Quality Assurance

Introduction & concept of quality assurance.

Suhair.A.A./ Quality Assurance / 3rd year 1

 Objectives:
 Introducing Some Quality Concepts
 Recognition of Quality Principles & Concepts
 concept of quality assurance

Suhair.A.A./ Quality Assurance / 3rd year 2

 ‫قال تعاىل ‪:‬‬ ‫•‬

‫المنل ‪• 88‬‬ ‫” صنع هللا اذلي أتقن لك يشء“ ‪-‬‬

‫” اذلي خلق املوت واحلياة ليبلومك أيّمك أحسن مع ا‬
‫ل ” ‪ -‬املكل ‪•2‬‬

‫السجدة ‪•7‬‬ ‫” اذلي أحسن ّ‬

‫لك يشء خلقه “ ‪-‬‬
‫الكهف ‪•30‬‬ ‫” انّ ا ضييع أر نن أحسن معل “ ‪-‬‬
‫وعن ال سول صىل هللا عليه وسمل قال‪•:‬‬
‫حيب اذا معل أحدمك معل أن يتقنه“‬
‫”ان هللا ّ‬ ‫‪3‬‬
‫‪Suhair.A.A./ Quality Assurance / 3rd year‬‬
 Quality has several definitions

❑ Excellence

❑ Fitness for purpose to realise the aims: Resource

allocation
❑Trust

❑ International acceptance: Meeting some

basic standars
❑ Accountability :Meeting the needs and expectations
Suhair.A.A./ Quality Assurance / 3rd year 4
Quality is a very essential concept in the modern
world in the field of service in general & health in
particular & considered as a way of life.

5
 Concepts of Quality
⚫ The ability of a product or service to satisfy
stated or implied needs of a specific
customer
⚫ In the lab: accuracy, precision and
timeliness
⚫ Achieved by conforming to established
requirements and standards.

Suhair.A.A./ Quality Assurance / 3rd year 6

Achieving a 99% level of quality

means

accepting a 1% error rate 1%

7
 Result: 1% failure

Suhair.A.A./ Quality 8Assurance / 3rd year

Why Quality?
Test
Site
Quality
Accurate,
Reliable
Testing

Quality in
All Aspects
of Health Care

Suhair.A.A./ Quality Assurance / 3rd year 9

A Systems Approach to Quality
• Considers all components
within a system
– Such as organs working
together as a system in the
body.
• To produce quality service in
the laboratory, all facets are
needed to work together

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

Quality assurance (QA)
⚫ Quality assurance (QA) is a comprehensive
set of policies, procedures, and practices that
are followed to ensure that a laboratory’s
results are reliable.
⚫ QA evaluates the quality of the services
provided.

Suhair.A.A./ Quality Assurance / 3rd year 11

⚫ QA provides a way to
prevent problems as well as
deal with problems that
occur. Quality System

⚫ It differs from quality control Quality Assurance

(QC) in that QC is Science
included as part of a QA Quality Control
program.
⚫ QC ensures that a particular
test method is working
properly and that results of
that test are reliable.
Suhair.A.A./ Quality Assurance / 3rd year 12
Quality assurance (QA)
⚫ QA includes record keeping, maintenance
and calibration of equipment, proficiency
testing, quality control, and training of
personnel.
⚫ QA is a commitment to quality.
⚫ Physician and patient relations are a part of
this plan.

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

Quality Assurance
⚫ Quality assurance refers to establishing and
maintaining a certain level of quality in a
product or service.
⚫ Therefore, quality assurance in a medical lab
refers to making sure the lab is running
smoothly, safely, and effectively without any
errors.

Suhair.A.A./ Quality Assurance / 3rd year 14

Quality Assurance
⚫ The procedures performed in a medical lab
can be divided into three main phases:

Phase of a Medical Lab Description

Obtaining patient information
Pre-analytical and taking the specimen
sample
Examining and testing the
Analytical
sample
Analyzing the test results and
Post-analytical
creating an official report
15
Suhair.A.A./ Quality Assurance / 3rd year
Suhair.A.A./ Quality Assurance / 3rd year 16
Suhair.A.A./ Quality Assurance / 3rd year 17
Pre-examination Processes

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

Examination Processes

Suhair.A.A./ Quality Assurance / 3rd year 19

Post-examination Processes

Suhair.A.A./ Quality Assurance / 3rd year 20

Quality Assurance
⚫ A process, not an end-point
⚫ Must be independent of financial pressures
⚫ Must ensure that quality policies are followed
⚫ Must have final authority in product acceptance,
rejection and release to public
⚫ Integral to production, not an add-on
⚫ Responsible for day-to-day operations and for
longer term goal settings

Suhair.A.A./ Quality Assurance / 3rd year 21

Quality is....

⚫ invisible when GOOD

⚫impossible to ignore
when BAD
Consequences of poor quality
⚫ Inappropriate action
⚫ Over-investigation
⚫ Over-treatment
⚫ Mistreatment
⚫ Inappropriate inaction
⚫ Lack of investigation
⚫ No treatment
⚫ Delayed action
⚫ Loss of credibility of laboratory
⚫ Legal action
What is the goal of QC?

1. To detect SIGNIFICANT
errors rapidly
2.Report out good results in
a timely manner
3. Be cost effective and
simple to use
4.If there is an error, identify
the source of the error.

Suhair.A.A./ Quality Assurance / 3rd year 24

Why is the Quality System
Important to Patient Sample Testing?
⚫ Becomes the core of a monitoring, evaluation, and
improvement system

⚫ Reduces costs

Even the simplest Rapid Test is not

foolproof

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

Key point : Who Is Responsible
for Quality?
• Laboratory management and
supervisory staff establish
quality assurance policies EVERYONE!
procedures
• Test site personnel
implement the quality
assurance procedures.

Suhair.A.A./ Quality Assurance / 3rd year 26

Suhair.A.A./ Quality Assurance / 3rd year 27