Pre-employment/Team Health

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Does your Team Health department work under a separate CLIA then your laboratory does? Our Team Health department is wanting to start saliva drug screen pre-employment testing. They would be reading a preliminary result and sending out for confirmatory testing. I have been digging into what I can find regarding this and it seems a very grey area/fine line with CLIA requirements. This test is NOT waived, so does anyone know- would it be moderately complex requirements or does it change it over to a forensic type testing? Any info is appreciated!

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If this testing is done for pre-employment purposes (forensic) then it does not fall under CLIA, and you can ignore. If it will be used to treat or monitor patients, then it is considered a medical test and you will have to do all the things for a moderate complexity test, including a CLIA license, etc. Of course, you have to follow any state requirements.

This would be Quest Diagnostics Express Results saliva drug screen test. The Team Health nurses would read prelim results and then send to Quest for the confirmation. So this would be considered a forensic test and therefore be CLIA exempt? If that is the case then I would not need to ensure QC and proficiency testing requirements- correct? 

That is correct.

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