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

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

 Wha t?

› 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

 WHY?

› E nsure da y-to -da y c o nsiste nc y o f me a sure me nts

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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

 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

 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 re a g e nt 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

 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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 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

• 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 … tha t pro vide s e q uiva le nt q ua lity te sting , the la b o ra to ry must …

 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

 E

a c h q ua lita tive pro c e dure , inc lude a ne g a tive a nd po sitive c o ntro l ma te ria l

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 Sinc e 2003, this ha s b e e n the CMS

a ppro ve d pro c e dure .

› T hre e o ptio ns, spe c ific imple me nta tio n instruc tio ns  Optio n 4 › 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

 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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 E

P23 is a to o l, b ut no t re q uire d

› Pro vide s to o l kit to pe rfo rm risk a na lyse s › E xpla ins ho w risk a sse ssme nt c a n a ffe c t Qua lity Pla n › Do e s no t pro vide g uida nc e o n QC fre q ue nc y

 Ho w to imple me nt I

QCP is site a nd te st syste m de pe nde nt

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 I

QCP 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)  I

QCP pha se -in ha s b e g un

› Co ntinue a s no w until IQCP Pla ns re a dy › Imple me nt fo r e a c h te st a s Pla ns a va ila b le  E

duc a tio n a nd T ra nsitio n Pe rio d

 I

QCP imple me nta tio n de a dline Ja nua ry 2016

› E q uiva le nt QC NOT a c c e pta b le › IQCP only o ptio n to

 2 le ve ls QC e a c h da y o f pa tie nt te sting  e ve ry 8 ho urs fo r b lo o d g a se s a nd c o a g ula tio n

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 L

• ts o f he lp a va ila b le :

› CMS

 IQCP do wnlo a ds: http:/ / www.c ms.g o v/ Re g ula tio ns-

a nd- Guida nc e / L e g isla tio n/ CL I A/ I ndividua lize d_Qua lity_Co ntro l_Pla n_IQCP.html

 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:/ / c lsi.o rg / e du/ wo rksho ps/ e p23-q a /

› 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_2014.

htm

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 Risk Asse ssme nt (RA)

› T he b ulk o f the up-fro nt e ffo rt

 Qua lity Co ntro l Pla n (QCP)

› Wha t ne e ds to b e do ne mo ving fo rwa rd

 Qua lity Asse ssme nt (QA)

› L

• o king b a c k to e nsure e ffic a c y

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 Ac ro ss e ntire te sting pro c e ss  Pre -a na lytic , a na lytic , po st-a na lytic

› Spe c ime n › E nviro nme nt › Re a g e nt › T e st syste m › T e sting pe rso nne l

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 Pra c tic e s, re so urc e s, a nd pro c e dure s to c o ntro l the

q ua lity o f a pa rtic ula r te st pro c e ss

› E nsure a c c ura c y, re lia b ility & re sult q ua lity a ppro pria te fo r pa tie nt c a re › Inc lud e the numb e r, type , fre q ue nc y o f c o ntro l

 Crite ria fo r a c c e pta b le re sults o f the q ua lity c o ntro ls  Ma y inc lud e :

 E

le c tro nic c o ntro ls

 Pro c e dura l c o ntro ls  T

ra ining a nd c o mp e te nc y a sse ssme nt

 Othe r spe c ifie d q ua lity c o ntro l a c tivitie s

 De ve lo pme nt a nd imple me nta tio n o f QCPs ma y

b e de le g a te d (in writing ) to a q ua lifie d individua l

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 Re vie w syste m fo r mo nito ring I

QCP e ffe c tive ne ss

 Re vie w ma y inc lude , b ut is no t limite d to : › QC › Pro fic ie nc y te sting re c o rds › Pa tie nt re sults re vie w › Spe c ime n re je c tio n lo g s › T urna ro und time re po rts › Re c o rds o f pre ve ntive a c tio ns, c o rre c tive a c tio ns, & fo llo w-up › Pe rso nne l Co mpe te nc y Re c o rds

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

› Mo dify if ne e de d

 Allo ws e a c h lo c a tio n to ha ve diffe re nt

QC re q uire me nts

 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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 Pro c e ss ma pping

› F ishb o ne Dia g ra m >F lo w Cha rts › T a b le s › Wha te ve r yo u fe e l c o mfo rta b le using

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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
• Ord 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 s, whe re

a pplic a b le

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Pr e e xamination (Pr e analytic al) Pr

• c e sse s

Applie s? Risk/ Mitigation

• Or

de r ing

• 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

• Sample c olle c tion

and labe ling

• Ye s

Wro ng sa mple type ; d e la y in te sting ; unla b e le d sa mple

• Sample tr

anspor t

• No
• Sample r

e c e ipt and ac c e ssioning

• No
• Pr

e e xamination sample pr

• 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

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Spe c ime n E nvironme nt Re age nt T e st Syste m T e sting Pe rsonne l Orde ring

T ype No t a pplic a b le T ra ine d in

• rd e r

syste m

Sample Colle c tion

So urc e ; type ; c o lle c tio n te c hniq ue T e mpe ra ture / humid ity c o ntro l re q uire d Sto re d pro pe rly At ro o m te mp Pre -wa rm Re a d y to a c c e pt sa mple T ra ine d in sa mple c o lle c tio n a nd syste m pre p

Sample Proc e ssing

Mixing / se nd ing to a no the r lo c a tio n? No t a pplic a b le T ra ine d in pro c e ssing

 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

xamination

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 r

e vie w and follow- 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?

• Me dic al r

e vie w

Ye s Wa s c linic ia n no tifie d a s pe r po lic y?

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Spe c ime n E nvironme nt Re age nt T e st Syste m T e sting Pe rsonne l E xamination

Visib le pro b le ms with sa mple ? T e mpe ra ture / humid ity c o ntro l re q uire d ? QC a ppro pria te ? Spe c ime n a d d e d pro pe rly No fla g s/ wa rning s o r e rro rs Pro fic ie nt in running spe c ime n

Re sults re vie w & follow- up

No t a pplic a b le Da ta d ispla ye d / sto re d a s e xpe c te d I nc o nsiste nt re sults fla g g e d / re pe a te d

Me dic al re vie w

No t a pplic a b le Pro pe r c ut-

• ffs /

re fe re nc e ra ng e Clinic ia n No tifie d

 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 r

e por ting

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 ar

c hiving

Ye s

• Sample ar

c hiving

No

• Char

ging for e xaminations, whe r e applic able

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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Spe c ime n E nvironme nt Re age nt T e st Syste m T e sting Pe rsonne l Re sults re porting

No t a pplic a b le Da ta re c o rd e d / tra nsmitte d a s re q uire d Clinic ia n a le rte d a s ne e d e d

Re sults arc hiving

No t a pplic a b le Da ta in pe rma ne nt re c o rd / E MR Ve rify tra nsfe r o f re sults

Charging for e xaminations

No t a pplic a b le , ye t risk e xists a nd must b e a sse sse d

 Ha za rd I

de ntific a tio n

› Ana lyse s just re vie we d

 Risk e stima tio n

› Po te ntia l fre q ue nc y o f pro b le m

 Risk e va lua tio n

› Critic a lity o f pro b le m

 Risk Co ntro l

› Mitig a tio ns in pla c e o r to b e imple me nte d

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 Critic a lity is pro duc t o f pro b a b ility

(fre q ue nc y) a nd se ve rity (c o nse q ue nc e s)

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Se ve r ity

Se rio us Injury L imite d Injury Ne g lig ib le Injury

Pr

• bability

L ike ly

High

Mo d e ra te L

• w

Re mo te Mo d e ra te L

• w

L

• w

Impro b a b le L

• w

L

• w

L

• w

 F

ina l pla n must sho w AL L re sidua l risks a re a c c e pta b le

 I

f “No ”, must imple me nt a dditio na l mitig a tio n

 No t ne c e ssa rily inc re a se d L

QC

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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

› PAPE RWORK , PAPE RWORK , PAPE RWORK  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 rs 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 re visio n if a dditio na l risks ide ntifie d

• 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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