性能驗證和質(zhì)量規(guī)范課件

檢驗質(zhì)量規(guī)茳與能評怙分析質(zhì)量目標(biāo)質(zhì)量控制流程性能評估檢驗參考值確定質(zhì)呈目標(biāo)采取評估改進(jìn)措施現(xiàn)有性能制定室間比對質(zhì)控方案心執(zhí)行室內(nèi)質(zhì)控%TEa一%biasPr。cesssigma%oCvameasureof“goodnessmeassigmaDPM。(D。fect-6210OPPortuniBias(%o)Testingmaterialofknown/certifiedqualityUseofareferencemethodeCvo(Truevalue-observedvaluetruevalueParticipationinaQc×100%interlaboratorycoparitionprogramTEa(%):衛(wèi)生部臨檢中心(生化)件定的總滿差拒標(biāo)與其粒國家屬蓋指標(biāo)比壁臨床生物化學(xué)檢常煖目分橋質(zhì)量指標(biāo)木文件規(guī)定的總?cè)徽鬯c其國家出標(biāo)比見表B1n.12誤差指與其國家侵蓄指標(biāo)比較床生物化字驗規(guī)現(xiàn)目分析質(zhì)量臨標(biāo)是表A1表A.1臨床生物化學(xué)規(guī)檢驗項日分析質(zhì)量指標(biāo)大利xTE河就±U/L(≤4U/[失門基編谷熊基轉(zhuǎn)移我我型甘準(zhǔn)三中中后行的樣為自四用TEa(%):衛(wèi)生部臨檢中心(臨檢表9準(zhǔn)確度驗證的允許偏差檢測項目RBCMC\MCHMCHC相對偏差≤15.0%≤6.0%≤6.0%≤9.0%「≤20.0%≤7.0%≤7.0≤8.0%表5日間精密度檢測要求檢測項目MCVMCHMCHC受異系數(shù)25%≤20%40%≤80≤2.5≤2.5%3.0表12準(zhǔn)確度驗證的允許偏差檢測項目相對偏差≤15.0%≤20.0%日間精密度以室內(nèi)質(zhì)控在控結(jié)果的變異系數(shù)為評價指標(biāo),日間精密度應(yīng)符合表11的要求表11凝血試驗的日間精密度檢測要求檢測項目APTT正常樣本≤6,5變異系數(shù)異常樣本≤10.0%質(zhì)量和Q的關(guān)系∥OCneededforatestdependsonsigmaperformanceofmethod[TEa-偏左)Cv6sigmaprocess-anycommonsingleruleQCwildo5sigmaprocess-singleruleQCwith2,5slimitsandNof2-34-sigmaprocess-singleruleQCwith2,5slimitsormultiruleQC西倍3-sigmaprocess-doallQCpossibleNsof6-8Can'taffordtorunenoughcontrolstodetectmedicallyimportanterrors!武需要的QC依」方法的世格瑪能6西格瑪過程可以使用何Q現(xiàn)則使用Q為2.55或N36的多規(guī)則QC子西格瑪過程N為68全部可能的QC上的重要誤差相同檢測項目兩套系統(tǒng)(相同)WorkplaceStaxRunStssnCumulativeCotrolstallCundafveCantralεPitched27的n2囂g24從BPlyphachss8ePn296器民自intTELF2MphatheckSanl143115515671ESuTallOSBE3751544TBLFMphachsMSeP11443115522541551uman031229154P2lphacheckSsl1230028770.13uTall141120130075nmSe4254游2Ln40bhon8