LESSON 2
• It reflects the ability of the method to detect true-
• System of ensuring accuracy and precision in
the laboratory by reagents (quality control) in
every series of measurement
• Process of ensuring that analytical results are
correct by testing known samples (control
solution) that resembles patient samples
• Involves the process of monitoring the
characteristics of the analytical processes and
detects analytical errors during testing
• It is one component of the quality assurance
system.
1. SENSITIVITY
• The ability of an analytical method to measure
the smallest concentration of the analyte of
interest.
2. SPECIFICITY
• Is the ability of an analytical method to measure
only the analyte of interest.
3. ACCURACY
• Nearness or closeness of the assayed value to
the true or target value.
4. PRECISION OR REPRODUCIBILITY
• Ability to give repeated results on the same
sample that agree with one another.
5. PRACTICABILITY
• Degree by which a method is easily repeated.
6. RELIABILITY
• Ability of analytical method to maintain accuracy
and precision over extended period of time
during which equipment, reagents and personnel
change.
7. DIAGNOSTIC SENSITIVITY
• Ability of the test to detect proportion of individual
with that disease who test positively with the test.
• Indicates the ability of the test to generate more
true-positive results and few false-negative
8. DIAGNOSTICS SPECIFICITY
• Ability of the test to detect proportion of individual
with that disease who test negatively with the
test.
PASCUAL
negatives with very few false-positive.
KINDS OF QUALITY CONTROL
INTRALAB (Internal QC)
• Involves the analysis of control samples together
with patient specimens.
• Important for the daily monitoring of accuracy
and precision of anlytical methods.
• Detects both random and systemic error.
INTERLAB (External QC)
• Involves proficiency testing programs that
periodically provide samples of unknown
concentration of analytes to participating
laboratories
• Important in maintaining long term accuracy of
the analytical method
• Difference of >2 in the results indicates that a
laboratory is not in agreement with the rest of the
laboratories included in the program.
OBJECTIVES OF QUALITY CONTROL
1. To check the stability of the machine
2. To check the quality of reagents
3. To check technical errors
CHARACTERISTICS OF AN IDEAL QC
MATERIAL
1. Resembles human sample
2. Inexpensive and stable for long periods
3. No communicable disease.
4. No matrix effects/known matrix effects.
5. With known analyte concentrations.
6. Convenient packaging for easy dispensing and
storage.
NOTES TO REMEMBER
• Quality control materials should resemble human
sample and be available for a minimum of one
year (same lot number)
• Bovine control material – not the choice for
immunochemistry, dye-binding and certain
bilirubin assays.
• Control limits are calculated from the mean and
standard deviation
QUALITY MANAGEMENT | 5

RANDOM ERROR
• Non repeating, occurs once
• The basis for varying differences between
repeated measurement - R
• It is due to instrument, operator, and
environmental conditions
o Pipeting errors, mislabeling of samples,
temperature fluctuations, improper mixing of
sample and reagent.
SYSTEMATIC ERROR
• Repeating, can be predicted
• Often related to calibration problems,
deterioration of reagents and control materials,
unstable and inadequate reagent blanks,
contaminated solutions, failing instrumentation
and poorly written procedures.
• It is a measure of the agreement between the
measured quantity and the true value – A
a. Constant Error
o refers to a difference between the target
value and the assay value.
o Independent of sample concentration
b. Proportional/Slope/Percent Error
o Results in greater deviation from the target
value due to higher sample concentration.
CLERICAL ERROR
• The highest frequency of clerical errors with the
use of handwritten labels and request forms.
PRE-ANALYTIC ERRORS
1. Improper patient preparation.
2. Mislabeled specimen.
3. Incorrect order of draw.
4. Incorrect patient identification
5. Wrong specimen container
6. Incorrect anticoagulant to blood ratio.
7. Improper mixing of sample and additives.
8. Incorrect specimen preservation.
9. Incorrect used of tubes for blood collection.
10. Mishandled specimen (transport and storage)
11. Missed or incorrectly interpreted laboratory
requests.
PASCUAL
POST-ANALYTICAL ERRORS
1. Unavailable or delayed laboratory results.
2. Incomplete laboratory results.
3. Wrong transcription of the patient’s data and
laboratory results.
• Is the science of gathering, analyzing,
interpreting and presenting data.
MEAN
• A measure of central tendency. It is associated
with symmetrical or normal distribution.
STANDARD DEVIATION
• a measure of the dispersion of values from the
mean.
• It helps describe the normal curve.
• A measure of the distribution range
COEFFICIENT OF VARIATION
• A percentile expression of the mean
• Index of precision
VARIANCE
• Is called the standard deviation squared
• Measure of variability
TERMINOLOGIES
MEDIAN
• Value of the observation that divides the
observations into two groups, each containing
equal numbers of observation.
• It is a midpoint of distribution
• 50th percentile
MODE
• Is the most frequent observation
INFERENTIAL STATISTICS
• Are used to compare the means or standard
deviations of two groups of data.
T-TEST
• Is used to determine whether there is statistically
significant difference between the means of two
groups of data.
QUALITY MANAGEMENT | 6
F-TEST YOUDEN/TWIN PLOT
• Is used to determine whether there is statistically • It is used to compare results obtained on a high
significant difference between the standard and low control serum from different
deviations of two groups of data. laboratories.
• The points falling from a center but on the 45o
QUALITY CONTROL CHART line suggest a proportional error, and points
falling from the center but not on the 45 o line
GAUSSIAN CURVE
suggest a constant error.
• Bell-shaped curve
• It occurs when the data set can be accurately
described by the SD and mean
• It is obtained by plotting the values from multiple
analysis of a sample. Figure 2-3
• It occurs when the data elemnts are centered Youden/Twin
around the mean with most elements close to the Plot

mean.
• It focuses on the distribution of errors from the
analytical method rather than the values from a
healthy or patient population.

SHEWHART LEVEY-JENNING CHART

• Most widely used system in clinical laboratory
• Allows the laboratorians to apply multiple rules
Figure 2-1 without the aid of a computer
Gaussian Curve • A graphic representation of the acceptable limits
of variation in the results of an analytical method.

CUMULATIVE SUM GRAPH (CUSUM)

Figure 2-4
• It calculates the difference between QC results Levey-
and the target means. Jenning Chart
• V mask is the most common method – requires
computer implementation
• Identifies consistent bias problems.
• This plot will give the earliest indication of
systematic errors (trend)
• Results are out of control when the slope ERRORS WHICH CAN BE OBSERVED
exceeds 45o or a decision (+/- 2.7 SD) is a. Trend
exceeded. o Is formed by control values that either
increase or decrease for six consecutive
days.
o Main cause: deterioration of reagents

Figure 2-2
Cumulative Sum
Graph
Figure 2-5
Trends

PASCUAL QUALITY MANAGEMENT | 7

b. Shift
• Is formed by control values that distribute
• It recognized that the use of simple upper and
themselves on one side or either side of the
lower control limits are not enough to identify
mean for six consecutive days.
analytical problems.
• Shift in the reference range is due to transient
• Westgard used the term control rule to indicate if
instrument differences
the analytical process is out of control.
• Main cause: improper calibration of the
instrument.
CONTROL RULES
12s
• use as rejection or warning rule when one control
result exceeds the mean +/- 2SD; for screening
Figure 2-6
Shift
purposes.

c. Outliers
• Are control values thatt are far from the main
set of values.
• They are highly deviating values
• Cause by random or systematic errors

NOTES
• 95% confidence limit (+/- 2SD) – acceptable
range.
• Kurtosis- refers to the degree of flatness or Figure 2-7 12s Rule

sharpness in the peak of a set of values

having a gaussian distribution. 13s
• An analytical method is considered in • reject a run when one control result exceeds the
control when ther is symmetrical distribution mean +/- 3SD.
of control values about the mean and there
are few control values outside the 2s control
limits.
• If the analytical test results to control values
are not within the +/- 2SD confidence range,
run a new set of controls and repeat
specimen testing.
• A control value between 2s and 3s is a sign
of potential problem.
• A value outside 3s would require corrective
action.
• Continued QC failure requires more trouble
shooting – preparation of new reagents,
recalibration, instrument maintenance and
Figure 2-8 13s Rule
repair, and contacting the
dealer/manufacturer for technical support or
service.

PASCUAL QUALITY MANAGEMENT | 8

22s R4s
• reject a run when the last 2 control results (or 2 • reject a run if the range or difference between the
results from the same run); exceed either the highest and lowest control result within an
mean +/- 2SD. analytical run exceeds 4SD.

Figure 2-11 R4s Rule

10x
• reject a run when ten consecutive results are on
the same side of the target mean.

Figure 2-9 22s Rule

41s
• reject a run when the last four (or any four)
consecutive control results exceed either mean
+/- 1SD.

Figure 2-12 10x Rule

Figure 2-10 41s Rule

PASCUAL QUALITY MANAGEMENT | 9

 TERMINOLOGIES
ANALYTICAL RUN
• a set of control and patient specimens
assayed, evaluated and reported together.
DELTA CHECK
• Is the most commonly used patient based-QC
technique
• It requires computerization of test data
• The difference between two consecutive
measurement of the same analytes on the same
individual.
POINT OF CARE TESTING
• Analytical testing performed outside the confines
of the central laboratory, usually by non
laboratorians personnel
• Use of portable whole blood glucose meters for
the management of patients with diabetes- most
commonly used POCT
• Other names: near-patient testing, decentralized
testing, bedside testing, alternate site testing.
REFERENCE LIMIT / REFERENCE INTERVAL /
REFERENCE VALUE
• A value obtained by observation or
measurement of a particular type of quantity on
a reference individual.
• Usual values for a healthy population that
represents 95% central tendency.
FIVE FACTORS WHEN ESTABLISHING
REFERENCE INTERVALS:
1. The composition of reference population
2. The criteria of excluding and including
individuals from the reference population.
3. The physiologic and environmental conditions of
the reference population
4. Specimen collection procedure, preparation for
testing
5. Analytical method used

NOTES
• Atleast 120 individuals should be tested for each
age and sex category
• However 20 reference individual need to be
sampled for analysis on the test instrument (not
more than 2 out of 20)
• Reference values vary slightly depending upon
method and specimen type.

PASCUAL QUALITY MANAGEMENT | 10