Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical Institutions Article 15
After being accredited, the testing institution shall accept , and shall not evade, hinder, or decline the performance test conducted by the executive institution once every three months.The accuracy of performance 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 drug to be tested and the mean value of the testing institution participated in the test shall be within 20% or two standard deviations, and it is not allowable that the difference reaches 50% or more for two consecutive times.The values measured by the testing institutions that are 20% or two standard deviations above the mean value shall not be included in the calculation of the mean value.
中文原文 濫用藥物尿液檢驗及醫療機構認可管理辦法第15條
檢驗機構經認證後,每三個月應接受執行機關績效監測,不得規避、妨礙或拒絕。
績效監測之正確率應達百分之九十以上,且不得有偽陽性結果出現,其中連續二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二十或二個標準差之內者,應達百分之八十以上,且不得連續二次有與平均值差距達百分之五十以上。
檢驗機構檢測值超過平均值百分之二十或二個標準差者,不列入平均值之計算。
績效監測之正確率應達百分之九十以上,且不得有偽陽性結果出現,其中連續二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二十或二個標準差之內者,應達百分之八十以上,且不得連續二次有與平均值差距達百分之五十以上。
檢驗機構檢測值超過平均值百分之二十或二個標準差者,不列入平均值之計算。