CLIA

[Les Slaback <lester.slaback@nist.gov>]

You may recall a prior discussion of the applicability of CLIA to bioassay
procedures, and an interpretation that CLIA does apply and is being
enforced upon certain DoE operations.  I offer the following legal opinion
obtained from an agency lawyer ....

I concur in your
assessment that these activities are outside the coverage of the CLIA
requirements under 42 CFR 493.3(b)(2), which states that "These rules do
not apply to components or functions of research laboratories that test
human specimens but do not report patient specific results for the
diagnosis, prevention or treatment of any disease or impairment of, or the
assessment of the health of individual patients."

So for those losing sleep worrying on this issue note that there is at
least one differing
legal opinion.
Disclaimer:  the above are the personal musings of the author, and do not
represent any past, present, or future position of NIST, the U.S. government,
or anyone else who might think that they are in a position of authority. 
Lester Slaback, Jr.  [Lester.Slaback@NIST.GOV] 
NBSR Health Physics 
Center for Neutron Research 
NIST 
Gaithersburg, MD  20899 
301 975-5810