RE: [Histonet] New CAP Regulations - Breast Tissue Must Be Fixed inFormalin

From:"Lance Erickson"

There is a new CAP checklist for Anatomic Pathology that was updated on the CAP website October 5th. These changes are effective September 27, 2007. All of the new checklist questions involve Her2 testing both IHC and FISH. And actually there is a question that addresses the use of fixatives other than formalin. Look at the notes section of question ANP 22997 you must validate your method with a minimum of 25 (recommended 25-100)and if you use a fixative other than formalin you must show that the results are concordant with the results from formalin-fixed tissues. The next new question specifically addresses the length of time in fixative. Take a look at these new questions at go to the "accreditation and laboratory improvement" tab under the inspection information click the "inspection checklists" and print off the new AP questions. -Lance, Primary Children's, SLC,UT   

-----Original Message-----
From: [] On Behalf Of Rene J Buesa
Sent: Thursday, October 18, 2007 3:19 PM
To: Jones, Laura; Histonet (E-mail)
Subject: Re: [Histonet] New CAP Regulations - Breast Tissue Must Be Fixed inFormalin

This CAP (and FDA) regulation is a hindrance in any efforts to eliminate carcinogenic  formalin from the histo lab, but has to be followed to be in compliance, or to participate in studies about breast cancer.
  This fact does not qualify for a special treatment/charge.
  René J.

"Jones, Laura"  wrote:
  Hi all. I am wondering if anyone else out there is NOT using formalin on a routine basis any more, and now must bring it back in order to comply with the new CAP regulation. We routinely process everything in Shandon's Glyofixx. Our Pathologist would like to have breast tissues only submitted in formalin, left overnight to fix, and then process from alcohols on during the next day. He feels that the small biopsies will be our main concern, as these are what we usually send for ER/PR, Her2Neu and FISH. If anyone else is going through this same situation, we'd appreciate hearing how you are handling this. 

Also, a question from my managers: in this situation, can we charge anything for the "special" treatment of the tissue? My feeling was this it was kind of our "fault" that we had to do this, so there probably could not be a charge, but I told them I'd ask the experts. Thanks to all in advance.

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