Statutes, codes, and regulations
New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTHChapter II - Administrative Rules and RegulationsSubchapter D - LaboratoriesPart 58 - Clinical Laboratories And Blood Banks
Subpart 58-8 - Human Immunodeficiency Virus (hiv) Testing
Section 58-8.1 - Definitions

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-8.1

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Current through Register Vol. 46, No. 50, December 11, 2024
Section 58-8.1 - Definitions

For the purposes of this Subpart, unless the context indicates otherwise, the terms below shall have the following meanings:

(a) Department means the New York State Department of Health.
(b) Donor means a human being, living or dead, who is the source or potential source of a body, organ, tissue or fluid for transfusion, transplantation, transfer, artificial insemination or implantation.
(c) FDA means the Food and Drug Administration of the United States Department of Health and Human Services.
(d) HIV antibody screening means the performance of tests to detect HIV antibodies, which tests are not sufficiently specific to ensure definitive evidence of HIV infection.
(e) HIV identification testing means the performance of tests or characterize HIV or HIV viral components, including, but not limited to, HIV protiens and HIV nucleic acid. HIV identification testing shall also include cultivation of the infectious virus.
(f) HIV confirmatory testing means the performance of one or more supplemental tests to substantiate or refute results of HIV testing procedures that are not sufficiently specific to ensure definitive evidence of HIV infection.
(g) HIV diagnostic testing means the performance of HIV tests for purposes of diagnosing, assessing or monitoring HIV infection in persons who may have been exposed to HIV, are at risk of exposure to HIV, or are known to be HIV-infected, but shall not include testing of donors. HIV testing of individuals in conjunction with an application for insurance shall be considered HIV diagnostic testing whenever test results are communicated to the applicant or his/her medical provider by the insurance company's medical director or a consulting physician or a physician under the medical director's supervision.
(h) Preliminary finding of HIV infection means results of antibody screening that have been neither substantiated nor refuted by HIV confirmatory testing.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-8.1