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

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 CDC FDA

Clinical Laboratory Oversight Scientific Consultation Test 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
• ta l Numb e r o f L

a b o ra to rie s: 244,564

• Co mplia nc e L

a b s: 18,959

• Ac c re dite d L

a b s: 16,081

• Wa ive d L

a b s: 165,058

• 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

• 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
• n so und la b o ra to ry pra c tic e s
• Surve yo rs de te rmine :
• 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

• Re g ula to ry c o mplia nc e
• Pe rfo rming te sts a ppro pria te fo r a Co W

la b

CLIA

CDC Educational Materials

• 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

• 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

16

Educational booklet with job aids Poster and postcards

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

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:
• All ma nufa c ture r’ s instruc tio ns a nd
• Applic a b le CL

I A re q uire me nts

• AO re q uire me nts
• 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

18

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

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!

19

CLIA

20

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

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)

21

CLIA

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)

22

CLIA

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”

23

CLIA

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

24

CLIA

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”

• n the CL

I A/ CMS we b site

• www.c ms.hhs.g o v/ CL

I A

25

CLIA

CLIA

CLIA Personnel & Competency Policies

T

• 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

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

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
• 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

CLIA Personnel Policies

• I

f a n individua l do e sn’ t me e t e duc a tio n, tra ining o r e xpe rie nc e re q uire me nts, po sitio n no t fille d o r re spo nsib ilitie s no t me t, a c o nditio n le ve l de fic ie nc y is c ite d.

• Co mpe te nc y is a sse sse d pe r the re g ula tio ns

fo r T C/ T S.

• So lo pra c titio ne rs a re no t a sse sse d.

CLIA

CLIA Personnel Policies: Rationale

• Individua ls do wnlo a d q ua lific a tio ns fro m the

We b , use fra udule ntly to o b ta in CL I A c e rtific a te s, a nd b ill Me dic a re fo r millio ns o f $$.

• Mo re tha n 100 fa lse a pplic a tio ns re c o rde d so

fa r. Ma ny she ll la b s c a ug ht b y pre -a ppro va l re vie w o f a pplic a tio n c re de ntia ls.

• ASCP ha s c ha ng e d its c re de ntia ling pro c e ss

a fte r disc o ve ring individua ls who sub mitte d fa lse c re de ntia ls fo r the ir c e rtific a tio n.

CLIA

CLIA Personnel Policies: Rationale

• T

he re is g re a t risk to CL I A & pa tie nts if a n individua l in a re g ula te d po sitio n is I D’ d a s unq ua lifie d & q ua lity issue s a re a lso fo und

• L

a b w/ multiple , c o nse c utive PT fa ilure s ha d T P w/ fa lsifie d HE W c a rd. All la b re sults ha d to b e re vie we d .

CLIA

CLIA Personnel Policies: Rationale

• Offsho re o pe ra tio n upg ra de s de g re e s fo r a

fe e ; diplo ma mills; q uic kie de g re e s.

• T

P (with o nly 10th g ra de e duc a tio n) no t fo llo wing mfg r’ s. instruc tio ns fo r inte nde d use (e ndo c e rvic a l) - te sting ma le s fo r GC/ Chla mydia

• L

a b w/ a ll pe rso nne l unq ua lifie d fo r hig h c o mple xity mic ro te sting it pe rfo rme d.

CLIA

CLIA Personnel Policies: Rationale

• Imme diate Je opardy fo und in la b

whe re GS ha d no fo re ig n e q uiva le nc y do ne .

• T

P w/ no HS de g re e o r GE D – te st re sults impa c te d.

• POL

w/ re pe a te d de fic ie nc ie s –MD’ s hig h sc ho o l a g e so n pe rfo rming te sting .

CLIA

CLIA Personnel Policies - Goals

1.

All o ve rsig ht a g e nc ie s ha ve a nd e nfo rc e c o nsiste nt pe rso nne l po lic ie s. 2.Pa tie nts a re pro te c te d b y q ua lifie d pe rso nne l a t a ll le ve ls.

CLIA

CLIA Competency Assessment

• Co mpe te nc y is re q uire d fo r a ll

te c hnic a l, supe rviso ry & te sting pe rso nne l (T P).

• Re q uire s 6 e le me nts fo r a ll te sts fo r T

P.

• Va rio us re la te d re q uire me nts a re

inte rspe rse d thro ug ho ut the re g ula tio ns.

CLIA

CLIA Competency Assessment

• Co mpe te nc y is NOT

the sa me a s a pe rfo rma nc e e va lua tio n/ tra ining .

• Qua lity ma na g e me nt inc lude s

pe rso nne l, pro c e sse s, & pro c e dure s, a s do e s c o mpe te nc y.

CLIA

CLIA Competency Assessment

• Studie s indic a te tha t mo re e duc a tio n & tra ining

pro duc e hig he r q ua lity re sults.

• T

he me a ns to c o nfirm tra ining e ffe c tive ne ss is c o mpe te nc y e va lua tio n.

• In CL

I A, la b o ra to ry dire c to r’ s q ua lific a tio ns a re string e nt due to o ve ra ll q ua lity re spo nsib ility.

• But q ua lific a tio ns fo r te sting pe rso nne l a re

minima l, b a se d o n te st c o mple xity.

CLIA

CLIA Competency Assessment

• CL

I A surve y e xpe rie nc e indic a te s ma ny pro b le ms c a use d b y pe rso nne l e rro rs whic h ma y ha ve a pa tie nt impa c t.

• Ro utine c o mpe te nc y e va lua tio ns he lp

pre ve nt e rro rs; hig hlig ht impo rta nc e o f c o mpe te nc y, re g a rdle ss o f e duc a tio n.

CLIA

CLIA Competency Assessment: Key Requirement

T e c hnic al Consultant/ Supe rvisor Re sponsibilitie s (§493.1413(b)(8)(9) and §493.1451(b)(8)(9))

• E

va lua ting the c o mpe te nc y o f a ll te sting pe rso nne l & a ssuring tha t the sta ff ma inta in the ir c o mpe te nc y to pe rfo rm te st pro c e dure s & re po rt te st re sults pro mptly, a c c ura te ly, & pro fic ie ntly.

CLIA

CLIA Competency Assessment

Must Inc lude :

• 1. Dire c t o b se rva tio n o f ro utine pa tie nt te st

pe rfo rma nc e , inc luding pa tie nt pre pa ra tio n, if a pplic a b le , spe c ime n ha ndling , pro c e ssing & te sting .

• 2. Mo nito ring the re c o rding & re po rting o f te st

re sults

CLIA

CLIA Competency Assessment

Must Inc lude :

• 3. Re vie w o f inte rme dia te te st re sults o r

wo rkshe e ts, QC re c o rds, PT re sults, & pre ve ntive ma inte na nc e re c o rds

• 4. Dire c t o b se rva tio n o f pe rfo rma nc e o f instrume nt

ma inte na nc e & func tio n c he c ks

CLIA

CLIA Competency Assessment

Must Inc lude :

• 5. Asse ssme nt o f te st pe rfo rma nc e thro ug h te sting

pre vio usly a na lyze d spe c ime ns, inte rna l b lind te sting sa mple s, o r e xte rna l PT sa mple s; a nd

• 6. Asse ssme nt o f pro b le m so lving skills

CLIA

Competency Assessment Tips

• Ope ra to r tra ining prio r to te sting is c ritic a l &

re q uire d

• Co mpe te nc y a sse ssme nts must b e

do c ume nte d

• I

ndividua l c o nduc ting c o mpe te nc y a sse ssme nts must b e q ua lifie d (T S/ GS o r T C)

CLIA

Competency Assessment Tips

• Compe te nc y asse ssme nt is not PT

!

• PT

c a n b e use d to me e t so me e le me nts o f c o mpe te nc y, b ut no t a ll!

• Pa tho lo g ists sho uld b e e va lua te d b y the

la b o ra to ry dire c to r a s te c hnic a l supe rviso rs.

CLIA

Competency Assessment Tips

• Co mpe te nc y re c o rds sho uld ma tc h the

la b o ra to ry’ s a c tua l pro c e dure s pe rfo rme d b y its pe rso nne l.

• Whe n o b se rving te st pe rfo rma nc e , use the

pro c e dure ma nua l (PM) / pa c ka g e inse rt (PI ) to e nsure PM is c urre nt.

• Co mpe te nc y fo r c linic a l & te c hnic a l

c o nsulta nts & supe rviso rs is b a se d o n the ir re g ula to ry re spo nsib ilitie s.

CLIA

Competency Assessment Tips

• L

a b o ra to ry dire c to r is no t sub je c t to c o mpe te nc y re q uire me nts, b ut is a c c o unta b le . Re spo nsib ilitie s c he c ke d

• n surve ys.
• Do no t ha ve to do a ll a t o ne time ; c a n

c o mb ine e le me nts.

• Ca n o fte n c o mb ine a na lyte s o n

multic ha nne l a na lyze rs.

CLIA

Competency Assessment Tips

• Ca n use c o mpe te nc y a sse ssme nt fo r QA

whe n c o nfirming te sts o rde re d ma tc h re po rte d/ c ha rte d re sults.

• F
• llo w up o n QC c o rre c tive a c tio ns will

de mo nstra te pro b le m so lving a b ility.

• Che c klists a re o nly minima lly o k.

CLIA

Competency Assessment Tips

• Co mpe te nc y e va lua tio ns must b e do ne

fo r Pro vide r Pe rfo rme d Mic ro sc o py (PPM) individua ls.

• Pe rso nne l pe rfo rming pre & po st a na lytic

a c tivitie s, b ut no t in re g ula to ry po sitio ns a re no t sub je c t to c o mpe te nc y, b ut it’ s g o o d QA.

Resources:

• CL

I A We b site

• http:/ / www.c ms.g o v/ CL

I A

• http:/ / www.a c c e ssda ta .fda .g o v/ sc ripts/ c drh

/ c fdo c s/ c fCL I A/ se a rc h.c fm

• http:/ / www.c dc .g o v/ mmwr/ pdf/ rr/ rr5413.pdf
• CDC: Re a dy, Se t, T

e st b o o kle t

• http:/ / www.c dc .g o v/ dls/ wa ive dte sts

CLIA

Contact

K a re n.Dye r@ c ms.hhs.g o v 410-786-3531 Da ra lyn.Ha ssa n@ c ms.hhs.g o v 410-786-9360

CLIA