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Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems.

ABSTRACT: To develop and implement a failure mode and effect analysis (FMEA)-based commissioning and quality assurance framework for dynamic multileaf collimator (DMLC) tumor tracking systems.A systematic failure mode and effect analysis was performed for a prototype real-time tumor tracking system that uses implanted electromagnetic transponders for tumor position monitoring and a DMLC for real-time beam adaptation. A detailed process tree of DMLC tracking delivery was created and potential tracking-specific failure modes were identified. For each failure mode, a risk probability number (RPN) was calculated from the product of the probability of occurrence, the severity of effect, and the detectibility of the failure. Based on the insights obtained from the FMEA, commissioning and QA procedures were developed to check (i) the accuracy of coordinate system transformation, (ii) system latency, (iii) spatial and dosimetric delivery accuracy, (iv) delivery efficiency, and (v) accuracy and consistency of system response to error conditions. The frequency of testing for each failure mode was determined from the RPN value.Failures modes with RPN > or = 125 were recommended to be tested monthly. Failure modes with RPN < 125 were assigned to be tested during comprehensive evaluations, e.g., during commissioning, annual quality assurance, and after major software/hardware upgrades. System latency was determined to be approximately 193 ms. The system showed consistent and accurate response to erroneous conditions. Tracking accuracy was within 3%-3 mm gamma (100% pass rate) for sinusoidal as well as a wide variety of patient-derived respiratory motions. The total time taken for monthly QA was approximately 35 min, while that taken for comprehensive testing was approximately 3.5 h.FMEA proved to be a powerful and flexible tool to develop and implement a quality management (QM) framework for DMLC tracking. The authors conclude that the use of FMEA-based QM ensures efficient allocation of clinical resources because the most critical failure modes receive the most attention. It is expected that the set of guidelines proposed here will serve as a living document that is updated with the accumulation of progressively more intrainstitutional and interinstitutional experience with DMLC tracking.

SUBMITTER: Sawant A

PROVIDER: S-EPMC3016096 | biostudies-other | 2010 Dec

REPOSITORIES: biostudies-other

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Project description:Electromagnetic Tracking (EMT) is a novel technique for error detection and quality assurance (QA) in interstitial high dose rate brachytherapy (HDR-iBT). The purpose of this study is to provide a concept for data acquisition developed as part of a clinical evaluation study on the use of EMT during interstitial treatment of breast cancer patients. The stability, accuracy, and precision of EMT-determined dwell positions were quantified. Dwell position reconstruction based on EMT was investigated on CT table, HDR table and PDR bed to examine the influence on precision and accuracy in a typical clinical workflow. All investigations were performed using a precise PMMA phantom. The track of catheters inserted in that phantom was measured by manually inserting a 5 degree of freedom (DoF) sensor while recording the position of three 6DoF fiducial sensors on the phantom surface to correct motion influences. From the corrected data, dwell positions were reconstructed along the catheter's track. The accuracy of the EMT-determined dwell positions was quantified by the residual distances to reference dwell positions after using a rigid registration. Precision and accuracy were investigated for different phantom-table and sensor-field generator (FG) distances. The measured precision of the EMT-determined dwell positions was ? 0.28 mm (95th percentile). Stability tests showed a drift of 0.03 mm in the first 20 min of use. Sudden shaking of the FG or (large) metallic objects close to the FG degrade the precision. The accuracy with respect to the reference dwell positions was on all clinical tables < 1 mm at 200 mm FG distance and 120 mm phantom-table distance. Phantom measurements showed that EMT-determined localization of dwell positions in HDR-iBT is stable, precise, and sufficiently accurate for clinical assessment. The presented method may be viable for clinical applications in HDR-iBT, like implant definition, error detection or quantification of uncertainties. Further clinical investigations are needed.

Project description:Real-time dynamic multileaf collimator (MLC) tracking for management of intrafraction tumor motion can be challenging for highly modulated beams, as the leaves need to travel far to adjust for target motion perpendicular to the leaf travel direction. The plan modulation can be reduced by using a leaf position constraint (LPC) that reduces the difference in the position of adjacent MLC leaves in the plan. The purpose of this study was to investigate the impact of the LPC on the quality of inversely optimized arc radiotherapy plans and the effect of the MLC motion pattern on the dosimetric accuracy of MLC tracking delivery. Specifically, the possibility of predicting the accuracy of MLC tracking delivery based on the plan modulation was investigated.Inversely optimized arc radiotherapy plans were created on CT-data of three lung cancer patients. For each case, five plans with a single 358° arc were generated with LPC priorities of 0 (no LPC), 0.25, 0.5, 0.75, and 1 (highest possible LPC), respectively. All the plans had a prescribed dose of 2 Gy × 30, used 6 MV, a maximum dose rate of 600 MU/min and a collimator angle of 45° or 315°. To quantify the plan modulation, an average adjacent leaf distance (ALD) was calculated by averaging the mean adjacent leaf distance for each control point. The linear relationship between the plan quality [i.e., the calculated dose distributions and the number of monitor units (MU)] and the LPC was investigated, and the linear regression coefficient as well as a two tailed confidence level of 95% was used in the evaluation. The effect of the plan modulation on the performance of MLC tracking was tested by delivering the plans to a cylindrical diode array phantom moving with sinusoidal motion in the superior-inferior direction with a peak-to-peak displacement of 2 cm and a cycle time of 6 s. The delivery was adjusted to the target motion using MLC tracking, guided in real-time by an infrared optical system. The dosimetric results were evaluated using gamma index evaluation with static target measurements as reference.The plan quality parameters did not depend significantly on the LPC (p ≥ 0.066), whereas the ALD depended significantly on the LPC (p < 0.001). The gamma index failure rate depended significantly on the ALD, weighted to the percentage of the beam delivered in each control point of the plan (ALD(w)) when MLC tracking was used (p < 0.001), but not for delivery without MLC tracking (p ≥ 0.342). The gamma index failure rate with the criteria of 2% and 2 mm was decreased from > 33.9% without MLC tracking to <31.4% (LPC 0) and <2.2% (LPC 1) with MLC tracking.The results indicate that the dosimetric robustness of MLC tracking delivery of an inversely optimized arc radiotherapy plan can be improved by incorporating leaf position constraints in the objective function without otherwise affecting the plan quality. The dosimetric robustness may be estimated prior to delivery by evaluating the ALD(w) of the plan.

Project description:IntroductionParaspinal stereotactic body radiotherapy (SBRT) involves risks of severe complications. We evaluated the safety of the paraspinal SBRT program in a large academic hospital by applying failure modes and effects analysis.MethodsThe analysis was conducted by a multidisciplinary committee (two therapists, one dosimetrist, four physicists, and two radiation oncologists). The paraspinal SBRT workflow was segmented into four phases (simulation, treatment planning, delivery, and machine quality assurance (QA)). Each phase was further divided into a sequence of sub-processes. Potential failure modes (PFM) were identified from each subprocess and scored in terms of the frequency of occurrence, severity and detectability, and a risk priority number (RPN). High-risk PFMs were identified based on RPN and were studied for root causes using fault tree analysis.ResultsOur paraspinal SBRT process was characterized by eight simulations, 11 treatment planning, nine delivery, and two machine QA sub-processes. There were 18, 29, 19, and eight PFMs identified from simulation, planning, treatment, and machine QA, respectively. The median RPN of the PFMs was 62.9 for simulation, 68.3 for planning, 52.9 for delivery, and 22.0 for machine QA. The three PFMs with the highest RPN were: previous radiotherapy outside the institution is not accurately evaluated (RPN: 293.3), incorrect registration between diagnostic magnetic resonance imaging and simulation computed tomography causing incorrect contours (273.0), and undetected patient movement before ExacTrac baseline (217.8). Remedies to the high RPN failures were implemented, including staff education, standardized magnetic resonance imaging acquisition parameters, and an image fusion process, and additional QA on beam steering.ConclusionsA paraspinal SBRT workflow in a large clinic was evaluated using a multidisciplinary and systematic risk analysis, which led to feasible solutions to key root causes. Treatment planning was a major source of PFMs that systematically affect the safety and quality of treatments. Accurate evaluation of external treatment records remains a challenge.

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Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems.

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