[ RadSafe ] Urinalysis and CLIA in the US
bjbagg at sbcglobal.net
Tue Aug 29 08:37:00 CDT 2006
I have recently been challenged, by an internal group in the company where I
work, that the urinalysis we conduct to assess internal radiation dose is
subject to the United States' Clinical Laboratory Improvement Amendments
(CLIA). I am the RSO for an Agreement State licensee in the US. Some in
our company are stating that our lab must be certified by CLIA, obtain an
exemption from CLIA requirements, or that we must send our samples out to a
CLIA certified lab for analysis.
I read the CLIA regulations, including the scope, applications and
definitions, and in my opinion, CLIA does not apply to the collection and
analysis of urine samples to assess internal radiation dose. CLIA is
clearly written to apply to clinical labs that assess samples from humans
for the diagnosis, prevention and/or treatment of disease. However, the
definitions are written rather broadly, unfortunately.
The CLIA regulations are codified at 42 CFR 493. The basis and scope states
"This part applies to all laboratories as defined under ``laboratory'' in
Sec. 493.2 of this part.". Laboratory is defined as "a facility for the
biological, microbiological, serological, chemical, immunohematological,
hematological, biophysical, cytological, pathological, or other examination
of materials derived from the human body for the purpose of providing
information for the diagnosis, prevention, or treatment of any disease or
impairment of, or the assessment of the health of, human beings.
As above, I could clearly argue that we are not diagnosing, preventing or
treating any disease, only assessing internal radiation dose for compliance
with the annual occupational dose limits. But, the "or the assessment of the
health of human beings" may be somewhat problematic to defend.
I've searched the HPS journal and NRC documents (and the DHHS website) to
see if there is anything stating that CLIA does not apply - but have been
unsuccessful. Does anyone know if this topic has been researched or
I have some documented ammunition to defend my position that Occupational
Dose Records are not governed by the US Health Insurance Portability and
Accountability Act (HIPAA) - something that they are also trying to state -
but can't seem to find any documentation on whether the collection of urine
samples for the assessment of internal radiation dose is applicable to CLIA.
Any help would be greatly appreciated.
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