q,a;e Fc ) ORIGINAL EVALUATION. FH9-B 2017 Hematology Auto Differentials, FH9

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1 etiee INSTITUTION: ATTENTION: CAP NUMBER: KIT INFORMATION: COPIED TO: LKF Laboratorium fur Klinische Forschung GmbH Schwentinental GE Volker El-Samalouti PhD Kit# 1 Kit ID: Kit Mailed: Original Evaluation: /8/2017 6/13/2017 CAP Next Mailing Date: 9/25/2017 LEGEND: Exception Reason Codes appearing in this evaluation: = Educational challenge. Reviewed By q,a;e Fc ) The College of American Pathologists recomrnends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory Page 1 of 9

2 Specimen FH9-B 2017 Hernatology Auto Differentials, FH9 - No. of Limits of Acceptability your Result Mean S.D. Labs S.D.I Lower Upper Grade Plot of the Relative Distance of Results from MCV FH Acceptable --,,,,- fl, FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH Acceptable I FH Acceptable FH Acceptable X: Result is outside the acceptable limits MCH FH Acceptable Pg FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D /L FH Acceptable FH Acceptable FH Acceptable MCHC FH Acceptable g/dl FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable._._. FH Acceptable - Platelet Count FH Acceptable x 10E9/L FH Acceptable FH9-B 2017 'M=. SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable.e.., FH Acceptable -. The College of American Pathologists recommends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory Page 3 of 9

3 I _ No. of Limits of Acceptability Specimen Result Mean S.D. Labs S.D.I Lower Upper Grade Plot of the Relative Distance of Results from Lymphs FH Acceptable % FH Acceptable FH9-B 2017, SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable...,,, FH Acceptable Lymphs Absolute FH Acceptable x 10E9/L FH Acceptable FH9-B 2017,...L..., SYSMEX XE-2100,2100D/L FH Acceptable I - - FH Acceptable I FH Acceptable Monocytes FH Acceptable `)/0 FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable Monocytes Absolute FH Acceptable. x 10E9/L FH Acceptable FH9-B 2017 '. SYSMEX XE-2100,2100D/L FH M Acceptable.. FH Acceptable FH Acceptable The College of American Pathologists recomrnends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory Page 5 of 9

4 I.* , 0. **041.4,45, eige4,11.1,0** Specimen Result Mean S.D. No. of Labs Limits of Acceptability S.D.I Lower Upper IG FH % FH SYSMEX XE-2100,2100D/L FH FH FH yo ur Grade 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 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 Method Specimen Result Good Response Acceptable Response Grade Blood Cell ID BCP-11 OVALOCYTE OVALOCYTE Good BCP-12 LYMPHOCYTE LYMPHOCYTE Good BCP-13 MONOCYTE MONOCYTE Good The College of American Pathologists recommends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory Page 7 of 9

5 im* e..feeefb* tem* e fbio e.06 et fbe CAP CAP #: Subspecialty : Hematology Proficiency Event Proficiency Event Proficiency Event Current Event Performance Cumulative CLIA '88 Performance Regulated Analyte Event Score A Event Score % Event Score % Interpretation Interpretation Cell ID/Flow Differential FH9-C 5/5 100 FH9-A 5/5 100 FH9-B 5/5 100 Satisfactory Successful Erythrocyte Count (RBC) H-19-C 5/5 100 FF19-A 5/5 100 F1-19-B 5/5 100 Satisfactory Successful Hematocrit FH9-C 5 / FH9-A 5/5 100 FH9-B 5/5 100 Satisfactory Successful Hemoglobin FH9-C 5/5 100 FH9-A 5/5 100 FH9-B 5/5 100 Satisfactory Successful Leukocyte Count (WBC) 1+19-C 5/5 100 FH9-A 5/5 100 FH9-B 5/5 100 Satisfactory Successful Platelet Count FH9-C 5/5 100 FH9-A 5/5 100 FH9-B 5/5 100 Satisfactory Successful Fibrinogen CGL-C 5/5 100 CGL-A 5/5 100 Pending Successful <4> PTT CGL-C 5/5 100 CGL-A 5/5 100 Pending Successful <4> Prothrombin Time CGL-C 5 / CGL-A 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 recomrnends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of ani, individual clinical laboratoit Page 9 of 9

6 444, Method Specimen Result Good Response Acceptable Response Grade BCP-14 PLATELET, NORMAL PLATELET, NORMAL Good BCP-15 BASOPHIL, ANY STAGE BASOPHIL, ANY STAGE Good Blood Cell ID Ungraded BCP-16 LYMPHOCYTE BCP-17 POLYCHROMATOPHILIC RBC BCP-18 MONOCYTE BCP-19 NEUTROPHIL, SEG/BAND BCP-20 SPHEROCYTE The College of American Pathologists recommends 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

7 Specimen City / State: Schwendnental GE No. of Limits of Acceptability your Resuh Mean S.D. Labs S.D.I Lower Upper Grade Eosinophils FH Acceptable A) FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable -100 Plot of the Relative Distance of Results from 4. _ ' _ Eosinophils Absolute FH Acceptable x 10E9/L FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable Basophils FH Acceptable w A) FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D /L FH M Acceptable FH Acceptable FH Acceptable Basophils Absolute FH Acceptable x 10E9/L FH Acceptable FH9-B , SYSMEX XE-2100,2100D/L FH , t Acceptable ' FH Acceptable FH Acceptable 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 Page 6

8 Specimen Result Mean S.D. No. o f Limits of Acceptability Labs S.D.I Lower Upper Grade Plot of the Relative Distance of Results from MPV FH Acceptable fl FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable RDW FH Acceptable FH Acceptable FH9-B SYSMEX XE-2100,2100D/L FH9-08 ' Acceptable._. fl FH Acceptable FH Acceptable Neut/Gran 'FH Acceptable % FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D /L FH Acceptable FH Acceptable FH Acceptable Neut/Gran Absolute FH Acceptable x 10E9/L FH Acceptable FH9-B 2017 I SYSMEX XE-2100,2100D/L FH Acceptable., F1-19-C2016 FH Acceptable., E.: FH Acceptable The College of Arnerican Pathologists recommends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any individual clinical laboratory Page 4

9 325 Waukegan Road, NorthfieEd, Illinois cap.org Specimen No. of Limits of Acceptability your Result Mean S.D. Labs S.D.I Lower Upper Grade Plot of the Relative Distance of Results from White Blood Cell Count FH Acceptable x 10E9/L FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH t Acceptable FH Acceptable FH Acceptable Red Blood Cell Count FH Acceptable x 10E12/L FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH Acceptable FH Acceptable FH Acceptable _ I t Hemoglobin FH Acceptable g/dl FH Acceptable FH9-B 2017 I I SYSMEX XE-2100,2100D/L FH Acceptable I i FH Acceptable FH Acceptable Hematocrit FH Acceptable % FH Acceptable FH9-B 2017 SYSMEX XE-2100,2100D/L FH M Acceptable FH FH Acceptable Acceptable The College of American Pathologists recommends that the result of this interlaboratory comparison not be used as a sole criterion for judging the performance of any indiyidual clinical laboratory Page 2