H.B. No. 988
1-1 AN ACT
1-2 relating to home collection kits for human immunodeficiency virus
1-3 infection testing; providing penalties.
1-4 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-5 SECTION 1. Chapter 85, Health and Safety Code, is amended by
1-6 adding Subchapter J to read as follows:
1-7 SUBCHAPTER J. HOME COLLECTION KITS FOR HIV INFECTION TESTING
1-8 Sec. 85.251. DEFINITIONS. In this subchapter:
1-9 (1) "Home collection kit" means a product sold to the
1-10 general public and used by an individual to collect a specimen from
1-11 the human body and to submit the specimen to a laboratory for
1-12 testing and a report.
1-13 (2) "Service provider" means the manufacturer of a
1-14 home collection kit or a person designated by the manufacturer to
1-15 provide the services required by this subchapter.
1-16 Sec. 85.252. PROHIBITIONS RELATING TO HOME COLLECTION KIT.
1-17 A person may not market, distribute, or sell a home collection kit
1-18 for HIV infection testing in this state unless the kit complies
1-19 with Chapter 431.
1-20 Sec. 85.253. PROHIBITIONS RELATING TO HOME TESTING. (a) A
1-21 person may not market, distribute, or sell a product to be used by
1-22 a member of the public to test a specimen collected from the human
1-23 body for HIV infection unless the kit complies with Chapter 431.
1-24 (b) This section does not apply to a product marketed,
2-1 distributed, or sold only to physicians or other persons authorized
2-2 by law to test for HIV infection a specimen collected from the
2-3 human body.
2-4 (c) A person may not require an individual to be tested for
2-5 HIV infection as provided in Section 81.102.
2-6 Sec. 85.254. PACKAGE OF SERVICES. A home collection kit for
2-7 HIV infection testing shall be sold as part of a package of
2-8 services that includes:
2-9 (1) laboratory testing by a qualified facility;
2-10 (2) reporting of test results;
2-11 (3) verification of positive test results;
2-12 (4) counseling as required by this subchapter; and
2-13 (5) information, upon request, describing how test
2-14 results and related information are stored by the service provider,
2-15 how long the information is retained, and under what circumstances
2-16 the information may be communicated to other persons.
2-17 Sec. 85.255. QUALIFIED FACILITY. A laboratory facility that
2-18 conducts testing of a specimen collected with a home collection kit
2-19 for HIV infection testing must comply with the Clinical Laboratory
2-20 Improvement Amendments of 1988 (42 U.S.C. Section 263a).
2-21 Sec. 85.256. ORAL REPORTING. A service provider shall
2-22 report test results from a home collection kit for HIV infection
2-23 testing orally to the individual tested. Notwithstanding Section
2-24 81.109, the test results may be provided by telephone.
2-25 Sec. 85.257. COUNSELING; COUNSELING PROTOCOLS. (a) A
2-26 service provider shall provide pretesting counseling to an
2-27 individual who is considering using a home collection kit for HIV
3-1 infection testing. This counseling may be provided orally by
3-2 telephone or through written information included with the home
3-3 collection kit.
3-4 (b) At the time the test results are reported to the
3-5 individual tested, the service provider shall provide counseling
3-6 and appropriate referrals for care and treatment.
3-7 (c) Counseling provided by a service provider, including
3-8 written information provided under Subsection (a) and referrals,
3-9 must conform with counseling protocols adopted by the board.
3-10 Except as provided by Section 85.256, the counseling protocols must
3-11 be consistent with the requirements of Section 81.109 and the
3-12 protocols adopted under Section 85.081.
3-13 (d) Counseling provided by a service provider under this
3-14 section must be provided in English and in Spanish. The board may
3-15 require a service provider to provide counseling in another
3-16 language if the board finds that the service provider is marketing
3-17 home collection kits in a community in which a significant portion
3-18 of the population speaks a language other than English or Spanish.
3-19 (e) A service provider, in providing counseling, may not:
3-20 (1) solicit the purchase of additional services or
3-21 products; or
3-22 (2) refer the individual being counseled to an entity:
3-23 (A) that is owned or controlled by the service
3-24 provider;
3-25 (B) that owns or controls the service provider;
3-26 (C) that is owned or controlled by an entity
3-27 that owns or controls the service provider; or
4-1 (D) that has another ongoing financial
4-2 relationship with the service provider.
4-3 Sec. 85.258. LABELING. (a) A home collection kit for HIV
4-4 infection testing shall meet the requirements of Chapter 431.
4-5 (b) In addition to the requirements in Subsection (a), the
4-6 labeling shall explain which persons and entities will have access
4-7 to the test results for the individual.
4-8 (c) In addition to the labeling requirements in Subsections
4-9 (a) and (b), a home collection kit labeled in Spanish must also be
4-10 available. The board may require a service provider to label a
4-11 home collection kit in another language if the board finds that the
4-12 service provider is marketing home collection kits in a community
4-13 in which a significant portion of the population speaks a language
4-14 other than English or Spanish.
4-15 Sec. 85.259. ENFORCEMENT. A home collection kit for HIV
4-16 infection testing is a "device" as that term is defined in Section
4-17 431.002 and is subject to the provisions for enforcement contained
4-18 in Chapter 431. Any violation of the requirement in Section 85.258
4-19 shall be subject to the enforcement provisions of Chapter 431.
4-20 Sec. 85.260. CONFIDENTIALITY. (a) Any statement that an
4-21 identifiable individual has or has not been tested with a home
4-22 collection kit for HIV infection testing, including a statement or
4-23 assertion that the individual is positive, is negative, is at risk,
4-24 or has or does not have a certain level of antigen or antibody, is
4-25 confidential as provided by Section 81.103.
4-26 (b) A person commits an offense if the person violates this
4-27 section. The punishment for an offense under this section is the
5-1 same as the punishment for an offense under Section 81.103.
5-2 Sec. 85.261. CERTAIN TECHNOLOGY PROHIBITED. A service
5-3 provider may not use technology that permits the service provider
5-4 to identify an individual to whom test results or counseling is
5-5 provided or to identify the telephone number from which that
5-6 individual is calling.
5-7 Sec. 85.262. REPORTS. A service provider shall report test
5-8 results from a home collection kit for HIV infection testing in the
5-9 manner provided by Subchapter C, Chapter 81.
5-10 SECTION 2. (a) The legislature encourages manufacturers of
5-11 home collection kits for human immunodeficiency virus infection
5-12 testing to make the kits available, at reduced cost, to appropriate
5-13 nonprofit organizations for use in human immunodeficiency virus
5-14 infection testing and counseling programs.
5-15 (b) It is the intent of the legislature that the use of home
5-16 collection kits for human immunodeficiency virus infection shall
5-17 not affect the accessibility of anonymous testing programs
5-18 established by the Texas Department of Health.
5-19 SECTION 3. The importance of this legislation and the
5-20 crowded condition of the calendars in both houses create an
5-21 emergency and an imperative public necessity that the
5-22 constitutional rule requiring bills to be read on three several
5-23 days in each house be suspended, and this rule is hereby suspended,
5-24 and that this Act take effect and be in force from and after its
5-25 passage, and it is so enacted.