[ RadSafe ] CLIA Certification for Radiobioassay Labs?

[Bob Shannon]

I am interested in requirements for CLIA certification for radiobioassay
laboratories. Labs performing radiobioassay tend to have certification
although I can say from having visited quite a few labs, that this is not
universally the case. 

 

In looking at the CLIA application, only two tests listed under
radiobioassay: 'Red cell volume' and 'Schilling's test'.  I do not see that
any radiochemical tests are listed.

 

Can anyone tell me whether a laboratory that performs contract radiochemical
determinations of uranium or other radionuclides in urine and feces (i.e.
they perform measurements in support of, but do not administer the internal
dosimetry program and do not perform any dose assessment or ever directly
interface with the subjects of investigation) are required to maintain CLIA
certification?  If so, what is the specific source of the requirement and
who is responsible for regulatory oversight in this area?

 

Thanks for your help in this matter. 

 

 

Bob Shannon 

QRS, LLC

Denver, CO

Tel: 303-432-1137