[Histonet] RE: New CAP question

[Joe Nocito]

Greetings all,
I contacted CAP just before my on-site inspection last year. I was told that 
all validation studies had to be on file until the antibody/ special stain/ 
or equipment was no longer used. Sad to say. Now, I understand for 2012, CAP 
has added another "lab specific" checklist. My understanding is that some of 
the General Checklist questions will now be department specific. It's like a 
subset of the General Checklist. I was told by a co-worker, I haven't seen 
anything in print yet, but come on people. A General  department checklist 
from the General checklist. Then why have a General Checklist? Let's keep 
adding checklists because we can? This is what happens when a monopoly is 
formed. I'm going to start my own inspection company. I'm going to start 
from the toes and work my way up.

JTT
----- Original Message ----- 
From: "Carol Bryant" <cbrya <@t> lexclin.com>
To: "'Vickroy, Jim'" <Vickroy.Jim <@t> mhsil.com>; 
<histonet <@t> lists.utsouthwestern.edu>
Sent: Thursday, August 25, 2011 11:09 AM
Subject: [Histonet] RE: New CAP question


Please respond to all.  I would like the information also.
Thank you,
Carol

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu 
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Vickroy, Jim
Sent: Thursday, August 25, 2011 12:01 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] New CAP question

One of the new CAP questions is ANP.22976 ER/PgR validation.

If the laboratory performs immunohistochemistry for estrogen receptor and/or 
progesterone receptor as a prognostic/predictive marker on breast carcinoma, 
the laboratory has documented appropriate validation for the assays.  In the 
note it says should include a minimum of 40 cases and validation should be 
performed by comparing the laboratory's results with another assay that has 
been appropriately validated.

We have been doing ER/PR's for over ten years.  Originally we compared our 
ER/PR testing with the old immunology method that used frozen breast tissue. 
We also compared our ER/PR results with another hospital.  Problem is that 
this has been over ten years and we do not keep quality control records that 
long.   Am I missing something?
I know we use the FDA approved protocol from Ventana on our Ventana 
Benchmark XT.
Should we do another validation study using Ventana or another hospital that 
is using the FDA approved method?   Anybody understand what CAP is wanting 
and how to accomplish this?

James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor
Memorial Medical Center
217-788-4046


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