Coronavirus Testing and Emergency Preparedness
Coronavirus Testing and Emergency Preparedness
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Please carefully read the following informed consent
You are consenting to participation in a COVID-19 Safety Program. As part of this program, you may be asked to participate in a Medical Exam, or undergo laboratory testing for COVID-19 diagnosis, prevention, and treatment. The Medical Exam and/or COVID-19 Swab test may be purchased by an employer, state agency, or other purchasing organization (“Purchasing Organization”) as part of the COVID-19 Safety Program.
Purpose of the Medical Exam. This medical exam is to help determine if you have Covid-19. A negative test result does not ensure that you do not have Covid-19. (No test is perfect.) Despite a negative test result, as the CDC advises if you exhibit the following symptoms, you should still self- quarantine at home for 14 days: cough, shortness of breath or difficulty breathing, and at least two of the following: fever (above 100.4 degrees Fahrenheit), chills, repeated shaking with chills, muscle pain, headache, sore throat, new loss of taste or smell. If you develop any of the following emergency warning signs for COVID-19, get emergency medical attention immediately: trouble breathing, persistent pain or pressure in the chest, new confusion or inability to arouse, bluish lips or face.
You agree to seek medical help locally if you exhibit any of the foregoing symptoms, and that where appropriate and possible, a patient-provider relationship is being established between you and a medical group or designee of the Purchasing Organization.
Explanation of the Medical Exam and Associated Risks. This medical exam will include the following:
1. Interview and Exam
You may undergo an interview in person, on the phone, or complete a questionnaire and a physical exam.
2. Specimen Collection
A specimen for testing shall be collected. For example, you will use a special swab to take a sample from your nose. This may feel uncomfortable. These effects are temporary.
Informed Consent
By ordering or registering with DxCOVID (the “Site”, “we”, “us” or “our”), its subdomains or affiliates, you agree to following:
a) I authorize this Site and its testing unit to conduct collection and testing for COVID-19 through a nasopharyngeal swab, nasal swab, or other approved method, as ordered by an authorized medical provider or public health official.
b) I authorize a medical exam and interview.
c) I authorize my test results to be disclosed to the county, state, or to any other governmental entity as may be required by law.
d) I acknowledge that a positive test result is an indication that I must continue to self-isolate in an effort to avoid infecting others.
e) I understand that I am not creating a patient relationship with the Site by participating in testing. I understand the testing unit 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, or if my condition worsens.
f) I understand that, as with any medical test, there is the potential for false positive or false negative test results can occur.
g) I acknowledge that I have read and understood the Site Terms and Conditions and the Privacy Policy.
h) I acknowledge that I have been informed about the test purpose, procedures, possible benefits and risks, and I have received a copy of this Informed consent. I have been given the opportunity to ask questions before I sign, and I have been told that I can ask other questions at any time.
i) I voluntarily agree to testing for COVID-19.
j) I voluntarily participate in the COVID-19 Safety Program.
k) If I am being provided testing as part of an applicable group Service Agreement, I authorize the sharing of my interview, physical exam, and Swab test results with my employer or group test purchasing organization, and physicians or healthcare providers involved in my healthcare, consistent with HIPAA and all other relevant privacy laws and regulations.
I am told that COVID 19 is not well understood, and that tests for COVID-19 are being developed and improved over time. I understand that no test is perfect. I understand that despite following the best procedures, and using appropriate equipment and supplies, and through no fault of the Site a test result may be incorrect. I release the Site, its affiliates, their employees, officers and agents, and my employer or Group Purchasing Organization from responsibility for incorrect results from testing that is performed in accordance with approvals by the US FDA (Food and Drug Administration) and relevant regulatory authorities. I authorize the Site and its affiliates to use my sample and all derivative works for research and commercial use. If my test results come back as positive, I understand that repeat testing is necessary, in order to confirm a positive result. I understand that an initial negative result does not guarantee that all subsequent results will be negative.
I acknowledge that my consent is valid for the current sample testing and any future sample testing. I acknowledge that I have the right to receive a copy of this authorization. I consent to being approached by the Site and its affiliates through email, phone or postal service for participation in clinical research. This consent form supersedes all prior consent forms that I may have signed with regard to the COVID-19 Safety Program.
I acknowledge that I have read this document in its entirety and agree to the above. If under the age of 18, I agree not to participate in this medical exam without the written consent of a parent or legal guardian. I also fully understand the attendant risks and discomforts of this test.
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