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SECTION 5
QUALITY CONTROL AND ASSURANCE
QUALITY CONTROL AND ASSURANCE TESTS ARE LEFT TO THE SOLE DISCRETION
OF THE LABORATORY DIRECTOR WHERE THE HEMATASTAT II MICROHEMATOCRIT
SYSTEM IS IN USE.
5.1 USE OF HEMATOLOGY REFERENCE CONTROL
To insure proper daily performance of the HemataStat II, STI provides a
hematology reference control called HemataChek
™
. The product has an assay value
for the hematocrit test and is packaged in a variety of combinations of LOW,
NORMAL and HIGH (See Section 8).
The HemataStat II’s accuracy and the user’s technique can be confirmed by using
HemataChek hematology reference control.
HemataChek
does not require refrigeration and features a 2 year expiration from
date of manufacture and a 31 day open vial stability. It provides hematocrit assay
values for all HemataStat
centrifuges as well as for other microhematocrit
centrifuges.
WHEN USING HEMATACHEK:
Step 1 Ensure bottle cap is tightly closed.
Step 2 Vigorously tap the bottle against the palm of your free hand. As soon as
the plastic mixing bead can be heard, continue to tap the bottle for one
minute.
Step 3 After mixing one minute, look through the bottom of the bottle. If a clump
of unmixed control material can still be seen, repeat Steps 1 and 2.
Step 4 Use this mixing technique each time before filling capillary tubes.
Step 5 After each use, clean the threads of the vial and the cap with an absorbent
material.
Step 6 Always replace the cap after use.
5.2 CALIBRATION
Microprocessor technology is used to monitor the speed and spin cycle of the
HemataStat II. A maximum packing time test is not applicable. If an abnormal
operating condition is encountered, a programmed error message will automatically
appear in the display. The accuracy of the HemataStat II hematocrit tube reader can
be verified by using HemataChek hematology reference control, available from STI.
