[Histonet] CLIA REGS RE: Grossing: Chime In

Fri Mar 3 15:35:37 CST 2006

Thanks to Lance Erickson the final answer is within reach.  The new
federal register CLIA interpretive guidelines appendix C subpart M
effective April 24, 2003 states in section 493.1461(e) "In the case if
gross examinations, the technical supervisor may delegate to individuals
qualified under 493.1498 (This is the section I quoted in the first
e-mail) the responsibility for the physical examination/description,
including color, weight, measurement, and other characteristics of the
tissue; or other mechanical procedures for which a specific written
protocol has been developed."

So under this interpretive guideline measuring cores and putting them
into a cassette constitutes High Complexity Testing.  You are right when
you said, "  "Grossing" by your comment below does not differentiate
between shave biopsy and a prostatectomy."  That is because in the eyes
of CLIA there is no difference.

Charles Embrey PA(ASCP) 

-----Original Message-----
From: Roxanne Soto [mailto:godsgirlnow <@t> msn.com] 
Sent: Friday, March 03, 2006 2:21 PM
To: LuckG <@t> empirehealth.org; Charles.Embrey; Histonet <@t> pathology.swmed.edu
Subject: RE: [Histonet] CLIA REGS RE: Grossing: Chime In

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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