CLIA

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

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.


Lester Slaback
NBSR Health Physics
Center for Neutron Research
NIST
Gaithersburg, MD  20899
301 975-5810