Ma rc ia L . Zuc ke r, Ph.D. ZI VD L L C 1 Se t o f pro c e - - PowerPoint PPT Presentation

Ma rc ia L . Zuc ke r, Ph.D. ZI VD L L C

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 Se t o f pro c e dure s de sig ne d to mo nito r the te st

me tho d & re sults to e nsure a ppro pria te te st syste m pe rfo rma nc e

 QC inc lude s: › te sting o f no rma l a nd a b no rma l c o ntro l ma te ria ls › c ha rting the re sults a nd a na lyzing the m to ide ntify so urc e s o f e rro r › e va lua ting a nd do c ume nting a ny re me dia l a c tio n ta ke n a s a re sult o f this a na lysis;  Ma in o b je c tive : › E nsure da y-to -da y c o nsiste nc y o f me a sure me nts

 if po ssib le , in a g re e me nt with a n ind ic a to r o f truth, suc h

a s a c o ntro l ma te ria l with e nd -use r a ssig ne d va lue s

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e xc e rpte d fro m CL SI Ha rmo nize d T e rmino lo g y Da ta b a se

 CL

I A Re g ula tio ns

› Sub pa rt K

• -Qua lity Syste ms fo r No nwa ive d

T e sting › Se c . 493.1256 Sta nda rd: Co ntro l pro c e dure s

 mo nito r the a c c ura c y a nd pre c isio n o f the

c o mple te a na lytic a l pro c e ss

 la b must e sta b lish the numb e r, type , a nd

fre q ue nc y o f te sting c o ntro l ma te ria ls

 c o ntro l pro c e dure s must–

 (1) De te c t imme dia te e rro rs tha t o c c ur due to

 te st syste m fa ilure  a d ve rse e nviro nme nta l c o nd itio ns  a nd o pe ra to r pe rfo rma nc e .

 (2) Mo nito r o ve r time the a c c ura c y a nd pre c isio n o f te st

pe rfo rma nc e

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 CL

I A Re g ula tio ns

› Unle ss CMS a ppro ve s a pro c e dure …

 F

• r e a c h te st syste m, pe rfo rm c o ntro l pro c e dure s

… At le a st o nc e e a c h da y pa tie nt spe c ime ns a re a ssa ye d

 He ma to lo g y a nd Blo o d Ga s re q uire a t le a st o nc e pe r

e ig ht ho ur shift

 E

a c h q ua ntita tive pro c e dure , inc lude two c o ntro l ma te ria ls o f diffe re nt c o nc e ntra tio ns

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 T

wo le ve ls o f liq uid QC a va ila b le fro m ma nufa c ture rs

› Re c o mme nde d fre q ue nc y o fte n missing › E nd use rs o fte n una wa re tha t QC is re q uire d › Pro c e ss no t re fle c tive o f pa tie nt te st pe rfo rma nc e

 Still true fo r ma ny syste ms  Ha pha za rd imple me nta tio n

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 POCT

a wa re ne ss inc re a se d

› Inspe c to rs ta ke a c tive lo o k a t POC pro c e sse s › Inc re a se d imple me nta tio n o f QC pro g ra ms

 Co mplia nc e diffic ult  E

xpe nse o f POCT g re a tly inc re a se d

 I

ntro duc tio n o f E le c tro nic QC

› 1994 E SVT c le a re d fo r He mo c hro n tub e syste m › 1998 He pT ra c c le a re d fo r HMS syste m › Othe rs c le a re d with instrume nt

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 QC de sig ne d to re pla c e liq uid c o ntro ls

› Ge ne ra lly o nly a pa rtia l re pla c e me nt › De sig ne d to insure syste m pe rfo rma nc e witho ut surro g a te sa mple (L QC) te sting

 QC pe rfo rme d using pre pa re d sa mple s in a

ma nne r simila r to tha t use d fo r pa tie nt te sting

 E

le c tro nic QC

› Inte rna l o r e xte rna l › E va lua te s instrume nt func tio n o nly › Inc lude s dry c a rtridg e QC a lte rna tive s

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 On-b o a rd

› Ge ne ra lly re fe re nc e s inte rna l liq uid c o ntro ls › E va lua te s instrume nt a nd re a g e nt func tio n › So me a lso e va lua te o pe ra to r te c hniq ue

 Built-in

› E le c tro nic a nd / o r o n-b o a rd

 E

q uiva le nt QC

› T e rm c o ine d b y CMS to re fe re nc e a ny no n- surro g a te sa mple QC

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 APPE

NDI X C - Surve y Pro c e dure s a nd I nte rpre tive Guide line s fo r L a b o ra to rie s a nd L a b o ra to ry Se rvic e s

 http:/ / www.c ms.g o v/ CL

IA/ d o wnlo a d s/ a pc po lic y.pd f

› Re q uire s re vie w o f QC po lic ie s a nd va lida tio n o f the se pro c e dure s

 CL

I A Bro c hure # 4 - E q uiva le nt Qua lity Co ntro l Pro c e dure s

 http:/ / www.c ms.g o v/ CL

IA/ d o wnlo a d s/ 6066b k.pd f

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 Pub lishe d 2003 jo intly b y the CDC a nd CMS

› Initia lly de fine d a s “e duc a tio na l”

 Be c a me the de fa ult po lic y, de spite b e ing

e duc a tio na l a s no o the r syste m e xiste d

› Re q uire s e q uiva le nt QC pro c e dure e va lua tio n

 de mo nstra te tha t a te st syste m is sta b le a nd c a n g

e ne ra te c o rre c t te st re sults o ve r time .

 If re sults a re a c c e pta b le OK

to re duc e the fre q ue nc y o f e xte rna l QC

› De fine s thre e le ve ls o f c o ntro ls

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T e st Syste m De sc ription E valuation Proc e ss: E quivale nt QC Proc e dure T e sting F re que nc y

I nte rna l QC T e st 2 L e ve ls E xte rna l QC

Option 1 Test systems with internal monitoring that checks ALL analytic components Daily testing with acceptable results Results acceptable for 10 consecutive testing days Testing external controls at least once per calendar month and daily testing by the internal monitoring system Option 2 Test systems with internal monitoring that checks SOME analytic components Daily testing with acceptable results Results acceptable for 30 consecutive testing days Testing external controls at least once per calendar week and daily testing by the internal monitoring system Option 3 Test systems WITHOUT internal monitoring System N/A Results acceptable for 60 consecutive testing days Testing external controls at least once per calendar week

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 CL

SI unde rto o k the c ha rg e to de ve lo p a risk b a se d me tho d fo r de te rmining QC pro c e dure s a nd fre q ue nc y

› E P-23 L a b o ra to ry Qua lity Co ntro l Ba se d o n Risk Ma na g e me nt

 Pub lishe d Oc to b e r 2011  F

• rms the b a sis fo r IQCP

 CL

• SI. L

ab o rato ry Quality Co ntro l Base d o n Risk Manag e me nt; Appro ve d Guide line . CL SI do c ume nt E P23-A. Wa yne , PA: Clinic a l a nd L a b o ra to ry Sta nda rds Institute ; 2011.

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 Me mo ra ndum issue d No ve mb e r 2011

› CMS’ a do ptio n o f E P-23 fo r CL IA QC a s a QC

• ptio n.

› Da te to b e a nno unc e in 2012

 L

a b o ra to rie s ma y b e g in to imple me nt E P-23

› E P-23 will b e vo lunta ry › De fa ult QC re q uire me nt will b e 42 CF R 493.1256(d)(3): › E q uiva le nt Qua lity Co ntro l (E QC) will b e pha se d o ut

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 L

• ts o f he lp a va ila b le :

› CMS

 F

AQ: www.c ms.g o v/ c lia

 q ue stio ns: IQCP@ c ms.hhs.g o v

› CL SI

 Wo rksho ps

We b ina rs

 Wo rkb o o k

Wo rkshe e t

 F

AQ:

http:/ / www.c lsi.o rg / Co nte nt/ Na vig a tio nMe nu/ E duc a tio n/ E P23QA/ E P23_Q_A.htm

› POCC g ro up we b ina rs

 White ha t Co mmunic a tio ns

 http:/ / www.white ha tc o m.c o m/ POC_Gro up_We b ina rs_2

012.htm

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 Re q uire s re vie w o f c urre nt pra c tic e s

› Risk ide ntific a tio n › Risk Asse ssme nt › Risk Mitig a tio n

 No QC to o l c o nsiste ntly pre ve nts o r

de te c ts a ll fa ilure s.

› Wha t is ne e de d fo r yo ur site ?

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Pr e e xamination (Pr e analytic al) Pr

• c e sse s

E xamination (Analytic al) Pr

• c e sse s

Poste xamination (Postanalytic al) Pr

• c e sse s
• E

xa mina tio n

• rd e ring
• Sa mple c o lle c tio n

a nd la b e ling

• Sa mple tra nspo rt
• Sa mple re c e ipt

a nd a c c e ssio ning

• Pre e xa mina tio n

sa mple pro c e ssing

• E

xa mina tio n

• Re sults re vie w a nd

fo llo w-up

• Me d ic a l re vie w
• Re sults re po rting
• Re sults a rc hiving
• Sa mple a rc hiving
• Cha rg ing fo r

e xa mina tio ns, whe re a pplic a b le

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Pro c e ss Ma pping

Pr e e xamination (Pr e analytic al) Pr

• c e sse s

Applie s ? Risk/ Mitigation

• E

xa mina tio n

• rd e ring
• Ye s

Sta nd a rd o rd e ring pro c e ss? Pa rt o f a pre d e fine d a lg o rithm? T ra ining re q uire d

• Sa mple c o lle c tio n

a nd la b e ling

• Ye s

Wro ng sa mple type ; d e la y in te sting ; unla b e le d sa mple T ra ining re q uire d

• Sa mple tra nspo rt
• No
• Sa mple re c e ipt

a nd a c c e ssio ning

• No
• Pre e xa mina tio n

sa mple pro c e ssing

• ?

Sa mple tub e no t mixe d ; Multi-ste p a na lysis no t pe rfo rme d c o rre c tly T ra ining re q uire d

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 All risks mitig a te d b y tra ining

› Do e s tra ining c o ve r a ll ide ntifie d risks? › Do e s c o mpe te nc y c o ve r a ll ide ntifie d risks? › Are e rro rs fo und in c linic a l use tha t sug g e st tra ining ne e ds to b e mo difie d?

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E xamination (Analytic al) Pr

• c e sse s

Applie s ? Risk/ Mitigation

• E

xa mina tio n

• Ye s

Quality Co ntro l pro c e sse s must b e d e sig ne d spe c ific to e a c h syste m

• Re sults re vie w a nd

fo llo w-up

• Ye s

Do e s o pe ra to r re c o g nize re sults inc o nsiste nt with pa tie nt pre se nta tio n? Are re pe a ts pe rfo rme d a s d e fine d b y po lic y? T ra ining re q uire d .

• Me d ic a l re vie w
• Ye s

Wa s c linic ia n no tifie d a s pe r po lic y? T ra ining re q uire d

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 E

va lua te c urre nt pro c e dure s:

› If using Built In Co ntro ls

 Info rma tio n o n e ffe c tive ne ss in risk mitig a tio n

sho uld b e o b ta ine d fro m the ma nufa c ture r.

 Ofte n do e s no t c o ntro l fo r e ntire pro c e ss

› L iq uid QC

 Is fre q ue nc y suffic ie nt to ide ntify pro b le ms with

re a g e nt?

› Pro fic ie nc y studie s

 Do e s pe rfo rma nc e sug g e st a c c ura te re sults

b e ing o b ta ine d

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 E

va lua te c urre nt pro c e dure s:

› E va lua te Co mpla int histo ry

 Do e nd use rs / c linic ia ns q ue stio n the re sults?  Do e s fre q ue nc y sug g e st pro b le ms with

syste m?

› E va lua te va lida tio n pe rfo rme d whe n c urre nt pro c e dure imple me nte d

 Ha s fre q ue nc y o f e rro rs c ha ng e d?  Is the re re a so n to b e lie ve the re a re risks tha t

c a n b e b e tte r mitig a te d?

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Poste xamination (Postanalytic al) Pr

• c e sse s

Applie s ? Risk/ Mitigation

• Re sults re po rting
• Ye s

E le c tro nic d a ta tra nsfe r o r ma nua l? Ho w is a c c ura c y o f tra nsfe r c o ntro lle d ? Ho w a re e rro rs ke pt fro m the E MR?

• Re sults a rc hiving
• Ye s
• Sa mple a rc hiving
• No
• Cha rg ing fo r

e xa mina tio ns, whe re a pplic a b le

• Ye s

Wo rk with IT pe rso nne l to e nsure tra nsfe r to pro pe r b illing pe rso nne l

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 Ha za rd I

de ntific a tio n

 Risk e stima tio n  Risk e va lua tio n  Risk Co ntro l

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T arge te d F ailure Mode (Hazard) Me asuring Syste m F e ature

• r

R e c omme nde d

Ac tion Known L imitations of F e ature or

R e c omme nde d

Ac tion Control Proc e ss E ffe c tive ? T he QCP Ac tions Re quire d to Addre ss Known L imitations Re sidual Risk Ac c e ptable ? (Ye s/ No)

Sa mple ta b le fo rma t to do c ume nt finding s in E P-23

 E

va lua tio n o f e ffe c tive ne ss

› Ve rify ide ntific a tio n o f e rro rs › Re vie w c o mpla ints › T ra c k c o mpla ints a nd inve stig a tio ns

 Co rre c tive Ac tio ns

› If pro b le m with b uilt-in c o ntro ls, inc re a se fre q ue nc y o f e xte rna l c o ntro ls › If o pe ra to r e rro rs, mo dify tra ining a nd pro c e dure s

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 I

t will ta ke time

 Re q uire s:

› de ta ile d kno wle dg e o f syste m func tio ns

 a sk ma nufa c ture r’ s fo r info rma tio n

› de ta ile d unde rsta nding o f c linic a l a pplic a tio ns

 a sk c linic ia ns fo r info rma tio n to a id in

ide ntifying risks

 ho w “wro ng ” must a re sult b e to inc re a se risk?

› Do c ume nta tio n o f finding s a nd de c isio ns

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 I

ndividua lize d QC Po lic y

› Allo ws the de finitio n o f a po lic y tha t fits yo ur institutio n

 e .g ., Diffe re nt QC pro g ra ms fo r hig h a nd lo w

vo lume te sts

› Ma y no t diffe r fro m c urre nt pro c e sse s

 Ne e d to a sse ss e ffic a c y o f c urre nt pro c e sse s in

lig ht o f ide ntifie d po te ntia l risks

 Ma y ne e d mino r re visio n if a dditio na l risks

ide ntifie d o r no n-va lue a dde d ste ps no te d

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Ma rc ia L . Zuc ke r, Ph.D. ZI VD, L L C mlzuc ke r@ ve rizo n.ne t

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