105年度濫用藥物尿液認可檢驗機構之品質評估結果   全文下載

Evaluation of the Quality of Drug Abuse Urine Testing Institutions in 2016

為瞭解國內14家濫用藥物尿液認可檢驗機構之檢驗品質狀況，衛生福利部食品藥物管理署於105年度辦理其績效監測與實地評鑑。檢驗機構的績效監測係依據「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，分析其檢驗機構檢測定量值的準確度；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，探討檢驗機構常見的缺失項目及促其改善。105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。雖105年度績效監測結果有11家檢驗機構之定量值曾超出平均值±2SD或±20%之情形，但14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，顯示部分檢驗機構仍有系統或隨機誤差情形。而在實地評鑑的部分，以「品質手冊」，及「品質管制與品質保證」二類缺失比例較高。本研究績效監測與實地評鑑的結果，可作為食藥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。"

In 2016, 14 accredited drug abuse urine testing institutions underwent proficiency tests and in situ inspections to validate the reliability and quality of their laboratory work. The results were analyzed based on article 16 of the “Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical Institutions”. The Youden chart was used to detect systematic or random errors. The “Inspection Guidelines for the Drug Abuse Urine Testing Institutions” were used by inspectors to categorize and identify the category with the most non-conformance reports (NCRs). The proficiency tests items included morphine, codeine, amphetamine, methamphetamine, MDMA, MDA, marijuana, ketamine and norketamine. The proficiency test results indicated that the accuracy of 11 institutions exceeded ± 20% (or ± 2SD) of the mean value. However, this did not occur in two consecutive tests for all 14 institutions, and was thus considered acceptable. Systematic and random errors were noted in some institutions, when the Youden chart analysis was applied. During the in situ inspections, the most nonconformances were found in the areas of “Quality Manual” and “Quality Control and Assurance”. The results of the proficiency tests and inspections not only help to enhance the supervision and management of the accredited testing institutions, but also serve as references for them to continuously improve their quality of work.