1、全面品質控制.何謂品質ISO定義:一個產品或一項服務的整體特征和性質，此特征和性質讓運用者 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.Quality Management.QP : Quality Planning (Plan)Purpose :prevent problem by implementing proper processesQLP :Quality Laboratory practices (DO) Purpose :establish laboratory standard processesQC :Qualit

2、y control (Check)purpose :detect problem ,contain the damageQA :Quality assurance (Check)Purpose :detect problem, plan improvements.QI : Quality improvement (action)Purpose :prevent problem by correcting processes.Step in the control processChoose what is to be controlled (quality characteristic)Cho

3、ose a unit of measurement (method)Set a standard for the quality characteristicChoose a sensing device which can measure the quality characteristic in terms of the unit measurementMeasure the actual performanceInterpret the difference between the actual quality and the standardTake action (if any) o

4、n the difference.Control MaterialCalibrator: To establish a standard curve 利用知濃度的試劑(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知濃度值，做成函數關係圖。 Control: To investigate the standard curve 利用知濃度範圍的試劑(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，比較能否在原知範圍濃度內.Comparison of qual

5、ity control materialsCriteriaFrozenLyophilizedLow-temperature liquidCostLowHighHighClarityClearTurbidClearStability12 months1824 months1824 monthsLyophili-zation errorAbsent PresentAbsent.Selection of control materialThe analysts concentration should be at medically significantThe material should be

6、 available in large quantitiesThe material matrix should be as much like the human sample as possibleConstituents should be stable for a long period of time.Selection of control materialMaterial should have low vial-to-vial variabilityAfter the vial has been opened and the material prepared it shoul

7、d be stable during the period of useThe material should be ready-to-use or require minimum preparation Control should be immediately available in emergency situationsThe control material should be reasonably priced.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(Twi

8、n Plots Method)低值畫在程度軸，高值畫在垂直軸，構成正方形圖，正方形的中心點，即為兩個平均值的交叉點 .College of American PathologistsExternal quality control 1946 with Belk and Sunderman1947 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 .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