Patient Safety/Quality Improvement Primer, Part II: Prevention of Harm Through Root Cause Analysis and Action (RCA2).

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.

Root Cause Analysis and Actions for the Prevention of Medical Errors: Quality Improvement and Resident 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.].

Development and Application of a Clinical Microsystem Simulation Methodology for Human Factors-Based Research of Alarm Fatigue.

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.

How to perform a root cause analysis for workup and future prevention of medical errors: a review.

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.

In situ medical simulation investigation of emergency department procedural sedation with randomized trial of experimental bedside clinical process guidance intervention.

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.

Locating Errors Through Networked Surveillance: A Multimethod Approach to Peer Assessment, Hazard Identification, and Prioritization of Patient Safety Efforts in Cardiac Surgery.

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.

ACR guidance document on MR safe practices: 2013.

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.

Pilot-phase findings from high-fidelity In Situ medical simulation investigation of emergency department procedural sedation.

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.

Rebound in ventilator-associated pneumonia rates during a prevention checklist washout period.

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.

Competence in patient safety: a multifaceted experiential educational intervention for resident physicians.

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.

Conclusion: You need human factors engineering expertise to see design hazards that are hiding in "plain sight!".

BACKGROUND: The Human Factors Engineering (HFE) series was launched to share the ideas and methods to aid deeper analyses of adverse events and provide tools to ensure more effective and lasting therapies. Articles in the series showed how human limitations and capabilities were important design issues in a variety of areas, ranging from labels and warnings to work place design and complex decision support systems. REMAINING QUESTIONS: After reading all the articles, one might ask a number of questions, such as who made all our "puzzle rooms?" How did it happen that so many device components "masquerade" as each other yet perform very distinct functions? What are the procurement systems that gave us medication containers, tubing, and connectors that are hard to see and easy to misconnect? Behind all those questions remains a key query: what stands in the way of developing or hiring the expertise to see and fix these catastrophic design hazards "hiding in plain sight?" SUMMARY AND CONCLUSION: HFE has already found its way into health care organizations and industry. As with most large changes in professions and industries, many small steps will need to be taken toward applying HFE methods and principles to the large problems of patient safety. But there already ample incentives and tools to start transforming your health care delivery or manufacturing organization.

John M. Eisenberg Patient Safety Awards. System innovation: Veterans Health Administration National Center for Patient Safety.

BACKGROUND: In 1998 the Veterans Health Administration (VHA) created the National Center for Patient Safety (NCPS) to lead the effort to reduce adverse events and close calls systemwide. NCPS's aim is to foster a culture of safety in the Department of Veterans Affairs (VA) by developing and providing patient safety programs and delivering standardized tools, methods, and initiatives to the 163 VA facilities. A NOVEL APPROACH: To create a system-oriented approach to patient safety, NCPS looked for models in fields such as aviation, nuclear power, human factors, and safety engineering. Core concepts included a non-punitive approach to patient safety activities that emphasizes systems-based learning, the active seeking out of close calls, which are viewed as opportunities for learning and investigation, and the use of interdisciplinary teams to investigate close calls and adverse events through a root cause analysis (RCA) process. Participation by VA facilities and networks was voluntary. NCPS has always aimed to develop a program that would be applicable both within the VA and beyond. KEY ACTION ITEMS AND RESULTS RELATED TO RCA: NCPS's full patient safety program was tested and implemented throughout the VA system from November 1999 to August 2000. Program components included an RCA system for use by caregivers at the front line, a system for the aggregate review of RCA results, information systems software, alerts and advisories, and cognitive acids. Following program implementation, NCPS saw a 900-fold increase in reporting of close calls of high-priority events, reflecting the level of commitment to the program by VHA leaders and staff.