以ASTM協定連結品管系統與檢驗報告驗證系統

Link Quality Control System and Laboratory Auto-verification System as ASTM Protocol

蕭文明(Wen-Ming Shiau)

指導教授 ： 吳帆

國立中正大學/管理學院/資訊管理學系/碩士(2015年)

摘要

在各級醫院中，臨床診斷之準確性是非常重要的一件事，實驗室的檢測報告結果也是臨床醫師據以制定醫療決策的根據之一。
　　臨床實驗室的作業流程，依工作處理的內容可以分為檢驗前、檢驗中、檢驗後等三個階段，就是檢驗前的檢體採集、保存、處理、運送。檢驗中則有分析測定、確保分析品質，以及檢驗後的分析結果正確性、資料傳輸回LIS等等，每一個流程、每一道步驟都能對分析結果產生不良的影響。唯有確保檢驗的過程中，每一個環節都是正確無誤，才能將正確的結果傳達給醫師知道，醫師才能據此做出最準確的臨床醫療處置行為。臨床實驗室採用自動化設備在20世紀90年代起快速增長，尤其是在歐美和日本等地。隨著自動化設備的普及也提升了臨床實驗室的工作效率，相對地，自動化設備的維護、定期保養、品質管控的工作，卻變成臨床實驗室的一項新課題。設備若疏於保養、維護則會影響分析結果的正確性。因此，臨床實驗室的品質管控，成為實驗室近幾年來不斷追求的工作，藉以維持分析結果正確性，並進一步追求與改善報告核放速度，提升醫療品質，增進良好的醫病關係。
　　報告自動驗證系統是目前各臨床實驗室正在追求的系統，加上實驗室現有存在的即時品質管控系統，透過ASTM協定，經由RS-232連結這二大系統，除了可以有效連結傳輸即時品質判讀結果，將二大系統緊密地結合在一起，並且能在最小的經濟成本下，快速達成全面報告結果自動驗證功能，提昇實驗室報告核發效率，再縮短臨床實驗室的檢驗時間。

關鍵字

即時監控品質管理系統 ； 檢驗報告結果自動驗證系統 ； 實驗室資訊系統 ； ASTM協定

並列摘要

The accuracy of clinical diagnoses is important at all levels of hospitals. Laboratory test reports offer one of the foundations upon which physicians make medical decisions.
　　The workflow of clinical laboratories can be divided by tasks into three stages, namely pre-examination, examination, and post-examination. The tasks in the pre-examination stage are collection, preservation, processing, and delivery of samples. The main task in the examination stage is to analyze the test while maintaining the analysis quality. The tasks in the post-examination stage are to validate the accuracy of the analysis results and to transmit data to laboratory information systems (LIS). Each process and step in these stages has a decisive effect on the analysis results. The analysis results can help physicians provide the most effective treatments only when each step of the test has been carried out with no error. In 1990s, there has been a rapid growth of laboratory automation facilities, especially in the US, European nations, and Japan. With the increasing prevalence of these automation facilities, the work efficiency at clinical laboratories has also improved. The maintenance and quality control of automation facilities has also become a new issue for clinical laboratories. Without regular and proper maintenance, the accuracy of the analysis results generated by these facilities will be affected. Therefore, quality control in clinical laboratories has been a common goal of all laboratories in recent years. Through quality control, they can maintain the accuracy of analysis results and further speed up the release of reports, improve the healthcare quality, and promote doctor-patient relationships.
　　Laboratory auto-verification system is a system that all clinical laboratories seek to build. By integrating the existing real-time quality management system and using ASTM protocol, the two systems can be connected via RS-232. In addition to providing real-time diagnosis of transmission quality, the system can achieve automatic verification of test reports, improve the report release efficiency, and shorten the required time of laboratory tests at a minimum cost.

並列關鍵字

Real-Time Quality management system ； Laboratory Auto-Verification system ； Laboratory Information System (LIS) ； ASTM protocol

參考文獻

顏瓊姿，劉建財，闕宗熙 (民96)。數值型檢驗報告自動驗證判斷準則參數之研究。醫療資訊雜誌，4(17)，11-24。

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