Background
Methods
Failure modes and effects analysis (FMEA)
The treatment planning stage within the proton beam RT process
Results and discussion
Sub-process | Potential failure mode |
---|---|
(III) Manual correction of external contour | Lack of removal of metallic skin markers |
(V) Localization of the origin of coordinates identified by lasers | Incorrect localization of the origin of coordinates identified by lasers (small amount, 1–2 mm) |
Incorrect localization of the origin of coordinates identified by lasers (large amount) | |
(VIII) Transfer of definitive isocenter coordinates to movable lasers if different from the origin of coordinates | Lack of information transfer (no virtual simulation) |
Wrong data transfer | |
Overwrite of file data | |
(XI) Target selection and dose prescription setting for each target (dose prescription type - point or volume, mean, median, minimum, - total dose, - fractionation scheme) | Incomplete target selection |
Wrong target selection | |
Wrong target dose prescription | |
(XIII) Assignment of targets to the field | Incomplete or wrong target assignment |
(XIV) Field isocenter position setting | Incorrect isocenter definition |
(XV - XVI) Selection of field direction (gantry angle and couch rotation) | Improper selection of gantry angle/couch rotation: tissue interfaces lying parallel to beam direction, when otherwise avoidable (i.e. when more robust alternative geometry would be feasible) |
Improper selection of gantry angle/couch rotation: not reachable position (potential collision or movement limitations) | |
(XVII) Setting of pencil beam parameters: | |
- Full Width Half Maximum (FWHM) | Improper selection of beam parameters: FWHM, scanning or energy step too low in relationship to the PTV volume |
- scanning step in the transversal plane | |
- energy step | |
- passive elements (range shifter and ripple filter) | |
(XVIII) Selection of the physical and biological database for dose calculation | Selection of unapproved (i.e. not validated for clinical practice, for experimental use only) database. |
(XX) Setting of the optimization modality (SFUD, IMPT) | Improper setting of the cost function parameters |
Improper selection of optimization modality rather than IMPT | |
(XXVII) Evaluation of the best plan | Improper selection of the best plan among the competing calculated onces in terms of optimal trade-off between plan quality (PTV dose coverage versus OAR sparing) and robustness |
(XXVIII) Creation of set-up fields and calculation of DRRs | Wrong definition of field isocenter (large amount) |
Improper selection of parameters for DRR calculation | |
(XXXI) Selection of the phantom for the verification plan | Improper phantom selection |
Sub-process | N | Potential failure mode | Potential causes of failure | Potential effects of failure | O | S | D | RPN |
---|---|---|---|---|---|---|---|---|
(I) Selection of the reference CT scan for planning | 1 | Error in selecting the CT scan (e.g. incorrect patient set up, outdated representation of the anatomy) in case of multiple CT scans | Human error, failure in the communication between operators | Wrong dose distribution/wrong dose delivery |
3
|
8
|
4
|
96
|
2 | Outdated representation of the anatomy (single CT scan) | Anatomical changes (related to time delay) | Wrong dose distribution/wrong dose delivery |
3
|
8
|
8
|
192
| |
(III) Manual correction of external contour | 3 | Incorrect external contour definition (body or patient mask countour underestimation, i.e. not fully included in the external contour) | Human error | Wrong dose distribution / wrong dose delivery |
4
|
5
|
4
|
80
|
4 | Failure of object/region identification | Human error | Wrong dose distribution |
3
|
8
|
4
|
96
| |
5 | Inaccurate delineation | Human error | Wrong dose distribution |
4
|
6
|
6
|
144
| |
(IV) Delineation of CT artefacts, altered structures, metal implants and manual assignment of specific HU numbers | ||||||||
6 | Incorrect HU number manual assignment | Human error or lack of documentation from the referring clinicians (e.g. surgeons) | Wrong dose distribution |
4
|
7
|
7
|
196
| |
7 | Lack of couch origin of coordinates definition | Human error | Unintended normal tissue irradiated and CTV missing |
3
|
10
|
3
|
90
| |
(IX) Couch origin of coordinates identification for absolute positioning | 8 | Wrong definition of couch origin of coordinates (large amount) | Human error | Unintended normal tissue irradiated and CTV missing |
3
|
10
|
3
|
90
|
9 | Wrong definition of couch origin of coordinates (small amount, in terms of 2–3 mm) | Human error | Unintended normal tissue irradiated and CTV missing |
4
|
5
|
6
|
120
| |
(XI) Target selection and dose prescription for each target (dose prescription type - point or volume, mean, median, minimum-, total dose, fractionation scheme) | 10 | Wrong setting of dose prescription type | Human error | Wrong dose delivery |
3
|
8
|
4
|
96
|
11 | Wrong dose fractionation setting | Human error and lack of verbal-written communication (patient chart) | Wrong dose delivery |
2
|
10
|
4
|
80
| |
12 | Improper selection of gantry angle/couch rotation: beam passing through OARs, when otherwise avoidable | Inadequate operator skill | Sub-optimal treatment quality: increased treatment toxicity |
4
|
6
|
4
|
96
| |
(XV - XVI) Selection of field direction (gantry angle and couch rotation) | 13 | Improper selection of gantry angle/couch rotation: beam stopping against OARs, when otherwise avoidable | Inadequate operator skill | Low plan robustness (range uncertainty) |
4
|
8
|
4
|
128
|
14 | Improper selection of gantry angle/couch rotation: beam passing through unstable tissues (such as bowel), when otherwise avoidable | Inadequate operator skill | Low plan robustness (range uncertainty) |
3
|
8
|
5
|
120
| |
(XVII) Setting of pencil beam parameters: | 15 | Improper selection of beam parameters: FWHM, scanning or energy step too large in relationship to PTV volume | Inadequate operator skill | Sub-optimal treatment quality: increased treatment toxicity or reduced TCP |
4
|
5
|
4
|
80
|
- FWHM | ||||||||
- scanning step in the transversal plane | ||||||||
- energy step | ||||||||
- passive elements | ||||||||
(XIX) Definition of dose calculation parameters: | 16 | Improper selection of physical beam model and/or calculation grid | Human error due to time pressure or inadequate skills | Wrong dose distribution |
4
|
7
|
5
|
140
|
- physical beam model | 17 | Improper selection of properties of the particles per spot matrix | Human error | Sub-optimal treatment quality |
4
|
4
|
5
|
80
|
- dose calculation grid | ||||||||
- properties of the particles per spot matrix | ||||||||
- dose calculation algorithm, nuclear correction, spot decomposition | ||||||||
(XX) Setting of the optimization modality (SFUD, IMPT) | 18 | Improper selection of IMPT modality | Inadequate operator skill | Low plan robustness: increased treatment toxicity or reduced TCP |
4
|
5
|
4
|
80
|
(XXII) Initial/iterative definition of target/OAR constraints and weights for dose optimization | 19 | Wrong or incomplete definition of one or more dose constraints | Inadequate operator skill or inattention | Sub-optimal treatment quality |
4
|
8
|
3
|
96
|
(XXV) Plan evaluation | 20 | Improper acceptance of results | Time pressure or inadequate operator skill | Sub-optimal treatment quality |
5
|
4
|
4
|
80
|
(XXVI) Production of competing plan | 21 | Lack of producing enough competing plans | Time pressure or inadequate operator skill | Sub-optimal treatment quality |
5
|
4
|
4
|
80
|
(XXVIII) Creation of set-up fields and calculation of DRRs | 22 | Wrong definition of field isocenter (small amount 2 mm) | Human error | Wrong dose delivery |
3
|
5
|
8
|
120
|
(XXX) Plan approval | 23 | Approval of wrong plan | Human error, failure in the communication between operators | Wrong delivery |
3
|
8
|
5
|
120
|