In the early 1960's Chapanis and Safren1 (Chapanis and Safrin, 1960, Safren and Chapanis, 1960a and Safren and Chapanis, 1960b) conducted one of the first human factors and ergonomics (HFE) studies on medication safety. The researchers used the critical incident technique to examine medication errors. They identified a total of 178 medication administration errors over a period of seven months: (1) wrong patient, (2) wrong dose of medication, (3) extra unordered medication, (4) medication not administered, (5) wrong drug, (6) wrong timing of medication administration, and (7) incorrect medication route. A range of work system factors contributed to medication errors, such as failure to follow required checking procedures, and verbal or written communication problems. This study highlighted the importance of work system issues in medication safety. However, it was not until the publication of the US Institute of Medicine report “To Err is Human: Building a Safer Health System” in 1999 (Kohn et al., 1999) that HFE and its systems approach were recognized as critical for patient safety across all healthcare domains.2
Healthcare professionals, leaders and organizations understand the importance of HFE as a scientific discipline that can produce knowledge to redesign healthcare systems and processes and improve patient safety and quality of care (Carayon et al., 2013; Gurses et al., 2012b; Institute of Medicine, 2012; Leape et al., 2002; Pronovost and Goeschel, 2011; Pronovost and Weisfeldt, 2012). For instance, the World Health Organization curriculum on patient safety includes 11 topics, among which two are core to HFE: (a) topic 2: What is human factors engineering, and why is it important to patient safety?, and (b) topic 3: Understanding systems and the impact of complexity on patient care (Walton et al., 2010). The US Agency for Healthcare Research and Quality (AHRQ) promotes an HFE approach to the design of health information technology (IT) (NRC Committee on the Role of Human Factors in Home Health Care, 2010, 2011) and has published a variety of guidance documents on using HFE systems models to analyze patient safety events in healthcare delivery (Henriksen et al., 2008, 2009). Various IOM reports have called for the incorporation of HFE, and of systems approaches generally, into health and healthcare research, design, and policy (Grossman et al., 2011; Institute of Medicine, 2001, 2004, 2006, 2012; Reid et al., 2005).
Given the complexity of healthcare (Carayon, 2006), HFE interventions that do not consider issues across the whole system, including organizational factors, are unlikely to have significant, sustainable impact on patient safety and quality of care. For instance, improving the physical design of a medical device or the cognitive interface of health IT is important; but without understanding the organizational context in which these technologies are used, workers may develop work-arounds, the tools may not be used safely, and health IT may be usable but not useful. Therefore, an HFE systems approach to healthcare quality and patient safety should include organizational HFE or macroergonomic considerations.
We have proposed an HFE systems approach to address patient safety and other quality of care problems (see Fig. 1). The SEIPS (Systems Engineering Initiative for Patient Safety) model of work system and patient safety (Carayon et al., 2006b) is based on the macroergonomic work system model developed by Smith and Carayon (Carayon, 2009, Carayon and Smith, 2000, Smith and Carayon-Sainfort, 1989 and Smith and Carayon, 2001), and incorporates the Structure-Process-Outcome (SPO) model of healthcare quality (Donabedian, 1978). The SPO model of Donabedian (1978) is the most well-known model of healthcare quality. The integration of the work system model with this prominent model of healthcare quality increases the acceptability of the SEIPS model by the healthcare community. In this paper, we first describe the SEIPS model of work system and patient safety and its research and practical applications. We then emphasize the principle of ‘balance’ and focus on system interactions that need to be considered in order to make significant progress in healthcare quality and patient safety.
The SEIPS model has been used successfully to introduce and promote HFE to healthcare researchers, professionals, and educators. Knowledge of specific HFE topics (e.g., teamwork, usability, coordination, physical stressors, resilience) is necessary to study healthcare quality and patient safety issues. We advocate that this specialized HFE knowledge focusing on specific aspects of the work system can have significant impact if it takes into account the entire work system. If the broad work system is not clearly considered, this specialized HFE knowledge is at risk of either examining the wrong problem or using the wrong approach to solve the problem. We encourage HFE researchers and practitioners to embrace the proposed HFE systems approach to increase the relevance and significance of their effort targeted at improving healthcare quality and patient safety.
Future research on the SEIPS model should explore work system interactions and their impact on healthcare quality and patient safety (Waterson, 2009). This research should help answer the question of how to redesign healthcare systems and processes to achieve benefits for both patients and healthcare workers. We also need to develop methodologies and measures for assessing balanced work systems that can produce benefits for all stakeholders.
