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