建置一內嵌知?模組之?床實驗室品管監控系統

Building a model-based quality-control system of clinical laboratory

陳慶順(Ching-Shun Chen)

指導教授 ： 蔣以仁

臺北醫學大學/醫學院/醫學資訊研究所/碩士(2006年)

摘要

檢驗資料長久以來便是臨床醫師診斷疾病、決定治療處置以及判斷預後的重要依據，而提供醫師一個快速又準確的檢驗數據，一直是每一個實驗室永無止盡的追求遠景，但是其中影響達成目標的重要因素除了人員素質外，儀器及試藥是實驗室最不容易掌控的，因為人員可以經由審慎遴選及再教育而達到要求，但儀器及試藥卻不容易能保證品質隨時合乎要求，是故品質管制很早便使用於實驗室，依據實驗室規模大小及成本考量，各實驗室自己會選擇適當的品管液及品管規範，以監控實驗流程，包含人員操作，儀器軟硬體以及試藥之品質，期能消弭實驗室所發之報告中的可避免錯誤，從而將每一筆數據之不準確度降之最低。使用品管液只是模擬，判讀品管液的結果才能真實了解是否除了隨機誤差外尚存在實驗室系統誤差，甚至是實驗模型本身之不適性。而為了判讀存在品管數據內之重要資訊，便發展出許多視覺化圖形及判斷規則，但受限於計算繁複以致甚少應用於臨床實驗室。而且影響檢驗報告準確性的因素，除了分析過程本身外，還包括分析前檢體處理及分析後報告發送，另外為了消弭各實驗室間變異使得實驗數據可在各實驗室間互相流通、也為了有一客觀之第三組織來對實驗室能力加以評估而實行之”院外品管”也應該納入品管監控。本研究嘗試建置ㄧ完整系統，涵蓋品管之各領域，提供儀器品管數據自動化傳輸，智慧型警示及建議改進步驟，根據每一檢驗項目其臨床意義提供不同之品管判定規則，將退件和危險值通報的記錄保留並分析，以涵蓋分析前及分析後之品管，也將病人每日檢驗數值平均數計錄以獲得病人數據品管。另外也記錄及分析院外品管結果。最後將所有數據依評鑑需求繪製列印成圖表，搭配web base的介面克服多院區的品管人員重複配置問題，期能將實驗室品管素質向上提升，藉以增進醫療品質及病人安全。

關鍵字

品管系統 ； 品質管? ； 管制圖

並列摘要

The clinical laboratory's data are one of the important resource to assist clinicians to identify the disease, provide treatment for patients and judge the prognostic efficacy for a long time. To offer doctors a fast and accurate test result is the laboratory's final goals, but the most important factors to reach the goals include the quality of personnel, instruments and experimental reagents. We can reeducate personnel and qualify them, but it is difficult to control the quality of instruments and reagents in order to match the requirements of the goals. Most of the laboratories had used statistical processing control to solve this issue. The laboratories select their own appropriate quality strategies depend on the different lab dimension in size. Use control material only helps simulate the condition of actual processing test, but cannot really improve the quality. The only and the most effective way is to find the error factor and exclude it so that a so-called quality can actually be improved and reached. In order to discovery the information of quality control test, many methods have been developed, including graphic visualization and the rules for judging quality. In addition computer-aid to calculate and present result for users is also an important part of it. The “External Quality Assessment”(EQA) provided by the third party used to evaluate the proficiency of laboratories is also a necessary part of the total quality control, so must to record and analyze it. Preanalytical and postanalytical errors must be controlled, as well. This study is aimed to build a web-based quality control system for clinical laboratory, by using computer power to save manual workload for the much amount of quality control data, the records of preanalytical and postanalytical error and the result of EQA, and to build a support decision system to help users to judge from the result of “statistical processing control”(SPC). This system can connect all instruments at different locations and provide the clinicians the reliable information about the quality of his ordering test at real time by internet. It is the hope that healthcare benefits from the use of this system cab be much improved.

並列關鍵字

Quality control system ； Quality control management ； Control chart

參考文獻

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