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Laboratory Procedure Manual

Analyte: Matrix: Method:

Complete Blood Count Whole Blood Complete Blood Count with 5-Part Differential

Method No.:

Revised: as performed by:

Contact:

Important Information for Users CDC periodically refines these laboratory methods. It is the responsibility of the user to contact the person listed on the title page of each write-up before using the analytical method to find out whether any changes have been made and what revisions, if any, have been incorporated.

Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004

Public Release Data Set Information
This document details the Lab Protocol for NHANES 2003–2004 data. A tabular list of the released analytes follows:

Lab Number

Analyte LBXWBCSI LBXLYPCT

SAS Label White blood cell count (SI) Lymphocyte (%)

LBXMOPCT Monocyte (%) LBXNEPCT LBXEOPCT LBXBAPCT Segmented neutrophils (%) Eosinophils (%) Basophils (%)

LBDLYMNO Lymphocyte number LBDMONO LBDNENO l25_c LBDEONO LBDBANO LBXRBCSI LBXHGB LBXHCT LBXMCVSI LBXMCHSI LBXMC LBXRDW LBXPLTSI LBXMPSI Monocyte number Segmented neutrophils number Eosinophils number Basophils number Red cell count SI Hemoglobin (g/dL) Hematocrit (%) Mean cell volume (fL) Mean cell hemoglobin (pg) MCHC (g/dL) Red cell distribution width (%) Platelet count (%) SI Mean platelet volume (fL)

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Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 1. Clinical Relevance and Summary of Test Principle Perform a complete blood count (CBC) in duplicate on all Sample Persons (SPs) age 1 and older. Perform the CBC on the Beckman Coulter MAXM. Run a CBC on home exam SP’s EDTA blood tubes after returning to the MEC. A. Purpose and Principle of Test The Beckman Coulter method of sizing and counting particles uses measurable changes in electrical resistance produced by nonconductive particles suspended in an electrolyte. A suspension of blood cells passes through a small orifice simultaneously with an electric current. A small opening (aperture) between electrodes is the sensing zone through which suspended particles pass. In the sensing zone, each particle displaces its volume of electrolyte. Beckman Coulter measures the displaced volume as a voltage pulse, the height of each pulse being proportional to the volume of the particle. The quantity of suspension drawn through the aperture is for an exact reproducible volume. Beckman Coulter counts and sizes individual particles at a rate of several thousand per second. This method is independent of particle shape, color, and density. The MAXM is a quantitative, automated, differential cell counter for in vitro diagnostic use. The MAXM measures these parameters in whole blood: Pulse size wavelength calculation ≥35 fL 36–360 fL 525 nm RBC x MCV/10 # × size of RBC/total RBC Hgb/RBC × 10 Hgb/Hct × 100 CV expressed in % of the RBC size distribution 2 to 20 fL Mean volume of Plt population under the fitted curve × constant # cells inside NE area/# cells inside total cell area × 100 NE%/100 × WBC count

Cell WBC RBC Hgb Hct MCV MCH MCHC

Parameter white blood cell count red blood cell count hemoglobin concentration hematocrit mean cell volume mean cell hemoglobin mean cell hemoglobin concentration red cell distribution width platelet count

Measured WBC bath RBC bath WBC bath computed derived from RBC histogram computer computed derived from RBC histogram RBC bath derived from Plt histogram

Reported units n × 103 cells/µL n × 106 cells/µL g/dL % fL pg g/dL

RDW Plt

% n × 103 cells/µL

MPV

mean platelet volume

fL

NE%

neutrophil percent

derived from scatterplot absolute number

% 103 cells/µL

NE #

neutrophil number

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Review all SP results at the Coulter DMS monitor. Observe universal precautions. The final decision to accept or reject a result is the responsibility of the medical technologist. Analysis and classification of WBCs use three simultaneous measurements of individual cell volume (V). 2. and laser light scatter (S). The Mobile Examination Center (MEC) Hazardous Chemicals Manual contains all Coulter Material Safety Data Sheets (MSDS). high frequency conductivity (C). Dispose of all biological samples in a biohazard container and wipe down all work surfaces with 1% bleach solution at the end of each session. Methodology: The methods used to derive CBC parameters are based on the Beckman Coulter method of counting and sizing. The scattergram plots the cells based upon the measurements of these three parameters. The hematology module in the laboratory application automatically receives the results or transmits them manually to the hematology module. 3.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 # cells inside LY area/# cells inside total cell area × 100 Ly%/100 × WBC count # cells inside MO area/# cells inside total cell area × 100 MO%/100 × WBC count # cells inside EO area/# cells inside total cell area × 100 EO%/100 × WBC count # cells inside BA area/# cells inside total cell area × 100 BA%/100 × WBC count LY% lymphocyte percent derived from scatterplot absolute number derived from scatterplot absolute number derived from scatterplot absolute number derived from scatterplot absolute number % 103 cells/μL LY# lymphocyte number MO% monocyte percent % 103 cells/µL MO# monocyte number EO% eosinophil percent % 103 cells/µL EO# eosinophil number BA% basophil percent % 103 cells/µL BA# basophil number *PDW – platelet distribution width and percent – platelet crit are NOT for diagnostic use and do not print. Wear safety glasses whenever operating the instrument in SECONDARY mode. It is mandatory to wear gloves and lab coat when handling all human blood products and Beckman Coulter controls. The laboratory application evaluates the data for completeness and accuracy. and a single beam photometer for hemoglobinometry. in combination with an automatic diluting and mixing device for sample processing. Page 4 of 32 . Coulter uses the value for PDW as an internal check on the reported platelet parameters. Special Safety Precautions All specimens may be potentially positive for infectious agents including HIV and the Hepatitis B and C virus. The WBC differential uses VCS technology. Pct and MPV. Computerization: Integrated Survey and Information System (ISIS) The MAXM Data Management System (DMS) transmits individual SP results to the MEC automated ISIS system.

PN 8546983 (1L) -.PN 7546915 (5 x 16-mL) • Expires 30 days after being opened.Erythrolyse II erythrocyte lytic reagent Diff Leukocyte Preservative -. 6. Calibration (Standards). Controls.a lytic reagent used for the CBC mode • Expires 60 days after being opened and installed on the instrument.PN 8546930 (5L) -.or 5-mL K3 EDTA tube on all SPs aged 1 year and older following established venipuncture protocol and procedures (a 1-2% dilution effect occurs in this liquid EDTA tube).PN 8546733 (20 L) -.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 All data are backed up and stored at Westat's home office. Specimen preparation Run the CBC as soon as possible. B. (5) Latron Controls . controls and calibrators (1) Isoton III -.an isotonic electrolyte • Expires on expiration date printed on container.PN 7547001 (9 x 3. Page 5 of 32 .3-mL) • Expires 13 days or 13 events after being opened. Preparation of Reagents. 5. Procedures for Collecting.a cleaning agent that cleans and rinses diluter parts • Expires 90 days after being opened and installed on the instrument. Storing. 4. and Handling Specimens. and All Other Materials. Abnormal I. (2) Beckman Coulter Clenz -. (4) Scatter Pak -.PN 8546917 • • • Diff Lytic Reagent -. Criteria for Specimen Rejection A.Do not prepare differential microscopic slides. A. Equipment and Instrumentation The MAXM DMS stores and maintains the lot numbers and expiration dates.PN 7546914 (5 x 16-mL) • Expires 30 days after being opened. Procedures for Microscopic Examination Not Applicable . (6) Latron Primer . Abnormal II . (3) Lyse-S III diff lytic reagent. Specimen collection The phlebotomist collects a 3. Reagents.StabiLyse leukocyte preservative Expires 60 days after being opened and installed on the instrument. there is no requirement to wait any length of time between drawing the blood and running the CBC. (7) 5C Cell Controls Tri Pack contains Normal.

25% sodium hypochlorite 1-800-292-2200 (4) Bottled distilled water (5) Three 30 mL plastic containers with lid (6) Two one-liter containers with lid (7) Plastic squirt bottle (8) Cotton gauze pads (9) Three-hole paper punch (10) Notebook (11) Fujitsu printer ribbon (12) Flashlight (13) 10-mL syringe with plastic tubing (14) Precision screwdriver set (15) Distilled water bottle (16) Disposable lab jacket. mix thoroughly by inversion and let bubbles settle before use.PN 7546808 (2 x 6-mL) (With Lin-CPN 6605374) • Use at the start of each stand. such as BSV or primary measurement. Calibration and Calibration-Verification Procedures S-CAL (PN 7546808 .Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (8) Calibration S-CAL . (2) Do not place reagents on or near electric cords or lines to avoid electrical interference. Use when calibrating with S-CALfor reproducibility study. 7.PN 7546923 (9 x 3. 5. Perform calibration: • • • • At the beginning of each stand After replacing any component dealing with dilution preparation.3-mL) • B.2 x 6-mL) The S-CAL calibrator kit determines the adjustment factors for the calibration of the Beckman Coulter MAXM. Perform calibration in the close-vial mode. 48 inches long C. 60-90°F). such as an aperture If the Beckman Coulter representative suggests calibration If controls show unusual trends or are outside limits Page 6 of 32 . Calibration is a procedure to standardize the instrument by determining its deviation from calibration references and to apply any necessary correction factors. Expires 1 hour after being opened. A. Notes (1) If reagents become frozen in transit. using S-CAL as an alternative to whole blood. at ambient room temperature range (16-32°C. Supplies (1) 3-mL K3 EDTA Becton Dickinson Hemogard Vacutainertube (2) Tube rocker (3) Clorox Bleach. (9) 5C Cell control normal .

Before calibrating. If status message is not Select Function or Compressor Off. 5C cell control for reproducibility studies. Materials required -. Page 7 of 32 . S-CAL is an acceptable alternative to whole blood calibration. Label the control vial with date and initial. Open and/or pooled vials are stable for 1 hour. Run.The supernatant should show no gross turbidity and be light red in color. To rinse the system. START-UP. [F3]. press [F9] Stop. and MPV parameters. Wait for green light before placing tube into the carousel. (b) Stop the system before it performs the Clean Needle procedure.Sealed vials are stable through the expiration date when stored at 2–8°C (35–46°F). Fixed erythrocytes simulate leukocytes. (2) Storage. Pre-calibration. RUN SAMPLE. MCV. go to SAMPLE ANALYSIS. Run 5C cell controls. and CLEAN NEEDLE. CALBRATION. perform daily Start Up. reproducibility. (c) Select SPECIAL FUNCTIONS. Potential biohazard – Each human donor used in preparation of this material was tested by an FDA-approved method for the presence of the antibodies to Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV). one plastic pipette. Then. RDW. It is a stabilized human-blood preparation. DIAGNOSTICS. (a) Prepare a fresh bleach solution. (1) Pre-calibration procedure Bleach the aspiration system using the Clean Needle procedure. and carryover check Perform a calibration after the instrument has been "Shut Down" for at least 30 minutes. (c) Select SPECIAL FUNCTIONS. The S-CAL divides the average result into the calibrator Assigned Value to give the Adjustment Factor. Press [F9] Stop. (2) Reproducibility check (a) Select SAMPLE ANALYSIS. Select DILUTOR FUNCTIONS. MCHC. handling and stability -. If NO. Select [F5] to access options. assemble the following materials: S-CAL kit containing two 6-mL vials of S-CAL calibrator.S-CAL consists of treated. go to step 3. MCH. Put one-mL Clorox bleach and 1 mL of distilled water into 5mL lavender top Vacutainertube. (d) Is “Sample Mode?” displayed? If YES. Hct. Select DILUTER FUNCTIONS. S-CAL calibrates the WBC. Press [Enter]. stabilized. RBC. normal-level. START UP [Enter]. Press [Enter] and follow the screen instructions. Plt.The MAXM uses the S-CAL kit that requires a calibrator to convert electronic measurements of each sample into accurate results expressed in clinical terms. Indications of instability or deterioration -.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 • When room temperature varies more than 10°F (5. Reagents .5°C) from the room temperature during the last calibration (1) Principle . Handle these reagents at Biosafety Level 2 because no test method can offer complete assurance that these and other infectious agents are absent. as well as for Hepatitis B surface antigen. it obtains and adjusts an instrument reading according to the Adjustment Factor. (b) Use an unopened. Change [F5] Print: to none and [F6] Host to Off. REPRO-DUCIBILITY [Enter]. OPERATOR OPTIONS. The calibration procedure uses replicate measurements of S-CAL calibrator. Hgb. and found to be negative (were not repeatedly reactive). B. human erythrocytes and platelet sized components in an isotonic bacteriostatic medium. and two empty glassmixing tubes with pierceable caps. RUN SAMPLES. FLUIDIC TESTS. Use of expired controls for this procedure is acceptable. and the DIFF parameters do not require calibration. Significant darkening of the supernatant might indicate hemolysis and a reduction of the red cell count.

0% Check the low to high difference (bottom line. then cap. (g) Notes (i) (ii) Be sure the PR↓ is on the status line before starting the reproducibility study. ARE YOU SURE?: NO." Press [Enter]. Press [Esc]. Insert the tube into the carousel when the green light appears. Does the following message appear? "MODE REQUIRES EXISTING RUNS TO BE DELETED. Press [F2] START PRIMARY.2 ≤4. (i) (ii) Use a routine 5-mL VacutainerEDTA (BD #369614) for the carryover check clean vials. Verify the average %CV does not exceed these limits: ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ WBC 2.0% MPV 3. Mix gently before each cycle. Press [Enter]. use the %CV line for CBC parameters only and the Diff line for the DIFF parameters only. Press [F3] Run [F9] STOP. and CARRYOVER.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (e) Press [F6].8 ≤1. This deletes the old data." Press [Enter]. CALBRATION. Press space bar to turn the DIFF ON. call the Beckman Coulter representative. (iv) Press [F4] to print the screen for the logbook. Press [F2] START PRIMARY.0% Hgb 1." If the message appears. Do not use the bar code reader. ARE YOU SURE?: NO. (iii) Check the results." Press [Enter]. Page 8 of 32 .8 MO% NE% EO% BA% ≤3.6 ≤1. press [F8] Delete. Do not use the bar code reader. Fill three separate vials with diluent. (iii) On the reproducibility screen. This deletes the old data. (f) Does the following message appear? "MODE REQUIRES EXISTING RUNS TO BE DELETED. press the space bar to answer "yes. This deletes the old data. Press the space bar to answer "YES. right hand side) for the diff parameters with these limits: LY% ≤4. Cycle the sample 11 times. press the space bar to answer "yes. Cycle two vials of normal blood and three vials of diluent.0% Plt 5. Insert the tube into the carousel when the green light appears. (3) Carryover check (Draw two 5-mL EDTA tubes of normal blood) (a) Select SPECIAL FUNCTIONS.6 If the results are outside the limits.5% MCV 2. Be sure to delete any data on the reproducibility screen before starting a new study. If there are runs present in the table and the message does not appear. The first sample is automatically marked DEL and its results are not included in the calculations. Proceed with a Carryover Check. (i) (ii) Follow the directions listed in Section X for preparation and mixing the 5C-cell control." If the message appears. Follow the screen directions.5% RBC 2.

stop and contact a Beckman Coulter representative. CALBRATION." Press [Enter]. Use cotton gauze pads to remove the rubber stopper from the vial.000 if possible. All other parameters should be within normal ranges. Ignore count period (CP) voteouts on diluent runs. C. Press the space bar to answer "yes. and CBC CALBRATION. Set one of these tubes aside in a test tube rack. If the result is not acceptable and the H flags appear next to the carryover value results. (b) Check the %CV values against these precision %CV limits. (b) Notes (i) (ii) Choose a sample with a WBC count of 10. Repeat these actions again. (b) Enter the expiration date and the lot number. (iv) 1st diluent sample . fill each of two mixing tubes to within 1/4 inch of the top.3rd diluent sample × 100 = % carryover 2nd sample. STOP and contact a Beckman Coulter representative. If the cells are not totally distributed. Absorb any spray produced by pressure within the vial by using the gauze pads. repeat the mixing procedure. Press [F9] to return to the main menu.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (iii) Check the lower right corner of the screen for CARRYOVER ACCEPTABLE. Press [F2] START PRIMARY. Do not use the bar code reader. (3) Prepare and cycle the calibrator (a) Mix by hand as follows: Roll the tube slowly between the palms of the hands eight times in an upright position. Press [Esc. Press [F3] Run. Invert the tube and slowly roll it again eight times. (c) With the pipette. Delete any data in the table. Dispose of extra SCal. (2) Prepare the CBC calibration screen. (b) Determine that all cells are uniformly distributed by inspecting the vial contents. Insert the tube into the carousel when the green light appears. If results are still OUT. If any parameter exceeds the limit. Do not refrigerate or place on rocker. Use Tube #1 for calibration and tube #2 is for verification if needed. Let it warm to ambient temperature for 20 minutes.000 ± 1. avoiding accidental contact with the product. Gently invert the tube eight times. (a) Enter the S-CAL calibrator assigned values from the Table of Assigned Values on the package insert on the REF: VALUES line at the cursor. If trending is present. press [F4] Print to print the screen for the logbook. repeat the procedure. Meanwhile. CBC calibration with S-CAL calibrator Take the S-CAL calibrator from the refrigerator. [F9] STOP. The Hct is not calibrated although the value is listed on the package insert. (iv) Press [F4] to print the carryover screen for the logbook. call the Beckman Coulter representative. Press [F8]. continue with the following steps: (1) Select SPECIAL FUNCTIONS. Page 9 of 32 . (iii) Percent carryover is calculated by the formula.] (4) Assess the run (a) Check for trending. (e) After the cycles are complete. (d) Cycle the first cap-pierceable calibrator 11 times. The first sample is automatically marked DEL and its results are not included in the calculations. Invert the vial and mix the S-CAL calibrator before each cycle.

50 (e) If both the FAC %DIFF and DELTA DIFF values for all parameters are less than or equal to these limits. (f) If the FAC %DIFF or DELTA DIFF value of any of these parameters is greater than these limits continue with the next steps to verify the calibration.78 ≤1.10 but ≤0. The values are absolute numbers).03 ≤0.70 ≤5.5 ≤2.00 ≤6.5 ≤2.00 >0.10 ≤1.0 ≤2.5 ≤9. (5) To verify calibration: (a) Determine which calibration factors to change. DO NOT calibrate: Press [F4] to print the screen for the logbook.0 ≤2.25 but ≤5.09 Page 10 of 32 .Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 Parameter WBC RBC Hgb MCV Plt MPV Precision (CV%) ≤2.70 but ≤2.18 ≤2. Parameter WBC RBC Hgb MCV Plt MPV Do not calibrate if FAC %DIFF is: ≤1.0 ≤3. Parameter WBC RBC Calibrate if FAC %DIFF is: >1.00 Do not calibrate if DELTA DIFF is: ≤0. STOP and call a Beckman Coulter representative.03 but ≤0.25 ≤0. If any parameter exceeds its limit. Parameter WBC RBC Hgb MCV Plt MPV Acceptable FAC %DIFF ≤5. Check the FAC %DIFF and DELTA DIFF values against these limits (disregard minus signs. The values are absolute numbers).0 (c) FAC %DIFF values against these limits (disregard minus signs.70 ≤0.0 ≤5.0 ≤20.10 ≤0.0 ≤1.0 ≤0.00 Calibrate if DELTA DIFF is: >0.0 (d) Determine the need for calibration.0 ≤3. Check the FAC % DIFF and DELTA DIFF values against these ranges.40 >0.

(6) Calibration terms and formulas (a) MEAN • • • • • • The average of the 10 S-CAL calibrator runs The calibration factor needed to obtain the S-CAL Calibrator Reference value. Gently invert the second cap-pierceable vial of SCAL calibrator 8-10 times.50 (d) If any value is above these limits. invert the vial and mix the S-CAL calibrator. Select TRANSMIT FACTORS.00 >1.03 ≤0. Press [Enter].00 DELTA DIFF ≤0. Check the FAC %DIFF and DELTA DIFF values results for all parameters against these limits (disregard minus signs) to be sure that they are below the lower limit. press [F3] Run [F9] STOP [Esc].OLD CALFAC × 100 = FAC %DIFF OLD CALFAC (b) NEW CALFAC (c) OLD CALFAC (d) %CV (e) FAC % DIFF • • • Page 11 of 32 .0 ≤0. is Select Function displayed? If NO. Parameter WBC RBC Hgb MCV Plt MPV FAC %DIFF ≤1. Before each cycle. NO for others.50 but ≤2.10 ≤1.00 >6.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 Hgb MCV Plt MPV >0.00 but ≤20. DO YOU WANT TO PRINT DATA? Y/N" Select N since the values have already been printed.40 >1. Check to ensure that the data being used is valid when making decisions to recalibrate or not. Cycle the S-CAL calibrator 11 times.00 >0. then.70 ≤5.10 ≤0.70 but ≤9. Turn the printer back on using Options. Press [Enter].00 ≤6.00 >5. The instrument calculates and displays it whether or not it needs to be changed.18 but ≤2.25 ≤0.00 but ≤2.DATA WILL BE CLEARED AFTER TRANSMISSION.70 ≤0. If YES. Press [F4] to print the screen for the logbook.78 ≤1.00 (b) If any value is outside these ranges. call a Beckman Coulter representative. Press [Esc]. NEW CALFAC .50 >2. (c) Press [F3] Run [F2] START PRIMARY. Reference Value x Old Cal Factor = NEW CALFAC S-CAL mean value (n=10) The current calibration factor Indicates the reproducibility of the S-CAL calibrator run. Press [F5].78 but ≤3. Rerun controls. The difference between the OLD CALFAC and the NEW CALFAC expressed as a percentage.10 but ≤0. The following message appears: "WARNING -.18 ≤2.0 >0. Choose SELECT PARAMETERS.0 but ≤20. Use the space bar to select YES for parameters that need adjusting.

Results outside limits turn red. wait and try reading the bar code label again. Press the corresponding function key to enter specific options. Press [Enter]. Run all three levels (normal. and abnormal II (pink). Press [F10] to save and exit. Use [F5] to change XB and DB to ON. (17) Identify the sample by holding the bar code label on the tube in front of the reader. (15) Is “Sample Mode?” displayed? If no. RUN SAMPLE [F3]. (6) Select SAMPLE ANALYSIS. SET UP. (g) REF VALUES. (21) Is “Sample Mode?” displayed? If no. (3) To begin Start Up. Press [Enter]. wait and try reading the bar code label again. Page 12 of 32 The absolute difference between the reference value and the S-CAL calibrator MEAN. cycle samples in the SECONDARY mode. Host to ON. evaluate the display. RUN SAMPLES. (9) Run Sample Persons (10) Review the placement of the bar code on the sample tube to make sure it is parallel to the stopper and does not cover the bottom of the tube. Make sure the Background and other Start Up results are within limits. Move the cursor and enter the correct date or time and press [Enter] or the arrow keys. Press [F2] to view detailed results. Use [F6] to turn Diff ON. abnormal I. Green light will beep -. (4) After Start Up is complete. This mode does not check sample and aspiration integrity. Press [Esc] to exit. Use [F6] to turn the Diff ON. To set date and time select SPECIAL FUNCTIONS. RUN SAMPLES. (20) Select SAMPLE ANALYSIS. Expired reagents and failed checks appear in red. (5) Review and verify sample analysis set up. Print to NONE. (19) Blood detectors are inactive in the SECONDARY mode. (11) Run all samples in duplicate. of Beckman Coulter 5Ccell control daily at the beginning of the first session. (14) Select SAMPLE ANALYSIS. . and START UP. (16) Press [F2] START PRIMARY. abnormal I (yellow). (7) Run controls (8) Run Beckman Coulter LATRON primer and latex control. and Display Only to OFF. Run samples in the SECONDARY mode only if the primary mode is unavailable. normal (blue). select DILUTER FUNCTIONS. If the red light appears.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (f) DELTA DIFF • • 8. press [F9] STOP. Press [Enter]. Assay Procedure (1) Run Start Up at the beginning of the first session each operational day. SYSTEM SET UP. (12) Run samples in the primary mode. Check to make sure the date and time displayed are correct. Results automatically print. Follow the instructions on the screen. (23) Identify the sample by holding the bar code label on the tube in front of the reader. Green light will beep. and all three levels. If the red light appears. Sample mode? Press [F5] for options. (22) Press [F3] SECONDARY. SET DATE/TIME. press [F9] STOP. (2) Leave the instrument on and operate the MAXM with all panels closed. The assigned value for each parameter. (13) Check to verify connection and working order of the printer. and abnormal II) of Beckman Coulter 5Ccell control at the beginning of the second session.Place the tube in the carousel. Use [F6] to turn Diff ON. (18) Alternatively.

Place reagent caps on all open containers. Results should be within tolerance. Use the Isoton® when performing the calibration carryover check. PRIME REAGENTS. (ii) When it is time to use the instrument. Turn off the power. 3 reproducibility. Turn off the power. When it is time to use the instrument. and perform a Start Up. Calibrate. Prolonged Shut Down If the instrument is going to be shut down for 48-72 hours. and verify QC checks according to procedure. Contact the local Beckman Coulter representative to perform an instrument verification procedure on set up day or as soon as possible. 3 carryover). (30) Daily Shut Down (i) (ii) (31) (32) (33) (34) (35) (36) (37) (38) (39) (40) (41) (42) (43) (44) (45) (46) Shut down the instrument at the end of each day. Shut down the instrument for at least 30 minutes but less than 48 hours. and a few plastic transfer pipettes. enough supplies to draw two 5-mL EDTA blood tubes. seven 3 or 5-mL EDTA tubes (1 clean aspiration system. Handle reagent tubes by the collar only to avoid contamination. When it is time to use the instrument. Let cleaning agent remain in the instrument for at least 30 minutes. Turn the power ON. Repeatedly perform Shut Down and Start Up procedures throughout the day. (28) Remove the sample when the instrument beeps. turn on the power and place the reagent pickup tubes into the reagent containers. Press [Enter]. Select DILUTER FUNCTIONS and SHUT DOWN. Perform daily QC and operate as usual. perform the following steps: Perform daily Shut Down. Results must be within tolerance. This should take approximately 5-6 minutes. and choose ALL. (27) Press and release the sample bar. Prime reagents through all the lines by selecting DILUTER FUNCTIONS. perform.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (24) Cycle the sample in the SECONDARY mode: (25) Mix the sample gently. perform the following steps: Place all reagent pickup tubes into distilled water. Perform Start Up to put diluent in the system. perform a shut down and then perform a Start Up. If the instrument is going to be shut down for more than 72 hours.(i) To begin shut down make sure the status line displays Select Function. Page 13 of 32 (47) (48) (49) (50) (51) (52) (53) (54) . prime all reagents. Perform daily QC and operate as usual. Results must be within tolerance. Beginning and end of stand operations Beginning of stand Obtain one urine collection container or a 50-mL conical tube. Results must be within tolerance. (26) Open the tube and immerse the aspirator tip in the sample. Using all new containers of reagents. (29) Monitor the aperture-viewing screens for debris during the COUNT period. carefully unwrap and place all reagent pickup tubes in their appropriate container after pouring 30-mL Isoton® III into 30-mL plastic container. turn power on. Perform daily QC and operate as usual. Perform the Start Up procedure. perform Start Up. Let distilled water remain in the reagent lines.

Select SPECIAL FUNCTIONS. Set shift 2 "Time" at 1230. Type in the following information where necessary and use the space bar to choose between the responses. Select IQAP ID#. Type in the IQAP number. date reagent opened (pressing [Enter] automatically gives today's date). Select Language. Set shift 3 "Time" at 2230. and the expiration date. Do not forget to enter revised expiration dates where appropriate. Press [Enter] after each item." Select. STKS 2A Host Mode No Enable Spooler Replace Null by SPNo Timeout (secs) 8 Baud rate 9600 Parity none Stop bits 1 Handshake Yes Block size 256 Graphic transmission DF1 No DF2 No CVS histograms No RBC histograms No PLT histograms No Press [F10] to save and [Esc] to return to previous screen. HOST COMPUTER DEFINITION." Press [F10] to save and exit.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (55) (56) (57) (58) Review and verify system set up. Select INSTITUTION. Select REAGENTS . Set shift 1 "Time" at 0800. Ensure the default is "ENG. SYSTEM SET UP: Select SHIFT Move the cursor and set up the starting times for each shift and press [Enter] or the arrow keys. "super. Enter 32979 1 T1 for instrument AA06042 Page 14 of 32 Yes (62) (63) (67) (68) (69) . (59) (60) (61) Press [F10] to save and return to the previous screen. Press [F10] to save the data and leave the reagent screen. Enter the "SUPER" password. Press [F10] to save. Type in: Name: NHANES Lab Director: Brenda Lewis Address: NCHS Maryland Telephone: 301-436-7080 (Default) Instrument: AA06042 AA31227 AB08075 Use space bar to choose YES for Name Printed on Graphic Printer and NO for all other information.Update reagent logs To record new reagent information: Key in the new reagent information: lot number. The system automatically calculates the end of the shift to prevent overlap. (64) (65) (66) Select COMMUNICATION DEF. Enter the SUPERVISOR PASSWORD. Use [Enter] or arrow keys to move to the appropriate field. SET UP.

PLT : DF2. RBC. DF3 : VCS Histograms : Demographics : S/D flags : Print Units : Print Diff Box : Print Normal Ranges Yes No No No Yes No No : No (76) Optional Printer Select "N. and SAMPLE ANALYSIS SET UP. Use the space bar to toggle to US 1. Press [F10] to save. Graphic Options Verify the following settings." Select DISPLAY FORMATS. Press [F10] to save and exit. Move the cursor and enter the correct date or time and press [Enter] or use the arrow keys. Press [F10] to save and [F9] to return to main menu. DEFINITIVE FLAG LIMITS [Enter]. Press space bar to choose 1 L. Select OPTIMIZE HARD DISK. Press [F9] to return to the main menu. REPORTING UNITS. Width/Font Page Format Wide/Large DF 1. Auto Print Format Select [GRAPHIC FORMAT] Ticket Options Verify the following settings. (71) (72) Select LYSE VOLUME. (73) (74) Review sample analysis set up. Type in the password "super" at the prompt and then press [Enter].Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 32979 1 T2 for instrument AA31227 32979 1 T3 for instrument AB08075 Press [F10] to save and exit. Select SPECIAL FUNCTIONS. SET UP. Page 15 of 32 . Type in the password "super. Use the spacebar to select YES. Press [F10] to save and exit." Select ACTION LIMITS [Enter]. PRINT UNITS: Y PRINT NORMAL RANGES: Y PRINT PARAMETER LABELS: Y TICKET PRINTER CONNECTED: N S/D FLAGS: Y DIFF ORDER: Standard AUTO-TICKET PRINT: N TICKET FORMAT START OF NEXT FORM Continuous Spooler Priority Leave [AUTO PRINT] as the default. (70) Select SET DATE/TIME. (75) Select PRINT OPTIONS.

The instrument defaults to 15 minutes. Download IQAP files to diskette following procedure in Section X. Mix 15 mL of Clorox bleach and 15 mL of distilled water in a plastic container. Return to main menu [F9]. Set lower limit for PCT to 0.9. "PRESS ANY KEY WHEN READY TO ASPIRATE BLEACH. (78) Select XB LIMITS. and PCT. PRIME.5 3 MCH 29. HIGH/LOW FLAG LIMITS [Enter].9 for all parameters except RBC.5 3 Press [F10] to save and exit.9 for all parameters except RBC. Limit % (83) (84) (85) (86) (87) (88) (89) (90) (91) (92) (93) (94) (95) (96) (97) Page 16 of 32 . Toggle through each reagent line using the space bar to change "ON" to "OFF. 33. Disable High/Low flag limits. Delete file [F8] -. Enter target and limit percent values. Review data and print [F4]. Set high limit to 99.990. Set RBC upper limit to 9.000.000. and PCT." Press any key. PLT to 999 (with no decimal) and PCT to 0. NO" message will appear. PLT. Let cleaning agent remain in the instrument for at least 30 minutes.990. Prepare a 25% solution of Clorox bleach (250-mL) and distilled water (750 mL) in one liter bottle. Put 30 mL of distilled water in a second plastic container.D. stop the procedure after 3 minutes.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 Disable definitive flag limits. PLT. print. Press [F10] and [Enter] to save and exit. Use the space bar to change NO to YES [Enter]. Bleach the apertures and flow cell. and clear error file. Perform daily Shut Down." Bleach the reagent lines. Press [Enter]. Place all reagent pickup tubes into the 25% bleach/distilled water solution. and DISINFECT. Press [Enter]. Aspirate all the bleach solution. Set low limit for all parameter values to zero except for PCT. Review. OPERATOR OPTIONS. DIAGNOSTIC. (77) Select ACTION LIMITS [Enter]. Perform Start-up. Set lower limit for PCT to 0. Select SPECIAL FUNCTIONS. and DISABLE REAGENT SENSORS. Press [F10] and [Enter] to save and exit. Disable the reagent sensors. Immerse the bleach probe in the bleach solution when the screen displays. Open the front panel. Select DILUTER FUNCTIONS. PRIME ALL. Wash and save the reagent collars. Select DILUTER FUNCTIONS. FLUIDIC TESTS. PLT to 999 (with no decimal) and PCT to 0. Set RBC upper limit to 9. ERROR FILE [Enter]. Select SPECIAL FUNCTIONS.9. Set high limit to 99. Press [Enter].5 3 MCHC (79) (80) (81) (82) End of stand Obtain three urine collection cups and three 5-mL EDTA blood tubes. Dispose of all open containers. Set low limit for all parameter values to zero except for PCT. Repeat this procedure two more times. Document any relevant information on the print out and file in the logbook. XB Limits Target MCV 88."Do you want to delete error file.1. Place all reagent pickup tubes into containers of distilled water. Remove all reagent pickup tubes from the reagent containers.

[F3]. Enter [F3]. Press [Enter]. Put one-mL Clorox bleach and one-mL distilled water into 5-mL lavender top Vacutainer tube. Select SPECIAL FUNCTIONS. Fill one 5-mL EDTA blood tube with this distilled water. DIAGNOSTIC. press [F9] Stop. RUN SAMPLE. (109) Cycle the instrument dry. Enter [F9] Stop. Vent.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (98) Immerse the bleach probe in the distilled water when the screen displays. Enter [F3]. and REPRODUCIBILITY. (105) Rinse the reagent lines. Stop the cycle after 3 minutes by pressing [F4]. seal tubing with check valve coming out of the bottom of the sheath tank. Press [Enter. Press [Enter]. Press [F6]. Do this by bending paper clip into a U and placing one end of paper clip into each of the open sockets on the instrument side of the junction. Press space bar to turn the DIFF OFF. Press [Enter]. Is “Sample Mode?” displayed? If YES. Turn the diff off. This will allow the instrument to Drain. CALBRATION. and REPRODUCIBILITY. (104) Perform reproducibility in Primary and Secondary mode using this 1% bleach solution. Make sure all reagent lines are immersed in containers of distilled water. (114) After cycles are complete. Repeat these actions at least three times. Press [F6]. and REPRODUCIBILITY. Repeat this procedure two more times. and DRAIN AND VENT. Perform one additional Start-Up procedure with the lines in the distilled water containers. press [F9] Stop. Select Primary and aspirate three samples of distilled water. Is “Sample Mode?” displayed? If YES. (99) (100) Disinfect the needle. Gently pull panel away from instrument. Press [F2] START PRIMARY. Aspirate all the distilled water. Select SPECIAL FUNCTIONS. Bleach the aspiration system using the Clean Needle procedure. Press [F9] Stop. (112) Open front cover. sample mode. remove paper clip. OPERATOR OPTIONS. "PRESS ANY KEY WHEN READY TO ASPIRATE WATER. Enter [F9] Stop. (110) Remove all reagent pickup tubes from the distilled water containers. Select Secondary mode and aspirate three samples of distilled water. go to step 3. PRIME REAGENTS and choose ALL. (107) Perform reproducibility in Primary and Secondary mode by using distilled water. Select Primary and aspirate three samples of 1% bleach. Press [Enter]. DIAGNOSTICS. (111) Continue to cycle the instrument dry by priming air through all the lines by selecting DILUTER FUNCTIONS. Select SPECIAL FUNCTIONS. Make sure containers are full. If status message is not Select Function or Compressor Off. When Select Function is displayed. and CLEAN NEEDLE. PRIME ALL. If NO. (103) Select SPECIAL FUNCTIONS. sample mode. (108) Select DILUTER FUNCTIONS. Disconnect the junction. Trace two red wires from top of sheath tank to plastic electrical connection. Prepare a 1% bleach solution and fill one 5-mL EDTA blood tube with this solution. Select DILUTER FUNCTIONS. Press [Enter] and follow the screen instructions. (101) Prepare a fresh bleach solution. Press [Enter]. START-UP. then remove hemostats. Press [Enter]. and Shut Down without reagent. Insert paper clip into junction so that a circuit is formed on the instrument side of the connector. Wait until the screen displays Select Function before touching any keys. Run. FLUIDIC TESTS. Select Secondary mode and aspirate three samples of 1% bleach solution. CALBRATION. PRIME. (102) Stop the system before beginning the Clean Needle procedure. continue with the following procedure. Loosen the four large screws that hold the panel containing the sheath tank. go to step 3. CALBRATION. reconnect junction. If NO. OPERATOR OPTION. Press space bar to turn the DIFF OFF. Wait for green light before placing tube into the carousel. go to SAMPLE ANALYSIS. Press [F2] START PRIMARY. Turn the diff off." Press any key. Page 17 of 32 . and SHUT DOWN. Select SPECIAL FUNCTIONS. Using hemostats.] (113) Select DILUTER FUNCTIONS. (106) Perform a Start Up. put panel back into instrument and tighten screws.

0% 10. (117) Turn off the power. This is referred to as the Triple Transducer Module (TTM). (4) Storage. and light scatter. Allow air to continue to dry the tubes.0 to 20. handling. date.05 or 2.0% 2.2 or 3. Keep vials tightly capped when not in use. (121) Blow air through the flow cell at the end of each stand. (2) Principle -. Discard vial if debris is visible and put new vial into use.0% 10.Sealed vials are stable until their expiration date when stored and used at 2–30°C (35–86°F).0 or 3. Page 18 of 32 . Reconnect the sample line.2 or 3. handling. Run this control at the beginning of each day.0 to 150.Before running control. (3) Reagents -. It measures these signals as volume. (118) Rinse exterior of BSV with distilled water to remove built up Isoton and blue Clenz agent. Do not use gauze.0 50. and stability -. Blot the BSV dry with lint free tissue. FLUIDIC TESTS. 9.9 0 to 7.Inability to recover expected results might indicate product instability or deterioration due to improper storage.0% 0.Latex particles suspended in a buffered bacteriostatic and fungistatic medium containing a surfactant. Toggle through each reagent line using the space bar to change "No" to "Yes. (119) Wash exterior of instrument with distilled water. (5) Indications of instability or deterioration -. and initial vials. Use the Latron control immediately following the Latron primer.5 x 16-mL) The Latron control is for use in monitoring the volume. or contamination. These particles pass through the flow cell and produce characteristic electrical signals.0% 0." (116) To protect the reagent pickup tubes from contamination. (120) Empty waste and rinse container. Beckman Coulter Reportable Range of Results Parameter WBC x 103 cells/μL RBC x 106 cells/μL Hgb g/dL MCV fL Plt x 10 cells/μL MPV fL 3 Linearity 0 to 99. Connect a 10-mL syringe with tubing to the 6-inch line and force air into the line to remove ALL remaining liquid from the flow cell and the 6-inch sample line. conductivity. Address questions to the service representative at 1-800-526-7694. Quality Control (1) Latron latex controls (PN 7546914 . and light scatter (VCS) parameters on the MAXM. and DISABLE REAGENT SENSORS. Select SPECIAL FUNCTIONS.0 or 7. wrap them securely in paper towels. conductivity.0% 5. Once open. Opened vials are stable for 30 days when stored at recommended temperatures.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (115) Enable the reagent sensors. DIAGNOSTIC.0 0 to 999 5. Remove the 6-inch sample line to the flow cell at the mixing chamber. (6) Instructions for use -.The Latron control is a ready-to-use suspension of latex particles. Date and initial the vials when opened.00 0 to 25. verify that a Start Up has been performed.0 Limits: The greater of 0.

This is inherent to the product and is not an indicator of product stability. (17) Reagents -. Mix a room-temperature control vial gently by inverting five (5) to eight (8) times.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (7) Run Latron primer in the secondary mode.Each human donor used in preparation of this material was tested by an FDA-approved method for the presence of the antibodies to Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) as well as for Hepatitis B surface antigen and found to be negative (were not repeatedly reactive). Press [Enter]. Note: The MCV and/or RDW parameters may show trending through the shelf life of the product. Choose SPECIAL FUNCTIONS. If the problem remains. Abnormal I (yellow).3 mL. [F3] Control (SECONDARY). and technician initials. (14) Setting up a Latex control file Set up a file each time a new lot number is received. Press [F4] to print results for the logbook. perform a Shut-Down and Start-Up procedure. Select CONTROLS. do the following: (10) Bubbles in the flow cell or improper vial handling -. The aspirate probe for open vials will begin to aspirate the control. If an H or L displays. Cycle the Latron latex control again. CONTROL SET-UP. 5C-cell control also contains a stabilized. Select a NOT SETUP or an inactive file. Press and release the sample bar. SETUP. correct them by selecting SPECIAL FUNCTIONS. Press [F4]. If the LATEX FILE does not appear. If there are no H's or L's.Be sure the assigned values and ranges match the ones on the Latron package insert. SET UP.5C-cell control consists of treated.) The 5C-cell control is a hematology reference control used to monitor the performance of instruments with complete CBC and VCS differential technology. and stability -. The aspirate probe for open vials will begin to aspirate the primer. Remove vial when the audible "beep" occurs. Compare the results to the Assigned Mean Values and Expected Coefficient of Variation. CONTROL SET UP. (18) Storage. press [F3] Run. Run this control at the beginning of each session. Date and initial open vials. (11) Contaminated control. or past open vial expiration date -. handling. When stored at 2–8°C. Assigned channel. expected range. When Select Function appears on the status line. results are within range. if necessary. Cycle the control by immersing the aspirator tip completely in the vial. platelet-sized component. Abnormal II (pink) (PN 7547001 . change them to assigned values on assay sheet. and light scatter for the Diff Mode only. Enter the name of the file. Opened vials are stable for 13 days or 13 events when stored at 2–8°C. repeat the actions 2 or 3 more times.Rerun the primer and control. Remove vial when the audible "beep" occurs. Press [Esc] to remove the primer run. Page 19 of 32 . Potential biohazard -. Handle these reagents at Biosafety Level 2 because no test method can offer complete assurance that these and other infectious agents are absent. Try a new vial of Latron control. Be careful to avoid foaming. and %CV are automatically entered. (9) Examine the Mean Channel and Coefficient of Variation for volume.Store 5C-cell control at 2–8°C. (8) Run the latex control. If in error. (15) 5C Cell Controls Tri Pack contains Normal (blue). Press [F10] to save and exit. Check for H (high) or L (low) beside the results. (16) Principle -. Date and initial the open vials. and fixed erythrocytes to simulate leukocytes. sealed vials are stable at least until the expiration date shown on the Table of Expected Results. Cycle the primer by immersing the aspirator tip completely in the primer. If problem continues. LATEX FILE. then CONTROL RUN and press [Enter]. Mix gently according to directions. (Latex). Press [F3] Run [F4] Primer. If the control is still "out" of range. press [F2] File. Cycle the Latron primer again. Press [F7] to PURGE the flow cell. improperly mixed. Press and release the sample bar.The 5C cell control consists of human blood so repeated measurements to monitor daily performance of the instrument system is possible. Press [Esc] [F3] [F3]. stabilized human erythrocytes in an isotonic bacteriostatic medium. (12) ":::::" System detects a clog in the flow cell -. (13) Assigned value or range is incorrect -. Check entries.Wipe the aspirator tip.9 × 3. call a Beckman Coulter representative for assistance. Select the LATEX FILE.Press [F3]. Lot #. expiration date. conductivity. Results should be less than 500. Evaluate primer results.

Try another vial or level of control. The lot number is now entered. Select SAMPLE ANALYSIS. However. Select CONTROLS. Repeat for other levels of controls. Do not confuse this pink color with deterioration of the product. SPECIAL FUNCTIONS.Inability to obtain expected values without known instrument problems or gross hemolysis (darkly colored supernatant) indicate product deterioration. Select a NOT SET-UP or an inactive file. Select CBC DIFF/FILE. (Values 2-10) (36) Manually select and enter Shift and Operator ID.Choose the correct section of the package insert to scan making sure to select the part with the correct Unit Format (US). (32) Place the wand in section 1. a slight pink color to the supernatant is normal. for the correct instrument (MAXM). (22) Identify the sample by holding the bar code label in front of the reader. Check for H (high) or L (low) beside the results. Complete the entire procedure and return the controls to the refrigerator within 30 minutes. continue with the following actions. (23) Check the results of each control. (30) Using bar code scanner Scanning bar code units -. press [F9] STOP. SET UP. Use [F2] to select another file and repeat actions. Press [F10] to save and exit.Rerun the control. (29) Setting up a CBC/Diff control file Set up a file whenever receiving a new lot number of control.Follow instructions and rerun control.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 (19) Indications of instability or deterioration -. SET UP. To print results for the logbook for the last control run. OR REPORT and [F2] to select a file for review. (37) Manual entry Page 20 of 32 . rocker. (33) Gently slide the wand back and forth over the bar code until the instrument beeps. press [F4] Print. Make sure the DIFF is on. REVIEW. Choose SPECIAL FUNCTIONS. (31) Hold the wand like a pencil. (35) Follow the same procedure for the expiration date and assigned values. Gently invert the tube eight times. If in error. results are within range. (27) Change in the control -. Review and print reports for all three controls and file in the logbook. or mechanical mixer. If there are no H's or L's.Watch for normal sample flow. After warming. Read this section first. Invert the tube and slowly roll it again eight times. If it is still out. (20) Instructions for use -. Enter information manually if necessary. Check all entries to make sure they are correct.Make sure the assigned values and ranges match those on the control package insert. and CONTROL SET-UP. Is “SAMPLE MODE?” displayed? If no. correct them by selecting. (21) Run the 5C-cell control in the Primary Mode of the instrument. Enter information using the bar code wand. If it is off. press [F6]. Lot No. If a H or L displays. Press [Enter]. mix by hand as follows: Do not use a rotator. (26) Chance (statistical outliner) -. Start and end each scan in the white space. Press [F2] START PRIMARY. RUN SAMPLES. (25) Control files set-up incorrectly -. Call Beckman Coulter representative to help troubleshoot abnormal operation. Roll the tube slowly between the palms of the hands eight full rotations in an upright position. Repeat these actions again. Enter control package insert information for control with differential.Remove 5C cell control tubes from refrigerator and warm to ambient temperature for 10–15 minutes. consider the following reasons and perform and document the following actions: (24) Improper mixing -. CONTROL SET UP. (28) Instrument change -. Choose one control file and [Enter]. (34) Beckman Coulter's expected ranges appear automatically when the control lot number is entered in an empty file. Place the control in the carousel.

Are you sure you want to delete?" No. Use ↓ and ↑ to select the correct file. Abnormal I. Print. [←] [→] Press [←] or [→] to see parameters not currently displayed on the screen. review. [F9] Menu Displays the main menu. Press [↓] at the end of each row. and delete cumulative statistics and graphs for all CBC/DIFF and LATEX files at the end of each stand after transferring information to the IQAP disk and file in the logbook. Enter the expiration date. and sending them to Page 21 of 32 . or. [F4] Print Prints the entire control file in a line list format on 8. A DEL appears in place of the run number. (42) Latex control review and report (43) Use this report to review and print control results and cumulative statistics and histograms for LATEX files. The statistics recalculate. Press the space bar to select Yes or No [←] [→] Press [←] or [→] to see parameters not currently display on the screen. The statistics recalculate. transferring them to a disk. Press [F4] to print. Continue to select each file in turn. Press [Enter]. (44) Screen-specific function keys: Press [←] To go back to DIFF Latex Control Review [F2] File Displays all available files. and [Enter]. [F9] Menu Displays the main menu. shifts. [F8] Delete File Deletes the current control file. and file. Normal. troubleshooting. Press [F2] to select one of the following files. if necessary. [F8] Delete File Deletes the current control file. Select CONTROLS. A DEL appears in place of the run number.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 Enter lot number. The IQAP program includes saving results of 5C Cell controls. (40) CBC/DIFF control review and report (41) Use this report to review and print control results and cumulative statistics for CBC files. Abnormal II. Pressing [F6] restores the run and original statistics. Displays a message "You have asked to delete ENTIRE control file. and Latex [Enter]. Use ↓ and ↑ to select the correct file. cumulative statistics and histograms for LATEX Files or Check cumulative results for trends or shifts as necessary for troubleshooting. The system automatically enters the level and default ranges based on the first two digits of the lot number. REVIEW OR REPORT. This enters the IQAP number automatically. (45) Interlaboratory Quality Assurance Program (IQAP) All instruments participate in Beckman Coulter's IQAP program. Review and file in logbook. cumulative statistics and graphs for CBC/DIFF files or Control results. print. and operator code. Press [Enter]. Press [F10] to save and return to the previous screen. [F6] Remove/Restore Removes a highlighted run from the calculations. Pressing [F6] again restores the run and original statistics. Press [Enter] after each entry. Screen-specific function keys: [F2] File Displays all available files. Are you sure you want to delete?" No. Check cumulative results to look for trends.5 x 11 in paper. [F6] Remove/Restore Removes a highlighted run from the calculations. Continue to enter the package insert data. Check to make sure all entries are correct. [F4] Print Prints the entire control on a graphic printer. shift. (38) Control statistics and graphs (39) Use to review and print: Control results. Displays a message "You have asked to delete ENTIRE control file. Press the space bar to select Yes or No.

press the eject button on the lower right of the diskette drive opening.5. START and END indicate beginning and end dates for each file. (52) Label the diskette with the supplied IQAP ID label. 87 and 88 refer to 5C Cell Controls. (48) Turn the computer OFF. the DMS displays the list of possible files on the screen for review and selection. MCH. Review. MCH. Perform this procedure at the end of each stand. print. SHIFT refers to the shift designation selected for running the controls. Target values are MCV = 88. Review and print the XB current batch at the beginning on each session when printing the 5CCell control results. Any alteration to this screen will affect only data on the IQAP diskette. who compares the results to other laboratories. and delete the Batch Means at the beginning of each week when performing the weekly laboratory QC and at the end of each stand. and MCHC parameters of SP samples. edit or delete the fields on this screen. a screen message will give instructions to follow. (46) Procedure to download IQAP files to diskette. Edit this field if necessary. Screen-specific function keys: Page 22 of 32 . or when a lot expires. Review. These fields are not editable. and press [Esc]. Wait 15 seconds. not in the MAXM computer. The MAXM calculates MCV. Select SAMPLE ANALYSIS. (49) The screen will indicate the process the system is performing. Evaluate the percentage difference from the target limit to determine whether the batch is in or out of control.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 Beckman Coulter.5. This method displays the moving average of SP samples and compares it to established target values. Prefixes 86. MCH = 29. Do not remove the diskette until the drive indicator light is off. and file the CoulterXB current batch at the beginning of each session when printing the 5CCell control results. When the process is complete. (53) XB analysis (54) XB analysis is a QC method monitoring instrument performance by tracking the MCV. (55) XB batch means: Use to view the calculated means for the last batch of 20 SP results. select [F5] Optns on the RUN SAMPLES screen. Follow these instructions and the computer will reboot to the routine program. follow the instructions on the bottom left portion of the screen. Press [F2] [F4]. (47) Slide the diskette into the drive with the arrow side up and pointed toward the drive in the Beckman Coulter Data Management System. If some of the values are incorrect. and then turn the computer back ON. After downloading and printing results. Gently push the diskette until it clicks into place. print. Read the instructions on the screen. the following screen message will appear. Beckman Coulter issues a report that contains a statistical analysis to evaluate performance. REPORT indicates whether IQAP will issue a report on the lot number. and MCHC = 33. file. and MCHC means. and CURRENT XB BATCH. XB. Follow procedure for CBC/DIFF and Latex control review and report. (50) FILE_NAME indicates the files by file number for downloading to the diskette. "Updating the IQAP Disk. These indices are very stable and show little variance between SP samples. A screen will appear showing the Beckman Coulter Corporation logo.5. Do not place the label over the drive spindle or high-density hole. ▪ ▪ ▪ ▪ ▪ LOT_# indicates the type of control. Use arrow keys to position. To remove the diskette. N_REC indicates the number of records found in the file. (51) Press [Esc] to leave this screen. delete control files [F8]. If the IQAP# and Serial# are present and valid." After writing the control files to the diskette. Place the diskette in pre-addressed mailer provided and mail. To change the status of XB. To exit this screen. Print and file in logbook.

Controls contain one each of Ultra Low Range.) Handle these reagents at Biosafety Level 2 Page 23 of 32 . Run either the Lin-Cor CAP LN9 survey material: ▪ ▪ At installation At least yearly Whenever experiencing an altitude change of 1 mile or more between stands ▪ (59) Principle . print. To ensure the accuracy of linearity control ranges. make a copy for the logbook. stabilized. file. Low Range.5 x 3. File in the logbook. (56) XB Graphs Review. Linearity controls also contain a stabilized platelet-sized component. Fill out the CAP result form. Select SAMPLE ANALYSIS.3-mL) The Lin-Clinearity controls verifies the reportable range of Beckman Coulter hematology systems that use both Isoton III diluent and Lyse S III diff lytic reagent. Storage of the control product in a cap down position might require additional mixing or complete resuspension of cellular components. and delete the Batch Means and graphs at the beginning of each week when performing the weekly laboratory QC and at the end of each stand. Beckman Coulter system calibrates with S-CAL calibrator. (58) Linearity for WBC. [←] [→] Press [←] or [→] to see parameters not currently displays on the screen. and Plt. Lin-Cverifies ranges for the following parameters: WBC.Ship Lin-Ccontrols in thermally insulated containers designed to keep kits cool. and send results to CAP. and stability -. [F6] Delete Last Batch Deletes the last batch. and [F4] to print. and Ultra High Range. [F8] Delete Table Deletes the entire table.Each human donor used in preparation of this material was tested by an FDA approved method for the presence of the antibodies to Human Immunodeficiency Virus (HIV) and Hepatitis C (HCV) as well as for Hepatitis B surface antigen and found to be negative (were not repeatedly reactive. handling. (61) Storage. Fill out the CAP result form.These materials are shipped twice per year and consist of 18 3-mL liquid specimens. (57) Proficiency testing Evaluation and participation in the College of American Pathologist (CAP) proficiencytesting program is part of the comprehensive quality control program. Hgb. (60) Reagents -. Run specimens in a manner identical to routine specimens. RBC. and fixed erythrocytes to simulate leukocytes. [F9] Menu Displays the main menu. Follow all CAP instruction in preparing the materials before performing the test. and send results to CAP. Hgb and Plt parameters Lin-C(PN 7547065 . XB. Store Lin-Clinearity controls between 2–8°C (35–46°F). Delete only if the batch is badly skewed because of nonrandom sampling or an instrument problem that it will adversely affect many later batches.Lin-Clinearity controls are human blood components from which repeated measurements verify the reportable range of Beckman Coulter hematology systems. Store vials in an upright position to achieve maximum product yield. human erythrocytes in an isotonic bacteriostatic medium. Mid Range.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 [F4] Print Prints the table. XB GRAPHS. RBC. High Range. These survey materials are shipped three times per year and consist of 5 3-mL whole blood specimens. Follow all CAP instruction in preparing and running the materials before performing the test. make a copy for the logbook. OR CAP Hematology Calibration Verification/Linearity Survey (LN9) .Lin-Ccontrols consist of treated. Potential biohazard -.

(69) Compare the mean value to the linearity control ranges listed on the Table of Expected Results on the package insert. press [F9] STOP. (70) Plot the instrument background count as a zero value to extend the reportable range. When ---. After warming mix by hand as follows: Do not use a rotator. (62) Indications of instability or deterioration -. and *V will occur.. (67) Run the Lin-C controls in the Primary Mode of the instrument. (64) Turn the blood detectors off to analyze the Ultra Low Range. (65) Disable the differential before analyzing Lin-Clinearity controls. Delete the first sample result. Is “SAMPLE MODE?” displayed? If no. or mechanical mixer. Controls expire 7 days after opening. Gently invert the tube eight times. OPERATOR OPTIONS.Inability to obtain expected values without known instrument problems or gross hemolysis (dark colored supernatant) indicates product deterioration. flags such as L. RR. Ignore Beckman Coulter histogram differential flags and results. CALBRATION. rocker. BSV TESTS. (63) Instructions for use -. and REPRO-DUCIBILITY. and BLOOD DETECTOR ON/OFF. DIAGNOSTICS. Hgb. Select SPECIAL FUNCTIONS. LL. HH. Beckman Coulter will prepare tabular summaries and graphic presentations of the data. (68) Beckman Coulter recommends that five sample results should be used to calculate the mean value.(voteout). Press [Enter].O BOX 169015 Miami. Invert the tube and slowly roll it again eight times. Use the ranges established by Beckman Coulter Corporation as a guideline. RBC.. FL 33116-9015 Page 24 of 32 . (incomplete computation) or ++++ (over range) flags occur.Remove Lin-Ccontrols from refrigerator and warm to ambient temperature for 10–15 minutes. Analyze controls six times and record the results for WBC. If it is on. press [F6]. Use space bar to select ON or OFF. *R. Plot mean recovered values on the Lin-C linearity control graphs.. Mean values should recover within the ranges. *. Press [Enter]. and Plt parameters for each sample on the worksheet. . Do not confuse this pink color with deterioration of the product. Press [Enter]. Press [F2] START PRIMARY. Make sure the DIFF is off. A slight pink color to the supernatant is normal.. Repeat flagged samples with non-numeric results. Submit the top copy of the worksheet to IQAP at the following address: Beckman Coulter Corporation IQAP (M/C 31 B04) P. Use a minimum of three samples to calculate the mean when repetitive results with nonnumeric values occur. Roll the tube slowly between the palms of the hands eight full rotations in an upright position. Select SPECIAL FUNCTIONS. H.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 because no test method can offer complete assurance that these and other infectious agents are absent. the sample should be repeated. Ignore these flags if a numerical result is obtained. R. Repeat these actions again. (66) When analyzing Lin-C linearity controls.

"Do you want to create an average based on a single run?" To record a "Yes" response. Evaluate each parameter for error. To Page 25 of 32 . evaluate XB for a drift. use the mouse to the No button and left click.2 fL 23 x 103 0.2 x 103 0. NE#. EO# and BA# are calculated and evaluated to determine if the differences are within the following CDC established precision limits.2 x 103 If RBC parameters are out of range. Evaluate and save results when precision limits are not exceeded. To save the results to the database. they are erased from the screen. Plt. Whenever a sample is run in duplicate. Evaluate results for all parameters. B. Running samples in duplicate. Review all results to make sure the hemoglobin and hematocrit are acceptable. evaluate the possibility of an instrument malfunction. Interpretation of Results and Remedial Action A. CDC-established precision limits: Test WBC RBC Hgb MCV Plt NE# LY# MO# EO# BA# Precision Limits 0. After results are saved. Run all samples in duplicate and average the data.1 x 106 0. LY#. it is acceptable to average and save only one run.4 g/dL 2. or press [Enter]. To average these two results. The hematocrit should be approximately three times the hemoglobin. If there are no checkmarks in the Precision column (no precision limit was exceeded). MCV. use the mouse to direct the mouse arrow to the Average Selected ID box and left click. A warning message text box displays that states. If a Yes response is recorded. If drift is evident. use the mouse to the Save button and left click or type [Shift] [S/s]. Run samples in duplicate whenever possible. or type [N/n]. Sample Person hemoglobin and hematocrit review and remedial actions. Hgb. RBC. and precision checkmarks. To record a "No" response. save the results to the database. the Comment box at the bottom of the window defaults to "result based on single run. "You have downloaded only one (1) run from the CoulterMAXM for SPID XXXXXX" and asks.2 x 103 0. If the whole blood is insufficient. use the mouse to Average ID#XXXXXX button and left click. use the mouse to the Yes button and left click or type [Y/y]. If any WBC differential absolute number is out of range.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 11. both results display in the SP Data section. The difference between duplicate values for WBC. the CBC results display in the bottom Results section of the window. check the WBC scattergram for abnormal cell population(s). overlimit." C. and "H" or "L" action limit and reference range flags. To save results where only one run is possible.4 x 103 0. For results where only one run was possible. A "No" response cancels the action and returns the window to its previous state. MO#.2 x 103 0.4 x 103 0.

the technologist is prompted to run a control and evaluate the control to determine if all control values fall within the control's established range. Reaverage. Whenever a sample is run more than once. Use the scroll bar to view all results." Run any one level of 5CCell control and evaluate the results. If there is insufficient blood to run the CBC a third time. use the mouse to direct the mouse arrow to each of the two check boxes and left click to record the check marks. and "H" or "L" action limit and reference range flags. If after four runs precision limits are still not met for any parameter. save the result to the database. The first three runs are recalculated to find the closest two results for parameters where the difference between any two results exceeded its precision limits. Save the responses to the check box questions. save the results to the database. and rerun specimens that exceed precision limits. and precision checkmarks. rerun the blood sample a third time. Evaluate each parameter for error." It instructs the technologist to "Please run a successful control for Session ID XXXXXX. Evaluate each parameter for error. When there are checkmarks in any of the Precision columns. To re-average these results. use the mouse to the Close button and left click or type [Shift] [C/c]. evaluate. and "H" or "L" action limit and reference range flags. and then run another sample for SP ID XXXXXX. To save the result to the Page 26 of 32 . Do not run a specimen more than four times. In general. meaning that the precision limit was exceeded. If there are no checkmarks in the Precision column (no precision limit was exceeded). run the specimen a fourth time and evaluate. If all parameters now meet precision limits (there are no checkmarks in the Precision column). The Hematology module will display data for multiple SPs in the SP Data section. evaluate. "Did you run a control run?” and "Were all control values within established range?” To confirm these actions. overlimit. The Hematology Control Run window indicates that the "Samples for SP ID XXXXXX are outside the defined precision limits. If any parameter exceeds its precision limit. run one SP in duplicate through the Coulter average the result. run the blood tube a fourth time. precision limits are exceeded for any individual parameter. Average the two results by using the mouse to direct the mouse arrow to the Average ID#XXXXXX button and left click. the Hematology Control Run window displays. Override the current averaged results for parameters that exceeded the precision limit with a new average.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 exit without saving the result to the database. Average. do so and save the result to the database. The initial averaged result for parameters that do not exceed precision limits are fixed and are not recalculated. and save the results. Run the blood sample a third time. If precision limits are still not met for any parameter. overlimit. use the mouse to direct the mouse arrow to Average ID#XXXXXX button and left click. a comment is automatically attached to the results. and save the data to the database. If necessary. and precision checkmarks. Each individual SP's results or pairs of results are displayed in a different color. Respond to the two questions. all results in the SP Data section are displayed. If at this point.

evaluate.. and MCHC results. or Plt result is +++++. NE#. use the mouse to the Save button and left click or type [Shift] [S/s].00 x 106 cells/μL Plt ≥1000 x 103 cells/μL If the WBC. Hgb. Monitor the aperture-viewing screen when cycling specimens that are likely to contain fibrin or debris. evaluate the control results. If there are any Precision checkmarks. re-average. If Hgb is over range an R appears next to MCH. then MCH. May indicate an erroneous result due to aperture blockage or lack of mixing bubble Appears next to parameter derived from the parameter with the single count period voteout "+++++" for parameter results Result exceeds: WBC ≥100. D. Hct are "----" "*V" Incomplete or abnormal computation Sample integrity check failed. and RDW results. and save the results. MCHC. If MCV is over range an R appears next to Hct. The MAXM displays abnormal parameter results for all cell populations and values. If RBC is over range an R appears next to Hct. EO# and BA# are "••••" If RBC is "-----".).. The following table describes the display and cause for the parameter codes. MCH. MCH.ASP message displayed "-----" for CBC parameter results. RBC. RDW. MAXM parameter codes Review the message The Beckman Coulter MAXM uses triplicate counting with strict voting criteria. an R appears next to the RBC. MCHC. MPV.. Plt and Diff % results. It has proprietary flagging algorithms to confirm parameter results before reporting. Hgb. To exit without saving the result to the database.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 database. E. rerun the blood tube a third time. then LY#. use the mouse to the Close button and left click or type [Shift] [C/c]. A partial aperture blockage may cause erroneous results.. MO#. Page 27 of 32 . Hct. Display All Parameters "••••" for a single parameter result "••••" for all parameter results and PART. and MCHC results.0 x 103 cells/μL IMPORTANT RBC ≥10. MCV.. run a 5C Cell control. Diff parameters do not vote out Cause Single-count period voteout. and no average histogram for the affected parameter If WBC is "-----". such as WBC count lower than what is present. Results for Diff% are dots (. MCHC. The instrument may not detect a transient or partial aperture blockage by any of these processes. short sample or clot Total voteout (none of the three counts agreed). MCV ≥1000 run a blank cycle to prevent carryover If WBC is over range to the next sample.

nrbc. do not report them.000.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 If Plt is over range an R appears next to WBC. IMPORTANT If the WBC. J. RDW. MCH. Results or [F3] Edit. Specific suspect messages indicate some abnormalities that exhibit characteristic cluster patterns. or Plt result is +++++. or Plt. [F3] next sample. RBC Parameters "R" next to RDW result Excessive asymmetry in RBC histogram. RBC. MCH. RBC. Remedial action -. or Total voteout of fitted curve. Hgb. Plt. MCHC. Hct. also "R" next to RBC. also "R" next to Diff Check of WBC lower threshold failed. IMPORTANT Sample dilution may result in erroneous differential results. Rerun the specimen if any of the parameter flags occurs. There are three types of clogs: FC = Full Clog PC1 = Partial Clog 1 (partial clog in the flow cell or sample line) PC2 = Partial Clog 2 (partial clog in the sheath system) "+++++" for parameter results F. or Plt <20. "????" for Diff results Questionable data Plt Parameter "R" next to Plt and MPV result PDW >20% mode not between 3 and 15 fL. numbers Particles are present at the 35 fL threshold (Plt clump. I. These values are for review only. H. Hgb. beneath the definitive flag section. MAXM suspect messages Suspect messages flag an abnormal cell distribution or population. diff# and Pct results. malarial parasites) "R" next to Diff percentages and numbers Low differential count statistics. "*R" next to MCV. Suspect messages indicate the possibility of a particular abnormality. Physician review. Remedial action Review the result for the affected parameter. or WBC is over range. or non-positive curve detected. The system generates these messages according to an internal algorithm. Set DIFF to OFF before cycling the diluted sample when WBC is over range. Page 28 of 32 .Rerun the specimen. These messages occur also: Population message: ABNORMAL WBC POP Suspect message: REVIEW SLIDE ":::::"for Diff results System detects a clog in the flow cell. giant Plt. Not every atypical scatterplot has a corresponding suspect message. G. and MPV WBC Parameters "*R" next to WBC. Data Base Query displays average values run a blank cycle to prevent carryover to the for over range WBC. MCV below lower limit of<50 fL MCH. or WBC or MCV over range. lyse resistant RBC.

7-17.5-35.0-50.3 157-414 6. platelet count.10-5.7-11. granulocytes. WBC.5 224-568 6. Reference Ranges A. The Coulterderives MCV. The Coultercalculates HCT.1 4. monocytes. Abnormally small WBCs could affect white count.8-10. The following are possible interfering substances or conditions: ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ Abnormal BUN. platelet count. lymphocytes. Interfering Substances and Conditions Because the Coulterdirectly measures RBC.6 13. MCV.5-16.3-31.60 11. RDW.3 194-477 6. Cryofibrinogen and cryoglobulin crystals could affect white count.7-14.1-99. Giant platelets could affect white count. MCHC. Evaluate CBC result carefully and report all parameters except the hemoglobin result Nucleated RBCs could affect the white count. The physician determines if referral for the SP for treatment is necessary.00-5. granulocytes.4 31. granulocytes.4 17.5-13. An elevated WBC count could affect RBC. Severely icteric plasma causes increased hemoglobin.6 138-407 6.30 10. and MPV parameters.3 . MCV. monocytes.5-70.8 33.60 11. C.0 11. lymphocytes. and DIFF # parameters. Clumped platelets could affect white count.1 4.6 Page 29 of 32 19-65 3.7-33. 13.9 20.7-10.8-51.4 25.3-93.1-50. lymphocytes.0-16. and granulocytes. RBC. and Diff %.9-35.3 24.8 32. monocytes. B. and MPV. lymphocytes. platelet count. RDW. RDW. RDW.7 31. Results outside action limits flash and transmit to the physician immediately. and MPV from RBC or platelet histograms. platelet count.7-29.6-9. and granulocytes.6-88.8 67.80 12. and MPV. monocytes.2 78. Limitations of Method: Specimen Rejection.1 12.8-35.2 25.3 11.0 6-18 3.9-101. lymphocytes. lymphocytes. PLT. Fragile WBCs could affect white count.9 4. and hemoglobin values. RBC. 12. monocytes. hemoglobin.9-12. Specimen rejection Reject clotted specimens and recollect. Hgb.1-16.0-48.10-5. platelet count.00 . glucose or sodium levels could affect the MCV. Abnormal WBCs could affect lymphocytes.0-56.3-9.8-40. and MPV.3 34. Hemolyzed specimens could affect RBC. The MEC physician reviews and interprets all CBC results.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 K. granulocytes.1 38. Lipemic specimens could affect MCV.8 31. A.5.3-14.7-16. platelet count. monocytes.1 11. hemoglobin.3 78.6-34. and MPV.3 74. granulocytes. and MPV.4-48.2 21. Interfering Substances and Condition This method limits samples to human whole blood.7 31.3 4. MCH. RBC.8-15. Males WBC (x 103 μL) RBC (x 106μL) Hgb (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) RDW (%) Plt (x 103 μL) MPV (fL) LY (%) 1-5 4.0-35.0 24. MCV. it is most important to concentrate on analytes and substances that interfere with these parameters.8 66+ 3. hemoglobin.9-12. monocytes.

sepsis.1 11.70-5. non-Gaussian distribution. polycythemia.7-35.5 3.8 0-12 39.3 0-8 0-2 0-13 44.2 32.5 g/dL or >14.1 147-440 6.7-100.3-69. ▪ ▪ ▪ ▪ ▪ WBC male and female (all ages) < or = to 3 x 103 μL or > or = to 16.9-12.9 24. there is no reason to retest the sample.7-81. liver disease Low WBC -.0 79.2-74.6 172-453 6.5 g/dL Hgb female (>6 years) <6.0-88.0-46. malignancies Low platelets -.7 17.8 202-476 6.0 12.7-58.1 11.8 0-8 0-2 0-12 21.2 24.3-30.2 25.0 73.risk of bleeding High platelets -.5 0-12 32.5 0-10 0-2 0-12 33.8-35.5 g/dL or >18.0-79.7-10.7-51. thalassemia and other hemoglobinopathies Low MCV -.0-45.risk of thrombosis Page 30 of 32 . or HCT -.20 10.4 229-581 6.4-70.Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 MONO (%) NE (%) EO (%) BA (%) B.0 g/dL PLT male and female (all ages) <50 x 103 μL or >800 x 103 μL Possible causes of abnormal parameters: ▪ ▪ ▪ ▪ ▪ ▪ ▪ ▪ High RBC.4 3.50-5.8 31.6 22. through ranking the observations and determining the lower (2. Hgb. The nonparametric (ranking) method was used because most measured hematology parameters have a skewed.4-35.5th percentile) and the upper (97.5 32.0 18.acute stress.5.3 0-10 0-2 6-18 4.9-70.20 10.8 0-8 0-2 66+ 4.3 31.5th percentile) reference limits.0-12.2-31.6-35.0-40.2 0-11 0-2 19-65 3. Since all specimens are run in duplicate.2-13.5 0-12 21.7-77.5-13.4 74.6 3.8 15.9-10.0-16.9-77.4-15.0-12.4-43.4-15.7 0-11 0-2 0-12 39.20 11.anemia. 14. infection.5-93.3 23. shock.microcytic anemia High MCV -.5 g/dL or >16.90-5.1 0-13 42.dehydration. chronic hypoxia Low RBC.6-77.6 69. marrow hypoplasia High WBC -.6-14. Hgb or HCT -. 1-5 4.7 32.8-16.8 31.5-15.1 31.9 0-8 0-2 Reference ranges for normal values were calculated from NHANES III data set using 95% reference interval(s) determined nonparametrically.3-9.8-52.90 .0 11.7 33. Action Limits Action limits are a guide to inform the physician that a CBC result(s) is/are abnormal.3 3.1-14.9-33.4-98.20 10.macrocytic anemia.2-33.8-10.0 x 103 μL Hgb male and female (<6 years) <6. Females Age in Years WBC (x 103 μL) RBC (x 106μL) Hgb (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) RDW (%) Plt (x 103 μL) MPV (fL) LY (%) MONO (%) NE (%) EO (%) BA (%) C.0 g/dL Hgb male (>6 years) <6.

7. C. Swaim W. Use only numerical identifiers for SP results. 3. and Clinical Applications. Specimen storage Store specimens capped and place on a rocker at room temperature until processed. (1983). Villanova. Inc. 5. 9. Run within 24 hours of drawing." 18. December). Beckman Coulter MAXM Analyzer Special Procedures and Troubleshooting. Villanova. 16. Page 31 of 32 . (1992. Procedures for the handling and processing of blood specimens. PN 4235933H. 3. (1995. Corash L. Test Results Reporting System: Protocol for Reporting Action Limits Results outside the action limits are automatically brought to the physician's attention for a decision as to "course-to-follow. (1984). Vol. 1996:106. 6. Twedl D. PN 4235934J. 8. New York: Alan R. National Committee for Clinical Laboratory Standards. Villanova. Specimen Storage and Handling during Testing A. Monitor 5C Cell control results for bias and maintain results for the entire study period. Beckman Coulter MAXM Analyzer Use and Function. 210. Specimen Accountability and Tracking All records. (1985). (1984).Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 15. Gottfried E. Beckman Coulter MAXM Analyzer Operator's Guide. NCCLS document H15-A. (1995. NCCLS document H7-A. Wise. NCCLS document H18-A. 17. Diurnal change of blood count analytes in normal subjects. Current Topics in Hematology. including QA/QC data will be maintained for 6 years. 4. National Committee for Clinical Laboratory Standards. Store EDTA tube at room temperature for no more than 24 hours. References 1. PN 4235935J. Quality Control Summary Statistics and Graphs Chapter 10 in the Laboratory Procedures Manual (April 2001) includes a separate detailed description of the comprehensive quality control plan. PA. Procedure for determining packed cell volume by the micro hematocrit method. 2. National Committee for Clinical Laboratory Standards. January 21). Compare all three instruments CAP proficiency results. B. p. Platelet Sizing: Techniques. PA. Reference procedure for the quantitative determination of hemoglobin in blood. Biological Significance. Am J Clin Path. Geigy Scientific Tables. 19. Restore the instrument to functionality and then run the specimen.723–727. (1990). PA. Alternative Method for Performing Test or Storing Specimens if Test System Fails There is no alternative method for this test. Jones AR. January).

Complete Blood Count (CBC) with Five-Part Differential NHANES 2003–2004 10. and Brecher G. PA. 14. NCCLS document H3-A3. NCCLS document H26-A. Villanova. Federal Register. (1996). Wayne. Villanova. (1991). 1984:81. National Committee for Clinical Laboratory Standards. AJCP. 7164. 57: 40. 12. Procedures for the collection of diagnostic blood specimens by skin puncture. Threatte GA. National Committee for Clinical Laboratory Standards. PA. Rules and Regulations. Page 32 of 32 . NCCLS. Andrados C. February 28). p. (1992. 11. Procedures for the collection of diagnostic blood specimens by venipuncture. PA. 13. Mean platelet volume: The need for a reference method.769–772. Performance goals for the internal quality control of multichannel hematology analyzers. Standard 493-1211. (1991). Approved Standard. NCCLS document H4-A3. Ebbe S.