[Histonet] Validation Protocols (ANP.23120)

Andrew Horvath ahorvath <@t> cogipath.com
Thu Jun 20 15:15:45 CDT 2013

The following is a copy of validation protocol I received from CAP...

Dear Andrew,


Here is the information for ANP.23120:


To validate a new processing schedule the user should run tissue samples
in duplicate. Side by side samples of the tissue that have been fixed
for the same amount of time and are of the same size and thickness.
Reagents on the processor should be of the same age and quality, i.e.
all fresh reagents. Process, embed cut and stain slides (at the same
time). The quality of the blocks should be evaluated on tissue quality
I.e. Firmness, ease of cutting etc. The slides can be blind evaluated
with the pathologist not knowing which processing schedule was used.
Grade on quality of section and staining quality. The new process
schedule must be of equal or better quality before put into use. 
This method can also be used when using the same processing schedule but
setting up a new processor of the same model or when setting up a new
brand of processor.
Multiple common tissue types should be evaluated. Fake biopsies can be
created so that patient tissues are not compromised. 


If you are changing a specific program on a single processor, like you
are adjusting the ties or reagents on a breast tissue program. You run
the first set of samples on the processor using the routine program and
the run the duplicate set of tissues on the same processor using the new
program to be validated. 

When validating programs for a new processor (especially when the new
processor is a new brand or different model) you run the first set of
tissues on the routine program on the old processor and the second set
using the same program on the new processor.

I hope this information has been helpful.




Arlene Clancy MBA MT(ASCP)SC

Technical Team, CAP Accreditation Programs

College of American Pathologists

Andrew Horvath, MBA, MA
Interim Operations Manager
303-770-4848 (O)
303-770-6641 (fax)
Colorado GI Pathology
7346 S. Alton Way
Suite 10E
Centennial, CO 80112
-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Matthew
Sent: Thursday, June 20, 2013 9:25 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Validation Protocols

Would anybody be willing to share their protocol/policy for the
of a new IHC stainer and/or tissue processor?
Matthew Roark- HT/HTL(ASCP)CM
Histology Specialist
Saint Francis Medical Center
211 Saint Francis Drive
Cape Girardeau, MO 63703
 <mailto:mroark <@t> sfmc.net> mroark <@t> sfmc.net
 <http://www.sfmc.net> http://www.sfmc.net
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