韩国直线加速器质量保证法规的研究:韩国现状与国际指南的比较研究
Study of quality assurance regulations for linear accelerators in Korea: A comparison study between the current status in Korea and the international guidelines
摘要:
医用直线加速器的质量保证(QA)对于适当的癌症治疗是必不可少的。一些国际组织和西方发达国家都对直线加速器提供了质量保证指南。目前,韩国医院直线加速器的QA法规规定了一种系统,其中每家医院规定了其独立的基于医院的QA程序(HP_QAP)协议,并根据这些HP_QAP进行QA,同时监管机构验证是否已执行这些HP_QAP下的项目。但是,由于这种监管方式无法保证全民治疗的质量,而且很多医院有公差标准的QA项目各不相同,因此,标准化的QA项目和公差标准的呈现至关重要。本研究以各医院及国际组织之卫生质量保证行动计划为例,探讨卫生质量保证行动计划中之质量保证项目。上述组织提出的直线加速器的QA项目与韩国医院目前正在实施的QA项目之间的一致率显示出每日QA为50%,每周QA为22%,每月QA为43%,年度QA为65%,所有QA项目的总体一致率约为48%。在韩国医院正在实施的QA项目和西方先进国家正在实施的QA项目之间的比较,一致率显示出每日QA的50%,每周QA的33%,每月QA的60%,每年QA的67%,所有QA项目的整体一致率约为57%。本研究的结果表明,韩国医院目前实施的HP_QAP作为放射治疗中使用的直线加速器的QA标准,不符合国际标准。为解决这一问题,有必要制定国家标准化的直线加速器质量保证项目和程序。
英文摘要:
Quality assurance (QA) for medical linear accelerators is indispensable for appropriate cancer treatment. Some international organizations and western advanced countries provide QA guidelines for linear accelerators. Currently, QA regulations for linear accelerators in Korean hospitals specify a system in which each hospital stipulates its independent hospital-based protocols for QA procedures (HP_QAPs) and conducts QA based on these HP_QAPs while regulatory authorities verify whether items under these HP_QAPs have been performed. However, because this regulatory method cannot guarantee the quality of universal treatment, and QA items with tolerance criteria are different in many hospitals, the presentation of standardized QA items and tolerance criteria is essential. In this study, QA items in HP_QAPs from various hospitals and those presented by international organizations. Concordance rates between QA items for linear accelerators that were presented by the aforementioned organizations and those currently being implemented in Korean hospitals were shown to exhibit a daily QA of 50%, a weekly QA of 22%, a monthly QA of 43%, and an annual QA of 65%, and the overall concordance rates of all QA items were approximately 48%. In comparison between QA items being implemented in Korean hospitals and those being implemented in western advanced countries, concordance rates were shown to exhibit a daily QA of 50%, a weekly QA of 33%, a monthly QA of 60%, and an annual QA of 67%, and the overall concordance rate of all QA items were approximately 57%. The results of this study indicate that the HP_QAPs currently implemented by Korean hospitals as QA standards for linear accelerators used in radiation therapy do not meet international standards. To solve this problem, it is necessary to develop national standardized QA items and procedures for linear accelerators.
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