PEPFAR Quality Control and Method Validation Activity 10: Part 3

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Technologies and Training for+lealthcaro Laboratories Results pack Test: we ARE _ot neeO> vou neeo• need) need; (QC) mat vou neeo> mat need) mat neeo• mat iou need' mat vou neeo• . at iou need> at iou neeo; at VOu need> VOU need) vou neeo you need) need' neeg• rose OC —HOME. —"WESTOARO APPLICATtONS•z LESSONS —HOME— -HOME, ESSAYS—QC APPLICATONS•LESSONS (HOMEÄ"WESTOARD —"WESTOARD - ESSAYS- -'WESTOARO —LESSONS "WESTOARO QC RESOURCES - —ABOUTUS "WESTOARO LESSONS —CLIA *STORE — RESOURCES —ABOUT US "WESTOARO ESSAYS— QC LESSON. & GOOWNLOAOS. RESOURCES —ABOUTUS RULES' DOWNLOADs= —•uourus DOWNLOADS —STORE—ARESOURCEE DOWNLOADS —STORE —RESOURCES US DOWNLOADS STSTORE — RESOURCES—ABOUT US — RESOURC WHERE WE EXPECT ro BE , QC Rules Platelet co. Look Look ,HOME- "WESTGARO RULES" "WESTOARD _ "WESTOARD — LESSONS - RULES". ESSAYS ESSAYS—QC APPLICATIONS —- LESSONS ESSAYS QC QC LESSONS DOWNLOADS—STORE —RESOURCESÄABOUT US RESOURCES —ABOUTUS- —"WestOARO HOW good can you get? The Biologic Variation database. compiled by the Spanish CC society —CUA QUALITY If Margin for Error is Comparing Verdicts from Comparing Verdicts -ABOUT Vanation QC Trest: arsons arsons faKen arsons —DOWNLOADS- — STORE DOWNLOADS — — mat iou package package .nser iou neeo; ABOUT US Aaourus —HOME — QC APPLICATIONS - arhons ac+mons arsons + Sons ons ±ahen achons as fohen QUALITY— "OOWNLOAOS —STORE , DOWNLOADS —ABOUTUS , DOWNLOADS WHERE WE ARE rois for a total of 2 control l- the Precinorm Abnormal controls for a total of 2 control ARE Number of WHERE WE ARE arson s insert ,nser Number Of 5.5 arget ± 3 SD based on percentage of different types of hen Gen Number WHERE 0.00 SO -z Ouaiity Control Grid 0.057 1-3.5s Incr Fr 2 Fr 2 How many evaluations 1k' 201b. Platelet Platelet cc Platelet C, Calculator • Recording - need) What need> mat vou need' mat vou mat you need? mat vou need> mat vou neetP mhat vou need> mat iou neetp What vou need; What vou need> mat vou need) Whal What vou need) What vou neeo• What vou What vou need; vou need? vou need> vou need) vou neetP vou neeo• need> need* need; neetP need) What neeo• What vou need) What neetP . iou neetP VOu need) vou need) •ou need) zed) WHERE WE ARE Platelet Co, WHERE ARE QC WHAT'S NEW Requirements 1:2s rule as Rule AST ALT WHERE WHERE WE ARE • Bili-Tot Calcium Bili-Tot Calcium- Design an appropriate, implementable and CK Creat Gluc Potassium Sodium Potassiurn - Consensus Statement 1' Number Of PA an appropria i/ WHERE WE ARE rest: WHEW ARE analytical Platelet co cc C« C. Yost: WHERE WE roE Minimum analytical cat run in each analytical run high control was calculated to be 18.1 g/dl and the measurements in each analytical run 0.061 t WHERE WEARE *arget t 25% lower/worse than peers C€ The Poor Guide What ac Nbnormal abnormal spociLcations. They aro modeled attor what's called the Omax, How does this specification and Dr. Carmen Ricos. not only includes dosniablo specifications for imprecision, bias and and Or. Carmon Ricos, not only includes dosriablo specifications for imprecision, bias and Plat Citferent Goals Controls co. mm01/L m mmol/L Note: Analytical Some may thø Note: Analytical percentage Some the Note: Analytical Oua'ity percentage, Some browner. To st: Controls . markers 0.06 J 0.171 0.171' 0.10; 81.40 10 WHERE Look for to help him develop a QC WHERE WE ARE QC samples abnorma,• oho'. oho'. blood markers Number of Number of Number Of a QC Test: Flipchart paper • Flipchart paper Flipch( 6.901 7.60 When the best isn't possible, How low can you go? The Biologic Variation database, When the best isn't possible. How low can you go? The Biologic Variation database. 3s 2s Ix Week Ix / Week -e 3S : ARE rose Parameter Units parameter units Parameter units Pa units 'arameter Units WHERE eter units units Low Normal Normal High high Calcium Para meter Parameter P arameter Variation database Units Low Use the What QC arameter eter LOW use the clustering 'WESTGARDRULES' ESSAYS QCAPPLEATIONS LESSONS CUA&QUAUTY DOWNLOADS STGARDRULES- ESSAYS • LESSONS CUA&QUAUTY DOWNLOADS STGARDRULES- ESSAYS QC 'LESSONS DOWNLOADS STORE RESOURCES ABOUT US Ptatolot Count STORE RESOURCES STORE RESOURCES ABOUT -s ' OC Calculators WHERE WE ARE Platolot Count Plato'ot Count chart for any measurement greater than ± 2SD. a scanning Interpretation Of Results Scan the chart for measurement greater than ± 2.SD. Scan the chart for measurement greater than ± 2SD. Platelet Count Number Of PATIE measurement greater than ± 2SD. abnor QC Rules • German Interpretation to measure rost: Yost: POO' useful to comparative purposes now • A Selection Of 2- Platelet quality requirements NCY accoptanco which inciudo nom tho "Ricos but of sot $80 00 NCY compare to TEa? Lot's total error, but also optimal specifications. For labs in search Of " •stretch" goals, tho Reading Laboratory management is curr Controls Control' Cont rots rules to Controls Controls appear If It not If not 2x / Week Ix Week Yes! 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Tho Scientitique de Sante Publique has a sot of Laboratory rest: Offerer* Gcais • rnarkers • markers mnarkers Sigma-metrics of a Mindray • markers • mnarkers device Platelet Count Controls PA *umber of 1:3s/ f apply optimal specifications for bias and total but also specifications. cost-effective QC strategy(ies) for all the g idi g/dl clustering 1:3s/20f •auality g,idl clusterin TE>T Quality R;quirements QC strateg TE>TEA TE>TE, DMax spec.ifications SAMF strategy for the XYZ analyzer strategy for the X Y/ of thoi[ own How do thoso to QUALITY Number :2s rule as :.2s rule as -I (TGI Error Count the placo to start. Updated for 2014 place to start, Updated for 2014 SS a scanning 3s 1:2s rule as 09 Platolot Count Ptatolot Cou '3 3S 2s rule as Control Limit Calculator report patient results. Stop! NO NOT report any results until acceptable quality is verified (Total Error < TEa) NO NOT report any results until acceptable quality is verified (Total Error < TEa) marke i:2s rule as Stop! it SAMPLE PATIEN Method Validation Tools QUALITY the mean optimal specifications for imprecision. bias and total error. but also minimum specifications. an age nt n device Nbnormal apply • Qua'ity Requwements NCY EQA specifications. How they and from the goals Plato/ot Co 3 3S 25.0 2.59 4.00 of ec-3600 BC-3600 hemato*ogy (PT) Remember your login HOME / & / REQUIREMENTS HOME / / / & / / & / REQUIREMENTS Spanash Minimum EQA 200.0 If a measurement is found, inspect the control data using 193.3 2.81 Specifications from LOGIN SIGN UP NCY PATIENT devicew upport to enroll in a proficiency ke action and repeat prior patrent•asstäted in Process # Q-111 SD was calculated to be 0.3 g/dl. The following Investi ate, take action and repeat prior patients as stated in Process # Q-111 Investigate, take action and repeat prior patients as stated in Process # Q-111 PHOTO YZ Ana toxicology Register support to enroll i away f away from 3 SS of Test 'igOxin Dtgoxin arget value t or 02 ng/mL (greater) awa) total For tabs to achiovo tho Of quality. at toast is tho floor on For labs to achieve the Of quality, at toast is tho floor on For labs unable to achieve the recommended lovol ot quality, horo at toast is tho floor on away PA su move / CONTROL for Cats, and scanning to seeing? name and password so Mindray On the Blog Blog name and !cified QC rejection rule for the analyte. The Era The IQCP Era The filindray BC- Now on 1:3.5s/ workstation. Workstation. Mindray BC- analytes tested at the XYZ workstation. analvtestested at the X NOW on SAMPLI a scanning device CONTROL workstat / CLIA REQUIREMENTS VOR ANALYTICAL QUALITY / CLIA REQUIREMENTS ANALYTICAL 25% 35% Controls ICY Reportable Range Erythrocyte count 3S S SS S NCY NCY 40 Eioiogical Variation rule as PHOTO GALLERY Sigma Caiculators thus site. p/ease in. opcrt to roll In a proficiency Analytical Quality (tie (PT) Ncy messages 635.0 , 56359.0 635.0 438.0 251) 498.0 5635.0 1:3s SAMPLE -NT est or Analyte To access the private area of a. Within current run inspection 'n inspectlon PATIENT Reading that you can access the Mean away from 40 minutes PA Horses? from the mean for acceptance limits. which include some copied from the "Ricos goals" but most of themn sot Performance the m PATIENT Begins BC-3600 BC-36300 YouTube: You Tube: Your u be: ——40 minutes 40 minutes 40 40 minute Milan 2014 Consensus Draft on Quality Specifications 3600 WHAT'S 4() rninutes (PT) Six Sigma Risk A alysis goals to a sot of minimum for WHAT'S POPULAR (PT) database PATIENT Continuo Activity 10: inter-laboratory peer compari This is ONE nis is ssible C strate Ian. A rove or modi this before im lementin ! C strate Ian. A rove or modi this before im lementin im lementin ! 55 Quality • apply the from each material analyzer the value Username emtire site. You can logotT entire site. You can logoff device (QC) QUALITY REQUIREMENTS TEA% this site, please log ln. a scanning Mean 55 QUALITY deNice On on Normall:ed OPSpecs organizers later requested that this not be shared the public, Here only a summary of Level Level 1 Level 3 umol/L : umol/L 44,4 44.3? 44. S 14.5. 44.3? 1. 0.03 30.9 QUALITY nter-!abcratco clus 1.3 11 Antwerp Antwerp L•cmerick 35% Mean Ncy SAW SAMPLE CONTROL Antwerp Limerick s from each material • apply the 1:3.5s from each material apply the 1:2.5s from each material Under the CLIA essayes rtes Optimal Bio'oglcal Ana Creatinine SAMPLE Messaye Lithium • Include the following with each QC strategy: Include the following with each Include the following with each QC strategy: Gam Sigma Matters following wit ach QC stratog ratory peer OL from from this site by pressing QUALITY package insert information was provided: 3 SD based percentage Of types Target 3 SD based on percentage of d'fferent types of cell -L Under the DOWNLOADS Key Messages Messayes Messages t {essays Messares message: m•lessages• Mean Systematic Error (SE, multiples of s) arget value ± 0.3 or ± 20% (greater) messages WHAT'S NEW NCY ithtum WHAPS NEW WHATS NEW NEW the contents of the DRAFT. The official final Vandate is availabie. so this document is only on QUA SAI apply the 2:.2s and R:4s rules across materials apply the 2:2s and R:4s rules across materials ONLINE STORE 30 Lev1:Lev2 Combinations - 8 Tests in 6 Labs mbinatio Mean •control materials. Otoo QUALITY tab and 30 Levi:Lev2 co Winner Winner 2016 2016 SAMPLE to 18.2* 5659.0 157.0 QUALITY REQUIREMENTS 2.59 30.3 130.8 Vana•aon database any tab. LOG OUV any tab. The LOG OUT any tab. LOG OUT NCY aye S can ICY PATIENT A selection of specifications SS ages 55 through analysis Of their own participant performance. How do those specifications compare to Belgium EQA performance specifications TEA% tab, you will find free book TEA% TEA I epie(s), N, R, anÜup rvisol chart ifferentjation 25% b. Across-run inspection Phenobarbital ± 25% 1999 PATIENT Mean 55 Mean CONTROL 55 x 55 x 5.5 CONTROL cov Quality Requirements 55 materials. ± 25% 1:2.5s Mean TEA% CON—RO' ± 25% message '$4} message will appear on What will you need? What will you needo? On November 24th and 25th ot 2014, tho first EFLM Strategic Conference on 'Dotining analytical What PATIENT -z 55 x Phenyt01n review chapters, calculators 'ATIENT — Lack Messages 250' 25% CLIA Ricos CLIA and Ricos TEa? 25% no•lL CLIA Requirements for Analytical Quality Quality Grid 0.05 | CON 0.11 : 55 -3 Mean 6.90 | 87.01 0.05. 30.19 31.34 3.819 0.11 • -0.19 7.01 690 Erythrocyte count 4.11 Target t Control rule(s), N, R, and supervisor chart • Control rule(s), N, R, and supervisor chart Hemoglobin Process to select Q.C. Strategy Proce-_ss to select Q.C. Strategy Six wpervisor chart listing, you will find 55 x PhenytOin Guidelines for Quality PT) (PT) The an Compare Sigma Lev 1 Lev 2 Use Sigma 1 Lev the Glucose -2 the right French EQA performance specifications On November 24th and 25th of the CFL M Confetence 00 analytical eclSton an "tJNS "UNS can Another Thing ± 25% Password Database reference list and an and worksheets. The Under the •n ages TEA% two runs performance goals 15 years after the Stockholm Conference on Quality Specifications in Laboratory ec'ßton an Ti•e Tie Test 55 x _ an "n The pc ey o - Mean pu ass' assoned the tables for TEA for METRI ET RI RI . Define the true value for Messages 0.49* Hematocrit messages Member Login (QC) ess s Results SAMPLE -z A selection or ess ; ayes (QC) arget Mean Spanish Minimnum Consensus Performnance Specifications (QC) • apply the 4:1s rule within each material across the SAMPLI 1:3s 14.8. uie within each material across the .0 Key messages (Q Sigma-metric QC Selection messages Messages LESSONS tab about Theranoso. Key Theranos. tan Optimal Biological Variation database specifications about Theranos- About TA FA The accuracy and -3. about . about Theranos-. What's the minimum for quality? In 2012, tour Spanish EQA providers a Variation in -3 em descflbes for Dogs. Cats. and BIOLOGICAL Medicine' was he'd. On November 24th, at the end of the first day, a DRAFT consensus was handed Allowable Total Error (TEa%) Lev 1 3.1 Key messages AMES Procatnami(ie (and forget ± ssag€s -S essages biological variation ANAL Anothov country hoard Tho Institut Scientitique de Sante has a sot ot Low Normal High Higb Parameter Units I Parameter Units optimal specifications tor imprecision, bias and total but also mimtnum spocitjcattons. em descfibes Units 1. Define the true value for each sample as per lab policy/hierarchy Low review frequency b es SAMPLE hi Fem descflb es Sy*em descrt b e• last 4wo runs last two runs Hemoglobin ± 7% Key Messages as per tv K QC Key Messayes sys+em descftb es Fem descft b es em b es describes VARIATION V ARIA" ON • Handout 2: Monthly b es descftb es Consensus • Handou FOUNDER Procainamide (and metabolite) AVC Tool and Westgard Rule so you will find Jarget vatue How to Select Control Rules Example IQCP for Frequency eanassisned Leukocyte count Example for so VARIATION - VARIATION • CLIA Requirements for Analytical Quality On was m es es VARIATION Example Lev 2 6.9 Lev2 6.9 y messages SAMPLE a nc DU ean) out (the DRAFT had in fact been wtltten before the meeting was held). However, the conference working group to promote ot common minimum quality specifications clinical Horses ? (desirable, minimum, 12 14 so mmol/L or (T Ea units) To access the private area Of 8.70 2 Level 259 20.19 2.50 0.103 200.20 20.23 8.90 48.70 10.6. 0.68, 1.3} Calculator and l. 2.5 l. 2.5 c To access the private area of TO access the private area Of rom the last two runs and the two apply the 4:1s from the last two runs and the two • from the two runs and the two • apply the 4:1s from the last two runs and the two Goals Tho tables below contain information on CLIA proficiency testing foiteria acceptable Tho tables below contain information on CLIA proficiency testing for acceptablo 60 Cc 3. Gather recent mean & SD of all Q.C. Samples SD of all QVC. Samples BESTGARO Potassium SAMPLE JAMES worksheets used in the Leukocyte court listings for Basic analyzer Belgium 'P uinidine 'Target 25% QC calculators allow C, so and ISO Ono of tho loading EQA programs of Franco is ProBioQual. They havo their own sot of EQA Ono Of tho leading EQA programs Of Franco is ProBi0Qual. They havo their Own sot of EQA C. ane ISO and and optimal) and tacp an-d ISO IQCP ISO ISO measurements on each material CLIA Requirements 'or organizers later requested that thts DRAFT not be shared With the public, Here is only a summary of descr\ RCPA (Australasian) tests, this site, p/ease iog n. this site, in. thts site, p'ease bog in. System this Site, please log in. this site, please log ln. Number of Test dc this Site, please log ln. this site, please this site. bog in, Syså-em descr total protean de A Re this site, please iog ln. heophyliine Hi0tarchy WHERE analytical performance. as printed in the Federal Registeral February 28, analytical performance. as printed in the Federal Register February 28.se ) sages 55 1091L 4. Calculate Sigma for each sample workshop are located under 2,sages Mean FCUNOER QC Practices and Review Log Review I-cz Review 7.53 0.68, FOUNOER 55 x sys+em de 25% ARE you to calculate your latelet count When you plan for Doe! When you Plan for 3s If none of the rules from Step 2 are violated when When you plan tor Target Value Select a spokesperson • Select a spokesperson What's tho fbsoruto minimum quality? In 2015. four Spanish EQA providers heophyltine CLIA values used in -q so so Se s o esperson 15189: 15199: Target Value not 15189' Value the contents of the DRAFT The official final Vandate is availabie. so this document is only *arget ± 65% 9.3 Platelet count erson tan Clinical Decision Concentration Basic Method Worksheets. • French so Samples c13qsic ro Those guidelines for acceptable performance can be used as Analytical Quality Roquifoments Initially, you will login? 5. Select Q.C. Strategy for each sample based on Sigma Value 5. Q.C. Strategy for each sample ba uJsername will Validation Tools Username so Target Targe rejection rule for the analyte- mean, SD, %CV, and mean, SD, and applying the specified QC rejection rule for the analyte. and and d QvecÅSton 55 oss€sned assigned Quantifying SD The accuracy and an How good can you got? Tho Biologic Variation database, compiled by tho Spanish CC society Sigma-metric Segma•metrjc ibf jnogen triC e you the workshop the future. can you 10 the future, can you can the can you 2 x 1.39 1:3s/20f 1:3.5s 1:2.5s oatlior consensus goals to oxpand a sot of spoctflcations Target Value 88% 78% 68% 60 obramycln Remember me Level : umol/L m mol/L QC g/dl Incompatib'e? I ncompatib'e? Level 1 10.5 through analysis Of their own participant performance. How do these specifications comparo to Risk-Free The tables below contain information on CLIA proficiency testing criteria for acceptable analytical tables below contain information on CLIA proficiency testing criteria tor acceptable analytical the ig available, this document is only 1.4, 1.44 5635.0 6.90 Incom,patible? I-Igb eter Materials Incompatible? Inc so and Or, Ricos, only specifications bias and Clinical Quality ree Rdibak German German useful to comparative purposes now Validation. 5.5 5.5 ± 0.4 13.4±0.6 0.8 5.5 13.4±0.6 0.8 Key Messages DOTH DO TH Target Value accept the run and report patient test results. If a rule for XYZ Analyzer Sodium Observed Imprecision (CV%) need to register 60 y. cumulative statistics in the Wostgard QC Dosign and Planning process. can arget value 25%4, t Value Value alue 13. *arget t 25% Hand. 2 x SD • Worksheet 2: Candidate Worksheet 2: Candidate QC Rules & sources • Worksh analysis of the analysis Of the sources Key Messaq in QC Design Planning process, assume that quality Milan on thrombopiastin assume that IS is 60 The QC ean Inspection Tips Inspection SIGMA acid 2 x CLIA and Ricos TEa? tests. and Ricos TEa? to comparative Key messages an analyte is violated in Step 2, reject the run and do not performance. as printed in the Federal Register February These performance, as printed in the Federal Register February 28. Those SO Iaiue About Reqwtrements athe uo total but also optimal specifications. For lobs in of goals, tho i S Participate in the class discussion and create a login. Gwdelines for Quality Sigma 0.8 : • Pa ticipate in th class IS the Target Value xlO'lL iscussi n m mol/L IS 'IS b es 198.0 126.0 0.8: assijned 116.0 15635.0 1.40 30.3 193.3 52.7 24.50 can or (SD units) 60 60 xlO"/L Target Value 6.0 60 can Tho Czech EQA program SEKK has ono of tho largest lists of analytical quality performance Key Why use separate strategies at each level? Fibrinogen defines fie IS 60 sysfem descftb es ONLINE st0RÉ BC-360C 60 x100/L 3cflbes YOUR LAB READY FOR THE total error. but also optimal specifications. For labs in search of "stretch' • goals. hero's tho total error, but also optimal specifications. For labs in search of " •stretch' • goals. hero's tho Mindray BC-360C Mindray BC•360DC BC-36DC BC.30DC BC-WOO ac-3b00 60 xlO'1L fie specifications fie report patient test results for that analyte. no longer matters? no ton,ger matters? fie specificafiens fie fie ens no matters? ts+em es ts+em descfl b es sys+em es /ey Messages sac: Interview: Westgard Membership is Member Login is specifications guidolinos for accoptablo performance can be used as Analytical Quality Roquiromonts in tho Those guidelines for acceptable performance can be used as Analytical Quality Requirements in tho compare to TEa? Lot'S Interview: 4. SD ass€ned Interview: Westgatei Spanish Mtnjmum eanassiyed Reference Retorenco FUTURE? goals Contovonco on Quality sac. Observed Inaccuracy (Bias %) eon Rules QC Rules QC Rules, +0 bein9 an CALCULATCRS 2 x lo•tL 60 x un number to indicate the run was Troubleshooting Actions 1. Circle the analytical run number to indicate the run was Change can occur at one level and not the Other Back to top and not the other WE WHERE WE ARE Part 3 On the HOME page, Level 1 LJ/L g./L 0.2 $ 0.2 ; 52.7 41.6 71.8 0.171' -0.7 place to start. Updated for 2014 52.1 If If quality does free. What'S tho absolute minimum quality? in 2012, four Spanish EQA providots formed a 'Tafget +0 ardy±e bein make SDass€ned assined Back to Continue Reading ir The Pathologist in The Pathologist +e ardy+e bein +0 maKe Westgard QC Dosign and Planning process. in the Westgard QC cosign and Planning process. k. Password +e bein9 +0 e, assist the QA wit Based on the information contained in the table, assist the QA Officer with developing a QC strategy for this Based on the i Based theänformatio can ardyfe bein +0 maKe -We ardy+cal Consensus Forgot bein9 +0 ardy+e beins +0 bens +0 bein +0 maKe bein +0 make rejected S Resources Spocitjcations in Laboratogy Modicano' was hold. 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Method Validation Tools —WHERE WE EXPECT fie specificc*ions type of error occurring and the possible causes for the 'g and the possible causes for the type of error occurring and the possible causes for the workstation. Write your response. QC QC Calculators going to assure It? '1999 Stockholm Yaboratory ma OC WE EXPECT TO going to assure it? fie specihcafiens QC paper RE ro cm Somac Calculators specificåi ons Laboratory management is currently advocating upper management's Laboratory management is currently advocating upper managemer t's nie Level 1 Level 3 Analytical are a percentage, Some may character A selection of SEKI(-DMax specifications A selection of SEKK(-DMax specifications eon WESTGARD WEB SAD below the LOGIN specificdiøns LOGIN UP QC cm QC cm re-gee QC ihcafions *hen LOGIN SIGN UP ) *hen W+hen te strategies at each level. and How can you implement separate strategies at each level? 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