Pursuing Patient Safety at the Intersection of Design, Systems Engineering, and Health Care Delivery Research: An Ongoing Assessment.

OBJECTIVES: Despite endorsements for greater use of systems approaches and reports from national consensus bodies calling for closer engineering/health care partnerships to improve care delivery, there has been a scarcity of effort of actually engaging the design and engineering disciplines in patient safety projects. The article describes a grant initiative undertaken by the Agency for of Healthcare Research and Quality that brings these disciplines together to test new ideas that could make health care safer. METHODS: Collectively known as patient safety learning laboratories, grantee teams engage in phase-based activities that parallel a systems engineering process-problem analysis, design, development, implementation, and evaluation-to gain an in-depth understanding of related patient safety problems, generate fresh ideas and rapid prototypes, develop the prototypes, ensure that developed components are implemented as an integrated working system, and evaluate the system in a simulated or clinical setting. FINDINGS: Obstacles are described that can derail the best of intentions in deploying the systems engineering methodology. Based on feedback received from project teams, lessons learned are emerging that find considerable variation among project teams in deploying the methodology and a longer than anticipated amount of time in bringing team members from different disciplines together where they learn to communicate and function as a team. CONCLUSIONS: Three narratives are generated in terms of what success might look like. Much is yet to be learned about the limitations and successes of the ongoing learning laboratory initiative, which should be relevant to the broader scale interest in learning health systems.

The Architecture Of Safety: An Emerging Priority For Improving Patient Safety.

There is a lack of awareness regarding the pervasive influence of the built environment on caregiving activities, and how its design could reduce risks for patients and providers. This article presents a narrative review summarizing key findings that link health care facility design to key targeted safety outcomes: health care-associated infections, falls, and medication errors. It describes how facility design should be considered in conjunction with quality improvement legislation; projects under way in health systems; and the work of guideline-setting organizations, funding agencies, industry, and educational institutions. The article also charts a path forward that consolidates existing challenges and suggests what can be done about them to create safe and high-quality health care environments.

Simulation Research in Gastrointestinal and Urologic Care-Challenges and Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases and National Institute of Biomedical Imaging and Bioengineering Workshop.

: A workshop on "Simulation Research in Gastrointestinal and Urologic Care: Challenges and Opportunities" was held at the National Institutes of Health in June 2016. The purpose of the workshop was to examine the extent to which simulation approaches have been used by skilled proceduralists (not trainees) caring for patients with gastrointestinal and urologic diseases. The current status of research findings in the use and effectiveness of simulation applications was reviewed, and numerous knowledge gaps and research needs were identified by the faculty and the attendees. The paradigm of "deliberate practice," rather than mere repetition, and the value of coaching by experts was stressed by those who have adopted simulation in music and sports. Models that are most useful for the adoption of simulation by expert clinicians have yet to be fully validated. Initial studies on the impact of simulation on safety and error reduction have demonstrated its value in the training domain, but the role of simulation as a strategy for increased procedural safety remains uncertain in the world of the expert practitioner. Although the basic requirements for experienced physicians to acquire new skills have been explored, the widespread availability of such resources is an unrealized goal, and there is a need for well-designed outcome studies to establish the role of simulation in improving the quality of health care.

Challenges in Health Care Simulation: Are We Learning Anything New?

The growth of health care simulation in schools of medicine and nursing is noteworthy, as is the increasingly sophisticated simulation technology, support from funding agencies and foundations for research, well-attended annual conferences, and continued interest of accreditation and certification groups. Yet there are concerns preventing the full value of health care simulation to be realized when examined from a patient safety perspective. Basic questions are asked by funders of patient safety research when assessing past simulation projects undertaken to advance patient safety: Are the safety and quality of care to patients actually improved, and is something new being learned regarding the optimal use of simulation? Concerns focus on pursuing the right research questions to learn something new about the most effective use of simulation; doing more with simulation than simply providing an interesting, stand-alone educational experience; attending more seriously to how skill acquisition, maintenance, and progression get managed; and encouraging investigators, funders, and reviewers to expand their vision regarding what constitutes important inquiry and evidence in health care simulation. Patient safety remains a multifaceted challenge in the United States, requiring multifaceted approaches. Simulation training is considered a promising approach for improving the safety and quality of health services delivery. While it takes time for any new approach to gain momentum and learn from past efforts, it also will require addressing a systematic range of essential questions to improve existing knowledge on the optimal use of simulation, and to realize similar gains in safety that other high-risk industries have made.

Simulation Research in Gastrointestinal and Urologic Care-Challenges and Opportunities: Summary of a National Institute of Diabetes and Digestive and Kidney Diseases and National Institute of Biomedical Imaging and Bioengineering Workshop.

A workshop on ''Simulation Research in Gastrointestinal and Urologic Care: Challenges and Opportunities'' was held at the National Institutes of Health in June 2016. The purpose of the workshop was to examine the extent to which simulation approaches have been used by skilled proceduralists (not trainees) caring for patients with gastrointestinal and urologic diseases. The current status of research findings in the use and effectiveness of simulation applications was reviewed, and numerous knowledge gaps and research needs were identified by the faculty and the attendees. The paradigm of ''deliberate practice,'' rather than mere repetition, and the value of coaching by experts was stressed by those who have adopted simulation in music and sports. Models that are most useful for the adoption of simulation by expert clinicians have yet to be fully validated. Initial studies on the impact of simulation on safety and error reduction have demonstrated its value in the training domain, but the role of simulation as a strategy for increased procedural safety remains uncertain in the world of the expert practitioner. Although the basic requirements for experienced physicians to acquire new skills have been explored, the widespread availability of such resources is an unrealized goal, and there is a need for well-designed outcome studies to establish the role of simulation in improving the quality of health care.

Challenges and opportunities from the Agency for Healthcare Research and Quality (AHRQ) research summit on improving diagnosis: a proceedings review.

BACKGROUND: The Improving Diagnosis in Health Care report from the National Academies of Sciences, Engineering and Medicine (NASEM) provided an opportunity for many groups to reflect on the role they could play in taking actions to improve diagnostic safety. As part of its own process, AHRQ held a research summit in the fall of 2016, inviting members from a diverse collection of organizations, both inside and outside of Government, to share their suggestions regarding what is known about diagnosis and the challenges that need to be addressed. CONTENT: The goals of the summit were to learn from the insights of participants; examine issues associated with definitions of diagnostic error and gaps in the evidence base; explore clinician and patient perspectives; gain a better understanding of data and measurement, health information technology, and organizational factors that impact the diagnostic process; and identify potential future directions for research. Summary and outlook: Plenary sessions focused on the state of the new diagnostic safety discipline followed by breakout sessions on the use of data and measurement, health information technology, and the role of organizational factors. The proceedings review captures many of the key challenges and areas deserving further research, revealing stimulating yet complex issues.

Funding Research in Emergency Diagnostic Imaging: Summary of a Panel Discussion at the 2015 Academic Emergency Medicine Consensus Conference.

As part of the 2015 Academic Emergency Medicine consensus conference "Diagnostic Imaging in the Emergency Department: A Research Agenda to Optimize Utilization," a panel of representatives from the National Institute of Health's Office of Emergency Care Research, the National Institute of Biomedical Imaging and Bioengineering, the Agency for Healthcare Research and Quality, and the Patient-Centered Outcomes Research Institute was assembled to discuss future opportunities for funding research in this particular area of interest. Representatives from these agencies and organizations discussed their missions and priorities and how they distribute funding. They also addressed questions on mechanisms for new and established researchers to secure future funding.

A prospective tool for risk assessment of sendout testing.

OBJECTIVE: Errors associated with laboratory testing can cause significant patient harm. Sendout testing refers to tests sent by a primary lab to a reference lab when testing is unavailable at the primary lab. Sendout testing is particularly high risk for patient harm, due to many factors including increased hand-offs, manual processes, and complexity associated with rare, low-volume tests. No published prospective tools exist for sendout risk assessment. METHODS: A novel prospective tool was developed to assess risk of diagnostic errors involving laboratory sendout testing. This tool was successfully piloted at nine sites. RESULTS: Marked diversity was noted among survey respondents, particularly in the sections on quality metrics and utilization management. Of note, most sites had committees who managed rules for test ordering, but few places reported enforcing these rules. Only one site claimed to routinely measure the frequency clinicians failed to retrieve test results. An evaluation of the tool indicated that it was both useful and easy to use. CONCLUSIONS: This tool could be used by other laboratories to identify the areas of highest risk to patients, which in turn may guide them in focusing their quality improvement efforts and resources.

Improving diagnostic performance: some unrecognized obstacles.

The growing interest and activity focused on improving diagnostic performance is a needed and welcomed change to which the new journal, Diagnosis, nicely attests. While the importance of raising awareness and building the evidence-base needs to be underscored, these efforts by themselves do not translate directly into improvements for patients. The complex and multifaceted nature of diagnostic work is becoming better understood, yet many of the obstacles seem to operate beneath the surface where the press of daily practice allows many of the untoward issues to be tacitly ignored. The purpose of the paper is to shine a light on some of these less recognized issues or obstacles. Among the issues addressed is whether use of the error term as in diagnostic error or medical error is serving us well in gaining of better understanding of diagnostic work, the lack of sensible feedback mechanisms that deny diagnosticians and their organizations the opportunity to learn something about their diagnostic performances, the double-edge nature of feedback, the obstacle of frame blindness, and the need for innovative empirical testing of promising ideas for improving diagnostic performance such as taking advantage of diagnostic simulation techniques that are inexpensive to generate and do not put patients at risk.

The pursuit of better diagnostic performance: a human factors perspective.

Despite the relatively slow start in treating diagnostic error as an amenable research topic at the beginning of the patient safety movement, interest has steadily increased over the past few years in the form of solicitations for research, regularly scheduled conferences, an expanding literature and even a new professional society. Yet improving diagnostic performance increasingly is recognised as a multifaceted challenge. With the aid of a human factors perspective, this paper addresses a few of these challenges, including questions that focus on who owns the problem, treating cognitive and system shortcomings as separate issues, why knowledge in the head is not enough, and what we are learning from health information technology (IT) and the use of checklists. To encourage empirical testing of interventions that aim to improve diagnostic performance, a systems engineering approach making use of rapid-cycle prototyping and simulation is proposed. To gain a fuller understanding of the complexity of the sociotechnical space where diagnostic work is performed, a final note calls for the formation of substantive partnerships with those in disciplines beyond the clinical domain.

Cognitive interventions to reduce diagnostic error: a narrative review.

BACKGROUND: Errors in clinical reasoning occur in most cases in which the diagnosis is missed, delayed or wrong. The goal of this review was to identify interventions that might reduce the likelihood of these cognitive errors. DESIGN: We searched PubMed and other medical and non-medical databases and identified additional literature through references from the initial data set and suggestions from subject matter experts. Articles were included if they either suggested a possible intervention or formally evaluated an intervention and excluded if they focused solely on improving diagnostic tests or provider satisfaction. RESULTS: We identified 141 articles for full review, 42 reporting tested interventions to reduce the likelihood of cognitive errors, 100 containing suggestions, and one article with both suggested and tested interventions. Articles were classified into three categories: (1) Interventions to improve knowledge and experience, such as simulation-based training, improved feedback and education focused on a single disease; (2) Interventions to improve clinical reasoning and decision-making skills, such as reflective practice and active metacognitive review; and (3) Interventions that provide cognitive 'help' that included use of electronic records and integrated decision support, informaticians and facilitating access to information, second opinions and specialists. CONCLUSIONS: We identified a wide range of possible approaches to reduce cognitive errors in diagnosis. Not all the suggestions have been tested, and of those that have, the evaluations typically involved trainees in artificial settings, making it difficult to extrapolate the results to actual practice. Future progress in this area will require methodological refinements in outcome evaluation and rigorously evaluating interventions already suggested, many of which are well conceptualised and widely endorsed.

System-related interventions to reduce diagnostic errors: a narrative review.

BACKGROUND: Diagnostic errors (missed, delayed or wrong diagnosis) have recently gained attention and are associated with significant preventable morbidity and mortality. The authors reviewed the recent literature and identified interventions that address system-related factors that contribute directly to diagnostic errors. METHODS: The authors conducted a comprehensive search using multiple search strategies. First, they performed a PubMed search to identify articles exclusively related to diagnostic error or delay published in English between 2000 and 2009. They then sought papers from references in the initial dataset, searches of additional databases, and subject matter experts. Articles were included if they formally evaluated an intervention to prevent or reduce diagnostic error; however, papers were also included if interventions were suggested and not tested to inform the state of the science on the subject. Interventions were characterised according to the step in the diagnostic process they targeted: patient-provider encounter; performance and interpretation of diagnostic tests; follow-up and tracking of diagnostic information; subspecialty and referral-related issues; and patient-specific care-seeking and adherence processes. RESULTS: 43 articles were identified for full review, of which six reported tested interventions and 37 contained suggestions for possible interventions. Empirical studies, although somewhat positive, were non-experimental or quasi-experimental and included a small number of clinicians or healthcare sites. Outcome measures in general were underdeveloped and varied markedly among studies, depending on the setting or step in the diagnostic process. CONCLUSIONS: Despite a number of suggested interventions in the literature, few empirical studies in the past decade have tested interventions to reduce diagnostic errors. Advancing the science of diagnostic error prevention will require more robust study designs and rigorous definitions of diagnostic processes and outcomes to measure intervention effects.

Partial truths in the pursuit of patient safety.

The paper explores several issues in the form of partial truths that dominate current thinking as investigators continue their pursuit of patient safety. Among the partial truths examined−cast as bipolar orientations−are evidence-based medicine versus quality improvement, 'knowledge in the head' versus 'knowledge in the world', sharp end versus blunt end, reporting systems versus local knowledge, changing beliefs versus changing behaviour and system components versus system interdependencies. The paper provides a cautionary note regarding the downside of creating dichotomies that tend to assert too much. An enhanced understanding of patient safety will likely result from rising above bipolar orientations and valuing them as partial approaches to a complex and dynamic problem space.

The human factors of home health care: a conceptual model for examining safety and quality concerns.

OBJECTIVE: Increases in longevity, a growing elderly population, variation of skill and knowledge among home providers, and a steady migration of medical devices and technologies into the home are placing new demands on home heath care. The paper examines the human factors challenges associated with these converging trends. METHODS: A growing literature base relevant to home health care is examined, and with the aid of a socio-technical systems model, the paper explores safety and quality concerns to which the converging trends are likely to give rise. FINDINGS: The sensory, physical, and cognitive limitations of patients and their caregivers play a key role in the ability of patients to manage home health care needs. Other major components affecting successful home health care management are the nature of health care tasks undertaken, the design features of the physical environment, the medical devices and technologies used, the social and community environments, and distal but relevant external factors that shape the context of care. Home health care stakeholders can avoid foreseeable threats to safety and quality by recognizing that components need to be designed in a way that takes into account their interactions with one another and with the capabilities and limitations of patients and their providers. CONCLUSIONS: By examining the major components and interdependencies of the home health care delivery system, a human factors perspective offers insights into ways that safety and quality can be compromised and can help pave the way for new modes of thinking in home health care policy.

Communication failure: basic components, contributing factors, and the call for structure.

BACKGROUND: Communication is a taken-for-granted human activity that is recognized as important once it has failed. Communication failures are a major contributor to adverse events in health care. BASIC COMMUNICATION COMPONENTS AND PROCESSES: The components and processes of communication converge in an intricate manner, creating opportunities for misunderstanding along the way. When a patient's safety is at risk, providers should speak up (that is, initiate a message) to draw attention to the situation before harm is caused. They should also clearly explain (encode) and understand (decode) each other's diagnosis and recommendations to ensure well coordinated delivery of care. INDIVIDUAL, GROUP, AND ORGANIZATIONAL FACTORS: Beyond basic dyadic communication exchanges, an intricate web of individual, group, and organizational factors--more specifically, cognitive workload, implicit assumptions, authority gradients, diffusion of responsibility, and transitions of care--complicate communication. THE CALL FOR STRUCTURE: More structured and explicitly designed forms of communication have been recommended to reduce ambiguity, enhance clarity, and send an unequivocal signal, when needed, that a different action is required. Read-backs, Situation-Background-Assessment-Recommendation, critical assertions, briefings, and debriefings are seeing increasing use in health care. CODA: Although structured forms of communication have good potential to enhance clarity, they are not fail-safe. Providers need to be sensitive to unexpected consequences regarding their use.

Improving the health care work environment: a sociotechnical systems approach.

This issue examines findings on key elements of the hospital environment, identifies risks to safety and quality, and proposes operational and policy solutions.

Improving the health care work environment: implications for research, practice, and policy.

FUTURE RESEARCH: Despite the gains to date, we need better understanding of practices for implementing and sustaining improvements in health care work environments and further study of organizational conditions affecting implementation of improvements. PRACTICE: Limiting work hours, improving schedules, and providing sleep hygiene training will help combat clinician fatigue. Hospital crowding can be reduced through systemwide improvement of patient flow and capacity management, coupled with management support, measurement, and reporting on crowding. Long-term solutions to nurse staffing shortfalls include process redesign to enhance efficiency. Improvement of organizational climate, human resource management, and interoccupational relations will also contribute to staff retention. Evidence-based enhancements to patient rooms and other physical features in hospitals contribute directly to safety and quality and also affect staff performance. POLICY: Landrigan and his colleagues call for external restrictions on residents' work shifts. Clarke examines prospects for mandated nursing-staff ratios. Public reporting on staffing, crowding, and other risks may incent change. Reporting and pay for performance require standardized measures of targeted conditions. Organizations promoting care quality can help spread safe work practices; they can also support collaborative learning and other strategies that may enhance implementation of improvements in work environments.

The role of the physical environment in crossing the quality chasm.

BACKGROUND: Evidence-based design findings are available to help inform hospital decision makers of opportunities for ensuring that quality and safety are designed into new and refurbished facilities. FRAMEWORK FOR THE EVIDENCE: The Institute of Medicine's six quality aims of patient centeredness, safety, effectiveness, efficiency, timeliness, and equity provide an organizing framework for introducing a representative portion of the evidence. Design improvements include single-bed and variable-acuity rooms; electronic access to medical records; greater accommodation for families and visitors; handrails to prevent patient falls; standardization (room layout, equipment, and supplies for improved efficiencies); improved work process flow to reduce delays and wait times; and better assessment of changing demographics, disease conditions, and community needs for appropriately targeted health care services. THE BUSINESS CASE: A recent analysis of the business case suggests that a slight, one-time incremental cost for ensuring safety and quality would be paid back in two to three years in the form of operational savings and increased revenues. Hospitals leaders anticipating new construction projects should take advantage of evidence-based design findings that have the potential of raising the quality of acute care for decades to come.