Re: [Histonet] CLIA REGS RE: Grossing: Chime In

From:histology@gradymem.org


   

I've been off a couple of days and just read these mes= sages. 

When I was researching the CLIA grossing requirements I spoke to a= CLIA representative in OKC.  I was told that the reason that = grossing any specimen was considered high complexity testing was that the= gross description becomes part of the pathology report.

Angie Barnett, HTL(ASCP)
Grady Memorial Hospital
Pathol= ogy Department
405/224-2258
histology@gradymem.org <= BR>

----- Original Message -----

From: Roxanne Soto <GODSGIRLNOW@= msn.com>

Date: Saturday, March 4, 2006 8:36 = am

Subject: Re: [Histonet] CLIA REGS R= E: Grossing: Chime In

> So in reading the link that you sent me including= 493.1489, the
> person does not have to have a degree= , as long as they have 60
> credits including all of the= sciences and 3 months of training?
> ----- Original Mes= sage -----
> From: Lance
> Erickson< mailto:Lance.Erickson@intermountainmail.org>
>= ; To: Roxanne Soto<mailto:godsgirlnow@msn.com> ;
> Histonet@pathology.swmed.edu<mailto:Hist onet@pathology.swmed.edu>
> Sent: Friday,= March 03, 2006 4:10 PM
> Subject: RE: [Histonet= ] CLIA REGS RE: Grossing: Chime In
>
>=
> www.cms.hhs.gov/clia<http://www.cms. hhs.gov/clia> is the link to
> the CLIA '88 inf= ormation. See the new federal register CLIA
> intrepreti= ve guidelines appendix C subpart M that are effective
> Ap= ril 24, 2003. The guidelines are available at
> www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf<http: //www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf> under qualif= ications of high complexity testing personnel section 493.1489 (b)(7) i= t is clear that all tissue gross examination whether it is color, measu= rement, or advanced dissection is considered high complexity testing an= d individuals performing this type of testing must qualify under this sec= tion. That is why the new CAP question ANP 11610 was instated and is ef= fective April 28, 2005. CAP must abide by CLIA regulations and CLIA i= s part of the Center for Medicare and Medicaid Services which is a sectio= n of the US government's department of Health and Human Services. So = if you would like to maintain your CLIA license and CAP certification and= be paid by Medicare you must abide by the requirements for high complexi= ty testing personnel for each person performing any kind of gross examina= tion. The actual wording is: "Interpretive Guidelines 493.1489= (b)(7)In the case of gr oss examinations, the technical supervisor may delegate to individuals = qualified under 493.1489 the responsibility for the physical examina tion/description, including color, weight, measurement and other ch= aracteristics of the tissue; or other mechanical procedures for which a= specific written protocol has been developed. The technical supervisor= is ultimately responsible for the diagnosis related to the gross examina= tion and must sign the examination report. The technical supervisor is = not required to provide direct onsite supervision but is responsible for = the accuracy of all test results reported. All physical examinations/de= scriptions of tissue including color, weight, measurement and other c= haracteristics of the tissue; or other mechanical procedures performed = in the absence of the technical supervisor by individuals qualified under 493.1489 should be reviewed within 24 hours by the technical superv= isor. All microscopic tissue examinations must be performed by individu= als qualified under 493.1449(b), (l) or (m), as appropriate."=
>
> Lance Erickson
> Anatom= ic Pathology Supervisor
> Primary Children's Medical Cen= ter
> Salt Lake City, UT
>
>= -----Original Message-----
> From: histonet-bounces@l ists.utsouthwestern.edu<mailto:histonet-
> bo= unces@lists.utsouthwestern.edu> [mailto:histonet-
= > bounces@lists.utsouthwestern.edu] On Behalf Of Roxanne S= oto
> Sent: Friday, March 03, 2006 1:21 PM
= > To: LuckG@empirehealth.org<mailto:LuckG@empireh ealth.org>;
> Charles.Embrey@carle.com& lt;mailto:Charles.Embrey@carle.com>; Histonet@pathol ogy.swmed.edu<mailto:Histonet@pathology.swmed.edu=2 6gt= ;
> Subject: RE: [Histonet] CLIA REGS RE: Gros= sing: Chime In
>
>
> Greg,=
>
> Thank you for your comment-that is exa= ctly what I was
> trying to ask,
> but yo= u put it so much better than I did.
>
> This is what I need to know, as well, and I have had a very =
> difficult time trying to find the answer by looking at t= he
> CLIA website.
>
> Rox= anne
>
> ____________ _______________________ 5F_ _______________________ 5F_=
> From: "Luck, Greg D."
> < LuckG@empirehealth.org<mailto:LuckG@empirehealth.org 26g= t;> To:
> "'Charles.Embrey'"
= > <Charles.Embrey@carle.com<mailto:Charles. Embrey@carle.com>>,
> Histonet@patho logy.swmed.edu<mailto:Histonet@pathology.swmed.edu 26g= t;
> Subject: [Histonet] CLIA REGS RE: Grossing:= Chime In
> Date: Fri, 3 Mar 2006 10:47:45 -0800 <= BR>> >Charles,
> >In answer to th= e question below about
> requirements for
> "non-pathologists
> >grossing" you cited the s= pecific text from CLIA '88
> (493.1489) which states <= BR>> >the requirements for "analyzing patient samples"= but I
> don't see
> how that
> >strictly translates to "gros= sing" (in particular when
> we may be
> t= alking
> >about the simple transfer of an entire sp= ecimen
> into tissue
> cassettes with a <= BR>> >visual description and simple specimen prep and set= -
> up as in
> reducing the
>= >sizes of the sample to be processed; e.g.
>= bisection with a
> scalpel.
> >Wo uldn't simple (where the entire specimen is
> submitted = and no
> independent
> >decision has= to be made over what portions of the
> specimen to
= > submit and/or
> >not submit for micro exam= by the pathologist be
> analogous for
> ex= ample to a
> >Micro lab aid who does this on tissue cultures.
> "Grossing" by
> your com= ment
> >below does not differentiate between shave = biopsy
> and a
> prostatectomy.
> >Where in CLIA does it's 'text' specifically state = what
> constitutes >"grossing" and who can or c= an not perform
> CLIA's definition of
> g= rossing.
> >For those of us less familiar with th= e federal register
> can you
> provide > >me/us with the specific text from the federal regist= er
> that you
> cite in your
>= >response to the 2nd question of "does measuring cores and > placing them in a
> >cassette count as= grossing?" to which you have
> said yes it
&= gt; does. Thanks,
> >Greg
> & gt;Greg Luck, BS, HT(ASCP)
> >Anatomic Pathol= ogy Supervisor
> >Deaconess Medical Center
= > >800 W. 5th Ave
> >Spokane, WA = 99204
> >Phone 509.473.7077
> &= gt;Fax 509.473.7133
> >luckg@empirehealth.= org
> >www.deaconessmedicalcenter.org
&= gt; >
> >
> >
= > >
> >-----Original Message-----
> >From= : Charles.Embrey [mailto:Charles.Embrey@carle.com]
= > >Sent: Friday, March 03, 2006 7:10 AM
& gt; >To:
> Histonet@pathology.swmed.edu& lt;mailto:Histonet@pathology.swmed.edu>
>= >Subject: FW: [Histonet] CLIA REGS
> >= ;
> >
> >
> = >-----Original Message-----
> >From: Charl= es.Embrey
> >Sent: Friday, March 03, 2006 9= :09 AM
> >To: 'Roxanne Soto'
> >Subject: RE: [Histonet] CLIA REGS
> >= ;
> >CLIA '88 lists the requirements for non-pa= thologists
> grossing. Grossing is
> &g= t;considered high-complexity testing even if it's a punch
&= gt; biopsy or
> a shave.
> > <= BR>> >CLIA '88 states "On or before April 24 1995 (I)= be a
> high school
> graduate or
&= gt; >equivalent; and (b) have documentation of training
> appropriate for
> the test
> >performed before analyzing pat= ient
> specimens".............= ...After that date
> >it requires an associat= e degree in a biological or
> chemical science or
> >medical laboratory technology -or- qualify as a
= > medical technologist with a
> >bachelor'= s degree from an accredited institution -or-
> earned a <= BR>> bachelor's
> >degree in a chemical,= physical, biologic or clinical
> laboratory science. =
> >
> >ref. CLIA '88 493.= 1489
> >
> >As to your questi on: "Does measuring cores and putting
> them in a > cassette
> > Count as grossing?" Y= ES it does. Whether a simple
> small skin
>= tag or
> >dissection of an entire colon, the req= uirements are the same.
> >It falls under the CLI= A High Complexity Testing
> Personnel Qualifications, < BR> > >Federal Register VOl. 60, No. 78, April 1995, = section
> >493.1489
> > <= BR>> >Also CAP requires a written instruction detailing w= hat
> specimens may be
> >grossed wi= th direct vs indirect pathologists'
> observation. Dir= ect
> means that
> >the pathologist literally watches over your shoulder
> while you
&= gt; gross the
> >specimen. Indirect means that = he is readily available to
> consult. >
&= gt; >Now as far a Florida is concerned: Florida has one of <= BR>> the most
> stringent
> >= licensing systems in the US. I fully expect,
> now tha= t
> Pathologists'
> >Assistants ar= e a certified fact, that Florida will look
> closely at =
> their
> >licensure and may limit g= rossing in the state to licensed
> P.A.s, >Pa= thologists and residents. At this point it is
> just a g= uess but
> I wouldn't
> >be surprised to see it hap= pen in the not too distant future.
> >
&= gt; >Charles Embrey, PA(ASCP)
> >Carle C linic
> >Urbana, IL
> > <= BR>> >
> >
> >=
> >-----Original Message-----
> &= gt;From: histonet-
> bounces@lists.utsouthwestern. edu<mailto:histonet-bounces@lists.utsouthwestern.edu& gt;=
> >[mailto:histonet-bounces@lists.utsouthw estern.edu] On
> Behalf Of
> Roxanne So= to
> >Sent: Friday, March 03, 2006 6:39 AM =
> >To:
> HISTONET@PATHOLOGY.SW MED.EDU<mailto:HISTONET@PATHOLOGY.SWMED.EDU> > >Subject: [Histonet] CLIA REGS
>= >
> >
> > Would someo= ne from CLIA (or someone who knows
> the CLIA
&g= t; regs inside
> > and out) please contact regard= ing grossing of
> tissue-----what is
> > grossing per se--does measuring cores and putting > them in a
> cassette
> >= count as grossing? What education level doesn one
> hav= e to
> have
> >in
> &= gt; order to do this in the state of Florida? We are in
>= ; desperate need of
> > lab aides, but our lab = aides have always had BS
> degrees and they
>= > "gross" out prostate cores.......
&= gt; > Thanks in advance
> > Roxanne Soto <= BR>> >_________________ _______________________ 5F_= _____
> >Histonet mailing list
&= gt; >Histonet@lists.utsouthwestern.edu
> & gt;http://lists.utsouthwestern.edu/mailman/listinfo/histonet > >
> >_________ _______________________ 5F_= _____________
> >Histonet= mailing list
> >Histonet@lists.utsouthwestern.= edu
> >http://lists.utsouthwestern.edu/mailma n/listinfo/histonet
> >
> >___________________ _______________________ 5F_= ___
> >Histonet mailing list
>= >Histonet@lists.utsouthwestern.edu
> > http://lists.utsouthwestern.edu/mailman/listinfo/histonet
&= gt; _______________________ _______________________ 5F =
> Histonet mailing list
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