[Histonet] CLIA REGS RE: Grossing: Chime In
Roxanne Soto
godsgirlnow <@t> msn.com
Fri Mar 3 14:20:48 CST 2006
Greg,
Thank you for your comment-that is exactly what I was trying to ask,
but you 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 the CLIA website.
Roxanne
______________________________________________________________
From: "Luck, Greg D." <LuckG <@t> empirehealth.org>
To: "'Charles.Embrey'" <Charles.Embrey <@t> carle.com>,
Histonet <@t> pathology.swmed.edu
Subject: [Histonet] CLIA REGS RE: Grossing: Chime In
Date: Fri, 3 Mar 2006 10:47:45 -0800
>Charles,
>In answer to the question below about requirements for
"non-pathologists
>grossing" you cited the specific text from CLIA '88 (493.1489)
which states
>the requirements for "analyzing patient samples" but I don't see
how that
>strictly translates to "grossing" (in particular when we may be
talking
>about the simple transfer of an entire specimen into tissue
cassettes with a
>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.
>Wouldn'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
example to a
>Micro lab aid who does this on tissue cultures. "Grossing" by
your comment
>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 can not perform CLIA's definition of
grossing.
>For those of us less familiar with the federal register can you
provide
>me/us with the specific text from the federal register 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
does. Thanks,
>Greg
>Greg Luck, BS, HT(ASCP)
>Anatomic Pathology Supervisor
>Deaconess Medical Center
>800 W. 5th Ave
>Spokane, WA 99204
>Phone 509.473.7077
>Fax 509.473.7133
>luckg <@t> empirehealth.org
>www.deaconessmedicalcenter.org
>
>
>
>
>-----Original Message-----
>From: Charles.Embrey [mailto:Charles.Embrey <@t> carle.com]
>Sent: Friday, March 03, 2006 7:10 AM
>To: Histonet <@t> pathology.swmed.edu
>Subject: FW: [Histonet] CLIA REGS
>
>
>
>-----Original Message-----
>From: Charles.Embrey
>Sent: Friday, March 03, 2006 9:09 AM
>To: 'Roxanne Soto'
>Subject: RE: [Histonet] CLIA REGS
>
>CLIA '88 lists the requirements for non-pathologists grossing.
Grossing is
>considered high-complexity testing even if it's a punch biopsy or
a shave.
>
>CLIA '88 states "On or before April 24 1995 (I) be a high school
graduate or
>equivalent; and (b) have documentation of training appropriate for
the test
>performed before analyzing patient specimens"................After
that date
>it requires an associate 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
bachelor's
>degree in a chemical, physical, biologic or clinical laboratory
science.
>
>ref. CLIA '88 493.1489
>
>As to your question: "Does measuring cores and putting them in a
cassette
> Count as grossing?" YES it does. Whether a simple small skin
tag or
>dissection of an entire colon, the requirements are the same.
>It falls under the CLIA High Complexity Testing Personnel
Qualifications,
>Federal Register VOl. 60, No. 78, April 1995, section
>493.1489
>
>Also CAP requires a written instruction detailing what specimens
may be
>grossed with direct vs indirect pathologists' observation. Direct
means that
>the pathologist literally watches over your shoulder while you
gross the
>specimen. Indirect means that he is readily available to consult.
>
>Now as far a Florida is concerned: Florida has one of the most
stringent
>licensing systems in the US. I fully expect, now that
Pathologists'
>Assistants are a certified fact, that Florida will look closely at
their
>licensure and may limit grossing in the state to licensed P.A.s,
>Pathologists and residents. At this point it is just a guess but
I wouldn't
>be surprised to see it happen in the not too distant future.
>
>Charles Embrey, PA(ASCP)
>Carle Clinic
>Urbana, IL
>
>
>
>
>-----Original Message-----
>From: histonet-bounces <@t> lists.utsouthwestern.edu
>[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
Roxanne Soto
>Sent: Friday, March 03, 2006 6:39 AM
>To: HISTONET <@t> PATHOLOGY.SWMED.EDU
>Subject: [Histonet] CLIA REGS
>
>
> Would someone from CLIA (or someone who knows the CLIA
regs inside
> and out) please contact regarding 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 have to
have
>in
> 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.......
> Thanks in advance
> Roxanne Soto
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