Crossing Academic Boundaries for Diagnostic Safety: 10 Complex Challenges and Potential Solutions From Clinical Perspectives and High-Reliability Organizing Principles.

OBJECTIVE: We apply the high-reliability organization (HRO) paradigm to the diagnostic process, outlining challenges to enacting HRO principles in diagnosis and offering solutions for how diagnostic process stakeholders can overcome these barriers. BACKGROUND: Evidence shows that healthcare is starting to organize for higher reliability by employing various principles and practices of HRO. These hold promise for enhancing safer care, but there has been little consideration of the challenges that clinicians and healthcare systems face while enacting HRO principles in the diagnostic process. To effectively deploy the HRO perspective, these barriers must be seriously considered. METHOD: We review key principles of the HRO paradigm, the diagnostic errors and harms that potentially can be prevented by its enactment, the challenges that clinicians and healthcare systems face in executing various principles and practices, and possible solutions that clinicians and organizational leaders can take to overcome these challenges and barriers. RESULTS: Our analyses reveal multiple challenges including the inherent diagnostic uncertainty; the lack of diagnosis-focused performance feedback; the fact that diagnosis is often a solo, rather than team, activity; the tendency to simplify the diagnostic process; and professional and institutional status hierarchies. But these challenges are not insurmountable-there are strategies and solutions available to overcome them. CONCLUSION: The HRO lens offers some important ideas for how the safety of the diagnostic process can be improved. APPLICATION: The ideas proposed here can be enacted by both individual clinicians and healthcare leaders; both are necessary for making systematic progress in enhancing diagnostic performance.

Patient Partnership Tools to Support Medication Safety in Community-Dwelling Older Adults: Protocol for a Nonrandomized Stepped Wedge Clinical Trial.

BACKGROUND: Preventable harms from medications are significant threats to patient safety in community settings, especially among ambulatory older adults on multiple prescription medications. Patients may partner with primary care professionals by taking on active roles in decisions, learning the basics of medication self-management, and working with community resources. OBJECTIVE: This study aims to assess the impact of a set of patient partnership tools that redesign primary care encounters to encourage and empower patients to make more effective use of those encounters to improve medication safety. METHODS: The study is a nonrandomized, cross-sectional stepped wedge cluster-controlled trial with 1 private family medicine clinic and 2 public safety-net primary care clinics each composing their own cluster. There are 2 intervention sequences with 1 cluster per sequence and 1 control sequence with 1 cluster. Cross-sectional surveys will be taken immediately at the conclusion of visits to the clinics during 6 time periods of 6 weeks each, with a transition period of no data collection during intervention implementation. The number of visits to be surveyed will vary by period and cluster. We plan to recruit patients and professionals for surveys during 405 visits. In the experimental periods, visits will be conducted with two partnership tools and associated clinic process changes: (1) a 1-page visit preparation guide given to relevant patients by clinic staff before seeing the provider, with the intention to improve communication and shared decision-making, and (2) a library of short educational videos that clinic staff encourage patients to watch on medication safety. In the control periods, visits will be conducted with usual care. The primary outcome will be patients' self-efficacy in medication use. The secondary outcomes are medication-related issues such as duplicate therapies identified by primary care providers and assessment of collaborative work during visits. RESULTS: The study was funded in September 2019. Data collection started in April 2023 and ended in December 2023. Data was collected for 405 primary care encounters during that period. As of February 15, 2024, initial descriptive statistics were calculated. Full data analysis is expected to be completed and published in the summer of 2024. CONCLUSIONS: This study will assess the impact of patient partnership tools and associated process changes in primary care on medication use self-efficacy and medication-related issues. The study is powered to identify types of patients who may benefit most from patient engagement tools in primary care visits. TRIAL REGISTRATION: ClinicalTrials.gov NCT05880368; https://clinicaltrials.gov/study/NCT05880368. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57878.

Building Cultures of High Reliability: Lessons from the High Reliability Organization Paradigm.

Safety models from disciplines outside of health care have begun to diffuse into the health care safety arena. This article explores high reliability organizing (HRO) theory, which privileges culture as means to adaptively learn and reliably perform. A brief history of the HRO paradigm and factors that contribute to cultures of high reliability is provided, followed by review of existing research to discern which HRO ideas have diffused into research on anesthesiology and perioperative care. High reliability research is growing and concepts seem useful; but there is a long way to go before the benefits of HRO are fully realized.

Primary care teams' reported actions to improve medication safety: a qualitative study with insights in high reliability organising.

BACKGROUND: Our aim was to understand actions by primary care teams to improve medication safety. METHODS: This was a qualitative study using one-on-one, semistructured interviews with the questions guided by concepts from collaborative care and systems engineering models, and with references to the care of older adults. We interviewed 21 primary care physicians and their team members at four primary care sites serving patients with mostly low socioeconomic status in Southwest US during 2019-2020. We used thematic analysis with a combination of inductive and deductive coding. First, codes capturing safety actions were incrementally developed and revised iteratively by a team of multidisciplinary analysts using the inductive approach. Themes that emerged from the coded safety actions taken by primary care professionals to improve medication safety were then mapped to key principles from the high reliability organisation framework using a deductive approach. RESULTS: Primary care teams described their actions in medication safety mainly in making standard-of-care medical decisions, patient-shared decision-making, educating patients and their caregivers, providing asynchronous care separate from office visits and providing clinical infrastructure. Most of the actions required customisation at the individual level, such as limiting the supply of certain medications prescribed and simplifying medication regimens in certain patients. Primary care teams enacted high reliability organisation principles by anticipating and mitigating risks and taking actions to build resilience in patient work systems. The primary care teams' actions reflected their safety organising efforts as responses to many other agents in multiple settings that they could not control nor easily coordinate. CONCLUSIONS: Primary care teams take many actions to shape medication safety outcomes in community settings, and these actions demonstrated that primary care teams are a reservoir of resilience for medication safety in the overall healthcare system. To improve medication safety, primary care work systems require different strategies than those often used in more self-contained systems such as hospital inpatient or surgical services.

Becoming a high reliability organization.

Aircraft carriers, electrical power grids, and wildland firefighting, though seemingly different, are exemplars of high reliability organizations (HROs)--organizations that have the potential for catastrophic failure yet engage in nearly error-free performance. HROs commit to safety at the highest level and adopt a special approach to its pursuit. High reliability organizing has been studied and discussed for some time in other industries and is receiving increasing attention in health care, particularly in high-risk settings like the intensive care unit (ICU). The essence of high reliability organizing is a set of principles that enable organizations to focus attention on emergent problems and to deploy the right set of resources to address those problems. HROs behave in ways that sometimes seem counterintuitive--they do not try to hide failures but rather celebrate them as windows into the health of the system, they seek out problems, they avoid focusing on just one aspect of work and are able to see how all the parts of work fit together, they expect unexpected events and develop the capability to manage them, and they defer decision making to local frontline experts who are empowered to solve problems. Given the complexity of patient care in the ICU, the potential for medical error, and the particular sensitivity of critically ill patients to harm, high reliability organizing principles hold promise for improving ICU patient care.

The impact of safety organizing, trusted leadership, and care pathways on reported medication errors in hospital nursing units.

CONTEXT: Prior research has found that safety organizing behaviors of registered nurses (RNs) positively impact patient safety. However, little research exists on the joint benefits of safety organizing and other contextual factors that help foster safety. OBJECTIVES: Although we know that organizational practices often have more powerful effects when combined with other mutually reinforcing practices, little research exists on the joint benefits of safety organizing and other contextual factors believed to foster safety. Specifically, we examined the benefits of bundling safety organizing with leadership (trust in manager) and design (use of care pathways) factors on reported medication errors. SUBJECTS: A total of 1033 RNs and 78 nurse managers in 78 emergency, internal medicine, intensive care, and surgery nursing units in 10 acute-care hospitals in Indiana, Iowa, Maryland, Michigan, and Ohio who completed questionnaires between December 2003 and June 2004. RESEARCH DESIGN: Cross-sectional analysis of medication errors reported to the hospital incident reporting system for the 6 months after the administration of the survey linked to survey data on safety organizing, trust in manager, use of care pathways, and RN characteristics and staffing. RESULTS: Multilevel Poisson regression analyses indicated that the benefits of safety organizing on reported medication errors were amplified when paired with high levels of trust in manager or the use of care pathways. CONCLUSIONS: Safety organizing plays a key role in improving patient safety on hospital nursing units especially when bundled with other organizational components of a safety supportive system.

Gender Bias in Collaborative Medical Decision Making: Emergent Evidence.

This initial, exploratory study on gender bias in collaborative medical decision making examined the degree to which physicians' reliance on a team member's patient care advice differs as a function of the gender of the advice giver. In 2018, 283 anesthesiologists read a brief, online clinical vignette and were randomly assigned to receive treatment advice from 1 of 8 possible sources (physician or nurse, man or woman, experienced or inexperienced). They then indicated their treatment decision, as well as the degree to which they relied upon the advice given.The results revealed 2 patterns consistent with gender bias in participants' advice taking. First, when treatment advice was delivered by an inexperienced physician, participants reported replying significantly more on the advice of a man versus a woman, F(1,61) = 4.24, P = .04. Second, participants' reliance on the advice of the woman physician was a function of her experience, F(1,62) = 6.96, P = .01, whereas reliance on the advice of the man physician was not, F(1,60) = 0.21, P = .65.These findings suggest women physicians, relative to men, may encounter additional hurdles to performing their jobs, especially at early stages in their careers. These hurdles are rooted in psychological biases of others, rather than objective features of cases or treatment settings. Cultural stereotypes may shape physicians' information use and decision-making processes (and hinder collaboration), even in contexts that appear to have little to do with social category membership. The authors recommend institutions adopt policies and practices encouraging equal attention to advice, regardless of the source, to help ensure advice taking is a function of information quality rather than the attributes of the advice giver. Such policies and practices may help surface and implement diverse expert perspectives in collaborative medical decision making, promoting better and more effective patient care.

Treating the "Not-Invented-Here Syndrome" in Medical Leadership: Learning From the Insights of Outside Disciplines.

Physicians are being increasingly called upon to engage in leadership at all levels of modern health organizations, leading many to call for greater research and training interventions regarding physician leadership development. Yet, within these calls to action, the authors note a troubling trend toward siloed, medicine-specific approaches to leadership development and a broad failure to learn from the evidence and insight of other relevant disciplines, such as the organizational sciences. The authors describe how this trend reflects what has been called the "not-invented-here syndrome" (NIHS)-a commonly observed reluctance to adopt and integrate insights from outside disciplines-and highlight the pitfalls of NIHS for effective physician leadership development. Failing to learn from research and interventions in the organizational sciences inhibits physician leadership development efforts, leading to redundant rediscoveries of known insights and reinventions of existing best practices. The authors call for physician leaders to embrace ideas that are "proudly developed elsewhere" and work with colleagues in outside disciplines to conduct collaborative research and develop integrated training interventions to best develop physician leaders who are prepared for the complex, dynamic challenges of modern health care.

A framework for operationalizing risk: A practical approach to patient safety.

The importance of patient safety has grown tremendously; however, there are insufficient resources dedicated to its practical application. We provide an overview of the framework for addressing patient safety within the Johns Hopkins Health System, which approaches patient safety in the context of risk at the patient, provider, unit, and system levels. We present practical examples of how this approach is applied and highlight the resources needed as well as describe how it fits within the broader quality management infrastructure in the health system on its journey toward high reliability.

Latent risk assessment tool for health care leaders.

Efforts to improve quality of care and patient safety have concentrated on provider practice and frontline care processes. Little attention has focused on understanding the role that leadership decisions play in creating risk within a health care system. The framework and tool described in this article builds on Reason's construct of latent organizational failure, by assessing the latent risks of leadership decisions, and identifying appropriate mitigation strategies before the implementation of a change. Stakeholders who will be involved in or impacted by the change are engaged in the assessment to more thoroughly explore both technical and cultural risks.

Residents' responses to medical error: coping, learning, and change.

PURPOSE: To explore the significant emotional challenges facing resident physicians in the setting of medical mishaps, as well as their approaches to coping with these difficult experiences. METHOD: Twenty-six resident physicians were randomly selected from a single teaching hospital and participated in in-depth qualitative interviews. Transcripts were analyzed iteratively and themes identified. RESULTS: Residents expressed intense emotional responses to error events. Poor patient outcomes and greater perceived personal responsibility were associated with more intense reactions and greater personal anguish. For the great majority of residents, their ability to cope with these events was dependent on a combination of reassurance and opportunities for learning. Interactions with medical colleagues and supervisory physicians were critical to this coping process. CONCLUSIONS: Medical mishaps have a profound impact on resident physicians by eliciting intense emotional responses. It is critical that resident training programs recognize the personal and professional significance of these experiences for young physicians. Moreover, resident education must support the development of constructive coping skills by facilitating candid discussion and learning subsequent to these events.

Studying patient safety in health care organizations: accentuate the qualitative.

BACKGROUND: The study of patient safety can benefit from greater methodological diversity to improve scientific knowledge and to increase the effectiveness and tailoring of strategies aimed at improving it. METHODOLOGICAL DIVERSITY TO BETTER CAPTURE CAUSAL MECHANISMS AND PROCESSES: Additional methods for studying patient safety and errors to reflect the complexity of what goes on within health care organizations should be made routine. Interviews, focus groups, and observation--the predominant methods used in qualitative research--are infrequently used in health services research, generally and specifically in the study of errors and patient safety. However, they offer several advantages over quantitative designs. They often are less expensive and quicker to implement; they may not need a lot of advance work; and they can be used to study retrospectively a particular failure event, outcome, or situation. ACTION STEPS: Organizations can use an action agenda to better implement and promote the use of qualitative methods. Implementing these action steps can help achieve the attributes-trust, honesty, communication, participation, and efficiency-necessary to facilitate the qualitative approach in health care work settings. SUMMARY AND CONCLUSION: Qualitative approaches should be used in studying patient safety as a complement to (not a substitute for) quantitative approaches. They can be implemented more easily in organizations through structural and cultural adjustments that provide a more supportive foundation for this work.

Beyond the medical record: other modes of error acknowledgment.

BACKGROUND: Studies before and since the 1999 Institute of Medicine report have noted the limitations of using medical record reporting for reliably quantifying and understanding medical error. Quantitative macro analyses of large datasets should be supplemented by small-scale qualitative studies to provide insight into micro-level daily events in clinical and hospital practice that contribute to errors and adverse events and how they are reported. DESIGN: The study design involved semistructured face-to-face interviews with residents about the medical errors in which they recently had been involved and included questions regarding how those errors were acknowledged. OBJECTIVE: This paper reports the ways in which medical error is or is not reported and residents' responses to a perceived medical error. PARTICIPANTS: Twenty-six residents were randomly sampled from a total population of 85 residents working in a 600-bed teaching hospital. MEASUREMENTS: Outcome measures were based on analysis of cases residents described. Using Ethnograph and traditional methods of content analysis, cases were categorized as Documented, Discussed, and Uncertain. RESULTS: Of 73 cases, 30 (41.1%) were formally acknowledged and Documented in the medical record; 24 (32.9%) were addressed through Discussions but not documented; 19 cases (26%) cases were classified as Uncertain. Twelve cases involved medication errors, which were acknowledged in different categories. CONCLUSIONS: The supervisory discussion, the informal discussion, and near-miss contain important information for improving clinical care. Our study also shows the need to improve residents' education to prepare them to recognize and address medical errors.

Communication failures: an insidious contributor to medical mishaps.

PURPOSE: To describe how communication failures contribute to many medical mishaps. METHOD: In late 1999, a sample of 26 residents stratified by medical specialty, year of residency, and gender was randomly selected from a population of 85 residents at a 600-bed U.S. teaching hospital. The study design involved semistructured face-to-face interviews with the residents about their routine work environments and activities, the medical mishaps in which they recently had been involved, and a description of both the individual and organizational contributory factors. The themes reported here emerged from inductive analyses of the data. RESULTS: Residents reported a total of 70 mishap incidents. Aspects of "communication" and "patient management" were the two most commonly cited contributing factors. Residents described themselves as embedded in a complex network of relationships, playing a pivotal role in patient management vis-à-vis other medical staff and health care providers from within the hospital and from the community. Recurring patterns of communication difficulties occur within these relationships and appear to be associated with the occurrence of medical mishaps. CONCLUSION: The occurrence of everyday medical mishaps in this study is associated with faulty communication; but, poor communication is not simply the result of poor transmission or exchange of information. Communication failures are far more complex and relate to hierarchical differences, concerns with upward influence, conflicting roles and role ambiguity, and interpersonal power and conflict. A clearer understanding of these dynamics highlights possibilities for appropriate interventions in medical education and in health care organizations aimed at improving patient safety.

Resident perceptions of medical errors in the emergency department.

OBJECTIVES: To evaluate resident experience and perceptions of medical error associated with emergency department (ED) care. METHODS: Using a semistructured interview protocol, three researchers interviewed 26 randomly selected medical, surgical, and obstetrics residents regarding medical error. The authors chose a 16-case subset of incidents involving ED care for initial review. Interview transcripts were reviewed iteratively to draw out recurrent categories and themes. Two investigators separately analyzed all cases to ensure common understanding and agreement. RESULTS: Most cases involved misdiagnosis, misread radiographs, or inappropriate disposition. Two thirds of the case patients died or experienced delays in care. Residents felt that the complexity of the patients, as well as the complexity of their own jobs, contributed to error. Attending supervision, nurse evaluation, and additional physician involvement all were noted to be important checks within the hospital system. Residents most often held the ED responsible for error. In addition, they deemed themselves, their teams, and their lack of training responsible. Though residents often discussed events with their admitting teams, follow-up with the ED or other associated individuals was uncommon. The findings revealed seven common themes that include factors contributing to errors, checks and adaptations, and follow-up of the event. CONCLUSIONS: Residents are aware of medical error and able to recall events in detail. Whereas events are discussed among inpatient teams, little information finds its way back to the ED, potentially resulting in misunderstandings between departments and hindering learning from events. In-depth interviewing allows a nuanced and detailed approach to error analysis.

Management team learning orientation and business unit performance.

Although research has suggested that teams can differ in the extent to which they encourage proactive learning and competence development among their members (a team learning orientation), the performance consequences of these differences are not well understood. Drawing from research on goal orientation and team learning, this article suggests that, although a team learning orientation can encourage adaptive behaviors that lead to improved performance, it is also possible for teams to compromise performance in the near term by overemphasizing learning, particularly when they have been performing well. A test of this proposition in a sample of business unit management teams provides strong support. The results confirm that an appropriate emphasis on learning can have positive consequences for team effectiveness.