Integration of Core Techniques and Validation for High Bio-safety Level Isolation Wards in Hospital

如何興建符合高階生物安全標準之隔離病房，以避免突發之高危險感染不可控制。爆發疫情時立即有效安置治療病患，避免感染與保障安全抑制擴散。國內建築規劃設計、施工驗收者泰半缺乏對生物安全建築觀念，而現有隔離病房興建多依業主經驗所提供需求進行規劃興建，各領域專業技難以適時充分整合。 本研究首先彙整釐清「高階生物安全隔離病房」基本功能需求，確立計畫效能，整合各種需求系統於興建之界面及管理問題，使產品品質與管理品質得以整合，據以建構高階生物安全隔離病房RBS需求分解結構。其次，分析建立核心技術之IIW界面整合作業、IMM界面管理矩陣，以確立其核心技術之整合要項，進而釐清興建階段之各項功能系統與界面間問題，建立界面整合之IMD整合矩陣圖，以循序整合管理機制，確保執行效率。 最後，本研究解析確效精神與架構結合工程興建實務，建構高階生物安全隔離病房之確效管理，建立6Q＋3V確效管理方法，整合生物安全概念、感染防制隔離技術、工程興建技術與醫療設施設置，使工程興建與營運在妥善程序與方法規範進行。於全生命週期執行興建確效BV、用後確效PV及維護確效MV之三確效(3V)，各項確效進行設計驗證DQ、施工驗證CQ、工項驗證EQ、安裝驗證IQ、操作驗證OQ、性能驗證PQ等六驗證(6Q) 之系列驗證，並研擬空間診斷表CoSD及檢核確認表CVT可供應用，循序完成確效管理，確達需求功效。使得全生命週期高階生物安全等級隔離病房之性能，確保能符合需求，並穩定持續達成預期之功效。本研究所建構之確效管理計畫，應用於各類工程興建可全面提昇品質，賦予現有品管制度得以擴展至全面品質管理（TQM）觀念。Most of the architectural designers, the field workers and the inspectors lack of the concepts and the techniques of building biosafety facilities and isolation wards. They rely on the client’s experiences and the requirement instruction, which cannot coordinate both the medical and the construction disciplines in an efficient manner. Without the efficient cooperation, it is impossible to build the biosafety level compliance isolation wards in time to accommodate the infected patients to stop the spreading of the diseases. This study firstly coordinates the various demanding systems within the construction interfaces and management issues, and links the product quality and the management quality, so that the RBS of building the biosafety level isolation wards can be established. The study secondly coordinates the management mechanism in order to ensure the implementing efficiency. The management mechanism is to identify the work items of the core techniques with the IIW process and the IMM. As a result, every functional system and issue of interfaces is clarified by various building stages and the IMD is therefore possibly to be established. This study combines the results of above mentioned approaches, and eventually derives the “6Q+3V” validation management methodology. The validation management integrates the concepts of biosafety, affection prevention techniques, construction techniques, and medical facility installation techniques, and provides the appropriate procedures and means, such as CoSD and CVT, for the building and the operation. The 6Q, including DQ, CQ, EQ, IQ, OQ and PQ, are a series of validations of various building and operation stages. The 3V, including BV, PV and MV, are implemented in the whole life cycle. These validations and qualifications guarantee that the demands will be met, and the expected functions will be stable and continuous. The validation management program constructed in this study may be applied in every kind of buildings to improve the total quality, and bring the present quality management system to the level of Total Quality Management (TQM)