PEPFAR Quality Control and Method Validation Activity 4: Part 4

analy+ical t-cequency of (AC +es+ evenis Frequency of evenFs Frequency of even+s I) Frequency OF QC +es+ even+s l) Fcequency of QC +es+ evenfs Frequency of +es+ even+s 2 Type aod number of QC 2 Type number Of +esfed 2) Type aod number Of sampes 2 Type aod numbec Of sampes 2) Type number of sampks testea 2) Type nod number of sampks testea Type number of sampks ±es+ed 2) Type avid number of sampks testea Type number Of QC sampks ±es+ed Type number of Type aod numbec of sampks testea Type number Of sampks +es+ed Type number sampés ±es+ed Type aud number of (l sampks ±es+ed number Of sompks tesfed 2) Type number ov number Type aoid number of used I Frequency OF (AC +es+ even+s Type numbec of ±es+ed 2) Type number ofs e 2) Type number of sampks ±es+ed •i Type and number +es+ed 2) Type aod number of (l sampes +es+ed Type aod number Of Type aod number of sampks e 5 of 2) Type numbec of sampks Type aod number of CC sampks ±es+ed Type aud number sampks ±es+ed 2) Type aod numbec of sampks testea IAnalytical 5 of a. 23A 5 of Z3A) 5 of 23A) 5 st Type aod number sampks •Analytical 'Analytical 5 ms 5 of 5 of Z3A 2) Type number o Type avid numbec of (l sampks ±es+ed Type aod number Of GC sampks ±es+ed 3) used 3) used +0 Type aod numbec Of (l ±es+ed Type number sampks +es+ed , 'Analytical I Analytical "Analytical Analytical 'A analytical , Analytical Type numbec of CC sampks fes+ed 2 Type and number of QC +es+ed Analytical' Type number of sampks tes+ed 5 ms system System of Type number Of sampks ±es+ed Analytical of a. of used +0 Type numbec ±es+ed Analytical Scenario Z3 Type numbec of Scenario #3 Scenacio Scenario #3 Scenacio System 3) Type number of GC sampks ±fes+ed 2) Type number of QC sampks 'fes+ed Scenario Scenario #3 2 Type number of (R sampks ±es+ed Type avid number of QC sampks fes+ed Type and number of QC sampks fes+ed Type number Of GC sampks +es+ed Type numbec Of sompks fes+ed QC aseA Scotem QC used + o QC used 40 3) 5 of QC ased used ased and number sampks 'fes+ed number Of QC sampks fesfed 2) Type and number Of QC sompés 2 Type number of QC samples ±es+ed 2) Type anod number of GC sampks tested Type and number sampks ±es+ed 3) QC used iystem System Analytical QC + o Analytical' Scenario 3 Scenario I)) Frequency OF QC +es+ even+s QC used System System used 40 iystem Frequency OF *est evenfs l) Frequency of QC +es+ even+s l) Frequency Of even+s l) Frequency +es+C even+s l) Frequency OF QC +es+ evenfs l) Frequency OF +es+ eveni-s l) Frequency of QC events l)) Frequency of QC even+s QC System l) Frequency of QC 21)) Frequency OF (AC +es+ even+s l) Frequency +es+ even+s Frequency OF +es+ even+s Frequency of +es+ even+s Frequency OF QC +es+ even+s frequency of QC +es+ even+s Fcequency of QC even+s I Frequency OF QC +es+ even+s Frequency OF even+s QC used +0 Frequency of QC evenfs Frequency OF QC sampe evenfs Frequency OF QC fest even+s error Frequency of QC sampk± +es+ evenfs Frequency of +es+ evenfs Frequency of QC +es+ evenfs frequency of (AC +es+ even+s \ Frequency OF (AC +es+ even+s I) Frequency OF QC +es+ even+s I Frequency OF (AC +est even+s l) frequency OF QC even+s QC 40 I Frequency of AC +es+ events Quality I Fcequency of CAC even+s l) Frequency OF QC +es+ even+s frequency OF Sam* +es+ events I Frequency of QC +es+ even+s l) Frequency +es+AC even+s Frequency OF QC +es+ even+s I Frequency OF AC +es+ evenfs Frequency OF +es+ even+s QC used System used Frequency Of QC +es+ even+s 3) QC used 3) QC used 40 - 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Results hen resul+s *hen hen re hen hen resul+s en resu14s hen resul+s hen hen resul hen res *hen hen resul+s Scenacio hen resul+s hen resul+s +hen hen resul+s 1:3s 7, IL ALT, AST, Bili-Tot, creat Scenario 3 en resul+s Key Messages Key -massages Results Results YOUR CLIENTS AND THE Key "essages 1:3.5s TP, CK Results YOUR — Key messages ro Scenacio Key messages Key Tléssages Key •tessages Messages Scenacio. Key Essages messages eéy messages ua it Table -Z Scenario 3 Scenacio I Key Méssages •e we Scenario Z Quality ua It Key Messages 3) Glucose you SERVE' ro Quality YOUR Key Méösages Table l: Control ua It Scenario 3 ua 1 Scenario \ Scenotio 3 ua ua it Table H: ua It ua 1 we WHERE WE ARE Qualit ey essages Messages Analysis Of Control Material ua It Quality ua it Analyze one sample Of the precinorm Normal and one sample Of *HERE WE ARE WE ARE YOU SERVE! ua 1 Scenacio I WHERE ARE you SERVE' Scenario 3 Scena€io Scenort 3 Scenacio Scenonc 3 WE WC WHERE ARE Scenario Scenacio Scenario - Scenario Z Scenacic I Scenatio ua it Quality ua i ua It Scenario Scenacio 3 Scenacio I Scenario 3 *HERE WE ARE Scenacio I Scenario we ARE Quality Qualit Scenacio 3 Scenacio Scenario 3 Scenacio Scenacio I Scenorio 3 Scenacio I Scenario 3 Scenmc S Scenario Scena€io Scenacio 3 Scenono 3 ua ua It ua It on TabLe H: the Precinorm Abnormal controls for a total Of 2 control 3. Control ua 1 Control Scenafio H: ua Table I: 7, ua 1 Scenmc 3 4. 7, Z 7, Z ontrol ntroi n trol /6FÜ 3: Control, Control Table l: 7, Table 7, 4 ,ontrol 01 on tro ontrol Control 4. System Control -l WHERE WHERE wr measurements in each analytical run WHERE • ontrol on we ro ' wr exprcr • we ro we ro Be ro we ro BE ro l: 7 7, IA PATIENT Scenario 2 ontroll :ontroll :ontrol 'ontrol Control Table 1: Table q: Table -Z Table Z: Table I : Taleue H: Table 1 : Table \ : Table l: 7, provde a level of Table 7, L 7, U. l: 7, Z l: 7, L 7, Z 7, u. System 7, L System 2. 7, Z 7, u. l: 7,/6 l: 7, Z l: 7, uo Interpretation Of Results Table I: 7, Z: l: 7, Z 1. 2: PATIENT 7, Z l: as Scot 3: pcovde a hi%h level of we ARE Table I: 7, Table i: 7, WHERE Table H: WHERE WE ARE WHERE we WHERE WE WHERE WHERE we ARE WE we WHERE we WHERE we ARE we ARE we "Ste provde a high level of level of And the winning group is Z: q: 3: 23 3: 25 If no measurement is found, then accept the run and SAMPLE WHERE we a level of pcovde a h. level of 2. Table 2: 3: 2: /6FÜ 3: PROFICIENCY ROFICIENCY Z: 3: Table q: 3: provdeahigh level of 3) 3: q: 25 2) 2: 3: 2: 1. Z: 3) 3: 2: 3'. 2: Table 3: provde level of provde a high level of a hi%h level of level of provdeahi%h level of 2: PATIENT PATIENT Table l: Z: provde a hi%h level of provde a level of l: q 27 provde ahigh level of level PROFICIENCY pcovdeahi%h level of Table \: Z: of SAMPLE error de+echon while erroc capabili+y while at PATIENT H: 3) 3: 3: / 2: 3) 3: 2. 2) 1) erroc de-I-chon capabili+y while H: 3. Table l: Z: H: Table 3: Table I : Z: 2: H: Table l: If a measurement is found, inspect the control data using If a measurement is found. inspect the control data using Table H: erroc deåchon capabili+y while åhe SAMPLE TQbLe H: error capabili+y while PROFICIENCY Look for (lei-chon capabili+y while at erroc (lei-chon capabili+y while de+ethon capabili4y while deåechon while error capabili+y while ah erroc deåchon capabili4y while while error de-yec.hoo capabili+y while at åhe error deåechion capabili+y while erroc deåec±on capabili+y while Able l: Z Table 1: erroc de4echon capabili+y while åhe erroc de+echon capabili+y while ihe erroc deå-chon capabili+y while åhe erroc deåechon capabili+y while åhe PROFICIENCY q: Table 1: Table l: error TaboLe q: Table q: Table l: TQbLe H: TaloLe q: Table \: erroc delechon capabili4y while , •ICIENCY PATIENT errof defer-Hon capabili+y while PROFICIENCY PATIENT Scenario Z -Vime Keep reychon fakes PATIENT Z OFICIENCY PATIENT 2 PATIENT PATIENT TESTING (PT) . TESTING (P Keep %lee reyc+ion IoW. TESTING (PT) TEST PROFICIENCY PATIENT PATIENT Z P TIENT TIENT PROFICIENCY PATIENT Scenario 2 PROFICIENCY QROFICIENCY • apply the 1:32.Ss from each material apply the 1:3s from each material same Keep fakes same Keep reychon cafes -hme. Keep rerc±ion fates (ow. PROFICIENCY same Keep reychon cafes PATIENT .,STING (PT) yes same Keep cerci-ion Cafes S SAMPLE SAMPLE TESTING (PT) STING (PT) me Keep rerc±ion cafes low. PATIENT 2 PATIENT Scenario Z Scenario I Scenario 2) 20 PATIENT RUN PATIENT Z PATIENT Scenario Z PATIENT Z SAMPLE PATIENT ESTING (PT) yes same Keep reychon fates S same %AMPLE • apply the 1:32.5s from each material • apply the 1:32.Ss from each material • apply the 1:2.Ss from each material TESTING (PT) STING (PT) SAMPLE TESTING (PT) PATIENT Scenario 2 TESTING (PT) 5 ms PATIENT SAMPLE SAMPLE Table I Z Table 1 : Z Y. l: Z SAMPLE SAMPLE SAMPLE SAMPLE SAMPLE *AMPLE Table I : Z pcovide cleav Table 1: Table l: Table H: Table : -Z Table : -Z l: Z I yes yes SAMPLE l: -z q 27 Control Material: provide cleat Itns\ruc+ions +0 ±he- provide cleav •tns\t-ruc+ions +0 pcovide cleoq •tns\ruc+ions 71b Table l : Table 2: 21 27 provide cleav •tns\ruc+ions an 2: provide clear •tns\ruc+ions -t-o an provide cleat •tns\-ruc+ions ano provide clear •tns\-ruc+ions fr-o Ide clear •tns\ruc+ions -Yo provide cleat ins\ruc+ions +0 Slon Slon an 71b provide cleat •tns\ruc+ions +0 provide clear •tns\ruc+ions an provide cleav •tns\ruc+ions +0 provide cleat Ins\ruc+ions +0 provide cleav •tns\ruc+ions +0 Son an pcovide cleat •tnsYruc+ions fro Ahe- de cleav •tns\ruc+ions fro Son an provide cleav •tns\ruc+ions -t-o Ston pcovide cleat •tns\ruc+ions +0 provide cleat •tns\-ruc+ions -Yon provide cleat •tns\ruc+ions fro Son an provide cleav Insyruc+ions -t-o provide cleav Insyruc+ions cleat •tns\ruc+ions +0 an Table 3: / pcovide cleat fro an Table -Z 3: last two runs 3: b es Score hon+-line worKevs regarding 2n an worKers regarding worKevs regarding regarding Table 3: YOUR CLIENTS AND THE PATIENTS an es Table 1: Scot e • apply the 2:2s rule within each material across the • apply the 4:1s rule within each material across the escet b es Tqble q: b es Table H: Table l: Table I -z Table lie worKevs regarding q: line worKevs regarding line worKecs regarding ron+-line worKers regarding line worKets regarding b es . ron+-line wocKevs regarding line wocKers regarding line wocKevs regarding line worKers regarding line worHets regarding worKets regarding on worKeqs regarding an Score worKers regarding IS the Scot e last 4wo runs last 4 runs wocKers regarding regarding woryers regarding b es es worKevs regarding regarding Scot QC decision b es Sere QC decision cti±-etiæ. QC decision cri+eria-. Score Score Score Scote Scote Scot Score Score Score Score b es b es QC decision cti+eria„. Scot e QC decision b es QC decision cri+eria.. QC decision cri±-eria.. QC decision cti+eria.. yes measurements on each material QC decision The YOU SERVE! IS and able Table l: is 2) If none Of the rules from Step 2 are violated when able I The +hen *hen 3: and Then IS IS is (E an and *hen IS rule is rule IS (L is (L applying the specified rejection rule for the analyte, rule IS IS (L IS (i, IS is rule IS a. and •1001 save +hen an save accept the run and report patient test results. If a rule for Of is *he IS , IS save is Table H : -1001 can save •1001 can save arÅ 'IS +001 can save arÅ -1001 can save ar)Å -tool OQn save anci IS *he -bool con save arÅ IS IS the can gave arÅ can save arÅ can ana can enve an analyte is violated in Step 2, reject the run and do not -tool save arÅ can *001 can save save in manual QC is IS IS report patient test results for that analyte. 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