METADATA
last updated: 2026-01-01 RT
file_name: FloodLAMP Surveillance FAQ and Links (June 2022 DRAFT).md
file_date: 2022-06-01
title: FloodLAMP Surveillance FAQ and Links (June 2022 DRAFT)
category: regulatory
subcategory: surveillance
tags:
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license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
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notes: edited text to remove redundant quoted sections and links and instead link to other FL archive file
summary_short: The surveillance vs. diagnostic testing explainer contrasts patient-focused diagnostic testing (clinical care and individual results under the medical/CLIA framework) with population-focused surveillance testing used to monitor and mitigate spread without reporting patient-specific results. It summarizes federal agency roles and quotes CMS and FDA guidance indicating surveillance testing can occur outside CLIA and outside FDA authorization when individual results are not returned, while individual asymptomatic screening with reported results remains regulated.


CONTENT

## What is the difference between surveillance testing and diagnostic testing?
Diagnostic testing is within the medical framework, with exclusive focus on the individual and gaining information for the purpose of their care as a patient. Surveillance testing looks for infection in a population or community, and has expanded greatly during the COVID Public Health Emergency. The information from surveillance testing can be used for the purpose of stopping the spread of the disease and for managing risk mitigation measures for the group, such as wearing masks. No exchange of personal health information is required for surveillance. Further, a much greater degree of flexibility in where and how it's implemented enables programs such as FloodLAMP's to better meet the needs of groups looking to interact safely and protect their community.

## What are the federal regulations regarding surveillance testing?
3 federal agencies are involved in regulating human disease testing: the Center for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and Centers for Medicare and Medicaid Services (CMS) which governs clinical laboratories through the Clinical Laboratory Improvement Amendments (CLIA).

See [FloodLAMP Surveillance Information (Aug 2021 INTERNAL)](https://docs.google.com/document/d/1oh_RCaaB-9DOzv-k33xxkmhLUQdi2VPIlspGMpbeqLs)
FLOODLAMP ARCHIVE FILE PATH: regulatory/surveillance/FloodLAMP Surveillance Information (Aug 2021 INTERNAL).md