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Performance
and Blood
Component
Quality
07-19-01-518 – January 2009
A
C
LYX
OMPONENT
The quantity and quality of blood components collected by the
instrument depend primarily on the following:
• Amount of whole blood processed and the rate of processing
• Donor hematocrit
• Handling and storage of the components
• Instruments and techniques used to measure results
• Completion of a procedure as programmed
• Completion of the leukofiltration process without
interruption
The A
Component Collection System is expected to produce
LYX
pre-leukoreduction red cell products that contain the targeted
amount of absolute red cells ± 10%. For example, a target of
360 mL of red cells may yield 360 mL ± 36 mL, prior to
leukoreduction. Leukoreduced red cell products are expected to
meet the requirements for white cell reduction per unit as
specified by the appropriate regulatory agencies in each country.
The A
Component Collection System has been verified to
LYX
provide the volume of plasma collected accurately to within
± 10% that is displayed on the procedure information screen.
Situations that may prevent the instrument from producing
products at this level of quality include:
• Entering a donor hematocrit value into the procedure that is
incorrect by greater than ± 2 percentage units.
• Entering a donor hemoglobin value into the procedure that is
incorrect by greater than ± 1 g/dL.
• Inappropriate handling or storage of red cell products after
transfer to the final red cell storage containers. This includes
inappropriate product burping techniques that result in a
significant loss of red cells from the red cell storage
containers.
• Inappropriate sampling techniques that may cause erroneous
results.
• Laboratory or other instrumentation used to measure the
parameters of red cell products that may be out of calibration,
outside appropriate manufacturer quality control limits, or
operated improperly.
• Any time a procedure ends unexpectedly, red cell products
obtained should not be used as validation or quality control
samples.
C
S
O
OLLECTION
YSTEM
C
HAPTER
'
M
PERATOR
S
ANUAL
1 – I
NTRODUCTION
1-11
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