INFORMED CONSENT FOR CORONAVIRUS (COVID-19) TESTING

This is a test for the presence of SARS-CoV-2, the virus that causes COVID-19. Testing will be performed with either the BD Veritor Antigen test, Carestart COVID-19 Antigen test, or Abbott ID Now Rapid Molecular test and is performed after collection of a specimen by a nasal swab. This test is designed to detect the virus that causes COVID-19 in respiratory specimens. This test is not yet approved or cleared by the U.S. Food and Drug Administration (“FDA”). The FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA), which is supported by the Secretary of Health and Human Service’s declaration that circumstances exist to justify the emergency use of in vitro diagnostics for the detection and/or diagnosis of the virus that causes COVID-19. This EUA will remain in effect (meaning this test can be used) for the duration of the COVID-19 declaration.

 

Please complete the following information:

 

Please carefully read the following informed consent:
  1. I understand that receipt of this test is purely voluntary and of my own choosing and that I have the right to refuse this test.
  2. I authorize 15toKnow, LLC (“15toKnow”) to conduct the collection and testing for COVID-19 through a nasal swab.
  3. I understand there may be some discomfort in receiving the test and that should the discomfort persist, increase, or I determine that the discomfort is not tolerable, that I am fully responsible for obtaining follow-up medical care and for paying the associated costs in doing so.
  4. I understand that results and other pertinent information will be communicated to me using a variety of channels to include, but not be limited to: phone, mail, electronic/web-based delivery or other reasonable means, and I understand it is my responsibility to ensure 15toKnow has accurate contact information from me for purposes of delivering the test results as well as to provide all necessary communications.
  5. I authorize my test results to be disclosed to the county, state, or to any other governmental entity as may be required by law, and pursuant to the privacy consent I have received and authorized from 15toKnow.
  6. If I have received this test at the request of my employer, and if my employer is paying 15toKnow directly for this test, than I hereby authorize 15toKnow to disclose my test results to my Employer’s designated representative.
  7. I understand that I may be contacted by local health authorities to discuss a positive result.
  8. I understand that a positive test result will require me to fully and completely comply with all restrictions and guidance on preventing the further spread of COVID-19 provided by my local health authorities.
  9. I understand that I am not creating a patient relationship with 15toKnow by participating in testing. I understand that 15toKnow is not acting as my medical provider. Testing does not replace treatment by my medical provider. I assume complete and full responsibility to take appropriate action with regards to my test results. I agree I will seek medical advice, care and treatment from my medical provider if I have questions or concerns.
  10. I acknowledge that I have received a Fact Sheet containing information about this test.
  11. I understand that, as with any medical test, there is the potential for false positive or false negative test results to occur, and that my test result may not be accurate for a variety of reasons, including but not limited to, my sample being taken too early in the course of a Covid-19 infection (for false negatives).
  12. I understand that 15toKnow has at a minimum technicians/technician equivalents collecting samples and at a minimum lab technicians processing the samples, all of whom who have undergone specific training in personal protective equipment, quality control, running a patient test from a direct swab, maintenance and troubleshooting for the test, and for those processing the samples, training on clinical sample collection, but that errors in processing may occur from time to time such that no guarantee is made as to the accuracy of the results communicated.
  13. I understand that the role of 15toKnow is solely to collect and process the test sample, and that 15toKnow is not responsible in any way for the test itself, including but not limited to, its design and/or manufacture, and makes no independent claims about its capabilities, accuracy or reliability. 15toKnow does not in any way warrant the efficacy of the test itself.
  14. I agree to indemnify and hold harmless 15toKnow, and their affiliates, managers, agents, contractors, 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 as it relates to the subject matter of this informed consent and receipt of the test.
  15. I am aware that participating in testing during the COVID-19 pandemic involves certain inherent risks, dangers and hazards, which can result in serious infection, personal injury or death. I further acknowledge, understand, appreciate, and agree that my participation in this testing may result in possible exposure to and illness from COVID-19. While 15toKnow is taking steps to reduce this risk, the risk of serious injury, illness, and even death is not possible to fully mitigate. I hereby freely agree to assume and accept all known and unknown risks of exposure to COVID-19, even arising from the negligence of 15toKnow or others and assume full responsibility for my participation in this testing.
I, the undersigned, have been informed about the test, the test purpose, procedures, possible benefits and risks, and I have received a copy of this consent. I have been given the opportunity to ask questions before I sign, and I have understood that I can ask other questions at any time. I voluntarily agree to testing for COVID-19.