PEPFAR Quality Control and Method Validation Activity 8: Part 4

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WHERE IS IS we ARE and WHERE device VAR WE ARE abnormal WE clustering mean device ARe clustering ± 2SD Use the bces le26 -+he clustering Bias 0.410 5.80 0.410 0.24 ± ISD ±3SD 99.7% = Look for Upper and 1:2s rule as 6 — VARIATION VAR, the mean away and applied. and Does clinically fie fie and es away from IS applied. clinically Clinically ANALYTICAL Nbnormal VARIATION SS gppeor Gaussanbsfr,bu+ed on away from Appear Gausstonbis+f,bufed on away from the mean ANALYTICAL Absolute Bias is 5.73 0.410 0.237 0.241 is a scanning procedure." procedure. on 99.7% the mean the mean ± 2SD device VARIATION _ IS the _ be les *han *he be les *han -ihe be les *han be les A-han Ice les -fran -ihe les *han clinically the be IS *han be les *ban be les *han *he be les *hen ANALYTICAL IS be les VARIATION clinically fie IS +hen 99.7% clinically New Reagent Lot Number AEan sac: BIOLOGICAL 'IS is+f,bu+ed on IS is Analytical sac. Lower Target Upper ±3SD WE change analy+ical change fie analy+ical and IS •to analy+jcal fie analy+ical arnaly+ical ±3SD analy+ical Analytical VARIATION 99.7%: fcr PRE- be *han be les A-han TEA on 0.39 0.139 0.37 0.39 TEA Limit be IS *han Value TEA Limit be les be les *han be les *han -ibe be les *-han BIOLOGICAL be -fran -We ) +hen sys Fem sys+-em has occurced. sys+em has occutfed. sys+•em has occurted. •n has occurced. has occurs-ed. ) *hen a Change In ocuracy or p€ecision ±3SD s occuned. occutted. can WE IS a Change In ocuracy or ptecision IS the 5.80 cal TE < (yes or no) Yes NC No 0.39 5.73 5.21 5.80 0.239 5.84 5.739 assigned *hen ANALYTICAL Change fie analy+ical chanse to He analy+ical Me VARIATION )ange analy+ical fie analyiical 'expect ro fie e analy+ical VARIATION change hie anqly+ical Why Me For for For ISO 15189:5.5 for PRE- PRE- VARIATION PRE ANALYTICAL has occuvted. m has occuvted. sys+•em has occuned. VAR! ANALYTICAL ANALYTICAL nse he analyiica\ has occuned. Error change analy+ical the analyiical analyiical fed. BIOLOGICAL or p€ecision m has occuvted. VARIATION mn has occuvted. PRE- VARIATION Used correåly ANAL PRE- +hen used ANALYTICAL change Chante ocucacy 28 29 fro the analyiical WORKSTATION