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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

MLE – M2

PARTICIPANT SUMMARY

2 • 0 • 1 • 1

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

2011 Evaluation Criteria .............................................................................................................. 5 Hematology

HemoCue .................................................................................................................................................................................. 6

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

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

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

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

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

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

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

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

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

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

Sysmex Hematology with 3-part Automated Differential .................................................................................................... 12

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

Red Blood Cell Count ........................................................................................................................................................ 12

Hemoglobin ....................................................................................................................................................................... 13

Hematocrit ......................................................................................................................................................................... 13

Platelet Count.................................................................................................................................................................... 14

Automated Differential ....................................................................................................................................................... 14

Basic Hematology with 3-part Automated Differential ........................................................................................................ 16



Hemoglobin ....................................................................................................................................................................... 19

Hematocrit ......................................................................................................................................................................... 20

Platelet Count.................................................................................................................................................................... 22


Hematology with 5-part Automated Differential (DIF Samples).......................................................................................... 28



Hemoglobin ....................................................................................................................................................................... 29

Hematocrit ......................................................................................................................................................................... 29

Platelet Count.................................................................................................................................................................... 30


QBC Hematology .................................................................................................................................................................... 33

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

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


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


Reticulocyte Count ................................................................................................................................................................. 36

2011 MLE-M2 Participant Summary/ 3

Table of Contents (cont’d)

Hematology (cont’d)

Hematology with 5-part Automated Differential (BCX Samples) ........................................................................................ 36


Red Blood Cell Count ....................................................................................................................................................... 37

Hemoglobin ....................................................................................................................................................................... 38

Hematocrit......................................................................................................................................................................... 39

Platelet Count ................................................................................................................................................................... 40

Automated Differential ...................................................................................................................................................... 41

Hematology with 5-part Automated Differential (MX Samples) .......................................................................................... 46


Red Blood Cell Count ....................................................................................................................................................... 46

Hemoglobin ....................................................................................................................................................................... 47

Hematocrit......................................................................................................................................................................... 47

Platelet Count ................................................................................................................................................................... 48

Automated Differential ...................................................................................................................................................... 48

Waived Hematology ............................................................................................................................................................... 63

Hemoglobin ....................................................................................................................................................................... 63

Hematocrit......................................................................................................................................................................... 63

Blood Cell Identification ........................................................................................................................................................ 51

Blood Bank

ABO Group ............................................................................................................................................................................. 55

Rh Factor (D Type) ................................................................................................................................................................. 55

Rh Factor (Slide Method) ....................................................................................................................................................... 59

Unexpected Antibody Detection ........................................................................................................................................... 55

Antibody Identification…………………………………………………………………………………………………………………...56

Compatibility Testing ............................................................................................................................................................. 56

Coagulation

Prothrombin Time .................................................................................................................................................................. 57

International Normalized Ratio (INR) ................................................................................................................................ 58

Activated Partial Thromboplastin Time ................................................................................................................................ 59

Fibrinogen............................................................................................................................................................................... 59

CoaguChek XS Plus Prothrombin Time ............................................................................................................................... 60


ITC Protime Microcoagulation System Prothrombin Time ................................................................................................. 60


i-Stat Prothrombin Time ........................................................................................................................................................ 61


Fluid Cell Count/Crystals ...................................................................................................................................................... 62

WBC Count ....................................................................................................................................................................... 62

RBC Count ........................................................................................................................................................................ 62

Crystal Identification .......................................................................................................................................................... 62

4 / 2011 MLE-M2 Participant Summary

Table of Contents (cont’d) Urinalysis

Microalbumin, Urine ............................................................................................................................................................... 62

Dipstick ............................................................................................................................................................................. 62

Quantitative ....................................................................................................................................................................... 63

Creatinine, Urine..................................................................................................................................................................... 62

Dipstick ............................................................................................................................................................................. 62

Quantitative ....................................................................................................................................................................... 63

Urinalysis Dipstick ................................................................................................................................................................. 64

Specific Gravity ................................................................................................................................................................. 64

pH ..................................................................................................................................................................................... 65

Protein ............................................................................................................................................................................... 66

Glucose ............................................................................................................................................................................. 67

Ketones ............................................................................................................................................................................. 67

Bilirubin ............................................................................................................................................................................. 69

Urobilinogen ...................................................................................................................................................................... 70

Blood or Hemoglobin ......................................................................................................................................................... 71

Leukocyte Esterase ........................................................................................................................................................... 72

Nitrite ................................................................................................................................................................................. 73

Microalbumin (Dipstick Only)............................................................................................................................................. 74

Urine hCG ............................................................................................................................................................................... 75

Fecal Occult Blood ................................................................................................................................................................. 77

KOH Skin Preparation ............................................................................................................................................................ 64

Urine Sediment Identification ................................................................................................................................................ 78

Provider-Performed Microscopy (PPM)

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


2011 EVALUATION CRITERIA The evaluation criteria used in the 2011 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.

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). 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 pages 39-40 under the heading “Acceptable Ranges for Quantitative Results.” Hemoglobin 7 percent

Hemoglogin, Waived 3 SD Hematocrit 6 percent

Hematocrit, Waived 3 SD

White Blood Cell Count 15 percent

Red Blood Cell Count 6 percent

Platelet Count 25 percent

Automated Differential 3 SD

Body Fluid - White Cell Count 3 SD

Body Fluid - Red Cell Count 3 SD

Sedimentation Rate 3 SD

Prothrombin Time 15 percent

Activated Partial Thromboplastin Time 15 percent

Fibrinogen 20 percent

Whole Blood Prothrombin Time (IT samples) 3 SD Whole Blood Prothrombin Time (All other samples) 15 percent

International Normalized Ratio (INR) 3 SD

Specific Gravity 0.010

Reticulocyte Count 3 SD

Whole Blood Glucose – HemoCue 3 SD

Microalbumin (Quantitative) 3 SD

Creatinine, Urine (Quantitative) 3 SD

Qualitative For qualitative procedures, evaluation is based on participant or referee consensus. If participant consensus is not reached, CMS requirements call for grading by referee consensus. A minimum percentage of participants or referee laboratories must receive a passing score or the challenge is not evaluated due to lack of consensus. These percentages are listed below. Crystal Identification 80% Consensus

Blood Cell Identification 80% Consensus

Urine Dipstick 80% Consensus

Urine hCG 80% Consensus

Microalbumin (Semi-Quantitative) 80% Consensus

Fecal Occult Blood 80% Consensus

Urine Sediment Identification 80% Consensus

Provider-Performed Microscopy 80% Consensus

KOH Skin Preparation 80% Consensus

ABO Group 95% Consensus

Rh Factor (D Type) 95% Consensus

Unexpected Antibody Detection 95% Consensus

Antibody Identification 95% Consensus

Compatibility Testing 95% Consensus


HEMOCUE HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HQ-3 Specimen HQ-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

HemoCue 67 5.23 0.25 4.8 5.3 4.4 - 6.0 67 13.27 0.44 3.3 13.3 11.9 - 14.6

HEMOCUE HEMATOLOGYGLUCOSE (mg/dL)

Specimen HQ-3 Specimen HQ-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 73 56.1 8.9 15.9 56 29 - 83 70 92.5 9.2 10.0 94 64 - 121 HemoCue Glucose 201/+ 61 56.2 6.9 12.2 56 35 - 77 60 94.0 7.6 8.1 95 71 - 117

SEDIMENTATION RATE (MM/HR)

Specimen ES-3 Specimen ES-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 225 45.0 13.0 28.9 42 5 - 84 225 8.6 2.6 29.9 9 0 - 17 HiChem Mini-Ves 16 76.8 9.3 12.2 74 48 - 105 17 7.2 3.5 48.5 6 0 - 18 Polymedco Sedimat 17 40.6 5.4 13.2 41 24 - 57 18 7.0 2.5 36.3 7 0 - 15 Streck ESR-Auto Plus 13 61.9 5.9 9.5 63 44 - 80 13 11.8 1.5 12.4 12 7 - 17 Vital Diagnostics Excyte M/10 20 54.5 4.4 8.0 54 41 - 68 20 8.9 2.5 27.7 8 1 - 17 Westergren - diluted 128 40.7 8.8 21.7 40 14 - 68 127 8.6 2.7 31.3 9 0 - 17 Westergren - undiluted 14 40.0 11.8 29.5 40 4 - 76 15 9.3 1.8 19.3 10 3 - 15 Wintrobe 11 30.6 6.5 21.1 31 11 - 50 11 9.8 2.6 26.5 9 2 - 18

SEDIMAT SEDIMENTATION RATE (MM/HR)

Specimen MAT-3 Specimen MAT-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range Polymedco Sedimat 15 21 53.0 8.2 15.4 53 28 - 78 22 1.8 1.0 55.4 2 0 - 5


HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x K/uL)

Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 38 3.01 0.14 4.7 3.0 2.5 - 3.5 36 20.67 0.58 2.8 20.7 17.5 - 23.8 All Abbott Cell-Dyn Instruments 38 3.01 0.14 4.7 3.0 2.5 - 3.5 36 20.67 0.58 2.8 20.7 17.5 - 23.8 Abbott Cell-Dyn 3200 21 3.06 0.14 4.4 3.0 2.6 - 3.6 21 20.67 0.66 3.2 20.7 17.5 - 23.8 Abbott Cell-Dyn Ruby 11 2.95 0.14 4.9 2.9 2.5 - 3.4 10 20.98 1.17 5.6 20.7 17.8 - 24.2

Specimen CL-8 Specimen CL-9


Specimen CL-10 All Method 36 20.63 0.55 2.7 20.6 17.5 - 23.8 All Abbott Cell-Dyn Instruments 36 20.63 0.55 2.7 20.6 17.5 - 23.8 Abbott Cell-Dyn 3200 20 20.62 0.55 2.7 20.8 17.5 - 23.8 Abbott Cell-Dyn Ruby 11 20.89 0.86 4.1 20.6 17.7 - 24.1

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

Specimen CL-6 Specimen CL-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 35 2.138 0.052 2.4 2.14 2.00 - 2.27 36 5.293 0.103 2.0 5.28 4.97 - 5.62 All Abbott Cell-Dyn Instruments 35 2.138 0.052 2.4 2.14 2.00 - 2.27 36 5.293 0.103 2.0 5.28 4.97 - 5.62 Abbott Cell-Dyn 3200 19 2.151 0.110 5.1 2.13 2.02 - 2.29 20 5.257 0.095 1.8 5.25 4.94 - 5.58 Abbott Cell-Dyn Ruby 11 2.140 0.072 3.4 2.13 2.01 - 2.27 11 5.367 0.151 2.8 5.34 5.04 - 5.69



Specimen CL-10

All Method 36 5.283 0.119 2.2 5.29 4.96 - 5.60 All Abbott Cell-Dyn Instruments 36 5.283 0.119 2.2 5.29 4.96 - 5.60 Abbott Cell-Dyn 3200 19 5.252 0.085 1.6 5.25 4.93 - 5.57 Abbott Cell-Dyn Ruby 11 5.325 0.148 2.8 5.31 5.00 - 5.65


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






HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)




Specimen CL-10



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


All Method 37 80.3 6.3 7.8 79 60 - 101 37 512.6 30.4 5.9 510 384 - 641 All Abbott Cell-Dyn Instruments 37 80.3 6.3 7.8 79 60 - 101 37 512.6 30.4 5.9 510 384 - 641 Abbott Cell-Dyn 3200 21 79.1 6.0 7.5 78 59 - 99 21 509.5 29.2 5.7 510 382 - 637 Abbott Cell-Dyn Ruby 10 80.4 6.9 8.6 79 60 - 101 10 531.5 29.3 5.5 528 398 - 665


All Method 38 278.9 19.7 7.1 279 209 - 349 37 78.9 5.5 7.0 78 59 - 99 All Abbott Cell-Dyn Instruments 38 278.9 19.7 7.1 279 209 - 349 37 78.9 5.5 7.0 78 59 - 99 Abbott Cell-Dyn 3200 22 278.8 17.7 6.4 280 209 - 349 21 77.6 4.7 6.0 77 58 - 97 Abbott Cell-Dyn Ruby 10 290.1 18.1 6.2 291 217 - 363 10 78.2 5.0 6.3 78 58 - 98

Specimen CL-10 All Method 37 511.1 30.4 6.0 508 383 - 639 All Abbott Cell-Dyn Instruments 37 511.1 30.4 6.0 508 383 - 639 Abbott Cell-Dyn 3200 21 513.2 30.0 5.8 508 384 - 642 Abbott Cell-Dyn Ruby 10 525.3 20.7 3.9 533 393 - 657

HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)




Specimen CL-10



HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)


All Method 37 37.51 1.60 4.3 37.6 32.7 - 42.4 35 18.21 1.30 7.1 18.0 14.3 - 22.2 All Abbott Cell-Dyn Instruments 37 37.51 1.60 4.3 37.6 32.7 - 42.4 35 18.21 1.30 7.1 18.0 14.3 - 22.2 Abbott Cell-Dyn 3200 21 37.96 1.58 4.2 38.2 33.2 - 42.7 21 18.26 1.40 7.6 17.7 14.0 - 22.5 Abbott Cell-Dyn Ruby 10 36.76 1.70 4.6 37.2 31.6 - 41.9 9 - - - 18.0 14.3 - 22.2




HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)




Specimen CL-10



HEMATOLOGY W/ 5-PART DIFFERENTIALEOSINOPHILS (percent)






HEMATOLOGY W/ 5-PART DIFFERENTIALBASOPHILS (percent)




Specimen CL-10



SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen SYX-6 Specimen SYX-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 49 2.76 0.10 3.5 2.8 2.3 - 3.2 49 19.87 0.37 1.9 19.9 16.8 - 22.9 All Sysmex Instruments 48 2.76 0.10 3.5 2.8 2.3 - 3.2 48 19.87 0.37 1.9 19.9 16.8 - 22.9 Sysmex K - 800,1000,4500,KX-21 31 2.73 0.08 3.0 2.7 2.3 - 3.2 32 19.73 0.32 1.6 19.7 16.7 - 22.7 Sysmex pocH-100i 17 2.82 0.10 3.4 2.8 2.3 - 3.3 16 20.14 0.32 1.6 20.2 17.1 - 23.2

Specimen SYX-8 Specimen SYX-9


Specimen SYX-10 All Method 50 19.92 0.40 2.0 20.0 16.9 - 23.0 All Sysmex Instruments 49 19.91 0.40 2.0 19.9 16.9 - 23.0 Sysmex K - 800,1000,4500,KX-21 32 19.77 0.36 1.8 19.8 16.8 - 22.8 Sysmex pocH-100i 17 20.19 0.34 1.7 20.2 17.1 - 23.3

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

/L)





Specimen SYX-10

All Method 49 5.738 0.069 1.2 5.73 5.39 - 6.09 All Sysmex Instruments 48 5.735 0.068 1.2 5.73 5.39 - 6.08 Sysmex K - 800,1000,4500,KX-21 33 5.719 0.055 1.0 5.73 5.37 - 6.07 Sysmex pocH-100i 17 5.802 0.120 2.1 5.78 5.45 - 6.15


SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMOGLOBIN (g/dL)





Specimen SYX-10 All Method 50 17.82 0.21 1.2 17.9 16.5 - 19.1 All Sysmex Instruments 49 17.81 0.21 1.2 17.9 16.5 - 19.1 Sysmex K - 800,1000,4500,KX-21 32 17.88 0.16 0.9 17.9 16.6 - 19.2 Sysmex pocH-100i 17 17.69 0.23 1.3 17.7 16.4 - 19.0

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMATOCRIT (percent)

Specimen SYX-6 Specimen SYX-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 50 17.50 0.61 3.5 17.4 16.4 - 18.6 49 47.93 1.49 3.1 47.4 45.0 - 50.9 All Sysmex Instruments 49 17.48 0.59 3.4 17.4 16.4 - 18.6 48 47.88 1.44 3.0 47.4 45.0 - 50.8 Sysmex K - 800,1000,4500,KX-21 33 17.16 0.31 1.8 17.1 16.1 - 18.2 33 47.14 0.71 1.5 47.0 44.3 - 50.0 Sysmex pocH-100i 16 18.14 0.49 2.7 18.1 17.0 - 19.3 16 49.83 1.83 3.7 50.0 46.8 - 52.9



Specimen SYX-10



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


All Method 51 59.2 3.2 5.4 59 44 - 75 50 366.1 19.7 5.4 368 274 - 458 All Sysmex Instruments 50 59.2 3.2 5.4 59 44 - 75 49 366.5 19.7 5.4 368 274 - 459 Sysmex K - 800,1000,4500,KX-21 32 58.4 2.6 4.5 58 43 - 74 33 376.2 14.0 3.7 374 282 - 471 Sysmex pocH-100i 17 60.2 3.3 5.5 60 45 - 76 16 346.6 13.8 4.0 350 259 - 434


All Method 50 190.4 9.6 5.0 190 142 - 238 51 60.5 3.7 6.1 61 45 - 76 All Sysmex Instruments 49 190.6 9.6 5.0 190 142 - 239 50 60.6 3.7 6.1 61 45 - 76 Sysmex K - 800,1000,4500,KX-21 33 193.9 9.4 4.9 194 145 - 243 33 60.7 3.2 5.2 61 45 - 76 Sysmex pocH-100i 16 183.7 5.3 2.9 184 137 - 230 17 60.5 4.7 7.8 62 45 - 76

Specimen SYX-10 All Method 51 367.0 21.2 5.8 366 275 - 459 All Sysmex Instruments 50 367.6 21.0 5.7 366 275 - 460 Sysmex K - 800,1000,4500,KX-21 33 377.4 15.9 4.2 377 283 - 472 Sysmex pocH-100i 17 348.5 16.2 4.6 351 261 - 436

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




Specimen SYX-10



SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALMONO/MIXED W/MCR (percent)


Specimen SYX-8 Specimen SYX-9 All Method 45 17.84 1.05 5.9 17.7 14.6 - 21.0 48 18.43 1.81 9.8 18.4 12.9 - 23.9 All Sysmex Instruments 44 17.85 1.06 6.0 17.9 14.6 - 21.1 47 18.47 1.81 9.8 18.4 13.0 - 24.0 Sysmex K - 800,1000,4500,KX-21 29 18.25 0.94 5.2 18.1 15.4 - 21.1 30 19.35 1.51 7.8 19.4 14.8 - 23.9 Sysmex pocH-100i 17 16.55 1.66 10.0 17.1 11.5 - 21.6 17 16.94 1.17 6.9 17.0 13.4 - 20.5

Specimen SYX-10


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





Specimen SYX-10



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

Specimen HD-6 Specimen HD-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 968 8.40 0.33 3.9 8.4 7.1 - 9.7 961 3.73 0.15 4.1 3.7 3.1 - 4.3 All Abbott Cell-Dyn Instruments 416 8.40 0.40 4.8 8.4 7.1 - 9.7 415 3.71 0.17 4.7 3.7 3.1 - 4.3 All ABX Instruments 109 8.28 0.22 2.6 8.3 7.0 - 9.6 111 3.65 0.12 3.3 3.6 3.1 - 4.2 All COULTER Instruments 379 8.44 0.23 2.7 8.4 7.1 - 9.8 380 3.78 0.12 3.2 3.8 3.2 - 4.4 All Danam/Drew Scientific Instruments 11 8.30 0.21 2.6 8.3 7.0 - 9.6 11 3.68 0.11 2.9 3.7 3.1 - 4.3 Abbott Cell-Dyn 1700 105 8.60 0.31 3.7 8.6 7.3 - 9.9 106 3.77 0.13 3.6 3.8 3.2 - 4.4 Abbott Cell-Dyn 1800 232 8.46 0.33 3.9 8.5 7.1 - 9.8 231 3.70 0.17 4.6 3.7 3.1 - 4.3 Abbott Cell-Dyn Emerald 70 7.92 0.30 3.8 8.0 6.7 - 9.2 69 3.61 0.16 4.5 3.6 3.0 - 4.2 ABX Diagnostics Micros/45/60 109 8.28 0.22 2.6 8.3 7.0 - 9.6 111 3.65 0.12 3.3 3.6 3.1 - 4.2 Boule Medonic CA 620 16 8.62 0.26 3.0 8.6 7.3 - 10.0 16 3.79 0.13 3.3 3.8 3.2 - 4.4 Boule Medonic M series 24 8.10 0.27 3.4 8.2 6.8 - 9.4 25 3.48 0.11 3.1 3.5 2.9 - 4.1 COULTER AcT 8/10 25 8.51 0.28 3.3 8.5 7.2 - 9.8 25 3.78 0.11 3.0 3.8 3.2 - 4.4 COULTER AcT diff/diff 2 349 8.43 0.22 2.6 8.4 7.1 - 9.7 350 3.78 0.12 3.2 3.8 3.2 - 4.4

Specimen HD-8 Specimen HD-9



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

Specimen HD-10 Instrument Labs Mean SD CV Median Range

All Method 968 3.75 0.20 5.3 3.7 3.1 - 4.4 All Abbott Cell-Dyn Instruments 412 3.74 0.19 5.1 3.7 3.1 - 4.4 All ABX Instruments 110 3.81 0.20 5.2 3.8 3.2 - 4.4 All COULTER Instruments 383 3.76 0.15 4.1 3.8 3.1 - 4.4 All Danam/Drew Scientific Instruments 11 3.71 0.12 3.3 3.7 3.1 - 4.3

Abbott Cell-Dyn 1700 104 3.77 0.16 4.2 3.7 3.2 - 4.4 Abbott Cell-Dyn 1800 230 3.67 0.16 4.4 3.7 3.1 - 4.3 Abbott Cell-Dyn Emerald 70 3.91 0.20 5.2 3.9 3.3 - 4.5 ABX Diagnostics Micros/45/60 110 3.81 0.20 5.2 3.8 3.2 - 4.4 Boule Medonic CA 620 16 3.71 0.20 5.4 3.7 3.1 - 4.3 Boule Medonic M series 25 3.32 0.13 4.0 3.3 2.8 - 3.9 COULTER AcT 8/10 24 3.82 0.15 4.0 3.9 3.2 - 4.4 COULTER AcT diff/diff 2 353 3.75 0.15 4.0 3.7 3.1 - 4.4

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-8 Specimen HD-9 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 958 2.769 0.118 4.2 2.75 2.60 - 2.94 959 5.129 0.154 3.0 5.12 4.82 - 5.44 All Abbott Cell-Dyn Instruments 407 2.872 0.086 3.0 2.88 2.70 - 3.05 406 5.227 0.132 2.5 5.24 4.91 - 5.55 All ABX Instruments 110 2.677 0.063 2.3 2.69 2.51 - 2.84 111 5.083 0.099 1.9 5.09 4.77 - 5.39 All COULTER Instruments 378 2.700 0.066 2.5 2.70 2.53 - 2.87 381 5.044 0.131 2.6 5.04 4.74 - 5.35 All Danam/Drew Scientific Instruments 10 2.792 0.082 3.0 2.77 2.62 - 2.96 10 5.231 0.103 2.0 5.21 4.91 - 5.55 Abbott Cell-Dyn 1700 105 2.863 0.063 2.2 2.87 2.69 - 3.04 106 5.270 0.125 2.4 5.28 4.95 - 5.59 Abbott Cell-Dyn 1800 225 2.905 0.077 2.6 2.91 2.73 - 3.08 225 5.219 0.131 2.5 5.23 4.90 - 5.54 Abbott Cell-Dyn Emerald 67 2.793 0.077 2.8 2.80 2.62 - 2.97 69 5.182 0.143 2.8 5.20 4.87 - 5.50 ABX Diagnostics Micros/45/60 110 2.677 0.063 2.3 2.69 2.51 - 2.84 111 5.083 0.099 1.9 5.09 4.77 - 5.39 Boule Medonic CA 620 16 2.681 0.040 1.5 2.69 2.51 - 2.85 15 5.097 0.059 1.2 5.10 4.79 - 5.41 Boule Medonic M series 25 2.669 0.048 1.8 2.68 2.50 - 2.83 25 5.094 0.080 1.6 5.09 4.78 - 5.40 COULTER AcT 8/10 24 2.711 0.065 2.4 2.71 2.54 - 2.88 24 5.103 0.134 2.6 5.12 4.79 - 5.41 COULTER AcT diff/diff 2 348 2.698 0.066 2.5 2.70 2.53 - 2.87 349 5.036 0.125 2.5 5.03 4.73 - 5.34

Specimen HD-10




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






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

Specimen HD-10 Instrument Labs Mean SD CV Median Range All Method 967 8.48 0.26 3.0 8.4 7.8 - 9.1 All Abbott Cell-Dyn Instruments 413 8.67 0.23 2.6 8.7 8.0 - 9.3 All ABX Instruments 110 8.30 0.15 1.8 8.3 7.7 - 8.9 All COULTER Instruments 377 8.35 0.17 2.1 8.3 7.7 - 9.0 All Danam/Drew Scientific Instruments 12 8.41 0.17 2.0 8.4 7.8 - 9.0


BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMATOCRIT (percent)



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


Specimen HD-10




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


All Method 957 107.7 17.2 16.0 108 80 - 135 965 261.6 24.5 9.4 263 196 - 327 All Abbott Cell-Dyn Instruments 405 118.1 14.7 12.4 118 88 - 148 413 276.0 18.2 6.6 276 207 - 346 All ABX Instruments 109 112.3 12.7 11.3 110 84 - 141 108 274.0 15.4 5.6 273 205 - 343 All COULTER Instruments 384 96.4 13.8 14.3 96 72 - 121 378 244.1 19.1 7.8 244 183 - 306 All Danam/Drew Scientific Instruments 11 114.0 13.7 12.0 114 85 - 143 11 267.4 25.4 9.5 270 200 - 335 Abbott Cell-Dyn 1700 105 106.0 12.8 12.1 104 79 - 133 108 268.0 20.0 7.5 267 201 - 336 Abbott Cell-Dyn 1800 224 121.9 12.4 10.1 120 91 - 153 228 280.6 15.4 5.5 280 210 - 351 Abbott Cell-Dyn Emerald 68 122.0 14.8 12.2 120 91 - 153 70 273.4 19.6 7.2 272 205 - 342 ABX Diagnostics Micros/45/60 109 112.3 12.7 11.3 110 84 - 141 108 274.0 15.4 5.6 273 205 - 343 Boule Medonic CA 620 16 99.8 12.3 12.4 101 74 - 125 16 240.3 20.1 8.4 237 180 - 301 Boule Medonic M series 25 102.0 11.2 11.0 102 76 - 128 25 244.8 15.8 6.5 242 183 - 307 COULTER AcT 8/10 25 90.9 14.1 15.5 90 68 - 114 24 240.1 18.2 7.6 237 180 - 301 COULTER AcT diff/diff 2 353 96.6 13.7 14.1 96 72 - 121 348 244.2 19.0 7.8 244 183 - 306


All Method 954 516.2 40.3 7.8 516 387 - 646 955 269.9 28.8 10.7 270 202 - 338 All Abbott Cell-Dyn Instruments 406 530.1 28.0 5.3 531 397 - 663 403 272.3 22.4 8.2 272 204 - 341 All ABX Instruments 109 567.6 28.7 5.0 568 425 - 710 110 267.8 22.3 8.3 268 200 - 335 All COULTER Instruments 375 486.2 29.7 6.1 486 364 - 608 380 268.7 35.7 13.3 272 201 - 336 All Danam/Drew Scientific Instruments 10 531.8 43.6 8.2 549 398 - 665 10 260.3 15.8 6.1 264 195 - 326 Abbott Cell-Dyn 1700 106 525.4 29.9 5.7 523 394 - 657 104 274.9 20.3 7.4 274 206 - 344 Abbott Cell-Dyn 1800 226 529.2 24.0 4.5 530 396 - 662 223 274.4 20.3 7.4 275 205 - 344 Abbott Cell-Dyn Emerald 69 541.7 37.3 6.9 541 406 - 678 69 262.7 27.8 10.6 258 197 - 329 ABX Diagnostics Micros/45/60 109 567.6 28.7 5.0 568 425 - 710 110 267.8 22.3 8.3 268 200 - 335 Boule Medonic CA 620 16 482.5 30.3 6.3 477 361 - 604 16 254.3 17.8 7.0 250 190 - 318 Boule Medonic M series 24 520.2 16.1 3.1 515 390 - 651 25 272.7 19.7 7.2 275 204 - 341 COULTER AcT 8/10 24 469.0 20.3 4.3 470 351 - 587 24 234.8 20.3 8.6 235 176 - 294 COULTER AcT diff/diff 2 345 487.3 29.7 6.1 486 365 - 610 350 271.0 35.6 13.1 274 203 - 339


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

Specimen HD-10 Instrument Labs Mean SD CV Median Range All Method 962 117.1 18.9 16.1 115 87 - 147 All Abbott Cell-Dyn Instruments 406 110.4 12.2 11.0 109 82 - 139 All ABX Instruments 109 124.9 14.2 11.4 122 93 - 157 All COULTER Instruments 385 121.1 23.7 19.5 124 90 - 152 All Danam/Drew Scientific Instruments 11 116.4 16.7 14.4 110 87 - 146

Abbott Cell-Dyn 1700 106 106.8 11.2 10.5 107 80 - 134 Abbott Cell-Dyn 1800 227 109.6 11.0 10.1 108 82 - 138 Abbott Cell-Dyn Emerald 69 120.8 15.4 12.8 118 90 - 152 ABX Diagnostics Micros/45/60 109 124.9 14.2 11.4 122 93 - 157 Boule Medonic CA 620 16 114.4 11.9 10.4 117 85 - 144 Boule Medonic M series 25 130.8 10.6 8.1 129 98 - 164 COULTER AcT 8/10 24 96.9 11.3 11.6 96 72 - 122 COULTER AcT diff/diff 2 355 122.8 23.5 19.2 126 92 - 154

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALLYMPHOCYTES (percent)



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


Specimen HD-10




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


All Method 895 3.59 1.18 32.8 3.8 0.0 - 7.2 894 5.70 1.91 33.5 6.3 0.0 - 11.5 All Abbott Cell-Dyn Instruments 387 3.95 1.02 25.8 4.3 0.8 - 7.1 386 5.35 1.35 25.2 5.7 1.3 - 9.4 All ABX Instruments 106 1.44 0.46 31.8 1.3 0.0 - 2.9 107 2.16 0.64 29.5 2.1 0.2 - 4.1 All COULTER Instruments 334 3.72 0.51 13.8 3.8 2.1 - 5.3 339 7.17 0.64 8.9 7.2 5.2 - 9.1 All Danam/Drew Scientific Instruments 11 2.79 0.31 11.0 2.8 1.8 - 3.8 11 4.12 0.53 12.7 4.1 2.5 - 5.7 Abbott Cell-Dyn 1700 98 4.01 0.50 12.4 4.0 2.5 - 5.6 96 5.35 0.62 11.6 5.3 3.4 - 7.3 Abbott Cell-Dyn 1800 214 4.54 0.46 10.0 4.5 3.1 - 6.0 214 6.14 0.63 10.3 6.1 4.2 - 8.1 Abbott Cell-Dyn Emerald 66 2.13 0.22 10.5 2.1 1.4 - 2.8 65 2.99 0.31 10.5 3.0 2.0 - 4.0 ABX Diagnostics Micros/45/60 106 1.44 0.46 31.8 1.3 0.0 - 2.9 107 2.16 0.64 29.5 2.1 0.2 - 4.1 Boule Medonic CA 620 15 5.32 0.41 7.7 5.4 4.0 - 6.6 16 6.59 1.64 24.9 7.2 1.6 - 11.6 Boule Medonic M series 23 4.95 0.34 6.9 5.0 3.9 - 6.0 24 6.90 1.01 14.7 6.9 3.8 - 10.0 COULTER AcT diff/diff 2 332 3.72 0.51 13.8 3.8 2.1 - 5.3 337 7.18 0.64 9.0 7.2 5.2 - 9.2

Specimen HD-8 Specimen HD-9 All Method 895 5.03 1.39 27.6 5.5 0.8 - 9.2 894 5.04 1.44 28.6 5.6 0.7 - 9.4 All Abbott Cell-Dyn Instruments 386 4.88 1.00 20.6 5.2 1.8 - 7.9 387 4.93 1.09 22.1 5.2 1.6 - 8.2 All ABX Instruments 109 2.42 0.61 25.1 2.2 0.5 - 4.3 109 2.37 0.56 23.5 2.2 0.6 - 4.1 All COULTER Instruments 337 6.08 0.33 5.4 6.1 5.0 - 7.1 333 6.12 0.32 5.3 6.1 5.1 - 7.1 All Danam/Drew Scientific Instruments 11 3.67 0.31 8.4 3.6 2.7 - 4.6 11 3.65 0.35 9.6 3.6 2.5 - 4.7 Abbott Cell-Dyn 1700 97 4.72 0.39 8.2 4.7 3.5 - 5.9 97 4.71 0.39 8.2 4.7 3.5 - 5.9 Abbott Cell-Dyn 1800 211 5.55 0.40 7.3 5.5 4.3 - 6.8 215 5.67 0.46 8.1 5.6 4.2 - 7.1 Abbott Cell-Dyn Emerald 64 3.13 0.21 6.8 3.1 2.4 - 3.8 64 3.03 0.23 7.6 3.0 2.3 - 3.8 ABX Diagnostics Micros/45/60 109 2.42 0.61 25.1 2.2 0.5 - 4.3 109 2.37 0.56 23.5 2.2 0.6 - 4.1 Boule Medonic CA 620 16 5.54 1.02 18.3 5.7 2.4 - 8.6 15 5.65 0.72 12.7 5.7 3.5 - 7.9 Boule Medonic M series 24 5.47 0.52 9.6 5.4 3.8 - 7.1 24 5.24 0.42 8.0 5.2 3.9 - 6.5 COULTER AcT diff/diff 2 335 6.08 0.33 5.4 6.1 5.0 - 7.1 331 6.12 0.32 5.3 6.1 5.1 - 7.1


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

Specimen HD-10 Instrument Labs Mean SD CV Median Range All Method 892 5.08 1.85 36.4 5.7 0.0 - 10.7 All Abbott Cell-Dyn Instruments 386 4.74 1.32 27.8 5.1 0.7 - 8.8 All ABX Instruments 106 1.59 0.48 30.3 1.5 0.1 - 3.1 All COULTER Instruments 335 6.52 0.54 8.3 6.4 4.9 - 8.2 All Danam/Drew Scientific Instruments 11 3.60 0.52 14.5 3.8 2.0 - 5.2

Abbott Cell-Dyn 1700 97 4.79 0.62 12.9 4.8 2.9 - 6.7 Abbott Cell-Dyn 1800 213 5.51 0.58 10.6 5.5 3.7 - 7.3 Abbott Cell-Dyn Emerald 66 2.39 0.31 13.1 2.4 1.4 - 3.4 ABX Diagnostics Micros/45/60 106 1.59 0.48 30.3 1.5 0.1 - 3.1 Boule Medonic CA 620 16 6.48 1.10 16.9 6.6 3.1 - 9.8 Boule Medonic M series 24 6.23 0.61 9.9 6.2 4.3 - 8.1 COULTER AcT diff/diff 2 333 6.52 0.54 8.3 6.5 4.9 - 8.2

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


All Method 892 71.59 1.15 1.6 71.5 68.1 - 75.1 897 57.63 2.20 3.8 57.6 51.0 - 64.3 All Abbott Cell-Dyn Instruments 388 71.63 0.91 1.3 71.6 68.8 - 74.4 385 58.85 1.40 2.4 58.9 54.6 - 63.1 All ABX Instruments 107 73.25 1.05 1.4 73.4 70.0 - 76.5 107 60.20 1.25 2.1 60.3 56.4 - 64.0 All COULTER Instruments 334 71.11 0.77 1.1 71.1 68.7 - 73.5 338 55.70 0.98 1.8 55.7 52.7 - 58.7 All Danam/Drew Scientific Instruments 11 71.63 0.70 1.0 71.6 69.5 - 73.8 11 57.43 2.03 3.5 57.4 51.3 - 63.6 Abbott Cell-Dyn 1700 96 71.61 0.86 1.2 71.6 69.0 - 74.2 98 58.43 1.78 3.1 58.7 53.0 - 63.8 Abbott Cell-Dyn 1800 216 71.45 0.72 1.0 71.4 69.2 - 73.7 217 58.66 1.12 1.9 58.6 55.2 - 62.1 Abbott Cell-Dyn Emerald 66 72.32 0.89 1.2 72.5 69.6 - 75.1 65 60.05 1.22 2.0 60.2 56.3 - 63.7 ABX Diagnostics Micros/45/60 107 73.25 1.05 1.4 73.4 70.0 - 76.5 107 60.20 1.25 2.1 60.3 56.4 - 64.0 Boule Medonic CA 620 16 70.21 1.23 1.8 70.0 66.5 - 74.0 16 55.54 2.84 5.1 55.1 47.0 - 64.1 Boule Medonic M series 25 71.14 1.47 2.1 71.2 66.7 - 75.6 25 56.66 1.58 2.8 56.6 51.9 - 61.5 COULTER AcT diff/diff 2 332 71.12 0.77 1.1 71.1 68.7 - 73.5 336 55.70 0.98 1.8 55.7 52.7 - 58.7


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

Specimen HD-8 Specimen HD-9 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 896 43.42 2.09 4.8 43.8 37.1 - 49.7 897 45.93 1.97 4.3 46.3 40.0 - 51.9 All Abbott Cell-Dyn Instruments 385 44.60 0.91 2.0 44.6 41.8 - 47.4 384 47.13 0.80 1.7 47.1 44.7 - 49.6 All ABX Instruments 110 46.29 0.93 2.0 46.3 43.4 - 49.1 110 48.47 1.23 2.5 48.6 44.7 - 52.2 All COULTER Instruments 336 41.21 0.60 1.5 41.2 39.4 - 43.1 333 43.93 0.54 1.2 43.9 42.3 - 45.6 All Danam/Drew Scientific Instruments 11 44.33 0.98 2.2 44.5 41.3 - 47.3 11 46.48 0.74 1.6 46.4 44.2 - 48.7 Abbott Cell-Dyn 1700 97 43.94 1.04 2.4 44.0 40.8 - 47.1 95 46.57 0.97 2.1 46.6 43.6 - 49.5 Abbott Cell-Dyn 1800 216 44.45 0.57 1.3 44.5 42.7 - 46.2 218 47.26 0.65 1.4 47.2 45.2 - 49.3 Abbott Cell-Dyn Emerald 67 45.79 0.58 1.3 45.9 44.0 - 47.6 67 47.35 0.76 1.6 47.4 45.0 - 49.7 ABX Diagnostics Micros/45/60 110 46.29 0.93 2.0 46.3 43.4 - 49.1 110 48.47 1.23 2.5 48.6 44.7 - 52.2 Boule Medonic CA 620 16 40.80 1.09 2.7 40.7 37.5 - 44.1 16 43.21 1.25 2.9 43.0 39.4 - 47.0 Boule Medonic M series 25 44.24 1.34 3.0 44.0 40.2 - 48.3 25 45.31 0.97 2.1 45.1 42.4 - 48.3 COULTER AcT diff/diff 2 334 41.21 0.60 1.5 41.2 39.4 - 43.1 331 43.93 0.54 1.2 43.9 42.3 - 45.6

Specimen HD-10


Abbott Cell-Dyn 1700 96 54.91 1.81 3.3 55.2 49.4 - 60.4 Abbott Cell-Dyn 1800 214 55.49 1.31 2.4 55.7 51.5 - 59.5 Abbott Cell-Dyn Emerald 67 51.89 1.94 3.7 52.1 46.0 - 57.8 ABX Diagnostics Micros/45/60 110 54.03 2.80 5.2 54.6 45.6 - 62.5 Boule Medonic CA 620 16 52.67 2.07 3.9 52.8 46.4 - 58.9 Boule Medonic M series 25 55.32 1.57 2.8 55.2 50.6 - 60.1 COULTER AcT diff/diff 2 334 52.80 1.01 1.9 52.8 49.7 - 55.9


HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen DIF-6 Specimen DIF-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 22 4.15 0.16 3.8 4.2 3.5 - 4.8 21 21.83 0.49 2.2 21.9 18.5 - 25.2 All COULTER Instruments 22 4.15 0.16 3.8 4.2 3.5 - 4.8 21 21.83 0.49 2.2 21.9 18.5 - 25.2 COULTER HmX 10 4.14 0.13 3.3 4.2 3.5 - 4.8 10 21.71 0.48 2.2 21.8 18.4 - 25.0

Specimen DIF-8 Specimen DIF-9


Specimen DIF-10 All Method 23 21.93 0.72 3.3 22.0 18.6 - 25.3 All COULTER Instruments 23 21.93 0.72 3.3 22.0 18.6 - 25.3 COULTER HmX 11 21.74 0.63 2.9 21.6 18.4 - 25.0

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

/L)





Specimen DIF-10

All Method 23 5.325 0.143 2.7 5.30 5.00 - 5.65 All COULTER Instruments 23 5.325 0.143 2.7 5.30 5.00 - 5.65 COULTER HmX 11 5.296 0.117 2.2 5.29 4.97 - 5.62







Specimen DIF-10





Specimen DIF-8 Specimen DIF-9 All Method 23 37.20 0.66 1.8 37.3 34.9 - 39.5 23 19.47 0.37 1.9 19.4 18.3 - 20.7 All COULTER Instruments 23 37.20 0.66 1.8 37.3 34.9 - 39.5 23 19.47 0.37 1.9 19.4 18.3 - 20.7 COULTER HmX 11 36.95 0.71 1.9 36.8 34.7 - 39.2 11 19.56 0.44 2.2 19.4 18.3 - 20.8



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


All Method 21 79.6 3.3 4.2 80 59 - 100 21 427.9 14.7 3.4 428 320 - 535 All COULTER Instruments 21 79.6 3.3 4.2 80 59 - 100 21 427.9 14.7 3.4 428 320 - 535 COULTER HmX 10 78.9 3.5 4.4 79 59 - 99 10 421.7 13.0 3.1 425 316 - 528


All Method 23 234.5 10.3 4.4 233 175 - 294 23 78.3 5.3 6.8 78 58 - 98 All COULTER Instruments 23 234.5 10.3 4.4 233 175 - 294 23 78.3 5.3 6.8 78 58 - 98 COULTER HmX 11 229.4 8.8 3.8 231 172 - 287 11 77.0 3.5 4.6 77 57 - 97

Specimen DIF-10 All Method 22 431.1 12.8 3.0 431 323 - 539 All COULTER Instruments 22 431.1 12.8 3.0 431 323 - 539 COULTER HmX 11 425.7 10.2 2.4 427 319 - 533






Specimen DIF-10



HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent)





Specimen DIF-10


HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent)






HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)





Specimen DIF-10


HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)






QBC HEMATOLOGYHEMATOCRIT (percent)

Specimen QBC-6 Specimen QBC-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 17 30.77 1.63 5.3 30.8 28.9 - 32.7 16 33.46 1.56 4.7 34.2 31.4 - 35.5 QBC Autoread-Cap. Std. Tube 6 32.07 1.00 3.1 32.2 30.1 - 34.0 5 33.96 1.80 5.3 34.6 31.9 - 36.0 QBC STAR - QBC STAR Tubes 5 31.08 0.61 2.0 30.9 29.2 - 33.0 5 34.24 0.49 1.4 34.4 32.1 - 36.3

Specimen QBC-8 Specimen QBC-9


Specimen QBC-10 All Method 17 30.48 1.76 5.8 30.5 28.6 - 32.4 QBC Autoread-Cap. Std. Tube 6 31.42 1.64 5.2 31.7 29.5 - 33.4 QBC STAR - QBC STAR Tubes 5 31.12 0.64 2.1 31.3 29.2 - 33.0

QBC HEMATOLOGYHEMOGLOBIN (g/dL)





Specimen QBC-10

All Method 17 10.55 0.55 5.2 10.6 9.8 - 11.3 QBC Autoread-Cap. Std. Tube 6 11.05 0.30 2.7 11.1 10.2 - 11.9 QBC STAR - QBC STAR Tubes 5 10.36 0.23 2.2 10.4 9.6 - 11.1


QBC HEMATOLOGYWHITE BLOOD CELL COUNT (x 109/L)






QBC HEMATOLOGYPLATELET COUNT (x 109/L)


All Method 10 283.4 74.6 26.3 354 212 - 355 9 165.9 60.2 36.3 185 124 - 208 QBC Autoread-Cap. Std. Tube 6 243.0 45.7 18.8 260 182 - 304 5 157.0 56.1 35.7 133 117 - 197 QBC STAR - QBC STAR Tubes 5 406.2 53.1 13.1 383 304 - 508 5 208.4 21.1 10.1 202 156 - 261


All Method 9 286.9 62.3 21.7 351 215 - 359 10 281.5 58.0 20.6 329 211 - 352 QBC Autoread-Cap. Std. Tube 5 261.2 23.7 9.1 256 195 - 327 6 256.5 23.1 9.0 255 192 - 321 QBC STAR - QBC STAR Tubes 5 374.2 26.2 7.0 359 280 - 468 5 386.2 32.0 8.3 370 289 - 483

Specimen QBC-10

All Method 10 285.5 57.8 20.2 341 214 - 357 QBC Autoread-Cap. Std. Tube 6 260.3 20.4 7.8 276 195 - 326 QBC STAR - QBC STAR Tubes 5 380.6 20.2 5.3 370 285 - 476


QBC HEMATOLOGYGRANULOCYTES (x 109/L)






QBC HEMATOLOGYLYMPHS/MONO (x 109/L)





Specimen QBC-10

All Method 17 3.72 0.49 13.1 3.7 2.2 - 5.2 QBC Autoread-Cap. Std. Tube 6 3.45 0.31 9.1 3.6 2.5 - 4.4 QBC STAR - QBC STAR Tubes 5 4.14 0.27 6.5 4.2 3.3 - 5.0


RETICULOCYTE COUNT (percent)

Specimen RT-3 Specimen RT-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 44 0.90 0.28 30.6 0.9 0.0 - 1.8 39 7.37 2.41 32.6 7.1 0.1 - 14.6 All Automated Methods 21 0.78 0.20 25.8 0.8 0.1 - 1.4 17 6.03 1.99 33.0 6.0 0.0 - 12.1 All Manual Methods 22 1.01 0.30 29.4 1.1 0.1 - 2.0 21 8.30 2.22 26.7 8.1 1.6 - 15.0 Manual-New Methylen Blue Stain 14 1.09 0.33 30.6 1.2 0.0 - 2.1 13 9.27 1.84 19.9 9.4 3.7 - 14.8


Specimen BCX-6 Specimen BCX-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 51 2.58 0.11 4.1 2.6 2.1 - 3.0 52 4.04 0.14 3.5 4.0 3.4 - 4.7 All ABX Instruments 28 2.59 0.11 4.2 2.6 2.1 - 3.0 28 4.06 0.14 3.5 4.1 3.4 - 4.7 All COULTER Instruments 21 2.59 0.14 5.3 2.6 2.2 - 3.0 21 4.00 0.13 3.4 4.0 3.4 - 4.6 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 2.58 0.12 4.6 2.6 2.1 - 3.0 16 4.06 0.17 4.1 4.0 3.4 - 4.7 ABX Diagnostics Pentra 80 / XL 80 11 2.60 0.10 3.8 2.6 2.2 - 3.0 11 4.06 0.11 2.8 4.1 3.4 - 4.7 COULTER AcT 5diff (version 2.01) 11 2.57 0.13 4.9 2.5 2.1 - 3.0 11 4.00 0.17 4.3 4.0 3.4 - 4.6

Specimen BCX-8 Specimen BCX-9

All Method 51 15.15 0.51 3.4 15.1 12.8 - 17.5 52 23.54 0.69 2.9 23.5 20.0 - 27.1 All ABX Instruments 28 15.22 0.57 3.7 15.1 12.9 - 17.6 28 23.63 0.69 2.9 23.6 20.0 - 27.2 All COULTER Instruments 20 15.06 0.46 3.1 15.1 12.7 - 17.4 21 23.40 0.71 3.0 23.4 19.8 - 27.0 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 15.41 0.53 3.4 15.3 13.1 - 17.8 16 23.79 0.77 3.2 23.6 20.2 - 27.4 ABX Diagnostics Pentra 80 / XL 80 11 15.07 0.41 2.7 15.0 12.8 - 17.4 11 23.35 0.49 2.1 23.2 19.8 - 26.9 COULTER AcT 5diff (version 2.01) 11 14.89 1.18 7.9 15.2 12.6 - 17.2 11 23.60 0.85 3.6 23.7 20.0 - 27.2

Specimen BCX-10

All Method 51 4.77 0.15 3.1 4.8 4.0 - 5.5 All ABX Instruments 27 4.77 0.13 2.8 4.8 4.0 - 5.5 All COULTER Instruments 21 4.78 0.17 3.6 4.8 4.0 - 5.5 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 4.81 0.22 4.5 4.8 4.0 - 5.6

ABX Diagnostics Pentra 80 / XL 80 11 4.77 0.11 2.3 4.8 4.0 - 5.5 COULTER AcT 5diff (version 2.01) 11 4.78 0.23 4.8 4.7 4.0 - 5.5



/L)

Specimen BCX-6 Specimen BCX-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range




Specimen BCX-10









Specimen BCX-10 All Method 52 12.71 0.18 1.4 12.7 11.8 - 13.7 All ABX Instruments 28 12.66 0.18 1.4 12.7 11.7 - 13.6 All COULTER Instruments 21 12.79 0.18 1.4 12.8 11.8 - 13.7 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 12.70 0.16 1.3 12.7 11.8 - 13.6








Specimen BCX-10






All Method 50 76.6 4.9 6.4 77 57 - 96 50 109.0 6.9 6.4 109 81 - 137 All ABX Instruments 27 75.2 5.5 7.3 76 56 - 94 27 108.4 7.1 6.6 108 81 - 136 All COULTER Instruments 21 77.1 5.3 6.8 77 57 - 97 20 109.2 6.7 6.1 112 81 - 137 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 79.2 6.3 7.9 79 59 - 99 16 112.5 10.4 9.3 110 84 - 141 ABX Diagnostics Pentra 80 / XL 80 11 71.7 5.2 7.2 74 53 - 90 11 105.6 6.9 6.5 104 79 - 133 COULTER AcT 5diff (version 2.01) 11 76.6 6.3 8.2 77 57 - 96 11 108.3 7.0 6.4 106 81 - 136


All Method 49 220.8 8.0 3.6 224 165 - 277 50 495.5 20.3 4.1 495 371 - 620 All ABX Instruments 27 220.8 8.4 3.8 224 165 - 277 27 499.9 21.6 4.3 496 374 - 625 All COULTER Instruments 20 222.1 10.2 4.6 225 166 - 278 20 489.2 18.2 3.7 493 366 - 612 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 15 222.7 9.2 4.1 226 167 - 279 15 497.5 19.8 4.0 495 373 - 622 ABX Diagnostics Pentra 80 / XL 80 11 219.4 6.6 3.0 218 164 - 275 11 503.5 25.3 5.0 504 377 - 630 COULTER AcT 5diff (version 2.01) 11 219.8 7.6 3.5 220 164 - 275 11 491.8 18.8 3.8 498 368 - 615

Specimen BCX-10 All Method 50 249.3 9.3 3.7 250 186 - 312 All ABX Instruments 27 250.7 9.0 3.6 250 188 - 314 All COULTER Instruments 20 246.5 9.6 3.9 247 184 - 309 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 15 252.5 8.3 3.3 250 189 - 316

ABX Diagnostics Pentra 80 / XL 80 11 249.2 9.8 4.0 251 186 - 312 COULTER AcT 5diff (version 2.01) 11 246.5 8.9 3.6 247 184 - 309





Specimen BCX-8 Specimen BCX-9 All Method 51 67.72 4.86 7.2 67.9 53.1 - 82.3 51 48.39 4.28 8.8 48.4 35.5 - 61.3 All ABX Instruments 27 69.34 4.53 6.5 70.5 55.7 - 83.0 27 50.07 3.63 7.2 50.4 39.1 - 61.0 All COULTER Instruments 21 65.08 4.36 6.7 64.2 52.0 - 78.2 20 46.12 3.00 6.5 46.3 37.1 - 55.2 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 71.04 3.19 4.5 72.1 61.4 - 80.7 17 51.18 3.22 6.3 51.4 41.5 - 60.9 ABX Diagnostics Pentra 80 / XL 80 11 66.88 5.17 7.7 67.7 51.3 - 82.5 11 47.06 5.13 10.9 47.6 31.6 - 62.5 COULTER AcT 5diff (version 2.01) 11 64.75 3.10 4.8 64.1 55.4 - 74.1 11 46.75 3.06 6.5 46.3 37.5 - 56.0

Specimen BCX-10




HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)








HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)








HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)








HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)


All Method 47 4.61 4.79 103.8 0.6 0.0 - 19.0 47 3.50 3.71 105.8 0.4 0.0 - 14.7 All ABX Instruments 22 0.53 0.06 12.2 0.5 0.3 - 0.8 23 0.39 0.04 10.7 0.4 0.2 - 0.6 All COULTER Instruments 20 10.05 1.08 10.7 10.1 6.8 - 13.3 20 7.72 0.84 10.9 7.9 5.1 - 10.3 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 15 0.55 0.06 11.6 0.6 0.3 - 0.8 14 0.40 0.00 0.0 0.4 0.4 - 0.4 COULTER AcT 5diff (version 2.01) 11 10.30 1.04 10.1 10.3 7.1 - 13.5 11 7.90 0.88 11.2 7.9 5.2 - 10.6


All Method 47 3.39 3.59 105.8 0.4 0.0 - 14.2 47 3.32 3.47 104.6 0.4 0.0 - 13.8 All ABX Instruments 21 0.40 0.00 0.0 0.4 0.4 - 0.4 21 0.40 0.00 0.0 0.4 0.4 - 0.4 All COULTER Instruments 20 7.47 0.89 11.9 7.5 4.8 - 10.2 20 7.29 0.53 7.2 7.4 5.7 - 8.9 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 14 0.40 0.00 0.0 0.4 0.4 - 0.4 14 0.40 0.00 0.0 0.4 0.4 - 0.4 COULTER AcT 5diff (version 2.01) 11 7.78 0.97 12.5 7.6 4.8 - 10.7 11 7.33 0.47 6.4 7.4 5.9 - 8.8

Specimen BCX-10


COULTER AcT 5diff (version 2.01) 11 8.51 0.93 10.9 8.4 5.7 - 11.3



Specimen MX-6 Specimen MX-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 28 3.92 0.22 5.6 4.0 3.3 - 4.6 28 19.00 1.01 5.3 18.8 16.1 - 21.9 All Sysmex Instruments 28 3.92 0.22 5.6 4.0 3.3 - 4.6 28 19.00 1.01 5.3 18.8 16.1 - 21.9 Sysmex XS-1000i 14 4.10 0.10 2.5 4.1 3.4 - 4.8 14 19.36 1.02 5.2 19.0 16.4 - 22.3

Specimen MX-8 Specimen MX-9


Specimen MX-10 All Method 28 19.06 0.95 5.0 18.8 16.2 - 22.0 All Sysmex Instruments 28 19.06 0.95 5.0 18.8 16.2 - 22.0 Sysmex XS-1000i 14 19.54 0.92 4.7 19.3 16.6 - 22.5


/L)













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



Specimen MX-8 Specimen MX-9 All Method 28 39.55 0.67 1.7 39.6 37.1 - 42.0 28 18.77 0.45 2.4 18.7 17.6 - 19.9 All Sysmex Instruments 28 39.55 0.67 1.7 39.6 37.1 - 42.0 28 18.77 0.45 2.4 18.7 17.6 - 19.9 Sysmex XS-1000i 14 39.23 0.66 1.7 39.4 36.8 - 41.6 14 18.46 0.32 1.7 18.5 17.3 - 19.6





All Method 28 59.7 5.2 8.7 60 44 - 75 28 406.3 16.8 4.1 403 304 - 508 All Sysmex Instruments 28 59.7 5.2 8.7 60 44 - 75 28 406.3 16.8 4.1 403 304 - 508 Sysmex XS-1000i 14 59.9 2.4 4.0 60 44 - 75 14 417.7 13.9 3.3 420 313 - 523


All Method 28 221.5 10.8 4.9 224 166 - 277 28 60.6 5.6 9.3 62 45 - 76 All Sysmex Instruments 28 221.5 10.8 4.9 224 166 - 277 28 60.6 5.6 9.3 62 45 - 76 Sysmex XS-1000i 14 226.2 5.5 2.4 226 169 - 283 14 60.8 4.7 7.7 61 45 - 76

Specimen MX-10 All Method 28 404.2 16.5 4.1 404 303 - 506 All Sysmex Instruments 28 404.2 16.5 4.1 404 303 - 506 Sysmex XS-1000i 14 415.4 12.3 3.0 418 311 - 520

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



Specimen MX-8 Specimen MX-9 All Method 28 53.72 4.23 7.9 56.3 41.0 - 66.5 27 67.44 2.75 4.1 68.6 59.1 - 75.7 All Sysmex Instruments 28 53.72 4.23 7.9 56.3 41.0 - 66.5 27 67.44 2.75 4.1 68.6 59.1 - 75.7 Sysmex XS-1000i 14 50.15 3.07 6.1 50.1 40.9 - 59.4 13 65.28 2.43 3.7 65.0 57.9 - 72.6



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





Specimen MX-10

All Method 28 21.45 3.92 18.2 23.7 9.7 - 33.2 All Sysmex Instruments 28 21.45 3.92 18.2 23.7 9.7 - 33.2 Sysmex XS-1000i 14 19.11 4.25 22.2 16.7 6.3 - 31.9

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





Specimen MX-10



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





Specimen MX-10


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





Specimen MX-10



BLOOD CELL IDENTIFICATION, 2011-M2 Specimens BC-7 through BC-12

CASE HISTORY A 65-year-old white male presented to his family physician complaining of frequent nosebleeds, dizziness, and blurry vision. His wife reported that he had become very weak and easily fatigued. The physical examination revealed enlarged lymph nodes, spleen, and liver. A series of laboratory tests, including a CBC, were performed. Significant results appear below.

Test Results Normal Range WBC 14.5 x 10

9/L 5 - 10 x 10

9/L

RBC 3.48 x 1012

/L 4.0 - 6.0 x 1012

/L

Hgb 9.7 g/dL 12 - 18 g/dL

Hct 28.9 % 35 - 54 %

MCV 83 fL 80 - 94 fL

MCH 28 pg 26 - 32 pg

MCHC 34 g/dL 32 - 36 g/dL

RDW 12 % 11 - 15 %

Plt 254 x 109/L 150 - 400 x 10

9/L

Sedimentation rate 55 mm/hr 0 - 20 mm/hr

PTT 41 seconds 20 - 34 sec.

Direct Antiglobulin Test Positive Negative

This patient was diagnosed with Waldenstrom macroglobulinemia. Waldenstrom macroglobulinemia (WM) is a Non-Hodgkin‟s lymphoma named after Jan Waldenstrom, the Swedish physician who first described it in 1944. Some lymphocytes mature into plasma cells that produce antibodies to help the body fight infection. In WM, a single clone of cells multiplies out of control, producing excessive amounts of monoclonal IgM antibodies. The malignant cells of WM have features of both plasma cells and lymphocytes and are called lymphoplasmacytoid. These cells produce a large amount of abnormal monoclonal immunoglobulin that may be detected as a single band, called an M-spike, using serum protein gel electrophoresis. Symptoms result from the proliferation of malignant cells and/or the increased quantity of IgM. Both processes can contribute to anemia: the abnormal protein can cause autoimmune hemolysis, and the production of red blood cells is suppressed when cancerous cells fill the bone marrow. The malignant cells also suppress normal immunoglobulin production, resulting in recurring bacterial infections due to inadequate production of normal antibodies. Patients may have enlarged lymph nodes, liver, and spleen due to infiltration of cancerous cells. IgM is a large protein molecule, referred to as macroglobulin. High levels of macroglobulins thicken the blood, interfering with blood flow to the skin, fingers, toes, nose, and brain. The thickened blood may aggravate heart conditions and cause increased pressure in the brain. Tiny blood vessels in the back of the eyes may bleed, resulting in retinal damage and impaired eyesight. Some patients develop symptoms of hyperviscosity syndrome including bleeding from the skin and mucous membranes, fatigue, weakness, headache, confusion, dizziness, and even coma. Some patients develop a condition in which the antibodies precipitate at cold temperatures and clog the blood vessels, causing pain and whiteness, especially in the hands. The macroglobulin is then called a cryoglobulin or cold agglutinin. Moderate normocytic, normochromic anemia, marked rouleaux formation, and a very high ESR are typical in Waldenstrom macroglobulinemia. Normal immunoglobulins are often decreased. Cryoglobulins, rheumatoid factor, or cold agglutinins may be present. Cryoglobulinemia and marked hyperviscosity can interfere with the performance of routine blood tests. For example, CBC specimens may need to be warmed in a 37˚C water bath in order to obtain reportable results. WM is incurable, but progresses slowly and has a much more positive prognosis than multiple myeloma (a similar disease). Treatment options for symptomatic WM patients include chemotherapy, plasma exchange, blood transfusions, and stem cell transplant.


BLOOD CELL IDENTIFICATION

Specimen BC-7

Identification Labs Percent Performance

Platelet, normal 310 99.04% Acceptable

The arrows in this photograph point to normal platelets. Platelets contain fine, red-violet granules surrounded by bluish cytoplasm. They are much smaller than red blood cells and rounded in shape, with irregular edges. To view another photo of normal platelets, see 2010 M3 Specimen BC-13. Specimen BC-8

Identification Labs Percent Performance Erythrocyte, normal 300 95.85% Acceptable

Microcyte 9 2.88%

The arrows in this photograph point to normal erythrocytes. As a “rule of thumb”, the nucleus of a small, mature lymphocyte can be used to provide a relative measurement of the size of the surrounding red blood cells. The arrowed cells are approximately the same size as the nucleus of the lymphocyte nearby. To view another photo of normal erythrocytes, see 2009 M3 Specimen BC-14. . Specimen BC-9


Rouleaux 295 94.25% Acceptable

Spherocyte 13 4.15%

The arrows in this photograph point to rouleaux. Rouleaux are stacks or long chains of red blood cells. In the presence of increased protein, RBCs stick together in a linear arrangement resembling a stack of coins that has been knocked over. The cells settle faster than normal, causing the erythrocyte sedimentation rate (ESR) to be elevated. A blue-staining background may be observed along with rouleaux due to the abnormally high amount of plasma protein. To view another photo of rouleaux, see 2006 M1 specimen BC-2.


BLOOD CELL IDENTIFICATION Specimen BC-10


Monocyte 305 97.44% Acceptable

The arrow in this photograph points to a monocyte. The nucleus is deeply indented and the nuclear chromatin is lacy with small clumps. The cytoplasm is pale gray-blue with a cloudy/turbid appearance, and contains numerous vacuoles. The cytoplasmic membrane is irregular, with pseudopods that appear to be pushing away adjacent red blood cells. To view another photo of a monocyte, see 2010 M1 Specimen BC-1. Specimen BC-11


Lymphocyte, reactive 202 65.54% Acceptable

Lymphocyte 106 33.87%

Immature/abnormal cell - refer 5 1.60%

The arrow in this photograph points to a reactive lymphocyte. The nuclear chromatin is dense and mature. The cytoplasm is light blue, with a deeper blue color at the extreme border, where it is indented by adjacent red blood cells. A normal, mature lymphocyte‟s nucleus would be about the same size and shape as a normal RBC, surrounded by a small amount of cytoplasm. This reactive lymphocyte is larger than a normal resting lymph, with abundant cytoplasm containing vacuoles and large azurophilic granules. The nucleus is large, appearing slightly elongated or stretched. To view another photo of a reactive lymph, see 2010 M1 Specimen BC-2. To view a normal lymph, see 2010 M2 Specimen BC-9. This challenge was graded by 93% referee consensus.


BLOOD CELL IDENTIFICATION Specimen BC-12


Plasma cell 277 88.78% Not graded

Immature/abnormal cell – refer 13 4.17%

Prolymphocyte 10 3.21%

Myelocyte cell 5 1.60%

The arrow in this ungraded, educational challenge points to a plasma cell. A plasma cell is characterized by an eccentric nucleus with very little cytoplasm on one side, purple-ish basophilic cytoplasm, and a perinuclear clear zone - a pale-staining area adjacent to the nucleus. The mature plasma cell has a perfectly round or oval nucleus with dense blue-purple, prominently clumped chromatin. There are two types of lymphocytes, B cells and T cells. B cells are the lymphocytes that transform into plasma cells, which make and release antibodies to fight infectious diseases and foreign substances. B lymphocytes cannot be distinguished from T lymphocytes with Wright stain. To view another photo of a plasma cell, see 2006 M1 Specimen BC-6. References: Berenson, J.R. (July 2008) Macroglobulinemia. The Merck Manuals Online Medical Library. Merck Sharp & Dohme Corp., Whitehouse Station, N.J. Copyright, 2010-2011. Available at: http://www.merckmanuals.com/professional/sec11/ch144/ch144c.html Accessed June 28, 2011. O‟Connor, B. H.: A Color Atlas and Instruction Manual of Peripheral Blood Cell Morphology. Williams & Wilkins, Baltimore MD, 1984. Rodak, B. F.: Hematology: Clinical Principles and Applications. 3

rd ed. W. B. Saunders, Philadelphia, 2007.

Waldenstrom Macroglobulinemia. (Revised 10/05/10) American Cancer Society. Copyright, American Cancer Society, Inc., 2011. Available at: http://www.cancer.org/Cancer/WaldenstromMacroglobulinemia/DetailedGuide/waldenstrom-macroglobulinemia-w-m Accessed June 29, 2011.

http://www.cancer.org/Cancer/WaldenstromMacroglobulinemia/DetailedGuide/waldenstrom-macroglobulinemia-w-m


BLOOD BANK ABO GROUP

Specimen Results Labs Percent Performance

BB-6 Group A 10 100% Acceptable

BB-7 Group O 10 100% Acceptable

BB-8 Group AB 10 100% Acceptable

BB-9 Group O 10 100% Acceptable

BB-10 Group B 10 100% Acceptable

RH FACTOR (D TYPE)


BB-6 Rh Positive 14 93.33% Acceptable

Rh Negative 1 6.67%


Rh Negative 1 6.67%

BB-8 Rh Negative 15 100% Acceptable

BB-9 Rh Negative 15 100% Acceptable


Rh Negative 1 6.67%

Specimens BB-6, BB-7 and BB-10 were graded by 100% referee consensus.

UNEXPECTED ANTIBODY DETECTION


AB-6 Unexpected antibody detected 10 100% Acceptable



AB-9 No unexpected antibody detected 10 100% Acceptable

AB-10 No unexpected antibody detected 10 100% Acceptable


BLOOD BANK

ANTIBODY IDENTIFICATION

No labs reported Antibody Identification. The vendor assay values for specimens AB-6 through AB-10 are: Anti-k, Anti-E, Anti-Jk

a, No antibody detected, and No antibody detected, respectively.

COMPATIBILITY TESTING


AB-6 Not Compatible 7 100% Acceptable

AB-7 Compatible 7 100% Acceptable

AB-8 Not Compatible 7 100% Acceptable




PROTHROMBIN TIME (seconds)

Specimen CG-6 Specimen CG-7 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 82 11.27 0.73 6.5 11.1 9.5 - 13.0 86 33.76 6.91 20.5 29.9 28.6 - 38.9 Dade Innovin Sysmex CA-500 22 10.71 0.25 2.3 10.7 9.1 - 12.4 22 38.77 1.72 4.4 38.5 32.9 - 44.6 All Coagulation Instruments 26 10.65 0.30 2.8 10.6 9.0 - 12.3 27 39.05 1.96 5.0 38.8 33.1 - 45.0 IL TEST PT Fibrinogen IL ACL, all models 24 11.75 0.32 2.7 11.8 9.9 - 13.6 24 28.85 0.98 3.4 29.0 24.5 - 33.2 PH/CMS Thromboplastin-D All Coagulation Instruments 6 11.13 0.34 3.0 11.1 9.4 - 12.9 6 28.33 1.72 6.1 29.2 24.0 - 32.6 TriniCLOT PT Excel OTC Coag-A-Mate XM 12 10.99 0.48 4.4 10.9 9.3 - 12.7 12 28.04 0.77 2.7 27.8 23.8 - 32.3 All Coagulation Instruments 15 11.03 0.44 4.0 10.9 9.3 - 12.7 15 27.83 0.83 3.0 27.7 23.6 - 32.1

Specimen CG-8 Specimen CG-9


Specimen CG-10

All Method 81 14.16 0.90 6.4 14.1 12.0 - 16.3 Dade Innovin Sysmex CA-500 20 13.91 0.38 2.7 13.9 11.8 - 16.0 All Coagulation Instruments 24 13.91 0.35 2.5 13.9 11.8 - 16.0 IL TEST PT Fibrinogen IL ACL, all models 24 14.73 0.40 2.7 14.7 12.5 - 17.0 PH/CMS Thromboplastin-D All Coagulation Instruments 6 13.82 0.64 4.6 14.1 11.7 - 15.9 TriniCLOT PT Excel OTC Coag-A-Mate XM 11 13.23 0.48 3.6 13.2 11.2 - 15.3 All Coagulation Instruments 14 13.26 0.44 3.3 13.3 11.2 - 15.3


PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)





Specimen CG-10

All Method 86 1.38 0.11 7.9 1.4 1.0 - 1.8 Dade Innovin Sysmex CA-500 22 1.36 0.06 4.3 1.4 1.1 - 1.6 All Coagulation Instruments 27 1.37 0.06 4.5 1.4 1.1 - 1.6 IL TEST PT Fibrinogen IL ACL, all models 24 1.43 0.11 7.9 1.4 1.0 - 1.8 PH/CMS Thromboplastin-D All Coagulation Instruments 7 1.50 0.10 6.7 1.5 1.2 - 1.8 TriniCLOT PT Excel OTC Coag-A-Mate XM 11 1.26 0.09 7.3 1.3 0.9 - 1.6 All Coagulation Instruments 14 1.26 0.08 6.7 1.3 1.0 - 1.6


ACTIVATED PARTIAL THROMBOPLASTIN (seconds)


All Method 33 29.1 1.3 4.5 29 24 - 34 33 60.9 3.7 6.0 60 51 - 71 Dade Actin FSL Sysmex CA-500 15 29.7 1.1 3.8 30 25 - 35 15 60.1 3.2 5.3 60 51 - 70 IL TEST APTT-SP IL ACL, all models 12 28.4 1.2 4.1 28 24 - 33 12 59.5 2.1 3.5 59 50 - 69


All Method 33 28.3 1.3 4.7 28 24 - 33 33 55.3 4.1 7.5 54 47 - 64 Dade Actin FSL Sysmex CA-500 15 28.1 1.1 4.0 28 23 - 33 15 55.5 2.3 4.1 55 47 - 64 IL TEST APTT-SP IL ACL, all models 12 28.1 1.2 4.4 28 23 - 33 12 52.8 1.6 3.1 53 44 - 61

Specimen CG-10 All Method 33 38.9 4.0 10.4 40 33 - 45 Dade Actin FSL Sysmex CA-500 15 35.4 1.9 5.4 36 30 - 41 IL TEST APTT-SP IL ACL, all models 12 43.1 1.8 4.1 43 36 - 50

Fibrinogen (mg/dL)

One participant reported Fibrinogen. The vendor assay values for specimens CG-6 through CG-10 are: 534 mg/dL, 367 mg/dL, 334 mg/dL, 284 mg/dL and 117 mg/dL respectively.

RH FACTOR (Slide Method)


RH-6 Rh Negative 2 100% Acceptable

RH-7 Rh Positive 2 100% Acceptable


RH-9 Rh Positive 2 100% Acceptable



COAGUCHEK XS PLUS PROTHROMBIN TIME (seconds)

Specimen XS-6 Specimen XS-8 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

Roche CoaguChek XS Plus 15 23.65 1.15 4.9 23.6 20.1 - 27.3 15 34.37 1.75 5.1 34.2 29.2 - 39.6

Specimen XS-8 Specimen XS-9 Roche CoaguChek XS Plus 15 15.03 0.43 2.9 14.9 12.7 - 17.3 15 23.81 0.79 3.3 23.7 20.2 - 27.4

Specimen XS-10 Roche CoaguChek XS Plus 14 14.94 0.48 3.2 14.9 12.6 - 17.2

COAGUCHEK XS PLUS PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)

Specimen XS-6 Specimen XS-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range Roche CoaguChek XS Plus 18 1.98 0.09 4.8 2.0 1.6 - 2.3 19 2.85 0.14 5.0 2.8 2.4 - 3.3

Specimen XS-8 Specimen XS-9 Roche CoaguChek XS Plus 18 1.24 0.05 4.0 1.2 1.0 - 1.4 19 1.98 0.07 3.6 2.0 1.7 - 2.2

Specimen XS-10 Roche CoaguChek XS Plus 18 1.23 0.05 3.9 1.2 1.0 - 1.4

ITC PROTIME MICROCOAGULATION SYSTEM PROTHROMBIN TIME (seconds)

Specimen IT-3 Specimen IT-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 18 19.89 2.62 13.2 19.6 12.0 - 27.8 18 31.73 3.42 10.8 32.6 21.4 - 42.1 ITC ProTime System - 3 Channel 9 - - - 19.6 12.0 - 27.8 10 32.99 3.25 9.8 32.6 23.2 - 42.8

ITC PROTIME MICROCOAGULATION SYSTEM INTERNATIONAL NORMALIZED RATIO (INR)

Specimen IT-3 Specimen IT-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 26 1.53 0.18 11.8 1.5 0.9 - 2.1 26 2.40 0.24 10.1 2.4 1.6 - 3.2 ITC ProTime System - 3 Channel 11 1.56 0.17 11.2 1.6 1.0 - 2.1 12 2.52 0.23 9.1 2.5 1.8 - 3.3 ITC ProTime System - 5 Channel 10 1.43 0.13 9.4 1.5 1.0 - 1.9 9 - - - 2.3 1.6 - 3.2


i-Stat PROTHROMBIN TIME (seconds)

Specimen PTI-6 Specimen PTI-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

i-Stat Prothrombin Time 11 34.00 2.29 6.7 33.1 28.9 - 39.1 11 13.87 1.17 8.5 13.3 11.7 - 16.0

Specimen PTI-8 Specimen PTI-9 i-Stat Prothrombin Time 11 13.81 0.97 7.0 13.7 11.7 - 15.9 11 34.51 2.60 7.5 34.4 29.3 - 39.7

Specimen PTI-10 i-Stat Prothrombin Time 11 13.93 1.26 9.0 14.1 11.8 - 16.1

i-Stat PROTHROMBIN TIME - INTERNATIONAL NORMALIZED RATIO (INR)

Specimen PTI-6 Specimen PTI-8 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range


Specimen PTI-8 Specimen PTI-9


Specimen PTI-10

i-Stat Prothrombin Time 11 1.16 0.11 9.6 1.2 0.8 - 1.5


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

Specimen BF-3 Specimen BF-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 0.0 0.0 0.0 0 0 - 0 6 212.7 48.3 22.7 225 67 - 358

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

Specimen BF-3 Specimen BF-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 10 0.0 0.0 0.0 0 0 - 0 8 122.5 55.4 45.2 125 0 - 289

FLUID CELL COUNT/CRYSTALS CRYSTAL IDENTIFCATION

Specimen Identification Labs Percent Performance

BF-3 CPPD Crystals 10 76.92% Not graded

Other, not listed 2 15.38%

BF-4 Cholesterol crystals 13 100% Acceptable

Specimen BF-3 is an ungraded due to lack of 80% participant consensus.

MICROALBUMIN, DIPSTICK

Specimen UM-2 Participant Results

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

ALL METHODS 47 - - 5 6 32 4 - Bayer Clinitek Microalbumin 37 - - 5 - 32 - - Roche Micral - 1 minute 10 - - - 6 - 4 - CREATININE, DIPSTICK

Specimen UM-2

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 37 - - - 1 8 25 3 Bayer Clinitek Microalbumin 34 - - - 1 6 25 2 Bayer Multistix Pro 3 - - - - 2 - 1


MICROALBUMIN, QUANTITATIVE

Specimen UM-2 Method Labs Mean SD CV Median Range

All Method 107 79.7 6.1 7.7 80 61 - 99 Axis-Shield Afinion AS100 10 78.4 10.7 13.7 80 46 - 111 Bayer DCA 2000(+) 17 75.5 4.7 6.3 74 61 - 90 Dade Dimension/AR/ES/RxL/Xpand 24 84.4 2.3 2.7 85 77 - 92 Roche Integra 10 80.6 2.2 2.7 81 74 - 88 Siemens DCA Vantage 18 78.8 5.9 7.4 79 61 - 97

CREATININE, URINE (mg/dL)

Specimen UM-2 Method Labs Mean SD CV Median Range All Method 92 74.1 4.9 6.6 74 59 - 89 Axis-Shield Afinion AS100 10 74.1 7.0 9.4 73 53 - 96 Bayer DCA 2000(+) 17 76.1 2.0 2.6 77 70 - 83 Dade Dimension/AR/ES/RxL/Xpand 20 69.7 3.7 5.4 68 58 - 81 Roche Integra 10 72.2 2.6 3.6 72 64 - 80 Siemens DCA Vantage 17 76.9 2.4 3.2 77 69 - 85

CREATININE, URINE (mmol/L)

Three participants reported Creatinine. The Vendor Assay for specimen UM-2 is 7.4 mmol/L.

WAIVED HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HD-6 Specimen HD-7 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 82 13.05 0.77 5.9 13.1 10.7 - 15.4 83 13.07 0.73 5.6 13.2 10.8 - 15.3 HemoCue 62 13.14 0.42 3.2 13.1 11.8 - 14.4 62 13.13 0.50 3.8 13.2 11.6 - 14.7

WAIVED HEMATOLOGYHEMATOCRIT (percent)


All Method 22 38.77 3.29 8.5 39.0 28.9 - 48.7 22 39.61 2.14 5.4 40.0 33.1 - 46.1 All Microhematocrit Methods 22 38.77 3.29 8.5 39.0 28.9 - 48.7 22 39.61 2.14 5.4 40.0 33.1 - 46.1


KOH SKIN PREPARATION Specimen Identification Labs Percent Performance K-3 Yeast/fungal elements absent 183 94.82% Acceptable Yeast/fungal elements present 10 5.18% Organism present in specimen K-3: Staphylococcus epidermidis. K-4 Yeast/fungal elements present 190 98.45% Acceptable Yeast/fungal elements absent 3 1.55% Organism present in specimen K-4: Trichophyton rubrum.

URINALYSIS DIPSTICKSPECIFIC GRAVITY

Specimen UA-2 Method Labs Mean SD CV Median Range All Method 1082 1.0062 0.0025 0.3 1.005 0.996 - 1.017 All PSS Select Methods 15 1.0100 0.0042 0.4 1.010 1.000 - 1.020 All Refractive Index Methods 11 1.0047 0.0005 0.1 1.005 0.994 - 1.015 Bayer Clinitek 10 / 100 28 1.0054 0.0013 0.1 1.005 0.995 - 1.016 Bayer Clinitek 50 112 1.0050 0.0000 0.0 1.005 0.995 - 1.015 Bayer Clinitek 500 23 1.0057 0.0016 0.2 1.005 0.995 - 1.016 Bayer Clinitek Advantus 16 1.0050 0.0000 0.0 1.005 0.995 - 1.015 Bayer Clinitek Status / Status+ 329 1.0059 0.0020 0.2 1.005 0.995 - 1.016 Bayer Reagent Strips 310 1.0054 0.0019 0.2 1.005 0.995 - 1.016 CTMI CT-120 Urine Analyzer 10 1.0120 0.0136 1.3 1.010 1.002 - 1.022 Diagnostic Test Group Clarity Urocheck 17 1.0059 0.0020 0.2 1.005 0.995 - 1.016 Hypoguard DiaScreen 10 1.0055 0.0037 0.4 1.005 0.995 - 1.016 McKesson 10SG Reagent Strips 18 1.0053 0.0011 0.1 1.005 0.995 - 1.016 Roche Chemstrip 101 13 1.0096 0.0032 0.3 1.010 0.999 - 1.020 Roche Chemstrips 62 1.0081 0.0025 0.2 1.010 0.998 - 1.019 Roche Criterion Analyzer 21 1.0095 0.0035 0.3 1.010 0.999 - 1.020 Roche Urisys 41 1.0098 0.0033 0.3 1.010 0.999 - 1.020


URINALYSIS DIPSTICKpH

Specimen UA-2 Participant Results

Method Labs 3.5 or less

4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0

ALL METHODS 1131 - - - 28 56 569 410 64 4 - - - Arkray PocketChem UA 1 - - - - - 1 - - - - - - Bayer Clinitek 10 / 100 30 - - - - 1 23 6 - - - - - Bayer Clinitek 200/200+ 1 - - - - - 1 - - - - - - Bayer Clinitek 50 118 - - - 1 24 87 6 - - - - - Bayer Clinitek 500 24 - - - - 1 5 18 - - - - - Bayer Clinitek Advantus 17 - - - - - 1 16 - - - - - Bayer Clinitek Atlas 4 - - - - - 2 2 - - - - - Bayer Clinitek Status / Status+ 333 - - - 3 18 254 57 1 - - - - Bayer Hemacombistix 1 - - - - - - 1 - - - - - Bayer Multistix Pro 2 - - - - - 2 - - - - - - Bayer Reagent Strips 333 - - - 15 2 106 200 8 2 - - - Consult Diagnostics Urine Analyzer 7 - - - - - 2 2 3 - - - - CTMI CT-120 Urine Analyzer 10 - - - - - 10 - - - - - - Diagnostic Test Group Clarity Urocheck 18 - - - - 1 13 4 - - - - - Germaine Laboratories AimStrip 2 - - - - - - 1 1 - - - - Hypoguard DiaScreen 11 - - - - - 8 3 - - - - - Iris Diagnostics vChem Urine Strips 1 - - - - - 1 - - - - - - McKesson 10SG Reagent Strips 20 - - - 1 - 1 14 4 - - - - Other Analyzer Method 2 - - - - - 2 - - - - - - Other Dipstick Method 7 - - - 1 - 2 3 1 - - - - pH Paper 1 - - - - - - 1 - - - - - PSS Select Reagent Strips 9 - - - - 1 3 2 3 - - - - PSS Select Urine Analyzer 7 - - - - 5 1 1 - - - - - Roche Chemstrip 101 13 - - - - - - 9 4 - - - - Roche Chemstrips 77 - - - 5 3 38 14 15 2 - - - Roche Criterion Analyzer 21 - - - 1 - - 18 2 - - - - Roche SuperUA/ChemstripUA 2 - - - - - - 1 1 - - - - Roche Urisys 45 - - - 1 - 1 28 15 - - - - Schein Urispec 7 - - - - - - 1 6 - - - - UriScan Reagent Strips 2 - - - - - 2 - - - - - -


URINALYSIS DIPSTICKPROTEIN QUALITATIVE

Specimen UA-2

Participant Results

Method Labs Negative Trace 30 mg/dL

(1+)

100 mg/dL

(2+)

300-500 mg/dL (3+)

>300 mg/dL

>1000 mg/dL

(4+)

ALL METHODS 1147 1116 29 1 - 1 - - Arkray PocketChem UA 1 1 - - - - - - Bayer Albustix 1 1 - - - - - - Bayer Clinitek 10 / 100 30 30 - - - - - - Bayer Clinitek 200/200+ 1 1 - - - - - - Bayer Clinitek 50 117 117 - - - - - - Bayer Clinitek 500 24 24 - - - - - - Bayer Clinitek Advantus 17 17 - - - - - - Bayer Clinitek Atlas 5 5 - - - - - - Bayer Clinitek Status / Status+ 331 330 1 - - - - - Bayer Hemacombistix 1 1 - - - - - - Bayer Multistix Pro 2 2 - - - - - - Bayer Reagent Strips 334 325 9 - - - - - Bayer Uristix 5 4 - - - 1 - - Consult Diagnostics Urine Analyzer 7 6 - 1 - - - - CTMI CT-120 Urine Analyzer 10 10 - - - - - - Diagnostic Test Group Clarity Urocheck 16 16 - - - - - - Germaine Laboratories AimStrip 2 1 1 - - - - - Hypoguard DiaScreen 12 12 - - - - - - Iris Diagnostics vChem Urine Strips 1 1 - - - - - - McKesson 10SG Reagent Strips 20 20 - - - - - - Other Analyzer Method 2 2 - - - - - - Other Dipstick Method 7 7 - - - - - - PSS Select Reagent Strips 9 9 - - - - - - PSS Select Urine Analyzer 7 7 - - - - - - Roche Chemstrip 101 13 13 - - - - - - Roche Chemstrips 91 74 17 - - - - - Roche Criterion Analyzer 21 21 - - - - - - Roche SuperUA/ChemstripUA 2 1 1 - - - - - Roche Urisys 45 45 - - - - - - Schein Urispec 6 6 - - - - - - Sulfosalicylic Acid 1 1 - - - - - - UriScan Reagent Strips 2 2 - - - - - -


URINALYSIS DIPSTICKGLUCOSE

Specimen UA-2 Participant Results Method

Labs

Negative

50-100 mg/dL (Trace)

150

mg/dL

250

mg/dL

500

mg/dL

1000

mg/dL

>1000 mg/dL

>2000 mg/dL

ALL METHODS 1152 1147 3 - 1 1 - - -

Arkray PocketChem UA 1 1 - - - - - - -

Bayer Clinitek 10 / 100 30 30 - - - - - - -

Bayer Clinitek 200/200+ 1 1 - - - - - - -

Bayer Clinitek 50 118 117 1 - - - - - -

Bayer Clinitek 500 24 24 - - - - - - -

Bayer Clinitek Advantus 17 17 - - - - - - -

Bayer Clinitek Atlas 4 4 - - - - - - -

Bayer Clinitek Status / Status+ 333 332 1 - - - - - -

Bayer Hemacombistix 1 1 - - - - - - -

Bayer Multistix Pro 2 2 - - - - - - -

Bayer Reagent Strips 336 335 - - 1 - - - -

Bayer Uristix 5 4 - - - 1 - - -

Consult Diagnostics Urine Analyzer 7 7 - - - - - - -

CTMI CT-120 Urine Analyzer 10 10 - - - - - - -

Diagnostic Test Group Clarity Urocheck 18 18 - - - - - - -

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

Hypoguard DiaScreen 12 12 - - - - - - -

Iris Diagnostics vChem Urine Strips 1 1 - - - - - - -

McKesson 10SG Reagent Strips 20 20 - - - - - - -

Other Analyzer Method 2 2 - - - - - - -

Other Dipstick Method 7 7 - - - - - - -

PSS Select Reagent Strips 9 9 - - - - - - -

PSS Select Urine Analyzer 7 7 - - - - - - -

Roche Chemstrip 101 13 13 - - - - - - -

Roche Chemstrips 91 91 - - - - - - -

Roche Criterion Analyzer 21 21 - - - - - - -

Roche SuperUA/ChemstripUA 2 2 - - - - - - -

Roche Urisys 45 44 1 - - - - - -

Schein Urispec 7 7 - - - - - - -

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


URINALYSIS DIPSTICKKETONES

Specimen UA-2

Participant Results

Method

Labs

Negative

Trace (5 mg/dL)

Small (1+, 15 mg/dL)

Moderate (2+, 40 mg/dL)

Large (3+, 80 mg/dL)

150 mg/dL ≥ 160 mg/dL

ALL METHODS 1127 1122 3 2 - - - - Arkray PocketChem UA 1 1 - - - - - - Bayer Clinitek 10 / 100 30 30 - - - - - - Bayer Clinitek 200/200+ 1 1 - - - - - - Bayer Clinitek 50 118 118 - - - - - - Bayer Clinitek 500 24 24 - - - - - - Bayer Clinitek Advantus 17 17 - - - - - - Bayer Clinitek Atlas 4 4 - - - - - - Bayer Clinitek Status / Status+ 334 333 - 1 - - - - Bayer Ketostix 1 1 - - - - - - Bayer Multistix Pro 2 2 - - - - - - Bayer Reagent Strips 330 327 2 1 - - - - Consult Diagnostics Urine Analyzer 7 7 - - - - - - CTMI CT-120 Urine Analyzer 10 10 - - - - - - Diagnostic Test Group Clarity Urocheck 18 17 1 - - - - - Germaine Laboratories AimStrip 2 2 - - - - - - Hypoguard DiaScreen 10 10 - - - - - - Iris Diagnostics vChem Urine Strips 1 1 - - - - - - McKesson 10SG Reagent Strips 20 20 - - - - - - Other Analyzer Method 2 2 - - - - - - Other Dipstick Method 7 7 - - - - - - PSS Select Reagent Strips 8 8 - - - - - - PSS Select Urine Analyzer 7 7 - - - - - - Roche Chemstrip 101 13 13 - - - - - - Roche Chemstrips 77 77 - - - - - - Roche Criterion Analyzer 21 21 - - - - - - Roche SuperUA/ChemstripUA 2 2 - - - - - - Roche Urisys 45 45 - - - - - - Schein Urispec 7 7 - - - - - - Test Not Performed 1 1 - - - - - - UriScan Reagent Strips 2 2 - - - - - -


URINALYSIS DIPSTICKBILIRUBIN

Specimen UA-2

Participant Results

Method

Labs

Negative

Small (1+)

Moderate (2+)

Large (3+)

ALL METHODS 1083 1081 1 1 - Arkray PocketChem UA 1 1 - - - Bayer Clinitek 10 / 100 30 30 - - - Bayer Clinitek 200/200+ 1 1 - - - Bayer Clinitek 50 115 115 - - - Bayer Clinitek 500 21 21 - - - Bayer Clinitek Advantus 15 15 - - - Bayer Clinitek Atlas 4 4 - - - Bayer Clinitek Status / Status+ 317 317 - - - Bayer Ictotest 4 4 - - - Bayer Multistix Pro 2 2 - - - Bayer Reagent Strips 317 316 1 - - Consult Diagnostics Urine Analyzer 7 7 - - - CTMI CT-120 Urine Analyzer 10 10 - - - Diagnostic Test Group Clarity Urocheck 17 17 - - - Germaine Laboratories AimStrip 2 2 - - - Hypoguard DiaScreen 9 8 - 1 - Iris Diagnostics vChem Urine Strips 1 1 - - - McKesson 10SG Reagent Strips 20 20 - - - Other Analyzer Method 2 2 - - - Other Dipstick Method 7 7 - - - PSS Select Reagent Strips 8 8 - - - PSS Select Urine Analyzer 7 7 - - - Roche Chemstrip 101 13 13 - - - Roche Chemstrips 73 73 - - - Roche Criterion Analyzer 21 21 - - - Roche SuperUA/ChemstripUA 2 2 - - - Roche Urisys 44 44 - - - Schein Urispec 7 7 - - - UriScan Reagent Strips 2 2 - - -


URINALYSIS DIPSTICKUROBILINOGEN Specimen UA-2 Participant Results

Method

Labs

0.2/Normal mg/dL

1.0 mg/dL

2.0 mg/dL

4.0 mg/dL

>8.0 mg/dL

ALL METHODS 1031 1023 2 4 2 - Arkray PocketChem UA 1 1 - - - - Bayer Clinitek 10 / 100 28 28 - - - - Bayer Clinitek 200/200+ 1 1 - - - - Bayer Clinitek 50 114 112 - 2 - - Bayer Clinitek 500 15 15 - - - - Bayer Clinitek Advantus 15 15 - - - - Bayer Clinitek Atlas 1 1 - - - - Bayer Clinitek Status / Status+ 317 316 1 - - - Bayer Multistix Pro 2 2 - - - - Bayer Reagent Strips 296 294 1 1 - - Consult Diagnostics Urine Analyzer 7 7 - - - - CTMI CT-120 Urine Analyzer 10 8 - - 2 - Diagnostic Test Group Clarity Urocheck 16 15 - 1 - - Germaine Laboratories AimStrip 2 2 - - - - Hypoguard DiaScreen 8 8 - - - - Iris Diagnostics vChem Urine Strips 1 1 - - - - McKesson 10SG Reagent Strips 9 9 - - - - Other Analyzer Method 2 2 - - - - Other Dipstick Method 7 7 - - - - PSS Select Reagent Strips 8 8 - - - - PSS Select Urine Analyzer 7 7 - - - - Roche Chemstrip 101 13 13 - - - - Roche Chemstrips 71 71 - - - - Roche Criterion Analyzer 21 21 - - - - Roche SuperUA/ChemstripUA 2 2 - - - - Roche Urisys 44 44 - - - - Schein Urispec 7 7 - - - - UriScan Reagent Strips 2 2 - - - -


URINALYSIS DIPSTICKBLOOD/HEMOGLOBIN

Specimen UA-2

Participant Results

Method

Labs

Negative

Trace

Small (5-10 RBC/µL, 1+)

Moderate (50 RBC/µL, 2+)

Large (250 RBC/µL, 3+)

ALL METHODS 1139 1125 13 1 - - Arkray PocketChem UA 1 1 - - - - Bayer Clinitek 10 / 100 30 30 - - - - Bayer Clinitek 200/200+ 1 1 - - - - Bayer Clinitek 50 118 115 3 - - - Bayer Clinitek 500 24 24 - - - - Bayer Clinitek Advantus 17 17 - - - - Bayer Clinitek Atlas 4 4 - - - - Bayer Clinitek Status / Status+ 334 328 5 1 - - Bayer Hemacombistix 1 1 - - - - Bayer Multistix Pro 2 2 - - - - Bayer Reagent Strips 332 329 3 - - - Consult Diagnostics Urine Analyzer 7 7 - - - - CTMI CT-120 Urine Analyzer 10 10 - - - - Diagnostic Test Group Clarity Urocheck 18 18 - - - - Germaine Laboratories AimStrip 2 2 - - - - Hypoguard DiaScreen 11 11 - - - - Iris Diagnostics vChem Urine Strips 1 1 - - - - McKesson 10SG Reagent Strips 20 20 - - - - Other Analyzer Method 2 2 - - - - Other Dipstick Method 7 7 - - - - PSS Select Reagent Strips 9 9 - - - - PSS Select Urine Analyzer 7 7 - - - - Roche Chemstrip 101 13 13 - - - - Roche Chemstrips 87 85 2 - - - Roche Criterion Analyzer 21 21 - - - - Roche SuperUA/ChemstripUA 2 2 - - - - Roche Urisys 45 45 - - - - Schein Urispec 7 7 - - - - UriScan Reagent Strips 2 2 - - - -


URINALYSIS DIPSTICKLEUKOCYTE ESTERASE

Specimen UA-2

Participant Results

Method

Labs

Negative

Trace

Small (1+)

Moderate (2+)

Large (3+)

ALL METHODS 1130 1114 13 1 1 1 Arkray PocketChem UA 1 1 - - - - Bayer Clinitek 10 / 100 30 30 - - - - Bayer Clinitek 200/200+ 1 1 - - - - Bayer Clinitek 50 117 117 - - - - Bayer Clinitek 500 24 24 - - - - Bayer Clinitek Advantus 17 17 - - - - Bayer Clinitek Atlas 4 4 - - - - Bayer Clinitek Status / Status+ 333 332 - 1 - - Bayer Multistix Pro 2 2 - - - - Bayer Reagent Strips 325 317 7 - - 1 Bayer Uristix 3 2 - - 1 - Consult Diagnostics Urine Analyzer 7 7 - - - - CTMI CT-120 Urine Analyzer 10 10 - - - - Diagnostic Test Group Clarity Urocheck 18 17 1 - - - Germaine Laboratories AimStrip 2 2 - - - - Hypoguard DiaScreen 9 8 1 - - - Iris Diagnostics vChem Urine Strips 1 1 - - - - McKesson 10SG Reagent Strips 20 20 - - - - Other Analyzer Method 2 2 - - - - Other Dipstick Method 7 6 1 - - - PSS Select Reagent Strips 9 9 - - - - PSS Select Urine Analyzer 7 7 - - - - Roche Chemstrip 101 13 13 - - - - Roche Chemstrips 87 85 2 - - - Roche Criterion Analyzer 21 21 - - - - Roche SuperUA/ChemstripUA 2 2 - - - - Roche Urisys 45 44 1 - - - Schein Urispec 6 6 - - - - UriScan Reagent Strips 2 2 - - - -


URINALYSIS DIPSTICKNITRITE

Specimen UA-2

Participant Results

Method Labs Positive Negative

ALL METHODS 1123 9 1114 Arkray PocketChem UA 1 - 1 Bayer Clinitek 10 / 100 30 - 30 Bayer Clinitek 200/200+ 1 - 1 Bayer Clinitek 2000 1 - 1 Bayer Clinitek 50 117 2 115 Bayer Clinitek 500 24 - 24 Bayer Clinitek Advantus 17 - 17 Bayer Clinitek Atlas 4 - 4 Bayer Clinitek Status / Status+ 328 1 327 Bayer Multistix Pro 2 - 2 Bayer Reagent Strips 325 1 324 Bayer Uristix 3 1 2 Consult Diagnostics Urine Analyzer 7 - 7 CTMI CT-120 Urine Analyzer 10 - 10 Diagnostic Test Group Clarity Urocheck 18 - 18 Germaine Laboratories AimStrip 2 - 2 Hypoguard DiaScreen 8 - 8 Iris Diagnostics vChem Urine Strips 1 - 1 McKesson 10SG Reagent Strips 20 - 20 Other Analyzer Method 2 - 2 Other Dipstick Method 7 - 7 PSS Select Reagent Strips 9 - 9 PSS Select Urine Analyzer 6 - 6 Roche Chemstrip 101 13 - 13 Roche Chemstrips 87 3 84 Roche Criterion Analyzer 19 - 19 Roche SuperUA/ChemstripUA 2 - 2 Roche Urisys 43 1 42 Schein Urispec 7 - 7 UriScan Reagent Strips 2 - 2


URINALYSIS MICROALBUMIN (dipstick only)

Specimen UA-2

Participant Results

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

ALL METHODS 106 58 45 - 1 2 - - Bayer Clinitek Microalbumin 56 8 45 - 1 2 - - DCL ImmunoDip 1 1 - - - - - - Micro-Bumintest 5 5 - - - - - - Roche Micral - 1 minute 39 39 - - - - - -


URINALYSIS URINE hCG Specimen UA-2 Participant Results

Method Labs Positive Negative

ALL METHODS 602 2 600 Alfa Scientific Instant View 5 - 5 Bayer Clinitek Status / Status+ 3 - 3 Beckman Coulter ICON 25 hCG 43 - 43 Cardinal Health SP Brand combo 26 - 26 Cardinal Hlth SPBrand-cassette 6 - 6 CONSULT diagnostics hCG Cassette 40 - 40 CONSULT diagnostics hCG Combo 14 - 14 CONSULT diagnostics hCG Dipstick 15 - 15 Diagnostic Test Group Clarity hCG Combo 4 - 4 Diagnostic Test Group Clarity hCG strip/cassette 6 - 6 Genzyme OSOM - Urine Test 10 - 10 Genzyme OSOM Card Pregnancy 22 - 22 Genzyme OSOM hCG Combo Test 12 - 12 Germaine Laboratories AimStrip 1 - 1 Henry Schein One Step 36 - 36 Immunostics Cept-D 1 - 1 Immunostics Detector Combi 2 - 2 Immunostics hCG Detector-urine 18 - 18 Inverness Acceava hCG Combo / II 2 - 2 Inverness Acceva hCG-Urine 5 - 5 Inverness Clearview 25 hCG Combo 9 - 9 Inverness Clearview hCG Cassette 12 - 12 Inverness Clearview hCG Combo II 4 - 4 LifeSign Status hCG 2 - 2 McKesson hCG Combo Cassette 17 - 17 McKesson hCG Urine Cassette 23 1 22 McKesson urine hCG - all 20 mIU kits 6 - 6 Meridian ImmunoCard STAT! 1 - 1 NDC Pro Advantage 15 - 15 PEP (Lab Supply) HCG 4 - 4


URINALYSIS URINE hCG cont’d Specimen UA-2 Participant Results Method Labs Positive Negative Permaxim Rediscreen 1 - 1 Polymedco Poly stat hCG 13 - 13 PSS Select hCG Cassette 6 - 6 PSS Select hCG Dipstick 1 - 1 Quidel QuickVue One-Step Combo 48 - 48 Quidel QuickVue One-Step Urine 101 1 100 Quidel QuickVue+ One-Step Combo 24 - 24 Quidel RapidVue 2 - 2 Stanbio QuPID 10 - 10 Stanbio QuPID One-Step Preg. 1 - 1 Stanbio QuPID Plus 2 - 2 Stanbio QuStick 1 - 1 Stanbio TRUE hCG 9 - 9 Sure-Vue hCG - 25mIU 6 - 6 Sure-Vue hCG-STAT 2 - 2


FECAL OCCULT BLOOD

Specimen OC-3 Specimen OC-4

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 520 2 518 518 511 7

Beckman Coulter Hemoccult ICT 44 - 44 44 44 -

Guiac (slide) Test 357 1 356 355 354 1

Hemosure IFOB 49 1 48 49 45 4

Inverness Clearview iFOBT Complete 1 - 1 1 1 -

Other Immunochemical FOB kit 16 - 16 16 15 1

Polymedco OC Auto Micro 80 6 - 6 6 6 -

Polymedco OC-Light iFOB 24 - 24 24 24 -

Quidel QuickVue iFOB 9 - 9 9 9 -

Wampole Clearview Ultra FOBT 3 - 3 3 2 1


URINE SEDIMENT IDENTIFICATION 2011 M2 Urine Sediment ID Specimens US-3 and US-4 CASE HISTORY: A 4-year-old male with a history of recent upper respiratory infections presented to the pediatrician with puffy eyes, hands, and ankles. Upon examination, the patient appeared pale with mild generalized edema. A urine specimen was collected for urinalysis. A large amount of white foam on the surface of the urine was observed. Results appear below. Color = Straw Appearance = Hazy Dipstick results: Specific gravity = 1.030 pH = 6.0 Protein = 4+ Glucose, ketones, bilirubin, urobilinogen, blood, leukocyte esterase, and nitrite = Negative This patient was diagnosed with nephrotic syndrome. Nephrotic syndrome is a result of damage to the glomerular membrane (the part of the kidney that filters the blood), which can occur due to a variety of underlying causes. The injured glomerulus allows larger molecules which would normally be retained in the bloodstream, such as proteins and fats, to pass through into the urine. The nephrotic syndrome is associated with marked proteinuria and high urine specific gravity. Urine specimens are often pale in color and foamy due to the large amount of protein. Blood testing may show decreased serum albumin and increased lipids (cholesterol and triglyceride). When the body cannot replace the lost proteins fast enough, hypoalbuminemia causes fluid to shift from the plasma to the interstitial spaces, causing swelling of the soft tissues. This patient’s results are normal. Specimen US-3


Renal tubular epithelial (RTE) 504 64.86% Acceptable

Identification Unknown - Refer 5 0.64% Acceptable

Transitional epithelial cell 146 18.79%

White Blood Cell (WBC) 53 6.82%

RTE with fat globules 39 5.02%

Squamous epithelail 21 2.70%

The arrows in this photograph point to renal tubular epithelial cells. Epithelial cells line the urinary tract. There are three types of epithelial cells that may be seen in the urine sediment. Renal tubular epithelial cells (RTEs) are the most clinically significant because they originate in the tubules inside the kidney. Transitional epithelial cells (TEs) line the urinary tract from the kidney to the upper urethra, and squamous epithelial cells (SECs) line the lower urethra. Morphology varies depending on the cell‟s site of origin along the urinary tract. Many participants mistakenly identified this challenge as transitional epithelial cells. An identifying feature of some RTEs is their cuboidal or columnar shape, which means they have at least one flat side, like the arrowed cell on the left. TEs, though usually round, may be pear shaped or have tail-like projections, but they do not have flat sides like RTEs. However, RTEs also appear rounded, like the pair of arrowed cells on the right, making them more difficult to distinguish from TEs. The main differences between RTEs and TEs are cell size and N:C ratio (amount of nucleus vs. amount of cytoplasm). Let‟s compare the rounded pair of RTEs arrowed in this photo with the transitional epithelial cells in the next photo (US-4, upper left). First, compare their sizes- RTEs are smaller than TEs. RTEs are slightly larger than white blood cells (WBCs), while TEs are 2-4 times as large as WBCs. The N:C ratio is higher in RTEs than in TEs. The RTE nucleus takes up more space than the cytoplasm does. The TE nucleus appears much smaller relative to the rest of the cell due to the TE‟s tendency to absorb water and swell. To view another photo of RTEs, see 2008 M3 Specimen US-5. To view a photo of transitional epithelial cells, see 2006 M3 Specimen US-6. This specimen was graded by 80% referee consensus. .


URINE SEDIMENT IDENTIFICATION cont’d Specimen US-4


Fatty Cast 205 26.45% Acceptable

Identification Unknown - Refer 11 1.42% Acceptable

Cellular (WBC) Cast 247 31.87%

Cellular (RTE) cast 156 20.13%

RBC/blood/hgb cast 119 15.35%

Granular cast 25 3.23%

The arrow in this photograph points to a fatty cast. Fat in the urine is a pathologic finding indicating severe renal dysfunction. Lipids can appear in the urine sediment as free fat droplets/globules, fat within cells, or fat within casts. Fat is frequently found in the nephrotic syndrome and may be found in many other conditions affecting the renal tubules. Besides massive proteinuria, the nephrotic syndrome is associated with the finding of fat, fatty casts, and oval fat bodies in the sediment. Fat globules vary greatly in size, as you can see in this cast and in the field surrounding the cast. Fatty casts may contain only a few fat droplets, or like the one pictured here, may be composed almost entirely of fat droplets of various sizes. Fatty casts and free fat droplets/globules may have a yellow-brown color. Some urine specimens containing fat may have visible fat globules floating on the surface and a brownish sediment. Many participants mistakenly identified this challenge as a cellular cast. Small fat droplets can resemble cells due to their spherical shape, however, fat droplets exhibit wide variation in size and shape, while cells are generally uniform in size and shape. Fat droplets often resemble bubbles- highly refractile, spherical, and transparent. Red blood cells usually have an innertube- or doughnut-like appearance due to their flattened biconcave shape. White blood cells should have visible nuclei. Renal epithelial cells are large, often cuboidal in shape, and contain large nuclei. To view a photo of fat droplets, see 2007 M3 Specimen US-6. To view a photo of a WBC cast, see 2006 M2 Specimen US-3. This specimen was graded by 80% referee consensus. References: Haber, M.H.: Urinary Sediment: A Textbook Atlas. Chicago, American Society of Clinical Pathologists, 1981. 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. Shankland, S. J. “Glomerular Diseases.” ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., 2004. 2004.


PROVIDER-PERFORMED MICROSCOPY (PPM) Wet Mount Preparation

Specimen PPM-7


Trichomonas vaginalis 588 95.61% Acceptable

Spermatozoa 21 3.41%

The arrows in this photograph of a vaginal wet prep point to trichomonas. . KOH Preparation Specimen PPM-8


Yeast/fungal elements absent 464 77.46% Acceptable

Yeast/fungal elements present 135 22.54%

Yeast and fungal elements are absent in this photograph of a vaginal KOH prep. The small cells scattered throughout the field are bacteria. Although some of the bacteria are rounded like yeast, they are too small relative to the epithelial cells in the photo. To view a photo of a positive KOH prep, see 2009 M2 Specimen PPM-8. This specimen was graded by 89% referee consensus.


PROVIDER-PERFORMED MICROSCOPY (PPM) Sperm Identification Specimen PPM-9


Sperm absent 593 99.00% Acceptable

Sperm present 6 1.00%

Sperm are absent in this photograph of a vaginal wet mount prep. Nasal Smear Specimen PPM-10


Eosinophils absent 181 90.05% Acceptable

Eosinophils present 20 9.95%

Eosinophils are absent in this photograph of Wright-stained nasal mucus. The leukocytes in this photo do not have the red-orange color characteristic of eosinophils, which comes from the orange dye eosin. To view a photo of eosinophils, see 2009 M2 Specimen PPM-10.


PROVIDER-PERFORMED MICROSCOPY (PPM) Fecal Leukocytes Specimen PPM-11


Leukocytes are present 210 99.53% Acceptable

Leukocytes are absent 1 0.47

Many white blood cells are present in this photograph of a Wright-stained stool preparation. Pinworm Preparation Specimen PPM-12


Pinworms/eggs absent 236 98.33% Acceptable

Pinworms/eggs present 4 1.67%

Pinworm eggs are absent in this photograph of a perianal pinworm prep.

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