[Histonet] Control block/slide regulation question

Morken, Timothy Timothy.Morken <@t> ucsfmedctr.org
Tue Sep 16 14:24:58 CDT 2014

Histonetters,  question came up about whether there are any regulations concerning where control blocks or slides are made. Specifically, whether a control TMA block must be made in a CLIA certified lab, as opposed to a research core facility.

I don't think there are any such regulations but would like to hear from anyone who has other knowledge. From what I know all that is required is that the TMA block/slides be validated per CLIA regulations within the CLIA -certified lab that is using them.

I've never known a vendor of controls to give any information concerning any type of FDA regulatory designation (IVD) either. So are they regulated at all? (maybe I should not even ask at the risk of giving them some bright ideas!?).

Tim Morken
Supervisor, Histology, Electron Microscopy and Neuromuscular Special Studies
UC San Francisco Medical Center

415.514-6042  (office)
tim.morken <@t> ucsfmedctr.org<mailto:tim.morken <@t> ucsfmedctr.org>

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