PEPFAR Quality Control and Method Validation Activity 6: Part 3

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agreeing, collaborating, combining, concurring, Frequency c; Where S when resul+s ±ahen when resul+s exceed exceed o +Q6en when eKceed ceed We Expect excee -e exceed 0 exceed occep%hole exce exceed SD Mean Mean ISD Flipchart OCQep%61e OCQep+üåIe OCQep+061e WHERE WE ARE exceed qccep%01e simultaneously simultaneously by yo We Are simultaneously by your siti simultaneously by your sit 100 100 umolJL Can compare methods that give different units • Can compare methods that give different units 5.0% Measure of random — Measure of randon — Measure of random WHERE CXPEC/ WE ARE Precision PEPFAR QC Workshop WHERE we EXPECT ro WHERE WE ARE WHERE Accuracy WHERE WE EXPECT ro BE' EXPECT ro ' WE ARE Quality ARE WHERE we ro WHERE we WE WHERE TO BE • WHERE we EXPECT ro WHERE WE EXPEcr BE WHERE WE AR BE' ua It WHERE we ro ARE Quality 5.0% WHERE WE Used as the basis for Used as the ba: Used at the cro: Used as the bas Used as the basis for comg Used at the cro:s -1 WHERE WE Expecr ro ' Quality direct WHERE ro WHERE wr ro WHERE WE ro BE 3) Calculate the Mean using the new lot number by analyzing the QC material 8-10 times. Confirm that the values coordinated, harmonious, joining, relating, we we ro we re, we WHERE we Wr ro WE expecr ro WHERE WE ro DE ua It i WHERE RE +3 SD ro WE WHERE WE ARE ro WHERE WE we WHERE WE ARE i WHERE WC WE ARE WHERE WE ro BE WHERE WRE WE ARE ro ae WHERE RE ro DE ro ae WHERE WE ARE E WE ARE WE E ARE WHERE WE ARE WHERE ua 1 HERE ARE when HERE AR WHERE WE ro BE WHERE RE WHERE WHERE WE ARE Goals — Measure of absolut( WHERE we ARE WHERE we ro WE ro WHERE WE WHERE WE ro DE WHERE WE ro DE ' WHERE WE expecr ro WHERE we ro BE WHERE we ro ; WHERE we expecr ro BE WHERE WE ro BE ' WHERE WE expecr ro DE WHERE WE expecr ro BE WHERE we expecr DE WHERE expecr ro BE ; WHERE WE AR BE WHERE WE expecr ro DE ' WHERE WE EXPECT ro BE' WHERE we ro DE RE we expccr ro DE ' we WHERE WE ARE RE WHERE WE ARE — Measure of absolut WHERE WHERE WC EXPECT ro BE HERE AR expecr ro BE Control WHERE we expecr ro BE ' WHERE we ro WHERE we expccr ro BE ' WHERE expecr ro ro DE ' WHERE we Control Coefficient of Coefficient of Variation - The great statistical equalizer ua It WHERE WE ro OE ' WHERE WE ro ac WHERE WC EXPECr WC WE EXPECT ro -4 WE EXPEC* WHERE WE EXPECT ro analyte Handout: Standard deviation (SD) perfo WHERE WE EXPECT ro BE' Quality WHERE WE ARE Quality we Provides a estimate of method precision over a range ARE RE WE ARE WE ARE we ARE WHERE WE BE WHERE WE ARE WHERE WHERE wr ro WHERE WE EXPECT ro BE WHERE RE ' WHERE WE ARE peer group peer group WHERE WE EXPECr TO BE WHERE WE ARE Control WE EXPECT ro WHERE WE ro BE WHERE we WHERE Wc WHERE W/ WHERE WHERE we ARE WHERE WE WHERE we ro DE WHERE we WHERE we a RE we ua 1 we ARE WHERE we ARE WC we WE ARE we WHERE WE EXPECT ' ua it Laboratory WHERE n m WHERE we ARE WHERE Goals Goals WHERE Control WE ARE Control. E WE ARE WHERE WHERE RE WHERE WE Ao RE WHERE ARE WHERE WC ARE WHERE WE ARE WE WHERE WE EXPECT ro WHERE WE A RE WHERE WE WHERE we ARE WHERE we A Re Run # Value u mol/L unpredictaE unpredicta WHERE we WHERE WE ARE on trol we ARE we Results 0b yste System Used at the cross-ove Used at the cross-owe Used at the cro: Used at the cross-over (pat Used at the cross-over (pal yste Control Used at the cro:s-cve obs wr we Coefficient of Variation Coefficient of Var Coefficient of Va WHERE WE ro WHERE ARE ro WHERE WE ARE 115 Results TESTING t WHERE ARE System i WHERE WE ARE of concentrations -i WHERE WHERE ARE WHERE WE ARE WHERE uniting yste l/ System WHERE WE 14 System WHERE WE. different lot #s different lot #s of con different lot #s of control n (QC) it the — Used to measure dispersion/scattering of a group — Measure of relative variability — Measure of relative variabi'ity QUALITY Mean (x) a short out-of date sh a short out-of c a short out-of d a short out-of date shelf lif a short out-of date shelf I WHERE QUALITY undergoing, a change Control — The great statistii — The great statist • Can assist with the selection of new methods or Can assist with the selection of new methods or Char ' — Provides an estir QUALITY Deter QUALITY •e QUALITY QUALITY QUALIT 10 115 QUALITY CONTROL materials) materials) PROFICIENCY of values around a mean Control QUALITY CONTROL CONTROL CONTROL PATIENT QUALITY PATIENT CONTRCL cor CONTF (QC) and CONTROL und un PROFICIENCY minstruments for your site instruments for your site PROFICIENCY Activity 6: Messages (QC) PROFICIENCY — Measure of relati — Measure of resolat SAMPLE TESTING (PT) CONTROL (QC) (QC) (QC) CONTROL (QC) SAMPLE PATIENT PATIENT TESTING essayes TESTING (PT) — Expresses the SD in percent SAMPLE s ayes SAMPLE TESTING (PT) ey essayes V essayes ayes Identif Messayes SS ayes SAMPLE Variation SAMPLE (QC) SAMPLE (0 SAMPLE SAMPLE — the average of a set of values SAMPLE QUALITY SA CONT'OL — Primary indicator of precision SD QUALITY QUALITY • Compares the precision of several instruments used Compares the precision of several instruments used used ssaoes essayes SAMPLE Deterr Dete CONTROL CONTROL PATIENT PATIENT •g The at Messages Messages PROFICIENCY CONTROL PATIENT r) Q. (QC) The a IENT +hen acct TESTING (PT) TESTING pr Accuracy accuracy sm cSton simultaneously by your site simultaneously by yo —t X X — Comparison of overall precision, since standard The pre SAMPLE SAMPLE analy+ic — primary indicator of accuracy — Measure of random error ( error in any direction) (QC) analy±ic ana PATIENT systeo sy*em b es system describes descflbes Solving for SD Tie es bes (QC deviation typically increases as the concentration of the b es SAMPLE Used as the basis for comparing with your laboratory's SAMPLE HERE AR WHERE rE — WE WHERE WHERE we ARE changeability, fluctuation, inconsistency, ARE 9, — Measure of absolute variability measure of systematic error (error in a given analyte increases and nd and = 5.8 umoI/L we we E ARC peer group we ARE The direction) IS the the OC IS fhe IS +he IS he -hen 5) Calculate your ranges for* ISD, 2 SD, 3 SD, 44 SD. To avoid errors with rounding, perform the rounding ofTat the IS and unpredictability we WE expÉ exp •crroD s the Used at the cross-cue/ (pareve' testing) between 2 Used at the cross-over (parallel testing) between 2 Coefficient of Variation — Estimates the SD at the concentration level of interest — Estimates the SD at the concéntcation level of interest 6-8 100% 2 SD WHERE •IS is different lot #s of cohtiol' mute/iåj when materials have WHERE we WC 117 104- 127 127 98- 133 92 - 139 Re different lot #s of control material when materials have is 115.4 - 115.4 92.2 WE exprcr ) +hen +hen is *hen 115.4 + (3)5.8 + (3)5.8 WHERE change a short out-of date shelf life (i.e, whole blood a short out-of date shelf life (i.e. whole blood a short out-of date blood Lnse fie =132.8 — The great statistical equalizer o. chary fro fie analy+ical change fro fie — Provides an estimate of method precision — Provides an estimate of metho& precision change Change o. change ge analyiical analyiical •be amlyiica I 2 analyiica I +hen lyiical 'lyiical amly+ical Verify the mean and SD on the new lot number When data from a longer period of stable operation becomes available. nalyiica materials) sys+em has has occuned. chan WHERE WE has occuvced WHERE AR WHERE WE ARE has occurced. WHERE as occuvced. e analyiical anqiyiical .lyiica\ the analy+ical *hen SF+em — Measure of absolutive variability — Measure of relative variability — Measure of resolative variability Sys WHERE has occuned. Ted. 14 10 11 13 12 ) +hen bash s Activity 6: Parallel Testing: Making History