Community-Based SARS-CoV-2 Infection Screening
COVID-19 is a viral respiratory disease. Infected people may be able to spread the virus before they feel sick. Additionally, some people do not have symptoms but can still spread the virus to others.
What will happen if you take part?
On Test Day:
If you haven’t already provided this in advance of today, we will ask you some brief questions about your household, you, and your child(ren), if they are here. After the questionnaire, we will then collect a nose and/or throat swab that will be tested for COVID-19 virus infection. We will collect this sample regardless of if you have had any symptoms or not.
If your test is positive:
A medical professional will contact you within 72 hours if your result or your child’s result is positive. We will again ask you about symptoms, discuss obtaining more swabs, and will recommend follow up with your healthcare provider if you are having symptoms.
We will have to provide this information to the state and local health departments as required by law. A public health worker will call people who test positive for COVID-19 to ask about their symptoms, how they may have been infected, and who they may have infected.
If your test is negative:
Your test results will be posted for you to access on a secure online portal or phone call-in system. We will provide you with this information, and how to access it when your sample is collected.
What side effects or risks can I or my child can expect from participating?
Potential side effects and risks include:
Upper respiratory tract 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 and my child(ren)’s specimens and information be used?
Mayo Clinic or the University of Minnesota will receive information and test specimens to process test results and provide the results to Primary Diagnostics, Inc. and Homeland Health Specialists, Inc. If the results are negative, Primary Diagnostics, Inc. will notify test subjects of the results. If the results are positive, medical personnel employed by Homeland Health Specialists, Inc. will notify test subjects. Public health officials at the Minnesota Department of Health and other public health departments will receive your information and test results as required by law to conduct disease surveillance and other public health activities. Information that could identify you will not be shared with any other person or organization unless required by law or court order. 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 this new information with you.
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. All computers and specimens will be maintained in a limited access building, in limited access pods behind locked doors.
How will information about me be kept private?
Participation may involve some loss of privacy. We will do our best to make sure that information about you is kept private. Your personal information may be given out if required by law.
Are there any costs to me for me to get tested?
No. The sponsor has agreed to pay for all costs associated with this COVID-19 screening; you or your insurer will not be billed.
Who is paying for your test? This project is funded by the State of Minnesota. Participation is voluntary.
Notice of Privacy Practices
This document describes how your health information may be used and disclosed, and how you can get access to this information.
Your information may be shared with the following:
- The Mayo Clinic or the University of Minnesota, for the purpose of processing the samples
- Homeland Health Specialists, Inc., the company providing the requisitioning physician and nurses who will be following up with you to explain your results if you test positive for COVID-19- Primary Diagnostics, Inc., a company partnering with the Minnesota Department of Health to run enrollment, sample requisition, and return your test results to you digitally
- Applicable government agencies, such as:
- Minnesota Department of Health and other public health departments for purposes of case investigation, contact tracing and other public health activities authorized by law.
- Your information may also be shared as required by law or court order
- Your private information may not be released without your written authorization for purposes other than stated above.
You may revoke your permission to release your private information at any time.
You have specific rights regarding your health information.
- You have the right to request restrictions on the use of your health information.
- You have the right to request we communicate with you about health matters in a certain way or at a certain location.
- You have the right to review, inspect and receive a photocopy of your health information. A fee will be charged for copies and mailing.
- You have the right to request changes to your health information, if you feel that information is incorrect or incomplete.
- You have the right to know who has accessed your health information and for what purpose.
- You have the right to a copy of this notice.
- You have the right to decline your or your child’s participation or withdraw your participation, at any time.
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 upper respiratory tract 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 insurers 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.
This waiver shall bind a minor participant if agreed to by that minor’s parent or legal guardian.
Consent is required to participate in this project.
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 THE MINNESOTA DEPARTMENT OF HEALTH. THEY ARE NEITHER RESPONSIBLE NOR LIABLE FOR ADDITIONAL FOLLOW-UP OR MY COURSE OF TREATMENT.
I FURTHER AGREE THAT MY SAMPLE AND THE INFORMATION I PROVIDE MAY BE SHARED WITH PRIMARY DIAGNOSTICS, INC., THE MAYO CLINIC, UNIVERSITY OF MINNESOTA, AND HOMELAND HEALTH SPECIALISTS, INC., FOR THE PURPOSES OF TEST REGISTRATION, PROCESSING MY SAMPLE, AND RETURNING MY TEST RESULTS TO ME. I UNDERSTAND THAT MY RESULTS WILL BE REPORTED TO THE MINNESOTA DEPARTMENT OF HEALTH OR OTHER HEALTH DEPARTMENTS AS REQUIRED BY LAW.