[Histonet] CAP question ANP.22978 - Her2 assay validation

[Martha Ward-Pathology]

Hello all,

I have been reading through the most recent revisions and want to see how others are handling this question.   The explanation states that it is for new and existing assays and that if your validation does not meet current standards that you must supplement and bring it into compliance.  Furthermore if you do not have any documentation from the initial validation the assay must be fully revalidated and documented.

Our lab has been performing the Herceptest from Dako (FDA approved) since before 2008 and participating in the HER2 proficiency testing since it was first offered.   We have our statistical results comparing our IHC patient results to FISH Her2 results since 2008 and we have always done well on our CAP proficiency testing (95%-100%).    We do inter-pathologist result comparisons, using know CAP slides and have 95% to 100% agreements.   

What I do not have however is the original results of the slides that were stained to set up the original assay.   Under these circumstances will we need to completely revalidate the assay, using the mandated 20+/20- cases, or can we simply do a retroactive formal review and write up of our past performances on our proficiency testing challenges?

Thanks in advance for your help with this!

 
Martha Ward, MT (ASCP) QIHC
Manager
 
Molecular Diagnostics Lab
Medical Center Boulevard  \  Winston-Salem, NC 27157