PEPFAR Quality Control and Method Validation Activity 4: Part 2

2) Type and number of GCs ±es+ed Frequency of QC +es+ even+s Laboratory 3 Type number of GC sampks ±es+ed 3 Type number of GC +esfed System 2) Type number Of QC sampks ±esfed 3 Type numbec Of QC sampks ±esfed Type number Of QC ±es+ed Type number Of QC sampks ±es+ed 3 Type number of QC ±es+ed Type and number ±es+ed Type number of GC sampks Type and number of QC ±es+ed Type number sampks tesfed Type number of QC ±es+ed Type number sampks •tes+ed and number sampes tes+ed Scenario #1 2 Type and number of tes+ed 2 Type number Of (X tesfed l) Frequency of sampe +es+ even+s 3) QC used Scenarios #1 and #2 number 3) Type and number of GC ±es+ed 2) Type and number sampés tes+ed review System analy+ica\ Analytical {Type avid number of sampks +es+ed enario #1 3) used +0 or and number of GC ±esfed Type and number of GC ±es+ed 2) Type and number of GC ±es+ed 2) Type number of GC ±es+ed QC used Scenarios #1 and #2 2) Type number sampks ±es+ed QC used +0 3) QC used +0 QC +0 QC ased +0 2 Type and number of QC sampks +es+ed used +0 evalua+e 'Analytical Results aAnalyiical Type number ±es+ed rend s •System or Quality ype and number ofGC sampés ±es+ed review QC used +0 3) QC used Qualit Laborator System Analytical evaluaVe evalua+e QC used QC +0 Laborator Type and number of Qampes tes+ed review for Traditional 'Westgard Rules' review Laboratory Results and used +0 System Quality Quali.y Quality Crate: Cete: Czte: Quality - review For Scenarios and 52 - review for QC used +0 review Analytical Laborator rends used +0 Results hen re Report Results rends review for Labr,rator Laboratory Results or Laborator or Type number tested In-Control QC used Laborator evalaa+e review for Laboratory ERE WE System System Quality rends rend S Results Res Tevtew For Results Cete: Ceata: Ceta Ceta: [Results rends Results Quality Tech: rends review quality hen rends Laborator Tevtew for hen resul+s Quality Laborator hen resul+s I hen resul+s ; ro revtew for Results Results - review for hen resal+s review Scenot\0 hen resul+s nen reed+s Laborator rend s for hen resul+s rends Results Quality Idualit rend S review Scenoci0 Results rend 3 rends Scenario 3 Laborator hen resul+s Scenacio ERE WE Scenario Z rends hen resdl+s Results Scenacio Results Scenacio Results Scenario 3 Quality hen resul+s Control or ERE WE Scenonio Scenario S Scenario I Scenario \ Scenario 3 Scenario I hen resul+s .ua it ua it ua It Scenario 3 uai Scenacio Scenacio I Scenotic 3 No enacio Scenacio ERE WE RE Control ERE ar ERE WE ar ERE we WE we wr ro yste Table l: Scena€io Control Table l: Table I : Scenario I Table l: oneControl In-Control _,-Control ua It one point out Control ERE WE EXPECT ro ro In-Control Table l: ERE WE l: 7 l: Scenafio Scenario Report WHERE WE ARE 7, IL Quality Scenario 3 l: 7, 'L Table 3 Scenacio Scenacio or Scenario 3 WHERE WE WHERE WE ARE we ERE we Wei: Control of 2 SD SD 3: able l: WHERE we yste Control we System - ualit 7, L WHERE WE ARE Table l: WHERE WE ARE yste Syste In-Control Control Table l: 2: Z: 3: one control Z: Table 3 yste Table l: 7 Table 27 3: ERE WE expect ro WHERE W 3: 21 WHERE we vstem 3: Table 3: 7, Z we or Table 3: / 3: l: Z: 3: TQbte 3: WHERE we 3: q: SAMPLE System WHERE WE ARE S ste WHERE we ARE WHERE A Re Table PROFICIENCY Syste_ l: ystem PATIENT 3: Z: Table 3: l: 3: Leq: Table PROFICIENCY TQbLe q: Table q: PATIENT TabLe SAMPLE PATIENT H : 3: PATIENT Z System PATIENT PATIENT Table l: 3: / l: FICIENCY PROFICIENC System_ PROFICIE' PROFICIENCY PROFICIENCV lox PROFICIEDCY PATIENT TQbLe H: 225 PATIENT Z PATIENT PATIENT Scenario Z No T Scenario Scenacio PROFICIENCY TING (PT) Table PATIENT SAMPLE Table l : TQbLe q: TESTING TESTING (PT TESTING (PT) TESTING 40 CONSECUTIVE 2 CONSECUJTME 10 CONSECUTIVE 20 CONSECUTMVE SA PATIENT 40 CONSECUTIVE 10 CONSECUTMVE 20 CONSECUTMVE SAMPLE PROFICIENCY SAMPLE SAM PLE TESTING (PT) b:ross runs) B:ross runs) one point out one point SAMPLE The range one gent SAMPLE control values on co values on Yes yes Yes SAMPLE PATIENT Z PROFICIEN values on ONE SAMPLE SA PATIENT Scenario Z yes PATIENT 2 out SD out sick SD outsick SD SO 2 CONSCIJTME 2 CONSECUJTME CONSCIJTME (difference) between Edifference) between 'Ion SAMPLE one sick of the one si&ofthe TESTIN 14 PATIENT wen PATIENT sick of the mean. 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