ORIGINAL EVALUATION. FH9-A 2017 Hematology Auto Differentials, FH9. oom 3089 Page 1 of 9

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1 . gb 8 e e. * INSTITUTION: ATTENTION: CAP NUMBER: KIT INFORMATION: COPIED TO: LKF Laboratorium fur Klinische Forschung GmbH Schwentinental GE Volker El-Sarnalouti PhD Kit# 1 Kit ID: Kit Mailed: Original Evaluation: /30/2017 3/3/2017 CAP Next Mailing Date: 5/8/2017 LEGEND: Exception Reason Codes appearing in this evaluation: = Educational challenge. (; ( C 2 eviewed By Date oom 3089 Page 1 of 9

2 of)4upe. 041.e*. oe...0 Test No. of Limits of Acceptability your Specimen Result Mean S.D. Labs S.D.I Lower Upper Grade Plot of the Relative Distance of Results from MCV FH Acceptable EL FH Acceptable FH9-A C M16 1 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable X: Result is outside the acceptable lirnits MCH FH Acceptable Pg FH Acceptable FH9-A 2017 FH9-C M16 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable MCHC FH Acceptable g/dl FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH9-C M16 FH Acceptable FH Acceptable Platelet Count FH Acceptable x 10E9/L FH Acceptable FH9-A 2017 e, SYSMEX XE-2100,2100D/L FH Acceptable...= FH Acceptable FH Acceptable Page 3 of 9

3 Test Specimen No. of Limits of Acceptability Result Mean S.D. Labs S.D.I Lower Upper Grade Plot of the Relative Distance of Resulis from Lymphs FH Acceptable % FH Acceptable FH9-A K Efflarn 6913=851Bk..., SYSMEX XE-21 00,21 00D/L FH Acceptable warapr' FH Acceptable FH Acceptable u 2u A.I.Iffl Lymphs Absolute FH Acceptable x 10E9/L FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable Monocytes FH Acceptable A) FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable Monocytes Absolute FH Acceptable x 10E9 /L FH Acceptable FH9-A SYSMEX XE-2100,2100D/L FH Acceptable 3 1 I FH Acceptable FH Acceptable Page 5 of 9

4 Test No. of Limits of Acceptability Specimen Resull Mean S.D. Labs S.D.I Lower Upper Grade IG FH % FH SYSMEX XE-2100,2100D/L FH FH FH Plot of the Relative Distance of Results from IG Absolute FH x 10E9/L FH SYSMEX XE-2100,2100D/L FH FH FH nrbc% FH A FH SYSMEX XE-2100,2100D/L FH echeck XE CONTROL FH FH nrbc Absolute FH x 10E3/uL FH SYSMEX XE-2100,2100D/L FH echeck XE CONTROL FH FH Test Method Specimen Result Good Response Acceptable Response Grade Blood Cell ID BCP-01 NEUT w/pelger-huet NUCL NEUT w/pelger-huet NUC Good BCP-02 EOSINOPHIL, ANY STAGE EOSINOPHIL, ANY STAGE Good BCP-03 BASOPHIL, ANY STAGE BASOPHIL, ANY STAGE Good Page 7 of 9

5 luets esse. s,.(eeere essee es -so-soste sf! se.e CAP CAP #: Subs ecial : Hematolo. Proficiency Event Proficiency Event Proficiency Event Current Event Cumulative CLIA Performance '88 Performance Regulated Analyte Test Event Score % Test Event Score % Test Event Score % Interpretation Interpretation Cell ID/Flow Differential FH9-B 5 / C 5/5 100 FH9-A 5/5 100 'Satisfactory Successful <4> Erythrocyte Count (RBC) FH9-B 5 / FH9-C 5/5 100 FH9-A 5/5 100 Satisfactory Successful <4> Hematocrit FH9-B 5 / FH9-C 5/5 100 FH9-A 5/5 100 Satisfactory Successful <4> Hemoglobin FH9-B 5 / FH9-C 5/5 100 FH9-A 5/5 100 Satisfactory Successful <4> Leukocyte Count (WBC) FH9-B 5 / FH9-C 5/5 100 FH9-A 5/5 100 Satisfactory Successful <4> Platelet Count FH9-B 5 / FH9-C 5/5 100 FH9-A 5/5 100 Satisfactory Successful <4> Fibrinogen CGL-B 5 / CGL-C 5/5 100 Pending Successful <4> PTT CGL-B 5 / CGL-C 5/5 100 Pending Successful <4> Prothrombin Time CGL-B 5 /5 100 CGL-C 5/5 100 Pending Successful <4> Hematology 45/ / / Satisfactory Successful <4> Scorecard performance pending future evaluation or may not be applicable due to discontinued testing or use of a waived method. The College of American Pathologists recornmends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory. 0( Page 9 of 9

6 Test Attention: Volker El-Sarnalouti PhD Method Specimen Result Good Response Acceptable Response Grade BCP-04 LYMPHOCYTE LYMPHOCYTE Good BCP-05 OVALOCYTE OVALOCYTE Good Blood Cell ID Ungraded BCP-06 TEARDROP GELL BCP-07 NEUTROPHIL, MYELOCYTE BCP-08 NEUTROPHIL PROMYELOCYT BCP-09 NUCLEATED RBC, NML/ABN BCP-10 BLAST GELL The College of American Pathologists recornrnends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory Page 8 or 9

7 50 * afe e lidiet 4 sr te fp s, Test Plot of the Relative Distance of Results from No. of Limits of Acceptability Specimen Result Mean S.D. Labs S.D.I Lower Upper Grade Eosinophils FH Acceptable torgpoi.ffl FH Acceptable 1H9-A 2017 ' 1 H9-C 2016 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable i Eosinophils Absolute FH Acceptable x 10E9/L FH Acceptable 1 H9-A SYSMEX XE-2100,2100D /L FH Acceptable FH Acceptable FH Acceptable Basophils FH Acceptable FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable F1-19 -C 2016 FH Acceptable FH Acceptable Basophils Absolute FH Acceptable x 10E9/L FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable Page 6 ui 9

8 Test Specimen Result Mean S.D. No. of Labs S.D.I Limits of Acceptability yo Lower Upper Grade Plot of the Relative Distance of Results from MPV FH Acceptable fl- FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable - FH Acceptable RDW FH Acceptable. FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable ""----"m--7 '''' 1-H9-B2016 x fl FH Acceptable FH Acceptable x: Result is outside the acceptable limits Neut/Gran FH Acceptable FH Acceptable FH) -A 2017 SYSMEX XE-2100,2100D/L FH Acceptable 1H9-C 2016 ', FH Acceptable...e FH Acceptable Neut/Gran Absolute FH Acceptable x 10E9/L FH Acceptable FH9-A SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable Page 4 or 9

9 Oeseir,04, eib.* Test Specimen No. of Limits of Acceptability your Result Mean S.D. Labs S.D.I Lower Upper Grade White Blood Cell Count FH Acceptable x 10E9/L FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable -100 Plot of the Relative Distance of Results from -80 -GO GO Red Blood Cell Count FH Acceptable x 10E12/L FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable GO Hemoglobin FH Acceptable g/dl FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable J FH Acceptable FH Acceptable GO GO Hematocrit FH Acceptable % FH Acceptable FH9-A 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable GO The College of American Pathologists recommends that the result of this interlaboratory comparison not be used as a sole criterion for judging the perforrnance of any individual clinical laboratory Page 2 or 9