100年度濫用藥物尿液認可檢驗機構之品質評估研究

100年辦理衛生署認可濫用藥物尿液檢驗機構之績效監測與實地評鑑，其目的在於了解國內13家衛生署認可濫用藥物尿液檢驗機構的品質。藉由各機構的績效監測檢測值與所有參與機構平均值之差距是否超出±2SD或±20%作為標準，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。結果有9家檢驗機構之定量值有超出平均值的±2SD或±20%之情形，惟13家檢驗機構皆符合濫用藥物尿液檢驗及醫療機構認可管理辦法第16條，連續兩次測試待測藥物之定量值與平均值差距在±20%或±2SD以內者，應達80%以上的法規規定。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種用濫用藥物，以尤頓圖分析顯示，除愷他命及去甲基愷他命外，其他7種測試項目均有部分檢驗機構可能存有隨機或系統誤差。實地評鑑部份，以品質手冊及品質管制與品質保證二項缺失比例較多。本研究績效監測與實地評鑑之結果，均做為檢驗機構持續改進品質之參考。

關鍵字

濫用藥物尿液檢驗；績效測試；實地評鑑

並列摘要

In 2011, thirteen drug abuse urine testing institutions underwent proficiency tests and in situ inspections to validate the reliability and quality of their laboratory work. This article presents an analysis of the quality of the institutions' testing procedures and execution. In the proficiency test, accuracy is accepted within the bounds of mean ±20% (or ±2SD), while systematic or random error is realized using a Youden chart. 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 results indicate that nine 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 80% or more of their results need to be within the mean ±20% (or ±2SD) boundary. All drugs except norketamine and codeine have been found to have systematic or random errors. The results also revealed that NCRs were found the most frequently in the sections ”Quality Manuals”, ”Quality Regulation and Assurance”, and ”Urine Specimen Collection, Disposal, and Storage”. Urine testing institutions may continue to improve upon the quality of their work according to the results of proficiency tests and inspections in the above analyses.

並列關鍵字

drug abuse urine testing ； proficiency testing ； inspection

國際替代計量

100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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