Abbott CELL-DYN 3200, Руководство оператора системы

Страница: 554 / 684

11-24
CELL-DYN ® 3200 System Operator’s Manual
9140181H—October 2001
Quality Control
Quality Control Guide
Section 11
Collect data from 25 batches of 20 specimens each for a total of 500 specimens.
Data collection should be from specimens which represent the typical specimen
population that is processed through the instrument. When all 25 batches are
complete, print the X-B DATA DISPLAY screen for RBC. Calculate the mean,
standard deviation (SD), and coefficient of variation (CV) for MCV, MCH, and
MCHC. The CV for each index should be < 1.5%. If the CV for each index meets
these criteria, enter the calculated mean value as the target value and set the action
limits to 3%.
NOTE: Laboratories analyzing specialized patient populations (as described
above) may need to widen the action limits slightly to accommodate
results from these abnormal patients.
If the CV for each index is >1.5%, evaluate another 500 specimens and repeat the
calculations.
When an acceptable target value has been entered, evaluate data from an additional
500 specimens to confirm the entered values.
Troubleshooting X-B RBC Results
When XB-RBC results are out of control, data should be reviewed for shifts and
trends in the results.
Shifts in results are usually caused by a non-random batch of 20 specimens such as
those from dialysis or pediatric units. Multiple repeats of the same abnormal
specimen within a given batch of 20 may also cause a non-random population in
that batch. Review the Data Log for the last 20 specimens and determine if this is
the case. Shifts caused by non-random data will usually be corrected in the next
batch of 20 as long as those data are random.
Shifts may also be caused by a change in reagent container or a lot number change.
If containers or lot numbers recently changed, try another container and see if the
problem persists.
Calibration changes may also cause a shift in results. If a shift cannot be explained
as described above, run commercial controls or run a patient selected from a
previous batch when X-B results were in control. If values are within acceptable
limits, a calibration shift is not the cause of the problem.
Trends in X-B results are usually caused by instrument problems. A recent
component change may also cause a trend in results. Use the following table to
determine the directly measured parameter(s) involved, and troubleshoot
accordingly. If a problem is not readily identified, perform routine maintenance and
repeat the commercial and patient controls to see if results are acceptable.
Since two of the RBC indices are calculated parameters, their inter-relationships
can be used to assist in troubleshooting. The following table uses the mathematical
relationships between the indices to aid in determining which directly measured
parameter(s) are involved when X-B is out of control. When the directly measured
parameter(s) are identified, refer to
Section 10: Troubleshooting and Diagnostics
for troubleshooting assistance with these parameters.