qc in clinical laboratories

8/18/2019 QC in Clinical Laboratories

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March 31, 2016 1Quality Assurance & Quality Control

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


8/28March 31, 2016 !Quality Assurance & Quality Control

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


9/28March 31, 2016 "Quality Assurance & Quality Control

(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 # + ! $ )



“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.)



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-



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$



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#



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#.



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



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.%


18/28March 31, 2016 1!Quality Assurance & Quality Control

It !# %#ed to he2 @IAS.

T$&e# >

87 Commer!all$ &re&ared.

(!)


19/28March 31, 2016 1"Quality Assurance & Quality Control

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.


27/28


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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qc in clinical laboratories

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