planTrue Patient Informed Consent for Genetic Testing

This information may be reviewed with patients as part of the informed consent process for planTrue genetic carrier screening from True Health.

PATIENT RESPONSIBILITY

If I would like genetic testing to be filed with my insurance, it is my responsibility as the patient to understand the requirements of my insurer’s policy guidelines on genetic testing. I understand that I may be responsible for portions of this test not covered by my health plan. For questions about my test results, I may call a True Health at 1.877.494.0030. To find a genetic counselor in my area I can contact my insurance company, visit http://www.nsgc.org/page/find-a-gc-search, or call 1.877.494.0030.

PATIENT CONFIDENTIALITY & GENETIC COUNSELING

I understand and acknowledge that further counseling may be required or recommended by my healthcare provider, and/or insurance company. To maintain confidentiality, my test results will only be released to my referring healthcare provider, to the ordering reference laboratory, to me, to other healthcare providers involved in my diagnosis and treatment, or to others as permitted by applicable law. The United States Federal Government has enacted several laws that prohibit discrimination based on genetic test results by health insurance companies and employers. In addition, these laws prohibit unauthorized use or disclosure of this information.

RESULTS OF GENETIC TESTING

The following describes the possible results from the testing ordered by my healthcare provider:

1) POSITIVE: A positive result indicates that a genetic variant has been identified that may increase the risk of a genetic condition manifesting in my offspring. It is possible to test positive for more than one genetic variant.
2) NEGATIVE: A negative result indicates that no disease-causing genetic variant was identified for the test performed. It does not guarantee that future offspring will be healthy or free from genetic disorders or medical conditions.

BENEFITS

My genetic test results may help guide me and my healthcare provider to make informed choices about my my and my family’s health. My genetic test results may also benefit my blood relatives by allowing them to learn whether they share any inherited risks.

RISKS

Side effects of having blood drawn are uncommon, but may include dizziness, fainting, soreness, bleeding, bruising, and rarely, infection.

LIMITATIONS

This test analyzes only specific genes associated with specific genetic conditions that may be passed from parent to child. There may be other genes associated with genetic conditions that are not yet identified or able to be tested.

SPECIMEN REMNANTS

After testing is complete, my specimen will be de-identified. In accordance with applicable law, no protected health information will be retained to link me to my de-identified specimen. The submitted specimen may be used for test development and improvement, internal validation, quality assurance, and training purposes. DNA specimens are not returned to individuals or to referring healthcare providers.