Standard Operating Procedure

Subject Complete Blood Count of Whole Blood on the Sysmex KX-21N

Index Number Lab-1535
Section Laboratory
Subsection Regional Clinic / Affiliate Hospital Laboratories
Category Departmental
Contact Rachel Blum
Last Revised 10/17/2018

References
Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers
for Medicare and Medicaid Services (CMS) and/or COLA.

Applicable To
Employees of Gundersen Health System clinical laboratories, Gundersen Palmer Lutheran Hospital and
Clinics Fayette Laboratories and Gundersen St. Joseph’s Hospital Laboratories.
Detail
PRINCIPLE:
The Sysmex KX-21N is a quantitative automated hematology analyzer for in vitro diagnostic use for
determining 17 hematological parameters. Examination of the numerical and/or morphologic findings of
the complete blood count are useful in diagnosis of such disease states as anemias, leukemias, allergic
reactions, viral, bacterial, and parasitic infections. The Sysmex KX-21N analyzer directly measures the
WBC, RBC, HGB, HCT, PLT, LYM#, MIXED# and NEUT#. The remaining parameters are calculated or derived,
MCV, MCH, MCHC, MPV, RDW-CV and RDW-SD, and differential percentages LYM%, MIXED%, NEUT%.

The KX-21N counts and sizes red blood cells (RBC) and platelets (PLT) using electronic resistance detection.
Hematocrit (HCT) is measured as the ratio of the total RBC volume to whole blood using cumulative pulse
height detection. Hemoglobin (HGB) is converted to methemoglobin, and read photometrically at 555 nm.

White blood cells (WBC) are analyzed by direct current and discriminated into a three-part differential
using Particle Distribution Analysis (PDA). The resulting WBC histogram is discriminated into lymphocyte,
neutrophil and mixed cell populations. The mixed cell population contains monocytes, basophils and
eosinophils.

SPECIMEN:
1. Required specimen: Whole blood anticoagulated with EDTA preferred.
2. Specimen volumes required: Optimal draw is a tube drawn to capacity. The collection tube should
be filled to a minimum of one-half full for acceptable results. An EDTA micro-container filled above
the 250 uL line is adequate for testing in the whole blood mode.
3. Unacceptable specimens including those listed below must be redrawn:
a. Clotted samples or those containing clots, fibrin strands, or platelet clumps. All specimens will
be checked visually for obvious clots prior to sampling by the analyzer.
b. Check capillary tubes manually with a toothpick for clots.
c. Grossly hemolyzed samples.
d. Samples drawn above an IV.
4. Characteristics that may affect test results are: lipemia, icterus, and cold agglutinins.

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 Standard Operating Procedure

5. Stored Specimen Stability

a. If stored at 4oC within 6 hours of collection, EDTA blood samples with normal results may be
analyzed up to 48 hours without significant loss of differential stability.
b. Sample stability at room temperature is 8 hours. Samples stored at room temperature may
exhibit an increase in MCV, and HCT, and a decrease in MCHC after 16 hours. These changes
may be minimized by refrigeration.
c. Capillary tubes are stable 4 hours when stored at 2-8oC (warm and remix before analyzing).
d. Allow refrigerated samples to come to room temperature for 30 minutes then mix by hand
inversion before analysis.
6. Do not place samples on a mechanical rocker. Constant rocking may cause PLT clumping and alter
white cell membranes resulting in inappropriate flagging.

WARNING: All patient specimens should be considered potentially infectious and must be handled with
precautions used for human blood, as described in CDC recommendations and in compliance with the
Federal OSHA Bloodborne Pathogen Standard, 29 CFR part 1910.1030. Follow specimen handling as
outlined by laboratory safety policy.
Recommended: Wear gloves, lab coat and safety glasses.

REAGENTS / MATERIALS:
Supplies
1. Deionized water
2. Lint-free, plastic lined lab wipes
3. "filler" pipette supplied with the unit or a 5 cc Syringe.
4. Clorox Ultra bleach (Use when Cellclean is indicated)
5. Sysmex reagents
6. Tri-level commercial controls, Eightcheck-3WP X-TRA
7. Sysmex SCS-1000 whole blood calibrator.
8. To ensure that the new reagent is completely cycled into the system, cycle the KX-21N analyzer 10
times before running controls and/or patients.
9. Run 2 levels of commercial QC to monitor reagent performance. Document QC “OK” on reagent
log.

Sysmex Reagents
1. A diluent, a hemoglobin/WBC lyse, and bleach are used on the Sysmex KX-21N analyzer. Reagents
and bleach are stored at room temperature and are to be used within the manufacturer’s
expiration date on each container.
2. Record date received, date opened and date expired on container. Record the lot, date and
expiration date on the Reagent Replenishment Record.
3. The reagents are azide free, and intended for in vitro diagnostic use only, DO NOT INGEST.

CELLPACK is a whole blood diluent for use in the determination of hemoglobin and electric counting and
sizing of blood cells.
Cellpack Active Ingredients
Sodium Chloride 6.38 g/L
Boric Acid 1.00 g/L
Sodium Tetraborate 0.20 g/L

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 Standard Operating Procedure

EDTA-2K 0.20 g/L

Cellpack Storage
1. Store at a controlled temperature of 15-30oC,
2. If frozen, thaw, mix thoroughly, and allow bubbles to disperse before use.
3. Cellpack is clear and colorless. If there are signs of contamination, instability or color change, do
not use.

Cellpack Stability
1. Unopened, 18 months after the date of production marked on the box.
2. Opened, Cellpack is stable for 60 days.

Cellpack Hazard Risk:

The OSHA hazard Communication Standard of 29 CFR part 1910.1200 requires MSDS documentation of
ingredients which have been determined to be health hazards, comprise 1% or greater of the composition,
are physical hazards, are capable of release to exceed permissible exposure limit/threshold limit values or
have been identified as carcinogens. Cellpack does not have ingredients with those characteristics.

STROMATOLYSER-WH:
Lyses RBCs for accurate measurement of Hgb, and enumeration of the WBC count and three differential
population.

Stromatolyser-WH Active Ingredients:

Organic quaternary ammonium salt 8.5 g/L
Sodium Chloride 0.6 g/L

Stromatolyser-WH Storage:
1. Store at controlled room temperature of 18-25oC.
2. If frozen, do not use.
3. Stromatolyser-WH is a clear, odorless liquid. If there are signs of contamination, instability, or
color change, do not use.

Stromatolyser-WH Stability:
1. Unopened, 12 months from the date of production marked on the box.
2. Opened, Stromatolyser-Wh is stable for 90 days.

Stromatolyser-WH Hazard Risk:

The OSHA Hazard Communication Standard of 29 CFR part 1910.1200 requires MSDS documentation of
ingredients which have been determined to be health hazards, comprise 1% or greater of the composition,
are physical hazards, are capable of release to exceed permissible exposure limit/threshold limit values or
have been identified as carcinogens. Stromatolyser-WH does not have ingredients with those
characteristics.

CAUTION: Avoid contact with skin and eyes. In case of contact with skin and eyes, flush with plenty of
water immediately. Consult with a physician in case of ingestion and/or eyes contact.

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 Standard Operating Procedure

CLOROX Germicidal bleach is recommended for use in cleaning and shutdown of the KX-21N analyzer
whenever Cellclean is indicated. See “Maintenance” section, page 12, for instructions to prepare a 5%
Clorox bleach solution as recommended for use by Sysmex.

Clorox Ingredients: Sodium Hypochlorite 8.25%

Clorox Storage: Store at room temperature (15-30oC) protected from light.

Clorox Stability: Stable under normal use and storage conditions.

WARNING: Avoid acidification or contact with ammonia containing products that can generate hazardous
chlorine gas.

Clorox Health Risk:

WARNING: Clorox contains a strong oxidizing agent. May irritate skin. Contact with eyes can cause severe,
but temporary injury to the eye. May cause nausea and vomiting if ingested. Exposure to vapor or mist
may irritate nose, throat and lungs.
Recommended: Wear gloves, a lab coat and safety glasses for protection.

EIGHTCHECK-3WP X-TRA
EIGHTCHECK-3WP X-TRA is a tri-level whole blood commercial control for use with the Sysmex KX-21N
hematology analyzer.

EIGHTCHECK-3WP X-TRA Ingredients (formulation)

EIGHTCHECK-3WP X-TRA consists of stabilized human erythrocytes, human and simulated leukocytes and
a platelet component in a plasma-like fluid. Each vial contains 2.0 mL of control material.

EIGHTCHECK-3WP X-TRA Storage

1. Vials should be stored in the upright position, at 2-8oC
2. DO NOT freeze or expose to excessive heat.

EIGHTCHECK-3WP X-TRA Stability

1. Unopened and properly stored, EIGHTCHECK-3WP X-TRA is stable until the expiration date stated
on the vial.
2. Open vial stability is 14 days when promptly refrigerated after each use.
3. Record the date on each vial upon opening. (Date opened and date expired)
4. Heat or freezing can damage EIGHTCHECK-3WP X-TRA without gross visible changes. Moderate
hemolysis can be normal. Deterioration is suspected when the mean of the control results is not
within the assay expected ranges after appropriate troubleshooting.
5. If deterioration is suspected, call the Sysmex Diagnostics Customer response Center at 1-888-879-
7639 (1-888-8SYSMEX).

Warning: Potentially Infectious Material.

The Human blood used in EIGHTCHECK-3WP X-TRA is non-reactive for Hepatitis B Surface Antigen and
negative for antibodies to HIV-1, HIV-2, and Hepatitis C Virus using FDA specified techniques. However, no
current tests can assure the absence of these pathogens EIGHTCHECK-3WP X-TRA should be considered

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 Standard Operating Procedure

potentially infectious and must be handled with precautions used for human blood as described in CDC
recommendations and in compliance with the Federal OSHA Bloodborne Pathogen Standard, 29 CFR,
1910.1030.

SCS-1000 CALIBRATOR:
Whole blood calibrator for use with the Sysmex KX-21N hematology analyzer. Assay values for primary
parameters are traceable to reference methods.

SCS-1000 Ingredients (formulation)

SCS-1000 consists of human red and white blood cells with a platelet component suspended in fluid
medium. Each vial contains 2.0 mL of calibrator material.

SCS-1000 Storage
Store vials in the upright position, at 2-8oC. DO NOT freeze or expose to excessive heat.

SCS-1000 Stability
1. Unopened and properly stored, SCS-1000 is stable until the expiration date stated on the vial.
2. Open vial stability is 4 hours.
3. Storage outside of 2-8oC can damage SCS-1000 causing deterioration that risks inaccurate
calibration. If deterioration is suspected, call the Roche Diagnositcs Customer Response Center at
1-888-879-7639 (1-888-8SYSMEX).
4. Use of the product at environmental temperatures that exceed 30oC (86oF) can reduce calibration
accuracy.

Warning: Potentially Infectious Material.

The Human blood used in SCS-1000 is non-reactive for hepatitis B Surface Antigen and negative for
antibodies to HIV-1, HIV-2, and Hepatitis C Virus using FDA specified techniques. However, no current tests
can assure the absence of these pathogens. SCS-1000 should be considered potentially infectious and
must be handled with precautions used for human blood as described in CBC recommendations and in
compliance with the Federal OSHA Bloodborne Pathogen Standard, 29 CFR, 1910.1030.

Reagent Replacement:
When the reagent level is low, "Not Ready" displays on the LCD and instrument operation stops.
1. Press [HELP]. Either "Replenish Diluent container" (Cellpack) or "Replenish Lyse container"
(Stromatolyser-WH) appears.
2. Open the new reagent container.
3. Using care to not contaminate the reagent line, remove the line from the empty container and
drop it directly into the new container.
4. Tighten the spout cap on the new container.
5. Record the open date and the open expiration date on the reagent box or bottle.
6. Press [1] "Asp. Reag.". Once the reagent is replenished, a background count is automatically
performed.
7. Record the reagent open date and the open expiration date on the reagent log.
8. Run 2 levels of commercial QC to monitor reagent performance. Document commercial QC "OK"
on reagent log.

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 Standard Operating Procedure

CAUTION: Wear gloves and lab coat and safety glasses when replacing reagents.

EQUIPMENT / INSTRUMENTATION:
KX-21N

Calibration:
Initial calibration is performed during installation and verified bi-annually during preventive maintenance
(PM) by the Sysmex Diagnostics Field Service Representative. Calibration compensates for any bias
inherent to the pneumatic, hydraulic and electrical system that may affect the accuracy of results.
Calibrators traceable to reference methods are used in the calibration of the instrument. WBC differential
parameters are calibrated in the factory prior to shipment, and verified by the field service representative
upon installation. The laboratory must verify calibration every 6 months or on an "as needed" basis to
ensure accuracy of system. Calibration is also required if one or more of the following occur:
1. Critical parts are replaced such as manometers, apertures or detector circuit boards.
2. Controls show an unusual trend or are outside of acceptable limits and cannot be corrected by
maintenance or troubleshooting.
3. When advised by Sysmex Diagnostics Field Service Representative.

Calibration verification may be performed by review and documentation of all three levels of commercial
control, proficiency testing results and patient control testing results. The operator may calibrate HGB and
HCT with normal fresh whole blood, or use SCS-1000 calibrator to calibrate WBC, RBC, HGB, HCT, and PLT.
Before calibration, ensure that the KX21N is both clean and precise.

Precision Check
1. Perform routine daily and weekly maintenance on the instrument, and perform a background
count to ensure counts are within acceptable limits.
2. Verify that there is sufficient volume of all reagents. Precision and Calibration procedures will be
aborted if the KX-21N runs out of reagent.
3. Obtain a sample of fresh normal whole blood. Do not use commercial controls or calibrators for
precision. The blood donor specimen should:
a. Be free from medication and interfering substances such as lipemia, icterus, platelet
clumps, etc.
b. Have morphologically and numerically normal CBC such as, WBC >4.00, RBC >4.00, PLT
>100, HGB >10, HCT between 35.5 – 55.5%.
c. Be drawn in EDTA anticoagulant tube using proper collection technique.
d. Minimum of 2 mL of sample.
4. Precision Check Specimen Analysis
a. Press [Select].
b. Press [3] Calibration.
c. Press [3]
d. Analyze the sample 11 times in the whole blood mode. The precision is determined on
the last 10 replicates, excluding the first analysis. If an error occurs during analysis, the
result is masked with “---.-“, and the next sample result replaces the error results.
e. After all 10 results are displayed, press [>] key to view the mean SD, and CV%. Press the
[<] to return the analysis results. This screen cannot be printed, record the precision
results for your records.

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 Standard Operating Procedure

f. If the CV%’s for all five parameters are within the limit % shown on the screen, the [1]
Calibration option appears to allow calibration using the SCS-1000 calibrator. If the CV%
exceed acceptable limits, press [3] Cancel to cancel calibration.

Calibration of WBC, RBC, HGB, HCT, and PLT

1. After the Precision Check is completed, press [1] Calibration.
2. Using the numeric keys, enter the Assay Target values from the Sysmex SCS-1000 Calibrator
product insert for WBC, RBC, HGB, HCT< and PLT on the “Analyzing Calibrator” screen. Press
[Enter] after each value. Press [C] to clear any entry errors.
3. Press [Select] after all five values have been entered correctly.
4. Use [< or >] keys to select “Set”, then press [Enter].
5. Analyze the SCS-1000 calibrator in the open mode six times. If an error occurs during analysis, the
result is masked with “---.-“, and the next sample result replaces the error results.
6. After all six analyses are displayed, press [< or >] keys to view the results.
7. “Current” is the present compensation value in the KX-21N. “New” is the proposed compensation
value.
a. If “Delta %” is less than the “ACPT LMT”, no adjustment to calibration is necessary.
b. If “Delta %” is greater than “SERV LMT”, calibration is not allowed. The instrument may
require service.
c. If “Delta%” is greater than “ACPT LMT”, “New” is the proposed change of the
compensation value, and a new calibration can be updated.
8. Press [Select]. New compensation values are calculated “Change?” appears on the screen.
9. Press [< or >] to “Yes to update the calibration value and return to the Analysis screen.
10. Press [Enter].
11. Using another fresh vial of the calibrator, verify the calibration by repeating the Calibration Check
steps 1-5. The judgment should be that no adjustments to calibration are necessary. Do not
execute calibration; exit the Calibration function.
12. Analyze the commercial controls.
13. Document the date of calibration and new calibration factors.

Auto Cal of HGB and/or HCT with whole blood performed by Sysmex Service Representative.
WARNING: Potential biohazard exposure when handling open patient specimens. Follow Standard
Precautions outlined by laboratory safety guidelines.
Recommended: Wear gloves, lab coat, and safety glasses. Use plastic lined lab wipes when opening.
1. Obtain five samples from five normal subjects, using the same criteria for these samples as for the
Precision Check.
2. Perform reference micro-hematocrits on the five normal samples in triplicate. Average each set of
three values, and record the averages of each sample. See NCCLS "Procedure for Determining
Packed Cell Volume by the Microhematocrit Method (H7-A)".
3. If hemoglobin is to be calibrated, perform hemoglobin analysis on the five samples, in triplicate,
using the cyanmethemoglobin reference method. Average each set of three values, and record
the averages of each sample. See NCCLS "Reference Procedure for the Quantitative Determination
of Hemoglobin in Blood (H15-A)".
4. Press [SELECT] when analyzer is in the "Ready" state.
5. Press [3] Calibration, and [ENTER].
6. Press [1] Auto Cal, and [ENTER].

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 Standard Operating Procedure

7. Select which parameters will be calibrated, by pressing [1] HGB, [2] HGB/HCT, or [3] HCT.
8. Enter the averages of the reference values for the five samples in the column for the parameter to
be calibrated, pressing [ENTER] after each value. Press [C] to clear any entry errors.
9. Press [SELECT].
10. Press [< or >] to select "Set", and press [ENTER].
11. With the system at 'READY", analyze the five samples in the same sequence as the reference
values entered for the HGB and/or HCT. The compensation % is calculated for each specimen
using the formula: Compensation % = 100 X (Reference value/KX-21N value)
12. Press [Select]. New compensation values are calculated using the formula: New Calibration =
(Current Calibration X Average compensation %)/100
a. If the average compensation % is greater than 5.0%, or if the new calculated
compensation value is greater than 20% different from the previous, a "Calibration Error"
displays and the calibration cannot be updated.
b. Verify the reference and analyzed values before updating the calibration.
13. If calibration is within range, "Change?" appears on the screen. Press [< or>] keys to select "Yes",
then [ENTER] to update the calibration value and return to the Analysis screen.
14. Analyze the same samples again on KX-21N. The results should not differ significantly from the
reference values.
15. Analyze the commercial controls.
16. Document the date of calibration and new calibration factors.

QUALITY CONTROL:
EIGHTCHECK-3WP X-TRA Instructions for Use
1. Remove EIGHTCHECK-3WP X-TRA vials from refrigerator and allow them to come to room
temperature (18-25oC), for approximately 15 minutes.
2. Mix vials by gentle end to end inversion until the cell button in the bottom of the vial is completely
suspended. Do not use a mechanical rocker.
3. Wipe residual blood off the cap and screw threads of the vial before replacing the cap.
4. Return vials to the refrigerator promptly after use.

WARNING: POTENTIALLY INFECTIOUS MATERIAL.

The human blood used in EIGHTCHECK 3-WP X-TRA is non-reactive for Hepatitis B Surface Antigen and
negative for antibodies to HIV-1, HIV-2, and Hepatitis C Virus using FDA specified techniques. However, no
current tests can assure the absence of these pathogens EIGHTCHECK-3WP X-TRA should be considered
potentially infectious and must be handled with precautions used for human blood as described in CDC
recommendations and in compliance with the Federal OSHA Bloodborne Pathogen Standard, 29 CFR,
1910.1030.

Frequency of Control Use and QC Data Review:

EIGHTCHECK-3WP X-TRA levels (low, normal, high) are run daily to monitor the performance of the
system. Clinics open for more than one (8 hour) shift will run 2 levels of commercial control every 8 hours
and after reagent change.

Quality Assurance for Laboratory Testing: Lab-0135

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 Standard Operating Procedure

The supervisor reviews commercial control reports every month. The on-site designated tech will review
and document QC results weekly for shifts and trends. Quality Control Lab-0170

QC Analysis
1. Press [Select].
2. Press [2] Quality Control.
3. Enter the QC file number (Files 1-6) or use the up/down arrow keys to select the QC file and press
[ENTER].
4. Press [1] QC Analyze.
5. Place the mixed open QC vial up to the sample probe and press the Start Switch.
6. When the KX-21N beeps, remove the vial. Do not wipe the sample probe.
7. When analysis is complete, "Accept Data?" displays. Press either:
a. [3] Print, for QC results with histograms.
b. [2] NG to reject results, or
c. [1] OK to accept results. The QC data prints without the histograms.
d. Document rejected results on troubleshooting log.
8. Repeat steps 3-7 for each level of control.
9. Press [SELECT] to exit QC program.

Viewing QC Charts
1. Press [SELECT].
2. Press [2] Quality Control.
3. Enter the QC file number to be viewed or use the up/down arrow keys to select the file and Press
[ENTER].
4. Press the up/down arrow keys to review the eight screens of charts.

Starting a new Lot of Control Material:

Parallel test new controls by analyzing the three levels of new control material a minimum of two days. All
data will be submitted to La Crosse for processing. The means will be determined for each new lot
parameter from the data collectively received from each regional location. The historical limit percent will
be applied to the calculated means to determine if the means fall within the historical limits. The assay
means will be validated for use if the calculated means fall within the historical limits.

KX-21 Historical Limits:

Historical limit % Historical Historical limit % Historical Historical limit % Historical
mean - Low Limit - Low mean - Normal Limit - Normal mean - High Limit - High
WBC 0.4 12% 0.7 10% 1.8 10%
RBC 0.21 9% 0.26 6% 0.26 5%
HGB 0.3 5% 0.6 5% 0.7 4%
HCT 1.5 9% 2.4 7% 3.5 8%
MCV 3.6 5% 3.9 5% 4.1 5%
MCH 2.5 9% 1.8 6% 1.8 6%
MCHC 3.5 9% 2.7 7% 2.8 7%
PLT 18 34% 40 21% 68 15%
LYMPH% 3.8 16% 3.1 10% 3.5 9%
MIXED% 3.5 28% 2.8 27% 2.8 19%

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 Standard Operating Procedure

NEUT% 5.3 8% 3.5 6% 3.9 8%

LYMPH# 0.2 25% 0.5 24% 0.8 12%
MIXED# 0.1 25% 0.2 29% 0.6 24%
NEUT# 0.3 14% 0.6 15% 1.0 12%
RDW CV 1.6 16% 1.5 16% 1.6 16%
RDW SD 5.3 17% 5.2 16% 4.9 14%
MPV 1.4 14% 1.0 11% 0.8 9%
W-SMV 9.4 15% 6.8 11% 6.1 10%
W-LMV 15.0 8% 15.1 8% 14.3 7%

Entering QC Targets and Limits

1. Press [SELECT].
2. Press [2] Quality Control.
3. Enter the QC file number, or use the up/down arrow keys to select the file and press [ENTER].
a. If old data exists in the file, erase it by using [3] Erase All.
b. Press [<] to select Yes, and [ENTER].
c. Press [<] to select Execute and [ENTER].
d. Press [2] Settings. The control lot number is selected. Use the up/down arrow keys to
select WBC Target.
4. Use the numeric keys to enter the mean of the new lot analyses for WBC and press [ENTER].
5. WBC limit is selected. Enter the laboratory's established historical limit for WBC, and press
[ENTER].
6. Repeat steps e-f above to enter the targets and limits for the remaining parameters.
7. Press [SELECT], and "OK to Set?" displays.
8. Press [>] to choose SET and press [ENTER].
9. Press [ENTER] to exit QC.

Quality Assurance Program (QAP):

Refer to policy Lab-0135 Quality Assurance for Laboratory Testing.
1. All labs are enrolled in Proficiency testing surveys.
2. EIGHTCHECK-3WP X-TRA values will be submitted for analysis monthly.

Sysmex Quality Control Program Telephone: 1-800-898-9563, FAX: 1-402-333-7874

1. Corrective Action for Out of Range QC Results: Refer to Lab-0170 Quality Control.
2. Recording and Storage of QC Data: Refer to Lab-0230 Retention of Laboratory Records and
Specimens.

Implementation
OPERATING PROCEDURE:
Start-Up
1. Check for fluid in the pneumatic trap chamber on the left side of the main unit.
a. If fluid is present, unscrew the chamber counter clockwise, empty and dry.
b. Replace the chamber taking care to make a good seal. Vacuum errors occur if not sealed
tightly.
2. Check paper supply.

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 Standard Operating Procedure

3. Power on the KX-21-N main unit, and allow the instrument to perform its automatic
microprocessor tests, motor check, auto-rinses and a background count. A background check is
performed on the third rinse. Two additional rinses occur if the background count was
unacceptable. Auto-rinse cycles are identified by the sample ID# of zero.
a. When the background counts of all parameters are acceptable, the instrument is "Ready".
b. If the counts are unacceptable "Background Error" displays and the alarm sounds briefly.
Repeat the Autorinse.
i. Press [SELECT].
ii. Press [5] Autorinse.

KX-21N Acceptable Background Counts

Parameter Count
WBC 0.3 x 103/uL or less
RBC 0.02 x 106/uL or less
HGB 0.1 g/dl or less
PLT 5.0 x 103/uL or less

4. If scheduled maintenance is due, an alarm sounds and reminder to perform maintenance displays.
a. Press [C] to silence the alarm.
b. Perform the maintenance indicated by following the instruction on the screen.
c. If you wish to perform the maintenance later, press [3] Cancel. This message appears again
next time the unit is powered on.
5. Analyze commercial controls.
6. If the KX-21N remains in the "Ready" mode without operation for 15 minutes the pneumatic unit
shuts down and the LCD displays "PU Sleeping." Press the start switch to bring the unit back up to
"Ready".
a. If the vacuum and pressures are not acceptable, error messages display and prints on the
thermal printer.
b. Press [Select], [7] Maintenance, and [5] Status Display to view the vacuum or pressures. Refer
to the KX-21N Operator's Manual, pp. 8-2 to 8-6.

Patient Sample Processing

WARNING: Potential biohazard exposure when handling open patient specimens. Follow Standard
precautions outlined by laboratory safety guidelines.
Recommended: Wear gloves, lab coat, and safety glasses. Use plastic-lined lab wipes when opening.

Whole Blood Mode (50 uL sample volume)

1. The LCD should display "WB" and "READY".
a. To change the mode, press [MODE].
b. Press [< or >] keys to select the "Whole Blood" mode.
c. Press [ENTER].
2. Press [SAMPLE No.]
3. Using the numeric keys enter the patient ID number (up to 15 digits), then press [ENTER]. Do not
use "0" for a patient ID number, as the results are not judged against any criteria, and will not
print.

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 Standard Operating Procedure

NOTE: If the hand held barcode reader is used, press the button on the reader and scan
the barcode to enter the ID number.
4. Mix the specimen tube well, remove the stopper and hold the tube up to the sample probe.
5. Press the Start switch.
6. When the KX-21N beeps twice, remove the sample form the sample probe. Do not wipe the
sample probe. Results print on the thermal printer after 60 seconds. See Retention of Laboratory
Records Policy Lab-0230.

Daily Shutdown. (Approximately 5 minutes to perform)

The shutdown program cleans the transducer chambers and the diluted sample line. Perform Shutdown at
the end of daily operation or at least once every 24 hours.
1. Press [SHUTDOWN]. The message "Aspirate CELLCLEAN" displays.
2. Place the 5% Clorox Ultra up to the sample probe. Press the Start switch. Remove the tube of
bleach when the unit beeps.
3. Once the Shutdown program finishes "Turn off the power" appears.
4. Power off the KX-21N.
5. Record the Shutdown on the Daily Maintenance Log.

Routine Maintenance:
This section includes written procedures for performing weekly, monthly, and quarterly maintenance.
Refer to Sysmex KX-21N Operator's Manual, Chapter 4 for detailed, illustrated procedures. During Start-
up of the KX-21N, any maintenance that is due based on cycle count is displayed on the LCD. Perform the
maintenance when prompted on the LCD, and the cycle counter is reset, OR press [3] to Cancel and bypass
performing the maintenance temporarily. The counter does not reset and the maintenance reminder
continues to reappear on Start-up.

Warning for All Maintenance:

Clorox Ultra contains a strong oxidizing agent. Causes substantial, but temporary eye injury. May irritate
skin. May cause nausea and vomiting if ingested. Exposure to vapor or mist may irritate nose, throat and
lungs. If contact with eyes, flush with copious amounts of water by using eye wash station and the
employee should seek medical attention if necessary and report incident to Employee Health. Potential
biohazard exposure when performing maintenance on the KX-21N.
Recommended: Wear gloves, lab coat and safety glasses for protection.

IMPORTANT NOTE FOR ALL MAINTENANCE:

Clorox Germicidal Bleach is an 8.25% sodium hypochlorite solution. The Sysmex Instructions for Use
manual recommends using a 5% Sodium Hypochlorite solution. Sodium Hypochorite solutions should be
made fresh at least weekly and stored in an opaque container or in the dark to prevent deterioration.
Approximately 35 ml of a 5% solution is made fresh daily using the formula below:
(Conc. 1) x (Vol. 1) = (Conc. 2) x (Vol. 2)
(8.25%) x (Vol. 1) = (5.00%) x (35 mL)
Vol. 1 = 5.00/8.25 x 35ml
Vol. 1 = 21.2 ml
Use 21.2 ml of 8.25% bleach diluted to 35 ml with distilled water to make 35 ml of 5% Sodium
Hypochlorite bleach solution.

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 Standard Operating Procedure

Weekly Maintenance
1. Clean the SRV (sample rotor valve) Tray. (Sysmex KX-21N Operator's Manual pp. 4-7 to 4-8)
a. Open the front cover of the main unit.
b. Slide the SRV tray toward you to remove, taking care not to loosen the sample probe
fixing screw.
c. Wash the tray clean with tap water, and dry.
d. Replace tray.
e. Close KX-21N front cover.
f. Record the cleaning on the maintenance log.

Monthly Maintenance
1. Clean the Waste Chamber. (Sysmex KX-21N Operator's manual, pp. 4-9 to 4-11) Approximately
15 minutes to perform.
a. Press [SELECT].
b. Press [7] Maintenance. Press [ENTER].
c. Press [1] Clean W. Chamber. Press [ENTER].
d. Clean the transducer aperatures using the small brush provided.
e. Place 5% Clorox Ultra up to the sample probe.
f. Press the Start Switch to aspirate the bleach.
g. Remove the bleach tube after the beeps.
h. After the automated cleaning and background count, the counter is automatically
reset.
i. Document in the maintenance log.
j. Clean the WBC and RBC Transducers. (Sysmex KX-21N Operator's Manual, pp. 4-12 to
4-15) Approximately 7 minutes to perform.
k. Open the front cover of the KX-21N.
l. Press [SELECT]
m. [7] Maintenance
n. Press [2] Clean Transducer
o. Open the transducer cover
p. Using the "filler" provided or a syringe, place 1mL (cc) of 5% Clorox Ultra into each of
the transducers. DO NOT OVERFILL.
q. Close the transducer cover and KX-21N front cover.
r. Press the Start switch. The KX-21N automatically performs a background check, and
resets the counter when the cleaning cycle is complete.
s. Document in the maintenance log.
2. Clean SRV valve. (Sysmex KX-21N Operator's Manual, pp. 4-16 to 4-23). It is easiest to clean
the apertures when you clean the transducer as you have emptied the chambers.
a. Prepare a fresh 1:10 Clorox Ultra solution using one part 5% Clorox Ultra bleach and
nine parts of distilled water.
b. Switch off the Main unit power. Allow the pressure and vacuum gauges to reach zero.
c. Open the front cover of the KX-21N. Place paper towels beneath the SRV to absorb
liquid from the valve.
d. Remove the SRV tray.
e. Gently pull down the rinse cup, removing it completely from the sample probe.
f. Turn the SRV thumbscrew counter clockwise to remove it.

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 Standard Operating Procedure

g. Remove the two front sections of the SRV. DO NOT remove the rear section with all
the tubing connections. Fluid "suction" holds the sections together tightly. Gently
twist, and slide the sections apart.
h. Using a lint free tissue moistened with 5% Clorox Ultra bleach solution, wipe all
surfaces of all sections of the SRV to remove blood, dirt, or fingerprints. DO NOT
scratch or chip the SRV sections.
i. Rinse well with deionized water.
j. Reassemble the wet sections of the SRV, placing the center section on the shaft with
the flat edge toward the top of the SRV and the metal knob between the two silver
stops and touching the bottom stop.
k. Replace the front section on the shaft.
l. Taking care not to pinch the tubing on the rear SRV section, replace the pressure fixing
screw by pushing and turning 1/4 turn clockwise.
m. Install the SRV tray.
n. Gently and slowly pull up the Manual Rinse mechanism on the sample probe.
o. Power on the KX-21N. Check for leaks during the autorinse.
p. Reset the SRV counter.
A. Press [SELECT], [7] Maintenance.
B. Press [3] Reset SRV counter.
C. Press [1] Reset.
q. Analyze commercial controls.
r. Record the data maintenance was performed on the maintenance log.
3. Cleaning the Rinse Cup
4. Cleaning the Transducer Apertures

As Needed Maintenance
Refer to the Sysmex KX-21N Operator's Manual, Chapter 4 for any "As Needed" Procedures including:
1. Replacing thermal paper
2. Replacing fuses

PROCEDURE NOTES:
1. For troubleshooting specifics refer to Sysmex KX-21N Operator's Manual, Chapter 7.
2. When megakaryocytes are present, send sample to La Crosse for analysis following instructions
listed on Result Verification Form, Lab-5074.6.
3. Do not place samples on a mechanical rocker. Excessive mixing may induce platelet clumping and
alter white cell membranes, resulting in false interpretive messages.
4. Clorox Ultra, filtered bleach, is recommended for use in cleaning. If Clorox Ultra is not available
generic bleach must be 5% Sodium Hypochlorite concentration and be free of particles that may
cause background contamination when used on the analyzer.

CALCULATIONS:
1. When using a diluted patient specimen (1:2) and NOT using the pre-dilute mode multiply the
directly measured parameters x 2.
2. When correcting the Hgb or Hct for interfering substances recalculate and correct the affected
indices:
MCHC = HGB/Hct x 100

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 Standard Operating Procedure

MCH = HGB/RBC x 10
MCV = Hct/RBC x 10
3. If a vote out occurs for Neut# the ANC should be calculated as follows:
(Regional sites that are unable to perform a manual differential must send an ANC vote-out to
La Crosse for verification.)

ANC = WBC x % Neutrophils (Seg +Band ) Example: 3.4 x 59 = 2.0

100 100
INTERPRETATION:
Reporting Results:
KX-21N ADULT REFERENCE RANGE
COMPLETE BLOOD COUNT REFERENCE RANGES (6/1/2014)
WBC RBC Hgb HCT MCV MCH MCHC RDW- PLT
CW
Age 103/uL 106/uL g/dL % fL pg g/dL % 103/uL
Group
ADULT
MALE 3.7 – 4.50 – 13.6 – 41-50 82-99 27-32 32-36 11.8 – 140 –
10.4 5.80 16.7 15.6 385
FEMALE 3.7- 4.00 – 11.8 – 36-46 82-99 27-32 32-36 11.8 – 140 -
10.4 5.20 15.1 15.6 385

KX-21N PEDIATRIC REFERENCE RANGE:

COMPLETE BLOOD COUNT REFERENCE RANGES (6/1/2014)
WBC RBC Hgb HCT MCV MCH MCHC RDW- PLT
CV
Age 10 /uL 10 /dL
3 6 g/dL % fL pg g/Dl % 103/uL
Group
0 - 24 9.0 – 4.10 - 15.0 – 44-70 102- 33-39 32-36 11.8 – 140-385
hours 30.0 6.70 24.0 115 15.6
2 – 30 5.0 – 4.10 - 15.0 – 44-70 102- 33-39 32-36 11.8 – 140-385
days 21.0 6.70 24.0 115 15.6
1-5 5.0 – 3.80 – 10.5 – 32-42 72-88 24-30 32-36 11.8 – 140-385
months 19.5 5.40 14.0 15.6
6-24 6.0 – 3.80 – 10.5 – 32-42 72-88 24-30 32-36 11.8 – 140-385
months 17.5 5.40 14.0 15.6
2-3 yrs. 6.0 – 4.00 – 11.5 – 33-43 76-90 25-31 32-36 11.8 – 140-385
17.0 5.30 14.5 15.6
4-5 yrs. 5.5 – 4.00 – 11.5 – 33-43 76-90 25-31 32-36 11.8 – 140-385
15.5 5.30 14.5 15.6
6-7 yrs. 5.0 - 4.00 - 11.5 – 33-43 76-90 25-31 32-36 11.8 – 140-385
14.5 5.30 14.5 15.6
8-9 yrs. 4.5 – 4.00 – 11.5 – 33-43 76-90 25-31 32-36 11.8 – 140-385
13.5 5.30 14.5 15.6

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 Standard Operating Procedure

10-15
yrs.
MALE 4.5 - 4.20 – 12.5 – 36-47 78-95 26-32 32-36 11.8 – 140-385
13.5 5.60 16.1 15.6
FEMALE 4.5 – 4.10 - 12.0 – 35-45 78-95 26-32 32-36 11.8 – 140-385
13.5 5.30 15.0 15.6
16-17
yrs.
MALE 4.5 - 4.20 - 12.5 – 36-47 78-95 26-32 32-36 11.8 – 140-385
13.0 5.60 16.1 15.6
FEMALE 4.5 – 4.10 12.0 – 35-45 78-95 26-32 32-36 11.8 – 140-385
13.0 5.30 15.0 15.6

1. Guidelines on acceptable Reporting Format: Reporting Criteria and format is built into the LIS.
2. Procedures to be used in reporting critical results to physicians: Please refer to Lab-0130 Critical
Call Values, Lab Reporting Protocol.
3. AUTO DIFFERENTIAL REFERENCE RANGES

NOTE: If mixed cell result >11%, perform scan. If results of scan show an abnormal amount of
either Baso, Eos or Monos, perform a manual differential. If the manual differential shows that all
Baso, Eos and Monos are within normal limits, report electronic differential. If the Baso, Eos, or
Mono numbers are abnormal, report the manual differential. Sites unable to scan a slide must
send the sample to La Crosse for verification if mixed cell population is >11% on a HEMG.

ELECTRONIC DIFFERENTIAL REFERENCE RANGES – ABSOLUTE VALUES

ANC Lymph Mixed Cell
Age Group K/uL K/uL K/uL
0 – 24 hours 6 -26 2.30 – 10.80 0.09 – 3.6
2 – 30 days 1.5 – 10.0 2.0 – 17.0 0.05 – 2.52
1-5 months 1-9 2.10 – 13.90 0.05 – 2.34
6-11 months 1-8.5 2.80 – 13.30 0.06 – 2.10
12-23 months 1.5-8.5 2.80 – 13.30 0.06 - 2.10
2-3 years 1.5-8.5 2.60 – 12.60 0.06 – 2.04
4-5 years 1.5-8.5 1.90 – 10.10 0.06 – 1.86
6-7 years 1.5-8.0 1.20 – 7.80 0.05 – 1.74
8 – 9 years 1.5 – 8.0 1.40 – 7.60 0.05 – 1.62
10 – 11 years 1.5-8.0 1.50 – 7.60 0.05 – 1.62
12-15 years 1.8-8.0 1.30 – 6.50 0.05 – 1.62
16-17 years 1.8-8.0 1.10 – 5.90 0.05 – 1.56
Adult 2.0-8.7 0.70 – 4.70 0.04 – 1.14

4. REPORTING CRITICAL RESULTS:

Please refer to Lab-0130 Critical Call Values, Lab Reporting Protocol
5. DATA REVIEW

Page 16 of 20
 Standard Operating Procedure

a. The instrument prints the result of each parameter measurement or calculation and prints any
of several flags to indicate possible sample or instrument problems. Review flags.
b. Refer to operators manual for the full explanation of all flags.
c. Use the Data Review Checklist to evaluate results.
6. Data Review Checklist - Sites not performing CBC testing (HEMG, WBC, HGB, HCT, and PLT only)
must send the sample to La Crosse for verification if the answer is "NO" to any of the following
questions:
a. Are the results within the range accepted by your laboratory?
b. Is the relationship between associated parameters believable? For example, a HGB of 12.0
g/dL with a HCT of 50% is not believable.
c. Are the instrument results compatible with other laboratory procedures? For example, does
the WBC count from the instrument differ from the WBC count estimated from the
differential?
d. Are the results physiologically possible? For example, a HGB of 30 g/dL is highly improbable.
e. Do patient results reflect a possible shift? In a series of patients' results, is one parameter
consistently higher (lower) than normal (for example, all WBC counts >10,000).
f. Scan a slide to help verify counts. The platelet estimate should be within 20%.
7. Abnormal Results
Anytime abnormal bloods are recognized, the analysis should be repeated and verified according
to laboratory procedure.
a. Any test below or above the linear range for your analyzer will need to be sent to La Crosse for
resulting or verification. You may report below or above linearity using less than (<) or greater
than (>)#. Example: if WBC is over range, report WBC >99.9.
WBC greater than 99.9 K/uL.
Hemoglobin greater than 25.0 gm/dl.
Hematocrit greater than 60.0 %.
Platelets less than 10,000 or greater than 999,000.
i. If results are needed on site:
I. In DI accept only the value that needs to be resulted and reject the rest of
the values. The result will cross into beaker and you will have to final verify
it. DI will also send over to beaker the appropriate comments, such as
“Above linearity” and “Below linearity”.
II. Send the sample to LaCrosse Lab following instructions on the Result
Verification Form, Lab-5074.4
ii. If results are not needed on site and no results are entered in LIS:
I. Send the sample to LaCrosse Lab following instructions on the Result
Verification Form, Lab-5074.4
NOTE: If HGB and HCT do not match send the specimen at room temperature
to La Crosse.
If MCHC >37.0:
1. Warm sample for 15-30 minutes by placing the tube in the incubator or warmer.
2. Order a rerun in DI for the specimen, then Mix the warmed sample and re-run on analyzer.
3. If the warmed MCHC is <37.0:
a. Add “Specimen warmed” to the RBC count by clicking in DI on the white box next to the
RBC count under the column “test comments” then click “Insert coded entry” and select
“Warmed Specimen”.

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 Standard Operating Procedure

b. Verify results as appropriate based on other flags present.

4. If the warmed MCHC is still >37.0: Send sample and verification form to Gundersen Health La
Crosse lab following directions listed below:
a. If results are not needed on site and no results are entered in LIS:
i. Follow instructions listed on the Result Verification Form, Lab-5074.4
b. If results are needed on site:
i. Spin an aliquot of the sample; examine the plasma for lipemia, hemolysis or
icterus.
ii. If the plasma is moderately to grossly hemolyzed, recollect the sample.
iii. If the plasma is lipemic, icteric or if the WBC is >100,000, the HGB may be
affected. Remove the HGB, MCH and MCHC value on the DI workspace and add
the comment “Unable to report due to unknown interfering substances. Sent to
GL-La Crosse lab for verification” to the test comment box to the right of every
removed value. Validate the results needed on site through DI and cancel any left.
Final verify the specimen in beaker and Follow instructions listed on the Result
Verification Form Lab-5074.4
iv. If the plasma is clear, the RBC and HCT may be inaccurate. Do not report the RBC,
HCT, MCV or MCHC. Remove the RBC, HCT, MCV, and MCHC value on the DI
workspace and add the comment “Unable to report due to unknown interfering
substances. Sent to GL-La Crosse lab for verification” to the test comment box to
the right of every removed value. Validate the results needed on site through DI
and cancel any left. Final verify the specimen in beaker and follow instructions
listed on the Result Verification Form, Lab-5074.4 Directions for sending
specimens to LaCrosse lab.
5. Follow instructions listed on the Result Verification Form, Lab-5074.4
6. Blood specimens for verification should be sent as soon as possible.
7. Send the blood sample, your stained smear and at least 2 to 6 unstained smears. ***This is only
necessary if the sample will not reach the laboratory for >12 hours.
8. Include with the tube a copy of your analyzer printout or preliminary report with patient ID.
9. Fill out and send a verification form. Please inform LaCrosse if results should be called to the
provider on the form and place a "call results" sticker on the tube.
10. Send the specimen refrigerated and the unstained smears at room temperature. If the MCHC is
>37.0, the specimen should be sent at room temperature.

LIMITATIONS:
KX-21N Manufacturer's Stated Linearity (Whole Blood Mode)
Parameter Range Units
WBC 1 – 99.9 x103/uL
RBC 0.3 – 7.00 x106/uL
HGB 0.1 – 25.0 g/dL
HCT 10 – 60.0 %
PLT 10 – 999 x103/uL
*Parameters that exceed these limits are flagged with an exclamation point (!) beside the result. The
sample must be sent to La Crosse for analysis and/or dilution. See instructions listed under “Procedure
Notes”.

Page 18 of 20
 Standard Operating Procedure

Known Interfering Substances

1. Specimens must be free of clots and fibrin strands.
2. Marked changes in plasma constituents (e.g., low sodium, extremely elevated glucose) may
cause cells to swell or shrink. The blood to anticoagulant ratio is important.
3. Red cell fragments, microcytic RBCs or white cell cytoplasmic fragments may interfere with
automated platelet counts.
4. Cold agglutinins produce spurious macrocytosis, elevated MCHs, MCHCs, falsely decrease RBC
counts and HCTs. Rare warm agglutinins produce the same spurious results as a cold
agglutinin.
5. Extremely elevated WBCs (>100,000 /uL) may cause turbidity and increase the hemoglobin.
6. Severely hemolyzed samples (in vitro) falsely decrease RBC and hematocrit. Recollect
hemolyzed specimens.
7. Giant platelets and clumped platelets may falsely elevate the WBC count and falsely decrease
the platelet count.
8. Platelet clumping and/or "platelet satellitism" can occur in specimens collected in EDTA. This
may falsely elevate the WBC and falsely decrease the platelet count.
9. Abnormal paraproteins found in Multiple Myeloma patients can falsely increase the HGB. See
above procedure for MCHC >37.0.
10. Lipemia falsely elevates the HGB & MCHC. See above procedure for MCHC >37.0
11. Severely Icteric samples may falsely elevate the HGB value and related indicies. Send to La
Crosse Lab for verification.
12. Rocking specimen excessively may affect the WBC differential.
13. Abnormal proteins as seen in multiple myeloma and Waldenstrom's macroglobulinemia may
falsely increase the WBC count.
14. The hemoglobin method on this analyzer cannot detect sulfhemoglobin, verdohemoglobin,
choleglobin or other unusual degradation products of hemoglobin.

ELECTRONIC DIFFERENTIAL TO MANUAL DIFFERENTIAL COMPARISON:

The KX21N instrument differential is checked against a tech performed 100 cell manual differential twice a
year for correlation of results.
1. Sample selection: Select 6 whole blood samples that provide a good distribution for all cell types
classified by the instrument. Review Sysmex printout to ensure that the instrument has not
flagged any results for the CBC or Differential. Samples should be run on the analyzer and a slide
made within 2 hours of collection. Samples should be kept at room temperature during analysis.
2. Procdure:
a. The instrument’s electronic differential is identified as the reference analyzer. The manual
differential will be compared to the reference analyzer.
b. Run all samples on the reference analyzer and record results from Sysmex printout for
Neut %, Lymph %, and Mixed Cell % on form Lab-5074.5.
c. Perform 100 cell manual differential and record results for Neut %, Lymph %, and Mixed
Cell % on form Lab-5074.5.
3. Confirm that all results for the manual differential fall within the appropriate 95% confidence
interval, as defined by the instrument’s electronic differential. See attachment Lab-5074.1 – 95%
Confidence Intervals for the defined acceptable ranges.
4. Evaluate the results, document overall acceptability, and sign off on the worksheet.

Page 19 of 20
 Standard Operating Procedure

a. When completed, send form and all supporting documentation to La Crosse for
Laboratory Director review.
b. Save signed forms and supporting documentation in the appropriate log book onsite.
c. Discrepancies/questions can be addressed to the Laboratory Director, Technical Leader, or
Sysmex Technical Assistance Center.
d. A linear regression may be performed at the request of the medical director.
5. If corrective action is necessary, it may include:
a. Analysis of additional specimens.
b. Repeat analysis of the manual differential by the same tech.
c. Repeat analysis of the manual differential by a different tech.
d. Repeat analysis of the electronic differential.
e. Troubleshooting with Sysmex Technical Service Representatives.

REVIEW AND CHANGES:

This document and all attached forms should be reviewed optimally on an annual basis, with 2 years as
the maximum review date. Review will be done by the Technical Leader, Supervisor, Manager, Medical
Director or designated person. Changes require retyping document or form and review by the medical
director.

REFERENCES:
1. Sysmex KX-21N Operator's Manual, Sysmex Corporation, Kobe, Japan. November, 2000.
2. Koepke, John. Practical Laboratory Hematology. Churchill Livingstone Inc. 1991. p. 24-25, 36-39.
3. NCCLS. Clinical Laboratory Technical Procedure Manuals - Third Edition; Approved Guideline.
(GP2-A3, 1996).
4. College of American Pathologists (CAP) Hematology Checklist, section 2, June 1998.
5. Brigden, Malcom L. Cell Counter-Related Abnormalities, Laboratory Medicine, May 1999, Vol. 30,
#5, p. 325-334.
6. Cornbleet J. Spurious Results From Automated Hematology Cell Counters. Lab Medicine. 1983;
8:509-514.
7. P. Garrity, J. Walters, Concepts in New Age Hematology, A Hematology Monograph, Baxter
Healthcare Corporation, Scientific Products Division, hematology Support Services. August 1990.
8. Gamperling N, Mast BJ, Hagblom R, Houwen B. Performance Evaluation of the Sysmex KX-21N
Automated Hematology analyzer. Sysmex Journal International, Vol. 8, #2, p. 96-101. 1998.
9. Sysmex Corporation of America, Long Grove, IL General Instructions for use of SCS-1000, Rev. 8,
21-Apr-00.
10. Sysmex Reagents of America, Inc. Los Alamitos, CA. MSDS sheets and reagent product inserts.
11. Sysmex Corporation of America, Long Grove, IL. EIGHTCHECK-3WP XTRA Hematology Control
Assay Sheet. Revision 5, 21-April-00.
12. Sysmex Corporation of America. Long Grove, IL. EIGHTCHECK-3WP XTRA Q.C. Suggested File
Limits. revision 5, 6-April-00.
13. Streck Laboratories, Omaha, NE. Sysmex Quality Control Program Instructions 1/01.
14. Clorox Ultra Professional products Company, Oakland, CA. Clorox Ultra product label 1998.
15. Sysmex Product Information Bulletin, Approved Cleaning Agents for Sysmex Analyzers, Document
Number: 63-1033, September 2012.
16. Nathan & Oski’s, Hematology of Infancy and Childhood, 7th Edition. p. 1774 Appendix 11, p. 1781
Appendix 26

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