Abstract
By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice.
Highlights
The preparation of a treatment plan for delivery of radiation therapy to a patient requires several process steps and checks spread over about a week with interactions and handoffs between a heterogeneous set of caregivers, hardware, and software interfaces
While comparable to serious error rates in chemotherapy [5], a field that is technologically less complex than radiotherapy, the adverse error rates in radiation medicine are less favorable than those in blood transfusion and anesthesiology [3], or in aviation [6] – an industry that is cognate with radiation therapy in its hierarchical organizational structures and reliance on complex machinery
In this work we reviewed incidents reported in our Aspectsof-Care (AOC) incident-reporting database to extract causes and contributory factors for known failures [20] and conducted a Failure-Mode-and-Effects-Analysis (FMEA) on our process-map [21] to predict hypothetical effects relative to patient safety
Summary
The preparation of a treatment plan for delivery of radiation therapy to a patient requires several process steps and checks spread over about a week with interactions and handoffs between a heterogeneous set of caregivers, hardware, and software interfaces. The rate of serious or adverse errors in radiation therapy is estimated to be around 0.2% per patient [1,2,3,4]. Twelve pertinent topics appeared in more than three of these reports These were training, staffing, documentation, standard-operatingprocedures, incident learning, communication, checklists, quality control, preventive maintenance, dosimetric audits, accreditation, minimizing interruptions, prospective risk assessments, and safety culture. While such recommendations are clearly valuable, the message to translate them uniformly, effectively, and efficiently to clinical practice in multiple departments appears nebulous as this study highlights
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