Quality Control
DR SARATH KRISHNAN M P
MBBS MD(BIOCHEMISTRY)
DEPARTMENT OF BIOCHEMISTRY
AIIMS RISHIKESH-249203
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Quality control in clinical laboratory
1. Quality control-Basics
2. Basic QC statistics
3. Levey –Jehnings chart; Westgard rules
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1. Quality control-Basics
What is QC?
A process designed to ensure reliable test results
Use controls and standards to ensure accuracy
Reject results when there is evidence of errors
It is a statistical process
Monitor and evaluate the analytical process that produces patients
results (Accurate & Reliable)
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Objectives of quality in lab
Support provision of high quality health care
◦ Reduce morbidity
◦ Reduce mortality
◦ Reduce economic loss
Ensure credibility of lab
Generate confidence in lab results
To give laboratory staff confidence in their methods
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How the reliability is ensured?
Regular testing of quality control products along with patient
samples
Comparison of QC results to specific statistical limits(ranges)
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Analytical system-Potentially unstable
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QC Products
Patient like material
Ideally made from human serum, urine or spinal fluid
Can be a liquid or freeze-dried (lyophilized) material
Composed of one or more constituents (analytes) of known
concentration
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QC Products
Normal control product- Contains normal levels for the analyte
being tested
Abnormal control product- Contains the analyte at a concentration
above or below the normal range for the analyte
Good laboratory practice requires testing normal and abnormal
controls for each test at least daily to monitor the analytical process
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QC terminologies
Accuracy: closeness of a result to the actual value (True value)
Precision: Reproducibility & Repeatability
Inaccuracy / Bias: measure of systematic error
Imprecision: A measure of dispersion of random errors
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Analytical
SENSITIVITY SPECIFICITY
The assays ability to detect very It refers to the ability of an
low concentrations of a given assay to measure on particular
substance in a biological substance, rather than others, in
specimen a sample
The smallest concentration that A method’s ability to measure
can be accurately measured only the analyte of interest
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Diagnostic
SENSITIVITY SPECIFICITY
The ability of a test to correctly The ability of the test to
identify those with the disease correctly identify those without
the disease
True negative rate
True positive rate
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Internal
quality control
Quality
control
External
quality control
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Internal QC
IQC is a daily process
Measure of precision
Definition: IQC refers to the set of procedures undertaken by the
lab staff for the continuous and immediate monitoring of lab work in
order to decide whether the results are reliable enough to be
released.
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External Quality Assessment/Proficiency
testing
It is used to evaluate your lab performance with reference to other
participant labs
This allows for comparison of the laboratory’s testing to a source
outside the laboratory
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External Quality Assessment/Proficiency
testing
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External Quality Assessment/Proficiency
testing
Definition: EQA refers to a system in which the performance of a
lab is assessed periodically and retrospectively by an independent
outside agency to indicate to the lab staff where there may be
shortcomings and hence indicates a need for improving and/or
changing IQC procedures
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Errors
Errors that affect every
Systematic errors test in a constant,
predictable manner
Errors
Errors that affect
individual sample in a
random &
Random errors unpredictable manner
Lack of reproducibility
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Causes of systematic error
Deterioration of the instrument Gradual deterioration of
light source incubation chamber temperature
(enzymes only)
Gradual accumulation of debris
in sample/reagent tubing Gradual deterioration of
calibration
Aging of reagents
Gradual deterioration of control
materials
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Causes of Random error
Improperly mixed/dissolved Unstable temp & incubation
reagents
Unstable power supply
Air bubbles in reagents and
Poor operator technique
reagents lines, sampling or
reagents syringes Improper mixing of processed
samples
Pipette tips is not fitting
properly Incorrect reconstitution of the
control material
A clogged pipettor
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2. Basic QC statistics
Mean
Standard deviation (SD)
Coefficient of variation (CV)
Standard deviation index (SDI)
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Internal QC
•Mean; SD
External QC
•SDI
Other QC statistics: CV
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Mean (X)
Calculated average of the values
The mean/average is the lab best estimate of the analyte’s true
value for a specific level of control
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Mean (X)
Calculation of mean
Data set for 5 values of glucose
90,92,100,102,96
X= (90+92+100+102+96) ÷ 5 =96mg/dl
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Standard deviation(SD)
SD=is a measure of how much the data varies around the mean
Used to measure dispersion/scattering of a group of values around
a mean
Primary indicator of precision
Measure of random error
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Standard deviation(SD)
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Standard deviation(SD)
Previous example; X=96
Individual (X-Xi)2=36; 16; 16; 36; 0
SD=√(36 + 16 + 16 + 36 + 0) ÷ (5 − 1)
= 104/4 ~ 5
SD=5
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Standard deviation(SD)-Example
Mean=100mg/dl; SD=2mg/dl
Range of acceptability = ±3SD
SD Ranges % of Data points
±1SD 98-102 68%
±2SD 96-104 95%
±3SD 94-106 99.7%
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What is Gaussian distribution in the
analytical phase in lab?
Normal distribution is exhibited by well preserved biological
material on repeated examinations
This property is used in the statistical quality controls
SQCs are used to verify the ongoing performance of analytical
system
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Coefficient of variation (CV)
CV is SD expressed as a proportion of the mean
CV(%)= (SD/Mean) x 100
Assess instruments, reagents, and control products using the
coefficient of variation.
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Why CV%
Analyte Method SD Mean CV%
Hexokinase 4.8 120 4
Glucose GOD-POD 4 100 4
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Standard deviation index(SDI)
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3. Levey-Jennings chart & Westgard rules
A graphical method for displaying control results and evaluating
whether a procedure is in-control or out-of-control
Daily control values are plotted versus time
Lines are drawn from point to point to understand any systematic,
or random errors
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Levey-Jennings chart
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Levey-Jennings chart
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Westgard rules
Dr James Westgard
Detecting changes in the analytical system
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Westgard rules for what?
Westgard has formulated rules to decide whether an analytical run
is in-control or out-of-control
These rules can be applied as single rules and as a group of rules
(multi-rules)
Westgard rules can be applied only if your QCs are plotted with the
range of 3SD
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Control rule nomenclature
NL or N:L 1:2S
2:2S Routine basis
N=Number of control 1:3S
measurements involved 4:1S
10X
L=Limit exceeded
R:4S
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1:2S Warning signal; Random error or
beginning of systematic error
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2:2S Systematic error; Rejection rule
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1:3S Random error; beginning of a
large systematic error; Rejection rule
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4:1S Systematic error; Rejection rule
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R:4S Random error; Rejection rule
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10X Systematic error; Rejection rule
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How to evaluate Westgard rules?
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Identify the violation?
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Thank you
Acknowledgement: Dr. Trupti Ramteke. [Link] (Biochemistry), DNB (Biochemistry).
Associate Professor, Biochemistry, Government Medical College, Nandurbar, Maharashtra
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