- 期刊
101年度濫用藥物尿液認可檢驗機構之品質評估研究
Evaluation of the Quality of Drug Abuse Urine Testing Institutions in 2012
摘要
為瞭解國內13家衛福部認可濫用藥物尿液檢驗機構檢驗品質狀況，101年度TFDA辦理衛福部認可濫用藥物尿液檢驗機構之績效監測與實地評鑑。檢驗機構的績效監測之執行及判定，係依據「濫用藥物尿液檢驗及醫療機構認可管理辦法」第16條之規範，分析檢驗機構定量值的準確度；另以尤頓圖（Youden）分析檢驗機構是否存有隨機或系統誤差。而實地評鑑則依照「濫用藥物尿液檢驗機構實地評鑑指引」之分類，探討檢驗機構常見的缺失項目。101年度績效監測項目係嗎啡、可待因、安非他命、甲基安非他命、3，4-亞甲基雙氧甲基安非他命、3，4-亞甲基雙氧安非他命、大麻、愷他命及去甲基愷他命等9種濫用藥物，績效監測結果有10家檢驗機構之定量值超出平均值 ± 2SD或 ± 20%之情形，惟13家檢驗機構並無連續兩次測試待測藥物之定量值與平均值差距超出 ± 20%或 ± 2SD，尚符合濫用藥物尿液檢驗及醫療機構認可管理辦法第16條法規之規定。以尤頓圖分析顯示，除愷他命、去甲基愷他命及大麻外，其它6種測試項目發現有部分檢驗機構仍可能存在系統或隨機誤差。實地評鑑部分，以品質管制與品質保證，及檢驗二項缺失比例較多。本研究績效監測與實地評鑑的結果，除列為TFDA制定加強監督管理認可檢驗機構之評估項目外，並供做檢驗機構持續改進品質之參考。
並列摘要
In 2012, thirteen drug abuse urine testing institutions underwent proficiency tests and in situ inspections to validate the reliability and quality of their laboratory work. Based on article 16 of ＂Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical Institutions＂, we analyzed the proficiency tests performance. Besides, Youden chart was used to realize whether there were systematic or random errors. The ＂Inspection Guideline of the Drug Abuse Urine Testing Institutions＂ is used by inspectors to categorize and identify which category has the most non conformance reports (NCRs). The proficiency tests items included morphine, codeine, amphetamine, methamphetamine, MDMA, MDA, marijuana, ketamine and norketamine. The results indicated that ten institutions failed to fall within the mean ± 20% (or ± 2SD) limits of accuracy in their proficiency test. However, all thirteen institutions met the criteria that two times of their results need to be within the mean ± 20% (or ± 2SD) boundary continuously. All drugs except ketamine, norketamine and marijuana, the other 6 items have been found to have systematic or random errors. The results also revealed that NCRs were found most frequently in the sections ＂Quality Regulation and Assurance＂ and ＂Drug Tests＂. The results of proficiency tests and inspections would not only be taken as management criteria, but also as references for institutions to improve the quality of their work continuously.
延伸閱讀
- 吳姿錞、呂在綸、陳映樺、遲蘭慧、李明鑫（2019）。107年度濫用藥物尿液認可檢驗機構品質管理研析報告。食品藥物研究年報，(10)，337-346。https://www.airitilibrary.com/Article/Detail?DocID=22195718-201912-201912310010-201912310010-337-346
- 謝郁琦、杜慧珍、葉美伶、林佳蓓、何明純、柳逸照、楊依珍、陳惠芳（2015）。101至103年度血液製劑檢驗封緘案件分析。食品藥物研究年報，(6)，173-181。https://www.airitilibrary.com/Article/Detail?DocID=22195718-201512-201601110026-201601110026-173-181
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