By Maxey H.B. No. 988 74R4637 DLF-D 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, the 1-19 marketing, distribution, and sale of the kit, and the laboratory 1-20 testing and reporting for the kit comply with this subchapter. 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. 2-1 (b) This section does not apply to a product marketed, 2-2 distributed, or sold only to physicians or other persons authorized 2-3 by law to test for HIV infection a specimen collected from the 2-4 human body. 2-5 Sec. 85.254. PACKAGE OF SERVICES. A home collection kit for 2-6 HIV infection testing shall be sold as part of a package of 2-7 services that includes: 2-8 (1) laboratory testing by a qualified facility; 2-9 (2) reporting of test results; 2-10 (3) verification of positive test results; and 2-11 (4) counseling as required by this subchapter. 2-12 Sec. 85.255. QUALIFIED FACILITY. The board shall adopt 2-13 rules governing the requirements for a laboratory facility that 2-14 conducts testing of a specimen collected with a home collection kit 2-15 for HIV infection testing. The facility shall use testing methods 2-16 approved by the United States Food and Drug Administration. 2-17 Sec. 85.256. ORAL REPORTING. A service provider shall 2-18 report test results from a home collection kit for HIV infection 2-19 testing orally to the individual tested. Notwithstanding Section 2-20 81.109, the test results may be provided by telephone. 2-21 Sec. 85.257. COUNSELING; COUNSELING PROTOCOLS. (a) A 2-22 service provider shall provide pretesting counseling to an 2-23 individual who is considering using a home collection kit for HIV 2-24 infection testing. This counseling may be provided orally by 2-25 telephone or through written information included with the home 2-26 collection kit. 2-27 (b) At the time the test results are reported to the 3-1 individual tested, the service provider shall provide counseling 3-2 and appropriate referrals for care and treatment. 3-3 (c) Counseling provided by a service provider, including 3-4 written information provided under Subsection (a) and referrals, 3-5 must conform with counseling protocols adopted by the board. 3-6 Except as provided by Section 85.256, the counseling protocols must 3-7 be consistent with the requirements of Section 81.109 and the 3-8 protocols adopted under Section 85.081. 3-9 (d) Counseling provided by a service provider under this 3-10 section must be provided in English and in Spanish. The board may 3-11 require a service provider to provide counseling in another 3-12 language if the board finds that the service provider is marketing 3-13 home collection kits in a community in which a significant portion 3-14 of the population speaks a language other than English or Spanish. 3-15 (e) A service provider, in providing counseling, may not: 3-16 (1) solicit the purchase of additional services or 3-17 products; and 3-18 (2) refer the individual being counseled to an entity: 3-19 (A) that is owned or controlled by the service 3-20 provider; 3-21 (B) that owns or controls the service provider; 3-22 (C) that is owned or controlled by an entity 3-23 that owns or controls the service provider; or 3-24 (D) that has another ongoing financial 3-25 relationship with the service provider. 3-26 Sec. 85.258. LABELING. (a) The board by rule shall adopt 3-27 labeling requirements for home collection kits for HIV infection 4-1 testing. 4-2 (b) The labeling requirements must: 4-3 (1) state any limitations on the appropriate use of 4-4 the kit for particular individuals, including any limitation on the 4-5 age of the individual from whom a specimen is to be collected; 4-6 (2) describe any procedures necessary for safe use of 4-7 the kit; 4-8 (3) state legal prohibitions against an employer or 4-9 other person requiring an individual to be tested for HIV 4-10 infection, including the prohibition of Section 81.102, and refer 4-11 the individual to appropriate sources for additional information on 4-12 these prohibitions; 4-13 (4) explain which persons and entities will have 4-14 access to the test results for the individual; 4-15 (5) describe how the individual will be advised of the 4-16 test results; and 4-17 (6) describe how test results and related information 4-18 are stored by the service provider, how long the information is 4-19 retained, and under what circumstances the information may be 4-20 communicated to other persons. 4-21 (c) Each home collection kit must be labeled as required by 4-22 this section in English and in Spanish. The board may require a 4-23 service provider to label a home collection kit in another language 4-24 if the board finds that the service provider is marketing home 4-25 collection kits in a community in which a significant portion of 4-26 the population speaks a language other than English or Spanish. 4-27 Sec. 85.259. MARKETING. (a) The board shall adopt rules 5-1 governing the marketing and distribution of home collection kits 5-2 for HIV infection testing. 5-3 (b) A person may not sell a home collection kit for HIV 5-4 infection testing to a person younger than 18 years of age. 5-5 Sec. 85.260. CONFIDENTIALITY. (a) Any statement that an 5-6 identifiable individual has or has not been tested with a home 5-7 collection kit for HIV infection testing, including a statement or 5-8 assertion that the individual is positive, negative, at risk, or 5-9 has or does not have a certain level of antigen or antibody, is 5-10 confidential as provided by Section 81.103. 5-11 (b) A person commits an offense if the person violates this 5-12 section. The punishment for an offense under this section is the 5-13 same as the punishment for an offense under Section 81.103. 5-14 Sec. 85.261. CERTAIN TECHNOLOGY PROHIBITED. A service 5-15 provider may not use technology that permits the service provider 5-16 to identify an individual to whom test results or counseling is 5-17 provided or to identify the telephone number from which that 5-18 individual is calling. 5-19 Sec. 85.262. REPORTS. A service provider shall report test 5-20 results from a home collection kit for HIV infection testing in the 5-21 manner provided by Subchapter C, Chapter 81. 5-22 Sec. 85.263. CONFORMITY WITH FEDERAL LAW. If the board 5-23 determines that any part of this subchapter conflicts with federal 5-24 law, the board shall: 5-25 (1) suspend enforcement of that part of the subchapter 5-26 to the extent necessary to conform to federal law; and 5-27 (2) notify the speaker of the house of representatives 6-1 and the lieutenant governor of the suspension. 6-2 Sec. 85.264. CRIMINAL PENALTY. (a) A person commits an 6-3 offense if the person violates this chapter or a rule adopted by 6-4 the board under this chapter. 6-5 (b) An offense under this section is a Class C misdemeanor. 6-6 (c) This section does not apply to an offense under Section 6-7 85.260. 6-8 Sec. 85.265. MARKETING, DISTRIBUTION, OR SALE PROHIBITED 6-9 BEFORE JANUARY 1, 1996. (a) A person may not market, distribute, 6-10 or sell a home collection kit for HIV infection testing in this 6-11 state before January 1, 1996. 6-12 (b) A person commits an offense if the person violates this 6-13 section. An offense under this subsection is a Class C 6-14 misdemeanor. 6-15 (c) This section expires January 1, 1996. 6-16 SECTION 2. The legislature encourages manufacturers of home 6-17 collection kits for human immunodeficiency virus infection testing 6-18 to make the kits available, at reduced cost, to appropriate 6-19 nonprofit organizations for use in human immunodeficiency virus 6-20 infection testing and counseling programs. 6-21 SECTION 3. (a) This Act takes effect September 1, 1995. 6-22 (b) Not later than December 31, 1995, the Texas Board of 6-23 Health shall adopt rules necessary to implement Subchapter J, 6-24 Chapter 85, Health and Safety Code, as added by this Act. 6-25 (c) An offense committed under Section 85.265, Health and 6-26 Safety Code, as added by this Act, before January 1, 1996, is 6-27 covered by the law in effect when the offense was committed, and 7-1 that law is continued in effect for this purpose. For purposes of 7-2 this subsection, an offense is committed before January 1, 1996, if 7-3 any element of the offense occurs before that date. 7-4 SECTION 4. The importance of this legislation and the 7-5 crowded condition of the calendars in both houses create an 7-6 emergency and an imperative public necessity that the 7-7 constitutional rule requiring bills to be read on three several 7-8 days in each house be suspended, and this rule is hereby suspended.