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RENOWN REGIONAL MEDICAL CENTER CLINICAL LABORATORY 77 Pringle Way Reno, Nevada, 89502
PRINCIPLE
The Sysmex XS-1000i is a quantitative automated hematology analyzer for in-vitro diagnostic
use for determining 21 hematological parameters. Examination of the numeric 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
XS-1000i analyzer directly measures the WBC, RBC, HGB, HCT, PLT, NEUT#, LYMPH#,
MONO#, EO#, and BASO#. The remaining parameters are calculated or derived: MCV, MCH,
MCHC, RDW-CV, MPV, and differential percentages.
The Sysmex-XS 1000i counts and sizes red blood cells and platelets using electronic resistance
detection enhanced by hydrodynamic focusing. Hematocrit is measured as the ratio of the total
RBC volume to whole blood using cumulative pulse height detection. Hemoglobin is converted to
SLS-hemoglobin, and read photometrically.
WBC count and differential are evaluated using flow cytometry with a semiconductor laser
utilizing scattered light and fluorescence to determine the differences in cell size, complexity, and
RNA/DNA content. The WBC differential channel classifies neutrophils, lymphocytes,
monocytes, eosinophils, and basophils by cellular complexity and nucleic acid content. The
differential cell placement is then enhanced utilizing Adaptive Cluster Analysis.
SPECIMEN COLLECTION
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
C. Storage and Handling Requirements
1. EDTA blood specimens are stable for 24 hrs at room temperature. EDTA blood
samples may be analyzed up to 48 hours if stored at 4ºC.
2. Allow refrigerated samples to come to room temperature and mix well before
analysis.
3. Microtainer samples must be checked for clots prior to analysis.
4. Specimens are considered unacceptable if blood is clotted, grossly hemolyzed,
contaminated (i.e. drawn above an IV) or the tube is improperly labeled. An
unacceptable specimen will be rejected and the patient must be redrawn.
5. All blood samples and body fluids should be handled as potentially infectious
materials with standard precautions being observed at all times.
REAGENTS
CALIBRATION
A. Calibration compensates for any bias inherent to the pneumatic, hydraulic, and
electrical system that may affect the accuracy of results. Sysmex SCS-1000 Calibrator
is a secondary whole blood calibrator for use with the Sysmex XS-1000i hematology
analyzer.
C. Calibration Frequency
1. Calibration should be performed on primary and secondary modes every 6
months, as required by CAP, and additionally when any of the following occur:
a. At installation.
b. Every six months or on an “as needed” basis to ensure accuracy of the
system.
c. When advised to do so by manufacturer.
d. When critical parts are replaced such as manometers, apertures, or
detector circuit boards.
e. When controls begin to show evidence of unusual trends.
C. Calibration Procedure
1. Precision Check
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
a. Perform routine daily and weekly maintenance on the instrument, and
perform a background count to ensure counts are within acceptable limits.
b. Obtain a sample of fresh normal whole blood. Do not use commercial
controls or calibrators for precision. The blood donor specimen should:
i. Be free from medication, and interfering substances such as
lipemia, icterus, platelet clumps, hemolysis, etc.
ii. Have morphologically and numerically normal CBC.
c. On the IPU, click [Menu] or press [F4].
d. Click on the “Controller” icon in the Menu window.
e. Double click on the “Precision Check” icon on the Controller menu.
f. Attach appropriate tube adapter to the sample position.
g. Analyze the sample 11 times in the Manual Mode, mixing gently before
each analysis. After each analysis, the results display on the IPU screen,
and the cursor moves to the next line.
h. The mean, SD, and CV% are calculated on the last 10 analyses. The
CV% values are displayed in red if they exceed the Precision Limit %. If
the CV% exceeds the precision Limits, click [CANCEL].
i. If all results are within Precision Limits, click [OK] on the Precision Check
screen to save the data and close the Precision Check window.
j. To print a hard copy of the Precision results, click on “Precision Check
List” on the “Controller” screen, then click [File] on the Menu Bar and click
[Print].
2. Calibration Check
a. Prepare the Sysmex SCS-1000 calibrator according to the product insert.
b. Click [Menu] or press [F4].
b. Click the “Controller” icon on the Main menu window.
c. Double-click the “Calibrator Calibration” icon on the Controller menu.
d. Click [ASSAY TARGET], then click in the parameter fields and use the
numeric keys to enter the target values for each parameter from the
Sysmex SCS-1000 assay sheet. Click in the next field after each entry.
Click [OK] when all values have been entered.
e. Attach the appropriate sample tube adapter.
f. Perform 6 consecutive analyses in the sampling mode. Do not mix in
th
between 6 analyses. Wait until the 6 analysis is complete, then review
the results.
g. After 6 analyses, the last 5 analyses are used to calculate the Range
Values and Delta percents. The parameter values are highlighted in red if
they are out of range.
i. Calibration cannot be performed if the Range Value exceeds the
Max Range Value, or if the Delta% exceeds the Service limit. See
troubleshooting section of the Sysmex XS-Series instruction
manual to correct the problem.
ii. If the Range Values and Delta Percents are within acceptable limits
and require calibration, click [ACCEPT]. The parameters are
displayed with a check in the check box beside the new
Compensation Rates. Parameters that are not within acceptable
limits cannot be selected for calibration.
iii. Click [OK] to execute the calibration or [Cancel] if calibration is not
desired or necessary. The display returns to the Controller menu.
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
h. Using another fresh vial of the calibrator, verify the calibration by repeating
the Calibration Check procedure. The analyzed values should all be within
acceptable limits. Do not execute calibration; exit the Calibration function.
i. Print the Calibration History
i. Click [Menu] or press [F4]
ii. Click the “Controller” icon
iii. Click the “Calibration History” icon
iv. Click on the calibration date in the Calibration History list
v. To print a hard copy of the Calibration results, click on
Calibration Check List on the “Controller” screen, then click
[File] on the Menu Bar and click [Print]
vi. Attach copies of the calibration verification to the CBC
calibration report in the Sysmex-XS calibration log book.
j. Following calibration, analyzed commercial controls. Adjust target values if
necessary.
QUALITY CONTROL
The Sysmex XS-1000i series analyzer operates in two modes; the Manual Aspiration Mode,
and the Capillary mode. Tests can be ordered and run as CBC, CBC+DIFF. Carefully identify
specimen(s) and attach the barcode label to the sample tube before running. Two identifiers
out of three on the specimen armband label must be legible and match exactly with the patient
ID numbers on the order. The three identifiers are the patient’s name, medical record number
and billing number. The Soft label should be placed so that the patient’s MRN and billing
number is visible.
B. Capillary Mode
1. Use when insufficient patient sample is available (<500 uL) or a sample has a
parameter above the linearity limits of the analyzer. Use if there are marked
changes in plasma constituents, (i.e. very low sodium or very high glucose).
2. Prepare a 1:7 dilution by pipetting 120 uL of CELLPACK into a tube, then adding
20 uL of whole blood. Allow to equilibrate before analysis
3. On the IPU, click [MANUAL] or press [F2].
4. Enter the specimen number (alpha or numeric characters) using the keyboard or
using the handheld bar code reader.
5. Click on CBC or CBC+Diff if this information is not being provided by the Host
Computer.
6. Click on the “Yes” radio button to select Capillary Mode.
7. Click [OK].
8. Attach the appropriate sample tube adapter.
REPORTING RESULTS
A. Results are printed by the analyzer and transmitted to the host LIS as the results are
available. Flags, codes and suspect or definitive messages are used to alert the
operator of an instrument problem, specimen abnormality, abnormal data pattern, or
abnormal results. Review as appropriate all results displaying a flag, code or message.
B. Remove printouts from the printer and keep them in the order that they came off the
printer. If a specimen needs to be repeated, set aside printout. Staple repeated results
together.
C. Printouts should be separated into three categories after each patient’s results are
reviewed, posted and/or verified from the Interface Menu on the host LIS.
1. Completed- Posted and verified all results.
2. Requires peripheral smear review- Partial posted and verified or posted and not
verified.
3. Requires repeat results- Skip in Interface Menu until repeat results are available.
D. Review each patient’s results in the Interface Menu on the host LIS. Review previous
results, delta flags, panic flags, abnormal flags, and instrument flags including RBC
morphology, RBC flags, WBC flags, platelet flags and sample system flags.
E. Based on Patient Results Repeat and CBC Release criteria, determine if further
evaluations, such as repeating results or peripheral smear review are required.
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
F. Evaluate all parameters before posting and verifying results.
G. Refer to Patient Results Repeat Criteria, CBC Release Criteria, and CBC release
procedure for specific instructions on repeating, posting and verifying results.
H. Patient Results Repeat Criteria and CBC Release Criteria do not apply to CBCOI (CBC
with Differential ordered from Outpatient Infusion) results. All CBCOI orders should be
posted and verified from the Interface Menu of the LIS unless a count is in question ie.
platelet clump flag or nucleated RBCS. The following comment will automatically report
for all CBCOI orders: Per physician request, the automated differential results
reported on this patient have not been verified by a manual method.
I. For CBCD results
1. If results do not need to be repeated and the peripheral smear review is not
indicated, post and verify all results from the Interface Menu. RBC morphology
results will automatically report and verify. If no RBC morphology is reported,
Normal will automatically report for RBC morphology.
2. If an POSITIVE flag is present and a peripheral review is not required as
indicated in the review criteria, results will be released with the following
comment; Less than 10 % bands are present.
3. If a peripheral smear review is required, a SCANS (Scan peripheral smear) test
will reflex when results are posted.
a. Partial post and verify (posts all results but verifies only the CBC without
differential portion) or
b. Post and do not verify results.
4. A SCAN can be reflexed if a peripheral smear review is not required by set
criteria, but a slide still requires review. Partial post and verify results. On the
diff worklist, at the result field RSCAN, select Reflex Scan from the keypad.
Save and Refresh results to reflex the SCANS test.
5. If the WBC count is <0.5 K/uL a peripheral smear review will be required. If
previous differential results appear in the LIS, SCANS should be resulted as
Cancel Diff from the keypad. Save and Refresh results. The automated
differential, LSHFT, HYPO, ANISO, MACRO, and MICRO results will
automatically cancel. The following comment will be added to the results:
Differential cancelled due to white blood count of less than or equal to 0.5 K/uL.
An instant report of the results will automatically print to the HP2 printer for
crediting charges. If previous differential results are not present in the LIS, a
manual differential count is warranted. Prepare peripheral smear from a buffy
coat preparation if necessary.
6. Results that are posted but not verified from the Interface Menu must be
completed at the DIFF template.
J. For Total Eosinophil Counts, post and verify the AEOSA (Absolute automated
eosinophil) result from the Interface Menu.
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
K. All panic values must be called to the appropriate nurse or physician. Each order that
includes critical results will have a call comment appended to the result by completing
the required information in the Call Box of the LIS.
L. Printouts of completed results are filed alphabetically in the Infusion Center Hematology
weekly file.
M. Refer to Supplemental Attachments for reference ranges, panic values, and technical
ranges.
1. WBC counts of less than 0.1 K/ul will be reported as <0.1K/L and WBC counts
greater than 400.0 K/uL will be reported as >400.K/uL.
2. RBC counts of greater tan 7.00M/uL must be diluted with saline, rerun and
multiplied by the dilution factor, or dilute 1:7 and use the capillary mode.
3. HGB result greater than 22.5 g/dL must be diluted with saline and repeated. The
diluted result must be multiplied by the dilution factor to obtain the correct result.
4. PLT results less than 5K/uL will be reported as <5K/uL and PLT results of
greater than 3500 K/uL will be reported as >3500K/uL.
PROCEDURAL NOTES
Refer to instructions in the instrument software or help list topics. Document and sign all
maintenance performed and any Instrument problems and how they were rectified in the
maintenance binder.
A. A daily start-up of the Sysmex XS-1000i will be performed at the beginning of each day
shift, and a daily shutdown will be performed at the end of each day shift.
B. After startup is completed, review the printed Daily Checks Report and file it in the
maintenance log. To view this on screen, select QA and the calendar. All results should
be green and read Pass. If they do not, repeat startup or perform troubleshooting for
the specific test.
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
LIMITS OF PROCEDURE
B. Any out of range control results will be documented and corrective action entered in the
comment box for the appropriate level of control. Deselect control if necessary.
RBC X 9 = Hematocrit
RBC X 3 = Hemoglobin
HGB X3 = Hematocrit
MCH X3 = MCV
1. The WBC count may be effected by: lyse-resistant red cells, malarial parasites,
giant platelets, platelet clumps, NRBC’s, fragmented white cells, agglutinated
white cells, cryoglobulin, some extremely elevated proteins, and any unlysed
particles greater than 35 fL size.
2. WBC counts >140 K/uL will interfere with the RBC count. In such cases only
spun hematocrit, WBC count and platelet count should be reported along with a
comment addressing the inability to report the other parameters due to
interference caused by high WBC count.
3. The RBC count may be effected by: Very high WBC count, high concentration
of large platelets and auto-agglutination.
4. Hgb may be effected by: Very high WBC count, severe lipemia, heparin, or RBC
abnormalities that resist lysing.
5. The Platelet count will be effect by: Giant platelets, platelet clumps, white cell
fragments, red cell fragments, or microcytic RBCs.
1. Saline Replacement
a. Obtain a printout of the specimen’s CBC.
b. Thoroughly mix the specimen and pipette an aliquot into a labeled tube.
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
c. Centrifuge the specimen for 5 minutes at 2500 RPM to insure all cells have
been removed.
d. After centrifugation, remove the plasma, being careful not to remove the
buffy coat.
e. Replace plasma with an equal amount of normal saline solution. For a cold
agglutinin, warm the diluent and specimen to 37°C.
f. Rerun the freshly prepared mixture through the manual mode. The
replacement process may need to be done several times.
g. Accept the new value for HGB and HCT and RBC indices.
2. Use the original WBC and platelet values if there is any discrepancy between
results of original specimen and saline diluted specimen.
D. Lipemia falsely elevates the HGB and MCHC. Perform a saline replacement, plasma
bank procedure, or make a 1:7 dilution with CELLPACK.
2. Plasma Blank
a. Obtain a printout of the specimen’s CBC.
b. Thoroughly mix the specimen and pipette an aliquot into a labeled tube.
c. Centrifuge the specimen for 5 minutes at 2500 RPM to insure all cells have
been removed.
d. After clearing the instrument with Sysmex CELLPACK, obtain a plasma
blank value by running the plasma on the instrument in the same fashion
you would whole blood.
e. Calculate a corrected hemoglobin result by the following formula:
= 12.3-5.5 x 0.707
= 12.3-3.9
= 8.4
g. Enter the corrected Hgb, MCH, MCHC, and MCV results with canned
message “Hemoglobin results were corrected for extreme lipemia.”
B. Severely Icteric samples may falsely elevate the HGB value and related indices. Make
a 1:7 dilution with Sysmex CELLPACK.
C. Severely hemolyzed samples (in vitro) falsely decrease RBC and hematocrit. Recollect
hemolyzed specimens.
D. 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. Recollect the
specimen in Sodium Citrate anticoagulant and multiply by 1.11 dilution factor. Enter
canned message in LIS, (under “Stay Comment” in Order Entry), to notify phlebotomy
that patient is a platelet clumper.
E. Nucleated RBCs
1. All CBCs with nucleated rbcs reported must be reviewed and the WBC count
evaluated.
2. False positive nrbcs results may be due to lymphocytes smaller than 35 fL, and in
rare cases, platelet clumps, giant platelets, malarial parasite or precipitated
proteins. Also, nucleated rbcs that are greater than 35 fL will be seen as a WBC
by the analyzer.
3. If the instrument has incorrectly identified nrbcs, further evaluation of the white
count is required. Perform manual differential and correct Sysmex XS-1000i
WBC count for the NRBC’s per 100 WBC’s counted.
F. Do not place samples on a mechanical rocker. Excessive mixing may induce platelet
clumping and alter white cell membranes resulting in false interpretive messages.
REFERENCES
Sysmex XS-1000i Instructions for Use, Sysmex Corporation, Kobe, Japan, February 2006
Sysmex XS-1000i Users Guide, Sysmex Corporation, Kobe, Japan, February 2006
Sysmex e-CHECK Hematology Control insert sheet for Sysmex XS-1000i Analyzer, Rev. 1, 30-
Aug-02
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
Sysmex Reagents of America, Inc. MSDS sheets and reagent product inserts
Koepke, John. Practical Laboratory Hematology. Churchill Livingstone Inc. 1991. p. 24-25, 36-
39
Garrity, P., Walters, J. Concepts in New Age Hematology, A Hematology Monograph, Baxter
Healthcare Corporation, Scientific Products Division, Hematology Support Services. August
1990
Brigden, Malcom L. Cell Counter-Related Abnormalities, Laboratory Medicine, may 1999, Vol.
30, #5, p. 325-128.
The author, or designee, shall update this procedure as new versions are applicable. The
Clinical Laboratory Medical Director or designee shall review this procedure annually. If there
is a change in the Clinical Laboratory Medical Director, the new Medical Director will review
and sign this procedure within six months of taking on the responsibilities of Medical Director.
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SYSMEX XS-SERIES HEMATOLOGY SYSTEM PROCEDURE
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