PEPFAR Quality Control and Method Validation Activity 11: Part 1

used S ase-d s used S ased S ± O ase-d +0 ± O used fo used +0 used use-d ± O Systex Systeml System ype and number of GC sampks ype and number of 3) QC V Frequency used ) i he QC ±es+ed 2) Type number ± o Moni numoe ( Z3A) MO 3)sVa Quality num S O System de QC used S IAS l) Frequency OF QC sampe +es+ even+s Of l) Frequency +es+ even+s used I) Frequency of QC Type and number of m S as as Quality l) Frequency System Analytes , used +0 Type and number 3) QC ased q) Analytical QC used +0 +0 number QC ased +0 b rator Analytesal •Analytesal 2) Type and number Quality American La boratory 3) used +0 urement procedure providere 2) Type and numb( Monit 3 Type numbec samples +es+ed Goals • meat procedure) System procedure asurement procedure 2) Type and number OF Analytical eva 2 numbec sampks ±esfed Fystem! r emeøt proc women t Cape Clinic Laboratory page Of I page I Of I QC used Type and number of GC scrnp Type and number of QC nt urement pr rement Zimbabwe National Quality Assurance Proqramme easutemcnt t pr On-going Evaluation of Your Quality Control Systems number 3) number of QC samples +esfed numbec samples +es+ed evalua+e Analytesal Kit ID: Customer No: 2) Type and number CAP Number: em ent Type number 3) use, Platelet Count 3) QC used +0 q) College American pathologists General Guidelines for Proficiency Testing number Laboratory used l) Fcequenc 2.8 Alerts us t ement Quality 2/ Type and number 3) QC used (90-100)/10 Activity: Complete the PT Report Goals System Each laboratory analyzes these samples just l) Freq l) Standard Deviation Index (SDI) l) Frequency of e,en+s Type and number 30 •Analytesall Hematology Samples Sample: Sample Reported Resported report Expected Reported Responsed excected •eported report.d Grade Proficiency Mean SDI SD OSD evalua+e 10 Eac} Zimbabwe 2) Type aud number ±es+ed 2) Type and number Of QC sampes ±es+ed For a single PT survey specimen, your peer CLIA No: Quality 4. Eac evalua+e Nean qean J Type number 2) Type and number of GC l) Frequency 3. 23 3) 325 Waukegan Road, Northfield, Illinois 60093-275" Waukegan Northfield, Illinois 60093-2750 Kit Mailed: Goals 2) 3) External Quality Assessment System number System Assessment L-J Chart for XYZ Chemistry Analyzer 3) QC used 40 evaiaa+e q) The OF review QC ased +0 QC used QC used +0 QC Llsed Laboratory Platelet Count QC used +0 LD The of review LD The of periodic review evaluaVe used +0 Analyticai' used Resultse (xlOE9/L) (85-75)/10 = WBC WBC Count on XE-2100 Count used System Laborator 3)s Job Aid 2: Inter retin PT Re orts 1108 Job Aid 2: Inter retin PTRe orts 1108 Survey 15/02/2013 Goals Laboratory proficiency testing (PT) is an essential element of laboratory quality assurance. Proficiency Results 800-32 • • http://w•.•.•v.cap.org SDI The of periodic Tevtew Report Date Address: review SDI La boratory Quality Institute Institution: Scheme Name Goals accuracy a accuracy em." t La boratory q) The of periodic review for q) The Laboratory 10/14/2010 Original Evaluation: The OF review q) The of review Proficiency Testing (P T) Programs Institution: ID of pevtodtc review for The of peniodic review The of periodic Quality The Analyte: Glucose, q) The of periodic revtew The of petiodic review Control Material: Leve•bl Control Material: Levebl Units: nunoVL The periodic revtew q) The of periodic review The of peviodlC review System Quality The of pee 3) QC q) The OF periodic review with Quality Goals Quality The of periodic review testing is an independent and unbiased assessment that evaluates the laboratory's ability to produce testing is an independent and unbiased assessment that evaluates the laborat of periodic Teview The OF revtew Analyte/Method Analytesalthod AnalytesMethod ID OF periodic review Results 3) QC Your laboratory Your labor The of pevtodtc review for Analytesalk q) penodjc de 30 2) The of pevtodlC review for The of periodic review for Results The of peviodtc review Results Resultse The of pectodic review ID The Types of EQAS Programs The of review The of periodic veview q) The of periodic revtew Quality of revtew Results Advancing Excellence Acceptable Performance Criteria q) The of periodic Tevtew for +0 Quality ua ity Repart Number: q) The periodic revtew for q) The of periodic review The OF periodic review Quality Qauality The pevtcdiC The September 25. 2012 q) The pe LD The q) The periodic re' City / State: '159 Ml Resultso the Goals correct answers. Proficiency testing provides an assessment of the validity of testing in your laboratory. el Laboratory Laborator q) The 09 review Lin' valid Laboratory grams q) The 09 periodic review ype and numt SD Quality The of petiodlC review evalua+e Quality Quality tor Goals (xlOE9/L) LD tua it Qualit) The Laborator Quality Itor Goals Laboratory Goals Results Sample Samples Sample: Laboratory Reported Expected Resported report Specimen excected Grade Hematology ematology Goals Mean Goals SDI so 3) used QC used Quality Laboratory Goals System Proficiency Testing — a laboratory testing program in which samples from a common pool are periodically sent to members of a group of laboratories for 31 Samples Sample Each laboratory analyzes these samples just as Gaussian is the Key to Quality Control The used q) de*ec Lot #: 1914120M assign 3.48 SD assign Mean. mean. Mean 610.0 q) The 09 defec+lnj 3-123 report Expected Exp Date: Expec ted Goals 0.05 q) The OF Quality Comparative Evaluation Laboratory Resultse Resgr Quality The defec+inj q) The viodic review q) The of q) The of pevicdjc review for defec+in and *rends Goals oodtc review for and *rends and defec+ The revjew detec+inj lory d *rends The 09 detec±iny and laboratory submitted a creatinine result of 85 de+ec+inj and + tory Laborator Goals q) The LD Quality defec±inj a The of revtew Expected Laborator q) The ID The and +cends tor Resultse The periodic revtew The of peviodic review The of .stodjc revrew The OF viodic review for The 09 pevicdic review for The vicdic review Consensus Laboratory Quality b) The ac+vons +Q6en when r Goals Goals defec defec+inj and Goals auality and +rends detec+inj and b) The achons defecåinj and +c defec±inj and - defec\inj and defecåinj a review for Results and *rends and defec±inj Laborator Handling Your PT Survey Results *rend s analysis, following which each laboratory's results are compared to those of other laboratories and/or to an assigned value and are subsequently reported to Goals The Results defec+inj and +cends Results The Results defec±inj and defec+lnj and +cends defecåinj and + Quality Goals defec+hnj and Laboratory and *rends and Results Laboratory and. b) The achions ±a6en Results defec+inj and *rends b) The achtons +aHen Laboratory 2010 Hematology / Coag / Microbiology - 2nd Event Goals b) The achons +ahen q) The ends defec+inj and +rends b) The achor-n Laboratory *010 b) and 2. submitted a 11.0 b) The achons ±a6en when and +cends defec%n b) The ad-ions Resultse Platelet Count La boratory 10.3 Acceptable Acceptable -0.4 Acceptable -0.9 Acceptable -0.3 Acceptable Acceptabilety Quality XE-06 - 61 62 30 336 31 3. 43 - 72 57.4 117.0 57.0 211.8 2. 2.8 2.3 231.8 q) The revtew defecfinj and +re Eac Count Goals 6.90% 6.10% defechinj and From. From: an Target Value Activ•tv Complete the PT Report TEa q) The of periodi 31 Useful for comparing PT results at the June 1, 1, Results b) The achons +Qhen when Goals Schemes Laborator b) The achons +a6en when resul+s Status of Report Quality ORIGINAL Results Resultse Resultse Laborator b) Laboratory Proiocal defe ical Analytical Analytesal Analyte/Method Analytosal AnalyteSal Analytes Analytesal Analytes . Goals Sysmex XE-2100 defec- Goals c: Analytesalthod Analyte/Metho AnalytesMethod b) peer b) The achons +ahen when Results Results the participating laboratory. 03 33 +3 +2 Activity Complete the PT Report The periodic review Resultse Quality b) The achons +Q6en when resul+s l) The achons The of penodi Quality Mean SO SDI e' b) The achons ±Qhe. b) The achons ±a6en when resul+s Laboratory Laboratory The Freeency Results b) The b) The achons ±ahen when resul+s b) The achons +QKen when resul+s No. of Hematology H ogy Laboratory Value The perdc Goals defec+inj b) The achons ±Q6en Activity ActivitVL Complete th Activitv• Complete the PT Report Activitv Complete the PT Report Activity; Complete the PT Report Activity. Complete the PT Report de Itor b) The achons ±Qhen Sample Reported Sample: Goals b) T be achons defec+inj Complete Complete th and *rends Sample Complete the PT Report 33 3.0 b) b) The achons + defechinj dåec+in WBC Count on XE-2100 reported Expected Laborator Response Note the date of receipt for your shipment Laboratory Laborator excected Quality SDI Hons +QKen when resal+s +Q6en when resul+s Expected Reported Reponted 5) The achons +Q6en when b) The achons ±Q16en when b) The achons when Peer cted Mean b) The achons when resul- Analyticsl This report shows the result you reported, expected result. mean, SD (Standard Deviation), SDI (Standard Deviation Interval). and your grade for This report shows the result you reported, expected result. mean, SD (Standard Deviation). SDI (Standard Deviation Interval). and your grade for This report shows the result you reported, expected result. mean, SD (Standard Deviation), SDI (Standard Deviation Interval), and your grade for and +rends b) The +Q14en when resul+s q) The pevicd'C revtew SD Grade defec±inj and 3. Analytic s SO SDI so SO and Grade defec+nj and +rends b) Evaluation and Com arative Method Statistics rend S ends Seconds b) The achons b) The achon Expected Laborator b) The achons +shen b) The achons when Goals +ecends rend s Analytes and +reods b) The achons b) The achons +a6en whet exceed Rexoceed and *rends LD q) System cc when resul+s Results Laborator Analyte/Method analyte/Method Analyle Tes}d Results Goals Analytical hen when resul+s Results Method co 1.3 Summary Acceptable Performance Criteria Reported Goals Laborator Results: ahen when Results esul-bs Pret-analytical Resultse Laboratory Laboratory Immediately inspect and reconcile the contents of your shipment with the accompanying each sample tested. The SDI compares your laboratory's result to the comparison group's mean and is defined as follows: What will you dop What you dop Goals Quality Quality eacn your to the Laboratory Resulfs This signifies Laboratory Goals b) Goals Comp Purpose Frequency c; b) The achons +0 (xlOE9/L) The +Qhen when resul+s The QC Hons +Q6en when resul+s and (xl i b) The achon b) The ac+ b) The ach b) The achon b) Limits of Acceptability Your Mean Label: en resul+s System Used to determine the limits of acceptability for Your c; b) The achons +QKen Sysmex Fystem b) The achot- exceed Sysmex XE-21()() exceed umol/L. The peer group's mean is 75 umol/L. xE-06 XE.06 43-72 43 72 exceed qccep%ble S7_a 2-8 sma S7_a 2.8 2-8 211.8 b) The achons +Q6en when b) The achons +a6en when Sysmex XE-2100 1. The PT provider sends laboratories several P Count Count / Results b) Pne achons +ahen when resul+s {dua it Frequency b) The achons fahen when 2.8 1.3 Number of Laboratories Enrolled The achons when achons +a6en Platelet Count matelet Count Goals N — the number of participating laboratories' data used in the calculation of the group's SD and/or mean. Frequency C; XE.os exceed and *rends 5) The achons defec+inj and paperwork 61 336 Laboratory ean 43-72 43 72 acceptable b) The creatinine 11 when resal+s 57 A 57.4 exceed QCCep+061e 2.8 211.8 vou esul+s I Results en resul+s Goals Reported Result - Comparison Mean Repotted - Comparison Reverted - Comparison Resultse - Comnarison Grade c' Tesults Results Reported - Laboratory Resultse excected exceed La boratory Results Labs XE-06 b) The achons when exceed acceptable Mean____ _+100 —Mean Quality This signifies CA p Goals 2, Purpose Puroose Purpose OCCep+061e Survey Results , Goals Types of EQAS programs Gdn S.D. I Lower Upper ts Results provider • If N is too low, statistics may not be calculated exceed c used the c' Goa Is Number of Responses Received S.D. Used the Used Used c,' Specimen Are all required specimens available? Results ka ua the vou exceed defec+ Laboratoryy b) The achons +QKen when eve Laborator Resultse exceed exceed QQQep+QåIe I exceed OCQep+Q61e Comparison Group Standard Deviation ts to the PT exceed pro exceed QQQep+ SDI dc exceed 5) achons +Q6en r b) The achons ±Q6en Control Laboratory Cafe ory same time Xceed acceptable , ontrol 0.4 exceed QQQep+Q61e exceed QQCep+QåIe Z\NQAP 'iControI 484.4 XE-2100 5) exceed accep+aåle exceed accep- .2 +2 ua ntrol Cafe Of y Results ex WHERE we WHERE WE achons +a6en 3, Is the quality and appearance of the specimens acceptable? b) The achons +a6en when WHERE exceed sysmex XE-2100 Sysmex XE-2100 WHERE we XE-2100 XE-2108 XE-os XE-07 XE-06 xE-06 XE.06 XE-08 Statistical Evaluations Statistics nave Deen calculated from the consesus of the robust mean Statistical Evaluations Statistics have deen calculated trom the of the robust mean excee . Working in pairs, you will: W kin exc 489 10 30 Contr;• ontrol 363 . 606 606 the 484.4 exceed tne 57.4 -0.3 Acceptable 07.4 -0.4 Acceptable 0.4 Acceptable 0.4 Acceptable b) -100 exceed ro WHERE WE ARE exceec Control Mean (targets values) are derived from all-participant mean values calculated by a robust statistical technique. In some cases, however, it is recognized that b) The achon• PT, quant The last page of your PT report was PEPFAR QC Workshop q. ua It that your exceed OQQep+061e nqlyie XE-07 exceed Analytes that are scored for CMS are designated by scores for these analytes are sent to CMS and are used to determine the overall scores Analytes that are scored for CMS are designated by scores for these analytes are sent to CMS and are used to determine the overall Scores Sysmex XE-2100 XE-09 XE-06 489 seconds 30 363 - 606 06 484.4 03 1130 117.3 19.1 117.6 11.30 Store the shipment properly 57.4 ua It Results +2 lab Cate ory Xl samples from a common pool. FBC co Results WHERE WE ro WHERE Contr 333.7 0.3 Acceptable Acceptable -043 Acceptable 0.3 Acceptable Acceptability Cafe ory Metrological Traceability There is no metrological traceability of consensus values. 250 the analyte Analytes Analytes Labs result of 90 WHERE we EXPECT ro 47.7 WHER& WE we WHERE WE ARE +115 E ARE labor WHERE Quality QualityD Quality Quality I Quality? 10 - 489 SD 241.44 tua it ua it Coagulation XE4J8 XE.08 WE ro method-, reagent-, and/or instrument-specific targets may be required and that peer-group-specific targets are used where appropriate. for each CMS specialty/sub-specialty. CA p 336 CMS rewired and that peer jup-sp ste 31 36 -418 333.7 333. T APT System WHERE ro ae WHERE WE ARE 8.2 0.3 Note due date Of results ro detec+ Cafe ory The peer group's SD is 10 umol/L. What is the The peer group's SD is 10 umoI/L. What is the Goals CA p 4. ua it that your result WHERE we ro BE ua It WHERE ro Quality ; Qualityü ua It A. .1 .2 Qu APT WE ro WHERE we ARE Laboratory Laboratory L aboratory Labor at ory TLaboratory Cate ory P -T O WHERE WE ARE WHERE for that peer group by the PT provider. CAP exceed APT 1. Proficiency Testing (P T) Survey Quality 2010 Y Goals 08 WHERE WHERE WE ARE WHERE WE EXPECT ro BE laborz we WHERE WE ARE SE Goals Goals Goals Goats ory uall CA p 04 smudged and unreadable. You need Quality Method used ( if n is less than 30 for each method. method statistics will not be displayed) 19.80 +1.02 Use the information supplied on WHERE WE ARE 4.7 27.34 Results SIEMENS SIEMENS INNOVIN 655.0 e WE cxpecr ro WHERE WE ARE 117.3 4.7 Acceptable •0.9 •O, 9 • O. 9 • O , 9 Analyle Tes}d ZINQAP 01 Reconstitute specimens with volumetric pipettes and correct diluent Control ua It col E WE WHERE ARE 336 ro WHERE ARE WHERE WE EXPECT ro WHERE WE ARE Laboratory is 2010 Fluid - 2nO Event we ro xE-06 xE.09 xE09 WHERE Laboratory ID Laboratory. at ory on trol WE ARE Labs L aboratory Goals Goal s Cont WHERE WE. La SD System WHERE WE WHERE WE ARE WHERE WE EXPECT he ory APT Results Results ; Results ua ua 1 Results Results V Results z Results ; Result WHERE ontrol WHERE ate ory APT Z Goals Acceptable -0.3 Acceptable 10.3 Acceptable -0.4 Acceptable -0.9 Acceptable 1.3 Acceptable ptable Platelet Count Analyie Tested XE-IO 45 61 336 43 - 72 WHERE 57.4 WE ARE 2. 211.8 209 2.8 13 183 11.0 1.2 ntrol J WHERE ARE Labor at CA p XE-07 i 13 WHERE L a us to chaleeé WHERE WE EXPEcr WHERE WE WHERE we ro 2113 61 31 30 87-147 WHERE WE EXPECT ro BE WE C Control ity Qualit) 2117.3 117.3 WHERE WE WHERE WE EXPECT WHERE WE azE WHERE we ARE 4-7 4.7 1.4 Acceptable -O, 9 Acceptable -0.39 Acceptable WHERE WE , we Be we ro w WHERE WE he ory Fec FBC WHERE WE EXPECT TO BE WHERE WE ua 1 , WHERE APT WHERE WRE Quality Cafe or-y or-y ory Laboratory WHERE WE EXPECT ro WHERE WHERE we ro BE jntrol Syste= Cafe Of y ro WHERE WE ARE ua it Control WHERE WHERE WE ARE WHERE ro WHERE ro Monitor the accuracy of your th Control WHERE WE EXPECT ro BE WHERE WE ARE WHERE WHERE WE ARE ults WHERE WE EXPEcr ro WHERE WE ARE scr ro BE Mix samples well before analyzing Mix samples well before analyzing WHERE WE ARE WHERE ARE Acceptable Range: Represents limits oecified by the PT pro Resultse Results z "its WHERE WE EXPECT TD B E WHERE WE A"; WHERE WE EXPECr ro BE WHERE WE ARE Control 025 result is 1.0 WHERE Acceptable Range: Represents limits established using criteria specified by the PT provider, such as CLIA, allowing for rounding to appropriate significant Results WERE WE WC EXPECT ro WHERE we ARE WHERE ro WHERE WE ARE WE "Its HERE WE EXPECTTOo BE ERE WE EXPECT ro BE ERE WE EXPECT ro DE WE EXPECT ro BE ro Your Response O BE WHERE WHERE WEARE WHERE WE EXPECT ro WHERE WE ARE WHERE WE BE WHERE WE ARE Coagulation FBC WHERE we WHERE Tesled WE ARE WE EXPECT ro BE' lith iit WHERE WE ARE WHERE WEARE E EXPECT TO BE' suc ro BE' It WHERE WE rc Sb CA p System± ARE WHERE WE ro BE WHERE WE ARE WHERE WE ro WHERE WE ARE i WHERE WE ARE WHERE WHERE ARE Quality WHERE 1+e ory Alerts us to changes in WHERE WE mRE ont - TO BE' used 211.8 -04 Acceptable 211.8 -0.4 Acceptable Cate ory XPECT ro BE • 211.8 -0.4 WHERE WE EXPECT ro BE WHERE WHERE WE EXPECT ro BE BE' TO BE' 158.265 211.8 70 211.8 211.8 7.0 -OA Acceptable WHERE WE WHERE WE ro BE WHERE WE EXPECr TO BE WHERE , Analytes Analytes •O BE ua ity ua It tua it WHERE we ARE WHERE to ' Look for systematic trends across different WHERE WE ro BE Xl Results Analytesal c,r TO 'E EXPECT ro BE 20s WHERE WE roE umol/L. What RE WE EXPECT ro we ARE ZINQAP ua ity FBC to complete the assessment of the PT EXPECT ro BE System -100 -40 -20 0 20 40 80 • WHERE we ARE QUALITY Control ontrol Control ro BE ua it Analytesal we ily eosqre APT WHERE Monitors and evaluates Pret-analytical Analytes post-Analytesal WHERE we 2. Inter-laboratory Comparison tontrol 31.4 XE-IO ontrol HEMATOLOGY - HEMATOLOGY - 5S WHERE WE EXPECT TO BE 42.4 209 336 23 158 • 158 158 • 265 158 265 WHERE WE ARE yste System WHERE we WHERE WC 13.04 Worksheet to calculate the SDI WHERE i WHERE WE ARE _0,4 Acceptable -0.3 Acceptable 0.3 Acceptable -O.4 Acceptable -0.4 Acceptable -0.9 Acceptable Acceptable Acceptabilety Acceptability WHERE WE ARE ua ity Z\NQAP vou need? WE Coagulation WHERE WE az WHERE WEAR WHERE WE WHERE WE EXPECr ro BE F BC Laboratory f D WE ARE WHERE WE roRE Cafe ory WE FBC WHERE WE ARE J WHERE WE digits. Results falling within this range are scored as acceptable. Any result exceeding these limits is considered unacceptable. WHERE WE ARE - WHERE ARE •j PROFICIE"CY 2. Each laboratory analyzes these samples just as to specified criteria. ro BE WHERE WE ARE HERE WE ARE WHERE WE, Control te is 1.0 group SDS WHERE PROFICIENCY WHERE WE ro WHERE we AR' WHERE WHERE group SDS coagulation , FBC System WHERE WE EXPECT ro BE Countrol QUALITY SD WHERE WE ARE WHERE ro we CA p Analyie Tested Units Coagulation SD What vou need? need? need? yr WHERE WE ARE WHERE we ARE What vou need* mat vou need? What Whit VOu need? mhat vou need? WE WE ARE vou oeeo Acceptabilety XE-07 XE-09 XE-06 336 WHERE WE 30 61 336 1130 250 - 418 250 18 Jntrol 333.7 LControI E WE 8.2 8-2 0.43 WHERE ! Control yested te 2.9 CA p CIENCY WHERE WE ARE FEC APT Seconds Various Analyze specimens at correct temperature. If shipment was stored in the refrigerator, Control ZINQAP Syste= l. ro we to s tor Can be determined by one of three ways tontrol PATIENT LE WHERE WE ARE we WHERE WE ARE (xlOE9/L) IOE9/L) CONTROL v WHERE WHERE we ARE WHERE WE azE WE ARE Cafe or-y Analytical WHERE WE mRE ' WHERE we WHERE WE Itor CA p CA p WHERE WHERE ARE , WHERE WE A RE , D WHERE WE ARE 4Control meth( WHERE WE ARE APT WHERE ZINQAP J WHERE WE ARE System WHERE WE ARE System ' •ontrol ntrol NCY Control QUALITY WHEARE JControl :ontrol .01 met WHERE WE ARE Cafe trol v WHERE ARE CA p F ARE TESTING Control_ ua SDI? i WHERE WE ARE FBC make WHERE wc Cafe A Cate ory I WHERE WHERE WE accuracy and precision The higher the N, the better an estimate of the Sample Label WHERE WHERE WHERE WEAR WHERE we AR WHERE WE ARE RE Control FBC Control J BORE WHERE ARE WHERE we, WHERE WE, WHERE WE ARE WHERE we. WHERE WHERE W iyie Testu Analyle Tes}d yie Tes+d Testu WHERE WE and mg,'dl (0/0, we we AR Cafe or-y FBC t WHERE WE ARE Analytesal Fec The OF pevicdiC Tevtew System Z S q:vste E WE ARE ua it WHERE WE EXPECT ro BE WE ARE we Cafe ory A Control Expected Result ARE specimens may need to come to room temperature before testing. ZINQAP Cafe Cafe ry Cafe f y Cafe A r I page Systex e od Reported Reported Result Expected Result Mean TESTING (PT) S.D.I SDI SDI Grade PATIENT System Ana ua It CONTROL 5. The WHERE we ntrol report today. You decide to perform WHERE Consensus Sample Size WHERE WE SAMPLE Control FBC Uncertabinity method performance Cont"ol CA p API Analytesal .1 r y A r I A r I 2. Inter-laboratory Comparison I Analytes Coagulation Your System ontrol CONTROL ry A r I Program using QC materials measure AnalyteSal QUALITY (QC) th yste Plot of the Relative Distance of Your Results from ry r y CAP WHERE WE ARE FBC -2 WHERE WE Analyte Tes}ed Analytes Coagulation (%, g/dl) WE ARE .2 .1 group SDS Analytes aly}e Tes}ed FBC The PT provider notifies eacB and Limits of Acceptability for the Cafe ory A ZINQAP F BC ZINCA SAMPLE WHERE APT Goals .1 Std. Dev. we WHERE ARE esso A PC CA p CA p Control WHERE and mg/dl (%, gJd1) g/dl) Z score ?ystem WHERE WE ARE ey essa essa Coagulation Tested Always refer to your survey instructions for storage and specimen handling. Syste FBC and mW/dl WE ARE i WHERE WE ARE Y>te ystem Cafe r y Cote FBC Survey Sa—ples System of Measurement Coagulation Analytesal Control SDI (Standard Deviation Index, or a.k.a. z-score) — a calculated value that indicates the number of SD units of each result from the group's mean; describes (%, gidl) PROFICIENCY pta the quality (p cafe Cafe C ate FBC ZINQAp, ZINQAP 28 ! WHERE :a+e or-y Ca+e ory Analy}e Testu CAP is the SDI? Xl FBC Cafe ory Coagulation Coagul+ation CA p Target as Percentages Of allowed Deviation 23 24 25 ple analysis with a Cafe Of y GFBC • If • SO: - APT CA p Cafe ory Analyte Testu Various SAMPLE WHERE ARE Cafe Of y Hematocrit (Hem - 5S) (Yo) - yste QUALITY Fte_ Ari CA p Testu System (QC) cote Coagulation Analytesal Tes}ed FBC2 k Analytes Limits Of Acceptability Your ste measure System 120 units System Analyie Tes}d Analytes 70 System ontrol aso ZOFICIENCY ystem FBC Survey Samples No. of ABOVE the peer Analyze PT specimens in the same fashion as patient specimens. WHERE we ARE they would patients. ZINQÄAP FBC .. QUALITY PATIENT Coagulation FBC 45.0 CONTROL :a+e ory r y Ana PT samples for a particular analyte Analytesal Analytes ZINQAP 42 48 Control Cate ory A Analyte Tes+&i XE-06 CA p 45.0 45 15 Cafe or-y SAMPLE Analytical Survey Various Cafe Of y A method on an on-going basis Speci•men Grade ZINQAP the necessary calculations to complete Analy-tesal - FBC Analytical WHE, Cafe ory APT Cafe ory APT F BC ory FBCI Levey-Jennings Graph Analytical 4.60 90 te 4. WHERE or-y ry ZINQAP 2. 33 the bias of a method in units of SD. SDI is expressed as either a positive or negative value, indicating whether your result is above or below the group's mean. tested daily ZINQAP (G ZIN(ÄAP QUALITY QUALITY Specimen Z\NQAP sysmex xe-2100 Coagulation QU ory PROFICIENCY I Analytes Analytosal ZINC Analytesal FBC Analytical FBC2 FBC Coagula'ion CA the of tne of tnen no the of no of no results of PROFICIENCY CA p APT CA PATIENT ZIN&AP Analytesal Sample: Coagulation CA p _ +100 Analytes FBC s' no Units OF- Units FEC Tesults PROFICIENC Survey -100 FBC- Testu QUALITY -553 Seconds 16.310 CA p OF- CA p 17-21 free thyroxine PT survey. TESTING SAMPLE Analyie Tes}d Cafe ory APT APT PATIENT Various 19 -100 target value can be determined for that PT Analytesal Peer Group — comprised of other laboratories that CONTROL.W, Survey Samples Cafe ory CA p Analyte Testu FBC Anatytesal Ca+e ory xe-06 - FEC Uni+s Reported XC.06 - XC10 Ana Analytes and QUALITY Various XZ-06 - —FBC Specimecn Analyie Tes}ed , FBC FBC FBC F BC NT ids Analyte Tested Coagulation Analytosal FBCI q) Tne review Acceptable 10.3 Acceptable - FBC XE-09 XE-06 XE-07 XE-08 XE-IO FEC 113 11.0 13 1.36 364.33 61 336 .0 31 30 87 - 147 87 - 117.3 117.0 4.7 evalaa+e Analyle Tested F BC The accuracy The and 2. In Coagulation FBC An 1. Target Value ± specified value Analytes Second Quality PATIENT Analße Tesfd Survey Analiytes Analytos , Analytesal For PT testing, the SDI indicates the relationship between the result you obtained from the PT sample and the expected result determined by the PT provider. Analyte/Method Various BELOW the APL E BC Analße Tes}d CONTROL Tes+d FBC System (%, gidl) Various functioning or is part Of your testing algorithm. functioning or is part of your testing algorithm. •0.9 -.9 Acceptable 1.3 Acceptable YSt FBCI IS FBC 41 -48 41-48 484.6 484.8 accuracy NT Analyie Tes+ed FBC COL' s TESTING QUALITY Units Control FBC2 FBC FBCI measure XE-06 - PATIENT Graded graded Grade 'ROFICIENCY CONTROL review CONTROL Analytes laboratory Seconds TesYed Tes+ed XE-06 - XEIO Seconds CONTROL An CONTROL FBC = FBC Tesid - XEIO QUALITY pr FBCf CA p 9" PATIENT Ana .9 Lower Seconds Analytesal Repried Results Coagulation CA p Seconds Cate or-y Various PROFICIENCY Specond TESTING (PT) Ito SAMPLE Analyte Tes}d Cafe ory (0/0, your analysis of free thyroxine. APT Seconds Various use the same or similar instruments and methods. Various i _ Analytes Unmiytes Analytesal COagui Coagulation FBC ZINQAP QUALITY PROFICIENCY units OF- *OFICIENCY PATIENT FBC g/dl) Analytes , (%, g/dl) (0/0, gidl) (Yo, gidl) (QC) measure (0/0, gldl) Various and mg/dl (%, CA p Activity 11: 45.0 QUALITY Coagulation SDI = (your result — expected result)/group SD Various FBC Analytes . Analytisal Analytecal V arious Unmits (0/0, Uni&s 034 18.9 OSO PATIENT es Seconds Analytic d Hemoglobin 136 283.51 Analyle Tesfed Analy}e Testu Analyie Tes+d Tes+ed Tesled CGI-Al 33.6 -0.95 Rotate testing responsibility for PT specimens between all laboratory personnel that are -0.43 CONTRI Tes}ed TESTING (PT) Activated PTT, quant Units OF- g,'dl) Analytes Ana tytes TESTING — FBC FBC An atytes Analyto•, FBCI & FBC2 31-36 QUALITY Analyte Tes}ed Tes}eå Limits 3. Split-sample analysis with a PROFICIENCY Analytical SBC 34 31 OFICIENCY (QC) Tbe FBC Analytes Analyteoal reported CO SAMPLE Analytos i i' 'ENCY TESTING (PT) asure PROFICIENCY OF— QUALITY FBC Coagulation QUALITY . Seconds Reported QUA' QUA and *rends analY+ic de Analytes Ana (%, Analytesal Analytical the quality SD Shi-em (0/0, g/dl) Tesfed Uni&s OF- and mg/Jdl (0/0, g/dl) . .4,. PATIENT PATIENT QUALITY Analytic d Analytesal Seconds Analytesalthod Analytes F.' g/dl) Your CONTROL nalße Tes+e4 nalyte Tes+d neasure Ana tytes Tes+d (0/0, gJdl) es (0/0, (0/0, g/dl) (O/a, (0/0, g/dl) Analyte Tesla Analytes (0/0, (%, g/dl) .npLE the I Various g}dl) and Analytes . and mg/dl and mg/dl (%, gidl) TESTING (P T) 2012 The thes de I Analytes QUALITY Analytes u. TING (PT) System System de Program using QC materials Analytes. Analytes and CONTROL Seconds Various and mgldl Seconds Ana 'ENCY APT) and mg/dl Units Units OF— SAMPLE Ana'; 6105.0 CGI..C20iO CGLC 2010 Analytical PATIENT gidl) CONTROL PROFICIENCY Anal•.r• Analyte/Method (QC) (QC) (QC) gldl) and mgfdl Analytic s OF— SAMPLE PATIENT CONT • •p oo ocoo SAMPLE routinely performing the analysis in your laboratory. Messages QUALITY accuracy meow e 268 SAMPLE • ISD Analytesal Analytes (0/0, (0/0, g/dl) CONTRO! i _ QUAL QUALITY and mg/dl Hematocrit -0.47 +2.6 Compare results with the other QUALITY sure (0/6, g]dl) CONTROL Various f Units CONTROL - Coagulation CONTROi CONTROL CONTROLF CONTPOL TESTING SA CONTROL (QC) measure Analyte Testu and mg'dl CONTR CONTROLF•• PATIENT OF— Analytical Coagulation 5.76 5.3-62 asure Units OF- Resultse —FBC PATIENT Analytes 3. Each laboratory reports its results to the PT FBC — -10 30 90 -0.4 58 n when resul+s measure XE ICY Analytesal FBC Messages NCY essayes 201 s (%, Various and mg,/dl TESTING (PT) ENCY Specimen Seconds and mg/dl g/dl) and mg/dl. Unmits Limits us CONTI CONTRO' CONTROV TESTING (PT) nits Various TESTING (PT) TESTING (PT) Expecfed CONTROL CONTROL v CONTRO CONTRCL CONTFOL PROFICIENCY Me (Yo, Survey TESTING Specimen Various Sec on I CONTRC, QUALITY VCY Sample: Sample: sample. Samples Sample. CONTRr CONT CONT • Vary CPT) -4 (QC) measures co so CONI ds and mg/dl essayes Survey Sa*ples PATIENT co• cot TESTING (PT) us Unmits Samples ICIENCY QUALITY (0/0, g/dl) (%, g/dl) g!dl) CONTR CONTROL Perform PT analysis well before due date of results. PATIENT SAMPLE and mg/dl (0/0, QUALITY Your (0/0, g!dl) SAMPLE QUAL Seconds (0%, and mg.'di Analyie Tesfd (QC) Survey Smplesl_ (0/0, g/dl) (QC) 489 30 363 - 606 606 0.437 484.4 1130 1136 and mg]di SAMPLE 4.46 PATIENT Various Units Units OF— Various Various Sysmex XE-2100 Sysmex XE-210 Specimen Sample: 79 a 146- 170 7.0 QUALITY -ONTROL (%, gldl) yes OF— (%, gidl) (0/0, gidl) Seconds Var# SAMPLE 53.36 53.5 'FICIENCY 'CIENCY and mg!dl Limits SIEMENS ACTIN FSL PROFICIENCY 58 'ENCY QUA Survey Samples Samples (%, when CONI with samples ' Serves as an "PT accuracy equalizer" to Serves as an "PT accuracy equalizer" to PATIENT PROFICIENCY QUA Specimen PATIENT (QC) ni&S Survey PROF' Sample: and mg,'dl (QC) (QC) 'ICIENCY (QC) SAMPLE 201.0 and mg/ldl and mgJ'dl CONTROL (QC) and mg'dl Sample: Seconds Seconds Various ar V arious Various OF-- and - ands PROFICIENCY ey essayes (QC) (a QC) *ROFICIENCY (%, gidl) g/dl) OF- and mg dl PAT' TESTING •TESTING (%, gidl) PATIENT peer mean. STING (PT) (QC) CONTROL PROFICIENCY QUALITY (0/0, g/dl) CIENCY CGI-B 2010 Seconds Saco' vari Seconds post-Analytical SAMPLE g;dl) Uni&s OF— (%, g,'dl) Various (%, SAMPLE; Seconds Value SAMPLE CGL16 Second Sec (0/0, gldl ey ess% Ini&s Speci men Samnple: and mgjdl (%, g/dl) Label: (%o, gidl) Wdl) €.49 2.49 SAMPLE and mg/'dl gJdl) 6.0. 70 60-70 Unmits Uni±s and mg/dl and mg.'di (0/0, gidl) g/dl) Specimer and mgJdl (%, g/dl) rep itey Sanples Specimen SAMPLE Labs PATIENT PATIENT ssages and mg/'dl Specimen Various and mgfdl g/dl) OF— smt Responsed PX PAT 4883 1.3 Acceptable QUALITY Spec Survey Samples Survey Samples XE-06 - XEIO XE-06- Specimec 32 81 62 CONTROL — Sample: OF— measure OF- (0%, Units g,'dl) (O/a, No, Of NO, of 204 13 29 ROL -ESTING (PT) QUALITY CONTR'L Various XE-06 - O xe-06 XEIO XE-06 - Seconds measure units Spec i mon No. of Samples Acceptabilety Acceptable Acceptable -0.4 Acceptable 10.3 Acceptable Survey Survey So—ples provided g/'dl) XE-IO 209 30 336 61 36 23 31 3. SDI? 158 - 265 pair working at your table. 117.3 11.0 211.0 211.8 711.8 211.6 4' NG (PT) 17.0 57.4 117.0 57.0 0.0 61.0 7.0 1.0 20.9 Ito r survey SIEMENS BCS, BCS XP Seconds Secor f XE-06 - XE-06 XE-06 - XEIO SAMPLE and mg/'dl 29 ENG (PT) XE-06- XEIO . Survey Samplts (%, g]dl) 200.5 and mg.idl 2. Percentage SAMP,E Results report. TESTING (PT) APT) - XEIO -ESTING (PT) PATIENT S' )FICIENCY (%, S, -v Various (Yo, Spec •mon Compare your results to other and mg/dl (0/0, gidn gldl) gfdl) CGI-IS g•dl) Spec i men g]dl) (%, gidl) (0/0, gldl) and mg}dl and mg,'dl SAMPLE (%, gidl) (0/0, g/d ey essay essay rvey Samples (%, measure and mg,'dl CGLII - and mgf'dl (0/0, CONTROL essaye amples . Spec i m on and mg/dl g,'dl) g;dl) Specimen and mg Sample: TESTING (PT) XE.06 - XEIO CONTROL (0/6, g/dl) (Yo, gidl) (0/0, gidl) gidl) SAMPLE TESTING (PT) Assure that your laboratory's results are reported according to the PT provider's Your ni&S OF— (%, g/dl) g/dl) and mg/dl (0/0, g/dl'"i specimen TESTING TESTING (PT) (%, XEIO gfdl) and (0/0, (0/0, g,'dl) (%, g"dl) PROFICIENCY PROFICIENCY Sample: TESTING (PT) g,'dl) Specimen 15.55 (QC) (QC) gJdl) SDI (06, Interpretation 167 (PT) CONT Units Label; Key messaqes and FBCI FBC2 and FBCI & FBC2 SAT, APT) CON Repor+d Results (%, (0/0, g/dl) Sp PATIENT PATIENT rep( CON- COL-IS on this g/dl) and mg/di Various (0/0, Spec' CC J SQC. QUA' Label: Spec CGL15 page Reported SAMPLE d- PATIENT measure CGI-Il - Various Seconds Your SAMPLE Mean Nean Seconds and mgldl Specimu. & FUC2 74,5 SAMPLE (QC) Message measurement XE-06 - Labs FOCI & FBC2 Oessages (PT) XE-06 - XEIO Mean report Tie Ti•e Teer Size (n) (QC) (QC) Samples 28 S i Survey Samples - (%, g/dl) (0/0, gidl) CGL--13 & FBC2 and g/dl XE-06 - Labsl: PATIENT APT) 3, g,'dl) and mg./dl Specimen Units (%, g,'dl) (0/0, (0/0, g/dl) provider SAMPLE Tie •n essayes (QC) measure Survey ean Limits & FBC2 instructions. CONTROL es Survey Samples b Specimen, and mg/dl Sample Response 124 4.91 •0.7 0.067 measure Your Spoc CONTROL Specim Spec i men TESTING PATIENT (85 umol/L— 75 umol/L) / 10 umol/L (0/0, FBCI & FBC2 xe-06 - XEIO and mg,'dl Specimen Sample: xe-06 & FOC2 XE-06- xe10 9-9 SD OLE What will you need? COLI' • ENT Specimen Your & FBC2 CGI-Il - IENT FBCI & FBC2 La bet: XE-06 - XEIO XE-06 - xe10 00 003 07 30 SAMPLE this Key Messages messages Messages Oessages SAMPLE XESO Reported SAMPLE Spe Key TESTING (PT) T) (QC) SAMPLE (0/0, FBC2 messages Key messages (QC) FBCI FBCI FBC2 Survey Not provided (0/0, g,'dl- PROFICIENCY GGLIS COL IS Samplesl! Spec i men XE-06 I Sample: Sample: Specimen Spec i men Sample: and mg/dl Spe , Spec i g!dl) excected XE-06 - xe10 Sample: Your laboratory's mean value is the same as the group (no bias) your laboratorv's mean valve is the same as the group (no bias) and mg./dl Spec i mon The accurac Sample Speci'men The accur Samples XE-06 - Your Spoc i mon FBC 2 SAMPLE SAMPLE The The accum (PT) FOCI & FOC2 TESTING (PT) Sample: • and mg! Specimen Sample Label SAMPLE Label: Label: Tesorted Sample. Resultse (Q & FBC2 Sample: XZ-06 - REI o Fact & FBC2 Ensure the proper method and instrument code are recorded for each test so that you are accuracy and (QC) rvey FBCI & FBC2 COLIS Expecfed Expected Your • 2 SD urvey Samples PROFICIENCY XZ-OS - REI o 15 tested daily XE-06 - XE-oo - No. Of Consensus The higher the N, the more data points can be they would patients. ss s Survey Samples} CGL15 Spoc Consensus, XE-06 XE-OS - SAMPLE XE-09 PROFICIENCY The accuracy purvey Samples specimen measure & VBC2 COLI 1 - XE-06 - 5.28 1136 Expected Consensus Sample Size PATIENT Responsed 61 16-1 Consensus Acceptability Spec imen - XEIO Label: OF sac. les S VBC2 CGL i. Determine the grade you would SAMPLE essayes ess »urvey So—ples measure and an La bel: accuracy XE-06- XEIO (QC) Survey So—ples PATIENT (QC) (QC) Reported (QC) Survey Samples; Platelet Count (Hem Count (Hem - 5S) (X IOE9/L) 5S) (x IOE9fL) (x IOE9fL) " (xlIOE9/L) (QC) Survey SampleskIl 189.0 Survey Samples Mean ka TING (PT) SAMPLE FBCI FBC2 reported - O Your Label • La be' XE-06 - KEIO compare amount of bias with the peer XE-06 - (Pr) )urvey Samples Durvey SaFplesi Your Repor+ed Results XE-06 - XE-oe - XE-06 Specimen CGI." - CGI-Il - CGLII - Durvey Samp Burvey Samples Specimen Your 6 peded part of the correct peer group. )urvey SamplesL )urvey Sa"'plest Samples - XE-06 - exceded Z - Score SAMPLE Plot of the Relative Distance of Your Results from Survey Samp XE-06 - XEIOJ XE-06 - XEIO- Analyte Name Units Response FBCI Survey Sa—p XE-OS - XEIO Survey Saptples les Sample XE-06 - XEIO XE-06 - REI O CGLIS Resported Sample: XE.06 - XEIO Abs SAMPLE XE-06 - XEIO Resultse XE-06 XE-OO - FBCI & Value •age s €.49 accuracy an Burvey Durvey purvey XE-06- XE-OS - XEIO- CGL15 & FOC2 363 -606 484.8 -0.3 Acceptable . Reported sages les Responsed Reported CGLI-IS Sample: Value 489 Survey - XEIO Acceptable performance when compared to your group Specimen CGLIS ± 1.0 Resu t les report. -0.4 Acceptable Acceptable The accuracy and Survey Sam p XE.06 - on this page Evaluation and Com arative Method Statistics 336 30 61 250 - 418 333.7 8.2 XEIO Your La Label: accuracy and an survey Survey FOCI & FBCI Reported e. SAMPLE smn Labsl: TESTING (PT) Repor+d Results Resultse Resported 198.5 sysrnex XE-2100 Sysmnex XE-2100 5. The accuracy and XE-06 CGI-IS Resultse Expected FOCI The accumcy and an The accuracy and an The TESTING (PT) CGL15 & F Target If test not performed is the correct answer because of equipment issues, then indicate this fid an analy+ic Results CGI-IS COLI S cGLIS CGL•15 COL' 5 FOCI & FBC2 FBCI FBC2 Fact FBC2 1 TEa Key messages Responsed FBCI & FBC2 Your CGL15 I {Results Your - Reported 3. Multiple of PT group standard deviation (SD) Res TEa XEIO CGL-IS Resultse PATIENT 333.7 333.8 333.0 8.2 SDI Reported Resported & FBC2 Size 250 • TEa (QC) Analytic s Encl & FUC2 336 QUALITY ot+ed Results peer & FDC2 Not provided Resported Reporied Results Reporte No. Of Survey Samplesg »urvey Samples purvey Samp Your Your Expected Expected XE-06 - reported Reported accuracy Y our Your so 0.973 0.05 Sys+em es & FBC2 XE-06 - XEIO Responted Your White Baod Count White Baod Count -l COLI S CGL15 FBCI & FBC2 SAMPLE Reported essayes analy+ic Shi-em es Survey Samples Survey Reponted Resultse • Worksheet: PT Calculations y+ic -svs+em es Results on this page Responted SAMPLE Reported Unit of Measure CGLII - report.d Your receive for each PT sample. on the form. The accuracy Nean Mean Neon qean reported FBCI 8 Problem may exist, laboratory should investigate problem with bias provided Messages v; Your ± 1.0 to 1.5 O SD ear) laboratories performing the same 87 - 147 CONTROL 117.3 Samples Resported 4. The PT provider evaluates the results according Total Error Responsed reported Your SAMPLE 113 The For CLIA, the %TEA for platelets is 25% Repocted Reported 1. Results XE.2100 accuracy and Expected Resultse Your Your Not provided Key Messages report report. CGI.' S accuracy CGLIS Your Analytical Your Expec ted CGLIS CGL15 -Mean. analy+ic s - XEIO report used to calculate the SD for the group. YO CGLIS The accu this Labs 007 Reported J' 2875 89 S urvey analy±ic sys+em descflb es Results ! Results Resultse 23.5 2.75 Red Blood Count co Upper Resultse report Limits o' Of The accuracy and an If the result obtained requires additional testing per your laboratory's algorithm, then If the result obtained requires additional testing per your alaborithm, then Sys+em descftbes analy+ic Sys+em descri sys+em descrtbes SAMPLE Repor+ed Results Your Its Lower (QC) System de sp+em descflb es Results No. La' • WHERE ARE Results 158 - 265 158 265 211.8 211.2 211.7 New Your 158-265 Resported The reported reported Reported Results Mean. Not provided Re Respone Respon es Samplesk No. of .ta With provided The PT provider evaluates the results according Your No. of 3.638 3.48 3.538 NO. Of with 0M No. Of Resu/ks i NO. Of NO, Of Samples fem descftb es Samples Size (n) Sample Sample; No. of accuracy The accuracy and Expected provided Ra Your b es sys+em descft b es sys+em describ es descflbes Not provided Your result falls among the laboratories with the poorest performance Sam. Reported Result Not provided Expe&ed Ra provided ± 2.0 or Sample: Samples accuracy Results Acceptability 5610.0 Sy*em des *u/fs mage Repr+ed Results Sample on On this p.a.. Resultse Respc Resu t Respons - c ONrROL dB of Expected Of Repried Results = 1.0 11.0 this Results Resp Your 022 indicate on the form to be sent to a reference laboratory or further testing required, but do we accuracy Not Expected 7.40 SD Change Hemoglobin a. he Repor+d Results Repor+d Resu/fs No. of Reported reported Sample. Result•s Results Not provided WHERE Sys+em descf(b es provided NO. Of on this page Labs _ pnks pnks -1.7 No. Of • Job Aid 2: Interpreting PT Reports Samples Your 15.9 - 16.7 15.9- 16.7 15.9- 167 15.9 16.7 16.31 11.51 Labs On this Resultse No. of es Labs Your O SD on this this Not provided N" 128 1.83 Labst: (Hem 5S) Provides a snapshot of the current accuracy or sys+em descftb es CGL-II Sample: on this page Size Visually plot each SDI point in the No. o NO. Of this Sample No. Of not actually send the PT sample to another laboratory. Labsl: Not pro-vided No. of No. of Not provided Labs Fi bri nogen group Resultse NO. Of this Size (n) NO, Of ro WHERE ARE NO t provided Labsl: this NO. Of 21.1 Consensus provided On this page Troubleshoot bias problem and perform corrective action Size (n) Of Not provided Sample No. of! 14.2 -150 WHERE WE ARE greater on page Limits o' 15.2 - 16.0 14.2 - 151) 14 62 analy+ic Sy*em descra es WHERE WE WHERE we ARE Re 14.2 - WHERE Labs accuracy Labs Net Size (n) Sample: Labs 3. Split-sample analysis with a Resported No. Of No. of Sample Repor • V. this No, Of No, No with this PT 309.180 ARE has Not Not provided provided to specified criteria. NO. of 243.91 Shi-em es WHERE WE On this Labs -0.4 Acceptable Samples Not pro provided Sysr-nex XE-2100 Sysrnex XE-2100 of sa 113 31 61 30 87 - 147 117.3 117.0 117.30 4.7 WHERE ARE WHCRC we ARE Mean Sam On this page • If 80% of the submitted results do not fall within If 80% of the submitted results do not fall within Results on this Review results for clerical errors on answer sheet, including decimal point placement. No. of On p•ge No. o Sample: CGL-2012 on concentration and provided WHERE we WHERE Not this NO. Of Labs 2suItS On this on mg/ d L Consensus 2CCucacy WE an Results Labs NO, Of on this pago -088 15.2 - 16.0 15.00 0.071 Sample Size (n) on this NO. of on this pcge Gcode. ka A. on page Size (n) MCV WHERE WE ARE we Not provided provided reference laboratory Size (n) Size (n) Repr+ed Results page No. of and an No. of sa CGI..B sysfem describ es Not provided O SD No. of NO. of c ONrROL SDI S.D. SO -2SD SD Value Mean On this page on this this Not provided -Z Size (n) On this Not Acceptabile Sample page on this page on this page fie On Labsl: Labs Size (n) S.D.'. this Consensus Labs so The higher the N, the less impact aberrant Labs Size Retain a copy Of answer sheet for your records. Attach all raw data and the instrument Nean • Calculation Device (e.g. phone, std. Dev. Consensus Size 27.346 ucacy and Mean Labsl; On this this 304.898 m mol/L and mean. •0.33 on this page on Labs this page SIEMENS U' Size G rode i as Of 13.2- 14.0 33.2 - 14.0 132 -140 14.62 13.04 20.9 we Labsl: Label: 85 45 30 70 61 90 100 75 histogram. 1.0 113 12.0 110 120 1.0 105 17.0 page page Grade The ccucacy ERE we s.o. Value Labs No. of 31 13 on this t provided method for a particular analyte Mean Size (n Platelets provided on this Labs ID '0 SD 'E on this SA Labsl: WHERE LD OSD Labsl: On Size (t) this Size anc this Labsl: so sol Labs Size (n) Labs IS Mean 'O SD Value Expeded Siz and Mean this Size (n) print-out to the answer sheet. evalua+e Labs Value S.DI WHERE specihca±iens Guidelines for evaluating PT testing results when 5 samples are analyzed for each analyte std. Dev. Key message. WHERE WE ARE No. Of 57.4 * 0.25 = 14.4 14.9 - 15.6 14.9- 15.6 157.3 0.912 0.051 Sample. cc +1.662 i? ARE Vvalua+e t' 3. 11.28 Consensus TEA in units = -value 325.120 Messages WHERE we SD Mean NO. Of No. Of fie specificat•iens fie specifica€iens Value Mean Not provided Ion this Mean Not lean Mean Es+ima+e WHERE WE Expedfed Ra Mean. page Sa Key Messages Labs No. of co WHERE WE A RE WE ARE this 3.638 33.8 us describes Consensus fie specihcafiens lhessages Cons Size If possible, retain specimens in freezer for confirmatory testing if needed. -60 .40 0 20 +e +0 maKe Sbi sbi Mean Sample: Value -80 -60 0 .80 -60 .40 0 provided (QC) so defines specificafions p rovided Consensus, IS (QC) Sample Response Comment: Meal . Consensus Mean IS 01 calculator) 1. .4 Acceptable SAC: — (O Peet Group O Peet Group 24288 30 IS *he. prov Consensus Cons co 70.4 2.18-2.47 2.951 WE ARE O SD Mean Mean Mean 2.3-62 IS Not provided Value Handy statistic to plot to trend PT results Mean Group 293.40 Z•Sc 303.602 and page Label: Labs Consens Valu basis Value on this page Pa Eshma+e Z-Score Red cell count (Hem - 5S) (x IOE12.tL) Rhited cell Count (Hem - 5S) (x IOEW/L) Rhited cell count (Hem - 5S) (x IOEW/L) Consensus WHERE WE ARPE On this page Consensus the limits of acceptability, then no results are Red Cell Count (Hem Limits Mean If 2 or more of the 5 SDI results exceed ± 1.0 SDI, then further investigation is warranted. Labs s.o.l, If you use the PT sample materials to cross-check other instrument or methods, or as part of +0 ardyfe +0 maKe WE WE sacs 1.0 1.3 Va Value Mean and 5. The PT provider notifies each laboratory as to Size (n) IS Mean Nean Size {-s+ima+e +0 aralyfe bein +0 make — Es+iwn+e m descftbes Value Assess the performance of free Acceptable Performance Criteria qean Ra S.DI'. aepec+ed with this provided Not provided 0.051 57.4 13 28 24/5 14 results or incorrectly defined outliers will have 231/5 27 28 Limits o' Value 28/5 18 28 23 30 33 36 61 4.89 5 53 Sys+e•m descflbes IS page Consensus 11.2 120 14 11 12 bein9 +0 Sac. Not provided Mean Value WHERE Mean this ka E.s+ima+e Of Limits Of Expec ted (xpected Reported provided 231.00 Run your competency training program, then be absolutely sure the PT results are submitted to SQC. -OF apeded Ra E..shrrn+e reference laboratory Limit. of with Of Value Va Limits Of Limits o' Unmits •fed Value 10.3 Acceptable -0.9 Acceptable Acceptable — Es+ima+e XE-IOo XE-06 XE-IO7 XE-08 with 209 336 31 36 158 - 265 211.8 57.4 57.0 30 117.0 70 +0 ardy\e bein9 +0 maKe Mean with PT Acceptability +0 ardy4e +0 maKe +0 beir,9 +ested +0 maKe sac: PI 2.551 13.64 1.6 excected with this 8xFecfed Expected E.s+ima+e 260 2.39 - 2.71 IS with Expecfed Acceptability 2.360 'i sac. and Expec\d Peer Group — comprised of other laboratories that If the average of the 5 SDI results is more than ± 1.5, then significant bias (SE) is present and calibration data should be reviewed to determine if a shift 5 SDI then significant bias determine if a shift 2. S(ACI with this sac Value with this Pt Acceptabilety O SD Consensus pHs With this PT Not p Finks < ± 1st) + E.s+ima the PT provider before starting these activities. SQCI Acceptability Expected +0 - Data for Siemens Diagnostics BCS, BCS XP and Siemens Diagnostics Instruments are statistically combined. Limits Limits o' Limits of Limits o Essential to verify the amount of bias present 17.0 Limits Limits ot Not provided with this PT Limits of this Abs Expecfed Pa Expec\ed Ra ka Ac 0.983 dean Ra d04a 4.91 -5.55 4.91 _ 5.55 523.' 5.2-34 Ra 5.20B 15.55 5.258 we a pecfed excected 610.0 635.0 report 635 _o Expecfed 605 _o 655.0 Value 6100 615.0 Concen±ra+ion 610.0 6250 Res bs sac. PT I Expected Limits o Not Not p od ons Expecfd Expected Reported Limits ot hma+e with Limit ARE with PT — E.shma+e ovided IS Reported Reponted - -2SD -ISD OSD -3SD -2SD -ISD OSD Limits of Consen fs+i thyroxine at your laboratory using report this PT - 3SD Limits o' -2SD -ISD OSD Abs Limn provided +1SD +2SD Resultse Limits of Expoct Limits or Not provided Results Limits Grade Shrrn with Receipt Of Results WHERE Limits Of Limits of Not provided Not pro v OF Mean Mean Expec ted Of Not p Not prov Not pro -1st has occurred. Value Acceptabilety Limits Not Not pr c. Results Ace Opt we ARE is SDI Grade with Acceptabilety Analytical amly+i0Ql 0.161 Not provided Not provided 4.202 we ARC Expecfed Expected report 4.23 this I Result Not provided with this PT PT *E-10 1, Limits Of with XE-IOT XE-09 with this d04a LS LS LS LS In itials AM AM AM ARE AM bs QC cm feqeci- AM mol/L reported the quality (proficiency) of the results in a Value QC S±ahshcs cm Expected provided da4n Limits of Of - 3SD reported Limits Limits provided Ra graded provided Graded Acceptability with this WHERE we WHERE (s Result Unmits Limits Acc Acceptability Acceptabilet -5 'ean on the group's SD and/or mean. Result Not and _ Reported I Expected with this WHERE 'IS we sacs bash S Limits ot with PT Ima+e Review your results with your peer grouping. With this PT Acceptabilety Limit* of Limits 0t Limits Of with IS Peer Reported Limit' of Acceptability with tm IS with this P ecfed report Reported Limits 3.58 Lower Limit = Value I Resutt 57.4 — 14.4 43 e&ed Abs apec\ed Ra Acceptabilety Expecfed this with Limits of Expected this std. Dev. If a single SD' is greater than ± 3.0, there is a high probability of random error (RE), Limits of APT With with QC s±afishcs cm ixpecfed Ra report. O SD Limits 27 5 report 26/5 31/5 (QC) QC cm Abs Date 1/6 2/6 4/6 0.0951 0.352 14.62 -0.9 Acceptable 11.6 Limits of 1.0 SD ABOVE the peer mean. 0. Acceptable Acceoptability with PT 4.62 - 6.74 OF with Ra I Result If a single SDI is greater than ± 3.0, there is a high probability of random error (RE). with Acceptability with this Abs since bias is used in our TE and TEA equations fie sac Expec+ed Pa Resultse Resulfse with this 30 3. +0 Unmits Limits o Resu t Limits with XE-2107 Finks report Acceptability Limits of 230.00 Not provided Reticulocyte Count (Hem - SS) report Expecfd S.D. apec\ed ka Expec\ed Ra Expecfed Pa Pa Reticulocyte Count (Hem - 5S) (Yo) Reticulocyte Count (Hem - 5S) (%) Count (Hem - 5S) Acceptabilety 0.4 Acceptable with this PT Investigate all unacceptable grades. Chanee fie analy+ical peer ERE WE Results Reported pnks nks the histogram and Job Aid 2. basis report WHERE ) +hen O SD WHERE WE pnks S.D.I. Results WHERE std. Dev. SDI E we Expecfed Ra use the same or similar instruments and methods. Acceptability 0.983 and Resultse std. Dev. (Lower & pnks rop WE 0.74 - 1.22 0.74 1.22 - 1.22 Acceptability Aeceoptahility - and Resu It O Peet Group Grade poin S.D. i: & upper) _ }soin4s •IS (Low" 8 Have the Laboratory Director and Supervisor review, and sign and date results. - 3SD -ISD -2SD OISD [END OF REPORTI *ISD +2SD +1SD +2SD Abs _ {040 pnks rep report SD If the range of SDI values between the highest and lowest PT results exceeds ± 4 SDI, random error is a possibility, and the method should be WE ro Cha so 4.7 1. 2. ted change IS S.D.I. Std. Dev. limi+s (Lowe' upper) ( Lower upper) (Lower Std. Dev. wkkxpecr S.D.I. Not pr ot pr defines fie ons Limits of S.DI ot change fro fie analy+ico SD Expected Rexpe&ted (Lower S.D.'. RE WE ARE defines fie specihcåions std. Dev. Expec ted S.D.I. Review results with testing personnel. Retain a copy for competency assessment and place change t-o he analy+ical Change to the analy+ical WHeRE WE SD SD Report defines fie specificåiens IS fie specificafien (pected QC cm e WE WHERE Change Limits of *hen Limits 16.51 20.105 -0.12 Mean SDI 2.4 3.4 2.321 221 Acceptabilety 10.3 Acceptable defines fie specihca+iens fie fie ons S.D.'. IS 2.9 defines fie defines fie specifica+iens applied. SbT report. Reported report.d reported S.D. Not provided XE.IO applied. fie Limits ot SDI S.D.I. e n S.D.'. defines fie specihcc&ions 3D E.S+ima+e White count (Ham - (x White cell Count (Hem SS) (x IOE9/L) change +0 he anqly+ fie specihcafions Std. Dev. defines fie specifications SAC. evaluated for sources of imprecision. rces of imprecision. with t defines fie specificQiens 121 31 Acceptability s.D. S.D.I. S.DI Win with Std. Dev. Std. Do fie specificc&ions fie specihcåiens 3D into personnel record. o. change t-o change Z-Score fie specificafiens fie specifications fie specihcafi QC cm Change anal Upper limit = SD 57.4+ 14.4 71.8 rounded to 72 57.4+ 14.4= 71.8 rounded to 72 Z-Score fie specihcåions fie specificåions d' Limits of so Std. Dev change to he analy+ical fie specificafions (pecfed Pa S.D. Std. D Std. 1 (.59 Concen+ation Sys+-em Limits Grade with this so SD S.D.I. 14.9 _ 203 17.59 SA S.D.'. 18.60 180 Chanoe fie analy+ical limi+s lirni+s Sys\-ey S.DI Acceptability dehoed and applied. to ) SD N = 30 laboratories that submitted a data point on a single PT sample MAY (month -1) XE-2106 •em Bas occurted. S.D. std. Dev. SDI SD (Lower & upper) std. De do S.D. MAY (current month) Z-Scorc Z.Score (current month) std. D •xpe&ed std. Dev. Sysmnex Sysmnex XE-2100 std. Dcv Std. Dev. S.D.'. JUNE 2012 Kit 3 2013 Kit 1 2012 Kit 2 chanse yro the analyiical change Yo fie analy+ical Change fie anal' std. Dev. wit rReported IS O SD VERE WE EXPECr ro g S.D.I. S.D.I, std. Dev. Investigate any failed responses and complete an EQA Failure Checklist assessment. 2012 Kiti 2012 Kit 2 2012 Kit 2 Sys+•em has occutced. repo SDI rep' re E defieed and applied. deficed and applied. S.D. 6.68 5.68 o. 19 31.0 1.2 15.6 -0.4 Acceptable IS 5.6-77 aralyfe beins +0 make he anal) the anal, fie analyiica\ Z-Score Sys+em has occurted. has occuned, specific bei +0 make SD Acceptability (Lower & Upper) & upper) and applied. S.D.I. (Lower +0 ardy+e bens +0 make — SD Activity 11: How Proficient Are We? +0 m nke concen±ra+ion Concen+ration analy+ical 31 01 14 30 12 13 17 1. 18 19 183 128 158 30 nee analy+ical 11 bel make SFs+em has occurced. Sys+em has occutfed. +0 ardyfe +0 make provided +0 ardy+e bel +0 make +0 bel +0 make +0 +0 maKe Mean 30 12 19 1, Follow-up with remedial actions if indicated. specific +0 +0 m Z-Score S.D. report Group S.D.'. specific +0 bein9 +0 m *ion Concen+ra±ien 16 36 2.4 - 3.4 2.4 3.4 - 34 15.90 +0 beino +0 maKe Concen±rati Z Score Yoasure +0 +e aralyfe bein9 +0 m Sys+em has Sys+•em has change ion +0 bein9 sys+em has occutted. change t-o the analy+ical concenyra±ion Concen+ra+ion Your specific +0 araly+e beinq 14 has OCCutCe apec SDI +0 +0 +e bein9 Not provided ation 20 minutes 10 beins +0 m +0 m O Peet Group (Lower & upper) Sys+em has occuvted. Peet Group OAP ( fion Concen+ra+ a amly±ical S.DI upper) Your has occuvted make Grade s.D,l. ardy+e +0 Z-Score S.D.'. Z-Score he analy+ical Z•Score Z-Score beinq this Run Sys+em has Change Your with this he ConQ -0.10 -1.7 5.8-19 5.8-79 5.8-77 ion 6.85 6.685 Aæcepta&le Acceptabilety Acceptable System mmol/ 6.7 mmol/l S.D.I. XE-06 XE-09 +0 m Z.Score g.. clintcallv Grade elimcallv . Clinicallv clinicallv he z-score S.D.I. Grade Z-Score S.D.I. Grade with Z-Scor Z•Score Z-Score z-Score