QUALITY CONTROL IN

HEMATOLOGY
Dr. A. Das Gupta
President International Laboratories
Mentor Hematology Services
Super Religare Laboratories
The Role of a Clinial La!orator"

The laboratory is critical to good medical

practice; test results have major role in
diagnosis and management of patients

It has an ethical obligation to provide reliable

(accurate), reproducible (precise) and cost-
effective results and observations within a
reasonable time frame (TAT)

It should provide opportunity for training and

career growth of professionals and laboratory
personnel

It should have a safe wor environment

Advance the speciality through research and

innovation
Qualit" s"ste# !e$ins an% en%s &ith the patient
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Data an% La!

Mana$e#ent

'afet"

Custo#er 'er(ie
!atient"#lient !rep
$ample #ollection
$ample %eceipt and
Accessioning
$ample Transport
&uality #ontrol
%ecord 'eeping
%eporting
!ersonnel #ompetency
Test (valuations
Testing
Co##onl" use% ter#inolo$ies

&uality assurance

&uality control (Internal &#, (&A, !T, Inter-

laboratory comparisons ) $tandardi*ation)

&uality management

Accuracy

!recision"reproducibility

Accreditation
Qualit" assurane )QA*
+bjective, &A in a laboratory is intended to
ensure reliability of the laboratory tests
Qualit" Assurane
#omponents of &A are related to the
various phases of testing

!re-analytic phase

Analytic phase

!ost-analytic phase
+roess ,lo& - Qualit"
Mana$e#ent
+re anal"ti $pecimen collection $tandard
conditions

$pecimen transport !osture

Test re-uest recorded
Tourni-uet
Anal"ti )IQC. EQA. 't%n.* Analysis $elected
methods
Instrument
calibration ) chec



+ost anal"ti .ata processing
%ecords
%eporting

Qualit" Mana$e#ent of +re/
anal"ti +hase

$tandardi*ation of all aspects of blood

collection, preservation and transport

Includes evacuated tubes, anticoagulant, ratio

of blood to anticoagulant, tourni-uet, fasting,
time of collection, labeling of sample,
temperature, transport conditions and transit
time
Qualit" Mana$e#ent of Anal"ti
+hase

/alidation of tests, e-uipment

$tandardi*ation of methods, reagents

%eference intervals

#alibration

Internal -uality control (I&#)

(0ternal -uality assessment ((&A)

Internal Qualit" Control
I&# primarily ensures precision and reliability of
results and is based on methods in actual use in
the laboratory and consists of,

#ontrol charts with tests on control material

.uplicate tests

.elta chec, comparison of current results with

previous ones

#onsistency of mean values of patient data

#orrelation checs (e1g1 blood film e0am)

E0ternal Qualit" Assess#ent

Involves participation in national and"or

international (&A (!roficiency Testing2!T3)
programmes

.oes not assess accuracy; rather it assesses

the technical competence of a laboratory

It also assesses the state of the art, identifies

problems with instruments and reagents

Individual laboratory4s result for each

analyte"parameter is compared with the
cumulative mean and $. derived from results
returned by all participants
E0ternal Qualit" Assess#ent

%esults from laboratories using the same

platform and reagents (peer group) are
compared and performance is reported as
5.eviation Inde06 (.I) or 7-score

(&A also involves interpretation of the results

#ell morphology is an important component

of (&A

(&A also promotes education and

improvement in technology
1HAT DO 1E ACHIE2E3

$tandardi*ation of all functions the laboratory

&uality monitoring

Identify and correct problems

8eet accreditation re-uirements

(Accepted by 9A:;)

5&uality culture6 among employees

Thank you!