[Histonet] RE: New CAP question

Thu Aug 25 12:32:44 CDT 2011

Yes, but I don't think this has always been the case, or at least it
hasn't been strictly enforced.  With all of the new specific CAP
guidelines regarding validation, it is not only a requirement now, but
the expectations/requirements are more clearly spelled out.  When I
started here in 2000, we had a Ventana ES IHC stainer and had no
validation records.  When we received a new IHC stainer in 2001, we
validated but the records we kept were very insufficient.  When we
upgraded again this year, we followed the CAP checklist requirements
(and I took several validation classes at NSH last year), and the
process was very extensive and time-consuming - but I have lots and lots
of documentation to show the inspectors.
Laurie

-----Original Message-----
From: Podawiltz, Thomas [mailto:tpodawiltz <@t> lrgh.org] 
Sent: Thursday, August 25, 2011 10:05 AM
To: Laurie Colbert; Vickroy, Jim; Martha Ward; Carol Bryant;
histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] RE: New CAP question

I might be wrong here but I thought that each time that you brought in
new testing, you had to validate it at that time, then had to keep those
records for the life of the test, plus a couple of years. 

Tom Podawiltz HT (ASCP)
Histology Section Head/Laboratory Safety Officer. 

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Laurie
Colbert
Sent: Thursday, August 25, 2011 12:46 PM
To: Vickroy, Jim; Martha Ward; Carol Bryant;
histonet <@t> lists.utsouthwestern.edu
Subject: RE: [Histonet] RE: New CAP question

I think it may depend on the inspector.  We had something similar happen
in Cytology during inspection.  They had no validation records for their
Thin Prep processing, which they had been doing for years.  They were
required to validate and provide documentation to CAP.
Laurie Colbert

-----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 9:31 AM
To: Martha Ward; Carol Bryant; histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] RE: New CAP question

I hope you're correct.

James Vickroy BS, HT(ASCP)

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

-----Original Message-----
From: Martha Ward [mailto:mward <@t> wakehealth.edu] 
Sent: Thursday, August 25, 2011 11:30 AM
To: Carol Bryant; Vickroy, Jim; histonet <@t> lists.utsouthwestern.edu
Subject: RE: New CAP question

We too have been performing ER and PR for at least 15 years, participate
in CAP proficiency testing and, when we switched staining platforms a
few years ago, validated the new antibody we switched to.   I have
interpreted the standard as necessary if you are introducing ER/PR in
your lab.  In my opinion you would not have to go back and revalidate
something you did years ago just to have something to show at inspection
time.  We had our CAP inspection this summer and a similar question
pertains to the HER2 assay, which we have also been doing for many
years, and that is what I told our inspector, which seemed to satisfy
them. 

Martha Ward, MT (ASCP) QIHC
Manager, Molecular Diagnostics Lab
Dept. of Pathology
Wake Forest Baptist Medical Center
Winston-Salem, NC 27157
336-716-2104

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Carol
Bryant
Sent: Thursday, August 25, 2011 12:10 PM
To: 'Vickroy, Jim'; histonet <@t> lists.utsouthwestern.edu
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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