M E D I C A L L A B O R A T O R Y
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- Magnus Stevenson
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1 M E D I C A L L A B O R A T O R Y E V A L U A T I O N PARTICIPANT SUMMARY Hematology, Coagulation, Blood Bank, Urinalysis, PPM MLE-M1 Total Commitment to Education and Service Provided by ACP, Inc.
2 Table of Contents Evaluation Criteria... 5 Hematology HemoCue... 6 Hemoglobin... 6 Glucose... 6 Sedimentation Rate... 6 Hematology with 5-part Automated Differential (CL Samples)... 7 White Blood Cell Count... 7 Red Blood Cell Count... 7 Hemoglobin... 8 Hematocrit... 8 Platelet Count... 9 Automated Differential... 9 Sysmex Hematology with 3-part Automated Differential (SYX Samples) White Blood Cell Count Red Blood Cell Count Hemoglobin Hematocrit Platelet Count Automated Differential Basic Hematology with 3-part Automated Differential (HD Samples) White Blood Cell Count Red Blood Cell Count Hemoglobin Hematocrit Platelet Count Automated Differential Hematology with 5-part Automated Differential (DIF Samples) White Blood Cell Count Red Blood Cell Count Hemoglobin Hematocrit Platelet Count Automated Differential QBC Hematology (QBC Samples) Hematocrit Hemoglobin White Blood Cell Count Platelet Count Automated Differential Reticulocyte Count 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.
3 Hematology (cont d) Table of Contents (cont d) Hematology with 5-part Automated Differential (BCX Samples) White Blood Cell Count Red Blood Cell Count Hemoglobin Hematocrit Platelet Count Automated Differential Hematology with 5-part Automated Differential (MX Samples) White Blood Cell Count Red Blood Cell Count Hemoglobin Hematocrit Platelet Count Automated Differential Waived Hematology Hemoglobin Hematocrit Blood Cell Identification Blood Bank ABO Group Rh Factor (D Type) Rh Factor (Slide Method) Unexpected Antibody Detection Antibody Identification Compatibility Testing Coagulation Prothrombin Time International Normalized Ratio (INR) Activated Partial Thromboplastin Time Fibrinogen CoaguChek XS Plus Prothrombin Time International Normalized Ratio (INR) ITC Protime Microcoagulation System Prothrombin Time International Normalized Ratio (INR) i-stat Prothrombin Time International Normalized Ratio (INR) CoaguChek XS INR Fluid Cell Count/Crystals WBC Count RBC Count Crystal Identification MLE-M1 Participant Summary/ 3
4 Urinalysis Table of Contents (cont d) Microalbumin, Urine Dipstick Quantitative Creatinine, Urine Dipstick Quantitative Urinalysis Dipstick Specific Gravity ph Protein Glucose Ketones Bilirubin Urobilinogen Blood or Hemoglobin Leukocyte Esterase Nitrite Microalbumin (Dipstick Only) Urine hcg Fecal Occult Blood KOH Skin Preparation Urine Sediment Identification Provider-Performed Microscopy (PPM) Provider-Performed Microscopy (PPM) / 2014 MLE-M1 Participant Summary
5 EVALUATION CRITERIA The evaluation criteria used in the MLE Program is in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) federal requirements for proficiency testing. The criteria are included below. Qualitative For qualitative procedures, evaluation is based on participant or referee consensus. If participant consensus is not reached, CMS requirements call for grading by referee consensus. A minimum percentage of participants or referee laboratories must receive a passing score or the challenge is not evaluated due to lack of consensus. These percentages are listed below. Crystal Identification Blood Cell Identification Urine Dipstick Urine hcg Microalbumin (Semi-Quantitative) Fecal Occult Blood Urine Sediment Identification Provider-Performed Microscopy KOH Skin Preparation ABO Group Rh Factor (D Type) Unexpected Antibody Detection Antibody Identification Compatibility Testing 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 80% Consensus 95% Consensus 95% Consensus 95% Consensus 95% Consensus 95% Consensus Quantitative For quantitative procedures, a mean and standard deviation (SD) are calculated for each peer group consisting of 10 or more laboratories except for QBC Hematology and Coagulation (CG Specimens) which consist of peer groups of 5 or more laboratories. Acceptable performance is established on a target value the intervals below. An explanation on how to calculate the range of acceptability based upon these limits is also provided in your MLE Program Guide on page 37 under the heading Acceptable Ranges for Quantitative Results. Hemoglobin 7% Hemoglogin, Waived 7% Hematocrit 6% Hematocrit, Waived 6% or 2 SD* White Blood Cell Count 15% Red Blood Cell Count 6% Platelet Count 25% Automated Differential 3 SD Body Fluid - White Cell Count 2 SD Body Fluid - Red Cell Count 2 SD Sedimentation Rate 3 SD Prothrombin Time 15% International Normalized Ratio (INR) 20% Activated Partial Thromboplastin Time 15% Fibrinogen 20% Specific Gravity Reticulocyte Count 3 SD Whole Blood Glucose HemoCue 12 mg/dl or 20%* Microalbumin (Quantitative) 3 SD Creatinine, Urine (Quantitative) 3 SD *Whichever is greater 2014 MLE-M1 Participant Summary/ 5
6 HEMOCUE HEMATOLOGY HEMOGLOBIN (g/dl) Specimen HQ-1 Specimen HQ-2 HemoCue HEMOCUE HEMATOLOGY GLUCOSE (mg/dl) Specimen HQ-1 Specimen HQ-2 All Method HemoCue Glucose 201/ SEDIMENTATION RATE (MM/HR) Specimen ES-1 Specimen ES-2 All Method All HiChem Methods All Vital Diagnostics Methods HiChem Mini-Ves Polymedco Sedimat Streck ESR-Auto Plus Vital Diagnostics Excyte M/ Westergren - diluted Westergren - undiluted SEDIMAT SEDIMENTATION RATE (MM/HR) Specimen MAT-1 Specimen MAT-2 Polymedco Sedimat / 2014 MLE-M1 Participant Summary
7 HEMATOLOGY W/ 5-PART DIFFERENTIAL WHITE BLOOD CELL COUNT (x K/uL) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby HEMATOLOGY W/ 5-PART DIFFERENTIAL RED BLOOD CELL COUNT (x M/uL) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby MLE-M1 Participant Summary/ 7
8 HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMOGLOBIN (g/dl) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMATOCRIT (percent) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby / 2014 MLE-M1 Participant Summary
9 HEMATOLOGY W/ 5-PART DIFFERENTIAL PLATELET COUNT (x K/uL) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby HEMATOLOGY W/ 5-PART DIFFERENTIAL NEUTROPHILS (percent) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby MLE-M1 Participant Summary/ 9
10 HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby / 2014 MLE-M1 Participant Summary
11 HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent) Specimen CL-1 Specimen CL-2 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-3 Specimen CL-4 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby Specimen CL-5 All Method All Abbott Cell-Dyn Instruments Abbott Cell-Dyn Abbott Cell-Dyn Ruby MLE-M1 Participant Summary/ 11
12 SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL WHITE BLOOD CELL COUNT (x 10 9 /L) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL RED BLOOD CELL COUNT (x /L) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i / 2014 MLE-M1 Participant Summary
13 SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL HEMOGLOBIN (g/dl) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL HEMATOCRIT (percent) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i MLE-M1 Participant Summary/ 13
14 SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL PLATELET COUNT (x10 9 /L) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL LYMPH W/SCR (percent) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i / 2014 MLE-M1 Participant Summary
15 SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL MONO/MIXED W/MCR (percent) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIAL NEUT W/LCR (percent) Specimen SYX-1 Specimen SYX-2 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-3 Specimen SYX-4 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i Specimen SYX-5 All Method All Sysmex Instruments Sysmex KX-21N & K - 800,1000, Sysmex poch-100i MLE-M1 Participant Summary/ 15
16 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL WHITE BLOOD CELL COUNT (x 10 9 /L) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D / 2014 MLE-M1 Participant Summary
17 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL WHITE BLOOD CELL COUNT (x 10 9 /L) cont d Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL RED BLOOD CELL COUNT (x /L) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D MLE-M1 Participant Summary/ 17
18 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL RED BLOOD CELL COUNT (x /L) cont d Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D Specimen HD-5 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D / 2014 MLE-M1 Participant Summary
19 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL HEMOGLOBIN (g/dl) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D MLE-M1 Participant Summary/ 19
20 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL HEMOGLOBIN (g/dl) cont d Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL HEMATOCRIT (percent) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D / 2014 MLE-M1 Participant Summary
21 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL HEMATOCRIT (percent) cont d Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D Specimen HD-5 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D MLE-M1 Participant Summary/ 21
22 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL PLATELET COUNT (x 10 9 /L) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D / 2014 MLE-M1 Participant Summary
23 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL PLATELET COUNT (x 10 9 /L) cont d Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT 8/ COULTER AcT diff/diff Drew Scientific D BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL LYMPHOCYTES (percent) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D MLE-M1 Participant Summary/ 23
24 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL LYMPHOCYTES (percent) cont d Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D Specimen HD-5 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D / 2014 MLE-M1 Participant Summary
25 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL MONO/MID/MIXED/MCR (percent) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D MLE-M1 Participant Summary/ 25
26 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL MONO/MID/MIXED/MCR (percent) cont d Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL GRANULOCYTES/NEUT (percent) Specimen HD-1 Specimen HD-2 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D / 2014 MLE-M1 Participant Summary
27 BASIC HEMATOLOGY W/ 3-PART DIFFERENTIAL GRANULOCYTES/NEUT (percent) cont d Specimen HD-3 Specimen HD-4 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D Specimen HD-5 All Method All Abbott Cell-Dyn Instruments All ABX Instruments All COULTER Instruments All Danam/Drew Scientific Instruments Abbott Cell-Dyn Abbott Cell-Dyn Abbott Cell-Dyn Emerald ABX Diagnostics Micros/45/ Boule Medonic CA Boule Medonic M series COULTER AcT diff/diff Drew Scientific D MLE-M1 Participant Summary/ 27
28 HEMATOLOGY W/ 5-PART DIFFERENTIAL WHITE BLOOD CELL COUNT (x 10 9 /L) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments HEMATOLOGY W/ 5-PART DIFFERENTIAL RED BLOOD CELL COUNT (x /L) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments / 2014 MLE-M1 Participant Summary
29 HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMOGLOBIN (g/dl) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMATOCRIT (percent) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments MLE-M1 Participant Summary/ 29
30 HEMATOLOGY W/ 5-PART DIFFERENTIAL PLATELET COUNT (x 10 9 /L) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments HEMATOLOGY W/ 5-PART DIFFERENTIAL NEUTROPHILS (percent) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments / 2014 MLE-M1 Participant Summary
31 HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments MLE-M1 Participant Summary/ 31
32 HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent) Specimen DIF-1 Specimen DIF-2 All Method All COULTER Instruments Specimen DIF-3 Specimen DIF-4 All Method All COULTER Instruments Specimen DIF-5 All Method All COULTER Instruments / 2014 MLE-M1 Participant Summary
33 QBC HEMATOLOGY HEMATOCRIT (percent) Specimen QBC-1 Specimen QBC-2 All Method Specimen QBC-3 Specimen QBC-4 All Method Specimen QBC-5 All Method QBC HEMATOLOGY HEMOGLOBIN (g/dl) Specimen QBC-1 Specimen QBC-2 All Method Specimen QBC-3 Specimen QBC-4 All Method Specimen QBC-5 All Method MLE-M1 Participant Summary/ 33
34 QBC HEMATOLOGY WHITE BLOOD CELL COUNT (x 10 9 /L) Specimen QBC-1 Specimen QBC-2 All Method Specimen QBC-3 Specimen QBC-4 All Method Specimen QBC-5 All Method QBC HEMATOLOGY PLATELET COUNT (x 10 9 /L) Specimen QBC-1 Specimen QBC-2 All Method Specimen QBC-3 Specimen QBC-4 All Method Specimen QBC-5 All Method / 2014 MLE-M1 Participant Summary
35 QBC HEMATOLOGY GRANULOCYTES (x 10 9 /L) Specimen QBC-1 Specimen QBC-2 All Method Specimen QBC-3 Specimen QBC-4 All Method Specimen QBC-5 All Method QBC HEMATOLOGY LYMPHS/MONO (x 10 9 /L) Specimen QBC-1 Specimen QBC-2 All Method Specimen QBC-3 Specimen QBC-4 All Method Specimen QBC-5 All Method MLE-M1 Participant Summary/ 35
36 RETICULOCYTE COUNT (percent) Specimen RT-1 Specimen RT-2 All Method All Automated Methods All Manual Methods Manual-New Methylen Blue Stain HEMATOLOGY W/ 5-PART DIFFERENTIAL WHITE BLOOD CELL COUNT (x 10 9 /L) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) / 2014 MLE-M1 Participant Summary
37 HEMATOLOGY W/ 5-PART DIFFERENTIAL RED BLOOD CELL COUNT (x /L) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) MLE-M1 Participant Summary/ 37
38 HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMOGLOBIN (g/dl) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) / 2014 MLE-M1 Participant Summary
39 HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMATOCRIT (percent) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) MLE-M1 Participant Summary/ 39
40 HEMATOLOGY W/ 5-PART DIFFERENTIAL PLATELET COUNT (x 10 9 /L) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) / 2014 MLE-M1 Participant Summary
41 HEMATOLOGY W/ 5-PART DIFFERENTIAL NEUTROPHILS (percent) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) MLE-M1 Participant Summary/ 41
42 HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) / 2014 MLE-M1 Participant Summary
43 HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) MLE-M1 Participant Summary/ 43
44 HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) / 2014 MLE-M1 Participant Summary
45 HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent) Specimen BCX-1 Specimen BCX-2 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-3 Specimen BCX-4 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) Specimen BCX-5 All Method All ABX Instruments All COULTER Instruments ABX Diagnostics Pentra 60C+ (version 2.21 and up) ABX Diagnostics Pentra 80 / XL COULTER AcT 5diff (version 2.01) MLE-M1 Participant Summary/ 45
46 HEMATOLOGY W/ 5-PART DIFFERENTIAL WHITE BLOOD CELL COUNT (x 10 9 /L) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i HEMATOLOGY W/ 5-PART DIFFERENTIAL RED BLOOD CELL COUNT (x /L) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i / 2014 MLE-M1 Participant Summary
47 HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMOGLOBIN (g/dl) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i HEMATOLOGY W/ 5-PART DIFFERENTIAL HEMATOCRIT (percent) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i MLE-M1 Participant Summary/ 47
48 HEMATOLOGY W/ 5-PART DIFFERENTIAL PLATELET COUNT (x 10 9 /L) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i HEMATOLOGY W/ 5-PART DIFFERENTIAL NEUTROPHILS (percent) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i / 2014 MLE-M1 Participant Summary
49 HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i MLE-M1 Participant Summary/ 49
50 HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent) Specimen MX-1 Specimen MX-2 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex Instruments Sysmex XS-1000i HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent) Specimen MX-1 Specimen MX-2 All Method All Sysmex XS/XN Instruments All Sysmex XT/XE Instruments Sysmex XS-1000i Specimen MX-3 Specimen MX-4 All Method All Sysmex XS/XN Instruments All Sysmex XT/XE Instruments Sysmex XS-1000i Specimen MX-5 All Method All Sysmex XS/XN Instruments All Sysmex XT/XE Instruments Sysmex XS-1000i / 2014 MLE-M1 Participant Summary
51 2014 M1 Specimens BC-1 through BC-6 Case History: A 26-year-old male presented for his first physical. He reported that he recently began an exercise program to overcome his life-long feelings of weakness and chronic fatigue. However, he was unable to make any progress toward his goal of physical fitness due to having dizzy spells whenever he tried to exert himself. Upon examination, the patient appeared pale, his pulse was elevated, and the physician heard a slight heart murmur. A CBC was performed, and the results appear below. Test Results Reference Range WBC 8.5 x 10 9 /L x 10 9 /L RBC 4.84 x /L x /L HGB 10.4 g/dl g/dl HCT 35.0 % % PLT 360 x 10 9 /L x 10 9 /L MCV 72 fl fl MCH 21 pg pg MCHC 30 g/dl g/dl RDW 16 % % This patient was diagnosed with hereditary sideroblastic anemia. Sideroblastic anemias are a group of hereditary and acquired disorders of heme synthesis. Heme is the red, ironcontaining portion of the hemoglobin molecule that carries oxygen. In the hereditary form, a genetic mutation disrupts the insertion of iron into developing heme molecules, which prevents red blood cells from making enough hemoglobin. This leads to a buildup of iron that would normally have been incorporated into hemoglobin. The body attempts to compensate for the low hemoglobin by absorbing even more iron from the diet. Serum iron and transferrin levels increase. Over time, severe complications such as heart disease and liver damage can evolve from the buildup of excess iron deposits in these organs. Signs and symptoms of hereditary sideroblastic anemia tend to appear in young adulthood, and result from a combination of low hemoglobin and iron overload. They include fatigue, dizziness, rapid heartbeat, pale skin, and enlarged liver and spleen. Disorders of iron metabolism often cause microcytic, hypochromic anemias. The peripheral smear of a patient with sideroblastic anemia may include distorted red blood cells, schistocytes, target cells, spherocytes, and basophilic stippling. A diagnostic feature of this disease is the presence of ringed sideroblasts (red cells containing iron deposits) on bone marrow smears stained with Prussian Blue MLE-M1 Participant Summary/ 51
52 BLOOD CELL IDENTIFICATION Specimen BC-1 Identification Labs Percent Performance Basophilic stippling % Acceptable The arrows in this photograph point to erythrocytes with basophilic stippling. These immature red blood cells have expelled their nuclei but still contain some residual RNA. The RNA is aggregated into small granular clumps that stain dark blue-purple. The clumps are evenly distributed throughout the cell, and may appear fine (smaller) or coarse (larger). Basophilic stippling is associated with increased RBC production, defective heme synthesis, anemia, thalassemia, and lead poisoning. These cells would be called reticulocytes only when examined with a supravital stain such as New Methylene Blue. To view another photo of basophilic stippling, see 2012 M3 Specimen BC-17. Specimen BC-2 Identification Labs Percent Performance Lymphocyte, reactive % Acceptable Immature/abnormal cell refer % Acceptable Monocyte % Lymphocyte % The arrow in this photograph points to a reactive lymphocyte. Reactive lymphs appear in a wide variety of forms, sizes and shapes. These large atypical lymphocytes are reacting to immune stimuli in the body. They are often increased in viral infections such as infectious mononucleosis. The cytoplasm is light blue, with peripheral basophilia- a deeper blue color at the extreme border. The edges of the cytoplasm tend to flow around the adjacent red blood cells. The nucleus is large, appearing slightly elongated or stretched. Some participants incorrectly identified this cell as a monocyte. Monocytes often appear to push away adjacent red cells with their cytoplasm, and lack the dark blue periphery that is typical of lymphocytes. To view another photo of a reactive lymphocyte, see 2013 M3 Specimen BC-14. To view a monocyte, see 2013 M1 Specimen BC / 2014 MLE-M1 Participant Summary
53 BLOOD CELL IDENTIFICATION Specimen BC-3 Identification Labs Percent Performance Hypochromic red cell % Acceptable Macrocyte % The arrows in this photograph point to hypochromic erythrocytes. A red blood cell is considered hypochromic when the zone of central pallor covers more than one-third of the diameter of the cell (or >3μm.) In normochromic (normal-colored) RBCs, the zone of central pallor comprises one-third or less of the total diameter of the cell. Hypochromic cells have more central pallor than a normal RBC due to lower concentration of hemoglobin. A decreased MCHC value is often associated with marked hypochromia. Specimen BC-4 Identification Labs Percent Performance Neutrophil-Segmented or band % Acceptable Hypersegmented neutrophil % The arrow in this photograph points to a segmented neutrophil. The cytoplasm of these normal cells is pale pink and filled with fine, violet-pink granules. The nucleus of the cell is divided into two to five segments, or lobes, connected by a thin thread-like filament. This filament connecting the segments must be visible to classify the cell as segmented. To view another photo of a normal seg, see 2013 M1 Specimen BC MLE-M1 Participant Summary/ 53
54 BLOOD CELL IDENTIFICATION Specimen BC-5 Identification Labs Percent Performance Microcyte % Acceptable Erythrocyte, normal % The arrows in this photograph point to microcytes. These small red blood cells have the same color, morphology, and central pallor as the normal RBCs in the field, but are simply smaller in size. The nucleus of a mature, resting lymphocyte such as the one in this photo is a good reference for estimating the size of red blood cells. A normal RBC will be approximately the same size as the lymph s nucleus. To view another photo of microcytes, see 2011 M3 BC-17. To view normal erythrocytes, see 2013 M1 specimen BC-2. Specimen BC-6 Identification Labs Percent Performance Pappenheimer body % Not graded Educational Challenge Howell-Jolly body % Immature/abnormal cell refer % Heinz body % The arrows in this ungraded educational challenge point to erythrocytes containing Pappenheimer bodies. Any condition that disturbs hemoglobin synthesis can cause Pappenheimer bodies. These red cell inclusions are small, blue, angular, irregular in size and shape, and tend to aggregate in small clusters near the edge of the cell. The cells would be called siderocytes when viewed with Prussian Blue staining, which would confirm that these particles contain iron. Howell-Jolly bodies are spherical and larger than Pappenheimer bodies. Heinz bodies are not visible in Wright-stained smears. To view another photo of Pappenheimer bodies, see 2009 M2 Specimen BC-11. References: Carr, J.H., Rodak, B.F.: Clinical Hematology Atlas, 3 rd ed. Saunders, St. Louis, Henderson, L. H.: The POL Microscopy Atlas. 2 nd ed. American Academy of Family Physicians, Leawood KS, O Connor, B. H.: A Color Atlas and Instruction Manual of Peripheral Blood Cell Morphology. Williams & Wilkins, Baltimore MD, Rodak, B. F.: Hematology: Clinical Principles and Applications. 3 rd ed. W. B. Saunders, Philadelphia, Schrier, S. L. Anemia: Production Defects. ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., X-linked Sideroblastic Anemia. (Reviewed April 2009) Genetics Home Reference. US National Library of Medicine. Web. Accessed Jan. 23, Available at: 54 / 2014 MLE-M1 Participant Summary
55 BLOOD BANK ABO GROUP Specimen Results Labs Percent Performance BB-1 Group B 7 100% Acceptable BB-2 Group AB 7 100% Acceptable BB-3 Group A 7 100% Acceptable BB-4 Group A 7 100% Acceptable BB-5 Group O 7 100% Acceptable RH FACTOR (D TYPE) Specimen Results Labs Percent Performance BB-1 Rh Negative % Acceptable BB-2 Rh Positive % Acceptable BB-3 Rh Positive % Acceptable BB-4 Rh Negative % Acceptable BB-5 Rh Positive % Acceptable UNEXPECTED ANTIBODY DETECTION Specimen Results Labs Percent Performance AB-1 Unexpected antibody detected 7 100% Acceptable AB-2 Unexpected antibody detected 7 100% Acceptable AB-3 No unexpected antibody detected 7 100% Acceptable AB-4 No unexpected antibody detected 7 100% Acceptable AB-5 No unexpected antibody detected 7 100% Acceptable 2014 MLE-M1 Participant Summary/ 55
56 BLOOD BANK ANTIBODY IDENTIFICATION Specimen Results Labs Percent Performance AB-1 Anti-Fy a 1 100% Acceptable AB-2 Anti-k 1 100% Acceptable AB-3 No antibody detected 1 100% Acceptable AB-4 No antibody detected 1 100% Acceptable AB-5 No antibody detected 1 100% Acceptable COMPATIBILITY TESTING Specimen Results Labs Percent Performance AB-1 Not Compatible 5 100% Acceptable AB-2 Compatible 5 100% Acceptable AB-3 Compatible 5 100% Acceptable AB-4 Compatible 5 100% Acceptable AB-5 Compatible 5 100% Acceptable 56 / 2014 MLE-M1 Participant Summary
57 PROTHROMBIN TIME (seconds) Specimen CG-1 Specimen CG-2 Reagent/ All Method Dade Innovin Dade Behring BFT II Other Instrument Specified Sysmex CA-500/600 series All Coagulation Instruments IL TEST PT Fibrinogen IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments Specimen CG-3 Specimen CG-4 All Method Dade Innovin Dade Behring BFT II Other Instrument Specified Sysmex CA-500/600 series All Coagulation Instruments IL TEST PT Fibrinogen IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments Specimen CG-5 All Method Dade Innovin Dade Behring BFT II Other Instrument Specified Sysmex CA-500/600 series All Coagulation Instruments IL TEST PT Fibrinogen IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments MLE-M1 Participant Summary/ 57
58 PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen CG-1 Specimen CG-2 Reagent/ All Method Dade Innovin Dade Behring BFT II Other Instrument Specified Sysmex CA-500/600 series All Coagulation Instruments IL TEST PT Fibrinogen IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments Specimen CG-3 Specimen CG-4 All Method Dade Innovin Dade Behring BFT II Other Instrument Specified Sysmex CA-500/600 series All Coagulation Instruments IL TEST PT Fibrinogen IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments Specimen CG-5 All Method Dade Innovin Dade Behring BFT II Other Instrument Specified Sysmex CA-500/600 series All Coagulation Instruments IL TEST PT Fibrinogen IL ACL, all models PH/CMS Thromboplastin-D All Coagulation Instruments / 2014 MLE-M1 Participant Summary
59 ACTIVATED PARTIAL THROMBOPLASTIN (seconds) Specimen CG-1 Specimen CG-2 Reagent/ All Method Dade Actin FSL Sysmex CA-500/600 series All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Specimen CG-3 Specimen CG-4 All Method Dade Actin FSL Sysmex CA-500/600 series All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Specimen CG-5 All Method Dade Actin FSL Sysmex CA-500/600 series All Coagulation Instruments IL TEST APTT-SP IL ACL, all models Fibrinogen (mg/dl) One participant reported Fibrinogen. The vendor assay values for specimens CG-1 through CG-5 are: 262 mg/dl, 595 mg/dl, 95 mg/dl, 320 mg/dl and 293 mg/dl respectively. RH FACTOR (Slide Method) Specimen Results Labs Percent Performance RH-1 Rh Negative 2 100% Acceptable RH-2 Rh Positive 2 100% Acceptable RH-3 Rh Positive 2 100% Acceptable RH-4 Rh Negative 2 100% Acceptable RH-5 Rh Negative 2 100% Acceptable 2014 MLE-M1 Participant Summary/ 59
60 COAGUCHEK XS PLUS PROTHROMBIN TIME (seconds) Specimen XS-1 Specimen XS-2 All Method Roche CoaguChek XS Plus Specimen XS-3 Specimen XS-4 All Method Roche CoaguChek XS Plus Specimen XS-5 All Method Roche CoaguChek XS Plus COAGUCHEK XS PLUS PROTHROMBIN TIME INTERNATIONAL NORMALIZED RATIO (INR) Specimen XS-1 Specimen XS-2 All Method Roche CoaguChek XS Plus Specimen XS-3 Specimen XS-4 All Method Roche CoaguChek XS Plus Specimen XS-5 All Method Roche CoaguChek XS Plus ITC PROTIME MICROCOAGULATION SYSTEM PROTHROMBIN TIME (seconds) Specimen IT-1 Specimen IT-2 All Method Not graded Not graded ITC PROTIME MICROCOAGULATION SYSTEM INTERNATIONAL NORMALIZED RATIO (INR) Specimen IT-1 Specimen IT-2 All Method Not graded Not graded 60 / 2014 MLE-M1 Participant Summary
61 i-stat PROTHROMBIN TIME (seconds) Specimen PTI-1 Specimen PTI-2 i-stat Prothrombin Time Specimen PTI-3 Specimen PTI-4 i-stat Prothrombin Time Specimen PTI-5 i-stat Prothrombin Time i-stat PROTHROMBIN TIME - INTERNATIONAL NORMALIZED RATIO (INR) Specimen PTI-1 Specimen PTI-2 i-stat Prothrombin Time Specimen PTI-3 Specimen PTI-4 i-stat Prothrombin Time Specimen PTI-5 i-stat Prothrombin Time MLE-M1 Participant Summary/ 61
62 FLUID CELL COUNT/CRYSTALS WHITE BLOOD CELL COUNT (ul) Specimen BF-1 Specimen BF-2 All Method FLUID CELL COUNT/CRYSTALS RED BLOOD CELL COUNT (ul) Specimen BF-1 Specimen BF-2 All Method FLUID CELL COUNT/CRYSTALS CRYSTAL IDENTIFCATION Specimen Identification Labs Percent Performance BF-1 CPPD Crystals % Ungraded Other, not listed % Cholesterol crystals % No crystals observed % Calcium Oxalate crystals % BF-1 is an ungraded challenge due to no referee group found. BF-2 MSU (Monosodium Urate) % Acceptable CPPD Crystals % 62 / 2014 MLE-M1 Participant Summary
63 MICROALBUMIN, DIPSTICK Specimen UM-1 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 Bayer Clinitek Microalbumin Roche Micral - 1 minute CREATININE, DIPSTICK Specimen UM-1 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 Bayer Clinitek Microalbumin Bayer Multistix Pro MLE-M1 Participant Summary/ 63
64 MICROALBUMIN, QUANTITATIVE Specimen UM-1 Method Labs Mean SD CV Median Range All Method Axis-Shield Afinion AS Beckman AU Siemens DCA Vantage Siemens Dimension/AR/ES/RxL/Xpand CREATININE, URINE (mg/dl) Specimen UM-1 Method Labs Mean SD CV Median Range All Method Axis-Shield Afinion AS Beckman AU Siemens DCA Vantage Siemens Dimension/AR/ES/RxL/Xpand WAIVED HEMATOLOGY HEMOGLOBIN (g/dl) Specimen HD-1 Specimen HD-2 All Method All Stanbio Methods HemoCue Stanbio HemoPoint H WAIVED HEMATOLOGY HEMATOCRIT (percent) Specimen HD-1 Specimen HD-2 All Method / 2014 MLE-M1 Participant Summary
65 KOH SKIN PREPARATION Specimen Identification Labs Percent Performance K-1 Yeast/fungal elements absent % Acceptable Yeast/fungal elements present % Organism present in specimen K-1: Staphylococcus epidermidis. K-2 Yeast/fungal elements present % Acceptable Yeast/fungal elements absent % Organism present in specimen K-2: Microsporum gypsum. COAGUCHECK XS - INTERNATIONAL NORMALIZED RATIO (INR) Specimen INX-1 Specimen INX-2 Roche CoaguChek XS MLE-M1 Participant Summary/ 65
66 URINALYSIS DIPSTICK SPECIFIC GRAVITY Specimen UA-1 Method Labs Mean SD CV Median Range All Method All Bayer Instruments All Roche Instruments Bayer Clinitek 10 / Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Status / Status Bayer Reagent Strips Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Other Dipstick Method Roche Chemstrip Roche Chemstrips Roche Criterion Analyzer Roche Urisys / 2014 MLE-M1 Participant Summary
67 URINALYSIS DIPSTICK ph Specimen UA-1 Method Labs 3.5 or less Participant Results ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Hemacombistix Bayer Reagent Strips Bayer Uristix Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method ph Paper PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips MLE-M1 Participant Summary/ 67
68 URINALYSIS DIPSTICK PROTEIN QUALITATIVE Specimen UA-1 Participant Results Method Labs Negative Trace 30 mg/dl (1+) 100 mg/dl (2+) mg/dl (3+) >300 mg/dl >1000 mg/dl (4+) ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Albustix Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Hemacombistix Bayer Reagent Strips Bayer Uristix Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec Sulfosalicylic Acid UriScan Reagent Strips / 2014 MLE-M1 Participant Summary
69 URINALYSIS DIPSTICK GLUCOSE Specimen UA-1 Method Labs Negative mg/dl (Trace) Participant Results 150 mg/dl 250 mg/dl 500 mg/dl 1000 mg/dl >1000 mg/dl >2000 mg/dl ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Clinitest, 5 drop Bayer Hemacombistix Bayer Reagent Strips Bayer Uristix Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Micro-Bumintest Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips MLE-M1 Participant Summary/ 69
70 URINALYSIS DIPSTICK KETONES Specimen UA-1 Method Labs Negative Trace (5 mg/dl) Participant Results Small Moderate (1+, 15 (2+, 40 mg/dl) mg/dl) Large (3+, 80 mg/dl) 150 mg/dl 160 mg/dl ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Acetest Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Ketostix Bayer Reagent Strips Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips / 2014 MLE-M1 Participant Summary
71 URINALYSIS DIPSTICK BILIRUBIN Specimen UA-1 Method Labs Negative Participant Results Small (1+) Moderate (2+) Large (3+) ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips MLE-M1 Participant Summary/ 71
72 URINALYSIS DIPSTICK UROBILINOGEN Specimen UA-1 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 Arkray DiaScreen Arkray DiaScreen Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips / 2014 MLE-M1 Participant Summary
73 URINALYSIS DIPSTICK BLOOD/HEMOGLOBIN Specimen UA-1 Participant Results Method Labs Negative Trace Small (5-10 RBC/µL, 1+) Moderate (50 RBC/µL, 2+) Large (250 RBC/µL, 3+) ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Hemacombistix Bayer Reagent Strips Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips MLE-M1 Participant Summary/ 73
74 URINALYSIS DIPSTICK LEUKOCYTE ESTERASE Specimen UA-1 Participant Results Method Labs Negative Trace Small (1+) Moderate (2+) Large (3+) ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Reagent Strips Bayer Uristix Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips / 2014 MLE-M1 Participant Summary
75 URINALYSIS DIPSTICK NITRITE Specimen UA-1 Participant Results Method Labs Positive Negative ALL METHODS Arkray DiaScreen Arkray DiaScreen Bayer Clinitek 10 / Bayer Clinitek 200/ Bayer Clinitek Bayer Clinitek Bayer Clinitek Bayer Clinitek Advantus Bayer Clinitek Atlas Bayer Clinitek Status / Status Bayer Ictotest Bayer Reagent Strips Bayer Uristix Consult Diagnostics Urine Analyzer CTMI CT-120 Urine Analyzer Diagnostic Test Group Clarity Urocheck Diagnostic Test Group Clarity Urocheck Germaine Laboratories AimStrip McKesson 10SG Reagent Strips Other Analyzer Method Other Dipstick Method PSS Select Reagent Strips PSS Select Urine Analyzer Roche Chemstrip Roche Chemstrips Roche cobas u Roche Criterion Analyzer Roche SuperUA/ChemstripUA Roche Urisys Schein Urispec UriScan Reagent Strips MLE-M1 Participant Summary/ 75
76 URINALYSIS MICROALBUMIN (dipstick only) Specimen UA-1 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 Bayer Clinitek Microalbumin DCL ImmunoDip Micro-Bumintest Roche Micral - 1 minute / 2014 MLE-M1 Participant Summary
77 URINALYSIS URINE hcg Specimen UA-1 Participant Results Method Labs Positive Negative ALL METHODS AimStep Combo Pregnancy 2-2 Alfa Scientific Instant View 4-4 Bayer Bili-Labstix 1-1 Bayer Clinitek Status / Status+ 1-1 Beckman Coulter ICON 25 hcg Beckman Coulter ICON II/20 HCG 2-2 Cardinal Health SP Brand combo Cardinal Hlth SPBrand-cassette 7-7 CONSULT diagnostics hcg Cassette CONSULT diagnostics hcg Combo CONSULT diagnostics hcg Dipstick Diagnostic Test Group Clarity hcg strip/cassette 6-6 Henry Schein One Step Immunostics Cept-D 1-1 Immunostics Detector Combi 1-1 Immunostics hcg Detector-urine Inverness Acceva hcg-urine 5-5 Inverness Clearview 25 hcg Combo 1-1 Inverness Clearview hcg Cassette 2-2 McKesson hcg Combo Cassette McKesson hcg Urine Cassette McKesson urine hcg-all 20 miu kits 4-4 NDC Pro Advantage 4-4 PEP (Lab Supply) HCG 2-2 Polymedco Poly stat hcg 9-9 PSS Select hcg Cassette 2-2 Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Sekisui OSOM - Urine Test 6-6 Sekisui OSOM Card Pregnancy 6-6 Sekisui OSOM hcg Combo Test Sekisui Signify-Urine/Serum 1-1 Stanbio QuPID 7-7 Stanbio QuPID Plus 1-1 Stanbio QuStick 1-1 Stanbio TRUE hcg 6-6 Sure-Vue hcg - 25mIU 4-4 Sure-Vue hcg-stat MLE-M1 Participant Summary/ 77
78 FECAL OCCULT BLOOD Specimen OC-1 Specimen OC-2 Method Labs Positive Negative Labs Positive Negative ALL METHODS Alfa Scientific Instant View Beckman Coulter Hemoccult ICT Guaiac (slide) Test Hemosure IFOB Inverness Clearview ifobt Complete Other Immunochemical FOB kit Polymedco OC Auto Micro Polymedco OC-Light ifob Quidel QuickVue ifob M1 Urine Sediment ID Specimens US-1 and US-2 CASE HISTORY US-1 and US-2: A 40-year-old pregnant female presented to her OB/GYN for a routine prenatal examination. A urine specimen was collected and refrigerated in the laboratory until urinalysis testing could be performed. Results appear below. Color = Pink Appearance = Turbid Dipstick results: Specific Gravity = ph = 5.5 Protein = Negative Glucose = Negative Ketones = Negative Bilirubin = Negative Urobilinogen = Normal/0.2 mg/dl Blood = Negative Leukocyte Esterase = Negative Nitrite = Negative 78 / 2014 MLE-M1 Participant Summary
79 Specimen US-1 Identification Labs Percent Performance Amorph urate/phosphate crystal % Acceptable Granular cast % Identification Unknown Refer % Yeast/fungi % Bacteria % White blood cell(wbc) % Fiber/fecal contamination % RBC/blood/hgb cast % The arrows in this photo point to amorphous urate crystals. Amorphous means without shape or form. Amorphous urate crystals are normal, nonpathologic crystals commonly seen in acidic, concentrated specimens that have been refrigerated. The specimen cup often contains a fluffy red precipitate described as brick dust. Microscopically, these small, formless urate crystals are identical to amorphous phosphate crystals, which are found in alkaline urines and form a white or colorless precipitate. To view another photo of amorphous crystals, see 2009 M1 Specimen US-2. Technical tip: Amorphous crystals can be so numerous that they obstruct the view of any other elements in the sediment. The crystals can be dissolved by washing the sediment with warm saline or heating a tube of the urine or sediment in a hot water bath. Specimen US-2 Identification Labs Percent Performance Hyaline cast % Acceptable Waxy cast % Granular cast % Fiber/fecal contamination % The arrow in this photo points to a hyaline cast. Hyaline casts are the most commonly seen casts in the urine. They are colorless and smooth, with a finely wrinkled surface and no granules. The sides are parallel and the ends are blunt and rounded. Hyaline casts are normal, and frequently seen in the urine sediment of healthy people in small numbers (less than two per low-power field.) They may be increased after strenuous exercise or in other conditions, including renal disease. Waxy casts are more broad and square, with cracks and blunt ends. Granular casts have much more prominent granularity. To view a photo of a waxy cast, see 2006 M1 Specimen US-1. To view a granular cast, see 2008 M2 Specimen US-3. Technical tip: Hyaline casts have a low refractive index, which makes them hard to see if the microscope s illumination is not set correctly. Use subdued lighting to examine urine sediment, with the sub-stage condenser raised all the way up, and the condenser iris diaphragm approximately 70% closed / 30% open. Do not lower the condenser to decrease brightness. This reduces the resolution and sharpness of the image, which could cause you to miss important elements like casts. References: Moore, M.C.: Troubleshooting Clinical Microscopes. Microscopy USA, Pottstown, PA, Mundt, L.A, Shanahan, K.: Graff s Textbook of Routine Urinalysis and Body Fluids, 2 nd ed. Philadelphia, Lippincott Williams & Wilkins, Ringsrud, K. M., Linné, J. J.: Urinalysis and Body Fluids/ A ColorText and Atlas. St. Louis: Mosby, MLE-M1 Participant Summary/ 79
80 PROVIDER-PERFORMED MICROSCOPY (PPM) Wet Mount Preparation Specimen PPM-1 Identification Labs Percent Performance White blood cell (WBC) % Acceptable Red blood cell (RBC) % Starch (Talc) granules % Yeast/fungi % The arrows in this photograph of a vaginal wet mount point to white blood cells. The nuclei within the cells give them a granular appearance. Presence of a large number of white blood cells is associated with infection such as Candidia, herpes, trichomonas, gonorrhea, or chlamydia. Red blood cells are smaller in size and appear hollow, sometimes resembling donuts or inner tubes. To view a photo of red blood cells in a wet mount, see 2011 M1 Specimen PPM-1. KOH Preparation Specimen PPM-2 Identification Labs Percent Performance Yeast/fungal elements absent % Acceptable Yeast/fungal elements present % Yeast and fungal elements are absent in this photograph of a KOH vaginal wet mount. The numerous small objects in this photograph are bacteria. To view a photo of yeast in a KOH prep, see 2013 M1 Specimen PPM / 2014 MLE-M1 Participant Summary
81 PROVIDER-PERFORMED MICROSCOPY (PPM) Sperm Identification Specimen PPM-3 Identification Labs Percent Performance Sperm present % Acceptable Sperm absent % Three sperm are present in this photograph of a vaginal wet mount preparation. Nasal Smear Specimen PPM-4 Identification Labs Percent Performance Eosinophils absent % Acceptable Eosinophils present % Eosinophils are absent in this photograph of Wright-stained nasal mucus. The purpose of examining the leukocytes in stained nasal secretions is to differentiate allergic conditions from infections. Eosinophils are a specific type of leukocyte (white blood cell) that is increased in allergic conditions. The cells shown in this photo are not eosinophils. They indicate infection rather than allergy. Eos have a unique red-orange color that makes them easy to spot and identify. The cytoplasm of an eosinophil is filled with large, round, orange-staining granules that surround the purple nucleus but do not obscure it from view. The orange color comes from the dye eosin, which is a component of Wright stain. To view a photo of eosinophils, see 2013 M2 Specimen PPM-10. Specimen PPM-4 is graded by 100% referee consensus MLE-M1 Participant Summary/ 81
82 PROVIDER-PERFORMED MICROSCOPY (PPM) PINWORM PREPARATION Specimen PPM-5 Identification Labs Percent Performance Pinworms are present % Acceptable Pinworms are absent % Three pinworm eggs are present in this photograph of a perianal skin prep.. Vaginal Fluid Preparation Specimen PPM-6 Identification Labs Percent Performance Ferning absent % Acceptable Ferning present % Ferning is absent in this photograph of air-dried vaginal secretions. References: Fischer, P. M.: The Office Laboratory. Norwalk, Conn.: Appleton-Century-Crofts, Mundt, L.A, Shanahan, K.: Graff s Textbook of Routine Urinalysis and Body Fluids, 2 nd ed. Philadelphia: Lippincott Williams & Wilkins, Ringsrud, K. M., Linné, J. J.: Urinalysis and Body Fluids/ A ColorText and Atlas. St. Louis: Mosby, Medical Laboratory Evaluation 25 Massachusetts Ave NW Ste 700 Washington, DC Fax: / 2014 MLE-M1 Participant Summary
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