PEPFAR Quality Control and Method Validation Activity 5: Part 3

al l) Fcequency of +es+ even+s lype avid numbec lype number ot scampks tes lype number sampks tes Iype number ot Iype number sampks -tes lwe avid number O number sampks number ro ateyy T 0Tfatesy sampks k tes+ed Sestem sys+em System tes+ed Type numbec of GC tes+ed Type number of GC ±es+ed Sestem System number aod number sompes ±es+ed Assigned = and •nalytical we QC used +0 SD assigned talytical QC ased QC used QC +0 QC when A change in ac lie fart SD Analytical used lie fartnt / 'Analytical Analytical 'Analytical •Analytical 2 Type number of sampks fes+ed 2 Type number of GC fes+ed 2 Type number of sampks iesfed 2 Type number of sampks fesfed 2 Type numbec sampks of a. Analytical What will 2 Type number of GC sampks fes+ed 2 Type number sampks fesfed 3 Type number of GC sampks fes+ed 2 Type number sampks fes+ed Type and number of (ÄC ±es+ed used Type number of GC Type avid number sompks fes+ed Type number of GC sornpks fes+ed Type number of (X ±es+ed Type and number sampés fesfed Type number of GC sampks Type number sampks fes+ed Type number sampks fesfed Type numbec -tes+ed Type number of GC sampks ±es+ed Type numbec fes+ed Type number of GC sampks fes+ed 2 Type number of GC sampks Type number of GC sampks tesfed Type numbec sampks fes+ed Type number of GC sampks fesfed Type number of QC sampks fes+ed 2) Type number of sampes fes+ed Type number of GC sampks ies+ed Type avid number of sampks ±es+ed Type and numbec of (X sampks tested Type numbec Of GC sampks tes+ed 2 Type number of (A sampks tested What Will you do What Will VOu do What Wharts Mean Type and number of GC tes+ed avis Of Z3A I Frequency of QC +esf even+s Frequency of (AC even+s 90 System 3 Type and number sampks fes+ed Type anumber of sampks +es+ed Gaussian of of of Z3A) on of of 2) Type numbec of fes+ed of a, number Of fesfed of Z3A Type number of CC sampks fes+ed Type number of sampks fes+ed Type and numbec of sampks tes+ed Type avid number Of Q sampks tes+ed of Z5A) number of number of sampks fes+ed of Type number of sampks 3) used l) Frequency of (AC +es+ even+s Type and number ofGC +esfed Type number of GC sampes ±es+ed for Control X Y/ System l)) Frequency of QC even+s 21)) Frequency of even+s I) Frequency OF (AC +es+ even+s Type and number of (AC fes+ed Type number ofGQC +es+ed used NY/ I) Fcequency of QC +es+ evenFs l) Frequency of QC sampe +es+ evenfs QC used Type number of GC sampks fes+ed used +0 I) Frequency of (IC +es+ even+s Type avid number of sampks ±es+ed QC used +0 QC ased +0 Type number of ±es+ed Puruose Clinic A analytical ) Frequency of QC Sam* +esf even+s Purpose cal 5 of Type number of GC sompes ±es+ed Type number of QC ±es+ed QC ased QC used for on (umol/l,) of a. 2M) number 2)) Fcequency of QC +es+ even+s Frequency of QC +es+ even+s Frequency ofC even+s System System I Frequency of QC sampe +es+ even+s used I Fcequency of +es+ even+s Frequency OF +esf evenes Frequency +esf even+s System used used +0 X assigned 90 Of 'Analytical of frequency OF +es+ evenfs Fcequency OF +es+ evenfs Creatinine (umolL) L-J Chaff for Control XYZ (exp 30/11X\) on Illustra Chemist1Y Analyzer (selial # 123) Creatinine (umolL) L-J Chaff for Control XYZ (exp 30/11X\) on Illustra Chemistl} Analyzer (selial # 123) Creatinine (umolL) L-J Chaff for Control XYZ (exp 30/11X\) on Illustra Chemistll Analyzer (selial # 123) Creatinine (umolL) L-J Chaff for Control XYZ (exp 30/11NX\) on Illustra Chemist1Y Analyzer (selial # 123) Creatinine (umol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) Creatinine (umolL) L-J Chaff for Control XYZ (exp 30/11X\) on Illustra Chemistl\ Analyzer (selial # 123) Creatinine (umolL) L-J Chalt for Control XYZ (exp 30/11X\) on Illustra Chemist1Y Analyzer (selial # 123) Frequency +esf evenes uesfed used l)) Frequency of (AC Sam* +es+ even+s A cha Activity: It Begins with the Right Chart- Cape Clinic Laboratory Of a. Z3A Part Il Of Z3A 5 of 5 of a. A change in ac assigned 2) Type number ±es+ed System used System Reasons for more data points to Reasons for analy+ic s 90.1 What for Control on System l) Frequency OF QC +es+ evenfs 2 Type number of sampks tes+ed QC 40 QC • To understand how our QC Working in • To understand how our QC working in • To understand how our QC working in pairs, System System l) Frequency OF (C +es+ even+s ) Frequency of QC +es+ evenfs Type aud number of ±esfed l) Frequency OF QAC +es+ even+-s QC ased QC used 40 QC aged (QC) QC used QC used +0 • TO understand how our QC Working in X assigned SD assigned assigned l)) Fcequency of QC even+s l) Frequency of +es+ even+s evalua+e l) Frequency of QC +es+ even+s • To understand how our QC Working in pairs, WC evaluaVe used I Frequency OF +es+ even+s I Frequency AC evenfs 3) QC used +0 2) Type avid number Frequency of QC -Fest evenfs 30 \ Frequency of fest even+s Frequency OF (IC evenis Frequency OF evenfs Frequency of QC sampe +es+ evenfs Frequency OF +es+ even+s l) Frequency OF QC +es+ even+s Frequency OF QC +esf even+s used 40 used QC used +0 When a chan l)) Fcequency OF QC +es+ even+-s Fcequency OF QC +es+ evenfs Fcequency of fest even+s Fcequency OF QC fest even+s Fcequency of (AC fest even+s Frequency of QC +es+ evenfs Frequency of even+s Analytical Analytical i frequency OF +es+ When QC used Purpose used used +0 ased +0 Chart Type and number of (ÄC ±es+ed Type number ±es+ed assigned +0 2 Type number of sampks -fes+ed 2 Type number of sampks 2 Type and number sampks evalua+e 2) Type number of GC ±es+ed evalua+-e Type number sampks tes+ed Frequency OF +es even+s Type number of tested Type and number Of sampks +es+ed ) Frequency OF AC +es+ evenes Type number sampes fesfed Type aud number sampes ±es+ed Type avid numbec Of sampks ±esyed Type avid number of sampks ±es+ed evalÅa+e Assigned Mean Frequency of (AC +esf even+s evalua+e number Analytical number 2 Type number sampks fesfed Type avid number of sampks evalaa+e A change in accuracy or SO A new population of data points is Type and number Of Q sampks fes+ed q) The of peviodlC review q) The OF peeiodiC review SO l) Frequency of AC SD assigned 3 assigned System l) Frequency of QC +esf even+s l) Frequency Of sampe +es+ evenfs I) Fcequency of (AC +es+ even+s l) Frequency OF +es+ even+s l) Frequency even+s SO assigned SD SO on I Frequency OF AC X assigned SD so X assigned SA 2 Type and number of (X sompks The of revtew I Fcequency of QCs+ even+s q) The OF review Quality so assigned XD assigned Type and number of sampks fes+ed q) The of periodic review Quality The review rules are rendered ineffective rules are rendered ineffective • rules are rendered ineffective • Comple The of review for The of pevic,dlC review The of peviodtc review The of peviodlC review for The OF review The of peviodlC review The 09 peviod,c review The of periodic review The of periodic review for The of review The of petiodtc review for The of periodic. review The OF periodic review for of review of periodic review for q) The peviodiC review for Quality q) The OF peviodtc review q) The A change in accu Worksheet The peviodIC review for q) The of peviodtc review q) The OF periodic review rules are rendered ineffective Complete work: rules are rendered ineffective • Complete work: rules are rendered ineffective Complete work' l) frequency of fest even+s The OF periodic review q) The OF peviodjc review The revtew X SD +4SD SD l) Frequency OF (C +es+ even+s A change in accurat Quality 2) Type aud number sampks evalaa+e evalaaVe evalua+e evaluaVe QC 40 2 Type and number of Type and number of sampks tes+ed Type and number fes+ed Quality Quality System number When a char 2 Type numbec sampks ±esfed 3 Type number sampks fes+ed Quality emerging due to a SMALL change In Type and number of +es+ed Type nod number of ±esi-ed Type and number of sampks •fes+ed Type aud number of (l' sampks +es+ed 2 Type number sampks 2 Type number of QC sompks 2 Type aod number sampks 2 Type number sampks fes+ed 2) Type number of sampks -tes+ed 2 Type and numbec sampks ies+ed 2 Type number of GC sampks tes+ed The review Frequency of even+s Frequency of 3Ampe +es+ even+s 3) used +0 Type and number of sompks •fes+ed 2 Type numbec of QC sampks 2) Type aud number sampks ±es+ed Type aud number fes+ed Type aud number Type number sampks fes+ed The of periodic The of revtei.e Type number sampks fesfed Type number sampks Type and numbec sampks Type numbec of CC sompks Type numbec sampks fes+ed Type number of Type number of GC sompks 2) Type number of sampks fes+ed Type and number of GC tes+ed Quality q) The of periodic review The OF periodic reuew The OF peviodlC review suits The of periodic review q) The periodic review evalua+e Laboratory number of sampks fesfed number of sampks fes+ed The review for The of revtew The periodic review System used aud number and number fes+ed Type number of fes+ed aud number sampks ±es+ed 3) used +0 QC used 3) Quality QC used +0 Type and number of sompks fesfed number evalaa+e evalaxa+e Type number Of sampks fes+ed Type number of sompks fesfed Cape Clinic Laboratory QC QC used The pevrodjc revtew measuremen Assigned *Observed QC used +0 used +0 90 Type number of sampks fes+ed Creatinine (umol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) LD The of revtew Laborator Goals used used Laboratory Laborator Laborator q) The OF review I) The of l) The of revtew ased review X assigned 90 Laborator when the wrong values are Goals used Laborator La boratory Laboratory Laborator Aaborator Labora.tor Laboratory and +rends Quality 2 Type number of GC sampks ±es+ed Lahorator 2 Type number of GC sampés Type number of GC ±es+ed Type number fesfed Type number of GC Type number of QC sampés or Type and number emerging due to a SMALL change in Goals The revtew The of pevtodtc review Goals The pevtod.c review Laboratory Laborator Goals q) The of review The of review Goals q) The of periodic r-evrew q) The review The OF vevtew The OF penodjc review for l) The OF periodic review q) The OF peoiodlC review q) The revtew we The OF review q) The of review The of The of periodic v•evaew The of pevicdic review q) The OF period.c review The OF review For The OF periodic review For and The of pevidc revaew for and *rends Determine Type avid number sampks QC used +0 Quality Quality 2) Type and number of samples ±es+ed The of periodic review Quality Quality The of review The OF pentod.c review Goals and +cervis 2) Type number of QC ±es+ed Type number sampks ±es+ed 3) QC used The peuiodtc revtew 3) QC detec+nq The review sults 3) Then The 09 revtew The pevtod.c review The pevtcdtc review X obsened X obsened 90 SD observed 3 X observed 90 SD observed 3 and + and +cends and and +rends The When a change occur X assigned 90 assigned X assigned 93 SD assigned XD assigned XD assigned 93 X obsened X assigned 93 SD assigned X assigned 90 SD assigned 3 assigned XD assigned SD observed XD assigned 3 SD assigned X assigned The 09 periodic review QC The of vevtew SD observed SD observed 3 observed and used QC used Assigned Observed (QC) Cape Clinic Laboratory assigned QC ased QC used {o The vevtew QC used review and -I-rends and +rervis and *rends A = numbe Laborato ry Laboratory, 93 ults detec+inj and +rervis and +rend3 and +cend3 and +rends assigned to the chart, suits to the chart. same popula measureme QC +0 and and +rend3 assigned to the chart. evaluaVe used and +rends Creatinine (umol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) suits sults ults +0 used and anci +rends Goals and *rends review Quality and +reo,ds eval„a+e sults suits suits evalaa+e 9, "Theoretically same Laborator suits evalaxa+e Goals Normal Laboratory Worksheet evaluaVe evalua+e Laboratory Laborator sultS val evalÅa+e ) *hen Laboratory b) The +Q-eons when resul+s b) The achons ±ahen when b) Tine achons when b) The achons when resul+s b) The achions when values for for Goals Goals QC +0 QC used QC used +0o Goals used b) The achons åQ6en when b) b) The achons ±Q6en when Laborator lie farther from the mean S whe b) The achons. b) The achons ±aKen b) The achoos sul+s b) The achons -hen b) The achons +ahen when b) The achons when res.l+s SD b) The ad-ions when b) The ac+ions ±ahen when Quality Control Rule Nomenclature Goals b) The achons b) The achons when res b) The achons when resu14s b) The achons when b) The achons b) The b) The GCA-ions +Q16en when resul+s b) Then when resul+s b) The achons fa14en when resul+s b) The achons +QKen when resul+s b) The achons +Q6en when resul+s Laborator b) achons when b) used b) The s ±Q6en when cesul+s QC used detec+inj and emerging due to a change in precision defec+inj defec+inj and +rends defec•iinj and +rends defeciinj \ons fahen when cesul+s ons +Qhen when resul+s • S åQ6en when resul+s åahen when resul+s QC +0 ons +Q14en when resul+s suits results sults suits used The of pericd.c review S when cesul+s when cesul+s b) The achons åQ6en when The achons when S when resu14s Sons when resul+s en when resul+s when used +0 10 q) The of pevtodtc r-evtew ions when resul+s S when resul+s en when cesul+s en when cesal+s when resul+s q) The OF review defec+inj and +cends q) The OF peoiodlC review q) The of revtew q) The of periodic review q) The review q) The OF periodic review and s and +rends n resul+s e ±Q6en when q) The 09 pevtc,d.c review q) The of review and *rends and +rends cesul+s "Theoretically, labora and +rend3 same popula Creatinine (umol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) Creatinine (umol/L) L-J Chaff for Control XYZ (exp 30/11/X\) on Illustra Chemist1Y Analyzer (selial # 123) Quality and and +cends b) Then when resul+s ons ±Q6en when resul+s b) The +Q-en when resul+s achons +QKen when resul+s s ±ahen when resul+s +Q16en when resul+s Sons +QKen when resul+s Quality and +rends and and and Goals and *rends suits sultS evalua+e end S Quality Quality The periodic review q) •sults evalua+e evalua+e and +rend3 and and +cend3 suits ults esults suits evalua+e mean and SD Distribution Quality The OF petiod.c review The OF review The period,c review for The of r-eview Laborator sults Quality b) Tne resul+s b) The ±QKen when resul+s SO when resul+s 4SD X assigned 90 SD assigned 3 x assigned XD assigned sults SD review suits b) The achons ±ahen b) The ad-ions b) The achon b) The b) The acho b) The achons +a16en when This is WHERE WE review Draw rhe Ge sultS Goals Goals b) The b) b) The achons fahen when b) The achons fal•6en whe assigned b) The achons w b) The achoos Quality LD The Draw the WHERE b) The +Q6en when resul+s b) The achons +aKen b) The achons fahen when b) The achons when resul+s b) The when resul+s Goal. b) The ac+ q) The 09 review b) The achons when resuls Rendering our QC q) The of re Laborator b) - when resul+s b) The ad-ions when Laborator Laboratory SD assigned 3 X assigned The revtew for b) b) The achons when re b) The achons when review evalua+e q) The 09 periodic revtew q) The of periodic revtew q) The of periodic review q) of periodic review LIN) The of pevicdiC review SO assigned q) The revtew q) The of review for q) The of peeiödlC review q) The of review evalaa+e Vvalua+e The OF q) The OF review l) The OF review q) The of pevtcåc revtew Laborator 105.0 +4SD s +a6en when resul+s ±ahen when resul+s Laborator Laborator Quality Quality The achons when resul+s achons +ahen when resul+s fa6en when resul+s Laborator {Q Hen when resul+s Activity It Begins tne Right Chan- pan Il Activity Beqjns wtlh the Rjqnt Chan- pan Il Activity It Begins tne Right Chart- Pan Il Activity Begins the Right Chan- pan Il Activity It Begins the Rjgnt Chart- part Il Goals exceed exceed pan Il Goals chons when Goals Goals Reasons tor more data points to The pevrodjc revue åahen when resul+s exceed exceed occep S when resul+s +en when resul+s Goals when resul+s exceed exceed occep+ohle exceed exceed occeptohje What Will you need? What will vou need? evalua+e ons when resul+s en when resul+s when hen q) The Laborator Laborator The of peviod.c review The of peuodjc. Tevtew The peoodtc revtew The of review for +ahen when resul+s n when resu14s What will you need? suits The OF periodic review q) The 09 periodic review The of revtew The of? vevtew The of peviodlC review The OF review for The OF peviodlC review The review The of review The of peviod'C review exceed resul+s mean and SD The 09 pevtcd.c vevtew e sul+s res„l+s when resul+s Goals OF review Quality The of review of peric,dtc review same population of m Quality The of peviodtc review for X assigned defec+inj and Goals Analytical fe anly+ical tnalytical 'Analytical X assigned 90 assigned q) OF periodic review q) OF review assigned SD assigned defecHnj and *rends and review defec+inj and +cends q) The 09 Answer the An Laborator accuracy The accuracy Laboratory, and *rends and +rerv-is and defec+nj and sults More than 50 suits Rendering Laborator Laborator suits and +rends and More than 5% e analy+ical b) The achons suits and Laboratory and *rends and +cend3 q) The of review q) The review Goals suits ecfinj and The of periodic review The of review f?or and +rends Quality Goals sults Goals suits. The 09 pericÅic review The of pevtodlC revtew s and +cends and psults of penodlC review Assigned Observed X assigned 90 assigned Goals XD assigned 30 SD assigned SD assigned 3 Laborator Goals exceed acceptüle 102.0 Quality exceed . exceed ex expect exceed acceptoåle exceed OCCep%åIe The of periodic review suits exceed The review System exceed lie farther trom the mean exceed exceed exceed Goals review b) The achons +Q6en when resul b) The achons. b) The achons +a6en when resal+ Worksheet a: 1--1 Chart b) The achons wh6en +Qhen when resul+s and b) The achons +Q16e b) The achoos b) The ad-ions b) The achons b) b) The when resul+s b) The achons when resul+s b) The achons when • Worksheet 4: Chart • Worksheet 1.0 Chart • Worksheet 4: L -J Chart Worksheet Worksheet a: L J Chart Worksheet L-J Chart Worksheet Chart 4 Worksheet a:O Chart Worksheet 4: Chart 4 Worksheet a: Chart What will you do? defec±inj and *rends defec+inj and +rends b) The ro we Laborator Laboratory • Worksheet 4: Chart 4 Change Char: use on EXPECTED TO BE - defec•hnj and +rends b) The achons +a6en when use one or more suits sults suits Purpose Goals ions when resul+s S when resul+s and +cends Goals and *rends and +rends suits suits sults suits and *rends and and +rends and and *rends and and +rends andl and , and *rends and m we A Working Working wit Working Wit wit defec+unj and —O Working, within your Working within your -O More than 50. accuracy Laborator suits ±Q64en when resul+s 102.0 LaboratorW +en when resul+s 16en when resul+s when resu14s b) The ad-ions +QKen when b) The ac ro Laborator ro ro Goals Goals Goals we A Re . n when resul+s n when cesq14s assigned S whe when cescd+s hen resul+s Assigned on purpose Purpose to wc we ARE defec+-inj and +ceods WC sults sults wHeRe resul+s we X assigned 90 SD obs SD assigned 3 WC ro WHERE WE ARE WHERE ARE HERE ARE we ARE WE ARE WHERE we ro OE ' WHERE ro ' we b) The achons ±a6en when The mean and/ defecHnj we b) achons +a6en defec+inj at use one b) The achons when resu14s b) The achons +ahen wh b) The achons whe b) The achons when resql+s b) The achons b) The b) The b) The achons +QKen when resul+s b) The b) WHERE wHERe we ro ' we m WHERE ro Dc The mean and, and b) T6e achons +ahen b) The ac+ions ±a14en LD The b) nKen when cesul+s and *rends and +cends WHERE we ro ' WHERE WE ro ' b) The achons when and WHERE WHERE ro WHERE we ro ro WHERE ro wyeRe we ro expecr ro WC wr ro we A In WC ro Worksheet 1_-1 Chart % suits sults WHERE WE ARE exceed WHERE WE expecr ro OE expecr ro wyeRe we De - wyege we expecrro - suits ro De we ARE A change in accuracy or precision The achons when resul+s Worksheet 5: 1--1 Chart 5 Worksheet a: L •J Chart 5 Worksheet 4: L-J1 Chart 4 and +rends and +rend3 and ARC achons when resul+s achons fahen when resul+s WHERE we WHERE wr ' • Worksheet 5: 1--1 Chart 5 Worksheet 6: L-J1 Chart 6 Worksheet 6: 1--1 Chart 6 Worksheet 5: Ch. Worksheet 5: I_-J Chart 5 Worksheet 6: L.-J Chart 6 Chart 5 we expccr ro Worksheet 6: L -J Chart 6 Worksheet 5: I-a Chart 5 Worksheet 5: ICJ1 Chart 5 Worksheet 5 Chart 5 achoos when cesul+s e achons when resul+s ad-tons when chonS when resul+s Hen when resul+s chons +aKen when resul+s +aKen when resul+s suits we we Re ro A Re we ARC suits sults we wr ARC n when resul+s Khen when resu14s ARC mint b) The achons +aHen when fen when resu14s en when resul+s 90 60 mint +0 60 GO mint 60 rniru rnint the chart 60 rninutes into PEPFAR QC Workshop n when cesal+s when resul+s +hen when when cesul+s when resul+s WHERE WHERE We exceed we ) The achons when resul+s we Be WC b) The achons when resul+s b) The achons +Qhen exceed WC Re WC exceed exceed OCQep±oCle ARE exceed we ro exceed excee . ex exc b) The achons ±0 roae we ) The achons ±ahen we exceed WHERE wc ro WHERE we Re ro we we ARE we we Re wHeRe What will you need? we ARE wc WC WC we ro b) The achons +Q6en when b) The achoos +Q-en when resul+s b) The achons when resul+s WHERE we 102.0 WHeRe wr ' Assigned Observed WHERE WE WHERE WRE WE ARE we we ARC we A Re The mean and WE ARC we WHERE RE ro De we ARE AERE WE ARE ro w, WE we ro wr WHERE based on the assigned WHERE WC we ARE we MEAN obs we io ' ARE WHERE WHERE we Be ' WHERE we ro Be ' we we ro De ' ro Be ' Mean we ro ar expecr ro ro ' xpecr ro ro DE ro Worksheet 6: Chart ' To understand how our QC Working in pairs, you will • To understand how our QC Working in pairs, you will WHERE WE ARE fall outs Worksheet 4: I-J Chart 4 Worksheet 1--1 Chart 6 Worksheet LA Chart 5 Worksheet G: L uJ Chart 6 fall outside the acceptab Worksheet 6: Chart 6 Worksheet 6: 1_-1 Chart 6 Worksheet 6: LAJ Chart 5 Worksheet G: L •J Chart 6 • Worksheet 5: La-J Chart 5 • Worksheet 4: L -J Chart 4 Worksheet 5: L--J Chart 5 Worksheet 4: L-J Chart 4 Worksh Median we Re we A Re wr ARC assigned X assigned or More than 5% of th exceed the L-J chart assigned a chart assigne J Re x assigned exceed need exceed exceed Quality I Laboratory ty WHERE we ARE WHERE WHERE A Re wHERe WHERE we exceed Mean when De we wc exceed we ARC we we +3SD Goats rule we we a Re Re when we ARE we we A Re WHERE Goals S WHERE WHERE we WHERE we A Re WHERE wr WE we Re Goals Coals Is we WC wr we ARE wc exceed pencils Pencils exceed the L-J char the L-. 870 .2SD - 2SD + 2S +3SD -Is pencils Pencils the L-J chart the mean +4SD Using fl we Using Using flipchart at using exceed Using flipchart a: 'u its The mean and/or SD are WHERE ro WHERE we expecr WHERE WHERE we ' Unfortu : we ARE wecxpecr De violation WHERE we A number of control measurements we WHERE wc WHERE we rules are rendered ineffective WC need? WHERE 102.0 ro WHERE WE we ARE we values of the chart wr ro wr expect ro . •••i•iiiiiiiiiiiiii Assigned valu Assigned Mean Assigned valui 99.0 Assigned valu• Assigned vall we expecr ro +e Assigned Mean Observed Mean When a change occurs in the mean or SD, the control we ro exceed Assign Complete Worksheets 4, 5, and 6 (60 minutes). Render Ing our QC rules •neffect•ve, ; Re Assigned Observed Worksheet 1: I-J1 Chart I Wharts charts a charts change Flipchart charts and inforr flipchart Flipchart What + IS WHERE ro WHERE we ARE we ARE we we WE I we ro WE ARE ro ae WHERE ARE WHERE WE ARE we RE we ARE Value Single ro ae WHERE wc WHERE we Re WHERE we ARE we wneRe we WHERE to incor WHERE ARE _ro we WHERE WE HERE WHERE RE WE ARE QUALITY ro ro ro WHERE we Re QUALITY wr QUALITY e we we QUALITY we we A Re we ARE TO we QUALITY we Invoived WHERE we ro WHERE expect ro we expecr ro we ro we EXPECT ro WHERE a RE WHERE WHERE 'e 99.1 we WHERE we WHERE we exp WHERE we WHERE we BE wr EXPECY ro ro we A Re WHERE we ARE chart Assigned valu SD assigned we assigned Ass: we ARC we we A Re WHERE ARE WHERE we WHERE WHERE we A Re we ARE Value when the wrong values are Select ' WHERE we A Re WHERE we ARE we Re QUALITY ro we + IS More than 50c Markers More than 50 Select a spokesp Select a Messages WHERE we • we Markers WHERE Re WHERE we WHERE ARE WHERE WE WHERE WE EXPECT ro ' More WHERE WE ro ro the L-J chart WHERE 90.0 PATIENT PATIENT ±3SD wc when we False Accept we we ARE CONTROL CONTROL NTROL PATIENT CONTROL PATIENT CONTROL CONTROL CONTRO we expecr ro or we QUALITY WHERE WHERE RE wr ARE PATIENT WHERE we WHERE we ARE we we ARE QUALITY WHERE WC WHERE WE we ARE WHERE WC ARC WHERE we ARE WE ARE WHERE QUALITY a multipl Determine the assigned values and observed Determine PATIENT PAT ENT Vvalua+e measurements after that change will not be part of the QUALITY CONTROL WC CONT (QC) we A Re Vvalua+e evalua+e V ail' e False es PATIENT 93.2 + 2S + IS SAMPLE More than 5% CONTROL (QC) . QC) SAMPLE SAMPLE (QC) (QC) SAMPLE (QC) What will You will Mean CONTR we SAMPLE' (QC) WHERE WHERE we DRE' NT we ARE we we A Re (QC (QC) Value Value 9 , we (QC) Pencils we Re PATIENT WHERE we ARE we PATIENT assigned to the chart. co CONTROL ENT CONTROL PATIENT 10 Messayes performance." perform perforrn PATIENT CONTROL QUALITY ey tessages essayes essayes SS ayes essayes Value essayes PATIENT value • + IS + 2S CONTROL 13s rule Value Value + IS Value Value SAMPLE co MPLE assigned SAMPLE Assigned Observed SAMPLE Messages SAMPLE PLE SAMPLE Messayes SA SAMPLE to 902.0 90.2 (QC) (QC) (QC) Value PATIENT values for the mean and SD es (QC) (QC) to the class to the LD The b) The values t is QUALITY tssages (QC) Flipchart SAMPLE QUALITY QUALITY (QC) QUAL au yes a multiple of the SD ey essayes essages Brooks calculate the mean and SD for a set of data and (QC) -2SD essayes es SAMPLE QUALITY QUALITY ayes essayes essrjes es esc QUALITY Select SA 781.0 99.0 + IS SAMPLE QUALITY PATIENT ROL SAMPLE CONTRO . SAMPLE More than 5% of the n same population of measurements used to assign the CONT co CON 896.0 The accuracy and CONTROL PATIENT SAMPLE SD SA MEAN obs SD (4 PAT' E NT Tbe accucocy Tbe accuracy an The accuracy and Activity 5: Markers More (QC) SAMPLE åistributions on the chart SAMPLE accuracy QUALITY QUALITY The accuracy an The accuracy and an The and an The and The accurocy and QUALITY QUALITY PATIENT PATIENT SAMPLE PATIENT IENT CONTROL CONTROL CONTROL ROL SAMPLE accuracy MEAN CONTROL False The CONTR +4SD +3SD and SAMPLE SAMPLE Draw the Gaussian distributions on the chart 102.0 co SAMPLE Messages QUALITY (QC) QUALITY The accuracy and analY+ic descrtb es PATIENT PATIENT CONTROL system describes MEAN obs describ es PATIENT CONTROL CONTRO SAMPLE SAMPLE SAMPLE PATIENT SD obs system PATIENT co violation (QC) The accuracy a The a d an (QC) (QC) (QC) (QC) False SD (QC e ayes (QC) an analY+ic Sh+em descri analytic .sys+em descrtb es analY+ic system es analY±ic Sys+em descflb es analY+ic system describ es The accuracy and an (QC) The and analY+ic sys+em describ es and The accuracy QCd accuracy an QUALITY The accurac The accuracy and The accuracy The aocucoc sp+em describ es sys+em descflb es accuracy PATIENT essayes fem es fem descrtb es sy*em descrtb es Shi-em describes +4SD +3SD m describ es p descfl b es and on descflb es What will you need? What will you needo? and and an e essayes ey essayes PATIENT + IS accuracy es ssages Value s ayes CONTROL The accuracy use one or more QC rules to warn when data essayes ey essayes essayes essayes PATIENT and and describes 93 on mean and SD on the L-J chart ASSIGNED SAMPLE SAMPLE SAMPLE SAMPLE (QC) (QC) (QC) PATIENT (QC) CONTROL +3SD -ISD - 2SD -3SD +4SD SAMPLE SAMPLE SAMPLE CONTROL 902.0 fem b es 43 SAMPLE (QC) Rejects SA s ages ssaoes essaynes es analytic Sys+em es essayes .ssaqe ayes ess ayes F*em descflbes 99.0 - 2SD ey ARE wHeRe yes essay Answer the questions (QC) describ es 102.0 analy analytical Analytical analyic s Sy*em descrtb es SAMPLE (QC) e we ARE A Re — we ARC System analy+ic sy*e m describes we SAMPLE WHERE we wHeRe we System system describes sp+em describ es describes scribes SAMPLE SAMP . SAMPLE essayes essayes essayes (QC) PATIENT 4SD SD Accepts assigned X assigned assign d SD assigned True Accept False Accept no SA ARE we - 2SD False and SAMPLE and and and and we A Re and CONTROL we A RE we ARE we ARE The accuracy and we The accuracy and an The accuracy The I SAMPLE MPLE ion an SAMPLE Tbe accuracy and 905.0 95 99.0 84.0 900 90.0 890.0 Re we ARE - 2SD +4SD and an — we when accuracy and on we CiSton an accuracy The and -A accuracy fall outside the acceptable range. an an Tbe accuracy — i S IS Working within your group of 5-6 participants More than 5% of the measurements will exceed ± 2SD IS It Begins With the Right Chart 781.0 accuracy The accuracy and is is the od an and involved The and The accuracy Median od IS the and - SD and The accuracy and psec'iSlon -ISD IS S whe — IS IS The an IS em describ es an X assigned assign d XD assigned assigned and IS exprcr ro es analv+ic es The accuracy and an analY+ic es WHeRe we ass and fem descetbes The and descrt b es IS accuracy and an and an fib es descft b es SPFem descri b es sys+em descftb es 787.0 accuracy Analytical an sac. -sac. es analy+ic s es Worksheet 5: L-J Chart 5 Worksheet 4: L-J Chart 4 y*em deecflbes sy+em descftb es IS IS analy+ic sys+em des Tbe accuracy Shfem es fem describ es escri b es Is the IS the IS IS fhe es accuracy is es IS the + IS — IS Il IS IS 60 minutes into the activity, your group will be +3SD is sp+em describ es 893.0 89.9 IS St*em descötb es descdlb es +4SD -3SD is we ARE •IS we •IS is sac:— sacr— IS we WHERE we ARE 870 .2SD sac. The mean and/or SD are not assigned correctly on and ARE 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 ) *hen 99.0 43SD +3SD +4SD WHERE *hen WHERE WHERE WHERE Worksheet 5: L-J Chart 5 Worksheet 4: L.-J Chart 4 Worksheet 4: L-J Chart 4 '3 WHERE Worksheet 4: L-J Chart 6 assigned ) *hen +hen and and ) +hen hen assigned a chart to review with the class ) +hen *han is +hen WHERE we RE is *hen WE ARE and +3SD WE we Me we is — is is and and and and and and — is is no+ IS Run 1 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 IS the wHeRe L = control limits often expressed as We ARE IS change to fie anqlyiical analy+ical Analytical we change analy+ical hie analy+ical change change fie analy+ical chanee fie analy+ical Chan Change the IS o, Chanee +0 fie analy+ical a Chanse the analy+ical chanee to fie analy+ical Chanee +0 he I change yo fie change fro even o. analy+ical a analy+ical Change to he analy+ical Analytical chanse +0 fie anqly+ical fe anly+ical e analy+ical Analytical analy+ical mange fie analy+ica\ fie analy+ical analyiical t-o fie analy+ical and 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 IS IS *hen 78.0 784.0 99.0 IS IS - 2SD Part 3 to incorrect conclusion about method even Mean hen IS IS WHERE ) Hen ) +hen fie analy+ical ) *hen When hen when is +he is +hen change fie Pencils IS es IS the Sp+em has occutted. change IS IS IS SF+ern has occuvted. has ane analyiical has occurced. Analytical the L-J chart Using flipchart and markers, create the necessary rkers, create the necessary System 787.0 Value 93 84 90 93 88 86 88 95 92 94 88 90 89 87 we (em has occuvced. SF+em has occuvced. Sys+-ern has occurced. a Change fie analy+ica\ has occuvced. has occucced. sys+•em has occurced. 840 984.0 o. Change analy+ical e analy+ical 91 90 94 88 97 90 91 95 90 85 91 94 89 91 85 89 Change +0 fie analy+ical Chanse +0 He analy+ical 81.0 878.0 99.0 +4SD -cuvced. cutted. catted. is Analytical sacr .3SD analytical IS Value Value 93 84 90 93 88 86 88 95 92 94 88 90 89 87 91 90 94 88 95 90 96 91 87 82 96 85 88 101 82 91 93 84 90 93 88 86 88 95 92 94 88 90 89 87 91 90 94 88 95 go 96 91 87 82 96 85 88 101 82 91 IS IS 93 84 90 93 88 86 88 95 92 94 88 90 89 87 91 90 94 88 95 90 96 91 87 82 96 85 88 101 82 91 change Chan Change fro nee fie analy+ical Change Change Analy+ical Analytical e analy+ical analy+ical c. Analytical hnaly+ical fie analy+ica\ analy+ical tnalytical change Mean What is 'Analytical Bas the analy+ical ana - SD nas occutced. — is is sys+ern has occuvted. SD observed Mean observed sys+em has Sys+-em has Mean 1 9 10 has occuned. has SysFem has charts and information (20 minutes) Flipchart IS SF+em has OCCu System SYS m has occuvced. has occuvted. has occutC has cuvted. is is is used is performance." System cuffed. Mean observed SD observed :cuvced. the mean to the L-J chart ± yccutced. -cunfed. We ARC we we SD WC ARE ccuned. (umol/L) hen Mean observed SD observed observed X obsened Median Mean ) +hen Mode is 87.0 Il ued +hen False Reject Assigned values Observed values +3SD 4ISD +hen *hen (umol/L) +hen Phen *hen +hen 984.0 90.0 99.0 fie analyiical he anly+ical 4SD +4SD when Select a spokesperson (umol/L) (umol/L) Analytical Markers change e analy+ical 2 analy+ical cal al Change fro analyiical Change yo the analy+ica\ e analy+ical Analytical Change chanse the analy+ical +hen 78.0 .2SD fe anly+ical change he anly+ical Brooks, Zoe C. Performance-Driven Run # 1-20 (stabie population) Run # 1-20 (stable population) 102.0 90.1 3.1 change fro fie analyiical change Change change fro Change fie amiyiica o. change anal change fie a change change to fie analyiical 15 Mean 22 R n # 1-20 (sta le p pul tio ) e analyiical ic.al analy+ical he analy+ical 99.0 86.2 93.0 Mean Run # 1-30 (stable population) 99.0 902.0 3.2 93.0 10 90 94 Run Change sys+em has occuv€ed. 88 86 19 10 14 Il IS 12 13 14 15 16 17 18 19 84 18 10 20 21 22 u 25 26 27 30 20 21 22 u 26 27 30 20 21 22 25 26 27 30 20 21 22 u 27 30 93 84 25 fem has change the analyiical m has occuvced. has occurted. s occuvved. +0 ange fie analy+ical cutted. chanse fie Run # 21-30 (emerging change population) Run # 1-20 (stable population) 89.9 99.1 99.0 4.3 6.3 3.3 System 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 You will have 5 minutes to provide a review Quality Control, 2001, p 70. a multiple of the SD sys+em has occucted. has occutted. Analyze( Sys+em has More than 5% of the measurements will exceed ± 2SD Sys+em has occutfed. sys+ern has sys+em has occu .cuvted. s occuvted. occuvced. Ted. ed. SYS+em has 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 sys+em has occu 78. o Run # 1-20 (stable population) Run I-3D (mixed population) em has occuvced. m has occuvted. XO assigned assigned X assigned 102.0 99.0 observed Run # 1-30 (mixbled population) 86.2 3.3 3.7 Value to the class 90 22 26 92 20 27 28 16 13 93 19 evalua+e Vvalua+e Value Value 93 32 93 Value 93 84 90 93 88 86 88 95 92 94 88 90 89 87 91 90 94 88 97 90 91 95 90 85 91 94 89 89 Value 93 84 90 93 88 86 88 95 92 94 88 90 89 87 91 90 94 88 95 90 96 91 87 82 96 85 88 101 91 89 84.0 84 88 88 90 89 87 91 90 94 88 97 87 90 94 88 97 90 91 95 90 85 91 85 89 91 95 90 85 91 85 89 90 91 95 90 85 91 94 85 89 90.0 93 93.0 99.0 90.0 93.0 93 88 86 88 95 88 84 95 90.0 92 93 92 95 93.0 94 89 90.0 it 80 minutes .1