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1、何謂品質何謂品質n nISO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。n n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Quality ManagementQP:Quality Planning(Plan)Purpose:prevent problem by implementing proper processesQLP:Quality Laboratory practices(DO)Purpose:establish laboratory standard processesQC:Quality contro
2、l(Check)purpose:detect problem,contain the damageQA:Quality assurance(Check)Purpose:detect problem,plan improvementsQI:Quality improvement(action)Purpose:prevent problem by correcting processesStep in the control processn nChoose what is to be controlled(quality characteristic)Choose what is to be c
3、ontrolled(quality characteristic)n nChoose a unit of measurement(method)Choose a unit of measurement(method)n nSet a standard for the quality characteristicSet a standard for the quality characteristicn nChoose a sensing device which can measure the quality Choose a sensing device which can measure
4、the quality characteristic in terms of the unit measurementcharacteristic in terms of the unit measurementn nMeasure the actual performanceMeasure the actual performancen nInterpret the difference between the actual quality and the Interpret the difference between the actual quality and the standard
5、standardn nTake action(if any)on the differenceTake action(if any)on the differenceControl Materialn nCalibrator:To establish a standard curve Calibrator:To establish a standard curve 利用已知濃度的試劑利用已知濃度的試劑(standard/calibrator)(standard/calibrator)，測定其與反應試劑作用之能量變化；並將此能量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
6、函數關係圖。變化值與該已知濃度值，做成函數關係圖。n nControl:To investigate the standard curve Control:To investigate the standard curve 利用已知濃度範圍的試劑利用已知濃度範圍的試劑(control serum)(control serum)，測，測定其與反應試劑作用之能量變化；並對照該反應定其與反應試劑作用之能量變化；並對照該反應之之standard curve standard curve，將能量變化值換算成濃度值，將能量變化值換算成濃度值後，比較後，比較是否在原已知範圍濃度內是否在原已知範圍濃度內Com
7、parison of quality control materialsCriteriaCriteriaFrozenFrozenLyophilizedLyophilizedLow-temperature liquidLow-temperature liquidCostCostLowLowHighHighHighHighClarityClarityClearClearTurbidTurbidClearClearStabilityStability 12 months12 months 1824 1824 monthsmonths1824 months1824 monthsLyophiliLyop
8、hili-zation-zation errorerrorAbsent Absent PresentPresentAbsentAbsentSelection of control materialn nThe analysts concentration should be at medically significantn nThe material should be available in large quantitiesn nThe material matrix should be as much like the human sample as possiblen nConsti
9、tuents should be stable for a long period of timeSelection of control materialn nMaterial should have low vial-to-vial variabilityMaterial should have low vial-to-vial variabilityn nAfter the vial has been opened and the material After the vial has been opened and the material prepared it should be
10、stable during the period of useprepared it should be stable during the period of usen nThe material should be ready-to-use or require material should be ready-to-use or require minimum preparation minimum preparation n nControl should be immediately available in Control should be immediately availab
11、le in emergency situationsemergency situationsn nThe control material should be reasonably pricedThe control material should be reasonably pricedExternal Proficiency Testingn n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)n n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 Colleg
12、e of American Pathologistsn nExternal quality control 1946 with Belk and Sundermann n1947 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
13、Cap surveys uses a calculated grading parameter called the standard deviation index(SDI)SDI=(laboratory value-group mean)/group SValues outside the group means+2SDI limits are not acceptableReference: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 谢谢观看/欢迎下载BY FAITH I MEAN A VISION OF GOOD ONE CHERISHES AND THE ENTHUSIASM THAT PUSHES ONE TO SEEK ITS FULFILLMENT REGARDLESS OF OBSTACLES.BY FAITH I BY FAITH