SARS-CoV-2 Infection Screening
Introduction
COVID-19 can spread easily and quickly in large groups of people who are close together for prolonged periods of time. Some people do not have symptoms but can still spread the virus to others.
What will happen if you take part?
On Test Day:
After confirming you have registered and consented, we will then collect a nose swab that will be tested for COVID-19 virus infection. If you have symptoms or have been in contact with someone who has testing positive for COVID-19, you will not be allowed access to the labs and will not be invited for testing.
After testing:
If your swab test is positive:
Our lab personnel will contact you within 24 hours if your result is positive and will urge you to follow up with your health care provider, regardless of whether you are having symptoms or not. Since the test that we use is a rapid test (with high specificity in people with symptoms) whose specificity is currently being tested on people without symptoms, we will recommend that you get a PCR test through your healthcare provider to verify the result.
We will have to provide this information to the state and local health departments as mandated by local government policy and procedure. This will lead to contact tracing and notification to Bay Area Medical Academy staff and students as required, though this is done anonymously. In some cases, this will allow others to know you had participated in this testing effort and would provide them information about your health status regarding COVID-19. You will also be contacted by Bay Area Medical Academy to identify close contacts for contact tracing purposes.
If your swab test is negative:
You will be informed of your result verbally and your swab results will be posted for you to access on a secure online portal. We will provide you with this information, and how to access it when you test.
What side effects or risks can I expect from participating?
Potential side effects and risks include:
nose swabbing may potentially cause mild discomfort and rarely may cause mild nose bleeding or cause a gag reflex.
There is risk of exposure to COVID-19 when leaving one’s home.
How will my specimens and information be used?
Public health officials will be informed via the local public health department. We will not ask you for additional permission to share this de-identified information. There may be times when public health officials using your information and/or specimens may learn new information. The public health officials may or may not share these results with you.
Security
The data collected about you will be kept private and secure from disclosure. All information will be maintained in a database on a secured server, and on computers that are encrypted, and password protected. The server is maintained in a limited access room behind locked doors. The specimen is discarded immediately after performing the analysis.
How will information about me be kept confidential?
Participation may involve some loss of privacy. We will endeavor to ensure that information about you is kept confidential. Your personal information may be given out if required by law.
Health Insurance Portability and Accountability Act of 1996, Notice of Privacy Practices
This document describes how your medical information may be used and disclosed, and how you can get access to this information.
Your information may be shared with the following:
- BAMA Institute, LLC, a CLIA certified laboratory for waved tests as part of the processing and analysis of samples
- Bay Area Medical Academy as part of the testing provided to you as a student or employee, including for the purposes of contact tracing
- Applicable government agencies, such as:
- San Francisco Department of Health
- Santa Clara Department of Health
- Your residential county department of health
- Those responsible for data safety monitoring related to the work of the lab
- To other healthcare professionals for the purpose of providing you with quality health care
- Your Health Information may also be shared as required by law
- For routine health care operations, such as medical records storage or quality review
Your confidential information may not be released without your written authorization for purposes other than stated above. You may revoke your permission to release confidential health care information at any time.
Your Rights
You have specific rights regarding confidential healthcare information.
- You have the right to request restrictions on the use of confidential healthcare information.
- You have the right to request we communicate with you about medical matters in a certain way or at a certain location.
- You have the right to review, inspect and receive a photocopy of your confidential healthcare information. A fee will be charged for copies and mailing.
- You have the right to request changes to your healthcare information, if you feel that information is incorrect or incomplete.
- You have the right to know who has accessed your healthcare information and for what purpose.
- You have the right to a copy of this notice.
- You have the right to decline your or your dependent’s participation or withdraw your participation, subject to applicable law.
Warning of Risks & Assumption of Risks
Participating in COVID-19 screening involves inherent health risks. There is a risk of exposure to COVID-19 when leaving one’s home. There is a risk that nose swabbing may cause discomfort, gag reflex, or nose bleed. All medical procedures have some degree of inherent risk, including unknown risk. By consenting to participate, I acknowledge that I understand the risk of participating and I voluntarily accept all health risks.
Waiver, Release, and Indemnification
I understand and acknowledge that no person or entity ensures my safety. I know that participating in this screening is a potentially hazardous activity and I hereby assume full and complete responsibility for any injury, illness, or accident which may occur during my participation. I hereby release, waive, hold harmless and covenant not to file suit against the administrators, sponsors, organizers, volunteers, employees, agents or any affiliated individuals or entities associated with this screening from any and all losses, damages, liabilities or other claims and causes of action that may arise out of my participation.
Consent is required to participate in testing.
I AGREE TO BE TESTED. I UNDERSTAND THIS TESTING SITE WILL NOT FOLLOW-UP WITH MY PRIMARY CARE PHYSICIAN. I UNDERSTAND I WILL BE CONTACTED WITH THE RESULTS OF THIS TEST AND IF IT IS POSITIVE, I WILL NEED TO FOLLOW-UP WITH MY PRIMARY CARE PHYSICIAN DIRECTLY. I UNDERSTAND THE PERSON WHO CALLS WITH MY RESULT IS AUTHORIZED ONLY TO COMMUNICATE MY RESULT AND SHARE GUIDANCE PROVIDED BY THE CENTERS FOR DISEASE CONTROL AND PREVENTION AND MY RESIDENTIAL COUNTY DEPARTMENT OF HEALTH. THEY ARE NEITHER RESPONSIBLE OR LIABLE FOR ADDITIONAL FOLLOW-UP OR MY COURSE OF TREATMENT.
Continuous Application of Waiver
This waiver applies to all testing carried out by BAMA Institute, LLC on behalf of Bay Area Medical Academy and BAMA Institute for up to 1 year from the date of signature of this waiver unless terminated in writing by me.
Participant Signature