Abbott CELL-DYN 3000, Руководство оператора

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CELL-DYN

3000 System Operator’s Manual
7-17
9140240E — May 1995
Chapter 7 Quality Control
Whenever a rule is violated, the bulletin line on the VIEW QC LOGS
Screen displays the message:
WESTGARD WARNINGS: SEE LEVEY-JENNINGS
Rule Violations
Only the directly measured parameters need to be monitored with
multiple rules.
4
In reference 4 (pp. 190–192) , Cembrowski suggests a
protocol for using the Westgard rules in hematology. The following is a
synopsis of that protocol.
Since three levels of control are typically used to monitor a hematology
analyzer, it is reasonable to consider all three runs at the same time. In
other words, check for rule violations across the three levels, not just
within a particular level. If the same rule is violated for more than one
level, determine whether the violation indicates a loss of precision or a
loss of accuracy and troubleshoot accordingly.
Cembrowski suggests that the results for all three levels first be checked
to see if they are within their 2SD limits. If all three levels meet this
criterion, the instrument is in control.
If any control result exceeds the 2SD limits, check to see if it exceeds the
3SD limits. If a result exceeds 3SD, there are two possibilities. There is
either an instrument problem or a problem with the particular level of
control. Therefore, if a result exceeds 3SD, run another bottle of that
control. If the problem persists, then additional investigation is required.
Check to see if either the 2 of 3
2s
or R
4s
rules have been violated for any
level or across levels. If the problem is confined to one level of control,
check for a 2
2s
rule violation for that level. Again, if the violations are
confined to one level of control, use another bottle and possibly another
lot. Check expiration dates and data entry. Check to be sure that the
control is run into the correct file.
If a combination of rules has been violated across the three levels,
determine whether the violations indicate a loss of precision or a loss of
accuracy and troubleshoot accordingly. If necessary, call the Abbott
Customer Support Center for assistance at
1 (800) CELL DYN.
When the problem has been resolved, Cembrowski suggests that all
levels be run again in duplicate to confirm that it has in fact been
corrected.
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