102年度濫用藥物尿液認可檢驗機構之品質評估研究

為瞭解國內13家認可濫用藥物尿液檢驗機構檢驗品質狀況，衛生福利部食品藥物管理署於102年度辦理其績效監測與實地評鑑。檢驗機構的績效監測則依據「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，分析其檢驗機構定量值的準確度；並以尤頓圖(Youden)分析檢驗機構之隨機或系統誤差性。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，探討此檢驗機構常見的缺失項目。102年度績效監測項目包括嗎啡、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。在第1及2次績效監測各有1家實驗室出現偽陽性結果，均要求實驗室提出改善報告，並進行實地評鑑。綜觀本年度績效監測結果雖有10家檢驗機構之定量值超出平均值 ± 2SD或 ± 20%之情形，但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，尚符合規定。以尤頓圖分析顯示，發現部分檢驗機構仍存有系統或隨機誤差情形。而在實地評鑑的部分，以「設施及維護」，及「檢驗報告及檔案管理」二項缺失比例偏高。本研究績效監測與實地評鑑的結果，可為本署制定加強監督管理認可檢驗機構之評估項目，並供檢驗機構持續改進品質之參考依據。

關鍵字

濫用藥物尿液檢驗；績效監測；實地評鑑

並列摘要

In 2013, 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. In addition, Youden chart was used to detect whether there were systematic or random errors. The ＂Inspection Guideline of the Drug Abuse Urine Testing Institutions＂ is used by inspectors to categorize and to 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. There was 1 institution had false positive result in the first and second proficiency test. TFDA had acquired those institutions to correct the problems and subsequently performed in situ inspections. The proficiency test results indicated that ten institutions exceeded within the mean ± 20% (or ± 2SD) limits of accuracy in their proficiency test. As all thirteen institutions had met the criteria, they had two uninterrupted satisfactory test results falling within the mean ± 20% (or ± 2SD) boundary continuously. System and random errors have been noted in some institutions, while Youden chart analysis was applied. The results had revealed the fact that NCRs were the most frequent and noticed items in the sections of ＂Equipment and Maintenance＂ and ＂Reports and record management＂. The results of proficiency tests and inspections would not only be taken as management criteria, but also continuously served as references for institutions to improve the quality of their work.

並列關鍵字

drug abuse urine testing ； proficiency testing ； inspection

國際替代計量

102年度濫用藥物尿液認可檢驗機構之品質評估研究

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