PEPFAR Quality Control and Method Validation Activity 7: Part 3

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WHERE WE EXPECT WHERE WE EXPECT WHERE Single System Random WHERE WE EXPECT ro WHERE WE ro BE WHERE WE EAPT ro WHERE WE EXPECT ro BE" Vastriaution WHERE WE ARE Analytical True W HERE WE ARE Standard WHERE WE WET TO WHERE WE EXPECT ro BE' Standard *100% RE detection WHERE WE WHERE Error (S E) Gaussian Bias Random 68-95.99 Single have fewer false % Total (SO) Goals (SO) 68-95-99 Gaussian Absolute Trule Population Absolute 145 150 145 - 150 Vastriaution Population detecti' WHERE WE RE WHERE A: value WHERE WE ARE WHERE WE WHERE WC RE A: Bias t WHERE RE RE Random Chavte Gaussian WHERE WE WARE WHERE WE WANT TO WHERE RE TE WHERE Systematic have Single Random Error (TE) Error (RE) Trule Messaje Jeopardy -hue value *cue value value X value X: value mean, SD value A: X Value Value V ariation Jeopardy vValue WHERE WE ARP SD value Vastriaution Value Value WHERE WE. Random Results Bias QUALITY Population RE WHERE Error (REA) WE Single Bias ICY V ariation RE SE (0 / 100% 0+ 1.65 *5 Random + 1.65 *3.3% Gaussian detection but ICY Value; CONTROL Vastrilation Error Error (RE) Viastriaution PATIENT WHERE DO WE WANT TO WHERE DO WE TO WHERE WE WENT TO WHERE WE EXPECT PATIENT WHERE WE WANT TO WHERE WE WARE WHERE WEP WHERE WE? WHERE WE WHERE WE ARE WHERE DO WE WANT True Value; Systematic Bias Analytical 605-99 inconsistent Inconsistent Messages QUALITY = 8.3 = 3.3% Look for Value y' A: mean, A: mean, SD than Value; the chart A: SD value A: *rue value *rue value A: mean A: value Sys tematic A: Value) SAMPLE mean, SD *rue value SD) value mean, SD *rue value X Value Value SD value Value; value SA mean True SE True SD rule Inconsistent System SAMPLE QUALITY abnormal essayes PATIENT ess ayes Messayes CONTROL QUALITY ± 2SD abnormal Pmprecision Error Capability Systematic •slave ICY Messages the IS We Are IS are care Analytical are from SAMPLE Capability % Total Systematic True Value; PATIENT *rue value CONTROL CONTROL QUALITY Error (SE) Messages •ustering Wue He *cue value ; PATIENT Wue from He *rue value Tessayes Single PT) PATIENT use the Gaussian from PATIENT (83.3 / 150) ssages -sages A: 5+ 1.65 *10 5+ 1.65 *5 3.3% + 1.65 *3.4% 145 150 145 - 150 150 Error SAMPLE Error V from Tbnotmal CONTROL worst case scenario (QC) 2SD Random my from True RE -E Error (RE) (QC) coefficient Vastriaution The accuracy SAMPLE clustering QUALITY 25 SAMPLE accuracy an case use scenario Random 1:2s rule as = 13.3 = 6.4% = 3.4% on SAMPLE Wnherent (QC) Coefficient ot Median Mean Value ? is/a€e • is/ace Is/ace . is/ace . is/ace an ±3SD 68% = ICY clustering True Trule — True True Consistent Single Look for Error PATIENT Total CONTRO RE CONTROL Use the a scanning SAMPLE Random ICY True Trule CONT Change Population — True Total co use the Change Normal ICY CONTRO chart es is QUALITY CONTROL PATIENT Total Error (TE) Error PATIENT Value Single Vastriaution X Value Laboratory B Laboratory C SAMPLE f:2s rule as The CONTROL (QC) X Value Value 68% = Change Single Laborato device Population Laboratory A Laboratory C Laboratory D % Total Single T) IRE (QC) b) WE ARE we ARE SE ARE o + 1.65*10 (10 WE ARE PATIENT an Look for : SamFk analysis hrs ses a scanning The accu : analysis has cre : quaff+ahve analysis has Population RE Use the We ARE (0 SAMPLE ± 2SD t ISD QUALITY SAMPLE •slate have Analyte WHERE we Use the Error Total abnormal and = 16.5 ? is(a€e ? is(ace ± 2SD ± ISD 1:2s rule as (QC) Look for WHERE device % Total we ARE CONTROL Total SAMPLE A: Total a scanning RE clustering (QC) 1:2s rule as abnormal Look for Assigned on 95% SAMPLE Use the IS 95% device the chan = the chart 99.7% Nbnormal ± 2SD away from the mean cumula+-ive cumula+ive device a scanning ± 2SD ±3SD clustering Lab B (5 / 100% WHERE DO WE TO WHERE DO WET TO WHERE WE A WHERE WE WANT TO WHERE WE (10 3.3% + 1.65 *3.4% 145 - 150 1450 - 150 1:2s rule as f:2s rule as the mean SAMPLE Look for away from mean Analytical 99.7% a scanning Error an from and WHERE WE = 21.5 = 6.7% = 6.9% -3.3% . is/ace 99.7% z the mean device Error •slate is(ave is/aqe is/ace device clustering ±3SD 99.7% =14.3 150 away from Total Look for ±3SD les es 145 150 Analytical on change fie analy+ical the mean abnormal change fro fie anqly+ical fro the analy+ical to fie analy+ical range fie analy+ical Analytical e analy+ica I Error (TAE) clustering TE RE on sys+em has occuvted. Systematic Sys+-em has occutted. has TE SE RE m has occuned. has occutfed. em has occuvced RE on ARE RE away from us occurted as occurced nas occurved. on on mean % Total the mean and - and and an RE +hen Error 26 25 24 on 24 25