[ RadSafe ] Radiobioassay and FDA Approval

Stan Morton stan.morton at gel.com
Fri Mar 2 10:37:59 CST 2012

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in
1988 establishing quality standards for all laboratory testing to ensure the
accuracy, reliability and timeliness of patient test results regardless of
where the test was performed.  The Centers for Medicare & Medicaid Services
(CMS) regulates all laboratory testing (except research) performed on humans
in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).
The objective of the CLIA program is to ensure quality laboratory testing.
CLIA requires all facilities that perform even one test, including waived
tests, on "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"
to meet certain Federal requirements. If a facility performs tests for these
purposes, it is considered a laboratory under CLIA and must apply and obtain
a certificate from the CLIA program that corresponds to the complexity of
tests performed.
FDA 'approval' remains a cloud concept whose origin seems to be unknown.  I
do know that FDA has implemented new quality control regulations concerning
the preparations of all PET nuclides produced by accelerator technology.
Stan Morton
Stan Morton, Manager
Radiobioassay Programs
GEL Laboratories, LLC
From: Clayton J Bradt [mailto:CJB01 at health.state.ny.us] 
Sent: Friday, March 02, 2012 9:17 AM
To: stan.morton at gel.com
Cc: radsafe at health.phys.iit.edu
Subject: re: Radiobioassay and FDA Approval
Stan, what's the difference between "CLIA certification" and "FDA approval"?

Clayton J. Bradt
Principal Radiophysicist
NYS Dept. of Health
Biggs Laboratory, Room D486A
Empire State Plaza
Albany, NY 12201-0509


It is my personal opinion that the analysis of excreta material is only a
part of the dose-evaluation process.  As long as the laboratory reporting
the analytical results does not provide a dose estimate, there is no reason
to require FDA 'approval' should it exist.  It should be understood that the
laboratory be required to participate in the appropriate
performance-evaluation programs (i.e., DOELAP, NAVLAP, Oak Ridge, etc.) that
determine ability to provide an acceptable result.  I agree the laboratory
should be CLIA certified. 

Most HP/MDs that provide dose estimates employ computer programs as part of
the process, i.e. IMBA , DCAL, etc.  I know of no program within the FDA
that has the ability to evaluate these codes, or do I know of a program
within FDA that can issue 'approval' to an analytical laboratory to perform
radiobioassay work.  In fact, I know of no program in any form that
evaluates the entire dosimetric assessment process.  One can see a need. 

Stan Morton
Manger, Radiobioassay Programs
GEL Laboratories 

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