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M E D I C A L L A B O R A T O R Y

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Total Commitment to Education and Service

Provided by ACP, Inc.

Hematology, Coagulation,

Blood Bank, Urinalysis, PPM

2016 MLE-M3

PARTICIPANT SUMMARY

2 • 0 • 1 • 6

COPYRIGHT ACP, Inc. Single copies of all material subject to this copyright may be photocopied for the non-commercial use of scientific or educational advancement.

Table of Contents

Evaluation Criteria ....................................................................................................................... 5 Hematology

HemoCue (Module 215) ............................................................................................................................................................ 6

Hemoglobin ......................................................................................................................................................................... 6

Glucose ............................................................................................................................................................................... 6

Sedimentation Rate .................................................................................................................................................................. 6

Hematology with 5-part Automated Differential (CL Samples – Module 223) ..................................................................... 7

White Blood Cell Count ....................................................................................................................................................... 7

Red Blood Cell Count .......................................................................................................................................................... 7

Hemoglobin ......................................................................................................................................................................... 8

Hematocrit ........................................................................................................................................................................... 8

Platelet Count...................................................................................................................................................................... 9

Automated Differential ......................................................................................................................................................... 9

Sysmex Hematology with 3-part Automated Differential (SYX Samples – Module 224) .................................................. 12

White Blood Cell Count ..................................................................................................................................................... 12

Red Blood Cell Count ........................................................................................................................................................ 13

Hemoglobin ....................................................................................................................................................................... 14

Hematocrit ......................................................................................................................................................................... 15

Platelet Count.................................................................................................................................................................... 16

Automated Differential ....................................................................................................................................................... 17

Basic Hematology with 3-part Automated Differential (HD Samples – Module 225) ........................................................ 20



Hemoglobin ....................................................................................................................................................................... 23

Hematocrit ......................................................................................................................................................................... 24

Platelet Count.................................................................................................................................................................... 26


Hematology with 5-part Automated Differential (DIF Samples – Module 226) .................................................................. 32



Hemoglobin ....................................................................................................................................................................... 33

Hematocrit ......................................................................................................................................................................... 33

Platelet Count.................................................................................................................................................................... 34


Blood Lead .............................................................................................................................................................................. 37

Reticulocyte Count ................................................................................................................................................................. 37

2016 MLE-M3 Participant Summary/ 3

Table of Contents (cont’d)

Hematology (cont’d)

Hematology with 5-part Automated Differential (BCX Samples – Module 228) ................................................................ 38


Red Blood Cell Count ....................................................................................................................................................... 39

Hemoglobin ....................................................................................................................................................................... 40

Hematocrit......................................................................................................................................................................... 41

Platelet Count ................................................................................................................................................................... 42

Automated Differential ...................................................................................................................................................... 43

Hematology with 5-part Automated Differential (MX Samples – Module 229) .................................................................. 48


Red Blood Cell Count ....................................................................................................................................................... 49

Hemoglobin ....................................................................................................................................................................... 50

Hematocrit......................................................................................................................................................................... 50

Platelet Count ................................................................................................................................................................... 51

Automated Differential ...................................................................................................................................................... 52

Waived Hematology (Module 213) ........................................................................................................................................ 72

Hemoglobin ....................................................................................................................................................................... 72

Hematocrit......................................................................................................................................................................... 72

Blood Cell Identification ........................................................................................................................................................ 57

Blood Bank

ABO Group ............................................................................................................................................................................. 61

Rh Factor (D Type) ................................................................................................................................................................. 61

Rh Factor (Slide Method) ....................................................................................................................................................... 65

Unexpected Antibody Detection ........................................................................................................................................... 61

Antibody Identification .......................................................................................................................................................... 62

Compatibility Testing ............................................................................................................................................................. 62

Coagulation

Prothrombin Time .................................................................................................................................................................. 63

International Normalized Ratio (INR) ................................................................................................................................ 64

Activated Partial Thromboplastin Time ................................................................................................................................ 65

Fibrinogen............................................................................................................................................................................... 65

CoaguChek XS Plus Prothrombin Time ............................................................................................................................... 66


CoaguChek XS INR ................................................................................................................................................................ 67

i-Stat Prothrombin Time ........................................................................................................................................................ 68


Fluid Cell Count/Crystals ...................................................................................................................................................... 68

WBC Count ....................................................................................................................................................................... 68

RBC Count ........................................................................................................................................................................ 68

Crystal Identification .......................................................................................................................................................... 69

4 / 2016 MLE-M3 Participant Summary

Table of Contents (cont’d) Urinalysis

Microalbumin, Urine ............................................................................................................................................................... 71

Dipstick ............................................................................................................................................................................. 71

Quantitative ....................................................................................................................................................................... 71

Creatinine, Urine..................................................................................................................................................................... 71

Dipstick ............................................................................................................................................................................. 71

Quantitative ....................................................................................................................................................................... 71

Urinalysis Dipstick ................................................................................................................................................................. 73

Specific Gravity ................................................................................................................................................................. 73

pH ..................................................................................................................................................................................... 74

Protein ............................................................................................................................................................................... 75

Glucose ............................................................................................................................................................................. 77

Ketones ............................................................................................................................................................................. 78

Bilirubin ............................................................................................................................................................................. 79

Urobilinogen ...................................................................................................................................................................... 80

Blood or Hemoglobin ......................................................................................................................................................... 81

Leukocyte Esterase ........................................................................................................................................................... 82

Nitrite ................................................................................................................................................................................. 83

Microalbumin (Dipstick Only)............................................................................................................................................. 84

Urine hCG ............................................................................................................................................................................... 85

Fecal Occult Blood ................................................................................................................................................................. 86

KOH Skin Preparation ............................................................................................................................................................ 72

Urine Sediment Identification ................................................................................................................................................ 87

Provider-Performed Microscopy (PPM)

Provider-Performed Microscopy (PPM) ................................................................................................................................ 89


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. ABO Group 95% Participant or 100% Referee Consensus

Antibody Identification 95% Consensus

Blood Cell Identification 80% Consensus

Compatibility Testing 95% Participant or 100% Referee Consensus

Crystal Identification 80% Consensus

Fecal Occult Blood 80% Consensus

KOH Skin Preparation 80% Consensus

Microalbumin (Semi-Quantitative) 80% Consensus

Provider-Performed Microscopy 80% Consensus

Rh Factor (D Type) 95% Participant or 100% Referee Consensus

Unexpected Antibody Detection 95% Consensus

Urine Dipstick 80% Consensus

Urine hCG 80% Consensus

Urine Sediment Identification 80% 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.” Activated Partial Thromboplastin Time 15%

Automated Differential 3 SD

Blood Lead 4 µg/dL or 10%*

Body Fluid - Red Cell Count 2 SD

Body Fluid - White Cell Count 2 SD

Creatinine, Urine (Quantitative) 17%

Fibrinogen 20%

Hematocrit 6%

Hematocrit, Waived 6% or 2 SD*

Hemoglobin 7%

Hemoglobin, Waived 7% or 2 SD*

International Normalized Ratio (INR) 20%

Microalbumin (Quantitative) 30%

Platelet Count 25%

Prothrombin Time 15%

Red Blood Cell Count 6%

Reticulocyte Count 30% or 2 SD*

Sedimentation Rate 2 SD

Specific Gravity 0.010

White Blood Cell Count 15%

Whole Blood Glucose – HemoCue 12 mg/dL or 20%*

*Whichever is greater


HEMOCUE HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HQ-5 Specimen HQ-6 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

HemoCue 36 15.21 0.25 1.7 15.2 14.1 - 16.3 35 5.04 0.18 3.5 5.1 4.6 - 5.4

HEMOCUE HEMATOLOGYGLUCOSE (mg/dL)

Specimen HQ-5 Specimen HQ-6 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 32 327.1 12.0 3.7 327 261 - 393 33 50.2 5.6 11.1 50 38 - 63 All HemoCue Methods 31 327.2 12.2 3.7 328 261 - 393 32 50.4 5.6 11.1 50 38 - 63 HemoCue Glucose 201/+ 31 327.2 12.2 3.7 328 261 - 393 32 50.4 5.6 11.1 50 38 - 63

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 159 47.8 13.7 28.6 45 20 - 76 157 7.5 2.6 34.5 8 2 - 13 All HiChem Methods 10 76.5 11.4 15.0 79 53 - 100 10 7.8 4.2 53.3 6 0 - 17 All Vital Diagnostics Methods 21 54.4 6.9 12.7 55 40 - 69 21 7.2 1.1 15.7 7 4 - 10 HiChem Mini-Ves 10 76.5 11.4 15.0 79 53 - 100 10 7.8 4.2 53.3 6 0 - 17 Polymedco Sedimat 10 42.2 5.4 12.8 42 31 - 53 10 3.8 2.5 66.6 4 0 - 9 Vital Diagnostics Excyte M/10 18 54.4 7.5 13.8 56 39 - 70 18 7.2 1.2 16.8 7 4 - 10 Westergren - diluted 85 43.0 8.7 20.3 40 25 - 61 85 7.3 2.0 26.8 8 3 - 12 Westergren - undiluted 11 44.5 7.2 16.1 45 30 - 59 11 8.1 2.5 31.0 9 3 - 14

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 11 66.9 5.8 8.7 66 55 - 79 11 2.1 0.9 45.1 2 0 - 4


HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE 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 15 21.48 0.71 3.3 21.5 18.2 - 24.8 15 8.33 0.31 3.7 8.4 7.0 - 9.6 All Abbott Cell-Dyn Instruments 14 21.41 0.69 3.2 21.5 18.2 - 24.7 14 8.35 0.31 3.7 8.4 7.0 - 9.7 Abbott Cell-Dyn Ruby 10 21.62 0.68 3.1 21.6 18.3 - 24.9 10 8.49 0.22 2.6 8.5 7.2 - 9.8

Specimen CL-13 Specimen CL-14


Specimen CL-15

All Method 15 8.34 0.27 3.2 8.4 7.0 - 9.6

All Abbott Cell-Dyn Instruments 14 8.36 0.26 3.1 8.4 7.1 - 9.7

Abbott Cell-Dyn Ruby 10 8.43 0.23 2.7 8.6 7.1 - 9.7

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x M/uL)





Specimen CL-15 All Method 15 4.749 0.092 1.9 4.77 4.46 - 5.04




HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)





Specimen CL-15

All Method 15 13.57 0.29 2.1 13.5 12.6 - 14.6



HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)









HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x K/uL)


All Method 15 508.1 35.0 6.9 520 381 - 636 15 278.2 22.6 8.1 287 208 - 348 All Abbott Cell-Dyn Instruments 14 511.9 33.0 6.4 521 383 - 640 14 280.7 21.2 7.5 288 210 - 351 Abbott Cell-Dyn Ruby 10 525.8 18.4 3.5 525 394 - 658 10 288.1 11.8 4.1 290 216 - 361

Specimen CL-13 Specimen CL-14 All Method 15 72.1 6.5 9.0 72 54 - 91 15 506.5 36.3 7.2 520 379 - 634 All Abbott Cell-Dyn Instruments 14 71.4 6.1 8.5 72 53 - 90 14 510.8 33.6 6.6 522 383 - 639 Abbott Cell-Dyn Ruby 10 73.2 5.0 6.8 73 54 - 92 10 525.2 20.3 3.9 532 393 - 657

Specimen CL-15 All Method 15 273.8 21.3 7.8 279 205 - 343

All Abbott Cell-Dyn Instruments 14 276.6 19.1 6.9 281 207 - 346

Abbott Cell-Dyn Ruby 10 284.5 13.6 4.8 286 213 - 356

HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)

Specimen CL-11 Specimen CL-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 15 75.63 0.42 0.6 75.7 74.3 - 77.0 15 63.51 0.80 1.3 63.4 61.1 - 66.0 All Abbott Cell-Dyn Instruments 14 75.60 0.42 0.6 75.7 74.3 - 76.9 14 63.38 0.65 1.0 63.4 61.4 - 65.4 Abbott Cell-Dyn Ruby 10 75.68 0.42 0.5 75.8 74.4 - 77.0 10 63.55 0.50 0.8 63.5 62.0 - 65.1

Specimen CL-13 Specimen CL-14 All Method 15 51.26 1.55 3.0 51.2 46.6 - 55.9 15 75.51 0.73 1.0 75.7 73.3 - 77.7 All Abbott Cell-Dyn Instruments 14 51.07 1.41 2.8 51.2 46.8 - 55.4 14 75.46 0.72 1.0 75.6 73.2 - 77.7 Abbott Cell-Dyn Ruby 10 51.61 1.21 2.3 51.5 47.9 - 55.3 10 75.29 0.69 0.9 75.3 73.2 - 77.4

Specimen CL-15

All Method 15 63.25 0.97 1.5 63.3 60.3 - 66.2




HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)





Specimen CL-15

All Method 15 26.53 0.97 3.6 26.5 23.6 - 29.5



HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)









HEMATOLOGY W/ 5-PART DIFFERENTIALEOSINOPHILS (percent)





Specimen CL-15

All Method 15 4.98 0.45 9.0 5.0 3.6 - 6.4



HEMATOLOGY W/ 5-PART DIFFERENTIALBASOPHILS (percent)









SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALWHITE 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 77 20.92 0.58 2.8 21.0 17.7 - 24.1 75 8.23 0.24 2.9 8.2 6.9 - 9.5 All Sysmex Instruments 76 20.93 0.58 2.8 21.0 17.7 - 24.1 74 8.23 0.24 2.9 8.2 6.9 - 9.5 Sysmex KX-21N & K-800, 1000, 4500 41 20.93 0.46 2.2 21.0 17.7 - 24.1 39 8.16 0.17 2.1 8.2 6.9 - 9.4 Sysmex pocH-100i 14 20.53 0.55 2.7 20.7 17.4 - 23.7 14 8.11 0.22 2.7 8.2 6.8 - 9.4 Sysmex XP-300 21 21.18 0.69 3.3 21.3 17.9 - 24.4 20 8.48 0.17 2.0 8.5 7.2 - 9.8 Specimen SYX-13 Specimen SYX-14

All Method 77 2.86 0.11 3.8 2.9 2.4 - 3.3 76 20.90 0.51 2.4 20.9 17.7 - 24.1 All Sysmex Instruments 76 2.86 0.11 3.8 2.9 2.4 - 3.3 75 20.91 0.51 2.4 20.9 17.7 - 24.1 Sysmex KX-21N & K-800, 1000, 4500 41 2.86 0.10 3.7 2.9 2.4 - 3.3 41 21.01 0.43 2.0 21.0 17.8 - 24.2 Sysmex pocH-100i 14 2.81 0.10 3.6 2.8 2.3 - 3.3 14 20.44 0.48 2.3 20.6 17.3 - 23.6 Sysmex XP-300 21 2.91 0.11 3.8 2.9 2.4 - 3.4 21 21.12 0.62 2.9 21.0 17.9 - 24.3 Specimen SYX-15

All Method 75 8.21 0.21 2.6 8.2 6.9 - 9.5

All Sysmex Instruments 74 8.21 0.21 2.6 8.2 6.9 - 9.5

Sysmex KX-21N & K-800, 1000, 4500 40 8.16 0.16 2.0 8.2 6.9 - 9.4

Sysmex pocH-100i 14 8.15 0.18 2.2 8.2 6.9 - 9.4

Sysmex XP-300 21 8.40 0.31 3.7 8.4 7.1 - 9.7


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)




All Method 75 4.145 0.047 1.1 4.14 3.89 - 4.40


Sysmex KX-21N & K-800, 1000, 4500 39 4.143 0.041 1.0 4.14 3.89 - 4.40

Sysmex pocH-100i 14 4.161 0.067 1.6 4.16 3.91 - 4.42

Sysmex XP-300 21 4.138 0.043 1.0 4.14 3.88 - 4.39


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMOGLOBIN (g/dL)




All Method 76 12.14 0.17 1.4 12.2 11.2 - 13.0


Sysmex KX-21N & K-800, 1000, 4500 40 12.18 0.17 1.4 12.2 11.3 - 13.1

Sysmex pocH-100i 14 12.03 0.22 1.9 12.0 11.1 - 12.9

Sysmex XP-300 21 12.17 0.11 0.9 12.2 11.3 - 13.1


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMATOCRIT (percent)




All Method 76 32.82 0.78 2.4 32.7 30.8 - 34.8


Sysmex KX-21N & K-800, 1000, 4500 40 32.49 0.57 1.8 32.5 30.5 - 34.5

Sysmex pocH-100i 14 34.03 0.41 1.2 34.0 31.9 - 36.1

Sysmex XP-300 21 32.60 0.45 1.4 32.7 30.6 - 34.6


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALPLATELET COUNT (x109/L)


All Method 77 389.1 25.2 6.5 394 291 - 487 76 201.8 8.7 4.3 201 151 - 253 All Sysmex Instruments 76 389.4 25.2 6.5 395 292 - 487 75 201.7 8.8 4.3 201 151 - 253 Sysmex KX-21N & K-800, 1000, 4500 41 397.2 14.3 3.6 397 297 - 497 41 203.0 7.2 3.6 203 152 - 254 Sysmex pocH-100i 14 345.4 14.3 4.1 344 259 - 432 14 189.4 7.8 4.1 192 142 - 237 Sysmex XP-300 21 403.4 12.6 3.1 406 302 - 505 21 205.9 7.9 3.9 207 154 - 258 Specimen SYX-13 Specimen SYX-14

All Method 77 64.2 4.0 6.2 65 48 - 81 77 389.0 23.8 6.1 394 291 - 487 All Sysmex Instruments 76 64.2 4.0 6.3 65 48 - 81 76 389.5 23.6 6.1 395 292 - 487 Sysmex KX-21N & K-800, 1000, 4500 41 65.0 3.8 5.8 65 48 - 82 41 396.2 15.7 4.0 396 297 - 496 Sysmex pocH-100i 14 61.3 4.1 6.8 61 45 - 77 14 350.3 12.0 3.4 352 262 - 438 Sysmex XP-300 21 64.6 3.6 5.6 65 48 - 81 21 402.5 12.7 3.2 404 301 - 504 Specimen SYX-15

All Method 76 202.4 9.8 4.9 203 151 - 253

All Sysmex Instruments 75 202.5 9.9 4.9 203 151 - 254

Sysmex KX-21N & K-800, 1000, 4500 40 203.8 8.9 4.4 204 152 - 255

Sysmex pocH-100i 14 191.9 6.5 3.4 192 143 - 240

Sysmex XP-300 21 207.0 8.6 4.2 208 155 - 259


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALLYMPH W/SCR (percent)




All Method 69 29.19 1.20 4.1 29.1 25.5 - 32.8


Sysmex KX-21N & K-800, 1000, 4500 39 29.60 1.45 4.9 29.8 25.2 - 34.0

Sysmex pocH-100i 12 28.53 0.66 2.3 28.9 26.5 - 30.6

Sysmex XP-300 18 29.02 0.91 3.1 29.1 26.2 - 31.8


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALMONO/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 68 12.10 0.81 6.7 12.0 9.6 - 14.6 68 15.73 1.19 7.6 15.7 12.1 - 19.3 All Sysmex Instruments 67 12.12 0.81 6.6 12.0 9.7 - 14.6 67 15.76 1.17 7.4 15.7 12.2 - 19.3 Sysmex KX-21N & K-800, 1000, 4500 39 12.03 0.75 6.3 12.0 9.7 - 14.3 38 15.84 0.89 5.6 15.7 13.1 - 18.6 Sysmex pocH-100i 12 11.54 0.42 3.6 11.6 10.2 - 12.8 12 14.79 1.54 10.4 14.6 10.1 - 19.4 Sysmex XP-300 17 12.95 1.09 8.4 12.9 9.6 - 16.3 17 16.25 1.10 6.8 15.9 12.9 - 19.6 Specimen SYX-13 Specimen SYX-14


All Method 69 15.58 1.21 7.8 15.5 11.9 - 19.3


Sysmex KX-21N & K-800, 1000, 4500 39 15.69 1.21 7.7 15.6 12.0 - 19.4

Sysmex pocH-100i 12 14.55 0.93 6.4 14.9 11.7 - 17.4

Sysmex XP-300 17 16.08 1.03 6.4 16.0 12.9 - 19.2


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALNEUT W/LCR (percent)

Specimen SYX-11 Specimen SYX-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 69 28.47 0.86 3.0 28.5 25.8 - 31.1 68 54.90 1.51 2.8 54.8 50.3 - 59.5 All Sysmex Instruments 68 28.45 0.85 3.0 28.5 25.8 - 31.1 66 54.78 1.36 2.5 54.8 50.6 - 58.9 Sysmex KX-21N & K-800, 1000, 4500 39 28.18 0.57 2.0 28.2 26.4 - 29.9 38 54.30 0.95 1.8 54.4 51.4 - 57.2 Sysmex pocH-100i 12 29.11 0.78 2.7 29.2 26.7 - 31.5 12 56.58 1.88 3.3 56.4 50.9 - 62.3 Sysmex XP-300 17 28.61 1.14 4.0 28.7 25.2 - 32.1 17 54.85 1.15 2.1 54.8 51.3 - 58.4 Specimen SYX-13 Specimen SYX-14


All Method 68 55.24 1.47 2.7 55.2 50.8 - 59.7


Sysmex KX-21N & K-800, 1000, 4500 38 54.86 1.32 2.4 55.2 50.9 - 58.9

Sysmex pocH-100i 12 56.92 0.99 1.7 56.7 53.9 - 59.9

Sysmex XP-300 17 54.81 1.23 2.2 54.9 51.1 - 58.5


BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALWHITE 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 611 20.94 0.94 4.5 21.0 17.7 - 24.1 615 7.67 0.44 5.8 7.7 6.5 - 8.9 All Abbott Cell-Dyn Instruments 194 20.40 0.98 4.8 20.3 17.3 - 23.5 194 7.64 0.32 4.1 7.6 6.4 - 8.8 All ABX Instruments 92 20.59 0.48 2.3 20.7 17.4 - 23.7 92 7.50 0.17 2.2 7.5 6.3 - 8.7 All Boule (CDS) Instruments 114 20.86 0.53 2.5 20.8 17.7 - 24.0 114 7.10 0.26 3.7 7.1 6.0 - 8.2 All COULTER Instruments 187 21.78 0.52 2.4 21.7 18.5 - 25.1 191 8.07 0.22 2.8 8.1 6.8 - 9.3 All Danam/Drew Scientific Instruments 12 20.13 0.35 1.7 20.3 17.1 - 23.2 13 7.69 0.19 2.5 7.7 6.5 - 8.9 Abbott Cell-Dyn 1700 21 21.22 1.05 5.0 21.2 18.0 - 24.5 21 8.10 0.35 4.3 8.1 6.8 - 9.4 Abbott Cell-Dyn 1800 66 21.07 0.66 3.1 21.1 17.9 - 24.3 66 7.68 0.28 3.7 7.7 6.5 - 8.9 Abbott Cell-Dyn Emerald 103 19.79 0.67 3.4 19.7 16.8 - 22.8 105 7.52 0.24 3.2 7.5 6.3 - 8.7 ABX Diagnostics Micros/45/60 92 20.59 0.48 2.3 20.7 17.4 - 23.7 92 7.50 0.17 2.2 7.5 6.3 - 8.7 Boule (CDS) Medonic M series 108 20.81 0.51 2.4 20.8 17.6 - 24.0 109 7.09 0.22 3.1 7.1 6.0 - 8.2 COULTER AcT diff/diff 2 180 21.79 0.55 2.5 21.7 18.5 - 25.1 183 8.08 0.23 2.8 8.1 6.8 - 9.3 Drew Scientific D3 12 20.13 0.35 1.7 20.3 17.1 - 23.2 13 7.69 0.19 2.5 7.7 6.5 - 8.9

Specimen HD-13 Specimen HD-14



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

Specimen HD-15 Instrument Labs Mean SD CV Median Range

All Method 610 7.67 0.45 5.9 7.7 6.5 - 8.9


All ABX Instruments 91 7.52 0.15 2.0 7.5 6.3 - 8.7

All Boule (CDS) Instruments 116 7.10 0.36 5.0 7.1 6.0 - 8.2

All COULTER Instruments 192 8.07 0.21 2.6 8.1 6.8 - 9.3

All Danam/Drew Scientific Instruments 13 7.61 0.34 4.5 7.7 6.4 - 8.8

Abbott Cell-Dyn 1700 20 8.17 0.37 4.5 8.1 6.9 - 9.4

Abbott Cell-Dyn 1800 67 7.71 0.29 3.8 7.7 6.5 - 8.9

Abbott Cell-Dyn Emerald 104 7.56 0.31 4.1 7.5 6.4 - 8.7

ABX Diagnostics Micros/45/60 91 7.52 0.15 2.0 7.5 6.3 - 8.7

Boule (CDS) Medonic M series 108 7.05 0.28 4.0 7.0 5.9 - 8.2

COULTER AcT diff/diff 2 183 8.08 0.20 2.5 8.1 6.8 - 9.3

Drew Scientific D3 13 7.61 0.34 4.5 7.7 6.4 - 8.8

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)




BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L) cont’d



Specimen HD-15

All Method 604 4.745 0.140 2.9 4.76 4.45 - 5.03






Abbott Cell-Dyn 1700 20 4.764 0.105 2.2 4.76 4.47 - 5.05

Abbott Cell-Dyn 1800 66 4.682 0.103 2.2 4.68 4.40 - 4.97







BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMOGLOBIN (g/dL)






BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMOGLOBIN (g/dL) cont’d


All Method 608 13.86 0.24 1.7 13.9 12.8 - 14.9






Abbott Cell-Dyn 1700 20 13.99 0.26 1.9 14.0 13.0 - 15.0

Abbott Cell-Dyn 1800 67 13.93 0.26 1.9 13.9 12.9 - 15.0






BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMATOCRIT (percent)




BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMATOCRIT (percent) cont’d



Specimen HD-15

All Method 608 39.35 1.53 3.9 39.5 36.9 - 41.8






Abbott Cell-Dyn 1700 20 39.59 1.17 3.0 39.7 37.2 - 42.0

Abbott Cell-Dyn 1800 67 40.58 1.09 2.7 40.6 38.1 - 43.1







BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALPLATELET COUNT (x 109/L)


All Method 609 534.8 40.2 7.5 535 401 - 669 606 257.8 17.1 6.6 259 193 - 323 All Abbott Cell-Dyn Instruments 196 549.7 44.1 8.0 546 412 - 688 191 265.1 16.1 6.1 264 198 - 332 All ABX Instruments 93 525.3 18.3 3.5 525 393 - 657 93 262.4 13.3 5.1 263 196 - 329 All Boule (CDS) Instruments 117 486.0 20.9 4.3 485 364 - 608 115 238.5 10.3 4.3 237 178 - 299 All COULTER Instruments 191 556.3 26.6 4.8 555 417 - 696 191 259.3 12.9 5.0 260 194 - 325 All Danam/Drew Scientific Instruments 13 538.8 31.5 5.9 540 404 - 674 13 271.6 18.5 6.8 273 203 - 340 Abbott Cell-Dyn 1700 21 580.8 49.1 8.5 565 435 - 726 21 276.8 22.7 8.2 275 207 - 346 Abbott Cell-Dyn 1800 66 578.3 32.1 5.5 580 433 - 723 66 267.2 14.8 5.5 267 200 - 335 Abbott Cell-Dyn Emerald 107 525.1 33.8 6.4 523 393 - 657 103 261.6 15.0 5.7 261 196 - 327 ABX Diagnostics Micros/45/60 93 525.3 18.3 3.5 525 393 - 657 93 262.4 13.3 5.1 263 196 - 329 Boule (CDS) Medonic M series 110 485.0 20.7 4.3 485 363 - 607 109 237.9 10.8 4.5 237 178 - 298 COULTER AcT diff/diff 2 183 556.1 26.4 4.7 555 417 - 696 183 259.2 13.0 5.0 260 194 - 324 Drew Scientific D3 13 538.8 31.5 5.9 540 404 - 674 13 271.6 18.5 6.8 273 203 - 340


All Method 609 65.1 8.9 13.7 65 48 - 82 612 534.5 40.1 7.5 534 400 - 669 All Abbott Cell-Dyn Instruments 193 66.4 9.3 14.0 65 49 - 83 196 549.0 43.6 7.9 546 411 - 687 All ABX Instruments 91 72.6 5.9 8.1 72 54 - 91 92 524.3 18.6 3.5 525 393 - 656 All Boule (CDS) Instruments 115 55.4 4.7 8.4 55 41 - 70 115 483.2 19.5 4.0 482 362 - 604 All COULTER Instruments 191 65.2 5.9 9.1 65 48 - 82 194 554.8 23.2 4.2 553 416 - 694 All Danam/Drew Scientific Instruments 13 76.5 6.1 8.0 76 57 - 96 13 545.2 29.8 5.5 550 408 - 682 Abbott Cell-Dyn 1700 21 62.6 7.8 12.5 59 46 - 79 21 580.5 42.6 7.3 578 435 - 726 Abbott Cell-Dyn 1800 65 63.8 4.1 6.4 64 47 - 80 66 576.2 30.6 5.3 578 432 - 721 Abbott Cell-Dyn Emerald 105 69.0 11.6 16.8 67 51 - 87 106 524.3 34.9 6.7 525 393 - 656 ABX Diagnostics Micros/45/60 91 72.6 5.9 8.1 72 54 - 91 92 524.3 18.6 3.5 525 393 - 656 Boule (CDS) Medonic M series 108 55.2 4.7 8.5 55 41 - 70 108 482.3 19.4 4.0 482 361 - 603 COULTER AcT diff/diff 2 183 65.1 6.0 9.2 65 48 - 82 186 554.5 23.1 4.2 553 415 - 694 Drew Scientific D3 13 76.5 6.1 8.0 76 57 - 96 13 545.2 29.8 5.5 550 408 - 682


BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALPLATELET COUNT (x 109/L) cont’d


All Method 606 257.6 16.9 6.6 258 193 - 323

All Abbott Cell-Dyn Instruments 192 265.3 17.3 6.5 266 198 - 332

All ABX Instruments 93 262.1 11.6 4.4 263 196 - 328

All Boule (CDS) Instruments 116 238.9 11.1 4.6 237 179 - 299

All COULTER Instruments 193 259.3 13.3 5.1 259 194 - 325

All Danam/Drew Scientific Instruments 13 260.7 18.6 7.1 254 195 - 326

Abbott Cell-Dyn 1700 21 271.2 18.5 6.8 271 203 - 339

Abbott Cell-Dyn 1800 66 264.0 15.9 6.0 266 197 - 330

Abbott Cell-Dyn Emerald 103 264.8 18.0 6.8 264 198 - 331

ABX Diagnostics Micros/45/60 93 262.1 11.6 4.4 263 196 - 328

Boule (CDS) Medonic M series 109 238.6 11.1 4.6 236 178 - 299

COULTER AcT diff/diff 2 185 259.2 13.3 5.1 259 194 - 324

Drew Scientific D3 13 260.7 18.6 7.1 254 195 - 326

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALLYMPHOCYTES (percent)




BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALLYMPHOCYTES (percent) cont’d



Specimen HD-15

All Method 593 28.92 2.57 8.9 29.0 21.2 - 36.7






Abbott Cell-Dyn 1700 22 28.50 1.48 5.2 28.3 24.0 - 33.0

Abbott Cell-Dyn 1800 66 26.04 1.03 4.0 26.0 22.9 - 29.2







BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALMONO/MID/MIXED/MCR (percent)






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


All Method 592 6.82 1.73 25.4 6.4 1.6 - 12.1






Abbott Cell-Dyn 1700 22 8.10 0.35 4.3 8.2 7.0 - 9.2

Abbott Cell-Dyn 1800 63 9.16 0.48 5.3 9.3 7.7 - 10.7






BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALGRANULOCYTES/NEUT (percent)




BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALGRANULOCYTES/NEUT (percent) cont’d



Specimen HD-15

All Method 587 64.27 2.34 3.6 64.5 57.2 - 71.3






Abbott Cell-Dyn 1700 22 63.40 1.58 2.5 63.6 58.6 - 68.2

Abbott Cell-Dyn 1800 66 64.77 1.01 1.6 64.8 61.7 - 67.9







HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE 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 13 22.58 0.64 2.8 22.5 19.1 - 26.0 13 10.42 0.23 2.2 10.4 8.8 - 12.0 All COULTER Instruments 13 22.58 0.64 2.8 22.5 19.1 - 26.0 13 10.42 0.23 2.2 10.4 8.8 - 12.0 COULTER UniCel DxH 600 10 22.46 0.38 1.7 22.6 19.0 - 25.9 10 10.44 0.11 1.1 10.4 8.8 - 12.1

Specimen DIF-13 Specimen DIF-14


Specimen DIF-15

All Method 13 10.34 0.30 2.9 10.2 8.7 - 11.9


COULTER UniCel DxH 600 10 10.36 0.21 2.0 10.3 8.8 - 12.0

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)





Specimen DIF-15 All Method 13 4.137 0.056 1.3 4.13 3.88 - 4.39









Specimen DIF-15

All Method 13 11.85 0.16 1.3 11.8 11.0 - 12.7








Specimen DIF-15

All Method 13 37.35 0.92 2.5 37.6 35.1 - 39.6




HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x 109/L)


All Method 13 520.5 33.0 6.3 518 390 - 651 13 264.2 17.2 6.5 255 198 - 331 All COULTER Instruments 13 520.5 33.0 6.3 518 390 - 651 13 264.2 17.2 6.5 255 198 - 331 COULTER UniCel DxH 600 10 508.8 17.3 3.4 515 381 - 636 10 251.6 3.2 1.3 252 188 - 315


All Method 13 89.0 7.3 8.2 88 66 - 112 13 536.8 51.9 9.7 547 402 - 671 All COULTER Instruments 13 89.0 7.3 8.2 88 66 - 112 13 536.8 51.9 9.7 547 402 - 671 COULTER UniCel DxH 600 10 87.2 3.4 3.9 88 65 - 109 10 565.0 43.1 7.6 550 423 - 707

Specimen DIF-15

All Method 13 261.8 18.1 6.9 256 196 - 328


COULTER UniCel DxH 600 10 245.4 8.6 3.5 247 184 - 307



All Method 12 66.21 3.46 5.2 66.9 55.8 - 76.6 12 59.79 4.75 7.9 61.1 45.5 - 74.1 All COULTER Instruments 12 66.21 3.46 5.2 66.9 55.8 - 76.6 12 59.79 4.75 7.9 61.1 45.5 - 74.1

Specimen DIF-13 Specimen DIF-14 All Method 12 52.16 2.01 3.9 52.1 46.1 - 58.2 12 66.14 3.24 4.9 67.7 56.4 - 75.9 All COULTER Instruments 12 52.16 2.01 3.9 52.1 46.1 - 58.2 12 66.14 3.24 4.9 67.7 56.4 - 75.9

Specimen DIF-15

All Method 12 59.65 4.56 7.7 61.4 45.9 - 73.4



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 12 19.31 0.56 2.9 19.4 17.6 - 21.0 12 28.43 2.43 8.6 28.4 21.1 - 35.8 All COULTER Instruments 12 19.31 0.56 2.9 19.4 17.6 - 21.0 12 28.43 2.43 8.6 28.4 21.1 - 35.8

Specimen DIF-13 Specimen DIF-14 All Method 12 39.18 1.91 4.9 39.6 33.4 - 45.0 12 19.47 1.03 5.3 19.4 16.3 - 22.6 All COULTER Instruments 12 39.18 1.91 4.9 39.6 33.4 - 45.0 12 19.47 1.03 5.3 19.4 16.3 - 22.6

Specimen DIF-15

All Method 12 29.23 3.37 11.5 29.0 19.1 - 39.4


HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent)





Specimen DIF-15

All Method 12 4.67 2.47 52.9 3.8 0.0 - 12.1



HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)







HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)








BLOOD LEAD (µg/dL)

Specimen LED-11 Specimen LED-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 15 45.85 2.70 5.9 45.0 41.2 - 50.5 17 3.22 0.39 12.2 3.3 0.0 - 7.3 All Magellan Diagnostics Methods 15 45.85 2.70 5.9 45.0 41.2 - 50.5 17 3.22 0.39 12.2 3.3 0.0 - 7.3 Magellan Diagnostics LeadCare II 15 45.85 2.70 5.9 45.0 41.2 - 50.5 17 3.22 0.39 12.2 3.3 0.0 - 7.3 Specimen LED-13 Specimen LED-14 Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 2.40 1.27 53.0 2.4 0.0 - 6.4 5 45.60 5.37 11.8 45.6 41.0 - 50.2 Specimen LED-15

All Method 5 65.00 0.01 0.0 65.0 58.5 - 71.5

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 0.96 0.30 31.5 0.9 0.3 - 1.6 34 3.85 1.87 48.7 3.1 0.1 - 7.6 All Automated Methods 21 0.88 0.15 17.6 0.9 0.5 - 1.2 21 2.78 0.58 20.8 2.6 1.6 - 4.0 All Manual Methods 12 1.23 0.54 43.9 1.1 0.1 - 2.4 12 5.34 1.87 35.1 5.1 1.5 - 9.1 Sysmex XN-1000 11 0.95 0.05 5.5 0.9 0.6 - 1.3 11 2.72 0.28 10.1 2.7 1.9 - 3.6



Specimen BCX-11 Specimen BCX-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 123 4.86 0.12 2.5 4.9 4.1 - 5.6 123 27.02 0.64 2.4 27.0 22.9 - 31.1 All ABX Instruments 82 4.86 0.12 2.5 4.9 4.1 - 5.6 82 26.90 0.59 2.2 27.0 22.8 - 31.0 All COULTER Instruments 43 4.89 0.15 3.0 4.9 4.1 - 5.7 43 27.35 0.81 2.9 27.3 23.2 - 31.5 ABX Diagnostics Pentra 60C+ 67 4.84 0.10 2.0 4.9 4.1 - 5.6 66 27.05 0.42 1.5 27.1 22.9 - 31.2 ABX Diagnostics Pentra 80 / XL 80 13 4.96 0.15 3.0 5.0 4.2 - 5.8 13 26.22 0.52 2.0 26.2 22.2 - 30.2 COULTER AcT 5diff 43 4.89 0.15 3.0 4.9 4.1 - 5.7 43 27.35 0.81 2.9 27.3 23.2 - 31.5

Specimen BCX-13 Specimen BCX-14


Specimen BCX-15 All Method 123 15.39 0.36 2.3 15.4 13.0 - 17.7



ABX Diagnostics Pentra 60C+ 67 15.35 0.27 1.8 15.4 13.0 - 17.7

ABX Diagnostics Pentra 80 / XL 80 13 15.19 0.35 2.3 15.2 12.9 - 17.5

COULTER AcT 5diff 43 15.55 0.46 3.0 15.5 13.2 - 17.9



/L)





Specimen BCX-15

All Method 125 4.264 0.068 1.6 4.25 4.00 - 4.53





COULTER AcT 5diff 43 4.273 0.059 1.4 4.26 4.01 - 4.53












COULTER AcT 5diff 43 10.93 0.16 1.5 11.0 10.1 - 11.8







Specimen BCX-15

All Method 124 31.78 0.59 1.8 31.8 29.8 - 33.7





COULTER AcT 5diff 43 31.56 0.52 1.7 31.6 29.6 - 33.5




All Method 125 248.6 8.8 3.5 248 186 - 311 125 394.2 13.1 3.3 394 295 - 493 All ABX Instruments 82 248.0 8.0 3.2 247 185 - 310 82 394.6 13.5 3.4 395 295 - 494 All COULTER Instruments 43 249.7 10.1 4.0 249 187 - 313 43 393.4 12.4 3.1 393 295 - 492 ABX Diagnostics Pentra 60C+ 68 246.9 8.0 3.2 247 185 - 309 68 393.9 13.6 3.4 393 295 - 493 ABX Diagnostics Pentra 80 / XL 80 13 253.3 5.9 2.3 253 189 - 317 13 396.6 12.2 3.1 397 297 - 496 COULTER AcT 5diff 43 249.7 10.1 4.0 249 187 - 313 43 393.4 12.4 3.1 393 295 - 492


All Method 123 295.5 11.6 3.9 295 221 - 370 123 255.6 9.5 3.7 255 191 - 320 All ABX Instruments 82 295.5 12.6 4.3 295 221 - 370 80 255.6 9.6 3.8 256 191 - 320 All COULTER Instruments 42 294.6 10.9 3.7 295 220 - 369 43 255.6 9.6 3.7 255 191 - 320 ABX Diagnostics Pentra 60C+ 67 293.3 10.3 3.5 292 219 - 367 67 255.0 9.7 3.8 255 191 - 319 ABX Diagnostics Pentra 80 / XL 80 13 302.9 16.9 5.6 303 227 - 379 13 262.4 17.6 6.7 257 196 - 328 COULTER AcT 5diff 42 294.6 10.9 3.7 295 220 - 369 43 255.6 9.6 3.7 255 191 - 320

Specimen BCX-15 All Method 124 215.5 8.5 3.9 216 161 - 270

All ABX Instruments 81 215.4 8.4 3.9 216 161 - 270


ABX Diagnostics Pentra 60C+ 67 214.4 8.6 4.0 215 160 - 268

ABX Diagnostics Pentra 80 / XL 80 13 220.3 5.3 2.4 219 165 - 276

COULTER AcT 5diff 43 215.5 8.7 4.0 217 161 - 270





Specimen BCX-13 Specimen BCX-14 All Method 121 49.24 4.27 8.7 49.8 36.4 - 62.1 122 54.64 3.34 6.1 55.1 44.6 - 64.7 All ABX Instruments 79 49.78 4.40 8.8 50.3 36.5 - 63.0 80 55.18 3.30 6.0 55.7 45.2 - 65.1 All COULTER Instruments 42 48.22 3.87 8.0 48.4 36.6 - 59.9 42 53.60 3.21 6.0 53.7 43.9 - 63.3 ABX Diagnostics Pentra 60C+ 68 50.44 3.99 7.9 50.9 38.4 - 62.5 68 55.89 2.65 4.7 56.1 47.9 - 63.9 ABX Diagnostics Pentra 80 / XL 80 13 43.82 6.42 14.6 44.4 24.5 - 63.1 13 50.45 4.45 8.8 50.3 37.0 - 63.9 COULTER AcT 5diff 42 48.22 3.87 8.0 48.4 36.6 - 59.9 42 53.60 3.21 6.0 53.7 43.9 - 63.3

Specimen BCX-15

All Method 123 66.65 4.23 6.3 66.7 53.9 - 79.4





COULTER AcT 5diff 42 63.43 3.19 5.0 64.2 53.8 - 73.1


HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)










COULTER AcT 5diff 42 21.88 2.54 11.6 21.5 14.2 - 29.6


HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)





Specimen BCX-15

All Method 119 1.15 0.69 59.9 1.0 0.0 - 3.3





COULTER AcT 5diff 41 1.39 0.67 48.1 1.3 0.0 - 3.4


HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)










COULTER AcT 5diff 43 4.24 0.70 16.5 4.2 2.1 - 6.4


HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)



Specimen BCX-13 Specimen BCX-14 All Method 78 0.26 0.05 18.3 0.3 0.1 - 0.5 78 0.32 0.04 12.1 0.3 0.2 - 0.5 All ABX Instruments 78 0.26 0.05 18.3 0.3 0.1 - 0.5 78 0.32 0.04 12.1 0.3 0.2 - 0.5 All COULTER Instruments 43 5.02 0.33 6.6 5.0 4.0 - 6.1 43 6.64 0.29 4.3 6.6 5.7 - 7.6 ABX Diagnostics Pentra 60C+ 66 0.27 0.05 17.8 0.3 0.1 - 0.5 66 0.32 0.04 12.5 0.3 0.1 - 0.5 ABX Diagnostics Pentra 80 / XL 80 12 0.25 0.05 20.9 0.3 0.0 - 0.5 11 0.30 0.01 0.0 0.3 0.2 - 0.4 COULTER AcT 5diff 43 5.02 0.33 6.6 5.0 4.0 - 6.1 43 6.64 0.29 4.3 6.6 5.7 - 7.6

Specimen BCX-15

All Method 78 0.46 0.05 10.8 0.5 0.3 - 0.7





COULTER AcT 5diff 43 8.88 0.32 3.6 8.9 7.9 - 9.9



Specimen MX-11 Specimen MX-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 69 20.76 0.81 3.9 20.6 17.6 - 23.9 70 7.72 0.29 3.8 7.7 6.5 - 8.9 All Sysmex XE/XT Instruments 10 20.20 0.83 4.1 20.0 17.1 - 23.3 10 7.53 0.34 4.5 7.4 6.4 - 8.7 All Sysmex XN/XS Instruments 59 20.85 0.77 3.7 20.6 17.7 - 24.0 60 7.75 0.28 3.6 7.8 6.5 - 9.0 Sysmex XN-1000 13 20.68 0.30 1.5 20.8 17.5 - 23.8 13 7.40 0.16 2.2 7.4 6.2 - 8.6 Sysmex XS-1000i 44 20.92 0.87 4.1 20.7 17.7 - 24.1 45 7.86 0.20 2.6 7.9 6.6 - 9.1

Specimen MX-13 Specimen MX-14


Specimen MX-15

All Method 70 7.70 0.26 3.4 7.7 6.5 - 8.9

All Sysmex XE/XT Instruments 9 7.51 0.29 3.8 7.5 6.3 - 8.7

All Sysmex XN/XS Instruments 60 7.73 0.24 3.2 7.8 6.5 - 8.9

Sysmex XN-1000 13 7.43 0.13 1.7 7.4 6.3 - 8.6

Sysmex XS-1000i 44 7.84 0.15 2.0 7.8 6.6 - 9.1



/L)





Specimen MX-15 All Method 70 4.761 0.058 1.2 4.75 4.47 - 5.05



Sysmex XN-1000 13 4.779 0.052 1.1 4.76 4.49 - 5.07

Sysmex XS-1000i 45 4.744 0.049 1.0 4.74 4.45 - 5.03







Specimen MX-15

All Method 69 13.43 0.13 0.9 13.4 12.4 - 14.4



Sysmex XN-1000 13 13.41 0.11 0.8 13.4 12.4 - 14.4

Sysmex XS-1000i 45 13.44 0.16 1.2 13.4 12.4 - 14.4

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





Specimen MX-15 All Method 70 39.33 0.68 1.7 39.4 36.9 - 41.7



Sysmex XN-1000 13 39.04 0.59 1.5 38.8 36.6 - 41.4

Sysmex XS-1000i 45 39.36 0.70 1.8 39.5 36.9 - 41.8




All Method 70 432.4 15.7 3.6 433 324 - 541 69 233.6 7.2 3.1 233 175 - 293 All Sysmex XE/XT Instruments 10 426.2 25.7 6.0 422 319 - 533 10 229.0 11.9 5.2 230 171 - 287 All Sysmex XN/XS Instruments 60 433.4 13.8 3.2 435 325 - 542 60 233.9 6.8 2.9 233 175 - 293 Sysmex XN-1000 13 442.6 11.3 2.6 440 331 - 554 13 232.3 5.8 2.5 231 174 - 291 Sysmex XS-1000i 45 430.0 13.0 3.0 429 322 - 538 45 234.3 7.2 3.1 234 175 - 293


All Method 70 59.9 4.5 7.5 60 44 - 75 68 434.9 13.6 3.1 434 326 - 544 All Sysmex XE/XT Instruments 10 60.4 5.9 9.8 61 45 - 76 10 424.0 25.0 5.9 426 318 - 530 All Sysmex XN/XS Instruments 60 59.8 4.3 7.2 60 44 - 75 59 435.7 12.3 2.8 435 326 - 545 Sysmex XN-1000 13 56.8 3.4 6.0 56 42 - 72 13 446.3 10.9 2.4 448 334 - 558 Sysmex XS-1000i 45 60.8 4.1 6.7 61 45 - 77 44 431.9 10.6 2.4 434 323 - 540

Specimen MX-15

All Method 69 232.6 8.6 3.7 233 174 - 291

All Sysmex XE/XT Instruments 10 230.4 15.0 6.5 229 172 - 289

All Sysmex XN/XS Instruments 59 233.0 7.3 3.2 233 174 - 292

Sysmex XN-1000 13 232.0 7.5 3.2 233 174 - 290

Sysmex XS-1000i 44 233.2 7.2 3.1 233 174 - 292


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





Specimen MX-15

All Method 67 50.66 3.56 7.0 49.7 39.9 - 61.4



Sysmex XN-1000 13 54.12 3.93 7.3 52.1 42.3 - 66.0

Sysmex XS-1000i 43 48.56 1.26 2.6 48.5 44.7 - 52.4


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





Specimen MX-15

All Method 68 26.73 3.97 14.9 28.7 14.8 - 38.7



Sysmex XN-1000 13 24.57 4.13 16.8 27.5 12.1 - 37.0

Sysmex XS-1000i 43 27.29 4.01 14.7 29.6 15.2 - 39.4


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





Specimen MX-15

All Method 69 4.14 3.42 82.6 2.3 0.0 - 14.5



Sysmex XN-1000 12 6.73 4.50 66.9 6.2 0.0 - 20.3

Sysmex XS-1000i 45 3.48 3.04 87.4 1.8 0.0 - 12.7


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





Specimen MX-15

All Method 68 13.97 3.71 26.6 12.9 2.8 - 25.2



Sysmex XN-1000 13 11.32 2.41 21.3 12.8 4.1 - 18.6

Sysmex XS-1000i 43 15.12 3.92 25.9 12.9 3.3 - 26.9


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


All Sysmex XE/XT Instruments 10 79.39 1.81 2.3 79.6 73.9 - 84.9 10 71.30 0.70 1.0 71.1 69.2 - 73.4 All Sysmex XN/XS Instruments 55 5.24 3.86 73.6 7.3 0.0 - 16.9 60 4.27 3.43 80.4 4.9 0.0 - 14.6 Sysmex XN-1000 13 2.68 2.43 90.4 4.7 0.0 - 10.0 13 2.64 2.35 89.1 4.6 0.0 - 9.7 Sysmex XS-1000i 40 6.21 3.87 62.3 8.3 0.0 - 17.9 45 4.82 3.58 74.2 7.0 0.0 - 15.6


All Sysmex XE/XT Instruments 10 84.22 3.36 4.0 83.6 74.1 - 94.4 10 79.47 1.90 2.4 79.7 73.7 - 85.2 All Sysmex XN/XS Instruments 59 4.98 3.89 78.1 5.0 0.0 - 16.7 54 5.22 3.73 71.5 7.4 0.0 - 16.5 Sysmex XN-1000 13 3.05 2.31 75.9 4.7 0.0 - 10.0 13 2.66 2.41 90.4 4.7 0.0 - 9.9 Sysmex XS-1000i 44 5.67 4.10 72.3 7.9 0.0 - 18.0 39 6.22 3.69 59.4 7.9 0.0 - 17.3

Specimen MX-15



Sysmex XN-1000 13 2.70 2.33 86.4 4.6 0.0 - 9.7

Sysmex XS-1000i 45 5.14 3.58 69.6 7.0 0.0 - 15.9


2016 M3 BLOOD CELL IDENTIFICATION Specimens BC-13 through BC-18

CASE HISTORY: A 70-year-old male presented to his internist requesting treatment to prevent nosebleeds that had been bothering him for several weeks. Upon physical examination, the patient appeared physically fit, but pale, with several visible bruises, and had a slight fever. He had lost weight since his last visit two months ago for a wound infection. The patient admitted feeling weak and lethargic, which he attributed to blood loss from the frequent nosebleeds. The patient denied trying to lose weight and taking any blood thinning medication. A CBC was performed, and the results appear below.

Test Results Reference Range

WBC 18.6 x 109/L 5 - 17 x 10

9/L

RBC 3.48 x 1012

/L 4.0 - 5.2 x 1012

/L

HGB 9.7 g/dL 10.2 - 15.2 g/dL

HCT 28.9 % 34 - 48 %

PLT 94 x 109/L 150 - 450 x 10

9/L

MCV 83 fL 78 - 94 fL

MCH 28 pg 23 - 31 pg

MCHC 34 g/dL 32 - 36 g/dL

RDW 13 % 11 - 15 %

This patient was diagnosed with acute lymphoblastic leukemia (ALL). ALL accounts for about 20% of acute leukemias in adults and is the most common cancer in children. In ALL, the bone marrow produces too many lymphoblasts. These cells do not develop into mature lymphocytes or function like normal lymphocytes. The lymphoblasts accumulate in the bone marrow, causing decreased production of normal blood cells. Decreased red blood cell production leads to anemia and symptoms of fatigue. Decreased platelet production leads to bleeding and bruising. Decreased neutrophil production increases the risk of infection and fever. There may be enlargement of the lymph nodes, spleen and liver as lymphoblasts proliferate in those organs. Bone pain, joint pain, and headaches are symptoms of lymphoblast infiltration into those areas.


BLOOD CELL IDENTIFICATION Specimen BC-13

Identification Labs Percent Performance

Neutrophil-Segmented or band 182 88.78%

Acceptable

Neutrophil-seg/band w/toxic granulation 23 11.22%

The cell in the center of this photograph is a band neutrophil. We apologize for the missing arrow. The band neutrophil is a less mature stage of development than the segmented neutrophil. The nucleus is indented greater than 50% of its width, resulting in a U-, C-, or S-shaped nucleus. The sides of the band’s nucleus are parallel and have a visible band of chromatin in between. The cytoplasm contains pink and blue granules. There is no toxic granulation in this cell. To view another photo of a band, see 2015 M3 Specimen BC-17. To view a photo of toxic granulation, see 2014 M3 Specimen BC-14. BLOOD CELL IDENTIFICATION Specimen BC-14


Erythrocyte, normal 193 93.69% Acceptable

Hypochromic red cell 7 3.40%

The arrows in this photograph point to normal erythrocytes (red blood cells.) The arrowed cells are approximately the same size as the nucleus of the mature lymphocyte nearby. In a normochromic cell the area of central pallor takes up about one third of the diameter of the cell. To view another photo of normal red cells, see 2015 M1 Specimen BC-3. .


Specimen BC-15


Eosinophil, any stage 193 93.69% Acceptable

Neutrophil-seg/band w/toxic granulation 11 5.34%

The arrow in this photograph points to an eosinophil. These cells are easily identified by their characteristic red-orange color, imparted by the dye eosin. The cytoplasm of an eosinophil is filled with large round red-orange granules which surround the nucleus but do not obscure it. The nucleus of the eosinophil usually only has two lobes. To view another photo of an eosinophil, see 2015 M2 Specimen BC-10. Specimen BC-16


Lymphocyte, reactive 71 34.63% Acceptable

Immature/ abnormal cell – refer 7 3.41% Acceptable

Monocyte 118 57.54%

The arrow in this photograph points to a reactive lymphocyte. Reactive lymphs come in a wide range of forms, sizes and shapes. These large, atypical lymphocytes respond to immune stimuli in the body and are often increased in viral infections. The cytoplasm of the reactive lymph is light blue, with the characteristic peripheral basophilia (darker blue color at the extreme border.) There can be occasional vacuoles, and the edges of the lymph tend to be indented by adjacent red cells. The nucleus is large and appears elongated or stretched. Monocytes have grayer cytoplasm with no peripheral basophilia. The nucleus of the monocyte is often folded, is lighter staining than the lymph, and has a more open, lacy, chromatin structure. To view another photo of a reactive lymphocyte, see 2015 M2 Specimen BC-8. To view a monocyte, see 2015 M3 Specimen BC-13.

Specimen BC-16 is graded by 80% referee consensus.


BLOOD CELL IDENTIFICATION Specimen BC-17


Nucleated red cell 176 85.44% Acceptable

Immature/ abnormal cell – refer 26 12.62% Acceptable

The arrow in this photograph points to a nucleated red blood cell (NRBC). These immature erythrocytes are not normally seen in the peripheral blood of healthy adults. Mature RBCs normally eject their nuclei before they leave the bone marrow and enter the peripheral blood stream. The presence of NRBCs is a sign of bone marrow activity in response to either decreased production of RBCs or increased RBC loss from bleeding or hemolysis. To view another photo of a nucleated red cell, see 2013 M2 Specimen BC-8. Specimen BC-18


Blast cell 95 46.34% Not graded – Educational Challenge

Immature/abnormal cell-refer 79 38.54%

Prolymphocyte 17 8.29%

Lymphocyte, reactive 6 2.93%

Promonocyte 5 2.44%

Monocyte 2 0.98%

Myelocyte cell 1 0.49%

The arrow in this ungraded educational challenge points to a blast cell, specifically, a lymphoblast. Blasts in the peripheral blood are always an abnormal finding. The blast stage is the earliest stage of white blood cell development, and is normally seen only in the bone marrow. Lymphoblasts are precursor cells to mature lymphocytes. Blast cells have a high ratio of nucleus to cytoplasm, and the cytoplasm is deeply basophilic. The round-oval nucleus of the lymphoblast may have a cleft. Compared to reactive lymphs, blasts have less variation in size and staining characteristics, and less cytoplasm. To view another photo of a blast cell, see 2013 M1 Specimen BC-6. References: Carr, J.H., Rodak, B.F.: Clinical Hematology Atlas, 3

rd ed. Saunders, St. Louis, 2009.

Larson, R.A. “Acute Leukemia.” ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., 2004. 2503-2504.


BLOOD BANK ABO GROUP

Specimen Results Labs Percent Performance

BB-11 Group A 8 100% Acceptable

BB-12 Group O 8 100% Acceptable

BB-13 Group O 8 100% Acceptable

BB-14 Group A 8 100% Acceptable

BB-15 Group B 8 100% Acceptable

RH FACTOR (D TYPE)


BB-11 Rh Positive 14 100% Acceptable


BB-13 Rh Negative 14 100% Acceptable

BB-14 Rh Negative 14 100% Acceptable


UNEXPECTED ANTIBODY DETECTION


AB-11 Unexpected antibody detected 8 100% Acceptable

AB-12 Unexpected antibody detected 8 100% Acceptable AB-13 No unexpected antibody detected 8 100% Acceptable AB-14 No unexpected antibody detected 8 100% Acceptable AB-15 No unexpected antibody detected 8 100% Acceptable


BLOOD BANK

ANTIBODY IDENTIFICATION


AB-11 Anti-K 1 100% Acceptable

AB-12 Anti-E 1 100% Acceptable

AB-13 No antibody detected 1 100% Acceptable AB-14 No antibody detected 1 100% Acceptable

AB-15 No antibody detected 1 100% Acceptable

COMPATIBILITY TESTING


AB-11 Not Compatible 5 100% Acceptable

AB-12 Compatible 5 100% Acceptable AB-13 Compatible 5 100% Acceptable AB-14 Compatible 5 100% Acceptable AB-15 Compatible 5 100% Acceptable


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 41 12.62 0.62 4.9 12.6 10.7 - 14.6 40 10.01 0.97 9.7 9.9 8.5 - 11.6 Dade Innovin Dade Behring BFT II 5 12.10 0.39 3.2 12.0 10.2 - 14.0 5 8.42 0.41 4.9 8.6 7.1 - 9.7 Sysmex CA-500/600 series 22 12.82 0.51 4.0 12.8 10.8 - 14.8 22 9.85 0.38 3.9 9.9 8.3 - 11.4 All Coagulation Instruments 29 12.64 0.58 4.6 12.6 10.7 - 14.6 29 9.56 0.67 7.0 9.6 8.1 - 11.0 HemosIL RecombiPlasTin 2G IL ACL, all models 5 12.40 0.37 2.9 12.4 10.5 - 14.3 5 11.08 0.17 1.5 11.1 9.4 - 12.8 IL TEST PT Fibrinogen IL ACL, all models 6 13.08 0.62 4.7 12.8 11.1 - 15.1 6 11.23 0.72 6.4 11.1 9.5 - 13.0

Specimen CG-13 Specimen CG-14


Specimen CG-15

All Method 41 10.29 0.93 9.1 10.2 8.7 - 11.9

Dade Innovin

Dade Behring BFT II 5 8.78 0.34 3.9 8.8 7.4 - 10.1

Sysmex CA-500/600 series 21 10.11 0.28 2.8 10.1 8.5 - 11.7

All Coagulation Instruments 29 9.88 0.69 7.0 10.1 8.4 - 11.4

HemosIL RecombiPlasTin 2G

IL ACL, all models 5 11.10 0.14 1.3 11.1 9.4 - 12.8

IL TEST PT Fibrinogen

IL ACL, all models 6 11.42 0.82 7.1 11.3 9.7 - 13.2


PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)



Specimen CG-13 Specimen CG-14 All Method 41 2.56 0.21 8.3 2.5 2.0 - 3.1 41 4.96 1.11 22.5 4.5 3.9 - 6.0 Dade Innovin Dade Behring BFT II 5 2.48 0.11 4.4 2.4 1.9 - 3.0 5 4.30 0.19 4.4 4.3 3.4 - 5.2 Sysmex CA-500/600 series 22 2.46 0.14 5.7 2.4 1.9 - 3.0 22 4.43 0.28 6.4 4.4 3.5 - 5.4 All Coagulation Instruments 29 2.46 0.13 5.3 2.4 1.9 - 3.0 29 4.40 0.26 6.0 4.4 3.5 - 5.3 HemosIL RecombiPlasTin 2G IL ACL, all models 5 2.63 0.10 3.6 2.7 2.1 - 3.2 5 5.03 0.15 3.0 5.1 4.0 - 6.1 IL TEST PT Fibrinogen IL ACL, all models 6 2.90 0.17 5.8 3.0 2.3 - 3.5 6 6.77 1.14 16.9 7.1 5.4 - 8.2

Specimen CG-15

All Method 41 1.00 0.04 3.9 1.0 0.7 - 1.2

Dade Innovin

Dade Behring BFT II 5 0.98 0.04 4.6 1.0 0.7 - 1.2

Sysmex CA-500/600 series 22 1.00 0.04 3.7 1.0 0.8 - 1.3

All Coagulation Instruments 29 1.00 0.04 3.8 1.0 0.8 - 1.2

HemosIL RecombiPlasTin 2G

IL ACL, all models 5 1.00 0.01 0.0 1.0 0.8 - 1.2

IL TEST PT Fibrinogen

IL ACL, all models 6 0.98 0.04 4.2 1.0 0.7 - 1.2


ACTIVATED PARTIAL THROMBOPLASTIN (seconds)


All Method 15 28.3 3.0 10.5 26 24 - 33 15 31.4 1.6 5.0 31 26 - 37 Dade Actin FSL Sysmex CA-500/600 series 8 26.1 0.8 3.2 26 22 - 31 8 30.5 0.5 1.8 31 25 - 36 Hemoliance SynthASil IL ACL, all models 5 31.7 0.6 1.8 32 26 - 37 5 32.7 1.2 3.5 32 27 - 38

Specimen CG-13 Specimen CG-14

All Method 15 54.5 8.0 14.7 51 46 - 63 15 75.2 12.2 16.2 69 63 - 87 Dade Actin FSL Sysmex CA-500/600 series 8 50.5 1.1 2.1 50 42 - 59 8 69.9 2.8 4.0 69 59 - 81 Hemoliance SynthASil IL ACL, all models 5 68.3 0.6 0.8 68 58 - 79 5 96.0 1.0 1.0 96 81 - 111

Specimen CG-15

All Method 15 26.3 0.9 3.6 26 22 - 31

Dade Actin FSL

Sysmex CA-500/600 series 8 25.8 0.5 1.8 26 21 - 30

Hemoliance SynthASil

IL ACL, all models 5 27.3 0.6 2.1 27 23 - 32

Fibrinogen (mg/dL)

One participant reported Fibrinogen. The vendor assay values for specimens CG-11 through CG-15 are: 101 mg/dL, 551 mg/dL, 266 mg/dL, 289 mg/dL and 293 mg/dL, respectively.

RH FACTOR (Slide Method)


RH-11 Rh Positive 1 100% Acceptable


RH-13 Rh Negative 1 100% Acceptable

RH-14 Rh Negative 1 100% Acceptable



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

All Method 26 14.31 0.31 2.2 14.2 12.1 - 16.5 26 25.10 1.40 5.6 24.9 21.3 - 28.9 All Roche CoaguChek XS Plus Instruments 26 14.31 0.31 2.2 14.2 12.1 - 16.5 26 25.26 1.29 5.1 25.0 21.4 - 29.1 Roche CoaguChek XS Plus - Waived 16 14.20 0.28 2.0 14.1 12.0 - 16.4 16 25.46 1.63 6.4 25.3 21.6 - 29.3 Roche CoaguChek XS Plus 10 14.46 0.30 2.1 14.4 12.2 - 16.7 10 25.03 0.83 3.3 24.7 21.2 - 28.8

Specimen XS-13 Specimen XS-14 All Method 15 32.39 2.49 7.7 32.6 27.5 - 37.3 15 14.23 0.40 2.8 14.2 12.0 - 16.4 All Roche CoaguChek XS Plus Instruments 15 32.39 2.49 7.7 32.6 27.5 - 37.3 15 14.23 0.40 2.8 14.2 12.0 - 16.4 Roche CoaguChek XS Plus - Waived 10 31.42 2.60 8.3 32.0 26.7 - 36.2 10 14.10 0.43 3.1 14.1 11.9 - 16.3

Specimen XS-15 All Method 15 32.08 2.18 6.8 32.9 27.2 - 36.9

All Roche CoaguChek XS Plus Instruments 15 32.08 2.18 6.8 32.9 27.2 - 36.9

Roche CoaguChek XS Plus - Waived 10 32.07 2.55 8.0 32.9 27.2 - 36.9


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 151 1.19 0.04 3.3 1.2 0.9 - 1.5 153 2.68 0.17 6.2 2.7 2.1 - 3.3

COAGUCHEK XS PLUS PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)

Specimen XS-11 Specimen XS-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 26 1.20 0.01 0.0 1.2 0.9 - 1.5 26 2.09 0.14 6.9 2.1 1.6 - 2.6 All Roche CoaguChek XS Plus Instruments 26 1.20 0.01 0.0 1.2 0.9 - 1.5 26 2.09 0.13 6.5 2.1 1.6 - 2.6 Roche CoaguChek XS Plus - Waived 16 1.20 0.01 0.0 1.2 0.9 - 1.5 16 2.08 0.16 7.9 2.1 1.6 - 2.5 Roche CoaguChek XS Plus 10 1.21 0.04 3.1 1.2 0.9 - 1.5 10 2.10 0.06 2.7 2.1 1.6 - 2.6

Specimen XS-13 Specimen XS-14

All Method 15 2.71 0.18 6.5 2.7 2.1 - 3.3 15 1.20 0.01 0.0 1.2 0.9 - 1.5 All Roche CoaguChek XS Plus Instruments 15 2.71 0.18 6.5 2.7 2.1 - 3.3 15 1.20 0.01 0.0 1.2 0.9 - 1.5 Roche CoaguChek XS Plus - Waived 10 2.67 0.17 6.2 2.7 2.1 - 3.3 10 1.19 0.03 2.8 1.2 0.9 - 1.5

Specimen XS-15

All Method 15 2.65 0.15 5.5 2.7 2.1 - 3.2

All Roche CoaguChek XS Plus Instruments 15 2.65 0.15 5.5 2.7 2.1 - 3.2

Roche CoaguChek XS Plus - Waived 10 2.64 0.15 5.7 2.7 2.1 - 3.2


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 10 29.52 1.52 5.1 28.9 25.0 - 34.0 10 30.28 1.97 6.5 29.9 25.7 - 34.9

Specimen PTI-13 Specimen PTI-14 i-Stat Prothrombin Time 10 14.54 0.40 2.8 14.5 12.3 - 16.8 10 30.42 2.45 8.0 29.8 25.8 - 35.0

Specimen PTI-15

i-Stat Prothrombin Time 10 14.52 0.37 2.5 14.4 12.3 - 16.7

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 10 2.54 0.15 6.0 2.5 2.0 - 3.1 10 2.64 0.17 6.3 2.6 2.1 - 3.2

Specimen PTI-13 Specimen PTI-14

i-Stat Prothrombin Time 10 1.24 0.05 4.4 1.2 0.9 - 1.5 10 2.64 0.23 8.7 2.6 2.1 - 3.2

Specimen PTI-15 i-Stat Prothrombin Time 10 1.22 0.04 3.7 1.2 0.9 - 1.5

FLUID CELL COUNT WHITE BLOOD CELL COUNT (µL)

Specimen BF-5 Specimen BF-6 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 313.3 77.7 24.8 290 157 - 469 5 4.0 1.7 43.3 3 0 - 8

FLUID CELL COUNT RED BLOOD CELL COUNT (µL)

Specimen BF-5 Specimen BF-6 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 5 1076.7 225.9 21.0 1100 624 - 1529 5 0.0 0.1 0.0 0 0 - 1


2016 M3 FLUID CRYSTAL IDENTIFICATION Specimens FC-5 and FC-6

Crystals are classified as being either optically isotropic or anisotropic. Isotropic solids refract light rays equally in all directions throughout the crystalline structure. All isotropic crystals interact with light in a similar manner, regardless of the crystal orientation. If you look at an object through a large isotropic crystal, such as a piece of glass, you see only one image. Anisotropic crystals have a different internal structure that will cause a single ray of light entering the crystal to split into two rays, each traveling in a different direction. This property of splitting light is called birefringence or double refraction. If you were to look at this page through a large anisotropic crystal, you would see two images. Anisotropic crystals interact with light in a manner that is dependent upon the orientation of the crystal. A light beam hitting the crystal from one direction or angle will react differently than a beam hitting the crystal at a different angle. Use of a compensator allows this optical property to be used to identify crystals. Synovial fluid analysis offers a valuable diagnostic tool for evaluating patients with gout or pseudogout. Gout is caused by monosodium urate crystals, while pseudogout is caused by calcium pyrophosphate crystals. Crystal analysis is done with compensated polarized light. An accurate diagnosis can be made by a trained observer by detecting and identifying MSU crystals or CPPD crystals.

Specimen FC-5


MSU (Monosodium Urate) crystals 7 87.50% Acceptable

The crystals in this photograph are monosodium urate (MSU) crystals. Uric acid in body fluid, at pH 7.4, exists in the urate form. Thus, when referring to uric acid in physiologic fluid it is preferable to use the term urate. The presence of MSU crystals in synovial fluid is used to diagnose gout. MSU crystals are usually thin and needle-like with pointed ends, and may be intracellular or extracellular. Since CPPD and steroid crystals can also be needle-shaped, a red plate compensator can help with identification. MSU crystals are anisotropic. They polarize light and are negatively birefringent, meaning crystals that are lying parallel to (aligned with) the compensator filter axis are yellow, whereas crystals not in line with the filter axis are blue.


2016 M3 FLUID CRYSTAL IDENTIFICATION Specimen FC-6


Cholesterol crystals 6 85.71% Acceptable

The arrows in this photograph point to cholesterol crystals. They appear as large, flat rectangular plates with notched corners. Cholesterol crystals are isotropic, so they do not split the light rays or change color like the MSU. Cholesterol may be present in chronic effusions from patients with osteoarthritis or rheumatoid arthritis. They are associated with chronic inflammatory conditions, and are considered a nonspecific finding. REFERENCES: Abramowitz, M, Davidson, MW. “Optical Birefringence.” Olympus Microscopy Resource Center. Accessed 7/28/16. Available at: http://www.olympusmicro.com/primer/lightandcolor/birefringence.html Al-Ashkar, F. “Gout and Pseudogout.” Cleveland Clinic Center for Continuing Education. Accessed 7/28/16. Available at: http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/rheumatology/gout-and-pseudogout/default.htm Carr, J.H., Rodak, B.F.: Clinical Hematology Atlas, 3

rd ed. Saunders, St. Louis, 2009.

"Double Refraction / Optics." Encyclopedia Britannica Online. Encyclopedia Britannica, n.d. Web. 18 May 2015. Available at: http://www.britannica.com/EBchecked/topic/170003/double-refraction Mundt, L.A, Shanahan, K.: Graff’s Textbook of Routine Urinalysis and Body Fluids, 2

nd ed. Philadelphia: Lippincott Williams & Wilkins, 2011.

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

http://www.olympusmicro.com/primer/lightandcolor/birefringence.html

http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/rheumatology/gout-and-pseudogout/default.htm

http://www.britannica.com/EBchecked/topic/170003/double-refraction


MICROALBUMIN, DIPSTICK Specimen UM-3

Participant Results

Method Labs Negative 10 mg/L 20 mg/L 30 mg/L 50 mg/L 80 mg/L 100 mg/L 150 mg/L + (4 - 8 mg/dL)

++ (>8 mg/dL)

ALL METHODS 37 - 2 - 2 1 18 3 11 - - Roche Micral - 1 minute 4 - - - - 1 - 3 - - - Siemens Clinitek Microalbumin 33 - 2 - 2 - 18 - 11 - -

MICROALBUMIN, QUANTITATIVE

Specimen UM-3 Method Labs Mean SD CV Median Range All Method 84 137.73 11.41 8.3 137.7 96.4 - 179.1

Axis-Shield Afinion AS100 10 119.55 7.88 6.6 117.4 83.6 - 155.5

Beckman AU 16 139.89 5.13 3.7 139.0 97.9 - 181.9

Siemens DCA Vantage 11 144.85 6.26 4.3 143.7 101.3 - 188.3

Siemens Dimension/AR/ES/RxL/Xpand 26 138.38 9.75 7.0 136.5 96.8 - 179.9

CREATININE, URINE (mg/dL)

Specimen UM-3 Method Labs Mean SD CV Median Range All Method 79 59.21 4.36 7.4 59.3 49.1 - 69.3

Axis-Shield Afinion AS100 10 55.41 3.10 5.6 54.9 45.9 - 64.9

Beckman AU 16 60.19 1.57 2.6 60.0 49.9 - 70.5

Siemens DCA Vantage 11 65.58 2.44 3.7 64.8 54.4 - 76.8

Siemens Dimension/AR/ES/RxL/Xpand 22 56.91 4.02 7.1 57.3 47.2 - 66.6

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 35 - - - 9 18 5 3 Siemens Clinitek Microalbumin 32 - - - 9 18 3 2 Siemens Multistix Pro 3 - - - - - 2 1


KOH SKIN PREPARATION Specimen Identification Labs Percent Performance K-5 Yeast/fungal elements present 148 95.48% Acceptable Yeast/fungal elements absent 7 4.52% Organism present in specimen K-5: Microsporum canis. K-6 Yeast/fungal elements present 106 68.39% Acceptable Yeast/fungal elements absent 49 31.61% Organism present in specimen K-6: Aspergillus niger. Specimen K-6 is graded by 80% referee consensus.

WAIVED HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HD-11 Specimen HD-12 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 97 18.02 0.59 3.3 18.0 16.7 - 19.3 100 13.68 0.43 3.2 13.7 12.7 - 14.7 All Stanbio Methods 30 18.33 0.86 4.7 18.4 16.6 - 20.1 30 13.83 0.51 3.7 14.0 12.8 - 14.9 Alere (Stanbio) HemoPoint H2 30 18.33 0.86 4.7 18.4 16.6 - 20.1 30 13.83 0.51 3.7 14.0 12.8 - 14.9 HemoCue 65 17.89 0.46 2.6 17.8 16.6 - 19.2 68 13.59 0.40 3.0 13.5 12.6 - 14.6

WAIVED HEMATOLOGYHEMATOCRIT (percent)


All Method 12 49.14 5.11 10.4 48.6 38.9 - 59.4 15 37.54 4.61 12.3 39.3 28.3 - 46.8 All Microhematocrit Methods 10 45.18 3.78 8.4 47.0 37.6 - 52.8 10 32.77 3.13 9.5 33.6 26.5 - 39.1


URINALYSIS DIPSTICKSPECIFIC GRAVITY

Specimen UA-3 Method Labs Mean SD CV Median Range

All Method 829 1.0119 0.0049 0.5 1.015 1.001 - 1.022

All Refractive Index Methods 18 1.0254 0.0014 0.1 1.025 1.015 - 1.036

All Roche Methods 42 1.0094 0.0036 0.4 1.010 0.999 - 1.020

All Siemens Methods 445 1.0144 0.0015 0.1 1.015 1.004 - 1.025

Diagnostic Test Group Clarity Urocheck 120 10 1.0125 0.0026 0.3 1.013 1.002 - 1.023

Henry Schein Urispec 17 1.0118 0.0043 0.4 1.015 1.001 - 1.022

McKesson 120 Urine Analyzer 21 1.0129 0.0030 0.3 1.015 1.002 - 1.023

Roche Chemstrips 45 1.0052 0.0021 0.2 1.005 0.995 - 1.016

Roche Urisys 31 1.0100 0.0032 0.3 1.010 1.000 - 1.020

Siemens Clinitek 10 / 100 10 1.0140 0.0066 0.6 1.015 1.004 - 1.024

Siemens Clinitek 50 30 1.0090 0.0033 0.3 1.010 0.999 - 1.019

Siemens Clinitek Advantus 22 1.0100 0.0001 0.0 1.010 1.000 - 1.020

Siemens Clinitek Status / Status+ 381 1.0150 0.0001 0.0 1.015 1.005 - 1.025

Siemens Reagent Strips 149 1.0062 0.0036 0.4 1.005 0.996 - 1.017


URINALYSIS DIPSTICKpH

Specimen UA-3 Participant Results

Method Labs ≤3.5 4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 ≥9.0

ALL METHODS 857 - - - 2 - 1 5 8 53 319 466 3 Arkray Aution Sticks 1 - - - - - - - - - 1 - - Beckman AU 2 - - - - - - - - 2 - - - Consult Diagnostics 10SG Reagent Strips 1 - - - - - - - - - 1 - - Consult Diagnostics Urine Analyzer 10 - - - - - - - - 6 4 - - CTMI CT-120 Urine Analyzer 9 - - - - - - - - - 9 - - Diagnostic Test Group Clarity Urocheck 4 - - - - - - - - 1 3 - - Diagnostic Test Group Clarity Urocheck 120 10 - - - - - - - - 4 6 - - Germaine Laboratories AimStrip 2 - - - - - - - - 1 1 - - Germaine Labs AimStrip Urine Analyzer 4 - - - - - - - - - 4 - - Henry Schein One Step Plus 2 - - - - - - - - - 2 - - Henry Schein Urispec 17 - - - - - - - - 1 16 - - Iris Diagnostics iChem Velocity Strips 5 - - - - - - - - - 5 - - Iris Ichem VELOCITY Urine Chemistry System 4 - - - - - - - - - 4 - - McKesson 10SG Reagent Strips 5 - - - - - - - - 1 3 1 - McKesson 120 Urine Analyzer 21 - - - - - - - 1 1 19 - - NDC Pro Advantage 1 - - - - - - - - - 1 - - Other Analyzer Method 8 - - - - - - - - 1 7 - - Other Dipstick Method 6 - - - - - - - - 1 4 - 1 pH Paper 1 - - - - - - - - 1 - - - PSS Select Reagent Strips 1 - - - - - - - - - 1 - - Roche Chemstrip 101 2 - - - - - - - - - 2 - - Roche Chemstrips 51 - - - 1 - 1 - - - 47 1 1 Roche cobas u 411 2 - - - - - - - - - 2 - - Roche Criterion Analyzer 6 - - - - - - - - - 6 - - Roche SuperUA/ChemstripUA 1 - - - - - - - - - 1 - - Roche Urisys 31 - - - - - - - 1 - 29 - 1 Siemens Clinitek 10 / 100 10 - - - - - - - 1 2 4 3 - Siemens Clinitek 50 30 - - - - - - - - 2 25 3 - Siemens Clinitek 500 5 - - - - - - - - 1 3 1 - Siemens Clinitek Advantus 24 - - - - - - - - 3 12 9 - Siemens Clinitek Atlas 3 - - - - - - - - 3 - - - Siemens Clinitek Status / Status+ 407 - - - 1 - - 1 1 12 7 385 - Siemens Hemacombistix 1 - - - - - - - - - - 1 - Siemens Multistix Pro 6 - - - - - - 1 - 2 2 1 - Siemens Reagent Strips 157 - - - - - - 3 4 7 84 59 - UriScan Reagent Strips 2 - - - - - - - - 1 1 - -


URINALYSIS DIPSTICKPROTEIN QUALITATIVE

Specimen UA-3

Participant Results

Method Labs Negative Trace (1+)

(2+)

(3+)

(4+)

10 - 20 mg/dL

30 - 70 mg/dL

75 mg/dL

100 - 200 mg/dL

≥300 - 600 mg/dL

>600 or ≥1000 mg/dL

ALL METHODS 892 816 62 4 - - - 3 6 - 1 - - Arkray Aution Sticks 1 1 - - - - - - - - - - - Consult Diagnostics 10SG Reagent Strips 1 1 - - - - - - - - - - - Consult Diagnostics Urine Analyzer 10 9 1 - - - - - - - - - - CTMI CT-120 Urine Analyzer 9 9 - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 3 2 1 - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 120 10 10 - - - - - - - - - - - Germaine Laboratories AimStrip 2 - 2 - - - - - - - - - - Germaine Labs AimStrip Urine Analyzer 4 4 - - - - - - - - - - - Henry Schein One Step Plus 2 2 - - - - - - - - - - - Henry Schein Urispec 17 12 - - - - - - 5 - - - - Iris Diagnostics iChem Velocity Strips 5 5 - - - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 4 4 - - - - - - - - - - - McKesson 10SG Reagent Strips 5 1 2 - - - - 1 - - 1 - - McKesson 120 Urine Analyzer 21 20 1 - - - - - - - - - - NDC Pro Advantage 1 1 - - - - - - - - - - - Other Analyzer Method 7 6 - - - - - 1 - - - - - Other Dipstick Method 7 5 1 1 - - - - - - - - - PSS Select Reagent Strips 1 - - 1 - - - - - - - - - Roche Chemstrip 101 2 2 - - - - - - - - - - - Roche Chemstrips 68 64 4 - - - - - - - - - - Roche cobas u 411 2 2 - - - - - - - - - - -


URINALYSIS DIPSTICKPROTEIN QUALITATIVE (cont’d)


Method

Labs Negative Trace (1+)

(2+)

(3+)

(4+)

10 - 20 mg/dL

30 - 70 mg/dL

75 mg/dL

100 - 200 mg/dL

≥300 - 600 mg/dL

>600 or ≥1000 mg/dL

Roche Criterion Analyzer 6 6 - - - - - - - - - - - Roche SuperUA/ChemstripUA 1 - 1 - - - - - - - - - - Roche Urisys 31 31 - - - - - - - - - - - Siemens Albustix 1 1 - - - - - - - - - - - Siemens Clinitek 10 / 100 10 10 - - - - - - - - - - - Siemens Clinitek 50 29 28 1 - - - - - - - - - - Siemens Clinitek 500 5 5 - - - - - - - - - - - Siemens Clinitek Advantus 24 24 - - - - - - - - - - - Siemens Clinitek Atlas 3 3 - - - - - - - - - - - Siemens Clinitek Status / Status+ 408 402 5 - - - - - 1 - - - - Siemens Hemacombistix 1 - 1 - - - - - - - - - - Siemens Multistix Pro 6 6 - - - - - - - - - - - Siemens Reagent Strips 161 128 31 2 - - - - - - - - - Siemens Uristix 17 7 10 - - - - - - - - - - Sulfosalicylic Acid 1 1 - - - - - - - - - - - UriScan Reagent Strips 2 1 - - - - - 1 - - - - -


URINALYSIS DIPSTICKGLUCOSE

Specimen UA-3 Participant Results Method Labs Negative

or Normal Trace

(1+)

(2+)

(3+)

(4+)

30 - 100 mg/dL

150 - 300

mg/dL

500 mg/dL

>500 or ≥1000 or

≥2000 mg/dL

ALL METHODS 879 877 - - - - - 1 - - 1

Arkray Aution Sticks 1 1 - - - - - - - - -

Consult Diagnostics 10SG Reagent Strips 1 1 - - - - - - - - -

Consult Diagnostics Urine Analyzer 10 10 - - - - - - - - -

CTMI CT-120 Urine Analyzer 9 9 - - - - - - - - -

Diagnostic Test Group Clarity Urocheck 4 4 - - - - - - - - -

Diagnostic Test Group Clarity Urocheck 120 10 10 - - - - - - - - -

Germaine Laboratories AimStrip 2 2 - - - - - - - - -

Germaine Labs AimStrip Urine Analyzer 4 4 - - - - - - - - -

Henry Schein One Step Plus 2 2 - - - - - - - - -

Henry Schein Urispec 17 17 - - - - - - - - -

Iris Diagnostics iChem Velocity Strips 5 5 - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 4 4 - - - - - - - - -

McKesson 10SG Reagent Strips 5 5 - - - - - - - - -

McKesson 120 Urine Analyzer 21 21 - - - - - - - - -

NDC Pro Advantage 1 1 - - - - - - - - -

Other Analyzer Method 7 7 - - - - - - - - -

Other Dipstick Method 8 8 - - - - - - - - -

PSS Select Reagent Strips 1 1 - - - - - - - - -

Roche Chemstrip 101 2 2 - - - - - - - - -

Roche Chemstrips 67 66 - - - - - - - - 1

Roche cobas u 411 2 2 - - - - - - - - -

Roche Criterion Analyzer 6 6 - - - - - - - - -

Roche SuperUA/ChemstripUA 1 1 - - - - - - - - -

Roche Urisys 31 31 - - - - - - - - -

Siemens Clinitek 10 / 100 10 10 - - - - - - - - -

Siemens Clinitek 50 30 29 - - - - - 1 - - -

Siemens Clinitek 500 5 5 - - - - - - - - -

Siemens Clinitek Advantus 24 24 - - - - - - - - -

Siemens Clinitek Atlas 3 3 - - - - - - - - -

Siemens Clinitek Status / Status+ 407 407 - - - - - - - - -

Siemens Hemacombistix 1 1 - - - - - - - - -

Siemens Multistix Pro 6 6 - - - - - - - - -

Siemens Reagent Strips 162 162 - - - - - - - - -

Siemens Uristix 4 4 - - - - - - - - -

UriScan Reagent Strips 2 2 - - - - - - - - -


URINALYSIS DIPSTICKKETONES

Specimen UA-3

Participant Results

Method Labs Negative Trace Small

Moderate

Large

(1+)

(2+)

(3+)

(4+)

5 - 10 mg/dL

15 - 20 mg/dL

40 - 60 mg/dL

80 - 100 mg/dL

≥150 mg/dL

ALL METHODS 857 852 3 1 - - 1 - - - - - - - - Arkray Aution Sticks 1 1 - - - - - - - - - - - - - Consult Diagnostics 10SG Reagent Strips 1 1 - - - - - - - - - - - - - Consult Diagnostics Urine Analyzer 10 10 - - - - - - - - - - - - - CTMI CT-120 Urine Analyzer 9 9 - - - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 4 4 - - - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 120 10 9 - - - - 1 - - - - - - - - Germaine Laboratories AimStrip 2 2 - - - - - - - - - - - - - Germaine Labs AimStrip Urine Analyzer 4 4 - - - - - - - - - - - - - Henry Schein One Step Plus 2 2 - - - - - - - - - - - - - Henry Schein Urispec 17 17 - - - - - - - - - - - - - Iris Diagnostics iChem Velocity Strips 5 5 - - - - - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 4 4 - - - - - - - - - - - - - McKesson 10SG Reagent Strips 5 4 1 - - - - - - - - - - - - McKesson 120 Urine Analyzer 21 21 - - - - - - - - - - - - - NDC Pro Advantage 1 1 - - - - - - - - - - - - - Other Analyzer Method 7 7 - - - - - - - - - - - - - Other Dipstick Method 7 7 - - - - - - - - - - - - - PSS Select Reagent Strips 1 - 1 - - - - - - - - - - - - Roche Chemstrip 101 2 2 - - - - - - - - - - - - - Roche Chemstrips 53 52 1 - - - - - - - - - - - - Roche cobas u 411 2 2 - - - - - - - - - - - - - Roche Criterion Analyzer 6 6 - - - - - - - - - - - - - Roche SuperUA/ChemstripUA 1 1 - - - - - - - - - - - - - Roche Urisys 31 31 - - - - - - - - - - - - - Siemens Clinitek 10 / 100 10 10 - - - - - - - - - - - - - Siemens Clinitek 50 30 30 - - - - - - - - - - - - - Siemens Clinitek 500 5 5 - - - - - - - - - - - - - Siemens Clinitek Advantus 24 24 - - - - - - - - - - - - - Siemens Clinitek Atlas 3 3 - - - - - - - - - - - - - Siemens Clinitek Status / Status+ 408 408 - - - - - - - - - - - - - Siemens Ketostix 1 1 - - - - - - - - - - - - - Siemens Multistix Pro 6 6 - - - - - - - - - - - - - Siemens Reagent Strips 159 159 - - - - - - - - - - - - - UriScan Reagent Strips 1 1 - - - - - - - - - - - - -


URINALYSIS DIPSTICKBILIRUBIN

Specimen UA-3

Participant Results

Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 0.5 - 1.0 mg/dL

2.0 - 4.0 mg/dL

6.0 - 10.0 mg/dL

>10.0 mg/dL

ALL METHODS 832 829 1 1 1 - - - - - - - - - Arkray Aution Sticks 1 1 - - - - - - - - - - - - Consult Diagnostics 10SG Reagent Strips 1 1 - - - - - - - - - - - - Consult Diagnostics Urine Analyzer 10 10 - - - - - - - - - - - - CTMI CT-120 Urine Analyzer 9 9 - - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 4 4 - - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 120 10 10 - - - - - - - - - - - - Germaine Laboratories AimStrip 2 2 - - - - - - - - - - - - Germaine Labs AimStrip Urine Analyzer 4 4 - - - - - - - - - - - - Henry Schein One Step Plus 2 2 - - - - - - - - - - - - Henry Schein Urispec 17 17 - - - - - - - - - - - - Iris Diagnostics iChem Velocity Strips 4 4 - - - - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 4 4 - - - - - - - - - - - - McKesson 10SG Reagent Strips 5 5 - - - - - - - - - - - - McKesson 120 Urine Analyzer 21 21 - - - - - - - - - - - - NDC Pro Advantage 1 1 - - - - - - - - - - - - Other Analyzer Method 7 7 - - - - - - - - - - - - Other Dipstick Method 7 7 - - - - - - - - - - - - PSS Select Reagent Strips 1 - 1 - - - - - - - - - - - Roche Chemstrip 101 2 2 - - - - - - - - - - - - Roche Chemstrips 50 50 - - - - - - - - - - - - Roche cobas u 411 2 2 - - - - - - - - - - - - Roche Criterion Analyzer 6 6 - - - - - - - - - - - - Roche SuperUA/ChemstripUA 1 1 - - - - - - - - - - - - Roche Urisys 31 31 - - - - - - - - - - - - Siemens Clinitek 10 / 100 10 10 - - - - - - - - - - - - Siemens Clinitek 50 30 30 - - - - - - - - - - - - Siemens Clinitek 500 5 5 - - - - - - - - - - - - Siemens Clinitek Advantus 23 23 - - - - - - - - - - - - Siemens Clinitek Atlas 3 3 - - - - - - - - - - - - Siemens Clinitek Status / Status+ 394 394 - - - - - - - - - - - - Siemens Multistix Pro 6 6 - - - - - - - - - - - - Siemens Reagent Strips 152 150 - 1 1 - - - - - - - - - UriScan Reagent Strips 1 1 - - - - - - - - - - - -


URINALYSIS DIPSTICKUROBILINOGEN Specimen UA-3 Participant Results

Method Labs Normal or 0.0 - 0.2 mg/dL

1.0 or <2.0 mg/dL

2.0/3.0 mg/dL

4.0 or 4.0/6.0 mg/dL

≥8.0 or ≥12.0 mg/dL

ALL METHODS 823 810 6 6 1 - Arkray Aution Sticks 1 1 - - - - Consult Diagnostics 10SG Reagent Strips 1 1 - - - - Consult Diagnostics Urine Analyzer 10 9 1 - - - CTMI CT-120 Urine Analyzer 8 8 - - - - Diagnostic Test Group Clarity Urocheck 4 3 1 - - - Diagnostic Test Group Clarity Urocheck 120 10 10 - - - - Germaine Laboratories AimStrip 2 2 - - - - Germaine Labs AimStrip Urine Analyzer 4 3 - 1 - - Henry Schein One Step Plus 2 2 - - - - Henry Schein Urispec 17 17 - - - - Iris Diagnostics iChem Velocity Strips 5 5 - - - - Iris Ichem VELOCITY Urine Chemistry System 3 3 - - - - McKesson 10SG Reagent Strips 4 4 - - - - McKesson 120 Urine Analyzer 20 17 - 3 - - NDC Pro Advantage 1 1 - - - - Other Analyzer Method 7 6 - - 1 - Other Dipstick Method 6 6 - - - - PSS Select Reagent Strips 1 - 1 - - - Roche Chemstrip 101 2 2 - - - - Roche Chemstrips 50 50 - - - - Roche cobas u 411 2 2 - - - - Roche Criterion Analyzer 6 6 - - - - Roche SuperUA/ChemstripUA 1 1 - - - - Roche Urisys 31 31 - - - - Siemens Clinitek 10 / 100 10 10 - - - - Siemens Clinitek 50 29 29 - - - - Siemens Clinitek 500 5 5 - - - - Siemens Clinitek Advantus 22 22 - - - - Siemens Clinitek Atlas 2 2 - - - - Siemens Clinitek Status / Status+ 394 392 1 1 - - Siemens Multistix Pro 6 6 - - - - Siemens Reagent Strips 153 150 2 1 - - UriScan Reagent Strips 1 1 - - - -


URINALYSIS DIPSTICKBLOOD/HEMOGLOBIN

Specimen UA-3

Participant Results

Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) (5+) 5 - 25 Ery/µL

50 - 100

Ery/µL

250 Ery/µL

±0.03 mg/dL

0.06 -

0.10 mg/dL

0.2 - 0.5 mg/dL

≥ 1.0 mg/ dL

ALL METHODS 863 852 10 - - - - - - - - 1 - - - - - -

Arkray Aution Sticks 1 1 - - - - - - - - - - - - - - - - Consult Diagnostics 10SG Reagent Strips 1 1 - - - - - - - - - - - - - - - -

Consult Diagnostics Urine Analyzer 10 10 - - - - - - - - - - - - - - - - CTMI CT-120 Urine Analyzer 8 8 - - - - - - - - - - - - - - - -

Diagnostic Test Group Clarity Urocheck 4 4 - - - - - - - - - - - - - - - - Diagnostic Test Group Clarity Urocheck 120 10 10 - - - - - - - - - - - - - - - - Germaine Laboratories AimStrip 2 2 - - - - - - - - - - - - - - - -

Germaine Labs AimStrip Urine Analyzer 4 4 - - - - - - - - - - - - - - - - Henry Schein One Step Plus 2 2 - - - - - - - - - - - - - - - -

Henry Schein Urispec 17 16 - - - - - - - - - 1 - - - - - - Iris Diagnostics iChem Velocity Strips 5 5 - - - - - - - - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 4 4 - - - - - - - - - - - - - - - -

McKesson 10SG Reagent Strips 4 4 - - - - - - - - - - - - - - - - McKesson 120 Urine Analyzer 20 20 - - - - - - - - - - - - - - - -

NDC Pro Advantage 1 1 - - - - - - - - - - - - - - - - Other Analyzer Method 7 7 - - - - - - - - - - - - - - - -

Other Dipstick Method 6 6 - - - - - - - - - - - - - - - -

PSS Select Reagent Strips 1 1 - - - - - - - - - - - - - - - -

Roche Chemstrip 101 2 2 - - - - - - - - - - - - - - - -

Roche Chemstrips 66 64 2 - - - - - - - - - - - - - - -

Roche cobas u 411 2 2 - - - - - - - - - - - - - - - -

Roche Criterion Analyzer 6 6 - - - - - - - - - - - - - - - - Roche SuperUA/ChemstripUA 1 1 - - - - - - - - - - - - - - - -

Roche Urisys 31 31 - - - - - - - - - - - - - - - - Siemens Clinitek 10 / 100 10 9 1 - - - - - - - - - - - - - - -

Siemens Clinitek 50 29 29 - - - - - - - - - - - - - - - -

Siemens Clinitek 500 5 5 - - - - - - - - - - - - - - - -

Siemens Clinitek Advantus 24 24 - - - - - - - - - - - - - - - -

Siemens Clinitek Atlas 3 3 - - - - - - - - - - - - - - - -

Siemens Clinitek Status / Status+ 406 399 7 - - - - - - - - - - - - - - -

Siemens Hemacombistix 1 1 - - - - - - - - - - - - - - - - Siemens Multistix Pro 6 6 - - - - - - - - - - - - - - - -

Siemens Reagent Strips 159 159 - - - - - - - - - - - - - - - - UriScan Reagent Strips 2 2 - - - - - - - - - - - - - - - -


URINALYSIS DIPSTICKLEUKOCYTE ESTERASE

Specimen UA-3

Participant Results

Method Labs Negative Trace Small Moderate Large (1+) (2+) (3+) (4+) 25 µL 75 or 100 µL

250 or 500 µL

ALL METHODS 872 864 8 - - - - - - - - - - Arkray Aution Sticks 1 1 - - - - - - - - - - -

Consult Diagnostics 10SG Reagent Strips 1 1 - - - - - - - - - - -

Consult Diagnostics Urine Analyzer 10 10 - - - - - - - - - - -

CTMI CT-120 Urine Analyzer 8 8 - - - - - - - - - - -

Diagnostic Test Group Clarity Urocheck 4 3 1 - - - - - - - - - -

Diagnostic Test Group Clarity Urocheck 120 10 9 1 - - - - - - - - - -

Germaine Laboratories AimStrip 2 2 - - - - - - - - - - - Germaine Labs AimStrip Urine Analyzer 4 4 - - - - - - - - - - -

Henry Schein One Step Plus 2 2 - - - - - - - - - - - Henry Schein Urispec 17 17 - - - - - - - - - - -

Iris Diagnostics iChem Velocity Strips 5 5 - - - - - - - - - - - Iris Ichem VELOCITY Urine Chemistry System 3 3 - - - - - - - - - - -

McKesson 10SG Reagent Strips 4 3 1 - - - - - - - - - -

McKesson 120 Urine Analyzer 20 20 - - - - - - - - - - -

NDC Pro Advantage 1 1 - - - - - - - - - - -

Other Analyzer Method 7 7 - - - - - - - - - - - Other Dipstick Method 6 4 2 - - - - - - - - - -

PSS Select Reagent Strips 1 1 - - - - - - - - - - - Roche Chemstrip 101 2 2 - - - - - - - - - - -

Roche Chemstrips 66 66 - - - - - - - - - - - Roche cobas u 411 2 2 - - - - - - - - - - -

Roche Criterion Analyzer 6 6 - - - - - - - - - - -

Roche SuperUA/ChemstripUA 1 1 - - - - - - - - - - -

Roche Urisys 31 31 - - - - - - - - - - -

Siemens Clinitek 10 / 100 10 10 - - - - - - - - - - - Siemens Clinitek 2000 2 2 - - - - - - - - - - -

Siemens Clinitek 50 29 29 - - - - - - - - - - - Siemens Clinitek 500 5 5 - - - - - - - - - - -

Siemens Clinitek Advantus 24 24 - - - - - - - - - - - Siemens Clinitek Atlas 3 3 - - - - - - - - - - -

Siemens Clinitek Status / Status+ 406 406 - - - - - - - - - - -

Siemens Multistix Pro 6 6 - - - - - - - - - - -

Siemens Reagent Strips 155 152 3 - - - - - - - - - -

Siemens Uristix 13 13 - - - - - - - - - - -

UriScan Reagent Strips 2 2 - - - - - - - - - - -


URINALYSIS DIPSTICKNITRITE

Specimen UA-3

Participant Results

Method Labs Negative Positive

ALL METHODS 875 869 6 Arkray Aution Sticks 1 1 - Consult Diagnostics 10SG Reagent Strips 1 1 - Consult Diagnostics Urine Analyzer 10 10 - CTMI CT-120 Urine Analyzer 8 8 - Diagnostic Test Group Clarity Urocheck 4 4 - Diagnostic Test Group Clarity Urocheck 120 10 10 - Germaine Laboratories AimStrip 2 2 - Germaine Labs AimStrip Urine Analyzer 4 4 - Henry Schein One Step Plus 3 3 - Henry Schein Urispec 16 16 - Iris Diagnostics iChem Velocity Strips 5 5 - Iris Ichem VELOCITY Urine Chemistry System 4 4 - McKesson 10SG Reagent Strips 4 4 - McKesson 120 Urine Analyzer 20 20 - NDC Pro Advantage 1 1 - Other Analyzer Method 7 7 - Other Dipstick Method 6 6 - PSS Select Reagent Strips 1 1 - Roche Chemstrip 101 2 2 - Roche Chemstrips 66 63 3 Roche cobas u 411 2 2 - Roche Criterion Analyzer 6 6 - Roche SuperUA/ChemstripUA 1 - 1 Roche Urisys 31 29 2 Siemens Clinitek 10 / 100 10 10 - Siemens Clinitek 50 29 29 - Siemens Clinitek 500 5 5 - Siemens Clinitek Advantus 24 24 - Siemens Clinitek Atlas 3 3 - Siemens Clinitek Status / Status+ 406 406 - Siemens Multistix Pro 6 6 - Siemens Reagent Strips 159 159 - Siemens Uristix 13 13 - UriScan Reagent Strips 2 2 -


URINALYSIS MICROALBUMIN (dipstick only)

Specimen UA-3

Participant Results

Method Labs Negative 10 mg/L

20 mg/L

30 mg/L

50 mg/L

80 mg/L

100 mg/L

150 mg/L + (4 - 8 mg/dL)

++ (>8 mg/dL)

ALL METHODS 73 13 47 7 1 3 - - 2 - - Roche Micral - 1 minute 13 2 1 7 - 3 - - - - - Siemens Clinitek Microalbumin 47 - 44 - 1 - - - 2 - - Siemens Clinitest, 2 drop 1 - 1 - - - - - - - -


URINALYSIS URINE hCG


Method Labs Positive Negative

ALL METHODS 510 1 509 AimStep Combo Pregnancy 1 - 1 Alere Acceava hCG-Urine 1 - 1 Alere Clearview 25 hCG Combo 2 - 2 Alere Clearview hCG Cassette 9 - 9 Alere Clearview hCG Combo II 3 - 3 Alfa Scientific Instant View 5 - 5 Beckman Coulter ICON 25 hCG 23 - 23 Beckman Coulter ICON II/20 HCG 7 - 7 BioSign hCG 1 - 1 Cardinal Health SP Brand combo 24 - 24 Cardinal Hlth SPBrand-cassette 1 - 1 CONSULT diagnostics hCG Cassette 59 - 59 CONSULT diagnostics hCG Combo 17 - 17 CONSULT diagnostics hCG Dipstick 30 - 30 Diagnostic Test Group Clarity hCG Combo 1 - 1 Diagnostic Test Group Clarity hCG strip/cassette 8 - 8 Germaine Laboratories AimStrip Pregnancy 4 - 4 Henry Schein One Step 61 - 61 Immunostics Cept-D 2 - 2 Immunostics Detector Combi 1 - 1 Immunostics hCG Detector-urine 4 - 4 McKesson hCG Combo Cassette 5 - 5 McKesson hCG Urine Cassette 10 - 10 McKesson urine hCG-all 20 mIU kits 1 - 1 MediChoice hCG Combi Cassette 8 - 8 Medline hCG Combo Test Cassette 2 - 2 Medline hCG Test Cassette 10 - 10 Medline hCG Test Strip 3 - 3 NDC Pro Advantage 2 - 2 PEP (Lab Supply) HCG 1 - 1 Polymedco Poly stat hCG 3 - 3 PSS Select hCG Cassette 1 - 1 Quidel QuickVue One-Step Combo 23 - 23 Quidel QuickVue One-Step Urine 64 - 64 Quidel QuickVue+ One-Step Combo 22 - 22 Quidel RapidVue 2 - 2 Quidel Sofia hCG 2 - 2 RefuAH hCG Dipstick 10 - 10


URINALYSIS URINE hCG


Method Labs Positive Negative

Sekisui OSOM - Urine Test 4 - 4 Sekisui OSOM Card Pregnancy 10 - 10 Sekisui OSOM hCG Combo Test 2 - 2 Siemens Clinitek Status / Status+ 8 - 8 Stanbio QuPID 9 - 9 Stanbio QuPID Plus 3 - 3 Stanbio TRUE hCG 9 - 9 Sure-Vue hCG - 25mIU 3 - 3 Sure-Vue hCG-STAT 10 1 9

FECAL OCCULT BLOOD

Specimen OC-5 Specimen OC-6

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 345 342 3 345 6 339

Alere Clearview iFOBT Complete 2 2 - 2 1 1

Beckman Coulter Hemoccult ICT 36 35 1 36 - 36

Guaiac (slide) Test 216 215 1 216 3 213

Hemosure IFOB 38 38 - 38 - 38

Other Immunochemical FOB kit 23 22 1 23 1 22

Polymedco OC Auto Micro 80 6 6 - 6 - 6

Polymedco OC-Light iFOB 10 10 - 10 - 10

Quidel QuickVue iFOB 10 10 - 10 1 9


2016 M3 Urine Sediment Identification SPECIMENS US-5 AND US-6

CASE HISTORY: A 27-year old female presented to her primary care physician with dysuria, nausea, and back pain. She was recently diagnosed with cystitis, however her symptoms did not resolve after treatment with nitrofurantoin. Upon physical examination, the patient appeared ill and had abdominal tenderness and a fever of 102˚F. A routine urinalysis was performed, and the results appear below. Color = Yellow Appearance = Hazy Dipstick results: Specific gravity = 1.020 pH = 5.5 Protein = 30 mg/dL (1+) Glucose = Negative Ketones = Negative Bilirubin = Negative Urobilinogen = Normal/0.2 mg/dL Blood = Small (1+) Leukocyte Esterase = Large (3+) Nitrite = Negative This patient was diagnosed with acute pyelonephritis. Acute pyelonephritis is a sudden bacterial infection of the kidney. The most common cause is a lower urinary tract/bladder infection that ascends to the upper urinary tract/kidneys. Common symptoms of pyelonephritis include urinary frequency, urgency, dysuria, flank pain, fever, chills, malaise, nausea, vomiting, anorexia, and abdominal pain. Young children and the elderly often present with different, less specific symptoms. Urinalysis results commonly show proteinuria, significant pyuria, microscopic hematuria, and moderate bacteriuria. Gross hematuria is more common in cystitis than in pyelonephritis. The nitrite test may or may not be positive in urinary tract infections (UTI). A positive nitrite test is highly specific for UTI, but the test is not highly sensitive. Unlike cystitis, pyelonephritis can cause permanent kidney damage and can be life threatening. Complications of pyelonephritis include abscess formation, sepsis, septic shock, and multi-organ system failure. Urine culture and susceptibility testing are necessary to ensure appropriate treatment of suspected urinary tract infections.


Urine Sediment Identification Specimen US-5


Bacteria 471 86.90% Acceptable

Yeast/fungi 38 7.01%

Fiber/fecal contamination 11 2.03%

Mucus strands 5 0.92%

The arrows in this photograph point to bacteria. Most urinary tract infections are caused by rod-shaped enteric bacilli such as E. coli, Proteus, Enterobacter, and Klebsiella. These pathogens make enzymes that convert nitrate, a normal waste product in the urine, into nitrite. Up to 90% of UTIs are caused by E. coli, a nitrite reducer, but the nitrite test is positive in only 25% of UTI patients. A positive dipstick nitrite test is a strong indication of the presence of a significant number of nitrate-converting bacteria. However, a negative result for nitrite does not rule out the possibility of a urinary tract infection. Not all pathogens convert nitrate to nitrite. In addition, urine must stay in the bladder at least 4 hours for the chemical conversion to take place. Frequent urination, a common symptom of UTI, can cause a false negative nitrite result because the urine has not remained in the bladder long enough for nitrite to form. This is one of the reasons that a first morning specimen is preferred for urinalysis testing. To view another photo of rod-shaped bacteria, see 2014 M3 Specimen US-6. To view a photo of round cocci bacteria, see 2012 M3 Specimen US-6. To view a photo of mucus strands, see 2015 M1 Specimen US-2. . Specimen US-6


Cellular (WBC) cast 501 92.44% Acceptable

White blood cell (WBC) 13 2.40%

Cellular (RTE) cast 12 2.21%

RBC blood/hgb cast 5 0.92%

The arrows in this photograph point to a white blood cell cast. These cellular casts are fairly easy to identify since the WBCs within the cast are most often neutrophils (PMNs) with multi-lobed, segmented nuclei. Since casts form in the nephrons inside the kidneys, the presence of WBC casts indicates the infection is inside the kidney (pyelonephritis) and is not just in the lower urinary tract (cystitis.) The presence of WBC casts is always a clinically significant finding. They are characteristically seen in acute pyelonephritis and occasionally in glomerulonephritis or other renal diseases with significant inflammation. To view another photo of a WBC cast, see 2006 M2 Specimen US-3 References: Mundt, L.A, Shanahan, K.: Graff’s Textbook of Routine Urinalysis and Body Fluids, 2

nd ed. Philadelphia: Lippincott Williams & Wilkins, 2011.

Fulop, T. (Updated 8/11/15) “Acute Pyelonephritis”. Copyright, WebMD LLC, 1994-2016. Available at http://emedicine.medscape.com/article/245559-overview#a2. Accessed 6/8/16.

http://emedicine.medscape.com/article/245559-overview#a2


PROVIDER-PERFORMED MICROSCOPY (PPM) Wet Mount Preparation

Specimen PPM-13


Red blood cell (RBC) 495 89.35% Acceptable

White blood cell(WBC) 17 3.07%

Strach (Talc) granules 12 2.17%

Identification Unknown – Refer 11 1.99%

Yeast/fungi 9 1.62%

The arrows in this photograph of a wet mount preparation point to red blood cells. KOH Preparation Specimen PPM-14


Yeast/fungal elements absent 491 95.34% Acceptable

Yeast/fungal elements present 24 4.66%

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


PROVIDER-PERFORMED MICROSCOPY (PPM) Sperm Detection Specimen PPM-15


Sperm present 509 100% Acceptable

Spermatozoa are present in this photograph of a vaginal wet prep. . Nasal Smear Specimen PPM-16


Eosinophils absent 80 52.98% Acceptable

Eosinphlis present 71 47.02%

Eosinophils are absent in this photograph of Wright-stained nasal mucus. The purpose of examining the leukocytes (white blood cells) in stained nasal secretions is to differentiate allergy from infection. The presence of neutrophils in this specimen indicates infection. The eosinophil is a specific type of leukocyte that is increased in allergic conditions. “Eos” have a unique red-orange color that makes them easy to spot and identify. The cytoplasm of an eosinophil is filled with large, round, orange-staining granules that surround the purple nucleus but do not obscure the nucleus from view. The orange color of the eosinophilic granules comes from the dye eosin, which is a component of Wright stain. The cells shown in this photo are pink (neutrophilic), not orange or eosinophilic. Another distinguishing characteristic is the nucleus of the eosinophil normally has only two segments or lobes, in contrast with the neutrophil, which can have up to five segments. To view a photo of eosinophils, see 2016 M1 Specimen PPM-4.

Specimen PPM-16 is graded by 80% referee consensus.


PROVIDER-PERFORMED MICROSCOPY (PPM) Fecal Leukocytes Specimen PPM-17


Leukocytes absent 187 89.05% Acceptable

Leukocytes present 23 10.95%

Leukocytes are absent in this photograph of a Wright-stained stool preparation. . Vaginal Fluid Preparation Specimen PPM-18


Ferning present 197 80.08% Acceptable

Ferning absent 49 19.92%

Ferning is present in this photograph of air-dried vaginal secretions. Unlike urine or normal vaginal secretions, amniotic fluid crystallizes when dried on a microscope slide to form a

pattern resembling a fern leaf. The fern test is used to test for ruptured membranes. Ferning indicates leakage of amniotic fluid due to a membrane rupture. REFERENCES:

Fischer, P. M.: The Office Laboratory. Norwalk, Conn.: Appleton-Century-Crofts, 1983. Henderson, L.R. The POL Microscopy Atlas, 2

nd ed. Leawood, KS: American Academy of Family Physicians, 2003.

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