Background
While patient safety is a new and emerging phenomenon, historical evidence indicates that concerns for patient safety have existed for a long time before modern healthcare. More than 150 years ago, Florence Nightingale stated that “the very first requirement in a hospital is to do no harm to patients” [
1]. In 2001, the Institute of Medicine (IOM) issued this concern in the form of “Crossing the Quality Chasm: A New Health System for the 21st Century”. IOM emphasized the safety of healthcare and that patients should be free of danger or risk caused by the healthcare system [
2].
Nowadays, modern advances and the complexity of healthcare have led to serious deficiencies in the quality of care and patient safety. The high prevalence of clinical risks and safety incidents have increased concerns and challenges for healthcare systems [
3,
4]. Although estimates of the size of the problem are imprecise, it is likely that millions of people suffer from disabling injuries or death in consequence of clinical risk and safety incidents [
5]. It is estimated that, in the hospitals of developed countries, one in ten patients is harmed while receiving unsafe care. Moreover, the risk of damage is much higher in developing countries than developed countries. For example, the risk of healthcare-associated infection in some developing countries is twenty times higher than that in developed countries [
6].
However, the majority of injuries and safety-related deaths are preventable by designing and planning safety processes and techniques [
5]. Therefore, to handle these challenges and to achieve quality and safety improvement, healthcare organizations are faced with increasing pressure to cultivate an effective safety culture [
7]. Patient safety culture is defined as a dimension of organizational culture [
8]. Specifically, it is the product of individual and group values, beliefs, attitudes, perceptions, norms, procedures, competencies, and patterns of behaviour that determine the commitment of an health organization to patient safety management [
7,
8].
Safety experts have suggested the essential components for safety culture such as teamwork, leadership support, communication [
7], and a just culture as well as a reporting and a learning culture [
9]. Organizations with a positive safety culture have communications based on mutual trust, shared perceptions of the importance of safety, and confidence in the efficacy of preventive measures and support for the workforce [
1]. Safety culture emphasizes preventive or predictive measures of safety more than retrospective ones [
10]. In addition, the safety culture emphasizes the system approach or “why” unsafe acts occurred rather than the person approach or “who” made the unsafe acts [
1]. By developing a system approach, hospitals should foster a continuous learning environment by reporting and discussing clinical risks and safety incidents without fear of punishment [
7].
To promote a safety culture and to ensure safer healthcare systems, the IOM has emphasized the development of clear patient safety programs; use of non-punitive systems for reporting and analysing safety incidents; incorporation of well-established safety principles such as standardized and simplified equipment, supplies, and work processes; and establishment of interdisciplinary team training safety programs. However, the IOM has announced that the biggest challenge for moving toward safety culture is changing the culture from one which lays the blame on individuals to a system approach [
11].
Institutionalizing a safety culture is the shared responsibility of all healthcare providers in the healthcare system [
12]. Nevertheless, nurses have the central role in improving patient safety culture. When facing the challenges of healthcare systems, nurses are well positioned to protect the safety of patients or harm them with unsafe practices [
13]. Therefore, both patients and nurses will be protected, a safe milieu for nurses will be created, and distress caused by safety incidents will be decreased by improving safety. Finally, these actions will reduce attrition and alleviate chronic nursing shortages [
14].
However, creating a positive safety culture is challenging for healthcare systems, and some studies suggest that healthcare providers, especially nurses, give more problematic responses to patient safety culture [
15,
16]. An Iranian study indicated that hospitals did not meet a proper level of patient safety and a punitive culture dominated the workplace [
17]. A systematic review on six qualitative studies has demonstrated that hospitals underestimate organizational resources, and support is required for making patient safety initiatives and changing the culture [
18]. In another systematic review, researchers attempted to address the interventions used to promote safety culture in healthcare, but they did not assess the challenges of safety culture [
8].
World Health Organization (WHO) noted that, due to the multidimensional nature of safety culture, a better understanding of the factors influencing the patient safety culture and addressing the interventions to improve patient safety are research priorities in developing countries and countries with transition economies [
5]. Additionally, Vlayen et al. mentioned that safety culture varies over time and this variation is linked with organizational context such as hospital statute and size and human resource characteristics such as educational background [
19]. In this respect, the experiences of nurses as the most important human resources can help develop appropriate theories and provide specific guidance for healthcare professionals in facilitating safe practice in both developed and developing countries [
13].
In-depth qualitative studies are required for a better understanding of factors impacting the development of patient safety initiatives and challenges facing the institutionalization of those factors [
20]. Although some effort has been made to improve safety culture in Iranian hospitals, there is no comprehensive, qualitative study that explores the challenges of implementing and integrating a positive safety culture in the Iranian healthcare from the nurses’ perspective. The aim of this study was to explore and describe the nurses’ experiences of the challenges facing the implementing a positive safety culture within the culture and context of Iranian hospitals.
Methods
Study design
A qualitative and conventional content analysis with a descriptive-explorative approach was used for data collection and analysis. The qualitative content analysis method is the process of understanding, interpreting, and conceptualizing the underlying meanings of qualitative data. Although this method can be implemented with various degrees of interpretation including manifest messages versus latent messages, both messages require interpretations which may vary in depth and level of abstraction [
21].
Settings
The settings for this study were four teaching and referral hospitals affiliated with Kerman University of Medical Sciences in southeast Iran. With the population of about 800,000, Kerman is the largest city in this part of the country. These hospitals have more than 1000 beds in emergency, neonate, pediatric, surgery, and internal medicine, dialysis wards; and CCU, ICU, NICU, etc. to provide specialised care to patients with, among others, cardiac, endocrine, pulmonary, gastrointestinal, neurological, and psychological disorders. They receive patients from southeast of Iran, within the radius of 500 km 24 h per day, 7 days per week. Different high-tech medical and surgical interventions are conducted in these hospitals by nursing and medical staff who collaborate with university-based medical scientists in educating healthcare students.
The implementation of healthcare policies is centralized in Iran, and Ministry of Health governs all the hospitals [
22,
23]. The political agenda is currently paying more attention to the reduction of patient harm, ensuring quality, and improvement of patient safety culture. To undertake this mission, all the hospitals are actively implementing “Clinical Governance” principles and “Hospital Accreditation Standards” [
24]. In addition, the distribution of healthcare providers is similar in all the hospitals all over the country. The majority of nurses have Bachelor’s degrees and the recruitment of nurses follows the same pattern in all the hospitals [
22].
Participants and sampling
Purposeful sampling was used to select participants who were informed and experienced. In each hospital, a number of eligible participants were selected by the first researcher and assistance from the nursing managers. Nurses were recruited by written invitation informing them of the aims and methods of the study and asking them to indicate their willingness to participate and organize an interview session. The first interviews were done with a key informed participant, who had enriched experiences regarding various roles of a clinical nurse. The sampling process continued based on the principles of maximum variation to capture the rich and diverse perspectives and experience of nurses Therefore, 23 nurses with different backgrounds in sex, age, years of work experience, degrees in nursing, position, and type of ward were enrolled until data saturation. The nurses were 15 women and 8 men aging 26–50 years with work experiences ranging from 1.5 to 26 years. Six nurses had a master’s degree and the others had a bachelor’s degree in nursing. Seven participants came from hospital 1, six from hospital 2, five from hospital 3 and five from hospital 4. The sample included a matron, three clinical supervisors, an educational supervisor, four head nurses, a quality improvement officer, and thirteen clinical nurses. Having at least bachelor’s degree in nursing, the work experience for at least one year, and willingness to participate in this study were the main inclusion criteria employed for the selection of the participants.
Data collection
Semi-structured, individual, face-to-face, in-depth interviews were carried out by one of the researchers who had a background in clinical nursing and patient safety work. Interviews were scheduled after explaining research objective to nurses. All interviews were initiated with an open question asking the participants to describe their patient safety work. The interviews were directed towards the purpose of the study by topic guide questions, e.g. “Would you please describe your experience with integrating safety culture in organizational culture?”, “To your experience, what requirements were necessary for safety culture in your hospital?”, “What activities have been carried out in improving the safety culture in your hospital?”, and “What barriers and challenges have you experienced for implementing these activities?”. Then, probing questions were asked to obtain more elaborative answers and nurses’ experiences, e.g. “Would you explain the situation clearly?” We considered patient safety in simple terms such as the prevention of errors and adverse effects to patients associated with healthcare.
The interviews lasted for 50–75 min and took place in a quiet room near the ward or in another location based on the participants’ preference. All interviews were audio-recorded with the participants’ permission and transcribed verbatim using Microsoft Office Word. The information was saturated after twenty-one interviews and two additional interviews were conducted to ensure data saturation.
Data analysis
Data analysis was conducted according to the method proposed by Graneheim and Lundman [
25]. In this approach, iterations consisted of the following: In the first step, every interview was transcribed verbatim by the first researcher, the researchers read the transcriptions several times to obtain an overall understanding of the content, and performed an initial coding individually. Second, the text was divided into meaning units that were then condensed. Each meaning unit comprised words and sentences containing aspects related to one another. Third, the condensed meaning units were abstracted and labelled using open codes. In the fourth step, the codes were classified into subcategories and categories based on similarities and differences. A category consists of similar codes in the manifest level. Finally, the underlying meaning and content of the data were extracted, and themes were formulated as the expression of the latent meaning of a text. All researchers discussed the content of the categories using triangulating analysis. When the authors disagreed, discussions and clarifications continued until achieving a consensus.
Trustworthiness
The trustworthiness of the data was determined using Lincoln and Guba’ criteria, including credibility, confirmability, dependability, and transferability [
25]. To enhance credibility, the researcher established a friendly relationship with the participants and had prolonged engagements with the research settings and data analysis (in the 7-month period from April to October 2016). Moreover, the data were initially coded and categorized independently by the researchers and the developed themes were compared. Where there was disagreement, discussions were held to reach consensus among all three co-authors. For member checking, a summary of the interviews and results was presented in prescheduled meetings with ten participants. They confirmed the contents as accurate and that the researchers were representing their real experiences and perspective; only three of them suggested minor changes to the situations and wording of codes. However the areas of disagreement were discussed, and feedback loops were used to ensure rigour. New codes were added and some codes were eliminated. The confirmability and dependability of data were assessed through member checks by colleagues and participants. In addition, external checks were carried out such that the first author met 5 nurses, 3 senior managers, 2 physicians who had not participated in the study and were informed of patient safety, and members of the patient safety committee in hospitals who confirmed the accuracy of our findings. In addition, research and decision-making processes were accurately recorded and reported so that the follow-up by others and data verification would be possible.
Discussion
The present study attempted to attain an insight into the challenges of establishing an effective safety culture using the experiences of nurses. These challenges have affected the performance, conception, and attitude of nurses to involve in safety culture and have slowed the movement towards an effective safety culture. The main theme of this study indicates that the healthcare system has a long way ahead to achieve an effective and positive safety culture.
One of the categories of this study was incompetent organizational infrastructure along with a number of subcategories, including the shortage of resources, unfavourable work condition and unsafe environment, and weakness of the staff’s professional competence and empowerment. These results were in agreement with previous studies [
26‐
28] which reported that lack of human resources, financial, time, equipment, and information technology was the main obstacle to implementing quality improvement and patient safety programs. In a qualitative study in the UK, human resources were considered as having a key role in the process of changing the culture. On the other hand, it was reported that the implementation of safety programs will be difficult due to limitations in financial resources for human resource management (i.e. training, recruitment, and empowerment) and the lack of qualified, skilled, and trained personnel [
29]. According to the results, nurses in general and newly graduated nurses in particular believed that nurses do not develop an adequate capability and competence for patient safety in university. In agreement with these results, Vaismoradi et al. [
30] confirmed that new graduates experience stress as they become healthcare professionals, and that nursing education does not seem to prepare nurses for complex and challenging work environments.
This study is consistent with other studies showing that the work condition and environment, e.g. mental and emotional setting, profession attrition [
31], working in shifts and fatigue [
32], lack of control over complex and unsafe working conditions [
33], high workload, crowded and irregular environment, and inadequate space [
27] affect patient safety and quality improvement. Mahmood et al. [
34] emphasized that inappropriate and unsafe work environment cause physical and mental pressure and stress for nurses, increasing the risk of accidents. They also indicated that factors, including comprehensive understanding of environmental factors, considering interventions and appropriate strategies for managing the challenges of physical environment, and mental and emotional settings, are prerequisites for managing the safety culture.
In the present study, insufficient leadership effectiveness along with some challenges, such as lack of commitment, non-supportive management, non-participatory decision-making, and low efficiency of safety management rounds and clinical audit, were significant challenges for the institutionalization of the safety culture. These findings are in agreement with the results of other studies showing that the programs of quality improvement have faced some challenges, including a lack of leadership commitment and inefficient management [
35], flaws in involving employees in safety programs, and lack of autonomy and a supportive setting [
36]. In another study, researchers acknowledged that when nurse leaders welcomed nurses’ participation in decision-making, asked for their perspectives, devolved the responsibility and authority of managerial duties, and administered appropriate supervision, nurses responded to the leaders’ trust by becoming more committed to patient safety [
37].
Low efficiency of safety management rounds and clinical audit was mentioned as one of the challenges in the present study. In a study in Iran, numerous obstacles were reported for the effectiveness of clinical audit and safety walk rounds. These obstacles were insufficient allocations of resources, inadequate standards for the audit, lack of trained personnel, shortage of personnel for follow-up safety measures, incomplete documentation, and low collaboration of clinicians in the audit process [
38]. Contrary to this study, however, safety management rounds were introduced as an effective tool in promoting risk management activities and safety culture in a mixed method study. These visits increased the commitment and accountability of senior management to the safety of patients, employees, and the society [
39]. In addition, clinical audit and feedbacks of the audit were mentioned as an important strategy for the continuation of quality and safety improvement activities in a systematic review [
40]. This difference is probably due to the inadequate organizational infrastructure of the hospitals mentioned in this study.
Failure to establish quality improvement and clinical risk management systems was another challenge for the effective safety culture. In this regard, a study in Iran reported similar challenges and obstacles, including limited financial resources and equipment, human resource constraints (e.g. lack of skilled workers and low motivation), management problems, weakness in training programs, failure in communications, cultural issues (e.g. feeling no need to change and lack of team participation), and laws and policies (e.g. the absence of harmonized rules and poor assessment of the Ministry and universities) [
35]. These suggest that progress in patient safety and quality improvement systems is still far from ideal in Iran. One of the important roots of this situation might be the failure to address the patient safety system in scientific, academic, and research gatherings, as well as the failure to provide proper infrastructure to implement them.
The culture of resistance to change towards a system approach was mentioned as one of the safety culture challenges. In a study, the political context of healthcare, lack of required skills among managers and the pressure to deliver quick and measurable changes were reported as barriers to changing the culture of quality and safety programs in [
41]. Another study reported that, with respect to the complexity of organizational factors such as culture, structures, and processes, change in the organizational fundament would not be easy but would be possible. Therefore, it is necessary to identify potential strategies for change [
26]. This study highlights that change in the organization, creation, and promotion of safety culture and quality improvement is impossible without the support and involvement of different levels of management and leadership or without providing organizational infrastructure.
Regarding challenge of the culture of blame and punishment, in agreement with present study, a study in Iran reported that non-punitive response to errors is weak in hospitals. The Iranian healthcare context must avoid the culture of “name, shame, and blame” and implement the system approach [
15]. In another study, factors related to the organization, e.g. the absence or lack of a safety culture, a culture of blame and reprimand, lack of support of the staff in the event of an error, an inappropriate function and reaction of managers, have been considered as barriers to error reporting [
42]. The culture of blame is a barrier to reporting the errors and learning from mistakes. It also restrains the nurses from patient protection [
43].
Weakness in feedback to reporting errors and weakness in the culture of organizational education and learning were the other challenges presented in this study. In agreement with this results a qualitative study in Australia which introduced the lack of receiving feedback from an error report, culture of blame, lack of value in the process, and failure to receive legal privileges as barriers to reporting the errors by nurses and doctors [
44]. In organizational learning, the emphasis is on learning from errors and mistakes, providing an opportunity to learn later. One method to improve patient safety is to lead the organization towards organizational learning by enforcing the appropriate setting for learning from errors and their proper management [
45]. Perhaps the reasons of weakness in organizational learning could be lack of learning conditions. For example, in a qualitative study by Heidari et al. [
46], the lack of a sense of attachment, confidence, and satisfaction with professional position were identified as the main concerns of nurses, especially those with a master’s degree, in the process of organizational learning. Also, the nurses highlighted issues such as lack of confidence at the obtained competencies, deficiency in work autonomy, lack of decision-making power, absence of autonomy to use their knowledge, and predominance of physicians’ opinions which had deterrent effects on the efforts of nurses to achieve personal and organizational promotion. The interesting point about the experiences of nurses was that, in the current system, higher knowledge and skills were not considered as benefits for nurses, even creating more duties and responsibilities for them.
The participants believed that the weakness in preventive culture was another challenge for the safety culture. This study was consistent with a study which concluded that the errors receive attention by a more passive and retrospective (reactive) approach and people are considered as the cause of errors in Iran. In addition, the researchers in that study reduced the incidence of errors in the processes of emergency department by using the prospective method of “failure modes and effects analysis”)FMEA). They introduced the FMEA as an efficient and effective technique for the advancement of system thinking and access to safe processes of patient care [
47].
Based on the results, challenges such as failure to redefine and clarify roles, gap in team coordination, and difficult dynamics of team interactions have overshadowed the values of team participation in the establishment of a safety culture. Castro-Sánchez et al. [
30] highlighted that the consequences of lacking awareness about professional responsibilities (own and others’) could threaten patient safety. Various studies have reported similar challenges and obstacles to team participation in patient safety programs, risk management, and quality improvement. Those challenges were inconsistency in team communication, negative attitude to teamwork, unwillingness to perform duties in the team [
48], lack of job descriptions [
13], gap in team engagement and coordination [
49], inadequacy in team communication and interaction [
50], and lack of a culture of teamwork [
42].
The participants in our study commented that an aspect of difficult dynamics of team interactions was the unfavorable relationship between nurses and physicians, leading to dissatisfaction among nurses and reduced patient safety. In consistent with the results other studies concluded that ineffective relationships affected nurses’ performance negatively and reduced care quality. Nurses reported that unfavorable relationships among some physicians and nurses disappointed the nursing staff, making them lose their motivation. In addition, lack of attention to nurses’ knowledge and capabilities by some physicians caused stress and unpleasant feelings regarding the work atmosphere, acting as a barrier to the proper delivery of nursing care [
51]. Disharmony in the interaction between physicians and nurses will cause conflicts among the members of healthcare team, resulting in error and disruptions in patient safety. Therefore, improving the interactions between nurses and physicians should be considered as one of the effective strategies to improve patient safety.
Limitations
This study explored merely a part of the challenges of institutionalization of an effective and positive safety culture based on the experiences of one professional group (nurses) in cultural and social fields in the hospitals of Iran. Therefore, the transferability of findings should be considered with caution and critiqued and compared with those of similar studies conducted in other contexts. In addition, others challenges may be recognized in different cultural and organizational contexts, with other groups of healthcare system, e.g. physicians, and even from a multidisciplinary perspective. Thus, more qualitative and quantitative studies must be performed to adopt the strategies and processes of the management of safety challenges proportionate to diverse cultural and organizational contexts. The results of such comprehensive research could pave the way for creating and institutionalizing a growing safety culture, leading to high quality and safe care in the unique cultural context.