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An FMEA evaluation of intensity modulated radiation therapy dose delivery failures at tolerance criteria levels

Purpose The objective of this work was to assess both the perception of failure modes in Intensity Modulated Radiation Therapy (IMRT) when the linac is operated at the edge of tolerances given in AAPM TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) as well as the application of FMEA to this specifi...

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Published in:Medical physics (Lancaster) 2017-11, Vol.44 (11), p.5575-5583
Main Authors: Faught, Jacqueline Tonigan, Balter, Peter A., Johnson, Jennifer L., Kry, Stephen F., Court, Laurence E., Stingo, Francesco C., Followill, David S.
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container_end_page 5583
container_issue 11
container_start_page 5575
container_title Medical physics (Lancaster)
container_volume 44
creator Faught, Jacqueline Tonigan
Balter, Peter A.
Johnson, Jennifer L.
Kry, Stephen F.
Court, Laurence E.
Stingo, Francesco C.
Followill, David S.
description Purpose The objective of this work was to assess both the perception of failure modes in Intensity Modulated Radiation Therapy (IMRT) when the linac is operated at the edge of tolerances given in AAPM TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) as well as the application of FMEA to this specific section of the IMRT process. Methods An online survey was distributed to approximately 2000 physicists worldwide that participate in quality services provided by the Imaging and Radiation Oncology Core ‐ Houston (IROC‐H). The survey briefly described eleven different failure modes covered by basic quality assurance in step‐and‐shoot IMRT at or near TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) tolerance criteria levels. Respondents were asked to estimate the worst case scenario percent dose error that could be caused by each of these failure modes in a head and neck patient as well as the FMEA scores: Occurrence, Detectability, and Severity. Risk probability number (RPN) scores were calculated as the product of these scores. Demographic data were also collected. Results A total of 181 individual and three group responses were submitted. 84% were from North America. Most (76%) individual respondents performed at least 80% clinical work and 92% were nationally certified. Respondent medical physics experience ranged from 2.5 to 45 yr (average 18 yr). A total of 52% of individual respondents were at least somewhat familiar with FMEA, while 17% were not familiar. Several IMRT techniques, treatment planning systems, and linear accelerator manufacturers were represented. All failure modes received widely varying scores ranging from 1 to 10 for occurrence, at least 1–9 for detectability, and at least 1–7 for severity. Ranking failure modes by RPN scores also resulted in large variability, with each failure mode being ranked both most risky (1st) and least risky (11th) by different respondents. On average MLC modeling had the highest RPN scores. Individual estimated percent dose errors and severity scores positively correlated (P < 0.01) for each FM as expected. No universal correlations were found between the demographic information collected and scoring, percent dose errors or ranking. Conclusions Failure modes investigated overall were evaluated as low to medium risk, with average RPNs less than 110. The ranking of 11 failure modes was not agreed upon by the community. Large variability in FMEA scoring may be caused by individual interpretation and/or experience,
doi_str_mv 10.1002/mp.12551
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Methods An online survey was distributed to approximately 2000 physicists worldwide that participate in quality services provided by the Imaging and Radiation Oncology Core ‐ Houston (IROC‐H). The survey briefly described eleven different failure modes covered by basic quality assurance in step‐and‐shoot IMRT at or near TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) tolerance criteria levels. Respondents were asked to estimate the worst case scenario percent dose error that could be caused by each of these failure modes in a head and neck patient as well as the FMEA scores: Occurrence, Detectability, and Severity. Risk probability number (RPN) scores were calculated as the product of these scores. Demographic data were also collected. Results A total of 181 individual and three group responses were submitted. 84% were from North America. Most (76%) individual respondents performed at least 80% clinical work and 92% were nationally certified. Respondent medical physics experience ranged from 2.5 to 45 yr (average 18 yr). A total of 52% of individual respondents were at least somewhat familiar with FMEA, while 17% were not familiar. Several IMRT techniques, treatment planning systems, and linear accelerator manufacturers were represented. All failure modes received widely varying scores ranging from 1 to 10 for occurrence, at least 1–9 for detectability, and at least 1–7 for severity. Ranking failure modes by RPN scores also resulted in large variability, with each failure mode being ranked both most risky (1st) and least risky (11th) by different respondents. On average MLC modeling had the highest RPN scores. Individual estimated percent dose errors and severity scores positively correlated (P &lt; 0.01) for each FM as expected. No universal correlations were found between the demographic information collected and scoring, percent dose errors or ranking. Conclusions Failure modes investigated overall were evaluated as low to medium risk, with average RPNs less than 110. The ranking of 11 failure modes was not agreed upon by the community. Large variability in FMEA scoring may be caused by individual interpretation and/or experience, reflecting the subjective nature of the FMEA tool.</description><identifier>ISSN: 0094-2405</identifier><identifier>EISSN: 2473-4209</identifier><identifier>DOI: 10.1002/mp.12551</identifier><identifier>PMID: 28862765</identifier><language>eng</language><publisher>United States</publisher><subject>FMEA ; IMRT ; quality assurance ; Radiation Dosage ; radiation therapy ; Radiotherapy Dosage ; Radiotherapy, Intensity-Modulated - adverse effects ; risk ; Surveys and Questionnaires ; Treatment Failure</subject><ispartof>Medical physics (Lancaster), 2017-11, Vol.44 (11), p.5575-5583</ispartof><rights>2017 American Association of Physicists in Medicine</rights><rights>2017 American Association of Physicists in Medicine.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4761-197cb26988dcb194a1e122279baf4dab9f69de9bd6ada9a0f08b151743f5ce673</citedby><cites>FETCH-LOGICAL-c4761-197cb26988dcb194a1e122279baf4dab9f69de9bd6ada9a0f08b151743f5ce673</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28862765$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Faught, Jacqueline Tonigan</creatorcontrib><creatorcontrib>Balter, Peter A.</creatorcontrib><creatorcontrib>Johnson, Jennifer L.</creatorcontrib><creatorcontrib>Kry, Stephen F.</creatorcontrib><creatorcontrib>Court, Laurence E.</creatorcontrib><creatorcontrib>Stingo, Francesco C.</creatorcontrib><creatorcontrib>Followill, David S.</creatorcontrib><title>An FMEA evaluation of intensity modulated radiation therapy dose delivery failures at tolerance criteria levels</title><title>Medical physics (Lancaster)</title><addtitle>Med Phys</addtitle><description>Purpose The objective of this work was to assess both the perception of failure modes in Intensity Modulated Radiation Therapy (IMRT) when the linac is operated at the edge of tolerances given in AAPM TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) as well as the application of FMEA to this specific section of the IMRT process. Methods An online survey was distributed to approximately 2000 physicists worldwide that participate in quality services provided by the Imaging and Radiation Oncology Core ‐ Houston (IROC‐H). The survey briefly described eleven different failure modes covered by basic quality assurance in step‐and‐shoot IMRT at or near TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) tolerance criteria levels. Respondents were asked to estimate the worst case scenario percent dose error that could be caused by each of these failure modes in a head and neck patient as well as the FMEA scores: Occurrence, Detectability, and Severity. Risk probability number (RPN) scores were calculated as the product of these scores. Demographic data were also collected. Results A total of 181 individual and three group responses were submitted. 84% were from North America. Most (76%) individual respondents performed at least 80% clinical work and 92% were nationally certified. Respondent medical physics experience ranged from 2.5 to 45 yr (average 18 yr). A total of 52% of individual respondents were at least somewhat familiar with FMEA, while 17% were not familiar. Several IMRT techniques, treatment planning systems, and linear accelerator manufacturers were represented. All failure modes received widely varying scores ranging from 1 to 10 for occurrence, at least 1–9 for detectability, and at least 1–7 for severity. Ranking failure modes by RPN scores also resulted in large variability, with each failure mode being ranked both most risky (1st) and least risky (11th) by different respondents. On average MLC modeling had the highest RPN scores. Individual estimated percent dose errors and severity scores positively correlated (P &lt; 0.01) for each FM as expected. No universal correlations were found between the demographic information collected and scoring, percent dose errors or ranking. Conclusions Failure modes investigated overall were evaluated as low to medium risk, with average RPNs less than 110. The ranking of 11 failure modes was not agreed upon by the community. Large variability in FMEA scoring may be caused by individual interpretation and/or experience, reflecting the subjective nature of the FMEA tool.</description><subject>FMEA</subject><subject>IMRT</subject><subject>quality assurance</subject><subject>Radiation Dosage</subject><subject>radiation therapy</subject><subject>Radiotherapy Dosage</subject><subject>Radiotherapy, Intensity-Modulated - adverse effects</subject><subject>risk</subject><subject>Surveys and Questionnaires</subject><subject>Treatment Failure</subject><issn>0094-2405</issn><issn>2473-4209</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp1kcFu1DAQQC0EoktB4guQj1xSbMdx4gvSqmopUis4tGdrYk-okRMH29kqf8_SLYUeeprDPL0Z6RHynrMTzpj4NM4nXDQNf0E2QrZ1JQXTL8mGMS0rIVlzRN7k_JMxpuqGvSZHouuUaFWzIXE70fOrsy3FHYQFio8TjQP1U8Ep-7LSMbolQEFHEzh_AMotJphX6mJG6jD4HaaVDuDDkjBTKLTEsEcmi9QmXzB5oAF3GPJb8mqAkPHdwzwmN-dn16cX1eW3L19Pt5eVla3iFdet7YXSXedsz7UEjlwI0eoeBumg14PSDnXvFDjQwAbW9bzhrayHxqJq62Py-eCdl35EZ3EqCYKZkx8hrSaCN083k781P-LOKCl4J-Ve8PFBkOKvBXMxo88WQ4AJ45IN17XiqhGq-4faFHNOODye4cz86WPG2dz32aMf_n_rEfwbZA9UB-DOB1yfFZmr7wfhbx7LnEU</recordid><startdate>201711</startdate><enddate>201711</enddate><creator>Faught, Jacqueline Tonigan</creator><creator>Balter, Peter A.</creator><creator>Johnson, Jennifer L.</creator><creator>Kry, Stephen F.</creator><creator>Court, Laurence E.</creator><creator>Stingo, Francesco C.</creator><creator>Followill, David S.</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201711</creationdate><title>An FMEA evaluation of intensity modulated radiation therapy dose delivery failures at tolerance criteria levels</title><author>Faught, Jacqueline Tonigan ; Balter, Peter A. ; Johnson, Jennifer L. ; Kry, Stephen F. ; Court, Laurence E. ; Stingo, Francesco C. ; Followill, David S.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4761-197cb26988dcb194a1e122279baf4dab9f69de9bd6ada9a0f08b151743f5ce673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>FMEA</topic><topic>IMRT</topic><topic>quality assurance</topic><topic>Radiation Dosage</topic><topic>radiation therapy</topic><topic>Radiotherapy Dosage</topic><topic>Radiotherapy, Intensity-Modulated - adverse effects</topic><topic>risk</topic><topic>Surveys and Questionnaires</topic><topic>Treatment Failure</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Faught, Jacqueline Tonigan</creatorcontrib><creatorcontrib>Balter, Peter A.</creatorcontrib><creatorcontrib>Johnson, Jennifer L.</creatorcontrib><creatorcontrib>Kry, Stephen F.</creatorcontrib><creatorcontrib>Court, Laurence E.</creatorcontrib><creatorcontrib>Stingo, Francesco C.</creatorcontrib><creatorcontrib>Followill, David S.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Medical physics (Lancaster)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Faught, Jacqueline Tonigan</au><au>Balter, Peter A.</au><au>Johnson, Jennifer L.</au><au>Kry, Stephen F.</au><au>Court, Laurence E.</au><au>Stingo, Francesco C.</au><au>Followill, David S.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>An FMEA evaluation of intensity modulated radiation therapy dose delivery failures at tolerance criteria levels</atitle><jtitle>Medical physics (Lancaster)</jtitle><addtitle>Med Phys</addtitle><date>2017-11</date><risdate>2017</risdate><volume>44</volume><issue>11</issue><spage>5575</spage><epage>5583</epage><pages>5575-5583</pages><issn>0094-2405</issn><eissn>2473-4209</eissn><abstract>Purpose The objective of this work was to assess both the perception of failure modes in Intensity Modulated Radiation Therapy (IMRT) when the linac is operated at the edge of tolerances given in AAPM TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) as well as the application of FMEA to this specific section of the IMRT process. Methods An online survey was distributed to approximately 2000 physicists worldwide that participate in quality services provided by the Imaging and Radiation Oncology Core ‐ Houston (IROC‐H). The survey briefly described eleven different failure modes covered by basic quality assurance in step‐and‐shoot IMRT at or near TG‐40 (Kutcher et al.) and TG‐142 (Klein et al.) tolerance criteria levels. Respondents were asked to estimate the worst case scenario percent dose error that could be caused by each of these failure modes in a head and neck patient as well as the FMEA scores: Occurrence, Detectability, and Severity. Risk probability number (RPN) scores were calculated as the product of these scores. Demographic data were also collected. Results A total of 181 individual and three group responses were submitted. 84% were from North America. Most (76%) individual respondents performed at least 80% clinical work and 92% were nationally certified. Respondent medical physics experience ranged from 2.5 to 45 yr (average 18 yr). A total of 52% of individual respondents were at least somewhat familiar with FMEA, while 17% were not familiar. Several IMRT techniques, treatment planning systems, and linear accelerator manufacturers were represented. All failure modes received widely varying scores ranging from 1 to 10 for occurrence, at least 1–9 for detectability, and at least 1–7 for severity. Ranking failure modes by RPN scores also resulted in large variability, with each failure mode being ranked both most risky (1st) and least risky (11th) by different respondents. On average MLC modeling had the highest RPN scores. Individual estimated percent dose errors and severity scores positively correlated (P &lt; 0.01) for each FM as expected. No universal correlations were found between the demographic information collected and scoring, percent dose errors or ranking. Conclusions Failure modes investigated overall were evaluated as low to medium risk, with average RPNs less than 110. The ranking of 11 failure modes was not agreed upon by the community. Large variability in FMEA scoring may be caused by individual interpretation and/or experience, reflecting the subjective nature of the FMEA tool.</abstract><cop>United States</cop><pmid>28862765</pmid><doi>10.1002/mp.12551</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record>
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subjects FMEA
IMRT
quality assurance
Radiation Dosage
radiation therapy
Radiotherapy Dosage
Radiotherapy, Intensity-Modulated - adverse effects
risk
Surveys and Questionnaires
Treatment Failure
title An FMEA evaluation of intensity modulated radiation therapy dose delivery failures at tolerance criteria levels
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