QUALITY

ASSURANCE (Q.A.)
and
QUALITY
CONTROL (Q.C.)
March 31, 2016

Quality Assurance & Quality Control

the major role of the

clinical biochemistry laboratory is
the measurement of substances in
the body fluids or tissues for the
purpose
of
DIAGNOSIS,
TREATMENT or PREVENTION of
disease and for the greater
understanding
of
disease
processes.
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Quality Assurance & Quality Control

What is Quality ?
The
problem
with
quality
management is not what people
dont know about it. The problem
is what they think they do know
Philip Crosby, 1979

March 31, 2016

Quality Assurance & Quality Control

In this regard;
Everyone is for it.
Everyone feels they understand it.
Everyone thinks execution is only a
matter
of
following
natural
inclinations.
And of course most people feel
that problems in these areas are
caused by other people. (If only
they would take the time to do
things right.) Philip Crosby,
March
31, 2016
Quality Assurance & Quality Control
4
1979

Quality
All systemic actions necessary to
Assurance
(Q.
provide adequate confidence that
laboratory
service will satisfy given
A.
):
medical needs for patient care.
An over all term which covers
these procedures which take place
both
outside
and
inside
the
laboratory to ensure reliability of
the test results.

March 31, 2016

Quality Assurance & Quality Control

QA Support Laboratory
Process
Planning
Improvement

EQA
Program

Information
network

Kit
Evaluation
Assay
selection
Validation
Process

Reference
Testing

Control

Assessment

QC
Standard Quality Process Program
March 31, 2016

Laboratory

The Quality Assurance

Cycle
Patient/Client Prep
Sample Collection
Reporti
ng

Personnel
Competency
Data and LabTest Evaluations
Management
Safety
Customer
Service
Sample Receipt
and
Accessioning

Record
Keeping

Sample
Transport
Quality Control
Testing

March 31, 2016

Laboratory

(Q.A.) Outside The

This include:
Laboratory:

1\ Selection of an appropriate test.

2\ Preparation of patient.
3\ Correct collection, labeling, storage,
transport of specimens.
4\ Correct filling of the Request Form.
5\ Correct recording of results.
6\ Correct interpretation of laboratory
results.
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Quality Assurance & Quality Control

(Q. A.) Inside The

This include:
Laboratory:
1\ Training of staff.
2\ Standards.
3\ Control Specimens.
4\ E. Q.C. programs.
5\ Report results clearly (NO DELAY).
6\ Correct using of equipment.
March 31, 2016

Quality Assurance & Quality Control

Q U ALITY ASSU R AN CE
(Q U ALI TY C O N TR O L)

P r e - A n a ly t ic a l
P h a se

A n a ly t ic a l
P h a se

P o s t A n a ly t ic a l
P h a se

P t . P r e p e r a t io n

S p e c im e n C o lle c t io n

R e j e c t io n C r it e r ia

R e c e p t io n O f S p e c im e n

R e p o r t in g

S p e c im e n H a n d e lin g

S p e c im e n S t o r a g e

R e lia b ilit y

P r a c t ic e A b ilit y

R e c o r d in g

S p e c im e n L a b e lin g

S p e c im e n D is p a t c h

M e t h o d S e le c t io n

M e th o d A sse sm e n t

D is p a t c h O f R e s u lt s

H o w T o I n tro d u c e
A n e w M e th o d

C o m p a r is o n B e t w e e n
M e th o d s

R e j e c t io n C r it e r ia

C a lc u la t io n s

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Quality Assurance & Quality Control

10

Quality Control
(Q.
Study C.):
of these errors which

are
under the responsibility of the
laboratory, and the procedures used
to recognize and minimize
them.
This between the receipt
of the
specimen and the dispatch
of
report.
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Quality Assurance & Quality Control

11

Internal Quality Control:

The purpose of quality control
is in the laboratory is to ensure
that tests are performed reliably,
reported correctly and the results
reach those treating patients at an
early enough stage to influence
clinical decision making
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Quality Assurance & Quality Control

12

External Quality Assessment

A system of objectively checking
the laboratorys results by means
of an external agency

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Quality Assurance & Quality Control

13

EQA Benefits

Allows comparison of performance and

results
Serves as an early warning-system
for problems
Identifies systematic kit problems
Provides objective evidence of
laboratory quality
Serves as an indicator of where to
direct improvement efforts
Identifies training needs

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Quality Assurance & Quality Control

14

The main emphasis of (Q.C.) is on

the monitoring of the performance of
characteristics of analytical methods.
The purpose of the quality control
system is to:
1. Monitor analytical processes.
2. Detect analytical errors.
3. Prevent reporting of incorrect
patient values.
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Quality Assurance & Quality Control

15

Q U A L I T Y
C O N T R O L
I N T E R N A L
Q U A L I T Y
C O N T R O L

March 31, 2016

E X T E R N A L
Q U A L I T Y
C O N T R O L

Quality Assurance & Quality Control

16

Reliability: -
1. Accuracy #
Errors)

Inaccuracy (Bias / Systematic

2. Precision # Imprecision (Random Errors)

3. Specificity # Interference
4. Sensitivity

# Detection limit

Practicability: 1. Speed.
2. Cost ( Reagents, Equipments, Maintenance,
Consumables).
3. Technical skill.
4. Dependability
(Record
for
breakdown
and
machine failure.)
March 31, 2016
Quality Assurance & Quality Control

equipment
17

Control Sera (Control

specimen)
It is used to check BIAS.
Types :
1\ Commercially prepared.

(i) Freeze dried lyophilized"

(ii) Solutions
2\ Pooled sera

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Quality Assurance & Quality Control

18

Analytical
Errors
These may be separated to:
1.Random Errors components.
2.Systematic Errors component.

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Quality Assurance & Quality Control

19

Errors of scatter (Random

Errors)
( imprecision )
These are irregular :-

1\ Faulty technique ( pipetting, mixing, incubation )

2\ Dirty tubes, pipettes, glass ware.
3\ Heavy work load.(faulty technique) "Mistakes".
4\ Low workload.(loss of conc.).
5\ Unstable main voltages supply.
6\ Finger spot and air bubbles in cuvette.
7\ Incomplete removing of interfering substance.
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Quality Assurance & Quality Control

20

Errors of Bias (Systematic

Errors)
They are(inaccuracy)
consistent or regular errors:1\ Usage of unsatisfactory reagent:Impure chemicals.

Wrongly prepared.
Incorrect stored.
Expired.

2\ Incorrect
method.

or

infrequent

calibration

of

atest

3\ Usage of incorrect control sera.

4\ Incorrect wavelength.
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Quality Assurance & Quality Control

21

General Operation of Statistical

Quality Control System:
Used to monitor analytical variations that occur
during testing (From Random or Systematic Errors).
There was 3 stages in Statistical Quality-Control
program:
1. Establishing allowable statistical limits of variation.
2. Using above limits to evaluate quality control data.
3. Taking remedial action when indicated.

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Quality Assurance & Quality Control

22

LeveyMean
line shows Accuracy & other lines measures
Jennings
Imprecision at the time of method introduced.
Chart:
2SD Warning Limit LWL & UWL
3SD Action Limit

LAL & UAL

Change In
Accuracy:
Indicated
by greater

variability from the Mean and

results passes beyond the Warning Limit .
If results fall beyond the Action Limit, there is a
real danger that the results are erroneous.

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Quality Assurance & Quality Control

23

Change In
Accuracy:
Detected
before

Warning limit.

the

graph

passes

beyond

the

Accumulation of 6 points in one side of mid line

indicate change in accuracy, this occur by:- Using new STD or Reagent.
- Deterioration in STD or Reagent.
- Change in pipettes or. instruments
- Over change in operator.
- Evaporation of samples (samples in cups for time
before analysis).
- Addition of STD to the batch in different time
of samples, STD not similarly treated as TEST.
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Quality Assurance & Quality Control

24

Dont forget the difference

Quality Control

Procedures to ensure technical quality of result

[Accuracy, Precision]

Quality Assurance

Procedures to ensure quality of entire process

[Audit, Clinical Utility, Interpretation,
Timeliness, User perceptions, EQA etc.]

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Quality Assurance & Quality Control

25

Refere
nces:
1. Clinical Chemistry:

Principles, Procedures, Correlations (Bishop)

2. Practical Clinical Biochemistry (Varley)

Further
Readings:
TEITZ
TEXTBOOK
CHEMISTRY.

March 31, 2016

OF

CLINICAL

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26

Analytical Method:

Set of instructions which describes the procedure,

materials and equipments necessary to obtain a
result, the value obtained for a measured quantity.
Accuracy:
Agreement between the best estimate of the
quantity and its true value, inaccuracy the
numerical difference between the mean of the set
of replicate measurements and the true value.
Precision:
Agreement between replicate measurements,
imprecision the SD or CV of the results in a set
replicate measurements .
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Specificity:
The ability of an analytical method to determine
solely the component(s) it purports to measure,
interference the effect of a component, which
does not by itself produce a reading, on the
accuracy of measurement of another component .
Sensitivity:
The ability of the an analytical method to detect
small quantities of the measured component ,
detection limit the smallest single result which
with the stated probability (95%) can be
distingushed from suitable blank.

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Quality Assurance & Quality Control

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