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Title: SU-F-T-245: The Investigation of Failure Mode and Effects Analysis and PDCA for the Radiotherapy Risk Reduction

Abstract

Purpose: To optimize the clinical processes of radiotherapy and to reduce the radiotherapy risks by implementing the powerful risk management tools of failure mode and effects analysis(FMEA) and PDCA(plan-do-check-act). Methods: A multidiciplinary QA(Quality Assurance) team from our department consisting of oncologists, physicists, dosimetrists, therapists and administrator was established and an entire workflow QA process management using FMEA and PDCA tools was implemented for the whole treatment process. After the primary process tree was created, the failure modes and Risk priority numbers(RPNs) were determined by each member, and then the RPNs were averaged after team discussion. Results: 3 of 9 failure modes with RPN above 100 in the practice were identified in the first PDCA cycle, which were further analyzed to investigate the RPNs: including of patient registration error, prescription error and treating wrong patient. New process controls reduced the occurrence, or detectability scores from the top 3 failure modes. Two important corrective actions reduced the highest RPNs from 300 to 50, and the error rate of radiotherapy decreased remarkably. Conclusion: FMEA and PDCA are helpful in identifying potential problems in the radiotherapy process, which was proven to improve the safety, quality and efficiency of radiation therapy in our department. Themore » implementation of the FMEA approach may improve the understanding of the overall process of radiotherapy while may identify potential flaws in the whole process. Further more, repeating the PDCA cycle can bring us closer to the goal: higher safety and accuracy radiotherapy.« less

Authors:
; ; ; ;  [1]
  1. Fudan University Shanghai Cancer Center, Shanghai, Shanghai (China)
Publication Date:
OSTI Identifier:
22648861
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; ERRORS; HAZARDS; IMPLEMENTATION; MEDICAL PERSONNEL; PROCESS CONTROL; QUALITY ASSURANCE; RADIOTHERAPY

Citation Formats

Xie, J, Wang, J, P, J, Chen, J, and Hu, W. SU-F-T-245: The Investigation of Failure Mode and Effects Analysis and PDCA for the Radiotherapy Risk Reduction. United States: N. p., 2016. Web. doi:10.1118/1.4956385.
Xie, J, Wang, J, P, J, Chen, J, & Hu, W. SU-F-T-245: The Investigation of Failure Mode and Effects Analysis and PDCA for the Radiotherapy Risk Reduction. United States. doi:10.1118/1.4956385.
Xie, J, Wang, J, P, J, Chen, J, and Hu, W. 2016. "SU-F-T-245: The Investigation of Failure Mode and Effects Analysis and PDCA for the Radiotherapy Risk Reduction". United States. doi:10.1118/1.4956385.
@article{osti_22648861,
title = {SU-F-T-245: The Investigation of Failure Mode and Effects Analysis and PDCA for the Radiotherapy Risk Reduction},
author = {Xie, J and Wang, J and P, J and Chen, J and Hu, W},
abstractNote = {Purpose: To optimize the clinical processes of radiotherapy and to reduce the radiotherapy risks by implementing the powerful risk management tools of failure mode and effects analysis(FMEA) and PDCA(plan-do-check-act). Methods: A multidiciplinary QA(Quality Assurance) team from our department consisting of oncologists, physicists, dosimetrists, therapists and administrator was established and an entire workflow QA process management using FMEA and PDCA tools was implemented for the whole treatment process. After the primary process tree was created, the failure modes and Risk priority numbers(RPNs) were determined by each member, and then the RPNs were averaged after team discussion. Results: 3 of 9 failure modes with RPN above 100 in the practice were identified in the first PDCA cycle, which were further analyzed to investigate the RPNs: including of patient registration error, prescription error and treating wrong patient. New process controls reduced the occurrence, or detectability scores from the top 3 failure modes. Two important corrective actions reduced the highest RPNs from 300 to 50, and the error rate of radiotherapy decreased remarkably. Conclusion: FMEA and PDCA are helpful in identifying potential problems in the radiotherapy process, which was proven to improve the safety, quality and efficiency of radiation therapy in our department. The implementation of the FMEA approach may improve the understanding of the overall process of radiotherapy while may identify potential flaws in the whole process. Further more, repeating the PDCA cycle can bring us closer to the goal: higher safety and accuracy radiotherapy.},
doi = {10.1118/1.4956385},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = 2016,
month = 6
}
  • Purpose: To conduct a failure mode and effects analysis (FMEA) as per AAPM Task Group 100 on clinical processes associated with teletherapy, and the development of mitigations for processes with identified high risk. Methods: A FMEA was conducted on clinical processes relating to teletherapy treatment plan development and delivery. Nine major processes were identified for analysis. These steps included CT simulation, data transfer, image registration and segmentation, treatment planning, plan approval and preparation, and initial and subsequent treatments. Process tree mapping was utilized to identify the steps contained within each process. Failure modes (FM) were identified and evaluated with amore » scale of 1–10 based upon three metrics: the severity of the effect, the probability of occurrence, and the detectability of the cause. The analyzed metrics were scored as follows: severity – no harm = 1, lethal = 10; probability – not likely = 1, certainty = 10; detectability – always detected = 1, undetectable = 10. The three metrics were combined multiplicatively to determine the risk priority number (RPN) which defined the overall score for each FM and the order in which process modifications should be deployed. Results: Eighty-nine procedural steps were identified with 186 FM accompanied by 193 failure effects with 213 potential causes. Eighty-one of the FM were scored with a RPN > 10, and mitigations were developed for FM with RPN values exceeding ten. The initial treatment had the most FM (16) requiring mitigation development followed closely by treatment planning, segmentation, and plan preparation with fourteen each. The maximum RPN was 400 and involved target delineation. Conclusion: The FMEA process proved extremely useful in identifying previously unforeseen risks. New methods were developed and implemented for risk mitigation and error prevention. Similar to findings reported for adult patients, the process leading to the initial treatment has an associated high risk.« less
  • Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis. Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1–10). An RPN of highermore » than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies. Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planning with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150. Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments. Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.« less
  • The staff at three Washington State hospitals and Battelle Pacific Northwest Division have been collaborating to apply Failure Mode Effects and Criticality Analysis (FMECA) to assess several hospital processes. The staff from Kadlec Medical Center (KMC), located in Richland, Washington; Kennewick General Hospital (KGH), located in Kennewick, Washington; and Lourdes Medical Center (LMC), located in Pasco, Washington, along with staff from Battelle, which is located in Richland, Washington have been working together successfully for two and a half years. Tri-Cities Shared Services, a local organization which implements shared hospital services, has provided the forum for joint activity. This effort wasmore » initiated in response to the new JCAHO patient safety standards implemented in July 2001, and the hospitals’ desire to be more proactive in improving patient safety. As a result of performing FMECAs the weaknesses of six medical processes have been characterized and corresponding system improvements implemented. Based on this collective experience, insights about the benefits of applying FMECAs to healthcare processes have been identified.« less
  • Highlights: • This study is based on a real case in hospital in Taiwan. • We use Failure Mode and Effects Analysis (FMEA) as the evaluation method. • We successfully identify the evaluation factors of bio-medical waste disposal risk. - Abstract: Using the failure mode and effects analysis, this study examined biomedical waste companies through risk assessment. Moreover, it evaluated the supervisors of biomedical waste units in hospitals, and factors relating to the outsourcing risk assessment of biomedical waste in hospitals by referring to waste disposal acts. An expert questionnaire survey was conducted on the personnel involved in waste disposalmore » units in hospitals, in order to identify important factors relating to the outsourcing risk of biomedical waste in hospitals. This study calculated the risk priority number (RPN) and selected items with an RPN value higher than 80 for improvement. These items included “availability of freezing devices”, “availability of containers for sharp items”, “disposal frequency”, “disposal volume”, “disposal method”, “vehicles meeting the regulations”, and “declaration of three lists”. This study also aimed to identify important selection factors of biomedical waste disposal companies by hospitals in terms of risk. These findings can serve as references for hospitals in the selection of outsourcing companies for biomedical waste disposal.« less
  • Purpose: The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. Methods: The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of riskmore » priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. Results: The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. Conclusions: The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.« less