[Histonet] Re: IHC Validation

[Leslie Graves]

Thank you to everyone who sent a template.  This is very helpful.  I do
need clarfication on the 10 cases that are required for validation.  Do you
include the 10 cases on this same form, or do you have something separate
for that?  These look ideal for optimization.  From what I have read
online, 10 cases need to be run after optimization has been completed.
When validating these 10 cases, accuracy, sensitivity, specificity and
reproducibility need to be monitored.  Are all of you using separate form
to capture this data and approval from the Pathologists?  Maybe I am going
overboard, but I want to make sure that I have everything covered.  We are
bringing a new platform into our lab in 2 weeks, and I want to have
everything ready to go.

Leslie Graves
Technical Specialist
Cape Fear Valley Medical Center
Fayetteville, NC  28341
910-615-6142
lgrav <@t> capefearvalley.com

On Mon, Jul 14, 2014 at 1:55 PM, Leslie Graves <lsgraves70 <@t> gmail.com> wrote:

> Does anyone have a sample IHC Validation worksheet that they used in their
> lab for review.  I know that the requirements have changed since our last
> inspection.  I want to make sure that I am including all of the criteria,
> and would like to see how other labs are documenting this process.
>
> Leslie Graves
> Technical Specialist
> Cape Fear Valley Medical Center
> 1638 Owen Drive
> Fayetteville, NC 28341
> 910-615-6142
> lgrav <@t> capefearvalley.com
>