Informed Consent - COVID-19 Molecular Testing

I voluntarily request of GTX to perform viral RNA RT-PCR testing for the detection of the SARS-COV-2 virus, in an attempt to determine whether I have contracted COVID-19.

I understand that the genetic material required for such an analysis may be obtained from one of several sample collection techniques including nasopharyngeal swab sampling procedure. The nasopharynx is precariously placed at the base of the skull, above the roof of the mouth. When we breathe, air flows through the nose into the throat and nasopharynx, and eventually into the lungs.

The following points were explained, and I understand that:

1. It is the responsibility of the referring physician or health care provider to understand the specific use and limitations of the testing ordered, and to educate the patient regarding these limitations.
2. A nasopharyngeal swab is required to complete the test(s) requested. Additional samples may be needed if the sample is damaged in shipment or inaccurately submitted. In these cases, the swab procedure may be repeated to complete the requested test(s).
3. Accurate interpretation of test results is dependent upon the patient’s medical history and only tests ordered by medical professionals with the intent of diagnosing is considered medically necessary.
4. The results of the test in no way guarantees the health of the patient.
5. Direct access screening is not considered medically necessary and are not approved as diagnostic tests.
6. Results will be reported directly to my ordering provider, or to the individual who authorized the test to be performed. This includes employers who authorized this test for an employee. Patient-identifying results and information will remain confidential and may only be released to other parties with my expressed written consent or as permitted or required by applicable law.
7. GTX will perform the testing and provide you with your results; however, we cannot interpret or treat you for the results obtained through a direct access screening program. Direct access screening results will be mailed to the address listed on your consent form unless otherwise requested. A Photo ID will be required to pick up direct access screening results.

Payment:

1. GTX will bill Medicare for medically necessary testing ordered by a licensed medical professional for Medicare beneficiaries.
2. For Non-Medicare beneficiaries GTX will not bill the insurance that will likely be covered for medically necessary testing, however we will provide receipt of testing for the beneficiaries filling purposes.
3. GTX will not bill insurance for direct access screening. GTX requires payment at the time of service for any and all direct access screening. Specimens will not be collected until payment in full is made.
4. Acceptable forms of payment include online payment.

Consent for Payment:

1. GTX is not acting as a tax adviser or attorney when providing assistance as an assister and cannot provide tax or legal advice within your capacity as an assister, and including all the consumer protection standards that apply through CMS regulations to your assister type, such as conflict of interest requirements.
2. I provide consent for GTX to access and use my PHI in order for GTX to carry out their Marketplace functions and responsibilities.
3. I may revoke any part of the authorization at any time, as well as a description of any limitations that the consumer wants to place on your access or use of my PHI.
4. I am not required to provide GTX with any PHI.
5. The services provided are based only on the information I provide, and if the information provided is inaccurate or incomplete, the services might not be able to offer all the help that is available for the my situation.
6. GTX will ask for the minimum amount of PHI necessary to carry out necessary functions and responsibilities.

This is to certify that I consent to and authorize GTX to collect my biological sample for analysis of the ordered test(s) and my PHI that would be pertinent to delivering the results and to receive payment for the services. I authorize GTX to release my results to me through the method indication on the requisition. In the event of any positive result, I understand that GTX is required by law to submit my test result to the Department of Health.

I understand that GTX is not acting as my doctor, that this does not replace treatment by a physician and that I assume complete and full responsibility to take appropriate action with regard to test results, up to and including consulting with a physician. In this regard, I do not and will not hold GTX responsible for my test results and absolve them of their affiliates of any liability.

I agree that I will seek medical advice, care, and treatment from my usual source of healthcare if I have questions or concern, have any symptoms of illness, or become ill. I understand that the nasopharyngeal swab involves a small medical risk. In the event of an accidental blood/body fluid exposure to GTX staff member involved in the collection or processing of the sample(s), I consent to any routine blood tests deemed necessary for the safety of the staff. As with medical testing of any nature, the potential for falsely elevated, lowered, positive or negative laboratory values is present.

I agree to take full financial responsibility for the tests requested and I understand that payment is required prior to specimen collection. I understand that these tests will not be billed to a third party by GTX, other than Medicare, and no results will be sent to a physician or healthcare provider unless ordered by a physician or healthcare provider.

I understand the cost of these tests may increase in the future without prior notice. I understand that medical insurance generally does not cover the cost of direct access screening and will not reimburse these charges or apply them towards a deductible as they are not ordered by a physician. I accept full responsibility for inquiring with my insurer in this regard.

I represent that I am eighteen (18) years of age or older. I guarantee that the sample I provide is my sample; if you are completing this consent form on behalf of a person for whom you have legal authorization, you are confirming that the sample provided will be the sample of that person.

Neither GTX nor any of its services are designed or intended to attract children under the age of 13. A parent or guardian, however, may order and set up an account for GTX services on behalf of his or her child. The parent or guardian assumes full responsibility for ensuring that the information that he/she provides to GTX about his or her child is kept secure and that the information submitted is accurate.

The risks, benefits and limitations of COVID-19 molecular testing have been explained to me. I have read and will receive a copy of this consent form.

Physician/Counselor/Clinician Statement (IF APPLICABLE): I have explained COVID-19 molecular testing to the patient/parent/guardian. The consent form and limitations of genetic testing were reviewed with the patient/parent/guardian. I accept responsibility for pre- and post-test counseling. I will use my independent professional judgment and the patient’s best interests in advising the patient/parent/guardian regarding test results, the use, and limitations of same.