[Histonet] non pathologist grossing vs processing continued

Charles.Embrey Charles.Embrey <@t> carle.com
Mon Nov 12 14:28:36 CST 2007

Hi Vince, Sorry to take so long in getting back to you but things here
have been very busy. By CLIA's guidelines it sounds as though CAP has
removed themselves as an "acceptable" private accreditation when they
loosened the restrictions on grossing.  CLIA's database may not list
grossing but CLIA did publish a guideline to clarify their position:
This is the CLIA '88 guideline for high complexity testing personnel-
CLIA '88 493.1489
"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.

A few years ago CLIA put out this interpretive guideline, (printed
below), to clear up the question of grossing.  As you see, it references
493.1498 (the above "high complexity guideline").  They basically sum up
that if you examine/describe the tissue for record noting color weight
or measurement then it is grossing and falls under 493.1498.  Tissue
processing as CAP calls it involves noting size and other
characteristics and qualifies as grossing under CLIA.

The new federal register CLIA interpretive guidelines appendix C subpart
M effective April 24, 2003 states in section 493.1461(e) "In the case if
gross examinations, the technical supervisor may delegate to individuals
qualified under 493.1498 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."

I hope this helps.  I don't know which side will budge first but I have
heard whisperings of CLIA doing something in the near future but what
ever it is it will probably only muddy the water further.  All I can say
is that CLIA is what happens when a government bureaucracy gets involved
with healthcare.   

Charles Embrey PA(ASCP)
Histology Manager
Carle Clinic

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
Vancleave, Vince
Sent: Monday, November 12, 2007 1:55 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] non pathologist grossing vs processing continued

From: Vancleave, Vince
Sent: Wed 11/7/2007 2:39 PM
To: histonet <@t> lists.utsouthwestern.edu
Cc: Webster, John A. M.D.
Subject: Still not sure about this low complexity or not

"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)"
Charles makes a great point but:
I'm just not sure I'm sold on this yet, b/c also in the CLIA regs it
states in sec. 493.559 about exemption from CLIA, via using a private
accreditation agency (which is what CAP is), and states clearly that
this agency can only be deemed acceptable if their requirements for the
laboratory are equivalent or more stringent and the laboratory would
meet CLIA requirements if the laboratory had not been granted deemed

Ya'll are right, this is a mess!

So, wouldn't this essentially mean that according to CLIA, since CAP is
an acceptable private agency, they are giving the ok for CAP's decision
on this?  Wouldn't CAP be unallowed to do what they do if it was less
stringent than CLIA?  I also find nothing in the entire CLIA 88' that
indicates that this would not be ok.  In fact, CLIA has a criteria for
categorization of complexity:
http://www.fda.gov/cdrh/clia/categorization.html .  And in their
database of tests that they have said has to absolutely be a certain
way, I find no reference to tissue description, gross examination,
tissue examination, or processing.

Have I stumped anyone yet, or is there some more things I am missing?  I
really appreciate all ya'lls willingness to re-visit this issue again.
I guess I am a stuborn monkey!


Vince Van Cleave, BS, PA(ASCP), HTL, HT
Laboratory Manager and Pathologist Assistant
Clinical Pathology Associates
Abilene, TX


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