Patient Consent and Financial Agreement Terms
Patient Consent Terms
Section 1: Test Information
How will the patient’s sample be used?
The buccal swab sample (“Sample”) of the patient will be used to test for genetic markers using the Genomind® PGx test, which assists clinicians in making treatment decisions based on the patient’s genetic profile. Results may indicate which medications are likely to work or cause adverse effects, and the patient may wish to consult their ordering clinician, seek genetic counseling, or consider further independent testing. No other testing will be performed with the patient’s Sample other than as described herein.
What are the limitations and risks of the test?
The test will not detect all variants possible within the patient’s genes, nor will it indicate if the patient is allergic to certain medications. Several sources of error are possible, including, but not limited to, clinical misinterpretation, sample misidentification, sample contamination, and inaccurate results due to donor genetic material in transplant recipients. The results of this test may indirectly reveal familial information (e.g., paternity/non-paternity) and/or be indeterminate due to technical limitations.
What are the patient’s rights?
The patient has the right not to agree to have their Sample tested. They may wish to obtain professional genetic counseling prior to consenting to testing. They may withdraw their consent to testing at any time until their results are received by their clinician. The patient’s Sample and test results are confidential and will be released to them and to the clinician who ordered the test.
Section 2: Patient Acknowledgment
The patient understands that Genomind® PGx is an analysis of genes to identify variations. Variations can help inform the patient’s clinician as to the medication options they recommend for the patient. The use of this test, as well as the limitations, risks, and alternatives, has been explained to the patient by their treating clinician, and the patient has had the opportunity to ask questions of their clinician and receive answers to those questions. The patient consents to the collection of a Sample for themselves or any listed minor or other dependent for the purpose of receiving the Genomind® PGx test. The patient understands that Genomind and its representatives are not responsible for any medical or other decisions made based on the results of the Genomind® PGx ordered by their clinician. The patient agrees that they have the authority under the laws of the state or jurisdiction in which they reside to provide this release.Section 3: Patient Privacy Acknowledgement
The patient understands and agrees that Genomind will gather their Protected Health Information (PHI), as that term is defined by the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (HIPAA). Genomind employs a number of organizational, technical, and physical safeguards designed to protect the confidentiality of the patient’s PHI. The patient understands and agrees that Genomind will only use or disclose their PHI with their consent or for purposes of their treatment, payment of their treatment, normal business operations, or as otherwise permitted by applicable law, including HIPAA.
Section 4: Authorization to Retain Sample for Research (optional)
The patient understands that after their testing is complete, their leftover Sample may be useful for future research, including future genetic tests. If the patient consents to allow their leftover Sample to be used for such research, including research conducted by third parties, they understand that their sample will be stripped of all information that identifies them so that the researchers would not be able to identify or link the sample to the patient. The patient acknowledges that their sample will be retained and NOT be destroyed within 60 days of testing, as may otherwise be required by state law. Genomind’s policy is to conduct research in accordance with federal human subject protection laws and applicable privacy laws.
Patient Financial Responsibility Acknowledgement Terms
The patient agrees that they are financially responsible for all payment obligations arising in connection with this test and guarantees payment for such services. The patient is financially responsible for services that are not covered by their health insurance plan or that are covered but are not paid in full, including, but not limited to, any deductibles, copayments, co-insurance amounts, or any other patient responsibility indicated by their insurance carrier or Genomind’s policies. If insured, the patient authorizes Genomind, or its agents or contractors, to bill their insurer(s), and the patient hereby reassigns any payments from their insurance carrier to Genomind. The patient further authorizes Genomind to provide all available information to their insurer as necessary to validate services and receive payment.
