85R7541 LED-D
By: Burton S.B. No. 1080
A BILL TO BE ENTITLED
AN ACT
relating to required disclosures for prenatal genetic screening;
imposing a civil penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. The heading to Subchapter W, Chapter 161, Health
and Safety Code, is amended to read as follows:
SUBCHAPTER W. INFORMATION REGARDING DOWN SYNDROME AND PRENATAL
GENETIC SCREENING
SECTION 2. Subchapter W, Chapter 161, Health and Safety
Code, is amended by adding Sections 161.654 and 161.655 to read as
follows:
Sec. 161.654. REQUIRED DISCLOSURES FOR PRENATAL GENETIC
SCREENING. (a) A laboratory that performs prenatal genetic
screening shall include with the written screening results:
(1) detailed information regarding the accuracy and
reliability of the results, including the rate of false positive
results; and
(2) prominently displayed in bold print above the
results the following, or a substantially similar, statement:
"PRENATAL GENETIC SCREENING RESULTS ARE NOT SUFFICIENTLY RELIABLE
TO FORM A FINAL DIAGNOSIS OF A POTENTIAL CHROMOSOMAL DISORDER; SEEK
FURTHER DIAGNOSTIC TESTING BEFORE MAKING ANY MAJOR HEALTH CARE
DECISION."
(b) The executive commissioner shall adopt rules that
require a laboratory that performs prenatal genetic screening to
provide medically accurate information in the disclosures required
under this section.
Sec. 161.655. CIVIL PENALTY. (a) A laboratory that
violates Section 161.654 is liable for a civil penalty of not more
than $1,000 for each act of violation.
(b) In determining the amount of the penalty, the court
shall consider:
(1) the laboratory's previous violations;
(2) the seriousness of the violation, including the
nature, circumstances, extent, and gravity of the violation;
(3) the demonstrated good faith of the laboratory;
and
(4) the amount necessary to deter future violations.
(c) The attorney general may sue to collect the penalty.
The attorney general may recover reasonable expenses in obtaining
the penalty, including investigation costs, court costs,
reasonable attorney's fees, witness fees, and deposition expenses.
(d) A penalty collected under this section by the attorney
general shall be deposited to the credit of the general revenue
fund.
SECTION 3. (a) As soon as practicable after the effective
date of this Act, the executive commissioner of the Health and Human
Services Commission shall adopt the rules necessary to implement
Section 161.654, Health and Safety Code, as added by this Act.
(b) The changes in law made by this Act apply only to a
prenatal genetic screening conducted on or after January 1, 2018. A
prenatal genetic screening conducted before that date is governed
by the law in effect immediately before the effective date of this
Act, and that law is continued in effect for that purpose.
SECTION 4. This Act takes effect September 1, 2017.