Re: CLIA

[Robert Loesch <loesch@list.eh.doe.gov>]

My interpretation is that hair, nasal smears and saliva wipes would be
included
but not in vivo counting facilities since no samples are obtained from a
human.
Like Les has stated, the key to this effort is the assessment of health.
However,
playing devils advocate, one could argue that if an individual were exposed
"unknowingly" to accident levels of a transuranic, then a misanalysis (i.e.
the
lab falsely reporting a negative) could have potential health implications.
 DOE is
taking the following steps: first, our GC will be requested to determine if
DOE is exempt
per the Atomic Energy Act; and second, communicate with HCFA our
interpretation
and formally request a determination if CLIA is applicable. If HCFA asserts
(and our GC
agrees) that CLIA is applicable to this category of samples, then DOE will
probably
request that our DOELAP for Radiobioassay be accepted as demonstration of
compliance.
This would cover DOE facilities, but it let NRC licensees and DoD
facilities out on a limb
since, currently, DOELAP is only available to DOE facilities.


At 10:44 AM 4/23/98 -0500, you wrote:
>Les and all --
>
>It would seem that these are applicable to laboratories doing hair analysis
>as well as to every nuclear medicine laboratory in the U.S., according to
>the definition of 'laboratory'.  One could even interpret this to include
>all health physics and industrial hygiene laboratories, and especially in
>vivo counting facilities, since these clearly either provide information for
>diagnosis and prevention of disease and the assessment of health in human
>beings.
>
>Ron
>
>
>
>At 09:45 AM 4/23/98 -0500, Les Slaback wrote:
>>Bob Loesch was a bit cryptic in his reference to CLIA, and the assertion
>that bioassay programs are subject to its provisions.  FYI a bit more info
>follows:
>>
>>
>>It is reported that HEW is asserting that organizations conducting bioassay
>programs are subject to the requirements of CLIA, and are requiring
>contracted services to meet CLIA requirements.  This certainly appears to be
>well beyond the stage of a rumor.  
>>
>>
>>CLIA rules are in 42CFR493.  The stated purpose of this section is
>>
>>
>>Sec. 493.1  Basis and scope.
>>
>>    This part sets forth the conditions that all laboratories must meet to
>be certified to perform testing on human specimens under the Clinical
>Laboratory Improvement Amendments of 1988 (CLIA). It implements sections
>1861 (e) and (j), the sentence following section 1861(s)(13), and 1902(a)(9)
>of the Social Security Act, and section 353 of the Public Health Service
>Act. This part applies to all laboratories as defined under ``laboratory''
>in Sec. 493.2 of this part. This part also applies to laboratories seeking
>payment under the Medicare and Medicaid programs. The requirements are the
>same for Medicare approval as for CLIA certification.
>>
>>
>>The definition of laboratories is.....
>>
>>    Laboratory means 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. These examinations also include
>procedures to determine, measure, or otherwise describe the presence or
>absence of various substances or organisms in the body. Facilities only
>collecting or preparing specimens (or both) or only serving as a mailing
>service and not performing testing are not considered laboratories.
>>
>>
>>****Note - " for purpose of health assessment"***
>>
>>
>>My comment....
>>
>>Bioassays conducted by most radiation protection program are for the
>purpose of regulatory compliance, not health assessment.  Radiation
>exposures within regulatory limits have no direct or immediate health
>impact.  As such it would appear that this regulation is not applicable by
>definition.  Aside from that the purpose of the act was to correct
>conditions relating to the health evaluation and treatment of people.
>Bioassay programs serve no purpose in this regard.
>>

>>
>>In the section titled applicability ....
>>
>>
>>Sec. 493.3  Applicability.
>>
>>    (a) Basic rule. Except as specified in paragraph (b) of this section, a
>laboratory will be cited as out of compliance with section 353 of the Public
>Health Service Act unless it--
>>
>>    (1) Has a current, unrevoked or unsuspended certificate of waiver,
>registration certificate, certificate of compliance, certificate for PPM
>procedures, or certificate of accreditation issued by HHS applicable to the
>category of examinations or procedures performed by the laboratory;
>>
>>or
>>
>>    (2) Is CLIA-exempt.
>>
>>    (b) Exception. These rules do not apply to components or functions of--
>>
>>    (1) Any facility or component of a facility that only performs testing
>for forensic purposes;
>>
>>    (2) 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; or
>>
>>    (3) Laboratories certified by the National Institutes on Drug
>Abuse(NIDA), in which drug testing is performed which meets NIDA guidelines
>and regulations. However, all other testing conducted by a NIDA-certified
>laboratory is subject to this rule.
>>
>>    (c) Federal laboratories. Laboratories under the jurisdiction of an
>agency of the Federal Government are subject to the rules of this part,
>except that the Secretary may modify the application of such requirements as
>appropriate.
>>
>>
>>It would appear that most federal organizations would be exempt under (b)2
>or under (c), and most universities under (b)(2).
>>
>>
>>This may be a tempest in a teapot BUT application of this added set of
>regulations would appear to have no benefit for the at-this-point unknown
>added costs.  As Bob indicated, added personal research might be in order.
>His personal comments to me indicated that this was well beyond a rumor.
>>
>>
>>
>><color><param>0000,ffff,ffff</param>Lester Slaback
>>
>>NBSR Health Physics
>>
>>Center for Neutron Research
>>
>>NIST
>>
>>Gaithersburg, MD  20899
>>
>>301 975-5810</color>
>>
>>
>