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  • 2022년 02월호
    [J Appl Clin Med Phys.] Failure mode and effect analysis for linear accelerator-based paraspinal stereotactic body radiotherapy

    Memorial Sloan Kettering Cancer Center / 이상규*

  • 출처
    J Appl Clin Med Phys.
  • 등재일
    2021 Dec
  • 저널이슈번호
    22(12):87-96. doi: 10.1002/acm2.13455. Epub 2021 Oct 28.
  • 내용

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    Abstract
    Introduction: Paraspinal 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.

    Methods: The 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.

    Results: Our 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.

    Conclusions: A 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.

     

     

    Affiliations


    1Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
    2Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.

  • 키워드
    failure modes and effects analysis; quality assurance; root cause analysis; spinal metastasis; stereotactic body radiotherapy.
  • 편집위원

    최근 방사선치료기기 및 치료법은 고도화되고 복잡해짐에 따라 방사선치료의 질적 향상 및 환자의 안전관리를 위해 방사선치료의 전 단계에 대한 단계별 리스크 관리가 중요하다. 본 연구에서는 고위험⋅고선량⋅저분할횟수로 치료되고 있는 선형가속기 기반 고정밀 정위신체방사선치료(SBRT) 기법에 대하여 사고유형 및 영향분석(FMEA)을 적용하여 프로그램의 안정성을 평가하는데 있다. 분석 및 평가를 위해 방사선치료 다학제 연구팀의 참여와 체계적인 위험 분석을 사용하여 평가하였다는 데 의의가 있다고 사료된다. 따라서 방사선치료 사고/사고는 기존의 방사선치료기기의 기계적 오류보다는 인적오류에 의해 다수 발생되고 있고, 기계적 중심의 품질관리에서 환자중심의 품질관리로 패러다임이 전환되어야 하며, 국내에서도 환자맞춤형 고정밀 방사선치료의 경우 방사선치료 구성원 전원이 참여하는 리스크관리 시스템이 구축되기를 기대한다.

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