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 1

 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 e xc e rpte d fro m CL SI Ha rmo nize d T e rmino lo g y Da ta b a se 2

 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 3

 CL I A Re g ula tio ns › Unle ss CMS a ppro ve s a pro c e dure …  F o 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 4

 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 5

 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 6

 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 7

 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 8

 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 9

 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 10

valuation Proc e ss: T e st Syste m E E quivale nt QC De sc ription Proc e dure T e sting I nte rna l QC T e st 2 L e ve ls F re que nc y E xte rna l QC Option 1 Test systems with Daily testing Results Testing external controls internal monitoring with acceptable for at least once per calendar that checks ALL acceptable 10 month and daily testing analytic results consecutive by the internal monitoring components testing days system Option 2 Test systems with Daily testing Results Testing external controls internal monitoring with acceptable for at least once per calendar that checks SOME acceptable 30 week and daily testing by analytic results consecutive the internal monitoring components testing days system Option 3 Test systems N/A Results Testing external controls WITHOUT acceptable for at least once per calendar internal monitoring 60 week System consecutive testing days 11

 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 o 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. 12

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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 o 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 14

 L o 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 15

 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 ? 16

Pro c e ss Ma pping Pr e e xamination E xamination Poste xamination (Pr e analytic al) (Analytic al) (Postanalytic al) oc e sse s oc e sse s oc e sse s Pr Pr Pr • E xa mina tio n o rd e ring • Re sults re po rting • Sa mple c o lle c tio n • • E xa mina tio n Re sults a rc hiving a nd la b e ling • • Re sults re vie w a nd Sa mple a rc hiving • Sa mple tra nspo rt • fo llo w-up Cha rg ing fo r • Sa mple re c e ipt • Me d ic a l re vie w e xa mina tio ns, a nd a c c e ssio ning whe re a pplic a b le • Pre e xa mina tio n sa mple pro c e ssing 17

Pr e e xamination Applie s Risk/ Mitigation (Pr e analytic al) ? oc e sse s Pr Sta nd a rd o rd e ring pro c e ss? • E xa mina tio n • Ye s Pa rt o f a pre d e fine d a lg o rithm? o rd e ring T ra ining re q uire d Wro ng sa mple type ; d e la y in • Sa mple c o lle c tio n • Ye s te sting ; unla b e le d sa mple a nd la b e ling T ra ining re q uire d • • Sa mple tra nspo rt No • Sa mple re c e ipt • No a nd a c c e ssio ning Sa mple tub e no t mixe d ; Multi-ste p • Pre e xa mina tio n • ? a na lysis no t pe rfo rme d c o rre c tly sa mple pro c e ssing T ra ining re q uire d 18

 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? 19

E xamination Applie s Risk/ Mitigation (Analytic al) ? oc e sse s Pr Quality Co ntro l pro c e sse s must b e • • E xa mina tio n Ye s d e sig ne d spe c ific to e a c h syste m Do e s o pe ra to r re c o g nize re sults inc o nsiste nt with pa tie nt • Re sults re vie w a nd • Ye s pre se nta tio n? Are re pe a ts fo llo w-up pe rfo rme d a s d e fine d b y po lic y? T ra ining re q uire d . Wa s c linic ia n no tifie d a s pe r • • Me d ic a l re vie w Ye s po lic y? T ra ining re q uire d 20