PEPFAR Quality Control and Method Validation Activity 8: Part 1

Frequency of +es+ even+s evalua+e group will determine If the method can produce test results that are Based on the Frequency of (AC Frequency o of Numbers Systeml •Analytical System Syste=»! group Analytical 'Analytical Based on the supplied QC chart, your l) Frequency Based on tho supplied char Based on the supplied QC chart Working 3) QC used QC ase-d of Based on the supplied QC chart, vowr 3) used +0 Based on the suppliecl QC chart, your Analytical can produce test results that are Analytical QC used evalua+e Purpose can produ QC used 2 number sampks tested group will cietermme if the method group q) The periodic review for q) The OF review clinically acceptable for the intended Frequency Of +es+ evenfs System q) The of review group will 2) Type and number of QC Type and number of The of review Activity: How Correct are the Test Results? The of peviodlC review for The of pevtodic review group group will determine If the me group will determine if the met q) The of periodic revtew for The OF periodic revtew for Quality The of periodic review for group will determine if the method group Begin 2) Type and number Of QC Wor 2) Type and number of With Quality group Quality I Frequency OF QC +es+ evenFs that Frequency of (AC -Yes} even+s Frequency OF QC even+s q) The of pevtodic revtew Quality Frequency of sampk? +es+ even+s clinically acceptable for the intended Purnose System Puroose The of review System Goals clinically Quality Quality 3) QC used +0 can produce test results that are The of PeviodlC Tevtew can procluce test results that or Worksheet 1: Intended Use • Worksheets 1A— 4: Intended Use Worksheet Intended Worksheets 2A -4: Intended worksheet Intended OF pevtod,c revtew produce Purpose can produce test results that use of the test. Puroose Quality Type aud number of sampks can produce results th,it Quality can produce 3) The of pevicdlC review defe number Of (X sampks +es+ed 3) Participate Laboratory Type number ±es+ed Tvoe number sampks fes+ed Type number Of QC snmpks fes+•ed Goals Goals Type number Of GC sampks tesfed The of periodic review tor Goals Laborator q) The review Quality use of the clinically acceptable for the In tended clinically • Worksheet 1 : Intended Use use of the test. Goals and *rends clinically defec+inj and +cends eval evalue Quality and +cends clinically acceptable for the int( defecåinq e, and *rends Laborator Quality defecåinj and *rends es and *fends clinically acceptable for the In The revjew defecåinq_ Based on the supplied QC chart, The of review defecfano anÅ clinically acceptable for the intended Goals on the evalu q) The of peciodic review acceptable ID pevtodjc review of the System Laboratory x Analytical Frequency Goals and *rends Results Laborator Quality of Quality ot evaluaVe discussion The pevtcdiC review QC used 40 and +cends QC ased QC used +0 Laborator Goals defec+inj Quality QC ased +0 defec+lnj and *rends defec and and +cends of the test. Laboratorn QC used Laboratory Results Results q) ,Results q) The of the QC ased group will determine If the methc use of the test _ use of the test. Will Goals b) The achons +ahen b) The achons +Q6en when resul+s l) The of of the test, group will will Laborator b) Goals b) The achons when and b) The achons b) The ac b) The achons when Quality The OF peviodl group The achons ±Q6en when defec+lnj and *rends The achons ±ahen when when resul+s Goals Based on the following QC chart, does this method produce test resuiCs that are clinically theintended use of this test? defec+inj and *rends Goals and *rends Laborator Based on the following QC chart, does this method produce test results that are clinically acceptable for the intended use of this test? defec+inj and 3B Results Results b) The achons fahen defec+inj and n when resul+s defec+-inj and *rends q) The of pe consensus. Worksheet Goals Quality q) The Fretuenc b) The achons ±Q6en when Quality can produce results that Goals and Results b) The achons Results b) The achons ±Qhen defec+inj and +ceods The of periodic review can produce test results that are Laborator and *rends Laborator The OF revtew defec+inj Goals Results on Quality b) The achons fQhen when What will you need? b) The achons fahen when Laboratory Goals b) The when resul+s Activity: How Correct are the Test Results? What Will you need9 defecfinj b) The achons fahen when resql+s WHERE WE EÄpscr b) The achons ±Q6en when b) The achons Numbers b) The when q) The of review q) The of r-evtew for Complete WE Goals b) b) The ach Laboratory ID The defec- will Analytical Laborator b) The achons wahen defec clinically acceptable for the defec+iny The of review The of revtew cy 09 peviodIC review Goals Quality The of peviodic review for What will you needo? y of for b) The ac+ Laborator Laborator b) The ac Goals exceed q) The of periodic review System detecflnj exceed Goals able Goals Laborator when Results and Quality Worksheet l: Intended Use and +rends l) Frequency exceed Laborator What Will you need? defec+inj a WHERE W What will you do? defec+inj Frequency Frequency o Will you need? b) The achons What Purpose Laboratory Quality defec+inj anc WHERE WE exceed . WhIat will you need? Results What will you need? of Of test exceed exceed OQQep+061e b) q) Goals Goals Goals Laborator and Laborator Results Results b) defec+inj and *hen Laborator use of the test. • Worksheet l: Intended exceed Results Goals Quality exceed b) The achons ±QKen when acceptable and Work defec+inj La boratory WHERE WE ARE Puroose Purpose Puruose • Worksheet IV intended Use • Worksheets l: Intended Results b) The achons +Q6en when resul+s exceed Worksheet and *rends What b) The ach and +cends b) The achons +QKen when exceed OQQep" • Worksheets 1A — 4: Intended Use Laborato Worksheet l: Intended b) The achons +QKen Worksheet Goals Quality Goals Worksheets Intended defec+inj and +cends Worksheet I. Intended defecfinj b) The achons when b) The achons Worksheet In tencieci Use and *hen • Worksheet l: Intended Use b) The achons +Q6e and +ceods • Worksheet l: Results +3SD b) The when resul+s b) The achons when resul+s b) The ±Q16en when worksheet Intended b) The when b) The ad-ions ±Q14en when resul+s b) Results • Worksheets Il — 4: Intended Use • Worksheets 2A •4: Intended b) The achons +ahe What will you need? WHERE ARE • Worksheet l: Intendiedi • Worksheet 1 : Intended Use (Laboratory„ Goals Worksheets PA -4 Intended and Working in groups of 4 (table), you will: b) The achons +aKen when b) The achons ±Q6en when Based on the supplied QC chart, your b) The achons when resul+s • Worksheets 2A — 4: Intended Use WHERE WE exceed exceec excel b) The achons +a6en when Worksheets 2A - Worksheets b) The achons Worksheet 1: Intended Use IS What you need? exceed your WHERE WE EXPECT ro It WHE/ WHERE WE .RE WE ARE RE WHERE WE EXPECT ro BE , What need? it it WE ARE is Worksheets 2A —4. Intended Use Working WHERE WE WHERE WE ro WHERE WE Continue WHERE WE ro DE WHERE roe WHERE WHERE we WHERE ARE WHERE WE , WHERE WE EXPECT ro , It Worksheet WHERE WE EXPECT ro BE' WHERE WE EXPECT WHERE WE EXPECT ro BE What Will you need? ity • job Aid I Work WHERE WE EXP WHERE WE EXPECT ro WE exceed [ b) The when b) The achons faHen when b) The achons WHERE WE EXPECT ro BE Quality What will you do? exceed Il exceed Worksheets + 2SD it ro WHERE WE RE Absolute Worksheets 2A — 4: Intended WHERE WE WHERE ARE it exceed WHERE WE ARE exc ed exceed exceed WHERE we WHERE ro ' • Job Aid 1 WHERE WE expecr ro BE Job Atd I exceed WHERE we TO we ro i WHERE WE ARE j WHERE ro we WHERE we ARE Goals • Job Aid I • Job Aid 1 WE ARE WHERE WE ro group will determine if the method group will deterrmine if the method WE ro WHERE WE ARE WHERE WE EXPECT ro WHERE WE ro BE WHERE WE ARE wHERe WE EXPECT ' Begin with Worksheet 1. Worksheet WHERE WE EXPECT ro BE ro WHERE W directed Goais Goats exceed WHERE WE EXPECT ro BE • Job I • Job Aid I WHERE WE it WHERE WE ARE WE ARE • Calculation Device (e.g. phone, WHERE WE EXPECT ro J WHERE W WHERE " WHERE WE ARE WHERE WHEW WHERE WE WHERE WE ARE , f, WHERE WEARE WHERE WE ARE I, WHERE WE ARE • Job Aid 1 WHERE WE roE exceed WHERE WRE WHERE WE EXPECT ro BE WHERE WHERE wE WHERE WRE WHEARE it HERE WE EXPECT ro BE' • Job Aid _l Job Aid I we • Job Aid 1 it WHERE WE WHERE WE • Calculation Device (e L', phone. WHERE WE ARE WHERE WHERE we A RE WHERE wr WHERE WC ARE WHERE WE WHERE WE ARE WHERE WE ARE WHERE we WHERE WHERE we ARE Calculation Device phone WHERE WE ARE Worksheets Intended Use Worksheet WHERE A Re ARE WHERE we It WE ARE ro WHERE WE IS WHERE it it Worksheets 2A A: Intended U • Calculation Device (e 8'. phone, we Re ARE WHERE wc expecr ro ac • Calculation Device (e g. phone, it Calculation , WHERE WE group can produce test results that are Calculation (e g phone, What What vou need? What will you need? What need? WHERE ro WE WHERE WE ARE WHERE WERE it WHERE WE ARE WHERE WE ARE WHERE WHERE we WHERE WE , Bias for WE ARE • Calculation Device (e.g'. phone, WHERE WE A m WHERE WRE WHERE we ARE WHERE WE. WHERE ARE Calculation) • Calculation Device (ex8. phon€, Calculation . Calculati Calculation) WHERE WE ARE • Calculation Device (e.g. phone, calculator j WE ARE Calculation Device (e 4', It Participate in your group's WHERE WHERE we • -alculat101 WHERE WE OF WHERE WC ARE WHERE WE we ro WHERE WE ARE • Job I WHERE i WHERE WE ARE calculator) t WHERE ARE ro WHERE WE ARE Worksheets 2A- Intended CJs ; WHERE ARE WHERE we ARE WHERE WE ARE • Job Aid WHERE ro WHERE ARE WHERE WHERE we Re WHERE WE RE oat's WHERE we • Pencils WHERE we calculatior) m WHERE WE WHERE we ro WHERE WE ARE clinically acceptable for the intended calculat( (e pencils calculator) we pencils WHERE we Re WHERE we ARC we ARE Pencils ro WHERE WE ARE WE ARE t WHERE we ARE (QC) Pencils WHERE we ARE • Pencils Calculation , Device • Pencils • Pencils • Job Aid I we WHERE Job Aid discussion and reach a WHERE WE WHERE WC ARe WHERE ARE pencils Pencils SE calculatior) calculator) WHERE use of the test. use of the tes€. pencils CONTROL QUALITY Pencils • Pencils • Pencils -3SD -ISD -I3SD ISD Calculation Device (e g. phone QUALITY QUALITY Pencils pencils QUALITY QUALITY CONTROL QUALITY consensus. calculator) PATIENT CONTROL PATIENT PATIENT QUALITY PATIENT CONTROL PATIENT PATIENT CONTROL • Pencils Messages Pencils CONT' PATIENT QUALITY PATIENT CONTROL SAMPLE (QC) QUALITY SAMPLE QUALITY (QC) SAMPLE CONTROL Messages Message Complete the appropriate section QUALITY CONTROL (QC) (QC) (QC) essayes essayes ages CY ey essayes SAMPLE PATIENT 'PT) 'PT) (QC) PATIENT essayes PATIENT PATIENT SAMPLE SS ayes CONTROL CONTROL SAMPLE essayes PATIENT CONTROL PATIENT What will you need? What will you needo? What Will you need? I essayes CONTROL (QC) SAMPLE CONTROL (QC) on Worksheet 1 and proceed to Messages SAMPLE (QC) SAMPLE (QC) SAMPLE ICY SAMPLE SAMPLE SAMPLE (QC) (QC) an on (QC) SD SAMPLE PATIENT CONTROL essayes and CONTROL PATIENT The QUALITY (QC) The accuracy and essages (QC) The accuracy and SAMPLE The accuracy and an • Worksheets 1A — 4: Intended Use Worksheets Intended • Worksheets 2A — —4: Intended Use • Worksheets 2A — 4: Intended Use the next worksheet as directed. SAMPLE SAMPLE The accuracy and i, CONTROL SAMPLE The accuracy 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 24 25 26 27 28 29 30 The accucacy Sys+em b es System describ es System an (QC) The accuracy The accuracy and Continue working on your analy+ic System The SAMPLE your The accuracy and accuracy and WHERE WERE If yes, explain your answer. After your response, proceed to Worksheet 2A. Analytical sac. b e S Shi-em descftbes accuracy escri b es System b es is Sys+em describ (QC) directed worksheets until your • Job Aid 1 The accuracy and and ; WHERE ARE WHERE WHERE WHERE we WHERE WRE we WHERE Sys+em ( WHERE WHERE WE A R' IS WHERE WE ARE — WHERE A RE MERE WE ARE WHERE ARC WHERE WHERE WHERE WE group reaches Job Aid 1. IS • Calculation Device (e.g. phone, and WE we and WHERE we and sac. and and sacs IS calculator) WHERE we WHERE we Is is With SQ IS 'IS the IS IS If nos, explain your answer. If yes, explain your answer. If no, explain your answer. Specify what other information do you believe you need. After your response, proceed to Worksheet 2B. do you believe you need. After your response, proceed to Worksheet2B. wk is —WHERE WE EXPECT we ARC IS the —WHERE WE ro • Pencils Pencils sacs WHERE WE ARE +he WHERE we chanee he Change to the analy+ical WE Analytical a charee he analy+ical change analy+ical we WHERE WE WHERE we WE Change change change yo we expect ro WHERE WE *hen What +hen +hen +hen Change Sys+em has oc Change change 45 minutes he WE System Sys+ey Sys+em