[Histonet] RE: New CAP question

[Laurie Colbert]

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


________________________________
This message (including any attachments) contains confidential
information intended for a specific individual and purpose, and is
protected by law. If you are not the intended recipient, you should
delete this message. Any disclosure, copying, or distribution of this
message, or the taking of any action based on it, is strictly
prohibited.
_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet


NOTICE OF CONFIDENTIALITY

This message, including any attachments, is intended only for the sole
use of the addressee and may contain confidential or privileged
information that is protected by the State of Kentucky and/or Federal
regulations.  If you are not the intended recipient, do not read, copy,
retain or disseminate this message or any attachment. If you have
received this message in error, please call the sender immediately at
(859)258-4000 and delete all copies of this message and any attachment.
Any unauthorized review, use, disclosure, copying or distribution is
strictly prohibited.  Neither the transmission of this message or any
attachment, nor any error in transmission or misdelivery shall
constitute waiver of any applicable legal privilege. 


_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet

_______________________________________________
Histonet mailing list
Histonet <@t> lists.utsouthwestern.edu
http://lists.utsouthwestern.edu/mailman/listinfo/histonet