Improving the safety of radiotherapy treatment processes via incident-driven FMEA feedback loops.
error rates
failure mode and effects analysis (FMEA)
incident reporting system (IRS)
radiotherapy
risk assessment
Journal
Journal of applied clinical medical physics
ISSN: 1526-9914
Titre abrégé: J Appl Clin Med Phys
Pays: United States
ID NLM: 101089176
Informations de publication
Date de publication:
05 Aug 2024
05 Aug 2024
Historique:
revised:
22
05
2024
received:
20
03
2024
accepted:
26
06
2024
medline:
5
8
2024
pubmed:
5
8
2024
entrez:
5
8
2024
Statut:
aheadofprint
Résumé
Failure mode and effects analysis (FMEA) is a valuable tool for radiotherapy risk assessment, yet its outputs might be unreliable due to failures not being identified or due to a lack of accurate error rates. A novel incident reporting system (IRS) linked to an FMEA database was tested and evaluated. The study investigated whether the system was suitable for validating a previously performed analysis and whether it could provide accurate error rates to support the expert occurrence ratings of previously identified failure modes. Twenty-three pre-identified failure modes of our external beam radiotherapy process, covering the process steps from patient admission to treatment delivery, were proffered on dedicated FMEA feedback and incident reporting terminals generated by the IRS. The clinical setting involved a computed tomography scanner, dosimetry, and five linacs. Incoming reports were used as basis to identify additional failure modes or confirm initial ones. The Kruskal-Wallis H test was applied to compare the risk priorities of the retrospective and prospective failure modes. Wald's sequential probability ratio test was used to investigate the correctness of the experts' occurrence ratings by means of the number of incoming reports. Over a 15-month period, 304 reports were submitted. There were 0.005 (confidence interval [CI], 0.0014-0.0082) reported incidents per imaging study and 0.0006 (CI, 0.0003-0.0009) reported incidents per treatment fraction. Sixteen additional failure modes could be identified, and their risk priorities did not differ from those of the initial failure modes (p = 0.954). One failure mode occurrence rating could be increased, whereas the other 22 occurrence ratings could not be disproved. Our approach is suitable for validating FMEAs and deducing additional failure modes on a continual basis. Accurate error rates can only be provided if a sufficient number of reports is available.
Sections du résumé
BACKGROUND
BACKGROUND
Failure mode and effects analysis (FMEA) is a valuable tool for radiotherapy risk assessment, yet its outputs might be unreliable due to failures not being identified or due to a lack of accurate error rates.
PURPOSE
OBJECTIVE
A novel incident reporting system (IRS) linked to an FMEA database was tested and evaluated. The study investigated whether the system was suitable for validating a previously performed analysis and whether it could provide accurate error rates to support the expert occurrence ratings of previously identified failure modes.
METHODS
METHODS
Twenty-three pre-identified failure modes of our external beam radiotherapy process, covering the process steps from patient admission to treatment delivery, were proffered on dedicated FMEA feedback and incident reporting terminals generated by the IRS. The clinical setting involved a computed tomography scanner, dosimetry, and five linacs. Incoming reports were used as basis to identify additional failure modes or confirm initial ones. The Kruskal-Wallis H test was applied to compare the risk priorities of the retrospective and prospective failure modes. Wald's sequential probability ratio test was used to investigate the correctness of the experts' occurrence ratings by means of the number of incoming reports.
RESULTS
RESULTS
Over a 15-month period, 304 reports were submitted. There were 0.005 (confidence interval [CI], 0.0014-0.0082) reported incidents per imaging study and 0.0006 (CI, 0.0003-0.0009) reported incidents per treatment fraction. Sixteen additional failure modes could be identified, and their risk priorities did not differ from those of the initial failure modes (p = 0.954). One failure mode occurrence rating could be increased, whereas the other 22 occurrence ratings could not be disproved.
CONCLUSIONS
CONCLUSIONS
Our approach is suitable for validating FMEAs and deducing additional failure modes on a continual basis. Accurate error rates can only be provided if a sufficient number of reports is available.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e14455Subventions
Organisme : Bavarian Ministry of Economic Affairs, Regional Development, and Energy
ID : 07 03/686 68/288/21/7/22/8/23/9/24
Organisme : Bavarian Ministry of Economic Affairs, Regional Development, and Energy
ID : 07 03/686 68/287/21/4/22/5/23/6/24
Informations de copyright
© 2024 The Author(s). Journal of Applied Clinical Medical Physics published by Wiley Periodicals LLC on behalf of American Association of Physicists in Medicine.
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