[Histonet] RE: breast fixation times

Weems, Joyce JWeems <@t> sjha.org
Wed Oct 27 11:22:08 CDT 2010

Thanks for this good explanation, Bill.

One can not follow the guidelines and document the variant in the report, but not following them could hurt the patient if there is a clinical trial they might participate in. Clinical trials follow the protocol to the letter and if the FDA requirement is not met, the patient can not participate. 

The times were extended for ER and PR to 72 hours, but NOT yet for Her2. So...because the tissue is all the same, we must follow the 48 hour limit. We just had a case this weekend. Had the clinical staff remove it from the processor on Sun morning and embedded it Monday. We don't ususally have this problem as we are a 6-day lab, but it was finished too late on Fri. 


Joyce Weems 
Pathology Manager 
Saint Joseph's Hospital 
5665 Peachtree Dunwoody Rd NE 
Atlanta, GA 30342 
678-843-7376 - Phone 
678-843-7831 - Fax 

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Tench, Bill
Sent: Wednesday, October 27, 2010 11:50
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] breast fixation times

There is no exception for core biopsies, as reasonable as that may seem.
I have had that discussion with the purveyors of the guidelines.  6-48 is the current standard.  there was a lot of discussion about exceeding
48 and using the FISH option.  My colleague responsible for this wrote:
It is in the CAP checklist, ANP 22998:

If the laboratory assesses Her2 by IHC or Her2 gene amplification by in-situ hybridization (FISH, CISH, SISH), does the lab have a documented procedure for ensuring appropriate length of fixation of specimens tested? 

Specimens subject to Her2 testing should be fixed in 10% neutral buffered formalin for at least 6 hours and no longer than 48 hours.
While fixation outside of these time limits is not an absolute exclusion criterion for Her2 testing, labs should qualify any negative results for specimens fixed less than 6 hours or longer than 48 hours. For cases with negative results by IHC, consideration should be given to performing confirmatory analysis by in-situ hybridization. 

 There is also a table in the original ASCO/CAP Guideline Recommendations for Her2 in Breast Cancer (Arch Pathol Lab Med, Vol 131, Jan 2007) that states that tissue fixed in formalin for greater than 48 hours is not an absolute exclusion criterion, but if known to be fixed longer than 48 hours or unknown, the report should qualify any negative result with this information (table 6). 

As for upcoming changes, i don't know other than these time limitations are suppose to be more rigorously applied to ER and PR, along with the newly instituted documentation of time between excision and time placed in fixative.
Bill Tench
Associate Dir. Laboratory Services
Chief, Cytology Services
Palomar Medical Center
555 E. Valley Parkway
Escondido, California  92025
Bill.Tench <@t> pph.org
Voice: 760- 739-3037
Fax: 760-739-2604

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