MEDICAL LABORATORY

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PARTICIPANT SUMMARY

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Hematology, , Bank, Urinalysis, PPM MLE-M3

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Table of Contents

Evaluation Criteria ...... 5

Hematology HemoCue ...... 6 Hemoglobin ...... 6 Glucose ...... 6 Sedimentation Rate ...... 6 Hematology with 5-part Automated Differential (CL Samples)...... 7 White Blood Cell Count ...... 7 Count ...... 7 Hemoglobin ...... 8 Hematocrit ...... 8 Count...... 9 Automated Differential ...... 9 Sysmex Hematology with 3-part Automated Differential (SYX Samples) ...... 12 White Blood Cell Count ...... 12 Red Blood Cell Count ...... 12 Hemoglobin ...... 13 Hematocrit ...... 13 Platelet Count...... 14 Automated Differential ...... 14 Basic Hematology with 3-part Automated Differential (HD Samples) ...... 16 White Blood Cell Count ...... 16 Red Blood Cell Count ...... 17 Hemoglobin ...... 19 Hematocrit ...... 20 Platelet Count...... 22 Automated Differential ...... 23 Hematology with 5-part Automated Differential (DIF Samples)...... 28 White Blood Cell Count ...... 28 Red Blood Cell Count ...... 28 Hemoglobin ...... 29 Hematocrit ...... 29 Platelet Count...... 30 Automated Differential ...... 30 QBC Hematology (QBC Samples) ...... 33 Hematocrit ...... 33 Hemoglobin ...... 33 White Blood Cell Count ...... 34 Platelet Count...... 34 Automated Differential ...... 35 Reticulocyte Count ...... 36

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Table of Contents (cont’d)

Hematology (cont’d) Hematology with 5-part Automated Differential (BCX Samples) ...... 36 White Blood Cell Count ...... 36 Red Blood Cell Count ...... 37 Hemoglobin ...... 38 Hematocrit...... 39 Platelet Count ...... 40 Automated Differential ...... 41 Hematology with 5-part Automated Differential (MX Samples) ...... 46 White Blood Cell Count ...... 46 Red Blood Cell Count ...... 46 Hemoglobin ...... 47 Hematocrit...... 47 Platelet Count ...... 48 Automated Differential ...... 48 Waived Hematology ...... 63 Hemoglobin ...... 63 Hematocrit...... 63 Blood Cell Identification ...... 51

Blood Bank ABO Group ...... 55 Rh Factor (D Type) ...... 55 Rh Factor (Slide Method) ...... 59 Unexpected Antibody Detection ...... 55 Antibody Identification ...... 56 Compatibility Testing ...... 56

Coagulation Prothrombin Time ...... 57 International Normalized Ratio (INR) ...... 58 Activated Partial Thromboplastin Time ...... 59 Fibrinogen...... 59 CoaguChek XS Plus Prothrombin Time ...... 60 International Normalized Ratio (INR) ...... 60 ITC Protime Microcoagulation System Prothrombin Time ...... 60 International Normalized Ratio (INR) ...... 60 i-Stat Prothrombin Time ...... 61 International Normalized Ratio (INR) ...... 61 CoaguChek XS INR ...... 64 Fluid Cell Count/Crystals ...... 61 WBC Count ...... 61 RBC Count ...... 61 Crystal Identification ...... 62

2013 MLE-M3 Participant Summary/ 3

Table of Contents (cont’d)

Urinalysis Microalbumin, Urine ...... 62 Dipstick ...... 62 Quantitative ...... 63 Creatinine, Urine...... 62 Dipstick ...... 62 Quantitative ...... 63 Urinalysis Dipstick ...... 65 Specific Gravity ...... 65 pH ...... 66 Protein ...... 67 Glucose ...... 68 Ketones ...... 69 Bilirubin ...... 70 Urobilinogen ...... 71 Blood or Hemoglobin ...... 72 Leukocyte Esterase ...... 73 Nitrite ...... 74 Microalbumin (Dipstick Only)...... 75 Urine hCG ...... 76 Fecal Occult Blood ...... 77 KOH Skin Preparation ...... 64 Urine Sediment Identification ...... 78

Provider-Performed Microscopy (PPM) Provider-Performed Microscopy (PPM) ...... 80

4 / 2013 MLE-M3 Participant Summary EVALUATION CRITERIA

The evaluation criteria used in the MLE Program is in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) federal requirements for proficiency testing. The criteria are included below.

Qualitative

For qualitative procedures, evaluation is based on participant or referee consensus. If participant consensus is not reached, CMS requirements call for grading by referee consensus. A minimum percentage of participants or referee laboratories must receive a passing score or the challenge is not evaluated due to lack of consensus. These percentages are listed below.

Crystal Identification 80% Consensus Blood Cell Identification 80% Consensus Urine Dipstick 80% Consensus Urine hCG 80% Consensus Microalbumin (Semi-Quantitative) 80% Consensus Fecal Occult Blood 80% Consensus Urine Sediment Identification 80% Consensus Provider-Performed Microscopy 80% Consensus KOH Skin Preparation 80% Consensus ABO Group 95% Consensus Rh Factor (D Type) 95% Consensus Unexpected Antibody Detection 95% Consensus Antibody Identification 95% Consensus Compatibility Testing 95% Consensus

Quantitative

For quantitative procedures, a mean and standard deviation (SD) are calculated for each peer group consisting of 10 or more laboratories except for QBC Hematology and Coagulation (CG Specimens) which consist of peer groups of 5 or more laboratories. Acceptable performance is established on a target value  the intervals below. An explanation on how to calculate the range of acceptability based upon these limits is also provided in your MLE Program Guide on page 37 under the heading “Acceptable Ranges for Quantitative Results.”

Hemoglobin  7% Hemoglogin, Waived  7% Hematocrit  6% Hematocrit, Waived  6% or  2 SD* White Blood Cell Count  15% Red Blood Cell Count  6% Platelet Count  25% Automated Differential  3 SD Body Fluid - White Cell Count  2 SD Body Fluid - Red Cell Count  2 SD Sedimentation Rate  3 SD Prothrombin Time  15% International Normalized Ratio (INR)  20% Activated Partial Thromboplastin Time  15% Fibrinogen  20% Specific Gravity  0.010 Reticulocyte Count  3 SD Glucose – HemoCue  12 mg/dL or  20%* Microalbumin (Quantitative)  3 SD Creatinine, Urine (Quantitative)  3 SD

*Whichever is greater

2013 MLE-M3 Participant Summary/ 5

HEMOCUE HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HQ-5 Specimen HQ-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

HemoCue 44 4.95 0.13 2.7 5.0 4.6 - 5.3 46 17.20 0.40 2.4 17.2 15.9 - 18.5

HEMOCUE HEMATOLOGYGLUCOSE (mg/dL)

Specimen HQ-5 Specimen HQ-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 56 59.0 6.2 10.5 59 47 - 72 56 297.9 13.3 4.5 300 238 - 358 HemoCue Glucose 201/+ 51 59.4 6.0 10.0 59 47 - 72 51 297.3 13.3 4.5 299 237 - 357

SEDIMENTATION RATE (MM/HR)

Specimen ES-5 Specimen ES-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 187 8.2 2.2 27.0 8 1 - 15 187 51.4 14.8 28.7 50 7 - 96 All Vital Diagnostics Methods 22 8.7 1.5 17.2 9 4 - 14 22 62.1 5.6 9.0 61 45 - 79 HiChem Mini-Ves 10 6.9 2.5 35.8 6 0 - 15 10 88.3 14.4 16.3 91 45 - 132 Polymedco Sedimat 14 6.1 1.7 27.7 7 1 - 12 14 51.2 7.1 13.9 52 29 - 73 Streck ESR-Auto Plus 12 11.3 0.8 6.9 11 8 - 14 13 68.4 8.4 12.2 68 43 - 94 Vital Diagnostics Excyte M/10 17 8.5 1.4 16.1 9 4 - 13 17 61.5 5.5 9.0 59 44 - 79 Westergren - diluted 105 8.1 2.1 26.4 8 1 - 15 106 45.7 10.6 23.3 45 13 - 78 Westergren - undiluted 12 9.0 2.0 22.2 10 3 - 15 12 47.9 14.1 29.5 48 5 - 91

SEDIMAT SEDIMENTATION RATE (MM/HR)

Specimen MAT-5 Specimen MAT-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

Polymedco Sedimat 15 18 2.0 1.2 61.8 2 0 - 6 19 62.5 15.0 24.1 63 17 - 108

6 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x K/uL)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 21.02 0.72 3.4 20.9 17.8 - 24.2 31 7.94 0.23 2.9 8.0 6.7 - 9.2 All Abbott Cell-Dyn Instruments 29 20.91 0.60 2.9 20.8 17.7 - 24.1 29 7.95 0.23 2.9 8.0 6.7 - 9.2 Abbott Cell-Dyn 3200 12 21.07 0.70 3.3 20.9 17.9 - 24.3 12 7.95 0.27 3.4 8.0 6.7 - 9.2 Abbott Cell-Dyn Ruby 12 20.92 0.46 2.2 21.0 17.7 - 24.1 12 7.99 0.18 2.3 8.0 6.7 - 9.2

Specimen CL-13 Specimen CL-14

All Method 31 3.23 0.11 3.3 3.2 2.7 - 3.8 31 7.92 0.23 2.9 7.9 6.7 - 9.2 All Abbott Cell-Dyn Instruments 29 3.23 0.11 3.4 3.2 2.7 - 3.8 29 7.92 0.24 3.0 7.9 6.7 - 9.2 Abbott Cell-Dyn 3200 12 3.28 0.10 2.9 3.3 2.7 - 3.8 12 8.08 0.21 2.6 8.1 6.8 - 9.3 Abbott Cell-Dyn Ruby 12 3.24 0.11 3.3 3.2 2.7 - 3.8 12 7.88 0.18 2.2 7.9 6.6 - 9.1

Specimen CL-15

All Method 31 20.94 0.82 3.9 20.9 17.7 - 24.1 All Abbott Cell-Dyn Instruments 29 20.82 0.72 3.4 20.8 17.6 - 24.0 Abbott Cell-Dyn 3200 12 21.03 0.87 4.1 21.1 17.8 - 24.2 Abbott Cell-Dyn Ruby 12 20.73 0.51 2.5 20.9 17.6 - 23.9

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x M/uL)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 30 5.250 0.135 2.6 5.25 4.93 - 5.57 30 4.865 0.130 2.7 4.86 4.57 - 5.16 All Abbott Cell-Dyn Instruments 29 5.239 0.163 3.1 5.25 4.92 - 5.56 28 4.871 0.133 2.7 4.87 4.57 - 5.17 Abbott Cell-Dyn 3200 12 5.120 0.156 3.0 5.17 4.81 - 5.43 12 4.803 0.143 3.0 4.82 4.51 - 5.10 Abbott Cell-Dyn Ruby 12 5.337 0.080 1.5 5.34 5.01 - 5.66 12 4.934 0.102 2.1 4.94 4.63 - 5.24

Specimen CL-13 Specimen CL-14

All Method 31 2.268 0.050 2.2 2.27 2.13 - 2.41 30 4.853 0.117 2.4 4.85 4.56 - 5.15 All Abbott Cell-Dyn Instruments 29 2.270 0.051 2.2 2.28 2.13 - 2.41 28 4.859 0.118 2.4 4.87 4.56 - 5.16 Abbott Cell-Dyn 3200 12 2.255 0.047 2.1 2.25 2.11 - 2.40 12 4.806 0.101 2.1 4.77 4.51 - 5.10 Abbott Cell-Dyn Ruby 12 2.274 0.050 2.2 2.28 2.13 - 2.42 12 4.901 0.103 2.1 4.89 4.60 - 5.20

Specimen CL-15

All Method 30 5.234 0.121 2.3 5.25 4.91 - 5.55 All Abbott Cell-Dyn Instruments 28 5.238 0.124 2.4 5.26 4.92 - 5.56 Abbott Cell-Dyn 3200 12 5.143 0.180 3.5 5.19 4.83 - 5.46 Abbott Cell-Dyn Ruby 12 5.290 0.103 2.0 5.29 4.97 - 5.61

2013 MLE-M3 Participant Summary/ 7

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 30 16.56 0.40 2.4 16.7 15.4 - 17.8 31 13.88 0.34 2.4 13.9 12.9 - 14.9 All Abbott Cell-Dyn Instruments 28 16.57 0.42 2.5 16.7 15.4 - 17.8 29 13.88 0.35 2.5 13.9 12.9 - 14.9 Abbott Cell-Dyn 3200 12 16.28 0.58 3.5 16.3 15.1 - 17.5 12 13.80 0.34 2.5 13.8 12.8 - 14.8 Abbott Cell-Dyn Ruby 12 16.78 0.32 1.9 16.8 15.6 - 18.0 12 14.06 0.34 2.4 14.0 13.0 - 15.1

Specimen CL-13 Specimen CL-14

All Method 31 5.59 0.14 2.6 5.6 5.2 - 6.0 31 13.86 0.27 2.0 13.9 12.8 - 14.9 All Abbott Cell-Dyn Instruments 29 5.60 0.15 2.6 5.6 5.2 - 6.0 29 13.87 0.28 2.0 13.9 12.9 - 14.9 Abbott Cell-Dyn 3200 12 5.63 0.17 2.9 5.7 5.2 - 6.1 12 13.84 0.32 2.3 13.9 12.8 - 14.9 Abbott Cell-Dyn Ruby 12 5.58 0.15 2.6 5.6 5.1 - 6.0 12 13.95 0.25 1.8 13.9 12.9 - 15.0

Specimen CL-15

All Method 30 16.52 0.35 2.1 16.5 15.3 - 17.7 All Abbott Cell-Dyn Instruments 28 16.51 0.36 2.2 16.5 15.3 - 17.7 Abbott Cell-Dyn 3200 12 16.26 0.53 3.2 16.4 15.1 - 17.4 Abbott Cell-Dyn Ruby 12 16.72 0.36 2.2 16.7 15.5 - 17.9

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 44.78 3.33 7.4 44.1 42.0 - 47.5 30 39.51 2.48 6.3 38.9 37.1 - 41.9 All Abbott Cell-Dyn Instruments 24 43.27 1.71 3.9 43.4 40.6 - 45.9 24 38.49 1.38 3.6 38.5 36.1 - 40.9 Abbott Cell-Dyn 3200 12 42.13 1.51 3.6 42.8 39.5 - 44.7 12 37.76 1.29 3.4 37.8 35.4 - 40.1 Abbott Cell-Dyn Ruby 12 44.42 0.97 2.2 44.5 41.7 - 47.1 12 39.23 1.05 2.7 39.2 36.8 - 41.6

Specimen CL-13 Specimen CL-14

All Method 31 15.89 1.02 6.4 15.5 14.9 - 16.9 30 39.22 2.06 5.3 38.6 36.8 - 41.6 All Abbott Cell-Dyn Instruments 24 15.40 0.40 2.6 15.5 14.4 - 16.4 24 38.40 1.12 2.9 38.2 36.0 - 40.8 Abbott Cell-Dyn 3200 12 15.24 0.38 2.5 15.2 14.3 - 16.2 12 37.78 0.86 2.3 37.5 35.5 - 40.1 Abbott Cell-Dyn Ruby 12 15.55 0.37 2.4 15.6 14.6 - 16.5 12 39.03 1.03 2.6 38.8 36.6 - 41.4

Specimen CL-15

All Method 31 44.60 3.17 7.1 43.5 41.9 - 47.3 All Abbott Cell-Dyn Instruments 24 43.16 1.65 3.8 43.3 40.5 - 45.8 Abbott Cell-Dyn 3200 12 42.27 1.62 3.8 42.7 39.7 - 44.9 Abbott Cell-Dyn Ruby 12 44.06 1.14 2.6 44.0 41.4 - 46.8

8 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x K/uL)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 494.3 34.1 6.9 494 370 - 618 30 269.3 15.8 5.9 275 201 - 337 All Abbott Cell-Dyn Instruments 29 497.9 32.0 6.4 498 373 - 623 28 271.5 13.4 4.9 275 203 - 340 Abbott Cell-Dyn 3200 12 472.3 22.3 4.7 477 354 - 591 12 264.5 14.1 5.3 264 198 - 331 Abbott Cell-Dyn Ruby 12 507.1 21.4 4.2 501 380 - 634 12 274.8 10.6 3.9 277 206 - 344

Specimen CL-13 Specimen CL-9

All Method 31 75.3 6.4 8.5 75 56 - 95 30 270.6 18.3 6.8 273 202 - 339 All Abbott Cell-Dyn Instruments 29 75.1 6.5 8.7 75 56 - 94 28 273.8 14.0 5.1 274 205 - 343 Abbott Cell-Dyn 3200 12 71.9 5.6 7.7 73 53 - 90 12 269.8 14.5 5.4 270 202 - 338 Abbott Cell-Dyn Ruby 12 74.5 4.8 6.4 74 55 - 94 12 274.5 14.3 5.2 274 205 - 344

Specimen CL-15

All Method 31 494.7 36.3 7.3 497 371 - 619 All Abbott Cell-Dyn Instruments 29 499.1 32.6 6.5 497 374 - 624 Abbott Cell-Dyn 3200 12 480.6 33.2 6.9 485 360 - 601 Abbott Cell-Dyn Ruby 12 502.8 22.6 4.5 500 377 - 629

HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 75.68 0.93 1.2 75.6 72.8 - 78.5 31 65.54 0.88 1.3 65.5 62.8 - 68.2 All Abbott Cell-Dyn Instruments 29 75.60 0.91 1.2 75.6 72.8 - 78.4 29 65.54 0.92 1.4 65.4 62.7 - 68.3 Abbott Cell-Dyn 3200 12 75.82 0.73 1.0 75.7 73.6 - 78.1 12 64.92 0.44 0.7 65.0 63.6 - 66.3 Abbott Cell-Dyn Ruby 12 75.13 0.86 1.1 75.0 72.5 - 77.8 12 65.79 0.97 1.5 65.8 62.8 - 68.7

Specimen CL-13 Specimen CL-14

All Method 31 51.75 1.13 2.2 52.0 48.3 - 55.2 31 65.75 0.79 1.2 65.8 63.3 - 68.2 All Abbott Cell-Dyn Instruments 29 51.67 1.13 2.2 51.9 48.2 - 55.1 29 65.77 0.82 1.2 65.8 63.3 - 68.3 Abbott Cell-Dyn 3200 12 51.08 1.34 2.6 50.7 47.0 - 55.1 12 65.49 0.59 0.9 65.6 63.7 - 67.3 Abbott Cell-Dyn Ruby 12 52.01 0.61 1.2 52.0 50.1 - 53.9 12 65.90 0.98 1.5 66.2 62.9 - 68.9

Specimen CL-15

All Method 31 75.79 0.83 1.1 76.0 73.3 - 78.3 All Abbott Cell-Dyn Instruments 29 75.74 0.83 1.1 76.0 73.2 - 78.3 Abbott Cell-Dyn 3200 12 75.53 0.77 1.0 75.5 73.2 - 77.9 Abbott Cell-Dyn Ruby 12 75.71 0.93 1.2 75.8 72.9 - 78.6

2013 MLE-M3 Participant Summary/ 9

HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 14.67 0.77 5.3 14.8 12.3 - 17.0 31 25.65 0.87 3.4 25.3 23.0 - 28.3 All Abbott Cell-Dyn Instruments 29 14.70 0.77 5.2 14.8 12.4 - 17.1 29 25.70 0.87 3.4 25.3 23.0 - 28.3 Abbott Cell-Dyn 3200 12 14.58 0.60 4.1 14.7 12.7 - 16.4 12 26.03 0.94 3.6 26.1 23.2 - 28.9 Abbott Cell-Dyn Ruby 12 15.00 0.77 5.2 15.0 12.6 - 17.4 12 25.58 0.80 3.1 25.3 23.1 - 28.0

Specimen CL-13 Specimen CL-14

All Method 31 38.25 1.45 3.8 38.5 33.8 - 42.7 31 25.62 0.80 3.1 25.6 23.2 - 28.1 All Abbott Cell-Dyn Instruments 29 38.41 1.36 3.5 38.6 34.3 - 42.5 29 25.69 0.78 3.0 25.8 23.3 - 28.1 Abbott Cell-Dyn 3200 12 38.93 1.13 2.9 39.3 35.5 - 42.4 12 25.79 0.97 3.8 25.8 22.8 - 28.8 Abbott Cell-Dyn Ruby 12 37.85 0.90 2.4 37.9 35.1 - 40.6 12 25.58 0.70 2.7 25.6 23.4 - 27.7

Specimen CL-15

All Method 30 14.51 0.77 5.3 14.6 12.2 - 16.9 All Abbott Cell-Dyn Instruments 29 14.64 0.93 6.4 14.6 11.8 - 17.5 Abbott Cell-Dyn 3200 12 14.84 0.85 5.7 15.0 12.3 - 17.4 Abbott Cell-Dyn Ruby 12 14.46 1.14 7.9 14.6 11.0 - 17.9

HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 3.01 0.38 12.8 3.1 1.8 - 4.2 31 3.99 0.47 11.8 3.9 2.5 - 5.4 All Abbott Cell-Dyn Instruments 29 3.01 0.40 13.1 3.1 1.8 - 4.2 29 3.92 0.40 10.1 3.9 2.7 - 5.2 Abbott Cell-Dyn 3200 12 2.91 0.33 11.4 3.1 1.9 - 4.0 12 3.96 0.45 11.5 4.0 2.5 - 5.4 Abbott Cell-Dyn Ruby 12 3.11 0.33 10.8 3.1 2.1 - 4.2 12 3.88 0.40 10.2 3.8 2.6 - 5.1

Specimen CL-13 Specimen CL-14

All Method 31 5.97 0.97 16.3 5.9 3.0 - 8.9 31 3.98 0.48 12.0 4.0 2.5 - 5.5 All Abbott Cell-Dyn Instruments 29 5.95 0.99 16.6 5.9 2.9 - 9.0 29 3.92 0.42 10.8 4.0 2.6 - 5.2 Abbott Cell-Dyn 3200 12 5.85 0.98 16.8 5.8 2.9 - 8.8 12 3.98 0.49 12.3 4.1 2.5 - 5.5 Abbott Cell-Dyn Ruby 12 6.03 0.77 12.9 5.9 3.7 - 8.4 12 3.87 0.43 11.2 3.9 2.5 - 5.2

Specimen CL-15

All Method 31 3.00 0.49 16.2 3.2 1.5 - 4.5 All Abbott Cell-Dyn Instruments 29 2.98 0.49 16.6 3.2 1.4 - 4.5 Abbott Cell-Dyn 3200 12 2.96 0.63 21.3 3.1 1.0 - 4.9 Abbott Cell-Dyn Ruby 12 3.08 0.32 10.3 3.2 2.1 - 4.1

10 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALEOSINOPHILS (percent)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 30 6.05 0.20 3.3 6.1 5.4 - 6.7 30 4.40 0.26 5.9 4.4 3.6 - 5.2 All Abbott Cell-Dyn Instruments 29 6.04 0.19 3.2 6.0 5.4 - 6.7 29 4.42 0.24 5.5 4.4 3.6 - 5.2 Abbott Cell-Dyn 3200 12 6.05 0.23 3.8 6.1 5.3 - 6.8 12 4.50 0.24 5.4 4.6 3.7 - 5.3 Abbott Cell-Dyn Ruby 12 6.03 0.20 3.3 6.1 5.4 - 6.7 12 4.35 0.17 3.9 4.3 3.8 - 4.9

Specimen CL-13 Specimen CL-14

All Method 31 3.34 0.33 9.9 3.3 2.3 - 4.4 31 4.21 0.28 6.7 4.2 3.3 - 5.1 All Abbott Cell-Dyn Instruments 29 3.36 0.33 9.8 3.4 2.3 - 4.4 29 4.23 0.27 6.4 4.2 3.4 - 5.1 Abbott Cell-Dyn 3200 12 3.30 0.40 12.0 3.2 2.1 - 4.5 12 4.31 0.31 7.1 4.3 3.3 - 5.3 Abbott Cell-Dyn Ruby 12 3.48 0.27 7.8 3.5 2.6 - 4.4 12 4.18 0.27 6.5 4.2 3.3 - 5.0

Specimen CL-15

All Method 29 6.02 0.23 3.7 6.0 5.3 - 6.7 All Abbott Cell-Dyn Instruments 28 6.00 0.20 3.3 6.0 5.3 - 6.6 Abbott Cell-Dyn 3200 12 6.00 0.22 3.7 6.0 5.3 - 6.7 Abbott Cell-Dyn Ruby 12 5.98 0.22 3.6 6.0 5.3 - 6.7

HEMATOLOGY W/ 5-PART DIFFERENTIALBASOPHILS (percent)

Specimen CL-11 Specimen CL-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 0.65 0.28 42.7 0.6 0.0 - 1.5 31 0.46 0.27 58.6 0.4 0.0 - 1.3 All Abbott Cell-Dyn Instruments 29 0.66 0.28 41.8 0.6 0.0 - 1.5 29 0.43 0.25 57.2 0.4 0.0 - 1.2 Abbott Cell-Dyn 3200 12 0.63 0.32 51.1 0.6 0.0 - 1.6 12 0.59 0.25 41.7 0.7 0.0 - 1.4 Abbott Cell-Dyn Ruby 12 0.73 0.19 26.4 0.7 0.1 - 1.3 12 0.35 0.16 46.4 0.3 0.0 - 0.9

Specimen CL-13 Specimen CL-14

All Method 31 0.72 0.42 58.4 0.7 0.0 - 2.0 31 0.45 0.27 60.1 0.5 0.0 - 1.3 All Abbott Cell-Dyn Instruments 29 0.65 0.34 51.8 0.7 0.0 - 1.7 29 0.41 0.23 56.5 0.4 0.0 - 1.2 Abbott Cell-Dyn 3200 12 0.83 0.36 42.6 0.9 0.0 - 1.9 12 0.45 0.25 55.7 0.5 0.0 - 1.3 Abbott Cell-Dyn Ruby 12 0.55 0.21 38.4 0.6 0.0 - 1.2 12 0.45 0.20 44.9 0.5 0.0 - 1.1

Specimen CL-15

All Method 31 0.63 0.28 44.1 0.6 0.0 - 1.5 All Abbott Cell-Dyn Instruments 29 0.64 0.28 43.4 0.6 0.0 - 1.5 Abbott Cell-Dyn 3200 12 0.66 0.38 57.0 0.6 0.0 - 1.8 Abbott Cell-Dyn Ruby 12 0.69 0.12 17.9 0.7 0.3 - 1.1

2013 MLE-M3 Participant Summary/ 11

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 54 20.51 0.34 1.6 20.5 17.4 - 23.6 57 8.34 0.20 2.5 8.3 7.0 - 9.6 All Sysmex Instruments 53 20.51 0.34 1.7 20.5 17.4 - 23.6 56 8.33 0.20 2.4 8.3 7.0 - 9.6 Sysmex KX-21N & K - 800,1000,4500 35 20.47 0.44 2.1 20.5 17.3 - 23.6 36 8.27 0.18 2.2 8.3 7.0 - 9.6 Sysmex pocH-100i 20 20.46 0.38 1.9 20.4 17.3 - 23.6 20 8.43 0.19 2.3 8.5 7.1 - 9.7

Specimen SYX-13 Specimen SYX-14

All Method 57 2.86 0.10 3.4 2.8 2.4 - 3.3 57 8.33 0.22 2.6 8.3 7.0 - 9.6 All Sysmex Instruments 56 2.86 0.10 3.5 2.8 2.4 - 3.3 56 8.33 0.22 2.6 8.3 7.0 - 9.6 Sysmex KX-21N & K - 800,1000,4500 36 2.84 0.10 3.5 2.8 2.4 - 3.3 36 8.25 0.20 2.4 8.2 7.0 - 9.5 Sysmex pocH-100i 20 2.89 0.09 3.2 2.9 2.4 - 3.4 20 8.46 0.18 2.2 8.5 7.1 - 9.8

Specimen SYX-15

All Method 57 20.44 0.47 2.3 20.5 17.3 - 23.6 All Sysmex Instruments 56 20.44 0.47 2.3 20.5 17.3 - 23.6 Sysmex KX-21N & K - 800,1000,4500 36 20.48 0.52 2.5 20.5 17.4 - 23.6 Sysmex pocH-100i 20 20.38 0.39 1.9 20.4 17.3 - 23.5

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALRED BLOOD CELL COUNT (x 1012/L)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 56 5.593 0.083 1.5 5.61 5.25 - 5.93 57 4.196 0.054 1.3 4.20 3.94 - 4.45 All Sysmex Instruments 55 5.595 0.082 1.5 5.61 5.25 - 5.94 56 4.197 0.054 1.3 4.20 3.94 - 4.45 Sysmex KX-21N & K - 800,1000,4500 35 5.576 0.071 1.3 5.58 5.24 - 5.92 36 4.179 0.040 1.0 4.18 3.92 - 4.43 Sysmex pocH-100i 20 5.629 0.091 1.6 5.64 5.29 - 5.97 20 4.229 0.061 1.4 4.24 3.97 - 4.49

Specimen SYX-13 Specimen SYX-14

All Method 56 2.529 0.039 1.5 2.53 2.37 - 2.69 57 4.202 0.062 1.5 4.21 3.94 - 4.46 All Sysmex Instruments 55 2.529 0.039 1.6 2.53 2.37 - 2.69 56 4.203 0.061 1.5 4.21 3.95 - 4.46 Sysmex KX-21N & K - 800,1000,4500 35 2.516 0.026 1.0 2.52 2.36 - 2.67 36 4.179 0.048 1.2 4.18 3.92 - 4.43 Sysmex pocH-100i 20 2.551 0.049 1.9 2.55 2.39 - 2.71 20 4.248 0.058 1.4 4.25 3.99 - 4.51

Specimen SYX-15

All Method 56 5.617 0.064 1.1 5.61 5.27 - 5.96 All Sysmex Instruments 55 5.618 0.064 1.1 5.61 5.28 - 5.96 Sysmex KX-21N & K - 800,1000,4500 35 5.599 0.052 0.9 5.60 5.26 - 5.94 Sysmex pocH-100i 20 5.652 0.070 1.2 5.66 5.31 - 6.00

12 / 2013 MLE-M3 Participant Summary

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 54 18.20 0.23 1.2 18.2 16.9 - 19.5 55 12.22 0.14 1.1 12.2 11.3 - 13.1 All Sysmex Instruments 53 18.21 0.22 1.2 18.2 16.9 - 19.5 54 12.22 0.14 1.1 12.2 11.3 - 13.1 Sysmex KX-21N & K - 800,1000,4500 35 18.23 0.20 1.1 18.3 16.9 - 19.6 36 12.27 0.13 1.0 12.3 11.4 - 13.2 Sysmex pocH-100i 20 18.17 0.41 2.3 18.1 16.8 - 19.5 19 12.12 0.15 1.2 12.1 11.2 - 13.0

Specimen SYX-13 Specimen SYX-14

All Method 57 6.34 0.12 1.9 6.3 5.8 - 6.8 56 12.23 0.15 1.2 12.2 11.3 - 13.1 All Sysmex Instruments 56 6.34 0.12 1.9 6.3 5.8 - 6.8 55 12.23 0.15 1.2 12.2 11.3 - 13.1 Sysmex KX-21N & K - 800,1000,4500 36 6.37 0.10 1.5 6.4 5.9 - 6.9 36 12.27 0.13 1.1 12.3 11.4 - 13.2 Sysmex pocH-100i 20 6.28 0.13 2.1 6.3 5.8 - 6.8 20 12.15 0.18 1.5 12.2 11.2 - 13.0

Specimen SYX-15

All Method 56 18.19 0.23 1.3 18.2 16.9 - 19.5 All Sysmex Instruments 55 18.20 0.23 1.3 18.2 16.9 - 19.5 Sysmex KX-21N & K - 800,1000,4500 36 18.28 0.18 1.0 18.3 17.0 - 19.6 Sysmex pocH-100i 19 18.04 0.23 1.3 18.0 16.7 - 19.4

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMATOCRIT (percent)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 57 48.06 1.23 2.6 47.9 45.1 - 51.0 57 32.59 0.99 3.1 32.3 30.6 - 34.6 All Sysmex Instruments 56 48.05 1.24 2.6 47.9 45.1 - 51.0 56 32.57 0.99 3.0 32.3 30.6 - 34.6 Sysmex KX-21N & K - 800,1000,4500 36 47.44 0.69 1.5 47.6 44.5 - 50.3 36 31.95 0.44 1.4 32.0 30.0 - 33.9 Sysmex pocH-100i 20 49.16 1.25 2.5 49.2 46.2 - 52.2 20 33.68 0.69 2.0 33.7 31.6 - 35.8

Specimen SYX-13 Specimen SYX-14

All Method 57 17.42 0.59 3.4 17.2 16.3 - 18.5 57 32.68 0.99 3.0 32.5 30.7 - 34.7 All Sysmex Instruments 56 17.41 0.59 3.4 17.2 16.3 - 18.5 56 32.66 0.99 3.0 32.5 30.7 - 34.7 Sysmex KX-21N & K - 800,1000,4500 36 17.06 0.25 1.5 17.0 16.0 - 18.1 36 32.03 0.46 1.4 32.2 30.1 - 34.0 Sysmex pocH-100i 20 18.04 0.49 2.7 18.0 16.9 - 19.2 20 33.80 0.59 1.8 33.7 31.7 - 35.9

Specimen SYX-15

All Method 57 48.19 1.10 2.3 47.9 45.2 - 51.1 All Sysmex Instruments 56 48.17 1.10 2.3 47.9 45.2 - 51.1 Sysmex KX-21N & K - 800,1000,4500 36 47.57 0.59 1.2 47.5 44.7 - 50.5 Sysmex pocH-100i 20 49.25 0.97 2.0 49.2 46.2 - 52.3

2013 MLE-M3 Participant Summary/ 13

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALPLATELET COUNT (x109/L)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 56 376.6 18.9 5.0 380 282 - 471 57 201.4 8.9 4.4 202 151 - 252 All Sysmex Instruments 56 376.6 18.9 5.0 380 282 - 471 56 201.6 8.9 4.4 202 151 - 252 Sysmex KX-21N & K - 800,1000,4500 36 385.6 14.1 3.7 389 289 - 483 36 204.5 8.3 4.1 205 153 - 256 Sysmex pocH-100i 20 360.3 15.1 4.2 361 270 - 451 20 196.2 7.4 3.8 196 147 - 246

Specimen SYX-13 Specimen SYX-14

All Method 55 65.1 3.3 5.1 65 48 - 82 56 203.2 6.6 3.3 201 152 - 254 All Sysmex Instruments 54 65.0 3.3 5.1 65 48 - 82 55 203.3 6.6 3.2 201 152 - 255 Sysmex KX-21N & K - 800,1000,4500 34 65.1 3.0 4.6 65 48 - 82 36 203.6 7.2 3.5 202 152 - 255 Sysmex pocH-100i 20 64.9 3.9 6.0 65 48 - 82 18 201.8 3.7 1.8 201 151 - 253

Specimen SYX-10

All Method 57 378.2 22.0 5.8 381 283 - 473 All Sysmex Instruments 56 378.9 21.5 5.7 381 284 - 474 Sysmex KX-21N & K - 800,1000,4500 36 390.2 15.3 3.9 390 292 - 488 Sysmex pocH-100i 20 358.6 15.0 4.2 360 268 - 449

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALLYMPH W/SCR (percent)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 53 61.00 0.73 1.2 61.1 58.8 - 63.2 54 28.95 1.00 3.5 29.0 25.9 - 32.0 All Sysmex Instruments 52 60.99 0.74 1.2 61.1 58.7 - 63.3 53 28.95 1.01 3.5 29.0 25.9 - 32.0 Sysmex KX-21N & K - 800,1000,4500 32 61.30 0.54 0.9 61.3 59.6 - 63.0 34 29.41 0.76 2.6 29.5 27.1 - 31.7 Sysmex pocH-100i 19 60.57 0.68 1.1 60.6 58.5 - 62.7 19 28.13 0.90 3.2 28.2 25.4 - 30.9

Specimen SYX-13 Specimen SYX-14

All Method 54 9.57 1.22 12.8 9.6 5.9 - 13.3 54 28.70 1.09 3.8 28.8 25.4 - 32.0 All Sysmex Instruments 53 9.61 1.21 12.6 9.6 5.9 - 13.3 53 28.71 1.10 3.8 28.8 25.4 - 32.1 Sysmex KX-21N & K - 800,1000,4500 34 10.26 0.88 8.6 10.3 7.6 - 13.0 33 29.28 0.71 2.4 29.2 27.1 - 31.4 Sysmex pocH-100i 19 8.44 0.76 9.0 8.5 6.1 - 10.8 19 27.84 0.97 3.5 28.0 24.9 - 30.8

Specimen SYX-15

All Method 54 61.07 0.79 1.3 61.1 58.7 - 63.5 All Sysmex Instruments 53 61.08 0.79 1.3 61.1 58.7 - 63.5 Sysmex KX-21N & K - 800,1000,4500 34 61.21 0.85 1.4 61.4 58.6 - 63.8 Sysmex pocH-100i 19 60.84 0.60 1.0 60.7 59.0 - 62.7

14 / 2013 MLE-M3 Participant Summary

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALMONO/MIXED W/MCR (percent)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 53 11.83 0.85 7.2 11.9 9.2 - 14.4 53 15.36 0.91 5.9 15.4 12.6 - 18.2 All Sysmex Instruments 52 11.84 0.86 7.3 11.9 9.2 - 14.5 52 15.38 0.91 5.9 15.5 12.6 - 18.2 Sysmex KX-21N & K - 800,1000,4500 33 12.29 0.60 4.9 12.3 10.4 - 14.1 33 15.69 0.70 4.5 15.6 13.5 - 17.8 Sysmex pocH-100i 19 11.06 0.67 6.0 10.8 9.0 - 13.1 19 14.86 0.99 6.7 15.0 11.8 - 17.9

Specimen SYX-13 Specimen SYX-14

All Method 52 17.69 1.65 9.3 17.9 12.7 - 22.7 53 15.17 1.19 7.9 15.1 11.5 - 18.8 All Sysmex Instruments 50 17.86 1.44 8.1 18.0 13.5 - 22.2 52 15.18 1.20 7.9 15.2 11.5 - 18.8 Sysmex KX-21N & K - 800,1000,4500 32 18.47 1.20 6.5 18.5 14.8 - 22.1 33 15.76 0.93 5.9 15.5 12.9 - 18.6 Sysmex pocH-100i 19 16.57 1.48 8.9 16.5 12.1 - 21.1 19 14.16 0.93 6.6 14.3 11.3 - 17.0

Specimen SYX-15

All Method 53 11.94 0.99 8.3 11.9 8.9 - 15.0 All Sysmex Instruments 52 11.96 0.99 8.2 11.9 9.0 - 15.0 Sysmex KX-21N & K - 800,1000,4500 33 12.50 0.73 5.9 12.3 10.3 - 14.8 Sysmex pocH-100i 19 11.02 0.57 5.1 11.0 9.3 - 12.8

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALNEUT W/LCR (percent)

Specimen SYX-11 Specimen SYX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 52 27.17 1.20 4.4 26.8 23.5 - 30.8 53 55.71 1.48 2.7 55.5 51.2 - 60.2 All Sysmex Instruments 52 27.17 1.20 4.4 26.8 23.5 - 30.8 52 55.68 1.49 2.7 55.5 51.2 - 60.2 Sysmex KX-21N & K - 800,1000,4500 33 26.48 0.71 2.7 26.5 24.3 - 28.7 33 54.92 1.02 1.9 54.8 51.8 - 58.0 Sysmex pocH-100i 19 28.36 0.89 3.1 28.6 25.6 - 31.1 19 57.01 1.21 2.1 57.2 53.3 - 60.7

Specimen SYX-13 Specimen SYX-14

All Method 53 72.62 2.55 3.5 72.6 64.9 - 80.3 52 56.15 1.78 3.2 56.0 50.8 - 61.5 All Sysmex Instruments 52 72.52 2.46 3.4 72.5 65.1 - 80.0 51 56.13 1.79 3.2 56.0 50.7 - 61.5 Sysmex KX-21N & K - 800,1000,4500 33 71.10 1.64 2.3 71.0 66.1 - 76.1 33 55.07 1.09 2.0 55.2 51.8 - 58.4 Sysmex pocH-100i 19 74.98 1.52 2.0 75.1 70.4 - 79.6 18 58.07 1.00 1.7 58.3 55.0 - 61.1

Specimen SYX-15

All Method 53 26.98 1.21 4.5 26.7 23.3 - 30.7 All Sysmex Instruments 52 26.94 1.19 4.4 26.7 23.3 - 30.6 Sysmex KX-21N & K - 800,1000,4500 33 26.24 0.79 3.0 26.2 23.8 - 28.7 Sysmex pocH-100i 19 28.14 0.70 2.5 28.2 26.0 - 30.3

2013 MLE-M3 Participant Summary/ 15

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 784 7.50 0.29 3.9 7.5 6.3 - 8.7 786 15.31 0.55 3.6 15.3 13.0 - 17.7 All Abbott Cell-Dyn Instruments 299 7.56 0.34 4.5 7.6 6.4 - 8.7 301 15.23 0.65 4.3 15.3 12.9 - 17.6 All ABX Instruments 116 7.35 0.14 2.0 7.3 6.2 - 8.5 117 15.19 0.31 2.0 15.2 12.9 - 17.5 All COULTER Instruments 266 7.59 0.21 2.8 7.6 6.4 - 8.8 266 15.57 0.38 2.5 15.5 13.2 - 18.0 All Danam/Drew Scientific Instruments 16 7.18 0.19 2.6 7.2 6.1 - 8.3 16 14.66 0.29 2.0 14.7 12.4 - 16.9 Abbott Cell-Dyn 1700 29 7.69 0.35 4.6 7.7 6.5 - 8.9 30 15.81 0.65 4.1 15.9 13.4 - 18.2 Abbott Cell-Dyn 1800 153 7.69 0.31 4.0 7.7 6.5 - 8.9 151 15.48 0.50 3.2 15.5 13.1 - 17.8 Abbott Cell-Dyn Emerald 115 7.35 0.30 4.0 7.4 6.2 - 8.5 116 14.75 0.52 3.5 14.8 12.5 - 17.0 ABX Diagnostics Micros/45/60 116 7.35 0.14 2.0 7.3 6.2 - 8.5 117 15.19 0.31 2.0 15.2 12.9 - 17.5 Boule Medonic CA 620 12 7.63 0.36 4.8 7.6 6.4 - 8.8 12 15.79 0.35 2.2 15.8 13.4 - 18.2 Boule Medonic M series 72 7.22 0.24 3.3 7.2 6.1 - 8.4 71 14.88 0.49 3.3 14.9 12.6 - 17.2 COULTER AcT 8/10 14 7.55 0.29 3.9 7.5 6.4 - 8.7 14 15.67 0.47 3.0 15.6 13.3 - 18.1 COULTER AcT diff/diff 2 249 7.59 0.21 2.8 7.6 6.4 - 8.8 247 15.57 0.36 2.3 15.5 13.2 - 18.0 Drew Scientific D3 16 7.18 0.19 2.6 7.2 6.1 - 8.3 16 14.66 0.29 2.0 14.7 12.4 - 16.9

Specimen HD-13 Specimen HD-14

All Method 782 6.53 0.25 3.8 6.5 5.5 - 7.6 787 16.11 0.60 3.7 16.1 13.6 - 18.6 All Abbott Cell-Dyn Instruments 297 6.56 0.27 4.1 6.6 5.5 - 7.6 303 16.03 0.72 4.5 16.0 13.6 - 18.5 All ABX Instruments 117 6.37 0.14 2.2 6.4 5.4 - 7.4 115 16.02 0.28 1.7 16.0 13.6 - 18.5 All COULTER Instruments 264 6.62 0.18 2.8 6.6 5.6 - 7.7 268 16.38 0.41 2.5 16.4 13.9 - 18.9 All Danam/Drew Scientific Instruments 16 6.36 0.15 2.4 6.4 5.4 - 7.4 16 15.45 0.40 2.6 15.4 13.1 - 17.8 Abbott Cell-Dyn 1700 29 6.59 0.24 3.7 6.7 5.6 - 7.6 30 16.51 0.59 3.6 16.6 14.0 - 19.0 Abbott Cell-Dyn 1800 146 6.58 0.24 3.7 6.6 5.5 - 7.6 150 16.39 0.54 3.3 16.5 13.9 - 18.9 Abbott Cell-Dyn Emerald 116 6.49 0.28 4.3 6.5 5.5 - 7.5 116 15.46 0.52 3.3 15.5 13.1 - 17.8 ABX Diagnostics Micros/45/60 117 6.37 0.14 2.2 6.4 5.4 - 7.4 115 16.02 0.28 1.7 16.0 13.6 - 18.5 Boule Medonic CA 620 12 6.67 0.23 3.5 6.7 5.6 - 7.7 12 16.53 0.51 3.1 16.6 14.0 - 19.1 Boule Medonic M series 70 6.28 0.20 3.1 6.3 5.3 - 7.3 70 15.56 0.48 3.1 15.5 13.2 - 17.9 COULTER AcT 8/10 14 6.66 0.21 3.2 6.7 5.6 - 7.7 14 16.53 0.31 1.9 16.5 14.0 - 19.1 COULTER AcT diff/diff 2 246 6.62 0.18 2.8 6.6 5.6 - 7.7 250 16.38 0.40 2.5 16.4 13.9 - 18.9 Drew Scientific D3 16 6.36 0.15 2.4 6.4 5.4 - 7.4 16 15.45 0.40 2.6 15.4 13.1 - 17.8

16 / 2013 MLE-M3 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L) cont’d

Specimen HD-15

Instrument Labs Mean SD CV Median Range

All Method 785 6.24 0.23 3.7 6.2 5.3 - 7.2 All Abbott Cell-Dyn Instruments 297 6.25 0.24 3.8 6.2 5.3 - 7.2 All ABX Instruments 116 6.07 0.14 2.3 6.1 5.1 - 7.0 All COULTER Instruments 268 6.35 0.17 2.7 6.4 5.4 - 7.4 All Danam/Drew Scientific Instruments 16 6.06 0.13 2.1 6.1 5.1 - 7.0 Abbott Cell-Dyn 1700 29 6.44 0.18 2.7 6.5 5.4 - 7.5 Abbott Cell-Dyn 1800 150 6.28 0.21 3.4 6.3 5.3 - 7.3 Abbott Cell-Dyn Emerald 114 6.16 0.24 3.8 6.2 5.2 - 7.1 ABX Diagnostics Micros/45/60 116 6.07 0.14 2.3 6.1 5.1 - 7.0 Boule Medonic CA 620 12 6.37 0.17 2.7 6.4 5.4 - 7.4 Boule Medonic M series 72 6.02 0.21 3.5 6.0 5.1 - 7.0 COULTER AcT 8/10 14 6.39 0.19 3.0 6.4 5.4 - 7.4 COULTER AcT diff/diff 2 250 6.35 0.17 2.7 6.4 5.4 - 7.4 Drew Scientific D3 16 6.06 0.13 2.1 6.1 5.1 - 7.0

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012/L)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 706 3.252 0.168 5.2 3.27 3.05 - 3.45 776 4.464 0.132 3.0 4.47 4.19 - 4.74 All Abbott Cell-Dyn Instruments 242 3.161 0.169 5.3 3.16 2.97 - 3.36 297 4.438 0.158 3.6 4.46 4.17 - 4.71 All ABX Instruments 100 3.194 0.125 3.9 3.21 3.00 - 3.39 114 4.408 0.091 2.1 4.42 4.14 - 4.68 All COULTER Instruments 263 3.371 0.109 3.2 3.37 3.16 - 3.58 266 4.528 0.101 2.2 4.52 4.25 - 4.80 All Danam/Drew Scientific Instruments 12 2.988 0.183 6.1 2.97 2.80 - 3.17 16 4.260 0.219 5.1 4.32 4.00 - 4.52 Abbott Cell-Dyn 1700 20 3.173 0.111 3.5 3.16 2.98 - 3.37 29 4.553 0.125 2.8 4.57 4.27 - 4.83 Abbott Cell-Dyn 1800 131 3.249 0.145 4.5 3.25 3.05 - 3.45 149 4.498 0.122 2.7 4.51 4.22 - 4.77 Abbott Cell-Dyn Emerald 88 3.026 0.117 3.9 3.02 2.84 - 3.21 114 4.333 0.146 3.4 4.33 4.07 - 4.60 ABX Diagnostics Micros/45/60 100 3.194 0.125 3.9 3.21 3.00 - 3.39 114 4.408 0.091 2.1 4.42 4.14 - 4.68 Boule Medonic CA 620 12 3.258 0.089 2.7 3.26 3.06 - 3.46 12 4.429 0.090 2.0 4.44 4.16 - 4.70 Boule Medonic M series 70 3.274 0.090 2.8 3.27 3.07 - 3.48 72 4.433 0.097 2.2 4.43 4.16 - 4.70 COULTER AcT 8/10 14 3.233 0.106 3.3 3.23 3.03 - 3.43 14 4.502 0.059 1.3 4.51 4.23 - 4.78 COULTER AcT diff/diff 2 246 3.381 0.101 3.0 3.38 3.17 - 3.59 249 4.531 0.105 2.3 4.52 4.25 - 4.81 Drew Scientific D3 12 2.988 0.183 6.1 2.97 2.80 - 3.17 16 4.260 0.219 5.1 4.32 4.00 - 4.52

2013 MLE-M3 Participant Summary/ 17

12 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALRED BLOOD CELL COUNT (x 10 /L) cont’d

Specimen HD-13 Specimen HD-14

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 782 5.974 0.149 2.5 5.97 5.61 - 6.34 764 3.312 0.138 4.2 3.32 3.11 - 3.52 All Abbott Cell-Dyn Instruments 300 5.935 0.150 2.5 5.94 5.57 - 6.30 292 3.268 0.173 5.3 3.29 3.07 - 3.47 All ABX Instruments 117 5.967 0.124 2.1 5.98 5.60 - 6.33 113 3.246 0.104 3.2 3.24 3.05 - 3.45 All COULTER Instruments 264 6.013 0.157 2.6 6.01 5.65 - 6.38 263 3.393 0.088 2.6 3.39 3.18 - 3.60 All Danam/Drew Scientific Instruments 16 5.900 0.157 2.7 5.91 5.54 - 6.26 12 3.168 0.086 2.7 3.19 2.97 - 3.36 Abbott Cell-Dyn 1700 29 6.096 0.153 2.5 6.09 5.73 - 6.47 27 3.344 0.125 3.7 3.35 3.14 - 3.55 Abbott Cell-Dyn 1800 152 5.929 0.122 2.1 5.93 5.57 - 6.29 148 3.345 0.149 4.5 3.38 3.14 - 3.55 Abbott Cell-Dyn Emerald 116 5.902 0.163 2.8 5.90 5.54 - 6.26 114 3.146 0.150 4.8 3.14 2.95 - 3.34 ABX Diagnostics Micros/45/60 117 5.967 0.124 2.1 5.98 5.60 - 6.33 113 3.246 0.104 3.2 3.24 3.05 - 3.45 Boule Medonic CA 620 12 5.994 0.101 1.7 6.01 5.63 - 6.36 12 3.290 0.059 1.8 3.28 3.09 - 3.49 Boule Medonic M series 71 6.013 0.115 1.9 6.01 5.65 - 6.38 71 3.293 0.069 2.1 3.29 3.09 - 3.50 COULTER AcT 8/10 14 6.094 0.123 2.0 6.07 5.72 - 6.46 14 3.316 0.142 4.3 3.35 3.11 - 3.52 COULTER AcT diff/diff 2 246 6.010 0.158 2.6 6.01 5.64 - 6.38 246 3.397 0.088 2.6 3.40 3.19 - 3.61 Drew Scientific D3 16 5.900 0.157 2.7 5.91 5.54 - 6.26 12 3.168 0.086 2.7 3.19 2.97 - 3.36

Specimen HD-15

All Method 789 4.772 0.120 2.5 4.77 4.48 - 5.06 All Abbott Cell-Dyn Instruments 302 4.781 0.131 2.7 4.78 4.49 - 5.07 All ABX Instruments 116 4.724 0.098 2.1 4.74 4.44 - 5.01 All COULTER Instruments 267 4.796 0.115 2.4 4.80 4.50 - 5.09 All Danam/Drew Scientific Instruments 16 4.759 0.125 2.6 4.79 4.47 - 5.05 Abbott Cell-Dyn 1700 29 4.865 0.151 3.1 4.90 4.57 - 5.16 Abbott Cell-Dyn 1800 150 4.830 0.095 2.0 4.83 4.53 - 5.12 Abbott Cell-Dyn Emerald 115 4.694 0.111 2.4 4.70 4.41 - 4.98 ABX Diagnostics Micros/45/60 116 4.724 0.098 2.1 4.74 4.44 - 5.01 Boule Medonic CA 620 12 4.708 0.105 2.2 4.74 4.42 - 5.00 Boule Medonic M series 72 4.741 0.084 1.8 4.73 4.45 - 5.03 COULTER AcT 8/10 14 4.847 0.095 2.0 4.85 4.55 - 5.14 COULTER AcT diff/diff 2 249 4.794 0.116 2.4 4.80 4.50 - 5.09 Drew Scientific D3 16 4.759 0.125 2.6 4.79 4.47 - 5.05

18 / 2013 MLE-M3 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 797 9.75 0.30 3.1 9.7 9.0 - 10.5 798 13.64 0.38 2.8 13.6 12.6 - 14.6 All Abbott Cell-Dyn Instruments 303 9.96 0.26 2.6 10.0 9.2 - 10.7 303 13.95 0.30 2.1 14.0 12.9 - 15.0 All ABX Instruments 117 9.55 0.15 1.6 9.6 8.8 - 10.3 117 13.35 0.19 1.4 13.4 12.4 - 14.3 All COULTER Instruments 267 9.56 0.22 2.3 9.6 8.8 - 10.3 266 13.44 0.28 2.1 13.4 12.4 - 14.4 All Danam/Drew Scientific Instruments 16 9.78 0.21 2.1 9.9 9.0 - 10.5 16 13.63 0.27 1.9 13.7 12.6 - 14.6 Abbott Cell-Dyn 1700 29 9.98 0.19 1.9 9.9 9.2 - 10.7 29 13.89 0.25 1.8 13.8 12.9 - 14.9 Abbott Cell-Dyn 1800 152 10.06 0.24 2.4 10.1 9.3 - 10.8 150 14.06 0.27 1.9 14.1 13.0 - 15.1 Abbott Cell-Dyn Emerald 117 9.82 0.23 2.3 9.8 9.1 - 10.6 118 13.84 0.28 2.0 13.9 12.8 - 14.9 ABX Diagnostics Micros/45/60 117 9.55 0.15 1.6 9.6 8.8 - 10.3 117 13.35 0.19 1.4 13.4 12.4 - 14.3 Boule Medonic CA 620 12 9.71 0.11 1.1 9.7 9.0 - 10.4 12 13.30 0.20 1.5 13.3 12.3 - 14.3 Boule Medonic M series 71 9.89 0.18 1.9 9.9 9.1 - 10.6 72 13.63 0.25 1.9 13.6 12.6 - 14.6 COULTER AcT 8/10 14 9.73 0.22 2.3 9.7 9.0 - 10.5 14 13.54 0.27 2.0 13.5 12.5 - 14.5 COULTER AcT diff/diff 2 249 9.54 0.22 2.3 9.5 8.8 - 10.3 248 13.43 0.28 2.1 13.4 12.4 - 14.4 Drew Scientific D3 16 9.78 0.21 2.1 9.9 9.0 - 10.5 16 13.63 0.27 1.9 13.7 12.6 - 14.6

Specimen HD-13 Specimen HD-14

All Method 792 18.16 0.50 2.8 18.1 16.8 - 19.5 792 10.61 0.32 3.0 10.6 9.8 - 11.4 All Abbott Cell-Dyn Instruments 301 18.56 0.39 2.1 18.6 17.2 - 19.9 303 10.87 0.26 2.4 10.9 10.1 - 11.7 All ABX Instruments 116 17.74 0.23 1.3 17.8 16.4 - 19.0 114 10.37 0.14 1.3 10.4 9.6 - 11.1 All COULTER Instruments 263 17.92 0.37 2.1 17.9 16.6 - 19.2 267 10.43 0.24 2.3 10.4 9.6 - 11.2 All Danam/Drew Scientific Instruments 16 18.22 0.40 2.2 18.3 16.9 - 19.5 16 10.63 0.23 2.1 10.7 9.8 - 11.4 Abbott Cell-Dyn 1700 29 18.26 0.31 1.7 18.2 16.9 - 19.6 29 10.84 0.21 2.0 10.8 10.0 - 11.6 Abbott Cell-Dyn 1800 152 18.66 0.40 2.2 18.7 17.3 - 20.0 150 11.00 0.23 2.1 11.0 10.2 - 11.8 Abbott Cell-Dyn Emerald 116 18.51 0.35 1.9 18.5 17.2 - 19.9 116 10.73 0.20 1.9 10.7 9.9 - 11.5 ABX Diagnostics Micros/45/60 116 17.74 0.23 1.3 17.8 16.4 - 19.0 114 10.37 0.14 1.3 10.4 9.6 - 11.1 Boule Medonic CA 620 12 17.88 0.21 1.2 17.9 16.6 - 19.2 12 10.39 0.17 1.6 10.4 9.6 - 11.2 Boule Medonic M series 71 18.10 0.32 1.8 18.1 16.8 - 19.4 70 10.63 0.20 1.8 10.6 9.8 - 11.4 COULTER AcT 8/10 14 17.97 0.35 2.0 17.9 16.7 - 19.3 14 10.59 0.25 2.4 10.6 9.8 - 11.4 COULTER AcT diff/diff 2 245 17.91 0.37 2.1 17.9 16.6 - 19.2 248 10.42 0.23 2.2 10.4 9.6 - 11.2 Drew Scientific D3 16 18.22 0.40 2.2 18.3 16.9 - 19.5 16 10.63 0.23 2.1 10.7 9.8 - 11.4

2013 MLE-M3 Participant Summary/ 19

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMOGLOBIN (g/dL) cont’d

Specimen HD-15

Instrument Labs Mean SD CV Median Range

All Method 796 14.56 0.39 2.7 14.5 13.5 - 15.6 All Abbott Cell-Dyn Instruments 301 14.87 0.31 2.1 14.9 13.8 - 16.0 All ABX Instruments 115 14.29 0.22 1.5 14.3 13.2 - 15.3 All COULTER Instruments 266 14.37 0.30 2.1 14.4 13.3 - 15.4 All Danam/Drew Scientific Instruments 16 14.63 0.26 1.8 14.7 13.6 - 15.7 Abbott Cell-Dyn 1700 29 14.71 0.23 1.6 14.6 13.6 - 15.8 Abbott Cell-Dyn 1800 151 14.95 0.29 2.0 14.9 13.9 - 16.0 Abbott Cell-Dyn Emerald 116 14.80 0.29 2.0 14.8 13.7 - 15.9 ABX Diagnostics Micros/45/60 115 14.29 0.22 1.5 14.3 13.2 - 15.3 Boule Medonic CA 620 12 14.26 0.18 1.3 14.3 13.2 - 15.3 Boule Medonic M series 72 14.48 0.24 1.7 14.5 13.4 - 15.5 COULTER AcT 8/10 14 14.50 0.27 1.8 14.5 13.4 - 15.6 COULTER AcT diff/diff 2 248 14.36 0.30 2.1 14.3 13.3 - 15.4 Drew Scientific D3 16 14.63 0.26 1.8 14.7 13.6 - 15.7

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 731 28.36 1.20 4.2 28.5 26.6 - 30.1 785 41.24 1.52 3.7 41.2 38.7 - 43.8 All Abbott Cell-Dyn Instruments 252 28.61 1.18 4.1 28.7 26.8 - 30.4 298 42.29 1.37 3.3 42.4 39.7 - 44.9 All ABX Instruments 112 26.95 0.99 3.7 27.0 25.3 - 28.6 114 39.52 0.85 2.2 39.5 37.1 - 41.9 All COULTER Instruments 265 28.88 0.80 2.8 28.9 27.1 - 30.7 266 41.17 0.96 2.3 41.1 38.6 - 43.7 All Danam/Drew Scientific Instruments 12 27.74 1.25 4.5 28.0 26.0 - 29.5 16 40.35 1.62 4.0 40.9 37.9 - 42.8 Abbott Cell-Dyn 1700 25 27.74 1.30 4.7 27.5 26.0 - 29.5 27 42.44 1.05 2.5 42.5 39.8 - 45.0 Abbott Cell-Dyn 1800 124 28.75 1.17 4.1 28.7 27.0 - 30.5 150 42.39 1.33 3.1 42.5 39.8 - 45.0 Abbott Cell-Dyn Emerald 99 28.67 1.06 3.7 28.8 26.9 - 30.4 116 42.17 1.45 3.4 42.1 39.6 - 44.7 ABX Diagnostics Micros/45/60 112 26.95 0.99 3.7 27.0 25.3 - 28.6 114 39.52 0.85 2.2 39.5 37.1 - 41.9 Boule Medonic CA 620 12 26.94 0.73 2.7 27.0 25.3 - 28.6 12 38.84 1.30 3.4 39.1 36.5 - 41.2 Boule Medonic M series 70 28.05 0.74 2.6 27.9 26.3 - 29.8 72 40.58 1.06 2.6 40.7 38.1 - 43.1 COULTER AcT 8/10 14 28.94 0.53 1.8 28.8 27.1 - 30.7 13 41.62 0.47 1.1 41.6 39.1 - 44.2 COULTER AcT diff/diff 2 248 28.91 0.82 2.8 28.9 27.1 - 30.7 249 41.16 0.97 2.3 41.1 38.6 - 43.7 Drew Scientific D3 12 27.74 1.25 4.5 28.0 26.0 - 29.5 16 40.35 1.62 4.0 40.9 37.9 - 42.8

20 / 2013 MLE-M3 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMATOCRIT (percent) cont’d

Specimen HD-13 Specimen HD-14

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 790 56.53 1.87 3.3 56.5 53.1 - 60.0 759 30.82 1.33 4.3 30.9 28.9 - 32.7 All Abbott Cell-Dyn Instruments 301 57.77 1.47 2.6 57.8 54.3 - 61.3 278 31.62 1.12 3.5 31.7 29.7 - 33.6 All ABX Instruments 117 54.77 1.15 2.1 55.0 51.4 - 58.1 111 28.98 0.78 2.7 29.0 27.2 - 30.8 All COULTER Instruments 266 55.91 1.54 2.8 55.9 52.5 - 59.3 267 31.05 0.85 2.7 31.1 29.1 - 33.0 All Danam/Drew Scientific Instruments 16 55.96 1.69 3.0 55.7 52.5 - 59.4 13 30.28 1.21 4.0 30.8 28.4 - 32.2 Abbott Cell-Dyn 1700 28 58.19 1.58 2.7 58.3 54.6 - 61.7 26 31.28 1.18 3.8 31.4 29.4 - 33.2 Abbott Cell-Dyn 1800 151 57.57 1.33 2.3 57.5 54.1 - 61.1 139 31.86 1.13 3.5 31.9 29.9 - 33.8 Abbott Cell-Dyn Emerald 117 57.93 1.63 2.8 57.9 54.4 - 61.5 109 31.42 1.02 3.3 31.4 29.5 - 33.4 ABX Diagnostics Micros/45/60 117 54.77 1.15 2.1 55.0 51.4 - 58.1 111 28.98 0.78 2.7 29.0 27.2 - 30.8 Boule Medonic CA 620 12 53.99 1.69 3.1 54.0 50.7 - 57.3 12 28.84 0.81 2.8 28.8 27.1 - 30.6 Boule Medonic M series 71 56.77 1.45 2.6 56.8 53.3 - 60.2 70 30.08 0.69 2.3 30.0 28.2 - 31.9 COULTER AcT 8/10 14 56.96 1.08 1.9 57.1 53.5 - 60.4 14 31.14 0.80 2.6 31.3 29.2 - 33.1 COULTER AcT diff/diff 2 248 55.87 1.54 2.8 55.8 52.5 - 59.3 249 31.05 0.85 2.7 31.1 29.1 - 33.0 Drew Scientific D3 16 55.96 1.69 3.0 55.7 52.5 - 59.4 13 30.28 1.21 4.0 30.8 28.4 - 32.2

Specimen HD-15

All Method 792 45.59 1.80 3.9 45.5 42.8 - 48.4 All Abbott Cell-Dyn Instruments 301 47.13 1.28 2.7 47.2 44.3 - 50.0 All ABX Instruments 116 43.58 0.96 2.2 43.6 40.9 - 46.2 All COULTER Instruments 267 45.03 1.14 2.5 45.1 42.3 - 47.8 All Danam/Drew Scientific Instruments 16 45.85 1.38 3.0 45.8 43.0 - 48.7 Abbott Cell-Dyn 1700 27 47.22 1.36 2.9 47.2 44.3 - 50.1 Abbott Cell-Dyn 1800 149 47.33 1.15 2.4 47.3 44.4 - 50.2 Abbott Cell-Dyn Emerald 117 46.88 1.28 2.7 47.0 44.0 - 49.7 ABX Diagnostics Micros/45/60 116 43.58 0.96 2.2 43.6 40.9 - 46.2 Boule Medonic CA 620 12 42.57 1.49 3.5 42.9 40.0 - 45.2 Boule Medonic M series 72 44.87 1.13 2.5 44.8 42.1 - 47.6 COULTER AcT 8/10 14 45.71 0.89 1.9 45.8 42.9 - 48.5 COULTER AcT diff/diff 2 249 45.01 1.13 2.5 45.0 42.3 - 47.8 Drew Scientific D3 16 45.85 1.38 3.0 45.8 43.0 - 48.7

2013 MLE-M3 Participant Summary/ 21

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 796 474.7 71.0 15.0 504 356 - 594 795 283.2 36.7 13.0 288 212 - 355 All Abbott Cell-Dyn Instruments 302 526.6 26.1 4.9 525 394 - 659 302 316.2 17.5 5.5 315 237 - 396 All ABX Instruments 117 525.8 20.9 4.0 526 394 - 658 116 292.8 12.7 4.3 291 219 - 367 All COULTER Instruments 265 382.3 26.3 6.9 381 286 - 478 268 242.6 18.2 7.5 240 181 - 304 All Danam/Drew Scientific Instruments 16 535.4 22.0 4.1 534 401 - 670 16 323.3 13.9 4.3 320 242 - 405 Abbott Cell-Dyn 1700 30 534.6 31.8 5.9 533 400 - 669 30 305.0 19.8 6.5 303 228 - 382 Abbott Cell-Dyn 1800 152 519.0 22.9 4.4 521 389 - 649 150 312.6 14.7 4.7 312 234 - 391 Abbott Cell-Dyn Emerald 114 535.5 22.2 4.1 536 401 - 670 116 322.7 17.0 5.3 322 242 - 404 ABX Diagnostics Micros/45/60 117 525.8 20.9 4.0 526 394 - 658 116 292.8 12.7 4.3 291 219 - 367 Boule Medonic CA 620 12 490.3 22.5 4.6 484 367 - 613 12 281.6 45.7 16.2 279 211 - 352 Boule Medonic M series 72 496.0 23.3 4.7 496 372 - 621 70 269.0 11.7 4.4 269 201 - 337 COULTER AcT 8/10 14 384.8 23.1 6.0 390 288 - 481 14 243.3 22.2 9.1 236 182 - 305 COULTER AcT diff/diff 2 248 381.9 26.5 6.9 379 286 - 478 248 241.9 17.1 7.1 240 181 - 303 Drew Scientific D3 16 535.4 22.0 4.1 534 401 - 670 16 323.3 13.9 4.3 320 242 - 405

Specimen HD-13 Specimen HD-14

All Method 795 530.0 82.4 15.6 539 397 - 663 791 242.8 33.5 13.8 251 182 - 304 All Abbott Cell-Dyn Instruments 304 609.1 39.6 6.5 608 456 - 762 304 268.3 17.9 6.7 268 201 - 336 All ABX Instruments 117 539.0 18.2 3.4 539 404 - 674 115 260.2 11.4 4.4 261 195 - 326 All COULTER Instruments 265 433.7 31.6 7.3 433 325 - 543 263 202.6 15.3 7.6 201 151 - 254 All Danam/Drew Scientific Instruments 16 585.6 21.0 3.6 588 439 - 733 16 273.9 12.6 4.6 271 205 - 343 Abbott Cell-Dyn 1700 30 606.1 42.8 7.1 601 454 - 758 30 256.0 15.6 6.1 255 192 - 320 Abbott Cell-Dyn 1800 153 632.4 29.4 4.6 634 474 - 791 150 260.0 13.0 5.0 260 195 - 326 Abbott Cell-Dyn Emerald 117 578.6 28.1 4.9 579 433 - 724 117 281.1 15.1 5.4 280 210 - 352 ABX Diagnostics Micros/45/60 117 539.0 18.2 3.4 539 404 - 674 115 260.2 11.4 4.4 261 195 - 326 Boule Medonic CA 620 12 531.2 31.0 5.8 536 398 - 664 12 238.9 17.0 7.1 236 179 - 299 Boule Medonic M series 71 525.8 26.2 5.0 525 394 - 658 70 243.8 14.2 5.8 243 182 - 305 COULTER AcT 8/10 14 431.9 22.2 5.1 432 323 - 540 14 206.4 30.8 14.9 197 154 - 258 COULTER AcT diff/diff 2 247 432.9 31.3 7.2 433 324 - 542 245 202.2 14.5 7.2 202 151 - 253 Drew Scientific D3 16 585.6 21.0 3.6 588 439 - 733 16 273.9 12.6 4.6 271 205 - 343

22 / 2013 MLE-M3 Participant Summary

9 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALPLATELET COUNT (x 10 /L) cont’d

Specimen HD-15

Instrument Labs Mean SD CV Median Range

All Method 790 120.7 18.6 15.4 122 90 - 151 All Abbott Cell-Dyn Instruments 302 135.3 12.1 9.0 134 101 - 170 All ABX Instruments 116 126.1 10.4 8.2 124 94 - 158 All COULTER Instruments 266 101.6 10.4 10.2 100 76 - 128 All Danam/Drew Scientific Instruments 16 134.3 11.7 8.7 137 100 - 168 Abbott Cell-Dyn 1700 30 130.9 9.6 7.3 132 98 - 164 Abbott Cell-Dyn 1800 147 130.6 8.9 6.8 131 97 - 164 Abbott Cell-Dyn Emerald 118 141.3 12.6 8.9 142 105 - 177 ABX Diagnostics Micros/45/60 116 126.1 10.4 8.2 124 94 - 158 Boule Medonic CA 620 12 121.7 10.5 8.7 121 91 - 153 Boule Medonic M series 70 115.6 9.8 8.5 115 86 - 145 COULTER AcT 8/10 14 98.6 5.5 5.6 100 73 - 124 COULTER AcT diff/diff 2 248 101.5 10.2 10.0 100 76 - 127 Drew Scientific D3 16 134.3 11.7 8.7 137 100 - 168

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALLYMPHOCYTES (percent)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 750 36.09 3.19 8.8 36.6 26.5 - 45.7 752 53.51 3.31 6.2 54.2 43.5 - 63.5 All Abbott Cell-Dyn Instruments 288 35.77 3.93 11.0 36.9 23.9 - 47.6 288 52.43 4.15 7.9 53.9 39.9 - 64.9 All ABX Instruments 110 34.57 1.03 3.0 34.4 31.4 - 37.7 109 52.11 1.09 2.1 51.9 48.8 - 55.4 All COULTER Instruments 244 38.27 1.80 4.7 38.4 32.8 - 43.7 239 55.84 1.48 2.6 55.9 51.4 - 60.3 All Danam/Drew Scientific Instruments 16 35.26 2.07 5.9 35.0 29.0 - 41.5 16 53.82 2.36 4.4 52.8 46.7 - 61.0 Abbott Cell-Dyn 1700 26 39.02 1.59 4.1 38.8 34.2 - 43.8 27 57.13 1.41 2.5 57.0 52.9 - 61.4 Abbott Cell-Dyn 1800 140 38.47 1.72 4.5 38.5 33.3 - 43.7 141 55.36 1.51 2.7 55.5 50.8 - 60.0 Abbott Cell-Dyn Emerald 109 31.38 0.92 2.9 31.4 28.6 - 34.2 110 47.71 0.71 1.5 47.7 45.5 - 49.9 ABX Diagnostics Micros/45/60 110 34.57 1.03 3.0 34.4 31.4 - 37.7 109 52.11 1.09 2.1 51.9 48.8 - 55.4 Boule Medonic CA 620 12 35.08 0.92 2.6 35.2 32.3 - 37.9 12 54.41 1.13 2.1 54.4 51.0 - 57.9 Boule Medonic M series 69 33.20 1.14 3.4 33.1 29.7 - 36.7 70 52.16 1.04 2.0 52.2 49.0 - 55.3 COULTER AcT 8/10 11 33.25 2.71 8.2 33.1 25.1 - 41.4 11 49.87 2.65 5.3 49.3 41.9 - 57.9 COULTER AcT diff/diff 2 234 38.42 1.60 4.2 38.4 33.6 - 43.3 235 55.88 1.43 2.6 55.9 51.5 - 60.2 Drew Scientific D3 16 35.26 2.07 5.9 35.0 29.0 - 41.5 16 53.82 2.36 4.4 52.8 46.7 - 61.0

2013 MLE-M3 Participant Summary/ 23

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALLYMPHOCYTES (percent) cont’d

Specimen HD-13 Specimen HD-14

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 742 34.78 2.24 6.4 34.9 28.0 - 41.6 751 54.82 3.16 5.8 55.5 45.3 - 64.3 All Abbott Cell-Dyn Instruments 283 34.48 2.91 8.4 34.7 25.7 - 43.3 289 53.77 3.70 6.9 55.2 42.6 - 64.9 All ABX Instruments 110 33.97 1.05 3.1 33.9 30.8 - 37.2 110 53.70 1.05 2.0 53.5 50.5 - 56.9 All COULTER Instruments 241 36.05 1.35 3.7 36.0 32.0 - 40.2 236 57.40 1.30 2.3 57.6 53.5 - 61.3 All Danam/Drew Scientific Instruments 16 34.66 2.00 5.8 34.4 28.6 - 40.7 16 55.14 1.68 3.0 54.7 50.1 - 60.2 Abbott Cell-Dyn 1700 26 37.81 1.66 4.4 37.6 32.8 - 42.8 28 58.21 1.67 2.9 58.1 53.2 - 63.3 Abbott Cell-Dyn 1800 137 35.95 1.76 4.9 35.9 30.6 - 41.3 141 56.32 1.26 2.2 56.5 52.5 - 60.2 Abbott Cell-Dyn Emerald 112 31.68 1.26 4.0 31.5 27.8 - 35.5 112 49.49 0.61 1.2 49.4 47.6 - 51.4 ABX Diagnostics Micros/45/60 110 33.97 1.05 3.1 33.9 30.8 - 37.2 110 53.70 1.05 2.0 53.5 50.5 - 56.9 Boule Medonic CA 620 12 35.25 1.00 2.8 35.3 32.2 - 38.3 12 54.32 1.04 1.9 54.3 51.1 - 57.5 Boule Medonic M series 70 33.54 0.91 2.7 33.5 30.8 - 36.3 69 52.44 1.06 2.0 52.4 49.2 - 55.7 COULTER AcT 8/10 11 31.71 1.92 6.1 31.4 25.9 - 37.5 11 51.67 2.60 5.0 50.7 43.8 - 59.5 COULTER AcT diff/diff 2 235 36.11 1.27 3.5 36.0 32.2 - 40.0 232 57.39 1.27 2.2 57.6 53.5 - 61.3 Drew Scientific D3 16 34.66 2.00 5.8 34.4 28.6 - 40.7 16 55.14 1.68 3.0 54.7 50.1 - 60.2

Specimen HD-15

All Method 748 33.86 2.31 6.8 34.1 26.9 - 40.9 All Abbott Cell-Dyn Instruments 286 33.19 2.65 8.0 33.7 25.2 - 41.2 All ABX Instruments 111 33.11 1.04 3.2 32.9 29.9 - 36.3 All COULTER Instruments 239 35.59 1.23 3.5 35.6 31.8 - 39.3 All Danam/Drew Scientific Instruments 16 34.59 1.70 4.9 34.2 29.4 - 39.7 Abbott Cell-Dyn 1700 27 36.67 1.36 3.7 36.6 32.5 - 40.8 Abbott Cell-Dyn 1800 137 34.66 1.24 3.6 34.7 30.9 - 38.4 Abbott Cell-Dyn Emerald 111 30.42 1.08 3.5 30.2 27.1 - 33.7 ABX Diagnostics Micros/45/60 111 33.11 1.04 3.2 32.9 29.9 - 36.3 Boule Medonic CA 620 12 34.47 0.56 1.6 34.5 32.7 - 36.2 Boule Medonic M series 70 31.99 1.09 3.4 32.1 28.7 - 35.3 COULTER AcT 8/10 11 31.63 2.11 6.7 31.0 25.2 - 38.0 COULTER AcT diff/diff 2 233 35.60 1.19 3.3 35.6 32.0 - 39.2 Drew Scientific D3 16 34.59 1.70 4.9 34.2 29.4 - 39.7

24 / 2013 MLE-M3 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALMONO/MID/MIXED/MCR (percent)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 719 6.83 2.26 33.1 6.7 0.0 - 13.7 736 7.74 2.34 30.2 7.2 0.7 - 14.8 All Abbott Cell-Dyn Instruments 284 7.65 2.29 30.0 7.2 0.7 - 14.6 284 8.52 2.83 33.2 7.9 0.0 - 17.0 All ABX Instruments 109 8.67 0.71 8.2 8.7 6.5 - 10.8 109 9.39 0.82 8.7 9.6 6.9 - 11.9 All COULTER Instruments 219 4.70 1.36 28.9 4.6 0.6 - 8.8 236 6.32 1.41 22.3 6.4 2.1 - 10.6 All Danam/Drew Scientific Instruments 16 7.91 1.70 21.5 8.5 2.7 - 13.1 16 8.06 2.20 27.3 9.0 1.4 - 14.7 Abbott Cell-Dyn 1700 28 4.76 0.84 17.7 4.7 2.2 - 7.3 28 5.03 0.99 19.7 5.0 2.0 - 8.0 Abbott Cell-Dyn 1800 137 6.25 1.11 17.8 6.1 2.9 - 9.6 134 6.65 1.16 17.5 6.5 3.1 - 10.2 Abbott Cell-Dyn Emerald 108 10.18 0.68 6.6 10.3 8.1 - 12.3 111 11.67 0.46 3.9 11.7 10.2 - 13.1 ABX Diagnostics Micros/45/60 109 8.67 0.71 8.2 8.7 6.5 - 10.8 109 9.39 0.82 8.7 9.6 6.9 - 11.9 Boule Medonic CA 620 13 7.12 0.49 6.9 7.2 5.6 - 8.7 13 7.00 0.36 5.1 7.1 5.9 - 8.1 Boule Medonic M series 69 7.08 0.71 10.0 7.0 4.9 - 9.2 69 6.83 0.56 8.2 6.7 5.1 - 8.6 COULTER AcT diff/diff 2 217 4.70 1.35 28.8 4.6 0.6 - 8.8 234 6.33 1.41 22.2 6.4 2.1 - 10.6 Drew Scientific D3 16 7.91 1.70 21.5 8.5 2.7 - 13.1 16 8.06 2.20 27.3 9.0 1.4 - 14.7

Specimen HD-13 Specimen HD-14

All Method 736 6.79 1.79 26.3 6.6 1.4 - 12.2 734 6.85 2.19 32.0 6.4 0.2 - 13.5 All Abbott Cell-Dyn Instruments 283 7.49 1.90 25.4 7.5 1.7 - 13.2 284 7.77 2.52 32.5 7.1 0.2 - 15.4 All ABX Instruments 107 8.01 0.58 7.3 8.1 6.2 - 9.8 107 8.38 0.66 7.8 8.5 6.4 - 10.4 All COULTER Instruments 237 5.48 1.28 23.3 5.4 1.6 - 9.4 236 5.14 1.21 23.6 5.2 1.4 - 8.8 All Danam/Drew Scientific Instruments 16 7.09 1.89 26.7 7.9 1.4 - 12.8 16 7.08 1.59 22.4 7.7 2.3 - 11.9 Abbott Cell-Dyn 1700 27 4.75 0.93 19.6 4.8 1.9 - 7.6 28 4.57 0.93 20.3 4.7 1.7 - 7.4 Abbott Cell-Dyn 1800 137 6.56 1.09 16.6 6.4 3.2 - 9.9 136 6.15 1.05 17.1 6.1 3.0 - 9.4 Abbott Cell-Dyn Emerald 110 9.41 0.50 5.3 9.5 7.9 - 11.0 112 10.58 0.41 3.8 10.6 9.3 - 11.8 ABX Diagnostics Micros/45/60 107 8.01 0.58 7.3 8.1 6.2 - 9.8 107 8.38 0.66 7.8 8.5 6.4 - 10.4 Boule Medonic CA 620 13 7.15 1.09 15.3 6.9 3.8 - 10.5 13 6.91 0.51 7.3 7.0 5.3 - 8.5 Boule Medonic M series 68 6.43 0.68 10.6 6.3 4.3 - 8.5 67 6.55 0.39 5.9 6.5 5.3 - 7.8 COULTER AcT diff/diff 2 234 5.47 1.27 23.2 5.4 1.6 - 9.3 233 5.12 1.20 23.4 5.2 1.5 - 8.8 Drew Scientific D3 16 7.09 1.89 26.7 7.9 1.4 - 12.8 16 7.08 1.59 22.4 7.7 2.3 - 11.9

2013 MLE-M3 Participant Summary/ 25

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALMONO/MID/MIXED/MCR (percent) cont’d

Specimen HD-15

Instrument Labs Mean SD CV Median Range

All Method 724 5.82 1.88 32.3 5.6 0.1 - 11.5 All Abbott Cell-Dyn Instruments 282 6.67 2.01 30.1 6.6 0.6 - 12.7 All ABX Instruments 108 7.00 0.58 8.2 7.1 5.2 - 8.8 All COULTER Instruments 228 4.23 1.14 27.0 4.1 0.8 - 7.7 All Danam/Drew Scientific Instruments 16 5.78 1.51 26.1 6.2 1.2 - 10.4 Abbott Cell-Dyn 1700 28 3.74 0.71 19.1 3.8 1.5 - 5.9 Abbott Cell-Dyn 1800 137 5.58 1.08 19.4 5.5 2.3 - 8.9 Abbott Cell-Dyn Emerald 112 8.78 0.45 5.2 8.8 7.4 - 10.2 ABX Diagnostics Micros/45/60 108 7.00 0.58 8.2 7.1 5.2 - 8.8 Boule Medonic CA 620 13 5.92 0.82 13.8 6.1 3.4 - 8.4 Boule Medonic M series 68 5.74 0.74 12.8 5.7 3.5 - 8.0 COULTER AcT diff/diff 2 225 4.21 1.13 26.8 4.1 0.8 - 7.6 Drew Scientific D3 16 5.78 1.51 26.1 6.2 1.2 - 10.4

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALGRANULOCYTES/NEUT (percent)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 730 57.10 1.63 2.9 57.0 52.2 - 62.0 734 38.66 1.43 3.7 38.3 34.3 - 43.0 All Abbott Cell-Dyn Instruments 281 56.63 1.91 3.4 56.4 50.9 - 62.4 284 38.98 1.50 3.9 38.6 34.4 - 43.5 All ABX Instruments 112 56.74 0.74 1.3 56.8 54.5 - 59.0 112 38.45 0.60 1.6 38.5 36.6 - 40.3 All COULTER Instruments 236 57.12 0.86 1.5 57.1 54.5 - 59.7 238 37.84 0.65 1.7 37.8 35.8 - 39.8 All Danam/Drew Scientific Instruments 15 56.45 0.56 1.0 56.2 54.7 - 58.2 16 38.12 0.55 1.5 38.1 36.4 - 39.8 Abbott Cell-Dyn 1700 25 56.23 1.18 2.1 56.3 52.6 - 59.8 26 37.90 0.92 2.4 38.1 35.1 - 40.7 Abbott Cell-Dyn 1800 139 55.29 1.18 2.1 55.5 51.7 - 58.9 140 37.99 0.61 1.6 38.0 36.1 - 39.9 Abbott Cell-Dyn Emerald 111 58.37 1.32 2.3 58.5 54.4 - 62.4 110 40.55 0.89 2.2 40.5 37.8 - 43.3 ABX Diagnostics Micros/45/60 112 56.74 0.74 1.3 56.8 54.5 - 59.0 112 38.45 0.60 1.6 38.5 36.6 - 40.3 Boule Medonic CA 620 12 57.72 0.99 1.7 58.0 54.7 - 60.7 12 38.55 1.19 3.1 38.4 34.9 - 42.2 Boule Medonic M series 69 59.73 1.46 2.4 59.6 55.3 - 64.2 69 41.07 1.12 2.7 41.1 37.6 - 44.5 COULTER AcT diff/diff 2 233 57.13 0.86 1.5 57.1 54.5 - 59.7 235 37.84 0.65 1.7 37.8 35.8 - 39.8 Drew Scientific D3 15 56.45 0.56 1.0 56.2 54.7 - 58.2 16 38.12 0.55 1.5 38.1 36.4 - 39.8

26 / 2013 MLE-M3 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALGRANULOCYTES/NEUT (percent) cont’d

Specimen HD-13 Specimen HD-14

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 723 58.42 1.19 2.0 58.4 54.8 - 62.0 729 38.28 1.38 3.6 37.9 34.1 - 42.5 All Abbott Cell-Dyn Instruments 278 58.09 1.46 2.5 58.2 53.7 - 62.5 284 38.49 1.35 3.5 38.2 34.4 - 42.6 All ABX Instruments 112 58.14 0.82 1.4 58.1 55.6 - 60.6 112 37.94 0.54 1.4 38.0 36.3 - 39.6 All COULTER Instruments 235 58.48 0.74 1.3 58.5 56.2 - 60.7 234 37.47 0.62 1.7 37.5 35.6 - 39.4 All Danam/Drew Scientific Instruments 16 58.24 0.82 1.4 58.4 55.7 - 60.8 16 37.78 0.36 1.0 37.9 36.7 - 38.9 Abbott Cell-Dyn 1700 25 57.41 1.25 2.2 57.7 53.6 - 61.2 26 37.42 0.95 2.5 37.5 34.5 - 40.3 Abbott Cell-Dyn 1800 135 57.52 1.30 2.3 57.7 53.6 - 61.5 140 37.58 0.61 1.6 37.6 35.7 - 39.5 Abbott Cell-Dyn Emerald 113 58.89 1.29 2.2 59.1 55.0 - 62.8 111 39.93 0.75 1.9 39.9 37.6 - 42.2 ABX Diagnostics Micros/45/60 112 58.14 0.82 1.4 58.1 55.6 - 60.6 112 37.94 0.54 1.4 38.0 36.3 - 39.6 Boule Medonic CA 620 12 57.55 1.08 1.9 57.6 54.2 - 60.9 12 38.69 1.30 3.4 38.8 34.7 - 42.7 Boule Medonic M series 70 59.98 1.06 1.8 60.1 56.8 - 63.2 67 41.07 1.09 2.6 41.1 37.8 - 44.4 COULTER AcT diff/diff 2 232 58.48 0.74 1.3 58.5 56.2 - 60.7 231 37.48 0.61 1.6 37.5 35.6 - 39.4 Drew Scientific D3 16 58.24 0.82 1.4 58.4 55.7 - 60.8 16 37.78 0.36 1.0 37.9 36.7 - 38.9

Specimen HD-15

All Method 724 60.31 1.12 1.9 60.2 56.9 - 63.7 All Abbott Cell-Dyn Instruments 282 60.17 1.16 1.9 60.1 56.6 - 63.7 All ABX Instruments 113 59.94 0.79 1.3 60.0 57.5 - 62.3 All COULTER Instruments 238 60.31 0.85 1.4 60.3 57.7 - 62.9 All Danam/Drew Scientific Instruments 16 59.63 0.47 0.8 59.8 58.2 - 61.1 Abbott Cell-Dyn 1700 26 59.61 1.07 1.8 59.7 56.3 - 62.9 Abbott Cell-Dyn 1800 139 59.78 0.93 1.6 59.8 56.9 - 62.6 Abbott Cell-Dyn Emerald 111 60.81 1.13 1.9 60.9 57.4 - 64.2 ABX Diagnostics Micros/45/60 113 59.94 0.79 1.3 60.0 57.5 - 62.3 Boule Medonic CA 620 12 59.40 1.03 1.7 59.1 56.3 - 62.5 Boule Medonic M series 69 62.27 1.33 2.1 62.3 58.2 - 66.3 COULTER AcT diff/diff 2 235 60.32 0.85 1.4 60.3 57.7 - 62.9 Drew Scientific D3 16 59.63 0.47 0.8 59.8 58.2 - 61.1

2013 MLE-M3 Participant Summary/ 27

HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 17 22.72 0.33 1.5 22.7 19.3 - 26.2 18 10.40 0.18 1.7 10.4 8.8 - 12.0 All COULTER Instruments 17 22.72 0.33 1.5 22.7 19.3 - 26.2 18 10.40 0.18 1.7 10.4 8.8 - 12.0

Specimen DIF-13 Specimen DIF-14

All Method 19 4.04 0.13 3.3 4.0 3.4 - 4.7 18 10.30 0.18 1.7 10.3 8.7 - 11.9 All COULTER Instruments 19 4.04 0.13 3.3 4.0 3.4 - 4.7 18 10.30 0.18 1.7 10.3 8.7 - 11.9

Specimen DIF-15

All Method 19 22.57 0.37 1.6 22.7 19.1 - 26.0 All COULTER Instruments 19 22.57 0.37 1.6 22.7 19.1 - 26.0

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012/L)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 18 5.419 0.076 1.4 5.44 5.09 - 5.75 19 4.058 0.064 1.6 4.06 3.81 - 4.31 All COULTER Instruments 18 5.419 0.076 1.4 5.44 5.09 - 5.75 19 4.058 0.064 1.6 4.06 3.81 - 4.31

Specimen DIF-13 Specimen DIF-14

All Method 19 2.602 0.050 1.9 2.61 2.44 - 2.76 19 4.031 0.074 1.8 4.03 3.78 - 4.28 All COULTER Instruments 19 2.602 0.050 1.9 2.61 2.44 - 2.76 19 4.031 0.074 1.8 4.03 3.78 - 4.28

Specimen DIF-15

All Method 19 5.414 0.077 1.4 5.41 5.08 - 5.74 All COULTER Instruments 19 5.414 0.077 1.4 5.41 5.08 - 5.74

28 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 18 16.88 0.22 1.3 16.9 15.6 - 18.1 18 11.84 0.11 1.0 11.9 11.0 - 12.7 All COULTER Instruments 18 16.88 0.22 1.3 16.9 15.6 - 18.1 18 11.84 0.11 1.0 11.9 11.0 - 12.7

Specimen DIF-13 Specimen DIF-14

All Method 19 6.52 0.08 1.2 6.5 6.0 - 7.0 18 11.81 0.13 1.1 11.8 10.9 - 12.7 All COULTER Instruments 19 6.52 0.08 1.2 6.5 6.0 - 7.0 18 11.81 0.13 1.1 11.8 10.9 - 12.7

Specimen DIF-15

All Method 19 16.82 0.18 1.1 16.9 15.6 - 18.0 All COULTER Instruments 19 16.82 0.18 1.1 16.9 15.6 - 18.0

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 18 52.90 0.97 1.8 53.2 49.7 - 56.1 19 36.36 0.76 2.1 36.3 34.1 - 38.6 All COULTER Instruments 18 52.90 0.97 1.8 53.2 49.7 - 56.1 19 36.36 0.76 2.1 36.3 34.1 - 38.6

Specimen DIF-13 Specimen DIF-14

All Method 19 19.98 0.41 2.0 19.9 18.7 - 21.2 19 36.16 0.87 2.4 36.1 33.9 - 38.4 All COULTER Instruments 19 19.98 0.41 2.0 19.9 18.7 - 21.2 19 36.16 0.87 2.4 36.1 33.9 - 38.4

Specimen DIF-15

All Method 19 52.92 0.95 1.8 52.8 49.7 - 56.1 All COULTER Instruments 19 52.92 0.95 1.8 52.8 49.7 - 56.1

2013 MLE-M3 Participant Summary/ 29

HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 485.6 25.3 5.2 484 364 - 607 19 255.9 16.7 6.5 258 191 - 320 All COULTER Instruments 19 485.6 25.3 5.2 484 364 - 607 19 255.9 16.7 6.5 258 191 - 320

Specimen DIF-13 Specimen DIF-14

All Method 19 80.1 3.5 4.3 80 60 - 101 19 254.6 21.0 8.2 253 190 - 319 All COULTER Instruments 19 80.1 3.5 4.3 80 60 - 101 19 254.6 21.0 8.2 253 190 - 319

Specimen DIF-15

All Method 19 480.4 29.2 6.1 478 360 - 601 All COULTER Instruments 19 480.4 29.2 6.1 478 360 - 601

HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 67.64 2.08 3.1 67.7 61.3 - 73.9 19 61.56 1.98 3.2 60.9 55.6 - 67.5 All COULTER Instruments 19 67.64 2.08 3.1 67.7 61.3 - 73.9 19 61.56 1.98 3.2 60.9 55.6 - 67.5

Specimen DIF-13 Specimen DIF-14

All Method 18 50.94 0.82 1.6 51.0 48.4 - 53.4 19 61.29 2.25 3.7 60.2 54.5 - 68.1 All COULTER Instruments 18 50.94 0.82 1.6 51.0 48.4 - 53.4 19 61.29 2.25 3.7 60.2 54.5 - 68.1

Specimen DIF-15

All Method 19 66.62 2.27 3.4 66.3 59.8 - 73.5 All COULTER Instruments 19 66.62 2.27 3.4 66.3 59.8 - 73.5

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HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 17.22 4.66 27.1 19.3 3.2 - 31.2 19 27.13 2.83 10.4 28.2 18.6 - 35.7 All COULTER Instruments 19 17.22 4.66 27.1 19.3 3.2 - 31.2 19 27.13 2.83 10.4 28.2 18.6 - 35.7

Specimen DIF-13 Specimen DIF-14

All Method 19 38.97 2.31 5.9 40.0 32.0 - 45.9 19 28.20 2.26 8.0 28.6 21.4 - 35.0 All COULTER Instruments 19 38.97 2.31 5.9 40.0 32.0 - 45.9 19 28.20 2.26 8.0 28.6 21.4 - 35.0

Specimen DIF-15

All Method 19 18.36 3.38 18.4 19.6 8.2 - 28.6 All COULTER Instruments 19 18.36 3.38 18.4 19.6 8.2 - 28.6

HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 7.44 1.14 15.3 7.5 4.0 - 10.9 19 4.35 1.03 23.7 4.7 1.2 - 7.5 All COULTER Instruments 19 7.44 1.14 15.3 7.5 4.0 - 10.9 19 4.35 1.03 23.7 4.7 1.2 - 7.5

Specimen DIF-13 Specimen DIF-14

All Method 19 0.34 0.31 90.8 0.2 0.0 - 1.3 19 4.11 1.06 25.8 4.1 0.9 - 7.3 All COULTER Instruments 19 0.34 0.31 90.8 0.2 0.0 - 1.3 19 4.11 1.06 25.8 4.1 0.9 - 7.3

Specimen DIF-15

All Method 19 7.64 1.38 18.1 7.9 3.4 - 11.8 All COULTER Instruments 19 7.64 1.38 18.1 7.9 3.4 - 11.8

2013 MLE-M3 Participant Summary/ 31

HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 5.23 0.57 11.0 5.0 3.5 - 7.0 19 5.47 0.54 9.9 5.4 3.8 - 7.1 All COULTER Instruments 19 5.23 0.57 11.0 5.0 3.5 - 7.0 19 5.47 0.54 9.9 5.4 3.8 - 7.1

Specimen DIF-13 Specimen DIF-14

All Method 19 8.12 0.34 4.2 8.1 7.0 - 9.2 19 5.55 0.36 6.5 5.5 4.4 - 6.7 All COULTER Instruments 19 8.12 0.34 4.2 8.1 7.0 - 9.2 19 5.55 0.36 6.5 5.5 4.4 - 6.7

Specimen DIF-15

All Method 19 5.36 0.47 8.8 5.3 3.9 - 6.8 All COULTER Instruments 19 5.36 0.47 8.8 5.3 3.9 - 6.8

HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)

Specimen DIF-11 Specimen DIF-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 19 2.55 3.17 124.1 0.6 0.0 - 12.1 19 1.50 3.02 201.4 0.5 0.0 - 10.6 All COULTER Instruments 19 2.55 3.17 124.1 0.6 0.0 - 12.1 19 1.50 3.02 201.4 0.5 0.0 - 10.6

Specimen DIF-13 Specimen DIF-14

All Method 19 1.02 1.52 149.1 0.3 0.0 - 5.6 17 0.37 0.34 91.4 0.3 0.0 - 1.4 All COULTER Instruments 19 1.02 1.52 149.1 0.3 0.0 - 5.6 17 0.37 0.34 91.4 0.3 0.0 - 1.4

Specimen DIF-15

All Method 19 2.03 2.87 141.8 0.5 0.0 - 10.7 All COULTER Instruments 19 2.03 2.87 141.8 0.5 0.0 - 10.7

32 / 2013 MLE-M3 Participant Summary

QBC HEMATOLOGYHEMATOCRIT (percent)

Specimen QBC-11 Specimen QBC-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 33.59 0.91 2.7 33.7 31.5 - 35.7 9 33.43 0.76 2.3 33.2 31.4 - 35.5 QBC STAR - QBC STAR Tubes 5 33.48 0.85 2.5 33.8 31.4 - 35.5 5 33.44 0.91 2.7 33.9 31.4 - 35.5

Specimen QBC-13 Specimen QBC-14

All Method 9 29.46 0.52 1.8 29.3 27.6 - 31.3 9 21.49 0.85 4.0 21.3 20.1 - 22.8 QBC STAR - QBC STAR Tubes 5 29.52 0.51 1.7 29.3 27.7 - 31.3 5 20.96 0.53 2.5 21.1 19.7 - 22.3

Specimen QBC-15

All Method 9 33.41 0.79 2.4 33.3 31.4 - 35.5 QBC STAR - QBC STAR Tubes 5 33.68 0.99 2.9 33.8 31.6 - 35.8

QBC HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen QBC-11 Specimen QBC-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 11.29 0.31 2.7 11.3 10.4 - 12.1 9 11.28 0.33 2.9 11.2 10.4 - 12.1 QBC STAR - QBC STAR Tubes 5 11.12 0.18 1.6 11.1 10.3 - 11.9 5 11.08 0.24 2.2 11.2 10.3 - 11.9

Specimen QBC-13 Specimen QBC-14

All Method 9 9.90 0.31 3.2 10.0 9.2 - 10.6 9 7.37 0.41 5.6 7.2 6.8 - 7.9 QBC STAR - QBC STAR Tubes 5 9.70 0.26 2.7 9.6 9.0 - 10.4 5 7.04 0.13 1.9 7.1 6.5 - 7.6

Specimen QBC-15

All Method 9 11.39 0.48 4.2 11.2 10.5 - 12.2 QBC STAR - QBC STAR Tubes 5 11.34 0.61 5.3 11.2 10.5 - 12.2

2013 MLE-M3 Participant Summary/ 33

QBC HEMATOLOGYWHITE BLOOD CELL COUNT (x 109/L)

Specimen QBC-11 Specimen QBC-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 15.33 3.06 20.0 15.6 13.0 - 17.7 15.33 9 18.84 3.72 19.7 19.5 16.0 - 21.7 QBC STAR - QBC STAR Tubes 14.98 1.81 12.1 15.3 12.7 - 17.3 14.98 5 20.02 1.75 8.8 19.5 17.0 - 23.1

Specimen QBC-13 Specimen QBC-14

All Method 9 9.83 2.11 21.5 10.2 8.3 - 11.4 9 6.63 0.82 12.4 6.7 5.6 - 7.7 QBC STAR - QBC STAR Tubes 5 11.16 1.36 12.2 11.4 9.4 - 12.9 5 6.90 0.42 6.1 6.7 5.8 - 8.0

Specimen QBC-15

All Method 8 14.74 2.47 16.8 14.5 12.5 - 17.0 QBC STAR - QBC STAR Tubes 5 15.08 1.50 10.0 15.1 12.8 - 17.4

QBC HEMATOLOGYPLATELET COUNT (x 109/L)

Specimen QBC-11 Specimen QBC-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 173.2 47.2 27.2 171 129 - 217 9 134.8 24.9 18.4 147 101 - 169 QBC STAR - QBC STAR Tubes 5 193.0 22.8 11.8 201 144 - 242 5 139.0 24.9 17.9 150 104 - 174

Specimen QBC-13 Specimen QBC-14

All Method 9 331.3 61.2 18.5 354 248 - 415 9 640.6 71.1 11.1 667 480 - 801 QBC STAR - QBC STAR Tubes 5 354.8 35.6 10.0 358 266 - 444 5 658.8 47.6 7.2 667 494 - 824

Specimen QBC-15

All Method 9 164.6 38.8 23.6 160 123 - 206 QBC STAR - QBC STAR Tubes 5 169.6 21.2 12.5 160 127 - 212

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QBC HEMATOLOGYGRANULOCYTES (x 109/L)

Specimen QBC-11 Specimen QBC-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 8.72 3.61 41.4 9.5 0.0 - 19.6 9 11.12 3.63 32.7 12.9 0.2 - 22.1 QBC STAR - QBC STAR Tubes 5 9.54 1.01 10.6 9.5 6.4 - 12.6 5 12.34 2.03 16.5 13.0 6.2 - 18.5

Specimen QBC-13 Specimen QBC-14

All Method 9 6.72 1.60 23.8 7.2 1.9 - 11.6 9 4.80 1.06 22.1 5.1 1.6 - 8.0 QBC STAR - QBC STAR Tubes 5 7.20 1.13 15.7 7.9 3.7 - 10.7 5 4.98 0.39 7.8 5.1 3.8 - 6.2

Specimen QBC-15

All Method 9 8.96 3.20 35.7 8.9 0.0 - 18.6 QBC STAR - QBC STAR Tubes 5 9.00 1.44 16.0 8.9 4.6 - 13.4

QBC HEMATOLOGYLYMPHS/MONO (x 109/L)

Specimen QBC-11 Specimen QBC-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 6.37 1.44 22.5 6.5 2.0 - 10.7 9 7.24 1.00 13.8 7.2 4.2 - 10.3 QBC STAR - QBC STAR Tubes 5 6.14 1.73 28.2 6.3 0.9 - 11.4 5 6.82 1.16 17.0 6.8 3.3 - 10.3

Specimen QBC-13 Specimen QBC-14

All Method 9 2.83 1.07 37.8 2.4 0.0 - 6.1 9 1.83 0.42 23.0 1.9 0.5 - 3.1 QBC STAR - QBC STAR Tubes 5 3.46 1.03 29.8 3.4 0.3 - 6.6 5 1.92 0.27 14.0 1.9 1.1 - 2.8

Specimen QBC-15

All Method 9 6.24 1.26 20.2 6.4 2.4 - 10.1 QBC STAR - QBC STAR Tubes 5 5.60 1.35 24.1 5.6 1.5 - 9.7

2013 MLE-M3 Participant Summary/ 35

RETICULOCYTE COUNT (percent)

Specimen RT-5 Specimen RT-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 32 6.84 1.60 23.4 7.2 2.0 - 11.7 32 1.33 0.43 32.0 1.3 0.0 - 2.7 All Automated Methods 18 6.48 1.72 26.5 7.2 1.3 - 11.7 18 1.22 0.23 18.5 1.3 0.5 - 2.0 All Manual Methods 15 7.74 2.12 27.4 7.3 1.3 - 14.2 15 1.63 0.86 52.4 1.5 0.0 - 4.3

HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 69 2.58 0.07 2.8 2.6 2.1 - 3.0 72 3.66 0.10 2.7 3.7 3.1 - 4.3 All ABX Instruments 29 2.59 0.08 2.9 2.6 2.2 - 3.0 31 3.69 0.08 2.1 3.7 3.1 - 4.3 All COULTER Instruments 36 2.57 0.06 2.2 2.6 2.1 - 3.0 37 3.64 0.10 2.9 3.6 3.0 - 4.2 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 2.58 0.08 3.1 2.6 2.1 - 3.0 18 3.66 0.10 2.7 3.7 3.1 - 4.3 ABX Diagnostics Pentra 80 / XL 80 11 2.62 0.06 2.3 2.6 2.2 - 3.1 14 3.70 0.08 2.1 3.7 3.1 - 4.3 COULTER AcT 5diff (version 2.01) 34 2.57 0.06 2.3 2.6 2.1 - 3.0 34 3.63 0.10 2.7 3.6 3.0 - 4.2

Specimen BCX-13 Specimen BCX-14

All Method 72 19.88 0.40 2.0 19.9 16.9 - 22.9 72 8.93 0.18 2.0 8.9 7.5 - 10.3 All ABX Instruments 32 19.91 0.38 1.9 19.9 16.9 - 22.9 32 8.94 0.17 1.9 8.9 7.6 - 10.3 All COULTER Instruments 37 19.87 0.43 2.2 19.9 16.8 - 22.9 37 8.92 0.20 2.2 8.9 7.5 - 10.3 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 19.94 0.46 2.3 20.0 16.9 - 23.0 18 8.94 0.20 2.3 9.0 7.6 - 10.3 ABX Diagnostics Pentra 80 / XL 80 14 19.86 0.27 1.4 19.8 16.8 - 22.9 14 8.94 0.12 1.3 8.9 7.6 - 10.3 COULTER AcT 5diff (version 2.01) 34 19.84 0.44 2.2 19.8 16.8 - 22.9 34 8.91 0.20 2.2 8.9 7.5 - 10.3

Specimen BCX-15

All Method 71 25.46 0.48 1.9 25.4 21.6 - 29.3 All ABX Instruments 31 25.55 0.51 2.0 25.5 21.7 - 29.4 All COULTER Instruments 37 25.42 0.46 1.8 25.4 21.6 - 29.3 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 25.65 0.53 2.1 25.5 21.8 - 29.5 ABX Diagnostics Pentra 80 / XL 80 13 25.40 0.47 1.8 25.4 21.5 - 29.3 COULTER AcT 5diff (version 2.01) 34 25.42 0.47 1.9 25.4 21.6 - 29.3

36 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012/L)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 2.039 0.036 1.7 2.04 1.91 - 2.17 71 3.837 0.059 1.5 3.83 3.60 - 4.07 All ABX Instruments 31 2.028 0.035 1.7 2.03 1.90 - 2.16 31 3.825 0.048 1.2 3.82 3.59 - 4.06 All COULTER Instruments 37 2.048 0.034 1.7 2.04 1.92 - 2.18 37 3.850 0.066 1.7 3.84 3.61 - 4.09 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 2.042 0.030 1.5 2.05 1.91 - 2.17 18 3.836 0.040 1.1 3.83 3.60 - 4.07 ABX Diagnostics Pentra 80 / XL 80 13 2.010 0.034 1.7 2.00 1.88 - 2.14 13 3.810 0.054 1.4 3.81 3.58 - 4.04 COULTER AcT 5diff (version 2.01) 34 2.050 0.034 1.7 2.05 1.92 - 2.18 34 3.847 0.065 1.7 3.84 3.61 - 4.08

Specimen BCX-13 Specimen BCX-14

All Method 72 4.095 0.061 1.5 4.09 3.84 - 4.35 72 5.526 0.085 1.5 5.53 5.19 - 5.86 All ABX Instruments 32 4.083 0.057 1.4 4.09 3.83 - 4.33 32 5.523 0.073 1.3 5.53 5.19 - 5.86 All COULTER Instruments 37 4.104 0.060 1.4 4.09 3.85 - 4.36 37 5.530 0.092 1.7 5.54 5.19 - 5.87 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 4.097 0.046 1.1 4.11 3.85 - 4.35 18 5.505 0.064 1.2 5.50 5.17 - 5.84 ABX Diagnostics Pentra 80 / XL 80 14 4.066 0.067 1.6 4.07 3.82 - 4.32 14 5.547 0.078 1.4 5.53 5.21 - 5.88 COULTER AcT 5diff (version 2.01) 34 4.101 0.059 1.4 4.09 3.85 - 4.35 34 5.519 0.087 1.6 5.53 5.18 - 5.86

Specimen BCX-15

All Method 70 4.881 0.076 1.6 4.88 4.58 - 5.18 All ABX Instruments 31 4.872 0.060 1.2 4.87 4.57 - 5.17 All COULTER Instruments 36 4.892 0.085 1.7 4.89 4.59 - 5.19 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 4.877 0.052 1.1 4.87 4.58 - 5.17 ABX Diagnostics Pentra 80 / XL 80 13 4.864 0.070 1.4 4.89 4.57 - 5.16 COULTER AcT 5diff (version 2.01) 33 4.885 0.083 1.7 4.89 4.59 - 5.18

2013 MLE-M3 Participant Summary/ 37

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 6.45 0.11 1.8 6.4 6.0 - 7.0 72 10.40 0.15 1.4 10.4 9.6 - 11.2 All ABX Instruments 31 6.37 0.09 1.3 6.4 5.9 - 6.9 32 10.37 0.11 1.1 10.4 9.6 - 11.1 All COULTER Instruments 37 6.52 0.10 1.5 6.5 6.0 - 7.0 37 10.44 0.17 1.6 10.4 9.7 - 11.2 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 6.36 0.09 1.4 6.4 5.9 - 6.9 18 10.37 0.14 1.3 10.4 9.6 - 11.1 ABX Diagnostics Pentra 80 / XL 80 13 6.39 0.08 1.2 6.4 5.9 - 6.9 14 10.36 0.08 0.8 10.4 9.6 - 11.1 COULTER AcT 5diff (version 2.01) 34 6.52 0.10 1.5 6.5 6.0 - 7.0 34 10.44 0.17 1.6 10.4 9.7 - 11.2

Specimen BCX-13 Specimen BCX-14

All Method 72 11.89 0.15 1.3 11.9 11.0 - 12.8 72 16.21 0.22 1.3 16.2 15.0 - 17.4 All ABX Instruments 32 11.89 0.14 1.2 11.9 11.0 - 12.8 31 16.31 0.16 1.0 16.3 15.1 - 17.5 All COULTER Instruments 37 11.89 0.16 1.4 11.9 11.0 - 12.8 37 16.15 0.21 1.3 16.1 15.0 - 17.3 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 11.91 0.14 1.2 11.9 11.0 - 12.8 18 16.30 0.22 1.4 16.3 15.1 - 17.5 ABX Diagnostics Pentra 80 / XL 80 14 11.86 0.13 1.1 11.9 11.0 - 12.7 14 16.29 0.16 1.0 16.3 15.1 - 17.5 COULTER AcT 5diff (version 2.01) 34 11.89 0.17 1.4 11.9 11.0 - 12.8 34 16.14 0.21 1.3 16.1 15.0 - 17.3

Specimen BCX-15

All Method 71 14.24 0.18 1.3 14.2 13.2 - 15.3 All ABX Instruments 31 14.29 0.16 1.1 14.3 13.2 - 15.3 All COULTER Instruments 37 14.21 0.20 1.4 14.2 13.2 - 15.2 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 14.30 0.19 1.3 14.3 13.2 - 15.4 ABX Diagnostics Pentra 80 / XL 80 13 14.27 0.12 0.8 14.3 13.2 - 15.3 COULTER AcT 5diff (version 2.01) 34 14.20 0.20 1.4 14.2 13.2 - 15.2

38 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 70 18.34 0.43 2.4 18.4 17.2 - 19.5 72 30.17 0.60 2.0 30.1 28.3 - 32.0 All ABX Instruments 30 18.44 0.42 2.3 18.5 17.3 - 19.6 32 30.25 0.54 1.8 30.1 28.4 - 32.1 All COULTER Instruments 37 18.26 0.43 2.3 18.2 17.1 - 19.4 37 30.13 0.63 2.1 30.1 28.3 - 32.0 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 18.26 0.37 2.1 18.2 17.1 - 19.4 18 30.14 0.52 1.7 30.1 28.3 - 32.0 ABX Diagnostics Pentra 80 / XL 80 12 18.71 0.33 1.8 18.8 17.5 - 19.9 14 30.39 0.55 1.8 30.5 28.5 - 32.3 COULTER AcT 5diff (version 2.01) 34 18.21 0.41 2.3 18.2 17.1 - 19.4 34 30.06 0.58 1.9 30.1 28.2 - 31.9

Specimen BCX-13 Specimen BCX-14

All Method 72 34.39 0.66 1.9 34.4 32.3 - 36.5 72 46.69 0.83 1.8 46.7 43.8 - 49.5 All ABX Instruments 32 34.47 0.58 1.7 34.5 32.3 - 36.6 32 46.62 0.73 1.6 46.5 43.8 - 49.5 All COULTER Instruments 37 34.32 0.67 2.0 34.2 32.2 - 36.4 37 46.75 0.89 1.9 46.9 43.9 - 49.6 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 34.44 0.51 1.5 34.5 32.3 - 36.6 18 46.65 0.73 1.6 46.6 43.8 - 49.5 ABX Diagnostics Pentra 80 / XL 80 14 34.49 0.69 2.0 34.6 32.4 - 36.6 14 46.59 0.75 1.6 46.5 43.7 - 49.4 COULTER AcT 5diff (version 2.01) 34 34.25 0.64 1.9 34.2 32.1 - 36.4 34 46.67 0.88 1.9 46.8 43.8 - 49.5

Specimen BCX-15

All Method 71 41.30 0.83 2.0 41.2 38.8 - 43.8 All ABX Instruments 31 41.33 0.68 1.6 41.3 38.8 - 43.9 All COULTER Instruments 37 41.30 0.90 2.2 41.2 38.8 - 43.8 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 41.40 0.64 1.5 41.4 38.9 - 43.9 ABX Diagnostics Pentra 80 / XL 80 13 41.24 0.75 1.8 41.2 38.7 - 43.8 COULTER AcT 5diff (version 2.01) 34 41.22 0.88 2.1 41.0 38.7 - 43.7

2013 MLE-M3 Participant Summary/ 39

HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 72.5 4.4 6.1 72 54 - 91 71 118.1 6.4 5.4 117 88 - 148 All ABX Instruments 31 71.5 4.1 5.8 70 53 - 90 32 117.8 7.1 6.1 117 88 - 148 All COULTER Instruments 37 73.4 4.7 6.5 74 55 - 92 36 118.6 5.8 4.9 118 88 - 149 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 72.8 4.3 5.9 73 54 - 91 18 118.0 7.2 6.1 119 88 - 148 ABX Diagnostics Pentra 80 / XL 80 13 69.8 3.2 4.6 70 52 - 88 14 117.5 7.4 6.3 115 88 - 147 COULTER AcT 5diff (version 2.01) 34 73.8 4.5 6.1 76 55 - 93 33 118.7 6.0 5.0 118 89 - 149

Specimen BCX-13 Specimen BCX-14

All Method 72 480.6 15.0 3.1 481 360 - 601 70 246.6 9.5 3.9 245 184 - 309 All ABX Instruments 32 483.4 15.4 3.2 482 362 - 605 31 248.7 8.2 3.3 249 186 - 311 All COULTER Instruments 37 478.9 14.8 3.1 482 359 - 599 36 245.5 10.5 4.3 244 184 - 307 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 483.1 14.1 2.9 482 362 - 604 18 247.1 8.4 3.4 248 185 - 309 ABX Diagnostics Pentra 80 / XL 80 14 483.9 17.4 3.6 480 362 - 605 14 253.2 11.4 4.5 252 189 - 317 COULTER AcT 5diff (version 2.01) 34 479.8 14.7 3.1 482 359 - 600 33 244.1 9.3 3.8 242 183 - 306

Specimen BCX-15

All Method 70 491.9 15.8 3.2 491 368 - 615 All ABX Instruments 31 497.3 17.4 3.5 494 372 - 622 All COULTER Instruments 37 489.5 16.1 3.3 487 367 - 612 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 491.5 12.9 2.6 490 368 - 615 ABX Diagnostics Pentra 80 / XL 80 13 505.2 20.0 4.0 500 378 - 632 COULTER AcT 5diff (version 2.01) 34 488.1 14.7 3.0 486 366 - 611

40 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 70 64.72 4.67 7.2 64.6 50.7 - 78.8 72 57.48 4.28 7.4 57.7 44.6 - 70.4 All ABX Instruments 30 67.66 4.17 6.2 67.9 55.1 - 80.2 31 58.53 3.53 6.0 58.4 47.9 - 69.2 All COULTER Instruments 37 62.48 3.89 6.2 62.6 50.8 - 74.2 37 56.82 4.41 7.8 56.8 43.5 - 70.1 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 68.16 3.73 5.5 68.0 56.9 - 79.4 18 59.69 3.24 5.4 60.1 49.9 - 69.5 ABX Diagnostics Pentra 80 / XL 80 14 65.50 7.24 11.1 66.9 43.7 - 87.3 14 56.09 4.51 8.0 57.0 42.5 - 69.7 COULTER AcT 5diff (version 2.01) 34 62.25 3.75 6.0 62.5 50.9 - 73.6 34 56.88 4.57 8.0 57.0 43.1 - 70.6

Specimen BCX-13 Specimen BCX-14

All Method 71 72.63 5.20 7.2 72.2 57.0 - 88.3 72 68.92 5.67 8.2 67.7 51.8 - 86.0 All ABX Instruments 32 74.69 6.05 8.1 75.2 56.5 - 92.9 32 73.36 5.04 6.9 75.2 58.2 - 88.5 All COULTER Instruments 36 70.90 3.76 5.3 72.2 59.6 - 82.2 36 65.55 2.61 4.0 66.0 57.7 - 73.4 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 78.33 3.55 4.5 79.2 67.6 - 89.0 18 75.71 3.04 4.0 76.5 66.6 - 84.9 ABX Diagnostics Pentra 80 / XL 80 14 70.02 5.40 7.7 70.6 53.8 - 86.3 14 70.33 5.57 7.9 72.9 53.6 - 87.1 COULTER AcT 5diff (version 2.01) 33 70.98 3.84 5.4 72.2 59.4 - 82.6 33 65.50 2.69 4.1 66.2 57.4 - 73.6

Specimen BCX-15

All Method 71 50.30 3.46 6.9 50.5 39.9 - 60.7 All ABX Instruments 32 51.96 3.83 7.4 52.2 40.4 - 63.5 All COULTER Instruments 37 49.21 3.23 6.6 49.7 39.5 - 58.9 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 53.64 2.18 4.1 54.1 47.1 - 60.2 ABX Diagnostics Pentra 80 / XL 80 14 49.81 4.47 9.0 49.2 36.4 - 63.3 COULTER AcT 5diff (version 2.01) 34 49.21 3.28 6.7 49.7 39.3 - 59.1

2013 MLE-M3 Participant Summary/ 41

HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 70 21.32 3.63 17.0 21.1 10.4 - 32.3 71 29.46 3.98 13.5 29.1 17.5 - 41.4 All ABX Instruments 31 23.74 3.72 15.7 23.3 12.5 - 34.9 32 31.80 4.23 13.3 31.4 19.1 - 44.5 All COULTER Instruments 37 19.82 3.19 16.1 19.6 10.2 - 29.4 37 28.05 3.63 12.9 27.6 17.1 - 39.0 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 23.39 3.07 13.1 23.3 14.1 - 32.6 18 30.26 3.33 11.0 30.3 20.2 - 40.3 ABX Diagnostics Pentra 80 / XL 80 13 24.22 4.56 18.8 23.1 10.5 - 37.9 14 33.78 4.55 13.5 32.9 20.1 - 47.5 COULTER AcT 5diff (version 2.01) 34 19.92 3.03 15.2 19.7 10.8 - 29.1 34 27.86 3.57 12.8 27.5 17.1 - 38.6

Specimen BCX-13 Specimen BCX-14

All Method 71 16.12 4.46 27.7 14.4 2.7 - 29.6 70 17.20 2.96 17.2 16.4 8.3 - 26.1 All ABX Instruments 32 18.51 5.63 30.4 18.5 1.6 - 35.5 32 19.85 3.58 18.0 19.0 9.1 - 30.6 All COULTER Instruments 35 14.11 2.54 18.0 13.9 6.4 - 21.8 36 15.51 1.72 11.1 15.3 10.3 - 20.7 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 15.02 3.26 21.7 13.7 5.2 - 24.8 18 18.02 2.40 13.3 17.6 10.8 - 25.3 ABX Diagnostics Pentra 80 / XL 80 14 23.01 4.81 20.9 22.3 8.5 - 37.5 14 22.20 3.52 15.8 21.1 11.6 - 32.8 COULTER AcT 5diff (version 2.01) 32 13.83 2.32 16.8 13.8 6.8 - 20.8 33 15.37 1.68 10.9 15.1 10.3 - 20.5

Specimen BCX-15

All Method 70 39.45 3.28 8.3 38.6 29.6 - 49.3 All ABX Instruments 31 42.35 3.36 7.9 41.8 32.2 - 52.5 All COULTER Instruments 37 37.57 2.07 5.5 37.4 31.3 - 43.8 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 40.31 1.96 4.9 40.3 34.4 - 46.3 ABX Diagnostics Pentra 80 / XL 80 13 45.18 2.80 6.2 44.7 36.7 - 53.6 COULTER AcT 5diff (version 2.01) 34 37.41 1.93 5.2 37.3 31.6 - 43.3

42 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 68 1.11 0.84 76.2 0.9 0.0 - 3.7 70 0.97 0.74 76.3 0.8 0.0 - 3.3 All ABX Instruments 30 1.15 0.92 79.8 1.0 0.0 - 3.9 31 0.86 0.60 69.4 0.7 0.0 - 2.7 All COULTER Instruments 35 1.04 0.80 77.1 0.8 0.0 - 3.5 35 1.01 0.80 79.1 0.8 0.0 - 3.5 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 1.70 1.66 97.7 1.3 0.0 - 6.7 18 1.02 0.76 74.0 0.8 0.0 - 3.3 ABX Diagnostics Pentra 80 / XL 80 14 1.06 0.93 88.1 0.8 0.0 - 3.9 14 0.81 0.65 80.0 0.6 0.0 - 2.8 COULTER AcT 5diff (version 2.01) 32 1.10 0.82 74.5 1.0 0.0 - 3.6 32 1.00 0.81 80.8 0.8 0.0 - 3.5

Specimen BCX-13 Specimen BCX-14

All Method 69 1.51 1.08 71.5 1.3 0.0 - 4.8 69 1.56 1.20 76.8 1.0 0.0 - 5.2 All ABX Instruments 32 1.31 0.99 75.5 1.1 0.0 - 4.3 32 1.32 1.17 88.8 0.8 0.0 - 4.9 All COULTER Instruments 37 2.15 1.93 89.6 1.8 0.0 - 8.0 35 1.91 1.41 73.8 1.4 0.0 - 6.2 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 1.41 1.17 83.2 0.9 0.0 - 5.0 18 1.47 1.36 92.4 0.9 0.0 - 5.6 ABX Diagnostics Pentra 80 / XL 80 14 1.17 0.70 59.4 1.2 0.0 - 3.3 14 1.12 0.88 78.8 0.8 0.0 - 3.8 COULTER AcT 5diff (version 2.01) 34 2.27 1.96 86.2 1.8 0.0 - 8.2 32 2.04 1.39 68.1 1.8 0.0 - 6.3

Specimen BCX-15

All Method 69 1.42 0.90 63.6 1.3 0.0 - 4.2 All ABX Instruments 32 1.23 0.89 72.6 0.9 0.0 - 4.0 All COULTER Instruments 36 1.80 1.28 71.1 1.6 0.0 - 5.7 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 1.36 1.09 80.3 0.9 0.0 - 4.7 ABX Diagnostics Pentra 80 / XL 80 14 1.06 0.54 51.1 0.9 0.0 - 2.7 COULTER AcT 5diff (version 2.01) 33 1.91 1.27 66.9 1.6 0.0 - 5.8

2013 MLE-M3 Participant Summary/ 43

HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 5.75 1.69 29.3 5.8 0.6 - 10.9 72 8.13 1.66 20.5 7.9 3.1 - 13.2 All ABX Instruments 31 6.05 1.78 29.5 6.2 0.6 - 11.4 32 8.47 1.66 19.5 8.2 3.5 - 13.5 All COULTER Instruments 37 5.53 1.66 30.0 5.5 0.5 - 10.6 37 7.89 1.70 21.5 7.7 2.7 - 13.0 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 5.91 1.39 23.6 6.4 1.7 - 10.1 18 8.72 1.92 22.0 8.3 2.9 - 14.5 ABX Diagnostics Pentra 80 / XL 80 14 6.21 2.21 35.6 6.1 0.0 - 12.9 14 8.15 1.23 15.1 8.1 4.4 - 11.9 COULTER AcT 5diff (version 2.01) 34 5.56 1.73 31.1 5.8 0.3 - 10.8 34 8.02 1.67 20.9 7.8 3.0 - 13.1

Specimen BCX-13 Specimen BCX-14

All Method 72 4.56 0.61 13.4 4.6 2.7 - 6.4 71 3.96 0.56 14.2 3.9 2.2 - 5.7 All ABX Instruments 32 4.60 0.61 13.3 4.6 2.7 - 6.5 32 4.04 0.66 16.2 4.0 2.0 - 6.1 All COULTER Instruments 37 4.49 0.63 13.9 4.5 2.6 - 6.4 37 3.97 0.58 14.6 3.9 2.2 - 5.8 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 4.84 0.57 11.7 4.8 3.1 - 6.6 18 4.16 0.71 17.2 4.1 2.0 - 6.3 ABX Diagnostics Pentra 80 / XL 80 14 4.28 0.53 12.4 4.4 2.6 - 5.9 14 3.89 0.56 14.4 3.9 2.2 - 5.6 COULTER AcT 5diff (version 2.01) 34 4.54 0.60 13.3 4.5 2.7 - 6.4 34 3.97 0.60 15.2 3.9 2.1 - 5.8

Specimen BCX-15

All Method 70 4.02 0.52 12.8 4.0 2.4 - 5.6 All ABX Instruments 31 4.13 0.61 14.7 4.2 2.3 - 6.0 All COULTER Instruments 36 3.90 0.39 10.0 3.9 2.7 - 5.1 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 4.27 0.55 12.8 4.3 2.6 - 6.0 ABX Diagnostics Pentra 80 / XL 80 13 3.94 0.65 16.6 4.2 1.9 - 5.9 COULTER AcT 5diff (version 2.01) 33 3.93 0.39 10.0 4.0 2.7 - 5.2

44 / 2013 MLE-M3 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)

Specimen BCX-11 Specimen BCX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 70 6.47 5.18 80.0 10.0 0.0 - 22.0 70 3.58 2.88 80.4 5.6 0.0 - 12.3 All ABX Instruments 30 0.57 0.05 9.6 0.6 0.4 - 0.8 30 0.30 0.00 0.0 0.3 0.3 - 0.3 All COULTER Instruments 37 10.89 0.74 6.8 10.9 8.6 - 13.2 37 6.05 0.44 7.3 6.1 4.7 - 7.4 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 0.57 0.06 10.5 0.6 0.3 - 0.8 18 0.30 0.00 0.0 0.3 0.3 - 0.3 ABX Diagnostics Pentra 80 / XL 80 12 0.57 0.05 8.7 0.6 0.4 - 0.8 12 0.30 0.00 0.0 0.3 0.3 - 0.3 COULTER AcT 5diff (version 2.01) 34 10.91 0.76 6.9 11.0 8.6 - 13.2 34 6.04 0.46 7.5 6.1 4.6 - 7.5

Specimen BCX-13 Specimen BCX-14

All Method 69 4.82 3.90 81.1 7.9 0.0 - 16.6 69 7.56 6.12 81.0 12.3 0.0 - 26.0 All ABX Instruments 30 0.40 0.00 0.0 0.4 0.4 - 0.4 30 0.65 0.05 7.8 0.6 0.4 - 0.8 All COULTER Instruments 36 8.21 0.20 2.4 8.2 7.6 - 8.9 36 12.88 0.58 4.5 13.0 11.1 - 14.7 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 18 0.40 0.00 0.0 0.4 0.4 - 0.4 18 0.65 0.05 7.9 0.7 0.4 - 0.9 ABX Diagnostics Pentra 80 / XL 80 12 0.40 0.00 0.0 0.4 0.4 - 0.4 12 0.64 0.05 8.0 0.6 0.4 - 0.8 COULTER AcT 5diff (version 2.01) 33 8.22 0.18 2.2 8.2 7.6 - 8.8 33 12.91 0.59 4.6 13.1 11.1 - 14.7

Specimen BCX-15

All Method 70 4.34 3.44 79.3 7.1 0.0 - 14.7 All ABX Instruments 29 0.40 0.00 0.0 0.4 0.4 - 0.4 All COULTER Instruments 37 7.30 0.20 2.7 7.3 6.6 - 7.9 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 0.40 0.00 0.0 0.4 0.4 - 0.4 ABX Diagnostics Pentra 80 / XL 80 12 0.40 0.00 0.0 0.4 0.4 - 0.4 COULTER AcT 5diff (version 2.01) 34 7.31 0.20 2.7 7.3 6.7 - 7.9

2013 MLE-M3 Participant Summary/ 45

HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 37 20.48 0.81 4.0 20.6 17.4 - 23.6 37 7.76 0.27 3.4 7.8 6.6 - 9.0 All Sysmex Instruments 37 20.48 0.81 4.0 20.6 17.4 - 23.6 37 7.76 0.27 3.4 7.8 6.6 - 9.0 Sysmex XS-1000i 21 20.80 0.76 3.7 20.6 17.6 - 24.0 21 7.93 0.16 2.1 7.9 6.7 - 9.2

Specimen MX-13 Specimen MX-14

All Method 37 4.04 0.14 3.4 4.0 3.4 - 4.7 37 7.74 0.30 3.8 7.8 6.5 - 9.0 All Sysmex Instruments 37 4.04 0.14 3.4 4.0 3.4 - 4.7 37 7.74 0.30 3.8 7.8 6.5 - 9.0 Sysmex XS-1000i 21 4.10 0.10 2.4 4.1 3.4 - 4.8 20 7.94 0.17 2.1 8.0 6.7 - 9.2

Specimen MX-15

All Method 37 20.35 0.78 3.8 20.2 17.3 - 23.5 All Sysmex Instruments 37 20.35 0.78 3.8 20.2 17.3 - 23.5 Sysmex XS-1000i 21 20.66 0.72 3.5 20.5 17.5 - 23.8

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012/L)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 36 5.631 0.065 1.2 5.62 5.29 - 5.97 36 4.874 0.053 1.1 4.87 4.58 - 5.17 All Sysmex Instruments 36 5.631 0.065 1.2 5.62 5.29 - 5.97 36 4.874 0.053 1.1 4.87 4.58 - 5.17 Sysmex XS-1000i 21 5.657 0.067 1.2 5.66 5.31 - 6.00 21 4.866 0.061 1.2 4.85 4.57 - 5.16

Specimen MX-13 Specimen MX-14

All Method 37 2.493 0.051 2.0 2.49 2.34 - 2.65 36 4.881 0.057 1.2 4.88 4.58 - 5.18 All Sysmex Instruments 37 2.493 0.051 2.0 2.49 2.34 - 2.65 36 4.881 0.057 1.2 4.88 4.58 - 5.18 Sysmex XS-1000i 21 2.462 0.037 1.5 2.45 2.31 - 2.62 20 4.869 0.057 1.2 4.87 4.57 - 5.17

Specimen MX-15

All Method 35 5.641 0.062 1.1 5.64 5.30 - 5.98 All Sysmex Instruments 35 5.641 0.062 1.1 5.64 5.30 - 5.98 Sysmex XS-1000i 20 5.662 0.064 1.1 5.67 5.32 - 6.01

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HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 36 17.59 0.24 1.4 17.6 16.3 - 18.9 37 13.55 0.14 1.0 13.6 12.5 - 14.5 All Sysmex Instruments 36 17.59 0.24 1.4 17.6 16.3 - 18.9 37 13.55 0.14 1.0 13.6 12.5 - 14.5 Sysmex XS-1000i 21 17.68 0.15 0.8 17.7 16.4 - 19.0 21 13.56 0.14 1.0 13.6 12.6 - 14.6

Specimen MX-13 Specimen MX-14

All Method 37 6.13 0.08 1.4 6.1 5.6 - 6.6 36 13.54 0.15 1.1 13.5 12.5 - 14.5 All Sysmex Instruments 37 6.13 0.08 1.4 6.1 5.6 - 6.6 36 13.54 0.15 1.1 13.5 12.5 - 14.5 Sysmex XS-1000i 21 6.10 0.08 1.3 6.1 5.6 - 6.6 20 13.56 0.14 1.0 13.6 12.6 - 14.6

Specimen MX-15

All Method 36 17.60 0.27 1.5 17.6 16.3 - 18.9 All Sysmex Instruments 36 17.60 0.27 1.5 17.6 16.3 - 18.9 Sysmex XS-1000i 20 17.71 0.15 0.9 17.7 16.4 - 19.0

HEMATOLOGY W/ 5-PART DIFFERENTIAL – HEMATOCRIT (percent)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 37 51.77 1.07 2.1 52.0 48.6 - 54.9 37 39.74 0.73 1.8 39.8 37.3 - 42.2 All Sysmex Instruments 37 51.77 1.07 2.1 52.0 48.6 - 54.9 37 39.74 0.73 1.8 39.8 37.3 - 42.2 Sysmex XS-1000i 21 51.67 0.96 1.9 51.5 48.5 - 54.8 21 39.56 0.67 1.7 39.6 37.1 - 42.0

Specimen MX-13 Specimen MX-14

All Method 37 18.84 0.41 2.2 18.7 17.7 - 20.0 36 39.75 0.73 1.8 39.8 37.3 - 42.2 All Sysmex Instruments 37 18.84 0.41 2.2 18.7 17.7 - 20.0 36 39.75 0.73 1.8 39.8 37.3 - 42.2 Sysmex XS-1000i 21 18.65 0.30 1.6 18.7 17.5 - 19.8 20 39.56 0.69 1.7 39.6 37.1 - 42.0

Specimen MX-15

All Method 36 51.78 1.05 2.0 51.9 48.6 - 54.9 All Sysmex Instruments 36 51.78 1.05 2.0 51.9 48.6 - 54.9 Sysmex XS-1000i 20 51.62 1.00 1.9 51.8 48.5 - 54.8

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HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 37 415.8 16.4 3.9 416 311 - 520 37 224.9 10.7 4.8 225 168 - 282 All Sysmex Instruments 37 415.8 16.4 3.9 416 311 - 520 37 224.9 10.7 4.8 225 168 - 282 Sysmex XS-1000i 21 420.3 11.6 2.8 420 315 - 526 21 225.4 8.1 3.6 224 169 - 282

Specimen MX-13 Specimen MX-14

All Method 37 63.7 5.2 8.2 63 47 - 80 37 223.5 12.2 5.5 225 167 - 280 All Sysmex Instruments 37 63.7 5.2 8.2 63 47 - 80 37 223.5 12.2 5.5 225 167 - 280 Sysmex XS-1000i 21 63.0 4.4 7.0 62 47 - 79 21 223.7 13.6 6.1 226 167 - 280

Specimen MX-15

All Method 36 413.9 13.9 3.3 413 310 - 518 All Sysmex Instruments 36 413.9 13.9 3.3 413 310 - 518 Sysmex XS-1000i 20 415.3 9.4 2.3 416 311 - 520

HEMATOLOGY W/ 5-PART DIFFERENTIAL – NEUTROPHILS (percent)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 36 59.91 5.74 9.6 61.7 42.6 - 77.2 37 51.31 3.59 7.0 50.8 40.5 - 62.1 All Sysmex Instruments 36 59.91 5.74 9.6 61.7 42.6 - 77.2 37 51.31 3.59 7.0 50.8 40.5 - 62.1 Sysmex XS-1000i 20 58.33 7.28 12.5 54.3 36.4 - 80.2 21 48.46 1.79 3.7 47.9 43.0 - 53.9

Specimen MX-13 Specimen MX-14

All Method 37 63.08 4.14 6.6 61.7 50.6 - 75.6 37 51.54 3.40 6.6 51.2 41.3 - 61.8 All Sysmex Instruments 37 63.08 4.14 6.6 61.7 50.6 - 75.6 37 51.54 3.40 6.6 51.2 41.3 - 61.8 Sysmex XS-1000i 21 59.67 1.49 2.5 59.5 55.1 - 64.2 21 48.87 1.71 3.5 48.5 43.7 - 54.0

Specimen MX-15

All Method 36 60.11 5.47 9.1 61.2 43.6 - 76.6 All Sysmex Instruments 36 60.11 5.47 9.1 61.2 43.6 - 76.6 Sysmex XS-1000i 20 58.71 6.93 11.8 54.7 37.9 - 79.5

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HEMATOLOGY W/ 5-PART DIFFERENTIAL – LYMPHOCYTES (percent)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 37 20.98 2.39 11.4 21.3 13.8 - 28.2 37 26.37 3.36 12.8 27.0 16.2 - 36.5 All Sysmex Instruments 37 20.98 2.39 11.4 21.3 13.8 - 28.2 37 26.37 3.36 12.8 27.0 16.2 - 36.5 Sysmex XS-1000i 21 20.85 2.89 13.8 22.7 12.1 - 29.6 21 26.20 4.42 16.9 29.2 12.9 - 39.5

Specimen MX-13 Specimen MX-14

All Method 37 14.80 1.59 10.7 15.3 10.0 - 19.6 37 25.98 3.46 13.3 26.3 15.5 - 36.4 All Sysmex Instruments 37 14.80 1.59 10.7 15.3 10.0 - 19.6 37 25.98 3.46 13.3 26.3 15.5 - 36.4 Sysmex XS-1000i 21 14.67 1.64 11.2 15.3 9.7 - 19.6 21 25.73 4.44 17.3 28.4 12.4 - 39.1

Specimen MX-15

All Method 37 20.67 2.55 12.4 20.9 13.0 - 28.4 All Sysmex Instruments 37 20.67 2.55 12.4 20.9 13.0 - 28.4 Sysmex XS-1000i 21 20.48 3.15 15.4 22.6 11.0 - 30.0

HEMATOLOGY W/ 5-PART DIFFERENTIAL – MONOCYTES (percent)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 37 2.80 1.25 44.6 2.9 0.0 - 6.6 37 5.32 2.55 48.0 5.1 0.0 - 13.0 All Sysmex Instruments 37 2.80 1.25 44.6 2.9 0.0 - 6.6 37 5.32 2.55 48.0 5.1 0.0 - 13.0 Sysmex XS-1000i 21 2.56 1.45 56.5 1.7 0.0 - 6.9 21 5.23 3.23 61.8 3.1 0.0 - 15.0

Specimen MX-13 Specimen MX-14

All Method 36 1.64 0.89 53.9 1.6 0.0 - 4.4 37 5.29 2.63 49.7 5.5 0.0 - 13.2 All Sysmex Instruments 36 1.64 0.89 53.9 1.6 0.0 - 4.4 37 5.29 2.63 49.7 5.5 0.0 - 13.2 Sysmex XS-1000i 21 1.60 1.10 68.7 1.0 0.0 - 4.9 21 5.25 3.34 63.6 3.2 0.0 - 15.3

Specimen MX-15

All Method 36 2.74 1.19 43.4 3.0 0.0 - 6.4 All Sysmex Instruments 36 2.74 1.19 43.4 3.0 0.0 - 6.4 Sysmex XS-1000i 21 2.46 1.48 60.3 1.6 0.0 - 6.9

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HEMATOLOGY W/ 5-PART DIFFERENTIAL – EOSINOPHILS (percent)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 37 12.55 2.42 19.3 13.4 5.2 - 19.9 37 14.14 3.00 21.2 12.9 5.1 - 23.2 All Sysmex Instruments 37 12.55 2.42 19.3 13.4 5.2 - 19.9 37 14.14 3.00 21.2 12.9 5.1 - 23.2 Sysmex XS-1000i 21 12.02 2.52 20.9 13.2 4.4 - 19.6 21 15.34 3.37 21.9 13.0 5.2 - 25.5

Specimen MX-13 Specimen MX-14

All Method 37 16.94 3.56 21.0 15.5 6.2 - 27.7 37 14.29 2.99 20.9 13.2 5.3 - 23.3 All Sysmex Instruments 37 16.94 3.56 21.0 15.5 6.2 - 27.7 37 14.29 2.99 20.9 13.2 5.3 - 23.3 Sysmex XS-1000i 21 18.35 3.99 21.7 15.5 6.3 - 30.4 21 15.43 3.44 22.3 13.3 5.1 - 25.8

Specimen MX-15

All Method 36 12.80 2.08 16.2 13.3 6.5 - 19.1 All Sysmex Instruments 36 12.80 2.08 16.2 13.3 6.5 - 19.1 Sysmex XS-1000i 21 12.18 2.45 20.1 12.9 4.8 - 19.6

HEMATOLOGY W/ 5-PART DIFFERENTIAL – BASOPHILS (percent)

Specimen MX-11 Specimen MX-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 15 82.89 2.55 3.1 9.4 75.2 - 90.6 15 69.58 1.77 2.5 8.0 64.2 - 74.9 All Sysmex XS/XN Instruments 22 5.16 4.39 85.0 7.8 0.0 - 18.4 22 4.57 3.77 82.6 6.8 0.0 - 15.9 All Sysmex XT/XE Instruments 15 82.89 2.55 3.1 84.0 75.2 - 90.6 15 69.58 1.77 2.5 70.0 64.2 - 74.9 Sysmex XS-1000i 21 5.40 4.35 80.4 7.8 0.0 - 18.5 21 4.77 3.74 78.4 6.8 0.0 - 16.0

Specimen MX-13 Specimen MX-14

All Method 15 83.81 0.97 1.2 9.9 80.8 - 86.8 15 69.44 0.78 1.1 8.0 67.1 - 71.8 All Sysmex XS/XN Instruments 22 5.46 4.57 83.6 8.2 0.0 - 19.2 22 4.53 3.73 82.3 6.8 0.0 - 15.8 All Sysmex XT/XE Instruments 15 83.81 0.97 1.2 83.7 80.8 - 86.8 15 69.44 0.78 1.1 69.5 67.1 - 71.8 Sysmex XS-1000i 21 5.71 4.52 79.1 8.2 0.0 - 19.3 21 4.73 3.70 78.1 6.8 0.0 - 15.9

Specimen MX-15

All Method 15 83.25 2.47 3.0 9.1 75.8 - 90.7 All Sysmex XS/XN Instruments 22 5.09 4.31 84.7 7.8 0.0 - 18.1 All Sysmex XT/XE Instruments 15 83.25 2.47 3.0 84.5 75.8 - 90.7 Sysmex XS-1000i 21 5.32 4.28 80.3 7.8 0.0 - 18.2

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2013 M3 BLOOD CELL IDENTIFICATION Specimens BC-13 through BC-18

CASE HISTORY: A 21-year-old male fell into a campfire and was hospitalized for burn treatment. Twenty-four hours post-admission, a routine CBC was ordered. Results appear below.

Test Results Reference Range

WBC 15.2 x 109/L 4.5 - 15.0 x 109/L RBC 4.5 x 1012/L 4.6 - 6.0 x 1012/L HGB 13.6 g/dL 14.0 - 18.0 g/dL HCT 38 % 40 - 54 % PLT 141 x 109/L 150 - 450 x 109/L MCV 87 fL 80 - 94 fL MCH 30 pg 26 - 32 pg MCHC 36 g/dL 32 - 36 g/dL RDW 16 % 11.5 - 14.5 %

This patient was diagnosed with thermal burn injury. Major burns are a severe form of trauma that can wreak havoc on many systems within the body. Hematologic changes are caused by destruction of red blood cells, white blood cells, and , loss of fluid volume, and infusion of fluids. At first there can be many red cell fragments in circulation, which may be erroneously counted as platelets by automated instruments, resulting in pseudothrombocytosis. There may also be real or artifactual hemoconcentration or hemodilution, due to the massive fluid loss through burned skin and blistering, as well as infusion of fluids. In this hypothetical case, we allowed 24 hours for stabilization of the patient’s test results. Common red cell changes following burn injuries include spherocytosis, fragmentation, and vesiculation. Other complications following severe burns include hypoalbuminemia, persistent anemia, hypercoagulability, and increased susceptibility to .

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BLOOD CELL IDENTIFICATION

Specimen BC-13 Identification Labs Percent Performance Spherocyte 224 89.96% Acceptable Microcyte 23 9.24%

The arrows in this photograph point to spherocytes. The deep red color and absence of central pallor distinguishes spherocytes from microcytes. Microcytes look just like average RBCs, only smaller. To view another photo of spherocytes, see 2010 M3 Specimen BC-15.

Specimen BC-14 Identification Labs Percent Performance Lymphocyte, reactive 190 77.24% Acceptable Monocyte 26 10.57% Immature/abnormal 21 8.54%% Lymphocyte 9 3.66%

We apologize for inadvertently omitting the arrow from this photograph. The large cell in the center of the field is a reactive lymphocyte. The nucleus is large, appearing slightly elongated or stretched, and has clumped chromatin. The cytoplasm is indented by the adjacent red blood cell, and is light blue, with peripheral basophilia- a deeper blue color at the extreme border. Some participants incorrectly identified this cell as a monocyte. Monocytes lack the dark blue periphery that is typical of lymphocytes. Monos have a grayer cytoplasm and a more lacy nuclear chromatin structure. To view a photo of a monocyte, see 2013 M1 Specimen BC-3. This challenge was graded by 100% referee consensus. . Specimen BC-15 Identification Labs Percent Performance Polychromatophilic red cell 239 95.98% Acceptable Reticulocyte 7 2.81%

The arrows in this photograph point to polychromatophilic red blood cells. These immature red cells have a distinctive gray-blue color that is due to diffused residual RNA, which will be absorbed later. They are also larger than the mature RBCs around them. The number of immature RBCs appearing in the peripheral blood is an indicator of bone marrow activity. When the bone marrow cannot keep up with the need for new red cells, it compensates by releasing cells into circulation before they are fully mature. Polychromasia is seen in hemolytic states, and post-splenectomy. These cells would be called reticulocytes only when examined with a supravital stain such as New Methylene Blue. To view another photo of polychromatophilic RBCs, see 2011 M1 Specimen BC-1.

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BLOOD CELL IDENTIFICATION

Specimen BC-16 Identification Labs Percent Performance Platelet, normal 238 95.58% Acceptable Platelet, abnormal 7 2.81%

The arrows in this photograph point to normal platelets. Platelets are much smaller than red blood cells and rounded in shape, with irregular edges. They contain fine, red-violet granules surrounded by bluish cytoplasm. To view another photo of normal platelets, see 2011 M2 Specimen BC-7.

Specimen BC-17 Identification Labs Percent Performance Neutrophil-seg/band w/toxic granules 217 87.85% Acceptable Neutrophil-Segmented or band 26 10.53%

The arrow in this photograph points to a segmented neutrophil with toxic granulation. Normal neutrophils have fine pink, lilac, and light blue granules. The cytoplasm of cells with toxic granulation contains small, coarse, dark purple granules. The presence of toxic granulation is a sign of stress, usually an infection or ingestion of a toxic substance. Technical tip: one way to distinguish toxic granulation from an overly stained smear is that true toxic granulation will vary from cell to cell with some of the older (pre-insult) cells having no toxic granulation and younger (post insult) cells having it to varying degrees. A poorly stained smear will have a consistent look to all of the neutrophils. To view another photo of toxic granulation, see 2011 M1 Specimen BC-2.

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BLOOD CELL IDENTIFICATION

Specimen BC-18 Identification Labs Percent Performance Döhle body 224 91.06% Not graded – Educational Challenge Immature/abnormal cell-refer 13 5.28% Auer rod 7 2.85%

The arrow in this ungraded educational challenge points to a Döhle body within a neutrophil. Döhle bodies appear as irregular blue inclusions in the cytoplasm of some granulocytes. They are associated with burns, pregnancy, infection, and cytotoxic agents. Döhle bodies are pieces of rough endoplasmic reticulum that has not been dismantled and recycled in the cell due to a faster rate of maturation (commonly called a faster transit time in the marrow). They often appear with other signs of toxicity such as toxic granulation, vacuoles, shift to the left, and elevated WBC count. To view another photo of a Döhle body, see 2011 M3 Specimen BC-13.

References:

Blood Smear: Details on RBCs, WBCs. (Modified 7/21/13) Lab Tests Online. Copyright, American Association for , 2001-2013. Available at: http://labtestsonline.org/understanding/analytes/blood-smear/details/start/1 Accessed 9/27/13.

EI-Sonbaty M.A., EI-0tiefy M.A. “Hematological Change in Severely Burned Patients” Annals of Burns and Fire Disasters. December 1996. Available at: http://www.medbc.com/annals/review/vol_9/num_4/text/vol9n4p206.htm Accessed 10/29/13.

Rodak, B. F.: Hematology: Clinical Principles and Applications. 3rd ed. W. B. Saunders, Philadelphia, 2007.

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BLOOD BANK

ABO GROUP

Specimen Results Labs Percent Performance BB-11 Group AB 9 100% Acceptable BB-12 Group A 9 100% Acceptable BB-13 Group A 9 100% Acceptable BB-14 Group B 9 100% Acceptable BB-15 Group O 9 100% Acceptable

RH FACTOR (D TYPE)

Specimen Results Labs Percent Performance BB-11 Rh Positive 13 100% Acceptable BB-12 Rh Negative 12 92.31% Acceptable Rh Positive 1 7.69% BB-13 Rh Positive 13 100% Acceptable BB-14 Rh Negative 12 92.31 % Acceptable Rh Positive 1 7.69% BB-15 Rh Positive 13 100% Acceptable

Challenges BB-12 and BB- 14 were graded by 100% referee consensus.

UNEXPECTED ANTIBODY DETECTION

Specimen Results Labs Percent Performance AB-11 No unexpected antibody detected 9 100% Acceptable AB-12 No unexpected antibody detected 9 100% Acceptable AB-13 Unexpected antibody detected 9 100% Acceptable AB-14 Unexpected antibody detected 9 100% Acceptable AB-15 Unexpected antibody detected 9 100% Acceptable

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BLOOD BANK

ANTIBODY IDENTIFICATION

Specimen Results Labs Percent Performance

AB-11 No antibody detected 1 100% Acceptable AB-12 No antibody detected 1 100% Acceptable AB-13 Anti-Fy(a) 1 100% Acceptable AB-14 Anti-c 1 100% Acceptable AB-15 Anti-M 1 100% Acceptable

COMPATIBILITY TESTING

Specimen Results Labs Percent Performance

AB-11 Compatible 7 100% Acceptable AB-12 Compatible 7 100% Acceptable AB-13 Compatible 7 100% Acceptable AB-14 Not Compatible 7 100% Acceptable AB-15 Not Compatible 7 100% Acceptable

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PROTHROMBIN TIME (seconds)

Specimen CG-11 Specimen CG-12

Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 64 24.26 3.28 13.5 25.2 20.6 - 27.9 65 40.35 8.91 22.1 41.8 34.2 - 46.5 Dade Innovin Dade Behring BFT II 5 26.92 0.54 2.0 27.0 22.8 - 31.0 5 49.52 1.48 3.0 48.9 42.0 - 57.0 Sysmex CA-500/540/560 25 25.89 1.25 4.8 25.6 22.0 - 29.8 24 42.92 2.69 6.3 42.7 36.4 - 49.4 All Coagulation Instruments 36 26.12 1.25 4.8 25.9 22.2 - 30.1 36 44.69 3.76 8.4 44.4 37.9 - 51.4 IL TEST PT Fibrinogen IL ACL, all models 15 20.49 1.13 5.5 20.4 17.4 - 23.6 15 30.05 1.82 6.1 30.0 25.5 - 34.6 PH/CMS Thromboplastin-D All Coagulation Instruments 5 20.20 1.71 8.5 20.2 17.1 - 23.3 5 30.46 3.37 11.1 29.0 25.8 - 35.1

Specimen CG-13 Specimen CG-14

All Method 63 11.00 0.66 6.0 10.9 9.3 - 12.7 65 10.87 0.83 7.7 10.8 9.2 - 12.5 Dade Innovin Dade Behring BFT II 5 10.00 0.39 3.9 9.9 8.5 - 11.5 5 9.38 0.34 3.6 9.5 7.9 - 10.8 Sysmex CA-500/540/560 25 10.79 0.25 2.4 10.8 9.1 - 12.5 24 10.58 0.31 2.9 10.6 8.9 - 12.2 All Coagulation Instruments 36 10.63 0.42 3.9 10.7 9.0 - 12.3 36 10.42 0.60 5.7 10.5 8.8 - 12.0 IL TEST PT Fibrinogen IL ACL, all models 15 11.59 0.42 3.6 11.6 9.8 - 13.4 15 11.33 0.44 3.8 11.3 9.6 - 13.1 PH/CMS Thromboplastin-D All Coagulation Instruments 5 11.26 0.93 8.3 11.3 9.5 - 13.0 5 11.04 0.97 8.7 11.4 9.3 - 12.7

Specimen CG-15

All Method 62 13.54 0.61 4.5 13.5 11.5 - 15.6 Dade Innovin Dade Behring BFT II 5 13.46 0.40 3.0 13.2 11.4 - 15.5 Sysmex CA-500/540/560 25 13.42 0.39 2.9 13.4 11.4 - 15.5 All Coagulation Instruments 35 13.39 0.43 3.2 13.3 11.3 - 15.4 IL TEST PT Fibrinogen IL ACL, all models 15 13.73 0.59 4.3 13.6 11.6 - 15.8 PH/CMS Thromboplastin-D All Coagulation Instruments 5 13.04 1.22 9.4 12.8 11.0 - 15.0

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PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)

Specimen CG-11 Specimen CG-12

Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 65 2.70 0.33 12.3 2.6 2.1 - 3.3 67 5.11 1.26 24.7 4.6 4.0 - 6.2 Dade Innovin Dade Behring BFT II 5 2.52 0.18 7.1 2.5 2.0 - 3.1 5 4.26 0.30 7.0 4.4 3.4 - 5.2 Sysmex CA-500/540/560 25 2.49 0.15 6.1 2.5 1.9 - 3.0 25 4.15 0.34 8.2 4.2 3.3 - 5.0 All Coagulation Instruments 36 2.51 0.15 6.1 2.5 2.0 - 3.1 36 4.21 0.33 7.8 4.3 3.3 - 5.1 IL TEST PT Fibrinogen IL ACL, all models 15 3.00 0.38 12.5 3.0 2.4 - 3.6 15 6.09 0.90 14.8 6.2 4.8 - 7.4 PH/CMS Thromboplastin-D All Coagulation Instruments 6 3.32 0.37 11.0 3.4 2.6 - 4.0 6 7.65 0.59 7.7 7.8 6.1 - 9.2

Specimen CG-13 Specimen CG-14

All Method 66 1.03 0.05 5.3 1.0 0.8 - 1.3 65 1.00 0.06 6.5 1.0 0.8 - 1.3 Dade Innovin Dade Behring BFT II 5 1.06 0.05 5.2 1.1 0.8 - 1.3 5 1.04 0.05 5.3 1.0 0.8 - 1.3 Sysmex CA-500/540/560 25 1.03 0.05 4.6 1.0 0.8 - 1.3 25 1.02 0.06 5.5 1.0 0.8 - 1.3 All Coagulation Instruments 36 1.04 0.05 4.7 1.0 0.8 - 1.3 36 1.02 0.05 5.1 1.0 0.8 - 1.3 IL TEST PT Fibrinogen IL ACL, all models 15 1.05 0.12 11.3 1.0 0.8 - 1.3 15 1.03 0.19 18.9 1.0 0.8 - 1.3 PH/CMS Thromboplastin-D All Coagulation Instruments 6 1.00 0.06 6.3 1.0 0.8 - 1.2 6 0.98 0.08 7.7 1.0 0.7 - 1.2

Specimen CG-15

All Method 65 1.32 0.10 7.3 1.3 1.0 - 1.6 Dade Innovin Dade Behring BFT II 5 1.38 0.08 6.1 1.4 1.1 - 1.7 Sysmex CA-500/540/560 25 1.28 0.06 4.5 1.3 1.0 - 1.6 All Coagulation Instruments 35 1.30 0.07 5.3 1.3 1.0 - 1.6 IL TEST PT Fibrinogen IL ACL, all models 15 1.44 0.19 13.1 1.4 1.1 - 1.8 PH/CMS Thromboplastin-D All Coagulation Instruments 6 1.33 0.14 10.2 1.3 1.0 - 1.6

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ACTIVATED PARTIAL THROMBOPLASTIN (seconds)

Specimen CG-11 Specimen CG-12

Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 28 48.9 5.5 11.3 49 41 - 57 28 73.8 8.2 11.2 74 62 - 85 Dade Actin FSL Sysmex CA-500/540/560 16 47.8 2.9 6.1 49 40 - 55 16 72.8 5.2 7.1 74 61 - 84 All Coagulation Instruments 18 48.3 3.2 6.7 49 41 - 56 18 72.8 5.0 6.9 74 61 - 84 IL TEST APTT-SP IL ACL, all models 7 45.0 3.2 7.1 45 38 - 52 7 68.3 4.6 6.7 69 58 - 79

Specimen CG-13 Specimen CG-14

All Method 26 26.3 0.8 3.2 26 22 - 31 26 27.8 1.1 3.8 28 23 - 32 Dade Actin FSL Sysmex CA-500/540/560 16 26.6 1.2 4.3 26 22 - 31 16 27.8 0.8 3.0 28 23 - 32 All Coagulation Instruments 17 26.2 0.8 2.9 26 22 - 31 18 27.7 0.9 3.3 28 23 - 32 IL TEST APTT-SP IL ACL, all models 7 26.3 1.1 4.2 26 22 - 31 7 28.7 2.7 9.4 28 24 - 34

Specimen CG-15

All Method 28 33.7 5.1 15.2 32 28 - 39 Dade Actin FSL Sysmex CA-500/540/560 16 30.3 1.7 5.6 31 25 - 35 All Coagulation Instruments 18 30.2 1.6 5.4 31 25 - 35 IL TEST APTT-SP IL ACL, all models 7 38.9 0.9 2.3 39 33 - 45

Fibrinogen (mg/dL)

One participant reported Fibrinogen. The vendor assay values for specimens CG-11 through CG-15 are: 293 mg/dL, 262 mg/dL, 320 mg/dL, 592 mg/dL and 108 mg/dL respectively.

RH FACTOR (Slide Method)

Specimen Results Labs Percent Performance RH-11 Rh Negative 3 100% Acceptable RH-12 Rh Positive 3 100% Acceptable RH-13 Rh Positive 3 100% Acceptable RH-14 Rh Positive 3 100% Acceptable RH-15 Rh Negative 3 100% Acceptable

2013 MLE-M3 Participant Summary/ 59

COAGUCHEK XS PLUS PROTHROMBIN TIME (seconds)

Specimen XS-11 Specimen XS-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

Roche CoaguChek XS Plus 21 14.36 0.30 2.1 14.4 12.2 - 16.6 21 32.77 1.24 3.8 32.9 27.8 - 37.7

Specimen XS-13 Specimen XS-14

Roche CoaguChek XS Plus 21 32.51 1.29 4.0 32.8 27.6 - 37.4 21 14.16 0.41 2.9 14.1 12.0 - 16.3

Specimen XS-15

Roche CoaguChek XS Plus 21 32.79 1.72 5.2 32.4 27.8 - 37.8

COAGUCHEK XS PLUS PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)

Specimen XS-11 Specimen XS-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

Roche CoaguChek XS Plus 23 1.19 0.04 3.6 1.2 0.9 - 1.5 23 2.69 0.11 4.1 2.7 2.1 - 3.3

Specimen XS-13 Specimen XS-14

Roche CoaguChek XS Plus 22 2.68 0.11 4.1 2.7 2.1 - 3.3 22 1.18 0.04 3.4 1.2 0.9 - 1.5

Specimen XS-15

Roche CoaguChek XS Plus 22 2.70 0.14 5.1 2.7 2.1 - 3.3

ITC PROTIME MICROCOAGULATION SYSTEM PROTHROMBIN TIME (seconds)

Specimen IT-5 Specimen IT-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 11 23.28 2.65 11.4 23.5 19.7 - 26.8 11 38.48 4.46 11.6 37.2 32.7 - 44.3

ITC PROTIME MICROCOAGULATION SYSTEM INTERNATIONAL NORMALIZED RATIO (INR)

Specimen IT-5 Specimen IT-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 12 1.74 0.19 11.1 1.8 1.3 - 2.1 12 2.96 0.29 9.7 3.0 2.3 - 3.6

60 / 2013 MLE-M3 Participant Summary i-Stat PROTHROMBIN TIME (seconds)

Specimen PTI-11 Specimen PTI-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range i-Stat Prothrombin Time 12 29.17 6.95 23.8 26.2 24.7 - 33.6 12 13.70 0.78 5.7 14.1 11.6 - 15.8

Specimen PTI-13 Specimen PTI-14 i-Stat Prothrombin Time 12 14.16 1.54 10.9 13.9 12.0 - 16.3 12 28.64 7.18 25.1 25.7 24.3 - 33.0

Specimen PTI-15 i-Stat Prothrombin Time 12 13.96 1.20 8.6 14.0 11.8 - 16.1 i-Stat PROTHROMBIN TIME - INTERNATIONAL NORMALIZED RATIO (INR)

Specimen PTI-11 Specimen PTI-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range i-Stat Prothrombin Time 12 2.51 0.57 22.8 2.3 2.0 - 3.1 12 1.13 0.08 6.7 1.1 0.9 - 1.4

Specimen PTI-13 Specimen PTI-14 i-Stat Prothrombin Time 12 1.17 0.13 10.7 1.2 0.9 - 1.5 12 2.47 0.59 23.9 2.2 1.9 - 3.0

Specimen PTI-15 i-Stat Prothrombin Time 12 1.16 0.10 8.4 1.2 0.9 - 1.4

2013 MLE-M3 Participant Summary/ 61

FLUID CELL COUNT/CRYSTALS  WHITE BLOOD CELL COUNT (uL)

Specimen BF-5 Specimen BF-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 1294.0 234.9 18.1 1310 824 - 1764 9 1199.0 146.2 12.2 1222 906 - 1492

FLUID CELL COUNT/CRYSTALS  RED BLOOD CELL COUNT (uL)

Specimen BF-5 Specimen BF-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 9 1.1 3.3 300.0 0 0 - 8 9 5.6 7.7 138.9 2 0 - 21

FLUID CELL COUNT/CRYSTALS  CRYSTAL IDENTIFCATION

Specimen Identification Labs Percent Performance

BF-5 CPPD Crystals 13 81.25% Acceptable No crystals observed 1 6.25% Calcium Oxalate crystals 1 6.25% Cholesterol crystals 1 6.25%

BF-6 MSU (Monosodium Urate) 16 100% Acceptable

MICROALBUMIN, DIPSTICK

Specimen UM-3 Participant Results

Method Labs Negative 10 mg/L(Pos) 20/30 mg/L 50 mg/L (+) 80 mg/L 100 mg/L (++) 150 mg/L

ALL METHODS 40 - - - 1 4 6 29 Bayer Clinitek Microalbumin 33 - - - - 4 - 29 Roche Micral - 1 minute 7 - - - 1 - 6 -

CREATININE, DIPSTICK

Specimen UM-3 Participant Results Method Labs Negative 10 mg/dL 30 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL

ALL METHODS 33 - - 1 - - 10 22 Bayer Clinitek Microalbumin 31 - - 1 - - 8 22 Bayer Multistix Pro 2 - - - - - 2 -

62 / 2013 MLE-M3 Participant Summary

MICROALBUMIN, QUANTITATIVE

Specimen UM-3

Method Labs Mean SD CV Median Range

All Method 95 149.5 13.2 8.8 149 109 - 189 Axis-Shield Afinion AS100 10 162.9 14.2 8.7 167 120 - 206 Beckman (Olympus) AU 12 142.5 8.5 6.0 143 116 - 169 Dade Dimension/AR/ES/RxL/Xpand 26 151.7 16.4 10.8 152 102 - 201 Siemens DCA Vantage 19 150.8 9.3 6.1 153 123 - 179

CREATININE, URINE (mg/dL)

Specimen UM-3

Method Labs Mean SD CV Median Range

All Method 91 213.1 10.7 5.0 212 181 - 246 Axis-Shield Afinion AS100 10 208.5 3.3 1.6 208 198 - 219 Beckman (Olympus) AU 10 214.0 9.4 4.4 215 185 - 243 Dade Dimension/AR/ES/RxL/Xpand 19 207.0 6.6 3.2 206 187 - 227 Siemens DCA Vantage 19 221.5 10.5 4.7 222 190 - 254

WAIVED HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 97 9.12 0.44 4.9 9.1 8.4 - 9.8 95 12.86 0.51 4.0 12.9 11.9 - 13.8 All Stanbio Methods 22 9.41 0.44 4.7 9.5 8.7 - 10.1 22 13.13 0.78 5.9 13.3 12.2 - 14.1 HemoCue 74 9.01 0.37 4.2 9.0 8.3 - 9.7 75 12.78 0.47 3.7 12.8 11.8 - 13.7 Stanbio HemoPoint H2 17 9.51 0.25 2.7 9.5 8.8 - 10.2 18 13.28 0.40 3.0 13.4 12.3 - 14.3

WAIVED HEMATOLOGYHEMATOCRIT (percent)

Specimen HD-11 Specimen HD-12

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 14 25.33 1.67 6.6 25.0 21.9 - 28.7 15 36.18 2.37 6.6 36.0 31.4 - 41.0

2013 MLE-M3 Participant Summary/ 63

KOH SKIN PREPARATION

Specimen Identification Labs Percent Performance

K-5 Yeast/fungal elements present 145 85.29% Acceptable Yeast/fungal elements absent 25 14.71%

Organism present in specimen K-5: Trichophyton mentagrophytes.

K-6 Yeast/fungal elements present 169 99.41% Acceptable Yeast/fungal elements absent 1 0.59%

Organism present in specimen K-6: Trichophyton tonsurans.

COAGUCHECK XS - INTERNATIONAL NORMALIZED RATIO (INR)

Specimen INX-5 Specimen INX-6

Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

Roche CoaguChek XS 72 2.67 0.10 3.6 2.7 2.1 - 3.3 74 1.21 0.04 3.3 1.2 0.9 - 1.5

64 / 2013 MLE-M3 Participant Summary

URINALYSIS DIPSTICKSPECIFIC GRAVITY

Specimen UA-3

Method Labs Mean SD CV Median Range

All Method 936 1.0160 0.0040 0.4 1.015 1.005 - 1.026 All Bayer Instruments 453 1.0171 0.0036 0.4 1.015 1.007 - 1.028 All Roche Instruments 71 1.0135 0.0035 0.3 1.015 1.003 - 1.024 Bayer Clinitek 10 / 100 14 1.0171 0.0032 0.3 1.018 1.007 - 1.028 Bayer Clinitek 50 65 1.0128 0.0030 0.3 1.015 1.002 - 1.023 Bayer Clinitek 500 16 1.0147 0.0022 0.2 1.015 1.004 - 1.025 Bayer Clinitek Advantus 21 1.0133 0.0024 0.2 1.015 1.003 - 1.024 Bayer Clinitek Status / Status+ 330 1.0182 0.0028 0.3 1.020 1.008 - 1.029 Bayer Reagent Strips 252 1.0139 0.0035 0.3 1.015 1.003 - 1.024 Consult Diagnostics Urine Analyzer 16 1.0194 0.0040 0.4 1.020 1.009 - 1.030 CTMI CT-120 Urine Analyzer 11 1.0182 0.0040 0.4 1.015 1.008 - 1.029 Diagnostic Test Group Clarity Urocheck 120 14 1.0214 0.0036 0.4 1.020 1.011 - 1.032 Other Dipstick Method 16 1.0200 0.0058 0.6 1.020 1.010 - 1.030 Roche Chemstrips 54 1.0133 0.0026 0.3 1.015 1.003 - 1.024 Roche Criterion Analyzer 16 1.0128 0.0026 0.3 1.015 1.002 - 1.023 Roche Urisys 48 1.0136 0.0039 0.4 1.015 1.003 - 1.024

2013 MLE-M3 Participant Summary/ 65

URINALYSIS DIPSTICKpH

Specimen UA-3 Participant Results

Method Labs 3.5 or 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 less

ALL METHODS 963 1 - - 18 13 241 607 82 1 - - - Arkray DiaScreen 1 - - - 1 ------Arkray DiaScreen 50 4 - - - - - 4 ------Bayer Clinitek 10 / 100 14 - - - 1 - 2 11 - - - - - Bayer Clinitek 200/200+ 1 - - - - - 1 ------Bayer Clinitek 50 68 - - - - 3 22 43 - - - - - Bayer Clinitek 500 18 - - - - - 8 10 - - - - - Bayer Clinitek Advantus 21 - - - - - 5 16 - - - - - Bayer Clinitek Atlas 5 ------5 - - - - - Bayer Clinitek Status / Status+ 332 - - - - 7 18 252 55 - - - - Bayer Hemacombistix 1 - - - - - 1 ------Bayer Reagent Strips 262 - - - 10 1 31 204 15 1 - - - Consult Diagnostics Urine Analyzer 17 - - - 1 2 13 - 1 - - - - CTMI CT-120 Urine Analyzer 11 - - - - - 10 1 - - - - - Diagnostic Test Group Clarity Urocheck 7 - - - 1 - 5 1 - - - - - Diagnostic Test Group Clarity Urocheck 120 14 - - - - - 13 1 - - - - - Germaine Laboratories AimStrip 4 - - - - - 4 ------Immunostics Detector Combi 1 ------1 - - - - McKesson 10SG Reagent Strips 9 1 - - - - 6 2 - - - - - Other Analyzer Method 5 - - - - - 4 1 - - - - - Other Dipstick Method 17 - - - 2 - 10 3 2 - - - - pH Paper 1 ------1 - - - - - PSS Select Reagent Strips 4 - - - - - 4 ------PSS Select Urine Analyzer 1 - - - - - 1 ------Roche Chemstrip 101 5 - - - - - 1 4 - - - - - Roche Chemstrips 59 - - - 1 - 54 4 - - - - - Roche cobas u 411 1 - - - - - 1 ------Roche Criterion Analyzer 16 - - - - - 2 13 1 - - - - Roche Urisys 47 - - - 1 - 16 26 4 - - - - Schein Urispec 6 - - - - - 2 3 1 - - - - UriScan Reagent Strips 1 - - - - - 1 ------

66 / 2013 MLE-M3 Participant Summary

URINALYSIS DIPSTICKPROTEIN QUALITATIVE

Specimen UA-3 Participant Results

Method Labs Negative Trace 30 100 300-500 >300 >1000 mg/dL mg/dL mg/dL mg/dL mg/dL (1+) (2+) (3+) (4+)

ALL METHODS 998 980 15 2 - - 1 - Arkray DiaScreen 6 5 - 1 - - - - Arkray DiaScreen 50 4 4 ------Bayer Albustix 1 1 ------Bayer Clinitek 10 / 100 14 14 ------Bayer Clinitek 200/200+ 1 1 ------Bayer Clinitek 50 68 68 ------Bayer Clinitek 500 18 18 ------Bayer Clinitek Advantus 21 21 ------Bayer Clinitek Atlas 5 5 ------Bayer Clinitek Status / Status+ 331 331 ------Bayer Hemacombistix 1 1 ------Bayer Reagent Strips 265 261 3 - - - 1 - Bayer Uristix 16 16 ------Consult Diagnostics Urine Analyzer 17 17 ------CTMI CT-120 Urine Analyzer 11 11 ------Diagnostic Test Group Clarity Urocheck 6 3 3 - - - - - Diagnostic Test Group Clarity Urocheck 120 14 14 ------Germaine Laboratories AimStrip 4 3 1 - - - - - Immunostics Detector Combi 1 1 ------McKesson 10SG Reagent Strips 9 7 2 - - - - - Other Analyzer Method 5 5 ------Other Dipstick Method 17 12 4 1 - - - - PSS Select Reagent Strips 3 3 ------PSS Select Urine Analyzer 1 1 ------Roche Chemstrip 101 5 5 ------Roche Chemstrips 71 69 2 - - - - - Roche cobas u 411 1 1 ------Roche Criterion Analyzer 16 16 ------Roche Urisys 47 47 ------Schein Urispec 6 6 ------Sulfosalicylic Acid 2 2 ------UriScan Reagent Strips 1 1 ------

2013 MLE-M3 Participant Summary/ 67

URINALYSIS DIPSTICKGLUCOSE

Specimen UA-3 Participant Results 50-100 mg/dL 150 250 500 1000 >1000 >2000 Method Labs Negative (Trace) mg/dL mg/dL mg/dL mg/dL mg/dL mg/dL

ALL METHODS 966 6 9 30 450 304 100 55 12 Arkray DiaScreen 6 - - - 2 3 - 1 - Arkray DiaScreen 50 4 - - - 2 1 1 - - Bayer Clinitek 10 / 100 14 - - - 6 8 - - - Bayer Clinitek 50 67 1 1 1 14 41 - 7 2 Bayer Clinitek 500 18 - - - 7 11 - - - Bayer Clinitek Advantus 20 - - - 4 15 - - 1 Bayer Clinitek Atlas 5 - - - - 2 - 3 - Bayer Clinitek Status / Status+ 327 3 2 18 240 64 - - - Bayer Clinitest, 5 drop 1 - - - - 1 - - - Bayer Hemacombistix 1 - - - 1 - - - - Bayer Reagent Strips 261 1 1 7 114 108 27 - 3 Bayer Uristix 16 - - 1 4 9 1 - 1 Consult Diagnostics Urine Analyzer 17 - - - 4 9 2 - 2 CTMI CT-120 Urine Analyzer 11 - 1 - 10 - - - - Diagnostic Test Group Clarity Urocheck 7 - - - 7 - - - - Diagnostic Test Group Clarity Urocheck 120 14 - - - 14 - - - - Germaine Laboratories AimStrip 4 - 2 - 1 1 - - - Immunostics Detector Combi 1 - - - - 1 - - - McKesson 10SG Reagent Strips 9 - - - 5 4 - - - Other Analyzer Method 5 - 1 - 2 2 - - - Other Dipstick Method 17 1 1 1 4 9 1 - - PSS Select Reagent Strips 4 - - - 2 1 1 - - PSS Select Urine Analyzer 1 - - - - 1 - - - Roche Chemstrip 101 5 ------5 - Roche Chemstrips 57 - - - 1 3 50 - 3 Roche Criterion Analyzer 15 - - - - 1 14 - - Roche Urisys 42 - - - 1 5 - 36 - Schein Urispec 6 - - 1 - 3 - 2 - UriScan Reagent Strips 1 - - - 1 - - - -

68 / 2013 MLE-M3 Participant Summary

URINALYSIS DIPSTICKKETONES

Specimen UA-3

Participant Results Small Moderate Large Trace (1+, 15 (2+, 40 (3+, 80 150 Method Labs Negative (5 mg/dL) mg/dL) mg/dL) mg/dL) mg/dL ≥ 160 mg/dL

ALL METHODS 949 2 1 1 17 381 48 499 Arkray DiaScreen 1 ------1 Arkray DiaScreen 50 4 - - - - - 1 3 Bayer Acetest 1 - - - - 1 - - Bayer Clinitek 10 / 100 15 - 1 - - 10 - 4 Bayer Clinitek 200/200+ 1 - - - - 1 - - Bayer Clinitek 50 65 2 - - - 63 - - Bayer Clinitek 500 16 - - - 1 15 - - Bayer Clinitek Advantus 21 - - - - 20 - 1 Bayer Clinitek Atlas 5 - - - - 4 - 1 Bayer Clinitek Status / Status+ 327 - - 1 - 49 - 277 Bayer Ketostix 1 - - - - 1 - - Bayer Reagent Strips 258 - - - - 73 - 185 Consult Diagnostics Urine Analyzer 17 - - - 7 9 1 - CTMI CT-120 Urine Analyzer 11 - - - - 11 - - Diagnostic Test Group Clarity Urocheck 7 ------7 Diagnostic Test Group Clarity Urocheck 120 14 - - - - 14 - - Germaine Laboratories AimStrip 4 - - - - 2 - 2 Immunostics Detector Combi 1 ------1 McKesson 10SG Reagent Strips 9 - - - 1 3 - 5 Other Analyzer Method 5 - - - - 4 - 1 Other Dipstick Method 17 - - - - 11 1 5 PSS Select Reagent Strips 3 - - - - 2 1 - PSS Select Urine Analyzer 1 - - - 1 - - - Roche Chemstrip 101 5 - - - - 2 3 - Roche Chemstrips 58 - - - - 57 - 1 Roche cobas u 411 1 - - - - 1 - - Roche Criterion Analyzer 16 - - - - 5 11 - Roche Urisys 47 - - - 7 11 29 - Schein Urispec 6 - - - - 5 - 1

2013 MLE-M3 Participant Summary/ 69

URINALYSIS DIPSTICKBILIRUBIN

Specimen UA-3 Participant Results Small Moderate Large Method Labs Negative (1+) (2+) (3+)

ALL METHODS 934 928 1 2 3 Arkray DiaScreen 1 1 - - - Arkray DiaScreen 50 4 4 - - - Bayer Clinitek 10 / 100 14 14 - - - Bayer Clinitek 200/200+ 1 1 - - - Bayer Clinitek 50 66 66 - - - Bayer Clinitek 500 17 17 - - - Bayer Clinitek Advantus 19 19 - - - Bayer Clinitek Atlas 5 5 - - - Bayer Clinitek Status / Status+ 318 318 - - - Bayer Reagent Strips 257 252 1 2 2 Consult Diagnostics Urine Analyzer 17 17 - - - CTMI CT-120 Urine Analyzer 11 11 - - - Diagnostic Test Group Clarity Urocheck 7 7 - - - Diagnostic Test Group Clarity Urocheck 120 14 14 - - - Germaine Laboratories AimStrip 4 4 - - - Immunostics Detector Combi 1 1 - - - McKesson 10SG Reagent Strips 9 8 - - 1 Other Analyzer Method 5 5 - - - Other Dipstick Method 17 17 - - - PSS Select Reagent Strips 3 3 - - - PSS Select Urine Analyzer 1 1 - - - Roche Chemstrip 101 5 5 - - - Roche Chemstrips 57 57 - - - Roche cobas u 411 1 1 - - - Roche Criterion Analyzer 16 16 - - - Roche Urisys 47 47 - - - Schein Urispec 6 6 - - - UriScan Reagent Strips 1 1 - - -

70 / 2013 MLE-M3 Participant Summary

URINALYSIS DIPSTICKUROBILINOGEN

Specimen UA-3 Participant Results

Method Labs 0.2/Normal mg/dL 1.0 mg/dL 2.0 mg/dL 4.0 mg/dL >8.0 mg/dL

ALL METHODS 903 896 2 1 2 2 Arkray DiaScreen 1 1 - - - - Arkray DiaScreen 50 3 3 - - - - Bayer Clinitek 10 / 100 14 14 - - - - Bayer Clinitek 200/200+ 1 1 - - - - Bayer Clinitek 50 65 64 1 - - - Bayer Clinitek 500 11 11 - - - - Bayer Clinitek Advantus 19 19 - - - - Bayer Clinitek Atlas 3 3 - - - - Bayer Clinitek Status / Status+ 318 318 - - - - Bayer Reagent Strips 238 238 - - - - Consult Diagnostics Urine Analyzer 17 15 1 1 - - CTMI CT-120 Urine Analyzer 11 11 - - - - Diagnostic Test Group Clarity Urocheck 7 7 - - - - Diagnostic Test Group Clarity Urocheck 120 13 13 - - - - Germaine Laboratories AimStrip 3 3 - - - - Immunostics Detector Combi 1 1 - - - - McKesson 10SG Reagent Strips 9 7 - - 1 1 Other Analyzer Method 5 4 - - 1 - Other Dipstick Method 17 17 - - - - PSS Select Reagent Strips 3 3 - - - - PSS Select Urine Analyzer 1 1 - - - - Roche Chemstrip 101 5 5 - - - - Roche Chemstrips 56 56 - - - - Roche cobas u 411 1 1 - - - - Roche Criterion Analyzer 16 16 - - - - Roche Urisys 47 47 - - - - Schein Urispec 5 5 - - - - UriScan Reagent Strips 1 - - - - 1

2013 MLE-M3 Participant Summary/ 71

URINALYSIS DIPSTICKBLOOD/HEMOGLOBIN

Specimen UA-3 Participant Results

Small (5-10 Moderate (50 Large (250 Method Labs Negative Trace RBC/µL, 1+) RBC/µL, 2+) RBC/µL, 3+)

ALL METHODS 971 930 35 2 3 1 Arkray DiaScreen 1 - - - 1 - Arkray DiaScreen 50 4 3 1 - - - Bayer Clinitek 10 / 100 14 14 - - - - Bayer Clinitek 200/200+ 1 1 - - - - Bayer Clinitek 50 68 66 2 - - - Bayer Clinitek 500 18 17 1 - - - Bayer Clinitek Advantus 21 21 - - - - Bayer Clinitek Atlas 5 5 - - - - Bayer Clinitek Status / Status+ 331 316 14 - 1 - Bayer Hemacombistix 1 1 - - - - Bayer Reagent Strips 264 251 11 1 - 1 Consult Diagnostics Urine Analyzer 16 16 - - - - CTMI CT-120 Urine Analyzer 11 11 - - - - Diagnostic Test Group Clarity Urocheck 7 7 - - - - Diagnostic Test Group Clarity Urocheck 120 14 14 - - - - Germaine Laboratories AimStrip 3 3 - - - - Immunostics Detector Combi 1 1 - - - - McKesson 10SG Reagent Strips 9 9 - - - - Other Analyzer Method 5 5 - - - - Other Dipstick Method 17 16 1 - - - PSS Select Reagent Strips 4 4 - - - - PSS Select Urine Analyzer 1 1 - - - - Roche Chemstrip 101 5 5 - - - - Roche Chemstrips 69 66 3 - - - Roche cobas u 411 1 1 - - - - Roche Criterion Analyzer 16 16 - - - - Roche Urisys 47 46 1 - - - Schein Urispec 6 4 - 1 1 - UriScan Reagent Strips 1 1 - - - -

72 / 2013 MLE-M3 Participant Summary

URINALYSIS DIPSTICKLEUKOCYTE ESTERASE

Specimen UA-3 Participant Results

Small Moderate Large Method Labs Negative Trace (1+) (2+) (3+)

ALL METHODS 984 4 16 191 548 225 Arkray DiaScreen 6 1 - - 1 4 Arkray DiaScreen 50 4 - - - - 4 Bayer Clinitek 10 / 100 14 - - 4 10 - Bayer Clinitek 200/200+ 1 - - - 1 - Bayer Clinitek 50 68 - 3 27 26 12 Bayer Clinitek 500 18 - - 2 16 - Bayer Clinitek Advantus 21 - - - 20 1 Bayer Clinitek Atlas 5 - - - - 5 Bayer Clinitek Status / Status+ 332 1 13 138 107 73 Bayer Reagent Strips 256 2 - 16 208 30 Bayer Uristix 14 - - 1 12 1 Behring Reagent Strips 1 - - - 1 - Consult Diagnostics Urine Analyzer 17 - - - - 17 CTMI CT-120 Urine Analyzer 11 - - 1 8 2 Diagnostic Test Group Clarity Urocheck 7 - - - 6 1 Diagnostic Test Group Clarity Urocheck 120 14 - - - 9 5 Germaine Laboratories AimStrip 4 - - - 2 2 Immunostics Detector Combi 1 - - - - 1 McKesson 10SG Reagent Strips 9 - - - 4 5 Other Analyzer Method 5 - - - 1 4 Other Dipstick Method 17 - - - 9 8 PSS Select Reagent Strips 4 - - - 1 3 PSS Select Urine Analyzer 1 - - - - 1 Roche Chemstrip 101 5 - - - 3 2 Roche Chemstrips 70 - - - 62 8 Roche Criterion Analyzer 16 - - - 12 4 Roche Urisys 47 - - - 24 23 Schein Urispec 6 - - - - 6 UriScan Reagent Strips 1 - - - - 1

2013 MLE-M3 Participant Summary/ 73

URINALYSIS DIPSTICKNITRITE

Specimen UA-3 Participant Results

Method Labs Positive Negative

ALL METHODS 984 978 6 Arkray DiaScreen 6 6 - Arkray DiaScreen 50 4 4 - Bayer Clinitek 10 / 100 14 14 - Bayer Clinitek 200/200+ 1 - 1 Bayer Clinitek 50 67 67 - Bayer Clinitek 500 18 18 - Bayer Clinitek Advantus 21 21 - Bayer Clinitek Atlas 5 5 - Bayer Clinitek Status / Status+ 330 330 - Bayer Reagent Strips 258 256 2 Bayer Uristix 14 14 - Consult Diagnostics Urine Analyzer 16 16 - CTMI CT-120 Urine Analyzer 11 11 - Diagnostic Test Group Clarity Urocheck 7 7 - Diagnostic Test Group Clarity Urocheck 120 14 13 1 Germaine Laboratories AimStrip 4 4 - Immunostics Detector Combi 1 1 - McKesson 10SG Reagent Strips 9 8 1 Other Analyzer Method 5 5 - Other Dipstick Method 16 16 - PSS Select Reagent Strips 4 4 - PSS Select Urine Analyzer 1 1 - Roche Chemstrip 101 4 4 - Roche Chemstrips 70 70 - Roche cobas u 411 1 1 - Roche Criterion Analyzer 15 15 - Roche Urisys 47 47 - Schein Urispec 6 5 1 UriScan Reagent Strips 1 1 -

74 / 2013 MLE-M3 Participant Summary

URINALYSIS MICROALBUMIN (dipstick only)

Specimen UA-3 Participant Results

Method Labs Negative 10 mg/L(Pos) 20/30 mg/L 50 mg/L (+) 80 mg/L 100 mg/L (++) 150 mg/L

ALL METHODS 76 22 38 12 2 - - 2 Bayer Clinitek Microalbumin 37 - 34 1 - - - 2 Bayer Clinitek Status / Status+ 3 1 2 - - - - - Beckman Coulter ICON microALB 1 - 1 - - - - - DCL ImmunoDip 1 1 ------Micro-Bumintest 3 3 ------Roche Micral - 1 minute 30 16 1 11 2 - - -

2013 MLE-M3 Participant Summary/ 75

URINALYSIS URINE hCG

Specimen UA-3 Participant Results

Method Labs Positive Negative

ALL METHODS 557 1 556 AimStep Combo Pregnancy 2 - 2 Alfa Scientific Instant View 5 - 5 Bayer Clinitek 50 1 - 1 Bayer Clinitek Status / Status+ 1 - 1 Beckman Coulter ICON 25 hCG 36 - 36 Beckman Coulter ICON II/20 HCG 3 - 3 Cardinal Health SP Brand combo 27 - 27 Cardinal Hlth SPBrand-cassette 7 - 7 CONSULT diagnostics hCG Cassette 53 - 53 CONSULT diagnostics hCG Combo 22 - 22 CONSULT diagnostics hCG Dipstick 16 - 16 Diagnostic Test Group Clarity hCG Combo 1 - 1 Diagnostic Test Group Clarity hCG strip/cassette 7 1 6 Genzyme OSOM - Urine Test 4 - 4 Genzyme OSOM Card Pregnancy 6 - 6 Genzyme OSOM hCG Combo Test 26 - 26 Germaine Laboratories AimStrip 1 - 1 Henry Schein One Step 47 - 47 Immunostics Cept-D 1 - 1 Immunostics Detector Combi 1 - 1 Immunostics hCG Detector-urine 15 - 15 Inverness Acceva hCG-Urine 6 - 6 Inverness Clearview 25 hCG Combo 1 - 1 Inverness Clearview hCG Cassette 2 - 2 McKesson hCG Combo Cassette 13 - 13 McKesson hCG Urine Cassette 21 - 21 McKesson urine hCG-all 20 mIU kits 3 - 3 Meridian ImmunoCard STAT! 1 - 1 NDC Pro Advantage 5 - 5 PEP (Lab Supply) HCG 2 - 2 Polymedco Poly stat hCG 11 - 11

76 / 2013 MLE-M3 Participant Summary

URINALYSIS URINE hCG (cont’d)

Specimen UA-3

Participant Results

Method Labs Positive Negative

PSS Select hCG Cassette 2 - 2 Quidel QuickVue One-Step Combo 34 - 34 Quidel QuickVue One-Step Urine 74 - 74 Quidel QuickVue+ One-Step Combo 15 - 15 Schein Urispec 1 - 1 SmithKline ICON Fx hCG 1 - 1 Stanbio QuPID 7 - 7 Stanbio QuPID Plus 2 - 2 Stanbio QuStick 1 - 1 Stanbio TRUE hCG 8 - 8 Sure-Vue hCG - 25mIU 8 - 8 Sure-Vue hCG-STAT 5 - 5

FECAL OCCULT BLOOD

Specimen OC-5 Specimen OC-6 Method Labs Positive Negative Labs Positive Negative

ALL METHODS 443 439 4 443 5 438 Alfa Scientific Instant View 1 1 - 1 - 1 Beckman Coulter Hemoccult ICT 38 38 - 38 - 38 Guaiac (slide) Test 278 275 3 278 4 274 Hemosure IFOB 48 48 - 48 - 48 Inverness Clearview iFOBT Complete 3 3 - 3 - 3 Other Immunochemical FOB kit 22 21 1 22 1 21 Polymedco OC Auto Micro 80 7 7 - 7 - 7 Polymedco OC-Light iFOB 15 15 - 15 - 15 Quidel QuickVue iFOB 9 9 - 9 - 9 Wampole Clearview Ultra FOBT 1 1 - 1 - 1

2013 MLE-M3 Participant Summary/ 77

2013 M3 Urine Sediment Identification SPECIMENS US-5 AND US-6

CASE HISTORY:

A 60-year-old female with a history of lupus presented to her primary care physician with nausea, vomiting, weight loss, and fatigue. A routine urinalysis was performed, and the results appear below.

Color = Amber Appearance = Cloudy

Dipstick results: Specific gravity = 1.010 pH = 6.5 Protein >/= 1000 mg/dL (4+) Glucose = Negative Ketones = Negative Bilirubin = Negative Urobilinogen = Normal/0.2 mg/dL Blood = Moderate (50 RBC/µL, 2+) Leukocyte Esterase = Trace Nitrite = Negative

This patient was diagnosed with renal failure. The main functions of the kidneys include filtering the to remove waste products and maintaining the proper balance of water in the body. Chronic renal failure is a progressive in which the kidneys gradually lose the ability to excrete waste, concentrate urine, and conserve electrolytes. Many patients with advanced renal failure lose the ability to concentrate urine, and the urine specific gravity stays fixed at 1.010, regardless of physiologic conditions. Immune-mediated injury is the most common cause of glomerular disease, and lupus is an autoimmune disease that may affect almost any part of the body. Up to 40% of patients with lupus develop kidney disease due to inflammatory injury to the glomeruli of the kidneys. Fatigue and loss of physical endurance can be the result of anemia as well as acidosis.

Specimen US-5 Identification Labs Percent Performance Red blood cell (RBC) 645 94.16% Acceptable Fat droplets or globules 24 3.50%

The arrows in this photograph point to red blood cells. They contain no nuclei and are smaller than the two granular white blood cells nearby. Red blood cells in urine, such as the arrowed cell on the left, often resemble donuts or inner tubes due to the biconcave disk shape. The microscopic presence of red cells and the positive dipstick result for blood, as well as proteinuria, indicate glomerular disease. To view another photo of red blood cells, see 2012 M1 Specimen US-2. To view a photo of fat droplets, see 2007 M3 Specimen US-6.

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URINE SEDIMENT IDENTIFICATION cont’d

Specimen US-6 Identification Labs Percent Performance Waxy cast 577 84.98% Acceptable Identification Unknown – Refer 8 1.18% Acceptable Hyaline cast 55 8.10% Fiber/fecal contamination 17 2.50% Granular cast 11 1.18% RBC/blood/hgb cast 6 0.85%

The arrows in this photograph point to waxy casts. Casts are cylindrical bodies of mucoprotein and plasma proteins molded in the lumen of the renal tubule. Waxy casts are homogenous like hyaline casts, however waxy casts usually have fissures or cracks and broken or blunt ends. Hyaline casts usually have rounded ends and are more translucent. Since they are associated with renal stasis, indicating advanced renal disease, waxy casts are accompanied by abnormal chemical and microscopic findings. This fact can help in recognizing contaminating fibers that may resemble casts in an otherwise normal urine sample. Cloth fibers are flat, rather than cylindrical like casts; and fibers usually have dark edges, while casts do not. To view another photo of a waxy cast, see 2006 M1 Specimen US-1. To view a photo of a hyaline cast, see 2010 M3 Specimen US-6.

References:

Cohen,E.P. “Chronic Renal Failure and Dialysis.” ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., 2004. 1988

Mundt, L.A, Shanahan, K.: Graff’s Textbook of Routine Urinalysis and Body Fluids, 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 2011.

Ringsrud, K. M., Linné, J. J.: Urinalysis and Body Fluids/ A ColorText and Atlas. St. Louis: Mosby, 1995.

Shankland,S.J. “Glomerular .” ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., 2004. 1997-1999.

Sterns,R.H. “Renal Function and Disorders of Water and Sodium Balance.” ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., 2004. 1929.

Swan,S.K. “Approach to the Patient with Renal Disease.” ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., 2004. 1915.

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PROVIDER-PERFORMED MICROSCOPY (PPM)

Wet Mount Preparation Specimen PPM-13 Identification Labs Percent Performance Trichomonas vaginalis 582 99.66% Acceptable

The arrows in this photograph of a vaginal wet mount point to trichomonas. Trichomonas vaginalis is a sexually-transmitted parasite. Trichomonas is pear-shaped, and about the same size as a white blood cell. It is easily identified in a wet prep under the microscope by its distinctive irregular, rotating motility. It has a single nucleus, four anterior flagella, an anterior undulating membrane, and a sharp protruding posterior axostyle. Some participants mistook these trichomonads for spermatozoa. Spermatozoa have very small oval heads about one-fourth the size of a red blood cell, and very long tails. To view another photo of Trichomonas, see 2012 M1 Specimen PPM-1. To view a photo of sperm, see PPM-15.

KOH Preparation Specimen PPM-14 Identification Labs Percent Performance Yeast/fungal elements absent 505 90.99% Acceptable Yeast/fungal elements present 50 9.01%

Yeast and fungal elements are absent in this photograph of a vaginal KOH prep.

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PROVIDER-PERFORMED MICROSCOPY (PPM)

Sperm Identification Specimen PPM-15 Identification Labs Percent Performance Sperm present 559 99.82% Acceptable Sperm absent 1 0.18%

Two spermatozoa are present in this photograph of a vaginal wet prep.

Nasal Smear Specimen PPM-16 Identification Labs Percent Performance Eosinophils absent 173 86.07% Acceptable Eosinophils present 28 13.93%

Eosinophils are absent in this photograph of Wright-stained nasal mucus. The purpose of examining the leukocytes (white blood cells) in respiratory secretions is to differentiate allergic conditions from . Eosinophils are a specific type of leukocyte that are associated with allergic conditions. “Eos” have a unique red-orange color that makes them easy to spot and identify. The color comes from the dye eosin, which is a component of Wright stain. The cytoplasm of an eosinophil is filled with large, round, orange-staining granules that surround the purple nucleus but do not obscure it from view. The cells shown in this photo are not eosinophils. To view a photo of eosinophils, see 2013 M2 Specimen PPM-10.

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PROVIDER-PERFORMED MICROSCOPY (PPM)

Fecal Leukocytes Specimen PPM-17 Identification Labs Percent Performance Leukocytes are present 218 98.20% Acceptable Leukocytes are absent 4 1.80%

Leukocytes are present in this photograph of a Wright-stained stool preparation.

Vaginal Fluid Preparation Specimen PPM-18 Identification Labs Percent Performance Ferning absent 277 98.93% Acceptable Ferning present 3 1.07%

Ferning is absent in this photograph of air-dried vaginal secretions.

Reference: Fischer, P. M.: The Office Laboratory. Norwalk, Conn.: Appleton-Century-Crofts, 1983.

Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC 20001-7401 800-338-2746  202-261-4500  Fax: 202-835-0440 www.acponline.org/mle

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