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

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
   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

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

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@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Roxanne
Sent: Friday, March 03, 2006 6:39 AM
Subject: [Histonet] CLIA REGS

   Would  someone  from  CLIA  (or someone who knows the CLIA regs
   and  out)  please  contact  regarding  grossing  of tissue-----what
   grossing  per  se--does measuring cores and putting them in a
   count  as  grossing?   What  education level doesn one have to have
   order to do this in the state of Florida?  We are in desperate need
   lab  aides,  but  our  lab  aides  have always had BS degrees and
   "gross" out prostate cores.......
   Thanks in advance
   Roxanne Soto
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