Quality Assurance Concepts

Mohammad I. Dawoud
Blood Bank Specialist
Shifa Hospital - CBB
 Quality
According to (ISO)
• Totality of features and characteristics of a
product or service that influence the ability
to satisfy stated or implied needs.
• It involves paying attention to process,
involving staff and responding to customer
needs.
 Quality Assurance
- All those planned and systematic actions
necessary to provide adequate confidence
that a product or service will satisfy given
requirements for Quality.
• It is the creation and operation of standards,
programs & management system to ensure
quality.
• All measures to improve the efficiency and
effectiveness of lab with a view to the
maximum benefit of individual and community
& to ensure lab performance with minimal risk
for lab worker.
Quality Assurance (WHO)
The right result, on
the right specimen,
from the right
patient, with result
interpretation based
on, with correct
reference data, at the
right price.
Quality Control
• All techniques, procedures and
activities that are used to fulfill the
requirements of quality.
It monitor:
• performance.
• Sources of errors & alert lab
personal when there is a problem.
• Process of assessing the accuracy &
precision.
 Quality Assessment (EQC)
• Quality assessment (also known as
proficiency testing) is a means to
determine the quality of the results
generated by the laboratory. Quality
assessment is a challenge to the
effectiveness of the QA and QC
programs.
 Accuracy & Precision

• Accuracy:- Agreemen
tbetween estimate & its
value.

• Precision:-Agreement between
replicate
measurements.
 Objectives of Quality
• To help lab to establish, manage and monitor a testing
process.
• To identify problems and solve them with
documentation of problem & solution.
• To develop uniform standards of performance.
• To assess lab performance in relation to other labs
(External).
• To increase confidence in lab work
• Important for patient care.
• Correct result for database.
• Health planners.
• system of accreditation.
• Reduces costs.
The Quality Assurance Cycle

Patient/Client Prep
Sample Collection
Personnel Competency
Reporting Test Evaluations
•Data and Lab
Management
•Safety
•Customer
Service Sample Receipt
and Accessioning

Record Keeping

Quality Control Sample Transport

Testing
 Types of Errors

• Random Error
A Precision Problem
• Random errors create a
x

characteristic spread of x
x x
x

results for any test method

True x x x x
Value x x x
x x x

and cannot be accounted

x
x

for by applying corrections. x

• Random errors are difficult

to eliminate
 Systematic Error

An accuracy problem
• Systematic errors may
be induced by factors
such as variations in
incubation temperature, x

blockage of plate
x x x x x x x
True x
Value

washer, change in the

reagent batch or
modifications in testing
method.
 Levey - Jennings Control Chart

Levey – Jennings control chart use for single value measurement or

replicate measurements.
Westgard multirule control chart.
12S Rule
1 Control exceed mean ± 2 sd
* Warning rule
* Need just adjustment
13S Rule
1 Control exceed mean ± 3 sd
* Mainly Random error

Reject the run when a single control measurement exceeds the

±3SD control limit
22S Rule
2 Consecutive control measurements exceed the same
mean + 2 sd or the same mean – 2 sd
* denote systemic error.

Reject the run when 2 consecutive control

measurements exceed the same ± 2 SD control limit
R4S Rule
One control observation exceeding + 2SD

and in the next day exceed – 2SD

* Denote random error.

+ 3SD

+ 2SD

+ 1SD

mean

- 1SD

- 2SD

- 3 SD

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

Reject the run when 1 control measurement exceed the +2SD

and the other exceeds the -2SD control limit
41s Rule
4 Consecutive result exceed the same mean ± 1SD
* Denote systemic error

115
+ 3SD
+ 3SD
110
+ 2SD+ 2SD
+ 1SD
105
mean + 1SD
- 1SD
100
- 2SD mean
- 3 SD
95
- 1SD
90
- 2SD
85
- 3 SD
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

Reject when 4 consecutive control measurements exceed the

.same mean ± 1sd
10x Rule
10 Consecutive control result all falling on one side of

Either above or below.

* systemic error
+3SD

+2SD
+1SD

Mean

-1SD
-2SD
10x rule
-3SD
violation

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

Reject the run when 10 consecutive control measurements fall on

one side of the mean
7T Rule
7 seven control measurements trend in the same
directions (Up or Down) through the mean.
* systemic error.

115
+ 3SD
110
+ 2SD
105
+ 1SD
100
Mean

95
-1SD

90
-2SD 7T Rule violation
- 3 SD
85
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24

Day

Reject the run when 7 control measurements trend in

.same direction up or down
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