Patient Safety Culture and Health Care Ethics
Skypecker07
Journal of Medical Ethics and History of Medicine
Case Report
Ethical and legal aspects of patient’s safety: a clinical case report
Maliheh Kadivar1, Arpi Manookian2*, Fariba Asghari3, Nikoo Niknafs4, Arash Okazi5,
Asal Zarvani6
1Professor, Division of Neonatology, Department of Pediatrics, Children’s Medical Center, Tehran University of Medical
Sciences, Tehran, Iran. 2Assistant Professor, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran. 3Associate Professor, Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences, Tehran,
Iran. 4Assistant Professor, Division of Neonatology, Department of Pediatrics, Vali-e-Asr Hospital, Tehran University of Medical
Sciences, Tehran, Iran. 5Assistant Professor, Department of Forensic Medicine, Tehran University of Medical Sciences, Tehran, Iran. 6Nursing Student, School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran.
Corresponding Author: Arpi Manookian
Address: School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehran, Iran.
Postal Code: 1419733171.
Email: [email protected] Tel: (+98) 21 61054322
Received: 2 Jul 2017 Accepted: 25 Dec 2017 Published: 30 Dec 2017
J Med Ethics Hist Med, 2017, 10:15
© 2017 Medical Ethics and History of Medicine Research Center, Tehran University of Medical Sciences. All rights reserved.
Abstract
Since patient safety is multidimensional and grounded in ethical and legal imperatives, both ethical and legal challenges should
be taken into account. In this regard, a falling incident case of a 12-day-old newborn was raised in the monthly ethics round in
the Children's Medical Center of Tehran University of Medical Sciences, Iran, and the ethical and legal dimensions of patient
safety were discussed by experts in various fields.
This report presents different aspects of patient safety in terms of root cause analysis (RCA) and risk management, the role of
human resources, the role of professionalism, the necessity of informing the parents (disclosure of medical errors), and forensic
medicine with focus on ethical aspects.
Keywords: Patient safety, Risk management, Ethics, Legislation, Case study
J Med Ethics Hist Med 10: 15, December, 2017 jmehm.tums.ac.ir Maliheh Kadivar et al.
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Introduction According to the non-maleficence principle of
medical ethics, ensuring patients’ safety and
preventing any injury or damage to them is a major
priority for healthcare providers (1). Thus, it has been
the most emphasized component of the quality of
health care services all around the world. The Institute
of Medicine (IOM) released a report in 1999 entitled
"Man is fallible: create a safe health system" in
relation to the incidence of medical errors in United
States, and consequently, initiated widespread
international change in the field of patient safety (2).
Correspondingly, the Iranian health care system
implemented special plans purposed to deliver
standard health care services and prevent any
mistakes and an organized approach to risk
management, systematic deficiency, and patient
safety improvement (3). One of these programs is
clinical governance which was introduced by the
Ministry of Health and Medical Education (MOHME)
and initiated since November 2009. Although great
emphasis has been placed on the importance of
clinical governance by the MOHME, there are some
challenges in achieving the desired outcomes (4). This
could be the result of healthcare providers’ inadequate
understanding about the importance of clinical
governance and lack of organizational safety culture
(5, 6).
Studies showed that a non-negligible percentage of
patients are exposed to health care-related injuries.
Based on World Health Organization (WHO) report,
the possibility of harming patients in the process of
providing health care services is 1 out of 300, whereas
the possibility of aviation accidents is 1 out of
100,000. Since 2004, with the beginning of the patient
safety project, so far 140 countries have attempted to
improve their patients' safety plans in their own health
system (7). The most common cause of injury is
medication errors and falling. Although falling
includes 21% of total incidents, only 4% of them are
serious. Meanwhile the neonatal falling statistics in
the USA is 1.6-4.4 in 10,000 live births, an estimated
600-1600 falling incidents in a year. These cases are
often the result of shortcomings in systems and
processes, organizational complexity and ambiguity,
and poor communication (8, 9).
Despite various patient safety guidelines and
standards, less attention is paid to the ethical and legal
aspects of this issue. From a moral perspective, the
main goal of patient safety in the health system can be
studied from two aspects. It can be studied as a
practical value, in the sense that the main focus is its
positive outcomes and benefits. It can also be studied
as a moral value by focusing on the protection and
promotion of humanity and human dignity. It should
be emphasized that both aspects are important in the
health system. From a professional point of view,
moral values in patient safety are not separated from
basic medical obligations, but are so central that they
may be the source of other moral values emphasized
in medicine. This means that patient safety is closely
related to the concept of human dignity and all patient
safety measures taken must insure the protection of
human’s dignity (10). In other words, the
responsibility of the health care staff and professional
commitment, in general, are closely related to human
dignity (11).
This case was raised in the monthly ethics round in
the Children's Medical Center of Tehran University of
Medical Sciences, Iran, and ethical dimensions of
patient safety were discussed by experts in various
fields. The opinions expressed in this article are a
summary of the views of experts in various fields
including neonatology, medical law, ethics, and
nursing.
It is worth mentioning that the ethics round has been
held every month for more than 5 years in the
Children's Medical Center. A complicated case is
discussed in each session with the presence of
different relevant experts.
The clinical case
A 12-day old newborn infant was hospitalized in the
neonatal intensive care unit (NICU) because of
multiple seizures. He was the first child of the family.
The mother’s and family history was negative for
seizures or any other disease. Seizures were
controlled by medications, and diagnostic
assessments including electroencephalography (EEG)
were ordered. As the infant was stable and had
tolerated breast feeding, it was planned to transfer him
to the level II NICU, but it was postponed due to lack
of available beds.
On the evening shift of the third day of admission, his
nurse heard a sudden noise and noticed that the
incubator door was open and the baby was on the
floor. The in-charge nurse immediately announced the
incident to the on-call physician. The newborn was
examined thoroughly and no physical injuries were
found. Moreover, the incident was reported to the
chief physician of the department and the record of
this incident was immediately sent to the hospital
officials. Later, all other incubators were inspected to
make sure they were secure enough.
When the staff informed the newborn’s father of the
falling, he accused the mother of neglecting the child,
although she had said that she was resting at the time
of the incident.
The questions raised in the meeting were as follows:
What are the factors leading to this incident? How
could this incident been prevented? What is the
responsibility of the staff in dealing with this
incident? Based on professional commitments, what
is the duty of medical and nursing staff in such events?
What are the ethical issues of patient safety in this
case? What are the legal obligations and
consequences of this case?
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Discussion Root cause analysis and risk management
Searching for the causes and finding the right
solution, in other words, the basic analysis of the
incident is one of the initial and essential measures
taken to decrease the incidence of patient injuries. It
should be noted that the mentioned process must be
free of any bias and should focus on finding the main
cause and resolving it instead of identifying the
responsible person. One way of preventing such
events is to have a special guideline for reporting the
event in a suitable organized ethical atmosphere
without accusing anyone. Indeed, fear of blame,
penalties, limited organizational support, inadequate
feedback, and lack of knowledge about the associated
factors are some of the barriers to reporting medical
errors in hospitals (12).
Assessment and reduction of patients’ risk of injury,
or risk management in the clinical setting is
influenced by several factors. One way is the
establishment of an organizational culture based on
mutual trust and effective communication in all
hospital levels (13, 14).
From an ethical perspective, the value of
trustworthiness is a prerequisite of successful risk
management. This value is connected to safety culture
since it refers to physical safety, psychological safety,
and cultural safety. Thus, the managers’ responsibility
is to create mental and physical safety settings based
on openness in order to promote patient safety and
care quality. Furthermore, it is important for the
managers to encourage multidisciplinary
collaboration to facilitate transparent reporting (10).
In this case, the apparent reason was that the incubator
door was left open by someone or was not correctly
closed. Questions raised in this context include the
following: Was the nurse occupied with other
emergency and essential actions? Was the incubator
door latch broken? Why would the nurse forget to
accurately examine the door? Is it possible that lack of
guidelines for patient safety led to this incident?
The most important step to reduce the possibility of
such events in clinical settings is to establish policies
and procedures that work best for each ward.
Furthermore, the continuous training of the personnel
in patient safety, steady supervision, and controlling
the efficacy level of the performed actions are some
other steps that can be taken in this regard. For
instance, in this case, frequent checking of the
incubator door, the use of two locks, and explanation
of safety tips regarding the incubator to the staff are
also important. Furthermore, evaluation and constant
controlling of compliance with patient safety rules,
and feedback are also necessary.
The role of human resources
The quantity of human resources is also noteworthy
in the field of patient safety. In other words, quality
assurance depends on the quantity of manpower.
Therefore, in order to prevent similar incidents,
providing an adequate number of staff at the bedside
is essential (12).
The role of professionalism
Professional ethics and patient safety are intertwined
fundamental concepts in medicine. Patient safety is
grounded in ethical principles which are considered as
care quality indicators (15). The realization of patient
safety requires the provision and implementation of a
professional code of ethics. Based on the Iranian
healthcare professional code of conduct, it is expected
that all patients be treated with dignity and be
protected from any possible harm (16). Accordingly,
adherence to ethical principles requires healthcare
providers to identify potential safety failures to
prevent falling incidents (15).
The establishment of patient safety has different
individual, professional, and organizational aspects
with a special focus on ethics. Professional and
organizational commitment leads to detecting and
reporting of both one’s own and others’ errors (10).
From an ethical view, the following actions are
recommended:
Following professional and institutional guidelines (if
any exist) related to falling incidents; Taking basic
actions to assess the patient’s physical health and
rescue his/her life; Informing the in-charge staff;
Punctual assessment of the situation, and complete
documentation and reporting of the event (important
data such as the time of the incident, the infant’s
position, level of consciousness, vital signs, those
present at the scene, actions taken in the process, and
etc.) should be documented; Informing the parents
and providing them with emotional support.
Informing parents (Disclosure of medical errors)
It seems in case of any error made by the care team,
the event must be announced to the parents honestly
without blaming the care providers. Moreover,
irritating phrases such as “It happens” and “Nothing
has happened though” should not be used.
Under circumstances in which errors were caused by
inappropriate pattern of providing hospital services,
parents should be reassured that all services will be
paid for by the hospital. It would be better if the
parents were informed by the chief physician or the
head nurse and given enough time to express their
concern or anger.
Although anger under such circumstances is a natural
reaction, we cannot hide medical errors because of
fear of parents’ reaction. Moreover, parents’ anger
would be more severe if they found out that the hospital
personnel have concealed the truth.
It should be considered that knowing the truth is one
of the basic rights of patients and their family
members. According to similar studies, explaining the
error to the patients could be a stressful situation
combined with intense emotional reactions from
patient/family members or the care team. Generally,
the person who committed the error has a sense of
guilt or fear of punishment, and patient/family
members experience feelings such as anger and
anxiety. Furthermore, it should be noticed that
J Med Ethics Hist Med 10: 15, December, 2017 jmehm.tums.ac.ir Maliheh Kadivar et al.
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primary conversations usually take place when there
is not accurate and comprehensive information about
the event, so recognizing, understanding, and
explaining all the details in complicated clinical
situations is not possible. Thus, it is suggested that in
such situations, information be given in several stages
and by providing psychological support for the
patient. Furthermore, while they may need supportive
interventions, the patient's family can be considered
as an important source of information in the process
of root cause analysis (RCA) of similar incidents (17-
20). Since creating ethical patient safety is a
multidimensional accomplishment, it should be
considered that actively partnering with the patient’s
family may be a high-yield approach to detecting and
preventing medical errors (10).
In addition, regarding the presented case, the father
should be ensured that hospitalizing the newborn was
necessary and the mother should not be blamed. In
fact, he should be ensured that the incident was
entirely due to system error and not by the mother.
Basically, maintaining the integrity of the family is
essential and medical staff must consider family
support at all stages, especially in such circumstances.
Indeed, an important ethical point in this case is the
necessity of offering an honest apology. It is not
always as simple as saying: “We are sorry”. The way
of informing the parents is a sensitive issue and there
is an urgent need for training healthcare providers in
sensitive interpersonal relationships and related skills
to facilitate honest and proper communication with
the patient’s family (20).
Forensic medicine aspect
Laws and regulations related to patient safety, which
may vary based on the legislation system of each
country, should encourage the disclosure of medical
errors while supporting the implementation of the
ethical imperatives of patient safety. In general, based
on the medical law, the patient who is a victim of
negligence is supposed to be fairly compensated. In
addition, these rules provide possibilities for
promotion of transparency and open communications
in all levels. Reaching this goal requires regarding all
stakeholders in the healthcare system (21).
In the mentioned case, some questions could be
raised. Either the falling was in the presence of the
mother or not. If it was in her presence, the hypothesis
is that she dropped the baby intentionally. However,
if there is no sign of any apparent trauma, it seems
there was no specific hurtful force or he fell from his
mother’s arms, and it shows the mother’s lack of
experience.
Accordingly, it should be considered that maternal
postpartum sleepiness is one of the major risk factors
for falling of newborns. Half of all newborn falling
incidents in hospitals have occurred while the mother
was holding the infant in a hospital bed. Therefore,
recognizing the risks of neonatal falling during
mother–baby care situations and teaching the mothers
is a major nursing responsibility (22).
If the mother is incapable of taking care of the
hospitalized baby, she should be under supervision of
the care team and should be educated. Furthermore,
notifying the father is an appropriate act if the
complaint was raised by the father.
The main task of the physician or nurse after a detailed
examination and treatment is the detailed registration
and description of all events without any assumptions.
If the examinations found evidence of neglect, it
would be a completely different discussion and
calling the social services would be absolutely
necessary.
The question might also be raised that “if nothing
happened to the child and we did all the assessments
to insure his health, are we obligated to inform the
parents?”
There is an obligation to inform the patient or the
family about every unwanted event in healthcare
settings. The idea that there is no need to disclose
errors which did not affect the patient is based on the
traditional stance of the law. Furthermore, today, it is
well known that such disclosures will enhance
patients’ trust to healthcare professionals while
making them aware of that which is going on around
them. In addition, through this approach, healthcare
professionals can respect the patients’ autonomy and
dignity (21, 23).
Conclusion Despite increased attention toward the quality of
health care services, there are still numerous threats to
patient safety in healthcare settings. Since patient
safety is multidimensional and grounded in ethical
and legal imperatives, both ethical and legal
challenges should be taken into account.
Reaching the ultimate goal of the healthcare system,
which is to ensure quality and safety of the services,
requires structured policies and processes to foster the
safety settings based on mutual trust. This can be
facilitated by encouraging multidisciplinary
collaboration for the transparent reporting of medical
errors and also active participation of the patients and
their families in detecting medical errors.
Furthermore, the provision of emotional support and
legal protection of the staffs by the organization is
essential to encourage voluntary reporting of
incidents.
Moreover, training and emphasizing on the
professional code of ethics can be effective on
deepening the understanding of and belief in the
moral foundations of patient safety.
Conflict of interest The authors declare that there is no conflict of interest.
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