美國臨床實驗室之認證

Accreditation of Clinical Laboratory in the US

醫療的過程中經常是需要配合實驗室檢查的結果來作判定與訂定治療計 畫，因此，如何確保臨床實驗室檢查的品質，是追求優質醫學不可或缺的一 環，不可否認的，目前國內各醫院或檢查機構的實驗室間確實存有差異性， 甚至是彼此不信任對方的檢查結果，伴隨而來的就是不必要的重複性檢查， 以致於健係醫療資源的浪費或是病患受到二次傷害等，乃至於因而延誤病情 危害到患者生命的安全！ 避兔不必要的重複測試，早已經是國際問普遍的共識，在做法上就是採 用第三機構的認證制度，透過組織外部的稽核，使得公眾識別出其所執行之 計畫或該組織伶、符合已訂定之規範和標準。換句話說，臨床實驗室若能夠經 由審查、比對相關的標準和公眾肯定等程序，來確認、臨床實驗室之勝任能力 和其執行結果之品質，勢必能夠大幅地改善品質不確定性的問題。本文將介 紹美國臨床實驗室之認證，借鏡於他山之石，將來若能導入實施，對方令提昇 我國臨床實驗室之品質和追求優質醫學將會有莫大的助益。

There is increasing pressure to raise healthcare standard whilst controlling costs. Accreditation of clinical laboratories is one means of achieving this goal. Accreditation is basically an external audit of ability of a laboratory to provide a high quality service. To comply with the accreditation, a laboratory shall demonstrate her service conformed to published standard, have a management system to address internal and external measures of quality, and be inspected by an accreditation body. The Congress of US passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988. Based on CLIA, the Centers for Medicare & Medicaid Services (CMS) of US established the quality standards for all laboratories testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. All clinical laboratories in US must be properly certified to receive Medicare or Medicaid payments. The US clinical laboratory accreditation system would be adopted to improve healthcare quality in Taiwan.