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.