[Histonet] Re: HER2 and the 48 hour rule

patsy ruegg pruegg <@t> ihctech.net
Sat Jan 27 19:07:21 CST 2007

I think CAP is addressing the issue of under fixed samples by saying that
your methods must be compared or validated against methods using a minimum
standard formalin fixation, if you do not fix long enough to protect the
sample from alcohol and xylene processing I don't think the samples are
going to stand up in this comparison with adequately formalin fixed samples
then paraffin processed which you have to demonstrate.  Alcohol and glycol
fixatives are a problem for her2 as it really loves alcohol and you may get
more positives when compared with adequate formalin fixation which should be
used as the standard.

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
RSRICHMOND <@t> aol.com
Sent: Tuesday, January 23, 2007 5:23 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Re: HER2 and the 48 hour rule

Here's a truly radical solution: if the pathologist on call comes in on 
Saturday (or Sunday) morning, let the pathologist embed the breast biopsies!
about time pathologists learned to embed.

Short of that revolutionary approach, I'd want the tissue to fix overnight, 
then be passed to 70% alcohol, then processed Sunday night. - But it isn't 
known that this approach works, and it doesn't comply with the rules (which
new, actually). But it's got to be preferable to leaving the specimen in 
xylene (or substitute) or in molten wax.

Don't forget the issue of non-formalin fixatives, including glyoxal - they 
haven't been tried. 

I'm more concerned about tissue that isn't left in formalin for long enough.

If it's not, it fixes in the processor in alcohol. I'm even more concerned 
about delay in fixation. In many radiology services, stereotactic and 
wire-localization specimens aren't placed in formalin until after specimen
radiography is 
completed and the specimen is leisurely taken to the pathology lab.

I was appalled, but not surprised, by the CAP's failure to address any of 
these issues.

Let's remind ourselves what's at stake here. HER2 status determines whether
patient is treated with trastuzumab (Herceptin), a $50,000 treatment with a 
potential for damaging the heart. Estrogen receptor determination is also 
affected by fixation, and expensive and hazardous treatment depends on that

The lack of concern about this issue by primary care physicians, surgeons, 
and oncologists once again underlines the "redhaired stepchild" status of 
anatomic pathology in the laboratory and in the health care system. Remember
when you read the newspapers and magazines and read that faceless
are responsible for all of these procedures.

Bob Richmond
Samurai Pathologist
Knoxville TN
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