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 call 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."
Charles Embrey PA(ASCP)
Histology Manager
Carle Clinic
-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Douglas
D Deltour
Sent: Wednesday, April 18, 2007 11:18 AM
To: Charles.Embrey; 'Amy Self'; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Processing Specimens
What is CLIA's definition of "grossing tech" and "high complexity
testing"?
I have looked through the CLIA regs and have not seen a true definition.
What a mess! :)
Douglas D. Deltour HT(ASCP)
Histology Manager
Professional Pathology Services, PC
One Science Court
Suite 200
Columbia, SC 29203
(803)252-1913
Fax (803)254-3262
*****************************************************
PROFESSIONAL PATHOLOGY SERVICES, PC
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-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of
Charles.Embrey
Sent: Wednesday, April 18, 2007 9:42 AM
To: Douglas D Deltour; Amy Self; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Processing Specimens
Douglas, You are right, according to CAP. You have to remember that
CLIA and CAP are separate and not interconnected with their
requirements. The problem is that CLIA has not changed the standard
since CLIA '88 and it doesn't look like they are about to any time soon.
My lab is both CAP and CLIA certified so I have to follow the stricter
rule on grossing. CAP cannot dictate to CLIA or soften CLIA standards
since they are two entirely different entities (civilian vs.
government). As far as CLIA '88 dictates processing techs (as outlined
by CAP) and grossing techs must both meet High Complexity testing
standards because CLIA does not differentiate between processing and
grossing.
Charles Embrey PA(ASCP)
Histology Manager
Carle Clinic
-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Douglas
D Deltour
Sent: Wednesday, April 18, 2007 9:55 AM
To: Charles.Embrey; 'Amy Self'; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Processing Specimens
Charles,
Now we are touching on another issue about grossing. Grossing is now
different from processing.
"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."
If you have to exercise judgment on what to submit then it is "grossing"
or
"high complexity testing".
If you are submitting all of the tissue then it is "processing". Tissue
"processing" can be performed according to standardized protocols.
Grossing techs have to follow CLIA and all of the requirements for high
complexity testing.
ANP.11610 Phase II N/A YES NO
If individuals other than a pathologist or pathology resident assist in
gross examinations, do such individuals qualify as high complexity
testing
personnel under CLIA-88 regulations?
This includes the 60 semester hours of sciences and other courses.
If you are processing then you do not have to be "CLIA eligible".
For years histo techs have done "processing" and when the CLIA thing
came
into place they were not eligible anymore. In my opinion this change
(processing) was made because labs were having a difficult time finding
the
new CLIA grossing techs who meet the requirements. This was forcing labs
to
find anyone with a BS and training them to gross.
Douglas D. Deltour HT(ASCP)
Histology Manager
Professional Pathology Services, PC
One Science Court
Suite 200
Columbia, SC 29203
(803)252-1913
Fax (803)254-3262
*****************************************************
PROFESSIONAL PATHOLOGY SERVICES, PC
NOTICE OF CONFIDENTIALITY
This message is intended only for the use of the individual or entity to
which it is addressed and may contain information that is privileged,
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reader
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that
any dissemination, distribution, or copying of this communication is
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-----Original Message-----
From: Charles.Embrey [mailto:Charles.Embrey@carle.com]
Sent: Wednesday, April 18, 2007 8:33 AM
To: Douglas D Deltour; Amy Self; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Processing Specimens
Amy, Douglas has explained it better than anyone could. Keep in mind
that if you are also CLIA certified you have to go by their stronger
policy. Under CLIA '88 any grossing (even what CAP now calls
"processing") is high complexity testing and the person performing it
must qualify. It is a snare that is bound to catch someone.
Charles Embrey, PA(ASCP)
Histology Manager
Carle Clinic, IL
-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Douglas
D Deltour
Sent: Tuesday, April 17, 2007 3:51 PM
To: 'Amy Self'; histonet@lists.utsouthwestern.edu
Subject: RE: [Histonet] Processing Specimens
Amy,
CAP defines processing as....
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.
So basically you need to have a "processing procedure" in place for the
different type of specimens that are being "processed". If you have a PA
or
a Pathologist grossing everything then this would be N/A.
Douglas D. Deltour HT(ASCP)
Histology Manager
Professional Pathology Services, PC
One Science Court
Suite 200
Columbia, SC 29203
(803)252-1913
Fax (803)254-3262
*****************************************************
PROFESSIONAL PATHOLOGY SERVICES, PC
NOTICE OF CONFIDENTIALITY
This message is intended only for the use of the individual or entity to
which it is addressed and may contain information that is privileged,
confidential and exempt from disclosure under applicable law. If the
reader
of this message is not the intended recipient, you are hereby notified
that
any dissemination, distribution, or copying of this communication is
strictly prohibited by law. If you have received this communication in
error, please notify me immediately.
-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Amy Self
Sent: Tuesday, April 17, 2007 2:33 PM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] Processing Specimens
Hello Histonetters,
I was just thumbing through the checklist and came across a NEW
question and wanted to see how some of you answered or would answer the
following question; Thanks in advance, Amy
ANP 11665
Are there written procedures for processing specimens.
NOTE: this question applies if a non-pathologists process
specimens.
Amy Self
Georgetown Memorial Hospital
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