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題名 | 放射免疫分析室參與認證之品質分析=Assessment of Quality Parameters in A Radioimmunometric Assay Laboratory |
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作者 | 廖建國; 田惠蘭; 邱建勳; 莊紫翎; 王昱豐; | 書刊名 | 核子醫學雜誌 |
卷期 | 20:4 2007.12[民96.12] |
頁次 | 頁209-215 |
分類號 | 303.4 |
關鍵詞 | 品質指標; 放射免疫分析; 實驗室認證; Quality parameter; Radioimmunometric assay; Accreditation; |
語文 | 中文(Chinese) |
中文摘要 | 背景:我們利用品質指標之監控,進行改善措施,以達到品質持續的提升。對於參與認證一年來品質指標之變化情形如何,檢驗品質是否持續往上提昇,期間未達目標項目之改善措施是否持續有效,整體效益究竟如何,我們希望進一步探討。方法:收集初期(95年6月至9月)、中期(95年10月至96年1月)及後期(96年2月至5月)之指標數據,共區分爲人員能力評估不合格率、檢體退檢率、品管失敗率、能力試驗不符合率、報告逾時率、報告修改率、警告值未通報率及客戶抱怨率等八項,利用MedCal進行百分比卡方檢定,比較各期之差異情形,以評估其間之效益,並作原因分析和檢討。結果:整體而言,實驗室參與認證後各項品質指標均有不同程度之進步。在中期及後期,各指標值均較初期改善,其中檢體退檢率、品管失敗率、報告逾時率、報告修改率、警告值未通報率及客戶抱怨率等六項指標統計上有顯著差異(P<0.05)。在中期各項指標即有進步,直至後期,各項指標全部達目標值。結論:實驗室定期執行品質指標監測、檢討異常現象及改善措施,並追蹤成效,可達到提升檢驗品質之目的。本院放射免疫分析實驗室品質指標分析結果顯示,實驗室導入認證體系之品質管理系統後,品質指標顯著改善,整體效益明顯且快速,在後續檢討改進之措施亦皆持續有效。 |
英文摘要 | Background: We used quality parameter monitoring to process some management strategies in order to achieve the continuous quality improvement for our laboratory. For evaluating the degree of our efforts, quality parameters were assessed. The purposes of this study are to explore the changing of the quality parameters within the study period. In addition, the benefits of the laboratory quality improvement were also discussed. Methods: Quality parameters were collected and divided into first (2006/6-2006/9), second (2006/10-2007/1), and third (2007/2-2007/5) three different periods, prospectively. There were total eight items, including staff ability failure rates, sample rejection rates, internal control failure rates, proficiency test failure rates, report delay rates, report correction rates, warning value notice rates and custom complain rates. Chi-square test using MedCal was performed to compare the measurements of each stage. We also examined the causes of the abnormalities and considered the methods of correction. Results: The results showed that the quality of our laboratory was improved after the process of accreditation participation. All quality parameters of second and third stages were better than the first stage, especially in sample rejection rates, internal control failure rates, report delay rates, report correction rates, warning value notice rates and custom complain rates (P<0.05). Importantly, at the third stage, all quality parameters reached the ideal targets. Conclusions: Laboratory accreditation is a fundamental method for quality assurance. However, continuous quality improvement should be the major motive power for the laboratory. Practically, regular quality parameters monitoring, abnormal events evaluating, results of the improvement tracking can be effectively promote the laboratory's whole qualities and marked up the accuracy of the reports. Our assessment of the quality parameters in the radioimmuno-metric assay laboratory showed that the efficiency of establishing quality management system was obvious and rapid, and it should be performed continuously. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。