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

From:"Roxanne Soto"


   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.


     From:  "Luck, Greg D." 
     To:  "'Charles.Embrey'"                 ,
     Subject:  [Histonet] CLIA REGS RE: Grossing: Chime In
     Date:  Fri, 3 Mar 2006 10:47:45 -0800
     >In   answer   to   the   question  below  about  requirements  for
     >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
     >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
     >Wouldn't  simple  (where  the  entire specimen is submitted and no
     >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
     >Where in CLIA does it's 'text' specifically state what constitutes
     >"grossing"  and  who  can  or can not perform CLIA's definition of
     >For  those  of  us less familiar with the federal register can you
     >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 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
     >-----Original Message-----
     >From: Charles.Embrey []
     >Sent: Friday, March 03, 2006 7:10 AM
     >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
     >degree  in  a  chemical, physical, biologic or clinical laboratory
     >ref. CLIA '88 493.1489
     >As  to  your question: "Does measuring cores and putting them in a
     >    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
     >Federal Register VOl. 60, No. 78, April 1995, section
     >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
     >licensing   systems   in   the   US.  I  fully  expect,  now  that
     >Assistants are a certified fact, that Florida will look closely at
     >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-----
     >[]  On  Behalf  Of
     Roxanne Soto
     >Sent: Friday, March 03, 2006 6:39 AM
     >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
     >    count  as  grossing?   What  education level doesn one have to
     >    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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