Academic emergency physicians and data scientists collaborated on a research program to reduce false alarms and to increase the utility of patient monitor systems for detecting significant cardiopulmonary events and clinical deterioration. An experimental hardware-software framework to study patient monitoring and alarm fatigue mitigation was implemented in 15 Emergency Department (ED) urgent care spaces of a regional medical center. Patients who triggered multi-parametric alerts [MPA] consisting of two or more red alarms (critical cardiac rhythm, heart rate [HR], blood pressure [BP], or oxygen saturation) within a 15-minute window were consented and matched into 1:1:1 study triads with patients who only triggered standard, single parameter (red) alarms [SPA] and those who remained in a non-alarm state [NA]. Study patients’ red alarms and triggering physiologic abnormalities (vital signs; cardiac rhythm and pulse oximetry photoplethysmography waveforms) were adjudicated and annotated for validity (chart review) and interpretability (clinician gestalt). Each subject was then followed for 3 months via in-network medical records. Subjects’ characteristics, alarms, clinical courses, and outcomes were descriptively and comparatively analyzed. The relationship between alarm-triggering waveform interpretability and alarm validity was analyzed with correlational statistics, along with the association between multi-parametric alerts and severity of patient state.Of 264 ED patients enrolled over 24 months, 183 matched into 61 triads matched for sex, age, Emergency Severity Index (ESI), and chief complaint; 27.1% of MPA, 10.9% of SPA, and 5.2% of NA subjects started care in ED critical care (X2(2)=6.47, p=0.04). MPA and SPA subjects triggered single parameter red alarms of all types, with a predominance of tachycardia and hypoxia alarms. Asystole and ventricular fibrillation/ventricular tachycardia (VFib/VTach) alarms were mostly adjudicated as non-valid, and hypoxia alarms were frequently of indeterminate validity, whereas HR and BP alarms were generally valid. Five (8.2%) MPA subjects and no SPA subjects (and no NA subjects) were transferred to ED critical care while monitored in the study area, X2(1)=9.41, p=0.002). Eleven (18.1%), five (8.2%), and two (3.3%) MPA, SPA, and NA subjects, respectively, were admitted from the ED to an intensive or intermediate care unit (p<0.001). Higher rates of symptomatic/unstable tachycardia (p=0.02) and post-ED escalation in care unit requirement (p=0.001) were recorded in MPA and SPA groups than in the NA group. Waveform interpretability scores in the 53 MPA subjects with complete data exhibited moderate positive correlation with the adjudicated validity of their red alarms, r(51)=0.528, p<0.001. The difference in composited 3-month tracer metrics between MPA and SPA groups did not attain statistical significance, although death (4.9%), Advanced Life Support (1.6%), and cardiac arrest (1.6%) were noted only in MPA patients.ED patient monitor datastreams were acquired and analyzed to explore novel biomedical engineering approaches to mitigate alarm fatigue. Safe experimentation in a live ED environment demonstrated the potential for near-real-time signals-level analysis of standard biomedical device outputs to differentiate true alarms from false alarms and to identify patients with a higher likelihood of poor outcomes.

This paper des cribes the use of heuristic evaluation on a clinical guideline for the treatmentof diabetic ketoacidosis, a medical emergency. After an hour of instruction, two novices tousability testing applied a heuristic tool revealing numerous usability issues in the dom ainsof metaphor, organization, typology and layout. When compared to Nielsen’s principles ofheuristics, the findings identified multiple sources of potential error. A dditionally, thispaper demonstrates that novices to usability testing can perform effective heuristicevaluation with limited training and the use of a heuristic tool. The findings will guideredesign of the studied guideline as well as prompt and more readily accessible usabilitytesting of other high-risk and high-volume clinical guidelines.

Human Factors and ergonomics (HFE) expertise continues to have difficulty integrating its experts into healthcare. This persistent disconnect is compounded by unique aspects of healthcare as an institution, industry and work system. Clinically-embedded HFE practitioners, a new HFE sub-specialty, are a conduit for addressing substantive mismatches between the two domains. Greater HFE penetration will require a fundamental change in stance for both domains, however, the burden will lie with HFE to be the more adaptive of the two. Learning more about the in situ work of this sub-specialty will provide insights for more nuanced approaches to bridging domain specific mismatches and obstacles.

With increasing emphasis on patient safety/quality improvement, health care systems are mirroring industry in the implementation of root cause analysis (RCA) for the identification and mitigation of errors. RCA uses a team approach with emphasis on the system, as opposed to the individual, to accrue empirical data on what happened and why. While many otolaryngologists have a broad understanding of RCA, practical experience is often lacking. Part II of this patient safety/quality improvement primer investigates the manner in which RCA is utilized in the prevention of medical errors. Attention is given to identifying system errors, recording adverse events, and determining which events warrant RCA. The primer outlines steps necessary to conduct an effective RCA, with emphasis placed on actions that arise from the RCA process through the root cause analysis and action (or RCA2) rubric. In addition, the article provides strategies for the implementation of RCA into clinical practice and medical education.

The quality of care delivered by orthopedic surgeons continues to grow in importance. Multiple orthopedic programs, organizations, and committees have been created to measure the quality of surgical care and reduce the incidence of medical adverse events. Structured root cause analysis and actions (RCA2) has become an area of interest. If performed thoroughly, RCA2 has been shown to reduce surgical errors across many subspecialties. The Accreditation Council for Graduate Medical Education has a new mandate for programs to involve residents in quality improvement processes. Resident engagement in the RCA2 process has the dual benefit of educating trainees in patient safety and producing meaningful changes to patient care that may not occur with traditional quality improvement initiatives. The RCA2 process described in this article can provide a model for the development of quality improvement programs. In this article, the authors discuss the history and methods of the RCA2 process, provide a stepwise approach, and give a case example. [Orthopedics. 2017; 40(4):e628-e635.].

Objectives: (1) To develop a clinical microsystem simulation methodology for alarm fatigue research with a human factors engineering (HFE) assessment framework and (2) to explore its application to the comparative examination of different approaches to patient monitoring and provider notification. Background: Problems with the design, implementation, and real-world use of patient monitoring systems result in alarm fatigue. A multidisciplinary team is developing an open-source tool kit to promote bedside informatics research and mitigate alarm fatigue. Method: Simulation, HFE, and computer science experts created a novel simulation methodology to study alarm fatigue. Featuring multiple interconnected simulated patient scenarios with scripted timeline, “distractor” patient care tasks, and triggered true and false alarms, the methodology incorporated objective metrics to assess provider and system performance. Developed materials were implemented during institutional review board–approved study sessions that assessed and compared an experimental multiparametric alerting system with a standard monitor telemetry system for subject response, use characteristics, and end-user feedback. Results: A four-patient simulation setup featuring objective metrics for participant task-related performance and response to alarms was developed along with accompanying structured HFE assessment (questionnaire and interview) for monitor systems use testing. Two pilot and four study sessions with individual nurse subjects elicited true alarm and false alarm responses (including diversion from assigned tasks) as well as nonresponses to true alarms. In-simulation observation and subject questionnaires were used to test the experimental system’s approach to suppressing false alarms and alerting providers. Conclusions: A novel investigative methodology applied simulation and HFE techniques to replicate and study alarm fatigue in controlled settings for systems assessment and experimental research purposes.

Providing quality patient care is a basic tenant of medical and surgical practice. Multiple orthopaedic programs, including The Patient Safety Committee of the American Academy of Orthopaedic Surgeons (AAOS), have been implemented to measure quality of surgical care, as well as reduce the incidence of medical errors. Structured Root Cause Analysis (RCA) has become a recent area of interest and, if performed thoroughly, has been shown to reduce surgical errors across many subspecialties. There is a paucity of literature on how the process of a RCA can be effectively implemented. The current review was designed to provide a structured approach on how to conduct a formal root cause analysis. Utilization of this methodology may be effective in the prevention of medical errors.

While the FDA provides guidance documents on the application of human factors and usability engineering (HF/UE) to medical devices, the non-specific, recommendatory nature of these documents can lead to varying interpretation by the different entities involved in the HF/UE process. While appropriate HF/UE processes are beneficial to all stakeholders, whether it be the end user, the patient, the medical device manufacturer, a third party HF/UE consultant, or the FDA, the lack of a common understanding of the process combined with the differing perspectives, constraints, and drivers of each party, can lead to inconsistent, and less-than-ideal, implementation of HF/UE. This is exacerbated by the fact that financial incentives may not be aligned with optimizing safety and usability at the expense of development time. This presents the potential for business and ethical conflicts among the involved parties. Our expert panel will review the perspectives of the various stakeholders involved in the HF/UE process and facilitate a meaningful discussion on how a common understanding of HF/UE as it relates to medical device development and regulatory approval can be achieved across the medical device industry. We will focus on the implications of improper application of HF/UE processes and methods to better manage discrepancies in HF/UE implementation, and discuss the impact of the recently-released FDA final guidance.

Introduction Patient safety during emergency department procedural sedation (EDPS) can be difficult to study. Investigators sought to delineate and experimentally assess EDPS performance and safety practices of senior-level emergency medicine residents through in situ simulation. Methods Study sessions used 2 pilot-tested EDPS scenarios with critical action checklists, institutional forms, embedded probes, and situational awareness questionnaires. An experimental informatics system was separately developed for bedside EDPS process guidance. Postgraduate year 3 and 4 subjects completed both scenarios in randomized order; only experimental subjects were provided with the experimental system during second scenarios. Results Twenty-four residents were recruited into a control group (n = 12; 6.2 ± 7.4 live EDPS experience) and experimental group (n = 12; 11.3 ± 8.2 live EDPS experience [P = 0.10]). Critical actions for EDPS medication selection, induction, and adverse event recognition with resuscitation were correctly performed by most subjects. Presedation evaluations, sedation rescue preparation, equipment checks, time-outs, and documentation were frequently missed. Time-outs and postsedation assessments increased during second scenarios in the experimental group. Emergency department procedural sedation safety probe detection did not change across scenarios in either group. Situational awareness scores were 51% ± 7% for control group and 58% ± 12% for experimental group. Subjects using the experimental system completed more time-outs and scored higher Simulation EDPS Safety Composite Scores, although without comprehensive improvements in EDPS practice or safety. Conclusions Study simulations delineated EDPS and assessed safety behaviors in senior emergency medicine residents, who exhibited the requisite medical knowledge base and procedural skill set but lacked some nontechnical skills that pertain to emergency department microsystem functions and patient safety. The experimental system exhibited limited impact only on in-simulation time-out compliance.

OBJECTIVES:The objectives were to develop a scientifically sound and feasible peer-to-peer assessment model that allows health-care organizations to evaluate patient safety in cardiovascular operating rooms and to establish safety priorities for improvement.METHODS:The locating errors through networked surveillance study was conducted to identify hazards in cardiac surgical care. A multidisciplinary team, composed of organizational sociology, organizational psychology, applied social psychology, clinical medicine, human factors engineering, and health services researchers, conducted the study. We used a transdisciplinary approach, which integrated the theories, concepts, and methods from each discipline, to develop comprehensive research methods. Multiple data collection was involved: focused literature review of cardiac surgery-related adverse events, retrospective analysis of cardiovascular events from a national database in the United Kingdom, and prospective peer assessment at 5 sites, involving survey assessments, structured interviews, direct observations, and contextual inquiries. A nominal group methodology, where one single group acts to problem solve and make decisions was used to review the data and develop a list of the top priority hazards.RESULTS:The top 6 priority hazard themes were as follows: safety culture, teamwork and communication, infection prevention, transitions of care, failure to adhere to practices or policies, and operating room layout and equipment.CONCLUSIONS:We integrated the theories and methods of a diverse group of researchers to identify a broad range of hazards and good clinical practices within the cardiovascular surgical operating room. Our findings were the basis for a plan to prioritize improvements in cardiac surgical care. These study methods allowed for the comprehensive assessment of a high-risk clinical setting that may translate to other clinical settings.

Objectives The objectives were to develop a scientifically sound and feasible peer-to-peer assessment model that allows health-care organizations to evaluate patient safety in cardiovascular operating rooms and to establish safety priorities for improvement. Methods The locating errors through networked surveillance study was conducted to identify hazards in cardiac surgical care. A multidisciplinary team, composed of organizational sociology, organizational psychology, applied social psychology, clinical medicine, human factors engineering, and health services researchers, conducted the study. We used a transdisciplinary approach, which integrated the theories, concepts, and methods from each discipline, to develop comprehensive research methods. Multiple data collection was involved: focused literature review of cardiac surgery-related adverse events, retrospective analysis of cardiovascular events from a national database in the United Kingdom, and prospective peer assessment at 5 sites, involving survey assessments, structured interviews, direct observations, and contextual inquiries. A nominal group methodology, where one single group acts to problem solve and make decisions was used to review the data and develop a list of the top priority hazards. Results The top 6 priority hazard themes were as follows: safety culture, teamwork and communication, infection prevention, transitions of care, failure to adhere to practices or policies, and operating room layout and equipment. Conclusions We integrated the theories and methods of a diverse group of researchers to identify a broad range of hazards and good clinical practices within the cardiovascular surgical operating room. Our findings were the basis for a plan to prioritize improvements in cardiac surgical care. These study methods allowed for the comprehensive assessment of a high-risk clinical setting that may translate to other clinical settings.

Because there are many potential risks in the MR environment and reports of adverse incidents involving patients, equipment and personnel, the need for a guidance document on MR safe practices emerged. Initially published in 2002, the ACR MR Safe Practices Guidelines established de facto industry standards for safe and responsible practices in clinical and research MR environments. As the MR industry changes the document is reviewed, modified and updated. The most recent version will reflect these changes. J. Magn. Reson. Imaging 2013;37:501–530. © 2013 Wiley Periodicals, Inc.

Introduction Emergency department procedural sedation (EDPS) is becoming widespread. Simulation may enhance patient safety through evidence-based training, effective assessment, and research of EDPS operators in pertinent knowledge, skills, processes, and teamwork. Methods Investigators developed a 2-scenario in situ simulation-based methodology and research tool kit for objective examination of EDPS practice. The emphasis was on protocol-driven presedation preparation, intrasedation vigilance and readiness for adverse events, and postsedation reassessment. Pilot sessions were conducted to test the methodology at an academic 719-bed hospital, with Institutional Review Board approval. Results Five interns and 5 attending emergency physicians completed pilot sessions resulting in protocol revisions to optimize simulation consistency, research tool sets, data acquisition, and operational conditions. Pilot data sets demonstrated interscenario consistency and intersubject reproducibility for timing, progression, and duration of critical EDPS events; high levels of perceived realism and relevance; and utility and suggested validity of the study methodology as an EDPS research mechanism. Small sample sizes limited the study methodology’s ability to distinguish between the subject groups’ clinical performances (critical action completion, probe detection, and situational awareness) except with composite scoring of presedation and postsedation assessments. Key EDPS preparation, adverse event management, and reassessment actions were selected to derive a Simulation EDPS Safety Composite Score that differentiated inexperienced [4.60 ± 0.8 on a 10-point score (n = 3)] and experienced EDPS operators [8.95 ± 1.03 (n = 5); P = 0.0007]. Conclusions In situ simulation is a useful and relevant means to investigate EDPS patient safety. Pilot sessions have cleared the way for further experimental safety intervention research and development with the simulation-based methodology.

BACKGROUND:The need to provide efficient, effective, and safe patient care is of paramount importance. However, most physicians receive little or no formal training to prepare them to address patient safety challenges within their clinical practice.METHODS:We describe a comprehensive Patient Safety Learning Program (PSLP) for internal medicine and medicine-pediatrics residents. The curriculum is designed to teach residents key concepts of patient safety and provided opportunities to apply these concepts in the "real" world in an effort to positively transform patient care. Residents were assigned to faculty expert-led teams and worked longitudinally to identify and address patient safety conditions and problems. The PSLP was assessed by using multiple methods.RESULTS:Resident team-based projects resulted in changes in several patient care processes, with the potential to improve clinical outcomes. However, faculty evaluations of residents were lower for the Patient Safety Improvement Project rotation than for other rotations. Comments on "unsatisfactory" evaluations noted lack of teamwork, project participation, and/or responsiveness to faculty communication. Participation in the PSLP did not change resident or faculty attitudes toward patient safety, as measured by a comprehensive survey, although there was a slight increase in comfort with discussing medical errors.CONCLUSIONS:Development of the PSLP was intended to create a supportive environment to enhance resident education and involve residents in patient safety initiatives, but it produced lower faculty evaluations of resident for communication and professionalism and did not have the intended positive effect on resident or faculty attitudes about patient safety. Further research is needed to design or refine interventions that will develop more proactive resident learners and shift the culture to a focus on patient safety.

Objective: To describe the washout effect after stopping a prevention checklist for ventilator-associated pneumonia (VAP).Methods: VAP rates were prospectively monitored for special cause variation over 42 months in a paediatric intensive care unit. A VAP prevention bundle was implemented, consisting of head of bed elevation, oral care, suctioning device management, ventilator tubing care, and standard infection control precautions. Key practices of the bundle were implemented with a checklist and subsequently incorporated into the nursing and respiratory care bedside flow sheets to achieve long-term sustainability. Compliance with the VAP bundle was monitored throughout. The timeline for the project was retrospectively categorised into the benchmark phase, the checklist phase (implementation), the checklist washout phase, and the flowsheet phase (cues in the flowsheet).Results: During the checklist phase (12 months), VAP bundle compliance rose from < 50% to > 75% and the VAP rate fell from 4.2 to 0.7 infections per 1000 ventilator days (p < 0.059). Unsolicited qualitative feedback from frontline staff described overburdensome documentation requirements, form fatigue, and checklist burnout. During the checklist washout phase (4 months), VAP rates rose to 4.8 infections per 1000 ventilator days (p < 0.042). In the flowsheet phase, the VAP rate dropped to 0.8 infections per 1000 ventilator days (p < 0.047).Conclusions: Salient cues to drive provider behaviour towards best practice are helpful to sustain process improvement, and cessation of such cues should be approached warily. Initial education, year-long habit formation, and effective early implementation demonstrated no appreciable effect on the VAP rate during the checklist washout period.

We are all "hard wired" to have limited ability to quickly and accurately communicate and work with each other. These limitations are especially acute in our urgent, stressful, and interruption-filled world. New views on these limitations include phenomena-like situational awareness and inattentional blindness. Development and testing of communication tools and interventions to improve communication and handoffs has undergone some research evaluation, but is mainly evidence-guided. Understanding human limitations in ability to communicate will help us create, test, and continually judge communication tools, especially automation and team training.

Many hospitals and medical device manufacturers are making patient safety a top priority. When medical devices or software have poor usability, they represent latent failures, or accidents waiting to happen. Not only can these latent failures cause harm to the patient, they can also cause injury, unnecessary cognitive workload, and inefficiency for the healthcare worker. Human factors engineering (HFE) principles and methods can assist in finding and fixing these patient safety problems. However, often these methods require expertise in the discipline of HFE. We discuss here 10 simple ways that can be used by HFE novices and experts alike to identify HFE hazards that could otherwise be overlooked.