hospitalized patients. A classification scheme
made by frontline healthcare providers and managers can help
organizations make excellent decisions on which events to study.
2. Secondly, it was discussed that self-reports tend to identify serious
events with bad outcomes, while other events go unrecognized. When
events are corrected before harm occurs, there is a potential system
vulnerability, and important loss of learning opportunity. There must
be a focus on those events with greater opportunities to create
strategies and lessen harm on patients.
3. Thirdly, there are doubts about the way front-line providers or
managers categorize types of PSEs and which type(s) are believed to
present valuable learning opportunities with one recent exception. In
one article some researchers found that PSEs are sometimes "defined
away," thereby decreasing the opportunities to learn on how patient
safety can be improved.
4. Finally, studies gave priority to a lack of a common language and
inconsistency in error identification that hinders systematic reporting
of PSEs. It also limits the potential to learn from these events since
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the possibility for learning is directly related to how potentially
dangerous events are understood, interpreted and categorized.
Medical Errors
“Primum non nocere” or translated as “first, do no harm” is the universal
medical caveat attributed to Hippocrates. Over the last 20 years, the U.S.
healthcare system had positively increased awareness of the seriousness of
medical errors. That is why in the year 2000, the Institute of Medicine (IOM)
published its landmark study, “To Err is Human: Building a Safer Health
System”. From here, it was reported to have raised the specter of Americans
delaying and/or avoiding necessary health care intervention because of the
knowledge and/or fear of being subjected to widespread medical errors.7
Medical errors are traumatic for patients and also for healthcare
professionals. The public does not realize the full toll medical errors have on
healthcare professionals since patients or the victims receive more publicity
than those in the healthcare field.8
The definition of medical errors may include adverse events or outcomes
that can be prevented depending on the medical knowledge of the person
involved. These medical errors are better understood as doing an actual
harm to a person resulting in any kind of injury, accident or illness - but
were also averted by timely intervention.7 There are effective tools that have
been discovered for the prevention of medical errors.8
According to Dr. Mamta Gautam, professional burnout symptoms of medical
providers and other healthcare staff may initiate a vicious cycle of medical
errors that increase burnout. It is then important to also focus on these
healthcare professionals to help discuss the feelings and emotions with
regards to medical errors and how to move on and continue doing their job.8
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The concerns about medical errors in the U.S. healthcare system come from
three categories: overuse intervention, underuse beneficial intervention and
misuse, which is inappropriate intervention.7 Several decades ago, medical
errors were a well kept secret by medical practitioners, but since the release
of the report “To err is human”, medical safety and the disclosure of errors
have been revealed to the public’s knowledge.6 The disclosure of medical
providers to medical errors is very important for the public, most especially
the patients and other health care professionals. It is a normal reaction that
providers may be hesitant to discuss the medical misdiagnosis or errors due
to the fear of consequences as well as disciplinary actions or penalty charges
they may face.6
Programs To Prevent Medical Errors
Local Programs
Since the start of the twenty-first century, people became more focused on
the quality of health care systems. Hospitals, clinics and even health insurers
monitor and keep the data about specific cases or events of patients and
treatment outcomes in order to improve their services. There are also
several initiatives of implementing a well-designed infection control program,
which can reduce nosocomial and acquired infections.7
Regional and National Programs
In the U.S., the following national programs known to help in preventing
medical errors are the following: U.S. Food and Drug Administration (FDA)
which is a mandatory program report for the medicines, vaccines, medical
devices, and blood products; Centers for Disease Control (CDC) National
Nosocomial Infections Surveillance System which is responsible for health
care-related infections; State agencies of New York, Massachusetts, and
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Florida which monitors health parameters, and non-governmental
organizations (NGOs) such as Joint Commission on Accreditation of
Healthcare Organizations (JCAHO) oversee medical error reporting
programs.7
Ideal Medical Error Reporting Programs
There are two programs that are successful in reducing its medical error
rates. One is the Department of Anesthesiology and the other one is the US
Department of Veterans Affairs. The anesthesiology team became successful
by reducing its medical error rate from 25–50 per million patients to
something of the order of 4–7 per million patients. This happened due to
first initiating a system analysis of errors and then by constantly making
improvements on technology, cooperation, simplification, standardization
and adoption of the practice guidelines. The same is also the true for the
U.S. Department of Veterans Affairs, which has reduced medication errors
70% by introducing a handheld, wireless medication bar coding system.7
Preventable Adverse Event And Adverse Event
Despite the highest quality care for the patient, there are reasons why
medical errors or poor treatment still happen. This is because of the different
treatment outcomes or adverse effects that the patients are encountering. It
is said that adverse responses to medical care may not necessarily imply the
intervention of medical error.7 Adverse events are “injuries that are related
to medical treatment which can be measured by its disability”, while an
unpreventable adverse event is mentioned as a “complication that cannot be
prevented given the current state of medical knowledge”.7
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Preventable or avoidable adverse events are defined as “a direct result of
failure(s) to follow recognized, evidence-based best practices or guidelines
at the individual and/or system level”.1
The following may cause these avoidable or preventable adverse medical
events: misdiagnosis, forgetting to diagnose the patient, a delay in
treatment and diagnosis, delay in follow up and poor performance by
medical practitioners. These all lead to medical liability.1 A study tried to
identify the potential causes and contributing factors of preventable adverse
drug events (ADEs) in a national sample of spontaneously reported ADEs,
focusing in particular on the contribution of information management. A
classification approach was being developed for types of ADEs, which
included 11 main classes and their subclasses. Six of the main classes were
identified from the study data and they found that ADEs occurring in the
prescription, transcription and administration stages were most frequent,
and human factors were the leading class of underlying cause.29
Data concerning patient complaints and reporting incidents have been used
for research purposes with the advantage of covering the entire nation. Also,
there are different sources of data, which gave different levels of detail
especially with respect to system factors. Data in official statements typically
have substantial information about these factors that can be used in order to
understand complex phenomenon and their causes. The principle limitation
of patient complaints is reporting bias, and under-reporting is a major
issue.29
Adverse drug events were found out to be common in the prescription,
transcription and administration stages of the medication use process and
human factors were important for all of these. Human factors issues as a
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cause were associated with a large proportion of preventable ADEs. In one
study, Nuckols et al., found human factors to have a 46% of hospital
incident report narratives, but their objective was to study the content of the
narratives and ascertain whether or not they could find contributing factors.
Some of the most common human factors issues were related to calculation,
misunderstanding, inadequate knowledge and reliance on memory. The
majority of human factors issues in information management errors fall into
the categories of slips and lapses, which arise from informational problems,
such as forgetting or incomplete knowledge.25
The importance of data in the medication management process is greatly
emphasized. Omissions of use of patient data were another common cause
for information management errors. This usually happens when no one in
the healthcare team tends to review the patient’s records, which is accurate.
One reason for omissions might be due to a hurried or rushed environment
such as the setting of the emergency room, which involve deviations from
safe practice commonly identified in health care.32
Information management errors are due to the following: documentation,
copying the data or contraindicated prescriptions that happen in the
prescription and transcription or admission phases. The typical contributing
factors are the use of the copy–paste method and information transfer but
duplicated documentation, lack of documentation, verification of dictation,
ignoring guidelines, work processes and availability of patient data also
contributed to errors in information management. Even medication data are
collected and stored in multiple phases, and information management is
partly based on the copy–paste method, one that is prone to human errors.
Utilizing the possibility of electronic data entries and structured
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documentation systems at the point of care should easily prevent this type
of error.32
One research study carefully analyzed the funnel-shaped distribution data of
adverse event (AE) and preventable adverse event (PAE) rates with sample
size as a problematic consequence of variation. Further research is needed
to explain the results of this study; however, it definitely affirmed that AE
and PAE cause serious problems across all healthcare settings and medical
procedures.44
In a hospital setting, the transfusion and clinical laboratory services are
integral parts of inpatient and outpatient care that heavily affect outcomes
and costs. Laboratory data may influence up to 70% of important decisions
made throughout a hospital stay, and up to 2.7 million blood product
transfusions occur yearly in the United States. It has clearly been shown that
serious safety events arise. Preventable errors have been shown to cause
patient suffering, permanent disability, and death. As a result, blood
transfusion and clinical laboratory safety have been priorities for both
governmental and accrediting healthcare organizations.67
In the U.S., the different responsibilities of health care organizations were
reported relative to blood transfusion services. The FDA Center for Biologics
Evaluation and Research (CBER) inspects facilities according to specific
quality standards and the reporting of fatalities related to blood collection,
transfusion, or medical device use is mandatory. The College of American
Pathologists (CAP) provide comprehensive safety standard and The Joint
Commission (TJC) prioritizes problems with incompatible blood transfusions,
laboratory patient identification, and communication by designating them as
National Patient Safety Goals. The incompatible blood transfusions are
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specified as “serious reportable events” and “never events” by the Centers
for Medicare and Medicaid Services (CMS) and the National Quality Forum
(NQF), respectively.67
One of the most effective monitoring techniques has been to use adverse
event and “near-miss” data to direct and measure quality improvement
efforts. There are numerous reports that many healthcare sites have
voluntary reporting systems that capture various event types in either paper
or electronic forms. The examination of data such as contributing factors,
system failures, and outcomes may facilitate discovery of event trends that
can be used to inform safety initiatives, broaden communication lines, and
enhance patient care coordination.67
Discontinuities In Care
Many hospitals, most especially teaching hospitals, are dependent on
transfers of patient care to another medical provider just to abide a rule on
duty hour restrictions, and this is called hand-offs. This actually impacts
medical students to a great degree.53 For example, a medical student who
evaluates a patient initially is more likely to learn from the patient encounter
than a student who received the patient as a hand-off the next morning after
all the clinical and diagnostic tasks were done.53
There are also three analyses found in research that causes serious harm to
the flow of handling patient care information during the hand-offs of nurses
in a hospital. These are the following: (1) different ways in nurse
documentation and communication; (2) easy accessibility of the patient's
electronic health record, i.e., easily accessible by the entire care team; and
(3) rarity of interdisciplinary communication.55
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Patient Hand-offs and Interdepartmental communication
In the field of medicine and healthcare, interdisciplinary departments with
varied team associates tend to involve communication processes that rely
upon human memory and mental processing of information than other
industries, which comes with a high risk of failures and errors. More often
than not, these medical errors for information transfers among healthcare
providers increase the possibilities of adverse effects or impacts, most
especially when erroneous information becomes “fact” for the person or
team receiving it. Research also shows that there are 70% cases for
malpractice claims in teaching settings, and hand-off errors were the second
most known problem due to lack of monitoring. Failure of good
communication also contributed to 60% of the problems encountered in
healthcare settings.61
In a discussion of skill development in third-year medical students on a
clerkship and subject exam performance, a group of researchers found a
statistically significant but casual association of hand-offs between the
numbers of new patients seen. It proposed that exposure to hand-off
patients may have less educational value compared to learning from patients
with undiagnosed presentations. However, this situation plays a less
important role for the students who score higher on the subject exam and a
more important role for students who score lower.62
There are several categories of skills reported which are involved in
diagnostic reasoning, including data acquisition and reporting, problem
representation, and generation of hypotheses, which involves searching for
and selecting an illness script. These set of skills have been negatively
influenced by hand-offs. An example would be a night float resident might
admit a patient complaining of headache, weakness, poor appetite,
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generalized aches and a cough and then appropriately hypothesize that the
patient has influenza. A student would likely have more difficulty sifting
through these complaints, prioritizing them, and linking the other symptoms
to the cough. The student will definitely learn from the diagnosis and
experience on initial assessment more than a student that will see the
patient the next day. All night float residents performed usually the most
important part, which includes data gathering on the patient, creating an
assessment and differential diagnosis. This also includes creating an
evaluation and treatment plan. It was observed that students who scored
lower on the exam were more dependent on the hand-off than those
practicing skills on new patients.62
A number of factors have been analyzed on the night float systems on the
number of hand-off patients that students see and it may also include
daytime system as well. According to the report given by five hospitals,
students saw approximately 50% more hand-off patients if the teams
admitted patients daily than if the teams admitted on an every 4th day call
cycle. Also, residents may assign more stabilized hand-off patients to
students whom they perceive as less proficient.62
One study was done to assess whether a modified "ABC-SBAR" mnemonic
(airway, breathing, circulation followed by situation, background,
assessment, and recommendation) improved hand-offs by pediatric interns
in a simulated critical patient scenario; further studies are needed to check
hand-off in an emergency situation.56 There is a real need to provide formal
training in hand-off quality early in medical residency training. General
surgery trainees clearly prefer and performed better, though not perfectly,
hand-offs with the in-person method.63
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A rule was implemented in 2003 to limit the hours of residents in the
hospital but these have increased the cases of hand-offs while at the same
time may have reduced the transferring of information. The rules have also
increased the scheduling model tools like cross-coverage and night-float for
resident medical providers. This had increased errors due to lack of
familiarity to the case of patients.61
Recent research found that there’s little effect or medication error to the
pediatric residents with regards to hand-offs, but this created concerns
about the impact of duty limit hours of hand-offs. A report done by the
Institute of Medicine showed that it is necessary that resident doctors should
learn the patient hand-offs and make this a priority research.61 Hand-offs
were grouped to qualitative and quantitative study.
Qualitative Study on Patient Hand-offs
In a qualitative study, verbal interactive hand-offs predominated in internal
medicine, obstetrics–gynecology and pediatrics, and all who were
interviewed said that they believed they made up one-half of hand-offs in
surgery. During face-to-face hand-offs, resident providers only relied on
written, verbal and non-verbal cues such as gestures and emphasis.
Interviewees expressed a preference for verbal, interactive hand-offs. Most
hand-offs without a face-to-face interaction were just conducted over the
telephone, yet 15–20% of the hand-offs in surgery solely happened with the
outgoing resident leaving an electronic or paper summary or handwritten
notes.
Participants reported that the number of asynchronous hand-offs was
increasing.61 It was also observed that hand-off quality was also dependent
on residents’ clinical and diagnostic skills. Outgoing resident providers must
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have a good understanding of the clinical conditions and events for them to
have a better focus on relevant information. Additional informal decision
algorithms must also be used for more hand-off information.61
The residents admitted that trust and confidence to the hand-off participants
are important and they usually made decisions based on the clinical
diagnosis and interactions. The interviews found that confidence in hand-off
participants’ abilities was important, with residents reporting they made
judgments about the value of information based on prior clinical interactions.
When using the formal data summaries, residents reported that the number
of data items in the forms might distract from a focus on the information
critical for managing patients. Handwritten notes focused on patients’
current status, likelihood of complications or events and “to do” lists for the
upcoming duty period.61
One of the factors of having errors during hand-offs is when it lacked true
two-way exchange of information between medical providers and other
healthcare professionals. Examples would include hand-offs between
residents not in good terms or not comfortable with each other, hand-offs
just like or similar to the hand-off data form, and hand-offs during the first
day of a rotation or when residents just came back from vacation. It could
also be due to longer absences and by staff new in a setting more prone to
errors.61
When some planned tasks were erased and wrong information was given on
the patient, there were continued errors and communication problems in
hand-offs. Outgoing shifts tend towards increased errors, delays in patient
care and, hence, longer hospital stays. Its been reported that coordination
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problems mostly occur when there is no face-to-face hand-off and no form
of notes given to the incoming duty resident.61
Quantitative Study on Patient Hand-offs
According to one research, hand-offs lasted on average of just over 12
minutes, with a very small number of hand-offs lasting significantly longer
than 20 minutes. An inverse relationship of the number of patients handed
off and minutes per patient set the total time for the hand-off. Time
constraints are determined by attempts to have hand-off efficiency with a
large patient number, a fixed time to establish rapport, and hand-offs under
cross-coverage with a large census; potentially occurring under a model of a
reduced mandate for care and more limited information-sharing.61
In 2003, the Accreditation Council for Graduate Medical Education restricted
residency duty hours; and, because of it, there developed much concern
about the increased frequency of hand-offs whereby patient care
responsibility is transferred from one resident who is leaving the hospital to
another incoming resident. This resulted in a heightened focus on the
importance of quality hand-offs.60
The hand-off process, also known as “sign-out,” can be a written or verbal
transfer of patient care information. Each time a hand-off occurs the
possibility for miscommunication arises. It is estimated that the contribution
of communication failures to adverse events has been between 15% and
67%.60 Theories from the psychology of communication describe the quality
of hand-offs as reflecting the mentality of people; the more knowledge that
people have to share, the worse they communicate new material because
they overestimate the knowledge of the other. These psychological
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processes could systematically affect the effectiveness of communication
during hand-offs.60
A study made by pediatric medical interns of their hand-off communication
showed that 40% of the time they failed to give pertinent information to
their patients. From the examples used in the study, a correlation was found
between communication psychologies to the poor hand-off communication.
Residents also overestimated the fact that there would never be a problem
to communication and therefore no double-check was made. This is also the
reason why endorsements between outgoing residents or interns should be
communicated carefully to incoming duty.60 Since no formal hand-off
curriculum was identified in the study, this suggests that senior residents are
not that good in handling hand-off communication compared to interns.60
A review by the National Aeronautics and Space Administration reported that
hand-off communication has been found to be most effective when it is
driven by “problems, hypotheses, and intent” rather than long lists. It is
much better to train interns to communicate better by using this framework,
and avoid unnecessary knowledge items that cannot be remembered. This
will prevent cognitive overload for on-call interns by tailoring information
that is communicated. This is an area that requires additional studies.60
Interdepartmental Communications
As raised earlier, hand-off communication is a good example of how a
medical error in patient care occurs. This involves communication errors as
the main underlying factor of adverse events and patient’s harm. Hand-off
error greatly increased in the intensive care environment and the problem
happened for two reasons: (1) residency work hour restrictions shows more
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incomplete or incorrect transfer of information and (2) handoffs are done by
people who have not yet been given formal training for this process.40
There were many lapses to consider in communication in a multicenter study
of hospitalists and non-hospitalists in six U.S. academic medical centers.
There were a few primary care providers (PCPs), which had direct
communication with the inpatient medical team during their patients’
hospitalizations; however, the problem was that more than half reported
they had not received any discharge summary within 2 weeks. Almost, one
quarter of PCPs did not have any knowledge that their patients had been
admitted at all.52
There is a big difference between the rates of adverse effects of hospitals
and hospital departments. There were more preventable adverse effects
found in hospital departments as compared to hospitals in general. Patient
safety at the hospital department level can still be improved independently
of those reported between hospitals or hospital departments in general.39
A sample of patient groups with a higher risk of preventable adverse effects
has been studied. The inter-departmental variance in both the rates of
adverse events (AEs) and the rates of preventable AEs was mainly explained
by differences in the patient mix and department type. Increasing age and
higher co-morbidity were two associated factors with an increased risk of
preventable AEs. Thus, patient safety interventions should give more priority
to elderly patients and patients with co-morbidity. It is also considered that
longer hospital stays were associated with an increased risk of preventable
AEs, but still questionable whether length of stay is a cause or a result of the
occurrence of preventable AEs. In addition, patients who undergo a surgical
procedure are at a higher risk. Healthcare providers should obtain better
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documentation of surgical patients to prevent adverse outcomes because of
the increased risk of adverse effects.39
There are recommendations on how to improve the overall patient safety
within a hospital. Recommendations include there must be interventions
tailored for individual hospital departments which are necessary to reduce
their patient safety risks. In order to do this, there must be a deeper
understanding of the nature and underlying causes of adverse effects of a
particular department, since such understanding will facilitate
implementation of effective interventions to reduce the variation.39 The
hospital management team should be aware of the appropriate interventions
and implementation strategies that will help limit the adverse effects and
problems of specific hospital departments. Hospital managers should give
importance to the high risk departments with higher preventable adverse
effects to give the necessary safety programs for the patients such as elderly
patients and patients that undergo surgical procedures.39
There was a study that found the majority of medical adverse events are
secondary to errors in communication. There were approximately 5632
sentinel events that were reported to the Joint Commission (known until
2007 as the Joint Commission on the Accreditation of Healthcare
Organizations) since January 1995, which revealed that 70% are the result
of communication. Due to such an overwhelming number, the Joint
Commission's 2009 national patient safety goals have challenged medical
professionals along with hospital administrations to engage in continuous
improvement of effective communication among caregivers.43
The Cincinnati Children's Hospital Medical Center (CCHMC) in 2007 was
reviewed in terms of the root cause of non-perioperative serious safety
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events (SSEs) and found out that the common cause of these events is the
failure in team communication or team situation awareness (SA). It was
reported that four of seven SSEs (57%) involved poor recognition of
abnormal vital signs or poor communication of parents’ or nurses’ concerns
and these events usually occurred at night time when there are least
number of resources, multiple sign-outs of physicians and nurses, and
communication among nurses, physicians, and patients’ families is less
frequent. With the release of the new Institute of Medicine regulations about
hours for residents and the potential for increased discontinuity of care and
increased transfers of care (handoffs), there is really a need to improve SA
and communication.43
A night discussion session was implemented in one study and they put great
emphasis on standardized questions, formal discussion time, inclusion of
nurses and residents, and follow-up discussion with the attending medical
provider. The study was able to show that a combination of these
components into a Night Talks approach significantly decreased the rate of
near misses. It was observed that there are also additional effects on the
culture of safety. Night-shift nurses reported feeling more a part of the team
because they are now involved in the patients’ care plans. The residents also
appreciated the attending providers supervising their decisions at a point in
the night when they feel most vulnerable. Finally, the attending providers
are more aware of the issues at night so that plans can be initiated earlier
and adverse events can be prevented.43 It was also learned that a visible
reminder in the workspaces of the medical residents and nurses helped. The
addition of an administrative assistant to hand the forms to the pediatric
chief resident each week improved the return. Convincing the pediatric chief
residents that a phone call every night in the middle of the night would
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improve patient care and that patient safety is a continuing challenge helped
to improve safe outcomes, as the data demonstrated an impact.43
Instituting a standardized Night Talk between the bedside nurse, PCP,
intern, senior resident, and attending physician substantially reduced nearmiss events in the neurosurgical patients on one unit. It was found out that
a discontinuity of care occurs due to restriction in work hours, and medical
practice evolving into more shift work, which in turn brings more
discontinuity of care. By improving communication during high-risk times
such as the night shift, as well as by improving team SA, adverse events can
be substantially reduced. There should be more discipline and focus to meet
the demands of the Joint Commission's national patient safety goals, in
order to gain improvement in communication.43
In a study to improve the ophthalmic histopathology request form and its
completion by ophthalmology staff at the Royal Hallamshire Hospital,
Sheffield, improving written communication is important to the hospital for a
number of reasons. Firstly, maximizing the relevant clinical information
available to the histopathologist when specimens are reported enables them
to investigate the specimen appropriately and can definitely provide the
most likely clinical diagnosis and possible differentials, which allow clinicians
to plan appropriate patient management.65
The quality and clarity of patient-provider communication in the hospital is of
highest importance. Ineffective communication in the hospital contributes to
poor care transitions and post-discharge complications. Patients commonly
leave the hospital with a poor understanding of what transpired like
diagnoses, treatment provided, or even major test results and inadequate
knowledge about the self-care activities that they must perform upon
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returning home, such as medication management, physical activity, and
follow-up appointments. Poor communication is often cited as the main
underlying and remediable factor behind medical errors, adverse events, and
the readmissions that commonly occur after hospital discharge. The results
of this study provided exact evidence, showing that patients often feel they
have experienced suboptimal communication in the hospital setting. There
must be more priority in improvement in care transitions and patient safety,
particularly among patients with inadequate health literacy.90
Schillinger and colleagues found that patients with inadequate functional
health literacy reported significantly worse communication on the domains of
general clarity, explanations of processes of care, and explanations of
condition and prognosis. Subsequent analyses by Sudore and colleagues
demonstrated that patients with inadequate or marginal health literacy more
often reported that physicians did not give them enough time to say what
they thought was important, did not explain processes of care well, and did
not ask about problems in following the recommended treatment.90
Major And Common Hospital Adverse Events
There are identified problem areas that need to be solved in a hospital
setting, which may affect medication therapy; these include hand hygiene
and medication safety. According to the reports, errors happen because of
the following reasons:
●
Errors that happen during the prescription, preparation, and
administration of medical drugs.
●
Errors that happen because of wrong identification of a patient or
procedure, miscalculation a drug, writing mistakes, reading
mistakes, mishearing, or reaching for the wrong substance.
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Also, some of the other problematic areas are the following:
●
Patient information was lacking on one treating or specialty
department to the next, and necessary treatments were not done
properly or done in an erroneous manner.
●
Patients and/or procedures have been mixed up due to confusion and
one patient may have given the medication of another patient or
have underwent a different operation not suited for the patient.
●
Patients are often passive “consumers” because of their illness.
Studies from New York and Utah and Colorado showed statistics after
retrospective patient chart review that 3.7% of patients (New York) and
2.9% of patients (Utah and Colorado) had experienced adverse events in
the hospital. Additionally, 58% and 53% of these events were categorized
as avoidable.46 Another study investigated that increased workload and
capacity utilization increase the occurrence of medical error, an effect that
can be offset by a positive safety climate but not by formally implemented
safety procedures and policies.79
Patient safety remains to be one of the biggest challenges for the public
health sector, which in reality is often affected by mistakes made in prehospital emergency care. A culture of safety is encouraged and health
professionals have new tools at their disposal to help them maintain that
safety.81
Drug-Related
Medication use sometimes accidentally happens by unwanted adverse
reactions that are very detrimental to a person’s health. It was documented
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in 2001 that over 4 million people experienced medication adverse events,
which was 1.5 times the rate observed in 1995. The Institute of Medicine
also has estimated that 1.5 million preventable adverse events occur every
year and up to 50% could have been prevented by the modification of
prescribing methods. There are also unknown risks and unpreventable side
effect risks that were discussed. The FDA's Safe Use Initiative (SUI) focuses
on preventable risks that are significant and amenable to implementable
interventions that have potential impact and measurable outcomes.38
It is very essential to find ways to reduce the harm from different
medications or drugs and identifying, describing, and understanding the root
cause of significant preventable risks are very important. FDA's SUI
describes four main categories of preventable risks and these are the
following:38
1.
Medication errors
2.
Unintended/accidental exposure
3.
Intentional misuse/abuse, and
4.
Drug quality defects
Medication errors are broken into subcategories:38
1.
Informational errors in prescribing or by patients/consumers
2.
Procedure and process type errors
Procedure type errors usually happen in hospital settings. It was reported
that in a critical care unit individual patients experienced 1.7 medication
errors per day. A review of the literature focusing on hospital practices
indicated that most medication errors occurred during administration (53%),
but they also occurred during prescription (17%), preparation (14%), and
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transcription (11%). Though the procedural and process type errors are of
concern, the major focus of FDA's SUI is informational errors.38
Medication use remains to be a high-risk activity. A recent Institute of
Medicine (IOM) report on this subject is that the rates and impact of
medication errors have a great impact but are less understood. The
President of the Institute of Safe Medication Practices (ISMP), Michael Cohen
shared his thoughts to a committee of the US Congress, estimating that the
dollar cost of adverse drug events was about $200 billion across all health
care settings. In ambulatory settings, medication errors and adverse drug
events (ADEs) are one of the most important safety issues. A study based
on the National Ambulatory Medical Care Survey (NAMCS) found that officebased physicians prescribed at least one inappropriate medication to nearly
8% of the elderly who received prescriptions. There was also another study
of ambulatory elderly patients with polymorbidity and associated
polypharmacy that documented 35% reported experiencing at least one ADE
within the previous year.35
In the United Kingdom (UK) and other countries, there have been
tremendous deficits in the safety and quality of medication use to a degree
that constitutes a public health threat. It has been found that 3% to 4% of
all unplanned hospital admissions are caused by preventable adverse drug
events. Antiplatelets, non-steroidal anti-inflammatory drugs (NSAIDs), oral
anticoagulants, diuretics, and other potentially nephrotoxic agents account
for approximately 60% of all preventable admissions.35
In accordance with research evidence, the “use of antiplatelets and oral
NSAIDs in patients at increased risk of gastro-intestinal bleeding” and “use
of oral NSAIDs in patients at increased risk of renal failure” were identified
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as key priorities for quality improvement in primary care by a Delphi
(research) panel of primary care clinicians.36
More studies show that drug administration errors are among the highest
medical errors. Children are always at risk for such medication errors
because of the need to calculate doses depending on each body weight and
height measurements. Pediatric doses that are ten times the correct amount
are occasionally given and can be life-threatening. In a pediatric emergency
room, this type of error happens for every one of the thirty-two medications
ordered. The highest error rates are to be expected in pre-hospital
emergency medicine.21
Vaccines can prevent a disease from occurring in the first place and can also
decrease the risk of complications and risk of transmission, which is why this
became one of the most important developments in public health. It helps
decrease the communicable diseases most especially in children. Due to its
effectiveness, people became concerned about its safety and side effects.
There are live vaccines such as BCG, DPT, Polio, Measles, Hepatitis B which
cause transient minor adverse events including swelling, redness or soreness
at the injection site, and low-grade fever, crying and irritability (in infants).24
The adverse events caused by an error in these vaccines are related to
manufacturing, handling, cold chain maintenance, vaccination schedule or
administrations, which are program errors. They are generally preventable
and detract from the overall benefit of the immunization program. These
incidents, which result in needless deaths or life-threatening illness and
damage to vaccination programs are preventable if proper reconstitution of
vaccines and proper handling procedures are followed.24
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Some factors that also play a role to medication errors include labels,
appearance and location of ampoules and syringes, inattention, poor
communication, carelessness, and fatigue on the part of the
anesthesiologist. There is one case of drug error-induced polymyoclonus that
happened due to injection of tranexamic acid for spinal anesthesia, as the
two different ampoules had a similar appearance. The lesson learned is it is
important to double-check the medication to reduce such errors.12
There are only few studies about the effect of direct intrathecal
administration of tranexamic acid in humans. De leede et al., has reported a
case of a 68-year-old man who accidentally received an intrathecal injection
of 50 mg tranexamic acid. Immediately after the injection, he developed
status epilepticus. The outcome was complicated, with hypotonic paresis of
all four limbs, which resolved but resulted in residual bilateral peroneal
palsy. Yeh et al. reported that seizures and refractory ventricular fibrillation
after accidental intrathecal administration of 500 mg tranexamic acid were
associated with fatal outcome. The exact mechanism by which tranexamic
acid induces seizures or ventricular fibrillation is not known. There are,
however, reports of neurotoxicity in experimental studies, and when applied
topically to the cerebral cortex in animal studies, this drug is known to
produce seizures.12
There were also case reports about medication errors that were due to
confusion between hyperbaric Bupivacaine and tranexamic acid, since the
ampoules of tranexamic acid and Bupivacaine were similar in appearance.
The reports led the manufacturer to change the ampoule configuration of
hyperbaric Bupivacaine so that such serious complications would cease to
happen.12
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According to statistics reviewed by the American Institute of Medicine,
approximately 7000 people die every year in the U.S. because of medication
errors, including self-medication and doctors’ prescriptions in patients of all
ages. In hospitals, drug administration errors are one of the most common
medical errors. Because of age group–specific contraindications and the
need for personalized dose calculation, children can be expected to be
particularly at risk of medication errors. There are certain improvement
measures, which had already been put in place such as using an electronic
prescription system and standardized drug preparation, most especially for
children. In a prospective study, during simulated resuscitation by pediatric
emergency physicians as many as one in every thirty-two prescriptions were
found to contain a tenfold error. The type of real-time events identified in
the simulated resuscitations had potential to cause immediate serious harm
and in many cases prove fatal.21
A high error rate that is expected in the pre-hospital pediatric emergency
care has been reported, and this is because neither exclusively pediatric
staff nor treatment procedures optimized for pediatric patients can be
provided. A retrospective analysis of 360 pre-hospital prescriptions in the
U.S. also showed medication errors in 35% of all cases. There were also high
doses of intravenous epinephrine given in amounts much higher than the
recommended dose. No specific incidence rates from larger populations are
available for emergency medicine but it is likely that a considerable number
of pre-hospital medication errors are not reported. This means that the likely
frequency and the consequences of medication errors in prehospital pediatric
emergency care give rise to a substantial danger, which must be reduced.21
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Non Drug-Related: Adults Versus Pediatrics
Pediatrics
Children with medical conditions in academic pediatric centers have been
identified in adverse event reports, even after adjusting for the medical
status before admission, such as controlling for level of medications,
technological device dependency, and having a complex chronic condition. In
general, there were 9.2% of children admitted to the hospital who had an
adverse event. Adverse events related to surgery were the most frequent in
this type of pediatric center, while in community hospitals diagnostic adverse
events were due to “other clinical management” were more common.9
In community hospital settings, adverse events in the emergency
department were more common among children aged 1–5 years than among
other age groups; and, medically related adverse events were significantly
more common in children during the first year of life. Drug-related adverse
events mostly occur in children aged greater than 1-5 years in academic
pediatric centers as compared to other age groups. Children 5–18 years of
age in community hospitals had the most adverse events related to surgery,
diagnostics and drugs.9
There have been reports that various factors affect the higher rates of
adverse events among children in pediatric centers in Canada. Such reports
indicate that the adverse events can be due to several reasons, such as:
complexity of care, higher number of caregivers, trainees and handoffs, and
different standards of documentation. Children with complex medical
conditions are the highest group with an increased vulnerability to adverse
events. There are events that are related to surgery. This high incidence in
academic pediatric centers could be explained by the Canadian practice of
performing most surgery in children under 5 years of age in such facilities.9
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In a comparison of community hospitals to academic pediatric centers,
adverse events in community hospitals attributed to visits to the emergency
department were more common as were diagnostic adverse events.
Diagnostic errors are recognized hazards in pediatric emergency care,
whereas, the issue of adverse events in community hospitals is partly owing
to emergency department physicians being more familiar with adult
medicine than pediatric medicine, and the lack of standardized emergency
pediatric protocol.9
Everyone in health care is fully aware of the negative consequences when
drugs that are potent chemicals are given to sick patients. The complex drug
use process can be at fault, or the potent chemicals themselves can cause
adverse drug events (ADEs). Both sources of problems are implicated in
causing patient harm. It was believed that in order to solve problems health
care workers voluntarily report events, both actual and near misses.
However, in reality, voluntary reporting tends to be incomplete because of
time pressure, fear of punishment, and other problems. One of the most
common findings or actions after an ADE has been carefully described as
“triggers.” Use of triggers allows more confident detection of rates and
characteristics of ADEs. A trigger tool finds events that have had a negative
patient consequence, and generally, some action has been taken.68
Adults
In cases involving adult patients, the elderly groups are the higher risk
group for adverse effects due to their poor immune system. Elderly patients
also are at high risk due to medical conditions, disabilities and
polypharmacy. These issues are being discussed and explained in the
outpatient department or during admission to the hospital. Prevention of
adverse effects in the elderly population poses challenges to medical
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professionals because their disease presentation is often atypical and
complex.25
Studies have shown that hospitalizations among adults, ages 65 years old
and above, due to adverse drug events have increased in the U.S., which led
to more chronic medical conditions and the need to take more medications.
Age-related physiological changes, a greater degree of frailty, a larger
number of coexisting conditions, and polypharmacy have been associated
with increased cases of adverse events. Older adults are nearly seven times
as likely as younger persons to have adverse drug events that require
hospitalization.23
The ultimate goal of the federal initiative “Partnership for Patients” which is
amounting to one billion dollars is that preventable re-hospitalizations will
decrease by 20% by the end of 2013; to reduce further harm and promote
patient safety to patients as well as reduce healthcare costs. The focus of
this partnership program is on clinical care and avoiding further adverse
drug events.23 The elderly population is increasing which also has a
concomitant increase in chronic diseases and functional impairment. As
mentioned earlier, many elderly due to their poor immune system suffer
from co-morbid conditions and disabilities that necessitate multiple
medications or polypharmacy.33
Adverse drug events are more common in ambulatory care settings for
elderly people, and up to 35% of high-risk elderly outpatients develop
preventable adverse drug events. One causative factor of preventable
adverse drug events is the prescription of inappropriate medications.
Inappropriate medication prescription (IMP) are prescription(s) that
introduce a significant risk of an adverse drug related event when there is
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evidence for an equally or more effective alternative medication. It is also
known as the failure to achieve the optimal quality of medication use. IMP
has been categorized as under prescribing, misprescribing or
overprescribing. Several factors increase the risk of IMP to elderly persons,
including physiological changes like reduction in renal and hepatic function,
both of which are detrimental outcomes of drug metabolism, and other
disabilities like visual and cognitive decline.33
Despite putting great efforts to scrutinize and improve the quality of
medication prescription among elderly persons in the primary care setting,
inappropriate medication prescriptions are still common. Approximately one
in five prescriptions to elderly persons are inappropriate. Diphenhydramine
and Amitriptiline are the most common inappropriately prescribed
medications with high-risk adverse events. These medications are good
candidates for being targeted for improvement, for example, through the
use of computerized clinical decision support. Focused and systematic
interventions are needed to improve the quality of medication prescription in
this patient group.33
Institute Of Medicine And AHRQ Reports
On Patient Safety
A current patient safety culture evaluation is the initial step to establish a
positive patient culture.2 The hospital setting involves a network of
healthcare professionals when dealing with both inpatient and outpatient
departments, either directly or indirectly. Once a patient is admitted, he or
she will then receive diagnosis and treatment from different specialty
medical providers and hospital medical sections, depending upon the type of
diagnosis or condition of the patient.
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Hospital Patient Safety Indicators (HPSI)
In hospital departments, a rapid and safe service for patients is needed
24/7. Since shifting service occurs in order to provide simultaneous services
of the medical or hospital team, there are high-risk complications that can
happen. This is especially a concern relative to the diagnosis and treatment
of the very young such as neonates and infants, and the very old who are
critically ill or disabled patients.46 Consequently, there should be certain
safety rules developed for health teams caring for vulnerable groups at high
risk of an adverse event.71
Hospital acquired infections and sterilization techniques
One of the primary problems that threaten the safety of patients care is a
healthcare-associated infection, which is an increasing worldwide concern.
Surgical procedures conducted in hospital and other health care settings
involve direct patient contact with a medical device or surgical instrument
that can lead to severe life-threatening infections. Controlling this problem is
a major criterion for hospital accreditation worldwide. Proper sterilization of
instruments between patients is needed in order to remove all microbes and
prevent harmful adverse effects as a result of cross contamination.71
There are different types of sterilization techniques available, and the most
common method for sterilization of medical instruments is steam
sterilization. However, neither steam sterilization nor autoclaving are
guaranteed to be 100% effective in killing all microorganisms, so the quality
of sterilized products should be assessed by physical, chemical, and
biological indicators. According to the Centers for Disease Control and
Prevention, “to ensure heat penetration to all instruments during each cycle,
a chemical indicator should be placed inside and in the center of a load of
unwrapped instruments, routinely in every sterilization process”. Biological
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indicators are also used from time to time for monitoring of the quality of
sterilization processes.71
During the past years, not all developing countries used both chemical and
biological indicators. There were two studies that tried to determine the
sterilization processes in various countries. One study gathered the history
of sterilization processes of hospitals in Poland between the years 1997 to
2000, which greatly revealed that more improvement was needed. In the
year 2005, 30 indicators were created after assessing the sterilization
process in Thailand hospitals. This report also showed that there is a greater
need for attention to sterilization processes for both inpatient and outpatient
hospital departments, and adequately trained medical personnel as well as
national guidelines are immediately needed. The international studies
mentioned above mainly focused on improving the sterilization process to
gain knowledge and be consistent with the World Alliance for the Patient.
Greater improvements can happen if there is a continuous training program.
The use of chemical indicators has resulted in great improvements in
sterilization control.71
Patient safety performance indicators
In Spain, the Patient Safety movement has influenced the Spanish National
Health Service; The Spanish patient safety efforts was especially based on
the Healthcare Cost and Utilization Project by the U.S. Agency for Healthcare
Research and Quality (AHRQ) and the requirements made by the
Organization for Economic Co-operation and Development (OECD) or the
Healthcare Quality Indicators Project Overview. In one study, the Patient
Safety Indicators (PSI) is well followed. Approximately five PSI has been
considered for empirical validation in public hospitals across Spain. All acute
care areas have manifested systematic variability or variation beyond
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chance, which was proven to have a cluster effect and that, importantly,
detected hospitals above the expected. The empirical properties were seen
as very useful to screen for healthcare performance in Spanish hospitals.74
As for the lessons learned from the aforementioned study, it was found that
hospitals with more complex problems are signaled as poor hospital
performers, especially if they have high incidences of secondary diagnoses.
There are still several debates that need further clarification on hospital
validity issues to fully trust using the Patient Safety Indicators (PSI). As for
the Spanish National Health System (NHS), there is five PSI proven to have
good performance, positive likelihood ratio (+LR). The studied even
reported:
“The most conservative estimation yielded a + LR of 26.8 in decubitus
ulcer, a + LR of 406.3 in catheter-related infection, a + LR of 149.3 in
PE-DVT and a + LR of 25.32 in postoperative sepsis”.74
The result showed a high + LR except in decubitus ulcer, which are affected
by both underreporting or present admission cases, and either false negative
or false positive cases. More studies are needed to evaluate the stability of
PSI; taking this as a screening tool and assessing its limits in specified
contexts might give us the intervention that hospitals truly need.74
Nurse overtime working hours is an issue affecting adverse outcomes in
hospitals and were positively associated with the following nurse-sensitive
patient safety outcome indicators: patient falls, decubitus/pressure ulcers,
near errors in medication, medication errors, unplanned extubation,
hospital-acquired pneumonia, and hospital-acquired urinary tract infections.
Risks of patient falls, decubitus/pressure ulcers, unplanned extubation,
hospital-acquired pneumonia, and hospital-acquired urinary tract infections
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significantly increased when the patient-nurse ratio exceeded 7:1. It was
concluded that nurse workforce and nurse-sensitive patient outcome
indicators are positively correlated. The results of this study will help
professional nursing groups and hospital managers define suitable nursing
workforce standards for hospital settings.78
Agency for Healthcare Research and Quality (AHRQ) HPSI
The Agency for Healthcare Research and Quality (AHRQ) has developed
various healthcare decision-making and research tools to be used by
program managers, researchers, and others at the Federal, State and local
levels. The Quality Indicators (QIs) are used for readily available hospital
inpatient administrative data to be analyzed and measured. The QIs are
helpful for potential quality concerns, in order to help identify areas that
need further study and investigation, and track changes over time.100
AHRQ's Center for Quality Improvement and Patient Safety are integrally
involved with patient safety initiatives, and their main responsibility is to
support the Center for Primary Care, Prevention, and Clinical Partnerships.
There are four elements that were made by AHRQ for patient safety and
these are: identifying threats to patient safety; identifying and evaluating
effective patient safety practices; teaching, disseminating, and implementing
effective patient safety practices; and maintaining vigilance.103 Current
AHRQ QI modules enumerate several aspects of quality surveillance, and
these surveillance strategies include the following:100
●
List hospital admissions in geographic areas that evidence suggests
may have been avoided through access to high-quality outpatient care
(first released November 2000, last updated March 2012).
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●
Reflect the hospital quality of care, including across geographic areas
and inpatient mortality for medical conditions and surgical procedures
(first released May 2002, last updated March 2012).
●
Reflect hospital quality care as well as geographic areas, to focus on
potentially avoidable complications and iatrogenic events (first
released March 2003, last updated March 2012).
●
Use indicators from the other three modules with adaptations for use
among children and neonates to reflect quality of care inside hospitals,
as well as geographic areas, and identify potentially avoidable
hospitalizations (first released April 2006, last updated March 2012).
The Agency for Healthcare Research and Quality has faced a bigger
responsibility on improving patient safety given the recent problems facing
the U.S. health care system today, as well as the limited support and
resources needed. Utilizing AHRQ extensive experience, new processes to
discover facts are needed to improve the use of safety practices in
healthcare.103 Healthcare-associated infection (HAI) is the most frequent
result of unsafe patient care worldwide, but only limited data is available
from the developing world. The most obvious finding of one time-trend study
was significant improvement in sterilization control especially in the
development of the use of chemical indicators.71
Surgical
In a surgery department or in a surgical team in the hospital, professionals
working in different departments create a team to support care for a specific
patient; they contribute to patient care from different health science
disciplines wherein both their training and end goal for the patient are
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different. This contributes to one reason for a lack of communication
between the operating room personnel, and a primary basis for surgical
errors to occur.13 There are approximately 43% of surgical errors that
happened due to miscommunication involving different healthcare personnel.
Most of the time, surgical errors occurring in the operating room were
between surgeons, anesthesiologist, nurses and internist.13
In a recent analysis by the American College of Surgeons’ closed claims
database, communication problems were traced back to not just happening
during surgery but also before and after the surgery started. There are
about 85% of adverse events solely on communication problems with only
4% on written communication. This is the reason why the AHRQ and the
Joint Commission (JC) both recommend the implementation of read backs
among medical professionals specifically in the operating room setting. Read
backs are recommended for telephone orders with regards to medication
administration and verbal orders with highly critical results where there is no
written documentation yet generated.14 Dr. Eddie Hoover eloquently
described the surgery industry’s reticence to engage in read backs in a 2007
Archives of Surgery editorial when he noted that “Getting surgeons to read
back orders and instructions will age you 10 years, yet the Navies of the
world have demonstrated for eons that it improves efficiency, promotes
safety, and saves lives.”14
The reports on surgical adverse outcomes are very important but it depends
on the health system and underlying resources. For example, in the
Netherlands and some other hospital systems with a complicated hospital
registration system, there is much dependence on the accuracy of the
reporting and documentation through various resources.57 It was analyzed
that the LHCR system (the acronym for national surgical adverse event
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registration in the Netherlands) was poorly reported or underreported and
that less severe events tended to be reported less frequently, except in the
nursing file, which was not designed to serve as input for the LHCR. The
medical file rather than the nursing file seems the most appropriate
additional resource for this purpose.57
There has been under-reporting due to reluctance or negligence among
medical providers to report adverse outcomes. Particularly strong
disincentives for reporting are shame, fear of liability, loss of reputation and
peer disapproval. The awareness that medical errors, and also surgical
complications, are frequently system errors rather than an individual liability
has helped to abandon a shame-and-blame culture and has harnessed the
medical professional to report errors and adverse outcomes. There is also an
increase in patient awareness and demand to expect safety and
transparency in healthcare, creating more awareness within health
administrations of the importance to contribute to safer outcomes, and a
better quality of care.57
In one study, it was concluded that the registration, management and
prevention of surgical adverse outcomes are not to be neglected in daily
clinical practice, impacting the selection of patients to be treated and
procedures to be performed. It was claimed that hospitals and clinicians
should be willing to put effort into a structural and reliable means to list not
only the beneficial but also the harmful effects of their professional activities
or clinical management to improve the quality of care for their patients.57
Entry or admission nursing assessments of in-hospital patients are strongly
associated with in-hospital mortality; and, predischarge nursing assessments
of in-hospital patients are associated with post discharge mortality. These
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assessments, part of what is termed as the ‘head-to-toe’ patient
assessment, and which are a standard part of nursing school curricula, are
collected and recorded at all hospitals. Simplified summaries of assessments
can be constructed. Since nursing assessments are recorded at least every
12 hours throughout the patient's stay, they represent a changing indicator
of patient condition. They are a real-time longitudinal sensitivity that no
static measurements, such as demographics or principal diagnosis, can
provide.72
It has been proven that this compact clinical data source in the EMR is a
natural longitudinal source of information, which allows medical providers to
have continuing insights of nurses as recorded throughout the patient's
entire stay. Such dynamic information should allow medical providers to
improve patient care. The latest observation on EMR technology does not
allow quick and easy access to nurses’ observations and assessments, so
changes in current record-keeping software or adjuncts to it will be
necessary to make this information more accessible.72
Post Operative Surgical Complications
Two million surgical operations per year that have surgical site complications
and approximately 30% of surgical patients resulted in patients experiencing
sepsis.101 Studies on surgical site complications also showed outcomes
whereby more than 40 million major surgical operations annually performed
in the U.S. resulted in 800,000 to two million complications due to surgical
site infections.101
There are two types of surgery that were being compared, and it was
between elective and non-elective surgery. Comparing these two, sepsis and
death were more likely to happen after non-elective than elective surgery.
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This was observed to increase significantly after elective and non-elective
procedures over the last 17 years, and this may due to medical errors and
poor outcome of the surgery. No improvement for the hospital mortality rate
of patients having elective surgery has been revealed by some studies.
There are also disparities in surgical outcomes being noted and these relate
to age, sex, and ethnicity and the development of postoperative surgical
sepsis.101
In the U.S., surgery patients are vulnerable to surgical sepsis, and reports
suggest that surgical sepsis accounts for almost 30% of all septic patients.
These are considered as high-risk patients since the surgical procedures they
underwent promoted metabolic, hematologic, and immunologic responses in
their body. The immune function after surgery pose increased patient
vulnerability to experience perioperative bacterial infection, hemorrhage,
blood transfusion, or anesthesia up to severe suppression that promotes
sepsis.101
One study found that due to progress in surgical care on patients with
greater utilization of surgical intensivists, alterations in the antibiotics or
strategies employed, the overall mortality rate between surgical patients has
dramatically improved. On the other hand, it was stated that elective
surgery had the greatest increases in sepsis rates and worst severe sepsis
cases. This type of surgery also failed to show a decrease in age-adjusted
rates of death for postoperative sepsis over time. It is therefore important to
start using population data for postoperative sepsis which may include the
analysis of the specific procedures associated with sepsis and a focused
evaluation of the various racial and sex disparities in the development of
postoperative sepsis.101
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Medical Health Risks
The Agency for Healthcare Research and Quality defined patient safety
indicators (PSIs) has been shown to be an effective tool for monitoring and
tracking safety events in the general hospitalized population. From a medical
standpoint, one study showed that approved PSIs supported patient
outcomes in the following:102

Complication of anesthesia

Death in low-mortality diagnosis-related groups

Decubitus ulcer

Failure to rescue

Foreign body left during procedure

Iatrogenic pneumothorax

Selected infections due to medical care

Postoperative hip fracture

Postoperative hemorrhage or hematoma

Postoperative physiologic and metabolic derangements

Postoperative respiratory failure

Postoperative pulmonary embolism or deep venous thrombosis

Postoperative sepsis

Postoperative wound dehiscence

Accidental puncture or laceration

Transfusion reaction
Additional experimental PSIs include:

Physiologic and metabolic derangements in all diagnoses
among all discharges

Aspiration pneumonia

Coronary artery bypass graft after percutaneous transluminal
coronary angioplasty
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
Postoperative in-hospital myocardial infarction

Technical difficulty with procedure

Dosage complications

Postoperative iatrogenic complications

Postoperative iatrogenic cardiac complications
In a study focused on the medical condition of chronic kidney disease (CKD),
it showed a lack of standardized PSIs were associated with undetected
safety events, which are likely to contribute to adverse outcomes in this
disease. This study sought to determine the proportion of CKD patients who
experience multiple potentially hazardous events from varied causes and to
identify risk factors for the occurrence of “multiple hits.” It referenced CKD
patients in the Veterans Health Administration (VHA) that were
retrospectively examined for the occurrence of one or more safety events
from a set of indicators defined a priori, including AHRQ PSIs, hypoglycemia,
hyperkalemia, and dosing for selected medications not accounting for
CKD.102
Chronic kidney disease is becoming rampant in the U.S. and CKD patients
are very vulnerable to adverse outcomes that may be due to delivery of care
by a medical professional. Hospitalized patients with CKD have greater risk
for having AHRQ-defined PSIs than patients without CKD. Hyperkalemic and
hypoglycemic events were individually found to be common adverse safety
events as well as risk factors for mortality in patients with CKD. Also,
medication errors are very common, which is the reason why patients with
CKD are at risk of an assortment of safety events beyond the scope of those
previously considered.102 Patient safety events have costly consequences for
patients and healthcare networks, increasing the length of stay, hospital
readmissions, and the risk of death. Preventing these adverse events can
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improve quality of care and patient outcomes. Further studies are definitely
needed on this type of condition.102
In patients admitted with acute coronary syndrome (ACS), significant
discrepancies were observed between the medical record and patient selfreport for 13 health conditions of importance to the care of ACS patients.
Discrepancies are reported but since important treatment decisions in ACS
patients are made based in part on information from the initial clinical
history, the findings reported here are of great potential significance for
these patients in particular. There is an urgent need for research that
identifies the most effective and efficient means to obtain accurate health
information. This may result in improved care for ACS patients, and improve
the patient care quality and safety more broadly.73
The linking of the 'maturity' of the hospitals' quality improvement system
score (MI) to quality and patient safety outcomes in 43 Spanish hospitals are
first analyzed in one study. The data suggests that adjusted hospital
complications are associated with the development of the hospitals' quality
improvement systems: hospitals with more mature quality improvement
systems present lower complication rates. Similar results, although
borderline significant and partly confounded by hospital size can be observed
for adjusted hospital readmissions.76
Common Types Of Post-Discharge Adverse Events
There are many adverse events that most likely happen after the patient has
been discharged from the hospital. These can be related to drugs or
medications, nosocomial or hospital acquired infections, procedure related
infections or problems, pressure ulcers and diagnostic errors.
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In 2004, Baker and colleagues estimated that up to 23,750 Canadians die
annually from preventable adverse events (AEs) and adverse drug-related
events (ADREs) are the most common type of preventable AEs in patients
admitted to hospital; and, ADRE’s cause up to 12% of visits to the
emergency department (ED) in Canadian tertiary care centers. Research on
drug-related morbidity has focused on inpatient and community settings, but
not enough on the contribution of emergency physicians (EPs) to this
problem. Emergency physicians practice in high-risk settings for medication
errors and other AEs, treat high-acuity patients, work under time pressure,
and treat patients based on incomplete information regarding medical
history or medication consumption.45
In order to evaluate the tolerability of prescriptions given on discharge from
the ED, it was observed that higher-acuity patients are more often admitted
to hospital, evaluated serially by nurses, physicians and pharmacists for the
development of ADREs, and tend to receive closer follow-up after discharge
from the hospital or ED. In comparison, lower-acuity patients are more likely
to be discharged from the ED without specific follow-up plans or monitoring
in place for ADREs, even though they commonly receive prescriptions on
discharge from the ED. The underlying assumption that these patients do
not run into significant problems with medications prescribed on discharge
from the ED has not been tested.45
In Australia, medication administration errors are common when patients are
discharged from hospital to a residential care facility (RCF). This usually
happens because it is compulsory that the primary treating provider needs
to attend to the RCF at short notice just by documenting on a medication
administration chart. If the doctor cannot attend, doses may be missed or
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delayed and a locum doctor may be called to document on a medication
chart.19
It really puts a big challenge on healthcare professionals when it comes to
the continuity of medication management because, more often than not, it is
compromised when patients are discharged from hospitals to residential care
facilities (RCF) such as ‘nursing homes’ and ‘care homes’. These are usually
patients who have complex and intensive medication needs. The missed,
delayed or incorrect medication administration is unfortunately common. An
Australian study reported that patients discharged to RCFs were prescribed
an average of 11 medications of which seven were new or had been
modified during hospitalization. The median time between arrival at the RCF
and the first scheduled medication dose was 3 hours, and ‘when required’
(prn) medications were sometimes needed sooner.19
A U.S. study revealed that most patients transferred to a RCF had one or
more medication doses missed; on average, 3.4 medications per patient
were omitted or delayed for an average of 12.5 hours. In another U.S. study,
medication discrepancies related to transfers to and from hospitals and RCFs
resulted in ADEs in 20% of patients. An analysis of medication incidents that
resulted in patient harm in Canadian long-term care facilities identified
patient transfer as a common factor.19
The delays on the medication chart can be a cause of several adverse
events; such as the RCF staff may withhold medications, administer them
without a current medication chart or revert to pre-hospitalization
medication regimens. When this happens, infections can develop due to
inadequate medication management and the patient’s poor immune system.
Procedure related problems tend to manifest because there is no recent
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medication chart, which is needed to support care of the patient. The clinical
importance of delays or errors in medication administration depends on the
clinical status of the patient, the nature of the medications involved, and the
length of the delay.
Depending on a patient’s condition, in some cases, no adverse event occurs
but then these delays in access to medications for symptom control (for
example, analgesics and medications for terminal care) can greatly impact
quality of life. Delays or errors with regularly scheduled medications (for
example, anti-epileptics and antibiotics) may have serious consequences.
Unplanned hospital readmissions have been reported as a result of failure to
receive prescribed medications after transfer to a RCF.19
Older adults who are discharged home after a medical illness have an
increased fall rate. Some researchers have suggested that a high risk for
falls is not limited to the 65 and older post-hospitalized population. All adults
who have fallen during their hospitalization have a high rate of falls during
their immediate post-hospitalization period, especially patients who have
fallen on more than one occasion during their hospitalization. One study
suggests that weekly phone calls are well accepted by patients and may
potentially be a feasible hospital-based surveillance system to monitor postdischarge fall risk factors, and could be utilized to test future interventions
that reduce falls in this high-risk population.91
There should be a targeting exercise intervention program for people at
increased risk without expensive large-scale screening programs. People
who have been in hospital are known to be at increased risk of falls and
disability so some health systems have developed an exercise program and
recruitment strategy for this population. One exercise program allows for
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flexibility in exercise prescription to best cater to the needs of this
population; it is optimally designed to address the major problems of falls
and disability in older adults and could be readily translated into clinical
practice.92
Diagnostic Errors Or Misdiagnoses
Several studies have shown that patients and their medical providers
consider medical errors, and particularly diagnostic errors, common and
potentially harmful. Diagnostic errors are also accounted for about 50% of
mistakes in such surveys although figures between 20% and 25% were also
reported, depending on the medical setting and the materials used to
determine the rate of diagnostic errors.
Statistics
The studies of clinical practice based on autopsies, second opinions, or case
reviews yielded different diagnostic error rates, depending on each area or
expertise or clinical discipline. In perceptual disciplines, such as
dermatology, pathology, or radiology, diagnostic errors occurred in 2% to
5% of cases while in clinical fields requiring more data gathering and
synthesis, up to 15% of patients might suffer from a diagnostic error. Schiff
et al. reported that the most common missed or delayed diagnoses were
pulmonary embolism (4.5%), drug reactions or overdose (4.5%), lung
cancer (3.9%), colorectal cancer (3.3%), acute coronary syndrome (3.1%),
breast cancer (3.1%), and stroke (2.6%).93
How many times adverse events happen due to diagnostic errors is difficult
to assess. One study reported, “retrospective studies indicate that more than
8% of adverse events and up to 30% of malpractice claims are related to
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diagnostic errors, but prospective studies are lacking”. This is in contrast to
other varied opinion about “the definition of diagnostic errors, since they
may not be considered as such in some studies if there was no harm”.93
Mechanisms of diagnostic errors
In a study of 100 errors in internal medicine defined as “autopsy
discrepancies, quality assurance activities, and voluntary reports,” a study
made by Graber et al., the researchers tried to determine the contribution of
system-related and cognitive aspects to diagnostic error. The causes of
diagnostic errors involved cognitive causes in 28% of the cases, the context
or the system in 19%, and mixed causes in 46%. Thus, cognitive factors,
that is, how doctors think, were involved in almost 75% of the cases. This
reinforces the importance of understanding physicians’ thinking, decisionmaking, and the processes of clinical reasoning, which will be addressed in
the following section.93
Types of Diagnostic Errors
Diagnostic errors can also be defined as not intentional with regards to the
mistake, delay or missed as judged from a definite information, and it is
categorized as: false negative, false positive, and discrepant.4
A false negative diagnosis is frequently ruled out, such as an abnormality on
the patient’s condition, but in fact it is indeed present. A false positive
diagnosis is when the medical professional overanalyzes the diagnosis or
stated an abnormality but actually there is none to talk about. A discrepant
diagnosis is an entirely different diagnosis made from an actual diagnosis.4
According to a study of Schiff and colleagues, they found that failure or
delay in considering the diagnosis was the most common failure in the
diagnostic process. The most commonly missed diagnoses include cancer,
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pulmonary embolus, coronary disease, aneurysms, and appendicitis, which
have all been documented in previous studies; but, little is known about the
presenting complaints or initial (incorrect) diagnoses that precede these
missed diagnoses.5 There are medical providers who reported their own
lessons in treating their patients and the errors they have committed, and
their reports could definitely help researchers and serve as a guide to
develop preventive strategies.5
In other studies, diagnostic errors or misdiagnoses are discussed as serious
problematic and detrimental to the health of the patient. It is actually a
common error. Diagnostic errors include errors in diagnostic reasoning and
judgment, inability to perform, interpret or even follow-up the test or failure
to make an order from the start. Inability to choose the right treatment is
also included. According to the Harvard Medical Practice Study II in one of
the earlier studies, this type of diagnostic error is said to be the reason for
17 % of preventable adverse events.10
Other of the important statistics by different researches is as follows:

There are 59% malpractice claims in a retrospective review analysis
involved on diagnostic error that put the patient’s life in danger.10

For the self-reports of doctors with regard to diagnostic error, errors
happened mostly in the phase of testing which is 44 % and this includes
failure to constantly order, report or follow-up the results; and, it is
followed by errors on the medical professionals clinical judgment or
assessment (32%), by poor history taking (10%), physical assessment
(10%) and errors in consultation, referral and delays (3%).10

Cognitive factors by medical internists also contribute to this type of
error by 74% of cases.10
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When dealing with diagnostic errors or what we have called “misdiagnosis”,
it is an embarrassment and unacceptable for healthcare professionals to be
incompetent in their field. But we also have to remember that some
diagnostic errors are hard to detect since it will take some time to determine
if the diagnosis is incorrect depending on what happened in the patient’s
case within a few months. It is important to consider that most empirical
studies regarding the intervention of these diagnostic errors are not that
successful, and unable to identify ways to eliminate harmful effects on
patients.10
Diagnostic errors are proven to be cognitive in nature, not so much involving
knowledge deficiency, but related to the appropriateness of data collection
from the patient, as well as data integration and verification of diagnostic
hypotheses. Their risk of occurrence increases in the real field of busy
medical practice, which is assumed to be always under time pressure, when
medical providers use reasoning shortcuts (heuristics) and are subject to
biases. The latter is related to their personal traits (i.e., overconfidence),
their mental representation of diseases (i.e., anchoring bias), and their
environment. Many providers induce a premature diagnostic closure. Ways
to prevent these errors involve the self-awareness of medical providers,
training in medical education, and external support.93
There must be effective ways to reduce diagnostic errors. Certain conditions
must be fulfilled to increase the chance that such interventions bring some
change, and these are the following:93
1. First, medical providers should be enthusiastic about making diagnoses
and decisions. They should adopt an evidence-based attitude towards
medical education issues instead of relying merely on their own
opinions.
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2. Second, all the organizations and schools such as the teaching clinical
structures and medical schools, as well as medical professional
societies should support medical education research, train their
clinicians as supervisors and teachers, and valorize clinical supervision
and feedback in clinical contexts.
3. Finally, pre-, post-, and continuous education must be specific in
training to help physicians detect and correct their own reasoning
flaws. With all these conditions fulfilled, one may hope to really make
a difference on the burden represented by diagnostic errors and thus
increase patient safety.
Clinical Scenarios:
Inpatient Or Post-Discharge Adverse Events
Two surgeons reviewed hospital records concerning surgical care with
screening criteria and they used a standardized procedure within a
structured electronic review form just to determine or identify if and AE had
occurred, and if they were preventable. The surgeons defined an AE based
on three criteria: (1) an unintended physical and/or mental injury; (2) a
result in temporary/permanent disability, death or prolongation of hospital
stay; (3) caused by the patient’s medical management rather than the
disease state.26
Adverse Event: Unavoidable Versus Preventable
Preventable adverse events are defined as events that do not meet the
current standard criteria of medical professionals or healthcare systems.
Unavoidable adverse events are the events that cannot be prevented. Also,
described as unavoidable injury due to appropriate medical care. An example
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is when an unknown drug reaction occurs in a patient who just received the
appropriate administration of a particular drug for the first time. If a drug
reaction occurred in a patient who knowingly had a previous allergic reaction
to that particular drug, the adverse event would be considered preventable
and might be considered negligent.
The causes, consequences and prevention strategies of adverse events must
also be carefully studied. Like for example in one study surgeons were able
to review the surgical adverse events or events that played a big factor in
surgical treatment and care. The surgeons classified the surgical adverse
events by the clinical procedure involved, such as diagnostic process,
surgical procedure, drug/fluid, medical procedure, other clinical
management, discharge, and other. Consequences were also assessed such
as a prolonged hospital stay, extra treatment, a readmission to the hospital,
extra outpatient care, a temporary or permanent disability at discharge, and
death as a result of an adverse event. The type of injury also classified it,
such as: bleeding, infection, shock, thrombosis, necrosis, fistula forming,
and abnormal wound healing. This classification by injury was according to
the national reporting system of adverse outcomes developed by the
Association of Surgeons in The Netherlands.26
We should also realize that an adverse event usually happens due to several
causal factors, including technical, organizational, human, and patientrelated factors. It is better to use the well-known tool called the Eindhoven
Classification Model of PRISMA-Medical, a root cause analysis tool. In this
study, causal factors of surgical AEs were judged to be predominantly
human factors (65%) and less often organizational (13%) or technical
(4%).26
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The categories of the taxonomy are:
●
Human factors which are skill-based, for example failures in the
performance of highly developed skills, or, rule-based, for example an
incorrect fit between an individual's training or education and a
particular task, or knowledge-based, for example inadequate
application of existing knowledge.
●
Organizational factors, for example inadequate or unavailable
protocols, management priorities, inadequate transfer of information
and cultural aspects.
●
Technical factors, for example material defects, failures due to poor
design of equipment, software, labels or forms.
●
Patient-related factors, for example, co-morbidity, age, and treatment
compliance.
Types of preventable adverse events
There are about four studies that reported the types of preventable adverse
events in acute hospitals. Three of these studies showed that most of the
adverse events and preventable adverse events were associated with a
surgical operation.48 Key points from these studies are listed below:

Operative adverse events accounted for 24%–53% of adverse events
and 20%–42% of preventable adverse events.

The errors in evaluation and diagnosis and errors in treatment
(including drug treatment) were the next most common types of
preventable adverse events.
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
Therapeutic adverse events accounted for 15% to 28% of preventable
adverse events.

Diagnostic adverse events accounted for 9% to 21%.

Drug related adverse events were the next most frequent type,
accounting for about 10% of preventable adverse events.
The most frequent type of preventable adverse drug event was error in
medication dose, followed by error in method of use, inadequate monitoring
or follow up, inappropriate drug use and administering a drug to the wrong
patient. Preventable adverse drug events were the most common cause of
avoidable readmissions to ICU and readmissions due to preventable cardiac
arrests.48
Although the rate of surgical preventable adverse events was highest,
surgical adverse events were least likely to be preventable. There are about
75% to 100% of diagnostic adverse events and 50% to 77% of therapeutic
adverse events that were preventable, whereas only 17% to 44% of
operative adverse events were considered preventable.48
Contributing factors
Preventable adverse events were often associated with more than one
contributing factor. Most are individual error and a large proportion of these
caused serious patient harm or death. On the other hand, a small proportion
of adverse events were associated with equipment failure, which rarely
caused serious harm or death. The proportion of system failures contributing
to preventable adverse events varied widely, ranging from 3% to 83%.
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Generally, studies, which used reporting data, interview or questionnaire,
reported a higher rate of system failure than studies.48
Unavoidable Adverse Event Example
To follow are some case scenarios of unavoidable or non-preventable
adverse events:42
1. First case involves the drug tacrolimus in a patient with graft-versushost disease after bone marrow transplantation for chronic
myelogenous leukemia. After giving the prescribed medication fatal
acute renal failure occurred resulting in death.
2. Second case is an anemic patient who is experiencing syncope and
coronary artery disease and developed a severe life threatening
transfusion related acute lung injury after receiving a red blood cell
transfusion.
3. Third case is of a patient with pseudomonas pneumonia who was given
imipenem for his treatment but during the time the patient was being
given imipenem, despite appropriate antibiotic dosing, seizures ensued
and after changing the prescribed antibiotic treatment the severe
tonic-clonic seizures still occurred.
4. Fourth case is about a procedural complication. This is a case of a 55year-old patient with known liver cirrhosis who presented with
shortness of breath and distended abdomen. The patient underwent
paracentesis in the ED and returned 2 days later, stating that fluid was
leaking from paracentesis sites. AE severity: required an ED return
visit.
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5. Fifth case relates to a nosocomial infection. This is a case of a patient
who presented to the ED with 5 days of bilateral leg weakness followed
by sudden onset of paresthesias. Spinal cord compression was
diagnosed and a Foley catheter was inserted. Three days later, the
patient developed urinary tract infection confirmed by culture. AE
severity: required medical intervention.
Preventable Adverse Event
Below are examples of a preventable adverse medical event:1

Wrong surgical procedure such as wrong surgical site, wrong patient
and wrong surgical procedure

Retained foreign body left during surgery on the patient

Blood donor or organ transplant incompatibility

Infectious agent transmission to a patient

Administering incorrect medication or dosage

Trauma or accident in the hospital such as falls or burns

Heart conditions such as DVT (deep venous thrombosis) or PE
(pulmonary embolus) without the right prophylactic treatment

A surgical site infection without giving any antibiotic prophylaxis

Pressure ulcers
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
Catheter-acquired infections
Additional detailed examples of preventable adverse events are described
below.
Operating room setting
Case 1:
Two factors were considered as a proximate cause for an error in this
operating room case. One involved a process factor when a postinsertion chest x-ray was not obtained and second is a controllable
environmental factor when the surgeon failed to realize that the guide
wire was much shorter than expected on the patient. Before this
happened, there was no policy requiring the surgeon to inspect the
guide wire when it was pulled out. After this incident, there were three
action plans made that required all medical staff must complete an inservice training program specifically for this procedure, all procedures
must be performed under fluoroscopy and following immediately a
chest x-ray is required, and audits of the administration or quality
assurance department for ensuring complete compliance.20
Case 2:
A human factor arose regarding where to place the sponges as they
are being counted. An additional system issue or human resource issue
was identified and the reason is because the circulating nurse and the
scrub technician did not perform their duties as expected such as
counting the number of sponges being used during the operation. The
surgeon in this case was not at fault. After this incident, new strategies
were developed. Firstly, a Devon Bag-It sponge counter bag (Covidien,
Mansfield, MA) was to be used in all operating rooms (which looks like
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a shoe holder that hangs on a pole). Each slot holds one sponge that
can be viewed by the scrub technician and by the circulating nurse as
they are counting aloud and concurrently. Secondly, leadership
accountability was identified to prevent drift from and workarounds of
existing policies. Thirdly, adequate in-service education programs were
provided. Finally, random audits by the quality assurance team were
set in motion to ensure proper compliance procedure.20
According to the report project of medical accidents dated July 2010 to
March 2011, which was issued by the Ministry of Health, Labour, and
Welfare, in Canada, there were also several incidents involving radiological
technologists that occurred among young and experienced technologists so
this became the focus of discussion. The researchers sent out questionnaires
to different radiological technologists and examined the causal relationship
between years of their experience and their concerns about patient
treatment and safety. They found that their concerns about patient
treatment and safety are different depending on years of experience. New
technologists were on a low level of caring relative to the philosophy "To err
is human"; they stated that the causes of the errors were neither the
devices nor the system of the devices. Comparing to mid-career
technologists, the report stated that they identified the most common cause
of errors is the liability of the person concerned. Experienced technologists
stated that the cause of the error is excluding the person concerned; also,
due to the devices, patients, or advanced specialization of the examinations.
It was concluded that technologist education is an important factor to
improve skills and the depth of concern about patient safety.15
Preventable case scenarios are described below with correlating AE
severities:42
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1. Suboptimal follow-up:
A case of a 53-year-old patient with a history of smoking,
hypertension and coronary artery disease presented with left-arm
paresthesias and weakness. CT head, chest radiography and ECG were
all negative. Discharged with neurology follow-up in 2 weeks. On
telephone follow-up 2 weeks later the patient stated that the
symptoms had worsened and that an appointment had not yet been
received. [AE severity: symptoms only]
2. Fall:
A case of a 98-year-old patient diagnosed with myocardial infarction
and congestive heart failure. No documentation of universal fall
precautions in place in the ED or on the ward. The next day the patient
fell in the bathroom — no physical injury was documented. The fall
was deemed related to poor vision and physical reconditioning. The
patient received physiotherapy and occupational therapy treatment.
[AE severity: required medical intervention]
3. Unsafe disposition decision:
A case of a 70-year-old patient with a history of chronic obstructive
pulmonary disease presented with increasing shortness of breath and
fever. The patient was noted to be in moderate respiratory distress. No
acute changes on ECG or chest radiograph. The patient was treated
and discharged as COPD exacerbation. Returned 8 hours later and in
severe respiratory distress. [AE severity: required admission]
4. Diagnostic issue:
A case of a 55-year-old patient presented with chest pain similar to
usual angina. The nurse noted the pain radiated to the patient's back
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and blood pressure was unequal between arms. ECG and chest
radiograph were noted as nil acute and troponin T positive. The patient
was referred to cardiology and there was a 7-hour delay in diagnosis
of aortic dissection. [AE severity: death]
5. Medication adverse effect:
A case of a 28-year-old patient presented with a 1-week history of
confusion. The patient was found to be hyperglycemic, attributed to
recent course of steroids. The patient was treated with IV insulin
infusion, and 2 serial levels of hypokalemia occurred before treatment
initiation. [AE severity: required medical intervention]
6. Management issue:
In a case of a 90-year-old patient who fell and sustained a hip
fracture, the patient was admitted for conservative management
without deep venous thrombosis prophylaxis. Two weeks later the
patient developed pulmonary embolism and responded to heparin
treatment. [AE severity: required medical intervention]
Recommendations For Improvement
Technical errors were the most frequent cause of preventable adverse
events followed by failure to request or arrange investigation or procedure:
the failure to synthesize, decide or act on information and lack of care.
Inexperience and communication errors were the two most frequent types of
system failures. This pattern was reported by virtually all of the studies,
which provided relevant data irrespective of the specialty, and the methods
used.48
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Individual and System Failures
A review of preventable adverse events found that they are often associated
with more than one contributing factor, and mostly are associated with
individual error and a significant proportion with system failure. While
technical errors and cognitive failures were the most common types of error,
lack of experience, inadequate supervision of junior staff and problems in
communications were the most common types of system error.48 There are
two factors associated with the wide variation in the proportion of system
failure, and these are discussed below.48
Firstly, the majority of preventable adverse events, which were associated
with a system failure, were also associated with other factors related to
individual human error. Even in studies in which a large proportion of
adverse events were associated with a system failure, only a small number
of reported system failures were identified as the main or the sole cause of
an adverse event. Studies that reported a small proportion of adverse events
due to a system failure, only noted system failure when it was the main or
the sole rather than a contributory cause of adverse events.
Secondly, the reported proportion of system failures was strongly related to
the methods used. Studies using case note review to identify and analyze
adverse events reported a significantly lower proportion of system failures
than studies that used an interview, questionnaire or reporting system data.
This is because the retrospective case note review often focuses more on the
actions of clinicians in the frontline, and less on the actions of other staff or
systems with a more supportive role. Some potentially important contextual
events might not be recorded in the case notes. Hence, retrospective case
note review may not provide sufficient information to uncover the underlying
causes of adverse events, such as system failures.48
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The data collected by the reporting system, interview, or questionnaire may
be biased toward the role of system failure and focus less on the role of the
individual error. Clinicians may report adverse events in a way that shifts the
responsibility from the individual and toward system factors. Case note
review, overestimates the role of individual human factors and
underestimates the role of system factors, while reporting systems and
interviews or questionnaire-based studies probably do the reverse.48
A well-established model to evaluate system failure is the Swiss Cheese
Model of Systems Errors. In any system-based approach, in order to prevent
system failure or an error, there must be enough barriers and defenses.
Consider a slice of cheese as representative of each system barrier; in
reality, different barriers present themselves as a gap, or the hole in a slice
of Swiss cheese. Gaps or holes do happen because of either an active or
latent failures in the system or both. When comparing active errors, these
are the errors committed by the front liners. These front liners in the
healthcare field are the medical providers, nurses and pharmacists. While
latent errors are the conditions that surround the error. There may be long
standing problems and loopholes that become visible due to triggering
factors based on the active errors. The kinds of latent errors or failures in
the healthcare system would be the organizational process itself and the
management. This latter type of failure may be prevented if identified and
corrected early.105
If the errors in diagnosis are not reported properly, systemic failures and
immediate medical attention will not occur. This is very alarming because it
can undermine patient safety and cause harm. The best way to detect
avoidable error and prevent it from happening is to report right away known
errors, and to try to find the reason for any errors or failures. Once the
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reasons for any errors are identified, the recommendation is to outline the
arrangement of clinical events in chronological order and consider
developing safe and effective solutions to reverse the possible outcome of a
patient’s condition. Its important to remember that human errors can be
included in the chain of events and medical providers tend to forget this.104
Historically, the surgical morbidity and mortality conference (SMMC) has
been a core educational venue, a quality-assurance (QA) tool, and a way to
socialize a surgical trainee into the culture of surgery. But most of the times,
it is focused on human errors and just occasionally discusses system failures
that are responsible for the vast majority of medical errors. More recently,
health care delivery systems place greater emphasis on the root cause
analysis (RCA), which is one of the most effective ways to analyze system
failures and find possible solutions to them. Initial data showed RCA
improved patient safety. The best thing to do is to combine using RCA
results in SMMC to enhance surgical education, QA, and teaching of patientsafety skills in surgical settings.20
Root Cause Analysis
Root cause analysis is one of the effective tools to identify the potential
system and organizational problems, which will lead to adverse event or
events. Most of the RCA will not be that practical to use for every adverse
event. In order for this to become effective, RCA must be performed at the
onset of pattern of events or in every serious event.104
Transitional Care
Transitional care has three sets of priorities in mind and these are: goaloriented, time-limited and therapy-focused. An example would be after a
hospital stay when a patient is provided with a package of different services
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that includes low intensity therapy such as physiotherapy, occupational
therapy, social worker and nursing support and/or personal care. Most
transitional care helps people complete the entire healing process and
develop back their functional capacity, while assisting them and their family
to make long-term care arrangements.106
There are different transitional care programs that are specific for older
people who would otherwise be eligible for residential aged care. This
program can be organized by the hospital where the client has received their
acute or sub-acute care. A transition care client can only enter transitional
care directly upon discharge from hospital.106
There are two types of transitional care to choose from and it is either a
home-like residential setting or in the community setting. The average
duration of transitional care for the elderly is 7 weeks, with a maximum
duration of 12 weeks that may in some circumstances be extended by a
further 6 weeks.106
A transitional care program is designed to improve a patient’s independence
and confidence after every hospital stay. It is very important to create a
transitional care team, which includes a medical provider, nurse coordinator,
dietician, pharmacist, psychologist, and social worker (most especially for
elderly people). This team must follow the patient through inpatient and
outpatient hospital settings as well as transitional interface. The transitional
care team should contribute significantly to reduced readmissions, ER visits,
deaths, adverse events, and cost of care.104
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Medication Reconciliation
Medical Reconciliation is a process of detecting the most accurate list of
medications of a patient that are a big part of patient care. This includes
knowing the name of the medicine, its dose, frequency, route as well as its
uses and adverse effects. This information must be well known to provide
proper medicines for patients. The process also needs to compare all the list
of the patient’s current medications with the admitting notes of the medical
provider, its transfer and discharge orders.104
A study noted that 7% of adverse drug events occur in acute care hospitals,
and at least 58% of these can be prevented. These are resulting from
incomplete drug information, prescribing or dispensing errors, and overuse
or underuse of medications. It is very essential to have effective
implementation of medication reconciliation in order to lessen the
preventable adverse drug events occurring at transitions between
community and hospital care.
To ensure that medication reconciliation is used for all high-risk patients,
many hospitals today have a paper-based or electronic-based medication
reconciliation process. This is also in compliance with the accreditation
standards. It was noted that adherence of this is poor which is generally
conducted in less than 20 % of patients at risk. There are new electronically
enabled discharge reconciliation processes that represent an innovative
approach to this problem.22
One of the main barriers of medical reconciliation is time and the resources
it requires to gather the data, such as the community drug list
determination, most especially in the emergency departments (ED) where
most patients are admitted. For a typical ED with 50,000 visits per year, it is
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reported that an estimated additional 2,900 hours of nursing time and
8,750 hours of pharmacist time would be required; not to mention, the
added wages on these health care personnel of $349,500 at $30/hour just to
complete the admission medication reconciliation for patient visits where it is
required. It was also observed that at least 20% of patients died or were
discharged before having complete information related to the community
drug list. Healthcare departments for further improvement on medication
reconciliation adherence and compliance must appropriately address this.
To overcome such inefficiencies to adherence, Brigham and Women’s
Hospital established a prototype medication reconciliation module that
integrated data from the ambulatory electronic medical record and discharge
medication orders. This had improved adherence to 68.7% because more
medical providers could reduce their time to complete the process by
ten minutes. Another hospital that followed this method of medication
reconciliation was Bellevue Hospital in New York, where the decision was
made to block admission and discharge orders until medication reconciliation
was completed. We should take note that this is possible only for hospitals
with computerized prescriber order entry (CPOE), which represents less than
20% of hospitals in the United States, and even fewer in Canada.22
Improved Electronic Medical Record (EMR) Strategic Use
Current healthcare systems are increasing and changing tremendously, and
that is the reason why there is acceleration of diagnostic and therapeutic
tools, multiplication of stakeholders, and an escalation of economical and
societal challenges. This complexity leads to inevitable discontinuities, and
many gaps have been identified, including their impacts on the quality and
safety of healthcare processes documented.51
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Specifically in relation to the lack of safety in the healthcare industry,
reports have highlighted the important contribution of various discontinuities
in healthcare as a basis to develop corrections and reforms; and,
simultaneously, addressing the potential role of information and
communication technologies to help improve the situation. For example, in
2001, a recommendation for “… an information infrastructure to support
health care delivery, consumer health, quality measurement and
improvement, public accountability, clinical and health services research,
and clinical education…”.51 The U.S. President’s Information Technology
Advisory Committee in 2004 summarized the existing evidence and provided
recommendations for a framework in the 21st century healthcare
information infrastructure to lower cost, reduce errors and improve quality,
based on four components: electronic medical records, clinical decisionsupport systems, computerized provider order entry (CPOE), and a secure,
private, inter-operable health information exchange.51
Since the new health system vision was announced, the healthcare
information technology (HIT) industry, has gone through various stages of
what is called Gartner’s hype cycle: from a peak of inflated expectations,
illustrated by the following statements: “… the potential of IT to improve the
delivery of care while reducing costs is enormous…”; “… increased mortality
after implementation of a commercially sold computerized physician order
entry system …” (an evolutionary stage in the cycle that reflects a period of
disillusionment due to conflicting bad outcomes following implementation of
a new CPOE); and, “… hospitals with automated notes and records, order
entry, and clinical decision support had fewer complications, lower mortality
rates, and lower costs …” (a slope of enlightenment that all is not as bleak or
disruptive as described in the preceding phase of the cycle). The last stage
of the Gartner’s hype cycle, known as the “plateau of productivity”, has not
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been reached yet, as reflected in the existing literature for strong evidence
of the impact of electronic medical records or CPOE.51
Presently, for the patient to be well informed, the increasing nature of
information and communication technologies is enabling new developments
in electronic medical records, with potential significant impacts on improving
care transitions. Most people and consumers are getting ready and equipped
with their “digital proxy”, a mobile that is always on, permanently
connected, and with a context-aware device such as a smart phone. Now,
homes can be made intelligent, aware and reactive to the wishes and needs
of their inhabitants. There is rapid development of “ambient assisted living”
tools occurring, providing intelligent technologies aimed at supporting
ageing, chronically-ill populations that want to remain autonomous, at
home, for as long as possible. With the ability to supervise and monitor this
kind of healthcare task, there is correlating acceleration of the different
responsibilities among medical professionals towards patients, and most
especially their families and friends.51
In an increasingly consumer-oriented healthcare era, there is both
opportunity and risk involved because it requires further personalization of
healthcare services. The opportunity exists to increase acceptance of
consumer-adapted tools, and to be able to make use of additional,
personalized contextual information to enhance their relevance, accuracy
and usefulness. The risk relates to further fragmented information and
services, as witnessed when looking at all those small “apps” that are being
installed on smart phones, each with a different purpose. If these become a
success, we will move one step closer to providing personalized, adapted,
coherent and interoperable electronic health services to individuals and their
care professionals.51
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The transitions in healthcare truly accounts for a significant share of
preventable medical errors, but electronic health tools can totally help
secure these transitions by improving communication and coordination; and,
by involving and empowering patients and enabling new ways to access
quality care. There are many challenges such as improving issues of trust
amongst the multiple and diverse stakeholders. This involves being able to
create a sustainable, open infrastructure on which innovative services can be
developed, and to demonstrate their added value, return on investment, and
contribution to improving healthcare and health outcomes.51
Patient harm resulting from medical care remains very common as validated
by U.S. studies. There is little progress to no improvement, for example,
only 1.5% of hospitals in the U.S. have implemented a comprehensive
system of electronic medical records, and only 9.1% have even basic
electronic record keeping in place. Only 17% of U.S. hospitals and clinics
have computerized provider order entry (CPOE). Physicians-in-training and
nurses alike routinely work hours in excess of those proven to be safe. The
compliance with even the simplest interventions, such as hand washing, is
poor in many health centers.41
A reliable measurement strategy is required to enhance patient safety and
most medical centers are still dependent on voluntary reporting to track
institutional safety, despite repeated studies showing the inadequacy of such
reporting. The patient-safety indicators of the AHRQ are susceptible to
variations in coding practices, and many of the measures have limited
sensitivity and specificity. Recent studies have shown that the trigger tool
has very high specificity, high reliability, and higher sensitivity than other
methods. The only problem is the manual use of the trigger tool, which is
time consuming; but, as electronic medical records become more
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widespread, automating trigger detection could substantially decrease the
time required to use this surveillance tool.41
The CPOE systems are computer applications that allow direct, electronic
entry of orders for medications, laboratory, radiology, referral, and
procedures. CPOE systems for ordering medications are sometimes called
electronic prescribing (e-prescribing) systems. CPOE systems are often
implemented with clinical decision support (CDS) alerts to guide ordering.
There is early research demonstrating the benefits of CPOE systems in
reducing medication errors by as much as 55 – 86 % and subsequent
adverse drug events (ADEs), although the latter occur less frequently and
are more difficult to identify.47
There is evidence from several systematic reviews about the benefits of
CPOE systems relative to medication safety. The studies included in these
reviews overlap, and vary widely in design and results; few include
randomized, controlled trials. The heterogeneity of the studies prevented all
but one author from conducting a meta-analysis, but these authors found
CPOE systems were associated with a 66% reduction in the odds of an error
occurring. The results of such studies show that even a basic CPOE system,
without clinical decision alerts, can have a favorable impact on medication
safety. That this work was conducted in an independent medical group
practice suggests that CPOE implementation is associated with improved
medication safety in the real-world setting.47
CPOE with clinical decision alerts is a critical component of the electronic
medical record order-management system. This order-management system
must support the patient's care team as it cooperates in performing the subprocesses of:
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1. Care-plan development and communication (by medical providers,
nurses, and pharmacists)
2. Order planning (by medical providers, nurses, and pharmacists)
3. Order entry (by nurses and medical providers)
4. Order review, modification, and fulfillment (by pharmacists, nurses,
and medical providers)
5. Order review and administration (by nurses and medical providers)
Clinical decision support is an important feature of health information
technology. In the future, its effectiveness will depend not only upon the
design and implementation of clinical decision support functionality but also
upon consideration of changes to the work system in which it is
implemented.
Electronic Medical Records (EMRs) have become very useful today. It helps
automate the medical provider’s workflow, and it generates a complete
record of a patient with all the pertinent information needed; such as,
patient demographics, progress notes, problems, medications, vital signs,
past medical history, immunizations, laboratory data and radiology reports.
It also supports any clinical patient encounter as well as other health-care
related activities, which directly or indirectly include evidence-based decision
support, quality management, and outcomes reporting.54 EMRs are useful in
the healthcare setting due to their ability to have a single system that can
store and generate all of the relevant information for a health team. EMRs
have definite potential to improve efficiency, patient safety, and quality of
care and to reduce barriers to effective communication between health
providers.54
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As a computer based system, EMRs use a prescription system wherein
required doses, routes of administration, and frequencies are entered into a
software program and the computer performs the calculation. This
functionality has been shown to reduce the rate of incomplete prescriptions
although in isolation it cannot reduce the rate of dangerous dosing errors.
This is very helpful in the pediatric therapy database, which includes
information on dosing recommendations; and, in one study focused on the
use of a computerized prescription system it was shown it could save 45
minutes of time per day.54
Before the first introduction of this system in the U.S. in the 1970s,
expectations about CPOE systems reducing medication errors and patient
harm were high. There were reasons to suppose that CPOE/CDSS systems
would be effective in reducing medication errors and adverse drug events,
and thereby improving medication safety. A number of studies
(predominantly from the U.S.) showed CPOE with clinical decision support
systems were indeed successful strategies for reducing medication errors,
and there was some indication of patient harm being reduced. As mentioned
earlier, there were also other studies that showed negative effects in the
sense that new medication errors were being introduced through CPOE or
that mortality increased after implementation of CPOE in a Children's
Hospital.49
Different studies that looked into the effect of electronic prescribing were
predominantly performed in the U.S., because it was there that CPOE was
first introduced into clinical practice. The findings from these studies may
not apply to the European hospital setting due to differences in computer
systems and work processes between countries. Therefore, studies using an
information technology design with segmented linear regression analysis in
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order to evaluate the effect that CPOE with clinical decision support has had
on the incidence of medication errors, and to relate this to patient harm, is
also underway in European hospital systems.49
Medical provider resistance is a major perceived barrier for hospitals to
adopt EMR systems. As fully functional EMRs become more commonplace,
having a single system that can store and generate all of the relevant
information that a health team needs will become easier. Improved
efficiency, patient safety, and quality of care with the use of such tools can
hopefully reduce the barrier of medical provider resistance.64
It has been demonstrated that an EMR-generated rounding report could save
medical provider’s time, increase satisfaction, and improve patient safety.
Similar to the findings of Van Eaton research (mentioned earlier), junior
medical residents reported significant timesavings of 45 minutes per day.
However, the system did not report any timesavings for attending providers,
and the timesavings for senior residents was estimated at 30 minutes.
In contrast, it has also been reported that EMR-generated rounding provides
a 45-minute timesavings across all levels of provider training. This may be in
part to the automated nature of some single system designs where the
report has been fully integrated into the EMR, not as a separate system, and
where users have remote access to allow notes. Some researchers believe
this particular document format and the use of the EMR to generate all of
the data for a Rounding Report to be unique. All previously reported systems
in the literature describe a separate rounding and sign-out system from their
EMR system.64
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A good example that EMR is useful relates to an EMR-derived automated
adverse-event detection system as an efficient and effective method to
identify hypoglycemia in hospitalized children. Hypoglycemia is a common
adverse event in pediatric inpatients. Neonatal ICU patients, premature and
low birth weight infants, and patients receiving insulin therapy are at the
highest risk for hypoglycemia. Although the results are based on a single
institution's experience, one study demonstrated how the EMR could
significantly aid in the development of strategies to reduce hypoglycemia in
hospitalized children.69
Patient flow delays occur during the implementation of an EMR in a busy
pediatric emergency department. It is difficult to know how much benefit is
gained through interventions of increased staffing and limited diversion of
low acuity patients.77 Every user of an EMR continues to make suggestions
about their needs and requirements, and the EMR system has evolved to
optimize ease of use and special functionalities for particular groups of users
and particular subspecialties. Based on some experiences and the lessons
learned in the course of maintaining full-EMR systems, some researchers
have suggested that the key goals to be considered for future EMR system
development include the following: innovative new user-interface
technologies, special extended functions for each user group's specific taskoriented requirements, powerful and easy-to-use functions to support
research, new flexible system architecture, and, patient-directed functions.82
Improved Screening Methods
To Identify Patients With Adverse Events
The priority of research on patient safety and the transformation of the work
environment have typically focused on inpatient acute care settings. The
Institute of Medicine (IOM) reported clearly and recommended that work be
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done on “studies and development of methods to better describe, both
qualitatively and quantitatively, the work nurses perform in different care
setting”.29 The recommendation is that research on patient safety needs to
be addressed across care settings. Preventive services, primary care, and
ambulatory care settings are areas where there is a more limited body of
research related to patient safety.
There are two national task forces that have been commissioned to evaluate
existing preventive services. The Agency for Healthcare Research and
Quality (AHRQ) convened the United States Preventive Services Task Force
(USPSTF), an independent body of experts, to evaluate and make
recommendations for clinical preventive services. The Centers for Disease
Control and Prevention (CDC) established the Community Task Force to
evaluate public health prevention programs. Both task forces focus on
establishing the efficacy of prevention strategies and also consider the
relative harms and benefits of preventive services.29
Adverse events usually happens in one third of hospital admissions and
reliance on detecting methods could lead to improper ways of improving
patient safety. Recent studies showed that the adverse event detection
methods commonly used to monitor patient safety in the U.S. today, such as
performing reports voluntarily as well as using and helping out with the
AHRQ’s Patient Safety Indicators, is flagged as very poor performance
comparing to other screening methods. This fact is believed to be the cause
of 90 % misses of adverse events. Researchers discovered that the Institute
for Healthcare Improvement’s Global Trigger Tool is ten times more effective
than other methods.107
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There are many questions with regards to the reliability of automated
measures on patient safety, and such measures can confuse quality teams if
automated measures are neither sensitive nor specific to identify adverse
events. There are some methods that only rely on the medical charts of
providers and nurse reviews, and this approach was used in the Harvard
Medical Practice Study of adverse events in hospital patients. Since this
method is very time consuming, it only has limited use.108
Clinical surveillance has a lot of advantages over some adverse detection
methods. It involves active surveillance and has an independent view on
voluntary reporting; and, the collection of information relevant to case
classification is timely and accurate, and it does not rely solely on what is
documented in charts. The only problem is that it has not yet been used in
multiple or various settings due to a lack of popular knowledge on its
benefits.27
There are many countries that believe in and perform retrospective patient
record review studies, and utilize this method as the most helpful way and
solution to identify adverse events in their hospitals. However, there is
recognition that this method has some disadvantages too, such as being
time-consuming, pricey and laborious.28 According to one study, reporting
sources are very helpful to hospitals, which can provide information on
patient safety periodically and on demand. Incident reporting is recognized
by a lot of medical providers and healthcare professionals. It is also true that
relatives of patients can play an important role in signaling safety issues.28
The Vaccine Safety Datalink (VSD) project created a real-time active
surveillance system that detects real safety problems, and in which problems
can be investigated and ruled out internally without generating false alarms
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to the public. The VSD shared experience offers lessons that may be useful
to others who are establishing similar systems.31 The VSD's active
surveillance system also improves as lessons are learned from past
experience, and has already proven valuable. In 3 years of operation, there
was detection of one vaccine-safety problem that led to a revised Advisory
Committee on Immunization Practices recommendation for the MMRV
vaccine. Nine other signals were fully investigated and ruled out. The
different causes of these spurious signals were due to uncertainty in the
estimated background rates, changes in true incidence or coding over time,
other confounding, inappropriate comparison groups, miscoding of
outcomes, and chance. It was reported, “Some of these causes are
preventable and have been corrected in subsequent VSD analyses, whereas
some will be problematic for any active surveillance system.”31
One of the most significant barriers to reducing errors and improving quality
of care is lack of awareness of the type, the incidence, and consequences of
errors in any setting. The most commonly used method for estimating
vulnerabilities in healthcare is to retrospectively collect and count errors
through voluntary reporting systems (often referred to as “incident
reports”). These are fraught with difficulty due to underreporting (according
to IOM's 1999 report, only 5% of known errors are typically reported; and,
then there are unknown errors) and abuse, for example, reports filed and
counter filed as a means of retaliation against colleagues. Error reporting
often does not promote understanding of the organizational structure and
processes of care but it tends to be associated with blame and shame, and
frequently results in antagonism between team members undermining
mutual respect, trust, and cooperation.35
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The Patient Safety and Quality Improvement Act (2005) was introduced in
large part to stimulate increased error reporting through the creation of
Patient Safety Organizations (PSOs). Bates and colleagues have described
difficulties involved in defining and quantifying errors. They report that even
direct observational studies, which are highly labor intensive, often miss
errors. An alternative approach that is prospective, rather than
retrospective, and encourages involvement of all team members for
identifying and prioritizing safety and quality problems invokes Failure Modes
and Effects Analysis (FMEA). This has been widely used in other high-risk
industries and has been advocated by the IOM9 as a means of analyzing a
system to identify its weaknesses (“Failure Modes”), possible consequences
of failure (“Effects”), and to prioritize areas for improvement. Some have
adapted and tailored this methodology to allow for levels of resources and
expertise available in ambulatory settings, and developed an instrument that
has been shown to be effective in a variety of these settings. The details of
the rationale and processes behind this instrument termed ‘‘Safety
Enhancement and Monitoring Instrument that is Patient Centered” (SEMI-P)
are described elsewhere.35
It is important to know that a vital step toward creating a strong safe
medical model is to close the medical provider divide so as to maintain
communication and coordination. This has drawn attention to the fact that
currently practice meetings are “universally unpopular” despite their
indispensability. The medical model that invokes a paradigm of complex
adaptive systems is designed to aid formation of central “attractors” in the
form of self-empowered effective learning teams, with a common vision to
help their complex microsystems adapt. Thriving systems are endowed with
simple rules, shared vision, and opportunities for team members to
innovate.35
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In order to be more practical, reliable and less time consuming, the Institute
for Healthcare Improvement developed the Global Trigger Tool. This new
method has been used widespread by hospitals in the U.S. and the U.K. The
tool has also been used by organizations in need of quality assurance, and
by U.S. regulators like the Department of Health and Human Services (HHS)
Office of Inspector General, which has used it in a study to estimate the
incidence of adverse events in hospitalized Medicare patients.108 The success
of the study by the HHS Office of Inspector General has led to
recommendations that the Centers for Medicare and Medicaid Services
develop new detection methods for adverse events in hospitalized Medicare
beneficiaries. The study has also informed ongoing work to evaluate and
update national patient safety measures at the National Quality Forum, a
nonprofit organization that seeks to build consensus around national
performance measures for quality and to disseminate them.108
The Global Trigger Tool uses specific methods for reviewing medical charts.
The closed patient review chart happens between two or three employees
mainly nurses and pharmacists, who are trained to review the charts in a
systematic and reliable manner by looking at discharge codes and
summaries, medications, laboratory results, operation records, nursing
notes, physician progress notes, and other notes or comments to determine
whether there is a “trigger” or an abnormal laboratory result or medication
stop in the chart. It there’s any trigger noticed then a medical provider who
needs to examine and sign off on a chart review further investigates.
In one recent study, the three methods (the hospital’s voluntary reporting
system, the AHRQ’s Patient Safety Indicators, and the Institute for
Healthcare Improvement’s Global Trigger Tool) were examined in terms of
utility to figure out any adverse events among hospitals in the inpatient
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department. The performance of each method was being compared and
rated. Based on the findings, it was stated, “the Global Trigger Tool method
had both high sensitivity and high specificity, the Patient Safety Indicators
method had very low sensitivity and high specificity, and voluntary reporting
systems seemed to be very insensitive.”108 The Global Trigger Tool is well
developed, with adverse event detection rates of 3.9 percent and 2.7
percent, respectively, in New York and Utah/Colorado. The detection levels
were also higher than those of adverse events with other methods in
hospitalized patients from England, Australia, and Canada.108
Use of the European Foundation for Quality Management (EFQM) model to
build the assessment tool allows information to be structured and to
organize safety standards and indicators of security in a consistent manner.
This methodology proposes a suitable tool for measuring patient safety in an
extra-hospital situation. The application of this tool will identify areas for
improvement related to patient safety. To create this tool use of the SENECA
study (a European multicenter study) provides the foundation; and, the
indicators were created using the Delphi Method (relying on a panel of
experts).81
Despite that a decade has already passed since the Institute of Medicine
report on patient safety, hospital adverse events have been reported to still
be high and not fully managed. This observation should be an incentive for
incoming policy makers, reviewers and researchers to evaluate methods for
the detection of adverse events in hospital patients. Specifically, the results
could influence the work of the Centers for Medicare and Medicaid Services
and the AHRQ as they evaluate methods to detect patient safety problems in
Medicare inpatients; as well, the ongoing work at the National Quality Forum
to evaluate and develop new national measures of safety. A Global tool to
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identify adverse events and rates of organizational performance to a
universal scale is a stepping-stone to progress toward a high level of patient
safety.108
A Preventive Model To Avoid Adverse Events
The limited body of evidence on the prevention of errors and adverse events
requires the need for additional research to move forward in the area of
patient safety. Some of the evidence from studies in ambulatory and primary
care will assist to provide future direction for research and subsequent
evidence-based practice. It is clear that there is potential for errors and
adverse events in a preventive model. The evidence that is available is
largely from either descriptive studies or from randomized controlled trials
examining the efficacy of preventive services to avoid adverse events. There
is less systematic evaluation of some aspects of prevention, for example,
counseling interventions for prevention. The nature of preventive services,
their outcomes and where they are delivered has exciting possibilities, yet
increases the complexity of establishing an evidence-based program and
implications for practice. The continued evaluation of using information
technology to address risks and adverse events is a promising area for study
and practice in future venues of health care, including prevention services.29
The main focus in safety and quality research in health care has been on
preventable events rather than on preventive services. Screening and
counseling are key elements of preventive services. The evidence relative to
errors and adverse events in the area of preventive services is limited and
needs to be developed to provide direction for practice.29
The need to eliminate health care–associated preventable harm by ensuring
implementation of evidence-based recommendations for patient care is also
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essential and depends on a well-organized investment in research. Policy
makers should start with the goal of eliminating preventable harm and work
backward to fill in knowledge gaps necessary for attaining that goal. For
national prevention programs to be fully successful and broadly
implemented, resources must be available to support and develop all phases
of the translational research process. This full investment will ensure that
patients actually receive the benefits of evidence-based prevention practices,
and thereby reduce preventable harm.30
Medication errors can have a serious public health impact and can be
extremely expensive. The Safe Use Initiative (SUI) is a non-regulatory effort
within the FDA and one of its focus points is to identify areas where
medication errors can be prevented. Through collaboration with key
stakeholders, the SUI hopes to raise awareness of these issues and support
the health care community to make changes. As a result of the combined
efforts of SUI and its partners, a number of key areas have been identified
as worth addressing. For example, the optimization of pain therapy and
healthcare provider education on pain medication use is necessary for the
protection of a patient's wellbeing. Improving physician (and other
healthcare providers) adherence to pain medication guidelines, such as
NSAIDs, and enhancing understanding of the pharmacology of pain
medication, notably in the geriatric population, is an essential step to reduce
medication errors. Finding new and innovative ways to promote education
and awareness should be a task that the entire healthcare community
addresses.38
Despite documented success to reduce medical errors in surgical anesthesia
and a medication delivery system, such as in the Veteran Health
Administration, adverse events and medical errors continue to represent an
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indelible stain upon the practice, reputation, and success of U.S. health care
improvement initiatives. What may be required to successfully reduce the
unacceptably high severity and volume of medical errors is a locally directed
and organized initiative sponsored by individual healthcare organizations
that is coordinated, supported, and guided by state and federal
governmental and nongovernmental agencies.
A comprehensive approach as suggested above would require trained and
designated personnel at or consulting with diverse health care organizations
to undertake the following:

Detect and observe the manifestation of medical mistakes in
identifiable patient groups at greatest risk, and comprehend their
cognizable root causes.

Scrutinize, decipher, and distribute data to clinicians and interested
parties.

Execute error diminution stratagems based upon reanalysis and
restructuring of health care systems.

Where required, call upon health care experts for technical support
and on-site surveys.

Evaluate the impact of newly implemented programs on patient
safety.
Factors that presently reduce the efficacy of medical error prevention
programs include:

Extant performance improvement and continuous quality
improvement programs most often do not specifically address the
issue of medical errors.

Initiatives aimed at medical error reduction traditionally operate in
isolation.
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
Infection control and employee safety initiatives typically receive low
priority at health centers.

Passive error reporting systems suffer from incomplete reporting and
underreporting of identifiable medical errors.

Active reporting systems are expensive to implement and maintain.
Furthermore, active reporting systems that hold individuals
responsible understandably suffer from intentional underreporting of
errors.

The new reduced working hours of house staff has resulted in the new
dilemma of frequent patient handoffs to the new doctors coming on
service. These handoffs have resulted in a new potential pitfall for
errors that will need to be addressed in the upcoming years.

Despite the present mandate for electronic records so that medical
information can be more easily shared by collaborating physicians and
subspecialties, the varied types of electronic medical records and
challenges with their ability to communicate, is causing electronic
sharing of information to be potentially fraught barriers and necessary
steps must be take to address implementation strategies and to avoid
increased gaps in communication and patient safety.
The Quality Interagency Coordination Task Force has concluded the
following:
“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 the data
from the system, and are not unduly burdened by the effort involved
in reporting.” 7
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There is continuous enhancement requests for electronic medical record
rounding reports; and, there exists a need to expand the electronic record to
include a report that extends to other services, such as the special needs
and requirements of the pediatric populations, nursing staff, emergency
room, surgical subspecialties, intensive-care unit, and obstetrics. Health
team members other than physicians and nursing staff, can utilize the
electronic medical record and reporting strategies in many departments,
such as social services when transferring patients to outside facilities or
nursing homes.54
Ongoing studies support the position that the hand-off is important to
enhancing the culture of safety and continuity of patient care. Without
effective hand-offs, current and potential future limits on shift work hours,
such as those of medical residents in training, might result in poor outcomes
and errors attributable to fatigue and to inadequate transfer of information
during the hand-off. Under team- and shift-based approaches to care, handoffs are not limited to any one provider or health team member, and
improving them is germane to safe and effective care. Thus, progress to
improve patient safety will ultimately need to go beyond past efforts;
making learners the repository and conveyors of information through
creation of reliable systems to manage and move information critical to
patient care. This should include finding more effective approaches for
asynchronous hand-offs, including systems to support information transfer
and continuity of care when members of the health team cannot meet face
to face.
Research also is needed to study the decision-making models and algorithms
that underlie the hand-off and how these could be better understood and
taught to promote safe care during end-off-shift hand offs and facility
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transfers. Related work includes efforts to enhance the salience of
information in hand-offs through the use of three heuristics—“reduce, reveal
and focus,” with this approach based on naturalistic approaches to enhance
decision-making. Such research also may benefit the design of future handoff summaries. Additionally, work is needed to explore the best approaches
for senior nurses and medical faculty, including students and residents in
training, and all health team members in general, to assist in the recovery of
information lost or distorted in the hand-off. Research in all of these areas
has a high potential of contributing to better approaches for patient
information hand-off teaching and practice.61
The communication issues implicated as a root cause in greater than 80% of
reported adverse events represent an opportunity for the development of
technological tools designed to improve the exchange of information.
Specifically, computerized sign-out tools can facilitate standardization of the
handoff process and access to clinical data. In doing so, these electronic
sign-out applications have the potential to improve communication and
reduce preventable adverse events. The benefits of using computerized signout tools to facilitate the handoff process have been demonstrated in various
medical disciplines, including pediatrics and the newborn intensive care
unit.40 Clinical surveillance can also be an effective means of detecting
patient safety issues. Although it was reported as effective, further
evaluations are recommended,27 such as a comparison of the findings of
clinical surveillance with other detection methods of identifying patient
safety events.
There are many solutions that have been presented to prevent factors
associated with the risk of duplicate medication ordering errors. The
solutions conform to the principles of designing systems to do the following:
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support communication and collaboration among the healthcare team;
enhance error recovery by improving team and individual situation
awareness, particularly around shift changes and other hand-offs; improve
teamwork with regards to order entry; and, improve the usability and
functionality of computer order entry screens and medication alerts.58 Some
other recommendations that need to be considered in the long run include:
1. Manufacture medication databases to:
a. Identify the same medication, regardless of combination,
formulation, or route of delivery.
b. Identify potentially additive medications regardless of medication
class.
c. Identify medication combinations (including doses) that could
potentially be additive but have been demonstrated to be safe
and effective, for example, the combination of aspirin 81–625 mg
once a day with clopidogrel 75 mg a day.
2. Manufacture electronic health record algorithms for checking for
potentially duplicate and additive medication orders.
3. Make the patient's medication record —recently administered and
planned — more accessible and comprehensible during order
planning, entry, review, and administration.
4. Create more accessible and comprehensible alerts.
5. Select, implement, and maintain health information technology
products and services for both safety and effectiveness.
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6. Develop context appropriate policies for order entry. For example:
a. Review all recent and planned medications before entering or
fulfilling orders.
b. Identify one person on a rounding team to enter orders during
patient rounds and a supervising physician to review orders
immediately after rounds.
7. Require hand-offs (for example, at change of shift and patient
transfer) to include communication of recent and planned medication
orders.
8. Review and optimize protocols for care processes likely to create
duplicate or additive orders, for example, electrolyte replacement in
patients on total parenteral nutrition, anticoagulation, or verbal
orders.
To prevent an increase in duplicate medication orders will take the concerted
efforts of multiple stakeholders, which include policy makers, medication
database manufacturers, electronic health record manufacturers, healthcare
organizations, healthcare teams, and individual clinicians. The availability of
safe and effective medication databases and EMRs requires safety measures,
such as certification requirements and additional software systems (i.e.,
medication databases) that align with certification schemes. Health
information technology manufacturers will need to enact the solutions listed
above that are relevant to them. Healthcare organizations will need to
include the above solutions in their efforts to maximize the benefits and
decrease the risks when they implement information technologies.
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Two demonstrated risks of CPOE are particularly relevant to medication
safety: increased duplicate errors and alert fatigue. The EMR manufacturers
must perform usability evaluations of CPOE and design the technology with
the contexts of use in mind. Healthcare organizations must work with
manufacturers to inform them about those contexts, ensuring that alerts
encompass all predictable, relevant situations. Healthcare organizations
should provide competency-based EMR training and feedback to users (as
well as their supervisors) regarding the frequency of duplicate order entry.
Of course, this reporting should not be seen as an adequate substitution for
the more effective solutions discussed above. Definitions of healthcare
professionalism will need to be extended to include the management of
electronic patient information.58
Multiple improvement activities, particularly continuous improvement of any
model of healthcare (care-delivery organizations, care teams, and clinicians)
and the health information technology organized to service them, are
recommended. Systems factors such as teamwork, communication,
organizational decision-making, and user-centered health information
technology represent important areas for further research and health team
engagement.58
Summary
This study module has provided a domestic and international perspective on
the progress of preventable adverse events. It has been emphasized that
the standardization of patient safety data can enhance adverse event
reporting, aggregation, and analysis. Certainly, the main goal is to attain a
standardized safety model to produce accessible data for query and local and
international comparisons. Meaningful safety data allow for the development
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of evidence-based actions that can be prospectively applied to patient care
processes and provides a means for intervention validation. Those involved
in health care quality and patient safety should concentrate on classification
development and integration into health system reporting structures to
ensure the application of meaningful data to improve patient safety in their
organizations.
A best practice classification can serve as a model to other health systems
and organizations seeking to integrate standardized data collection into their
operational functions. As health teams continue to work on patient safety
initiatives, new funding avenues and opportunities may evolve to further
incentivize and to reach out to a wider arena of patient safety leaders to
improve terminology and future outcomes.67
Please take time to help NurseCe4Less.com course planners evaluate
the nursing knowledge needs met by completing the self-assessment
of Knowledge Questions after reading the article, and providing
feedback in the online course evaluation.
Completing the study questions is optional and is NOT a course
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1.
The data on preventable events has not shown that:
a. Incidence study categories are problematic for staff.
b. Preventable events should be a learning focus.
c. Near misses are an important, complex category, based on harm
potential and proximity to patients.
d. Staff agree on events that caused or had potential for severe harm.
2.
True or False: In acute care, 24/7 shifting simultaneous service
of the medical or hospital team can lead to high-risk
complications that can happen.
a. True
b. False
3.
The data on preventable events has not shown that:
a. two-way exchange of information was lacking.
b. staff not on good terms or uncomfortable with each other.
c. long absences from work and/or being new in a setting
d. all of the above
4.
The most common missed or delayed diagnoses have been:
a. urinary tract infection
b. pulmonary embolism
c. drug reaction and overdose
d. answers b and c above
5.
True or False: Blood donor or organ transplant incompatibility is
a preventable adverse event.
a. True
b. False
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6.
Approximately _________________% of surgical errors were
found to happen due to miscommunication between healthcare
personnel.
a. 90 %
b. 25 %
c. 43 %
d. none of the above
7.
True or False: The AHRQ patient safety indicators are based on
measures with high sensitivity and specificity.
a. True
b. False
8.
The Global Trigger Tool uses the following specific methods to
review medical charts:
a. trained professionals to review charts in a systematic manner
b. record review to identify a “trigger”, i.e., abnormal laboratory result
c. a non-medical person to further investigate
d. answer a and b above
9.
Adverse events occur due to system failures and errors due to:
a. lack of necessary education for health professionals
b. staff fatigue and stress
c. demands and flow of the healthcare system
d. all of the above
10. True or False: Medical error reduction initiatives tend to operate
in isolation and reduce the efficacy of medical error prevention
programs.
a. True
b. False
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11. There are different types of errors that cause adverse events. A
therapeutic error is one where
a. there is a failure to make a diagnosis.
b. a response was either not ordered or not delivered.
c. an untimely diagnosis.
d. the error takes place during a procedure.
12. Adverse drug events were found out to be common in
___________________ stages of the medication use process.
a. the prescription
b. transcription
c. administration
d. all of the above
13. A medical student who evaluates a patient initially is
____________ to learn from the patient encounter than a
student who received the patient as a hand-off.
a. more likely
b. less likely
c. equally likely
d. less likely (because second student has a more complete chart)
14. Research shows that 70% of cases for malpractice occur
a. because of hand-offs.
b. in the teaching setting.
c. lack of monitoring.
d. because of poor communication.
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15. Failure of good communication also contributed to _______ of
the problems encountered in healthcare settings.
a. 70%
b. 60%
c. half
d. 30%
16. __________________________ is often cited as the main
underlying and remediable factor behind medical errors.
a. Post-discharge complications
b. Patient health literacy
c. Lack of monitoring
d. Poor communication
17. Elderly patients are at higher risk for adverse effects due to
a. having chronic medical conditions.
b. the need to take more medications.
c. having a poor immune system.
d. health illiteracy.
18. True or False: Diphenhydramine and Amitriptyline are the most
common inappropriately prescribed medications with high-risk
adverse events.
a. True
b. False
19. One of the primary problems that threaten the safety of patients
care is a healthcare-associated
a. diagnosis.
b. infection.
c. stress.
d. two-way exchange of information.
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20. Steam sterilization and autoclaving are _____________
effective in killing all microorganisms.
a. marginally
b. 50%
c. 100%
d. less than 100%
21. A chemical indicator should be placed inside and in the center of
a load of unwrapped instruments in ___________________
sterilization process.
a. every
b. periodic
c. every other
d. None of the above
22. Biological indicators should be used ____________________
for monitoring of the quality of sterilization processes.
a. from time to time
b. every time
c. annually
d. None of the above
23. Patient safety outcome indicators significantly increased when
the patient-nurse ratio exceeded a _________ ratio.
a. 5:1
b. 3:1
c. 7:1
d. 10:1
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24. True or False: Sepsis and death were more likely to happen after
elective than non-elective surgery.
a. True
b. False
25. Elective surgery had the ________ sepsis cases.
a. greatest increase in
b. worst
c. most severe
d. All of the above
26. Patients with ______________ are at risk of an assortment of
safety events beyond the scope of those of other conditions.
a. chronic kidney disease
b. infections
c. sepsis
d. acute coronary syndrome
27. A false negative diagnosis is described as
a. an abnormality that is present.
b. a diagnosis that is not present.
c. a wrong diagnosis.
d. a missed diagnosis.
28. A discrepant diagnosis is when
a. the abnormality diagnosed is present.
b. an entirely different, wrong diagnosis is made.
c. the medical professional overanalyzes the diagnosis.
d. the medical professional states a diagnosis that isn’t there.
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29. The most commonly missed diagnoses includes
a. cancer.
b. aneurysms.
c. appendicitis.
d. All of the above
30. Diagnostic errors are proven to be cognitive in nature related to
a. data collection from the patient.
b. a knowledge deficiency.
c. abnormal diagnosis.
d. analysis of a diagnosis.
31. A patient who has an adverse reaction to a drug he received for
the first time is said to have
a. a wrong diagnosis.
b. an avoidable adverse event.
c. an unavoidable adverse event.
d. a missed diagnosis.
32. True or False: The most frequent type of preventable adverse
drug event was error in medication dose.
a. True
b. False
33. Which of the following is NOT an example of a preventable
adverse medical event?
a. Wrong surgical site
b. Donor organ transplant incompatibility
c. A preferred medication that has an expected side effect
d. Pressure ulcers
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34. A well-established model to evaluate gaps and holes in a system
that lead to system failure is
a. the Safe Medical Model.
b. European Foundation for Quality Management (EFQM) Model.
c. the quality-assurance (QA) tool.
d. the Swiss Cheese Model of Systems Errors.
35. Statistics show that __________ of hospitals in the U.S., have
implemented a comprehensive system of electronic medical
records.
a. 10%
b. 1.5%
c. half
d. 20%
36. True or False: Clinicians may report adverse events in a way that
shifts the responsibility from the individual to system factors,
while case note reviews overestimate the role of the individual.
a. True
b. False
37. Computerized prescriber order entry (CPOE) systems for
ordering may reduce medication errors by __________ .
a. 10%
b. 25% to 46%
c. half
d. 55% to 86%
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38. Electronic Medical Records (EMRs)
a. generate complete patient records.
b. provide a single system to store medical records.
c. reduce barriers to effective communication.
d. All of the above.
39. Communication issues were seen as a root cause in greater than
_________ of reported adverse events.
a. half
b. 1/3
c. 80%
d. 50%
40. True or False: Medical provider resistance is a major perceived
barrier for hospitals to adopt EMR systems.
a. True
b. False
41. An active error includes those errors committed by
a. a pharmacist.
b. hospital management.
c. organizational processes.
d. the patient.
42. One of the biggest reasons why there are threats to patient
safety is due to understaffing, most especially when it comes to
a. pharmacists.
b. hospital management.
c. nurses.
d. physicians.
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43. ___________________ are a threat to patient safety, but this is
hardly noticed nor documented in any adverse effect studies.
a. Documentation errors
b. Triage errors
c. Medication errors
d. Surgical errors
44. In order to achieve a positive safety environment, the
organization should first
a. install an electronic medical records system.
b. introduce education and knowledge courses to staff.
c. reduce patient hand-offs.
d. evaluate their current culture on patient safety.
45. Operative adverse events occurred more during
a. discharge.
b. diagnosis.
c. the actual surgical procedure.
d. the peri-operative period.
46. In the year 2000, the Institute of Medicine (IOM) published a
landmark study that reported Americans avoid necessary
healthcare
a. due to EMR privacy issues.
b. due to fear of medical errors.
c. due to healthcare illiteracy.
d. due to communication barriers.
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47. True or False: The phrase “Primum non nocere” translates “To
Err is Human.”
a. True
b. False
48. Contributing factors to information management errors is/are
a. copy–paste method of transferring information.
b. failure to verify dictation.
c. lack of documentation.
d. All of the above.
49. A patient-related factor, which may lead to an adverse event is
a. a patient’s treatment compliance.
b. inadequate or unavailable protocols.
c. a patient’s training or education.
d. a rule-based failure.
50. Most medication errors occurred during
a. administration.
b. prescription.
c. preparation.
d. transcription.
51. Approximately ______________ of prescriptions to elderly
persons are inappropriate medication prescriptions (IMPs).
a. 8%
b. one in five
c. 2%
d. one in ten
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52. A technical factor, which may lead to an adverse event is
a. a patient’s treatment compliance.
b. knowledge-based.
c. related to labels or forms.
d. a rule-based failure.
53. _______________________ are recommended for telephone
orders with regards to medication administration.
a. Complete patient records
b. Written prescriptions
c. Transcriptions
d. Read backs
54. In the U.S., surgery patients are vulnerable to surgical sepsis,
and reports suggest that surgical sepsis accounts for almost
_______________ of all septic patients.
a. 40%
b. 13%
c. 30%
d. less than 7%
55. True or False: Lower-acuity patients are more likely to be
discharged from an emergency department without specific
follow-up plans or monitoring in place for adverse drug-related
events.
a. True
b. False
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56. Diagnostic errors are proven to be cognitive in nature, which
means
a. they involve verification of diagnostic hypotheses.
b. they involve patient awareness.
c. they involve knowledge deficiencies.
d. data collection.
57. The risk of diagnostic errors increase when the healthcare
provider
a. is confident.
b. uses reasoning shortcuts, i.e., trial and error.
c. relies on past experience.
d. verifies and double-checks.
58. True or False: Medical providers should be enthusiastic about
making diagnoses and decisions.
a. True
b. False
59. A Human factor that is skill-based, which may lead to an adverse
event is
a. is confident in one’s skill.
b. inadequate transfer of information.
c. an inadequate application of existing knowledge.
d. patient treatment compliance.
60. An organizational factor, which may lead to an adverse event is
a. an incorrect fit between a provider’s training and a particular task.
b. failures due to poor design of equipment.
c. a patient’s age and comorbidity.
d. inadequate or unavailable protocols.
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Correct Answers:
1. d
11. b
21. a
31. c
41. a
51. b
2. a
12. d
22. a
32. a
42. c
52. c
3. d
13. a
23. c
33. c
43. b
53. d
4. d
14. b
24. b
34. d
44. d
54. c
5. a
15. b
25. d
35. b
45. d
55. a
6. c
16. d
26. a
36. a
46. b
56. a
7. b
17. c
27. a
37. d
47. b
57. b
8. d
18. a
28. b
38. d
48. d
58. a
9. d
19. b
29. d
39. c
49. a
59. c
10. a
20. d
30. a
40. a
50. a
60. d
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