Using failure mode and effects analysis (FMEA) to generate an initial plan check checklist for improved safety in radiation treatment

Abstract

To apply failure mode and effect analysis (FMEA) to generate an effective and efficient initial physics plan checklist. Methods: A team of physicists, dosimetrists, and therapists was setup to reconstruct the workflow processes involved in the generation of a treatment plan beginning from simulation. The team then identified possible failure modes in each of the processes. For each failure mode, the severity (S), frequency of occurrence (O), and the probability of detection (D) was assigned a value and the risk priority number (RPN) was calculated. The values assigned were based on TG 100. Prior to assigning a value, the team discussed the values in the scoring system to minimize randomness in scoring. A local database of errors was used to help guide the scoring of frequency. Results: Twenty-seven process steps and 50 possible failure modes were identified starting from simulation to the final approved plan ready for treatment at the machine. Any failure mode that scored an average RPN value of 20 or greater was deemed "eligible" to be placed on the second checklist. In addition, any failure mode with a severity score value of 4 or greater was also considered for inclusion in the checklist. As a by-product of this procedure, safety improvement methods such as automation and standardization of certain processes (e.g., dose constraint checking, check tools), removal of manual transcription of treatment-related information as well as staff education were implemented, although this was not the team's original objective. Prior to the implementation of the new FMEA-based checklist, an in-service for all the second checkers was organized to ensure further standardization of the process. Conclusion: The FMEA proved to be a valuable tool for identifying vulnerabilities in our workflow and processes in generating a treatment plan and subsequently a new, more effective initial plan checklist was created.

Failure modes and effects analysis for surface‐guided DIBH breast radiotherapy

“…It would be burdensome to produce an action plan for every failure mode, and that is not the intent according to TG‐100; it is often a compromise in choosing only the highest priority processes to improve with the available resources to act upon them. 7 As others have done, 10 , 11 we have chosen a somewhat arbitrary RPN threshold (1 SD from mean = 92), but more consideration was given to narrowing down our final selections from those 33 failure modes. The variance was calculated for each process/failure mode: those with a high variance were chosen precisely because there was vast disagreement between members of the cohort.…”

“… 4 FMEA has been used in many areas of radiation oncology, including processes already deemed to be risky such as SBRT/SRS (sometimes in the presence of SGRT) as well as treatment planning system and equipment commissioning, but also to analyze more routine situations such as quality assurance (QA), treatment delays, and chart checks. 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 Implementation has typically involved a group of experts determining the various opportunities for failure in a given process and then scoring the risks (individually or by consensus) based on standard variables. These variables include the likelihood for occurrence, detectability, and severity; the product of these 3 variables forms a risk priority number (RPN) which is used to compare different potential failures in a process.…”

Using Failure Mode and Effects Analysis to Evaluate Risk in the Clinical Adoption of Automated Contouring and Treatment Planning Tools

“…A failure mode and effects analysis (FMEA) has been used to examine the weaknesses of new technologies, helping to predict and mitigate potential errors. [17][18][19] In this study, we applied the FMEA approach to the RPA to understand the risk of deploying this tool in clinics locally and in low-and middle-income countries. Based on the results of our FMEA, changes were made to the RPA workflow to reduce associated risk.…”

Financial and Safety Impact of Simulation-based Clinical Systems Testing on Pediatric Trauma Center Transitions

“…[6][7][8] Once LSTs are identified, they can be better characterized and prioritized using failure mode and effects analysis (FMEA), an established tool for investigating failures, their etiology, and their consequences. [9][10][11][12] The utility and benefits of FMEA have been recognized by the Agency for Healthcare Research and Quality, the Institute for Healthcare Improvement, and the Joint Commission. Terminology and definitions are provided for reference in Table 1.…”