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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 “near-

miss” data to direct and measure quality improvement efforts. There are numerous reports

that many healthcare sites have voluntary reporting systems that capture various event

types in either paper or electronic forms. The examination of data such as contributing

factors, system failures, and outcomes may facilitate discovery of event trends that can be

used to inform safety initiatives, broaden communication lines, and enhance patient care

coordination. [67]


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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 hand-

off patients that students see and it may also include daytime system as well. According to

the report given by five hospitals, students saw approximately 50% more hand-off patients

if the teams admitted patients daily than if the teams admitted on an every 4th day call

cycle. Also, residents may assign more stabilized hand-off patients to students whom they

perceive as less proficient. [62]

One study was done to assess whether a modified "ABC-SBAR" mnemonic (airway,

breathing, circulation followed by situation, background, assessment, and recommendation)

improved hand-offs by pediatric interns in a simulated critical patient scenario; further

studies are needed to check 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 non-

verbal cues such as gestures and emphasis. Interviewees expressed a preference for verbal,

interactive hand-offs. Most hand-offs without a face-to-face interaction were just conducted

over the telephone, yet 15–20% of the hand-offs in surgery solely happened with the


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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 cross-

coverage with a large census; potentially occurring under a model of a reduced mandate for

care and more limited information-sharing. [61]

In 2003, the Accreditation Council for Graduate Medical Education restricted residency duty

hours; and, because of it, there developed much concern about the increased frequency of

hand-offs whereby patient care responsibility is transferred from one resident who is leaving

the hospital to another incoming resident. This resulted in a heightened focus on the

importance of quality hand-offs. [60]


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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]


14

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


15

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


16

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


17

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. Medication errors

2. Unintended/accidental exposure

3. Intentional misuse/abuse, and

4. Drug quality defects

Medication errors are broken into subcategories: [38]

1. Informational errors in prescribing or by patients/consumers

2. Procedure and process type errors

Procedure type errors usually happen in hospital settings. It was reported that in a critical

care unit individual patients experienced 1.7 medication errors per day. A review of the

literature focusing on hospital practices indicated that most medication errors occurred

during administration (53%), but they also occurred during prescription (17%), preparation

(14%), and 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


18

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 oral NSAIDs in patients

at increased risk of gastro-intestinal bleeding” and “use of oral NSAIDs in patients at

increased risk of renal failure” were identified as key priorities for quality improvement in

primary care by a Delphi (research) panel of primary care clinicians. [36]

More studies show that drug administration errors are among the highest medical errors.

Children are always at risk for such medication errors because of the need to calculate

doses depending on each body weight and height measurements. Pediatric doses that are

ten times the correct amount (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


19

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].


20

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


21

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


22

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 healthcare-

associated infection, which is an increasing worldwide concern. Surgical procedures

conducted in hospital and other health care settings involve direct patient contact with a

medical device or surgical instrument that can lead to severe life-threatening infections.

Controlling this problem is a major criterion for hospital accreditation worldwide. Proper

sterilization of instruments between patients is needed in order to remove all microbes and

prevent harmful adverse effects as a result of cross contamination. [71]

There are different types of sterilization techniques available, and the most common method

for sterilization of medical instruments is steam sterilization. However, neither steam

sterilization nor autoclaving are guaranteed to be 100% effective in killing all

microorganisms, so the quality of sterilized products should be assessed by physical,

chemical, and biological indicators. According to the 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


23

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, hospital-

acquired 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


24

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]


25

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


26

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 real-

time 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]


27

In the U.S. surgery patients are vulnerable to surgical sepsis, and reports suggest that

surgical sepsis accounts for almost 30% of all septic patients. These are considered as high-

risk patients since the surgical procedures they underwent promoted metabolic,

hematologic, and immunologic responses in their body. The immune function after surgery

pose increased patient vulnerability to experience perioperative bacterial infection,

hemorrhage, blood transfusion, or anesthesia up to severe suppression that promotes

sepsis. [101]

One study found that due to progress in surgical care on patients with greater utilization of

surgical intensivists, alterations in the antibiotics or strategies employed, the overall

mortality rate between surgical patients has dramatically improved. On the other hand, it

was stated that elective surgery had the greatest increases in sepsis rates and worst severe

sepsis cases. This type of surgery also failed to show a decrease in age-adjusted rates of

death for postoperative sepsis over time. It is therefore important to start using population

data for postoperative sepsis which may include the analysis of the specific procedures

associated with sepsis and a focused evaluation of the various racial and sex disparities in

the development of postoperative sepsis. [101]

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 Complication of anesthesia

2 Death in low-mortality diagnosis-related groups

3 Decubitus ulcer

4 Failure to rescue

5 Foreign body left during procedure

6 Iatrogenic pneumothorax

7 Selected infections due to medical care

8 Postoperative hip fracture

9 Postoperative hemorrhage or hematoma

10 Postoperative physiologic and metabolic derangements

11 Postoperative respiratory failure

12 Postoperative pulmonary embolism or deep venous thrombosis

13 Postoperative sepsis

14 Postoperative wound dehiscence

15 Accidental puncture or laceration

16 Transfusion reaction

Additional experimental PSIs include:

1 Physiologic and metabolic derangements in all diagnoses among all discharges

2 Aspiration pneumonia


28

3 Coronary artery bypass graft after percutaneous transluminal coronary angioplasty

4 Postoperative in-hospital myocardial infarction

5 Technical difficulty with procedure

6 Dosage complications

7 Postoperative iatrogenic complications

8 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]


29

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 high-

acuity patients, work under time pressure, and treat patients based on incomplete

information regarding medical history or medication consumption. [45]

In order to evaluate the tolerability of prescriptions given on discharge from the ED, it was

observed that higher-acuity patients are more often admitted to hospital, evaluated serially

by nurses, physicians and pharmacists for the development of ADREs, and tend to receive

closer follow-up after discharge from the hospital or ED. In comparison, lower-acuity

patients are more likely to be discharged from the ED without specific follow-up plans or

monitoring in place for ADREs, even though they commonly receive prescriptions on

discharge from the ED. The underlying assumption that these patients do not run into

significant problems with medications prescribed on discharge from the ED has not been

tested. [45]

In Australia, medication administration errors are common when patients are discharged

from hospital to a residential care facility (RCF). This usually happens because it is

compulsory that the primary treating provider needs to attend to the RCF at short notice

just by documenting on a medication administration chart. If the doctor cannot attend,

doses may be missed or 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


30

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 hospital-

based 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


31

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 system-

related and cognitive aspects to diagnostic error. The causes of diagnostic errors involved

cognitive causes in 28% of the cases, the context or the system in 19%, and mixed causes

in 46%. Thus, cognitive factors, that is, how doctors think, were involved in almost 75% of

the cases. This reinforces the importance of understanding physicians’ thinking, decision-

making, 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


32

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 self-

awareness of medical providers, training in medical education, and external support. [93]

There must be effective ways to reduce diagnostic errors. Certain conditions must be

fulfilled to increase the chance that such interventions bring some change, and these are

the following: [93]


33

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


34

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


35

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]


36

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


37

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


38

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.


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.


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


39

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


40

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, time-

limited 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,


41

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


42

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,


43

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


44

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 order-

management 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


45

(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 adverse-

event detection system as an efficient and effective method to identify hypoglycemia in

hospitalized children. Hypoglycemia is a common adverse event in pediatric inpatients.

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


46

optimize ease of use and special functionalities for particular groups of users and particular

subspecialties. Based on some experiences and the lessons learned in the course of

maintaining full-EMR systems, some researchers have suggested that the key goals to be

considered for future EMR system development include the following: innovative new user-

interface technologies, special extended functions for each user group's specific task-

oriented 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]


47

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


48

errors. They report that even direct observational studies, which are highly labor intensive,

often miss errors. An alternative approach that is prospective, rather than retrospective,

and encourages involvement of all team members for identifying and prioritizing safety and

quality problems invokes Failure Modes and Effects Analysis (FMEA). This has been widely

used in other high-risk industries and has been advocated by the IOM9 as a means of

analyzing a system to identify its weaknesses (“Failure Modes”), possible consequences of

failure (“Effects”), and to prioritize areas for improvement. Some have adapted and tailored

this methodology to allow for levels of resources and expertise available in ambulatory

settings, and developed an instrument that has been shown to be effective in a variety of

these settings. The details of the rationale and processes behind this instrument termed

‘‘Safety Enhancement and Monitoring Instrument that is Patient Centered” (SEMI-P) are

described elsewhere. [35]

It is important to know that a vital step toward creating a strong safe medical model is to

close the medical provider divide so as to maintain communication and coordination. This

has drawn attention to the fact that currently practice meetings are “universally unpopular”

despite their indispensability. The medical model that invokes a paradigm of complex

adaptive systems is designed to aid formation of central “attractors” in the form of self-

empowered effective learning teams, with a common vision to help their complex

microsystems adapt. Thriving systems are endowed with simple rules, shared vision, and

opportunities for team members to innovate. [35]

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.


49

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


50

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.


51

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 incomplete reporting and

underreporting of identifiable medical errors;

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


52

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 hand-

offs, including systems to support information transfer and continuity of care when

members of the health team cannot meet face to face.

Research also is needed to study the decision-making models and algorithms that underlie

the hand-off and how these could be better understood and taught to promote safe care

during end-off-shift hand offs and facility transfers. Related work includes efforts to enhance

the salience of information in hand-offs through the use of three heuristics—“reduce, reveal

and focus,” with this approach based on naturalistic approaches to enhance decision-

making. Such research also may benefit the design of future 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


53

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 design principles to create more accessible and

comprehensible alerts.

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.


54

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]


55

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