CLIA Equipment or Software Validation Requirements

I hope this is the right place for this question/thread. I've lurked around these forums for a while and you all seem generally helpful and so I will take a shot here.

I am looking at bringing in some new testing equipment for a portion of my company that operates under CLIA standards.

Does anyone know of any particular CLIA requirements for validation other than method validation? Specifically I'm looking to determine if there are any equipment and/or software validation requirements under CLIA.

I am not a CLIA specialist by any means and I have searched summarily through the online documents that I could find on CLIA and most speak exclusively about method validation only.

Thanks in advance, and my apologies if this topic belongs elsewhere!

CLIA = Clinical Laboratory Improvement Amendments?

Stijloor.

Yes, sorry, I should have been clearer. That's what CLIA stands for.

Erik said:

Yes, sorry, I should have been clearer. That's what CLIA stands for.

Click to expand...

Just for the benefit of our Members who may not be as familiar with this.

Thanks.

Stijloor.

Look at the thread tags.

If you look at the regulations 493.1250 requires "the laboratory to monitor and evaluate the overall quality of the analytic systems..." Section 493.1252 of the standard states Test systems, equipment, instruments, reagents, material and supplies. They use terminology such as "accurate and reliable test system operation". This implies to me that in order to meet the intent of the standard the equipment as well as the method needs to be validated to be consistent with the manufacturer's instructions.
Appendix C Interpretive Guidelines for Laboratories may also be helpful.