[Histonet] CAP checklist, question ANP.23041.

[Jesus Ellin]

Mark this is a new question and let me answer this for you from a
inspection point of view.  Currently there are 15 to 18 new questions
that deal with predicative markers and the digital images, most of these
are QA/QC related.  But the issue with images is that your people are
inspecting them.  When you are looking at an image it is more than just
click and go.  There are technical issues of Tiling, focus with z
stacking, AOI ( if the full image was captured), magnification, etc.
This is just technical to images, but then there are the aspects that
are to the histology world as in staining components, microtomy,
fixation, etc.  To say that they don't make a decision is a huge
understatement.  As far as I know CAP put this in because people were
just scanning images and sending them off.  There are also issues were
the scanner scans for possible algorithm studies.  You have to make sure
this is inline.  So as for the High complexity testing to what CLIA
defines, that is a back and forth issue.  Currently within our facility
you have to be licensed HT/HTL to do scanning.  This comes in line with
the CAP looking at creating a QM program and having the
technician/Technologist maintain competencies and assessments for this
technology.  There is also a competency and assessment due for the
pathologist as well for this technology.  I can go on and on, but you
can contact me off line for this.

Jesus Ellin
Yuma Regional Medical Center
928-336-1743

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Mark
Turner
Sent: Wednesday, March 16, 2011 4:36 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] CAP checklist, question ANP.23041.

Regarding CAP checklist, question ANP.23041.  "The operation of the
imaging system is performed by high-complexity testing personnel."

 

We have a question regarding the qualifications of the operators.  The
operators of the Aperio system are simply scanning entire slides to make
a record for us prior to returning slides to the client.  Our operators
make no evaluation of the image other than whether the scan is adequate
for recording purposes, and this is verified by our medical staff prior
to release of the materials.  In your opinion, does this constitute
high-complexity testing and require CLIA compliant qualifications for
the operators?

Mark Turner, Ph.D, HT(ASCP) QIHC

IHC / Histology Manager

CSI Laboratories

 

770-817-0817 x 394                  

678-205-4669  FAX

mturner <@t> csilaboratories.com <mailto:nmonroe <@t> csilaboratories.com> 

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