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

Ma rc ia L . Zuc ke r, Ph.D. ZI VD L L C 1

 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 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

 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 3

 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 4

 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 5

 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 6

 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 7

 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 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  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 8

 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 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. 9

 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 10

 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 11

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 L o 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 13

 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 o king b a c k to e nsure e ffic a c y 14

 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 15

 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 16

 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 17

 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 ? 18

 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 19

Pr e e xamination E xamination Poste xamination (Pr e analytic al) (Analytic al) (Postanalytic al) Pr oc e sse s Pr oc e sse s Pr oc e sse s • Ord e ring • Sa mple c o lle c tio n • Re sults re po rting • a nd la b e ling E xa mina tio n • Re sults a rc hiving • • Sa mple tra nspo rt Re sults re vie w a nd • Sa mple a rc hiving • Sa mple re c e ipt fo llo w-up • Cha rg ing s, whe re • a nd a c c e ssio ning Me d ic a l re vie w a pplic a b le • Pre e xa mina tio n sa mple pro c e ssing 20

Pr e e xamination (Pr e analytic al) Applie s? Risk/ Mitigation Pr oc e sse s Sta nd a rd o rd e ring pro c e ss • • Ye s Or de r ing Pa rt o f a pre d e fine d a lg o rithm • Wro ng sa mple type ; d e la y in Sample c olle c tion • Ye s te sting ; unla b e le d sa mple and labe ling • • No Sample tr anspor t • Sample r e c e ipt • No and ac c e ssioning • Sa mple tub e no t mixe d ; Multi-ste p Pr e e xamination oc e ssing • ? a na lysis no t pe rfo rme d c o rre c tly sample pr 21

Spe c ime n E nvironme nt Re age nt T e st Syste m T e sting Pe rsonne l Orde ring T ra ine d in T ype No t a pplic a b le o rd e r syste m Colle c tion Sto re d T ra ine d in So urc e ; T e mpe ra ture Sample pro pe rly Re a d y to sa mple type ; / humid ity At ro o m a c c e pt c o lle c tio n c o lle c tio n c o ntro l te mp sa mple a nd syste m te c hniq ue re q uire d Pre -wa rm pre p Proc e ssing Mixing / Sample se nd ing to No t a pplic a b le T ra ine d in a no the r pro c e ssing lo c a tio n? 22

 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? 23

E xamination (Analytic al) Applie s? Risk/ Mitigation Pr oc e sse s Quality Co ntro l pro c e sse s must b e • xamination Ye s E 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 r e vie w and Ye s follow- up 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? Wa s c linic ia n no tifie d a s pe r • Ye s Me dic al r e vie w po lic y? 24