• “Values outside of the normal ranges
are flagged and reported. For results
outside of critical ranges, the numerical
results are not reported to the operator
and follow-up steps are recommended
instead, such as referring the
specimen to a core laboratory for test
completion,” noted Taylor. “This
ensures that erroneous data is not
used to support the diagnosis or treat
conditions.” Should tests return
abnormal results due to machine
error, or if the operator cannot bring
the analyzer within standard control
ranges, the machine locks out all
operators, blanks out all viewable test
data, and reports to Sysmex. “What
happens next is a unique feature of
this system,” added Taylor. “Sysmex
will deliver a replacement analyzer
the next day. Physicians return the
malfunctioning unit using the box in
which their new unit was delivered.
This reduces maintenance and
training requirements, ensures proper
operation of the analyzer, and
minimizes downtime for the physician.”
A sign of the times, and the universal
application of modern digital technology
is that Sysmex has adopted the same
replacement policy that consumers
expect with their computers, printers,
smart phones, and similar devices. Call
the company, report the malfunction, and
a replacement is immediately shipped
with a return label so that the
malfunctioning device can be sent back
to the manufacturer.
For moderately complex labs that
may worry about demand for one of its
highest-volume tests shifting to POL
and CLIA-waived environments, and
taking revenue streams with them, here
are some additional considerations: is an analyzer that enables on-site CBC
testing at near patient sites, resulting in
more rapid patient treatment at reduced
cost, saving the patient time, and return
visits. It also enhances efforts to enact
value-based medicine through improved
efficiency and cost savings. However,
many operational restrictions have been
built into this instrument in order to
ensure that facility staff can operate it
without sacrificing patient safety. It is also
not intended for higher levels of patient
Under Defined Conditions Blood
Samples Will Still Be Referred To
the Core Lab:
“This analyzer is designed so that
samples will still be referred to central
labs for either repeat testing or more
detailed hematology tests that will give a
greater level of information back to
clinicians,” stated Taylor. “Our goal with
this analyzer is to deliver information
within the POL environment that allows
clinicians to respond quickly and rapidly
to begin treatment. Meanwhile, central
labs will continue to provide detailed
information that will be used to further
refine treatment”’ test volume; nor to be used for automated
transmission of test results remotely.
It is intended for use in patients 2 years
of age and older who require a whole
blood cell count and white blood cell
differential However, it is not intended to
diagnose or monitor patients with primary
and/or secondary hematologic diseases,
including o ncology and critically ill
patients. While many point of care sites
may acquire this analyzer to enable them to
provide improved patient care, especially if
they do not presently have an analyzer that
can provide differentials, the built in
restrictions will more likely limit its use in
larger facilities to that of supplementing the
more complex hematology instruments that
have a larger test menu, rapid throughput,
and greater IT capabilities.
Conclusion
The Sysmex XW-100 hematology
analyzer is the first waived CBC with 3-
part differential, approved by the FDA. It
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