- 期刊
西園醫院參與醫學實驗室認證之經驗分享
The Experience to Participate the Medical Laboratory Accreditation in the West Garden Hospital
摘要
民國92年ISO(International Organization for standardization)公告ISO 15189國際標準，以及新制評鑑採取新標準後，建立符合國際標準的品質管理系統，已是醫學實驗室刻不容緩的趨勢。本文為西園醫院參與全國認證基金會Taiwan Accreditation Foundation(TAF)醫學實驗室認證之經驗分享。以西園醫院檢驗科為研究對象。資料收集時間自民國94年8月起至民國96年2月底止，再依導入認證的三個時間點：中請認證前（民國94年12月）、通過認證前（民國95年8月）、監督評鑑前（民國96年2月），依序切割為三個時期。希望藉由認證前、中、後三期的實驗室各項品質指標，來分享參與認證之經驗。報告完成時間不合格率月平均在前期為2.4%、中期為2.15%、後期為1.9%。報告錯誤率各為0.0025%、0.001%、0.0021%。檢體退件率各為0.1125%、0.049%、0.064%。顧客抱怨方面，除了在中期有兩個月各有一件外，其餘月份每月顧客抱怨件數皆為0件。危險值通報率各為98.2%、100%、100%。能力試驗合格率各為95.8%、100%、98.4%。內部品管合格率各為98%、99.8%、100%。顧客滿意度調查從中期的92%滿意，到後期的94%滿意。報告完成時間不合格率、檢體退件率皆下降。報告錯誤率及顧客抱怨件數等品質指標，則呈現持平。危險值通報率、能力試驗合格率、內部品管合格率等品質指標及顧客滿意度皆提昇。結論：藉由導入認證，吾等從無常規統計期，到建立品質管理系統，及常規統計監控品質指標、不斷持續改善等，都是認證的效益。以地區教學醫院檢驗科的人力、經費、設備，要導入ISO15189品質系統雖是艱辛的過程，但對於品質的提昇，檢驗效能、報告正確性、快速性，以及形象行銷企劃和後期經濟效益，確實有具體提昇效果。希望藉此經驗分享，可作為地區醫院評估是否導入醫學實驗室認證之參考。
並列摘要
After ISO (International Organization for Standardization) announced the ISO 15189 standards, as well as the new hospital accreditation assumed the new standards, there is an urgent tendency to establish the laboratory quality management system which could be conformed to the international standards. This article discusses the experience to participate the TAF (Taiwan Accreditation Foundation) medical laboratory accreditation in the West Garden Hospital.The investigative period was from Aug. 2005 to Feb. 2007. We divided the investigative period into three stages, such as the front stage (Aug. 2005~Nov. 2005), the middle stage (Dec. 2005-July. 2006), and the latter stage (Aug. 2006-Feb. 2007).We evaluated the quality indicators from the front stage to the middle stage, and extended to the latter stage. The unquali0cd rate of reports turn around time was 2.4% to 2.15% to 1.9%. The rate of the returned specimens was 0.1125% to 0.049% to 0.064%. The indicators dropped. The rate of the wrong reports was 0.0025% to 0.0016% to 0.0021%. Except one event in Jan. 2006 and one event in Mar. 2006, the numbers of the monthly client complaints were zeros. The indicators were stable. The rate of the critical interval circulars was 98.2% to 98.4% to 100%. The acceptable rate of proficiency testing was 95.8% to 100% to 98.4%. The acceptable rate of internal quality control was 98% to 99.8% to 100%. The indicators increased. Investigating the client satisfaction, the satisfaction rate was from 92% in Dec. 2005 to 94% in Dec. 2006.In brief, to induct the accreditation, we passed through the non-quality indicators stage to establish the completely total quality management system. All of the improvements are the experience to participate the TAF-accreditation.