METADATA last updated: 2026-03-05 by BA file_name: FloodLAMP Non-Diagnostic Surveillance Testing Materials Acknowledgment and Waiver.md file_date: 2022-08-20 title: FloodLAMP Non-Diagnostic Surveillance Testing Materials Acknowledgment and Waiver category: regulatory subcategory: surveillance tags: source_file_type: gdoc xfile_type: docx gfile_url: https://docs.google.com/document/d/1-PRKoreVDQMN_69fPmctDcbyA-7so3eBtGXkM0Hw4y8 xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/FloodLAMP%20Non-Diagnostic%20Surveillance%20Testing%20Materials%20Acknowledgment%20and%20Waiver.docx pdf_gdrive_url: https://drive.google.com/file/d/1naqR7kPOfiVc3GvRZafSWpHx26AJKUF_ pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/FloodLAMP%20Non-Diagnostic%20Surveillance%20Testing%20Materials%20Acknowledgment%20and%20Waiver.pdf conversion_input_file_type: docx conversion: pandoc license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 727 words: 413 notes: summary_short: The FloodLAMP Non-Diagnostic Surveillance Testing Materials Acknowledgment and Waiver is an entity-facing agreement for using FloodLAMP-provided materials and protocols to run a non-diagnostic SARS-CoV-2 surveillance test without providing individual results. It sets participant notification and referral requirements, clarifies the test is not FDA-authorized or CLIA testing and should not be relied on for individual decision-making, and includes disclosure permissions plus a broad liability waiver and release for FloodLAMP. CONTENT ***INTERNAL TITLE:*** FloodLAMP Non-Diagnostic Surveillance Testing Materials Acknowledgment and Waiver The Entity understands and agrees to the following: 1. FloodLAMP Biotechnologies, PBC, a Delaware public benefit corporation (“**FloodLAMP**”) may provide materials to perform a non-diagnostic molecular surveillance test (the "**Test**") of samples from employees, contractors, students, or affiliated third parties (“**Participants**”) of the Entity to indicate the potential presence of SARS-CoV-2, the virus that causes COVID-19, or may provide materials, equipment, and protocols in order to perform the Test. 2. Entity agrees to ensure that Participants will not be given individual results from the Test. In the event an individual or pooled sample indicates the presence of the SARS-CoV-2 virus, Participants will be referred to take a diagnostic test. 3. The Entity agrees to notify Participants that a referral to a diagnostic test is not a substitute for diagnostic testing. 4. Information received from the Test should not be relied on for decision-making purposes. 5. The Entity agrees not to misrepresent the purpose of the Test. 6. The Test has not been authorized or approved by the FDA or CDC. The Test is not being performed in a CLIA laboratory and is not CLIA waived. 7. The purpose of the Test is to improve public health and to determine appropriate mitigation measures for a population. The Test is not for individual medical or diagnostic purposes. 8. The Test does not rule out the possibility that an individual may have been exposed to or is infected with SARS-CoV-2. 9. FloodLAMP is not acting as a medical provider and the Test does not replace treatment by a medical provider. The Entity agrees to advise Participants to seek medical advice, care, and treatment from a medical provider for questions or concerns. 10. Each sample will be used for the purpose of performing the Test. Results obtained will be used for the purpose of SARS-CoV-2 public health surveillance, as described herein. 11. The Entity agrees that FloodLAMP may disclose Test results and associated information to appropriate county, state, or other governmental and regulatory entities as may be required or permitted by law. 12. The Entity expressly waives and releases FloodLAMP and its employees and agents from any and all rights, claims, lawsuits or damages of any nature whatsoever arising directly or indirectly from the Test or surveillance testing program. 13. Revocation of this waiver must be received by FloodLAMP by email at support@floodlamp.bio. **Entity: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_** By: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Name: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Title: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Date \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Doc Control ID: EAWM01