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Patient Safety and Medical Errors:
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DOI: 10.4018/978-1-5225-2337-6.ch003
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DOI: 10.4018/978-1-5225-2337-6.ch003
Chapter 3
61 
Patient Safety and 
Medical Errors:
Building Safer Healthcare 
Systems for Better Care
ABSTRACT
Patient Safety is considered to be the most important parameter of quality that every 
contemporary healthcare system should be aiming at. The terms “Patient Safety” 
and “Medical Errors” are directly linked to the “Safety Culture and Climate” in 
every organization. It is widely accepted that medical errors constitute an index 
of insufficient safety and are defined as any unintentional event that diminishes or 
could diminish the level of patient safety. This chapter indicates that a beneficial 
safety culture is essential to enhance and assure patient safety. Furthermore, health 
care staff with a positive safety culture is more probable to learn openly and suc-
cessfully from errors and injuries.
Vasiliki Kapaki
University of Peloponnese, Greece
Kyriakos Souliotis
University of Peloponnese, Greece
Patient Safety and Medical Errors
62
INTRODUCTION
The adverse events in healthcare constitute a major issue of global interest since 
they could be traced in the healthcare systems of every country regardless of their 
level of development. Worldwide, millions of patients suffer or get injured and die 
annually due to the provision of unsafe care and treatment. Hospital infections, 
inadequate diagnosis, delays in treatment, adverse drug events and omissions of 
surgical procedures make up the most common root causes of medical errors or 
adverse events that may be avoided.
Donabedian (1980) suggested the evaluation of healthcare quality and linked it 
directly to the patient safety. Moreover, he suggested that the assessment of quality 
should be applied according to the structure (resources and administration), the pro-
cess (culture and professional co-operation) and outcome (competence development 
and goal achievement). Twenty years after the Donabedian’s model, the managers 
of healthcare services adopted the principles of Total Quality Management (TQM) 
from Deming’s work. TQM promotes not only the team spirit and the coordination 
but also the clarification of the procedures, the commitment to the goals of the or-
ganization and the change, ultimately aiming at the constant pursuit and assurance 
of quality services. In healthcare, the Continuous Quality Improvement (CQI) has 
been considered as interdependent with the integrated implementation of a program 
which is based on a trustworthy risk management policy aimed at minimizing the 
chances of further instance of a preventable medical error (Donabedian, 1980). 
According to McFadden, Stock and Gowen (2014) although CQI initiatives are 
extremely associated with improved process quality, they are also connected with 
higher hospital-acquired condition rates, a measure of patient safety (McFadden, 
Stock, & Gowen, 2014).
Within the discussion framework about medical error prevention, European and 
non-European Organizations keep talking about methods and tools, which will effec-
tively contribute to the assurance of a safe and high quality healthcare environment. 
According to Nix, Coopey and Clancy (2006) the quality tools include websites, 
protocols, data bases, newsletters, guidelines and other mechanisms in order to help 
healthcare professionals, legislators in the healthcare sector and patients to create, 
promote and cultivate quality conditions in healthcare organizations or in their daily 
lives. The significance of the above methods in CQI and patient safety is obvious 
(Nix, Coopey, & Clancy, 2006).
The main objectives of this chapter are first of all, the discription of “safety” as 
a parameter of healthcare quality as well as the categorization of concepts regard-
ing the “patient safety”. Secondly, the clarification of the terms “patient safety 
Patient Safety and Medical Errors
63
culture” and “patient safety climate”, revealing the relation between them as well 
as the role of “patient safety culture” in the analysis of medical errors and adverse 
events and the presentation of the parameters linked to it. Finally, the authors give 
prominence to the importance of “safety culture” evaluation within the healthcare 
units and clearly present the methods of research for the evaluation of “Patient Safety 
Culture”, which are internationally used.
BACKGROUND
Research by Cameron and Quain (2011) and Talbot (2008) argued that the term 
of “safety” is mentioned to the degree to which organizations provide the required 
responsibility to meet the demands of
1. The citizens’ satisfaction,
2. The justice in employment, and
3. The implementation of standards and controls, through bureaucratic procedures 
(Cameron & Quain, 2011; Talbot, 2008).
Patient safety, as a term, appearsfor the first time in literature in 1960 (Lauter-
stein & Mustoe, 1960). However, the systematic study of this acceptation has started 
the last two decades. Legido – Quigley et al. (2008) argued that patient safety is 
traditionally considered one of the aspects of high quality healthcare environment 
just as the efficiency, the effectiveness, the accessibility, the equality, the patients 
satisfaction, the improvement of the health and wellbeing, the continuation of the 
provided care, the adequacy and the acceptance of healthcare on an individual and 
social level (Legido – Quigley et al., 2008).
According to Rice (2003) “safe care”, from one hand, is the care that is provided 
without errors and omissions, which have negative impact on the patients’ wellbe-
ing and has objective parameters. On the other hand, quality healthcare expresses 
perfection and is subjective naturally (Rice, 2003).
National Patient Safety Foundation (NPSF) in the United States determines the 
patient safety as the avoidance, the prevention, and the improvement of unfortunate 
events or and personal injuries during healthcare provision. Brewer and Colditz (1999) 
claimed that the acceptation of safety is relevant and suggest that the acceptance 
of an unfortunate event depends on the severity of the disease and the availability 
of alternative therapies (Brewer & Colditz, 1999). In the report which was entitled 
“To err is human: Building a Safer Health System” and was published in 2000 by 
Patient Safety and Medical Errors
64
The Institute of Medicine (IOM) the patient safety is defined as the exemption 
from the risk of accidental injury during healthcare provision (Homsted, 2000). 
The assurance of patient safety entails the development of functional systems and 
procedures which minimize the possibility of error and increase the possibility of 
its prevention when this occurs. The above interpretation of “patient safety” has 
been adopted by Agency for Healthcare Research and Quality (AHRQ) and World 
Health Organization (WHO).
Furthermore, relevant definition has been attributed to patient safety, by Card 
(2014) according to which, patient safety is the freedom from accidental injuries, 
throughout healthcare provision, and the activities that are carried out for the avoid-
ance, prevention or correction of the adverse outcomes, which may result from the 
healthcare provision (Card, 2014). Spath (2000) argued that patient safety refers to 
actions undertaken by individuals and organizations to protect health care recipients 
from being harmed by the effects of health care services (Spath, 2000).
The acceptation of patient safety is also included in the dictionary of the European 
Society for Quality in Healthcare, ESQH as the constant recognition, analysis and 
management of risks and events related to the patients, in order to make healthcare 
provision safer and minimize the harm which is caused to patients. Safety is the 
result of the interaction between the additional parts and the procedures of the system 
(Kristensen, Bartels, Sabroe & Mainz, 2014; Kristensen, Mainz & Bartels, 2007).
In any case, the signification of patient safety is much wider than the simple 
absence of errors and adverse events, throughout the healthcare provision. As an 
acceptation, it is multidimensional, and taking into consideration that, the health 
sector is defined by the increased complexity and risk. In addition, the solutions of 
patient safety problems could be found in the broader environment of the healthcare 
system. It should be underlined that patient safety constitutes a set of procedures 
which express, evaluate, minimize the dangers and are constantly improved. The 
result could be presented by less medical errors and limited risks (Homsted, 2000).
The term of safety culture was used for the first time in 1987 by the Nuclear 
Agency, concerning the accident that happened in Chernobyl in 1986. In the re-
port of International Nuclear Safety Advisory Group (2001) the safety culture is 
described as following:
Safety culture is defined as the set of characteristics and attitudes which determines 
that safety issues of nuclear plants are of paramount significance and that safety 
should be getting the appropriate attention, due to its significance, so much for 
individuals as well as for organizations. 
Patient Safety and Medical Errors
65
This meaning was entered in order to explain the way by which the luck of knowl-
edge and understanding of risk and safety so much on the side of the employees as 
much as on the side of the organizations as a whole, contributed to the result of the 
destruction (International Nuclear Safety Advisory Group, 2001, p.4). In addition, 
according to the Advisory Committee on the Safety of Nuclear Facilities, “safety 
culture” is defined as
the result of individual and collective values, attitudes, views, abilities and patterns 
of behavior, which determines the level of commitment, the style and the effective-
ness of the organizations and risk management (ACSNI, 1993, p.15).
In health sector, a widely known definition which refers to “safety culture” is 
the one which was developed by the Health and Safety Executive (HSE) in UK and 
describes it as “the product of collective and individual values, mindsets, abilities 
and attitudes which determine the devotion, the style and the experience of organiza-
tions’ Health and Safety Management system” (Human Engineering for the Health 
and Safety Executive, 2005, pp.3-4).
The above mentioned definitions are among the dominant and the most used ones 
that could be found in literature. Although, many studies, regarding the perception 
of safety culture, have been carried out, no unanimity in a common definition has 
been achieved.
As a consequence, the term “safety culture” having achieved international use 
in the previous decade, is generally used to describe a corporate culture, which the 
safety has become perceptible and accessible as the main priority. In the light of this 
evidence, it is clear that “safety culture” constitutes a subset of the overall organiza-
tional culture. This means that safety performance in organizations is significantly 
influenced by the parameters of management, which are traditionally not approached 
as “part of the safety” (Institution of Engineering and Technology, 2009).
From 1980 and on, there is a variety of researches on the issues regarding culture 
of safety, but as it has already been mentioned previously, the “concept” remains 
“indistinctly defined” to a great extent. There are, however, some common character-
istics, which can be recognized in most of the terms. These common characteristics, 
which are linked to safety culture, incorporate the concepts of beliefs, values, and 
attitudes shared by a group of people. Glendon, Clarke and Mckenna (2006) pointed 
out that a number of terms regarding safety culture depend on the views, shared by 
the members of a team within organizations or the social environment. Therefore it 
becomes obvious that there is a trend to express safety culture in terms of mindsets 
and attitudes. Moreover they highlight the fact that in the attempt to define culture 
of safety, the intention of some researchers focuses on mindsets whereas others 
Patient Safety and Medical Errors
66
emphasize on the culture of safety through attitudes and working activities. In their 
point of view, the culture of safety in organizations serves as a guide regarding the 
way that employees shall behave within the work environment. The attitudes of the 
employees are influenced or/and defined by which number of them is accepted and 
rewarded at the same time. Therefore it is important to define the organizations’ 
perception of culture safety, since it constitutes the most decisive factor of human 
performance and organizational safety (Glendon, Clarke & Mckenna 2006).
On the other side, the acceptation of “safety climate” has been widely researched 
over the lastdecades in the industries in order to prevent unsafe attitudes and to 
ascertain the incidence of injuries and accidents (Sexton et al., 2011). The term 
“safety climate” was used for the first time by Zohar (1980) in his attempt to have 
described the perceptions of the employees on the value and the role of safety in 
their organizations. To be more precise, Huang, Chen and Grosch (2010) and Zohar 
(1980) argued that “the safety climate” states the perceptions of the employees on 
the policies, the procedures and the practices applied in the organizations, as they 
are linked to the value, the significance and the real priority of safety within the 
organizations (Huang, Chen & Grosch 2010; Zohar, 1980). Furthermore, according 
to Pronovost et al. (2003) “safety climate” refers to the characteristics of “safety cul-
ture” which are distinguished for the attitudes and the perceptions of the employees 
at a given time. It is considered that it is an indicator of the dominant safety culture 
by a working group or generally organizations. It includes factors which are related 
to the powerful and preventive commitment to “patient safety”. The term “power-
ful” includes the way in which issues of “patient safety” and “adverse events” are 
being mentioned, managed and treated whereas the term “commitment” relates to 
the attitudes of the executives in organizations towards “patient safety” (Pronovost 
et al., 2003). In other words, Blegen, Pepper and Rosse (2005) claimed that the 
“safety climate” refers to the perceptions of the personnel regarding the protection 
of patients from medical errors and injuries, occurring during the healthcare provi-
sion and at the work environment (Blegen, Pepper & Rosse 2005).
Strong commitments of the executives within the organizations suggest an inte-
gral part of the agency’s safety. Edmondson (2004) argued that in “positive safety 
climate”, the agencies are mainly guided by the commitment to “patient safety” and 
the improvement of quality more than by other issues of the organizations such as 
budgets (Edmondson, 2004).
Niskanen defined “safety climate” as the “set of attitudes that may be perceived 
for a specific task within organizations, which may arise from policies and practices 
that same organizations impose on the employees and their superiors” (as cited in 
Guldenmund, 2000, pp. 227 - 229). Research by Olsson, Forsberg and Bjerså (2016) 
shows recent knowledge regarding the safety climate and willingness to put into 
effect evidence-based practice and person centered care in general surgical wards in 
Patient Safety and Medical Errors
67
university hospitals and points out significant connections between the above two 
areas. The inferred safety climate is extremely related to evidence-based practice 
and person centered care. While registered nurses for the most part reported af-
firmative job satisfaction and a worthy team work culture in their units, there were 
signs that betterments in organizational management are needed (Olsson, Forsberg, 
& Bjerså, 2016).
According to Ginsburg and Gilin Oore (2016) organizations or units wishing to 
acquire a view of their safety climate(s) will have a much more complete picture if 
they investigate both the level and the strength of climate scores, and consider also 
the shape of units’ climate profiles. Examining a unit’s mean score (ie, level), the 
standard deviation of the climate score and a simple histogram of the scores can 
provide this comprehensive picture. Focusing on patient safety culture level and 
strength can also further knowledge of the extent to which patient safety culture is 
a key variable in the domain of PS (Ginsburg & Gilin Oore, 2016).
Yule (2003) highlighted the fact that, the definitions of “safety climate” were 
directly related to the definitions of “safety culture” (Yule, 2003). Guldenmund 
(2000) recognized common points in both of these definitions (Guldenmund, 2000). 
However, there are some important differences to be distinguished since “safety 
culture” refers more to subjectively common beliefs, values and attitudes towards 
employment and the organizations in general, whereas the “safety climate” is closer 
to the operations of the organizations. Specifically it is characterized by the casual 
beliefs in relation to the work environment, the working practices, the policies of 
the organizations and the administrative activities.
Safety as Priority for Organizations
As the more ardent proponents of safety and CQI are the managers and the leaders, 
as higher is the level of the employees’ commitment, which has a positive influ-
ence on the performance of the employees and the prevention of errors and adverse 
events. The tangible commitment includes the provision of sufficient human and 
financial resources in a constant effort towards the direction of safety and quality. 
Researches by Cooper (2000) and Leape (2000) illustrated that the desired behaviors 
are often developed through the assimilation of the observed behaviors of others 
and the body of suggestions which provide almost imperceptible messages for the 
acceptance of the particular behaviors (Cooper, 2000; Leape, 2000).
Additionally, it is necessary to redefine the acceptation of the one “accountable” 
and the one “responsible” therefore significantly limiting the punitive aspect of errors. 
What is a contradiction in terms of the adoption of such an approach is that every 
member of organizations undertakes even bigger responsibility as to safety. Accord-
ing to Leape (2000) it was a fact that there must be no delay in demonstrating who 
Patient Safety and Medical Errors
68
was responsible for the errors and this burden should be equally allocated among 
the employees, who must be alert in order to trace and report any imperfections of 
the system, which create unsafe conditions and work together for the improvement 
of the procedures and the prevention of errors and adverse events (Leape, 2000).
Taking everything into account, both safety and quality could not be treated as a 
supplementary process to the strategic decisions but they should constitute a priority 
and have a central role in every level of the organizations.
Classification of the Concepts in Relation to Patient Safety
There are many definitions in literature, regarding patient safety, which bear many 
similarities but also important differences, as it has already been mentioned. Their 
differentiation is not always obvious and distinct. Simultaneously, there is also a 
practical difficulty regarding the classification of adverse events and the determi-
nation of the indexes for the measuring of the safety. Taking under consideration 
the above mentioned difficulties, it was deemed necessary to create the third axis 
in relation to the activities of a “World Alliance for Patient Safety”, which is titled 
“Taxonomy for patient safety” (WHO, 2005a). Efforts of equal importance have been 
scheduled and realized apart from WHO and AHRQ, also by ESQH which has a 
guiding role in the program “Safety improvement for Patients in Europe, SimPatIE” 
which is funded by the European Union.
In autumn of 2003, WHO Working Group on Patient Safety Taxonomy was 
held in Geneva, firstly in order to discuss the need to adopt a common terminology 
for everything related to patient safety, secondly to present the various definitions 
regarding patient safety and thirdly to help the classification methods of adverse 
events and near misses among various countries become known. Last but not least, 
the development of a common classification framework for patient safety is among 
the main objectives of the specific working group. In this meeting it was also sug-
gested to create three working groups, in order to initiate the implementation of the 
above mentioned goals (WHO, 2003).
One of the six goals of World Alliance for Patient Safety of WHO, was the real-
ization of a program for International Patient Safety Event Taxonomy, based on thework which has already been realized by the above mentioned working group. The 
first meeting took place in Vancouver in 2005, in order to set the goals and the im-
portance of classification and strategic planning for its development (WHO, 2005b).
Within the same year, a literature review by WHO (2005) for the years 2003 - 
2005 was published regarding the taxonomies which were related to patient safety. 
Seventeen classifications were found in the review, eleven of which were carried out 
for specific issues related to patient safety, such as diagnosis, laboratory test results 
Patient Safety and Medical Errors
69
etc. and the other six were specifically carried out to be used along with adverse 
effects reporting systems (WHO, 2005a).
Two years later in 2007, WHO published the Conceptual Framework for the 
International Classification for Patient Safety (ICPS) (WHO, 2007). This report, 
apart from the framework analysis, included a set of definitions for 46 terms, which 
were related to the framework and the patient safety. The terms were the following: 
classification, concept, class, semantic relationship, patient, healthcare, health, safety, 
hazard, circumstance, event, agent, patient safety, health-care associated harm, patient 
safety incident, error, violation, risk, adverse event, harm, disease, injury, suffer-
ing, disability, near-miss, contributing factor, incident type, patient characteristics, 
attributes, incident characteristics, adverse reaction, side effect, preventable, detec-
tion, mitigating factor, patient outcome, degree of harm, organizational outcome, 
ameliorating action, actions taken to reduce risk, resilience, accountable, quality, 
system failure, system improvement, root cause analysis (WHO, 2007).
Kristensen, Mainz and Bartels (2007) claimed that the SimPatIE program of the 
European Union entails the completion of a vocabulary which includes twenty four 
terms related to the acceptation of patient safety. The purpose of its development is 
multiple: (a) to determine the basic terms and acceptation related to patient safety, 
(b) to facilitate communication and understanding in the whole Europe, (c) to make 
sure that these are easily understandable even by people who are not native English 
speakers (d) to take under consideration the various European views regarding the 
different cultures. The grouping of the above mentioned terms becomes as follows 
(Kristensen, Mainz &Bartels, 2007):
1. Detection Risk:
a. Patient Safety,
b. Adverse Event,
c. Actual Event,
d. Near Miss,
e. Complication,
f. Sentinel Event,
g. Critical Incident,
h. Complaint,
i. Reporting System, and
j. Professional Standard.
2. Analysis of Risk:
a. Harm,
b. Adverse Outcome,
c. Risk,
d. Calculated Risk,
Patient Safety and Medical Errors
70
e. Barrier, and
f. Situational Awareness.
3. Resulting Actions:
a. Risk Management,
b. Error Management,
c. Action Plan,
d. Culture of Safety, and
e. Human Factor.
4. Failure Mode:
a. Negligence,
b. Situational Factor, and
c. Error.
Another classification which is just as useful and effective for the estimation of 
patient safety, is the one that related to quantitative indicators, part of which are also 
the various kinds of errors. In 2006, OECD published a relevant technical text which 
included twenty one measurable indicators for patient safety which are presented 
below (McLoughlin et al., 2006):
1. Hospital – Acquired Infections:
a. Ventilator pneumonia,
b. Wound infection,
c. Infection due to medical care, and
d. Decubitus ulcer.
2. Operative and Post-Operative Complications:
a. Complications of anesthesia,
b. Postoperative hip fracture,
c. Postoperative pulmonary embolism (PE) or deep vein thrombosis (DVT),
d. Postoperative sepsis, and
e. Technical difficulty with procedure.
3. Sentinel Events:
a. Transfusion reaction,
b. Wrong blood type,
c. Wrong-site surgery,
d. Foreign body left in during procedure,
e. Medical equipment-related adverse events, and
f. Medication errors.
4. Obstetrics:
a. Birth trauma - injury to neonate,
b. Obstetric trauma – vaginal delivery,
Patient Safety and Medical Errors
71
c. Obstetric trauma - caesarean section, and
d. Problems with childbirth.
5. Other Care-Related Adverse Events:
a. Patient falls, and
b. In-hospital hip fracture or fall.
The first results of part of SimPatIE program were published in 2007. The primary 
goal of SimPatIE, was the development of a set of patient safety indicators. Kris-
tensen, Mainz and Bartels (2007) claimed that forty two indicators were registered, 
twenty nine of which were classified in the following thematic subsections: infection 
control, surgical implications, pharmaceutical errors, topics of obstetrics, patient 
falls. The other nine were general indicators regarding the operation of organizations 
such as, mortality rates and the other four concerned specialized diseases such as the 
risk of suicide for schizophrenic patients etc (Kristensen, Mainz & Bartels, 2007).
Simultaneously AHRQ (2007) has published a list with ten exhortations for 
patient safety in hospitals, which is being constantly updated. These exhortations 
with direct practical implementation aim at minimizing the adverse events, so as 
to insure the maximum level of patient safety. These exhortations are the following 
(AHQR, 2007):
1. Evaluate and improve the patient safety culture in your hospital.
2. Cultivate the team spirit and create constructive partnerships.
3. Limit the shifts of the personnel as much as possible.
4. Place tubes in the chest safely.
5. Prevent the occurrence of hospital infections
6. Utilize appropriately the department directors and particularly of ICU.
7. Use credible tools which support the clinical decision making.
8. Create an adverse events reporting system.
9. Minimize the use of urinary catheters to three days.
10. Minimize the unnecessary interruptions of health care professionals during 
the performance of their tasks.
The Role of Safety Culture in the Expansion of the Accidents
Over time special value has been given to the causes of professional accidents and 
the research in high risk industries has contributed a lot to the understanding of the 
impact of the systems and the human factors to the organizational safety. At this 
point, the reference to new theoretical approaches for human errors, which arose 
from the research studies of the accidents, is important.
Patient Safety and Medical Errors
72
According to the Systems Theory, the majority of errors are not caused by neg-
ligence or inability but by the vulnerabilities of the systems, rendering the work 
environment prone to errors. Latent conditions arise from insufficiencies or defects 
in organizational functions, such as the development of policies and protocols, 
budgets, employment, equipment maintenance and process management. Such 
insufficiencies are possible to create working conditions which cause the human 
tendency to errors and additionally they challenge the limits of human efficiency 
(as cited in Reason, 1990).
According to Reason (1990) “The Human Factors Theory” is based on the fol-
lowing principle: “the change of human nature is not possible, but what is possible 
is the change of the conditions within which humans work.” The relation of “Human 
Factors Theory” with the development of “safety culture” is based on 3 principles 
guiding the systems design as follows:
1. Prevention of errors by designing such systems, which eliminate the predict-
able human weaknesses, making it harder to make an error.
2. Not concealing errors aiming at their management.
3. The development of methods which moderate the consequences of the errors 
upon their occurrence (Reason, 1990).
The Characteristics of Positive Safety Culture
Many publications aim at the examination of specific management policies, which 
serve as a prediction for safety efficiency. Reason (1998) argued that
the ideal culture of safetyconstitutes an “engine” that guides the system through 
the achievement of the goal of maintaining the highest possible resistance against 
the corporate risks.
The researcher himself also believes that in periods of adequate safety efficiency, 
the best way to remain cautious is to “collect the appropriate information.” That 
means that it is necessary to create a culture of information and communication 
in general within the work environment. A culture of communication requires the 
administration on matters of safety to be alert for various factors (for example hu-
man, technical, organizational and environmental), which influence the systems of 
safety (Reason, 1998, p.294).
Ultimately one could say that the organizational culture of safety reflects the 
way in which safety is addressed in the work environment. It is however important 
to note that a safety management system does not simply consist of a set of policies 
and processes on a library shelf, but it is safety management and the way in which 
Patient Safety and Medical Errors
73
the policies and the processes are applied in everyday practice in the work environ-
ment. In addition, the nature of safety management in the work environment (for 
example resources, policies, practices and processes, control etc.) influences the 
culture and the safety climate in organizations.
The findings of a recent study forcefully point out that investing in activities and 
procedures that strengthen organizational learning and enhancing safety climate 
can importantly contribute to increased cognizance about the theme and, as a con-
sequence, make safer processes not only for patients, but for the organization as a 
whole (Silva, Barbosa, Padilha, & Malik, 2016).
Shanon, Mayr and Haines (1997) conducted a review of 10 studies, which exam-
ined the relation between organizational factors and the incidence rate of accidents. 
In their review they included only the studies which made comparisons among at 
least 20 work environments. In order for a variable to considered, firmly associated 
with the accidents rate or relation it should:
1. Be statistically important in the direction of at least the two thirds of the stud-
ies under examination, and
2. Not be significant in the opposite direction in another study. The variables 
which were classified by various organizations were 17.
What was found was that every variable met the criteria of being firmly associated 
with a low incidence rate of accidents. Some of those variables include (Shanon, 
Mayr & Haines 1997):
• The training received by the Committee for Health and Safety.
• The good relation between the administration and the employees.
• The monitoring and the control of unsafe working attitudes.
• The low departure rate of the personnel from the companies / organizations.
• The safety control of the equipment.
There is also a level of agreement as to which practices of safety management 
are considered ideal. Mearns, Whitaker and Flin (2003) reassured that some issues 
of general interest which emerge from literature are for example (Mearns, Whitaker 
& Flin 2003):
• The commitment of management to safety, which includes:
 ◦ The priority of safety in the phase of production.
• The maintenance of safety’s high profile in the conferences:
 ◦ Personal participation of the owners in the conferences regarding safety.
 ◦ Particular descriptions of job positions which also include safety terms.
Patient Safety and Medical Errors
74
• The communication on safety issues also including among others:
 ◦ Channels of official and unofficial communication.
 ◦ Regular communication between the administration, the auditors and 
the human resources.
• The involvement of employees includes:
 ◦ Strengthening/Authorization.
 ◦ A Delegation responsible for safety.
 ◦ Encouragement for commitment to the organizations.
At this point, it is also important to mention that the nature and the number of 
accidents, which have occurred as a result of insufficient safety management, led 
to the development of inspection tools which make sure that these management 
practices are ultimately successful. Mearns et al. (2003) argued that the evaluation of 
these practices contributes to the estimation of a safety climate (Mearns et al., 2003).
Finally, Reason (1998) claimed that organizational culture cannot be instantly 
created, but it is developed over time. The safety culture of organizations is a result 
of the between the working environment, the human resources, the health practices, 
the safety and the leadership (Reason, 1998).
The Parameters Linked to the “Patient Safety Culture”
The safety culture in the healthcare sector is influenced by various factors, which 
are mentioned as factors or parameters with specific characteristics. These factors 
are linked to the leadership, the work environment, the personnel and the safety 
factors and constitute additional parameters of “safety culture”.
Kristensen et al. (2015) supported that more clinical leaders than frontline clini-
cians have a positive sensory awareness of teamwork and safety climate (Kristensen 
et al., 2015). Moreover, Moutier et al. (2016) claim that in order to improve a culture 
of respect in the learning environment, institutions can successfully involve academic 
leaders and ability at all levels to give attention to disruptive behavior and improve 
affirmative climate factors (Moutier et al., 2016).
According to the research of Sammer, Lykens, Singh, Mains and Lackan (2010) 
the above parameters were leadership, team work, the integration of knowledge based 
on evidence, communication, the organizations that learn from its mistakes, the ac-
countability of the system and not individuals for the errors as well as the heath care 
focused on the patient (Sammer, Lykens, Singh, Mains, & Lackan, 2010). Similar 
results were also shown in the research of El-Jardali, Dimassi, Jamal, Jaafar and 
Hemadeh (2011) according to which the factors which contribute to the achievement 
of a “positive culture of safety” are the report of adverse events and the non-punitive 
reaction to errors, the appropriate communication, the commitment of leadership 
Patient Safety and Medical Errors
75
and management to the development of a safety culture, the sufficient employment 
and the accreditation of the hospital (El-Jardali, Dimassi, Jamal, Jaafar, & Hemadeh, 
2011). In addition, according to the evaluation tool created by Sorra and Nieva in 
the United States in 2004, “safety culture” is examined through twelve parameters 
which are presented below (Sorra & Nieva, 2004):
• Teamwork Within Units.
• Supervisor/Manager Expectations & Actions Promoting Patient Safety.
• Organizational Learning—Continuous Improvement.
• Management Support for Patient Safety.
• Overall Perceptions of Patient Safety.
• Feedback & Communication About Error.
• Communication Openness.
• Frequency of Events Reported.
• Teamwork Across Units.
• Staffing.
• Handoffs & Transitions.
• No punitive Response to Errors.
The Significance of Safety Culture Evaluation by the Patient
Research by Hellings, Schrooten, Klazinga and Vleugels (2010) illustrated that the 
evaluation of “safety climate” constitutes the first stage in the development of a 
culture of safety, since it constitutes an indication of the level of safety of the orga-
nizations and contributes to the prevention of errors (Hellings, Schrooten, Klazinga 
& Vleugels, 2010). Zohar, Livne, Tenne –Gazit, Admi and Donchin (2007) argued 
that the evaluation of “safety climate” requires its measurement, which is mainly 
carried out by the use of structured questionnaires or interviews. The questionnaires 
are completed anonymously by health professors and their scores are summed up 
for the overall evaluation of safety climate in the organizations and the identifica-
tion of the basic parameters that influence it (Zohar, Livne, Tenne-Gazit, Admi, & 
Donchin, 2007). The evaluation results include the views of theemployees regard-
ing the parameters of safety culture, their wish to report the adverse events and the 
overall score given by them to the departments they work at (Sorra &Nieva, 2004). 
This process shows the level to which patient safety constitutes a priority in the 
organizations and reveals information for the attitude of health care professionals 
towards the errors.
Patient Safety and Medical Errors
76
The benefits from the evaluation of the “safety climate” are many so much on 
an individual as well as an organizational level. Researches by Smits, Wagner, 
Spreeuwenberg, van der Wal and Groenewegen, (2009) and Nieva and Sorra, (2003) 
illustrated that on an individual level, the information of the personnel is enhanced 
from the parameters and the attitudes, which influence the “patient safety”. Simulta-
neously they give feedback regarding the errors and the omissions that occur. On an 
organizational level, the evaluation of a safety climate is required by the international 
accreditation organizations, and it is used as a diagnostic tool for the identification 
of the parameters of “safety culture” which need to be improved. Also, it is used for 
the evaluation of the safety improvement programs, as well as for the comparative 
evaluation of safety climate at the hospital in comparison to other hospitals (Smits, 
Wagner, Spreeuwenberg, van der Wal, & Groenewegen, 2009; Nieva & Sorra, 
2003). Additionally, Neal and Griffin (2004) claimed that it is one of the means 
of improvement of the hospitals credibility, since it contributes to the redesign of 
the existed processes and the correction of the organizational factors, which make 
health professionals more prone to errors (Neal & Griffin, 2004).
Sources of “Patient Safety Culture” Evaluation Tools
In December of 2003, AHRQ developed a webpage, which hosts the quality tools 
for health. This webpage was established as a data base, and a web portal about 
practices and ready for use tools for the evaluation, measurement, promotion and 
improvement of health care quality in America. This service aims at providing the 
health care providers, the political leadership of every Ministry of Health, the patients 
– consumers of health services and the researchers an accessible mechanism, which 
can provide suggestions, initiations and principles for the improvement of quality, 
improve medical treatment provision and receipt, help the decisions, regarding 
medical treatment, and train each of the customers separately regarding the needs 
of healthcare (Nix et al., 2006).
Quality Tools include summaries of tools, which constitute an easy to use 
mechanism for obtaining standardized information on tools, while at the same time 
they include external links for other websites dedicated to each tool separately (Nix 
et al., 2006).
Patient Safety and Medical Errors
77
National Guideline Clearinghouse
National Guideline Clearinghouse (NGC,www.guideline.gov) of AHRQ, the online 
repository of practical guides, based on evidences which were created on 1998, con-
stitutes an additional source of tools. Although Quality Tools and NGC are similar 
websites, one of the criteria of Quality Tools is that the tool must be accessible from 
the internet, which does not apply for NGC. Therefore, the nursing stuff can find 
tools in NGC which are not available in Quality Tools. The tools, which are available 
in NGC have been developed in combination with the instructions in order to help 
health care providers (nurses, doctors, hospitals) implement them. NGC includes 
more than 1.500 tools accompanied by instructions. Clinical algorithms, pocket 
guides and short helping guides constitute more than the 2/3 of the total number of 
tools. Most of those in charge for the creation and the development of guidelines and 
the relevant tools, usually develop more than 1 tools. Just like Quality Tools, NGC 
is updated every week with new improved tools and guidelines (Nix et al., 2006).
Patient Safety Network
The tools, which were developed for use in program related to patient safety, 
may be downloaded from the webpage Patient Safety Network» of AHRQ PSNet 
(http://psnet.ahrq.gov/). This webpage constitutes a portal of paramount value for 
the improvement of patient safety and the prevention of medical errors, whereas 
it also constitutes the first overall effort, in order to enlight health care providers, 
managers, and consumers – patients on every aspect of patient safety. The webpage 
includes summaries of tools and research findings on patient safety, information 
regarding oncoming meetings and conferences as well as links with articles, books 
and references. The following type of tools along with their available number are 
among the categories in this page: 23 audiovisual means, 108 books/references, 8 
clinical guiding instructions and 154 web pages, which include links to courses of 
study / curriculums, data bases, forums and government WebPages (Nix et al., 2006).
Modification of Federal Tools
In addition, federally funded guidelines and tools are provided by the public sector, 
which means that they can be used without the acquisition of relevant permission, 
that subjects to copyright law. Some of them, however, are likely to include particu-
lar tables or content, which subject to copyright restrictions. In the event that the 
authors maintain the copyright of their product, they must grand their permission 
for the use of their material or ask for a monetary exchange. Every page refers to its 
Patient Safety and Medical Errors
78
requirements for downloading and using its tools, and to what extend a copyright 
license is required (Nix et al., 2006).
Research Tools for the Evaluation of Patient Safety Culture
Research by Sexton et al. (2006) illustrated that the initial efforts for the evaluation 
and the improvement of “safety culture” and later the more clearly defined role of 
“patient safety” are facilitated by the measurements regarding safety culture. By 
determining the characteristics of organizations, which are negative for the clients 
and perhaps they are linked to safety, the supervisors have the ability to intervene 
so as to improve the quality of healthcare (Sexton et al., 2006).
Moreover Sexton et al. (2006) argued that the existed tools for the evaluation 
of patient safety culture are many, whereas there are few references in literature, 
which provide guidance to the users or the researchers regarding the selection of 
research tools or initiations in relation to measurements for the improvement of 
safety (Sexton et al., 2006).
The variety of tools are confirmed by the results of the extended literature review, 
which was carried out by EUNetPas (2009), 24 patient safety culture evaluation tools 
were identified and used immediately within and outside the European Union and 
they are the following (EUNeTPaS, 2009):
• Checklist for Assessing Institutional Resilience.
• Culture of Safety Survey.
• Danish Patient Safety Culture Questionnaire.
• Error Orientation Questionnaire.
• Hospital Culture Questionnaire.
• Hospital Survey on Patient Safety.
• Hospital Survey on Patient Safety Culture.
• Manchester Patient Safety Assessment Framework.
• Nursing Unit Cultural Assessment Instrument.
• Patient Safety Climate in Aesthesia.
• Patient Safety Culture Questionnaire.
• Patient Safety Culture in Healthcare Organizations Survey.
• Safety Attitudes Questionnaire.
• Safety Climate Assessment Tool.
• Safety Climate Scale.
• Safety Climate Survey.
• Stanford Safety Culture Instrument.
• Teamwork and Patient Safety Attitudes Questionnaire.
• Trainee Supplemental Survey.
Patient Safety and Medical Errors
79
• TUKU – Safety Culture in Health Care Survey.
• Veteran Affairs Palo Alto / Stanford Patient Safety Center for Inquiry.
• Veterans Health Administration Patient Safety Culture Questionnaire.
• Vienna Safety Culture Questionnaire.
• World Alliance for Patient Safety Hand Hygiene Campaigns Healthcare - 
UnitsSurvey on Patient Safety Culture.
The majority of these tools have been designed and applied for the evaluation 
of patient safety culture in hospitals, but few of them have been applied to Primary 
Health Care structures, nursing homes and Emergency Departments. According to 
a report which was elaborated and published by EUNetPaS (2009), the tools for the 
assessing of patient safety culture, which are widely used in the European Union 
are the following (EUNeTPaS, 2009):
• Clinical Risk Management:
 ◦ Austria.
• Drug risk perception with respect to NSAIDs:
 ◦ Slovakia.
• Error Orientation Questionnaire:
 ◦ Denmark.
• Healthcare workers’ perception of adverse events and incident reporting:
 ◦ Italy.
• Hospital Survey on Patient Safety Culture:
 ◦ Belgium,
 ◦ United Kingdom (Scotland),
 ◦ Switzerland,
 ◦ Netherlands,
 ◦ Italy,
 ◦ Spain,
 ◦ Croatia,
 ◦ Sweden,
 ◦ Iceland,
 ◦ France,
 ◦ Norway, and
 ◦ Finland.
• Information System for Surveillance and Control of Adverse Events:
 ◦ Spain.
• Manchester Patient Safety Assessment Framework:
 ◦ United Kingdom,
 ◦ Germany, and
Patient Safety and Medical Errors
80
 ◦ Netherlands.
• Patient perception of safety in health services. CASSES Questionnaire:
 ◦ Spain.
• Patient safety care in healthcare organizations - Quality Standards:
 ◦ Spain.
• Safety Attitudes Questionnaire (different versions):
 ◦ Hungary,
 ◦ Norway,
 ◦ Germany, and
 ◦ United Kingdom.
• Safety Climate Assessment Instrument:
 ◦ United Kingdom by European Federation of Nurses.
• The Danish Patient Safety Culture Questionnaire:
 ◦ Denmark.
• TUKU – Safety culture in health care survey:
 ◦ Finland.
• Vienna Safety Culture Questionnaire:
 ◦ Austria.
• World Alliance for Patient Safety Hand Hygiene Campaigns Healthcare - 
Units Survey on Patient Safety Culture:
 ◦ Portugal.
According to the results of a recent study, important variation and opportunities 
for enhancement in patient safety culture exist across neonatal Intensive Care Unit. 
Significant systematic differences exist between Safety Attitudes Questionnaire and 
Hospital Survey on Patient Safety Culture such that these tools should not be used 
interchangeably (Profit et al., 2015). The above findings are ensured by another 
study which was concluded that there were differences in perception regarding 
patient safety among ICUs, which confirms the existence of local micro cultures. 
The study did not illustrate equality between the Safety Attitudes Questionnaire and 
the Hospital Survey on Patient Safety Culture (Santiago & Turrini, 2015).
The Internal Market Information System (IMI) was developed by the European 
Union, and aims at contributing to patient safety through the prompt and modern 
information exchange among the regulatory nursing bodies, regarding its well-
functioning and the activity of their members. Through the IMI system, the Euro-
pean Federation of Nursing Regulators will improve its electronic database, which 
refers to nurses, so as to allow the national regulatory nursing bodies to exchange 
the information required for the recognition of the educational and professional 
qualifications and skills of the nurses. According to Stievano, Jurado, Rocco and 
Sasso (2009) this process enables the mobility of professionals, and ensures the high 
Patient Safety and Medical Errors
81
quality of nursing care in a smooth and consistent way throughout the European 
Union (Stievano, Jurado, Rocco, & Sasso, 2009).
In 2004, the head of patient safety at the Health Service of the University of 
Pennsylvania set up a specific task force which consisted of people responsible for 
the quality and the patient safety at the hospitals-members. This taskforce undertook 
the development of a learning program for those who support this purpose regard-
ing patient safety, so as to take action and develop a program to ensure safety in 
healthcare sector. That is how Delta were brought together with the vision that over 
time patient safety would be integrated in the safety culture of the organizations 
and the attitude of the nursing stuff, eliminating the need for a specific program. 
The role of each member in Delta was to participate in the meetings in order to be 
trained in the theoretical approach and the practice of safety principles, protect the 
patient safety in the work environment and cooperate with their colleagues to find 
ways for the improvement of patient safety (Schwoebel & Creely, 2010).
According to the Institute for Save Medication Practices, insulin, the hormone, 
which controls the blood sugar levels, is often involved in errors which put patients 
at risk. The patients who have gone through severe hypoglycemia are likely to have 
been granted wrong doses, wrong type of insulin or right doses in the wrong time. 
Bass, Will, Todd and Weatherford (2007) supported that In order to be able to 
comprehend how is it possible for all those errors to occur, one has to examine the 
various types of insulin, as well as the available medicine, which enhance insulin 
and additionally the fact that most patients have been subscribed more than one type 
of medicine. In addition, many of those products have similar names and package. 
Therefore, it is only a miracle the fact that even more errors don’t occur (Bass, Will, 
Todd, & Weatherford, 2007).
Bass et al. (2007) suggested the nurses’ familiarization with the new insulin 
therapies, the new methods and the precautions that must be taken, for patient safety. 
Initially it is suggested to develop Table, enumerating the insulin products, which 
are used in the hospital and the time of administration for each. In order to limit the 
confusion, the evolution of the insulin therapy from its older typical form to the most 
recent medication for the enhancement of insulin is recorded. The nurse must also 
confirm the existence of a practical table, so as to control the commencement, the 
peak and the duration of the action of every product before administration, whereas 
it is also suggested that the prescription and the doses are checked by a colleague 
before administering the medication (Bass et al., 2007).
According to the findings of the above French research in some cases, and in 
particular in cases of vulnerable patients with serious problems, the adherence to 
health care protocols is not always sufficient for the prevention of adverse events. 
Taking also under consideration the fact that, they may be found in emergency, their 
situation is not sufficiently covered by clinical guidance. The particular research, 
Patient Safety and Medical Errors
82
with a sample of 8.754 patients in 292 rooms, in 71 hospitals over 35.234 days of 
hospitalization aimed at the estimation of adverse events in medical and surgical 
activity so much in public as well as in private hospitals, whereas it also aimed at the 
evaluation of the clinical condition of the patients and the active errors. The results 
showed that the prevention of adverse events is influenced by the compliance with 
the recommendations on correct practices (Bass, et al., 2007).
Michel, Quenon, Djihoud, Tricaud-Vialle and de Sarasqueta (2007) claimed 
that the complex nature of care as well as the increased use of technology consti-
tutes factors which contribute to the increased risk of patients. Paediatric patients 
represent one of the most vulnerable populations of patients due to age, height, as 
well as their anatomical and natural development and the severity of the injury or 
disease. In addition children offen fail to protect themselves from possible risks and 
therefore they are based on their parents who many not feel sufficiently prepared to 
act on their behalf. These factors underline the need for a coordinated effort for the 
protection of this population from risks (Michel, Quenon, Djihoud, Tricaud-Vialle, 
& de Sarasqueta, 2007).
Moreover the plan of C&W hospital on safety in hospitals, expresss the need to 
develop a culture, which does not use punishment as a meansto remove the stain 
of error and encourage the reporting of errors, allowing the organizations to learn 
from its mistakes and unpredictable events. Verschoor et al. (2007) argued that 
this safety culture is based on trust, which is built on the abolishment of individual 
accountability for the errors, awareness and the cautiousness, open communica-
tion, learning and constant improvement (Verschoor et al., 2007). Notable is the 
contribution of the IHI which has developed methods to facilitate the development 
of safety culture in the hospital.
FUTURE RESEARCH DIRECTIONS
Recognizing the significance of “safety culture” as well as the importance of the 
opinion of healthcare professionals on the issues of safety constitutes dire need since 
they constitute the immediate and main healthcare providers. The assessment of 
safety culture is a process, which may contribute positively to the change of culture 
and signify the beginning of patient safety constant improvement. The combina-
tion of safety culture assessment and safety management is a field that needs to be 
further developed.
Patient Safety and Medical Errors
83
Within the framework of a holistic intervention for the development of “safety 
culture” in hospitals, the three basic determining parameters (scope of work, work 
environment and particular individual characteristics) must be addressed in parallel 
and globally. The important thing is the final result to aim at the most appropriate 
activities for each category of employees and situation. The development of a positive 
safety culture is considered a prerequisite for the prevention of errors and patient 
safety. In the future, the development and use of psychometric tools, especially 
designed for the evaluation of the attitude of healthcare professionals on issues of 
safety for particular group of patients such as psychiatric patients or patients with 
cancer, would be useful since it would contribute generally to the improvement of 
quality of healthcare services.
CONCLUSION
An important body of evidence, points to medical errors as a leading cause of death 
and harm during the healthcare provision. The terms “patient safety” and “medical 
errors” were directly linked to “safety climate” in organizations. “Safety climate” 
in work environment is a complex variable which is influenced by inherent charac-
teristics of health professions (tension – rate, work - stress, experience acquisition, 
type of events) as much as by parameters involving particular work conditions (the 
role of management, team work), and each of the health professionals (satisfaction 
from work, love for the profession).
Finally, patient safety appears to be a sector, which requires immediate action to 
be taken by all parties involved in the provision of health care. Health scientists owe 
to act according to Hippocratic admonition “Do no harm” attempting to adhere to 
all those rules and principles in the exercise of their task, which aim at not just the 
restoration of the patients’ physical and mental health but also to the prevention of 
additional emotional and personal injury.
Patient Safety and Medical Errors
84
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KEY TERMS AND DEFINITIONS
Adverse Events: Any kind of error, mistake, accident, failure or deviation from 
the safe treatment of the patients, whether or not causing harm on them.
Harm: Α negative consequence, whether or not it is obvious to the patient.
Learning: The hospitals learn from their errors and look for new opportunities for 
performance betterment. Learning is valued among a considerable number of staff.
Patient-Centered Care: Patient care is centered around the patients and their 
families. The patients are not only active participants in their own care, but also act 
as an intermediary between the hospital units and the community.
Patient Safety: The avoidance and prevention of patient injuries or adverse 
events that are the result of health care procedures.
Safety Culture: A complicated and enduring characteristic reflecting essential 
values, rules and suppositions.
Teamwork: A spirit of respect and cooperation among colleagues exists among 
executives and personnel. Relationships are unrestricted, secure, respectful and 
flexible.
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	Chapter 3: Patient Safety and Medical Errors