1-1 By: Maxey, et al. (Senate Sponsor - Gallegos) H.B. No. 988
1-2 (In the Senate - Received from the House March 15, 1995;
1-3 March 16, 1995, read first time and referred to Committee on Health
1-4 and Human Services; April 5, 1995, reported favorably, as amended,
1-5 by the following vote: Yeas 7, Nays 0; April 5, 1995, sent to
1-6 printer.)
1-7 COMMITTEE AMENDMENT NO. 1 By: Gallegos
1-8 Amend H.B. 988, Sec. 85.257 as follows: on page 2, line 15, after
1-9 the word "products;" delete the word "and" and insert the word "or"
1-10 A BILL TO BE ENTITLED
1-11 AN ACT
1-12 relating to home collection kits for human immunodeficiency virus
1-13 infection testing; providing penalties.
1-14 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1-15 SECTION 1. Chapter 85, Health and Safety Code, is amended by
1-16 adding Subchapter J to read as follows:
1-17 SUBCHAPTER J. HOME COLLECTION KITS FOR HIV INFECTION TESTING
1-18 Sec. 85.251. DEFINITIONS. In this subchapter:
1-19 (1) "Home collection kit" means a product sold to the
1-20 general public and used by an individual to collect a specimen from
1-21 the human body and to submit the specimen to a laboratory for
1-22 testing and a report.
1-23 (2) "Service provider" means the manufacturer of a
1-24 home collection kit or a person designated by the manufacturer to
1-25 provide the services required by this subchapter.
1-26 Sec. 85.252. PROHIBITIONS RELATING TO HOME COLLECTION KIT.
1-27 A person may not market, distribute, or sell a home collection kit
1-28 for HIV infection testing in this state unless the kit complies
1-29 with Chapter 431.
1-30 Sec. 85.253. PROHIBITIONS RELATING TO HOME TESTING. (a) A
1-31 person may not market, distribute, or sell a product to be used by
1-32 a member of the public to test a specimen collected from the human
1-33 body for HIV infection unless the kit complies with Chapter 431.
1-34 (b) This section does not apply to a product marketed,
1-35 distributed, or sold only to physicians or other persons authorized
1-36 by law to test for HIV infection a specimen collected from the
1-37 human body.
1-38 (c) A person may not require an individual to be tested for
1-39 HIV infection as provided in Section 81.102.
1-40 Sec. 85.254. PACKAGE OF SERVICES. A home collection kit for
1-41 HIV infection testing shall be sold as part of a package of
1-42 services that includes:
1-43 (1) laboratory testing by a qualified facility;
1-44 (2) reporting of test results;
1-45 (3) verification of positive test results;
1-46 (4) counseling as required by this subchapter; and
1-47 (5) information, upon request, describing how test
1-48 results and related information are stored by the service provider,
1-49 how long the information is retained, and under what circumstances
1-50 the information may be communicated to other persons.
1-51 Sec. 85.255. QUALIFIED FACILITY. A laboratory facility that
1-52 conducts testing of a specimen collected with a home collection kit
1-53 for HIV infection testing must comply with the Clinical Laboratory
1-54 Improvement Amendments of 1988 (42 U.S.C. Section 263a).
1-55 Sec. 85.256. ORAL REPORTING. A service provider shall
1-56 report test results from a home collection kit for HIV infection
1-57 testing orally to the individual tested. Notwithstanding Section
1-58 81.109, the test results may be provided by telephone.
1-59 Sec. 85.257. COUNSELING; COUNSELING PROTOCOLS. (a) A
1-60 service provider shall provide pretesting counseling to an
1-61 individual who is considering using a home collection kit for HIV
1-62 infection testing. This counseling may be provided orally by
1-63 telephone or through written information included with the home
1-64 collection kit.
1-65 (b) At the time the test results are reported to the
1-66 individual tested, the service provider shall provide counseling
1-67 and appropriate referrals for care and treatment.
1-68 (c) Counseling provided by a service provider, including
2-1 written information provided under Subsection (a) and referrals,
2-2 must conform with counseling protocols adopted by the board.
2-3 Except as provided by Section 85.256, the counseling protocols must
2-4 be consistent with the requirements of Section 81.109 and the
2-5 protocols adopted under Section 85.081.
2-6 (d) Counseling provided by a service provider under this
2-7 section must be provided in English and in Spanish. The board may
2-8 require a service provider to provide counseling in another
2-9 language if the board finds that the service provider is marketing
2-10 home collection kits in a community in which a significant portion
2-11 of the population speaks a language other than English or Spanish.
2-12 (e) A service provider, in providing counseling, may not:
2-13 (1) solicit the purchase of additional services or
2-14 products; and
2-15 (2) refer the individual being counseled to an entity:
2-16 (A) that is owned or controlled by the service
2-17 provider;
2-18 (B) that owns or controls the service provider;
2-19 (C) that is owned or controlled by an entity
2-20 that owns or controls the service provider; or
2-21 (D) that has another ongoing financial
2-22 relationship with the service provider.
2-23 Sec. 85.258. LABELING. (a) A home collection kit for HIV
2-24 infection testing shall meet the requirements of Chapter 431.
2-25 (b) In addition to the requirements in Subsection (a), the
2-26 labeling shall explain which persons and entities will have access
2-27 to the test results for the individual.
2-28 (c) In addition to the labeling requirements in Subsections
2-29 (a) and (b), a home collection kit labeled in Spanish must also be
2-30 available. The board may require a service provider to label a
2-31 home collection kit in another language if the board finds that the
2-32 service provider is marketing home collection kits in a community
2-33 in which a significant portion of the population speaks a language
2-34 other than English or Spanish.
2-35 Sec. 85.259. ENFORCEMENT. A home collection kit for HIV
2-36 infection testing is a "device" as that term is defined in Section
2-37 431.002 and is subject to the provisions for enforcement contained
2-38 in Chapter 431. Any violation of the requirement in Section 85.258
2-39 shall be subject to the enforcement provisions of Chapter 431.
2-40 Sec. 85.260. CONFIDENTIALITY. (a) Any statement that an
2-41 identifiable individual has or has not been tested with a home
2-42 collection kit for HIV infection testing, including a statement or
2-43 assertion that the individual is positive, is negative, is at risk,
2-44 or has or does not have a certain level of antigen or antibody, is
2-45 confidential as provided by Section 81.103.
2-46 (b) A person commits an offense if the person violates this
2-47 section. The punishment for an offense under this section is the
2-48 same as the punishment for an offense under Section 81.103.
2-49 Sec. 85.261. CERTAIN TECHNOLOGY PROHIBITED. A service
2-50 provider may not use technology that permits the service provider
2-51 to identify an individual to whom test results or counseling is
2-52 provided or to identify the telephone number from which that
2-53 individual is calling.
2-54 Sec. 85.262. REPORTS. A service provider shall report test
2-55 results from a home collection kit for HIV infection testing in the
2-56 manner provided by Subchapter C, Chapter 81.
2-57 SECTION 2. (a) The legislature encourages manufacturers of
2-58 home collection kits for human immunodeficiency virus infection
2-59 testing to make the kits available, at reduced cost, to appropriate
2-60 nonprofit organizations for use in human immunodeficiency virus
2-61 infection testing and counseling programs.
2-62 (b) It is the intent of the legislature that the use of home
2-63 collection kits for human immunodeficiency virus infection shall
2-64 not affect the accessibility of anonymous testing programs
2-65 established by the Texas Department of Health.
2-66 SECTION 3. The importance of this legislation and the
2-67 crowded condition of the calendars in both houses create an
2-68 emergency and an imperative public necessity that the
2-69 constitutional rule requiring bills to be read on three several
2-70 days in each house be suspended, and this rule is hereby suspended,
3-1 and that this Act take effect and be in force from and after its
3-2 passage, and it is so enacted.
3-3 * * * * *