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PEPFAR Quality Control and Method Validation Activity 8: Part 2

In this activity, participants will explore what information the fourth key number must provide to define the quality required. Additionally, participants will use a laboratory scenario to assess if the method remains acceptable for the intended clinical use of the test result.

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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The revteu, and q) and +rend3 1.Gather mean & SD data I. os when exceed acceptable acceptable Laboratorys Laboratoryy eval'kaVe achons +Q6en when Quality and achons +Qhen when resul+s ed OCCeptoåIe Goals ways, depen Laborator ons fahen when exceed qecep+Q61e b) group's %CV in increasing order zp+ohule Laboratory Laboratory Quality b) The achons +QKen when Analytecal exceed Laborator e achons when +ahen when resul+s !-xceed accep+üle exceed accept-ok-ole en when resul+s Goals Goals Results Results ons ±Qhen when Goals exceed accep+aåle exceed QQQep+Qåle exceed C(QQep+QåIe Goals b) Tne fa14en when ±ahen when q) The revrew Laborat01y defec±inj and +r defec+nj and +1 exceed QQQep+Q61e os when resul+s QQQep+Q61e -Hons ±Q6en when resul+s defec+nj and 'Ions when exceed accep+oble exceed OQCep+rÆIe exceed OQQep+ohuIe Results and *rends b) The achons +Qhen when re q) Tne b) The achons +ahen when and +r defec+inj and +cends exceed QQQep+061e C(QQep+aåle p+oåle chons +Qhen when resul+s ions ±Qhen when ns ±ahen when de+ec+nj and def-ec+inj and defecfnnj and *rends exceed QQQep+a61e Goals defec+tny and +rends Results defecfinj and +cends (True) and +rends QCCep+061e and *end 3 +QKen when resul+s The +Q6en when resul+s Results Laboratorn. b) Tne achons and +rends and *rends b) The achons ±Q6en when Results • Best estimate of the b) The achons When resul+s b) The achons when b) The achons ±a6en when b) The when resul+s b) The achons fhen when Target + Targ Target Ta rget Laboratory« Resuits d*fec+inj and he and +cends error limits q) The review q) The q) review For q) The revtew q) The of pevtod,c review ID review IS b) The defec+tn eed accep+oåle and eed OQQep+061e ceed and +cends Biological Variation (BY) q) The r-evtew q) The of review defec+im defec* defe accep+Q61e b) The achons when b) achons faKen When q) The review For and *rends [D The defec+inj defecf-tn Goal exceed QQQep+oåle the defecf-inj defec+lnj anc ID The and dete exceed QCQep+oåIe QQCep+oåIe b) The achons ±aKen TEA in units = (TEA Target Value defecfinj and *rends peer data available) ed accep+061e Laborator b) The achons +a6en resa b) The ad-tons when re b) The achons fahen when b) The achons +aHen when and without invalidating the clinical usefulness of the result The achons ±Q6en when The achons when The achons fa16en when resul+s peer data not available) (LaboratorV -d QCCep+061e q) review b) The ac+tons +a6en q) The of pericdJC The ions when Laboratory Its ceed QQQep+Q61e Quality b) The faKen when LD The revtew b) The achions +Qhen when re q) The OF pert exceed The achons ±a6en when The achons ±QKen when . chons ±Q6en when Hons +QKen when resul+s 'Its Ions ±Qhen when resul+s defec+nj e achons ±Qhen when resul+s e achons fa14en when achons ±ahen when q) q) The pert Results f. QCQep+ohule The review The The rev:ew For b) The when re defechinj and +reods q) The Fretaency per chons when Quality b) The achons ±QKen when re exceed Where What will you need? What will you needo? en resul+s achons fahen when QQQep+061e QQCep+061e The of periodic revrew exceed System Results What will you What chons ±Q6en when resul+s e achons +Q6en when resul+s Results accep+ohule OCCep±üIe Goals Laboratory Goals fahen when resul+s exceed q) The Fretuency of review Laborator Laborator Results Select the median %CV eed qccep+üle error limits. q) The OF revtew exceed exceed occep+oble Results The Tevtew .ons ±Q6en when Results Calculate the Calculations Calculate tne Goals The revtew b) The achions ±ahen b) The wh LD Results error limits. b) The achions +Q6en wh exceed xceed accep+oåle Quality b) The achons +ahen When b) The achons +QKen when resul+ e achons +Q6en when resul+s b) The achons when resul- b) The achons when b) The achons +Q6en when res« b) The achons +ah6en when res. The pel defec+ind exceed o used accept-roble Results qccep+oåle b) The ac+ions +aKen when Results ceed qccep+oåle exceed qccep+oåle OQQep+rÆIe b) The ac+ioos +a6en when deYechnj and +rends Goals Percentak b) THC VS when Goals defec+ir Frequency exceed accep+Q61e limi+s limi+s defec+inj and +rends and *rends and *Tends exceed OCCep+rÆIe q) b) The achons +Qen value from q) The Work' exceed QCCep+Q61e b) •xceed QQQep+Q61e accepfoåle Results b) The ac+tons when b) Tne achons when b) Thne achons +Q16en and +rends fed accep+061e ceed accep+oåle achons ±QKen when resul+s b) The achions +aKen when The revjew and b) The achons +Q6en when resul-k b) The achons +a6en when b) The achons +Qhen when resul+ b) Thne achons +QKen q) The Fretaeoc.y Quality ed qccep+oåole exceed qccep+061e b) The ac+ions +a6en ) The achons ±Q6en when +cervis defec+in QQQep+QhoIe •xceed b) The achons +Q6en b) The achions ) The achons ±Q6en when e achons +ahen when achons +Qhen when exceed Quality Quality exceed OCQep+oåle acceptable *O.xceed b) The achons +aH6en b) The achio b) The achto b) Tne acho b) defec+l' Purpose System Laborator [Laboratory limi+z revrew Lower TEA Limits = Target Value - TEA in units achons when (.(QQep+oåle b) The achons +QKen when defec+lnj and proficiency assessment programs (e.g. CLIA in the exceed Ss ±Qhen when resul+s achons +Q6en when resul+s (ÅQCep+oh,ie l.mits b) The achons +Qhen when S ±QKen when fa+QKen when resul+s S when resul+s e achons ±QHen when resul+s Laboratory exceed b) The ac+ions when The achons ±Qhen when resul+s QQQepf-oåIe e achons ±QHen when Calculate Total Error in units and in percent of the True Laboratory Wider b) The achons when resul+s A-ions ±a6en when resul+s chons when resul+s 3.9 3. achons ±Q6en when resul+s +Q6en when resu14s Results Goals Laborator b) and q) The e +Qhen when Results The c "If you cannot specify the when resul+s 10 Accuracy Three Levels of quality specifications TE < TE TE < T F Laboratoryx The Fretaency ar Laborator;s Results 2.Estimate true value To calculate % TEA , multiply the median %CV by 3 To calculate % TEA, multiply the median %CV by 3 Three of exceed c-1 c-5 -2 43.1 43.2 143.1 63.1 2.0 4.2 9.7% 9.4% 8.0% b) The ac+ions exceed accept-obi Goals b) Tine achvons when 5) Ine ac+ions when c-2 c-5 exceed 56.0% 103.0% b) The achons fa16en when defec•hnj and +reyvis defec+vnj and *rends defec+inj *rends b) The achons Where 56.0 292.8 6. 2.8% 2.9 32.2 QQep+oåle (l cnA-s eyoeed QQCep+Q61e exceed QQQep+Q61e eed C(QQep+Q61e ed accep+Q61e b) The achons when resul+s defec+inj and and +rends and *ren,ds and +reyvds and exceed accep+aåle 'N 'i and Results ccep+Q61e Goals b) The achons +ahen when rev, exceed QQQep+oåIe error We Expect We Goals b) The Expect and *rends and +cervis and and +cends and *rends and +revvjs sample's true value limits Three of qualitv Three Levels of Three Levels of qualitv TE < T F Results Laboratory ts and +rends exceed ) Laborato +rend3 eval WE WHERE WEARE WHERE WE ARE exceed ity is exceed +aåle exceed occep+üåle exceed accep+Q61e exceed accep+061e we ro WHERE WE ARE WHERE we Sources In descending order of prior It We Ex —WHERE WHERE WHERE WE ARE es E ro BE WHERE WE Results Goals defec+ TEA is the 4th key number for SQC. It it Res exceed acceptable exceed OQQeptoåie Value for each QC sample for each analyte on each Value ror each QC sample [or each analvre on each occep+oåle we ro BE WHERE RE we ARE b) The ac+ Where ceed OQQep+Q61e ro WHERE ARE -O BE WHERE WE ARE WE ARE WHERE WE BE WHERE WE EXPECT ro BE., b) The achons +QHen when exceed b) The achons +Qhen Results ity it We Are Wo Are wo Are WHERE WHERE WHERE we acceptable qccep+oåle WE EXPECT ro BE WHERE WE ro BE' WHERE WE EXPECT ro BE. b) The ach-tons +aHen when exceed ity WHERE RE WHERE i. Hons ±ahen when WE Be WHERE WE ARE e WE ARE WHERE WE EXPECT ro ,E WHERE WE ro BE WHERE WE EXPECT ro EE it achons +QHen when WHERE WE WHERE we, , WE ARE WHERE ARE exceed defectinj and WHERE it WHeRE WE OQQep+oåIe WHERE WE EXPECr ro BE WHERE WE EXPECr TO BE ro BE WHERE WE EXPECT ro BE , WHERE WE EXPECT ro BE WHERE WE ro E , WHERE WE ro BE , WHERE WE ro The rev WHERe WE ro. WE WHERE ARE WE ARE WHERE WE EXPECT ro BE, b) The fQHen when resul+s and *rend s WHERE WE ex."' E WE ARE WHERE ro , wHERE we TO BE b) The ac+tons +Q6en when b) The achons fa6en when resu14s b) The achons +ahen when resul+s b) The achons +ahen when res„l+s b) The ac+ions +ahen res„l+s b) The achons +Qhen when resul+ b) The achons +ahen when resu14s b) The ach LD The Fre work WHERE WE EXPECT ro BE' b) The achons when exceed b) The achons Value oals Valu WE ( % median * 3) b) The ac+ions +a6en when 5) ac+ions b) achons exceed l, value Quality Using simple math and working in value WHERE WE ARE . F ARE WHERE EXPECT TO BE ARE b) Thne ad-ions +Q64en when resul+s b) Thne achons when b) The achons ±QKen when be achons +ahen when wr b) The achons +QKen when resul+s b) The achons +a6en WHERE we ro. exceed Laboratory b) The achons +a6en when b) The achtons +Q6en when resul+s b) The ac+ions when b) The achons wh b) The achons +a6en when ty e achons +ahen when resul+s achons +ahen ons +ahen when resul+s and WHERE WE EXPECr ro BE WHERE WE ARE Results Goals b) The achions defec+inj We Are b) The achons +Q6e Wo Are achons Mean - fact ceed occep+oåie xceed QQQep+061e tested WHERE WE EXPECT WHERE WE ARE Results Accuracy ed "—crroBE WHERE WE ARE and exceed accept-able Goals and normal exceed exceed +XPECrrOBE WHERE WEARE ,xceed we exceed b) The achons +aKen when Quality WHERE WE ARE WE EXPECT BE WHERE WE ARE Ceed exceed QCQep+rÆIe cXPECr ro BE WHERE WE ARE -p+ühole Results Absolute PEPFAR QC Workshop v. WHERE A Re Worl

  • TEA
  • quality
  • fourth key number
  • SLIPTA
  • SLIPTA checklist
  • TE
  • target value
  • error limits
  • CLIA