PEPconnect

PEPFAR Quality Control and Method Validation Activity 7: Part 1

In this activity, participants are introduced to bias and true value. Using the information supplied by 3 key numbers, participants calculate the TE in units and percent. Additionally, participants explore the impact that bias and imprecision can have on TE and relate site-specific processes that affect TE to checklist items.

Note: Any reference to page numbers in the video may not correlate with supporting documents as documents may have been updated.

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'he amly+ical + Isd IS IS RE IS WE RE IS we wyeRE we — ARE accuracy and IS error (error in a we WE -o fie analy+ical fie I analy+ical IS we ARE IS WC the great statistical equalizer and the test -2 - and and we ARE -IOS — and +3sd -I (15 "c'Ston and -103 -105 -103 coo IS WHERE WE SE basis OF SQC.— Mean -105 Before basis OF sac. Part 1 5% Mea IS c. cone S(ÄC.— sac:- sacr sacs— sac:— IS sac:— sacs sacs WHERE WE fem descftb es Fem b es sac: -Isd ARE descrt b es sac. t WHERE ARE WHERE we can +3 we a. a) al IS ' Difficult to correctly determine accuracy from WHERE WE ARE and IS WE ARE +2sd • Pencil pencil ARE SAT WHERE WE ARE nd Analytical we s occuvced s occutqed. And assiyed s occutced. — IS the analy+ic Sys+em describes and Glucose analy+ic sy• analytical - IS analy ewe E IS the 10 WE : • Common multipliers with the SD are: • Common multiplie Common rnultipliers 'With analpc s IS 13) 3) Remains constant for the life Of the 3) Remains constant for the life of the SD -Isb IS and IS ISD IS is OF SQC. is the is Svs+em desc'lb - IS sac. — describes ISD cean es OF sac-.- IS +3 OF SAC. an sys - is Is ne+ is -105 IS +he 42sd SE IS fhe OF SCAC. StAC. svs+em dB OF OF SQC.— OF SQ baSlhS bash e IS IS ISD Bas SE IS assigned bash bas — is Illustrate the TE for Worksheet 2. • Illustrate the TE for Worksheet 2. internal sources ARE • Positive number performance we must compare SQ internal sources alone we OF SQ SAC we •IS is is 50 expecr ro is ne+ RE SE S OF — and - and {and and i S IS OF fid eRC We given direction) +2sd WHeRe DO we IS is IS DO RE (8.3 SE (20 SE (20 sac. IS b es +3 bass OF CODS con Assigned = Observed IS the wc ARE SCAC. achons edihg the same t Isd -OF SQC. — sac:- SQAC. SQC;— SAC. distribution measurements exceeding the same and l. IS OF SQC. OF IS -OF ution OF SQCJ sac. -sac: sac-. sac: specific lot number of QC material; it is the RE ratio often expressed in % •e We IS can IS fie _ is f' sac.- Bias of + 4 umol/L sac. - S(ÄC. fid •e we cxpecr ro _ IS Calcium (mmol/L) we cxpecr IS +Qhen +cend3 1, 'e Is 2.26 6.25 *hen OF F) *hen is — best estimate b) b. (QC) O;' The stable system you t ought you had may actually The stable system you thought you had may actually +hen when IS ($4 Expecrro -xpecrro IS +he +hen ) +hen *hen .1 Then +hen +he n is +he n *hen IS WHERE wt WHERE WE WHERE ) *hen *hen change analy+ica OF sac. WHERE we —WHERE WE we Ake ARE true value after all ARE c we wt W. we es sac:.- WHERE WC alcutat;e s 2 — commonly used for quick calculations 2 — common for only use quick WHERE& WE W, we A —WHERE basis OF WEAR' we A Re 2 — comm we we ARE sac'. sac. OF change yo analy+ical sac: sac-.- cean _ IS OF S(AC 'j' IS the •he IS Analytical SOC. is the Cal chary analyiical an have inherent prob'ems and constant bias have inherent problems and constant bias OF SQC is IS a he amiy+ical IS is sac OF o. change to fie analy+ical Chanee the analy+ical o. change fie analy+ical Analytical Analy+ical Change +0 the analyiical •e is no+ Then Chanee •r we woe we ARC expec* ro B and naly+ Chanse yro fie analy+ical change fro he analy+ical chanse +0 analy+ical chanee fie analy+cai he analy+ical +3sd o. chanse to the analyiical Is chanse 'th fie analy+ical change fie Inaly+ica I 'Analytical al chanse fro fie analy+ical change analy+ical chanseto fie analy+ical change fro fie analy+ical change yo fie analy+ical change the analy+ical o. change yo hie analyiical chanse to the analy+ical chanse tro the analy+ical hange o. Chanse analy+ical Chanee fie analyiica\ chan9e +0 the analyiical chanee fie amly+ical Chan9e fro fie analy+ical h e analy+ical o. Change +0 analy+ical o. Change +0 the analy+ical Change fro the analy+ical Change fi the analyiical Change +0 fie analy+ical Chanse he analy+ical Change fro fie analy+ical chanse fro the analy+ical Chanse fi he analy+ical chanse +0o fie analy+ical Change fr fie analy+ical WHERE WE ARE to WHERE we ARE to Analytical o. fro fie analyiical Chanse +0 Hie analy+ical basis -OF SCC EXPECT ro B ro B Change to hie analy+ical change +0 the analy+ical chanse fie analyiical change fie analy+ical Aanalytical +0 the +0 he analy+ical o. change the analy+ical change to fie analy+ical Chanse he analyiical fro the analy+ical +0 Hie analy+ical 'Analytical +0 He analy+ical tro he analy+ical +0o fie analy+ical +he n Sys fem o. Chan9e +0 change yro fie analy+ical o. chanse to fie analy+ical chanse +0 hie analy+ical anse -fie analy+ical fie be analy+ical Chanee fie amalyiical he I a he analy±ical to. the analy+ical He analy+ical Change analy+ical he analy+ical the analy+ical analyiical he anqly+ical Chan' Analytical fie analyiical analy+ical The • Sometimes TE equations do not specify an After iical OF SC OF OF SQCC SC.ÄC +hen he amly+ical the to hie analy+ical ical - S QC. S QC. and Savoe WHERe WEAR 04 has 4) The value used in comparison with the a) l' wr@xpec wÉexpe — IS WE ERE WE exp we descrt b es 1.96 — inclucl '7.5% *hen WHERE — ) +hen ERE eRr SYS+em has S)awqned has occutced. estirnates the SD at the estimates the SD at the c) a) sacs Even though the data has been shown to be sac. hacs Calcium Sp+em has control limit c. +he n has occurced. sunsø8 sys+em has occuvted. WHERE' EARE chanse SF+em has Sys+em has occuvced Chan SF+ern has o. change sys+em has change he IS SYS+em has Is he sys+em has occuvced. sys+em has ecuned. Sys}em has SF+em has occuned. SF+em has occutted. SFS+em has o. he analy+ical o. he when SYS+em has SFs+em has occutced. Sysi•em has occuntced. Sys+•em has occutt'ed. Sys+em has occutted. n has occurted. has occutfed. sys+•em has occunted. sys+em has occuned. sys+em has sys+•em has occuvced. sys+em has occurced. sps+•em has occuvced. Sp+•em has occutted. sys+-em has occutced. SF+-em has sys+•em has occutted. Mean cludes 97.5% program discussion. Bas sysi•em has occurted. has occurred. -4 SD -ISD -3SD -4SD cuffed. -4SD -4 SD I3SD -2SD IS SE -3SD _ +hen ) *hen +hen Sys+ern has Ted. , fed. 2SD 3SD 4SD has occutted. has has occuvted. Sys+em has has occutted. has occuvced. has occurted. has occurtced. has occurted. has has occuned, has occuvced. has occuvted has occutfed has occuned. has occutted. SYS+•em has arced. seed. sys+em has occutted. Chas even+s sys+•em has occutCed. sys+-em has occurceci. Sp+•em 6as occurted. o, chanse t-o he analy+ica Change bash iactced. sys}ern has occurvced. Sys+-em has occurs-ed. SF+em has Chanse to he analytical has .4 Bias Åas occurted o, Change he analy+ica he analy+ical he analy+jcal — and and nd has Bas information gained after a change has he analy+ica\ h. He analy+ical o. change t en occur fed Accuracy occurced. OBSERVED change Change fie has occuvted. cutted. o. Change Change sys+ern has o. chanoe fro change chanse he analy+ical O. o. change change to -t change fro o. chanse he analy+ical Calibration consistent from previous results over an extended chanse to he analy+ical chon o. IS LIS calu Bias of - +0 he analy+ical Bias of - analytical Analyiical chanse he Change to fie Change fie analy+ica\ Change he analy+ical 3 umol/L I change tro fie analy+ical he amaly+ical H e analy+ical change analy+ical He analy+ical o. chanse fie analy+ical 7 umol/L chanse fro fie ,'+ical fro fie analy+ical to he analy+jcal we is i. change fie anqlyiical t chanse the analyiical ,Change -Fo fie analyiical Error fie analy+ical IS J Ne*oqel hange analyiical to he analy+ical ecr ro fro fie analy+ical ro g eoncentration level of interest concentration level of interest +hen when WHERE WE WANT TO BE is ne+ Error analyiica\ Bas occutted. has occurtced. cal occurred to monitor the analytical system •he anqly+ical ve sacs fie analyiical )nalyiical Bas Bas occunced. Bas occurced. occuvced. he I lly+ica\ hen has occuvted. time period, you may actually be consistently wrong. e analyiical Analytical Analy+ical _ +hen ) +hen Sysi-em has occuvted. ne iical XPECÜO *hen ERE we we ARE WE e we absolute bias is being used. absolute bias is be•ng used. ERE WF SYS+em ha WHERE ARE Sys}em SYS*e sys} SYS Fe sys SYS + SYS+Fern has occ cpecr IS SYS} SYS Fem sys+-emn sys onse fro the analy+ica\ SYS SYS f System Sys i•ern SYSYem SYS fem sys+em has ha Sys+•em has occuned sys+e has SYS TE (28.3 SFS-em Bas occutted. has has occurced hacs has occuvted Bas SF+em has occutted nclu{ f, has occunted. SYS+em Bas occuvced. Sys+emn has occuvced. Sys+em has Bias Has occunced. 1.965 — includes 97.5% probability include o robabjlity. has occutced. fed. Bas occuvted. Bas has a. has occurced. Accurate and Preciseon Accuracy and Precision OH WORKSTATION fs+em has occutcted. occutfed. ys+em has occutfed. •he +•em has m has occuvced. has occutted. has IS the Yem has occuvted. has occutfed. chanee analy+ical change the analy+ical 1.65 SD bash S —o IS -m •u occurted. .8 change to -fie +hen te09 -o l) b) c) d) a. Ted. Analytical Change Method validation or verification studies were never jfication studies were never change fie Re He analy+ical +hen he nee he analy+ical se fro the analyiica\ te fro fie analy+ical -o fie analy+ica\ the analyiical Analy+ical 14 change to the I to fie analyiical e analy+ica\ fie o. ro B occuvted. occuvced. luffed vpecr ro g h. when 65 minutes e we ro ro weexpecrro •xpecr ro 4. occurted. c.curvced. 2 toe analy+ical to fie analy+ical S} Tie chanse le analyiica\ chon e I aly+ical change fro he a change the a o. Chanse he analyiical Analytical en Fyiica\ 'cal I) .6 Analyiical V/iical 19 15 lyiica\ i+ica\ 13 21 20 11 10 16 has occutted. Change fro He a •ica to he a fro fie a System 1.96 SD to he Chanee to the +0 a WORKSTATION we ha fie fie +0 performed to evaluate accuracy perf T med to evaluat 'ccuned +ical SF+ern has sys+em has Sys+em has sys+em has occuned. curacy change fie analy+ical (J hias (4 n has has Chan* inas as WHERE WE ARE E WE we ARE las ARE WHERE we ARI

  • total error
  • TE
  • bias
  • imprecision
  • largest variation
  • true value
  • target value
  • 3 key numbers
  • percent
  • SLIPTA
  • SLIPTA checklist
  • mean
  • SD
  • standard deviation
  • total variation
  • eliminate bias
  • reduce imprecision
  • absolute bias
  • cumulative mean