Quality Control

CLINICAL CHEMISTRY (LEC)

October 19, 2022

Quality Assurance ➢
High specificity = low number of false
A complete system of creating and following procedures positives
and policies to aim for providing the most reliable patient ❑ Accuracy
laboratory results and to minimize errors in the pre ➢ The extent to which the mean
analytical, analytical and post analytical phases. measurement is close to the true value.
➢ Indicates how close to the true value the
Monitors quality performance starting from the ordering of result is.
a laboratory determination to its reporting, the ➢ Counterchecked using the mean
interpretation of results, and then application to patient
care. ➢ Estimated using 3 types of studies
➢ Recovery
Involves total quality control which requires constant ✓ Determines how much
attention of all involved with the process or system. of the analyte can be
Principle: identified in the sample
✓ Every laboratory section must have a ➢ Interference
plan to address preanalytical, analytical ✓ Determines if specific
and postanalytical testing. compounds affect the
✓ Personnel must be trained in every laboratory tests like
procedure they perform, and they must hemolysis, turbidity, etc.
be tested annually for competency. ➢ Patient sample comparison
✓ Used to assess
➢ Pre-analytical - patient preparation, presence of error in
specimen collection, transport, and actual patient sample
storage ❑ Precision
➢ Analytical - Condition of ➢ Indicates how close the values are to
reagents/equipment, pipetting, QC, one another
personnel competency ➢ Counterchecked using COV
➢ Post-analytical - Reporting or results, ➢ Terms related to precision o
timely releasing of results, record ➢ Repeatability
keeping ✓ Closeness of
agreement between
✓ Procedure manuals, formatted results of successive
according to CLSI standards, must be instruments carried out
available for procedures and must be under the same
followed by personnel explicitly. conditions
✓ Instrument maintenance and calibration ❑ Diagnostic specificity
procedures and documentation of the ➢ Is the ability of the analytical method to
same must be in place. detect the proportion of individuals
✓ Problem logbooks should be used to without the disease
identify potential problems and course of ➢ It reflect the ability of the method to
action implemented. detect true-negatives with very few
false-positives
✓ Indicators should be identified to monitor ➢ Confirmatory test requires high
potential problems, thresholds set, and specificity to be certain of diagnosis
data collected. ➢ Specificity =
✓ A quality control program using control 𝑡ℎ𝑒 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑖𝑛𝑑𝑖𝑣𝑖𝑑𝑢𝑎𝑙𝑠 𝑤𝑖𝑡ℎ𝑜𝑢𝑡 𝑡ℎ𝑒 𝑑𝑖𝑠𝑒𝑎𝑠𝑒 𝑤𝑖𝑡ℎ 𝑎 𝑛𝑒𝑔𝑎𝑡𝑖𝑣𝑒 𝑡𝑒𝑠𝑡
𝑡𝑜𝑡𝑎𝑙 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑖𝑛𝑑𝑖𝑣𝑖𝑑𝑢𝑎𝑙𝑠 𝑡𝑒𝑠𝑡𝑒𝑑 𝑤𝑖𝑡ℎ𝑜𝑢𝑡 𝑡ℎ𝑒 𝑑𝑖𝑠𝑒𝑎𝑠𝑒
𝑥 100
material that resembles patient samples ❑ Delta check
must be run exactly as the patients ➢ The current test value is compared to a
previous value or values to detect large
Terminologies changes
❑ Sensitivity
➢ The ability of an analytical method to Quality Control
measure the smallest concentration of QC is concerned with the analytic phase of QA
the analyte of interest. It is a process of ensuring that analytical results are
➢ High sensitivity = none or low number of correct by testing known samples that resembles patient
false negatives samples.
❑ Specificity It involves the process of monitoring the characteristics
➢ The ability of an analytical method to of the analytical process and detects analytical errors
measure only the analyte of interest.
Wong, J.V.
 Quality Control
CLINICAL CHEMISTRY (LEC)
October 19, 2022

during testing, and ultimately prevent the reporting of ➢ Problem is constant or predictable from day to
inaccurate patient test results. day.
➢ Detected as either positive or negative bias
2 Major Types of QC
1. Internal QC / Intra-Laboratory QC ➢ Trend
➢ Involves analyses of control samples ✓ Values increase or decrease for six
together with the patient specimens. consecutive days (crosses the mean)
➢ Primarily monitors day to day ✓ Cause : deterioration of reagents
performance of laboratory tests.
➢ It is important for the daily monitoring of
accuracy and precision of analytical
methods.
2. External QC / Inter-Laboratory QC
➢ Involves proficiency training programs
that periodically provide samples of
unknown concentration to participating
clinical laboratories.
➢ It is important in maintaining long-term
accuracy of the analytical methods.
➢ Shift
Objectives of Quality Control ✓ Values distribute themselves on one
1. To check the stability of the machine side or either side of the mean for six
2. To check the quality of reagents consecutive days (does not cross the
3. To check technical / operator errors mean)
✓ Cause : improper calibration of the
Control Solutions / QC Materials instrument
➢ Solutions that are used to check the precision
and accuracy of an analytical method.
➢ It should resemble the patient specimen and be
run with the patients.
➢ Characteristics of ideal control solution
✓ Behaves like real sample
✓ Available to last a minimum of one year
✓ Should vary minimally in concentration
and composition from vial to vial
✓ No communicable diseases

Analytical Errors ➢ Examples

Errors encountered in the collection, preparation, and ✓ Calibration problems
measurement of specimens including transcription and ✓ Deterioration of reagents and control
releasing of results materials
✓ Improper preparation of standards and
Random Error controls
➢ Error that occurs unpredictably ✓ Contaminated solutions
➢ Affects precision and is the basis for varying ✓ Unstable and inadequate reagent blanks
differences between repeated measurements ✓ Failing instrumentation
➢ Examples ✓ Poorly written procedures
➢ Variations in technique
➢ Pipetting error Allowable Error
➢ Mislabeling of samples ➢ The quantity of error that will not
➢ Improper aliquoting negatively affect clinical decisions.
➢ Environmental conditions ➢ Total error must be less than the
➢ Temperature and voltage allowable error to be considered
fluctuation acceptable.

Systematic Error
➢ Error that occurs predictably once a pattern of
recognition is established.

Wong, J.V.
 Quality Control
CLINICAL CHEMISTRY (LEC)
October 19, 2022

Statistics ▪ Focuses on the distribution of errors from

Mode the analytical method rather than the
➢ The most frequently occurring value values from a healthy or patient
➢ Used to describe data with two centers population
(bimodal) ▪ The total area under the curve is 1.0 or
Range 100%
➢ The simplest expression of distribution
➢ Difference between the highest and the lowest
score in a data
Standard Deviation
➢ Measure of dispersion of the values from the
mean
➢ A measure of distribution range
➢ Most frequently used measure of variation
2

➢ Formula ∑(𝑥−x̅)
𝑆𝐷 = ඨ
𝑛 −1
Cumulative Sum Graph (CUSUM)
➢ In a normal distribution ▪ Calculates the difference between QC
✓ 1 SD = 68% of the total population results and the target means
✓ 2 SD = 95% of the total population ▪ Common method: V-mask
(maximum allowable SD) ▪ Identifies consistent bias problems; it
✓ 3 SD = 99.7% of the total population requires computer implementation
▪ This plot will give the earliest indication of
Coefficient of variation systematic errors (trend) and can be
➢ Expresses SD as a percentage of mean value used with the 13s rule
➢ Used to determine precision ▪ Very sensitive to small, persistent errors
➢ Formula 𝑆𝐷 that commonly occur in the modern, low
CoV = calibration-frequency analyzer
x̅ ▪ Rules are out of control when the slope
exceeds 45° or a decision (+- 2.7 SD) is
Variance exceeded.
➢ Standard deviation squared
➢ Measure of variability
➢ Difference between each value and the average
of the data
➢ Formula Variance = (SD)2

T test
➢ Used to determine whether there is a statistically
significant difference between the means of two
groups of data.
F test
➢ Used to determine whether there is a statistically
significant difference between the standard Youden/Twin Plot
deviations of two groups of data ▪ Interlab
▪ Used to compare results obtained on a
Quality Control Charts high and low control serum from different
Gaussian Curve (Bell-Shaped Curve) laboratories
▪ Occurs when the data set can be ▪ It displays the result of the analyses by
accurately described by the SD and the plotting the mean values for one
Mean. specimen on the ordinate (y-axis) and the
▪ Obtained by plotting the values from other specimen on the abscissa (x-axis)
multiple analyses of a sample
▪ Population probability distribution, that is
symmetric about the mean
▪ Occurs when the data elements are
centered around the mean with most
elements close to the mean
Wong, J.V.
 Quality Control
CLINICAL CHEMISTRY (LEC)
October 19, 2022

II. Systematic error

❑ 22s
➢ 2 consecutive control values are
greater than +/- 2SD
❑ 41s
➢ 4 consecutive control values on
one side of the mean
❑ 10x
➢ 10 consecutive control values on
one side of the mean

Shewhart Levey-Jennings Chart

▪ Most widely used QC chart in the clinical
laboratory
▪ It allows the laboratorians to apply
multiple rules without the aid of a
computer
▪ It is a graphic representation of the
acceptable limits of variations in the
results of an analytical method
▪ Easily identifies random and systematic
errors

Westgard Multirules
➢ Establishes a criteria whether an analytic
process is out of control
➢ According to Westgard, the use of simple
upper and lower control limits is not
enough to identify analytical problems.
➢ The combination of the control values
used in conjunction with a control chart
has been called the Multirule Shewhart
Plot

Rules
I. Random error
❑ 12s
➢ 1 control value exceeds 2 SD
➢ Warning rule – accept the run
❑ 13s
➢ 1 control value exceeds 3 SD
❑ R4s
➢ The difference between 2 control
values are equal to or greater
than 4 SD

Wong, J.V.