BILL ANALYSIS
H.B. 988
By: Maxey (Gallegos)
Health and Human Services
4-6-95
Senate Committee Report (Amended)
BACKGROUND
The fear of the divulgence of human immunodeficiency virus (HIV)
test results to an insurance agency or employer creates a barrier
to HIV testing for some persons. Technology has been developed
that allows a person to collect a blood sample and send it to a
laboratory for HIV testing. Seven to 10 days later, a person would
call a toll-free number, give the operator a code number, receive
anonymous counseling, get the test results, and be referred to a
service provider for follow-up services, if required.
PURPOSE
As proposed, H.B. 988 sets forth regulations regarding home
collection kits for human immunodeficiency virus infection testing
and provides penalties.
RULEMAKING AUTHORITY
It is the committee's opinion that this bill does not grant any
additional rulemaking authority to a state officer, institution, or
agency.
SECTION BY SECTION ANALYSIS
SECTION 1. Amends Chapter 85, Health and Safety Code, by adding
Subchapter J, as follows:
SUBCHAPTER J. HOME COLLECTION KITS FOR HIV INFECTION TESTING
Sec. 85.251. DEFINITIONS. Defines "home collection kit" and
"service provider."
Sec. 85.252. PROHIBITIONS RELATING TO HOME COLLECTION KIT.
(a) Prohibits a person from marketing, distributing, or
selling a home collection kit for human immunodeficiency virus
infection testing (kit) in this state, unless the kit complies
with Chapter 431.
Sec. 85.253. PROHIBITIONS RELATING TO HOME TESTING. (a)
Prohibits a person from marketing, distributing, or selling a
product for public use to test a specimen collected from the
human body (specimen) for human immunodeficiency virus (HIV)
infection, unless the kit complies with Chapter 431.
(b) Provides that this section does not apply to a product
marketed, distributed, or sold only to physicians or other
persons authorized by law to test a specimen for HIV
infection.
(c) Prohibits a person from requiring an individual to be
tested for HIV infection under Section 81.102.
Sec. 85.254. PACKAGE OF SERVICES. Requires a kit to be sold
as part of a package of certain services.
Sec. 85.255. QUALIFIED FACILITY. Requires a facility that
tests a specimen collected with a kit to comply with the
Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C.
Section 263a).
Sec. 85.256. ORAL REPORTING. Requires a service provider to
report test results from a kit orally to the individual
tested.
Sec. 85.257. COUNSELING; COUNSELING PROTOCOLS. (a) Requires
a service provider to provide pretesting counseling to an
individual who is considering using a kit, and authorizes the
counseling to be provided orally by telephone or through
written information included with the kit.
(b) Requires the service provider, at the time the test
results are reported to the individual tested, to provide
counseling and appropriate referral for care and treatment.
(c) Requires counseling to conform with counseling protocols
adopted by the Texas Board of Health (board). Requires the
protocols to be consistent with Sections 81.109 and 85.081.
(d) Requires counseling under this section to be provided in
English and Spanish. Authorizes the board to require a
service provider to provide counseling in another language
if the board finds that the service provider is marketing
kits in a community where a significant portion of the
population speaks a language other than English or Spanish.
(e) Prohibits a service provider, in providing counseling,
from soliciting the purchase of additional services or
products, or from referring the individual being counseled
to certain entities.
Sec. 85.258. LABELING. (a) Requires a kit to meet the
requirements of Chapter 431.
(b) Requires the labelling to explain which persons and
entities will have access to the test results.
(c) Requires a kit labeled in Spanish to be available.
Authorizes the board to require a service provider to label
a kit in another language upon finding that the provider
markets kits in a community where a significant portion of
the population speaks a language other than English or
Spanish.
Sec. 85.259. ENFORCEMENT. Calls a kit a "device" according
to the definition of "device" under Section 431.002, and
subjects a kit and any violation of Section 85.258 to the
provisions for enforcement under Chapter 431.
Sec. 85.260. CONFIDENTIALITY. (a) Makes confidential any
statement that an identifiable individual has or has not been
tested with a kit.
(b) Provides that a person commits an offense, punishable as
an offense under Section 81.103, if the person violates this
section.
Sec. 85.261. CERTAIN TECHNOLOGY PROHIBITED. Prohibits a
service provider from using technology that permits the
provider to identify an individual to whom test results or
counseling is provided, or to identify the telephone number
from which that individual is calling.
Sec. 85.262. REPORTS. Requires a service provider to report
test results from a kit in the manner provided by Chapter 81B.
SECTION 2. (a) Declares that the legislature encourages
manufacturers of kits to make the kits available, at reduced cost,
to appropriate nonprofit organizations for use in HIV testing and
counseling programs.
(b) Declares that the legislature intends that the use of kits
shall not affect the accessibility of anonymous testing
programs established by the Texas Department of Health.
SECTION 3. Emergency clause.
Effective date: upon passage.