title: Process-based quality management for clinical implementation of adaptive radiotherapy.
abstract: OBJECTIVE
  Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART.
  
  
  METHODS
  An experienced team of two clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200 were identified as potentially critical.
  
  
  RESULTS
  FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel.
  
  
  CONCLUSIONS
  Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily more) risks than standard IMRT and may be safely implemented with the proper mitigations.
authors.affiliation: Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri 63110.
authors.forename: Camille E
authors.initials: CE
authors.lastname: Noel
authors.affiliation: Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri 63110.
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Santanam
authors.affiliation: Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri 63110.
authors.forename: Parag J
authors.initials: PJ
authors.lastname: Parikh
authors.affiliation: Department of Radiation Oncology, Washington University School of Medicine, St. Louis, Missouri 63110.
authors.forename: Sasa
authors.initials: S
authors.lastname: Mutic
mesh_terms: D003198:Computer Simulation; D006801:Humans; D011785:Quality Assurance, Health Care / Q000379:methods*; D011786:Quality Control; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D012306:Risk
references.citation: Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):484-91
references.pmid: 22572077
references.citation: Int J Radiat Oncol Biol Phys. 2014 Apr 1;88(5):1161-6
references.pmid: 24661669
references.citation: Med Phys. 2012 Mar;39(3):1542-51
references.pmid: 22380386
references.citation: Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e263-9
references.pmid: 22682808
references.citation: Med Phys. 2000 Sep;27(9):2084-92
references.pmid: 11011737
references.citation: Cancer J. 2011 May-Jun;17(3):182-9
references.pmid: 21610472
references.citation: Med Phys. 2012 May;39(5):2544-58
references.pmid: 22559625
references.citation: Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S170-3
references.pmid: 18406920
references.citation: Radiother Oncol. 2008 Dec;89(3):330-7
references.pmid: 18701175
references.citation: Phys Med Biol. 2011 Jun 21;56(12):3659-68
references.pmid: 21610293
references.citation: Radiother Oncol. 2005 Mar;74(3):283-91
references.pmid: 15763309
references.citation: Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S33-7
references.pmid: 18406934
references.citation: Jt Comm J Qual Patient Saf. 2011 Jul;37(7):291-9
references.pmid: 21819027
references.citation: Med Phys. 2009 Dec;36(12):5420-8
references.pmid: 20095254
references.citation: Med Phys. 2011 Mar;38(3):1459-67
references.pmid: 21520857
references.citation: Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S2-12
references.pmid: 18406928
references.citation: Med Phys. 2011 Feb;38(2):719-26
references.pmid: 21452709
references.citation: Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):545-51
references.pmid: 21277097
references.citation: J Appl Clin Med Phys. 2012 Sep 06;13(5):3837
references.pmid: 22955649
references.citation: Nat Rev Clin Oncol. 2012 Dec;9(12):688-99
references.pmid: 23165124