移植用組織庫的稽查

Guideline for auditing tissue banks

人體組織的異體移植在臨床上已有相當程度的應用，由於移植用組織的來源也比較多，而且，同一個捐贈者的組織會移植到許多接受者身上，影響的層面比較廣，因此，移植用組織所要求的安全性和品質是要更為嚴謹，以確保組移植接受者的安全性與不會受到傳染性疾病的感染。為確認移植用組織的安全性和品質，導入標準操作程序、品質系統與文件化等的相關措施已經是移植用組織庫運作不可或缺的要件。本文論述稽查的程序與稽查重點項目，包含：行政架構與業務、組織捐贈勸募、組織擷取、組織處理、組織貯存以及組織配送，乃至於後續的追蹤和對不良事件的通報等。最主要的目的就是希望介紹移植用組織庫的相關稽查作業，以提供移植用組織庫運作的參考，從而可規劃出與運作為合乎標準的移植用組織庫。移植用組織庫也可根據本文所述的稽查重點來進行內部稽查，找出可能的問題或缺失，從而加以改進來確保移植用組織的安全性與品質。

The use of allograft tissues is increasingly popular in the clinical applications. As the use of allograft tissue increases, the safety and quality of allograft remains an issue of paramount importance. Moreover, the tissues from one donor may be transplanted to several different recipients. Therefore, tissue banks must establish and maintain a quality system to ensure safe, functional and effective tissues. The functions of a quality system should include maintaining appropriate written procedures, requirements for process validation, and equipment qualifications, as well as performing investigations of deviations from written procedures. This article tries to explain the audit procedure and guidance of auditing a tissue bank. The entire auditing process includes the organization of a tissue bank, tissue donation, tissue procurement, tissue processing, tissue storage, and tissue distribution. The purpose of the discussion is to introduce the auditing work and to provide all criteria of auditing. Based on the information, tissue banks should be able to establish and maintain a quality system to ensure safe, functional and effective tissues. Moreover, tissue banks can also perform an in-house audit according to the descriptions and find out the potential errors and deviations from the written procedures.