SERVICE TERMS, AUTHORIZATION AND INFORMED CONSENT FORM
Last updated: May 22, 2020
- Serological Antibody Testing Terms:
a. Healthcare Worker/Clinical Lab Use Only. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at-home testing.
b. Testing and Results. I authorize VidaCheck and Quansys to collect my and/or my child/dependent’s specimen (blood sample) (the “sample”) and to perform testing on such sample(s). I understand that testing and processing of the samples and communicating results to me may take between 2 to 5 business days.
c. Testing is Not 100% Reliable. Serological antibody testing is not 100% reliable, and there is a possibility that the test will indicate I have been infected with the virus or disease that the test is designed for (for example, COVID-19) when I actually have not been infected (a “false positive”), or that I have not been infected with such virus or disease when I actually am (a “false negative”).
d. No Medical Treatment. VidaCheck and Quansys do not provide treatment for any disease and are not providing me with medical advice. I am and will remain solely responsible for seeking appropriate treatment based on the results of my test. It is also possible that my physician or other health care professional may want to conduct additional testing. I understand that if I am having trouble breathing or am suffering severe distress, I should call 911 or go to the nearest emergency care.
- FDA Guidance Regarding COVID-19 Testing. I understand that the FDA has allowed the use of VidaCheck’s COVID-19 test even though it has not yet been formally approved. I further understand that:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
- This test is not for the screening of donated blood.
- Assumption of Risk and Release. I recognize that there are certain inherent risks associated with medical testing, including the possible inaccuracy of test results. On behalf of myself, my heirs, executors, administrators, assigns, or personal representatives:
- I hereby knowingly and voluntarily agree to participate in VidaCheck’s serological antibody testing on the terms set forth in this Consent Form. Collection of blood samples is done through a finger-prick process that may be self-administered or performed by a family member, friend or other person. I acknowledge that the blood sample collection procedure used to obtain the sample may be uncomfortable and may cause fainting or other adverse consequences (for example, if the person taking the test is on blood thinner medication). I AGREE THAT VIDACHECK AND QUANSYS ARE NOT RESPONSIBLE FOR ANY ADVERSE RESULTS ARISING OUT OF MY USE OF THE KIT AND OUR SERVICES, INCLUDING THOSE CAUSED BY PRE-EXISTING MEDICAL CONDITIONS, REGARDLESS OF WHETHER THEY HAVE BEEN INFORMED OF SUCH CONDITIONS.
- I HEREBY WAIVE ANY AND ALL RIGHTS, CLAIMS, OR CAUSES OF ACTION OF ANY KIND WHATSOEVER ARISING OUT OF MY PARTICIPATION IN THIS TESTING, AND HEREBY RELEASE AND FOREVER DISCHARGE VIDACHECK AND QUANSYS, AND THEIR AFFILIATES, MANAGERS, MEMBERS, AGENTS, STAFF, REPRESENTATIVES, SUCCESSORS AND ASSIGNS, FOR ANY DAMAGES OR CLAIMS, INCLUDING PHYSICAL OR PSYCHOLOGICAL INJURY, ILLNESS, DEATH, OR ECONOMICAL OR EMOTIONAL LOSS, THAT I MAY SUFFER AS A RESULT OF MY PARTICIPATION IN THIS TESTING ACTIVITY.
- Neither VidaCheck nor Quansys is liable for any health consequences resulting from my participation in this program, and neither entity or its staff is responsible for ensuring that I have consulted with my physician regarding any test results or recommendations that I may receive.
- In the event that I should require medical care or treatment, I agree to be financially responsible for any costs incurred as a result of such treatment. VidaCheck and Quansys are not liable for any of my medical costs, regardless of the circumstances. I am aware and understand that I should carry my own health insurance.
- These releases are also binding on my heirs, executors and administrators.
- Indemnification. I agree to indemnify and hold harmless VidaCheck and Quansys, and their affiliates, managers, members, agents, attorneys, staff, volunteers, heirs, representatives, predecessors, successors and assigns, against any and all claims, suits, or actions of any kind whatsoever for liability, damages, compensation, or otherwise brought by me or anyone on my behalf, including attorney’s fees and any related costs, if litigation arises pursuant to any claims made by me or by anyone else acting on my behalf that arise out of or relate to the medical testing conducted by VidaCheck and Quansys. This section will not apply to any claim or action arising out of VidaCheck’s or Quansys’s gross negligence or willful misconduct.
- Privacy and Use of My Personal Information and Protected Health Information (PHI). I have been provided with access to copies of:
- VidaCheck’s Notice of Privacy Practices under HIPAA regarding VidaCheck’s use of my protected health information (“PHI”).
I have had the opportunity to review these documents. By, checking and accepting VidaCheck’s terms associated with setting up my account, I understand that I am agreeing to the terms of these documents and this consent form. I understand that I may download and copy such documents, or request paper copies from VidaCheck.
I also understand that my test results may be provided to public health officials and agencies on a need-to-know basis and as directed or permitted by HIPAA.
By providing my electronic signature at the time of registering my sample kit ID, in either Box 1 or Box 2, I am confirming and consenting as follows:
- I acknowledge that I have received a copy of VidaCheck’s Notice of Privacy Practices form and have had a chance to review it.
- I agree that VidaCheck and Quansys may use and disclose my protected health information (PHI) as described in this Consent Form and the Notice of Privacy Practices.
- I understand that I may contact the person named in the Notice of Privacy Practices if I have questions about the content of such Notice or this Consent Form. If I have any questions, they have been answered to my satisfaction.
- I hereby represent to VidaCheck that I have the authority to submit personal data and biomaterial samples for, and receive test results back for, any additional persons for whom I am ordering tests, either as a parent or legal guardian of such persons or by their express consent given under Box 2 below.
- I have read all of the information in this Consent Form and I have had time to think about it, and I agree to these terms.
- I am able to print out and keep a copy of this Consent Form, or access a copy of this Consent form at https://www.vidacheck.com/terms-and-conditions