Diagnostic errors comprise the leading threat to patient safety in healthcare today. Learning how to extract the lessons from cases where diagnosis succeeds or fails is a promising approach to improve diagnostic safety going forward. We present up-to-date and authoritative guidance on how the existing approaches to conducting root cause analyses (RCA's) can be modified to study cases involving diagnosis. There are several diffierences: In cases involving diagnosis, the investigation should begin immediately after the incident, and clinicians involved in the case should be members of the RCA team. The review must include consideration of how the clinical reasoning process went astray (or succeeded), and use a human-factors perspective to consider the system-related contextual factors in the diagnostic process. We present detailed instructions for conducting RCA's of cases involving diagnosis, with advice on how to identify root causes and contributing factors and select appropriate interventions.

Learning Objectives: 1) Understand real world presentation of Giant Cell Arteritis (GCA).2) Identify types of bias leading to a delayed GCA diagnosis.Case Report: A 72-year-old male presented with multiple complaints, including scrotal pain, transient vision loss, fatigue, weight loss and new headaches.ED work-up showed leukocytosis and aortic dilation on imaging.Clinicians recommended further work-up for possible infection but did not raise concern for GCA.The patient declined admission but re-presented 2 days later endorsing similar symptoms.Ultrasound showed epididymitis for which he received Bactrim.He presented to clinic several days later with "confusion" which was attributed to Bactrim.The following week, he represented with scrotal pain and confusion.Ultrasound showed improving epididymitis, but his symptoms were attributed to epididymitis, and he was prescribed cefpodoxime.Three days later, he re-presented with worsening headaches, temporal swelling, and elevated CRP, prompting admission.He underwent temporal artery biopsy which confirmed GCA.Discussion: GCA is the most common systemic vasculitis and should be considered for patients over 50 who have new headaches, visual disturbances, and vascular abnormalities.Patients may also present with confusion.Prompt identification and treatment with corticosteroids is imperative as untreated GCA can progress to blindness.Despite his age and multiple complaints consistent with GCA, this diagnosis was not initially considered.His presentation was attributed to epididymitis, which interestingly has been associated with GCA.This patient is emblematic of broader issues in prompt GCA diagnosis, which takes a mean of 9 weeks from symptom onset.Heuristics are a helpful tool for physicians to make diagnoses.However, using mental shortcuts may have played a role in this delay, as GCA is more common in females.Anchoring bias may also have contributed.This patient endorsed persistent scrotal pain and was diagnosed with epididymitis, which may have clouded his additional complaints.

Purpose/Problem: Electronic health record (EHR) based simulation provides an opportunity to teach and evaluate clinical reasoning and decision-making skills in a high-fidelity environment.We developed an EHR-simulation session for pediatric residents aimed at introducing diagnostic decision-making tools to overcome cognitive bias; participation was associated with persistent changes to EHR use patterns in clinical practice.Using the Situation Awareness Global Assessment Technique (SAGAT), we developed an instrument to stratify simulation performance across three domains: perception of relevant information, comprehension of information, and projection of potential outcomes.In this study, we conducted the session in a new population, clerkship medical students.Methods: The simulation and assessment were administered to clerkship medical students at the Perelman School of Medicine, as part of a required online course.Students were directed to assume the role of an admitting resident and were given 15 minutes to review a simulated EHR chart of an infant with physiologic hyperbilirubinemia and complete a simplified SAGAT.While documentation suggests the patient is stable, embedded safety probes, including unstable vital signs and labs, suggest neonatal sepsis.The session concluded with a virtual debriefing session to review the case and emphasize the utility of data visualization and information retrieval tools in the EHR.Outcomes: Five cohorts of clerkship medical students (n=106) participated in the simulation.The vast majority (96.2%) correctly perceived the heart rate.In the comprehension domain, 38.1% of students included abnormal vital signs and/or sepsis in a problem representation of the case.Responses on the projection item were mixed-58.5% of students concluded that the patient was stable for transfer to the floor, while the remainder thought more discussion was needed (34%) or that the patient was not stable for transfer (7.5%).Discussion: We implemented an EHR based simulation and decision-making assessment in clerkship medical students.Initial results indicate that medical students perform similarly to pediatrics residents in the perception and comprehension domains of the instrument.More detailed analysis is required to confirm and explore this trend.This study demonstrates that this simulation and assessment tool can be applied to different levels of learner.Significance: EHR based simulation provides an opportunity to evaluate and address deficits in diagnostic decisionmaking.A simulation-based strategy for assessment of clinical decision-making in medical students can be used to enhance clinical reasoning and diagnostic error education.

Background:The prevailing theory regarding disparities in diagnostic errors in primary care suggests implicit bias, and clinical reasoning as the major causal factors.This view is limited to physician-related factors, and excludes patient, system, and policy factors, as well as their interdependencies.Furthermore, we have yet to ascertain the views of ethnic minority patients on the contributors to diagnostic errors, specifically communication failures within the diagnostic process.Methods: In 2019, the authors performed four focus groups of adult Latino community members in Spanish and English, in San Antonio, Texas.Participants were recruited through community centers, churches, and community health worker, or promotors, networks.Each participant experienced a primary care diagnostic workup in the past year.The focus groups, which were audio recorded and transcribed verbatim, discussed participant's perceptions of the communication (e.g., face-to-face, electronic, telephone, and written) with their primary care clinic team during a new symptom evaluation.The Spanish transcripts were translated into English by a professional translation service.Two reviewers coded the transcripts using the National Academy of Medicine's Diagnostic Process as a guiding framework.The major themes arose from inductive analysis of the data.Results: Twenty-eight participants were included in focus groups.The average participant age was 54.Participants identified eight key contributors to communication-based errors in primary care.Language discordance, patient-physician mistrust, and objectification were the most commonly referenced contributing factors to communication failures during diagnostic workups.Participants acknowledged their position in a complex network of interdependent, communication-driven relationships, which serve to further alienate those unable to navigate the healthcare system.Conclusion: Despite patient reporting communication failures, they are yet unmeasured by current methodologic advancements in the field of diagnostic safety.Further investigation into these processes may uncover roles for medical education, policy and health care organization interventions to improve patient safety.

Background: Delays in cancer diagnosis can result from lack of timely follow-up of positive fecal occult blood tests (FOBT) and iron-deficiency anemia (IDA) for colorectal cancer (CRC) and elevated serum alpha-fetoprotein (AFP) levels for hepatocellular carcinoma (HCC).The VA implemented the patient-centered medical home (PCMH) model in 2010-2011 to provide patient-driven, team-based care with goals of improving healthcare outcomes.We hypothesized that PCMH will improve timely follow up of FOBT, IDA and AFP tests nationally in the VA.Methods: To identify patients with delayed follow-up after abnormal results, we applied previously validated electronic "trigger" algorithms to VA's national repository of electronic health record data.The trigger included patients with newly abnormal test results, excluding patients for whom follow-up was not required or action had been completed within 60 days of result.Positive predictive values of 57.0%, 55.1% and 82.3% for FOBT, IDA and AFP respectively, were higher than other known measures of diagnostic safety.We applied each trigger to all patients from 130 VA facilities across 18 national VA networks from 2006-2015.We derived yearly counts of trigger-positive patients based on VA facility and VA network to assess annual percent changes beginning in 2006.Negative binomial regression models were applied to assess overall and yearly changes in number of trigger-positive patients while accounting for clustering by VA network, over-dispersion and correlation due to repeated measures.An offset was created using expected number of trigger-positive patients by facility that adjusted for year and number of patients with primary care provider (PCP) visits that year.Final models were adjusted for VA network and PCP visits that year.Results: After excluding patients not meeting inclusion criteria, 5,887,006 and 37,762,419 patients had tests for FOBT and IDA from 2006-2015, respectively.Of patients who received FOBT tests, 245,776 patients met trigger-positive criteria and of those who received IDA tests, 303,323 met trigger-positive criteria.Similarly, 888,033 patients received AFP tests, with 12,098 patients meeting trigger-positive criteria.The trigger-positive count means for FOBT, IDA and AFP tests increased immediately following PCMH implementation, however the trigger-positive count means in subsequent years fluctuated between and among tests.Variability was also found by VA network, most likely due to facility size and complexity.Conclusion: Primary care medical home implementation does not appear to improve follow-up of abnormal test results that warrant cancer evaluation.Further contextual evaluation to explore lack of impact from this teamwork-based intervention is warranted.