QC Practice Test

1. Given: you are running two controls on a test, an upper level and a lower level control. The QC
procedure defined for this method is 12s control limits.
Question: When one control material is out beyond 2 sd control limits, what is the first
response in this scenario?

Reject the run; trouble-shoot

If the QC procedure you are using is 1 2s control limits, then you reject the run when one value is out
beyond 2s limits.

2. Given: Running three controls, an upper level, normal level and a lower level control. The QC
procedure defined for this method is 12s control limits.
Question: When one control material is out beyond 2 sd control limits, what is the first
response in this scenario?

Reject the run; trouble-shoot

Regardless of the number of controls being run - two or three - if the QC procedure is defined as 1 2s,
then if any of the control values is out beyond 2s limits, you reject the run and trouble-shoot.

3. Given a QC procedure 12s or 1:2s as a rejection rule - what does that mean?

Reject the run whenever one value is beyond 2s control limits

When a rule is defined as a rejection rule, then when it is violated, you reject the run. 1 2s or 1:2s means
to reject the run whenever one value is beyond 2s control limits. But some rules are defined as merely
"warning rules", where the run is not outright rejected but some further action is taken instead.
Typically, 2 SD limits are used, if at all, for warning rules, not rejection rules.

4. Given a new control material which is supplied with a mean and range of 2sd from the
manufacturer, what is the proper use of the mean and range?

Confirm that the laboratory mean is within the 2sd range of the mean supplied by the manufacturer.

Manufacturer means and ranges should be copied by the laboratory. While they provide guidance, they
are not to be adopted wholesale. Bottle values, etc., will have estimates that contain variability from
multiple laboratories. The laboratory should establish and use its own mean and sd, and make sure that
the mean falls within the acceptable range.

5. The basic principle of statistical QC is to measure a stable sample and identify values that are
unexpected by comparison to...

Mean value and sd determined in the laboratory

The mean value of the laboratory. There are often many recommendations to use different ranges, but
too often that advice merely makes more data false "in" when in fact it should be "out". This course will
focus on the best practices of setting up your QC.

6. How do you calculate control limits?

Determine the mean and standard deviation for your laboratory

Use your own mean and standard deviation, not someone else's. The data should reflect conditions in
your lab, not any other lab. Using other SDs from large groups of labs will artificially widen your limits,
and you will miss errors.

7. What is the best way to choose control rules?

Select control rules based on the quality required by the tests and performance observed for the
method

The QC for each method, should reflect both the performance of the method in your laboratory and the
quality required for the best use of the test. It was common practice in the past to use one rule on
everything, but that is grossly inefficient for today's labs, over-QC-ing many methods, and under-QC-ing
others. It is best practice to customize the QC

8. The traditional "Westgard Rules" include a 2s "warning rule." When the warning rule is
violated, what action do you take?

Check the other "Westgard Rules"

The popularly-known formulation of the "Westgard Rules", the 2s warning rule is a trigger: once it is
violated, you check all the other "Westgard Rules" to see if one of them is violated. More recent
guidelines will be discussed in the course which eliminate the use of the 2 SD warning rule, since it
causes so many false rejections.

9. Which of the following multirule combinations is considered the traditional "Westgard

Rules"?

12s/22s/R4s/41s/10x

The 1:2s/2:2s/R:4s/4:1s/10:x is considered the classic "Westgard Rules", first published in 1981 in
Clinical Chemistry. The course will discuss how this one combination - meant only to be a single example
of how rules could be combined - can be modified and customized based on the performance of the
method and quality required by the test.

10. Given: Running three controls, an upper level, normal level and a lower level control. The QC
procedure defined for this method is the 13s control rule.
Question: When one control material is out beyond 2 sd control limits, what is the first
response in this scenario?

Do nothing
If you have designed your QC so that you are using the 13s as your QC procedure, a 2s violation is not a
flag, not even a warning. Many labs are used to checking anything out past 2 SD, this course will try to
help laboratories move beyond this time-consuming and often fruitless chasing of ghosts.

11. Given: Running three controls, an upper level, normal level and a lower level control. The QC
procedure defined for this method is the 12s control rule.
Question: When one control material is out beyond 1 sd control limits, what is the first
response in this scenario?

Do nothing

If you have designed your QC to use the 12s QC procedure, a violation of the 1s limits is not a rejection,
nor a warning. This is a pretty easy situation, since a value outside of 1 SD will be quite common and is
usually not considered a warning or a rejection signal.

12. Given: Running three controls, an upper level, normal level and a lower level control. The QC
procedure defined for this method is the 12s control rule.
Question: When all three control materials are above the mean, what is the first response in
this scenario?

Do nothing

If you have defined/designed your QC as a 12s procedure, violations of a mean rule is not a cause for
rejection.

13. Given: Running two controls, an upper level and a lower level control. The QC procedure
defined for this method is the traditional set of "Westgard Rules".
Question: When both control materials are out beyond 2 sd control limits, what is the first
response in this scenario?

Reject the run; trouble-shoot

This is a violation of the 22s control rule, part of the traditional "Westgard Rules." The 22s rule is most
often used as a rejection rule, not a warning rule.

14. Given: Running two controls, an upper level and a lower level control. The QC procedure
defined for this method are the traditional "Westgard Rules".
Question: When both control materials are below their respective means, but within 1 SD of
the mean, what is the first response in this scenario?

Do nothing

There is no such control rule as a 2x or 2-mean. So there is no warning, no rejection. Two values below
the mean but within 1 SD is not uncommon or something to worry about.

15. Given: Running two controls, an upper level and a lower level control. The QC procedure
defined for this method are the traditional "Westgard Rules".
Question: When both control materials are below their respective means, and the values for
 the previous 4 runs were also below the mean, what is the first response in this scenario?
Assume the 2 SD warning rule has been triggered already.

Reject the run; trouble-shoot

The 10x rule is part of the traditional "Westgard Rules" and in the traditional form, it is used as a
rejection rule. This scenario describes 10 points below the mean, on both high and low levels. In other
words, a 10x or 10-mean violation.

16. Given: Running two controls, an upper level and a lower level control. The QC procedure
defined for this method are the traditional "Westgard Rules".
Question: The upper control value is above 1s, while the lower control is below 1s, what is the
first response in this scenario?

Do nothing

There is no such control rule as a R2s or Range of 2s. There is no warning, no violation.

17. Given: Running two controls, an upper level and a lower level control. The QC procedure
defined for this method are the traditional "Westgard Rules".
Question: The upper control value is above 2s, while the lower control is below 2s, what is the
first response in this scenario?

Reject the run; trouble-shoot

This is a violation of the R4s, where the control values exceed a range of 4s. This is a rejection.

18. Given: Running two controls, an upper level and a lower level control. The QC procedure
defined for this method are the traditional "Westgard Rules". The last four runs have been in
control as well.
Question: The upper control value is above 2s, while the lower control is below 1s, what is the
first response in this scenario?

Check other "Westgard Rules"

In the traditional "Westgard Rules", a 12s violation is only a warning, so after checking the other rules,
there would be no other violations found, so the run is in control. But the violation of the 2 SD limit
triggers the warning and checking of other rules.

19. Given a QC procedure defined as 10:x or "ten-mean" used as a "warning rule" - how does a
laboratory implement this?

Warning of a possible problem is indicated when 10 values are on one side of the mean. Further
investigation should be conducted.

Implementing a "warning rule" means that is the rule is violated, there isn't an immediate rejection of
the run, but instead, other rules are checked to see if there is another violation. Not this is an
improbable scenario where there is only the 10:x rule implemented, that is unlikely to happen. Most
often, there are many other "Westgard Rules" that are combined with the 10:x rule. A more interesting
question to ask with many modern methods - is a 10:x rule necessary, even as a warning rule? This is
something we will explore in the course.

20. Given a cholesterol test where the low control has a mean of 190 and SD of 3, and the high
control material has a mean of 250 and SD of 4, and given that the QC procedure is defined as
13s/22s /R4s what is proper interpretation when the control values observed within a run are
197 and 243?

Nothing is wrong. Accept the run.

This question shows all the complexity of today's QC implementation. How many rules are being used?
How are they being interpreted? What used to be considered a warning or rejection may no longer be
that today. We will discuss this in the course.