QUALITY CONTROL P.

2
DIAGNOSTIC TEST CUMULATIVE SUM GRAPH (CUSUM)

QC Result

Patient result

• Calculates the difference between QC results and

target means
QUALITY CONTROL CHARTS
• Common method: V mask
1. Gaussian Curve ( Bell- Shaped Curve)
• Identifies consistent bias problems; requires
2. Cumulative Sum graph
computer implementation
3. Youden Twin Plot
• This plot will give the earliest indication of
4. Shewart Levey Jennings Chart
systematic errors (trend) and can be used with
the 13s rule
• Results are out of control when the slope exceeds
GAUSSIAN CURVE
4S or a decision (±2SD) is exceeded.

YOUDEN/ TWIN PLOT

• Occurs when the data set can be accurately

described by the SD & the mean
• Obtained by plotting the values from multiple
analyses of samples
• Population probability distribution that is
symmetric about the mean
• It focuses on the distribution of errors from the
• Used to compare results obtained on a high and
analytical method rather than the values from a
low control serum from different laboratories
healthy or patient population
• are a graphical technique for analyzing interlab
• The total area under the curve is 1.0 or 100%
data when each lab has made two runs on the
same product or one run on two different
products.
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SHEWART LEVEY-JENNINGS CHART
 Most widey used QC chart in the clinical
laboratory
 Allows the laboratorians to apply multiple rules
without the aid of a computer’ it is a graphic
representation of the acceptable limits of
variation in the results of an analytical method.
 It easily identifies random and systematic errors
OPERATION OF A QC SYTSTEM
The QC program can be thought of as a three-stage
process:
1. Establishing allowable statistical limits of
variation for each analytic method
2. Using these limits as criteria for evaluating the
QC data generated for each test
3. Taking action to remedy errors when indicated
a) Finding the cause(s) of error
b) Taking corrective action
c) Reanalyzing control and patient data
Establishment of a Statistical Quality Control
New instrument or with new lots of control material:
 control material must be analyzed for 20 days.
Exceptions:
Machines that are highly precise
(CV < 1%),
Eg. blood gases: 5 days is adequate
Why establish own QC Ranges?
1. Assign target values and ranges for an unassayed
control
2. Improve accuracy of target values and ranges
3. Improve stringency of acceptable limits
4. To meet regulatory requirements
Steps in Establishing QC Reference ranges?
1. Establishing Mean Target Values using Parallel
Testing
2. Calculating Historical CV (CVh)
3. Determining Appropriateness of Calculated CVh
4. Establishing QC Ranges using CVh
STEP 1:
Establishing Mean Target Values Using Parallel
Testing
Parallel Testing is the name given to running the
current QC lot and a new QC lot in tandem.
• To perform Parallel Testing:
1. The new QC lot should then be analysed 2-3
times daily for approximately 10 days,
ensuring that at least 20 data points are
generated.
2. Review the data generated to ensure that
assay precision (CV) is lower than the CV
obtained in the manufacturer’s
specifications.
3. Calculate the Mean and Standard Deviation
(SD) for each analyte.
STEP 2:
Establishing Historical CV (CVh)
• CVh
 the historical instrument precision for that
method measured as a percent
(%CV = SD/Mean X 100)
 best established over several lots (3 or more)
 average CV or more preferable
 the highest acceptable CV over that period.
 If you have no previous CV data, then use the
current CV as the CVh basis increase slightly
(~1- 2%) in order to establish QC ranges that
are not too narrow.
 The calculated CVh should not exceed the
instrument-method CV provided by the
manufacturer(3).
 The CVh should not exceed the average
assay-specific CV provided by EQA schemes.
EQA schemes (e.g. RIQAS)
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STEP 3:
Establishing QC Ranges using CVh

• Parallel testing
• Calculate CV
• Calculate the SD
• Assigning Reference range

Assign the Reference range

Levey- Jennings Charts

& Westgard Rules

Comparison of Quality Control Results

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Create a Levey Jennings chart using a mean of 90 U/L Causes of trending may include:
& SD: 9 U/L  Deterioration of the instrument light source
Assume that each data point was obtained on  Gradual accumulation of debris in
separate days. sample/reagent tubing
Are the points outside the ±2s limit?  Gradual accumulation of debris on electrode
Level I (Normal Control) surfaces
Unassayed Chemistry Control  Aging of reagents
Lot No. 12345  Gradual deterioration of control materials
Test: Creatine Kinase  Gradual deterioration of incubation chamber
Instrument: ABC temperature (enzymes only)
Units: U/L  Gradual deterioration of light filter integrity
Control Values are:  Gradual deterioration of calibration
{94, 93, 97, 95, 95, 100, 100, 99, 100, 99}

Shift
• Abrupt changes in the control mean
• Shifts in QC data represent a sudden and
dramatic positive or negative change in test
system performance

Shifts may be caused by:

Using a Levey-Jennings Chart

to Evaluate Run Quality
• Maintaining a QC Log and using the Levey-
Jennings chart on a regular basis.
QC log
• can be maintained on a computeror on paper.
• should identify :
 name of the test, the instrument, units
 the date the test is performed
 the initials of the person performing the test,
 the results for each level of control assayed
Systematic Error
• The change in the mean may be gradual and
demonstrated as a trend in control values or it
may be abrupt and demonstrated as a shift in
control values.
Trend
• Indicates a gradual loss of reliability in the test
system. Trends are usually subtle.
 QUALITY CONTROL P.2
Westgard Rules
• Dr. James Westgard of the University of
Wisconsin
 Published an article on laboratory quality
control that set the basis for evaluating
analytical run quality for medical laboratories.
 devised a shorthand notation for expressing
quality control rules
 N represents the number of control
observations to be evaluated and
 L represents the statistical limit for evaluating
the control observations.

OUTLIERS
• Are control values that are far from the main set
of values
• Caused by systematic and random errors
• They are highly deviating values  This is a warning rule that is violated when a
single control observation is outside the ±2s
limits.
 This rule merely warns that random error or
systematic error may be present in the test
system.
 The relationship between this value and other
control results within the current and previous
analytical runs must be examined.
 If no relationship can be found and no source of
error can be identified, it must be assumed that a
single control value outside the ±2s limits is an
acceptable random error.
Random Error  Patient results can be reported
• Is any deviation away from an expected result.
• There is acceptable (or expected) random error as
defined and quantified by standard deviation.
• There is unacceptable (unexpected) random error
that is any data point outside the expected
population of data (e.g., a data point outside the
±3s limits).
QUALITY CONTROL P.2

• This rule identifies random error only, and is

applied only within the current run
• At least a 4s difference between control values
within a single run, the rule is violated for random
error
• Violation of any of the following rules does not
necessarily require rejection of the analytical
run.
• These violations typically identify smaller
systematic error or analytical bias that is not
often clinically significant or relevant.
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Additional Quality Control Statistics

The Coefficient of Variation [CV]

 Is the ratio of the standard deviation to the
mean and is expressed as a percentage.
 Allows the technologist to make easier
comparisons of the overall precision.
 statistical equalizer
 QUALITY CONTROL P.2
Coefficient of Variation Ratio [CVR]
• Although accuracy of test results is paramount in
the clinical laboratory, precision is just as
important.
• One way a laboratory can determine whether the
precision of a specific test is acceptable is to
compare its precision to that of another
laboratory performing the same test on the same
instrument using the same reagents (laboratory
peer group).
Standard Deviation Index [SDI]
Selecting a Control Product
Shelf Life
 Your quality control shelf life should match or
exceed the laboratory’s normal usage rate or
money will be wasted
Box Pricing
 Always ask for quality control product quotes on a
per mL basis and not box price.
Clinical Relevant Decision Levels
 It requires the laboratory to compare the relevant
clinical levels for each test to those provided in
the quality control product
Interlaboratory Comparison Programs
 One of the easiest methods to assess reliability
and imprecision is to compare the within-
laboratory method means and standard
deviations to other laboratories using the same
instrument and method (peer group).