Re: CLIA

[rkathren@tricity.wsu.edu (Ron L. Kathren)]

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>
>
>