§325-17  Quality assurance standards for HIVantibody testing.  (a)  All laboratories performing screening anddiagnostic tests for the presence of the antibody to HIV (humanimmunodeficiency virus) shall follow the recommended protocols as set forthbelow.  Any test used for other than experimental purposes shall be approved bythe Food and Drug Administration (FDA) of the United States for the use towhich it is put.  Any initially reactive FDA-approved screening test must beconfirmed by a second test of the same type.  Any specimen yielding reactiveresults to both FDA-approved screening tests must have a supplemental testperformed such as a Western Blot, an IFA (immunofluorescence assay), or anantigen detection assay; provided that these standards may be superseded byrules adopted by the department pursuant to chapter 91.

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

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