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.