組織庫的管理與品質管控

The Management and Quality Control for Tissue Bank

我國衛生主管機關依據「人體器官移植條例」定訂出「人體器官保存庫 管理辦法」草案，此管理辦法實施後將規範人體器官、組織、細胞之處理與 保存，及以組織工程、基因工程技術對組織、細胞所為處理及其衍生物之保 存，其目的就是希望能確保組織保存庫的品質，以免危害到捐贈者、受贈者 與操作者。本文擬勾勒出「人體器官保存庫管理辦法」的重點，與參考歐美 組織庫運作的模式，介紹相闊的品質管理機制，借鏡於他山之石，相信對於 確保我國組織保存庫之品質和追求優質醫學將會有所的助益。

According to the law of organ transplantation, the Department of Health, Executive Yuan is making the management rule for the tissue banks covering all organs, tissues and cells. The administration management rule aims to improve the quality of tissue banks. All tissue banks must comply the rule for continue operation. In this article, we will present the key points of official management rule for the tissue banks. To comply with the rule, it is necessary to introduce the quality management system. Therefore, the quality control issue will also be discussed in this article.