METADATA
last updated: 2026-03-05 by BA
file_name: Memo - USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney).md
file_date: 2021-09-01
title: Memo - USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney)
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: 
summary_short: The follow-up email summarizes guidance that COVID-19 surveillance testing is generally not regulated by FDA or CLIA when samples lack unique identifiers and no individual results are returned, citing FDA and CDC language. It recommends coordinating with local public health officials, structuring groups large enough to support anonymized aggregate reporting, and ensuring testing is administered by appropriately trained personnel consistent with state law.


CONTENT

Gentlemen –

Following up from our discussion today, I did connect with my colleague who is our CLIA lab expert.  We both agree that surveillance testing is not regulated either by FDA or under CLIA.  See the following:

**FDA**
Surveillance for COVID-19 includes ongoing systematic activities, including collection, analysis, and interpretation of health-related data, essential to planning, implementing, and evaluating public health practice. It is generally used to monitor for an occurrence, such as an infectious disease outbreak, in a population or community, or to characterize the occurrence once detected, such as looking at the incidence and prevalence of the occurrence. Surveillance testing is primarily used to gain information at a population level, rather than an individual level. Surveillance testing may be random sampling of a certain percentage of a specific population to monitor for increasing or decreasing prevalence and determining the population effect from community interventions such as social distancing. FDA generally does not regulate surveillance testing. An example of surveillance testing is a testing plan developed by a State Public Health Department to randomly select and sample 1% of all individuals in a city on a rolling basis to determine local infection rates and trends.

[https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2)

**CLIA**
If a laboratory conducts surveillance testing on a specimen without a unique identifier and the results of that testing are not returned to the individual, or to the individual’s healthcare provider, employer, etc., that laboratory does not need a CLIA certificate. Surveillance testing results may be returned in aggregate to the institution that requested the study. In such cases, surveillance testing may indicate the need to conduct additional and perhaps more targeted diagnostic testing or screening at the individual level in a CLIA-certified laboratory to improve population or setting-specific health. If at any time a facility conducting surveillance testing intends to report a patient-specific testing result, it must first obtain a CLIA certificate and meet all CLIA requirements to perform that testing.

[https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html](https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html)

We have also not identified any requirement that surveillance testing be done **only** by a public health authority.  As a result, we see no prohibition on surveillance testing being done by a private entity.  This being said, we believe there are benefits to cooperating/coordinating with a local public health entity to get their buy in prior to initiating testing, even if their approval is not strictly required.  Getting their buy in certainly would de-risk the scenario and we would therefore recommend we coordinate with local public health officials in advance.  We would be happy to participate in those discussions.

As we discussed, we should ensure that the test results are not communicated to the individual and should ensure that the pods of people are large enough that the testing can be anonymized and be considered “surveillance testing”.  (Note: there is no regulatory or official definition of “surveillance” such that the groups/pods need to be of a particular size but given the possibility this could be scrutinized by regulators (potentially including FDA), we would want them to be large enough that the testing can reasonably be described as surveillance testing.)   This is another reason why having local public health officials on board early who can be supporters of the public health benefits of such a program.

The testing should be performed/administered by trained technicians that are permitted under state law to perform COVID tests (given they are not yet authorized for consumer use).  We have not looked specifically at Florida state requirements but could do if needed.  While this could be done by CLIA lab employees, it is not necessary.

Best regards,