What You Need to Know About Waived Testing & Competency - PowerPoint PPT Presentation

What You Need to Know About Waived Testing & Competency Assessment for Non-waived Testing Ka re n Dye r MT (ASCP), DL M De puty Dire c tor, Division of L a bora tory Se rvic e s Ce nte rs for Me dic a re & Me dic a id Se rvic e s CLIA

Objectives • Ge ne ra l o ve rvie w o f CL I A • Guida nc e o n re g ula tio ns re g a rding wa ive d te sting • Guida nc e o n re g ula tio ns re g a rding c o mpe te nc y a sse ssme nt fo r no n- wa ive d te sting CLIA

What is “CLIA”? • Clinic a l L a b o ra to ry I mpro ve me nt Ame ndme nts • F e de ra l pro g ra m tha t e sta b lishe s q ua lity la b o ra to ry sta nda rds to pro te c t pa tie nt sa fe ty a nd impro ve he a lth c a re CLIA

CLIA Program Responsibilities CMS Clinical Laboratory Oversight CDC FDA Scientific Test Consultation Categorization CLIA

The CLIA regulations ….. • E sta b lishe d unifo rm q ua lity sta nd a rds fo r a ll la b o ra to ry te sting to e nsure a c c ura c y, re lia b ility a nd time line ss o f pa tie nt te st re sults re g a rd le ss o f whe re the te st wa s pe rfo rme d

CLIA Definition of Laboratory • Any fa c ility tha t e xa mine s huma n spe c ime ns fo r the dia g no sis, pre ve ntio n, o r tre a tme nt o f a ny dise a se o r impa irme nt o f, o r the a sse ssme nt o f the he a lth o f, huma n b e ing s CLIA

All clinical laboratories….. • tha t pe rfo rm te sting o n pa tie nt spe c ime ns must: • a pply fo r a CL I A c e rtific a te • pa y a ppro pria te fe e s a nd • fo llo w a pplic a b le CL I A re q uire me nts CLIA

Test Complexity • Wa ive d • Mo de ra te c o mple xity inc luding the sub c a te g o ry o f Pro vide r Pe rfo rme d Mic ro sc o py (PPM) • Hig h c o mple xity L a bor a tor ie s a r e c e r tifie d a t the hig he st le ve l of te sting pe r for me d CLIA

CLIA Certificate Types • Ce rtific a te o f Co mplia nc e (COC) • Ce rtific a te o f Ac c re dita tio n (COA) • Ce rtific a te fo r PPM pro c e dure s (PPMP) • Ce rtific a te o f Wa ive r (Co W) CLIA

Current Enrollment Statistics • T o ta l Numb e r o f L a b o ra to rie s: 244,564 o Co mplia nc e L a b s: 18,959 o Ac c re dite d L a b s: 16,081 o Wa ive d L a b s: 165,058 o PPM L a b s: 36,784 CLIA

Waived Tests…. • Simple la b o ra to ry e xa mina tio ns a nd pro c e dure s • Cle a re d b y F DA fo r ho me use ; • E mplo y me tho do lo g ie s tha t a re so simple a nd a c c ura te a s to re nde r the like liho o d o f e rro ne o us re sults ne g lig ib le ; o r • Po se no re a so na b le risk o f ha rm to the pa tie nt if the te st is pe rfo rme d inc o rre c tly. CLIA

Certificate of Waiver (CoW) • E nro ll in the CL I A pro g ra m • Pa y b ie nnia l c e rtific a te fe e s • Only pe rfo rm te sts c a te g o rize d a s wa ive d • No t sub je c t to ro utine inspe c tio ns • Must fo llo w ma nufa c ture r’ s instruc tio ns CLIA

CoW Personnel Requirements • Must ha ve a L a b o ra to ry Dire c to r o T he re a re no e duc a tio na l a nd e xpe rie ntia l re q uire me nts fo r L D • T he re a re no o the r pe rso nne l re q uire me nts CLIA

CoW Site Visits • Anno unc e d, de sig ne d to he lp e duc a te o n so und la b o ra to ry pra c tic e s • Surve yo rs de te rmine : o T e sting b e ing c o nduc te d in ma nne r tha t pro te c ts pa tie nt sa fe ty o Re g ula to ry c o mplia nc e o Pe rfo rming te sts a ppro pria te fo r a Co W la b CLIA

CDC Educational Materials o CDC ha s pub lishe d “Re a dy, Se t, T e st” b o o kle t - de sc rib e s re c o mme nde d pra c tic e s fo r physic ia ns, nurse s, me dic a l a ssista nts a nd o the rs pe rfo rming pa tie nt te sting unde r a CL I A Wa ive r Ce rtific a te o CDC a lso o ffe rs a n o n-line tra ining c o urse c o rre spo nding to “Re a dy, Se t, T e st”. CLIA

Go o d L a b o ra to ry Pra c tic e s fo r Wa ive d T e sting Site s Poster and postcards Educational booklet with job aids 16

Non-waived Testing • I nc lude s mo de ra te a nd hig h c o mple xity te sts • Must fo llo w: o All ma nufa c ture r’ s instruc tio ns a nd o Applic a b le CL I A re q uire me nts o AO re q uire me nts o Sta te re q uire me nts (e x. Ma ryla nd, Ne w Yo rk) Whe n in doubt, always follow the most stringe nt re quire me nts CLIA

New FDA BGM Limitation • F DA re q uire d limita tio n in ma nufa c ture r’ s BGM instruc tio ns/ pkg inse rts tha t pro hib it use o f me te r fo r c ritic a lly ill pa tie nts. • CMS o nly re c e ntly ma de a wa re o f this limita tio n b e ing pla c e d in instruc tio ns/ inse rts . CLIA 18

What does this limitation mean? • De vic e s use d o utside o f the ma nufa c ture r’ s re q uire me nts a re c o nside re d to b e te st modific ation/ off labe l use . • T his is no t a ne w CL I A re g ula tio n! CLIA 19

Test modification/off label use • Any c ha ng e to a te st syste m/ de vic e o r ma nufa c ture r’ s instruc tio ns o r inte nde d use tha t a ffe c ts the te st’ s pe rfo rma nc e spe c ific a tio ns fo r a c c ura c y, pre c isio n, se nsitivity o r spe c ific ity. • Mo difie d te sts b e c o me hig h c o mple xity te sts unde r CL I A CLIA 20

If using meters with the “critically ill” limitation: • De fine “c ritic a lly ill” fo r the ir spe c ific pa tie nt po pula tio ns • E sta b lish pe rfo rma nc e spe c ific a tio ns (42 CF R §493.1253) CLIA 21

If using meters with the “critically ill” limitation • Ob ta in a CL I A Ce rtific a te o f Co mplia nc e (COC) o r Ce rtific a te o f Ac c re dita tio n (COA), pa y a pplic a b le fe e s • Me e t a ll o the r hig h-c o mple xity re q uire me nts (e x. Pro fic ie nc y T e sting , Pe rso nne l re q uire me nts) CLIA 22

Definition of “Critically Ill” • Due to myria d o f fa c to rs, c irc umsta nc e s a nd pa tie nt po pula tio ns, it is up to e a c h la b o ra to ry/ fa c ility to de fine “c ritic a lly ill” fo r its spe c ific pa tie nt po pula tio ns. • F DA a nd CMS will no t de fine “Critic a lly I ll” CLIA 23

Other Laboratory Options • Use POC te st syste ms witho ut the “c ritic a lly ill” limita tio n • Se nd g luc o se te sts to ma in la b o ra to ry • Pre se nts pa tie nt c a re issue s due to vo lume o f b lo o d re q uire d, ne e d fo r fre q ue nt te sting CLIA 24

Performance Specification Resources • 42 CF R §493.1253 o f the CL I A I nte rpre tive Guide line s (I G) • CL I A Bro c hure # 2, “Ve rific a tio n o f Pe rfo rma nc e Spe c ific a tio ns” o n the CL I A/ CMS we b site o www.c ms.hhs.g o v/ CL I A CLIA 25

CLIA Personnel & Competency Policies T o pic s fo r Disc ussio n  CL I A Pe rso nne l Po lic ie s  Ra tio na le fo r Po lic ie s  Outc o me s  Go a l o f Disc ussio n  Co mpe te nc y Asse ssme nt CLIA

High Complexity Personnel • L a b o ra to ry dire c to r (L D) • T e c hnic a l Supe rviso r (T S) • Clinic a l Co nsulta nt (CC) • Ge ne ra l Supe rviso r (GS) • T e sting Pe rso nne l (T P) CLIA

Moderate Complexity Personnel • L a b o ra to ry dire c to r (L D) • Clinic a l c o nsulta nt (CC) • T e c hnic a l c o nsulta nt (T C) • T e sting pe rso nne l (T P) CLIA

CLIA Personnel Policies • Use CMS I nte rpre tive Guide line s (I G) & S & C L e tte r 10-07-07-CL I A a s a g uide • Qua lific a tio n e va lua tio ns a re do ne @ hig he st le ve l o f a c a de mic a c hie ve me nt fo r the po sitio n CLIA

CLIA Personnel Policies • All re q uire d po sitio ns & a sa mple o f T P a re re vie we d o nc e . • Re vie w a dd’ l. T P o n sub se q ue nt surve ys a lo ng w/ a ny c ha ng e s o r ne w pe rso nne l • I f a L D c ha ng e s, q ua ls. a re re vie we d b y the a ppro pria te AO/ SA upo n no tific a tio n prio r to a ppro va l. • L D re spo nsib ilitie s c o rre spo nd to a ll q ua lity sta nda rds CLIA

CLIA Personnel Policies Phle b o to mists, mic ro pla ting pe rso nne l, c le rks, • re a g e nt & spe c ime n pre p, e tc . who do no t te st a re NOT re vie we d. MT (ASCP) & nursing lic e nse s a lo ne a re n’ t • a c c e pta b le . E ve n if c e rtific a tio n is re q uire d b y CL IA; e .g ., CT , • de g re e s & tra nsc ripts, e tc . a re still re q uire d. If a Sta te lic e nse is re q uire d b y CL I A, it a lo ne is • a c c e pta b le . Mo st Sta te s do a n e xte nsive re vie w. Surve yo r ma y still re q ue st do c ume nta tio n. • CLIA

CLIA Personnel Policies • Co nside r te st c o mple xity whe n e va lua ting c re de ntia ls. • Ag e nc y e va lua tio ns a re n’ t a c c e pta b le , e xc e pt fo r fo re ig n c re de ntia ling e q uiva le nc y purpo se s. • F o re ig n e duc a te d individua ls must b e e va lua te d b y a na tio na lly re c o g nize d a g e nc y fo r e q uiva le nc y. CLIA