MLS 414 LAB – CLINICAL CHEMISTRY

BASIC QUALITY CONTROL STATISTICS

2ND SEMESTER | MIDTERM | DR. JHANNEAL BIANCA RAMIREZ, RMT, ASCPI, MD

OUTLINE 1SD
I. BASIC QUALITY CONTROL STATISTICS FORMULA: (MEAN) +/- (SD) (1) FOR 1SD
A. Mean
B. Standard deviation LOWER LIMIT 4.56 - (0.1)(1) = 4.56 - 0.1 = 4.46
a. 1SD HIGHER LIMIT 4.56 + (0.1)(1) = 4.56 + 0.1 = 4.66
b. 2SD
c. 3SD 2SD
C. Levey Jennings Chart FORMULA: (MEAN) +/- (SD) (2) FOR 2SD
D. Coefficient of Variation
E. Standard deviation
F. CV ratio LOWER LIMIT 4.56 - (0.1)(2) = 4.56 - 0.2 = 4.36
G. Shift vs Trend HIGHER LIMIT 4.56 + (0.1)(2) = 4.56 + 0.2 = 4.76
H. Westgard Multirule system
I. Systematic error, Random error 3SD
FORMULA: (MEAN) +/- (SD) (3) FOR 3SD
MEAN
The mean (or average) is the laboratory’s best estimate of LOWER LIMIT 4.56 - (0.1)(3) = 4.56 - 0.3 = 4.26
the analyte’s true value for a specific level of control. HIGHER LIMIT 4.56 + (0.1)(3) = 4.56 + 0.3 = 4.86

Link for the youtube video: How to Calculate the

Standard Deviation
Where:
Σ = sum https://youtu.be/IaTFpp-uzp0
xi = each data point
n = the number of data points in the set NORMAL DISTRIBUTION CURVE

EXAMPLE:

Glucose QC Values
using Level 1 as control material:

Day 1 4.5
Day 2 4.7
Day 3 4.6
Day 4 4.4
Day 5 4.6
_______
LEVEY JENNINGS CHART
22.8 / 5 runs = 4.56 Mean

It's obtained by simply dividing the sum of all values in a

data set by the number of values.

STANDARD DEVIATION
● Standard deviation quantifies how close numerical
values are in relation to each other.
● Also used to set up limits.

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BASIC QUALITY CONTROL STATISTICS

A Levey–Jennings chart is a graph that quality control

data is plotted on to give a visual indication whether a CVR (Coefficient of Variation Ratio)
laboratory test is working well. The distance from the mean ● A statistics that compares your lab’s precision to
is measured in standard deviations. that of other labs in a consensus group

Dapat at least 20 ang ma plot, kasi per month minimum of CVR = Your CV/Consensus Group CV
20 controls man ang gina run natin.

EXAMPLE: 10/5 = 2
COEFFICIENT OF VARIATION
● The Coefficient of Variation (CV) is a measure of
variability. ● Less than 1 - Acceptable performance; indicates
that precision is better than peer group
A method or instrument’s CV is expressed as a percent and ● 1 to 1.5 - acceptable to marginal performance; may
is calculated as: need to investigates test system imprecision
● 1.5 to 2.0 - marginal performance; may need to
CV (%) = (Standard Deviation / Mean) (100) perform corrective action

SHIFT
EXAMPLE: ● Is defined as abrupt changes in the control values
● Shifts data in QC data represent a sudden and
0.1 / 4.56 (100) = 2.19%
dramatic positive or negative change in the system
performance
IMPORTANCE OF CV
● Coefficient of Variation is useful for comparison of
precision for two different methods or instruments.
● It can also be used as a part of the Internal Quality
Control system when performing patients precision
testing.

The lower the CV, the better

SDI (Standard Deviation Index)

● A statistics that measures your lab’s bias relative to
your consensus group. An estimate of reliability.

Shifts may be caused caused by:

● Sudden failure or change in the light source
● Change in reagent formulation
EXAMPLE: ● Change of reagent lot
● Major instrument maintenance
100 - 98 / 2 = 1 ● Sudden change in incubation temperature
(enzymes only)
● 0 - ideal score; identical to your peer group ● Change in room temp. or humidity
● (+/-) 1.5 to 1.5 - acceptable to marginal ● Failure in sampling system & reagent dispense
performance; may need to investigate test system system
bias ● Inaccurate calibration/recalibration
● (+/-) 1.5 to 2.0 - marginal performance; may need
to perform corrective action

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BASIC QUALITY CONTROL STATISTICS

TREND ● Use when at least 2 levels of control are run with

● Indicates a gradual loss of reliability in the test the examination run
system ● Cannot use with only one control
● Trends are usually subtle
12s Rule

❖ 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
Trends may be caused by: systematic error may be present in the test system.
● Deterioration of the instrument light source
● Gradual accumulation of debris in sample/reagent 22s Rule
tubing
● Gradual accumulation of debris on electrode
surfaces
● Aging of reagents
● Gradual deterioration of control materials
● Gradual deterioration of incubator chamber temp.
● Gradual deterioration of light filter integrity
● Gradual deterioration of calibration

Trends and shifts are indicative of a problem and these

should be investigated and corrected! ❖ Violation indicates systematic error Two
consecutive controls exceed the mean by +/- 2SD
ERROR DETECTION
● Systematic Error 41s Rule
○ A trend or shift away from the laboratory
mean
● Random Error
○ Any random deviation away from the
laboratory mean

NUMBER OF CONTROLS
● If one control
○ Accept results if control is within ± 2SD
● If 2 levels of controls
○ Apply Westgard multirule system ❖ This indicates systematic error
❖ 4 consecutive controls on one side of the mean
WESTGARD MULTIRULE SYSTEM exceeds +/-1SD
● A “multi-rule” system developed by Dr. James O.
Westgard based on statistical concepts
● A combination of decision criteria or rules to
assess if a system in in-control

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BASIC QUALITY CONTROL STATISTICS
10 𝑥 Rule
❖ This indicates systematic error
❖ 10 consecutive controls on one side of the mean
Sources of Systematic Error
● Improper alignment of sample or reagent pipettes
resulting to change in reagent and calibrator
volume.
● Drift or shift in incubator chamber temperature,
deterioration of photometric light source
● Change of Calibration /reagent lot
● Deterioration of reagent/calibrator/control product
while in use, storage or shipment
● Incorrect handling of control product
● Inadequate storage of reagent or calibrators/control
products
● Change in test operator
BIAS/SDI RESULTS ACCURACY /RELIABILITY ARE
13s Rule
❖ This rule identifies random error
❖ Any QC result outside ± 3s violates this rule.
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R4s Rule
❖ If there is at least a 4s difference between control
values within a single run, the rule is violate for
random error
Sources of Random Error
● Power Supply
● Double pipetting of control sample
● Misplacement of Control sample within the run
● Random air bubbles in reagent or sample pipette
system
● Incorrect reconstitution of the control product
● Inappropriate Storage of control
● Inadequately mixed reagents
● Individual operator variation in pipetting , timing ,
etc.
AFFECTED
BASIC QUALITY CONTROL STATISTICS

PRECISION/REPEATABILITY/CV/ CVR ARE AFFECTED

IDEAL CONTROL RUNNING

Westgard Multirule QC

If QC is out of control
❖ STOP testing
❖ identify and correct problem
❖ repeat testing on patient samples and controls after
correction
❖ Do not report patient results until problem is
solved and controls indicate proper performance

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