[Histonet] New CAP question ANP.22760

[JMyers1 <@t> aol.com]

Tom:
 
As much as I agree with your acknowledgment that its seems a bit odd for 
the CAP to have a blood-banker responding to AP-related issue, I'm actually 
not surprised.  The folks in the 'clinical' lab have been performing more 
comprehensive and complex validation procedures for a very long time, and they 
wonder why IHC isn't expected to follow the same requirements as chemistry, 
immunology, etc. -- IHC is, after all, an awful lot like ELISA.  And 
rightfully so, because IHC is, under CLIA (which supersedes CAP), considered 
highly-complex, non-waived testing -- and is, therefore, subject to the same 
Quality Systems regulations (in particular, 42CFR493.1252-1256, 1273, and 1281) as 
the testing performed in other areas of the lab.
 
Could it be that, because AP produces qualitative results that are 
interpreted by a pathologist and CP produces quantitative results that are 
interpreted by an analyzer, we somehow think that CLIA rules don't apply to IHC?  I 
certainly don't have the answer to that, but it make me wonder what the 
future holds.  As witnessed by some of the newest CAP 'standards' (including the 
question in question...no pun intended), e.g. ER/PR, where a minimum of 20 
positive and 20 negative specimens must be tested, and where 10 of the 
positives must be weakly positive -- an acknowledgment that validation specimens 
must be carefully selected in order to obtain appropriate results), it 
certainly doesn't appear that the regulation of IHC testing is going to become 
more relaxed.
 
Joe Myers, M.S., CT(ASCP)
 
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Message: 12
Date: Fri, 18 Jun 2010 12:38:07 -0700
From: "Thomas Jasper" <tjasper <@t> copc.net>
Subject: RE: [Histonet] New CAP question ANP.22760
To: "Mark Tarango" <marktarango <@t> gmail.com>
Cc: _histonet <@t> lists.utsouthwestern.edu_ 
(mailto:histonet <@t> lists.utsouthwestern.edu) 

Mark,

Did you notice the credentials from this CAP representative? MT with a
Blood Bank specialty I believe.  What I glean from that is...more than
likely this person does not grasp the logistics of "contemporaneously"
staining identical Abs from separate lots.  She also likely does not
understand the logistical application for detection and automation
either.

I'm not trying to be overly critical of this person.  I'm sure she is
quite intelligent and would not have the MT/SBB if she wasn't
intelligent.  It comes down to a lack of understanding Anatomic
Pathology testing application re: automated IHC.  I believe this is a
common problem in and out of CAP. Many lab directors and other folks in
positions of authority without AP/Histology/Cytology backgrounds seem to
believe that broad clinical lab modalities apply to Anatomic Path
scenarios.  I used to refer to this in my former position as - "Trying
to put the yoke of clinical lab onto anatomic path."  We are
laboratorians, but in many instances do not fit the general clinical lab
mold.

It's unfortunate that CAP has put this person in the position to
respond.  It is apparent to me that she's not grasping the particulars
here.  She probably never will unless she decides to go into a working,
automated IHC "tissue" lab and take the time to ask questions and
understand (learn) what we're all about.

Thanks,
Tom Jasper

Thomas Jasper HT (ASCP) BAS
Histology Supervisor
Central Oregon Regional Pathology Services
Bend, OR 97701