No regulations that I can think of that stipulate a manufacturer produced
control material must have a certain FDA status for use in a clinical facility,
or that the producing facility must be CLIA or GLP. I think that manufacturers
want to create an impression of their product by promoting it if they are CLIA
licensed or a GLP facility. I know they often use pretty stringent quality
control, with lot tracking and provide a certificate of analysis ( showing
that they tested them in house and the results), with some control products.
Which does show a good faith effort to establish the reliability of the
control. However, since the burden of proving that any test system works in
house is on the user ( CLIA & CAP method validation), not the control producer,
it seems they might be off the hook for meeting a specific regulation or
accreditation requirement, especially with CLIA, since it is an old law
targeting clinical laboratories. It is not that big of a leap though, and I can
imagine that someone could argue that a faulty control could cause or
contribute to patient risk by leading to erroneous test interpretations ( enter
FDA regulations).
Manufacturers may not be bound to any specific legal requirements, but it seems
to me that it would be bad business if over time, their controls never worked
for any lab!
More research oriented people may be able to comment if control material is
used for FDA trials or other research, whether there is an actual legal,
regulatory or GLP requirement, that the source or distributor of controls be
CLIA, GLP or otherwise licensed or accredited for this type of work?
Joelle Weaver MAOM, HTL (ASCP) QIHC
> From: timothy.mor...@ucsfmedctr.org
> To: histonet@lists.utsouthwestern.edu
> Date: Tue, 16 Sep 2014 19:24:58 +0000
> Subject: [Histonet] Control block/slide regulation question
>
> 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
> USA
>
> 415.514-6042 (office)
> tim.mor...@ucsfmedctr.org<mailto:tim.mor...@ucsfmedctr.org>
>
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