Post on 07-Jul-2018
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QUALITY
QUALITYASSURANCE (Q.A.)ASSURANCE
(Q.A.)
andand
QUALITY
QUALITYCONTROL (Q.C.)CONTRO
L (Q.C.)
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“………the major role of the
l!n!al "!ohem!#tr$ la"orator$ !#the mea#%rement of #%"#tane# !nthe "od$ fl%!d# or t!##%e# for the&%r&o#e of 'IANOSISTREAT*ENT or +RE,ENTION ofd!#ea#e and for the -reater%nder#tand!n- of d!#ea#e&roe##e#.
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What is Quality ?
The &ro"lem /!th 0%al!t$mana-ement !# not /hat &eo&le
don1t 2no/ a"o%t !t. The &ro"lem!# /hat the$ th!n2 the$ do 2no/…
“Philip Crosby, 1979”
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In th!# re-ard3 E4er$one !# for !t.
E4er$one feel# the$ %nder#tand !t.E4er$one th!n2# e5e%t!on !# onl$ amatter of follo/!n- nat%ral
!nl!nat!on#. And of o%r#e mo#t &eo&le feelthat &ro"lem# !n the#e area# area%#ed "$ other &eo&le. (If onl$the$ /o%ld ta2e the t!me to do
th!n-# r!-ht.)“Philip Crosby,
1979”
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All #$#tem! at!on# nee##ar$ to&ro4!de ade0%ate onf!dene thatla"orator$ #er4!e /!ll #at!#f$ -!4en
med!al need# for &at!ent are.
An o4er all term /h!h o4er#
the#e &roed%re# /h!h ta2e &lae"oth o%t#!de and !n#!de thela"orator$ to en#%re rel!a"!l!t$ of
the te#t re#%lt#.
Quality
Assurance (Q.
A. )
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March 31, 2016 Laboratory6
QA Support LaboratoryProcess
Planning
Process
Control
Improvement
Assessment
Standard Quality Process
•KitEvaluation•Assayselection•Validati
on
•Reference
Testing
•QC
Program
Informationnetwork
•EQA
Program
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The Quality AssuranceCycle
•Data and LabManagement•Safety •CustomerService
Patient/Client PrepSample Collection
Sample Receiptand Accessioning
Sampleransport
Quality Control
Record!eeping
Reporti
ng
PersonnelCompetency
est "#aluations
Testing
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67 Corret !nter&retat!on of la"orator$
re#%lt#.
(Q.A.) !utsi"e #he
$aboratoryTh!# !nl%de:
87 Selet!on of an a&&ro&r!ate te#t.
97 +re&arat!on of &at!ent.
:7 Corret ollet!on la"el!n- #tora-etran#&ort of #&e!men#.
;7 Corret f!ll!n- of the Re0%e#t
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(Q. A.) %nsi"e #he
$aboratory
67 Corret %#!n- of e0%!&ment.
Th!# !nl%de>87 Tra!n!n- of #taff.
97 Standard#.
:7 Control S&e!men#.
;7 E. Q.C. &ro-ram#.
=7 Re&ort re#%lt# learl$ (NO 'ELAY).
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P t . P r e p e r a t i o n & p e c i ' e n C o l l e c t i o n
& p e c i ' e n a n " e l i n & p e c i ' e n & t o r a e
& p e c i ' e n $ a b e l i n & p e c i ' e n * i s p a t c h
+ e , e c t i o n C r i t e r i a
P r e - A n a l y t i c a l
P h a s e
+ e , e c t i o n C r i t e r i a + e c e p t i o n ! & p e c i ' e n
+ e l i a b i l i t y P r a c t i c e A b i l i t y
/ e t h o " & e l e c t i o n / e t h o " A s s e s ' e n t
o 0 # o % n t r o " u c e
A n e 0 / e t h o "
C o ' p a r i s o n 1 e t 0 e e n
/ e t h o " s
C a l c u l a t i o n s
A n a l y t i c a l
P h a s e
+ e p o r t i n
+ e c o r " i n
* i s p a t c h ! + e s u l t s
P o s t A n a l y t i c a l
P h a s e
Q 2 A $ % # 3 A & & 2 + A 4 C 5
( Q 2 A $ % # 3 C ! 4 # + ! $ )
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“St%d$ of the#e error# /h!h are%nder the re#&on#!"!l!t$ of the
la"orator$ and the &roed%re# %#edto reo-n!?e and m!n!m!?e them.Th!# "et/een the ree!&t of the
#&e!men and the d!#&ath ofre&ort.
Quality Control
(Q. C.)
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Internal Q%al!t$ Control>
“The &%r&o#e of 0%al!t$ ontrol!# !n the la"orator$ !# to en#%re
that te#t# are &erformed rel!a"l$re&orted orretl$ and the re#%lt#reah tho#e treat!n- &at!ent# at an
earl$ eno%-h #ta-e to !nfl%enel!n!al de!#!on ma2!n-
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E5ternal Q%al!t$ A##e##ment
A #$#tem of o"jet!4el$ he2!n-the la"orator$1# re#%lt# "$ mean#
of an e5ternal a-en$
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EQA @enef!t#Allo/# om&ar!#on of &erformane and
re#%lt# Ser4e# a# an earl$ /arn!n-#$#temfor &ro"lem#
Ident!f!e# #$#temat! 2!t &ro"lem# +ro4!de# o"jet!4e e4!dene ofla"orator$ 0%al!t$
Ser4e# a# an !nd!ator of /here tod!ret !m&ro4ement effort#
Ident!f!e# tra!n!n- need#
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The ma!n em&ha#!# of (Q.C.) !# on
the mon!tor!n- of the &erformane ofharater!#t!# of anal$t!al method#.
The &%r&o#e of the 0%al!t$ Bontrol
#$#tem !# to>8. *on!tor anal$t!al &roe##e#.9. 'etet anal$t!al error#.
:. +re4ent re&ort!n- of !norret&at!ent 4al%e#.
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I N T E R N A L
Q U A L I T Y
C O N T R O L
E X T E R N A L
Q U A L I T Y
C O N T R O L
Q U A L I T Y
C O N T R O L
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Reliability: -® ©
1. Accuracy # naccuracy !"ias Systematic$rrors%
&. Precision # m'recision !(andom $rrors%
). Specifcity # nterference
*. Sensitivity # Detection limit
Practicability: -
1. Speed.
&. Cost ! (eagents+ $,ui'ments+ Maintenance+Consumables%.
). Technical skill.
*. Dependability !(ecord for e,ui'ment
brea-don and machine failure.%
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It !# %#ed to he2 @IAS.
T$&e# >
87 Commer!all$ &re&ared.
(!)
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Analytical
5rrors The#e ma$ "e #e&arated to>
8.Random Error# om&onent#.
9.S$#temat! Error# om&onent.
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The#e are !rre-%lar >
87
F7 Inom&lete remo4!n- of !nterfer!n- #%"#tane.
5rrors o scatter (+an"o'5rrors)
( i'precision )
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The$ are on#!#tent or re-%lar error#>
87 U#a-e of %n#at!#fator$ rea-ent>
Im&%re hem!al#.
Gron-l$ &re&ared.
Inorret #tored.
E5&!red.
97 Inorret or !nfre0%ent al!"rat!on of ate#tmethod.
:7 U#a-e of !norret ontrol #era.
;7 Inorret /a4elen-th.
5rrors o ias (&yste'atic5rrors) (inaccuracy)
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eneral !peration o &tatisticalQuality 8Control &yste'
U#ed to mon!tor anal$t!al 4ar!at!on# that o%rd%r!n- te#t!n- (
8. E#ta"l!#h!n- allo/a"le #tat!#t!al l!m!t# of 4ar!at!on.
9. U#!n- a"o4e l!m!t# to e4al%ate 0%al!t$ ontrol data.
:. Ta2!n- remed!al at!on /hen !nd!ated.
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*ean l!ne #ho/# A%ra$ H other l!ne# mea#%re#Im&re!#!on at the t!me of method !ntrod%ed.
9S' Garn!n- L!m!t6 LGL H UGL6
:S' At!on L!m!t6 6 LAL H UAL
$eey- :ennin;s
Chart
Chane %nAccuracyInd!ated "$ -reater 4ar!a"!l!t$ from the *ean and
re#%lt# &a##e# "e$ond the Garn!n- L!m!t .
If re#%lt# fall "e$ond the At!on L!m!t there !# areal dan-er that the re#%lt# are erroneo%#.
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U#!n- ne/ ST' or Rea-ent.
• 'eter!orat!on !n ST' or Rea-ent.
• Chan-e !n &!&ette# or. !n#tr%ment#
• O4er han-e !n o&erator.
• E4a&orat!on of #am&le# (#am&le# !n % for t!me"efore anal$#!#).
• Add!t!on of ST' to the "ath !n d!fferent t!meof #am&le# ST' not #!m!larl$ treated a# TEST.
∀? 'eteted "efore the -ra&h &a##e# "e$ond theGarn!n- l!m!t.
• < A%m%lat!on of 6 &o!nt# !n one #!de of m!d l!ne!nd!ate han-e !n a%ra$ th!# o%r "$>
Chane %nAccuracy
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'on1t for-et the d!fferene
Q%al!t$ Control+roed%re# to en#%re tehn!al 0%al!t$ of re#%lt
A%ra$ +re!#!onJ
Q%al!t$ A##%rane+roed%re# to en#%re 0%al!t$ of ent!re &roe##
A%d!t Cl!n!al Ut!l!t$ Inter&retat!onT!mel!ne## U#er &ere&t!on# EQA et.J
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8. Cl!n!al Chem!#tr$>
+r!n!&le# +roed%re# Correlat!on# (@!#ho&)
9. +rat!al Cl!n!al @!ohem!#tr$ (,arle$)
+eerences
=urther+ea"ins
TEITK TET@OOM O< CLINICAL
CE*ISTRY.
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Anal$t!al *ethod>Set of instructions which describes the procedure,materials and equipments necessary to obtain are#%lt , the value obtained for a measured quantity.
A%ra$>Agreement between the best estimate of the
quantity and its true value, !na%ra$ thenumerical difference between the mean of the setof replicate measurements and the true value.
+re!#!on>Agreement between replicate measurements,!m&re!#!on the SD or C of the results in a setreplicate measurements .
®
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M h 31 2016 2!Q lit A & Q lit C t l
Sen#!t!4!t$>
!he ability of the an analytical method to detectsmall quantities of the measured component ,detet!on l!m!t the smallest single result whichwith the stated probability "#$%& can be
distingushed from suitable blan'
S&e!f!!t$>
!he ability of an analytical method to determinesolely the component"s& it purports to measure,!nterferene the effect of a component, whichdoes not by itself produce a reading, on the
accuracy of measurement of another component .
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