PEPFAR Quality Control and Method Validation Activity 6: Part 4

numoe numo num Quality 3) used The Then 3) used + used Results 3) QC used +0 Goals 3) used - evalua+e 3) used +0 Laboratory QC used On-going Evaluation of Your Quality Control Systems 3) QC used 3) used QC used +0 QC QC ased QC use-c 3) QC used QC ased +0 QC used Goals used QC used +0 Laborator Goals Results q) The of revtew Alerts us to change" 3) used +0 defec+inj defec+lnj Quality de+ec+inj Quality q) The of periodic review The Frequency OF pevtodjc revtew for QC used evalaaVe Results evalua+e Alerts evalua+e evalua+e used evaluaVe Goals evalua+e Quality acc:uracv and control limits are b) The achions b) The achons b) The achons wher 2) r) q) The OF revtew control Laborator Laboratory The of periodic re defec+lnj QC - The OF pevtodtc review The The of review Quality q) The of pe q) The periodic q) The revtew q) The OF periodic revie q) The of periodic Goals q) The 09 peciod,c review q) The 09 periodic rev q) The of periodic rev Qualit• q) The 09 periodic review q) The 09 periodic q) The OF periodic review q) The of review Quality Quality b) The achon: Laboratory The of period, The of periodic revie Quality The Fretuency of periodic revie The of periodic reve The of periodic review The 09 review defec+inj defec+inj and *rends and +cends q) The of periodic review The Frequency of periodic review The of pevto,d•c review evalua+e review q) The OF periodic re LaboratorÜ Gaussian is the Key to Quality Control b) The achons Laborator Laboratory x Goals Laborator Laborator Goals Goals Results Goals Laborator Laboratory Goals Results Goals defecHnj and +re b) The achons wher Quality de Quality Quality exceed defec+inj a 'Results defec+inj defec±inj o we and *rends d±ec+inj and defec+inj and defeciinj and defec+inj and *rends d*ec+inj and +re,- and and +cends and +rends defec+inj and +cends defec+ihnj and +-reMds and +rends and +rend and and +cends Results and and +rends Where Results b) The achons +Q6en when re Results b) The achons +ahen Results Laboratory Laboratory b) The achons +ahen whe b) The achons when b) The achons +Qhen when b) The achvons +Q64en when re Goals Goals Analytical Analytical b) The achtons b) The achons +QKen b) The achons b) The achons +Q6en when resul+s b) The achons +Q6en when r b) b) The achons ±Q14en when resul+s b) The achons +Q6en when re b) be b) The achons +Q6en when b) The achtons ±Q6en when b) The achoos b) when resul+s b) The achons +Q14en wher b) The achons wher b) The achvons +Qhen wher b) The achons +Qhen when re b) The achons ±ahen when re fa%en when resul+s b) The ac+ions ±Q6en when b) The achvons ±Q6en when res b) The achons ±Q14en when Quality New Anatytical fhen and *rends WHERE System Results Results Results Analytical WHERE m WHE ua It ua it Frequency c; Frequency ua i b) The achons +0 Where c; Day 4 Recap System achons WHERE WHERE EXPECT b) The achons when b) The achions +QKen WHERE WE AHERE WHERE WHÆ WE WHERE material. exceed WHERE Frequency C; r) exceed Il ro Dav 4 Recap Where exceed Sysatem ua 1 exceed WHERE ro WHE exceed Variation exceed WHERE WE rom WHERE WE WHERE WE ARE WHERE WHE ARE WHERE WERE Control. Con*trol. Control, Mean We Are Control con+col. Contro control confrol. J WHERE WEARE OC WHERE WE ARE exce Precision Mean WHERE WE ARE ; WHERE WE WHERE WHERE WHERE IS WHERE we WHERE WE ARE WHERE Step 1: Using the package insert information: WEARE Accuracy accuracy ua it exceed WHERE WE exceed Precision u ali WHERE we Applying C V Applying Applying C V Quality ua it Set the initial control limits, usually a ±2 SD range, for the new lot # of control. ua it ua i ua It perform WHERE WE ro WHERE ARE Sys+em ste System WHERE WE ro WHERE we ARE ro WHERE we ARE ro WHERE WE ARE WHERE wr ro 100% 10 - ua 1 WHERE ro WHERE WE ARE ua It Quality WHERE ro WHERE WE ARE WHERE WE ro WHERE WE ARE WHERE WHERE WE messages essages Messa3eq Qua it messa3es Messayes Messages WHERE we ro WHERE we A Re WE ARE WC WHERE WE ARE WHERE WE roE WHERE WE WHERE WE Perform ua WHERE wr WHERE ro WHERE WE WHERE WHERE we "Re WHERE WE ARE we WHERE we ARE m WHERE ARE C V WHERE WE EXPECT ro WE ro WHERE WE ARE WHERE WE ARE WHERE we WE ARE ro WHERE we WHERE WE A RE Laboratory Laboratory. WHERE WHERE WHERE WE ro BE Results Goals WHERE WHE ARE WHERE Use this range as a guideline only to ensure that the control material is acceptable (shipped and stored correctly). 10 - I WHERE we ARE Control Quality Control: Control , Con±trol ua i Contro ua WHERE WE ARE WHERE WE roRE WHERE we A RE Con±trol/ Control) Control Control, confrol Control, WHERE WE WHERE WE ARE WHERE we control Control. Control/ WHERE Results WHERE we WHERE WHERE WHERE WHERE IS WHERE wr WHERE WE Ro Control WHERE WHERE we WE A Re WHERE WE ARC ro WHERE WE ARE WHERE we WHERE we A Re WHERE WE A Re WHERE we , WHERE we : WHERE . WE ARE WE ARE we WHERE WE , ERE we A Re WHERE WE roRE WHERE WE ARE WHERE WE, WHERE we WHERE WE WE ARE WHERE WE A, Goals WHERE pplying C V WHERE WE ARE WHERE WE WHERE WER achons Alerts us to changes in Step 2: For each day of parallel testing: Laboratory Labor atory yste- WHERE WHERE WE ro 2) C V OF 2) OF cutten+ 2) C V OF 10+ 2) OF 2) 2) OF 10+ Results Monitors and evaluates QC material yste Contr•• Control System ysten. Control yste Syste System WHERE WE WHERE we ARE yste System system• ysterr System WHERE Results Results rule WHERE WE ARE wr System system YSte Test current lot number of control to confirm that the instrument/method is performing within quality specifications. achons (QC OF cuccen+ OF QUALITY OF OF Determi Determine if the system I accuracy and precision 2) OF 2) ROFICIENCY ROFICIE PROFICIENCY OF neo) System method performance System CONTROL messages WHERE Analyze the new control material and ensure that the data point falls between the ±2 SD range. under PATIENT New ESTING (PT) New numbes ESTING (PT) mean meanoges mean Gaussian undergoing a change OF 10+ mean mean Variation New numbess undergoing a cham •s Handle the new lot number material in the same manner to encompass the normal day-to-day sources of variability (inherent Identify Levey-Jennings Graph (QC) QUALITY QUALITY QUALITY QUALITY SAMPLE. (QCS (QC) 200.5 100% 100% 100 100% 100 L 5 PROFICIENCY SAW 100 PROF/CIENCY PROFICIF SAMPLE 100% 100% 100 PROFICIENCY mean 100 5 201.0 mean R CIENCY PROF' be In PROFICIENCY CONTROL QUALITY with Error PROFI 100 5 randomness) routinely encountered, such as: be A-e+ed be *eså-ed be be *-es+ed ey be wifh wi±h PATIEN CONTROL With with 10090* PATIE' CONTROL PATIENT PATIE PATIENT Messages SAMPLE TESTJ' TESTING TESTING CPT) CONTROL ALITY TEST' TESTING (PT) Systematic 100 L 100% TESTING (PT Determir TESTING (PTT TESTING TESTING (P T) TESTING d TESTING (PT' 100% TEST 3) Meanogs 100 • In-use expiration date —if an opened bottle of control material is used for more than I day routinely at your site, then this PROFICIFNCY P' OFICIENC SAMPLE QUALITY PROFICIENC TESTING (PT) PATIENT Meanogs SAMPLE Meanoges Observed (QC) (QC) Meanogs present to aid with trot Meanoges SAMPLE OF neu) ROL OF neco of neo OF neo) with (QC) CONTROL essayes OF net.) OF of neu) QUALITY of neo) OF neco OF neo) PATIEN g) Meanogs OF neo SD neo SAMPLE S, Observed CONTROL OF neu) I PROFICIENCY OF neo) OF OF neu) love OF PATIENT 'ATIENT ATIENT T) 201 S 201 s OF neo. SAMPLE OF neo.) OF neco Messages messa3es Messayes Mess Messaye. (QC) in-use confrol TESTING (PT) TESTING (PTT practice should be done with the new lot number so that control stability is reflected in your data. TESTING conk-ol TESTING (PTI messayes SAMPLE SAMPLF ey essayes Meanogs OF neo.) lo+e ey messages ey essaye essaye OF neu) Messayes messayes The accucc ,++, 'AMPLE „r+, iAMPLE SAMPLE SAMPLE SAMPLE with essaye QUALITY Meanogs New numbes QC) CONTROL The accuracy and The accuracy SAMPLE iAMPLE SAMPLE f ;AMPLE 'AMPLE SAMPL' The accuca The accura OF net.) SAMPLE • Technical staff routinely assigned to that workstation O- OF 203.0 202.5 is only pec$otmed CONTROL Meanogs PATIENT is only is only performed is only per$ocmed is only pec%tmed is only pecGormed essayes is only peéormed The accu 1-0 Calculate SD of neo Calculate SD of neo Calculate SD of net..) Messages Meanoges Message Mess ages Calculaåe SD of neo q) Calculate SD OF neoD us Calculate SD of neo Calculate Calculaåe SD OF neo 10+# Calcula±e SD of neo Calculaåe SD OF neo lot # Calculate SD of neoD Calculate SD OF neo Calculate SD neo Calculate Calculate SD OF neo lot # Calculaåe SD OF neo Calcula±e SD OF neo Calcula±e SD OF net.o loft* alculaåe SD net.) SD neo 202.5 2) r) SD OF net.) SD OF neo 1-4) Calculate SD of neo • Instrument maintenance performed as per schedule SAMPLE Tee SAMPLE Calculaåe SD of neo lot # (QC) Calculate SD neo lot* The acucacy SD neo The accuracy and an Calculate St) of neo Random r) Analytical and accuracy and b) The accuracy and -p The accuracy and SD of neo SAMPLE The accuracy and Pfeclsion The accumcy and analytics mean Change The accuracy The accuracy 0nd The accuracy and accuracy accuracy Calculaåe SD OF neo Calculate SD of neo Calculate net.) when instrume+ operakiooa//y when -he instrumerfr is operatiooa//y when inst-rumerfr operatiooa//y when -he ins-humerfr operatiooa//y when opera+iooa//y when instrumeqå- opera+iooa//y +he opemkiooa//y Step 3: Serial testing of new lot number of control material when is operatiooa//y when is opera+iooa//y when is opecatiooa//y when is operakiooa//y Instrumer+ opecakiooa// / when -Hie is opetatiooa//y when -He 189.0 De The accuracy an only 10090* A The accuracy and performed 199.0 198.5 Tee when analy+ic sy+e analY+ic Sys+e r) es Collect a minimum of 20 data points from the new lot number Target 100% A 1 TEa sy*em descfl b es descri b es TEa Sys+em descft b es SAMPLE Ssys+em desc sys+em descfl b ee Sysyem descft Shi-em descr sys+em desa Sys±-em desc sy*em descfl Tee es describ e b e OBS ogs WHERE ogs OBS OSS Total Error Error WHERE WE , • Preferably over a 20 day period we ARE WHERE oss analy+ical WHERE WE ARE — WHERE WE opera+iooa//y system describes WHERE WHE ARE WHERE WE ARE ARE WHERE WE .4 R' WHERE WE ARE WHERE WHE ARE WHERE A RI WHERE WE AaRE ro WHERE WE ARE WHERE WHERE WE A RE , ogs WHERE WE A WHCRE RE WE ARE we ARE WHERE WE WHERE WE A R' we OBS WHERE ARE WHERE WE A RE WHERE WERE ARE m WHERE WE ARE WHERE WE A' OBS If a shorter time frame must be used, then collect 20 data points over a 10 day period by analyzing the new lot number Serve 'y ms serve and Perform parallel testing to determine the Serve as Serve as cu serve as Serve as a. Serve and Defines an acceptable change vs. we WHERE WHERE RE WHERE WE A RE and WHERE twice a day WHERE WHERE we 'RE WHERE we wyeRE WE we bass we only am s}w/d— only s}w/d— am only only observed mean and observed SD for the •he -s IS 5) 5) cont-ol 5) Calcula+e contml IS 5) control basis 5) conHol Record your data points and keep instrument printouts if applicable and 5) confrol 5) unacceptable change (TE < TEA) Calcula+e conttol evalua+e WHERE we IS Calcula+e cont-sol serve as Calcula4e conhol Calcula+e conf@l Calcula4e con±tol Calcula4e confrol Calcula+e contT01 IS IS " IS ' control Control Serve as be used When L-J chaff be used whencrea+ny L-T chaff be ueoed whencrea+o L-J char* be used when creo+o L-J chary be when craHi/Y L-J chary be used when cr«Hi/Y +he L-J QC used be used when cr«Hiny He L-J chaff be used when cr«rho He be used whencrea+oy L-J chat* we Calcula+e conftol QC material material. be used whencr«hiD3 He chat* - s) be used wkmcrediny He L-J as IS Determines how far the mean can shift IS we ± 14 is IS Determine if the system is stable or neu.) con+tol. 5) cont-ol new cm-col. neo.) conå•tol. OF new con+fol. Control. conFoI. we we WHERE IS new con+col. we we we IS before erroneous results are reported we IS t$+col. +hen Q, i, Q, Q, Q, e, as fells us undergoing a change us us Q, (SEC and Sigma-metric) change mean Chan Cha o. change fro fie analy+ica chanse he analy+ica change fro 'fie analy+ical Chanse fro the analyiical Change to he analy+ical Q. Q, only c. hange fro the analy+ical con+fol. o, Chanee fro analy+ical in ±evms in in ±etms in +etms in +erms a. change He analy+ic change to chanee fro fie analy+ical change fie change fie analy+ical a. chanse he analy+i( Chanse +0 on chanse hie analy+ical when Chanee +0 he c. hange fro fie analy+ical change Change Chanse +0 fie C. hange fro hie analy+icall change Identify rule violations when a change occurs in in in +evms in Select appropriate control rules based on sys+e be used whencro•hny L-J be used L- analy±ical SYS+em has sys+em Has occuvted. Sys+em has occuvced. Change fro fie analy+ical sys+-em has occuvted. change sys+•em has occutted. Sys}em has occuned Sys+em has occuvtfed. sys+em has Sys+em has Sys+•em has occur Sys+em has occunted. sys\-em has occuned. sys+em has occuvted. Sys+em has occutted. sys+em has occunced. Sys+em has Sys+em has occuned. sys+em has occuvted, has occutted. Sys+em has c Determine the type of error (SE or RE) be used when crabg L-J the SEC or Sigma for that method has occuvted. sys+em has occuvced. present to aid with troubleshooting