PEPconnect

PEPFAR Quality Control and Method Validation Activity 6: Part 1

In this activity, participants create a parallel testing standard operating procedure (SOP) document based on their observation of a role-played laboratory scenario. % CV is introduced and used in the standard deviation (SD) computation of short shelf-life control materials.

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 accuracy and an The accuracy and The aocncy and ar AMPLE ey assayed SAMPLE The and an Assayed The accuracy an QUALITY Messages assayed package inserts essayes essaye€ SC SAMPLE (QC SS ayes accuracy and an — Expected (part of instrument maintenance assayed ess ages ee',ayes manufacturer accncy an accuracy Assayed ss -1 SD +1 SD ey analy+ic sys+em es SAMPLE SAMPLE Assayed SAMPLE ey essayes essayes SAMPLE*- Assayed The accuracy and an The accuracy and on CONT May experience more vial-to-vial variability (increase imprecision) if improper May experience more vial-to-vial variability (increase imprecision) especially if improper accuracy and (in o.ssages SAMPLE AMPLE (QC) IAMPLE control materials, wherever possible, especially at or control materials, wherever possible, es Shi-em es The (QC) CONTROL assayed sp+em es descri b es (QC) describes handling and reconstitution occurs rlENT the insert same manner (i.e. if patients results undergo a AMPLE b es SAMPLE The accuracy acid an Qruly±ic descra b es AMPLE Frequently has a shorter opened vial expiry interval Mean and ±2 SD range schedule) Shi-em describes WHERE WE Parallel Testing SAMPLE The CONTROL (QC) system The accuracy and The The accuracy Q and an The accuracy and •veclSton (QC) The accuracy L The accuracy and The accuracy and an The accumcy an The accu The accuracy and@qecÅSlon *hen The The accuracy accuracy accuracy The accuracy and Q The accuracy and The at-curacy an QtecÅSton accuracy WHERE wr Notepad and an ARE and near clinical decision values, which ensure the validity of near clinical decision values, which ens The accuracy aqd The accuracy uallfl& expensive than The accuracy and and The accuÄ The accuracy and an The The accurac SYB+•em WHERE WE ARE we ARE essayes WHERE WC The accuracy and@€ec'ßon WHERE Il less expensive than — Usually less expensive than +2 SD -2 SD -1 SD analy+ic sys Analytical analy he accuracy an ys+em descfl b es fem b es accuracy and an Mean and I SD Mean and ±2D Mean and 1 SD Mean and ISD sys+em descfib es shift, so should our QC results) fem descflbes sys+em es ic Shi-em describ es accuracy descftb e descrt b es sy*em descflb es pi-em b es Shi-em descflb es sys+em descfib es sys+em b es sys+em de sys+em Syså-em descrv syså-em desc Shi-em Syså-ev Sysfem describ fem describes fem describ es Shi-em es Shi-em descftbes syså-em descftbe descri b es SAMPLE sys+e des IS es sac: IS System es b. Eliminates many Of the handling and reconstitution errors b. many Of handling and and —Unexpected (a problem during testing is analy+i IS analyzed analy+ic sye Analytical Analy+ica\ OF Pen or pencil Q. Syså-em d sys+e sacs Sys+em descfl b es an Shi-em describes Sys+em descfl b sys+em b es Sysfem descrtb sys+em describ es Sys+e Sysfem descflb es OR System decisions made. RE WE ARE WHERE we ARE System b es sac:— QuiCK sys+em es Assayed assayed essayes Aessayed wr ARE WE ARE y WHERE WE WE ARE we WHERE WE ARE —WHERE WE — ARE WHERE WRE WHERE we ARE to WHERE WE ARE WHERE WE A RE WHERE A Re WE ARE WHERE WE ARE — WE WHERE w WHERE WE RE we RE WE we IS t; WHERE WHERE WHERE ARE ARE WHERE "e WHERE — Used to evaluate accuracy — Used to evaluate accuracy a — Used to evaluate accura sys+em describ es IS IS i. May discard or none Of product if consumed within opened expiry date The accuracy and and and anS ased WHERE we, WHERE ARE ' WHERE and WHERE WE A WHERE WE ARE WHERE and and and -sac:— We compare today's observed value with the The accucacy QC and WHERE WHERE WE WHERE Should detect changes at medical decision WHERE RE WHERE we ARE WHERE WE ARE WHERE WHERE WE A WHERE we m. Of lot number changes WHERE we we ARE WE we ARE WHERE we roE WHERE ARE we t; we The accuracy QCd The accuracy *hen parallel testing takes time and money (costs Of performing testing on QC is NOTE 2 Use of independent third party control and and precision precision — Used to evaluate precision and and WHERE 'IS IS fie analyiical IS IS Chart? WHERE WRE WHERE we IS IS —'WHERE WE EXPECr ro IS I S WHERE Is IS we EXPECT ro IS IS and WHERE he —'WHERE wk he I Ecr Analytical WHERE WE TOE we EXPECT ro D RE WE we WE we ro sp+em has WE EXPECT ro D IS With each QC material lot number change, lose access to summary or cumulative data chanse fie analy+ical sacs sis -sac: sac. IS Major component changed on the instrument basis OF we sacs System has occurs-ed. ARE nd past history of previous results has occuvced. - SQC. -oFEQC. sac: sac. sys+em Bas 'IS +hen has has occurted sac. sac: IS levels ) *hen IS the Chanee fie analy+ical only Goals —WHERE WE I WHERE we —WHERE B WHERE we ARE change fro the analyiical IS WHERE —WHERE WE —'WHERE we he analy+ical WE n WE E materials should be considered, either instead of, or in WE RE WE EXPECT ro B WE ro g IS — Avoid laboratory errors when aned i. Desired expiration date should be specified at time of purchase —WHERE WE — WHERE wk based on the stability of ty analy+ical a. change fro He analy•ical Change fro fie analy+ical Based on the past history change He analy+ical is Is Chanee he analy+ical is Is is no+ 'IS WHERE WHERE WE is is SQ is IS is is .1 is is no+ is IS Is ne+ WHERE WHERE WC ARE WHERe IS WHERE we i WHERE WE WHERE we ARC WHERE WE we WHERE RE IS WHERE we we we ARE we we ARC Re WE ARE we we ARC Sys+em Has WHERE WRE we is In parallel with the has occuvted. 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WHERE WE ro E —WHERE WE EXPECT ro BE Sys+em has occul SYS+em hange analy+ical SYS+em has 15 minutes sys+em has occuvced. Sys+em Sys+-em has occurced. sys+em has occurted. sys+•em has occur?ed. sys+em has occurced. m has occutfed. Sys+•em ha SYS+em h SYS+em hat sys+-em has occur? sys+em has occuvtced. sys+em has occuvted. System +0 analyiical d. Ability to sequester specified lot number and automatically ship and bill as outlined in the sys+em has occurced. has occuned. -m has occuvted. s occuvced. sys+em has occuvtfed. has occutfed. Sys+em has occunred. as occuvted. WC expect ro in-use as occuvced. occutfed. s occurced. occuvced. occuvted. Change naly+ica\ change. change fro fie analyiicai Analytical a change fie analy+iü Change Change fro the amaly+ical change amly+ical Change -to fie analyiical change hie analy+ica\ change fie analy+ical purchase agreement o. change fro he analy+ical Change analy+ical has occuvt em has OCCuvt WHERE we •u

  • parallel testing
  • observed mean
  • SD
  • standard deviation
  • SOP
  • standard operating procedure
  • percent CV
  • %CV
  • coefficient of variation
  • SLIPTA
  • SLIPTA checklist
  • L-J chart
  • matrix
  • matrix effect