臨床醫療之標準作業程序

Clinical Standard Operating Procedures

為穩定品質和降低各種因素所導致的差異性，就必須制定標準作業程 序，以作為品質改善與評估改進成效的基礎及準則。國內接連發生醫療院所 打錯針和給錯藥的重大醫療疏失，就是沒有按照標準作業程序，因此醫療院 所制定標準作業程序絕對是刻不容緩。而在衛生主管當局要求診所和醫院訂 定標準作業程序之際，當可以借鏡本文所論述優良實驗室規範中對標準作業 程序之相關規範。 原則上標準作業程序應、該是書面的、經過審視與核准、要有更新和稽核 的機制，內容方面則應包括有：機關單位名稱、標題、頁碼、版次與生效日 期、分送的人與單位、撰寫者姓名與簽名、審核者之姓名與簽名、適用範聞 與目的以及標準作業程序本體等。然而，更重要的是標準作業程序絕對不是 用來取代教育訓練的工作，相反的，而是要我們醫療機構在有了標準作業程 序後，要不斷地教育醫護人員依照標準作業程序來實施，才能夠真正確保醫 療之品質與有效性。

In the times of the quality improvement of services and cost reduction efforts, the role of Standard Operating Procedure (SOP) for both medical and nursing procedures gets increasing importance. To adopt the SOP, this article describes the very basic requirement of SOP to comply with the Good Laboratory Practice (GLP). The types of SOP include administrative and personnel, analyses, substances, quality assurance and records, test system, equipment, and field related. All SOP must be adequate in scope to describe the function in sufficient detail such that the study data are reproducible as well as be approved by a technology management level. The signatures for SOP responsibility, authorship, and Quality Assurance review adds strength and accountability to the SOP. In the event a procedure or method is performed differently from what is stated in the SOP, an SOP deviation is necessary. As methods and procedures are improved, SOP revisions are necessary to maintain SOP adequacy and applicability. The paper-based SOP should be adopted in day-to-day clinical works. However, the SOP is not used to replace the on-job training. On the contrary, the education needs to cooperate to SOP for better clinical service quality.