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Title: WE-A-BRC-03: Lessons Learned: IROC Audits

Abstract

Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted. Traditionally, quality assurance in radiation oncology has been driven largely by new technological advances, and safety improvement has been driven by reactive responses to past system failures and prescriptive mandates recommended by professional organizations and promulgated by regulators. Prescriptive approaches to quality and safety alone often do not address the huge variety of process and technique used in radiation oncology. Risk-based assessments of radiotherapy processes provide a mechanism to enhance quality and safety, both for new and for established techniques. It is imperative that we explore such a paradigm shift at this time, when expectations from patients as well as providers are rising while available resources are falling. There is much we can learn from our past experiences to be applied towards the new risk-based assessments. Learning Objectives: Understand themore » impact of clinical and technical quality on outcomes Understand the importance of quality care in radiation oncology Learn to assess the impact of quality on clinical outcomes D. Followill, NIH Grant CA180803.« less

Authors:
 [1]
  1. UT MD Anderson Cancer Center (United States)
Publication Date:
OSTI Identifier:
22654088
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
60 APPLIED LIFE SCIENCES; 61 RADIATION PROTECTION AND DOSIMETRY; CLINICAL TRIALS; LEARNING; PATIENTS; QUALITY ASSURANCE; RADIATION DOSES; RADIOTHERAPY; SAFETY

Citation Formats

Followill, D. WE-A-BRC-03: Lessons Learned: IROC Audits. United States: N. p., 2016. Web. doi:10.1118/1.4957724.
Followill, D. WE-A-BRC-03: Lessons Learned: IROC Audits. United States. doi:10.1118/1.4957724.
Followill, D. Wed . "WE-A-BRC-03: Lessons Learned: IROC Audits". United States. doi:10.1118/1.4957724.
@article{osti_22654088,
title = {WE-A-BRC-03: Lessons Learned: IROC Audits},
author = {Followill, D.},
abstractNote = {Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted. Traditionally, quality assurance in radiation oncology has been driven largely by new technological advances, and safety improvement has been driven by reactive responses to past system failures and prescriptive mandates recommended by professional organizations and promulgated by regulators. Prescriptive approaches to quality and safety alone often do not address the huge variety of process and technique used in radiation oncology. Risk-based assessments of radiotherapy processes provide a mechanism to enhance quality and safety, both for new and for established techniques. It is imperative that we explore such a paradigm shift at this time, when expectations from patients as well as providers are rising while available resources are falling. There is much we can learn from our past experiences to be applied towards the new risk-based assessments. Learning Objectives: Understand the impact of clinical and technical quality on outcomes Understand the importance of quality care in radiation oncology Learn to assess the impact of quality on clinical outcomes D. Followill, NIH Grant CA180803.},
doi = {10.1118/1.4957724},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = {Wed Jun 15 00:00:00 EDT 2016},
month = {Wed Jun 15 00:00:00 EDT 2016}
}
  • Quality and safety in healthcare are inextricably linked. There are compelling data that link poor quality radiation therapy to inferior patient survival. Radiation Oncology clinical trial protocol deviations often involve incorrect target volume delineation or dosing, akin to radiotherapy incidents which also often involve partial geometric miss or improper radiation dosing. When patients with radiation protocol variations are compared to those without significant protocol variations, clinical outcome is negatively impacted. Traditionally, quality assurance in radiation oncology has been driven largely by new technological advances, and safety improvement has been driven by reactive responses to past system failures and prescriptive mandatesmore » recommended by professional organizations and promulgated by regulators. Prescriptive approaches to quality and safety alone often do not address the huge variety of process and technique used in radiation oncology. Risk-based assessments of radiotherapy processes provide a mechanism to enhance quality and safety, both for new and for established techniques. It is imperative that we explore such a paradigm shift at this time, when expectations from patients as well as providers are rising while available resources are falling. There is much we can learn from our past experiences to be applied towards the new risk-based assessments. Learning Objectives: Understand the impact of clinical and technical quality on outcomes Understand the importance of quality care in radiation oncology Learn to assess the impact of quality on clinical outcomes D. Followill, NIH Grant CA180803.« less
  • Purpose: To analyze the most recent results of IROC Houston’s anthropomorphic H&N phantom to determine the nature of failing irradiations and the feasibility of altering pass/fail credentialing criteria. Methods: IROC Houston’s H&N phantom, used for IMRT credentialing for NCI-sponsored clinical trials, requires that an institution’s treatment plan must agree with measurement within 7% (TLD doses) and ≥85% pixels must pass 7%/4 mm gamma analysis. 156 phantom irradiations (November 2014 – October 2015) were re-evaluated using tighter criteria: 1) 5% TLD and 5%/4 mm, 2) 5% TLD and 5%/3 mm, 3) 4% TLD and 4%/4 mm, and 4) 3% TLD andmore » 3%/3 mm. Failure/poor performance rates were evaluated with respect to individual film and TLD performance by location in the phantom. Overall poor phantom results were characterized qualitatively as systematic (dosimetric) errors, setup errors/positional shifts, global but non-systematic errors, and errors affecting only a local region. Results: The pass rate for these phantoms using current criteria is 90%. Substituting criteria 1-4 reduces the overall pass rate to 77%, 70%, 63%, and 37%, respectively. Statistical analyses indicated the probability of noise-induced TLD failure at the 5% criterion was <0.5%. Using criteria 1, TLD results were most often the cause of failure (86% failed TLD while 61% failed film), with most failures identified in the primary PTV (77% cases). Other criteria posed similar results. Irradiations that failed from film only were overwhelmingly associated with phantom shifts/setup errors (≥80% cases). Results failing criteria 1 were primarily diagnosed as systematic: 58% of cases. 11% were setup/positioning errors, 8% were global non-systematic errors, and 22% were local errors. Conclusion: This study demonstrates that 5% TLD and 5%/4 mm gamma criteria may be both practically and theoretically achievable. Further work is necessary to diagnose and resolve dosimetric inaccuracy in these trials, particularly for systematic dose errors. This work is funded by NCI Grant CA180803.« less
  • Purpose: To highlight the IROC Houston on-site dosimetry audit program, and to investigate the impact of clinical conditions on the frequency of errors/recommendations noted by IROC Houston. Methods: The results of IROC Houston on-site audits from 2000-present were abstracted and compared to clinical parameters, this included 409 institutions and 1020 linacs. In particular, we investigated the frequency of recommendations versus year, and the impact of repeat visits on the number of recommendations. We also investigated the impact on the number of recommendations of several clinical parameters: the number and age of the linacs, the linac/TPS combination, and the scope ofmore » the QA program. Results: The number of recommendations per institution (3.1 average) has shown decline between 2000 and present, although the number of recommendations per machine (0.89) has not changed. Previous IROC Houston site visits did not Result in fewer recommendations on a repeat visit, but IROC Houston tests have changed substantially during the last 15 years as radiotherapy technology has changed. There was no impact on the number of recommendations based on the number of machines at the institution or the age of a given machine. The fewest recommendations were observed for Varian-Eclipse combinations (0.71 recs/machine), while Elekta- Pinnacle combinations yielded the most (1.62 recs/machine). Finally, in the TG-142 era (post-2010), those institutions that had a QA recommendation (n=77) had significantly more other recommendations (1.83 per institution) than those that had no QA rec (n=12, 1.33 per institution). Conclusion: Establishing and maintaining a successful radiotherapy program is challenging and areas of improvement can routinely be identified. Clinical conditions such as linac-TPS combinations and the establishment of a good QA program impact the frequency of errors/deficiencies identified by IROC Houston during their on-site review process.« less
  • Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis. Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1–10). An RPN of highermore » than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies. Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planning with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150. Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments. Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.« less
  • Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less