TOPIC

BASICS OF QUALITY CONTROL

Dr.Ikram din ujjan

 OBJECTIVES

• Explain the basis of a statistical Q.C Chart

• Provide awareness about Q.C terminology

• Preview the application of Q.C

 Quality Assurance
This describes all the steps taken both in and out side the
laboratory to ensure that the results are correct and
reliable. The factors affecting quality assurance include.
1. The selection and quality of specimen
containers,preservatives and anticoagulants.
2. Method of specimen collection.
3. Specimen labelling.
4. Completion of laboratory request forms.
1. Transportation of specimen to the laboratory.
2. Recording and labelling in the laboratory.
3. Skill of the technicians performing the tests.
4. Quality of reagents, equipment and laboratory
ware.
5. Quality of method employed.
6. Controls employed to check the analytical
process.
7. Method of reporting of the results.
 COURSE MATERIAL
• Basic Terminology
• To Calculate
– Mean
– Mode
– Variance
– Standard deviation
– Co-efficient of variation.
• To Plot L.J chart
• Error detection by using west gard rules
• Error prevention.
 OUT COME OF COURSE

• Show in develop your interest about Q.C

• Should be able to define basic terminology
(definitions) of Quality Control
• To plot L.J chart
• Identify the problem of Q. Control via L.J chart
• Carry out rectification procedures based your L.J
chart.
WHAT IS QUALITY

“Satisfying human wants at

minimum cost”

(Walter A shew hart)

QUALITY CHARACTERISTICS

• Quality is related to
customer’s need
 OUR CUSTOMERS

• Health Care Providers

(Clinician)

• Health Care Purchaser

(Patient or corporation)
 NEEDS OF OUR CUSTOMERS

• Accuracy

• Diagnostic efficacy

• Fast turn around time

• Cost effectiveness
CAN YOU JUDGE WHETHER A LAB
RESULT IS RIGHT OR WRONG BY

• Seeing ?
• Hearing ?
• Touching ?

So how can the Lab be sure of the results

that it reports to the patient
 CHOOSE THE BEST ONE

• Should only the senior technologist perform the

test ?
• Should the pathologist run the sample to assure
the quality ?
• Should lab run the sample in report the results
without being sure whether they are right or
wrong ?
• Send the sample to a well known lab to assure
correct results!

• None of the solution is correct so what to do

 EXAMPLE

If the patient sample is run along with a

sample with known results e.g control of
glucose with known value such as between
90-110 mg/dl
 The control results on a particular run are
between the given range.

Patient Control
88 mg/dl 102 mg/dl
Then the Lab knows that the
procedure is correct and the
results of the patient must be
too correct.
If the control results are out side the given range

For e.g
Control range = 90 – 110 mg/dl
Then the procedure is incorrect &

The result of the patient will also be wrong.

Because of multiple factors in a testing
procedure, the results will be slightly different
each time the sample is run but the result value
will be very close to each other.
Therefore the manufacture gives a range of the
controls and not an exact figure.
 RUNNING CONTROL IS NOT
ADEQUATE

• This is just the beginning of the story of qulaity

control for laboratories.

• To understand all the steps of Q.C some

Biostatistical terms have to be understand.
QUALITY CONTROL
• QC is the product
of quantitative
and statistical
method used in
the laboratory to
assure reliable
test results.
Goals Of Quality control

• Reliable Test Results

• Error Detection
• Error Prevention
 PRE ANALYTICAL ACTIVITIES

• That occur before the sample reaches the

Laboratory

For e.g
Wrong patient’s sample drawn
 ANALYTICAL ACTIVITIES

• That directly related with the analysis of the

sample

– For e.g
• Sample is analyzed incorrectly
 POST ANALYTICAL ACTIVITIES

• After the analysis is performed

– For e.g
Wrong results are written on working sheet.
 Central Tendancy

• Distribution of data around a central value

• Indicators of central tendancy
– Mean
– Mode
– Median
 MEAN

An average of a group of numbers

Symbol: X
 MEAN
Mean = Sum of the reading
Number of reading
X = ΣX
n
Σ = Sum
X = Reading
n = Number
X = Average or mean
• Example
A student was performing a normal
platelet count in Haematology lab in which
he obtained five replicate counts for
unknown sample. What is the mean
platelet count for the unknown.

• First Step
1. First add the five value platelet count & get the
sum.
60 + 70 + 80 + 65 + 75 = ______________
• 2nd Step
1. Then divide the sum by the total # of
replicates (n)

X = Σx = _________
n 5
The mean value for this group of platelet count
is
X = _____
 EXERCISE # 01

• Find mean of the following numbers

24, 32, 86, 91, 37

 EXERCISE # 02

Calculate mean of the following numbers

7, 3, 8, 5, 9, 4, 6.
 SOLUTION

• Exercise # : 01 = 54

• Exercise # :02 = 06
 MEDIAN

• Median is the central or middle number that

divides the data exactly into two halves.

• The median value may or may not be the same

as the mean value.
– For e.g
• 60 + 70 + 80 + 65 + 75
• First Step
First arrange numbers from lowest to highest value
60 Lowest
65
70
75
80 High
In this set total amount of values are 5 which is an odd# in case of odd# add 1
like,
5+1 = 6
Divide by 2
6 = 3
2
To see step 1st count down up to the third
60
65
70 - 3
75
80
 EXERCISE # 03

• Find out the Median of the following:-

20, 25, 25, 25, 30, 35, 43
 EXERCISE # 04

• Find out median of the following:-

4, 8, 2, 9, 3, 5, 6, 7, 1
 SOLUTION

• Exercise # 03 = Median = 25
• Exercise # 04 = Median = 05

– For e.g
If the quantity of numbers in the group is an
even# please calculate median
17, 14, 12, 15, 10, 11, 13, 16
• 1st Step
First arrange the numbers from lowest to highest
value.
• 10 Lowest
• 11
• 12
• 13
• 14
• 15
• 17 Highest
• 2nd Step
Total amount of values in this group divide by 2.
• 8/2 = 4
Next add 1 to this value.
• 4+1 = 5
• 3rd Step
• To step 1st, count down upto the 5
• 10
• 11
• 12
• 13
• 14
• 15
• 16
• 17
• The median is an average of 4th& fifth of group 4 + 5
= 13 + 14 = 13.5
• 2 2

• Median is 13.5, there is an equal quality of digits above

and below the median value.
 EXERCISE 06

• Find out the median

45, 56, 67, 68, 79, 98
 SOLUTION

• Exercise # 06 = 67.5
 MODE

Mode is the number that occurs most frequently

in a group of numbers
Mode can be more than one numbers
For e.g
What is the mode for the following group of
numbers?
25, 24, 22, 30, 26, 23, 22, 21
 FIRST STEP
• Arrange the data value from the lowest to the
highest
• 21
• 22
• 23
• 24
• 25
• 26
• 30
 SECOND STEP
• Determine the number or numbers that occur
the most frequently.
Number Frequency
21 01
22 02
23 01
24 01
25 01
26 01
 EXERCISE # 17

Find out the mode

2, 3, 4, 5, 5, 6, 7, 8, 8, 8, 9, 11
 Solution

Exercise # 07

Mode = 5 & 8
 EXERCISE # 08

• Find out the mode:-

2, 3, 4, 5, 6, 7, 8, 9, 11, 13, 17
 Solution

Exercise # 08

There is no mode.
• ACCURACY
That reflect the “true value” or target of the result

UL (Limit%)

Target

LL (Limit%)
• PRECISION
After repeated analysis the same result is achieved.

UL (Limit%)

Target

LL (Limit%)
• Both precise & Accurate

UL (Limit%)

Target

LL (Limit%)
Neither Accurate Nor Precise
UL (Limit%)

Target

LL (Limit%)
 VARIANCE

• The precision of a group of numbers is indicated

by the “variance”
• Symbol : S2
• Smaller variance means narrow range of a values
• Large variance means have wide range of values
 FORMULA
• S2 = Σ (x – x)2
n-1
Where
S2 = Variance
Σ = Sum of numbers within parentheses
X = An individual data point
X = Mean
N = Total amount of numbers with in the group
• For e.g
Calculate the variances of the following
group of glucose values. All values have the
unit of mg/dl
85, 83, 82, 90, 91, 83, 85, 88, 89, 87
 FIRST STEP
• Arrange the number from lowest to highest.
82 Lowest
83
83
85
85
87
88
89
90
91 Highest
 SECOND STEP

• To Calculate Mean
Mean = Σx / n
= 82+83+83+83+85+85+87+88+89+90+91
10
Add = x = 86.0 or 86.3 mg/dl
 THIRD STEP
• Subtract mean from each individual number.
Glucose results (mg/dl) x–x
82 82-86 = -4
83 83-86 = -3
83 83-86 = -3
85 85-86 = -1
85 85-86 = -1
87 87-86 = +1
88 88-86 = +2
89 89-86 = +3
90 90-86 = +4
91 91-86 = +5
 FOURTH STEP
• Square the difference
(x-x)2
(-4)2 = 16
(-3)2 = 09
(-3)2 = 09
(-1)2 = 01
(-1)2 = 01
(+1)2 = 01
(+2)2 = 04
(+3)2 = 09
(+4)2 = 16
(+5)2 = 25
 FIFTH STEP

• Sum of all square products

Σ (x - x) = 16+9+9+1+1+4+9+16+25 = 91
 SIXTH STEP

• By using the formula

Substitute calculated values
S = Σ (x – x)2
n-1
S2 = 91/9 = 10 mg2/dl2
 SEVENTH STEP
• To calculate standard deviation symbol

S= S2 or variance

S= Σ (x – x)2
n-1

S= 10 mg2/dl2
S= 3.2 mg/dl

S= + 3.2 mg/dl
 EIGHT STEP

• To calculate
(+) (-)
1 SD = xs = 86 + 3.2 86 – 3.2
2 SD = x 2s = 86 + 2(3.2) 86 – 2(3.2)
3SD = x 3s = 86 + 3(3.2) 86 – 3(3.2)
5 Replicates of a single bottle of quality control
were analyzed for haemoglobin. The values are

12.0, 13.0, 12.5, 14.0, 13.0

What would be the standard deviation ?
 Exercise

• Twenty replicates of a low levels were analyzed

for WBCs. The mean WBC value was 140 x
109/L
• The standard deviation was calculated to be 4 x
109/L
• What would be the 1, 2 & 3 standard deviation
ranges for quality control.
 SOLUTION
1 1SD = 4 X 109/L
Mean = 140 x 109/L
-1SD = 140.0 – 4.0 = 136.0 X 109/L
+1SD = 140.0 +4.0 = 144.0 X 10 9/L
1SD Range= 136.0 – 144.0 x 109/L
2SD = 1SD x 2 = 4.0 x2 = 8 x 10 9/L
-2SD = 14.0 – 8.0 = 132.0 x 109/L
+2SD = 14.0 + 8.0 = 148.0 x 109/L
2SD = 132 – 148 x 109/L

3SD = 1SD x 3 = 12 x 109/L

-3SD = 140.0 – 12.0 = 128.0 x 109/L
+3SD = 140.0 – 12.0 = 152.0 x 109/L

3SD = 128.0 – 152 x 109/L

 MEASURES OF DISPERSION

Variability in the data can be expressed by

• Range
• Standard deviation
• Coefficient of variation
 RANGE

It is a difference between minimum and the

maximum value of the data
80, 90, 90, 100, 100, 100, 100, 110, 110, 120

80 120
 STANDARD DEVIATION

• Dispersion of Gaussian data around the mean.

• Standard deviation is the most frequently used
measure of precision.
Symbol: “S”
Formula S = S2

Standard deviation is calculated mathematically

Deviation to right is considered as plus
in to left is minus

• Graph
STATISTICAL PROBABLITIES

• Observed in a normal distribution.

SD With in Without
SD of SD
1SD 68% 32%

2SD 95% 05%

3SD 99.7% 0.3%

 QUESTION ARISE

• What is an acceptable limit for any quality

control material result ?
 REMEMBER

• Q.C result outside of acceptable limit established

by the laboratory itself.
• Majority use 2SD
• If result fall out of 2SD there is a chance of
• 95% result invalid
• 05% result Valid
 MOVING AVERAGE
In HAEMATOLOGY LAB
• Used on automated analyzers
• To establish the control limits for the erythrocyte
indices
• Stable within a give population
 CALCULATION

• 20 Consecutives patient samples are batched

• Then calculated the mean by an instrument
• An overall mean established for every 20
batches of patient’s samples (400 patient)
• This technique uses a complex formula to
smooth the individual results with in the batches.
 HOW TO FIND OUT STANDARD
DEVIATION ?s

• First, determine the mean

• Substract mean from each individual number
• Difference is squared
• Sum of squared product
• This value is divided by total# of data minus 1
• The square root of this value is standard
deviation.
 COEFFICIENT OF VARIATION
• Dispersion or precision is the “Coefficient of variation.
• Lower the CV for a group of data, the more precise the data.
• Symbol : CV
• Formula % CV = S x 100
x
CV is expressed as a %
S= Standard deviation
X= Mean
CV= Coefficient of variation
%= Percentage
 EXERCISE

• The mean of glucose is 86 mg/dl, standard

deviation is 3.2 mg/dl
What would be the coefficient of variation of
above data.
Solution
% CV = 3.2 mg/dl x 100
86 mg/dl
 CONTROL CHART

• Graphical representation of numerical data

• Scale and label the chart with x-axis and y-axis
• X-axis represents the number
• Y-axis represents the frequency of that number
• Mark the values by points considering their
frequencies
• Connect all the points by straight line
 Types Of Quality Control
• INTERNAL QC
• Monitoring laboratory
performance.
• Utilizing control material
and/or repeated measurement
on routine specimen.
• The results generated in this
way are analyzed statistically
on daily basis.
• This ensures continuous
evaluation(real time QC).
• EXTERNAL QC
• It is the evaluation of a
laboratory by an independent
agency analyzing the performance
of many hundreds of laboratories.
• Control samples are sent on regular
intervals,laboratories analyze them
and the results are sent back to the
agency.
• Performance of each laboratory is
checked against the actual results of
all participating laboratories .
Type Of Errors in the Laboratory

TYPES OF ERROR

RANDOM ERROR SYSTEMATIC ERROR

RANDOM ERROR

• Random errors are the

result of chance or sampling
errors.
• Random errors do not affect
the entire batch of
specimens.
• Heavy workload resulting in
faulty technique or shortcuts
being taken.
• Fluctuating voltage.
• Interfering substances e.g
hemolysis,lipemia.
SYSTEMATIC ERROR

• Systematic errors affect all

specimens in a batch.
• Systematic errors are
attributed to causes other
than chance: e.g.,
deteriorating
reagents,instrument
malfunction.
ACCURACY
UL (Limit%)

Target

LL (Limit%)
PRECISION
UL (Limit%)

Target

LL (Limit%)
Neither Accurate Nor Precise
UL (Limit%)

Target

LL (Limit%)
 DEFINITION
• MEAN • STANDARD
• Sum of the DEVIATION
measurement • Absolute
divided by the measure of
number of dispersion
measurement.th around a mean.
e measurments
Points to Remember when using comercial
control

• Storage and stability

• Pre-analytical steps:
• mixing,warming,modes
of analysis.
• “Natural decay”of the
control material.
• Controls are
“artificial”and do not
always react like
patient samples.
 Use Of Commercial Controls

• ADVANTAGES • DISADVANTAGES
• Monitors the • Limited stability.
CBC/differential • Shipping/storage may affect
parameters. stability.
• Does not simulate patient
• Assayed known values.
specimens.
• Shipped on a regular • Each shipment requires
basis. verification of assay.
• QC interlaboratory stats • May cause false rejection of
available. analysis.
 LEVY-JENNING CHART
• Use to monitor
and interpret
cpntrol results
using single set
of control
limits.2SD or
3SD limits.
 WESTGARD’S RULES

• Westgard multirule chart further

specifies the L-J Quality control charts.
It makes use of a series of control rules
for interpretting control data.
• It has the advantage that probability of
false rejection is reduced and the error
detection is improved.
• The chart is governed by following
control rules. .
Dr WESTGARD
 1,2 SD
• One result
outside 2
SD:Warning-
possibly early
sign.
• RE or SE
 1,3 SD
• One result
outside 3SD:
REJECT
• RE or SE
 2,2 SD
• Two consecutive
results outside 2
SD: REJECT.
• SE
 R4 SD
• One control
observation
exceeds the+2
SD and the
second exceeds -
2 SD:REJECT.
• RE
 4,1 SD
• Four consecutive
results outside 1
SD:REECT.
• SE
 10 X

• Ten consecutive
control reading
on one side of the
mean:WARNIN
G.
• SE
THANK YOU
FOR YOUR
ATTENTION