| 1 | 1 | | 85R7541 LED-D |
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| 2 | 2 | | By: Burton S.B. No. 1080 |
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| 3 | 3 | | |
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| 4 | 4 | | |
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| 5 | 5 | | A BILL TO BE ENTITLED |
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| 6 | 6 | | AN ACT |
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| 7 | 7 | | relating to required disclosures for prenatal genetic screening; |
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| 8 | 8 | | imposing a civil penalty. |
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| 9 | 9 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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| 10 | 10 | | SECTION 1. The heading to Subchapter W, Chapter 161, Health |
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| 11 | 11 | | and Safety Code, is amended to read as follows: |
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| 12 | 12 | | SUBCHAPTER W. INFORMATION REGARDING DOWN SYNDROME AND PRENATAL |
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| 13 | 13 | | GENETIC SCREENING |
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| 14 | 14 | | SECTION 2. Subchapter W, Chapter 161, Health and Safety |
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| 15 | 15 | | Code, is amended by adding Sections 161.654 and 161.655 to read as |
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| 16 | 16 | | follows: |
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| 17 | 17 | | Sec. 161.654. REQUIRED DISCLOSURES FOR PRENATAL GENETIC |
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| 18 | 18 | | SCREENING. (a) A laboratory that performs prenatal genetic |
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| 19 | 19 | | screening shall include with the written screening results: |
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| 20 | 20 | | (1) detailed information regarding the accuracy and |
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| 21 | 21 | | reliability of the results, including the rate of false positive |
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| 22 | 22 | | results; and |
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| 23 | 23 | | (2) prominently displayed in bold print above the |
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| 24 | 24 | | results the following, or a substantially similar, statement: |
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| 25 | 25 | | "PRENATAL GENETIC SCREENING RESULTS ARE NOT SUFFICIENTLY RELIABLE |
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| 26 | 26 | | TO FORM A FINAL DIAGNOSIS OF A POTENTIAL CHROMOSOMAL DISORDER; SEEK |
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| 27 | 27 | | FURTHER DIAGNOSTIC TESTING BEFORE MAKING ANY MAJOR HEALTH CARE |
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| 28 | 28 | | DECISION." |
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| 29 | 29 | | (b) The executive commissioner shall adopt rules that |
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| 30 | 30 | | require a laboratory that performs prenatal genetic screening to |
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| 31 | 31 | | provide medically accurate information in the disclosures required |
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| 32 | 32 | | under this section. |
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| 33 | 33 | | Sec. 161.655. CIVIL PENALTY. (a) A laboratory that |
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| 34 | 34 | | violates Section 161.654 is liable for a civil penalty of not more |
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| 35 | 35 | | than $1,000 for each act of violation. |
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| 36 | 36 | | (b) In determining the amount of the penalty, the court |
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| 37 | 37 | | shall consider: |
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| 38 | 38 | | (1) the laboratory's previous violations; |
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| 39 | 39 | | (2) the seriousness of the violation, including the |
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| 40 | 40 | | nature, circumstances, extent, and gravity of the violation; |
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| 41 | 41 | | (3) the demonstrated good faith of the laboratory; |
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| 42 | 42 | | and |
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| 43 | 43 | | (4) the amount necessary to deter future violations. |
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| 44 | 44 | | (c) The attorney general may sue to collect the penalty. |
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| 45 | 45 | | The attorney general may recover reasonable expenses in obtaining |
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| 46 | 46 | | the penalty, including investigation costs, court costs, |
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| 47 | 47 | | reasonable attorney's fees, witness fees, and deposition expenses. |
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| 48 | 48 | | (d) A penalty collected under this section by the attorney |
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| 49 | 49 | | general shall be deposited to the credit of the general revenue |
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| 50 | 50 | | fund. |
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| 51 | 51 | | SECTION 3. (a) As soon as practicable after the effective |
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| 52 | 52 | | date of this Act, the executive commissioner of the Health and Human |
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| 53 | 53 | | Services Commission shall adopt the rules necessary to implement |
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| 54 | 54 | | Section 161.654, Health and Safety Code, as added by this Act. |
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| 55 | 55 | | (b) The changes in law made by this Act apply only to a |
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| 56 | 56 | | prenatal genetic screening conducted on or after January 1, 2018. A |
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| 57 | 57 | | prenatal genetic screening conducted before that date is governed |
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| 58 | 58 | | by the law in effect immediately before the effective date of this |
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| 59 | 59 | | Act, and that law is continued in effect for that purpose. |
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| 60 | 60 | | SECTION 4. This Act takes effect September 1, 2017. |
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