زنجیره ایمنی بیمار: اثر رهبری تحول گرا در فرهنگ ایمنی بیمار، ابتکارات و نتایج

The purpose of this study is to investigate the existence of a patient safety chain for hospitals. Drawing on high reliability organization theory, multifactor leadership theory and total quality management literature, we develop and test a model for improving patient safety – a critical issue facing hospitals today. Specifically, we hypothesize that improving patient safety begins at the highest level of the organization with a transformational leadership style. This leads to a sequence of linkages whereby transformational leadership has an important relationship with creating a culture of safety, which in turn is associated with the adoption of patient safety initiatives, and ultimately with positive improvements in patient safety outcomes. Using data from a nationwide survey of over 200 hospitals, we use structural equation modeling to provide empirical support for the effectiveness of this patient safety chain model. The results have major implications for enhancing operations in hospital settings.

Some organizations require great attention to preventing mistakes because errors could have serious implications to public safety. High reliability organizations (HROs) refer to organizations or systems that operate in complex and hazardous conditions and yet consistently achieve nearly error-free performance. They are termed HROs because they seem to function in a more reliable fashion than other similar organizations. Classic examples of HROs can be found in the aviation industry, the nuclear power industry, and some sections of the military. Failure rates in these organizations are much lower than those found in healthcare, an industry where injury to the public is a major concern. Healthcare organizations would benefit from operating as HROs. We propose that HRO status can be achieved through a systematic process linked to top leadership. We empirically test this proposition by building a model for improving patient safety in hospitals. Although operations management traditionally has been concerned with improving quality and reducing defects in manufacturing settings, recent research in this field has expanded to include the study of errors and safety in service industries such as aviation and healthcare (e.g., Barnett and Higgins, 1989 and Tucker, 2004). Product defects in manufacturing are synonymous with operational failures in aviation or healthcare, which have the potential to impact public safety. Safety is a critical component of quality improvement, and the term “operations safety” has emerged as a new and growing area of interest in the field (McFadden and Hosmane, 2001). Since Brown (1996) encouraged researchers to adopt safety in research agendas, and Bretthauer (2004) stressed the need for more service research on improving safety in healthcare, the problem of medical errors and their consequences is now receiving more attention in operations management literature (e.g., Tucker, 2004 and Gowen et al., 2006). Healthcare has become one of the largest service sectors of our economy, accounting for about 15% of Gross Domestic Product and providing the greatest number of new jobs of any industry in the United States (Mandel, 2006). Improving patient safety is one of the most highly publicized and critical issues facing this industry today. Although patient safety, defined by the National Patient Safety Foundation as “the avoidance, prevention and amelioration of adverse outcomes or injuries stemming from the process of healthcare,” is not a new concept, the first report issued by the Institute of Medicine (IOM), entitled To Err is Human: Building a Safer Health System ( IOM, 2000), broke the silence that had originally surrounded medical errors and their consequences. Their findings indicated that as much as 58% of the 98,000 error-related deaths that occur annually may be preventable. Consequently, the IOM recommended rigorous and widespread changes in healthcare processes. In addition, in November of 2000, The Leapfrog Group was established by a coalition of major employers in order to initiate breakthrough improvements in safety and reduce preventable medical errors, which are defined as “the failure of a planned action to be completed as intended (i.e., an error of execution) or the use of a wrong plan to achieve an aim (i.e., an error of planning)” ( IOM, 2000, p. 28). The Leapfrog Group and the IOM reports, along with the Joint Commission's adoption of patient safety standards and patient safety goals ( Joint Commission, 2009) have put serious pressure on hospitals to develop patient safety initiatives (PSI) designed to reduce medical errors. Nonetheless, hospitals have been slow in meeting patient safety goals and inconsistent in implementing safety systems ( Longo et al., 2007), despite the unprecedented focus on patient safety over the last 10 years. Prior to the first IOM report (2000), most efforts to reduce errors and improve patient safety focused on individuals rather than systems or processes (Woodhouse et al., 2004). In 1984, Perrow argued that about 70% of accidents in general were associated with human error. This error rate was substantiated in the highway traffic safety literature (Brehmer, 1990), as well as in aviation safety research (McFadden and Hosmane, 2001). Although humans often play a role in the occurrence of errors, the first IOM report used the popular adage of Alexander Pope – to err is human – to make the point that blaming individuals for being human is not an effective way to improve patient safety. Recent evidence now suggests that the majority of errors more accurately stem from system and process failures as opposed to human failures (Reason, 1990, Chassin and Becher, 2002, Gaba et al., 2003 and Tucker, 2004). With this new focus on systems and processes has come the identification of more effective methods for improving patient safety, including redesigning the hospital work environment, modifying systems and processes to make them more redundant, and implementing PSI, or activities intended to prevent or ameliorate adverse outcomes or injuries stemming from the process of healthcare. Empirical studies have found fewer medical errors tend to occur in hospitals that embrace a culture of safety (Katz-Navon et al., 2005), possess a group-oriented organizational culture (Stock et al., 2007), and implement PSI (McFadden et al., 2006a). Further research has shown the costly impact of medical errors, both financially (to the tune of $51,000 to $27 million per year for a 204-bed hospital at 75% occupancy) and in terms of customer dissatisfaction, hindrance to employees, and reduction of quality of care (Tucker, 2004). Of particular relevance to the present study, McFadden et al. (2006a) identified several barriers to the implementation of PSI in hospitals, including lack of top management support, lack of resources, lack of incentives, and lack of knowledge. On the other hand, something as simple as perceived importance of PSI was shown to facilitate their implementation. Given this increased emphasis on improving patient safety, this study seeks to identify a clear model of patient safety and its foundations. Specifically, this paper builds on high reliability organization theory (HROT) by testing the existence of a systematic process that is linked to safety improvements in hospitals. Although no empirical evidence currently exists in the literature to support a patient safety chain model, the prevailing research tends to substantiate such a concept. The unique contribution of this paper is to demonstrate that the patient safety chain can provide an impetus for healthcare organizations to achieve HRO status. Therefore, we use the terminology “patient safety chain” to reinforce that the focus of our paper is the model as a whole - a chain of mediated relationships, rather than the individual links in the chain (a set of bivariate relationships), as we follow the theme of HROs throughout our discussion of the model. Specifically, we propose that improving safety begins with top management's support of such efforts through the use of transformational leadership (TFL), the effects of which will “trickle down” through the links in our proposed chain, being ultimately related to improved safety outcomes. Following HROT's emphasis on leadership as an important factor in creating an HRO, this study provides evidence that hospitals wishing to reduce errors will need to focus their energies towards this top “link” in the chain. Specifically, we propose that TFL in hospitals will be associated with the creation of a patient safety culture (PSC), which then corresponds with the adoption of PSI and ultimately with positive improvements in patient safety outcomes (PSO). In the following section, we examine the literature that supports our theory.

This is the first study to provide empirical evidence for the existence of a patient safety chain, which is a set of linkages related to improvements in patient safety in hospitals. By exploring processes and strategies used within HROs that lead to improved error outcomes, we developed and tested a model that is applicable to hospital settings. Specifically, this study found that improving patient safety begins at the top of the organization with a hospital CEO who possesses a TFL style, and it empirically demonstrates that the charismatic-inspirational leadership style is directly related to a culture of safety within the hospital, which is tied to the successful implementation of PSI, and ultimately to improved PSO. These PSO include the reduction in the frequency, severity, and impact of errors, as well as heightened awareness and understanding of errors. Whereas organizations in other industries have been able to achieve high reliability, healthcare organizations have struggled with the problem of reducing medical errors (Gaba, 2001). We are supporting HROT by providing evidence of its applicability in a new industry for which higher reliability has been demanded. The validity of our model as a whole is demonstrated via structural equation modeling, as all of the hypothesized relationships are tested simultaneously. The results presented here therefore advance our overall understanding of processes and systems and their relationship to errors. Specifically, our results demonstrate that service organizations such as hospitals that are striving for reduction in errors need to use a systems approach whereby top leadership supports the patient safety culture and the implementation of safety initiatives. This study suggests that the TFL style contributes to the achievement of the cultural shift needed for safety initiative implementation to take place in an effective manner. More specifically, the charismatic-inspirational leader helps permeate safety values throughout the entire system. As a result of cultural influence, employees share in valuing safety as a priority of the organization. This serves as a form of normative control (Saxberg and Slocum, 1968, Sathe, 1983 and Schein, 1983) that ensures safety initiatives are enacted appropriately and uniformly, a necessary condition for HROs (Gaba, 2001). The mediated relationships supported in this study lend evidence to a chain of linkages that may help ensure desired patient safety outcomes are achieved. 6.1. Managerial implications and conclusions This study has major implications for hospital leaders, especially given that improving patient safety has become a national priority. This study provides empirical support that the CEO's leadership style is tied to PSO, suggesting that hospitals desiring to make patient safety improvements need to focus their attention on this top “link” in the chain. Our findings support both full and partial mediation as part of the patient safety chain model. Specifically, TFL has a direct relationship with creating a culture of patient safety and with the actual implementation of PSI. In addition, it has an indirect relationship with the implementation of initiatives as mediated through culture, and ultimately an indirect relationship with improved PSO as mediated through culture and initiatives. Therefore, these results indicate that the characteristics of charismatic-inspirational leaders is associated with the creation and fostering of a culture of safety, which includes making safety a top priority and devoting the necessary resources to PSI in order to realize maximal improvements in PSO. Because our study presents evidence that TFL is linked to improving safety, healthcare CEOs interested in improving PSO at their hospitals should actively seek feedback from employees to ensure they are effectively practicing the TFL style. They must also recognize the need to follow a systematic approach in order to achieve the desired outcomes in the area of patient safety. This involves not only enhancing their TFL style, but also using this leadership style to create a culture of safety. Creating a safety culture essentially means that patient safety is the top priority, and leadership provides a caring, safe environment free of blame, with open communication and collegiality, and the commitment and drive to be a safety-centered institution. This enhances the likelihood of actual implementation of a variety of PSI designed to reduce the frequency, severity and impact of errors as well as an increased understanding and awareness of errors. 6.2. Limitations and future research direction We must also acknowledge some limitations of our exploratory study. First, the reliance on perceptual data is a potential shortcoming common to survey research. Using multiple respondents from each hospital aids in addressing the first issue. In addition, studies suggest that self-reported assessments are highly consistent with more objective measures, especially when the respondents are at the appropriate level within the organization (Dess and Robinson, 1984, Robinson and Pearce, 1988 and Ketokivi and Schroeder, 2004). Similarly, Bommer et al. (1995) argue that subjective measures might not serve as proxies but objective measures are also no panacea due to their narrow focus. Second, the use of a single method of data collection is another potential limitation. However, triangulation with more objective data on PSO was prohibited due to the legal barriers to such information. In regards to the potential common method variance issue, the application of Harman's one-factor test (Podsakoff et al., 2003) reported here suggests that the single method of data collection is an acceptable risk. Replication of our design and analyses would enhance the generalizability of our findings. Finally, there may be other managerial or organizational variables to consider as possible explanations for PSI and PSO, particularly as mediators between TFL and PSI. The fact that the relationship was partially mediated suggests the presence of other such variables. The findings of this paper suggest several interesting areas for future research. For example, researchers may wish to explore other possible links in the patient safety chain. We have shown how leadership style, safety culture and safety initiatives are related to improvements in patient safety, but additional studies could explore the connections among these variables with organizational performance and competitive advantage. Moreover, it would also be interesting to explore how other possible links, such as employee and customer satisfaction, relate to the patient safety chain. Whereas the transformational leadership style was shown here to be an important link in the chain, additional research should also examine other leadership styles, such as transactional and laissez-faire leadership, to determine their differential relationships with safety culture, initiatives and outcomes. Additionally, a longitudinal study of culture, initiatives and performance outcomes would provide hospital leadership with data on the state of patient safety improvements and outcomes over time. The model presented here follows a chain from transformational leadership to patient safety outcomes, but extending this model to investigate any feedback mechanisms throughout the chain would provide hospital leaders with a more fluid model for ongoing improvement. Although confirmatory factor analysis supported the distinction between PSC and PSI presented here, future studies might further explore any possible overlap between these constructs. Finally, though our results indicated the patient safety chain process is the same for large and small, teaching and non-teaching hospitals, future studies might further investigate the managerial implications for this chain among various other hospital settings. The Joint Commission has exerted considerable pressure and placed a great deal of emphasis on the improvement of patient safety in hospitals. In fact, hospital accreditation has been increasingly tied to PSO. Nonetheless, research indicates that hospitals have been slow and inconsistent in meeting patient safety goals (Longo et al., 2007) and “few have succeeded in making substantial transformations needed to achieve those aims” (Lukas et al., 2007). In order to strengthen the quality of care nationwide, it is imperative that hospitals develop effective solutions to decrease the frequency and severity of medical errors. This study provides the basis for a systematic approach to addressing patient safety that relates to improved PSO and provides practical guidance for both managers and researchers in addressing this very important national issue.