107年度濫用藥物尿液認可檢驗機構品質管理研析報告   全文下載

Evaluation of the Quality of Drug Abuse Urine Testing Institutions in 2018

為瞭解國內15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（簡稱食藥署）於107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，檢驗機構經認可後，每三個月應接受執行機關績效監測一次，測試結果之正確率應達百分之90以上，且不得有偽陽性結果出現，其中連續2次測試待測藥物之定量值與參與檢驗機構平均值差距在百分之20或2個標準差之內者，應達百分之80以上，且不得連續2次有與平均值差距達百分之50以上。分析其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；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。107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107年度績效監測結果有13家檢驗機構之檢測定量值曾超出平均值±2SD或±20％之情形，全數皆符合前述認可管理辦法第16條之規定。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。實地評鑑的部分，以「品質管制與品質保證」及「品質手冊」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 2018, 15 accredited drug abuse urine testing institutions took part in proficiency tests and in situ inspections to validate the reliability and quality of their laboratory work based on article 16 of the “Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical Institutions”. Once accredited, the testing institution shall take the performance test conducted by the executive institution once every three months. The accuracy of test results shall reach 90% or above, and false positive result may not occur. For 80% or more of the results, the difference between the two consecutively measured values of the tested drug and the mean value of all testing institutions participating in the test shall be within 20% or two standard deviations, and it is not allowed that the difference reaches 50% or more for two consecutive times. The Youden chart was used to detect systematic or random errors. The inspectors identified and categorized the deficiency in the most non-conformance reports (NCRs) based on “Inspection Guidelines for the Drug Abuse Urine Testing Institutions”. The proficiency tests items included morphine, codeine, amphetamine, methamphetamine, MDMA, MDA, marijuana, ketamine and norketamine. The test results indicated that the accuracy of 13 institutions exceeded ± 20% (or ± 2SD) of the mean value. However, this was considered acceptable. Systematic and random errors were also noted in some institutions when the Youden chart analysis was applied. As to the in situ inspections, most of non-conformances were found in the categories of “Quality Control and Assurance” and “Quality Manual”. 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 the testing institutions to continuously improve their quality of work.