The thing you have to remember, Vince, is that CLIA and CAP are two
different, completely separate entities. CLIA is government controlled
and CAP is private. Whereas CAP recently decided to separate grossing
into two different complexities, CLIA has not. Bottom line...if you are
CLIA licensed you MUST follow the CLIA standard. If not, then you can do
whatever you like.
Charles Embrey Jr., PA(ASCP)
[mailto:firstname.lastname@example.org] On Behalf Of
Sent: Tuesday, November 06, 2007 12:59 PM
Subject: [Histonet] non pathologist grossing versus processing
So this is a subject that has been beat like a dead horse for a long
time on histonet. The subject is, a histotech describing, measuring
(color, description, measurments, etc) of G.I. and other non-complicated
specimens (some skins included...inking).
So, as a PA(ASCP) myself I spend much of my paid time with realy simple
specimens like G.I. biopsies and skins. Basically, these are specimens
that are boring and take up a lot of time cause there are so many of
them....not to say it makes me not like my job....I still LOVE it. But,
if I could delegate those to a histotech then I would have the time to
devote more to higher complexity specimens like radical nephrectomies,
mastectomies, pneumonectomies, etc.. We have some near by labs that our
pathologists contract out to, of which also have gross, but those
pathologists have been doing that gross. So, it would be great, in my
mind to be able to deligate the low complexity specimens to technicians
in both places and have myself grossing all the complex specimens so the
pathologists don't have to hire another pathologist or PA and I would be
expending what I get paid in a more effecient manner.
In the CLIA regs it states that anyone doing gross exam on specimens
needs to be a high complexity tester under CLIA 493.1489. It also
mentions that there is a distinction between processing specimens
(specimen preparation, what technicians do) and grossing specimens
(describing color, weight, measurements, submitting sections). I notice
on histonet that everybody always says that you have to be a 493.1489
tester to be able to do any type of gross. But, what if processing a
specimen could include the description, measurement, inking, color,
etc...of specimens that required no knowledge of anatomy and the entire
specimen was submitted? According to the CAP inspection checklist,
there is this exact destinction between two levels of macroscopic tissue
complexity and are clearly defined. The two levels are defined as
"1)Processing," and "2)Grossing."
"Are all macroscopic tissue examinations performed by a pathologist or
pathology resident, or under the supervision of a qualified pathologist?
NOTE: Two levels of complexity of macroscopic tissue examination are
defined, as follows:
"1)Processing is defined as a tissue examination limited to description,
inking and cutting of the specimen (if applicable), and submission of
the entire specimen to histology. Tissue processing can be performed
according to standardized protocols. Processing is generally limited to
small specimens (skin ellipses, small biopsies, curettings, etc.) and
does not require knowledge of anatomy."
"2) Grossing (or gross examination) is defined as a tissue examination
requiring a greater exercise of judgment and a knowledge of anatomy.
Dissection of the specimen and selection of tissue samples for
submission to histology are generally required. The specimen description
is not necessarily standardized."
Throughout this checklist it never requires one who processes tissues to
be qualified as a high complexity tester, or 493.1489 individual. You
must, however, include a lot of documentation about the nature of
supervision (direct or indirect, by a pathologist) and the specific
types of specimens that they are limited to, and exactly how they are to
My question is, why don't we here more about this? Why can't I find it
in the CLIA regs, but I can in the CAP checklist? And, is anybody out
there even aware of this disctinction? Well, it made my day...and
hopefully it will be a help to others out there!
Vince Van Cleave, BS, PA(ASCP), HTL, HT
Laboratory Manager and Pathologist Assistant
Clinical Pathology Associates
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