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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Amos Brooks Sent: Monday, March 14, 2011 6:04 PM To: histonet@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 _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet