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按一下以編輯母片標題樣式,按一下以編輯母片,第二層,第三層,第四層,第五層,*,来自,中国最大的资料库下载,全面品質管制,1,何謂品質,ISO,定義:一個產品或一項服務的整體特色和性質，此特色和性質讓使用者 覺得滿意的程度,。,臨床檢驗服務定義:在約定的費用與時間內，以及約定的條件下和事後必須的處置，交付可靠的訊息,2,Quality Management,3,QP,: Quality Planning (Plan),Purpose :prevent problem by implementing proper processes,QLP,:Quality Laboratory practices (DO),Purpose :establish laboratory standard processes,QC,:Quality control (Check),purpose :detect problem ,contain the damage,QA,:Quality assurance (Check),Purpose :detect problem, plan improvements,4,5,QI,: Quality improvement (action),Purpose :prevent problem by,correcting processes,6,Step in the control process,Choose what is to be controlled (quality characteristic),Choose a unit of measurement (method),Set a standard for the quality characteristic,Choose a sensing device which can measure the quality characteristic in terms of the unit measurement,Measure the actual performance,Interpret the difference between the actual quality and the standard,Take action (if any) on the difference,7,Control Material,Calibrator: To establish a standard curve 利用已知濃度的試劑(standard/calibrator) ，測定其與反應試劑作用之能量變化；並將此能量變化值與該已知濃度值，做成函數關係圖。,Control: To investigate the standard curve 利用已知濃度範圍的試劑(control serum) ，測定其與反應試劑作用之能量變化；並對照該反應之standard curve ，將能量變化值換算成濃度值後，比較,是否在原已知範圍濃度內,8,Comparison of quality control materials,Criteria,Frozen,Lyophilized,Low-temperature liquid,Cost,Low,High,High,Clarity,Clear,Turbid,Clear,Stability,12 months,1824 months,1824 months,Lyophili-zation error,Absent,Present,Absent,9,Selection of control material,The analysts concentration should be at medically significant,The material should be available in large quantities,The material matrix should be as much like the human sample as possible,Constituents should be stable for a long period of time,10,Selection of control material,Material should have low vial-to-vial variability,After the vial has been opened and the material prepared it should be stable during the period of use,The,material should be ready-to-use or require minimum preparation,Control should be immediately available in emergency situations,The control material should be reasonably priced,11,External Proficiency Testing,為Youdon 於1967年提出的 品管圖，以正常(低值)及異常(高值)兩種品管同時測定，製成雙值 管理圖(Twin Plots Method),低值畫在水平軸，高值畫在垂直軸，形成正方形圖，正方形的中心點，即為兩個平均值的交叉點,12,13,College of American Pathologists,External quality control 1946 with Belk and Sunderman,1947 College of American Pathologists (CAP) Performance limits and grading a:19661969within+2S as acceptable ，exceeding +2S as not acceptable b:1970within +1S as good ，within+2S as acceptable ， beyond +2S as not acceptable,14,Cap surveys uses a calculated grading parameter called the standard deviation index (SDI),SDI,=(laboratory value-group mean)/group S,Values outside the group means +2SDI limits are not acceptable,15,Reference :,臨床檢驗品質管理 理論與實務 林明泉 榮昇圖書事業股份有限公司,Taiwan symposium on Quality control James O . Westgard,臨床品質管制學 (中山講義) 江惠玲,16,
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