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[Audio] According to The Institute of Medicine ( IOM, 2001), a medical error is "The failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim ( Spath, 2021)." Therefore, medical errors can be considered preventable adverse events or sentinel events. This suggests most medical errors (negative outcomes) are the result of process failures. Although medical errors do not have an established definition, a root cause analysis ( RCA) can be conducted to investigate the underlying cause of process failures. There are two major types of medical errors ( Rodziewicz, et al., 2022): Errors of omission ( outcome of action not taken) Errors of commission (outcome of the wrong action taken) Deviations or variations of a process are influenced by structural factors, or characteristics of the healthcare setting, clinical personnel, tools, resources available to administer care, and physical infrastructure (Spath, 2021). Errors of omission or commission may be intentional or unintentional. This strongly supports the notion that systemic issues not unnecessarily specific to human error may be the source of medical errors. Furthermore, the variations of structural factors were not minimized before designing a process. For instance, workload imbalances can cause severe burnout in research nurses. He or she may not be able to complete tasks related to scheduling patient visits. As a result, the patient's condition worsened because the nurse was not able to schedule the treatment. A root cause analysis (RCA) is a process a healthcare manager can leverage to identify underlying causes for deviations in performance. A common technique used in an RCA is to visually map categories of possible causes using a Fishbone diagram. If a process RCA framework is adopted, the process failure can be annotated in the head of the Fishbone diagram. The fins of the model represent or brainstorms all possible causes. If the healthcare setting is considered a High -Reliability Organization ( HRO), the team will be brainstorming whether the process failure was caused by a missing structural element. The team can also draft timeline of events of the process failure. The timeline of events can be listed on a separate document to complement the investigation of the primary root cause (s). Managers can use 24 questions recommended by the Joint Commission to evaluate possible causes of the Fishbone Diagram. The 24-question framework recommended by the Joint Commission investigates a variety of situational factors related to systematic factors that influence process failure. ( Singh, et al., 2022). A 5-Whys Analysis is the simplest model for teams who are proficient with the process. The process is very simple and uses seven steps in the RCA: Convene SME and Owners of the Process Define the Process Failure Ask Why the Process Failure Occurred (Record Response) Ask Why x 4 ( Record Response) Determine if "Why" limit is reached (no longer can aggregate a cause) Apply Corrective Action (Implement Solution) Apply Preventative Action (Implement a Method to Monitor the Process) Using the research nurse example, let's apply the 5 Why's to identify possible root causes: Director of Regulatory Operations convenes as meeting with 3 SME who are delegated to a research study to conduct a RCA of the unscheduled patient visit. The director defines the issue as "unscheduled patient visit Why did the research nurse fail to schedule the patient visit for treatment? [ 1]A – Burnout Why was the nurse experiencing burnout [ 2] Staff Turnover T- Why did staff turnover cause burnout?[3]A - Workload imbalance T - Why did workload imbalance cause staff turnover?[4]A - No workload balancing feasibility committee to access the impacts of complex study protocols T- Why is no workload balancing feasibility committee?[5] A – Director not aware of workload balancing frameworks or the existence of feasibility committees that developed tools that scored logistical challenges of research protocols (e.g., Phase 1 trials) The director shows appreciation for the brainstorming and considers that a workload balancing committee is indicated to fix issues with missed scheduling. Furthermore, two similar protocol deviations were reported to the Institutional Review Board on the same study. She understood that the likely root cause was related to an unstructured delegation of study protocols. She immediately instructs the research nurse to reschedule the visit asap so that the patient receives treatment. The date the patient received treatment was recorded. Concomitant medications to treat the adverse effects of the delayed treatment were covered by the site. In addition, the standard-of-care treatments previously billed to the patient were reimbursed and remaining treatments for that indication were fully covered by the site. Larger stipends were also provided to the patient during visits with an option to receive home health visits to substitute for non-treatment visits (reduced travel burden). The patient remarked being highly satisfied with the research team's effort in correcting the scheduling error. (Corrective Action) She conducted a literature review based on the workload balancing suggestions made by one of her specialists. She proposed using a workload balance tool called Ontario Protocol Assessment Level ( OPAL) to improve study protocol delegation of all the staff to higher authority. In addition, she proposed that a workload feasibility committee should be established and comprised of all department heads of the research site. The committee would monitor impacts of workload per protocol complexity on the research staff (e.g., missed scheduling) ( Preventative Action).
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