Lab Policies Sysmex XN 450 XN 550 Lab 1532

Standard Operating Procedure
Subject Sysmex XN-450/XN-550 Complete Blood Count and Parameters – Whole Blood
Index Number Lab-1532
Section Laboratory
Subsection Regional Clinic/Affiliate Hospital Laboratories
Category Departmental
Contact Andrew Grigg
Last Revised 12/9/2019
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.
Detail
PRINCIPLE:
The Sysmex XN-450 and the XN-550 are multi-parameter quantitative automated hematology analyzesr
for in vitro diagnostic use in determining whole blood diagnostic parameters. Examination of the
numerical and/or morphological findings of the complete blood count by the physician are useful in the
diagnosis of disease states such as anemias, leukemias, allergic reactions, viral, bacterial, and parasitic
infections.
The devices perform hematology analyses based on the hydrodynamically focused impedance
measurement, the flow cytometry method (using a semiconductor laser) and the SLS-hemoglobin
method.
The device counts and sizes red blood cells (RBC) and platelets (PLT) using hydrodynamic impedance
counting (sheath flow DC method). At the same time the hematocrit (HCT) is measured as a ratio of the
total RBC volume to whole blood via the RBC pulse height detection method.
Cytometry is used to analyze physiological and chemical characteristics of cells and other biological
particles. Flow cytometry is a method used to analyze those cells and particles as they pass through
extremely small flow cells.
The Data Innovations Instrument Manager (DI) is a Data Innovations computer program which is used to
manage data coming from the XN-450 and 550 analyzers and sends that data to the Laboratory
Information System (LIS). Sets of WBC, RBC, and PLT rules determine how positive parameter flags are
handled by the instrument and/or operator and which samples are auto-validated by the DI. Manual
differentials and RBC/Platelet morphology is entered via the DI. Pending Orders are checked via the
Outstanding List in EPIC.
CLINICAL SIGNIFICANCE:
Lab-1532 |Sysmex XN-450/XN-550 Complete Blood Count and Parameters – Whole Page 1 of 25
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Examination of the numerical and/or morphological findings of the complete blood count by the
physician are useful in the diagnosis of disease states such as anemias, leukemia’s, allergic reactions,
viral, bacterial, and parasitic infections.
SPECIMEN:
A. Required specimen
1. Whole blood anticoagulated with a potassium EDTA is preferred.
2. Sodium Citrate may be used when EDTA platelet clumping or platelet satellitism is noted
on the EDTA specimen. Platelet counts, immature platelet fraction and WBC counts are
the only parameters that may be resulted from the Sodium Citrate specimen. If
reporting results from the Sodium Citrate specimen, attach canned comment (Citrated
sample. Results may vary from EDTA).
B. Specimen volumes required
1. Optimal draw is a tube drawn to capacity. The collection tube must be filled to a
minimum of one-half full for acceptable results.
2. A minimum of 1 mL of whole blood is required for sampler analysis.
3. An EDTA raised bottom microtainer filled above the 250 uL line is adequate. A standard
EDTA microtainer must contain 160 uL, though to maintain the proper anticoagulant
ratio it must have been filled to the 250 uL line at the time of collection.
C. Unacceptable specimens including those listed below must be redrawn:
1. Clotted samples or those containing clots or fibrin strands. All microtainer specimens
will be checked for clots prior to sampling by the analyzer.
2. Samples drawn above an IV.
D. Characteristics that may affect test results:
1. Lipemia (may falsely increase HGB)
2. Icterus (may falsely increase HGB)
3. Cold agglutinins (may falsely increase WBC count, MCV and MCHC; may falsely decrease
HCT & RBC count)
4. Severe hyponatremia (decreased plasma sodium level) may falsely decrease HCT causing
a falsely increased MCHC.
E. Stored Specimen Stability
1. If stored at 4-8oC within 6 hours of collection, EDTA blood samples with normal results
may be analyzed up to 48 hours without significant loss of differential stability. The
stability may be increased to 72 hours if results do not show a loss of specimen integrity.
2. Slides for a manual differential must be assessed for cellular integrity prior to reporting.
If cellular integrity is not intact a manual differential or morphology should not be
reported.
i. Slides for Pathology Review (PSMEARS) should be made within 12
hours, any slides made beyond 12 hours must be assessed for specimen
integrity. Because of this, PSMEAR addons should occur within 12 hours
of sample collections. PSMEARs may only be added on past 12 hours
with permission form a Hematology Tech who will confirm that the
slides are of adequate quality for interpretation.
ii. Instrument results for PSMEARS can be run up to 48 hours after
specimen collection.
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3. Sample stability at room temperature is 8 hours. Samples stored at room temperature

may exhibit an increase in MCV after 24 hours; this may be minimized by refrigeration.
4. Allow refrigerated samples to come to room temperature for 30 minutes and mix by
hand inversion before analysis.
F. Do not place samples on a mechanical rocker. Constant rocking may cause PLT clumping and
alter white cell membranes resulting in false interpretive messages.
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 document Lab-0105 Safety: Biological.
Recommended: Wear gloves and lab coat. Wear safety glasses if there is a risk of splashing.
REAGENTS / MATERIALS:
a. Supplies
1. Lint-free lined lab wipes
2. Gauze
3. Test tubes
4. CELLCLEAN® AUTO
5. Sysmex reagents (listed below)
6. Commercial controls; XN CHECKTM
b. Sysmex Reagents
1. Sysmex reagents and CELLCLEAN AUTO are used on the Sysmex XN-450/XN-550 Series
modules.
2. All reagents are used at room temperature and are to be used within the manufacturer’s
expiration date on each container.
3. Record date received and date opened on container.
4. All reagents are azide free and are intended for in vitro diagnostic use only. Do not ingest.
Reagent Volume Open Expiration
CELLPACK DCL 20L/10 L 60 days
SULFOLYSER 5.0 L 90 days
Lysercell WDF 2 x 4L 90 days
Fluorocell WDF 2 x 42 mL 90 days
c. Diluents:
1. CELLPACK DCL: Whole blood diluent for use in hematology analyzers.
2. CELLPACK DCL Storage:
a. Store at 2o-35oC away from direct sunlight.
b. If frozen, thaw and mix thoroughly before using.
c. CELLPACK DCL is clear and colorless. If it is showing signs of contamination or
instability such as cloudiness or discoloration, replace container.
3. CELLPACK DCL Stability:
a. Unopened, it is stable until expiration date printed on the container.
b. Opened, stable for 60 days.
4. CELLPACK DCL Hazard Risk:
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a. The OSHA Hazard Communication Standard of 29CFR part 1910.1200 requires SDS
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.
d. Lysing Reagents
1. Sulfolyser (SLS): Reagent for the automated determination of hemoglobin concentration of
blood. Sulfolyser is a lysing reagent that releases the hemoglobin to be measured by the SLS
hemoglobin method.
a. Sulfolyser Storage
i. Store at 1o-30oC away from direct sunlight.
ii. Allow the container to equilibrate to environmental temperature (15-30o)
prior to use.
iii. Replace the reagent if it is showing signs of contamination or instability such
as cloudiness or discoloration.
b. Sulfolyser Stability
i. Unopened, it is stable until expiration date printed on the container.
ii. Opened, stable for 60 Days (1.5L) or 90 Days (5L).
c. Sulfolyser Hazard Risk
i. The OSHA Hazard Communication Standard of 29CFR 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.
SULFOLYSER does not have ingredients with those characteristics.
2. Lysercell WDF: Reagent product to be combined and used with Fluorocell WDF. By
hemolyzing red blood cells with Lysercell WDF and dying the white blood cell component
with Fluorocell WDF< the counts and percentages of neutrophils, lymphocytes, monocytes,
eosinophils and basophils are analyzed.
a. Lysercell WDF Storage
i. Store at 2o-35oC away from direct sunlight.
ii. Use at an environmental temperature (15-35o)
iii. Do not use the reagent if it is suspected to have frozen.
iv. Replace the reagent if it is showing signs of contamination or instability such
as cloudiness or discoloration
b. Lysercell WDF Stability
ii. Opened, 1L stable for 60 days, 2 x 4L stable for 90 days.
c. Lysercell WDF Hazard Risk
requires SDS 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. Lysercell
WDF does not have ingredients with those characteristics.
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e. Staining Reagents
1. Fluorocell WDF: Used to stain the leukocytes in diluted and lysed blood samples for
determination of differential count in blood.
a. Fluorocell WDF Storage
i. Store at 2o-35oC in a dark place.
ii. Do not use the reagent if it is suspected to have frozen.
b. Fluorocell WDF Stability
ii. Opened, stable for 90 Days.
c. Fluorocell WDF Hazard Risk
requires SDS 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. Refer to
the SDS.
f. Cleaning Agent
1. CELLCLEAN AUTO: Detergent for fully automated hematology analyzers. To be used as a
strong alkaline detergent to remove lysing reagents, cellular residuals, and blood proteins
remaining in the hydraulics of the analyzer on XN Series/XN-L Series automated hematology
analyzers.
a. CELLCLEAN AUTO Storage
i. Store at 1-25oC, away from direct sunlight.
ii. Do not use the reagent if it is suspected to have frozen.
b. CELLCLEAN AUTO Stability
c. CELLCLEAN AUTO Hazard Risk
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. Refer to
the MSDS; CELLCLEAN AUTO is corrosive and may cause burns to skin.
g. Commercial Control Material:
1. XN-L CHECK
i. Manufactured by Streck, available as a tri-level package.
ii. Whole blood commercial control used to monitor performance of the XN analyzers.
iii. Formulation
i. Consists of human red and white blood cells with a platelet component
suspended in fluid medium.
ii. Each vial contains 3 mL of control material.
iv. Storage
i. Store vials at 2-8oC
ii. Do not freeze or expose to excessive heat.
v. Stability
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i. Unopened and properly stored, XN CHECK is stable until the expiration date
printed on the unopened vial.
ii. Open vial stability is 15 days when promptly refrigerated after each use.
iii. Record the date on each vial upon opening or cap piercing.
iv. Heat or freezing can damage XN CHECK 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.
v. If deterioration is suspected, call the Sysmex Technical Assistance Center.
1-888-879-7639 (1-888-8SYSMEX)
WARNING: POTENTIALLY INFECTIOUS MATERIAL.

The human blood used in XN-L CHECK 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. XN-L CHECK 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, 29CFR, 1910.1030.
h. Calibrators
1. XN CALTM: for use in calibrating the analyzer for WBC, RBC, HGB, HCT, PLT
2. XN CAL Storage: Store the calibrator in a dark refrigerator at 2-8oC
3. XN CAL Stability: Unopened and properly stored, XN CAL is stable until the expiration date
printed on the unopened vial.
Open vial stability is 4 hours.

Always wear PPE when using control blood products. Also, wash your hands after completing
the process. The basic blood used in the control blood has tested negative for HBs antigen,
HCV/HIV-1/HIV-2 antibodies, and serologic tests for syphilis. However, there are no tests that
can completely rule out any infections. In addition, it has not been tested for other viruses.
Therefore, handle it with the same level of care you would use when handling pother blood
samples that may be infectious.
i. XN-450/550 Reagent Replacement

1. When the replacement of reagent is required, an error message appears. Promptly acknowledge
the error message by clicking execute to enter the reagent replace dialog box and proceed to
replace the indicated reagent. Verify that “CAPS LOCK is off.
2. Replacing a new diluent / hemolytic agent
i. Touch the name of the reagent to be replaced.
ii. Place a check-mark next to ‘Replace the reagent,’ then place the cursor in the
reagent code text box.
iii. Using the hand-held reader, scan the reagent code on the new reagent
container.
NOTE: Scan Reagent Code 2 when available on the reagent container.
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a. Remove the cap from the expired/empty container and carefully remove the
spout.
b. Pull out the dispensing, set straight up.
c. Insert the dispensing set straight into the new reagent container and close the
cap.
d. Select [Execute]
i. Reagent replacement starts. When complete, the dialog box closes
automatically
3. Replacing Dye
• Display the [Reagent Replacement] dialog box.
• Prepare the new reagent cartridge.
o Confirm the reagent has not expired.
• Pull out the dye holder.
• Slowly remove the dye cover, taking care that dye does not drip.
• Remove the entire dye holder.
o When the dye holder is removed, a Help dialog box appears in the IPU screen.
• Remove the old reagent cartridge from its holder.
• Install the new reagent cartridge into the holder
o Make sure the color of the label on the new reagent cartridge matches the color
of the dye cover and install. Analyzer will beep as confirmation of new reagent
installation.
o If the wrong reagent is installed, the analyzer beeps
• Place the dye cover.
o Place into dye holder.
o The ID of the new reagent is read automatically, and the information is
registered.
• Close the dye holder.
i. Reagent replacement starts.
ii. When complete, the reagent replacement window closes
automatically.
CAUTION:
A. Do not use the reagent outside of the written intended use, or not according to the written
directions for use.
B. When replacing this reagent, do not refill and use the same container.
C. Handle the reagent with care to prevent air bubbles from foaming.
D. Do not sue expired reagents.
E. If the reagent is removed after it has been connected, (i.e. opened), it may become
contaminated with bacteria causing its performance to deteriorate. Therefore,
reconnecting an open reagent is not recommended.
F. NEVER allow contact of the reagent with the human body. Avoid contact with skin and eyes
and avoid ingestion. If it comes in contact with the skin, rinse skin thoroughly. If it gets in
the eye, rinse with large amounts of water and seed immediate medical attention. If
swallowed, seek medical advice immediately.
G. Before use, please read the safety data sheet carefully.
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4. Performance of new reagent lots and/or shipments is accomplished by a variety of methods

including:
 Running the Retained Patient Control or Commercial QC after reagent change
 Running the commercial quality control material within 8 hours of the reagent
change
EQUIPMENT/INSTRUMENTATION:
Sysmex XN-450/550; Data Innovations Middleware
Precision and Calibration:

Initial calibration is performed during installation by the Sysmex Field Service Representative. Perform
calibration as needed, e.g., when QC data is fluctuating. However, if the abnormality in the QC analysis
data was caused by an error in the analyzer, degradation of the reagent, or degeneration of the control
blood, do not perform calibration. Calibrators traceable to reference methods are used in the
calibration of the analyzer.
The laboratory must verify calibration every six months or on an "as-needed" basis to ensure accuracy of
system. Calibration verification is also required if one or more of the following occur:
A. Critical parts are replaced.
B. Controls show an unusual trend or are outside of acceptable limits and cannot be corrected by
maintenance or troubleshooting.
C. When advised by Sysmex Field Service Representative.
Calibration should only be completed when troubleshooting indicates that there is no major underlying
problem with the analyzer, reagents or quality control materials.
Calibration verification may be performed by review and documentation of commercial control and QC
data, proficiency testing results and patient control testing results. The operator may calibrate the
following parameters using XN CAL calibrator: WBC, RBC, HGB, HCT, and PLT.
The most common processes for Precision and Calibration of the Sysmex analyzer is the utilization of
Sysmex sponsored calibration/precision events defined by the analyzer service contract. Calibration
verification procedures may be done by a Sysmex SE on-site or remotely through the Sysmex Network
Communications System (SNCS™) with the Sysmex Calibration Specialist. The following items are
completed by the Sysmex representative during the calibration verification process:
A. Documentation and review of analyzer service history.
B. Documentation and review of QC testing results.
C. Documentation and review of historical Sysmex Insight™ reports.
D. Analyzing the Sysmex calibrator according to the manufacturer’s recommendations to verify
precision and calibration (accuracy) of the analyzer.
E. Documentation of calibration verification results and generation of a calibration verification
certificate for laboratory records.
Before calibration, ensure that routine cleaning has been performed and precision check is within
acceptable limits.
Precision Check will be performed at least two times per year.

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A. Precision Check
1. Perform routine maintenance on the analyzer 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 XN-450/550 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:
 Be a healthy person who is not taking any medication.
 Have morphologically and numerically normal CBC.
 Be drawn in potassium EDTA anticoagulant tube using proper collection
technique.
 Have a minimum of 2.5 mL of sample.
4. On the main unit, check the Status indicator LED. Confirm the LED is green
indicating the analyzer is Ready.
5. Select the Analyzer menu button on the control menu.
6. Select [Calibration] – [Precision Check]
7. Mix the vial containing the sample – 10 end-over-end inversions confirming cell
button is dispersed
8. Place the vial in the sample tube holder
9. Press the start switch on the analyzer.
10. Repeat mixing and analysis (total of 11 times).
11. The results are displayed in the [Precision Check] analysis dialog box.
a. If the analysis results do not satisfy conditions for normal results or if results
are outside acceptable limits, the test numbers of the tests that must be
repeated are displayed. Select and redo the manual analysis.
12. When all analysis results satisfy the conditions, select [OK] in the dialog box.
13. Select [Yes] to record passing precision results in the precision check history.
14. Document date performed on log.
NOTE: If an error occurs during analysis and the analysis can no longer continue, stop precision
check. Once the error is cleared, redo the manual analysis.
Corrective Action if Precision Fails:

i. Check reagent volumes and expiration dates.
B. Perform Clot Removal Maintenance.
C. Perform additional maintenance associated with a specific parameter.
D. Repeat the Precision Check.
E. Call customer support for further assistance.
B. Calibration – XN CAL
1. On the main unit, check the Status indicator LED. Confirm the LED is green
indicating the analyzer is Ready.
2. Select the Analyzer menu button on the control menu
3. Select [Calibration] – [Calibrator Calibration]
4. Mix the vial containing the calibrator according to package insert
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5. If sample tube holder is not ejected, press the sample tube holder open/close
switch.
6. Place the vial in the sample tube holder
7. Press the start switch on the analyzer.
8. Repeat mixing and analysis (total of 11 times).
9. The results are displayed in the [Calibrator Calibration] analysis dialog box.
10. If the analysis results do not satisfy conditions for normal results, or if results are
outside acceptable limits, the test numbers of the tests that must be repeated are
displayed. Select and redo the manual analysis.
11. When all analysis results satisfy the conditions, select [Calibration] in the dialog box.
12. Select [OK] to display results in the [Calibrator Calibration] execution dialog box.
13. Select the check box to include the calibration parameter in the calibration
exercise, clear the check box to exclude the parameter in the calibration exercise. If
a parameter meets all of the following criteria, the check box will automatically be
selected:
a. 80% < New Rate < 120%
b. New Rate – Current Rate < +5
c. Range Value < Max Range
d. Acceptable Limit < Delta Percent < Service Limit
If a parameter meets all of the conditions and the Delta Percent is less than
the Acceptable Limit, it is excluded from calibration as there is no need for
calibration.
If a parameter does not meet all of the conditions and the Delta Percent is
greater than the Acceptable Limit, the calibration cannot be performed.
Calibration is performed with the parameter excluded.
Selecting the check box enables you to manually enter a value in [New Rate
(%)]. A range of 80% to 120% may be entered.
14. Select [OK] to update the compensation rates. The calibration process is logged in
the calibrator calibration history.
15. Document date done in Log.
QUALITY CONTROL:
Utilizing the BeyondCare Quality Monitor (BCQM)
Quality control is performed in order to monitor an analyzer’s performance over time. XN-L CHECK is the
material used to monitor the performance of the XN-450/550 analyzer. Quality control should be run in
accordance with regulatory agency requirements. For the BeyondCare Quality Monitor program, a
minimum of 2 levels of controls are needed to be run at least once every 24-hours. It should be noted
that for troubleshooting purposes, additional control runs may be necessary. The BeyondCare Quality
Monitor program is a toll that will help you determine when troubleshooting is necessary and dynamic
screen prompts will guide the end user for the next action. All troubleshooting actions are logged in the
Activity Log. (Reference the BeyondCare Quality Monitor User Manual)
A. XN-L CHECK Commercial Controls Instructions for Use

1. Remove vials from refrigerator and allow them to come to room temperature (18-25oC),
for approximately 15 minutes.
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2. Mix vials according to the package insert accompanying the product until the cell button
in the bottom of the vial is completely suspended.
3. Perform a close visual inspection of each vial confirming the cell button is completely
removed from the bottom of the vial and cellular elements are uniformly suspended
with no aggregates.

The human blood used in XN CHECK 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. XN
CHECK 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, 29CFR, 1910.1030.
B. Frequency of Control use and review.

1. XN-L CHECK control levels 1, 2, and 3 will be run each morning before reporting patient
results.
2. The tech will review QC prior to reporting test results. If repeats are necessary,
document corrective action on the log. The lab supervisor reviews data logs and Insight
QC reports monthly.
C. Registering and modifying a QC file – lot information input
1. Select [QC File] icon
2. Select a QC file that does not have a lot registered.
3. Select [Register]
4. Select [Read Assay file]
5. Select the correct QC product, lot number, and level
6. Select [Ok]
7. Verify the QC lot number, level and expiration date matches the QC vials received by the
lab.
8. Repeat for each level of XN-L CHECK to be registered.
9. Perform parallel studies between production lot and new lot prior to production lot
expiration.
D. XN-L CHECK QC Analysis
1. Confirm the analyzer is in a Ready state.
2. If sample tube holder is not ejected, press the sample tube holder open/close switch.
3. Touch [Mode] on the control Menu.
4. Touch the Analysis Mode. Select Whole Blood.
5. Touch OK.
6. Touch the [QC] icon on the Menu screen.
7. Touch the [QC Analysis] icon.
8. From the QC file list, touch the file you want to analyze.
9. Perform Manual analysis on thoroughly mixed vial.
10. Check the analysis results in dialog box. Touch [Accept].
a. If analyzer displays GREEN, this indicates QC passed and analyzer is ready to
process samples.
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b. If analyzer displays YELLOW, more information is needed, or QC is overdue. The

resolve button becomes active if there is a QC value outside of limits.
c. RESOLVE is activated: If a QC error has been detected, resolve button becomes
active and dynamic troubleshooting prompt guides the end user to the next
course of action. The instructions button gives details on how to perform the
troubleshooting action.
d. QC is overdue: End user needs to analyze QC since it exceeds the timeframe
from the preferences screen.
e. If analyzer displays RED, QC failed analysis and analyzer is determined out of
service with a reference to a service call.
For a calendar view of whether the QC passed or failed, access the Summary report which
will also display background status,
• P= Last 2 different levels of QC passed
• F= QC failed
• B= Background counts pass
• X= Background counts failed
• ?= Run QC
• S= service event
• Calibration (EBC)
E. New QC lot crossover or parallel studies
As soon as the new QC lot is received, the new lot is analyzed in conjunction with the
current QC. The BeyondCare Quality Monitor program establishes the target and limit
values for the new QC lot as soon as the first vial of each level gets analyzed.
F. Reviewing Quality Control Results in BeyondCare Quality Monitor
1. If analyzer displays GREEN, this indicates QC passed and analyzer is ready to process
samples.
2. If analyzer displays YELLOW, more information is needed, or QC is overdue.
3. More information is needed: If a QC error has been detected, a Dynamic
troubleshooting prompt guides the end user to the next course of action. A video
display is also a selectable feature.
4. QC is overdue: End user needs to analyze QC since it exceeds the timeframe from the
preferences screen.
5. If analyzer displays RED, QC failed analysis and analyzer is determined out of service
with a reference to a service call.
For a calendar view of whether the QC passed or failed, access the Summary report which
will also display background status,
• P= Last 2 different levels of QC passed
• F= QC failed
• B= Background counts pass
• X= Background counts failed
• ?= Run QC
• S= service event
• Calibration (EBC)
• Document all reruns and corrective action on log.
6. Document all reruns and corrective action on log.
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Follow the BeyondCare Quality Monitor for troubleshooting Quality Control results
exceeding the upper or lower limit of acceptability.
BeyondCare Quality Monitor will automatically not manage (exclude) a QC run if a corrective
action has taken place and the same QC level is repeated and falls within the BeyondCare
Quality Monitor specification limits. A “SM” (system managed) symbol will appear next to
the raw data in the Insight report. No QC runs are ever deleted.
If the QC reviewer decides to manage (include data in calculations) or not manage (exclude
data from calculations the BeyondCare Quality Monitor application), log into Insight
(www.sysmex.com/Insight) and select Review QC data which will allow QC data
management by the Insight user.
G. Recording and Storage of QC Data

The BeyondCare Quality Monitor application stores the last 2.5 years of QC data on demand.
All QC data older than 2.5 years is archived.
H. Review of QC Data
1. Once Insight Report, Detailed Daily Verification Report, and Continuous Calibration
Verification Certificate reports have been reviewed through the BeyondCare Quality
Monitor application, they can be accessed by going to Activity _ Reviewed
Documents.
2. Reports are archived for 2.5 years in BeyondCare Quality Monitor. Reports that are
older than 2.5 years can be attained by contacting Sysmex Technical Assistance
Center.
I. Printing and saving QC Data
1. Select [QC Files] icon and highlight file to output.
2. Select [QC Chart] icon.
3. Set Range of points to output by clicking [Range] and capturing the points with the
cursors.
4. Select [Output] to print the selected chart to either GP or LP.
5. Select [File] to save the data to removable media.
NOTE: Comments that were added to the data do not print on the GP and LP
report.
In the event SNCS (Sysmex network communication system) loses connection:
a. BeyondCare Quality Monitor becomes unavailable until SNCS connection is
restored.
b. Review the QC files on the analyzer IPU
J. Insight™ Quality Assurance Program (QAP)
If your laboratory maintains an SNCS connection, the QC results will transmit automatically
to Insight after each run. There is no need to batch upload the data to Insight.
1. Each XN-L CHECK lot has 3 data submission dates for the 100-day dated product.
2. Data may be managed in the XN-IPU and/or in Insight. See Insight User Manuals.
3. Insert flash drive into USB port on the back of XN-L.
4. Select the QC file you want to output, click [File], [Output in Sysmex Insight]. Save
the file to the flash drive.
5. Repeat for each file needing Insight submission.
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6. Properly eject the flash drive from the IPU.

7. At a networked PC, establish connection with the Insight program via
www.sysmex.com/us and submit the data. Contact the Insight team with questions
at: 888-879-7639 (888-8SYSMEX).
K. X-barM Moving Patient Averages are not used due to patient volumes.
Note: Even if you decide not to use X-barM as part of your quality control program, it is still
highly recommended that you leave it on to collect data for troubleshooting purposes. X-
barM provides valuable information that assists Sysmex Field Service and Applications
associates when troubleshooting analyzer performance issues. The X-barM limits may be
widened to avoid X-barM control errors.
1. Touch the [QC] icon in the [Menu] screen.
2. Select X-barM Setting.
3. Click [Execute] to perform X-barM Control, Click [Cancel] to deactivate.
4. Click [OK].
L. X-barM function will remain activated for troubleshooting purposes.
M. Activating / deactivating X-barM Control
1. Touch the [QC] icon in the [Menu] screen.
2. Select X-barM Setting.
3. Click [Execute] to perform X-barM Control, Click [Cancel] to deactivate.
4. Click [OK].
N. Electronic Differential to Manual Differential Comparison
The XN-450/550 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. Procedure: The instrument’s electronic differential is identified as the reference
analyzer. The manual differential will be compared to the reference analyzer.
Run all samples on the reference analyzer and record results from Sysmex printout
for Neut %, Lymph %, Mono %, EOS %, and Baso % on form Lab-5074.6.
Perform 100 cell manual differential and record results for Neut %, Lymph %, Mono
%, EOS %, and Baso % on Regional Verification Form, (Lab-5074.4).
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.
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,
Supervisor, Technical Leader, or Sysmex Technical Assistance Center.
Blood
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.
O. Retained Patient Control
1. Retained patient samples may be used to verify instrument performance throughout
the day or with each reagent change.
2. Specimen Selection
a. Select a fresh 4 ml EDTA sample (male or female adult) that is within the
normal range for all parameters (mid-range is preferable: i.e., for WBC
normal range of 4.0-11.0, select a sample with WBC in the range of 6.0-9.0).
3. Analysis Procedure
a. Choose a sample for the retained patient control run.
b. Run in manual mode.
c. Record monitored parameters on paper log.
d. Verify that all results are within set limits or rerun outliers.
e. Review results, they must be within stated allowable differences. Record
data on Lab-1532.1
f. Date and initial
g. Retained patient will not be setup in Sysmex QC files.
P. Establishing Limit %s for Retained Patient Controls
1. Parameters monitored include: WBC, RBC, HGB, HCT, MCHC, MCV, PLT, RDW-SD,
NEUT %, Lymph %.
2. The acceptable limits are:
WBC RBC HGB HCT MCV PLT NEUT% LYMPH%
0.7 0.25 0.4 2.5 2.5 30.0 5.0 5.0
a. Limits for WBC, RBC, HGB, HCT, MCV, PLT, Neut %, Lymph % were
established by evaluating a minimum of 10 patient sets.
b. Average the CVs for each parameter and multiply the average CV% by 3 for
a 3CV% limit.
c. Selection of appropriate limits were based on 3CV% of the mid – normal
range values.
Q. Proficiency Testing:
Testing of API survey specimens is rotated through technical staff.
Implementation
START UP PROCEDURE:
A. Start-up Procedure
1. Checks prior to turning on:
a. Visual inspections of analyzer / system / reagents
i. If applicable, verify waste container is empty.
Blood
ii. Verify network / host connections are properly working.

iii. Verify sufficient reagent supply is nearby.
b. Turning ON the entire system
1. Verify that all power switches for the device is in the ON position
2. Press the GREEN power button on the front of the XN-L to power ON
the entire system.
c. Log on to the XN-450/550
1. When the logon dialog box appears, enter user name and password
d. Analyzers self-checks
1. XN-450/550: Initialization of the mechanical parts; Rinse; Temperature
stabilization; Background Check (up to 3 times).
XN-L Acceptable Background Counts
Parameters Acceptable Limit
WBC 0.10 x 103 / uL
RBC 0.02 x 106 / uL
HGB 0.1 g/dL
PLT-I 10 x 103 / uL
A. Analyze Quality Control Material
B. Analyze Quality Control and Retained Patient Control as outlined in the Quality Control section
of this policy. Record that this was performed on log.
Patient Sample Processing XN-450:

Wear gloves, lab coat and safety glasses for protection.
• Manual Analysis
o Check the status of the analyzer. Confirm the analyzer is ready.
o If the sample tube holder is not ejected, press the sample tube holder open/close
switch.
o If you want to change the analysis mode, touch [Mode] in the control menu.
o Select analysis mode.
i. [Whole blood] is selected when whole blood is being analyzed
ii. [Low WBC] Select this to perform low WBC analysis on whole Blood
iii. [Pre-Dilution} select when running 1:7 diluted blood.
o Select [OK]
o Select Manual Analysis button on the control menu
o Input sample ID or use handheld barcode reader to scan sample ID.
 Patient information – Touch Input to enter patient ID>
 Query to Host-Specify whether or not the host is queried for the analysis
order.
 Aspiration Sensor – Specify whether or not the aspiration sensor is used.
 Cap Open – Select this checkbox to perform micro sample analysis (analysis
with the sample tube cap open.)
 Raised Bottom Tube – See Instructions for Use Manual.
 Dispense – Used to prepare diluted blood. Touch to start dispensing
CELLPACK DCL. For the dispensing procedure, see the following. (section 4.8
Blood
Preparing diluted blood with the diluent dispensing function in the XN-L
Series XN-550/CN-450/XN-350 Basic Operation Manual)
o Select [OK]
o Properly mix the specimen and place in the tube holder.
 If running microtainer, remove the cap using caution to avoid splattering.
o Press the start switch on the analyzer.
 The tube holder will slide in and the sample will be aspirated.
 When the analysis is complete, the tube holder slides out.
o Remove the sample, repeat steps for additional samples.
o Review results in IPU to determine whether repeat or reflex testing is required.
o Rerun sample if required.
o Make smear if required.
o Stain and perform manual differential if required.
Patient Sample Processing XN-550:

j. System Analysis (sampler analysis)
a. Make sure the sampler cover (front) and sampler cover (manual unit) are closed.
b. Make sure the button on the right edge of the control menu is set as sampler. When the
mode is set to manual, press the mode switch.
c. Make sure that either the left or right sampler adapter holder is in a state to be pulled
out.
a. A sampler adapter holder can be pulled out when the sampler adapter status
indicator LED is solid green or OFF.
d. Pull out the sampler adapter holder that you want to use.
e. Remove the sampler adapter.
f. Mix the sample.
g. Place the sample tube in the sampler adapter.
h. Touch Sampler on the right edge of the control menu.
i. Touch an item to set the condition.
j. Touch [OK].
k. Place the sampler adapter in the sampler adapter holder selected in the sampler
settings box.
l. Push in the sampler adapter holder.
m. Press the sampler analysis start/stop switch.
n. On-Board rules engine will determine repeat or reflex testing.
o. Rack will run in reverse to perform repeat or reflex testing.
p. Remove the rack from the left sampler pool when analysis in completed.
q. Make smear if indicated.
k. Manual Analysis
a. Check the status of the analyzer. Confirm the analyzer is ready.
b. Make sure the button on right side of control menu is Manual. When it’s set to
Sampler, touch [Mode] in the control menu.
c. Select the Change Analysis Mode button on the control menu.
d. Select analysis mode
a. [Whole blood] is selected when whole blood is being analyzed
b. [Low WBC] Select this to perform low WBC analysis on whole blood
Blood
e. Select [OK]
f. Select Manual Analysis button on the control menu
g. Input sample ID or use handheld barcode reader to scan sample ID.
a. Patient information – Touch input to enter patient ID.
b. Query to Host-Specify whether or not the host is queried for the analysis order.
c. Aspiration Sensor – Specify whether or not the aspiration sensor is used.
d. Cap Open – Select this checkbox to perform micro sample analysis (analysis with
the sample tube cap open.)
• Raised Bottom Tube – Assure appropriate adaptor in use – See Instructions for Use
Manual.
5. Open the Sampler cover (manual unit).
6. Properly mix the specimen and place in the tube holder.
• If running microtainer, remove the cap using caution to avoid splattering.
1. Press the start switch on the analyzer
1. The tube holder will slide in and the sample will be aspirated.
1. When the analysis is complete, the tube holder slides out.
• Remove the sample, repeat steps for additional samples
• Review results in IPU to determine whether repeat or reflex testing is required. Rerun
sample if required. Make smear if required.
MAINTENANCE:
Wear gloves, lab coat and safety glasses for protection.
DAILY:
XN- 450/550 Shutdown – performed daily
1. Confirm analyzer and sample unit are at ready.
2. XN-450If sample tube holder is not ejected, press the sample tube holder
open/close switch.
XN-550 Open Sample Cover (manual unit).
3. If any tubes remain in holder, remove.
4. Touch [Menu] on Toolbar.
5. Touch [Shutdown]. Touch [OK].
A. XN-L on-board maintenance history will auto-populate Shutdown.
B. IPU will automatically shut off at the conclusion.
C. Press Green power button to restart IPU.
WEEKLY:
XN-450/550 Routine Cleaning – performed weekly.
CELLCLEAN AUTO is used to shut down the entire system. Refer to the XN-L Series
Troubleshooting Manual for detailed, illustrated procedures.
1. Confirm analyzer is at ready.
2. Touch the [Maintenance] Icon in the Menu screen.
3. Touch [Rinse Instrument].
4. Touch [Routine Cleaning].
1. XN-450 If sample tube holder is not ejected, press the sample tube holder
open/close switch and place CELLCLEAN AUTO in tube holder.
Blood
XN-550 Open Sampler Cover (manual unit) and place CELLCLEAN AUTO in tube
holder.
2. Press start switch.
3. On-board maintenance history will auto-populate Routine Cleaning.
CAUTION:
A. Use 1 vial of CELLCLEAN AUTO for each instrument. Do not reuse CELLCLEAN AUTO that has
previously been used.
B. During Shutdown, other sample tubes are not accepted.
Maintenance performed on the XN-450/550 will be automatically tracked in the maintenance

history.
Refer to the XN-L Series Troubleshooting Manual for ‘as needed’ maintenance.
PROCEDURE NOTES:
COMPLETE BLOOD COUNT REFERENCE RANGES (6/5/01)
RDW- RDW-
WBC RBC HGB HCT MCV MCH MCHC PLT
SD CV
Age
103/uL 106/dL g/dL % fL pg g/dL fL % 103/uL
Group
0 – 25 9.0 – 4.10 – 15.0 – 44 – 70 102 – 33 – 39 32 - 36 34 - 50 11.8 – 140 - 385
hours 30.0 6.70 24.0 115 15.6
1 – 30 5.0 – 4.10 – 15.0 – 44 – 70 102 – 33 – 39 32 - 36 34 - 50 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 34 - 50 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 34 - 50 11.8 – 140 - 385
months 17.5 5.40 14.0 15.6
2-3 6.0 – 4.00 – 11.5 – 33 - 43 76 - 90 25 – 31 32 - 36 34 - 50 11.8 – 140 - 385
years 17.0 5.30 14.5 15.6
4-5 5.5 - 4.00 – 11.5 – 33 - 43 76 - 90 25 – 31 32 - 36 34 - 50 11.8 – 140 - 385
years 15.5 5.30 14.5 15.6
6-7 5.0 - 4.00 – 11.5 – 33 – 43 76 - 90 25 – 31 32 - 36 34 - 50 11.8 – 140 - 385
years 14.5 5.30 14.5 15.6
8-9 4.5 - 4.00 – 11.5 – 33 – 43 76 - 90 25 – 31 32 - 36 34 - 50 11.8 – 140 - 385
years 13.5 5.30 14.5 15.6
10-15
years:
4.5 - 4.20 – 12.5 – 36 – 47 78 – 95 26 – 32 32 - 36 34 - 50 11.8 – 140 - 385
Male
13.5 5.60 16.1 15.6
4.5 – 4.10 – 12.0 – 35 – 45 78 – 95 26 – 32 32 - 36 34 - 50 11.8 – 140 - 385
Female
13.5 5.30 15.0 15.6
Blood
16-17
years:
4.5 - 4.20 – 12.5 – 36 – 47 78 – 95 26 – 32 32 - 36 34 - 50 11.8 – 140 - 385
Male
13.0 5.60 16.1 15.6
4.5 - 4.10 – 12.0 – 35 – 45 78 – 95 26 – 32 32 - 36 34 - 50 11.8 – 140 - 385
Female
13.0 5.30 15.0 15.6
Adult:
3.7 – 4.50 – 13.6 – 41 - 50 82 – 99 27 – 32 32 - 36 34 - 50 11.8 – 140 - 385
Male
10.4 5.80 16.7 15.6
3.7 – 4.00 – 11.8 – 36 - 46 82 - 99 27 - 32 32 - 36 34 - 50 11.8 – 140 - 385
Female
10.4 5.20 15.1 15.6
ELECTRONIC DIFFERENTIAL REFERENCE RANGES – ABSOLUTE VALUES

ANC LYMPH MONO EOS BASO IG
Age Group K/uL K/uL K/uL K/uL K/uL K/uL
0 – 25 hours 6 – 26 2.30 – 10.80 0.10 – 3.60 0.00 - 2.10 0.00 – 0.60 0-1.5
1 – 30 days 1.5 – 10.0 2.0 – 17.0 0.10 – 3.60 0.00 - 2.10 0.00 – 0.60 0-0.6
1-5 months 1 -9 2.10 – 13.90 0.10 – 2.30 0.00 – 1.40 0.00 – 0.40 0-0.04
6- 11 months 1 – 8.5 2.80 – 13.30 0.10 – 2.10 0.00 - 1.20 0.00 – 0.40 0-0.04
12-23 months 1.5 – 8.5 2.80 – 13.30 0.10 – 2.10 0.00 - 1.20 0.00 – 0.40 0-0.04
2-3 years 1.5 – 8.5 2.60 – 12.60 0.10 – 2.00 0.00 - 1.20 0.00 – 0.30 0-0.04
4-5 years 1.5 – 8.5 1.90 – 10.10 0.10 – 1.90 0.00 – 1.10 0.00 – 0.30 0-0.04
6-7 years 1.5 – 8.0 1.20 – 7.80 0.10 – 1.70 0.00 – 1.00 0.00 – 0.30 0-0.04
8-9 years 1.5 – 8.0 1.40 – 7.60 0.10 – 1.60 0.00 – 1.00 0.00 – 0.30 0-0.04
10-11 years 1.5 – 8.0 1.50 – 7.60 0.10 – 1.60 0.00 – 1.00 0.00 – 0.30 0-0.04
12-15 years 1.8 – 8.0 1.30 – 6.50 0.10 – 1.60 0.00 – 1.00 0.00 – 0.30 0-0.04
16-17 years 1.8 – 8.0 1.10 – 5.90 0.10 – 1.60 0.00 – 0.90 0.00 – 0.30 0-0.04
Adult 2.0 – 8.7 0.70 – 4.70 0.00 – 1.10 0.00 – 0.50 0.00 – 0.20 0-0.04
Reporting Critical Results:

Please refer to Lab-0130 Critical Call Values, Lab Reporting Protocol.
Detection of Erroneous Results:

A. The XN-450/550 has a bi-directional interface to the LIS. This allows patient demographics to
cross from the LIS orders to the XN IPU. This allows patient name, order #, MR #, DOB and
sex to print on each instrument printout and facilitates matching paperwork to specimen
and slides for manual differential.
B. %D flag is attached to the platelet result if the result varies more than 50% of previous result
within a seven-day time-period. Operator will check sample integrity, previous results, and
possibly a slide estimate to validate results.
C. %D flag is attached to the MCV result if result varies more than 5% of the previous result
within a five-day time-period. Operator will check sample integrity, previous results,
Blood
corresponding chemistry results, clinical condition, and method of draw to ensure proper
patient identification.
D. An instrument IP alarm message is activated if the MCHC is greater than 37.5. This alerts
the operator to investigate a possible cold agglutinin or other interfering substance. Send
sample to La Crosse for analysis.
E. If the instrument cannot read the barcode label, an error # will be assigned. The operator
will edit the barcode order # in the XN-450/550. All numbers and patient name will be
compared prior to verification.
F. Modified Result logs are printed each morning. The Supervisor or designee will review all
reports. Corrected reports or incident reports will be initiated if necessary.
G. Pending logs are monitored on a scheduled basis to detect uncompleted test and assure
adequate TAT of results.
PROCEDURE NOTES:
1. Do not place samples on a mechanical rocker. Excessive mixing may induce
platelet clumping and alter white cell membranes resulting in false interpretive
messages.
2. See Lab-0630 LIS Downtime Plan - Hematology for specific directions for editing
an I.D. For troubleshooting specifics, refer to the Sysmex XN-L Series
Troubleshooting Manual.
3. Nucleated RBCs: If 5 or more NRBC are counted on the differential, the
specimen should be sent to La Crosse for analysis.
4. Lipemic specimens generating a Turbidity/Hgb Interf?
If MCHC > 37.6:
a. Warm sample for 15-30 minutes by placing the tube in the incubator or warmer.
b. Order a RERUN by selecting the appropriate specimen ID and clicking on the
rerun/reflex icon and then clicking ok (you do not need to choose test codes).
c. Mix the warmed sample and re-run on analyzer.
d. If the warmed MCHC is < 37.5:
a. Add “Specimen warmed” to the RBC count in DI by double-clicking in
the comment box to the right of the RBC result. Click on “Insert Coded
Entry” from the top banner bar and select “Warmed Specimen” and OK.
This comment now will display next to the warmed RBC value.
b. Verify results as appropriate based on other flags present.
If the warmed MCHC is still > 37.6: 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:
a. Reject the specimen from the DI specimen worksheet.
b. Fill out and send a Regional Verification form (Lab-5074.4).
c. Put sample on packing list to La Crosse Lab.
B. If results are needed on site:
1. Spin an aliquot of the sample; examine the plasma for lipemia,
hemolysis or icterus.
2. If the plasma is moderately to grossly hemolyzed, recollect the sample.
Blood
3. If the plasma is lipemic, icteric or if the WBC is >100,000, the HGB may
be affected. Remove the HGB, MCH, and MCHC results in DI and leave
blank. Then click in the test comment column to the right of each result
field; click on “Insert Coded Entry” from the top banner bar and choose
“Unable to report due to unknown interfering substances. Sent to GL-La
Crosse lab verification.” Click OK.
4. Send a printout of the new order to LIS department with a note to
cancel the charge for this duplicate order.
5. Put sample on a packing list to La Crosse lab
6. Fill out Regional Verification form (Lab5074.4) and send it along with the
sample to La Crosse Lab.
7. If the plasma is clear, the RBC and HCT may be inaccurate. Do not
report the RBC, HCT, MCV or MCHC. Remove these values in DI and
leave blank. Then click in the test comment column to the right of each
result field.
8. Put sample on a packing list to La Crosse lab.
9. Fill out Regional Verification Form (Lab-5074.4) and send it along with
the sample to La Crosse lab.
INTERPRETATION:
1. Negative or Positive Result Status:
a. If no flags are generated, the specimen status will be “Negative”. Results are auto-
verified and a slide is not reviewed.
b. If a flag is generated, the status will be “Positive”. All positive CBCs will have a slide
review, as specified in Super DI rules.
c. The criteria for “Positive” CBCs are:
a. All analyzer flags (WBC, RBC< and PLT)
b. Immature Grans # >0.5
c. Children < 1 month of age with an ANC <2.0
d. Slides are made and stained on all “positive” flagged CBC’s.
e. Differential – entire or partial vote outs of electronic differential parameters; poor
separation of WBC populations. Report manual differential.
f. Specimens for verification:
i. Follow instructions listed on the Regional Verification Form
(Lab5074.4), to send the sample to La Crosse lab.
ii. Blood specimens should be sent as soon as possible. Send
(in a separate bag) the tube of blood, your stained smear, 2
unstained smears and a copy of your analyzer printout and
the Regional verification form labeled with patient ID. Call
the La Crosse lab and let them know that a specimen is
coming.
iii. Please inform La Crosse if results should be called to the
provider on the order form.
g. You may report below or above linearity using less than (<) or greater than (>) #.
Blood
Example: if WBC is over range, result WBC >490 in the computer if the provider needs a
result immediately. The following specimens should be sent to La Crosse for testing
following the instructions listed on the Regional Verification Form, (Lab5074.4):
A. WBC greater than 490 x 103 / uL.
B. RBC greater than 8.6 x 106 / uL.
C. Hematocrit greater than 75.0%
D. Platelets greater than 5000 x 103 / uL.
E. Specimens in which the MCHC is >37.0
F. If RDW does not calculate due to the shape of peak and trough use comment
“Microcytic/ Macrocytic or dimorphic RBC population”.
LIMITATIONS:
Stated Linearity:
Parameter Range Units
WBC 01. – 490 X 103 / uL
RBC 0.0 – 8.6 X 106 / uL
HGB 0.0 – 26.0 g/dL
HCT 0.0 – 75.0 %
PLT 0 – 5000 X 103 / uL
Possible Sample Interferences (For additional information, reference the analyzer). Instructions for
Use, Flagging Guides, and Clinical Case Reports located on the CRC).
A. Specimens must be free of clots and fibrin strands.
B. 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.
C. Red cell fragments, microcytic RBCs or white cell cytoplasmic fragments may interfere with
automated platelet counts.
D. Cold agglutinins produce spurious macrocytosis, elevated MCHs MCHCs, falsely decreased RBC
counts and HCTs. Rare warm agglutinins produce the same spurious results as a cold agglutinin.
E. Extremely elevated WBCs may cause turbidity and falsely increase the hemoglobin, in addition
to RBC and HCT values.
F. Severely hemolyzed samples (in vitro) falsely decrease RBC and hematocrit. Recollect
hemolyzed specimens.
G. Giant platelets and clumped platelets may falsely elevate the WBC count and falsely decrease
the platelet count. Platelet clumping and/or "platelet satellitism" can occur in specimens
collected in EDTA. This may falsely elevate the WBC count and falsely decrease the platelet
count. Send sample to La Crosse for analysis.
H. Abnormal paraproteins found in blood from patients with Multiple Myeloma can falsely increase
the HGB. Send to La Crosse for analysis.
I. Severely icteric samples may falsely elevate the HGB value and related indices. Send to La
Crosse for confirmation of results.
J. Rocking specimen excessively, may affect the WBC differential.
K. Megakaryocytes may falsely increase WBC counts on automated hematology analyzers.
Flagging and Action messages:
Blood
A. Abnormal samples on the XN-L Series are identified using flagging systems to alert the user of a
possible abnormality.
B. Suspect flags generate a message (e.g., Atypical Lymphocyte, WBC Abnormal Scattergram).
Numerical results will display an asterisk and the specimen result will display as “Positive”.
C. Analyzer generated error codes (e.g., DIFF channel errors). Error will display in both the Browser
and Explorer screens.
D. User defined flags (e.g., leukocytosis, anisocytosis). These flags are programmable by the
customer in the settings menu. When threshold limits are exceeded, a message appears, and
the specimen result will display as “Positive”.
E. Action Messages - The results are displayed in the Browser Screen.
Refer to the Sysmex XN-L Series Automated Hematology Systems Flagging Interpretation Guide for
additional information on flagging.
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:
A. Sysmex XN-L Series Basic Operation (North American Edition), Sysmex Corporation, Kobe, Japan.
B. Sysmex XN-L Series General Information (North American Edition), Sysmex Corporation, Kobe,
Japan.
C. Sysmex XN-L Series Troubleshooting (North American Edition), Sysmex Corporation, Kobe,
Japan.
D. Clinical and Laboratory Standards Institute (CLSI). Laboratory Documents: Development and
Control; Approved Guideline; Fifth Edition. (GP2-A5, 2006).
E. Sysmex Reagents of America Inc., Mundelein, IL. XN CAL, Hematology Calibrators: Calibrators
for Sysmex Hematology XN-L Series Analyzers, package insert.
F. Sysmex America Inc., Lincolnshire, IL. XN-L CHECK Hematology Control for Sysmex XN-L Series
Analyzers package insert.
G. Sysmex America Inc., Lincolnshire, IL. Sysmex Insight Participant Overview Guide.
H. Koepke, John. Practical Laboratory Hematology. Churchill Livingstone Inc. 1991.
h. 24-25, 36-39.
I. Cornbleet J., Spurious results from automated hematology cell counters. Lab Medicine.
1983;8:509-514.
J. Sysmex Reagents of America, Inc. SDS sheets and reagent product inserts.
K. College of American Pathologists (CAP) Hematology-Coagulation Checklist, July 2012.
L. Stewart, Charles and Koepke, John. Basic Quality Assurance Practices for Clinical Laboratories,
Van Nostrand Reinhold, 1989, p 189.
M. Gulati GL, Asselta A, Chen C. Using vortex to disaggregate platelet clumps, Laboratory Medicine,
28:665, 1997.
N. Zhou X, Xiaoli W. Amikacin Can Be Added to Blood to Reduce the Fall in Platelet Count, American
Journal of Clinical Pathology, 136:646-652, 2011.
Blood
O. Sysmex America Inc., Lincolnshire, IL. XN-L Applications Manual.

P. Sysmex America Inc., Lincolnshire, IL. BeyondCareSM Quality Monitor User Manual
Q. Sysmex XN-L Series Automated Hematology Systems Flagging Interpretation Guide, Document
Number: 1399-LSS, Rev 2, February 2019.
R. Reagent Unit RU-20 Instructions for Use. Sysmex Corporation, Kobe Japan.
S. CLSI document H56-A – Body Fluid Analysis for Cellular Composition; Approved Guideline. Vol
26, No 26.
Sysmex XN- 450/XN-550, CELLPACK DCL, DST, DFL, FLUOROCELL, LYSERCELL, XN-CHECK, XN-L CHECK, XN
CHECK BF, XN CAL, and Sysmex Insight are trademarks of the Sysmex Corporation.
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Lab Policies Sysmex XN 450 XN 550 Lab 1532

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Lab Policies Sysmex XN 450 XN 550 Lab 1532

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Standard Operating Procedure

3. Sample stability at room temperature is 8 hours. Samples stored at room temperature

WARNING: POTENTIALLY INFECTIOUS MATERIAL.

WARNING: POTENTIALLY INFECTIOUS MATERIAL.

i. XN-450/550 Reagent Replacement

4. Performance of new reagent lots and/or shipments is accomplished by a variety of methods

Precision and Calibration:

Precision Check will be performed at least two times per year.

Corrective Action if Precision Fails:

A. XN-L CHECK Commercial Controls Instructions for Use

WARNING: POTENTIALLY INFECTIOUS MATERIAL.

B. Frequency of Control use and review.

b. If analyzer displays YELLOW, more information is needed, or QC is overdue. The

G. Recording and Storage of QC Data

6. Properly eject the flash drive from the IPU.

d. A linear regression may be performed at the request of the medical

ii. Verify network / host connections are properly working.

Patient Sample Processing XN-450:

Patient Sample Processing XN-550:

Maintenance performed on the XN-450/550 will be automatically tracked in the maintenance

ELECTRONIC DIFFERENTIAL REFERENCE RANGES – ABSOLUTE VALUES

Reporting Critical Results:

Detection of Erroneous Results:

Flagging and Action messages:

REVIEW AND CHANGES:

O. Sysmex America Inc., Lincolnshire, IL. XN-L Applications Manual.

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