PEPFAR Quality Control and Method Validation Activity 8: Part 3

2) Type number Of GC sampks fes+ed Analytical Analytical The OF periodi ) lhe he number q) The of periodi Quality TE calculations can be applied to Quality analytical 2) Type and number of (X 2) Type and numb The of pevtodjc Tevtew urement proc 2) Type and number measurement 'Analytical l) Frequency of sampe evenf Goals 3) QC ased 40 Iaborator measurement pr System l) Frequency of QC +es+ even+s Laborator Quality defec+lnj Laborator Activity: Changing Reagent Lot Numbers new reagent lots to evaluate 2) Type and num Goals l) frequency of +es+ even+s acceptability System q) The of periodic review Goals l) Frequency AC +es+ even+ QC used +0 Laboratory Goals defectinj and used +0 l) Frequency of +es+ even+s Laborator The 09 periodic Tevtew The of periodic review Type number sampks tested ency of pevtodic vevtew defec+lnj and *rends System QC ased 2) Type aud number of GC Quality acceptability before putting the b) Worksheet 6: Rea ent Lot Number Chan e Laborator defecHlnj 9) QC used +0 QC used +0 and *rends Results defec±inj a b) The achons when Results Type aud number of +es+ed defecfinj and and 3) used Type number of QC sampks number Results Laborator Goals b) The achons when 3) used +0 Quality new lot into use with patient Quality testing used b) The achons ±QKen Results The OF periodic review of pertcd.c review b) The achons ± Results b) The achons defecfinj _ The of periodic review QC used 40 b) The achons +Q6en b) The achons wh By comparing the Total Error (TE) to the Total Allowable Error (TEA), we can assess whether or not a new lot number of reagent By comparing the Total Error (T E) to the Total Allowable Error (TEA), we can assess whether or not a new lot number of reagent used +0 used q) The 09 periodic review exceed 3) ased +0 QC used +0 Laboratory Quality q) The of periodic Laborator Goals The of periodic review for testing. q) The of periodic review The of pevtodic review q) The The OF periodi q) The q) Goals exceed b) The achons ±Q6en Quality b) The achons Quality b) The b) The achons when exceed Quality Quality exceed Il q) Quality defeciinj and *rends provides clinically acceptable results. In this exercise you will be evaluating two different lot numbers and answering questions What will you need? What will you needo? The periodic review Results Goals Results What Will you need? LD The Purpose Goals defec+inj and +cends and *rends The revtew exceed accep exceed Laborator Laborator What will you do? Goals The revcew Goals exceed exceed qccep+üle defecfinj and *rends q) The pevtcdiC revtew Laboratory -5 Results Goals Goals Laborator b) The achons ±Q6en when b) The achons +hen b) The achons +ahen when resul+s q) The of periodic review Goals q) The review defec+inj and • defec+inj and Laborator pertaining to your data. and +rends and *rends exceed CQQQep+oåIe Laborator and What Will you need? defecHinj Quality Quality The Results defecfinj and +rends G' defeciinj and *rends exceed defec+inj and +rends Results Worksheet Results Results b) The achons +a6en b) The achons detec±inj and b) The achons +Q6en Change b) The achons faher Working in groups of 4 (table), you Laborator Goals TE calculations can be applied to b) The achons +hen and *rends WHERE WE m BE WHER WHERE WE EXPECT ro BE WHERE b) The achons +Qhen when b) The achons ±Q6en when resul+s Results Goals defec+inj and *rends b The achons when defec+inj and and WHERE Number Change • Worksheet 6: Reagent Lot Worksheet 6: Reagent Lot Worksheet exceed Cape Clinic Laboratory WHERE WE ARE used +0 Results WHERE WE EXPECT ro BE WHERE WE ARE WHERE WE ro WHERE • Job Aid 2: Sample TEA b) The achons when rescd+s b) The achons when WHERE The achons b) The achons when resul+s defec+inj Current SD b) The achons ±ahen when b) The achons +a6en when resul* WHERE WEAE WHERE WE EXPECT ro WHERE WE A 'WHERE WE ARE WHERE WE ARE new reagent lots to evaluate WHERE WE EXPECT m BE WHERE b) The achons +a6en when resul+s WHERE WE EXPECT ro WHERE WE ARE WHERE WE Number exceed acceptable exceed Nurnber Change Number Change WHERE WE EXPECT exceed exceed I exceed exceed l, Glucose (mmol/L) Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) Glucose (mmol/L) L-J Chart for Control XYZ (exp 30/11/XX) on Illustra Chemistry Analyzer (serial # 123) I WHERE will: WHERE WE EXPECT ro BE • Job Aid 2: Samr exceed WHERE WE ro BE WHERE WE ARE WHERE WE ro WHERE BE WHERE WE EXPECT ro BE WHERE we ro BE WHERE we ARE WHERE WHERE WE u' i WHERE WE ARE x 5.80 mmol/L SD 0.10 mmol/L Target 5.60 mmol/L TE A 6.9% 6.9% 5) The achon acceptability before putting the • Job Aid 2: Sample T E n. • Job Aid 2: Samnple TE Calculations exceed "WHERE WE A4RE 01 WHERE WE WHERE ro WHERE WE ARE WHERE we EXPECr ro BE WHERE WE ARE WE ARE WHERE WE ARE WHERE WHERE Bias WHERE WHERE we ARE WHERE WE EXPECT ro BE E WE ARE . ARE WHERE ARE Calculations Complete Worksheet 6 (30 minutes) Complete Worksheet 6 (30 WHERE WHERE WE ARE WHERE WE ro WHERE WE ARE sheet WHERE we ro WHERE WE ARE DI WHERE we A. WHERE WE ARE new lot into use with patient WHERE WHERE WHERE we EXPECT ro WHERE WE WHERE WE ARE WHERE we ARE WHERE WE ARE WHERE WE WHERE ro WHERE WE ARE - WE EXPECr ro DE WHERE WE EXPECT ro WHERE WE ro B - WHERE WE ro WHERE WE ARE WHERE we WHERE WE expect ro BE WHERE WE ARE WHERE A RC WHERE WE EXPECT ro We WHERE we WHERE we A Re - WHERE WE expecr WHERE WE ARE ro WHERE we ARE WHERE WE EXPECT WHERE EXPECT WHERE WHERE we ARE 01 Calculating Device (e.g. Calculating Device • Calculating Device (e.g. WHERE we ARE WHERE AR I WHERE we WHERE we JRE WHERE WE WHERE ARC WHERE WE ARE WHERE WHERE calculator, pho ro WHERE WC DI * WHERE WHERE WE DI WHERE WE ARE WHeRE testing. WHERE WE ARE WHERE WHERE E WE ARE WHERE RE E WE ARE WHERE WHERE we WE ARE WHERE ARC Select a spokesperson to present the DI ( ARE 5 WHERE WE A WHERE WE WHERE we A. WHERE WRE we WHERE calculator, phone) WHERE w WHERE ARC pencil pencil WHERE we ARE 't WHERE WE ARE QUALITY • Pencil pencil group's answers. pencil Reagent Lot Number A New Reagent Lot Number AE • Glue stick • Glue stick Glue Glue stick CONTROL QUALITY + 2S + IS What will you need? QUALITY WE ARE • Glue stick Scissor NCY • Scissor Participate in the class discussion CONTROL (QC) PATIENT QUALITY Current TE QUALITY PATIENT QUALITY/ QUALITY QUALITY (PT) Scissor NCY NCY QUALITY NCY CY (QC) NCY (QC) PATIENT SAMPLE CONTROL CONTROL • Worksheet 6: Reagent Lot CONTROL CONTROL PATIENT PATIENT NCY CONTROL SAMPLE SAMPLE (PT) NCY QUALITY PATIENT (QC) NCY T) (PT) Plenary Discussion Messages PATIENT (QC) +4SD - 2SD +3SD SAMPLE (QC) (QC) essayes SAMPLE QUALITY essay Number Change N urnber Change PATIENT (QC) CONTROL SAMPLE SAMPLE SAMPLE 70 The accucac SAMPLE SAMPLE 5.73 - 2SD CONTROL— Putting TEA into Quality The accuracy and One group will be selected at random SAMPLE New Reagent Lot Number TE • Job Aid 2: Sample TEA The accuracy and on The accuracy Qfld The accurac Tbe accuracy The accucacy (QC) The accuracy ond 6.10 The accuracy and accuracy and accuracy and The accuracy and an to present their answers. The accuracy and on The accuracy and The accuracy and@qecls• The accucacy Calculations SAMPLE The accuracy and@€ecÅSlon 0 Sy*em es The accura The accuracy and The accucacy and Qqec Sys+em analy±ic WHERE WHERE A Re WHERE we ARE sy*em b es System The populated chart will be projected • Calculating Device (e.g. 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 we ARE By comparing the TE to the target value and TEA limit, we can conclude Reagent A is WHERE analy+i we WHERE WE ARE analy+ic WHERE WE and System WHERE sysfem acceptable / unacceptable — WHERE A RE WHERE ARE ' WHERE WE roE calculator, phone) WHERE Value WHERE WE ARE WHERE RE WHERE WE The spokesperson will address IS WHERE By comparing the TE to the target value and TEA limit, we can conclude Reagent B is IS and and IS WHERE and WHERE we ARE is sac. Values (mmol/L) obtained with Control XYZ using the New Lot Number Of Reagents • Pencil pencil WHERE WHERE acceptable / unacceptable Worksheet 6's questions Calculations sac: WHERE WE ro WHERE WHERE WHERE WE WHERE WE A RE 5.80 IS Reagent B Reagent Lot Reagent B and WHERE WE • Glue stick Glue stick Number A Number B sac: sacs WHERE W WHERE VARIATION 5.80 5.70 5.73 we WHERE WE WHERE we , to the analy+ical Chan9e he analyiical • Scissor Chanee to He analy+ical o. chanse hie analy+ical W' number Change change analy+ica\ WHERE WE ARE he WHERE WE he analy+ical WHERE EXPECr WHERe we +hen WE Activity 8: Putting TEA into Quality WHERE WHERE WE +hen +hen 40 minutes WHERE WE A, •hen WHERE we A. 'l WHERE WE ARE WHERE WE ARE WHERE we -5 o. change fie analy+ical Chanoe the analy+ical change —WHERE WE Change analy change Change Bas naly+ica\