Ayse P. Gurses

Work system design for patient safety: the SEIPS model

Models and methods of work system design need to be developed and implemented to advance research in and design for patient safety. In this paper we describe how the Systems Engineering Initiative for Patient Safety (SEIPS) model of work system and patient safety, which provides a framework for understanding the structures, processes and outcomes in health care and their relationships, can be used toward these ends. An application of the SEIPS model in one particular care setting (outpatient surgery) is presented and other practical and research applications of the model are described.

A Systematic Review of the Literature on Multidisciplinary Rounds to Design Information Technology

Multidisciplinary rounds (MDR) have become important mechanisms for communication and coordination of care. To guide design of tools supporting MDR, we reviewed the literature published from 1990 to 2005 about MDR on information tools used, information needs, impact of information tools, and evaluation measures. Fifty-one papers met inclusion criteria and were included. In addition to patient-centric information tools (e.g., medical chart) and decision-support tools (e.g., clinical pathway), process-oriented tools (e.g., rounding list) were reported to help with information organization and communication. Information tools were shown to improve situation awareness of multidisciplinary care providers, efficiency of MDR, and length of stay. Communication through MDR may be improved by process-oriented information tools that help information organization, communication, and work management, which could be achieved through automatic extraction from clinical information systems, displays and printouts in condensed forms, at-a-glance representations of the care unit, and storing work-process information temporarily.

Systems ambiguity and guideline compliance: a qualitative study of how intensive care units follow evidence-based guidelines to reduce healthcare-associated infections

Background: Consistent compliance with evidence-based guidelines is challenging yet critical to patient safety. We conducted a qualitative study to explore the underlying causes for non-compliance with evidence-based guidelines aimed at preventing four types of healthcare-associated infections in the surgical intensive care unit (SICU) setting. Methods: Twenty semistructured interviews were conducted with attending physicians (3), residents (2), nurses (6), quality improvement coordinators (3), infection control practitioners (2), respiratory therapists (2) and pharmacists (2) in two SICUs. Using a grounded theory approach, we performed thematic analyses of the interviews. Results: The concept of systems ambiguity to explain non-compliance with evidence-based guidelines emerged from the data. Ambiguities hindering consistent compliance were related to tasks, responsibilities, methods, expectations and exceptions. Strategies reported to reduce ambiguity included clarification of expectations from care providers with respect to guideline compliance through education, use of visual cues to indicate the status of patients with respect to a particular guideline, development of tools that provide an overview of information critical for guideline compliance, use of standardised orders, clarification of roles of care providers and use of decision-support tools. Conclusions: The concept of systems ambiguity is useful to understand causes of non-compliance with evidence-based guidelines aimed at reducing healthcare-associated infections. Multi-faceted interventions are needed to reduce different ambiguity types, hence to improve guideline compliance.

Time to accelerate integration of human factors and ergonomics in patient safety

Progress toward improving patient safety has been slow despite engagement of the health care community in improvement efforts. A potential reason for this sluggish pace is the inadequate integration of human factors and ergonomics principles and methods in these efforts. Patient safety problems are complex and rarely caused by one factor or component of a work system. Thus, health care would benefit from human factors and ergonomics evaluations to systematically identify the problems, prioritize the right ones, and develop effective and practical solutions. This paper gives an overview of the discipline of human factors and ergonomics and describes its role in improving patient safety. We provide examples of how human factors and ergonomics principles and methods have improved both care processes and patient outcomes. We provide five major recommendations to better integrate human factors and ergonomics in patient safety improvement efforts: build capacity among health care workers to understand human factors and ergonomics, create market forces that demand the integration of human factors and ergonomics design principles into medical technologies, increase the number of human factors and ergonomic practitioners in health care organizations, expand investments in improvement efforts informed by human factors and ergonomics, and support interdisciplinary research to improve patient safety. In conclusion, human factors and ergonomics must play a more prominent role in health care if we want to increase the pace in improving patient safety.

Identifying and categorising patient safety hazards in cardiovascular operating rooms using an interdisciplinary approach: a multisite study

Background Cardiac surgery is a complex, high-risk procedure with potential vulnerabilities for patient safety. The evidence base describing safety hazards in the cardiovascular operating room is underdeveloped but is essential to guide future safety improvement efforts. Objective To identify and categorise hazards (anything that has the potential to cause a preventable adverse patient safety event) in the cardiovascular operating room. Methods An interdisciplinary team of researchers used prospective methods, including direct observations, contextual inquiry and photographs to collect hazard data pertaining to the cardiac surgery perioperative period, which started immediately before the patient was transferred to the operating room and ended immediately after patient handoff to the post-anaesthesia/intensive care unit. Data were collected between February and September 2008 in five hospitals. An interdisciplinary approach that included a human factors and systems engineering framework was used to guide the study. Results Twenty cardiac surgeries including the corresponding handoff processes from operating room to post-anaesthesia/intensive care unit were observed. A total of 58 categories of hazards related to care providers (eg, practice variations), tasks (eg, high workload), tools and technologies (eg, poor usability), physical environment (eg, cluttered workspace), organisation (eg, hierarchical culture) and processes (eg, non-compliance with guidelines) were identified. Discussion Hazards in cardiac surgery services are ubiquitous, indicating numerous opportunities to improve safety. Future efforts should focus on creating a stronger culture of safety in the cardiovascular operating room, increasing compliance with evidence-based infection control practices, improving communication and teamwork, and developing a partnership among all stakeholders to improve the design of tools and technologies.

The Society of Cardiovascular Anesthesiologists' FOCUS initiative: Locating Errors through Networked Surveillance (LENS) project vision.

Peter J. Pronovost, MD, PhD* BACKGROUND Although the methods to measure preventable harm are imprecise and immature, preventable harm is one of the leading causes of death, disability, and increased costs of care. The field of anesthesiology has been recognized for its efforts to improve patient safety, but much work remains to reduce harm to patients having cardiac surgery. Despite significant publicity regarding patient safety and efforts to improve it since the publication of To Err Is Human 10 years ago, there is little empiric evidence that health care is safer. For example, reports of wrong-site surgery continue to increase year after year despite a national patient safety goal* and widespread efforts intended to reduce such events. Although the true increase in wrong-site surgery is debated and may represent reporting bias, we clearly have not eliminated this sentinel event or other events for which there are data. One logically asks why a country that spends more than 2 trillion dollars a year on health care, 17% of its gross domestic product, continues to produce significant preventable harm. Why do wrong-site surgeries and other adverse events continue despite substantial efforts by regulators, hospitals, and professional societies? The problem is complex and implementing solutions has been exceedingly difficult. However, the solution is conceptually simple: we must adequately develop and apply rigorous science to analyzing errors in the delivery of health care. For example, despite there being a national policy to prevent wrong-site surgery, there are little to no data showing the effectiveness of this intervention. Few quick fixes will improve safety. Similar to biomedical science, safety improvements will require a robust and disciplined science that matures over time. Perhaps the greatest barrier to measurable progress in patient safety is the inability to evaluate with scientific rigor whether patient safety interventions are effective. This is the result of insufficient research funding and, paradoxically, the interdisciplinary nature of patient safety. There is sparse research funding for “basic science” in patient safety, especially to develop measures and tools to improve it. As a result, measures are often of poor quality, and the interventions of limited effectiveness, if not harmful. There are many disciplines that inform the science of patient safety, including organizational sociology and industrial psychology, clinical medicine, human factors engineering, health services research, economics, epidemiology, biostatistics, and informatics. Each discipline views the world through a unique “lens” and has a different frame of reference for viewing various aspects of patient safety risks and interventions as compared with others. Unfortunately, these lenses are From the *Departments of Anesthesiology & Critical Care Medicine and Pediatrics, The Johns Hopkins University School of Medicine and the †Department of Health Policy & Management, Bloomberg School of Public Health, Baltimore, Maryland. Accepted for publication October 5, 2009. Supported by the Society of Cardiovascular Anesthesiologists (SCA) Foundation for the LENS Project. Elizabeth A. Martinez was supported by the Agency for Healthcare Research and Quality K08 grant #HS013904-02. The FOCUS Initiative is a collaborative project of the Society of Cardiovascular Anesthesiologists, the SCA Foundation, and the Johns Hopkins University Quality and Safety Research Group. FOCUS is funded exclusively by the SCA Foundation. Address correspondence and reprint requests to Peter J. Pronovost, MD, PhD, The Johns Hopkins University School of Medicine, 1909 Thames St., Second Floor, Baltimore, MD 21231. Address e-mail to ppronovo@jhmi.edu. Copyright

Macroergonomics in Health Care Quality and Patient Safety

The US Institute of Medicine and healthcare experts have called for new approaches to manage healthcare quality problems. In this chapter, we focus on macroergonomics, a branch of human factors and ergonomics that is based on the systems approach and considers the organizational and sociotechnical context of work activities and processes. Selected macroergonomic approaches to healthcare quality and patient safety are described such as the SEIPS model of work system and patient safety and the model of healthcare professional performance. Focused reviews on job stress and burnout, workload, interruptions, patient-centered care, health IT and medical devices, violations, and care coordination provide examples of macroergonomics contributions to healthcare quality and patient safety. Healthcare systems and processes clearly need to be systematically redesigned; examples of macroergonomic approaches, principles and methods for healthcare system redesign are described. Further research linking macroergonomics and care processes/patient outcomes is needed. Other needs for macroergonomics research are highlighted, including understanding the link between worker outcomes (e.g., safety and well-being) and patient outcomes (e.g., patient safety), and macroergonomics of patient-centered care and care coordination.

Technologies in the wild (TiW): human factors implications for patient safety in the cardiovascular operating room

We describe different sources of hazards from cardiovascular operating room (CVOR) technologies, how hazards propagate in the CVOR and their impact on cognitive processes. Previous studies have examined hazards from poor design of a specific CVOR technology. However, the impact of different CVOR technologies functioning in context is not clearly understood. In addition, the impact of non-design hazards in technology devices is unclear. Our study identified hazards from organisational, physical/environmental elements, in addition to design of technology in a CVOR. We used observations, follow-up interviews and photographs. With qualitative analyses, we categorised the different hazard sources and their potential impact on cognitive processes. Patient safety can be built into technologies by incorporating user needs in design, decision-making and implementation of medical technologies. Practitioner summary: Effective design and implementation of technology in a safety-critical system requires prospective understanding of technology-related hazards. Our research fills this gap by studying different technologies in context of a CVOR using observations. Qualitative analyses identified different sources for technology-related hazards besides design, and their impact on cognitive processes.

High Stakes and High Risk: A Focused Qualitative Review of Hazards During Cardiac Surgery

Cardiac surgery is a high-risk procedure performed by a multidisciplinary team using complex tools and technologies. Efforts to improve cardiac surgery safety have been ongoing for more than a decade, yet the literature provides little guidance regarding best practices for identifying errors and improving patient safety. This focused review of the literature was undertaken as part of the FOCUS initiative (Flawless Operative Cardiovascular Unified Systems), a multifaceted effort supported by the Society of Cardiovascular Anesthesiologists Foundation to identify hazards and develop evidence-based protocols to improve cardiac surgery safety. Hazards were defined as anything that posed a potential or real risk to the patient, including errors, near misses, and adverse events. Of the 1438 articles identified for title review, 390 underwent full abstract screening, and 69 underwent full article review, which in turn yielded 55 meeting the inclusion criteria for this review. Two key themes emerged. First, studies were predominantly reactive (responding to an event or report) instead of proactive (using prospective designs such as self-assessments and external reviewers, etc.) and very few tested interventions. Second, minor events were predictive of major problems: multiple, often minor, deviations from normal procedures caused a cascade effect, resulting in major distractions that ultimately led to major events. This review fills an important gap in the literature on cardiac surgery safety, that of systematically identifying and categorizing known hazards according to their primary systemic contributor (or contributors). We conclude with recommendations for improving patient outcomes by building a culture of safety, promoting transparency, standardizing training, increasing teamwork, and monitoring performance. Finally, there is an urgent need for studies that evaluate interventions to mitigate the inherent risks of cardiac surgery.

Variation in local institutional review board evaluations of a multicenter patient safety study.

&NA; Several highly visible quality improvement (QI) projects led to controversy over their ethical oversight, attracting attention from institutional review boards (IRBs) and the Office for Human Research Protection. While QI research has increased dramatically, there is limited empirical evidence regarding how multiple IRBs review the same study. This paper describes the variations in local IRB reviews for the same a multicenter QI study. The study, entitled “Locating Errors through Networked Surveillance”, used multiple data collection methods to identify patient safety risks in cardiovascular operating room services. This study involved 2‐day site visits to 5 hospitals by the research team to observe cardiac surgery procedures and interview staff regarding clinical practice and hazards. Surveys were self‐administered. The IRB process varied widely across the 5 hospitals. Reviews ranged from full committee review and approval with verbal consent required from patients and operating room staff, to an IRB determining the study exempt from review and participant consent. The time to IRB approval ranged from 6 weeks to 6 months. This variation suggests there is wide interpretation of the Federal regulations put in place to guide IRBs. The adoption of uniformity would not only reduce inefficiencies but also attenuate the perceived arbitrary nature of current IRB review processes that often inappropriately influence hypothesis‐generation and study design.