Quality Assurance and

Quality Control
CLINICAL CHEMISTRY 1

..As per ISO 8402:1994, standard

quality is defined as the totality of
characteristics of an entity that
bear on its ability to satisfy STATED
and IMPLIED needs.

OBJECTIVES
Importance of Quality
Management
Concepts of Quality Control
CLSI Guidelines
Basic QC STATISTICS
Quality Control Rules
Interpretations of Control
Results

QUALITY
ASSURANCE
QUALITY
CONTROL
METHOD
EVALUATION

..defined by WHO as the total

process whereby the quality of
laboratory reports can be
guaranteed.

right result, at the

- right time, on the
- right specimen, from the
- right patient, with result
interpretation based on
- correct reference data, and at the
- right price

Purpose of Quality
Assurance:
provide test results
that are relevant,
reliable, timely,
interpreted correctly.

4 Different Aspects of
Quality Assurance
QUALITY CONTROL
EXTERNAL QUALITY
ASSESSMENT
PROFICIENCY
SURVEILLANCE
STANDARDIZATION

STANDARD a solution that

contains a known amount of
analyte and used to calibrate an
assay method.
e.g., 100 mg/dL of glucose

CONTROL used to monitor the performance of

the assay method once it has been calibrated.
Controls are used to make sure that the
measurement process is stable and if the
results produced are ACCEPTABLE.

Control

Px
sample

Controls are run alongside

with patient samples.

Px
sample

Control Material attributes:

Matrix refers to all characteristics of
the sample.
e.g., serum, plasma or urine
Ideally, control material should have
the same matrix as the specimen being
tested so that they will behave the
same as the real specimen. (CLSI

When to run a CONTROL?

.Must be analyzed at least once
during each analytical run.
OUT of CONTROL
SITUATION
. Lab should have guidelines for out
of control situations
. Repeating controls/reanalyzing
control may be non productive

Quality Assurance - refers to

all those planned and
systematic activities to
provide confidence that the
results given out by the
laboratory are correct

Quality Control - refers to

operational techniques that
must be included during each
assay run to verify that the
requirements for Quality are
met with.

QUALITY
ASSURANCE
PROCESS

Preanaly
tical
process

Analytic
al
process

Postanalytic
al
process

Patient
instructi
on

Preanalytical
Process

Test
ordering
Specime
Labellin
n
g
Collectio
n Specime
n
transpor
t

Analytical Process
Test methods, equipments,
reagents, supplies
Validation of test methods
Equipment checks
QC monitoring procedures
Procedure manual

Post-Analytical QA Process
Validation of test results
Reporting of test results
Interfacing to Laboratory
Information Systems (LISs)
Corrective action plan
Records maintenance