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PEPFAR Quality Control and Method Validation Activity 4: Part 1

In this activity, participants are provided with QC charts and a Westgard Multirule algorithm and must apply the decision-making process to determine acceptability of the analytical run.

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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What will you do? will I System The Front-li Quality hen resul+s The Front-lil Control Frequency runs of Tech: Laboratory hen resul+s +hen Quality Go Laboratory Purpose Pumose Pumpose l) Frequency _ Results jc revtew for review For Results runs Go Work equency or review work Laborator Results review for Laboratory La boratorys rend s used No QC ased +0 •runds evalua+e Frequency System review System I) Ffequency Quality used review hen resul+s Purpose System I Frequency of ua it Analytical hen resul+s Ceta: Data Ceta Qualify To not Working •n groups of 4 (table), VOu To or not Working •n groups of (table), VOu To or not on Working In groups of 4 (table), VOu To or not an Working In groups of 4 (table), VOu To or not Working In groups of 4 (table), VOu To or not an Working •n groups of 4 (table), VOu To or not Working •n groups of 4 (table). VOu To or not Working In groups of 4 (table). VOu assess nor Working In groups of 4 (table), VOu assess or not an Working an groups of (table), VOu or not Working in groups of 4 (table). VOu or not on Working In groups of 4 (table). VOu or Working In groups of 4 (table), VOu or not Working In groups of 4 (table), VOu or not Working •n groups of (table). VOu To or not an Working •n groups of 4 (table). VOu or not an Working In groups of 4 (table), VOu abnormal Type ts Tech: ualit Laboratory Quality ua it Its review Laborator ua It yaboratory or 2) Type number of Type What number rend S rend S Go Quality Purpose Results revtew for Laboratory Labor atory Laborator ua 1 ua Quality No GO Go l) In-Control Cn-ontrol Date: Data: Data J Type number number run the run F, the run us Ing the run as the run a, the .s the the Will: System review Laboratory review Puruose rend s ua hen resul+s Laboratorß Quality Control rends Results rends ts Quality Results QC Go Laboratory Laboratory Go Go Scoring To assess whether or not an analytical Working in groups Of 4 (table), you algorithms provided algorithms algor.thms provided algor provided provided ype aid number review ua It rends Laborator Control pencils Results Control, Control 'c Results andorn HERE WE EXPECT ro BE' Sconnt Analytical Laboratory hen resu14s Results No number Laboratory Laborator • the QC • the QC sheets • the QC worksheets the QC worksheets the QC the QC Bork sheets the QC *orksheets Go Laboratory Results Control revtew Quality number Go Quality Tevrew for Go No Results Go rends Sconing +2 Quality Results review hen resul+s GO review evaluate Results runds What will VOu need? What will VOu needo? What will VOu needP What will VOu need1P What Will VOu need? What VOu need? What will VOu neet1P hen resul ERE WE EXPECT ro System Laboratory foce«iown until instructed to turn focedown until to turn facedown instructed to turn tocedown Instructed to turn toce&wn until 'instructed to turn up down until to turn down instructed to turn until instructed to turn until .nstructed to turn until Instructed to turn untti instructed to turn unto instructed to turn rends runs rend S instructed to turn Instructed to turn Instructed to to turn Go GO Go Go for Laborator Results Results Data System hen resul+s Laboratory Go Control System PROFICIENCY ERE WE EXPECT What vou need? Syste review Quality ua it yste rend S Qualit Laboratorym Laboratory a boratorw rend 3 Quality will will: ERE EXPECT ro WHERE WE ARE Report Data rend s hen re Laboratory What need? E EXPECT ro Scoring Laboratory Quality Roles Rules them up them—n. them +5 for HERE WE ro ua it Laboratory ua It up ERE WE EXPECT ro ERE WE EXPECT rc ERE WE Results What will Control 4. ali Labor atory Laboratory La boratory Laboratory hen resul+s hen resal+s hen hen resu14s WHERE WE ARE ua Results TESTING (PT) rend S ua it scoring i. HERE WE EXPECT ro BE' ERE WE EXPECr ro BE' Sconn Results ERE EXPECT ro ERE WF E EXPECT ro ali ERE WE EXPECT TO DE' ro or Results ERE WE EXPECT TO BE' review Quality Scenario ua System GO ERE WE EXPECT TO BE ERE WE expecr ro hen res« Multirule algorithms provided. +hen hen resul* Laboratorv hen resub* ERE WE EXPECT ro BE ' Results on control • Use the minutes provided to Use the provided to use the provided to Use provided to Use the minutes provided to Use the 6 minutes provided to Use the 6 provided to Use the prov•ded to Use the minutes Drov•ded to the mLnutes provided to the 6 provided to the minutes Orov•ded to the mtnutes provided to minutes Drov.ded to the minutes provided to hen + 5 for +5 for 5 for fork ERE WE EXPECT ro Quality a it control Control hen In-Control ERE WE EXPECT ro BE' PATIENT Results Control ts Results Laboratory is Go ERE WE ro BE Quality WHERE we ARE Control In-Control • 2 • Worksheet 2 2 2 2 ontrol • Worksheet 2 • Worksneet 2 • Worksheet Worksneet 2 Scenario Quality Results No hen resul+s HERE WE EXPECT ro ERE WE EXPECT ro WHERE WE Results ua it ERE WE +5 for the Quality Keep the QC scenario worksheets • the OC chart, determentng • Review the QC chart determn.mng Review the QC chart, determimng • Review the QC charr deterr'n.mng • Review the QC determtntng • the QC determvmng • Review the QC deterrnmtng • Review the QC chart determ.n.ng • RevLew the QC chart. deterrn'ntng • Review the QC chart, determining • Review the QC determ•mng • Review the QC chart, determrmng • Review the QC determtmng • Review the QC chart, determ•mng • Review the QC determ.mng • Review the QC deterrn»mng • Rev'ew the QC chart. determ'nsng Review the QC determensmng ua I SAMPLE the determ.ntng Review the QC chart, determining the QC determ.mng the QC chart determ.mng the QC chart. deterrn•mng ua it PATIENT ua WHERE WE ARE of Control Results WHERE WE ARE Results Laborator Qualit E WE EXPECT ro Report Data -3 • 3 • Worksneet3 Scenario 3 • Worksneet 3 • Worksheet 3 • Worksheet Worksheet 3 3 3 Scenario 3 WHERE WE ARE Scenario System ystem or Quality 5 for +5 for No Results WHERE WE ARE Go review Scoring Laboratory one control one point out ualit Control PROFICIENCY which yste runs runs ate runs. runds funs this run the rends tuns. are Control Syste- sC Report System review Pencils pencils 4. Control ystem System WE ua it SAMPLE Quality ua yste the mean ua WHERE WE ARE WHERE WE WHERE WHERE we ARE away Control WHERE WE ARE WHERE WE ARE ontrol + 5 for 5 for yste ;yste System System ua 1 Level PATIENT ua PROFICIENCY In-Control System ua it ro on trot Control orat unacceptable -7 for of What will VOu do? What will you needo? TESTING (PT) acceptable or unacceptable acceptable unacceptable acceptJble or unacceptable that unacceptable that are unacceptable Or unacceptable or unacceptable unacceptable wr Control ua it for Quality or se of yste face-down until instructed to turn until .nstructed to turn SAMPLE WHERE we we ARE yste we + 5 for or Q0e Control Qualit of control answer(s) ontrol we or of control ua It on scoring Scoring Sconing ystem Control In-Control ontrol Control -z SAMPLE Cn-ontrol Control SAMPLE WHERE WE ARE PATIENT ACTIVITY: 20f3 2s uali Quality an al Arrive at group consensus ali -7 for •t a group consensus and yste Scoring at group consensus at a group consensus a group consensus group consensus group a consensus consensus up Contrcl Control Control -l Sste ERE WE E •5 for be•n€ the first group completed •5 the first group completed • 5 for being the first group completed •5 for being the first group completed •5 for bene the first *roup completed •5 beng the first group completed •5 for the first completed •5 for beng the first completed • 5 for be•n€ the first group completed •5 for the first group completed 5 for being the first completed 5 tor be•n€ the first group completed 5 'or the first group completed for being the first group completed be.n€ the first completed TESTING No No •5 for the group completed •5 for be•ng the group completed 5 for the group completed No ua it ACTIVITY: ua System on Control Syste No Go ua it System or +3 -3 -7 for circling, an acce; ua In-Control PROFICIENCY + 5 o! on tro -2 ua it ontroi Control Circle the run numbers Circle the tun numbers the run numbers the numbers • Handout: Westgard Rules Traditional 'Westgard Rules' that Look and Cn-ontrol Control N)lSystem yste TESTING (PT) control ontrol Control 3 CONSECUTIVE 6 CONSECUTIVE 1 CONSECUTIVE on tro Controi PATIENT The range -l -z YSte YSte PATIENT The Frant The Front -2 •5 for Ono the correct, •S Only the •5 for Ono the out• •5 for Ono the •5 for Ons the •5 for Ono the correct. out- •5 for On'/ the out• for Only Control uaJi SAMPLE una •5 the •5 on" the Out• •5 only the •5 On'/ the out, •5 Ono the correct. •5 Ono the •5 on'/ the Yyes ACTIVITY: (across runs) (across runs. one point one point ou -3 on trol The range The Front PATIENT -te small control values on PROFICIENCY PROFICIENCY Control Control ACTIVITY: Control that ore unacceptable that unacceptable that are unacceptable orat unacceptable or unacceptable PROFICIENCY YSte unacceptable and/or for not circlir abnormal ot control answer's ' ot control or In-Control o' control ot control answer(s) ot one control yste that PROFICIENCY control ot control answer(s ' control answer's' TESTING CPT) P ROFICIENCY -2 -7 WHERE values on ONE •nd -2 Work CTIVITY: SAMPLE ACTIVI-Y: our YSt of work TESTING TESTING (PT) YSte this dec una 2 out of the last 3 PATIENT PATIENT outside 3 SD -l (difference) between -z -3 one side of the FICIENCY 415 Syste ACTIVITY: •7 for an run •7 an run -7 for an run •7 for an -7 tor an run SAMPLE • Worksheet 3: Scenario 3 • Worksheet 1: Scenario 1 SA LE • Turn vour worksheet facedlown and • Turn vow sheet facedown and • Turn vowr worksheet facedfown and • Turn Vour worksheet facedown and • Turn your worksheet facedown and • Turn vow sheet face-down and • Turn vour worvsheet and • Turn vour waresheet and • Turn vour worksheet facedown and • Turn vour worksheet and • Turn worksheet facedown and • Turn vour worksheet facedfown and • Turn vour Boresheet facedown and Turn vour worksheet facedown and e Front-line Worker System NG (PT) TESTING (PT) The Front-line V SAMPLE 'ROFICIENCY "Ste SAMPLE PROFICIENCY ystem side of the mean. sick of the mean. rustering PATIENT The PROFICIENCY IENCY and/or for not n/ Lin and/or for not an Jnd:'or for not sn andi'or not and/or for and/or for not in and/or not on and/or for not and/or for not n,- and/or for not circli and;'cr for not for not for not on this PROFICIENCY NT PROFICIENCY the minutes provided to Use the 6 minutes provided to: mean and further values outside the level The Front-line Worker FICIENCY from values two controls within a PROFICIENCY our raise vour hand soon your group raise hand soon as your group raise hand ais soon as your group hand soon as group Control 135 SE raise hand soon your group raise hand soon group raise t',and soon group raise hand soon 'Our group your hand soon group hand soon group hand as soon your group hand soon as your group OFICIENCY The Front-line PATIENT raise hand as soon as your group group System lox What (WKV? Because PATIENT TESTIN PROFICIENCY No unacceotab)le run Because unacceptable run Because unaccectable run Because The Front The Front-line Worker run Because tun Because Because Fr 225 TESTING (PT) Syste our patients' lives d SAMPLE -e The Front-line Wc PATIENT Worker than ISD from than ISD from, Completes the assessment completes the assessment completes the the the assessment thes yes this then TESTING (PT) PATIENT PROFICIENCY T) PATIENT TESTING ( TESTING PATIENT same 2 SD run exceeds 4 SDS. PATIENT this our our patients' lives depend upon Our patients' lives depend upon Our patients • lives depend upon TESTING (PT) PROFICIENCY mean • Worksheet 2: Scenario 2 TESTING PROF-ICIENCY -ICIENCY IENCY 2CONSECLlTIVE 1 CONSECUTIVE PROFICIENCY SAMPLE SAMPLE • AMPLE TESTI TESTING (PT PROFICIENCY TESTING (PT) PROFICIENCY TESTING (PT) TING (PT) 8 CONSECUTIVE 1 CONSECUTIVE PATIENT SAMPLE TING (PT) SAMPLE SAMPLE SC TESTING (PT) PATIENT PATIENT AMr 10 CONSECUTIVE 2 CONSECUTMVE 4CONSECIJTMVE 4 CONSEClJTIVE this decision!) the mean. them—n. this decision!) SAMPLE PATIENT PRO PROFI PROFICIENCY B:ross runs) (across runs. (a-ross runs) (across PROFICIF TESTING SC S*AMPLE SAMPLE 10 CONSECUTIVE 80 CONSECUTIVE T he range T he ran*e FICIENCY TESTING (PT) This rule is only to be PATIENT PATIENT one control across PROFICIENCY TESTING (PT) control values on yes Yes -2 -z SAMPLE PATIENT TESTING (PT) yes PA Yes across SAMPLE ING (PT) • Review the QC chart, determining Review the QC chart, determining across runs. b:ross runs) TESTING (PT) yes one point out one point one point ou The range 30 minutes • 30 minutes JO minutes TESTING j SAMPLE 30 minutesS 30 30 m •nuteS 30 minute S SAMPLE TESTING (PT) minutes PROFICIENCY TESTI PATIENT co ntrol on TESTING ( TESTING TESTING (PT) TES this yes SAMPLE TING (PT) SC 6 CONSECUTIVE SAMPLE PATIENT en an SAMPLE SAMPLE ING (PT) PROFICIENCY yes (within run) used within a run, not PROFICIENCY outsi& SD 2CONSECLlTIVE (differenæ)batvæen (difference) batvæen (differenæa) batvæen NG (PT) SAMPLE batvæen 3 consecutive runs conecutite runs. 6 consecutive runs 6 consecutite runs. values on ONE ayes TESTING (PT) yes one sideof the one side of the PATIENT This can be within Th is can be within SAMPLE b es •ICIENCY SAMPLE. TESTING SAMPLE outsick SD out sick SD 2 CONSCIJTME (difference) between Efference) between TESTING one sick of the SAMPLE PATIENT si&ofthe mean. si&k of the mean. sC is SAMPLE SAMPLE ges Yes ESTING (PT) TESTING (PT) ayes 2 out of the last 3 Yes one control across across runs. SAMPLE ualues ou the ou the 8. PROFICIENCY ROFICIENCY mean and further man and further an sick of the mean. TING (PT) which analytical runs are or PROFICIENCY tvn controls within a tvn nontrols within a Yes ualuesoutsßethe the se • Pencils o, tw,ocontrols within a tv,ocontrols within a tv,ocontols within a twocontols within a PROFICIENCY se PATIENT Slon yes SAMPLE values outside the SAMPLE PATIENT PATIENT than ID from PROFICIENCY sc SC Ston an Level same SD 2 SD SD run eceed54 SDS. an on TESTING (PT) TESTING Th is can be within ESTING (PT) than ISD from Son an Yes yes Zion an TESTING (PT) levtel Small same 2 SD run ocead54SD 5. run ocead54SD s. run ecead54SD 5. and Slon an PATIENT Th is can ba within an SAME 2 SD. or as b es TESTING (PT) an ion an acceptable or unacceptable. unacceptable run Because the man. them—n. The rant them up the mean. -z -z -3 The Front-line Worker b es For Son on Ston -3 Ston SAMPLE This isonty to be This iscnly to be This the rrean. of the mean. SAMPLE -z se -z within 3 controls within 2 controls one control a:ross escri es Ston an Son an PROFICIENCY escri b es This ruk iscnlyto be This ruk iscnlyto te This iscnlyto be -3 Slon Yes one control across IS -b ion of an or bes PATIENT b es SAMPLE consecutive runs, etc. SAMPLE bes escribes Yes on Yes Small escfl b es b es bes escft b es or -2 an SAMPLE escri b es across 2 across 1 Wwith in run) escrt b es updwithina run, rot uped within a run, rot 4 consecuthje runs 8 consecutåre runs 4 consecuthj.re runs 8 consecuthje runs IS Scoring on (with in run) With in run) usedwtthina run, not usedwtthina runt not ThÉcan bewithin lhÉcan bewithin 10 con secuttue runs consecutilje runs. 40 con secutiue runs 10 con secuthre runs 10 con secutmre runs Yes TESTING Th is can be within b es 3 consecutive runs 6 consecutive runs 6 consecutive runs. b es -3 •s the SAMPLE Yes at a group consensus Arrive at a group consensus escri es escfl b es b es STING (PT) escrtb es Yes fib es b es escf( b es escri b es escrt b es escft b es Yes one control a:ross one control acrass CONSECUTME 2 CONSECUTME -3 on descf( b es B:ross runs) runs. descft b es one control es or yes escflb es IS escri b es ayes Yes + 5 for being the first group completed ualues outside the outside the the and 4consecuthjeruns Small se ualuesoutsBethe ualuesoutsßethe values outsßethe 40 con secutiue runs 10 con secuthre runs 4 consecutiue runs with in 2controls with in 2 controls in se tee •s this and IS and yes Yes Yes Yes Yyes -3 and SAME SD. SAME 2 SD. SD. or IS and SAME SO. across 5 a:ross 2 across 2 S? Ston is with in 2 controls IS the Out-of-Control, Reject Analytical Run IS cansecuttve runs. canecuttve runs. 4consecutive runs. canecutitve runs. consecuttteruns. and runs and and that are unacceptable of control answer(s) one control across is IS IS and IS Yes crass 2 arcs 2 a:ross 2 Small and is IS is then *hen and en small IS consecutive run se conecutitje runs. conecutil.re runs. consecuttte runs. consecutilje runs. conecutttje runs. is no+ ) +hen Yes +hen escri e S es -7 for circling an acceptable run — is IS is IS the IS as IS escrt b Turn your worksheet face-down and • Turn your worksheet face-down and IS fhe IS Level IS s occurred. and IS run the ) +hen Problem: IS ) *hen and/or for not circli and/or for not circling an Yes IS IS +he raise your hand as soon as your group Analytical yes s occutfed is +he as hen and *hen analyiical Work unacceptable run Because as occunred +hen an and IS Is completes the assessment. vs as occuvted IS is no-k Yes is Analytical as occurted Is as as occuned. as occurted our patients' lives depend upon ) +hen Analytical Out-of-Control, Fkjeä Analytirzl Run Out-of-Control, Reject Analytirzl Run as occuvced Out-of-Cont rol, Reject Arelytirzl Run Is no+ s occutfed ) +hen as as occutted as occurred as occutced as s occuvced Analytical es ) +hen as occuned. level +hen s occutted this decision!) occurced es _ *hen Shen as occutced. +hen ) *hen ) +hen +rhen IS and ) +hen +hen Analytical •a ly+ical Image from http://www.westgard.com/downloads/cat_view/53-worksieets 30 minutes as occuvced. analy+icall analyiical as Image from http://www.westgard.com/downloads/cat_view/53-worksheets analyiical Analytical Anamly+ical Analytical /iical analyiica\ analy+ical as find out more at http•Jlwww.we

  • front line worker
  • analytical run
  • QC charts
  • Westgard Multirule algorithm
  • acceptability
  • SLIPTA
  • SLIPTA Checklist
  • multirules
  • error detection
  • false rejection
  • warning rules
  • 1:2s