[Histonet] CLIA REGS RE: Grossing: Chime In

[Luck, Greg D.]

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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