[Histonet] Re: Standardization??? 3, 000 Breast Cancer Specimens from Quebec Breast Cancer being retested

[Akemi Allison]

 From what I have experienced in my observations of various labs;  
numerous labs do not follow proper standardization practices which  
are set by FDA guidelines for Her2-neu.  Prognostic markers are  
particularly susceptible to heat. Baking slides in excess  
temperatures (over 62 degrees C) for prolonged lengths of time can  
also drop the antigenicity of the test tissues a full grade.  There  
has been documentation of this through publications.  Temperatures  
MUST be monotored and recorded. The Antigen Retrieval Process is very  
important and QC measures MUST be followed. Internal temperature and  
pressure MUST be met and recorded.  QC monitor strips will record and  
show any irregularities in this step. If the pressure and temp has  
not been met, the test should be repeated. A lot of IHC techs do not  
monitor this process.  Unfortunately, internal laboratory  
standardization can vary from shift to shift.  Just think about non- 
standardization practices throughout the country because of under- 
education and strict adherence to established guidelines.


Akemi Allison BS, HT (ASCP) HTL
Director
Phoenix Lab Consulting
Tele: 408.335.9994
E-Mail: akemiat3377 <@t> yahoo.com

On Apr 19, 2011, at 10:36 AM, Akemi Allison wrote:

> PhenoPath Laboratories Retests Nearly 3,000 Breast Cancer Specimens  
> from Quebec Breast Cancer specimens which may have been  
> misdiagnosed. In the re-analysis, results of which were just  
> announced, a total of 87 women were found to have received a false  
> negative result from the original pathology laboratory tests in  
> Quebec. Of this number, 39 were required to alter their treatment  
> and among them five women died. Minister of Health Yves Bolduc said  
> it was impossible to determine whether the women died as a result  
> of being improperly treated. Check out this link. http://www.ihc.co/ 
> a824362-seattle-based-phenopath-laboratories-retests-nearly-.cfm
>
>
> Akemi Allison BS, HT (ASCP) HTL
> Director
> Phoenix Lab Consulting
> Tele: 408.335.9994
> E-Mail: akemiat3377 <@t> yahoo.com
>
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