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THE WAIVED CBC:
A GAME CHANGER
By Irwin Z. Rothenberg, MBA, MS, CLS(ASCP), Technical Writer / Quality Advisor, COLA Resources, Inc.
On November 6, 2017, the U.S. Food and Drug Administration
(FDA) granted market clearance for the first ever CLIA – waived
hematology analyzer for complete blood count and three-part
differential testing. This analyzer, the Sysmex XW-100, is for use
in both traditional and non-traditional point of care patient
settings, including physician offices, community health clinics, and
other healthcare facilities, allowing a wide range of support staff
to provide patients with blood test results in as few as three
minutes. While not intended to replace more complex
laboratory hematology testing, this analyzer is the latest example
of a trend to improve laboratory testing capabilities in the near-
patient environment. The goal is to reduce the turn-around time
for test results, thus improving the delivery of patient care.
“A CBC is one of the most common physician-ordered tests
used to evaluate a patient’s blood levels, determine if an
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infection is present and if immediate intervention is needed.
However, in the current health care setting, non-hospitalized
patients who require a CBC can experience at least a 24-hour
wait for test results, if not longer, when the test is performed by
an off-site laboratory,” said Donald St. Pierre, acting director
of the Office of In Vitro Diagnostics and Radiological Health
in FDA’s Center for Devices and Radiological Health. “This
waiting period may be detrimental to the health of patients
whose care depends on quick results to rule out conditions that
may require immediate medical intervention. With the device
cleared today, processing time may now be reduced by making
testing available in these additional settings.”
In addition, 37% of patients said that not being able to get
laboratory results during the same visit was the reason a health
provider failed to meet their expectations. In the study, patients
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