METADATA
last updated: 2026-03-05 by BA
file_name: FloodLAMP Surveillance Information (Aug 2021 INTERNAL).md
file_date: 2021-08-01
title: FloodLAMP Surveillance Information (Aug 2021 INTERNAL)
category: regulatory
subcategory: surveillance
tags:
source_file_type: gdoc
xfile_type: docx
gfile_url: https://docs.google.com/document/d/1oh_RCaaB-9DOzv-k33xxkmhLUQdi2VPIlspGMpbeqLs
xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/FloodLAMP%20Surveillance%20Information%20%28Aug%202021%20INTERNAL%29.docx
pdf_gdrive_url: https://drive.google.com/file/d/1Jf3eJA_lPODfhtlKdRp-bu7IPEDrtrur
pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/FloodLAMP%20Surveillance%20Information%20%28Aug%202021%20INTERNAL%29.pdf
conversion_input_file_type: docx
conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 3906
words: 2239
notes: many links to other FL archive files
summary_short: The regulatory overview and FAQ memo explains how FloodLAMP frames pooled COVID-19 surveillance testing as a non-diagnostic public health activity under CMS guidance, emphasizing that no patient-specific results (e.g., “positive/negative/inconclusive”) are reported and participants are referred to CLIA-certified diagnostic testing when SARS-CoV-2 is detected in a pool. It contrasts surveillance testing, LDTs, and FDA-authorized EUA tests, cites CMS enforcement discretion and an eCFR research-lab exemption, and includes prepared language and supporting federal links to justify compliance for a municipal surveillance program.


CONTENT

[CMS Surveillance FAQ 10-21-21](https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf)
[CMS Surveillance FAQ 10-21-21  2021-10-21_CMS CLIA - Frequently Asked Questions SARS-CoV-2 Surveillance Testing.pdf](https://drive.google.com/file/d/1FN0e5vbU3eJ2hMSewH9to42yvYhWisCn)
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/surveillance/CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md

[CMS - CLIA SARS2 Variant FAQ 3-19-21](https://www.cms.gov/files/document/clia-sars-cov-2-variant.pdf)
[2021-03-19_CMS CLIA - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question.pdf](https://drive.google.com/file/d/15jnDb6cPCPAOkYUlintP0s-kO8am2-Gp)
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/surveillance/CMS - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question (2021-03-19).md

[FDA FAQ](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2)
[FDA Website - COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 (updated 2023-09-29).pdf](https://drive.google.com/file/d/1s8uGXw7Lq90NiNlR3_XpmNiXOKoNDEtt)
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/surveillance/FDA Website - COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 (updated 2023-09-29).md

[CDC FAQ](https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/sars-cov2-testing-strategies.html) (LINK DEAD)


## Regulatory Overview 
- Surveillance test:
  - Surveillance testing can be a useful tool for understanding infection in a population.
  - Surveillance testing is not diagnostic, and positive and inconclusive results should be accompanied by a referral to a clinically diagnostic test.
  - Surveillance testing must not furnish participants with patient specific diagnostic results.
  - CMS which has regulatory oversight over CLIA labs posted this [FAQ about surveillance testing](https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf) .
  [CMS Surveillance FAQ 10-21-21  2021-10-21_CMS CLIA - Frequently Asked Questions SARS-CoV-2 Surveillance Testing.pdf](https://drive.google.com/file/d/1FN0e5vbU3eJ2hMSewH9to42yvYhWisCn)
  _FLOODLAMP ARCHIVE FILE PATH:_ regulatory/surveillance/CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md
  - Surveillance testing can occur in CLIA and non CLIA labs.
- Laboratory Developed Test
  - LDTs are developed in-house at CLIA labs.
  - In some cases, samples can be processed in mobile or pop up labs.
  - These tests can offer clinical diagnostic results.
  - They are more expensive and require a partnership with a CLIA lab.
  - FloodLAMP can work with CLIA labs to bring up this capability.
- EUA Test
  - FloodLAMP has submitted its QuickColor™ COVID-19 Test to the FDA.
  - The FDA has not authorized or approved the test at this time.
  - EUA tests are authorized by the FDA to provide clinical diagnostic results for the intended use specified in the authorization documents.
  - Medical providers and CLIA lab directors have the discretion to use FDA EUA tests off label.

## FAQ
**Is FloodLAMP Biotechnologies and the City of Coral Springs violating any federal regulations on testing?**
No federal regulations have been violated. Per CMS: “Generally, SARS-CoV-2 surveillance testing can be performed in a facility that is NOT CLIA certified, and may use a test or technique NOT authorized by the FDA, provided that patient-specific results are not reported. If at any time a patient-specific result is reported, the facility is subject to CLIA and required to obtain an appropriate CLIA certificate in accordance with 42 CFR part 493.” [https://www.cms.gov/files/document/clia-university-lab-testing.pdf](https://www.cms.gov/files/document/clia-university-lab-testing.pdf)
[CMS - CLIA University Lab Testing FAQ (2020-08-28).pdf](https://drive.google.com/file/d/1tgBv4ypHFed2fe3T2KXxxGb3H7JoYMAS)
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/surveillance/CMS - CLIA University Lab Testing FAQ (2020-08-28).md

**Will FloodLAMP Biotechnologies and the City of Coral Springs provide patient-specific results, deliver a diagnosis, or provide results?**
No, FloodLAMP Biotechnologies and the City of Coral Springs will not provide patient-specific results, provide a diagnosis, or provide diagnostic test results. None of the following terms are utilized by FloodLAMP based on direct guidance from CMS (see both the attached Castillo CMS guidance letter and the CMS guidance email contained below) “negative, positive, inconclusive, presumptive positive, a result of clinical significance, or a result of potential clinical significance”. Further, the test configuration uses pooled samples at the point of collection. Pooling is the process of several participant samples into one test reaction. Once this pooling has occurred it is not possible to determine which sample was furnished by which participant. The result is all participants in pools where SARS-CoV-2 is detected are referred to a clinical diagnostic test. Conversely, all participants in pools where SARS-CoV-2 is not detected are notified that the absence of that detection is not conclusive to determine a participant's medical status.

**What language can be used to provide the results of a non-diagnostic?**
Per the email below from CMS: **“A CLIA certificate will not be required if you refer a patient to a CLIA certified laboratory.”**

Dr. Campbell,

The guidance listed in the CMS letter that you received would be the most current guidance and I would like to summarize the contents of the letter within the framework of your email correspondence.

**A CLIA certificate will be required if you report, or provide any of the following diagnostic testing information from your surveillance testing:**
**Negative, Positive, Inconclusive, Presumptive positive, A result of clinical significance, or a result of potential clinical significance.**
**A CLIA certificate will not be required if you refer a patient to a CLIA certified laboratory.**

**CMS does not have any written instructions on the referral of a patient to a CLIA certified laboratory.**

Should you have a specific question, kindly forward the question for a written response.

Thank you,
Raymond Castillo
Clinical Laboratory Scientist
Centers for Medicare and Medicaid Services
233 N. Michigan, Suite 600
Chicago, Illinois 60601

**Are FloodLAMP Biotechnologies and the City of Coral Springs authorized to run a diagnostic test and a diagnostic lab?**
Per CMS guidelines, the city will run a non-diagnostic surveillance test and refer participants to diagnostic tests in CLIA certified laboratories, as indicated by those guidelines or to rapid EUA point of care molecular and antigen tests. The test can be performed at a CLIA lab and the City can submit a CLIA application and acquire a CLIA number if it chooses to perform diagnostic tests. At this time, using the FloodLAMP lab-developed-non-diagnostic test most appropriately suits the City’s public health surveillance needs.

**Is FloodLAMP preparing to file for an EUA or FDA approval?**
It is a common misconception that CLIA labs need to use FDA approved tests. This is not true. CLIA labs can perform internally validated, Lab Developed Tests (LDTs). FloodLAMP has submitted EUA's to the FDA but have not yet received authorization. When the FloodLAMP QuickColor™ test is authorized (we're confident it will be based on the performance and comparative EUAs), CLIA labs will be able to run the test to offer individual diagnostic results without the need for individual labs to independently validate the test. The EUA authorization will not have any impact on non-diagnostic public health uses of FloodLAMP's COVID-19 tests.

**Does FloodLAMP Biotechnologies and the City of Coral Springs provide surveillance or screening?**
The issue associated with these terms is that surveillance testing does not normally allow for the reporting of individual results to participants. However, the guidance clearly demonstrates that there is a mechanism to refer individuals to diagnostic tests in the context of surveillance, and we are extremely careful to adhere to this guidance. This clear CMS guidance was issued in the context of the COVID-19 pandemic, and absent this guidance, the service we are providing to clients could be construed as diagnostic screening. However, given the very clear CMS guidance, which states that surveillance testing can be used to refer individuals to diagnostic tests (attached). We remain firm in our good-faith commitment to this guidance, but should situations develop that force *FloodLAMP Biotechnologies and the City of Coral Springs* to leverage a CLIA certification, we are prepared to do this to minimize any interruption of service to ensure the City’s ability to provide safe in-person working environments. Doing so at this point would disrupt the workflow and materially increase the program cost and complexity.

**Have other groups used this test in this way?**
Yes, our colleagues in Chicago and Colorado have used identical test chemistry to offer well over 1 million surveillance tests to support in person learning in K-12 settings. They have recently published their test in eLife, a highly respected scientific journal. Relevant information regarding this test…. “The Saliva TwoStep test described herein identified infections with 94% sensitivity and >99% specificity in individuals with sub-clinical (asymptomatic or pre-symptomatic) infections.”
[https://elifesciences.org/articles/65113](https://elifesciences.org/articles/65113)

**Does the FDA regulate surveillance testing?**
No. “The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” The FloodLAMP QuickColor test would be regulated by the FDA if it was being used to support medical diagnosis for individuals or as part of a diagnostic screening program. The linked section on [Surveillance Testing](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/pooled-sample-testing-and-screening-testing-covid-19#pooled) (LINK DEAD) notes that surveillance testing is generally overseen by the rule making authority of CMS through their CLIA oversite. Our good faith and collaborative relationship with [CMS has yielded that surveillance testing can be conducted with non FDA tests at CLIA labs during the COVID-19 public health emergency provided that participants are referred to CLIA labs for follow up and never provided patient specific results.](https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf)
[CMS Surveillance FAQ 10-21-21  2021-10-21_CMS CLIA - Frequently Asked Questions SARS-CoV-2 Surveillance Testing.pdf](https://drive.google.com/file/d/1FN0e5vbU3eJ2hMSewH9to42yvYhWisCn)
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/surveillance/CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md

**What statute exempts FloodLAMP Biotechnologies and the City of Coral Springs from CLIA requirements for their surveillance testing program?**
[§493.3 (B) (2)](https://www.ecfr.gov/cgi-bin/text-idx?node=pt42.5.493&rgn=div5#se42.5.493_13) “Research laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients”

The surveillance program is designed to manage city wide risk of COVID-19 infection. The program does not supplement, supplant or replace health care provider-directed clinical diagnostic testing for the diagnosis, prevention or treatment of COVID-19 at the individual level, nor does it support the assessment of the health of individual participants. CMS has provided explicit guidance in FAQ’s and letters how surveillance testing can be used during the COVID-19 public health emergency as indicated in this document.

**The following is an except of the regulatory section submitted for a review paper of the Global LAMP Consortium (gLAMP), authored by Randy True of FloodLAMP.**
**Surveillance and Asymptomatic Testing**
While the regulated pathways of COVID-19 testing have received most of the attention and funding, a completely unregulated pathway has opened up after being initially blocked. "Surveillance" testing is primarily used to gain information at a population level rather than an individual level. Surveillance testing may involve 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. The FDA generally does not regulate surveillance testing. \[[Wellesley](https://wellesleyps.org/viral-testing/wps-covid-19-pool-surveillance-testing-plan-faqs/), [CMS Surveillance FAQ](https://www.cms.gov/files/document/06-19-2020-frequently-asked-questions-covid-surveillance-testing.pdf)\]
However, in mid May, after the U.S. was already experiencing one of the worst COVID-19 epidemics in the world, the FDA shut down the Gates Foundation's home testing effort in the Seattle area. "The study lacked two kinds of clearance," the FDA said: a federal Emergency Use Authorization (a type of pandemic-era green light used to speedily clear tests and medical devices during an emergency) and approval from an outside group of experts tasked with providing ethical oversight for research (an Institutional Review Board). Obtaining either clearance could have allowed the effort to go forward, according to the FDA. \[[StatNews 5-27-2020](https://www.statnews.com/2020/05/27/coronavirus-testing-seattle-bill-gates-fda/), [NYT 5-15-2020](https://www.nytimes.com/2020/05/15/us/coronavirus-testing-seattle-bill-gates.html)\]

The following exchange occurred in July of 2020 during a webinar entitled "Government-University Dialogue on COVID-19 Surveillance and Testing":
**Francis Collins (Director of the NIH):** *If you’re doing surveillance (as you’ve just described) in a non-CLIA environment and using pooling, and you get a positive pool (I’ve heard of some places that were like, “Well, we still have the original samples, so we could actually quickly run the components of that pool and we can figure out which one of them was actually responsible for the positive, and then we just reach out to that one person and say, ‘You need to get yourself checked out in a CLIA lab.’”) is that allowable?*

**Seema Verma (Head of CMS which governs CLIA):** *Yes, that would work because you’re not actually giving results. You’re still making the referral to that particular person to have the actual diagnosis performed in a CLIA lab. So they can repeat that, but just as long as they’re not telling somebody, "Yes, you are positive or negative,” and just saying, “We’re referring you, you need to have a confirmatory test in a CLIA-certified lab.”*
\[[NIH Webinar 7-24-2020](https://videocast.nih.gov/watch=38226)\]

Further, the following document was published by CMS on Aug 28:

*CMS is temporarily exercising enforcement discretion under CLIA for SARS-CoV-2 surveillance testing where patient-specific results are reported (e.g., SARS-CoV-2 surveillance testing that does not utilize a pooling strategy). Specifically, neither CMS nor the State survey agencies on its behalf will cite non-CLIA certified facilities, such as university laboratories, that are performing such testing, provided that the facility does not report actual test results, but only refers an individual with a presumptive positive or inconclusive test result to a CLIA-certified laboratory for further testing.*
\[[CMS - CLIA University Lab Testing 8-28-2020](https://www.cms.gov/files/document/clia-university-lab-testing.pdf)\]
[CMS - CLIA University Lab Testing FAQ (2020-08-28).pdf](https://drive.google.com/file/d/1tgBv4ypHFed2fe3T2KXxxGb3H7JoYMAS)
_FLOODLAMP ARCHIVE FILE PATH:_ regulatory/surveillance/CMS - CLIA University Lab Testing FAQ (2020-08-28).md

In November the FDA stated the following:
*When you refer to public health — if it’s totally a surveillance program where individual results are not returned to patients in a CLIA testing manner, but \[instead\] groups of people are referred to CLIA testing — surveillance testing as defined by the CDC, CMS, FDA websites is not something the FDA is regulating. When it comes to asymptomatic screening, when you want to return a CLIA lab result to an individual patient….That we do regulate.*
\[[FDA Town Hall](https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/virtual-town-hall-series-coronavirus-covid-19-test-development-and-validation-01062021-01062021) 11-18-2020\]

Several universities and companies describe their testing programs using the term "surveillance". However, because surveillance testing is not formally regulated in the U.S., it is difficult to estimate the extent of testing being performed under this pathway.