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Improper Design or Use Of
Blood Collection Devices Adversely Affect Accuracy Of Lab Test
Results.
Improper design or use of blood
collection devices can adversely affect the accuracy of laboratory
test results. Vascular access devices, such as catheters and
needles, exert shear forces during blood flow, which creates a
predisposition to cell lysis. Components from blood collection
tubes, such as stoppers, lubricants, surfactants, and separator
gels, can leach into specimens and/or adsorb analytes from a
specimen; special tube additives may also alter analyte stability.
Because of these interactions with blood specimens, blood
collection devices are a potential source of pre-analytical error
in laboratory testing. Accurate laboratory testing requires an
understanding of the complex interactions between collection
devices and blood specimens. Manufacturers, vendors, and clinical
laboratorians must consider the pre-analytical challenges in
laboratory testing.
In May 2017, the FDA advised
Americans that Magellan's LeadCare test systems performed on blood
drawn from the vein (venous) may provide inaccurate results and
recommended that laboratories and health care professionals follow
the FDA's recommendations concerning retesting using blood drawn
from a finger or heel stick. Prior to this warning, Magellan
informed its customers that the inaccurate results may potentially
be related to the composition of the rubber stopper of certain
brand of blood collection tubes — specifically, tubes with
lavender- or tan-colored tops — and advised customers to no longer
use these types of tubes with Magellan’s blood lead tests.
During the investigation of the
manufacturing facility, it was revealed that the company failed to
comply with the good manufacturing practice requirements of FDA’s
Quality System regulation including violations of device design
validation requirements and failure to adequately review,
evaluate, and investigate complaints.
BCTs consist of tube walls, rubber
stoppers, lubricants, anticoagulants, separator gels, clot
activators, and SFs, all of which can affect the quality of the
specimens, accuracy and precision of laboratory tests.
Because BCTs function properly under
most circumstances, many laboratorians are unaware of their
complexity and limitations. A widespread surfactant (SF) problem
revealed how these devices can adversely affect laboratory test
results (7,8) and emphasized the importance of understanding
device limitations.
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3936985/)
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