Testing Authorization & Consent
- Kai Care TESTING AUTHORIZATION AND CONSENT
- Please do not use our services until you have first read this Testing Authorization and Consent and subsequently made an informed decision that our services are right for you.
BACKGROUND ON OUR SERVICES: Kai Care is pleased to facilitate at-home direct to consumer testing. This includes the performance of testing by saliva collection specimens by individuals who have opted-in for testing. Following processing of tested specimens, we will notify you of testing results.
CONSENT TO COVID-19 TESTING: You hereby agree to undergo testing in accordance with the instructions provided to you, including cooperation with all healthcare professionals and personnel to collect an appropriate specimen safely and effectively. You agree to comply with all instructions provided to you related to administration of the testing kit. You further acknowledge that the testing kit is available because 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. EUAs 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 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. 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 risk(s):
RISK OF DISCOMFORT: Testing may involve discomfort, including mild pain, tearing up, and/or triggering a gag reflux.
RISK OF INACCURACY: There is a risk the test will result in a false positive or false negative result. A positive or negative test result does not mean there are no additional possible adverse health conditions or outcomes I may experience. Please consult your primary care physician with any questions regarding your test results.
RISK OF EXPOSURE: Being present in the same space as others, despite my own efforts and those of the health professionals working with me, may increase the risk of my exposure to COVID-19 and the novel coronavirus (SARS-CoV-2). Even following best practices, it is possible for me and Provider personnel to be unaware that we are contagious even without symptoms, raising the possibility of infection. I am aware that exposure to COVID-19 can result in severe illness, intensive therapies, extended intubation and/or ventilator support, life-altering changes to my health, and even death.
RISK OF DISCLOSURE: The U.S. Centers for Disease Control and Prevention and the Texas Department of Health Services requires the Provider and the laboratory processing my specimen to report my test results, whether positive or negative, to my local public health authority. Governmental agencies are exempt from HIPAA Privacy Rules and may request the disclosure of Protected Health Information without your consent. In addition to the test results Kai Care will report certain personal information, not limited to, my age, sex, ethnicity, and zip code. You understand that although Kai Care implements a wide range of administrative, physical, and technical safeguards to protect health information and comply with HIPAA, it cannot guarantee the privacy and confidentiality of all health information. For more details, please review our Notice of Privacy Practices.
A TESTING SOLUTION:
Kai Care offers a testing solution. Kai Care does not diagnose, treat, nor advise the public as to any medical condition or treatment thereof. Diagnosis, treatment, and further care should be sought from your primary care physician. Therefore, you must seek other sources of care for your health needs.
NO PROVIDER/PATIENT RELATIONSHIP NOR DIRECT RESPONSIBILITY FOR CARE: Please note that Kai Care does not take direct responsibility for your health or care beyond facilitating needed testing. No provider/Patient relationship is created nor implied. You are responsible for selecting your primary health care provider, from whom you should seek appropriate medical advice. Any information provided from our website or our customer care are suggestions and should not be taken in place of medical advice. The responsibility of physician(s) who order your tests are limited to ordering your tests establish and no physician /patient relationship is established for any other purpose. TESTING LIMITATIONS: I understand the Test is available because of the FDA’s Emergency Use Authorization (“EUA”) under Section 564 of the Federal Food, Drug, and Cosmetic Act. The EUA’s make available diagnostic tests 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, Testing may be subject to certain limitations as set forth in this Informed Consent.
NOT TO BE USED FOR EMERGENCIES: Kai Care does not provide healthcare services, is not “on call” to answer medical questions. Kai Care is not a substitute for your physician. Call your primary care physician for treatment and advice regarding symptoms and next steps. Do not delay seeking medical care, especially in the case of a medical emergency. In an emergency, dial 911 or go to a hospital emergency department.
RIGHT TO DECLINE CLIENT: Please understand that Kai Care reserves right to refuse to provide collection kits, if, in Kai Care’s judgment, you are not a good candidate for our services.
If you do not understand anything in this Consent, do not proceed. If you go forward with the testing, we will assume that you understood and were able to discuss your questions and concerns to your satisfaction.
INFORMED CONSENT: By clicking that I have read and agree to this informed consent, I hereby acknowledge that I have been advised of the above risks, benefits, and alternatives identified below with respect to testing and the current changes to treatment and care. I have had the opportunity to discuss the risks identified below, to questions, and receive answers to my satisfaction. By signing below, I hereby authorize and direct the provider to administer testing.
I hereby hold harmless, release, and forever discharge Kai Care all health professionals involved in my testing from all claims, demands, and causes of action that I, my heirs, representatives, executors, administrators, or any other persons acting on my behalf or on behalf of my estate have or may have by reason of any problems associated with testing.
DO NOT DIGITALLY CONSENT TO THIS FORM UNLESS YOU HAVE READ IT AND UNDERSTAND IT. ASK ANY QUESTIONS YOU HAVE BEFORE ACKNOWLEDGING CONSENT.
I understand that I am not entering into a doctor-patient relationship with Kai Care, or ORDERING MEDICAL PROVIDER, and that any questions or required follow up shall be my responsibility to arrange with my own physician.
Based on the above, I certify that I have read the foregoing Informed Consent, had opportunities to ask questions, agree and accept all the terms above, and voluntarily consent as noted above.