Control of laboratory

investigations

Suhair.A.A./ Quality Assurance / 3rd

year 1
 Examination Processes

laboratory investigations
Suhair.A.A./ Quality
2 Assurance / 3rd year
◼ The performance of analytical methods can be
monitored by analyzing specimens whose
concentrations are known and then by
comparing the observed values with known
values. These specimen which has a known
values are known as control materials.
◼ The known values are usually represented by an
interval of acceptable values, or upper and lower
limits for control.

Suhair.A.A./ Quality Assurance / 3rd

3 year
Calibrators Controls
A substance with a specific A substance similar to
concentration. patients’ samples that
has an established
Calibrators are used to set concentration.
(calibrate) the measuring
points on a scale. Controls are used to ensure
the procedure is working
1 2 3 4 5 properly.
1 2 3 4 5

Suhair.A.A./ Quality Assurance / 3rd

4 year
Quality Control (Q.C)
◼ Q.C refers to the process of detecting analytical
errors within the lab to ensure both the reliability
and accuracy of test results in order to provide
the best possible patient care. i.e Q.C are the
measures taken to monitor the quality of the test
itself.
◼ Unreliable performance can result in
misdiagnosis, delayed treatment and increased
costs due to retesting etc. it is therefore of great
importance to ensure all results provided are
both accurate and reliable.
Suhair.A.A./ Quality Assurance / 3rd 5
year
Quality assurance in a medical lab can help prevent serious
medical errors.
6
Control materials
◼ Control material is a material used for
quality control purpose, that means is a
material used for checking the precision of
the method (reproducibility)in routine
practice.
◼ Control material should behave like real
specimens, be available in a sufficient
quantity to last a minimum of one year.

Suhair.A.A./ Quality Assurance / 3rd

7 year
Control materials
▪ Control material should be tested in same
manner as patient specimens.
▪ Control material should span the clinically
important range of the analyte's
concentrations

Suhair.A.A./ Quality Assurance / 3rd

year 8
Control material can be either
(1) commercially available in lyophilized form and
require reconstitution before use. Or
(2) homemade using extra sera from patient
sample which is more susceptible to
deterioration.
◼ Commercially control material can be made from
human serum which is more expensive or from
bovine based control material which are lower in
price.
Suhair.A.A./ Quality Assurance / 3rd year
9
◼ The most common method of comparing
the values observed for control materials
with their known values is through the use
of control chart.
◼ Control charts are simple graphical
displays in which the observed values are
plotted versus the time when the
observations were made.

10 Suhair.A.A./ Quality Assurance / 3rd year

◼ When the plotted points fall within the control
limits , this is generally interpreted to mean that
the method is perfuming properly. When the
plotted points fall out side the control limits,
problems may be developed.
◼ Control limit usually calculated from the mean
and SD obtained from repeated measurements
on a known specimens by a particular analytical
method .

Suhair.A.A./ Quality Assurance / 3rd year

11
◼ The initial estimate should be based on
measurements obtained over a period of
at least 1 month when a method is working
properly.
◼ Control charts are used to compare the
observed control values with the control
limits and to provide a visual display that
can be quickly inspected and reviewed.

Suhair.A.A./ Quality Assurance / 3rd year

12
◼ Interpretation of quality control data
involves both graphical and statistical
methods. Quality control data is most
easily visualized using a Levey-Jennings
chart
◼ The Levey-Jennings chart is a simple
graphical display that Quality control data
is plotted on to give a visual indication
whether a laboratory test is working well .

13 Suhair.A.A./ Quality Assurance / 3rd year

◼ The procedure is as follow:
Analyze samples of control material by the
analytical method to be controlled on at
least 20 different days,

Suhair.A.A./ Quality Assurance / 3rd year

14
calculate the mean &SD for the results. The
dates of analyses are plotted along the X-
axis and control values are plotted on the
Y-axis. The mean and one, two, and three
standard deviation limits are also marked
on the Y-axis.

15 Suhair.A.A./ Quality Assurance / 3rd year

◼ Some laboratories used the 2s limits as
warning limits and 3s limit as error limits
( action limits).
◼ Different criteria have been used to judge
whether control results indicate out of
control situations.

16 Suhair.A.A./ Quality Assurance / 3rd year

 Suhair.A.A./ Quality Assurance / 3rd year
17
LEVY- JENNINGS GRAPH

Advantage:
◼ Simple data analysis and display
◼ Easy adaptation and integration into existing
control practice
◼ An improved capability for detecting
systematic and random errors

Suhair.A.A./ Quality Assurance / 3rd year 18

Suhair.A.A./ Quality Assurance / 3rd 19
year
Levey-Jennings Chart
Shift

196.5 +3SD

194.5 +2SD
192.5 +1SD
190.5
MEA
188.5 -1SD

186.5 -2SD
184.6
-3SD

Days
20
Levey-Jennings Chart
Trend

196.5 +3SD

194.5 +2SD
192.5 +1SD
190.5
MEA
188.5 -1SD

186.5 -2SD
184.6
-3SD

Days
21
Other Quality Control examples
◼ QC for HIV Rapid Testing includes:
• Testing of samples with known results to
verify if the procedure is working properly
• Interpreting the presence or absence of
control bands/lines within the device itself
◼ If an error occurs, do not release or report
results until you have corrected the error.

Suhair.A.A./ Quality Assurance / 3rd

year 22
Sources of Controls
◼ Internal to the test Kit
 Controlsamples provided with the test kit with
known reactivity
 Region within the device, also termed
procedural or in-built control
◼ External to the test Kit
 Control samples not included with the test kit
provided an external source that has been
validated for use with a specific test kit

Suhair.A.A./ Quality Assurance / 3rd year

23
Internal and External Quality
Control
Internal Control External Control
Included in testing Known positive and
device or as part of the negative samples that are
kit used to validate the
reliability of the test system

Control
Band

24
Examples of Tests that Include
Internal Control

◼ Capillus Which test does not

have internal control
◼ Determine
built into its device?
◼ Hema-Strip
◼ Ora Quick
◼ Uni-Gold

25 Suhair.A.A./ Quality Assurance / 3rd year

Capillus Kit Comes with Internal
Control Samples
Positive and Negative
Control Samples

26
Sources of External Quality Control
Samples

Prepared by ◼ Store according to

Reference Laboratory instructions
◼ Date when opened
◼ Use before expiry date
Commercially ◼ Do not contaminate
prepared

Suhair.A.A./ Quality Assurance / 3rd

year
27
 Frequency of Use: When Should You
Test External Control Samples?
◼ Minimum once a week, beginning of the
week
◼ New shipment of test kits
◼ Beginning a new lot number
◼ Environmental conditions exceed range
needed for stability of kits

Suhair.A.A./ Quality Assurance / 3rd

year
28
Invalid Results – What Do You
Do?
◼ Repeat test
◼ If repeatedly invalid:
• assume problem with test product or
procedure
• continue with alternative testing algorithm

◼ Identify cause of problem

◼ Inform supervisor
◼ Take corrective actions
Suhair.A.A./ Quality Assurance / 3rd
year
29
 Troubleshooting Invalid Results
Problem Potential Cause Action
No control line • Damaged test device • Repeat the test using new device
or band present or controls and blood sample
• Proper procedure • Follow each step of testing according
not followed to SOP
• Re-check buffer and/or specimen
volumes
• Wait for the specified time before
reading the test
• Expired or • Check expiration date of kits or
improperly stored
controls. Do not use beyond
test kits or controls
stated expiration date
• Check temperature records for
storage and testing area
30 Suhair.A.A./ Quality Assurance / 3rd year
 Troubleshooting Invalid Results –
Cont’d
Problem Potential Cause Action
Positive
reaction with Incubation time Re-test negative control using a
negative exceeded new device and read results
external within specified time limit
control, i.e.
false positive

Extremely faint The control line No action required. Any visible line
control line can vary in intensity validates the results.

31
 Possible HIV Test Outcomes:
Parallel Algorithm
TEST 1 TEST 2 TEST 3 HIV Status
Non-reactive Non-reactive Negative
Reactive Reactive Positive
Non-reactive Reactive Non-reactive Negative
Reactive Non-reactive Non-reactive Negative
Non-reactive Reactive Reactive Positive
Reactive Non-reactive Reactive Positive

32
Exercise : Resolving
Unreportable Test Results
Determine Uni-gold Hema-strip

33
 Exercise : Resolving Un-
reportable Test Results – Cont’d
◼ Should you accept the results?
◼ If not,
• What should be your next steps?
• What might have caused the tiebreaker test to
yield an invalid result?
• What corrective actions might you take?

Suhair.A.A./ Quality Assurance / 3rd year 34

 Any Questions ????

Suhair.A.A./ Quality Assurance / 3rd year

35