[Histonet] Research and Clinical Labs

[Liz Chlipala]

Amos

We are a GLP compliant contract research lab, and we are currently in
the process of applying for a CLIA accreditation.  I don't see why you
would need to have separate equipment, etc.  In our case we will not be
processing standard diagnostic samples but we feel that the CLIA
accreditation will be good for us to have in order to process clinical
trial study samples.  Maybe Haji or someone from Phenopath labs can
comment I believe both of those labs are both CLIA accredited and GLP
compliant.

Liz

Elizabeth A. Chlipala, BS, HTL(ASCP)QIHC
Manager
Premier Laboratory, LLC
PO Box 18592
Boulder, Colorado 80308
office (303) 682-3949 
fax (303) 682-9060
www.premierlab.com
 
 
Ship to Address:
1567 Skyway Drive, Unit E
Longmont, Colorado 80504

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Amos
Brooks
Sent: Monday, March 14, 2011 6:04 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Research and Clinical Labs

Hi,
    Let me preface this by stating that I don't think this is a good
idea
and it is not what we are doing here. I have a hypothetical question
though.
What would be the regulatory ramifications of merging a research lab
testing
animal specimens (not regulated by any agencies other than Best
Practices
and OSHA) with a traditional (CAP, JACHO) clinical histology lab. What
equipment, if any, could be shared? In the event of a worst case
scenario
(like an inspector noticing mouse tissue and human tissue on the same
processor at the same time or expired chemicals not labeled "research
use
only") which regulations would be violated and how would one find out
potential fines that could be incurred. I have heard that there are labs
that are doing this. What precautions should a lab take if they end up
venturing down this path.

Thanks,
Amos
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