§325-17  Quality assurance standards for HIV
antibody testing.  (a)  All laboratories performing screening and
diagnostic tests for the presence of the antibody to HIV (human
immunodeficiency virus) shall follow the recommended protocols as set forth
below.  Any test used for other than experimental purposes shall be approved by
the Food and Drug Administration (FDA) of the United States for the use to
which it is put.  Any initially reactive FDA-approved screening test must be
confirmed by a second test of the same type.  Any specimen yielding reactive
results to both FDA-approved screening tests must have a supplemental test
performed such as a Western Blot, an IFA (immunofluorescence assay), or an
antigen detection assay; provided that these standards may be superseded by
rules adopted by the department pursuant to chapter 91.



(b)  Any laboratory performing tests for the
presence of HIV may be required by the department of health to refer a sample
from any specimen yielding a reactive result to the department for the purpose
of supplemental testing of some or all samples for quality assurance purposes. 
The department may specify the information which shall accompany the specimen
for epidemiological purposes; provided that the information shall not include
any personal identifiers.



(c)  The penalty for any violation of this
section shall be as specified in section 325-14. [L 1988, c 165, §2; am L 1997,
c 217, §4]