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PREVENTABLE ADVERSE EVENTS
ABSTRACT:
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. 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, such as
best practice education of health professionals, data collection and reporting. Professional
roles are evolving in medicine and nursing with quality at the center of health system
reform and trends to promote safe outcomes.
This article 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.
TARGET AUDIENCE AND LEARNING OBJECTIVES:
The target audience for this course is nurses and advanced practice nurses or other licensed
health providers interested in issues of quality healthcare. Course learning goals for the
learner includes being able to:
1. Explain the different medical errors and interventions intended to reduce them.
2. Differentiate between a preventable vs. non-preventable adverse event.
3. Identify processes to investigate the extent of drug-related medical errors.
4. Explain the different barriers in hands off-transfers by medical professionals.
5. Describe patient chart review processes of errors recorded by healthcare providers.
6. Identify the extent of inappropriate prescription to both child and adults.
7. Explain the importance of the Agency for Healthcare Research and Quality (AHRQ)
reports on patient safety and of accepted AHRQ Hospital Patient Safety Indicators (HPSI).
8. Identify the common types of adverse events of post-discharge patients and
recommendations to improve them.
9. Explain processes to investigate diagnostic errors in both clinical and hospital settings to
detect the warning signs for possible errors, and ways to improve it.
10. Describe the key elements of electronic health records, and its importance to
information flow between patients and healthcare providers.
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1. PATIENT SAFETY DEFINITIONS
Medical Errors
Preventable vs. Non-preventable adverse event
2. DISCONTINUITIES IN CARE
Hand-offs/transfers
Interdepartmental communication
3. MAJOR AND COMMON HOSPITAL ADVERSE EVENT AND MEDICAL ERROR STUDIES
Drug-related
Non drug-related: adults vs. pediatrics
4. INSTITUTE OF MEDICINE AND AHRQ REPORTS ON PATIENT SAFETY
Hospital Patient Safety Indicators (HPSI)
Accepted Agency for Healthcare Research and Quality (AHRQ) HPSI
Surgical
Post-Op
Medical
5. COMMON TYPES OF POST-DISCHARGE ADVERSE EVENTS
Drug related
Nosocomial
Procedure related
Pressure Ulcers
Diagnostic Errors
6. DIAGNOSTIC ERRORS AND MISDIAGNOES
Statistics
Types
7. CLINICAL SCENARIOS: INPATIENT/POST-DISCHARGE ADVERSE EVENTS AND MEDICAL
ERRORS
Adverse event clinical definitions (Unavoidable vs. Preventable)
Unavoidable adverse event example
Preventable adverse event example
8. RECOMMENDATIONS FOR IMPROVEMENT
System Failures
Improving transitional care
Medication reconciliation
Improved Electronic Medical Record (EMR) strategic use
9. IMPROVED SCREENING METHODS TO IDENTIFY PATIENTS WITH ADVERSE EVENTS
10. ON REFLECTION
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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 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 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
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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]
● 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 error causing adverse events
There are different types of errors that causes 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 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]
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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 front-line 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 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: [50]
First, 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. [50]
Second, 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. [50]
Third, 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. [50]
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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 the possibility for learning is directly related to how potentially
dangerous events are understood, interpreted and categorized. [50]
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]
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]
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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 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
There are reasons why despite the highest quality care for the patient, 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]
ADEs 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 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
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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 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 is clearly defined 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 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 “nearmiss” 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]
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DISCONTINUITIES IN CARE
Hand-offs/transfers and Interdepartmental communication
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]
Hand-offs/Transfers
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, 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
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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 handoff 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 handoff 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]
A rule was implemented in 2003 to limit the hours of residents in the hospital but these had
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
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 nonverbal 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
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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 is also dependent on residents’ clinical and
diagnostic skills. Outgoing resident providers must have a good understanding of the clinical
conditions and events for them to have a better focus on relevant information. This should
make handwritten notes be shared by the incoming residents. 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 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
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 crosscoverage 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]
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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 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 we know, hand-off communication is one 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 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]
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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 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 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
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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 appreciate 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 found out 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 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 near-miss 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
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results and inadequate knowledge about the self-care activities that they must perform
upon 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 EVENT/MEDICAL ERROR STUDIES
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.
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/Colorado showed statistics after retrospective patient
chart review that 3.7% of patients (New York) and 2.9% of patients (Utah/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
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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 pre-hospital 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 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.
2.
3.
4.
Medication errors
Unintended/accidental exposure
Intentional misuse/abuse, and
Drug quality defects
Medication errors are broken into subcategories: [38]
1.
2.
Informational errors in prescribing or by patients/consumers
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 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
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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 office-based 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
at increased risk of gastro-intestinal bleeding” and “use of oral
increased risk of renal failure” were identified as key priorities for
primary care by a Delphi (research) panel of primary care clinicians.
oral NSAIDs in patients
NSAIDs in patients at
quality improvement in
[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 (1000% of the correct dose) 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
prehospital 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, Hib
and their various combinations 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]
Some factors that also play a role to medication errors include labels, appearance and
location of ampoules and syringes, inattention, poor communication, carelessness, and
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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]
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 prehospital 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 prehospital
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 vs. 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]
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
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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 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 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
inappropropriate. Diphenhydramine and Amitriptiline are the most common inappropriately
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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
Hospital Patient Safety Indicators (HPSI)
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/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. In hospital departments, a rapid and safe service for patients is
needed 24/7, and 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 AE. [71]
Hospital Acquired Infections And Sterilization Techniques:
One of the primary problems that threaten the safety of patients care is a healthcareassociated 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 CDC and other medical programs, “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 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
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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 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”.
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, hospitalacquired pneumonia, and hospital-acquired urinary tract infections 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
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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)
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)
AHRQ 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]
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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 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 Agency for Healthcare Research and Quality (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
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
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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 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 realtime longitudinal sensitivity that no static measurement, 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 Op
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. 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]
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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 highrisk 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]
Medical
AHRQ defined patient safety indicators (PSIs) have 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]
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
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:
1 Physiologic and metabolic derangements in all diagnoses among all discharges
2 Aspiration pneumonia
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3
4
5
6
7
8
Coronary artery bypass graft after percutaneous transluminal coronary angioplasty
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 (CKD) 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 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 self-report 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 quality and safety of patient care 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]
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COMMON TYPES OF POST-DISCARGE ADVERSE EVENTS
There are many adverse events that most likely happen after the patient has been
discharged from the hospital, and these can be related to drugs or medications, nosocomial
or hospital acquired infections, procedure related infections or problems, pressure ulcers
and diagnostic errors.
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 highacuity 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 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
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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 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, and 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 hospitalbased surveillance system to monitor post-discharge 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 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/MISDIAGNOSES
Statistics:
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
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20% and 25% were also reported, depending on the medical setting and the materials used
to determine the rate of diagnostic errors. 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 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]
What are the 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 systemrelated 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
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 includes cancer, pulmonary embolus, coronary disease, aneurysms,
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
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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 misdiagnosis 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:
1. There are 59% malpractice claims in a retrospective review analysis involved on
diagnostic error that put the patient’s life in danger. [10]
2. 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]
3. Cognitive factors by medical internists also contribute to this type of error by 74% of
cases. [10]
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 is 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 selfawareness 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]
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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.
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.
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/POST-DISCHARGE
ADVERSE EVENTS AND MEDICAL ERRORS
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 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 Clinical Definitions (Unavoidable vs. 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 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
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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 patient-related 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]
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:
1. Operative adverse events accounted for 24%–53% of adverse events and 20%–42% of
preventable adverse events.
2. The errors in evaluation and diagnosis and errors in treatment (including drug treatment)
were the next most common types of preventable adverse events.
3. Therapeutic adverse events accounted for 15% to 28% of preventable adverse events.
4. Diagnostic adverse events accounted for 9% to 21%.
5. 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
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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%.
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:
First case involves the drug tacrolimus in a patient with graft-versus-host disease after bone
marrow transplantation for chronic myelogenous leukemia. After giving the prescribed
medication fatal acute renal failure occurred resulting in death.
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.
Third case is of a patient with pseudonomal 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.
Fourth case is about a procedural complication. This is a case of a 55-year-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. [42]
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. [42]
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Preventable adverse event example
To follow are preventable adverse medical event examples: [1]
1. Wrong surgical procedure such as wrong surgical site, wrong patient and wrong surgical
procedure
2. Retained foreign body left during surgery on the patient
3. Blood donor or organ transplant incompatibility
4. Infectious agent transmission to a patient
5. Administering incorrect medication or dosage
6. Trauma or accident in the hospital such as falls or burns
7. Heart conditions such as DVT (deep venous thrombosis) or PE (pulmonary embolus)
without the right prophylactic treatment
8. A surgical site infection without giving any antibiotic prophylaxis
9. Pressure ulcers
10. Catheter-acquired infections
Additional detailed examples of preventable adverse events are described below:
An operating room setting: two factors were considered as a proximate cause for an error.
One involved a process factor when a post-insertion 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 in-service 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]
An operating room setting: a human factor manifested 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 a shoe holder that hangs on a
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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]
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
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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 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: 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
System Failures
Type of individual and system errors:
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]
The review found out that preventable adverse events are often associated with more than
one contributory 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 as follows: [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
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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]
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 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
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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 patient-safety 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: goal-oriented, timelimited and therapy-focused. An example would be after a hospital stay when a patient is
provided with a package of different services 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/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]
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,
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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 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
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to inevitable discontinuities, and many gaps have been identified, including their impacts on
the quality and safety of healthcare processes documented. [51]
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 decision-support 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 COPE); 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 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 and of its ICT
enabling tools. The opportunity exists to increase acceptance of consumer-adapted tools,
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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]
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 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/CDS 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/CDS 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
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found CPOE/CDS 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 CDS
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 CDS is a critical component of the EMRs order-management system. This ordermanagement system must support the patient's care team as it cooperates in performing
the sub-processes of:
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)
CDS is an important feature of health IT. In the future, its effectiveness will depend not only
upon the design and implementation of the CDS 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]
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
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(predominantly from the U.S.) showed CPOE/CDSS 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/CDS or
that mortality increased after implementation of CPOE/CDSS 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/CDSS 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 ITS design with segmented linear regression analysis in order to
evaluate the effect that CPOE/CDSS 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 time
savings of 45 minutes per day. However, the system did not report any time savings for
attending providers, and the time savings for senior residents was estimated at 30 minutes.
In contrast, it has also been reported that EMR-generated rounding provides a 45-minute
time savings 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]
A very good example that EMR is useful relates to an EMR-derived automated adverseevent detection system as an efficient and effective method to identify hypoglycemia in
hospitalized children. Hypoglycemia is a common adverse event in pediatric inpatients.
NICU 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 ED. 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
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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 userinterface 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 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]
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]
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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 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]
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
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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 selfempowered 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]
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.
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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 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 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]
ON REFLECTION
The limited body of evidence on errors and adverse events in preventive services definitely
supports the need for additional research to move ahead 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, for example, in preventive
care. There are also unique errors and adverse events associated with preventive care. It is
clear that there is potential for errors and adverse events in a preventive model or service,
but additional evidence is needed to explicate what they are moving forward. 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, specifically in
cancer screening. There is less systematic evaluation of some aspects of preventions, for
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example, counseling interventions for prevention. The nature of preventive services and
their outcomes and where they are delivered is exciting, yet increases the complexity of
both 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, counseling, and chemoprophylaxis are the
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 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 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, in
the optimization of pain therapy. Healthcare provider education on NSAID use is necessary
for the protection of a patient's wellbeing. Improving physician (and other healthcare
providers) adherence to NSAID guidelines, and enhancing understanding of the
pharmacology of NSAIDs in the geriatric population, is an essential step to reducing
medication errors. Finding new and innovative ways to promote education and awareness
should be a task that the entire health care community addresses. [38]
Despite documented success to reduce medical errors in both surgical anesthesia and the
Veterans Health Administration Medication Delivery System, adverse events and medical
errors continue to represent an indelible stain upon the practice, reputation, and success of
U.S. health care improvement initiatives.
In that regard, what may be required to successfully attack 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.
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Within such a comprehensive approach, trained and designated personnel at or consulting
with diverse health care organizations would be able to undertake the following:
1. Detect and observe the manifestation of medical mistakes in identifiable patient
groups at greatest risk, and comprehend their cognizable root causes;
2. Scrutinize, decipher, and distribute data to clinicians and interested parties;
3. Execute error diminution stratagems based upon reanalysis and restructuring of
health care systems;
4. Where required, call upon health care experts for technical support and on-site
surveys;
5. Evaluate the impact of newly implemented programs on patient safety.
Factors that presently reduce the efficacy of medical error prevention programs include:
1. Extant performance improvement and continuous quality improvement programs
most often do not specifically address the issue of medical errors;
2. Initiatives aimed at medical error reduction traditionally operate in isolation;
3. Infection control and employee safety initiatives typically receive low priority at
health centers;
4. Passive error reporting systems suffer from
underreporting of identifiable medical errors;
incomplete
reporting
and
5. Active reporting systems are expensive to implement and maintain. Furthermore,
active reporting systems that hold individuals responsible understandably suffer
from intentional underreporting of errors;
6. 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;
7. 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
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timely feedback on the data from the system, and are not unduly burdened by the
effort involved in reporting.” [7]
There is continuous enhancement requests for the EMR Rounding Report than current
resources can keep up with; and, a need is seen to expand the report 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 rounding report as well as
social services when transferring patients to outside facilities such as nursing homes. [54]
Ongoing studies support that improving the hand-off is important to enhancing the culture
of safety and continuity of inpatient care. Without effective hand-offs, current and potential
future added limits on shift work hours, such as those of medical residents in training, might
result in an uncomfortable trade-off; such as, errors attributable to fatigue and errors due
to inadequate transfer of information during the hand-off. Under team- and shift-based
approaches to care, hand-offs are not limited to any one provider or health team member,
and improving them is germane to safe and effective care. Thus, efforts ultimately will need
to go beyond making learners, or any individuals, the repository and conveyors of this
information through creation of reliable systems to manage and move information critical to
patient care. This should include finding more effective approaches for asynchronous handoffs, 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 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 decisionmaking. Such research also may benefit the design of future hand-off summaries. Finally,
work is needed to explore the best approaches to charge nurses, senior residents and
faculty, and 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 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 sign-out 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] First, it is
recommended to compare the findings of clinical surveillance with other detection methods
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of identifying patient safety events. Second, economic analysis for the detection of adverse
events is also necessary to identify the best effective method. Third, an evaluation of this
method in different hospitals is also a priority. Finally, it is recommended further studies are
needed to determine if adverse event detection leads to improvement in patient outcomes.
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: 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 order entry screens
and medication alerts. [58]
Some other recommendations that needs 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 EHR algorithms for checking for potentially duplicate and additive
medication orders.
3. Apply human factors design principles to make the patient's medication record —
recently administered and planned — more accessible and comprehensible during
order planning, entry, review, and administration.
4. Apply human factors
comprehensible alerts.
design
principles
to
create
more
accessible
and
5. Select, implement, and maintain health IT products and services for both safety
and effectiveness.
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.
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8. Review and optimize protocols for care processes likely to create duplicate or
additive orders, for example, electrolyte replacement in patients on TPN,
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,
EHR 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 IT 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.
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 above. Finally, definitions
of healthcare professionalism will need to be extended to include the management of
electronic patient information. [58]
Based on these findings, multiple improvement activities, particularly continuous
improvement of any model of healthcare (care-delivery organizations, care teams, and
clinicians) and the health IT organized to service them, are recommended. Systems factors
such as teamwork, communication, organizational decision-making, and user-centered
design of health IT represent important areas for further research and health team
engagement. [58]
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 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]
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