Consent for At-Home Testing Program
Introduction: You have the opportunity to participate in an at-home testing program using laboratory-developed test services processed by a third-party laboratory that requires self-collection of a sample. This document provides information to help you understand the purpose, procedures, risks, and alternatives to the test so that you can make an informed decision about whether to participate. Please read this consent form carefully. If you have questions, you can reach out to Play at support@playhealth.com. You must be over the age of 18 to use this at-home testing kit.
1.Introduction: You have the opportunity to participate in an at-home testing program using laboratory-developed test services processed by a third-party laboratory that requires self-collection of a sample. This document provides information to help you understand the purpose, procedures, risks, and alternatives to the test so that you can make an informed decision about whether to participate. Please read this consent form carefully. If you have questions, you can reach out to Play at support@playhealth.com. You must be over the age of 18 to use this at-home testing kit.
2. Purpose of the Test: The purpose of the at-home testing program using a third-party lab to test certain of your hormone levels. The lab results will be reviewed by a physician, and the lab results will be transmitted to you through a web portal or as otherwise communicated. The purpose of the testing is not diagnostic and Play does not offer medical advice.
3. Procedures
Test Kit: You will receive a test kit that includes all necessary materials and instructions.
Sample Collection: Follow the instructions provided in the test kit to collect a blood sample. This typically involves using a lancet to prick your finger and collect in a provided container for a blood sample, swabbing an isolated area of your body for collecting a swab sample. Your test kit will include specific instructions, which you should follow precisely.
Sample Return: Once the sample is collected, use the pre-paid shipping materials to return the sample to the laboratory for analysis.
Results: You will receive your test results via the web portal within a general timeframe of 3-5 business days.
4. Risks and Discomfort:
Physical Discomfort: This test requires sample collection. This may involve a capillary sample extracted from the finger or arm. It may be uncomfortable, painful, potentially cause mild abrasion or bleeding or could result in mild skin irritation, bruising, scarring, infection, or other localized reactions at the collection site. No long-lasting side effects from testing are expected.
Psychological Discomfort: Receiving lab test results may cause health anxiety or stress.
Risk of False Positive or Negative. I understand that the testing may have limitations and the results may not be comprehensive or definitive. There is a risk of false negatives or false positives.
Confidentiality Risks: Although we take extensive measures to protect your privacy, there is a small risk that your personal health information could be inadvertently disclosed.
If you experience persistent pain, signs of infection (such as redness, warmth, swelling, or pus), or any concerning symptoms at the collection site you should immediately consult a healthcare provider.
5. Lab Developed Tests (LDT): The types of laboratory testing included in the services have not been authorized by the Food and Drug Administration (FDA). Instead, self-collected samples from test kits are processed by third-party laboratories as Lab Developed Tests (LDTs) in accordance with Clinical Laboratory Improvement Amendment (CLIA) regulations. The test kits and laboratory tests are solely for wellness testing purposes only and are not intended to diagnose, endorse or recommend any type of medical condition or treatment. Please consult your primary care physician to review the results.
6. Alternatives: You have the option to decline participating in this at-home testing program. Alternatives include:
Visiting a healthcare provider for in-person laboratory testing.
Utilizing other at-home testing services.
7. Confidentiality: Your test results and personal information will be kept confidential and will only be shared with authorized personnel involved in the testing process and as set forth in our privacy policy. Your information may also be shared with our third-party service provider, the third-party laboratory, the third-party health care provider assigned to your test, or as required by law. You will need to sign a separate HIPAA Authorization in order to permit the third-party laboratory to share information as part of the program.
8. Voluntary Participation: Your participation in this at-home testing program is entirely voluntary. You have the right to refuse to participate. If you want to withdraw your consent, you may do so at any time without penalty or loss of benefits to which you are otherwise entitled. However, if your sample has already been processed by the third-party laboratory, the laboratory is required by law to maintain information about your testing.
9. Consent: By checking the box, you acknowledge that you have read and understood the information provided in this form:
10. Contact Information and Process to Revoke Consent: If you have any questions about the test, the testing process, communication forms or issues, or your rights as a participant, or if you wish to revoke your consent, please contact Play Health at support@playhealth.com