Oropesa P, Woods M J, Olsovcová V, dos Santos J A
Centro de Isótopos, PO Box 3415, San José de las Lajas, Habana, Cuba.
Appl Radiat Isot. 2008 Mar;66(3):353-61. doi: 10.1016/j.apradiso.2007.07.008. Epub 2007 Jul 20.
The traceability of activity measurements performed during the development phase of the radiopharmaceutical and in its clinical application is essential for establishing the comparability of clinical results reported in the nuclear medicine field. This paper presents and discusses the evaluation over time of the quality of activity measurement results obtained in Cuban nuclear medicine, on the basis of statistical samples taken during the radionuclide calibrator comparison program. An attempt is also made to evaluate the role played by such comparisons in quality measurement improvement in nuclear medicine, on the basis of results obtained in a number of countries and published by several authors over a period of time. Specifically, improvements of the measurement performance over time assessed by such exercises were found dissimilar in magnitudes for different countries. Two phases could be distinguished in the improvement process over time. Firstly, a fast improvement can be obtained resulting from the improvement in measurement accuracy of devices. After that, the achievement of new and sustained improvements goes slowly and requires an application of quality assurance programs where the qualification upgrading of personnel become an essential point.
在放射性药物研发阶段及其临床应用过程中进行的活度测量的可追溯性,对于确立核医学领域所报告临床结果的可比性至关重要。本文基于放射性核素校准器比对计划期间采集的统计样本,展示并讨论了古巴核医学领域随时间推移对活度测量结果质量的评估。同时,还根据一些国家在一段时间内取得并由多位作者发表的结果,尝试评估此类比对在核医学质量测量改进中所起的作用。具体而言,通过此类活动评估得出的测量性能随时间的改进,在不同国家的幅度有所不同。随着时间推移的改进过程可分为两个阶段。首先,可通过设备测量精度的提高实现快速改进。在此之后,实现新的持续改进进展缓慢,需要应用质量保证计划,其中人员资质升级成为关键要点。