[Histonet] Control block/slide regulation question

Joelle Weaver joelleweaver <@t> hotmail.com
Tue Sep 16 16:18:12 CDT 2014

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