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PEPFAR Quality Control and Method Validation Activity 12: Part 2

In this activity, participants are introduced to coefficient of variation index (CVI). Based on the information supplied from the inter-laboratory comparison report, participants will investigate a QC problem.

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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QC used QC ased +0 QC +0 also have a Summary Statistic Summary evalua+e tatse L-J Chart for Unicel DxC Chemistry Analyzer conteoi limits set Lab 15— Lab 15. control evalua+e evaluaVe used +0 Inv rate "t used 40 used. Unassayed Chemistry IJnassayed Chemistry Unassayed Chemistry used Lot 16610 false rejection when 60 Lab 15— Lab 15. Lab 15— higher false rejection an "mits less closer to the mean. 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Lot 16610 Data For; 12-2012 Data Data For; Data For: 12-2012 Data 12-2012 Data 12—2012 Data For. 12—2012 Instrument Unicel DNC Instrument Data 12-2012 Data 12—2012 Data For; 12-2012 Lot 12-31-2012 Date Data For; 12—2012 Data For. 12—2012 Data For: 12—2012 Date 12—2012 rate The closer to the t. the q) The of periodic review for q) The OF periodic review q) The OF periodic teview H) Lot 12-31-2012 Control Material: Levebl Control Material: Levebl' I Control Material: Levebl/ I Units: num.o-l/L Units: num.o-UL Units: wunoUL Units: MM4.o-L/L Units: nun.ol/L Units: nuno-U/L Units: mono-I/ L Units: nuno-l/L Units: num.o-U/L Analyte: Analyte:al Ana the tradeoff is that Control Material: Points lormal The tradeoff is that Lat Exp: Lat Exp: 12-31-2012 Lot Exp: Lot Exp: 12-31-2012 Lot 12-31-2012 12-31-2012 Lot Exp: 12-31-2012 Lot Exp: Lot Exp: 12431-2012 Lot Lot Exp: 1241-2012 Lot Exp: 12—31-2012 Lot Exp: 12-31-2012 ormal Quality Quality Th. txadeon Quality Tin detection but The tradeoff evalua+e evaluaVe The of peciodic review The rate yste q) The OF petiodic review C: Printed: 05—14-2013 Printed: 05-14-2013 Points Printed: 05—'4-2013 Pri 4-2013 05—'4-2013 3:1s Printed: 05-14-2013 Printed: Printed: 05-14-2013 Printed: OS-14-2013 Printed: vs-14-2013 Printed: Printoc: us- printed: L-J Chart for Unicel DxC Chemistry Analyzer higher Page I will have detection you abo Platelet Count (cells x 109/L) Wider control E 12 —31 2012 QC Flags: SEC 2.0 SEC < 2.0 SEC SDI ± 2.0 SDI > CVI> 1.0 CM > 1.0 12.9 Page Page I Page I TE > TEa TE > > TEa ± 2.0 Page 2 Page I ssages TE TEa Page OF periodic tevhew for will Quality Wider con Suggested Interpretation The of peviodlC review for Wider con higher false reiection Wider q) The 09 review q) The of periodic review q) I-I) OF peviodlC Teview ID OF periodic review l) of petiodlC review Wider q) The of review q) The periodic revtew ID periodic review of review of peviod,c review are less limits are less OF periodic review q) The of peviodiC. review The of periodic revtew LD periodic revtew 3:1s higher false higher false rejection of peviodtc review The of review The OF peviodtc review The peviodrc review Quality Laborator review Goals Laboratory Laboratory The periodic review [ILaboratory Wider Laboraeory q) The of peviod,c review The of periodic review The 09 periodic review for Goals The OF peviod,c review Laboratory Goals Quality Wider control limits are less limits less Laboratory La ory The *etaency higher Control Material: Leveb2 Controls Affected: Level I Controls Affected: Level 1 Units: nun.o-VL Units: num.oVL Level 2 Other Leve Wider ribpulation limits are Analyte: Lot 16610 Lot#: 166101 Lot#•. 166101 Lot#:. 166101 Exp Date: 31/1/2015 R assign 114 31/1/2015 31/1/2015 assign 114 Units: Points Unints: SD assign SD asign SD a* n 4.0 4. 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Crite,ria Wider con limits tess limits less support of reported and test methods. the package insert specific anaMe claims and stability information. support of reported anarytes and test methods. Refer to the package insert tor specific claims and stability information. support of reported anatytes and test methods. support of reported and test methods. etertothepackage insert tor specific anaMe claims and stability information. support of reported and test methods. eter to the package insert specific anaMe claims and stability information. support of reported anatytes and test methods. Refer to the package insert tor specific anaMe claims and stability information. support of reported and test methods. gel to the package insert tor specific anabte claims and stability information. support of reported anatytes and test methods. 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Results 'We Ex {Wc Expect We Ex We Expect Wc Expect Data & Calculations Relatin to Four K Numbers in units lim • Results C um Cum Quality System Ex pect Expect Ex group in be Statistics in this be the Of Statistics in this be the written Of Statistics in this be written Of Statistics in this be used the written Of in this be the written Of this in be Of Goals Goals Goals t to Laboratory defecfinj and *rends of accuracy and/or precision is necessary and whether mrrective actions may be required. Results Wider con Results Need for Need Peer Need 'or defec±inj and *rends defecfinj and +cends Peer grcwp statistics contained in th and +rends Data & Calculat support reported and test to the claims information. Peer group statistics contained in this repott may not be used without the expressed written consent of Bio—Rad Laboratories. Peet group statistics contained in this repott may not be used wit-out the expressed written consent of Bio—Rad Laboratories. Peet group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories. Peer group statistics contained in this report may not be used without the expressed written consent of Bio—Rad Laboratories. Peet group statistics contained in this report may not be used without the expressed written consent of BicwRaC Laboratories. Peet group statistics contained in this report may not be used wittout the expressed written consent of Laboratories. Peet grcup statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories. Peer group statistics contained in this report may not be used without the expressed written consent of Bio-Rad Laboratories. peer group statistics contained in this report may not be used without the expressed written consent ot Bio-Rad Laboratories. e ex resse-d written consent of for defec+inj and defec+lnj *rends group Statistics in this be without the Of Peer group statistics contained in this repott may not be used without the expressed written consent of Bio—Ra•d Laboratories. Peer group statistics contained in this repott may not be used without the expressed written consent of BicwRa•d Laboratories. Peet group statistics contained in this repott may not be used without the expressed written consent of Bio—Rad Laboratories. Peer group statistics contained in this repott may not be used without the expressed written consent of Bio—Rad Laboratories. Peer group statistics contained in this report may not be used wittout the expressed written consent of BicwRa•d Laboratories. Peet group statistics contained in this repott may not be used without the expressed written consent of BicwRa•d Laboratories. Peer group statistics contained in this report may not be used without the expressed written consent of Bio—Rad Laboratories. Peer group statistics contained in this repott may not be used without the expressed written consent of Laboratories. Peet group statistics contained in this report may not be used without the expressed written consent of BicwR•d Laboratories. in this be without the written Of Results +ceods b) The ach-tons when resul+s We Are Wo Are W' Are and A-rends b) The achoos fa6en when fray detection but detection but Laborator Laboratory sensitive to Wider control- Captures our method's performance relative ' Captures our method's performance relative Wider control Are 4 Key Numbers defecfl sensitive to defecfinj and +rends a Key Numbers Analytical Analytical dåec+inj and +cends def-ec+inj and +cends Laboratory Laborator b) The 4 Key Numbers 4 Kev Numbers 4 Kev Numbers detection n) and and and +ceods tower Analytecal analytical Analytical .alytical Through: 2012 Target Val' and +cends and *rends Dear Customer, Dear Customer, detec+lnj and 4 Key Numl Group by Method Group Values by Method Group by 4 Kev Numbers Level Lot#: 166102 To Be Exp Date: E OC 31/1/2015 assign 485 Mode: sensitive to error SD assign b) The +Q6en when resul+s 102.0 b) limits are less From: December 2012 From: Decemvb-er 1 2012 From: Decenmber 1 2012 From: December 1 2012 Through: December 31, 2012 Value 107.3 TEa 12.04% ac Oc OC sensitive to detection but Through: December 31, 2012 Target Value 107.3 TEa 12.04% Through: 31, 2012 Value 107.3 TEa 12.04% Through: 31, 2012 Target Value 107.3 TEa 12.04% Through: 31, 2012 107.3 TEa 12.04% 2012 Target Val Activity: Calculating SDI and CVI b) The achons limits are less b) sensitive to error Results Laborator Goals control Wider controj Analytecalv Wider c Ace tam in Wider limits ave fewer false fewer fal fewer tats. fewer false Anal yle Analyte Anilyle Ana I "e Ana I yle yte Trueness Anal yle Analyte Anal yte IC•o.7 lc•o.7 100.5 11800.5 106.7 107.7 1200 e achons ±Qhen when resul+s Tye fewer fewer e achons ±ahen when e achons ±Q16en when resul+s achons ±ahen when achons ±Qhen when ad-ions ±Qhen when resul+s achons ±Q16en when CA-ions ±Qhen when resul+s ch-ions ±Qhen when resul+s Chons fa16en when resul+s ions ±Qhen when resul+s achons fahen A-ions when resul+s S ±Qhen when resul+s ±ahen when resul+s ±Q16en when resul+s Laboratory fewer "er chons when resul+s exceed Goals System system A. Beckman Dedicated Beckman Coulter Dedicated 3eckrnan Dedicated Beckman coulter Dedicated Precision fewer false Wowing statistics System Met4KYnits Temp Omits less limits less Trueness less - Svstem System system 'system Results Level I Level 2 limits are le Level I Level 2 b) The achons ±aKen when Level 2 Instrumenb'KYtniB Temp St Temp Method Units Temp detection but Temp Level 3 b) The achons when b) The achons when resul+s b) The åaKen when b) The achons fahen when resul+s b) The when resul+s b) The achoos fa16en when chons when St Temp MethodÆnits Temp Method Units Temp me Temp Temp ons when resul+s Ta et sensitive to limits Wider co The åaKen when resul+s e achons when achons ±QKen when hons when resul+s ±ahen when The ±ahen when resul+s ±aKen when resul+s Omits are limits are limits are less are The achons when Ions when ±a6en when resul+s Mean 4 Key Numbers Median Wider cont when resul+s What wOu b) The achons +Q6en when R:qs l) Frequency fewCt l) Frequency l) Frequency The achons when resul+s Pewer The ±QKen when resul+s 6. sensitive to erro fewer Wider Wider c Mea contro Purpose Frequency Frequenci.• Frequency - Frequenr Frequenc•.' t) Frequency Frequen Frequency fest Frequency • Frequency Wider Frequency c; Frequency Frequency C; Frequency fest Frequency - . Frequenty t-cequency Mean e ±Q6en when resul+s achons when Instrumen ±QKen when resul+s ±Q6en when resul+s re Mean exceed ave tewer false sensitive to erro Attached are your QC reports for the month of 12—2012. Based on comparisons to the l.) Frequency r equerry Attached are your QC reports for the month of 12—2012. Based on comparisons to the 12.9 Attached are your QC reports for the month of 12—2012. Bas 4 Key Numbers fewer f&tse Date System QC reports or the month of campar;sons o the h.ve fewer false this be used vou Mean - OS when resul+s Results Wider control F' equerry achons +QKen Results Quality azotes control System Frequ• • IQC and EQAS programs compliment each other sensitrve to to PEPFAR QC Workshop sensitive to error; Cum Mean other C um QC cm C um Beckman sensitive to VOu Laboratory Mean From: December 2012 From: Decemtbe,r I 2012 From: 'Decemtb-e,r 2012 From: Decewtbe,r 2012 sensitive limits are less Through: 31, 2012 Target Value 457.3 TEa 12.04% Acceptable Performance. Acceptable Performance From: J. 2012 Frequency Beckman Beckman Temp Wider control ave fewer false have fewer false fewer false sensitive to error Mean -22.0 17443 Mean 444519 reported peer group, the parameters listed below may require investigation Or review. reported peer group, the parameters listed below may require investigation or review. Z) Type 2) Type J Type J) Type sensitive to error Wider con calculation reflects current method 2) mmE•er reported peer group, the parameters listed below may require investigation Or review. reported peer group, the parameters listed below may requir reported p nt method Reagent detection but detection but but fewer false High Control h ave fewer false detection Your Lab Mean Reagent Results Mean 78 •a acd "cd number mrnber Your La number sensitive to error 56 12140 1214 545 detection but J' •v limits are less •sensitive to c" fewer talSe sensitive to cr exceed lima-vs l,mA-s occepf-oble Assi ed to chart exceed Assi ed to chart .eed accep+oåle exceed detectic exceed occep+oåle ceed OCQepfüle *eed occepf-oble exceed qccep+üle qccep%Cle . ed ed qccep+üle .d qccep+ohole ed d accep+üle 67M exceed ed OCCepi-oOle •xceed d qccep+ohole Mean fewe. fat •e fewer false *eed ed occept-oåle used ua lifni4-s •e accep+üle qccep+oh.le accep+ühoble QQCep+ohoIe :Qep+oh01e qccep+oåble ep+üle pi-able Laboratory fewer false rejection exceed qccep±-oåle •ewe' : ALT ALAT,GPT ! ALT ALAT,GPT •ALT ALAT,GPT i ALT ALAT,GPT occep+oble ALT T,GPT ALT TOPT ALT ALAT,GPT ALT fewer Goals to some measure of quality or peer data. limits are less detection but detection but to Marginal — May indicate to — May indicate the to Marginal — May indicate the moL"L Immunoturbidimetric Immunoturbidirretric Immunoturbidimetric moVL Immunotutbidimetric moVL Immunoturbidimetric moYL moVL moYL Immunoturbidimetric Immunoturbidimetric moa Immuncturbidimetric Immunoturbidimetric moaL Immuncturbidimetric moa Immunoturbidimetrlc moa moaL moYL Value tave fewer false -ts are less ua t' 4. h ave fewer false ave false have fewer false -qua I sensitive to error 4. UVwithoutP5P WL 37' C UV WL 37•C 37' C peer ua sensitive to to investigate test system accuracy precision. to i stigate test system accu Beckman coulter unicel re test system Beckman Coulter UniCeI DIC Beckman Coulter thCceI Beckman coulter Beckman Coulter UniCeI OXC Beckman Coulter Ii coulter coulter U coulter• Beckman Coulter Beckman coulter Beckman Coulter UniCeI Beckman Coulter UniCeI DIC Beckman Coulter Uni Beckman coulter ni Beckman coulter UniCeI Beckman coulter Unicel Beckman Covulter UniCeI DIC coulter Unicel coulter peer Control Results sensitive to error we Have fewer false fewer Quality? Quality IJLaboratory 68% = 'ewer false tewer false -028 -0, 28 fewer fatse I 4, Current actual 60 60 119.0 129.0 11950 SDI 106.7 19 107.7 Beckman Unicel Beckman Unicel 37 30 SD SD - Qualiiy Results Oed:cated Reagent Dedicated Dedicated Reagent Rean Rea V Reagent 28 Rea M Rea have fewer false Use t — ILab0ratory — 'Laboratory detection but Current ave fewer fals ave fewer false Quality SD to e Goals Dedicated Reage Dedicated Dedicated Reagent Dedicated Reaænt Dedicated Reage nt Dedicated nt Dedicated Reawnt Reagent Control ontr• •SD 4. SDI SD SDI: SC Is nt SDI ontrc Contrcl Contro Single 10 - Quality Assigned on Quality 4. Quality , QualitV(? Goals Y 1195 106_7 106.7 126.0 performance. performance per ormance. Goals Beckman 106.0 1026.0 123.0 106.6 You' Lab Your Lab 7400 74.00 71.4g we Your Lab You: Lab You' Lab 74_co 71.49 587.4 Mean Marginal Performance — Corrective action may Marginal Performance — Corrective action may necessary. 71.49 PRO IQC monitors the daily precision and accuracy of Marginal necessary'. Quality fewer false detection but .a boratory Laboratory chart Single Laboratory Laboratory Laboratory om .aboratory t_/borat to ry tory he Chan Laboratory — bo rato — —ILaboratory (U Laboratory - ALaboratory 'Laboratory ALaboratory 'ILaboratory La boratory —'Laboratory •IL.aboratory Laboratory Laborator ILaboratory atory •tory torY ratory ry Z Goals Peer Grou Method Peer Grou M peer Grou Method Peer Group Mean 4576 91 106.7 107.3 1806.7 126.8 Goals Goals Q Goals Goals Goals ARE WHERE WE ro BE 4576 SDI WHERE WE EXPECT ro ,E WHERE we EXPECT ro ' WHERE WE ro BE , WHERE WE ro BE. WHERE WE ro BE', WHERE WE EXPECT ro BE , WE expecr ro BE. WE ro BE. WE expecr ro BE WE ro BE , SDI SD so SC •SD the chant thart Y Quality 110.0 12_co 12.co 1200 12 2120 O WHERE WE ARE 115. 15.8 WC ARE " ro WHERE WE ro WHERE WE EXPECT ro BE. 12.co 12_co 312.co 12m the chart WHERE WE ro WHERE we ARE WHERE ro WHERE we ARE Wh•eRE wr ro Be WHERE WE ARE WHERE we ro WHERE we ARE wr ro we ARE wr ro WHERE WE ARE cr ro WHERE we ARE Be WHERE we ARE WHERE we ARE WE ARE WHERE WE EXPECT ro , WHERE WE ex-peer ro the we WHERE we ARE we ro Be WHERE we ARE WHERE WE ro WHERE ARE Your Lab WHERE WE DE , WE ro DE , WE EXPECT ro BE , 3t.co 31.co cvl cv 10.7 ro we e WHERE we 7.9 6.8 8.8 WHERE wr WHERE •Laboratory u ali Pro WHERE we expecr ro cumulative — •Laboratory WHERE WE EXPECT ro WE A RE *pulation Goals Syster WHERE we DE Laboratory we ro we DE wc Expccr WHERE we ARE ua 1 HERE WE A RE wr WHERE ro WHERE we ARE BE WHERE we ARE Z' ± 2SD ro Be WHERE WE O WHERE WHERE we lit WHERE WHERE WE ARE ts ts ts WHERE WE A All. p Method 17443 429 429 102.9 107.3 WHERE ARE WHERE WE TES Goals ua it WHERE WHERE WEARE WHERE WE EXPECT ro WHERE WE ro , ua 1 ua What need' WHERE WE EXPECT ro BE WHERE WE ro BE WHERE WE ro DE , WHERE we ro BE WE EXPECT ro -r ua It WHERE fewer false WHERE WHERE Observed 119.7 (Method3 C VR (Peer! cvR CVR WHERE WHE ARE Labo i rOBE WHERE WEARE r ro BE WHERE WE ARE What need) WHERE WE ARE HERE WE E WE ARE WE ARE WE CVR Use t Use t I Use t ua 1 ua ts .j WHERE ro BE Value ua It BE Use tt ts Z WHERE WE EXPECT ro BE WHERE WE EXPECT ro BE , SDI SD WHERE WE EXPECT ro WHERE ro SD C VR CVR c VR achons achons fahen re fahen fQhen fahe achons achons fahen d WHERE WE A Re fahen fQhen WHERE we ARE 129.0 c. WE ARE ua it Control WHERE Cumulative WHERE WRE a hen S Hen True Value •rue Value -s True Value True Value 9. rue Value ae Value e Value ? Value Value s. hen True Value True Value s. True Value Value Value - ts Controll CvR Mean True Group Values by True Value s.. . True Value True Value s. True Value - le Value Value True Value .. True Mean Oen re My Lab fahen Oen ontrol (Peer) (Peer) cvR (Peer) cvF (Peen) cvR (Peer) SDI (Peen cvR cvF cvR 10.7/11.3 = 0.9 True WHERE we WHERE WC A RE t n True True Value True Value - 10}.3 ±aKen b: WHERE we WHERE WHERE WE ARE WE ewe 10}.3 (peer SDI SDI _0,47 _Oß7 we ARE eon ARE R rator _0647 _0,47 _Oß7 _047 . WE we ARr ' Examples WHERE RE u ali achons 1:2s ru (0}.3 Assi ed to chart Assi cd to chart Assi to chart (0}.3 42.9 3.10 4.10 WHERE we ARE cvF Monthly: SDI # Labs Labs: # Points: Points: 104.3 10}.3 106.6 WHERE WE ARE : , WE ARE onthl . Monthly: SDI CVR Labs # Labs i WHERE WEA Pointsd: # Points Points Quality ua It ua it 572.4 CVR (Method _051 104.3 (Method WHERE WHE ARE ARE Control. C,ontrol ontrol ventrol Cont, Control 1:.2s ru processes, personnel, and instruments assigned on ' Verify the SD value SD - Verify the SD value used in the calculation SD Cop Control based on based on your peer group. WHERE WE WHERE W peer . i WHERE —2 SD Alkaline Phosphatase Alkaline Phosphatase True value Alkaline Pho 1:2s ru' 'Control points Value WHERE Value 7.9/8.8=0.9 6.8/8.1-0.8 7.9/8.8=0.9 (Peer) sol sol SD SO _0_71 _0.71 471 __0.71 __0_71 use t Use t • Use t ontrol e Value WHERE WE EX' WHERE WE ARE Your laboratory for accuracy and precisdn You r laboratory' coordinates for accuracy and precision You r laboratory moordinates for accuracy and precisOon CONTROL WHERE WHERE WE WHERE ME ARE 1:2s ru a sca s ru pNpp, AMP Buffer AMP Level 1 Level 2 ean pNpp, AMP pNpp, AMP Buffer AMP Buffer Level 1 Level Level 2 PNPP, AMP 4576 TE 1.0 System d in the calculation (Method) (Method) SC QC sol SC -0.14 126.6 Total Allowable Error (I E.O the chart 12.8 PROFICIENCY 10}.3 Current actual 3.10 PROFICIE on the (Peer Need Peer G TE yste (Peer) (Peer pPeer Total Allowable Error Ilea n 7574 76.74 7674 75.74 7074 QUALITY Mean 7074 3eckma%ouIter DxC Series 12.9 122.0 a scan Beckman Coulter BOO 2.53 2.50 9621 91 Total Allowable Error - Beckman Coulter UJniCeI DxC 800 Beckman Coulter IJniCeI DxC 800 Beckman Coulter DxC 800 Beckman Coulter UniCeI DxC 800 Beckman Coulter IJniCeI DxC BOO Beckman Coulter thCeI Fystem yste 2.53 0.56 91 Total Allowable Error (i Q) Ö.120t-( 11514 12514 123m 12.9 Total Allowable Error Total Allowable Error (i sno 12.8 5 WHERE W, (QC) a scan UniCeI DxC Series LJniCeI DxC Series DxC Series SDI SDI SD so J on Dxc seres so ro do 1:2s ru '1:2s ru a scar a scan yste Total Allowable Error - Total Allowable Error (TEA) Allowable Error . Total Allowable Error z, Total Allowable Error , Total Allowable Error Total Allowable Error (TE) Total Allowable Error ital Allowable Error Illowable Error \llowable Error )tai Allowable Error Ilowable Error .vable Error 'able Error ble Error e Error Error cumulative Cumulative Total Allowable Error (IQ) 5.78 Cumulative Date 12.3 assigned o PROFICIE . Total Allowable E Total Total Allowable E Total Allowable Allowable Allowable Total Allowable Error (TEAQ) - Total Allowable Error -T Q) - Total Allowable Error (TEA) - Total Allowable Error ( TQ) - Quality -ystem (04.3 Error - 21090 2120 121905 '260 54 2:yco 23 u so 2090 27±0 30 60 21 so 278) 27 1780 TESTING tory 107.3 SDI: -o. 26 -049 _022 _0_26 -022 Dedicated Reagent Use t! Dedicated Reagent [klicated Reagent Dedicated Reagent CY essayes Dedicate Syste S ste System System SDI is a statistical estimate of accuracy. ystem •s TE -c. 22 value N ua It racy.'. vste Control Assigned r Date Syste PATIENT (2.9 System Control 109.9 TIENT f. CONTROL dev peer Method 4576 91 Mean 3315 3.15 93.72 arc dev• devi -u yste 106.3 WL 370 C 370 C ean eon 370 c SAMPLE U/L Error # Points points 123m77 123m 1631 12.9 TESTING Error Detection Assigne Total 104.3 Activity 12: Total Allowable Error -i Lab SAMPLE ystem al Allowable Error (I E A) devi dev; eun =O.120q a scar dev' eon Coulter LJniCe DEC Coulter DEC Series Allowable Error i Labs Labs 39 Beckman Coulter LJnC.e DEC 2eckman DEC Coulter DEC Coulter DxC a sca dev Labs j Allowable Error (I E a) (Method) Method 17443 17443 429 Total Allowable Error - , Total Allowable Error 9.68 5.78 Use t Use t , t Use t. (A 1631 Printed: 9621 Capability Meun Total Allowable Error 1:2s ru EQAS maintains long-term accuracy Value N 1 7443 My Lab Group Values by Group Values by Method Values by Method (56-62)/7 = -0.9 (56-62)/7 = -0 9 Points: Group Values by Group Values by Method 962' Value assigned ossiqnd c, Assigned on CVR is a Of CV to monthly is a ratio Of monthly CV to is a ratio Of CV to is a Of CV to Control Date torrentsrnetho (04.3 1:2s ru -1 -012 QUALITY orat TEC on Current data T EC on current data S EC on Current data S EC On Current data (04.3 the chart = 7842 ste essayes reflects current method performance. assigned o group CV and an o' precisiom group CV and is an estimate ot precision. group CV and is an estimate of precision. 106.7 (04.3 9.3 Points Pornts 121105 121405 121905 125145 (0}.3 Quality Mean Albumin Bromcresol Purple Bromaesol Purple ean dev dev' 106.} nq.o 12.8 llq 25,76 enl QUA assigned o (214-215)/19 = -0.1 (214-215)/ (545-496)/40 = 1.2 76.28 SEC on Current data SEC on data on current data -1.26 Less than O -1.26 Less •1.26 Less than O •1.26 Less O -1.26 Less than O AST ALT -1.26 Less than 0 Less SAMPLE value N Use t Meon ean assigned Value Use t I Use t Mean a scan AST QUALITY QUALITY' value Observed 930 Jse TE (Peer) SDI (Peer) CVI Peer) *PIE , and Cie Value s and assi1qneÅ and Group by 1:2s ru PROFICIENCY System eon UV # Points 1744 t 744 47882 Pointsd: 1744 1714 17443 QUALITY QUALITY . CONTROL Beckman oxc Beckman OXC oxc DC Use t! veeÄvS10 Use tt 0) QUALITY (DO Information: OXC oxc oxc OXC (04.3 a scan QUALITY 118.0 +1 S 114.0 1780 PATIENT Value N Ise t 10 PAT' Q' cc • IBÅnefits PLE TE QUALITY Reagent QUALITY Mess ayes Messages -Messages messages Information: Value assigned ENT PATIENT CONTROL Messayes TE devi 12. q 12-.q QC Value N CONTROL c: PATIENT j CONTROL OL ean Va/ue IENT LENT 'ENT CONTI • CONTROL IENT 'ENT o' CONT assigned +0 PROFICIENCY CONTEOL c, c. cat, cd 2.96 PATIENT (112.0% TE CONTROL Albumin Al umin CONI CONT' CONT •e CONT..L Albumin cot, cot cc co . cot, cc. PAT QUALITY QUALITY Key Messages Key messages arc TESTING (PT) messages Messages A. o, Key Messages Messages messages ærcmcresol grcmcresol 495.0 +1 s (QC) Value Value True QUA' 4:2s ru CONTROL ua_ arc Current data meet quality specifications: Level I I (pc) 04 _ Bromcresol Pu B Purp*CP) B romcresol Purp*CP) B romcreSoI Purp*CP) 8rcmcresoI Pu aromcresol Purple (BCP) aromcresol Pu omcresol Purp*CP) Purp*CP) B romcresol Purp*CP) Bromcresol Pu B romcresol Purp*CP) C B romcresol Purple B omcresol Purp*CP) B romcreSoI Purp*CP) C B romcreSoI Purple omcresol Purp*CP) B Purp*CP) Puff Puffe Valve N B romcresol aromcresol Purple Srorncreso' Purple Bromcresol Purple B romcresol B romcreSOI I (00 SAMPLE 0.500 Sec an eon ean "ICAL I (90 TESTING (PT) (04.3 1:2s ru Use t! a scan 1:2s ru • EQAS Benefits CONTROL PLE The accuracy an (QC) (0}.3 SAMPLE essayes essays (acts (QC) messoges essages (0 SS ages ssages Beckman Coulter unicel devi 12.8 -2 SO Beckman Coulter UniCeI OXC Beckman Coulter Uni eI OxC Coulter U UruCel 'ROFICIENCY Coulter U Beckman Coulter Beckman Coulter DIiCeI DIC Beckman coulter {C Beckman coulter I ey ey Beckman Coulter Beckman coulter ni Beckman coulter Beckman Coulter ni Beckman coulter Dxc Beckman coulter I coulter U Coulter ni PATIENT True Value - Record the source of your true TESTING Vive PROFICIENCY 11839 1168829 1166829 11899 116899 CONTROL (QC) PROFICIENCY SAMPLE The target values are Level I The target values are valid: Level I The target values are I (DO e an PATIENT PROF VARIATION VARIATION - assigned o (00 assigned . 'CIENCY Corrective Action' Corrective Action: 'CIENCY ENCY SS ayes 119.0 De±cated Rea Pt tecated Da%ated Reagent tscated Rea pt Deftated Da%ated Rea Pt Deicated Reagent De±cated Reapent De%ated Reagent Dedicated Reagent Dedtcated Reagent SAN De%cated Reagent Dai•cated Reagent De%ated Reagent De%ated Rea pt Dedicated Reagent De%ated Reapnt Dai•cated Rea pt tscated Reagent Deicated Rea Pt Deicated Da%ated Rea pt Oed•cated Reapnt Daicated Reagent De%ated Rea pnt De%ated Da%•cated Rea pt De%•cated Reagent Dedzated Rea Daicated DB±zated Reagent Loet Moth r x' Rea pt Rea gent Reagent SAMPLE SAMPLE :ICIENCY Reagent Rea pt Reaport Meagent Feagent (DO (PC) 12.9 0.120% The target values are valid: Level I SAM'LE PATIENT 119.0 analy+ic es SAMPL SAM, 1•.2s ru sm Mean Messages 99.7% SAMPLE COMA PATIENT SAMPLE Value SAMP —Mean (00 SAMPLE 95.70/0 - Record the source of your true (90 (DO PATIENT CONTROL devi com -H-e 107.0 Valve N The T Ea limits arc valid: Level I The TEa limits arc valid: Level I The TEa limits are valid: Level I The TEa valid: Level I Lcvcl 2 Level 2 devi eon SAMPLES. AST ASAT/GO •AST ASAT/GO ASAT/GO 'ENCY PATHI bces No+ False Rejection ASAT,'GO 1195 Il 95 ean Mean SAMPLE 119.0 Boes No many Your Lab 10}.3 106.7 You' Lab Your Lab Yout Lab Understanding Inter-laboratory An bces SAMPLE Shi-em es PROFICIENCY (QC) TESTING Vive Key Messages SAMPLE ean Labs: Value Value TESTING (PT) UVwithoutP5P u,'L 37'C WL 37' C WL 37• C WL 37tc SAMPLE 0.514 T, 0.514 Tie The The (P T) What ac ac Oc Value •n The current actual mean and SDI indicate a positive or negative bias compared to the target assigreÅ Cumulafive eon cumulative Tie 4016 4576 17443 7443 4679 43679 12.9 c. TESTING s ru 12.8 Value The current actual mean and SDI indicate a positive PATII yste eon Beckman 4586 4679 fie Tie 1 195 I (DC) Value devi How many How HOW many BIOLOGICAL ANALYTICAL BiOLOGiCAL ANAOLYTICAL Peer Group Mean SAMPLE —— SAMPLE Meon Peer Group assigned many ANAL cumula+ive 2100 214 2150 215 11 119.0 SAMPLE assqneÅ o 496 . messages Key Messages Key messages mlessages me cumulafive Key messages messages messages Messages messayes assigned o (QC) @ANALYTICAL 'ANALYTICAL ' messages messages Value N Value (QC) rules to to ts t 0 ANALYTIC BIOLOGICAL Messages messages Messages fey messages (PT) Gaussiaais\fibu+ed on (saussaröis%ibufed on Gaussiant)iswtbu+ed on In (Pee CVR (Peer) CVI (Peer! cvR CVR CAL (Pee CVR (Peer) CVI CVR or peer TESTING Reaænt Report Reagent TESTING (PT) assiqneÅ on 1195 co sg-*em i The accuracy essays 106. (o T're acc 119.0 SD assigned essays 3Sa3€S sages Its scan ;can messages essages SS ages a scan QC OC QC sample. QC sam QC Sam plc. QC sample QC samples QC cm Ähe accuracy essayes Messayes Messages aye: ges us Key messages ess SAMPLE QUALITY essays SD Es+inn+e 4515.0 45105.0 messa3€s on .ppty apply appt y applty VARIATION VARIATION • VARIATION . VARIATION - Demonstration of technical competence uoa cacy an and an 18.0 (The accuracy and accucacy and an Cid techSaon sec'Saon The accuracy and an Ahe accuracy and an accuracy and an accuracy an at-curacy and an The current actual SD and CVI indicate increased imprecision compared to the assigned to chart SDI St) The accucacy be accuracy an accucacy an / : ssag€s iCK SD iCK St) accuracy 118.0 iCK scl ean ion 12.8 St) . VARIATION SAMPLE Gaussaöiswbu€ed on TE to measure to mea sure f r, nq.o y and@qecÅSton an 10.3 45K (9b 106. (o (q b Pees Gou > 106.6 178.0 119.0 1780.2 317126 178.02 178.2 17802 178.0 OF sac. da4n •n pveclslon da4tl rcucacy = 0.1204 bu+ed on *ed on aim for S 0.05 or 5% The accuracy on iCK SD SD Es+ima+e 106.' on an 106. (o bu+•ed or (Method (Me t h*SDI value for each control and verify its validity. value for each control and verify itls validity. ch control and verify its validity. IOC.' 106. (o ean mean, beginning this month (QC) on c" SD, , beginning this month assigned or gradually since _/ or gradually since /' or gradually since I' or gradually since / ed on SD SDI 62 1195 19 40 2140 SAMPLE or peer Value or peer 457' (9b ICON eon on Pees | CC. (o and (a -g Peet Gou p TESTING (PT) # Points nq.o Pointsd: Value aim S 0.05 or Messages eon Mean loon 118.0 SD ddn devi devi da+n Messayes S 0.05 or SD descflb es Cumulafive Patient results may be erroneously High Value N Imprecise Imprectise m describes 1195 Ags -579b c syså-em descftbes Shi-em descftb es sy*em descftbes em descrtb es analy+ic sysfem es sy*em b es Shf-em descftb es Shi-em descrtb es fem descftb es descft b es descrt b es descrtb es b es Value sys+em descftb es sy*em describ es sy*em descflb es -fem descftbes em b es Abs System degcftb es pfem descftbes da4a sy*fem es assigned ING (PT) (Peer) (Peen cvn (Peen cvP (Peen cvR (Peer) cvn (Peer) cvR cvR cvn Key Messages ±3SD Beckma%oulter UJniCeI DxC Series Beckma%oulter LlnCeI DIC Beckma%oulter LlnCeI DxC Series Beckma%oulter IJnCeI DxC Series 3eckma%ouIter LJniCeI DxC Series Beckma%oulter DxC Series Beckma%oulter LJniCeI DxC Series 3eckma%ouIter UlniCeI DxC Series 40 ges en on IL 95 twp roup sy*+em descetb es SY*em describes Ffem b es 40 When to ro to IS descfl b es rib SZ:V Value Value N cv cvl 4378 1195 11.3 106.7 119.0 107.7 210.0 1193 107.3 6.8 8.8 8.1 8.8 IJrtCe4 DIC Unit el DxC DxC DxC *ties 0.647 117637 Action: LlnCeI DxC 106 N DxC DxC *ties Dxc *ties a luf assigned cvR CVR IS (QC) S •seem loon SAMPLE on ICON 4400 4870 44.00 4400 04500 44 44 m es SD Peer (DO 0908 -5791) cumulafive 106.} ass' assigned GaussiarDisK,bu+ed on rcf rcS coup 457' (9b 0.500 0±500 0.500 •soo OEOO —0.14 osao osa:o Osco ouao osco ean 1192 Tre SD 106.? Mean Identify potential areas for improvement Cum. Value # Points pointsd: Points Points: Printed: -012 4016 1066 218005 128005 t 18005 118005 1180.05 117637 1076.7 t 17637 assi Pointsd: Points # Points Points: 4016 118005 119.05 119505 1 IBC05 1180.05 117637 1176.37 ass' (po 106. ass I (DO 0908 Verify validity Of statistics used to generate within-laboratory and peer data Verity validity Of all statistics used to generate within-laboratory and peer data Verify validity Of all statistics used to generate within-laboratory and peer data (Method) (Method) SO (Method SDI (Method) sol sol OF _O_IC _a_IC ARE Re 119.0 e WE ARE •q The accuracy and an 4505.0 4515.0 495.0 Comparison Programs Total Allowable Error (TEA) - . Total Allowable Error Total Allowable Error SD (TEA) - Labs The accuracy wable WHERE we WE Verify validity Of statistics used and an WHERE The accumc Error -IS 62 12 62 2100 12.7 Labs: Change the r,ef-.-l. WE ARE g Ports Points g PcRs PcRs 12514 the analytical evaluations Group Group Values by acutacy Values by Group Values by Method Group Values by Values by St) frt ass' 119.0 da4n Des 91 points: points: • Points: Pointsd: Points: aess aess' Less ass as S ASS 4586 17362 1 '829 Calculate mean and SD on recent data population SAMPLE Calculate mean and SD on recent d Mean 17362 SD Mean 43,47 4347 0647 43M 43.47 43.'7 43.47 43.'7 43<7 4347 43<47 SD Es+ima+e i.. (QC) iCK iCK SD assigned 79 > 1195 -O 106. (DO Calculate mean and SD on recent 10'. caned. Es*ima+e % Cm Cm Cum Precision cision lrecision PeevGcoup 45/6 (9b 106. do 10 aess assigned Peev peer Group Group 31.co 31.90 31 go 3t.co 31.go 3t,go 1492 1193 11899 1152 1195 1806 1802 178.2 100.5 106 18026 119.0 180.6 100.7 cucacy or Pees Group 106. (o We IS c€ecision curacy PNPP. AMP Buffer PNpp. AMP Buffer PNPP, AMP Buffer WC PNPP. AMP AM p by 27.70 Alkaline Phos A'kaline Phos IOC. (o Cumulafive has occurs-ed. secision ass ala * 106. es TE in unit$ of cells x 109/L and Value mean on QC chart: Level I We-assign SDan on QC chart: Level I Re-assign mean on QC chart: Level I Re-assign SDan on QC chart: Level I Level 2 No + ass' ned+o DxC Series WHeRC wr ARC Coulter DEC DEC DxC TE in units of cells x 109/L 1214 - 2151+1.65 * 17 = 29.1 ass' 119.0 WHERE we 1545 - 4961 + 1.65 * 37 = 110.1 1545 - 4961 + 1.65 * 37 = + 1.65 * 17 = 29.1 Dedicated 37•C 37' c 156-621+1.65*6 = 15.9 me we Beckman utter Beckman Coulter Uni Beckman Coulter Beckman utter uni kman utter uni kman utter U kman utter kman ulter utter 119.0 110.1 1106.7 118.0 210.0 110.7 wed on we ARE we A Re WE WHERE 10 cumulative 1195 guirubin, 1195 Ke # Points Points: Pointsd: points points Pointsd: # Points Points: Points UV Pi-em descri b es • fem descr•tb es fem describes Fem descfl b es fem b es -m b es -em descftb es m descftb es 24m descflbes descri b es scft b es b es Sys+em descrtb es o/ fewer descnÉ Des Sigma-metric UV Cumulative 2S4410 Labs Labs defres deqnes fie de+es fie de+es deqines fie Cumulatl Beckman OXC Beckman oxc Beckman Beckman Cox OXC canter DC cuter DC cuter de$ires fie def nes QC Re-assign SD on QC chart: I Re-assign SD on QC chart: Level I Level 2 Level 3 deqoes fie • Increase confidence in the accuracy of the Increase confidence in the accuracy of the 255036 .10 12 1195 Value e. Il IS the IS *he *hen 11950 defines fie define fie define* fie Cumulafive 10 Points PcRs Points: Printed: '367 1166829 116682 115142 116899 1168829 Beckman OXC Beckman cuter OXC Beckman Coulter UniCeI ve 119 5 RE IS bis%ibu+ed on ve 5 —WHERE IS 106. ? Pho Phos ha fie Alkaline Pho hatase Alkali Pho hatase N*kaline Ph hatase Alkaline Pho phatase Pho hatase A I saline Pho hatase Alkaline Phosphatase Aikaline Pho hatase A i Oline Pho hatase Alkaline Pho hatase Pho hatase cumulative 1195 hatase • 119 5 119.0 cumulative -0 1195 q. 95 106.} easons Why S, fie S WE ro D WE expecr ro 106.} 106. (o +0 106.3 ve WHERE expecr ro 60 11899 PNPP, AMP Buffer WC PNP", AMP Butter 37:C PNPP, AMP Buffer arc PNPP, 37:C PNPP, AMP Buffer 3TC PNPP, u,'L AMP Buffer 37:C AMP LYL arc WC 3TC 37:C 37'C PNP", AMP PNP", AMP WC PNP", AMP Butter WC PNPP, AMP Buffer 37:C PNPP, AMP Buffer 37:WC PNPP, AMP Buffer um WC PNP", AMP Buffer arc PNPP, AMP WC PNP", AMP Buffer um 37:C PNPP, AMP Buffer W7:C PNP", AMP Buffer WCc Plop, AMP Butter arc Plop, AMP Butter WC PNP", AMP Buffer 37:C PNPP, AMP Butter 37:C PNP", AMP Buffer W7:C PNPP, AMP Buffer arc PNPP, AMP Buffer um 37:C PNPP, AMP arc 10 37' c 37:C WC IS Is Used in PNPP, AMP Butter PNP", AMP Buffer WC PNPP, WHERE wr ro wr expecr ro we Expecr ro we EXPECT ro expecrro arc Peev 45166b Record the each—con defines +he ,u+ed on Hed on Re-assign target values: Level Re-assign target values: Level I target values: Level I level 2 Level defnes fie s change fro fie analyiical Group Values by on Record the source of your TEA for each control Group by Beckman Coulter UniCeI DIC Beckman Coulter UniCel DIC Beckma%oulter UniCeI DxC Series Beckman Coulter UniCeI Beckman Covulter UniCeI Beckman Coulter UniCeI OXC Beckman Cm"lter UniCeI OXC coulter coulter Unicel Beckman Beckman Coulter UniCeI DIC Beckman Cm"ter UniCeI Beckman Coulter thiCeI Beckman IJnCeI DIC Beckman coulter ni Beckman Coulter UniCeI DxC Beckman UniCeI Beckman Coulter IJnCeI DIC Beckma%oulter LJniCeI DxC Series Beckman UniCeI DIC Beckman Cmulter UniCeI DIC Beckman Cm"lter UniCeI DIC Beckman Ccvulter UniCeI DIC Beckman Coulter UniCel Beckman coulter unicel Beckman Cmflter DIC Beckman Coulter Uni Beckman Coulter Unicel DIC Beckman Coulter IJriCeI DIC ro control Chanse analy+ical used 'In cnlcula±ion used calcula±ion he anqlyiica\ (0 fie s fie 11026.0 114.0 106.3 122.0 1106.0 v, 11952 sac: SQC. S(ÄCA. t a Chante occuracy used a change ocucocy OF SQC. OF sac. OF S(AC. OF - S(ÄC-. OF SQ(J. OF S(ÄC. - sac. sacs S(ÄC. U. 17qq3(9Z9) -s used Change basis -OF SQ . ardyfe bein Reagent Reagen: Rea Mt OF Rea Mt Rea V Rea pt Report Reagent Rea gent sac. SDI bens Your +0 used In Used -OF 457" 9b 106. ardyte beins ardyfe beins 3rc easons 11950 119.0 WE ARE ARE RE r,bu+ed on 'Ibu+ed on (Peer ardyie bein Re-assign T Ea limits: Level I Re-assign TEa limits: Level 1 Re-assign TEa limits: Level I Level 2 Level 3 a Chant PeecG€oup 4576 (9b Peer Gtoup 4576 (9b 106. (o Peev PeevGcoup 45 (q I Hibu+ed on 104.3 s\qbu+ed on 45 -0.78 s Used in cnlcula±'ton 10.78 17W/3(9zq) All n cnlcuta±ion -0.49 Your Yout You' Lab Yout Lab Lab Labs 118005 1076.7 106.6 Your Lab 106. (o 118005 119.0 119005 119,0 -0.49 117637 100.7 10647 106.70 •3.10 14 n calcula±lon has irtorrec+lY 100.7 +0 beint laboratory's testing results ry's testing results on SD 957' (9b '020 '020 bein9 so to sol Part 2 Select QC rules and strategy to maximize detection 107.3 106.0 107.0 ' ozo so tos.o '0260 102.0 '02.0 wa.o 107.0 or minimize false rejection false rejection Its.7 Select QC rules and strategy to beins ctxorrecfly/ (DO cvl Select QC rules and strategy to maximize error detection loon I DOA Is no-k ts -We amly+ical -We cesul+ -We is ro+ twp 317126 +e 11514 17443 12514 Select QC rules and strategy to maximize detection Corrective Action: Corrective Action: Corrective Abs (go R viewed by: Reviewed by: canter Note: Date Date: amaly+ical mc elidity. Ensure the lir7it0?8u and 5.3 g 62 * 0.25 = 15.5 215 * 0.25 = 53.8 215 * 0.25 = 53.e 496 * 0.25 = 124.0 30 60 cbniQ/ty metnir cbniQ/ty 4430 TEA in units All 119.0 119 S and cbniCQlly clini@lly La — Is 4367 11482 1 '482 11899 4265 4285 eon of) WHERE we WHERE is is ne+ WHERE RE cbniCQ/lty WE Re ppeot Gaussianbis+frlbufed on Abs 10 cvR # Points: 1 1482 e Less O 84 C) (Poer) (Peen (Peer (Peet) (Peer) and verify its validity. Ensure the limit you and verify its va lidity. Ensure the limit you Less (Peer (Peet) (Peer) (Pee Off verif i validity. Ensure Cumulafive 104.0 assi All Initiate action reduce bias *ion 00k ac 10 ass mixed ardy+ical amoly+ioal itcorrecfly 17qq3(929) q QC cm ceqec+ n used calcula±ion All 17qq3(qzq) QC cm QC cm reqec+ All QC QC reqec+ e Less aess when QC S±ahshcs cm --- QC r o/ (Peer SDI Fee' SDI cbniQ/ly meanin (Peer SDI scl SDI -0 12 -0 -012 +he n (Peer (Peer scl loon -0 -0 12 -012 30 60 40 10 IIS homed incorre+ly coup *+hen ) *hen *hen Less expkcr 11950 Initiate corrective action to reduce bmpreciasion Initiate corrective action to reduce bimprecision Initiate corrective action to reduce tmpreciasion expgcr Less C) Less O of cells x 109/L of cells x 109/L- of cells x 109/1- c- O cm (Method SDI (Method Method SDI SDI (Method SDI (V,eti-od SDI SDI (Method cm ceqec+ CM 4722 a 722 722 Less QC cm me QC cm ceqec+ QC cm ceqec+ me Peev WE ) Hen QC cm m QC cm eFeefiely m QC cm reqe+ m +0 +hen QC cm m, feqeci- Cumulafive cumula+Wve Cumula+iv assi 4576 I ( on if-correc+lY 100.7 1106.0 6-8 ddQ ve is 11952 110.0 119005 11952 1152 119005 118005 11950 106.6 11.7 11.3 11952 119.0 1152 119505 11952 1492 11.7 3.10 10 SEC Used ion of the effectivenes'uf#rauogng 3.10 All - IS IS 'IS IS Verification of the effectiveness of training (q Arrange instrument service from manufacturer IS Less Less O e O Peer (q b e Less O 6-8 dda poi Cut Less O 6-8 d 10 ned+o WE EXPECT ro g cm m E ro ected is attain • EXPECT ro EXPECT ro EXPECT ro g EXPECt ro & ass' ned 4400 se\-up se+-up change the analyiicai t SQCV 4576 (9b (qb (q b Pees fie anqlyiicai fie analyiica\ ro 4016 toes 1068 1066 106.6 107647 107.3 107.37 106.37 '07.3 106.7 1078 1076.7 1073 107B3 1102.0 457.3 107.37 s attainable and defensiblet o. change to the analyiica\ o, change to the analyiica\ chanoe fie analyiical Change fro fie analyiicai to the analyiical fro analyiical the analyiica\ (Peer Need 106.6 106.7 110.0 106.6 1078 117637 106.3 107.3 106.7 1073 117.3 106.27 7074 11.3 107.7 10783 107 s change •to the analyiical Change analyiica\ fro analy+ica\ fie analy+ical fie analy+ica\ the analyiica selected is attainable and defensible. chary analyiical chanoe the analyiica\ trecision change +0 fie analyiicai chanse to the fie analyiicai the analyiicai qreciston face* kordted incorre+(y Less Less O change -to fie analyiical SD CK St) Es+ima+ series CK SD 1492 11952 18.2 fro fie analyiical DxC 1492 118005 11952 1152 119005 119.05 1802 SD Eshma+e Jess Temporarily discontinue reporting patient results Temporarily discontinue reporting I CK Es+ima+e nge the analy+ical , analyiical anqlyiical amly+ical assi C- Less 119 5 ve 5 1195 CK St) enals hordted Incorrec+(y sac. a +0 he analy+ical 1195 3.10 19 Labs rd (Peet 457' (9b (q) 14 ma + F accepQ Less points 123777 '23m 123m 12.9 4580 4400 4870 points Printed: 458.0 123777 1744 123m77 123m 487.0 4870 4576 SDI: —0.30 —0_30 -C 49 specific Peer Peer p Peet Group SEC ys+em has occuffed. has occuTfed. Reviewed by: Date: SYS+em has SYSJrem has occuvted. 30 has Reviewed by: has occuvced. 19 occutted. Reviewed by: Date: Reviewed All sysi•em has occuvtfed. has occuffed. has occuvted. occuned. als horded sys+em has occuvtced. Sys+em has occuvted. sys+em has occutted. 17qq3(qzq) s occuvted. s occuvtced. v • tatted. cuffed. and applied. als kondled kordled Frondled ned+o s occuvced. Less O hordted 123777 applied. sys+-em has occurted. 3.10 Youp sys+em has occuvted. fem has occuvted. TE < TEA 100.} NO YES m has YES 119 5 119.0 .10 has occuvced Investigation performed by occuvced. cunted. o/ defieed and applied. defioed and applied. Abs do da4a 6.120% da4n 10 so 106.} 100.6 da 4378 4870 43678 4265 13722 — is ne+ Youp 19 12 10 is no+ 3.10 mas 10 # Points: 43679 4297 13722 18 17 21 2100 da4Q Concen+ray bs WHERE we ARE 118.0 1195 climicallv me Itcorrec+lY do rd creof€ Concen+ration Concen- concen- Concen+ra+i. Concen clintcally_mean• ed 17 +0 3.10 clinically mean, elimcallv Run 2100 • modified from Brooks, (2001) Quality • Worksheet modified from Brooks, (2001) Control. • Worksheet modified from Brooks, Zoe (2001) • modified from Zoe (2001) • modified from Brooks, (2001) • Worksheet modified from Brooks, Quality • modified from Brooks, Zoe (2001) • modified from Brooks, Zoe (2001) Quality Control. Worksheet template modified from p • modified from from All All 17qq3(yzq) amly+ All 17qq3(929) amly% araly% aruly% eek-up All mean" Idled da4a Concentra-ko me concen Concenyrafion n *ration coptRlGHT 1991 BIO-RAD LABORATORIES COPYRIGHT 1991 B10-RA0 LABORATORIES, coptHlGHT 1991 BIO-RAD LABORATORIES, coptRlGHT 1991 BIO-RAD LABORATORIES, All. RIGHTS RESERVED 1991 BIO-RAD LABORATORIES. ALL RIGHTS RESERVED, ALL RIGHTS RESERVED. do rd Concentration Concen• rd Concen•' Concen±r Concent Concen+ra±i Conce Concen+raf, Concentrafion Concen+rafion Concen+a+i 0.120% do (0 COPYRIGHT 1991 BIO-RAD LABORATORIES. COP/AIGHT 1991 BIO-RAD LABORATORIES. ALL RIGHTS RESERVED. COPYRIGHT 1991 BIO-RAD LABORATORIES. ALL RIGHTS RESERVED. ALL RIGHTS RESERVED. All-pup ion on ve Clinically clinicallv clinically climcallv

  • inter-laboratory comparison
  • mean
  • SD
  • standard deviation
  • peer performance
  • coefficient of variation index
  • CVI
  • SLIPTA
  • SLIPTA checklist
  • proficiency testing
  • PT
  • target
  • true value
  • peer-based metric of imprecision
  • 4 key numbers
  • internal QC
  • external QC
  • EQA programs