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: akemiat3...@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: akemiat3...@yahoo.com
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