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A BILL TO BE ENTITLED
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AN ACT
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relating to required disclosures for prenatal genetic screening; |
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imposing a civil penalty. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. The heading to Subchapter W, Chapter 161, Health |
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and Safety Code, is amended to read as follows: |
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SUBCHAPTER W. INFORMATION REGARDING DOWN SYNDROME AND PRENATAL |
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GENETIC SCREENING |
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SECTION 2. Subchapter W, Chapter 161, Health and Safety |
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Code, is amended by adding Sections 161.654 and 161.655 to read as |
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follows: |
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Sec. 161.654. REQUIRED DISCLOSURES FOR PRENATAL GENETIC |
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SCREENING. (a) A laboratory that performs prenatal genetic |
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screening shall include with the written screening results: |
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(1) detailed information regarding the accuracy and |
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reliability of the results, including the rate of false positive |
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results; and |
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(2) prominently displayed in bold print above the |
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results the following, or a substantially similar, statement: |
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"PRENATAL GENETIC SCREENING RESULTS ARE NOT SUFFICIENTLY RELIABLE |
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TO FORM A FINAL DIAGNOSIS OF A POTENTIAL CHROMOSOMAL DISORDER; SEEK |
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FURTHER DIAGNOSTIC TESTING BEFORE MAKING ANY MAJOR HEALTH CARE |
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DECISION." |
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(b) The executive commissioner shall adopt rules that |
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require a laboratory that performs prenatal genetic screening to |
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provide medically accurate information in the disclosures required |
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under this section. |
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Sec. 161.655. CIVIL PENALTY. (a) A laboratory that |
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violates Section 161.654 is liable for a civil penalty of not more |
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than $1,000 for each act of violation. |
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(b) In determining the amount of the penalty, the court |
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shall consider: |
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(1) the laboratory's previous violations; |
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(2) the seriousness of the violation, including the |
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nature, circumstances, extent, and gravity of the violation; |
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(3) the demonstrated good faith of the laboratory; |
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and |
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(4) the amount necessary to deter future violations. |
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(c) The attorney general may sue to collect the penalty. |
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The attorney general may recover reasonable expenses in obtaining |
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the penalty, including investigation costs, court costs, |
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reasonable attorney's fees, witness fees, and deposition expenses. |
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(d) A penalty collected under this section by the attorney |
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general shall be deposited to the credit of the general revenue |
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fund. |
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SECTION 3. (a) As soon as practicable after the effective |
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date of this Act, the executive commissioner of the Health and Human |
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Services Commission shall adopt the rules necessary to implement |
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Section 161.654, Health and Safety Code, as added by this Act. |
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(b) The changes in law made by this Act apply only to a |
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prenatal genetic screening conducted on or after January 1, 2018. A |
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prenatal genetic screening conducted before that date is governed |
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by the law in effect immediately before the effective date of this |
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Act, and that law is continued in effect for that purpose. |
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SECTION 4. This Act takes effect September 1, 2017. |