臨床微生物檢驗室如何符合認證之技術要求

近年來陸續有多重抗藥性的細菌被發現及報導，由於微生物檢驗室的檢驗結果會影響醫師的治療決策，因此臨床抗生素的使用備受重視。臨床微生物檢驗室應建立檢驗前、中、後的標準化作業流程，以確保檢驗結果的準確性，以提昇檢驗品質及符合認證之要求。本文以美國病理學會（College of American Pathologists；CAP）的laboratory general及Microbiology Checklist及財團法人全國認證基金會（Taiwan Accreditation Foundation；TAF）的ISO 15189兩個認證機構的條文要求，從文件建立，人員訓練，檢體採集、保存、運送，儀器設備的保養維護，試劑、耗材的保存與品管，實驗室內、外部品管操作與檢討、報告核發、品質保證與改善、實驗室生物安全等面向。說明醫院的微生物檢驗室如何建立標準化技術系統，以符合認證之要求，做為臨床微生物檢驗室作業參考。藉由認證機構的定期查核，實驗室的持續品質改善，產生具有醫療價值的數據，提升病人安全及醫療品質。

關鍵字

美國病理學會；財團法人全國認證基金會；病人安全；醫療品質

並列摘要

In recent years, multidrug resistant bacteria have been discovered and reported in the paper, because the test results of the microbiology laboratory will affect the doctor's treatment decisions, the use of clinical antibiotics has get much attention. The clinical microbiology laboratory shall establish standardized procedure of pre-analytical, analytical and post-analytical phases, to ensure the accuracy of the test results, to improve the quality of the tests and to meet the requirements of the accreditation. This article is based on the provisions of the Laboratory General Checklist and Microbiology Checklist of the College of American Pathologists (CAP) and the ISO 15189 certification body of the Taiwan Accreditation Foundation (TAF). From all the aspects which include document establishment, personnel training, sample collection, storage, transportation, maintenance of instruments and equipment, preservation and quality control of reagent and consumables, internal and external quality control, and review the QC results, issue the test report, quality assurance and quality improvement, laboratory biosafety. To explain how to establish and standardize technical procedures in a microbiological laboratory, to meet the certification requirements, as a reference for clinical microbiology laboratory. Through periodically accreditation body audits, laboratory continuously quality improvement, for generating valued medical reports, and improving patient safety and laboratory quality.

並列關鍵字

CAP ； TAF ； Patient Safety ； Medical Quality

國際替代計量

臨床微生物檢驗室如何符合認證之技術要求

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