COVID -19 AT HOME TEST AUTHORIZATION AND CONSENT

Please accept our product and use our services only after you have read this information and subsequently made an informed decision that our products and services are right for you.

BACKGROUND ON OUR SERVICES: Directcare is a technology platform designed to facilitate COVID-19 testing, this includes but is not limited to the distribution of home collection kits for self-collection of nasal swab specimens by individuals who have been determined by a healthcare provider to be appropriate for COVID-19 home testing (hereinafter “COVID-19 home testing”).  You have accessed our platform and based on the results of your on-line questionnaire; a healthcare provider has determined you are an appropriate candidate for COVID-19 home testing.  

CONSENT TO COVID-19 HOME TESTING:  You hereby agree to undergo COVID-19 home testing in accordance with the instructions provided to you by Directcare and the healthcare provider assigned by Directcare to you.   As part of your receipt of the COVID-19 home testing kit, you agree to follow all specimen collection and mailing instructions provided with the kit.  In addition, you agree that upon receipt of the COVID-19 home testing kit, you will promptly undertake the methods of instruction provided, whether by accessing the video link provided by Directcare or initiating a telehealth encounter to receive further instructions on how to collect a specimen safely and effectively at home. You agree to comply with all instructions provided to you (in the enclosed materials, by video link, or by telehealth) related to your self-administration of the COVID-19 home testing kit.  You further acknowledge that the COVID-19 home testing kit is available as a result of the U.S. Food and Drug Administration’s Emergency Use Authorization (“EUA”) process under section 564 of the Federal Food, Drug, and Cosmetic Act.  EUA’s make available diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies by allowing unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by chemical, biological, radiological and nuclear threat agents when there are no adequate, approved, and available alternatives.  As a result, the COVID-19 home testing kit is subject to certain limitations. You understand that as with any type of medical or health related test, procedure or treatment, certain risks apply. COVID-19 home testing risks include the risk of injury as the result of administering the test; the risk of improper administration; and inaccurate test results.

In addition to the foregoing you acknowledge the following:

• SEEK OTHER SOURCES OF CARE FOR OTHER HEALTH NEEDS: Our services are limited to COVID-19 home testing. You need to seek other sources of care for your healthcare needs.
• RISKS TO ELECTRONIC HEALTH INFORMATION:  You understand that although Directcare implements a wide range of administrative, physical, and technical safeguards to protect health information and comply with HIPAA, Directcare cannot guarantee the privacy and confidentiality of all health information.  For more details about how Directcare will protect and use your health information and complies with HIPAA.
• NOT FOR EMERGENCIES:  Directcare does not provide healthcare on an emergency basis anywhere at any time and is not a substitute for your physician. Please do not delay seeking care from in a medical emergency or in place of your doctor. In an emergency, dial 911 or go to a hospital emergency department.
• NO DUTY OF CARE:  Please note that Directcare is not a healthcare provider and does not take direct responsibility for your health or care.
• RIGHT TO DECLINE CLIENT:  Please understand that Directcare reserves right to refuse to provide home collection kits, if, in Directcare’ s judgment, you are not a good candidate for this service.
• AGREEMENT TO ANSWER THE ONLINE QUESTIONAIRE TRUTHFULLY AND USE OUR PLATFORM HONESTLY: You understand that by, using the Directcare platform, you accept the responsibility to provide full and truthful answers to all questions and, when requested, to provide all other data in the most accurate form possible.  

IMPORTANCE OF READING ALL THE INFORMATION WE PROVIDE: You understand that Directcare will provide detailed information on its Website and in the telehealth encounter to facilitate you self-collection of the nasal swab specimen.

If you do not understand anything in this Consent, do not proceed. If you go forward with the COVID-19 home testing, we will assume that you understood and were able to discuss your questions and concerns to your satisfaction.