QUALITY

ASSURANCE
E L M A R I E T. S A L U N G A , R M T, M L S ( A S C P I )

DEFINITION OF TERMS
SENSITIVITY
It is the ability of an analytical method to measure
the smallest concentration of the analyte of
interest.

SPECIFICITY
It is the ability of an analytical method to measure
only the analyte of interest.

DEFINITION OF TERMS
ACCURACY
Is the nearness or closeness of the assayed value
to the true or target value.

PRECISION (REPRODUCIBILITY)
Is the ability of an analytical method to give
repeated results on the same sample that agree
with one another.

 What can you say about these two illustrations?

 What can you say about these two illustrations?

DEFINITION OF TERMS
PRACTICABILITY
Is the degree by which a method is easily repeated.

RELIABILITY
Is the ability of an analytical method to maintain
accuracy and precision over an extended period of
time during which equipment, reagents and
personnel may change.

QUALITY ASSURANCE
Quality assurance is a complete
system of creating and following
procedures and policies to aim for
providing the most reliable patient
laboratory results and to minimize
errors in the pre-analytic, analytic
and post-analytic phases of
testing.

PHASES OF ANALYSIS
PRE-ANALYTICAL (BEFORE ANALYSIS)
Occurs during sample collection and transport

ANALYTICAL (ANALYSIS)
Occurs during the testing process

POST-ANALYTICAL (AFTER ANALYSIS)

Occurs after the testing process

QUALITY CONTROL
Quality control in the
clinical laboratory is a
statistical process used to
monitor and evaluate the
analytical phase that
produces patient results.

KINDS OF QUALITY
CONTROL
1. INTRALAB QUALITY CONTROL (Internal QC)

It involves the daily analyses of quality control

reagents together with patient samples
It is important in the daily monitoring of accuracy
and precision of the laboratory

KINDS OF QUALITY
CONTROL
2. INTERLAB QUALITY CONTROL (External QC)

It involves proficiency testing programs that

periodically provide samples of unknown
concentrations to participating clinical laboratories
It is important in maintaining long-term accuracy of
the analytical methods.

QUALITY CONTROL
REQUIREMENTS

QUALITY CONTROL
(QC)
When a diagnostic test is performed in the laboratory,
the outcome of the test is a result.
Results may be patient results or quality control (QC)
results.
QC results are used to validate whether the
instrument is operating based on pre-defined
specifications, inferring that patient test results are
reliable.

QUALITY CONTROL
(QC)
Example:
Patients glucose value is 40 mg/dL.
How does the medical technologist
performing the test know that this result
is truly reliable?

QUALITY CONTROL
PRODUCTS
A quality control product is a patientlike material ideally made from
human serum, urine or spinal fluid.
Control products can also be animal
in origin, aqueous solutions or a
commercially prepared organic
matrix.

QUALITY CONTROL
PRODUCTS
A control product can be a liquid or
freeze-dried (lyophilized) material.
It is composed of one or more
constituents (analytes) of known
concentration.
Control products should be tested in
the same manner as patient samples.

QUALITY CONTROL
PRODUCTS
A normal control product contains
normal levels for the analyte being
tested.
An abnormal control product contains
the analyte at a concentration above or
below the normal range for the
analyte.

CONTROLS VS.
STANDARDS
CONTROL

Functions

Used in every
measurement to
ensure accuracy
and precision

Components
Universal color

Many analytes
Yellow

STANDARD
Used in every
measurement to
measure the
concentration of the
unknown solution
One analyte
Colorless

1
2
3
4

UNKNOWN
BLANK
STANDARD
NORMAL
CONTROL
5 ABNORMAL
CONTROL

QC: REGULAR TESTING

Good laboratory practice requires testing
normal and abnormal controls for each test
at least daily to monitor the analytical
process.
Regular testing of quality control products
creates a QC database that the laboratory
uses to validate the test system.

QC: REGULAR TESTING

To establish statistical quality control on a
new instrument or on new lot number of
control materials, the different levels of
control material must be analyzed for 20
consecutive days.

CONTROL LIMITS
(CONTROL VALUES)
These are expected values represented by intervals of
acceptable values with upper and lower limits.
If the expected control values are within the desired control
limits, the clinicians are assured that the test results are
accurate and precise.
Control within expected range = IN CONTROL= accept the
QC and report patient results

Control outside of expected range = OUT of CONTROL =

address (do not report patient results)

COMPARING RESULTS TO
THE APPROPRIATE RANGE
Control results - compared to their own range of
expected results determined by the control
manufacturer or individual laboratory

Patient results compared to published

reference values or patient population reference
ranges established within the laboratory.

EXAMINE THE TABLE.

OBSERVATION
The laboratory was out of control for
abnormal high potassiums on November
7 because the value obtained for the QC
material (8.0 mmol/L) was outside the
acceptable range (6.7 7.3 mmol/L).

WHAT SHOULD WE DO?

The laboratory should not report any
patient samples with an abnormally high
potassium result until the error is
resolved and the abnormally high
sample(s) are re-tested.

VARIATIONS
Are errors encountered in the collection, preparation
and measurement of samples, including transcription
and releasing of laboratory results.
Sources of Error
Reagents
Standards
Technique
Environment
Specimen collection, handling etc.

TYPES OF ERROR
1. Pre-Analytical error
Includes clerical error, wrong patient, wrong specimen
drawn, mislabeled specimen, improper patient
preparation, etc.
Through QUALITY ASSURANCE measures, the
laboratory tries to maintain control over these factors
Well trained phlebotomy staff

Use of easy patient & specimen identification methods, such as bar code
identification.
Willingness to be information resource and / or trainers for physicians and
floor personnel often involved with specimen collection.

TYPES OF ERROR
2. Analytical error
a. Random or indeterminate or unpredictable error
Is present in all measurements; it is due to chance
Is a type of error which varies from sample to sample
It is due to instrument, operator and environmental
conditions (variations in techniques) such as pipetting
errors, mislabeling of samples, temperature fluctuation
and improper mixing of sample and reagent.

TYPES OF ERROR
2. Analytical error
b. Systematic or determinate or predictable error
Have a definite cause, is an error that influences observations
consistently in one direction (constant difference)

It is detected as either positive or negative bias often related

to calibration problems, deterioration of reagents and control
materials, improperly made standard solutions, contaminated
solutions, unstable and inadequate reagent blanks, failing
instrumentation and poorly written procedures.

TYPES OF ERROR
2. Analytical error
Through QUALITY CONTROL measures, such as always
running controls, the laboratory limits these errors.

TYPES OF ERROR
3. Post-Analytical error
Errors that occur after the testing process is complete.
Unavailable or delayed laboratory results
Incomplete laboratory results

Wrong transcription of the patients data and laboratory results

QUALITY ASSURANCE measures must be implemented if
problems identified.

CALCULATION AND
USE OF QC STATISTICS
Statistical calculations are used to determine
analytical errors.
Quality control (QC) statistics for each test
performed in the laboratory are calculated from
the QC database collected by regular testing of
control products.

STATISTICS
MEAN
STANDARD DEVIATION
COEFFICIENT OF VARIATION
TESTS FOR STATISTICAL SIGNIFICANCE

MEAN (AVERAGE)
Mean is a measure of central tendency; it is associated
with symmetrical or normal distribution.
It is the target value in determining accuracy.
The mean is calculated by computing the sum of all the
values in the set and dividing this number by the
number of values in the set.

Calculate the mean for the normal control (Level I) in Table 1.

Calculate the normal and/or abnormal control mean

for each of the following sets of control data.

Calculate the normal and/or abnormal control mean

for each of the following sets of control data.

Calculate the normal and/or abnormal control mean

for each of the following sets of control data.

SUMMARY
Values
Mean

Laboratory A

Laboratory B

Laboratory C

Level I

Level II

Level II

Level I

Level II

97.2 U/L

318.2 U/L

181.6 U/L

95.9 U/L

318.7 U/L

STANDARD DEVIATION
Standard deviation is a statistic that quantifies
how close numerical values (i.e., QC values)
are in relation to each other.
Standard deviation is calculated for control
products from the same data used to calculate
the mean.

It provides the laboratory an estimate of test

consistency at specific concentrations.

Calculate the standard deviation for the normal level of control (Level I) in Table 1.

Calculate the standard deviation for each data set:

Calculate the standard deviation for each data set:

Calculate the standard deviation for each data set:

SUMMARY
Values

Laboratory A

Laboratory B

Laboratory C

Level I

Level II

Level II

Level I

Level II

Mean

97.2

318.2

181.6

95.9

318.7

SD

2.7

11.57

1.65

5.78

19.63

COEFFICIENT OF
VARIATION
It is a percentile
expression of the
mean; an index of
precision.

TESTS FOR STATISTICAL

SIGNIFICANCE

F-TEST

is used to determine whether there is a statistically

significant difference between two standard deviations
of two groups of data

T-TEST
is used to determined whether there is a statistically
significant difference between the means of two
groups of data.

QUALITY CONTROL
CHARTS
Are used to observe values of control
materials over time to determine reliability
of the analytical method
Are utilized to observe and detect analytic
errors such as inaccuracy and imprecision

GAUSSIAN CURVE
(BELL-SHAPED CURVE)
It occurs when data elements are centered
around the mean with most elements close to the
mean.
The total area under the normal curve is 100%.
In a normal distribution, mean = mode = median.
Half of the values are less than the mean, and
half of the values are greater than the mean.

GAUSSIAN CURVE
(BELL-SHAPED CURVE)

GAUSSIAN CURVE
(BELL-SHAPED CURVE)

GAUSSIAN CURVE
(BELL-SHAPED CURVE)
Of all the values in a group of values:
68.2% of them will lie within 1 standard deviation
from the mean
95.5% will fall within 2 standard deviations

99.9% fall within 3 standard deviations

GAUSSIAN CURVE
(BELL-SHAPED CURVE)
In most circumstances, values that fall within a
2 standard deviation range are acceptable for
assuring the reproducibility of an assay.
About only 4.5% of all data will be outside the
2s limits when the analytical process is in
control.

CALCULATING QUALITY
CONTROL LIMITS
The mean for the Level I potassium control
in Table 1 is 4.1 mmol/L and the standard
deviation is 0.1 mmol/L.
Determine 1s, 2s and 3s.
Add and subtract the SD values to get the
lower and upper limit.

CALCULATING QUALITY
CONTROL LIMITS
Values
Mean

Table 1
4.1 mmol/ L

SD
1SD
2SD

0.1
0.1
0.2

3SD
CV

0.3
2.4%

1SD
2SD

4.0 4.2 mmol/ L

3.9 4.3 mmol/ L

3SD

3.8 4.4 mmol/ L

CALCULATING QUALITY
CONTROL LIMITS
Values

Laboratory A

Laboratory B

Laboratory C

Level I

Level II

Level II

Level I

Level II

Mean

97.2

318.2

181.6

95.9

318.7

1SD

2.7

11.57

1.65

5.78

19.63

2SD
3SD
CV
1SD
2SD

3SD

SHEWHART LEVEYJENNINGS CHART

It is the most widely used quality control chart in the
clinical laboratory.
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.

ERRORS WHICH CAN BE

OBSERVED ON LJ CHART
1. TREND
is formed by control values that either
increase or decrease for six consecutive days
a gradual loss of reliability in the test system.
main cause: deterioration of reagents

ERRORS WHICH CAN BE

OBSERVED ON LJ CHART
2. SHIFT
is formed by control values that distribute
themselves on one side of the mean for six
consecutive days

abrupt changes in the control mean shifts

main cause: improper instrument calibration

ERRORS WHICH CAN BE

OBSERVED ON LJ CHART
3. OUTLIERS
are control values that are far from the main
set of values
are highly deviating values
are caused by random or systematic errors

main cause: pipetting errors

EXAMPLE #1
Create a Levey-Jennings chart for the Level I
control reported for Laboratory A using a mean of
90 U/L and a standard deviation of 9 U/L.
Assume that each data point was obtained on
separate days. Are there any points outside the
2s limits?

 Level 1: There are no points outside the 2s limits.

EXAMPLE #2
Create a Levey-Jennings chart for the Level II
control reported for Laboratory A using a mean
of 350 U/L and a standard deviation of 25 U/L.
Assume that each data point was obtained on
separate days. Are there any points outside the
2s limits?

GENERAL INTERPRETATION
OF QC RESULTS
The acceptable reference limit is set at 2SD.

The upper and lower reference limits define a

specified percentage, usually 95% of the values for a
certain group of population, hence 5% of the
population will fall outside the reference interval/limit
in the absence of an abnormality or disease.

GENERAL INTERPRETATION
OF QC RESULTS
An analytical method is considered in control when there is
symmetrical distribution of control values about the mean and
there are few control values outside the 2s control limits.
If the analytical test results are not within the 2SD confidence
limit, run a new set of controls and repeat specimen testing.
A control value between 2s and 3s is a sign of potential
problem.

A control value outside the 3s would require corrective action.

WESTGARD RULES
In 1981, 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.
Warning and rejection rules

12S WESTGARD RULE

A single control measurement exceeds two standard
deviations from the target mean

Action: WARNING

13S WESTGARD RULE

A single control measurement exceeds three standard
deviations from the target mean

Action: REJECT
Error: RANDOM

22S WESTGARD RULE

Two consecutive control measurements exceed the same
mean plus 2S or the same mean minus 2S control limit.

Action: REJECT
Error: SYSTEMATIC

R4S WESTGARD RULE

One control measurement in a group exceeds the mean
plus 2S and another exceeds the mean minus 2S.

Action: REJECT
Error: RANDOM

41S WESTGARD RULE

Four consecutive control measurements exceed the same mean
plus 1S or the same mean minus 1S control limit.

Action: REJECT
Error: SYSTEMATIC

10X WESTGARD RULE

Ten consecutive results are on the same side of the
target mean

Action: REJECT
Error: SYSTEMATIC

SUMMARY
WARNING: 12s
REJECT
SYSTEMATIC ERRORS: 22s 41s 10X
RANDOM ERRORS: 13s R4s

ANY VIOLATIONS?

ANY VIOLATIONS?

ANY VIOLATIONS?

ANY VIOLATIONS?

OTHER TYPES OF
CHARTS
Cumulative Sum Graph (CUSUM)
It calculates the difference between the QC results and the
target means
Common method: V-mask
It identifies consistent bias problems; it requires computer
implementation
This plot will give the earliest indication of systematic
errors (trend)

OTHER TYPES OF
CHARTS
Youden/Twin Plot
It is used to compare results obtained on a high
and low control serum from different laboratories
It displays the results of the analyses by plotting the
mean values for one specimen on the y-axis and
the other specimen on the abscissa (x-axis)

DELTA CHECK
Is the most commonly used patient based QC
technique
It requires computerization of test data so that
current results can be compared with past
results.

Is the difference between two consecutive

measurements of the same analytes on the
same individual.