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RULE §97.131Definitions

The following words and terms when used in this subchapter shall have the following meanings unless the context clearly indicates otherwise.

  (1) Acute HIV Infection--The stage immediately following HIV infection, as identified by clinical symptoms, history of exposure, and/or specific laboratory results. This includes, but is not limited to, a case that has a documented negative or indeterminate HIV test result that occurred no more than 180 days prior to the initial positive HIV test result.

  (2) AIDS and HIV Infection--Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) infection are as defined by the Centers for Disease Control and Prevention (CDC) and in accordance with the Health and Safety Code, §81.101.

  (3) Contract Research Organization (CRO)--An organization that is contracted by pharmaceutical, biotechnology, or medical device industries to provide various aspects of the clinical research process. A CRO may provide such services as clinical trials management and laboratory testing.

  (4) Drug Resistance Testing--Genotypic testing that identifies the nucleotide sequence and uses the resulting sequence to identify strains resistant to specific types of drug therapies.

  (5) Health professional--An individual whose:

    (A) vocation or profession is directly or indirectly related to the maintenance of the health of another individual or of an animal; and

    (B) duties require a specified amount of formal education and may require a special examination, certificate or license, or membership in a regional or national association.

  (6) HIV-Exposed Infant--Any infant suspected of HIV exposure through mother to child transmission.

  (7) Nucleotide Sequence--The relative order of base pairs in a fragment of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), a gene, a chromosome, or an entire genome.

  (8) Point of Care Tests--Analytic tests performed at or near the site of patient care outside of a laboratory setting.

  (9) Screening Test--The initial analytical test used to preliminarily detect the presence of disease. Positive screening test results should be followed by a supplemental test to verify the presence of that disease.

  (10) Sexually transmitted disease (STD)--An infection, with or without symptoms or clinical manifestations, that is or may be transmitted from one person to another during or as a result of sexual relations, and that produces or might produce a disease in, or otherwise impair, the health of either person, or might cause an infection or disease in a fetus in utero or a newborn. For purposes of this subchapter, the term "STD" refers to the following reportable conditions: HIV (including AIDS); chancroid; Chlamydia trachomatis; Neisseria gonorrhea; and syphilis infections. Each of these conditions is as defined by CDC.

  (11) Stages of HIV Infection--For purposes of this subchapter, HIV infection is classified into four stages (stage 0, 1, 2, or 3). The CDC definition of each stage is incorporated here by reference (see http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6303a1.htm?s_cid=rr6303a1_).

  (12) Supplemental test--The subsequent test or tests in a diagnostic testing algorithm that are performed following a preliminary positive on the initial/screening test. Positive or reactive results on supplemental tests, when performed in a specific sequence as part of a diagnostic algorithm, confirm disease infection. However, supplemental tests, when run outside of a testing algorithm, are not necessarily sufficient to diagnose infection.

Source Note: The provisions of this §97.131 adopted to be effective January 1, 1999, 23 TexReg 12668; amended to be effective August 5, 2001, 26 TexReg 5819; amended to be effective January 1, 2010, 34 TexReg 9445; amended to be effective October 14, 2015, 40 TexReg 7234

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