[Histonet] CLIA REGS RE: Grossing: Chime In
Lance Erickson
Lance.Erickson <@t> intermountainmail.org
Fri Mar 3 15:10:36 CST 2006
www.cms.hhs.gov/clia is the link to the CLIA '88 information. See the new federal register CLIA intrepretive guidelines appendix C subpart M that are effective April 24, 2003. The guidelines are available at www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf under qualifications of high complexity testing personnel section 493.1489 (b)(7) it is clear that all tissue gross examination whether it is color, measurement, or advanced dissection is considered high complexity testing and individuals performing this type of testing must qualify under this section. That is why the new CAP question ANP 11610 was instated and is effective April 28, 2005. CAP must abide by CLIA regulations and CLIA is part of the Center for Medicare and Medicaid Services which is a section 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 complexity testing personnel for each person performing any kind of gross examination. The actual wording is: "Interpretive Guidelines §493.1489(b)(7)In the case of gross examinations, the technical supervisor may delegate to individuals qualified under §493.1489 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. The technical supervisor is ultimately responsible for the diagnosis related to the gross examination 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/descriptions of tissue including color, weight, measurement and other characteristics 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 supervisor. All microscopic tissue examinations must be performed by individuals qualified under §493.1449(b), (l) or (m), as appropriate."
Lance Erickson
Anatomic Pathology Supervisor
Primary Children's Medical Center
Salt Lake City, UT
-----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 1:21 PM
To: LuckG <@t> empirehealth.org; Charles.Embrey <@t> carle.com; 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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