Chapter 13
Quality Assurance and Quality
Control in the Clinical Laboratory
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Chapter 13 Objectives
At the end of this chapter, the reader should be
able to do the following:
Define the following terms: quality control material,
outlier, shift, trend, random error, and systematic error.
Plot quality control results on a Levey-Jennings chart.
Evaluate quality control results for shifts and trends.
Evaluate quality control results and determine, using
Westgard multirules, whether the results are
acceptable.
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Basic Quality Assurance Concepts
Quality assurance
Process in which instruments and methodologies
are monitored to ensure an accurate result
Monitoring of any activity that is associated with a
laboratory result
• Preanalytical activities: occur before the sample
reaches the laboratory
• Analytical activities: occur in the laboratory and directly
deal with the analysis of the sample
• Postanalytical activities: activities after the analysis is
performed
Techniques include taking random samples
throughout activity phases.
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Quality Control Material
Material that is analyzed along with patient
specimens should be treated the same as
patient specimens.
Should be of the same matrix as the patient
sample
Matrix: the chemical and physical characteristics
of the material that contains the analytes to be
measured
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Quality Control Analysis
“What is an acceptable limit for my quality
control material result?”
If the quality control (QC) result is outside of the
acceptable limit established by the laboratory, the
patient results should not be reported until the
problem is solved.
No patient results should be reported until the
method is “in control.”
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Quality Control Analysis (Cont.)
Probabilities associated with standard deviations
(SDs)
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Errors That Cause a Method To
Be Out of Control
Out of control: a result outside of established
QC range
Two main reasons why a method is out of
control:
Random error
• Occurs solely by chance
• Related to the precision of the method
Systematic error
• All samples affected
• May produce a “bias” in the method
• Related to the accuracy of the method
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Levey-Jennings Charts
CLIA ’88 and good laboratory practice
require:
At least 2 QC materials/day for each nonwaived
method
• To ensure accurate and reliable patient results
• If equivalent quality control (EQC) is not the method
used
The results of the quality control material
should be analyzed to determine whether the
method is “in control” before patient results
are reported.
To analyze each control value, plot the value
on a Levey-Jennings control chart.
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Levey-Jennings Charts (Cont.)
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Levey-Jennings Charts (Cont.)
EXAMPLE:
Three levels of control are run daily on an automated
hematology analyzer in a physician’s office laboratory.
The mean for the “normal” level is 15 mg/dL with an SD of
1.5 mg/dL.
What will the Levey-Jennings chart look like if a
technician plotted hemoglobin results obtained from the
“normal” level of QC material over a 5-day period?
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Levey-Jennings Charts (Cont.)
The hemoglobin results that were obtained are:
Day 1 = 13 mg/dL
Day 2 = 12.5 mg/dL
Day 3 = 16.0 mg/dL
Day 4 = 15.5 mg/dL
Day 5 = 14 mg/dL
Because the mean for the “normal” level is 15
mg/dL with a SD of 1.5 mg/dL:
+/- 1 SD = 13.5 to 16.5 mg/dL
+/- 2 SD = 12 to 18 mg/dL
+/- 3 SD = 10.5 to 19.5 mg/dL
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Levey-Jennings Charts (Cont.)
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Levey-Jennings Charts (Cont.)
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Levey-Jennings Charts (Cont.)
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Shift and Trends
Shift
Occurs when QC results are all distributed on one
side of the mean for 5 to 7 consecutive days
Occurs because of systematic error
Cause must be found and corrected because the
method is “out of control”
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Shift and Trends (Cont.)
Levey-Jennings chart demonstrating a shift
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Shift and Trends (Cont.)
Trend
Occurs when QC results either decrease or increase
consistently over a period of 5 to 7 days
Is caused by a systematic error
Tends to occur more slowly
Cause must be found and corrected
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Shift and Trends (Cont.)
Levey-Jennings chart demonstrating a trend
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Quality Control Assessment
Each laboratory is responsible for establishing its own
criteria for acceptance or rejection of quality control
results
CLIA ’88 requires a minimum of two levels of controls for
most methods each day unless EQC or new voluntary,
customizable IQCP is used
At minimum, QC procedures must follow manufacturer’s
instructions, current CLIA QC regulations or ICQP
IQCP has three parts:
Risk assessment for identification and evaluation of potential
errors and failures in testing process
Quality control plan (QCP) describing lab’s control of quality for
a particular test method
Quality assessment plan (QA) written to ensure quality of lab
results
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Westgard Multirules
Set of quality control rules to interpret quality
control results in the clinical laboratory
The quality control result is first assessed against the
first rule, or “warning rule.”
If a rule is not broken, the next rule is assessed.
If, at any point, a rule, except for the warning rule, is
violated, the result is rejected, and the method may be
“out of control.”
The large number (1, 2, 4, or 10) = the number of QC
results that are out of control
The subscript numbers = the SDs that have been
violated
• For example, 12S means 1 QC value has violated 2 SD
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Westgard Multirules (Cont.)
QC rule flow chart for two levels of controls
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Westgard Multirules (Cont.)
The warning rule or 12S rule
The rule is violated if either of the 2 controls exceeds 2
SD from the mean in either a positive or negative
direction.
When this rule is violated, the other rules are applied.
If the quality control results do not violate any other
rule, even if one of the two results violates the 12S rule,
the control results are accepted.
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Westgard Multirules (Cont.)
EXAMPLE:
The following are two Levey-Jennings charts for level 1
and level 2 glucose control. Notice the results obtained
for both levels on day 5.
Do the results violate any Westgard multirules?
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Westgard Multirules (Cont.)
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Westgard Multirules (Cont.)
On day 5, the result for the level 1 control
exceeded +2 SD but was within +3 SD.
The result for the level 2 control was within 2 SD
If only one of the two quality control results
exceeded +2 SD, the 12S warning rule was
violated.
If no other rule was violated on that day, the run
can be accepted.
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Westgard Multirules (Cont.)
The 13S rule
Violated when the result of one of the two quality
control results is outside of 3 SD
If a result is outside of 3 SD:
• Less than 1% chance that the result is an accurate result
• 99.7% chance that the result is an outlier
When either of the QC results violates this rule:
• The result is rejected
• Run is out of control and should not be accepted
Usually caused by a random error
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Westgard Multirules (Cont.)
EXAMPLE:
The following are two Levey-Jennings charts for a level
1 and level 2 cholesterol control. Notice the result for
day 7.
What rule, if any, is violated?
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Westgard Multirules (Cont.)
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Westgard Multirules (Cont.)
On day 7, the result for the level 2 cholesterol
control was 360 mg/dL.
The result exceeded the +3 SD range for this
cholesterol control.
By default, if a result exceeds ±3 SD, it will
violate the 12S warning rule.
This sets off the sequential chain of analysis of
the rest of the Westgard multirules.
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Westgard Multirules (Cont.)
The next rule to analyze after a result has
broken the warning rule is the 13S rule.
The level 2 cholesterol control has violated this
rule.
The run should not be accepted, and the
control should be repeated.
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Westgard Multirules (Cont.)
The 22S rule
Can be violated in two ways:
• If both control results are either >2 SD or <2 SD from the
mean
• If one of the control results also exceeded 2 SD in the
same manner in the previous run
Violated because of a systematic error
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Westgard Multirules (Cont.)
EXAMPLE:
The following are two quality control charts for
level 1 and level 2 serum creatinine. Notice the
quality control results for day 10.
Is a Westgard rule violated on that day, and if
so, which one?
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Westgard Multirules (Cont.)
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Westgard Multirules (Cont.)
On day 10:
Both the level 1 and level 2 creatinine quality
control results are >2 SD from the mean.
The 12S warning rule is violated for level 1 (as well
as level 2).
This triggers the evaluation of the other rules.
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Westgard Multirules (Cont.)
13S rule: Neither control value violates the 13S
rule.
22S rule: Both control levels exceed +2 SD from
the mean, so this is violated.
The error must be found and corrected because
the method is “out of control.”
No patient results should be reported until the
error is corrected and the control results are
acceptable.
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Westgard Multirules (Cont.)
The R4S rule
Violated when the difference, or range, between the
two control values within a run is >4 SD
Violated when both control values violate the 12S rule
but in opposite directions
• One control is elevated higher than the +2 SD limit, and the
other is less than the 2 SD limit.
Usually violated caused by a random error
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Westgard Multirules (Cont.)
EXAMPLE:
Two levels of quality control for total serum
amylase are charted on the following Levey-
Jennings charts.
Notice the control results for day 12. Are any
quality control rules violated on that day?
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Westgard Multirules (Cont.)
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Westgard Multirules (Cont.)
On day 12, the control result for level 1 was 2.1
above the mean.
Violates the 12S rule
Triggers review of the other rules
The control result for level 2 was 2.2 less than
the mean.
The spread, or range, between the 2 control results is
4.3.
This violates the R4S rule.
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Westgard Multirules (Cont.)
The 41S rule
Can be violated in two ways:
• One level of control: four consecutive results fall on the same
side of the mean and exceed ±1 SD of the mean
• Two levels of control: when both levels of control for 2 runs in
a row exceed ±1 SD from the mean
Somewhat like the rule for a shift:
• The four results are on the same side of the mean (which is
statistically unlikely) and exceed 1 SD (but not 2 SD).
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Westgard Multirules (Cont.)
EXAMPLE:
Two levels of control for total bilirubin are charted on
the following Levey-Jennings chart.
Do any of the control results violate any Westgard
rules? If so, which one(s)?
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Westgard Multirules (Cont.)
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Westgard Multirules (Cont.)
On day 4, the level 1 control violated the 41S rule.
The control result for that day was the fourth
result to fall on the same side of the mean and
exceed +1 SD of the mean.
A systematic error is most likely the cause, and
the run is rejected until the problem is corrected.
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Westgard Multirules (Cont.)
The 10x rule
Can be violated in two ways:
• In 10 consecutive runs for one level of quality control, the
results are all on the same side of the mean
The 10 results can fall in either a positive or negative direction.
• When the results are all on the same side of the mean for
both levels of control for 5 days (or 5 runs) in a row
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Westgard Multirules (Cont.)
EXAMPLE:
The following are the Levey-Jennings charts of
two levels of control for serum total protein.
Do the control results violate any Westgard
rules? If so, which one(s)?
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Westgard Multirules (Cont.)
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Westgard Multirules (Cont.)
The level 2 control results violate the 10x rule on
day 15.
Level 1 control results do not violate any of the
Westgard rules.
A systematic error is occurring with the level 2
control.
The patient results should not be reported until
the error is corrected and the QC results are
acceptable.
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Westgard Multirules (Cont.)
Westgard rules for three levels of control
The (2 of 3)2S rule:
• Violated when two of the three levels of control exceed 2 SD
in the same direction
The 9x rule:
• Violated when nine results in a row for a single control all fall
on the same side of the mean
• Violated when for three runs, the results for all three levels of
control all fall on the same side of the mean
The 41S rule is not used when the levels of control are
used.
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Westgard Multirules (Cont.)
QC rule flow chart for three levels of control
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