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核醫放射免疫分析實驗室外部品質管制作業與管理

External Quality Control for Nuclear Medicine Radioimmunoassay Laboratory

摘要


核子醫學實驗室包括放射免疫分析與造影檢查之作業。放射免疫分析之結果提供臨床診斷、追蹤、治療。實驗室品質管制主要目的爲降低分析之隨機性誤差及系統性誤差,提昇分析之精確度及準確度。放射免疫分析品質管制包括內部品質管制與外部品質管制,內部品質管制可監控分析之精確度(precision),外部品質管制可提昇分析之準確度(accuracy)。外部品質管制爲醫院評鑑所要求及醫學實驗室認證所規範。外部品質管制在檢驗品質的展現與檢驗品質的改善有其重要性,也是臨床實驗室所追求的目標之一。核子醫學實驗室制定外部品質管制之政策、標準作業手冊、外部品管規則、矯正與預防措施、及相關管理規定,以提昇外部品質管制作業與管理之標準化,並可保證檢驗結果的可靠性、提昇核子醫學臨床醫療水準、及維護病人之健康,以確保病人的福祉與利益爲目的。

並列摘要


Nuclear medicine laboratory provides both in vitro (e.g., radioimmunoassay; RIA) and in vivo (e.g., radionuclide images) services. Results of RIA are used for the purposes of clinical diagnosis, follow-up, and treatment. A good laboratory quality control is essential to reduce analyzed-related errors, either systematically or randomly, and to increase analytic data precision and reproduction. Internal quality control (IQC) and external quality control (EQC) are the two major quality control elements applied for RIA laboratory. IQC was performed as a monitor for results precision, but EQC was focused on accuracy increment. Moreover, EQC is a mandatory issue for hospital or laboratory accreditation currently. We suggest that a good nuclear medicine laboratory should establish a practical protocol for EQC, not only for the purpose of clinical efficiency promotion, but also for the quality improvement of RIA laboratory.

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