| 摘要: | 濫用藥物尿液之檢驗結果為司法、檢查、衛生等單位執法的重要依據，涉及當事人之權益，為使各尿液檢驗機構的檢驗結果具正確性及公信力，主管機關須有適當的管理機制，尤其針對自尿液採集至完成分析結果之整體檢驗流程，必須符合品質保證及品質管制規範。管制藥品管理局訂定各項認可濫用藥物尿液檢驗機構管理及制度，相關法規如「濫用藥物尿液檢驗機構認可及管理辦法」2、「政府機關（構）濫用藥物尿液檢驗實驗室設置標準」3、「濫用藥物尿液檢驗作業準則」4及「濫用藥物尿液檢驗實地評鑑指引」5等，以提昇檢驗效能。為與國際趨勢接軌，提昇我國濫用藥物尿液檢驗機構水準，本計畫將針對現行管理系統與國際間使用的實驗室品質系統進行比較與評估，提供主管機關修正建議。 本計畫目標： 1.完成現行藥物濫用尿液檢驗相關法規與ISO/IEC 17025 及鑑識科學實驗室認證技術規範間之比較，將同異處，分別以項目別區分列表。 2.將計畫初步結果徵詢專家及主管機關主事長官之實務可行性意見，以利未來實務執行能順利。 3.將計畫成果整理，提出符合國際趨勢之我國濫用藥物尿液檢驗機構管理及制度之實務修正建議，供主管機關參考。 本計畫實施方法： 1.蒐集現行藥物濫用尿液檢驗相關法規，及國際規範ISO/IEC 17025 ，鑑識科學實驗室認證技術規範，進行原文內容確認。 2.進行比較現行藥物濫用尿液檢驗相關法規與ISO/IEC 17025 及鑑識科學實驗室認證技術規範間之同異處。 3.召開諮詢會議，針對本計畫初步整理之結果，商請實地評鑑委員及審議委員，及全國認證基金會專家，提供專業實務執行意見。 4.彙整意見並修正初步結果。 5.提出現行制度修正建議，供主管機關參考。
The accuracy and reliability of the test results on urine test for drug abuse are primarily important. The law enforcement of regulatory administrations of Justice, Inspection and Health Department is based on the measurement data of urine test for drug abuse. The human right is needed be concerned at the meantime. To establish an adequate assessment system applied to the laboratory management is the responsibility of administrative officers. The quality assurance and quality control system need be established and applied into the entire process including urine sampling, security insurance, storage, measurement, results confirmation, data interpretation, and documentations. For confirming the efficiency on testing performance, various regulations on management and operation systems dealing with drug abuse urine testing institutions, i.e., Regulations Governing Accreditation and Management of Drug Abuse Urine Testing and Medical Institutions, Standards Governing the Drug Abuse Urine Testing Laboratories Established by Government Agencies, Regulations Governing Drug Abuse Urine Testing Operations, and Instructions for on-site assessment of the Drug Abuse Urine Testing Laboratories, have been established by National Bureau of Controlled Drugs, Department of Health, Taiwan. If the local regulations are comparable with international standards on the drug abuse urine testing laboratories needs be evaluated, however. It is necessary to investigate the quality management system currently in used with criteria required by international laboratory accreditation bodies. The results evolved from this project will provide the comments for improvement on current management and operation systems dealing with drug abuse urine testing institutions for authorities concerned. The objectives of this project are: (1) To compare the contents of articles on various regulatory rules currently applied in the urine testing of drug abuse and medical institutions, the international standard of ISO/IEC 17025, and the Guidelines for Forensic Science Laboratories; (2) The primarily suggestions on the management and the operation system will be reviewed by the specialists from the Testing Institution Accreditation Review Committee and inspectors for practical application purpose; (3) The final report of this project will provide practical suggestions on the management and the operation system of the urine testing of drug abuse and medical institutions for authorities concerned. The procedures for this project are: (1) To collect and perform the contents of articles confirmation on various regulatory rules including the urine testing of drug abuse related regulations, the international standard of ISO/IEC 17025, and the Guidelines for Forensic Science Laboratories; (2) To make a comparison of management statements among the currently applied drug abuse urine testing regulations, ISO/IEC 17025 and the technical criteria for accreditation of inspection science laboratory; (3) To conduct the meeting(s) and invite the specialists from the Testing Institution Accreditation Review Committee and inspectors of drug abuse urine testing and medical institutions for consulting the primarily results; (4) To edit and revise the primary results based on comments; (5)To provide practical suggestions on the management and the operation system of the urine testing of drug abuse and medical institutions for authorities concerned. |
