Patient Safety Culture and Health Care Ethics

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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?

J Med Ethics Hist Med 10: 15, December, 2017 jmehm.tums.ac.ir Maliheh Kadivar et al.

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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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