METADATA last updated: 2026-03-10_105732 file_name: _archive-combined-files_surveillance_33k.md category: regulatory subcategory: surveillance gfile_url: **FLAGGED - TBD user-facing Google-hosted public file URL** words: tokens: CONTENT # _archive-combined-files_surveillance_33k (15 files, 33,458 tokens) # 8,194 _AI_Covid_Surveillance_Testing_Screening_Report.md METADATA last updated: 2026-03-01 file_name: _AI_Covid_Surveillance_Testing_Screening_Report.md file_date: 2026-03-01 title: FloodLAMP Surveillance, Testing, and Screening During the COVID-19 Pandemic category: regulatory subcategory: surveillance tags: surveillance, screening, testing, CLIA, FDA, CMS, CDC, regulatory-definitions, SCAN, wastewater, genomic-surveillance source_file_type: md xfile_type: NA gfile_url: https://docs.google.com/document/d/1heuoMq2c0YUEPD1-UvgW1QFI4pLIUBel4-iGuJk6MoM xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/_AI_Covid_Surveillance_Testing_Screening_Report.md pdf_gdrive_url: NA pdf_github_url: NA conversion_input_file_type: NA conversion: NA license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 8194 words: 4205 notes: Created by ChatGPT Pro 5.2 Extended during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** Comprehensive report on surveillance, testing, and screening regulatory history during the COVID-19 pandemic, covering U.S. regulatory architecture (FDA/CMS/CDC), key case studies (SCAN, SafeGuard/New Trier, FloodLAMP), operational patterns, and post-PHE transitions. Prompt not included. summary_short: Regulatory history and analysis of surveillance, testing, and screening distinctions during the COVID-19 pandemic, focusing on how "surveillance testing" was defined, contested, and regulated across U.S. programs (2020--2023). Covers FDA/CMS/CDC frameworks, key case studies (SCAN, SafeGuard/New Trier, FloodLAMP), wastewater and genomic surveillance, and post-PHE transitions, with appendices mapping FloodLAMP archive documents and primary sources. CONTENT ## Executive summary During COVID-19, U.S. testing split into three overlapping purposes--**diagnosis**, **screening**, and **surveillance**, but institutions often used the word *surveillance* to describe programs that looked, functioned, and felt like **screening** (routine testing of asymptomatic people to make individual decisions). That semantic slippage mattered because, in U.S. law and agency practice, whether a program is "diagnostic/screening" versus "surveillance" affects: - whether a site needs to operate as a **CLIA-certified laboratory** (or send testing to one), - whether a method must be **FDA-authorized/marketed** (e.g., EUA during the PHE), - what **results** may be returned to individuals, - what **reporting** is required to public health agencies, and - who has oversight authority (CMS, FDA, state agencies, IRBs, or local public health departments). A central dynamic of the pandemic was the attempt to scale fast, low-cost testing in schools, universities, and workplaces **before** regulators had simple, stable frameworks for frequent testing of asymptomatic people. Many programs therefore sought "escape hatches": - **Research framing** (IRB oversight; results sometimes handled differently), - **De-identified public health surveillance** (aggregate reporting; no individual results), - **Pooled testing + referral** (only "pool-level detection," with confirmatory individual diagnostic tests elsewhere), - **State authorization** (especially early 2020) before federal processes matured. The canonical early collision between these worlds occurred in Seattle: the **Seattle Flu Study** (a pre-pandemic influenza surveillance platform) and its COVID-era successor **SCAN** (Greater Seattle Coronavirus Assessment Network) encountered shifting FDA interpretations about home collection and the return of results. In mid-May 2020, FDA-directed pauses and press coverage created a durable "object lesson" for how a program can be described as "surveillance" but become regulated once it returns individual results. By 2021--2022, CMS (CLIA) and FDA guidance became more explicit about these distinctions, and regulators began pushing back when "surveillance" language appeared to mask **individual-result** testing--an issue that also appears in FloodLAMP's archive (e.g., FDA website review and requests to remove language implying individual follow-up testing). By 2023, as the federal COVID-19 PHE ended, mandatory nationwide reporting and many emergency flexibilities wound down. Surveillance increasingly shifted toward **sentinel systems**, especially **wastewater surveillance** and **genomic surveillance**, because case-based counting (and universal negative-result reporting) became less feasible as home testing expanded and public reporting requirements changed. ## 1. Why "surveillance" became a contested label ### 1.1 Pre-pandemic baseline meaning Before COVID-19, **public health surveillance** primarily meant population-level monitoring--collecting and analyzing data to track disease trends, detect outbreaks, and guide interventions. Surveillance generally did **not** mean providing an individual with a clinical test result to guide personal decisions. ### 1.2 COVID-era expansion and semantic drift During COVID-19, "surveillance" was sometimes used more broadly to describe: - routine testing programs for **asymptomatic** people (e.g., schools/workplaces), and/or - pooled testing programs where administrators wanted to claim they were not doing clinical testing even while **removing individuals from school/work** based on results. This produced a recurring tension: - **Regulators** tended to treat "returning individual results" as the key feature that makes testing *clinical* (diagnostic or screening). - **Operators** often used "surveillance" to signal a public-health purpose and to reduce friction, cost, or compliance burdens--especially for high-frequency testing. ## 2. Key definitions that shaped policy The FDA's "COVID-19 Test Uses" FAQ (content current as of **September 29, 2023**) summarizes the triad as follows (paraphrased): - **Diagnostic testing:** testing an individual when there is reason to suspect infection (symptoms or known/suspected exposure). - **Screening testing:** testing an individual even without suspicion or known exposure, with the intent to make **individual decisions** based on results (e.g., school/workplace testing to decide who returns). - **Surveillance testing:** systematic activities to generate **population-level** information, generally not reporting results to a patient or provider. Source (FDA): `regulatory/surveillance/FDA Website - COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 (updated 2023-09-29).md` https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2 ### 2.1 A practical "surveillance vs screening" test In practice, a useful question was: > **Will anyone use this test result to make an individual decision about one person?** > If yes, regulators usually treated it as **screening or diagnostic**, not surveillance. ## 3. U.S. regulatory architecture in plain language ### 3.1 CLIA (CMS): "Are you operating a laboratory that returns patient-specific results?" The Clinical Laboratory Improvement Amendments (**CLIA**) are administered by CMS and regulate laboratories that test human specimens for diagnosis, prevention, treatment, or health assessment. In general: - If a program returns **patient-specific** results, it often triggers **CLIA** requirements. - If a program is truly **de-identified** and results are not used for individual decisions, it can sometimes fall outside CLIA's clinical laboratory framework. COVID-era complexity: CMS issued multiple FAQs and memos clarifying when pooled or surveillance workflows might proceed without a traditional CLIA certificate (often under time-limited enforcement discretion). Post-PHE note: CMS emphasized that some flexibilities ended with the PHE and that its authority to require SARS-CoV-2 test reporting was linked to the federal PHE declaration. Key sources: - CMS QSO-23-15-CLIA (May 11, 2023): https://www.cms.gov/files/document/qso-23-15-clia.pdf - CMS "CLIA FAQs: Post-PHE Guidance" (May 11, 2023): https://www.cms.gov/files/document/clia-post-phe-guidance-faqs-only.pdf - CDC LOCS Lab Advisory on post-PHE CLIA reporting (May 19, 2023): https://www.cdc.gov/locs/2023/05-19-2023-Lab-Advisory-COVID-19_CLIA_Post-Public_Health_Emergency_Guidance.html ### 3.2 FDA: "Are you using an in vitro diagnostic (IVD) test for a clinical purpose?" In the U.S., SARS-CoV-2 tests are **medical devices** (IVDs) overseen by FDA. During the COVID-19 emergency, most tests entered the market via: - **Emergency Use Authorizations (EUAs)**, and/or - FDA's evolving testing **policies** (including enforcement discretion windows). A recurring flashpoint was **home collection** and "direct-to-consumer" workflows. Early in the pandemic, FDA's policies for home collection and home testing shifted repeatedly, contributing to confusion among research and public-health programs (and to headline-grabbing conflicts such as SCAN). ### 3.3 CDC and public health agencies: "What is the public health function?" CDC guidance documents helped define and compare diagnostic, screening, and surveillance strategies; they also reinforced that: - diagnostic/screening testing intended to return results to individuals comes with clinical lab and reporting expectations, - surveillance testing is typically de-identified and not returned to individuals. The FloodLAMP archive includes a CDC "Testing Strategies for SARS-CoV-2" document updated December 28, 2021, which contains a summary matrix comparing these strategies. **FLAG - add relative path to file** ## 4. Timeline of key events (selected) > This timeline is intentionally "U.S.-regulatory centered." It highlights moments when agency interpretation or public controversy changed how surveillance and screening were discussed. | Date | Event | Why it matters for surveillance vs. screening | |---|---|---| | **Nov 2018** | Seattle Flu Study (SFS) established as a community respiratory surveillance platform | Built "pre-pandemic" surveillance infrastructure later repurposed for SARS-CoV-2. | | **Feb 2020 (early)** | Seattle Flu Study begins seeking permission to use existing sample bank for SARS-CoV-2 surveillance | Shows early friction when research surveillance intersects with clinical/public health needs (discussed in ethics literature). | | **Feb 24, 2020** | First SFS SARS-CoV-2 community transmission case detected (specimen collected Feb 24) | Widely cited example of surveillance detecting community spread early; paper notes Gates Ventures support. | | **Mar 23, 2020** | SCAN launched (Seattle Flu Study + Public Health -- Seattle & King County) | Explicitly framed as a "disease surveillance platform." Also the date SCAN later cited as the start of its EUA process. | | **May 11--12, 2020** | FDA clarifies home self-collection policy; SCAN directed to pause returning results pending additional federal authorization | Key inflection: "surveillance" + **returning individual results** triggered FDA expectations for EUA/authorization. | | **Jun 10, 2020** | SCAN resumes testing; explains pause and EUA pathway | SCAN publicly documents its regulatory posture: surveillance framing, but acknowledgement of EUA needs for home collection + results return. | | **Aug 28, 2020** | CMS publishes university lab testing / surveillance FAQ (CLIA) | Institutional testing programs scale; CMS addresses pooled testing and surveillance workflows. | | **Dec 2020** | CMS issues notice letter on CLIA surveillance testing | Clarifies that returning patient-specific results generally triggers CLIA; describes enforcement discretion constraints. | | **Mar 19, 2021** | CMS publishes variant testing FAQ | Extends "surveillance without individual return" logic into genomic/variant sequencing. | | **Mar 30, 2021** | NYT story on New Trier High School testing scrutiny | A high-profile example of school testing being treated as regulated screening when individual students are flagged. | | **Oct 21, 2021** | CMS revises surveillance testing FAQ | More mature articulation of pooled surveillance testing risks and confirmatory testing expectations. | | **Dec 28, 2021** | CDC updates testing strategies guidance | Reinforces definitions and operational boundaries between diagnostic/screening vs surveillance. | | **Jan--Mar 2022** | FDA correspondence with FloodLAMP regarding website claims | Illustrates late-pandemic tightening on "surveillance" branding when individual follow-up pathways are implied. | | **May 11, 2023** | Federal COVID-19 PHE ends | Reporting requirements and emergency flexibilities change; surveillance systems (wastewater/genomic) become relatively more central. | | **Sep 29, 2023** | FDA updates "COVID-19 Test Uses" FAQ | A consolidated, post-crisis articulation of diagnostic vs screening vs surveillance definitions. | Primary source links for the Seattle portion of this timeline are in the next section. ## 5. Case studies and major programs ### 5.1 Seattle Flu Study -> SCAN (Greater Seattle Coronavirus Assessment Network) **Why this matters:** This is one of the clearest public examples of a pre-pandemic *influenza surveillance* platform being repurposed for SARS-CoV-2, and then colliding with regulatory boundaries when results were returned. #### 5.1.1 Seattle Flu Study as "pandemic surveillance platform" A short NEJM letter by Chu et al. describes the Seattle Flu Study as a multi-institutional pandemic surveillance platform established in **November 2018**, and reports early detection of SARS-CoV-2 community transmission through that infrastructure. The letter's disclosure footnote notes **Gates Ventures** support. - NEJM (full text): https://www.nejm.org/doi/full/10.1056/NEJMc2008646 - Open-access mirror (PMC): https://pmc.ncbi.nlm.nih.gov/articles/PMC7206929/ #### 5.1.2 Launch of SCAN as a public health surveillance program Public Health -- Seattle & King County announced SCAN on **March 23, 2020**, describing it as a disease surveillance platform to better understand how COVID-19 was spreading. - Public Health Insider (Mar 23, 2020): https://publichealthinsider.com/2020/03/23/introducing-scan-the-greater-seattle-coronavirus-assessment-network/ - SCAN Technical Report (Apr 17, 2020 PDF): https://publichealthinsider.com/wp-content/uploads/2020/04/SCAN-Technical-Report-v1-17-APR-2020.pdf #### 5.1.3 The May 2020 pause and "the surveillance/screening collision" In May 2020, SCAN paused returning results after FDA clarified policy for **home-based, self-collected samples** and indicated that **a separate federal EUA** was required to return results for self-collected tests. Primary/near-primary sources documenting this sequence: - Public Health Insider "SCAN resumes" explanation (Jun 10, 2020): https://publichealthinsider.com/2020/06/10/greater-seattle-coronavirus-assessment-network-scan-resumes-covid-19-testing/ - Reuters coverage of the pause (May 16--17, 2020): https://www.reuters.com/article/world/u-s-fda-suspends-gates-backed-at-home-covid-19-testing-program-idUSKBN22S0R7/ - STAT analysis and quotes from FDA + experts (May 27, 2020): https://www.statnews.com/2020/05/27/coronavirus-testing-seattle-bill-gates-fda/ **Key regulatory lesson illustrated:** Even if a program's *purpose* is public health surveillance, **returning results to individuals**--especially in a home-collection workflow--pulled the program into FDA/CMS compliance expectations typical of screening/diagnostic testing. #### 5.1.4 Ethical framing: research infrastructure repurposed for public health Legal/ethics scholarship used the Seattle Flu Study as an example of the complexities of using research infrastructure for urgent public health purposes, including result return and reporting mandates. - Doerr et al. (Journal of Law and the Biosciences, 2020; open access): https://pmc.ncbi.nlm.nih.gov/articles/PMC7381975/ ### 5.2 School-based saliva surveillance: Ed Campbell (SafeGuard) and the New Trier example **Why this matters:** K-12 schools became a major arena where "surveillance testing" was used colloquially to mean frequent testing, but regulators often treated it as **screening** because individual students were identified and acted upon. #### 5.2.1 Ed Campbell and SafeGuard surveillance / Safeguard Solutions Multiple media and case-study sources describe Dr. **Ed Campbell** (a virologist and Loyola University Chicago faculty member) as an organizer of school testing efforts under the company **Safeguard Solutions** (which later obtained CLIA certification) and link the saliva test lineage to collaboration with U Madison scientist **David (Dave) O'Connor**. - Hinsdale Magazine profile (Apr 2021): https://hinsdalemag.com/keeping-the-doors-open/ - Gilson "Safeguard Solutions: A COVID-19 Student Testing Operation" (case study): https://www.gilson.com/us/case-study-safeguard-solutions-a-covid-19-student-testing-operation #### 5.2.2 New Trier High School and "surveillance" vs "screening" The New York Times story `regulatory/surveillance/2021-03-30_NY Times - Why Virus Tests at One Elite School Ran Afoul of Regulators.md` https://www.nytimes.com/2021/03/30/us/covid-school-testing-fda.html is frequently cited because it shows the operational boundary regulators cared about: - If a test flags **specific students** and triggers individual action (send home, isolate, etc.), regulators tend to treat that as **screening/clinical testing**, not de-identified public health surveillance. - The resolution pathway described in coverage often involved moving toward CLIA-aligned operations and qualified oversight. ### 5.3 Dave O'Connor (University of Wisconsin): mobile RT-LAMP surveillance and genomic surveillance **Why this matters:** O'Connor's work appears in two "surveillance" modes: 1) **frequent, low-friction saliva testing** (often RT-LAMP) to support safer schools/workplaces, and 2) **genomic surveillance** (sequencing) to track viral spread and variants. #### 5.3.1 Mobile saliva RT-LAMP as a surveillance tool (summer--fall 2020) UW researchers evaluated a mobile, outdoor RT-LAMP workflow using saliva samples from volunteers, emphasizing that it was oriented toward surveillance and rapid turnaround rather than traditional clinical diagnostics. - Newman et al., "Initial evaluation of a mobile SARS-CoV-2 RT-LAMP testing strategy" (open access, 2021): https://pmc.ncbi.nlm.nih.gov/articles/PMC7809916/ - (Paper describes surveillance samples collected July--Nov 2020.) UW communications also described RT-LAMP as not yet approved for clinical diagnosis and advised confirmatory PCR for people who screened positive: - UW News (Aug 6, 2020): https://news.wisc.edu/uw-researchers-develop-new-method-to-test-for-covid-19/ Popular media coverage captured the "DIY/surveillance" framing and the regulatory barrier: - WIRED (Jul 23, 2020): https://www.wired.com/story/a-wisconsin-city-experiments-with-a-faster-diy-covid-19-test #### 5.3.2 Scaling school testing and related grants Wisconsin-focused reporting described efforts to improve school testing (including interest in methods like RT-LAMP): - Pediatrics Wisconsin (Jul 23, 2021): https://pediatricswi.org/new-grant-aims-to-improve-testing-in-wisconsin-schools/ #### 5.3.3 Genomic surveillance leadership in Dane County University of Wisconsin communications described how researchers (including David O'Connor) contributed to viral sequencing surveillance in Dane County, positioning the area as unusually advanced in surveillance density during outbreaks. - UW--Madison / Wisconsin.edu story (Oct 8, 2020): https://news.wisc.edu/residence-hall-outbreak-shows-virus-can-spread-quickly-even-when-precautions-taken/ ### 5.4 FloodLAMP pooled "non-diagnostic surveillance testing" and 2022 FDA correspondence (archive-based) **Why this matters:** FloodLAMP's archive reflects an approach many pandemic-era programs attempted: structure testing as **non-diagnostic surveillance**--often pooled--where results are not returned as patient-specific positives/negatives, and individuals are referred to CLIA diagnostic testing when a pool indicates SARS-CoV-2 presence. Relevant FloodLAMP Archive files include: - **Internal regulatory framing memos** (Aug 2021, Jan 2021, Sept 2021) arguing that pooled surveillance with non-patient-specific reporting can fall outside CLIA/FDA requirements if individual results are not returned. - **A "Non-Diagnostic Surveillance Testing Materials Acknowledgment and Waiver"** describing participant notification/referral, non-FDA authorization status, and a liability waiver. - **FDA email correspondence (Jan--Mar 2022)** in which FDA staff flagged website language that seemed to imply individual clinical follow-up testing by FloodLAMP and requested revisions to align with FDA's policy framing of surveillance vs screening. **Interpretive note:** These materials fit into a broader pandemic pattern: many operators sought to preserve speed/scale by using "surveillance" logic (aggregate reporting + referral), while regulators focused on whether the program's real-world operations or marketing implied individual diagnosis/screening. (See Appendix A for the archive file list and where each document fits.) ## 6. Other major U.S. surveillance modalities that expanded during COVID The term "surveillance" during COVID often refers to wastewater surveillance or genomic/variant surveillance. ### 6.1 Wastewater surveillance Wastewater surveillance measures SARS-CoV-2 RNA shed into sewage, providing community-level signals that are independent of clinical testing access and not impacted by whether individuals seek tests. CDC launched the **National Wastewater Surveillance System (NWSS)** in **September 2020** and continued to expand it. - CDC AMD "Wastewater Surveillance: A New Frontier" (Apr 15, 2024; includes launch date + scale claims): https://www.cdc.gov/advanced-molecular-detection/php/success-stories/wastewater-surveillance.html - CDC NWSS "About" page: https://www.cdc.gov/nwss/about.html - CDC NWSS national data view: https://www.cdc.gov/nwss/rv/COVID19-national-data.html Late-pandemic significance: when many infections were detected via home tests that never entered official reporting systems, wastewater became a key "sentinel" indicator. ### 6.2 Genomic/variant surveillance Genomic surveillance tracks viral evolution and spread by sequencing SARS-CoV-2. The U.S. scaled genomic surveillance substantially after a slow start. Federal coordination examples: - CDC press release launching **SPHERES** consortium (May 1, 2020; archived): https://archive.cdc.gov/www_cdc_gov/media/releases/2020/p0501-SARS-CoV-2-transmission-map.html - CDC "SPHERES" success story (Apr 12, 2024): https://www.cdc.gov/advanced-molecular-detection/php/success-stories/spheres.html A major CDC-affiliated pipeline is the **National SARS-CoV-2 Strain Surveillance (NS3)** program: - APHL NS3 overview: https://www.aphl.org/programs/infectious_disease/SARS-CoV-2/Pages/Sequence-Based-Surveillance-Submission.aspx - CDC "Variants and Genomic Surveillance" page (updated Aug 28, 2025): https://www.cdc.gov/covid/php/variants/variants-and-genomic-surveillance.html ### 6.3 Serosurveillance (antibody surveys) Because case counts under-captured true infection prevalence--especially early--serosurveillance programs used blood donors and residual sera to estimate the proportion of the population with SARS-CoV-2 antibodies. Examples of CDC-supported data products: - CDC Data: Nationwide Commercial Laboratory Seroprevalence Survey: https://data.cdc.gov/Laboratory-Surveillance/Nationwide-Commercial-Laboratory-Seroprevalence-Su/d2tw-32xv - CDC Data: 2020--2021 Nationwide Blood Donor Seroprevalence Survey: https://data.cdc.gov/Laboratory-Surveillance/2020-2021-Nationwide-Blood-Donor-Seroprevalence-Su/wi5c-cscz ### 6.4 Syndromic surveillance and "non-test" data streams As routine lab reporting became less comprehensive, syndromic surveillance (e.g., emergency department data) and other indicators were increasingly used to track trends. Media coverage around the end of the federal PHE highlighted a shift from "count every case" toward sentinel systems such as hospital admissions + wastewater. (One accessible overview of this shift:) - TIME (May 2023): https://time.com/6277396/covid-19-data-public-health-emergency-ends/ ## 7. Operational patterns: how programs tried to stay on the "surveillance" side of the line This section turns the definitions into concrete program design patterns seen in COVID-era "surveillance testing." ### 7.1 A simplified decision tree (conceptual) ``` TESTING PROGRAM | v Are results used for individual decisions or returned to a person/provider? | YES | NO v v DIAGNOSTIC or SCREENING Are specimens de-identified and | only aggregate/cohort results reported? | | |---> CLIA-certified YES | NO / UNCLEAR | testing site v v | (or send to PUBLIC HEALTH HIGH RISK of being | CLIA lab) SURVEILLANCE treated as screening | PARADIGM / clinical testing |---> FDA-authorized/ | | marketed test |---> Often described as outside | (e.g., EUA during | FDA/CLIA clinical frameworks | PHE) | if no individual results | | |---> Individual reporting |---> Still may require public health + public health coordination, ethics review, reporting and careful communication ``` **Caution:** During COVID, agencies also cared about *marketing/communications* (how a program described itself) and whether a "surveillance" workflow *functionally* produced patient-specific outputs (even if framed carefully). ### 7.2 A common "pooled surveillance + referral" workflow Many programs used a structure like: 1. **Collect samples** (often saliva or anterior nares) from a defined group (classroom, team, work unit). 2. **Pool samples** (combine into one test reaction). 3. If the pool shows evidence of SARS-CoV-2, **notify the group** (or the institution) at a cohort level. 4. **Refer individuals** to a CLIA-certified diagnostic test for confirmatory individual results. Regulatory rationale: - Step (3) attempts to avoid returning **individual** results while still enabling mitigation. - Step (4) is designed so that any individual medical decision rests on a CLIA/FDA-compliant diagnostic test. This logic appears in multiple CMS CLIA surveillance documents (in your archive) and in many school/university programs. ### 7.3 The "communication failure mode" In multiple high-profile controversies (SCAN, school programs, later FDA website reviews), a recurring issue was when a program: - described itself as "surveillance," but - provided participant-facing language that implied **individual follow-up testing** by the same non-CLIA/non-EUA pathway, or implied that results could be used as diagnostic information. This "communication layer" is often where programs were challenged, even when their technical workflow was intended to remain surveillance-oriented. ## 8. Late-pandemic transition and follow-up events (2022--2025 context) ### 8.1 Post-PHE CLIA reporting changes (May 2023) CMS emphasized that: - its authority to require SARS-CoV-2 test result reporting was tied to the federal PHE declaration, and - certain enforcement discretions/flexibilities would terminate with the PHE. Primary sources: - CMS QSO-23-15-CLIA memo (May 11, 2023): https://www.cms.gov/files/document/qso-23-15-clia.pdf - CMS post-PHE CLIA FAQs (May 11, 2023): https://www.cms.gov/files/document/clia-post-phe-guidance-faqs-only.pdf - CDC LOCS advisory (May 19, 2023) advising labs to check state reporting requirements: https://www.cdc.gov/locs/2023/05-19-2023-Lab-Advisory-COVID-19_CLIA_Post-Public_Health_Emergency_Guidance.html ### 8.2 The "surveillance backbone" becomes wastewater + sentinel sampling As case counting and universal lab reporting became less comprehensive, surveillance increasingly leaned on: - wastewater (NWSS), - sentinel lab networks, - syndromic surveillance (ED data), - and genomic surveillance pipelines. This was not a sudden invention; rather, COVID accelerated investment and normalization of these methods, which then persisted because they remained informative even as individual testing behavior changed. ## 9. Lessons learned (research framing) These are research/archival interpretations - useful as themes for an archive, not as prescriptions. 1. **Terminology needs operational anchors.** "Surveillance" should not be defined by intent alone; it must be defined by whether individual results are returned or used for individual decisions. 2. **Regulators respond to the full system, not just the assay.** Sample collection logistics, lab certification, reporting pipelines, and participant communications can each "flip" a program into the clinical category. 3. **Home collection is a special sensitivity.** SCAN shows how home-collection workflows triggered heightened FDA attention early in the pandemic. 4. **Pooled surveillance + referral was a scalable compromise.** It offered a way to monitor and mitigate spread while keeping clinical result return in CLIA-certified settings. 5. **Late-pandemic surveillance is increasingly environmental + sentinel.** Wastewater and genomic surveillance became critical as home testing eroded case-based counting. 6. **Archival value:** programs like FloodLAMP, SafeGuard, and SCAN are valuable not only technically but as evidence of how institutions navigated ambiguous regulatory boundaries under emergency conditions. ## Appendix A -- FloodLAMP archive pointers (regulatory/surveillance subcategory) Below is the list you provided (file names + short summaries). These documents are useful "anchor texts" for reconstructing the surveillance-testing regulatory story as experienced by operators. 1. **2021-03-30_NY Times - Why Virus Tests at One Elite School Ran Afoul of Regulators.md** NYT narrative of New Trier High School testing scrutiny; highlights confusion between "surveillance" and regulated screening. 2. **CDC - Testing Strategies for SARS-CoV-2 (includes Surveillance 12-28-2021).md** CDC definitions/contrast of diagnostic, screening, and public health surveillance testing, including a summary matrix. 3. **CMS - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question (2021-03-19).md** CMS positions sequencing-based surveillance as potentially non-CLIA if not reported to individuals; discusses limited enforcement discretion for public health reporting. 4. **CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md** CMS description of pooled surveillance testing, risks, and confirmatory testing expectations. 5. **CMS - CLIA University Lab Testing FAQ (2020-08-28).md** CMS explanation of when surveillance testing requires CLIA, including pooled cohort reporting and enforcement discretion pathways. 6. **CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020).md** Clarifies when a facility becomes a CLIA-regulated lab and describes temporary enforcement discretion for surveillance workflows. 7. **FDA Warning Emails to FloodLAMP - Re_ Testing Clinical COVID-19 Samples (March 2022).md** FDA outreach after reviewing FloodLAMP's website; requests revisions where surveillance language implied individual follow-up testing by FloodLAMP. 8. **FDA Website - COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 (updated 2023-09-29).md** FDA definitions and examples of diagnostic vs screening vs surveillance; setting/CLIA mapping for EUAs and traditional authorizations. 9. **FloodLAMP Non-Diagnostic Surveillance Testing Materials Acknowledgment and Waiver.md** Entity-facing agreement clarifying non-diagnostic status, no individual results, and referral requirements; includes liability waiver. 10. **FloodLAMP Surveillance FAQ and Links (June 2022 DRAFT).md** Contrasts diagnostic and surveillance testing; quotes CMS/FDA guidance about surveillance being outside CLIA/FDA when no individual results returned. 11. **FloodLAMP Surveillance Information (Aug 2021 INTERNAL).md** Internal memo on regulatory framing for pooled non-diagnostic surveillance; cites CMS enforcement discretion and research-lab exemptions. 12. **Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry).md** Plain-language digest of FDA/CMS surveillance framing and conditions under which presumptive positives may be routed to CLIA confirmatory testing. 13. **Memo - USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney).md** Notes surveillance testing generally not regulated when de-identified and no individual results returned; recommends coordination with public health and careful cohort sizing. ## Appendix B -- Selected primary sources and "high-signal" reading list ### B1. FDA (definitions, policies, and context) - FDA "COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2" (definitions; updated 9/29/23): `regulatory/surveillance/FDA Website - COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 (updated 2023-09-29).md` https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2 - FDA "FAQs on Testing for SARS-CoV-2" (developer-focused; updated 11/8/23): https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2 - FDA "Historical Information about Device Emergency Use Authorizations" (revoked/expired EUAs, revocation letters; updated 2026): https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/historical-information-about-device-emergency-use-authorizations ### B2. CMS / CLIA (post-PHE guidance and key memos) - CMS QSO-23-15-CLIA (post-PHE changes; 5/11/2023): https://www.cms.gov/files/document/qso-23-15-clia.pdf - CMS post-PHE CLIA FAQs (5/11/2023): https://www.cms.gov/files/document/clia-post-phe-guidance-faqs-only.pdf - CMS "Infectious diseases" landing page (links to CLIA COVID PDFs, including surveillance testing FAQ): https://www.cms.gov/about-cms/what-we-do/emergency-response/past-emergencies/infectious-diseases ### B3. Seattle surveillance (Seattle Flu Study / SCAN) -- the FDA/Gates touchpoint - NEJM: "Early Detection of Covid-19 through a Citywide Pandemic Surveillance Platform" (Chu et al.): https://www.nejm.org/doi/full/10.1056/NEJMc2008646 - Public Health Insider: SCAN launch (Mar 23, 2020): https://publichealthinsider.com/2020/03/23/introducing-scan-the-greater-seattle-coronavirus-assessment-network/ - Public Health Insider: SCAN resumes + pause explanation (Jun 10, 2020): https://publichealthinsider.com/2020/06/10/greater-seattle-coronavirus-assessment-network-scan-resumes-covid-19-testing/ - Reuters: FDA suspends Gates-backed at-home COVID-19 testing program (May 2020): https://www.reuters.com/article/world/u-s-fda-suspends-gates-backed-at-home-covid-19-testing-program-idUSKBN22S0R7/ - STAT: "Experts decry FDA's halting of a high-profile Covid-19 study..." (May 27, 2020): https://www.statnews.com/2020/05/27/coronavirus-testing-seattle-bill-gates-fda/ ### B4. School/community surveillance linked to Ed Campbell and Dave O'Connor - Hinsdale Magazine: "Keeping the Doors OPEN" (SafeGuard; Campbell + O'Connor linkage): https://hinsdalemag.com/keeping-the-doors-open/ - Gilson case study: Safeguard Solutions student testing operation: https://www.gilson.com/us/case-study-safeguard-solutions-a-covid-19-student-testing-operation - UW News: UW researchers develop saliva RT-LAMP testing method (Aug 6, 2020): https://news.wisc.edu/uw-researchers-develop-new-method-to-test-for-covid-19/ - Newman et al. (2021, open access): mobile RT-LAMP testing strategy: https://pmc.ncbi.nlm.nih.gov/articles/PMC7809916/ - WIRED: Wisconsin DIY/LAMP testing + O'Connor quotes (Jul 23, 2020): https://www.wired.com/story/a-wisconsin-city-experiments-with-a-faster-diy-covid-19-test/ - UW story on Dane County outbreak + sequencing surveillance (Oct 8, 2020): https://news.wisc.edu/residence-hall-outbreak-shows-virus-can-spread-quickly-even-when-precautions-taken/ ### B5. Wastewater & genomic surveillance (late-pandemic backbone) - CDC NWSS overview: https://www.cdc.gov/nwss/about.html - CDC wastewater surveillance success story (includes 2020 launch claim): https://www.cdc.gov/advanced-molecular-detection/php/success-stories/wastewater-surveillance.html - CDC SPHERES launch press release (May 1, 2020; archived): https://archive.cdc.gov/www_cdc_gov/media/releases/2020/p0501-SARS-CoV-2-transmission-map.html - APHL NS3 overview: https://www.aphl.org/programs/infectious_disease/SARS-CoV-2/Pages/Sequence-Based-Surveillance-Submission.aspx ### B6. Legal/policy analysis (useful for contextualizing archival documents) - Yale Law Journal Forum: "Deadly Delay: The FDA's Role in America's COVID-Testing Debacle" (Rao, 2020): https://yalelawjournal.org/essay/deadly-delay-the-fdas-role-in-americas-covid-testing-debacle # 1,749 _context-commentary_regulatory-surveillance.md METADATA last updated: 2026-03-01 RT file_name: _context-commentary_regulatory-surveillance.md category: regulatory subcategory: surveillance words: 1301 tokens: 1749 CONTENT ## Context #### Testing Types: Diagnostic, Screening, and Surveillance During the COVID-19 pandemic, U.S. testing was categorized into three overlapping purposes: - **Diagnostic testing**: Testing an individual when there is reason to suspect infection (symptoms or known exposure). Results are returned to the individual and their healthcare provider. The test must be FDA-authorized and performed in a CLIA-certified laboratory. - **Screening testing**: Testing an individual without symptoms or known exposure, with the intent of making individual decisions based on results (e.g., return to school or work). Like diagnostic testing, screening requires FDA-authorized tests and CLIA-certified labs, and results are returned to individuals. - **Surveillance testing**: Population-level monitoring, often but not always using de-identified specimens. Results are not returned to individuals and are not used for individual decision-making. Surveillance testing does not require FDA authorization or CLIA certification. The critical practical distinction: if a test result is used to make a decision about a specific person, regulators generally treated it as screening or diagnostic. #### Clarification: "Surveillance" in This Archive Throughout this subcategory and elsewhere in the FloodLAMP archive, "surveillance" refers to non-diagnostic, non-clinical testing programs designed to detect and limit the spread of COVID-19 in schools, workplaces, and communities. It does not refer to wastewater surveillance or genomic variant surveillance, both of which are distinct modalities covered in the AI-generated report referenced below. The absence of a clear regulatory category and standardized terminology for this type of frequent, pandemic stop-the-spread testing is itself a significant gap in pandemic preparedness and response frameworks. There is no good name for it and no established regulatory pathway — an unsolved problem that affected programs like FloodLAMP throughout the pandemic. #### Key Documents in This Subcategory For the authoritative regulatory definitions, two government documents provide the clearest framing: - **FDA "COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2" (updated 2023-09-29)** — The FDA's post-crisis summary of diagnostic, screening, and surveillance definitions, including examples and CLIA/setting requirements. - **CDC "Testing Strategies for SARS-CoV-2" (updated 2021-12-28)** — Includes a summary matrix comparing the three testing strategies across settings, reporting requirements, and whether results may be returned to individuals. FloodLAMP's own framing of how it operated under surveillance guidance is documented in: - **FloodLAMP Surveillance FAQ and Links (June 2022 DRAFT)** — Contrasts diagnostic and surveillance testing, cites CMS/FDA guidance, and explains FloodLAMP's compliance posture. Includes FAQ-style responses prepared for the Coral Springs pilot program. - **FloodLAMP Surveillance Information (Aug 2021 INTERNAL)** — A detailed internal memo on the regulatory framing for pooled non-diagnostic surveillance, including CMS enforcement discretion citations, an exchange between NIH Director Francis Collins and CMS Administrator Seema Verma on referral pathways, and the eCFR research-lab exemption. Two outside analyses by professionals that were shared with us are also included: - **Memo — Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry)** — A plain-language digest of FDA/CMS surveillance framing and the conditions under which presumptive positives may be routed to CLIA confirmatory testing. - **Memo — USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney)** — Guidance confirming that surveillance testing is generally not regulated when de-identified and no individual results are returned, and recommending coordination with local public health officials. For a comprehensive treatment of the surveillance testing regulatory landscape during COVID-19 — including the Seattle Flu Study/SCAN case study, school-based surveillance controversies (SafeGuard/New Trier), and the post-PHE transition to wastewater and genomic surveillance — see the AI-generated report: `_AI_Covid_Surveillance_Testing_Screening_Report.md`. ## Commentary #### Navigating the Surveillance Framework Surveillance testing was a regulatory gray area, and operating FloodLAMP's testing programs under this framework was a significant challenge. At the same time, the surveillance designation provided meaningful flexibility. #### Communicating Results Without Giving "Results" The central operational challenge was adhering to the requirement that surveillance programs not deliver "individual patient results." FloodLAMP's approach was to take the FDA's and CMS's language literally: when a sample indicated the presence of SARS-CoV-2, participants were told only that they were "referred to follow-up clinical testing." FloodLAMP did not tell participants they were positive or negative, and the company emphasized this distinction and terminology with program administrators. This approach was informed by what happened at other programs. The CMS notice letter in this archive (December 2020) was sent to surveillance program operators instructing them to stop using the language "results of potential clinical significance." It was FloodLAMP's understanding, received secondhand, that this terminology had been adopted by operators attempting to comply while still communicating something to participants. In practice, everyone involved — operators, participants, and regulators — likely understood that phrasing to mean the surveillance test was positive. FloodLAMP chose to use the FDA's language, and a "referral to follow-up (clinical) testing", along with the explanation that we were not allowed to give "positive/negative" results to individual participants. The resulting communication was initially confusing for participants and program admins, but after a few repetitions they then understood. This kind of linguistic dance does not serve the public interest during a pandemic. #### The Fundamental Regulatory Gap The core problem was that the FDA did not distinguish between two very different kinds of "individual decisions." On one hand, there are clinical medical decisions: using a test result as a diagnosis and relying on it for treatment. On the other hand, there are public health mitigation decisions such as going home from school/work, and isolating from family members, and getting a follow-up diagnostic test. In FloodLAMP's programs, the individual actions triggered by surveillance were of the second kind — participants went home, isolated, and in nearly all cases obtained confirmatory clinical testing (antigen, PCR, or both). A better framework for pandemic screening would require that public health screening programs mandate follow-up confirmatory testing for flagged participants and that participants report those results back to the program. This would serve two purposes: providing the comparison data needed to evaluate the screening program's performance, and codifying the principle that screening test results should not be the basis for medical decisions. #### The Coral Springs Experience The uncertain regulatory status of surveillance nearly prevented FloodLAMP's first major program from proceeding. The Coral Springs pilot covered municipal staff and first responders in a city of approximately 140,000 people and represented FloodLAMP's first significant commercial engagement. The city attorney raised concerns requiring due diligence on the surveillance framework. FloodLAMP was not fully informed of the internal discussions but provided supporting documentation, such as that in the "FloodLAMP Surveillance FAQ and Links" file. The matter reportedly came to a head in a meeting involving city officials, the medical director, regulators (apparently from both FDA and CMS), and at least one elected representative (state or federal level). The outcome was a "green light" for the program, though FloodLAMP never received written confirmation of this decision. (For more on the Coral Springs pilot, see the `pilots/pilot-data` subcategory.) #### Surveillance as a Fallback Operating under the surveillance framework was not FloodLAMP's first choice — it was a fallback. The company had submitted its test to the FDA for Emergency Use Authorization and had applied to the RADx program, but could not secure authorization, engagement, or even substantive attention through either channel. The opportunity to operate surveillance programs came about through our contact with EMS leadership and the FTFC conference in South Florida in mid 2021, where we offered pooled testing and made a presentation. One of the key executives at FloodLAMP had prior experience with surveillance and relationships with other operators of surveillance programs. That combined with the pull we were getting from the EMS community, who simply needed better, more effective testing/screening for their critical first responders, led us to do the FloodLAMP surveillance "pilot programs". These programs were very effective for the organizations that implemented them. The primary commentary on FloodLAMP's regulatory experience, including EUA submissions and FDA correspondence, is in the `regulatory/open-euas` subcategory. # 2,222 2021-03-30_NY Times - Why Virus Tests at One Elite School Ran Afoul of Regulators.md METADATA last updated: 2026-03-05 by BA file_name: 2021-03-30_NY Times - Why Virus Tests at One Elite School Ran Afoul of Regulators.md file_date: 2021-03-30 title: NY Times - Why Virus Tests at One Elite School Ran Afoul of Regulators category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/2021-03-30_NY%20Times%20-%20Why%20Virus%20Tests%20at%20One%20Elite%20School%20Ran%20Afoul%20of%20Regulators.NA pdf_gdrive_url: https://drive.google.com/file/d/1CYtfoTY9PrnsqejhIYBeOwtxSqgHZcS- pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/2021-03-30_NY%20Times%20-%20Why%20Virus%20Tests%20at%20One%20Elite%20School%20Ran%20Afoul%20of%20Regulators.pdf web_url: https://www.nytimes.com/2021/03/30/health/coronavirus-trier-schools-testing.html conversion_input_file_type: pdf conversion: megaparse license: 3rd Party tokens: 2222 words: 1790 notes: summary_short: The New York Times article “Why Virus Tests at One Elite School Ran Afoul of Regulators” recounts how New Trier High School’s large-scale COVID testing program triggered scrutiny over whether it was conducting regulated screening without proper CLIA certification or an FDA-authorized test. It highlights the practical confusion between “surveillance” and “screening” when individual students are flagged and sent home, and describes how the investigation ended after the testing vendor sought federal lab certification and added qualified oversight. CONTENT ***INTERNAL TITLE:*** Why Virus Tests at One Elite School Ran Afoul of Regulators In the suburbs of Chicago, New Trier High School offers a lesson in just how complicated it can be to track the coronavirus in schools. By Apoorva Mandavilli Published March 30, 2021 Updated April 12, 2021 It was supposed to be a pandemic triumph, a way for a prestigious school to keep its doors open when many others could not. Instead, the coronavirus testing program at New Trier High School, outside Chicago, offers a cautionary lesson about what happens when educators are asked to take on public health responsibilities. The Centers for Disease Control and Prevention has urged school administrators to implement regular testing of students in order to identify coronavirus outbreaks before they become more widespread. Late last year, New Trier, which serves families from some of Chicago's most affluent suburbs, rolled out a $1.3 million testing campaign, part of an ambitious plan to keep classrooms open for the school year regardless of rising infection rates in the community. Administrators made testing mandatory for all 4,000 students on the school's two campuses. But the school chose a lab that had not been certified to run a testing program of its kind, led by a scientist who was not qualified under federal guidelines to run a diagnostic lab. The saliva test the lab used was neither vetted nor authorized by the Food and Drug Administration. The test relies on a widely used technology, but a study describing its uses has not been published in a peer-reviewed journal nor validated by independent experts. According to federal guidelines, the assay should not be used to identify potentially infected students. New Trier may have inadvertently violated federal regulations on testing, and the Illinois Department of Public Health opened an investigation into the lab. "What concerns me is the lack of oversight on any quality," said Scott J. Becker, chief executive of the Association of Public Health Laboratories. "It sounds unkosher, and it just makes me uncomfortable." In early March, after being contacted by The Times, the testing company, SafeGuard Screening, applied to federal authorities for lab certification and hired a scientist with credentials to run the operation. After SafeGuard applied for certification, the state health department ended its investigation, saying it was taking no action against the testing company. The C.D.C. encourages K-12 schools to arrange for both diagnostic testing for students and staff members with symptoms of coronavirus infection, and weekly screenings for those without symptoms. (The only exceptions to the second recommendation are for those schools in areas with very low virus transmission rates; there are few communities in the United States that qualify.) The few schools that have tried to implement testing programs have found it extraordinarily difficult, according to a recent analysis by the Rand Corp. To make testing possible, schools need access to rapid testing, additional personnel and substantial technical assistance, the authors found. Simply persuading staff and students to accept regular testing can be an enormous challenge. Paul Sally, the superintendent at New Trier, believes his school has overcome the many obstacles that come with testing. "What we're most proud of is the fact that in our school, we don't have cases of transmission," he said. But for several weeks this winter, infection rates in the towns around New Trier topped 200 cases per 100,000 per week, resulting in a test positivity rate of 13 percent. The school has recorded scores of cases. After a party on Feb. 6, for example, 48 New Trier students tested positive for the coronavirus and more than 200 were quarantined. New Trier has remained open. By comparison, schools in New York City, the largest public school system in the country, are required to shut down after confirming just two cases. *Image Caption:* "A lot of kids don't even want to come to school because apart from the Covid risk, it's also just not enjoyable to be at school," said Eva Roytburg, 18, a senior at New Trier. Taylor Glascock for The New York Times The idea for the testing program formed last summer, when New Trier's administrators and a new reopening advisory board began planning ways to open the school and keep it that way. School administrators started by looking for a company that could handle testing of the school's sizable population and deliver same-day results at a reasonable price. They settled on SafeGuard, a start-up that had launched in September, paying the company to conduct saliva testing on willing students and staff. "At that moment, they were the only one available to do this type of screening in our environment," Dr. Sally said. Edward Campbell, a microbiologist at Loyola University, started SafeGuard after learning of a virus test developed by researchers at the University of Wisconsin- Madison. SafeGuard serves about 30 school districts and runs roughly 30,000 tests per week, at $11 per test, Dr. Campbell said. New Trier signed on, too, but the introduction of the test did not go smoothly. Tempers flared at school board meetings, with some arguing for the school to open, citing the harm being done to students' mental health. Others questioned the push to stay open despite skyrocketing Covid-19 rates in Illinois. Some parents made T-shirts, set up a website and held a rally in support of reopening; a group of students countered with an online rally. The testing program roiled the community, pitting the administration against teachers, students against the administration, parents against teachers and parents against parents. "A lot of kids don't even want to come to school because apart from the Covid risk, it's also just not enjoyable to be at school," said Eva Roytburg, 18, a senior at New Trier Still, the school pushed ahead with testing. Dr. Campbell's lab analyzed saliva samples from New Trier students and delivered the results in a spreadsheet, flagging students who needed a confirmatory test by a certified lab. Although SafeGuard technically did not deliver a diagnosis, the implication was clear — after rapid testing, some students were presumed to be infected, and they and their siblings were sent home. The company and the school refer to this as surveillance. But while surveillance programs may gauge the prevalence of a disease or a pathogen at a population level — that 10 of every 1,000 students are infected, for example — they do not provide results for individuals. The school and the company were instead "screening" students - flagging individual students who might be infected. And screening testing is subject to stringent regulation. Since the start of the pandemic, the Food and Drug Administration has granted emergency use authorizations for dozens of coronavirus tests. The C.D.C. details which kinds of testing are appropriate for different purposes. And the Centers for Medicare & Medicaid Services certifies labs for testing through its Clinical Laboratory Improvement Amendments program. School administrators wishing to implement testing must navigate through a maze of requirements from these agencies, keeping an eye on the subtle differences between surveillance, screening and diagnosis — or trusting a lab to do so for them. Surveillance does not require certification from C.L.I.A., for instance, but screening testing does. Because of rising confusion, the F.D.A. this month released detailed guidance for schools, workplaces and communities on the differences between screening and diagnostic testing programs. SafeGuard should have obtained C.L.I.A. certification for its tests, or New Trier should have applied for a waiver to implement its program, according to testing experts. "It's not hard for a school system to get a C.L.I.A. waiver," Mr. Becker, of the Association of Public Health Laboratories, said. Nearly 300,000 labs are certified to perform testing, and many schools and universities are already relying on those labs and on authorized tests, he noted. Dr. Campbell said that his lab operates well within current regulations, pointing to a new federal guideline saying that regulators will not cite a lab that is not C.L.I.A.-certified so long as the lab "does not report actual test results" but refers individuals for further testing instead. But on Dec. 28, officials at the Centers for Medicare & Medicaid Services sent Dr. Campbell a letter clarifying the requirements. "If at any time a patient specific result is to be reported by a facility, a C.L.I.A. certificate must be obtained," the agency warned. Dr. Campbell said his company had not requested emergency use authorization from the F.D.A. because of the expense and because the process was "so backlogged now." *Image Caption:* A student walks past New Trier High School, where SafeGuard tests were used despite not being vetted or authorized by the Food and Drug Administration. Taylor Glascock for The New York Times Stephanie Caccomo, a spokeswoman for the F.D.A., disputed the assertions. "There is no cost for submitting an E.U.A. request," she said, and companies can market their tests as soon as they validate them and notify the agency. In interviews, Dr. Campbell and school officials said the Illinois Department of Health was aware of the program and had given its blessing. But Melaney Arnold, a spokeswoman for the department, said state regulators "did not approve the use of SafeGuard Screening to provide test results to individuals." After initial publication of this article, Ms. Arnold contacted The Times to say that since SafeGuard had received federal certification, "at this time, there is no further recommended action." Dr. Campbell and New Trier administrators insist the testing program is legal and is keeping the school's doors open. "The guidance is very confusing," said Dr. Campbell. "What's a person trying to operate in good faith supposed to do?" **A correction was made on April 6, 2021:** Because of an editing error, an earlier version of this article misstated the federal agency to which SafeGuard had applied for lab certification. Such certifications are reviewed by the Centers for Medicare and Medicaid Services, not the Food and Drug Administration. **A correction was made on April 9, 2021:** An earlier version of this article included outdated information from the Illinois Department of Public Health about the status of its investigation into SafeGuard. After publication, the department responded to an earlier request from The Times about the investigation and said that it had ended its investigation in March, after SafeGuard received federal certification. When we learn of a mistake, we acknowledge it with a correction. If you spot an error, please let us know at nytnews@nytimes.com. Learn more **Apoorva Mandavilli** is a reporter focusing on science and global health. She is the 2019 winner of the Victor Cohn Prize for Excellence in Medical Science Reporting. A version of this article appears in print on, Section A, Page 4 of the New York edition with the headline: Elite High School's Screening Program Runs Afoul of Regulators # 1,412 CDC - Testing Strategies for SARS-CoV-2 (includes Surveillance 12-28-2021).md METADATA last updated: 2026-03-05 by BA file_name: CDC - Testing Strategies for SARS-CoV-2 (includes Surveillance 12-28-2021).md file_date: 2021-12-08 title: CDC - Testing Strategies for SARS-CoV-2 (includes Surveillance 12-28-2021) category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/CDC%20-%20Testing%20Strategies%20for%20SARS-CoV-2%20%28includes%20Surveillance%2012-28-2021%29.NA pdf_gdrive_url: https://drive.google.com/file/d/1L-g_TkHFq8MhbfJEZqc9lq_27j4DCsSk pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/CDC%20-%20Testing%20Strategies%20for%20SARS-CoV-2%20%28includes%20Surveillance%2012-28-2021%29.pdf conversion_input_file_type: pdf conversion: megaparse license: Public Domain tokens: 1412 words: 940 notes: summary_short: The CDC “Testing Strategies for SARS-CoV-2” guidance (updated Dec. 28, 2021) defines and contrasts diagnostic, screening, and public health surveillance testing, including intended use, who should be tested, and whether results can be returned to individuals. It states that diagnostic and screening testing require CLIA-certified testing sites and FDA-authorized (or FDA-policy) tests with individual and public health reporting requirements, while public health surveillance testing uses de-identified specimens, is not for individual decision-making, and does not require FDA/CLIA compliance. It includes a summary matrix comparing allowable settings, reporting, and result return across the three testing strategies. CONTENT ***INTERNAL TITLE:*** Testing Strategies for SARS-CoV-2 Updated Dec. 28, 2021 ## Summary of Recent Changes Updates as of August 13, 2021 - Updated information for fully vaccinated people given new evidence on the B.1.617.2 (Delta) variant currently circulating in the United States. ### Key Points - This guidance describes and compares different types of testing strategies SARS-CoV-2 (the virus that causes COVID-19), including their intended use and applications, regulatory requirements, and reporting requirements. - This guidance is intended for those who offer and perform SARS-CoV-2 testing. ## Diagnostic Testing Diagnostic testing is intended to identify current infection in individuals and should be performed on anyone that has signs and symptoms consistent with COVID-19 and/or following recent known or suspected exposure to SARS-CoV-2. Examples of diagnostic testing include: - Testing anyone with symptoms consistent with COVID-19 - Testing vaccinated and unvaccinated people who were exposed to someone with a confirmed or suspected case of COVID-19 ## Screening Testing Screening tests are intended to identify unvaccinated people with COVID-19 who are asymptomatic and do not have known, suspected, or reported exposure to SARS-CoV-2. Screening helps to identify unknown cases so that measures can be taken to prevent further transmission. Examples of screening include testing: - Employees in a workplace setting - Students, faculty, and staff in a school setting - A person before or after travel - Someone at home who does not have symptoms associated with COVID-19 and no known exposures to someone with COVID-19 ## Public Health Surveillance Testing Public health surveillance is the ongoing, systematic collection, analysis, and interpretation of health-related data essential to the planning, implementation, and evaluation of public health practice. See CDC’s [Introduction to Public Health Surveillance](https://www.cdc.gov/training-publichealth101/php/index.html). Public health surveillance testing is intended to monitor community- or population-level outbreaks of disease, or to characterize the incidence and prevalence of disease. Surveillance testing is performed on de-identifed specimens, and thus, results are not linked to individual people. Public health surveillance testing results cannot be used for individual decision- making. Public health surveillance testing may sample a certain percentage of a specifc population to monitor for increasing or decreasing prevalence, or to determine the population effect from community interventions such as social distancing. An example of public health surveillance testing is when a state public health department develops a plan to randomly select and sample a percentage of all people in a city on a rolling basis to assess local infection rates and trends. ## Regulatory Requirements for Diagnostic, Screening, and Public Health Surveillance Testing Any laboratory or testing site that performs diagnostic or screening testing must have a Clinical Laboratory Improvement Amendments ([CLIA](https://www.cdc.gov/clia/php/about/index.html)) certificate and meet all applicable CLIA requirements. For more information, see the Centers for Medicare & Medicaid Services [CLIA website](https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments?redirect=/clia) Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) or be offered under the policies in FDA’s [Policy for COVID-19 Tests](https://www.fda.gov/media/135659/download) Tests used for SARS-CoV-2 **public health surveillance** on de-identifed human specimens do not need to meet FDA and CLIA requirements for diagnostic and screening testing. ## Reporting Diagnostic, Screening, and Public Health Surveillance Testing Results Both diagnostic and screening testing results should be reported to the people whose specimens were tested and/or to their healthcare providers. In addition, laboratories that perform diagnostic and screening testing must report test results (positive and negative) to the local, state, tribal, or territory health department in accordance with Public Law 116-136, § 18115(a), the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The Department of Health and Human Services published guidance on [COVID-19 Pandemic Response, Laboratory Data Reporting CARES Act Section 18115](https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting-guidance.pdf)that specifies what data, in addition to results, laboratories and testing sites should collect and electronically report. Public health surveillance testing results cannot be reported directly to the people whose specimens have been tested and are not reported to their healthcare providers. Public health surveillance testing results (test results that are de-identified) can be reported in aggregate to local, state, tribal, or territory health departments upon request. Results from testing that is performed outside of a CLIA-certified facility or without an FDA-authorized test can only be reported to a health department if those results are used strictly for public health surveillance purposes, and not used for individual decision making. ## Summary of Testing Strategies for SARS-CoV-2 | | Diagnostic | Screening | Public Health Surveillance | |---|---|---|---| | Symptomatic | Yes | No | N/A | | Unvaccinated or vaccinated with known or suspected exposure to SARS-CoV-2 | Yes | No | N/A | | Unvaccinated and asymptomatic without known or reported suspected exposure to SARS-CoV-2 | No | Yes | N/A | | Characterize incidence and prevalence in the community | N/A | N/A | Yes | | Testing of personally identifiable specimens | Yes | Yes | No | | Results may be returned to individuals | Yes | Yes | No | | Results returned in aggregate to requesting institution | No | No | Yes | | Results reported to state public health department | Yes | Yes | If requested | | Testing can be performed in a CLIA-certified laboratory | Yes | Yes | Yes | | Testing can be performed in a non-CLIA-certified laboratory | No | No | Yes | | Test system must be FDA authorized or be offered under the policies in FDA’s guidance | Yes | Yes | No | || ## Resources - [Overview of Testing for SARS-CoV-2 (COVID-19)](https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html) - [FDA FAQs on Testing for SARS-CoV-2](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2) ## Previous Updates **Updates from May 25, 2021** - Revised to align with [Interim Public Health Recommendations for Fully Vaccinated People](https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html) Last Updated Dec. 28, 2021 # 1,012 CMS - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question (2021-03-19).md METADATA last updated: 2026-03-05 by BA file_name: CMS - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question (2021-03-19).md file_date: 2021-03-19 title: CMS CLIA - CLIA SARS-CoV-2 Variant Testing Frequently Asked Question category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: NA pdf_gdrive_url: https://drive.google.com/file/d/15jnDb6cPCPAOkYUlintP0s-kO8am2-Gp pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/CMS%20-%20CLIA%20SARS-CoV-2%20Variant%20Testing%20Frequently%20Asked%20Question%20%282021-03-19%29.pdf conversion_input_file_type: pdf conversion: megaparse-u license: public domain tokens: 1012 words: 749 notes: summary_short: The CMS CLIA “SARS-CoV-2 Variant Testing” FAQ (3/19/2021) outlines when sequencing-based surveillance for genetic variants can be done without a CLIA certificate, so long as results are not reported to individuals or their health care providers and are not used for individual decision-making. It describes CMS’s temporary enforcement discretion allowing non-CLIA facilities (and certain CLIA labs) to report patient-specific variant results to state/local public health departments for public health uses like outbreak detection and contact tracing. It also clarifies that if variant results are intended for diagnosis, prevention, treatment, or health assessment, testing must be performed in a CLIA-certified lab in compliance with CLIA requirements (including performance specifications expectations). CONTENT ***INTERNAL TITLE:*** CLIA SARS-CoV-2 Variant Testing Frequently Asked Question Date: 3/19/2021 __Does a facility that performs surveillance testing to identify SARS- CoV-2 genetic variants need a CLIA certificate?__ CMS is temporarily exercising enforcement discretion under CLIA for SARS-CoV-2 genetic variant testing on identified specimens in which patient-specific results are reported to State or local Public Health Departments. As defined by Centers for Disease Control and Prevention (CDC), public health surveillance testing for SARS-CoV-2 is intended to monitor community- or population-level outbreaks of disease, or to characterize the incidence and prevalence of disease. Public health surveillance testing is performed on de-identified specimens, and thus results are not linked to individuals. Public health surveillance testing cannot be used for individual decision-making. See CDC’s [Testing Strategies for SARS-CoV-2 (Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories)](https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#Testing-Strategies-for-SARS-CoV-2). Generally, surveillance testing using sequencing technology to identify SARS-CoV-2 genetic variants can be performed in a facility that is NOT CLIA certified, provided that patient-specific results are not reported to (1) the individual who was tested or (2) their health care provider. If at any time a facility intends to perform testing on identified specimens and report a patient-specific SARS-CoV-2 genetic variant test result to the individual who was tested or to their health care provider, the facility must comply with CLIA and is thereby required to obtain the appropriate CLIA certificate in accordance with 42 CFR Part 493, laboratory requirements. However, as indicated above, CMS will not take action against non-CLIA certified facilities that perform SARS-CoV-2 genetic variant testing on identified specimens and report patient-specific results to State or local Public Health Departments, provided that the facility only reports patient-specific results to a Public Health Department and the results are not intended to be used for purposes of an individual’s diagnosis, prevention, treatment, or health assessment. The Public Health Departments should only use these results for public health purposes, such as contact tracing, outbreak detection, etc. If at any time the SARS-CoV-2 genetic variant result is intended to be used for purposes of an individual’s diagnosis, prevention, treatment, or health assessment, the test must be performed in a CLIA certified laboratory and in compliance with all applicable CLIA regulations (42 CFR part 493). CLIA-certified laboratories continue to be permitted to report patient-specific results to authorized persons, which may include the individual who was tested, their health care provider, or a Public Health Department1, as applicable, for SARS-CoV-2 genetic variant testing and other tests. If a CLIA certified laboratory performing SARS-CoV-2 genetic variant testing decides to report patient-specific results to an individual or their healthcare provider, then the laboratory must establish performance specifications for their assay. See 42 CFR §493.1253(b)(2). CLIA regulations are not prescriptive as to the number of samples required to establish performance specifications. When a genetic variant is discovered during a public health emergency, there may be very limited number of samples available for the establishment of performance specifications. This does not necessarily prevent laboratories from utilizing assays testing for the novel variant. When the number of samples that a laboratory would normally run for the establishment of performance specifications are not available, it is the responsibility of the laboratory director (LD) to ensure that procedures used are adequate to establish the accuracy, precision, and other pertinent performance characteristics of the method. While initially there may not be many samples to establish performance specifications, as time goes on, and as more samples become available, the LD may choose to enhance their assay to the level of other tests in their laboratory. However, CMS will not cite CLIA certified laboratories that perform SARS-CoV-2 genetic variant testing on identified specimens and report patient-specific variant results to State or local Public Health Departments without establishing performance specifications as required by §493.1253(b)(2), provided that the laboratory only reports patient-specific results to a Public Health Department and the results are not intended to be used for purposes of an individual’s diagnosis, prevention, treatment, or health assessment. If at any time the SARS-CoV-2 genetic variant result is intended to be used for purposes of an individual’s diagnosis, prevention, treatment, or health assessment, the test must be performed in a CLIA-certified laboratory and in compliance with all applicable CLIA regulations. 1: While most if not all public health departments would likely meet the CLIA definition of an "authorized person", see 42 CFR §493.2 ("Authorized person means an individual authorized under State law to order tests or receive test results, or both."), this would technically be determined on a case-by-case basis. # 393 CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md METADATA last updated: 2026-03-05 by BA file_name: CMS - CLIA Surveillance Testing SARS-CoV-2 Frequently Asked Questions (2021-10-21).md file_date: 2021-10-21 title: CMS CLIA - Surveillance Testing SARS-CoV-2 Frequently Asked Questions category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: NA pdf_gdrive_url: https://drive.google.com/file/d/1FN0e5vbU3eJ2hMSewH9to42yvYhWisCn pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/CMS%20-%20CLIA%20Surveillance%20Testing%20SARS-CoV-2%20Frequently%20Asked%20Questions%20%282021-10-21%29.pdf conversion_input_file_type: pdf conversion: megaparse-v license: public domain tokens: 393 words: 287 notes: summary_short: The CMS CLIA “SARS-CoV-2 Surveillance Testing” FAQ (revised 10/21/21) explains when facilities using pooled surveillance testing with non-patient-specific cohort reporting do not need a CLIA certificate during the COVID-19 public health emergency. It highlights key risks of pooled surveillance testing (including dilution-related false negatives/positives) and states that any positive/inconclusive pool results must be confirmed via individual testing at a CLIA-certified facility. It also notes that because these facilities are not CLIA-certified, CMS does not have oversight authority over their quality and safety of result reporting. CONTENT ***INTERNAL TITLE:*** Frequently Asked Questions: SARS-CoV-2 Surveillance Testing *Revised 10/21/21* 1. **Does my facility need a CLIA certificate if we are performing SARS-CoV-2 surveillance testing using a pooled sampling procedure with non patient-specific reporting?** A. During this COVID-19 Public Health Emergency, facilities performing SARS-CoV-2 surveillance testing using a pooled sampling procedure to report *non patient-specific SARS-CoV-2 cohort results* will not require CLIA certification. This testing is not considered by CMS to be diagnostic of SARS-CoV-2 infection, and participants should not rely on information received from this type of testing for decision making purposes. If at any time a *patient specific result* is to be reported by your facility, you *must first obtain a CLIA certificate* and meet all requirements to perform testing. 2. **What are the potential risks of using a surveillance pooled sampling procedure?** A. There may be a risk of obtaining false negative or false positive results when utilizing a pooled sampling testing model. According to the FDA website, “Surveillance with pooled or batched testing should be validated on a test platform and test of high sensitivity and positive tests should have a confirmatory test. Because samples are diluted, which could result in less viral genetic material available to detect, there is a greater likelihood of false negative results, particularly if not properly validated.” To possibly mitigate this risk, all positive and inconclusive SARS-CoV-2 results from pooled sampling must be confirmed by having each participant whose sample was contained within the cohort to be tested by a CLIA-certified facility. 3. **Will CMS have oversight of testing facilities that perform pooled surveillance SARS-CoV-2 testing?** A. As these facilities are not CLIA certified, CMS will have no oversight authority to ensure quality and safety of result reporting. # 727 CMS - CLIA University Lab Testing FAQ (2020-08-28).md METADATA last updated: 2026-03-05 by BA file_name: CMS - CLIA University Lab Testing FAQ (2020-08-28).md file_date: 2020-08-28 title: CMS CLIA - University Lab Testing FAQ (2020-08-28) category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: NA pdf_gdrive_url: https://drive.google.com/file/d/1tgBv4ypHFed2fe3T2KXxxGb3H7JoYMAS pdf_github_url: NA web_url: https://www.cms.gov/files/document/clia-university-lab-testing-8/28/2020.pdf conversion_input_file_type: pdf conversion: megaparse license: Public Domain tokens: 727 words: 566 notes: summary_short: The CMS Q&A explains when SARS-CoV-2 surveillance testing requires CLIA certification, emphasizing that pooled, non-patient-specific cohort reporting is not considered diagnostic and does not require a CLIA certificate. It clarifies that reporting patient-specific results generally triggers CLIA requirements, but CMS exercised temporary enforcement discretion during the public health emergency if non-CLIA labs only issue presumptive positive/inconclusive referrals to a CLIA-certified lab rather than reporting definitive results. It also outlines pathways for universities to operate under an affiliated lab’s CLIA certificate (including temporary sites) or to apply for an expedited CLIA certificate with a qualified lab director. CONTENT **1. Does my facility need a CLIA certificate if we are performing SARS-CoV-2 surveillance testing using a pooled sampling procedure with non-patient-specific reporting?** Facilities performing SARS-CoV-2 surveillance testing using a pooled sampling procedure to report non patient- specific SARS-CoV-2 cohort results will not require CLIA certification. This surveillance testing is not considered by CMS to be diagnostic of SARS-CoV-2 infection, and individuals undergoing testing should not rely on information received from this type of testing for decision making purposes. **2. With some of the other surveillance platforms that use next-generation sequencing, there is no need for a pooling strategy (the samples are all bar-coded) – in that instance, is it acceptable for the university to notify a specific person that he or she should seek testing in a CLIA lab?** 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. However, 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. **3. If my University lab is not currently CLIA certified, what options are available to become CLIA certified or operate under an existing CLIA certificate?** As noted on our March 26, 2020 memorandum (https://www.cms.gov/files/document/qso-20-21-clia.pdf-0 ), CMS is committed to taking critical steps to ensure America’s clinical laboratories are prepared to respond to the threat of COVID-19 and to expand laboratory capacity during the public health emergency. University laboratories have several pathways to begin testing during the public health emergency: - University labs may operate under the existing CLIA certificate of an affiliated University lab, including as a temporary remote location of an existing lab. During this public health emergency, CMS is not enforcing the requirement to have a separate certificate for laboratories that are located at a temporary testing site, provided that the designated primary site has such a certificate and the work being performed in the temporary testing site falls within the parameters of the primary site’s certificate. - University labs may also apply for a CLIA certificate. CMS wants to ensure that laboratories located in the United States wishing to perform COVID-19 testing are able to begin testing as quickly as possible during the public health emergency, and have therefore expedited our review of CLIA certificate applications. Once the lab has identified a qualified lab director and has provided all required information, a CLIA number will be assigned and the lab can begin testing. - University labs may utilize the same lab director as an existing University CLIA-certified lab, even if the laboratory director supervises from a different university location. - Labs may also contract with a non-university affiliated lab director who meets CLIA requirements to operate the lab and fill the role of laboratory director. # 741 CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020).md METADATA last updated: 2026-03-05 by BA file_name: CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020).md file_date: 2020-12-28 title: CMS Notice Letter - RE CLIA SURVEILLANCE TESTING (Dec 2020) category: regulatory subcategory: surveillance tags: source_file_type: gdoc xfile_type: docx gfile_url: https://docs.google.com/document/d/1LU0avTD5u8AQTM_Ybz_jY8mRwK7FVr11o_NR_6nfIM8 xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/CMS%20Notice%20Letter%20-%20RE%20CLIA%20SURVEILLANCE%20TESTING%20%28Dec%202020%29.docx pdf_gdrive_url: https://drive.google.com/file/d/16GgSq3IeZElT55GLwFVo2iY8MUyiiiby pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/CMS%20Notice%20Letter%20-%20RE%20CLIA%20SURVEILLANCE%20TESTING%20%28Dec%202020%29.pdf conversion_input_file_type: docx conversion: pandoc license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 741 words: 507 notes: summary_short: The CMS CLIA Surveillance Testing notice (Dec. 28, 2020) explains when a facility is considered a CLIA-regulated laboratory and states that COVID-19 testing generally requires CLIA certification if patient-specific results are reported. It describes CMS’s temporary enforcement discretion for SARS-CoV-2 surveillance testing in non-CLIA facilities, allowing non-FDA-authorized methods so long as no individual results (e.g., negative/positive/inconclusive) are provided and individuals are only referred to CLIA-certified labs for follow-up. CONTENT DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Medicare & Medicaid Services Division of Clinical Laboratory Improvement & Quality Northeastern and Midwestern Operations Branch Chicago Office 233 North Michigan Avenue, Suite 600 Chicago, IL 60601-551 Sent via email to: IMPORTANT NOTICE – PLEASE READ CAREFULLY December 28, 2020 \[Recipient Redacted\] RE: CLIA SURVEILLANCE TESTING \[Recipient Redacted\], It has come to our attention that your facility \[Recipient Redacted\], is performing COVID-19 testing. In order to conduct COVID-19 testing, a facility must be a CLIA certified laboratory that meets applicable regulatory requirements appropriate for the complexity designation of the test. A CLIA certificate is required for any testing facility that meets the CLIA regulatory definition of a laboratory. The CLIA regulations at 42 CFR Part 493 define a laboratory as “a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. To become CLIA-certified, laboratories must comply with the accuracy, quality, and reliability requirements as dictated by the statute. The purpose of these requirements is to ensure that the information that patients or their health care providers receive from a clinical laboratory is accurate and reliable test results. Laboratories that wish to become CLIA certified must apply for a CLIA Certificate. You may access the CLIA regulations at: https://www.ecfr.gov/cgi-bin/text-idx?SID=1248e3189da5e5f936e55315402bc38b&node=pt42.5.493&rgn=div5 If you elect to apply for CLIA certificate, a CLIA application may be obtained from: \[State Public Health Department\] 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. CMS is temporarily exercising enforcement discretion under CLIA for SARS-CoV-2 surveillance testing, specifically, neither CMS nor the State survey agencies on its behalf will cite non-CLIA certified facilities, provided that the facility does not report actual test results, but only refers an individual to a CLIA-certified laboratory for further testing. No individuals can be given a patient-specific result from any testing, that is from a sample that is negative, positive, inconclusive, presumptive positive, a result of clinical significance, or a result of potential clinical significance. If at any time a patient specific result is to be reported by a facility, a CLIA certificate must be obtained, and the facility must meet all requirements to perform testing. You may contact Raymond Castillo via electronic mail at: raymond.castillo@cms.hhs.gov should you have additional questions. Sincerely, Ronisha Blackstone, Manager Division of Clinical Laboratory Improvement & Quality Northeastern and Midwestern Operations Branch (Chicago, Boston, New York and Philadelphia) cc: IDPH # 2,268 FDA Warning Emails to FloodLAMP - Re_ Testing Clinical COVID-19 Samples (March 2022).md METADATA last updated: 2026-03-05 by BA file_name: FDA Warning Emails to FloodLAMP - Re_ Testing Clinical COVID-19 Samples (March 2022).md file_date: 2022-03-01 title: FDA Warning Emails to FloodLAMP - Re_ Testing Clinical COVID-19 Samples (March 2022) category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/FDA%20Warning%20Emails%20to%20FloodLAMP%20-%20Re_%20Testing%20Clinical%20COVID-19%20Samples%20%28March%202022%29.NA pdf_gdrive_url: https://drive.google.com/file/d/1dUoHPLqsXbjQIPnRv4NLXVP6on1OViS6 pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/FDA%20Warning%20Emails%20to%20FloodLAMP%20-%20Re_%20Testing%20Clinical%20COVID-19%20Samples%20%28March%202022%29.pdf conversion_input_file_type: pdf conversion: megaparse license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 2268 words: 1568 notes: Title says March 2022, so used 2022-03-01 as date. summary_short: The FDA–FloodLAMP email thread (Jan–Mar 2022) documents FDA outreach after reviewing FloodLAMP’s website, requesting clarification on whether FloodLAMP was offering clinical COVID-19 testing, whether it held a CLIA certificate, and whether the method was EUA-authorized. FDA flagged website language suggesting individual follow-up testing with FloodLAMP after a positive pool as inconsistent with “surveillance” testing, and asked FloodLAMP to remove or revise claims and confirm plans to bring the site into compliance. The exchange ends with FloodLAMP stating it removed the individual follow-up FAQ language and FDA reiterating that FloodLAMP should review and align practices with the FDA’s revised COVID-19 testing policy guidance and that agency priorities may change. CONTENT ***INTERNAL TITLE:*** Re: Testing Clinical COVID-19 Samples ## EMAIL 2022-03-24 From FDA to FloodLAMP Condon, Peter * To: Randy True Thu, Mar 24, 2022 at 6:20 AM Good Morning Randy, Thank you for your cooperation in clarifying the services Floodlamp is offering. I do want to remind you that the FDA has published a guidance document entitled Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised November 2021). It can be located here; https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised. We recommend that you review the document to ensure that your practices are consistent with the guideline. I will also remind you again that policy may change as a result of the evolution of the pandemic and prioritization of response elements to the pandemic. Thank you again for your cooperation. Best regards, Peter Peter J. Condon, Ph.D. In-Vitro Diagnostic Subject Matter Expert Contractor, Tunnell Consulting, Inc. Center for Devices and Radiological Health OPEQ, OHT7 U.S. Food and Drug Administration Peter.condon@fda.hhs.gov Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: https://www.research.net/s/cdrhcustomerservice?ID=1930&S=E This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify FDA by email at: CDRH-EUA-Templates immediately. ## EMAIL 2022-03-07 From FloodLAMP to FDA From: Randy True Sent: Monday, March 7, 2022 8:29 PM To: Condon, Peter * Subject: EXTERNAL Re: Testing Clinical COVID-19 Samples CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe. Hi Peter, Apologies for the delay in replying, I was traveling for work last week. We removed that question in our web FAQ regarding individual follow up testing to avoid any confusion. We're very careful in all of our communications to emphasize our testing is surveillance and not diagnostic. Best Regards, Randy ## EMAIL 2022-03-03 From FDA to FloodLAMP On Thu Mar 3 2022 at 6:57 AM Condon Peter wrote: Dear Randy, I wanted to follow up with you regarding my initial inquiry into the Floodlamp Testing Service. You have indicated that you are offering a surveillance testing service and that your protocol was vetted during a conference call with representatives of CMS. I will point out that this conference was not attended by representatives of the FDA and therefore any information that you received does not indicate FDA's thinking on your testing methodology. On your web page https://floodlamp.bio/#FAQ you indicate that if a pool is positive, you recommend evaluating the individuals in the pool using the Floodlamp Molecular Test. Any testing that would provide results for individuals would not be construed as surveillance testing. This statement is antithetical to your assertion that you are providing solely surveillance testing. Please remove any claims on your site that are not consistent with your stated policy of providing surveillance testing. **What happens if a pool is positive?** - If a pool is positive, we recommend immediate follow up testing of the individuals in the pool, both with our test and a diagnostic test. The exact protocol is decided by the organization, as well as which diagnostic test is used. The protocol may vary depending on the relationship of the people in the pool (ie. whether they are family members or had exposure to each other). Follow up testing with antigen tests works well to "rule-in" an individual as positive, but because our test has higher sensitivity, we also recommend running the individuals with FloodLAMP or another molecular test. - Procedurally, when our lab staff reports a pool as positive in the system, it automatically notifies the administrators of the organization with the name and contact information for everyone in the pool. The administrators contact the individuals and instruct them on the next steps. I would like to remind you that the response to the ongoing pandemic is evolving as the nature of the pandemic itself evolves. The information conveyed to you during the August 2021 conversation you had with CMS may become obsolete as the response to the pandemic becomes updated. This note reflects issues noted by the FDA during review of your website. This may not be a fully comprehensive list. We recommend that you review the contents of your website to make sure it is compliant with all current requirements. Please respond to this e-mail by March 8, 2022, to inform us of your plans to bring your website into compliance. Best regards, Peter Peter J. Condon, Ph.D. In-Vitro Diagnostic Subject Matter Expert Contractor, Tunnell Consulting, Inc. Center for Devices and Radiological Health OPEQ, OHT7 U.S. Food and Drug Administration Peter.condon@fda.hhs.gov Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: https://www.research.net/s/cdrhcustomerservice?ID=1930&S=E This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify FDA by email at: CDRH-EUA-Templates immediately. ## EMAIL 2022-01-04 From FloodLAMP to FDA From: Randy True Sent: Tuesday, January 4, 2022 2:40 PM To: Condon, Peter Subject: [EXTERNAL] Re: Testing Clinical COVID-19 Samples CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe. Hi Peter, We operate surveillance not diagnostic programs. The first question in our FAQ explains that so I'm a bit confused. Did you see that and are you familiar with surveillance? We follow CMS guidance on surveillance testing. Best, Randy **What is the difference between FloodLAMP's surveillance testing and diagnostic COVID 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. ## EMAIL 2022-01-04 From FDA to FloodLAMP On Tue, Jan 4, 2022 at 11:28 AM Condon, Peter * Peter.Condon@fda.hhs.gov> wrote: Dear Mr. True, After evaluating your website https://floodlamp.bio/, and https://floodlamp.bio/#FAQ, you appear to be offering a testing service for COVID-19 clinical samples. We were unable to find a CLIA Identification Number associated with your organization. Could you please provide your CLIA Identification Number. Also could you please identify the testing method that you are using and indicate if the method has been authorized for emergency use? Best regards, Peter Peter J. Condon, Ph.D. In-Vitro Diagnostic Subject Matter Expert Contractor, Tunnell Consulting, Inc. Center for Devices and Radiological Health OPEQ, OHT7 U.S. Food and Drug Administration Peter.condon@fda.hhs.gov Excellent customer service is important to us. Please take a moment to provide feedback regarding the customer service you have received: https://www.research.net/s/cdrhcustomerservice?ID=1930&S=E This communication is consistent with 21 CFR 10.85 (k) and constitutes an informal communication that represents my best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. This communication is intended for the exclusive use of the recipient(s) named in this correspondence. It may contain information that is protected, privileged, or confidential, and it should not be modified. It may not be disseminated, distributed, reproduced, or copied to persons not authorized to receive such information. If you are not the intended recipient, any dissemination, distribution, or copying is strictly prohibited. If you think you have received this communication in error, please immediately delete all copies from the saved sources and notify FDA by email at: CDRH-EUA-Templates Covid19DX@fda.hhs.gov immediately. # 1,739 FDA Website - COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 (updated 2023-09-29).md METADATA last updated: 2026-03-05 by BA file_name: FDA Website - COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 (updated 2023-09-29).md file_date: 2023-09-29 title: COVID-19 Test Uses_ FAQs on Testing for SARS-CoV-2 _ FDA category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: NA pdf_gdrive_url: https://drive.google.com/file/d/1s8uGXw7Lq90NiNlR3_XpmNiXOKoNDEtt pdf_github_url: NA web_url: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2 conversion_input_file_type: website conversion: manual cut and paste license: Public Domain tokens: 1739 words: 1173 notes: summary_short: The FDA “COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2” explains where COVID-19 tests can be used (lab, point-of-care, home collection, and at-home) and how EUA-authorized settings map to CLIA requirements. It also defines diagnostic, screening, and surveillance testing and gives examples to clarify how intended use affects regulation and reporting. CONTENT ***INTERNAL TITLE:*** COVID-19 Test Uses: FAQs on Testing for SARS-CoV-2 This page is part of the [FAQs on Testing for SARS-CoV-2](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2) and provides answers to frequently asked questions related to uses for different types of COVID-19 tests and the settings in which they can be used. Questions and answers regarding other policies described in the [Policy for Coronavirus Disease-2019 Tests](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-revised) are found in other pages in [this section](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2). ## Q: In what settings can COVID-19 tests be offered or used? (9/29/23) A: Each Emergency Use Authorization (EUA) for a COVID-19 test includes the settings in which the test is authorized. The settings authorized in the EUAs are also noted in the EUA tables on the [In Vitro Diagnostics EUA](https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas) page. - Tests that are noted with an "H" in the Authorized Settings are limited to use in laboratories certified under CLIA that meet requirements to perform high-complexity tests. - Tests that are noted with an "H" and "M" in the Authorized Settings may be performed in laboratories certified under CLIA to perform high complexity and/or moderate complexity tests. - Tests that are noted with a "W" in the Authorized Settings are deemed to be CLIA-waived for use in patient care settings operating under a CLIA Certificate of Waiver. - Tests noted with an "H," "M," and "W" may be used in laboratories certified under CLIA that meet requirements to perform high complexity and/or moderate complexity tests and in patient care settings operating under a CLIA Certificate of Waiver. In addition to COVID-19 tests issued EUAs, there are SARS-CoV-2 tests that have been authorized through [traditional premarket review pathways](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-tests-granted-traditional-marketing-authorization-fda). The setting in which each test is authorized is also included in the tables of COVID-19 tests granted traditional marketing authorizations. ### Facilities Performing COVID-19 Testing - Facilities, including point-of-care settings such as health clinics, that perform COVID-19 testing must be certified as a laboratory under the Clinical Laboratory Improvement Amendments, or [CLIA, which is administered by the Centers for Medicare & Medicaid Services (CMS)](https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/). - Such laboratories may perform tests for which they meet the qualifications of the authorized settings included in the authorization. Laboratories authorized to use EUA-authorized tests are subject to various conditions that can be found in the EUA. ### Point-of-Care Tests Point-of-care (POC) settings include a variety of settings where testing can be performed near the patient, without transporting the sample for processing elsewhere, such as hospitals, physician offices, urgent care, outreach clinics, pharmacies, and temporary patient care settings that have appropriately trained personnel to perform the test. The term POC can generally be used to refer to near-patient testing with tests that are high, moderate, or waived complexity. As discussed in the [Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities), when the FDA issues an EUA for a test, it can indicate whether the test can be performed at a POC setting or only in a laboratory able to handle more complex tests. The FDA must make certain determinations for tests to be deemed to be CLIA waived tests under an EUA, and, in the EUAs, a test authorized to be performed at a POC setting is generally deemed to be CLIA waived. Generally, for the duration of the emergency declaration, such authorized tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Tests authorized for use at the point-of-care generally are not authorized for home specimen collection or at home testing unless otherwise specified. ### Home Sample Collection Several tests have been authorized to be performed in a laboratory, but for which the samples can be collected at home and sent to the laboratory. Such tests include "Home Collection" in the Attributes column in the authorization tables. ### At-Home Tests The FDA has also authorized COVID-19 tests that may be used at home, which is stated in the authorization. The Authorized Setting for such tests is noted as "Home" in the authorization tables. Tests authorized for home use can generally also be used for self-testing in settings outside of the home, such as offices or schools. ## Q: What is the difference between diagnostic, screening, and surveillance testing for COVID-19? (9/29/23) A: **Diagnostic testing** for COVID-19 looks for infections in individual people when there is a reason to suspect that a specific person may be infected. This includes testing people with signs or symptoms of infection and people without symptoms who have a recent known or suspected COVID-19 exposure. Some examples of diagnostic testing include testing symptomatic individuals presenting to their healthcare provider, testing individuals who indicate that they were exposed to an individual with a confirmed or suspected case of COVID-19, and testing all individuals present at an event where an attendee was later confirmed to have COVID-19. **Screening testing** for COVID-19 looks for infections in individual people even if there is no reason to suspect the specific person has an infection or known COVID-19 exposure. This includes broad screening of people without symptoms (asymptomatic) without known exposure to COVID-19 with the intent of making individual decisions based on the test results. The intent of screening tests is to identify infected people before they develop symptoms or who may never develop symptoms so that steps can be taken to prevent those people from infecting others. Some examples of screening testing include testing by a workplace or school of all employees, students, and/or faculty returning to the workplace or school regardless of exposure or signs and symptoms, with the intent of using those results to determine who may return or what protective measures to take on an individual basis. **Surveillance testing** 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. Surveillance testing is primarily used to gain information for a population of people (population level data), rather than for an individual person and does not report test results to a patient or their health care provider. 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 may be random sampling of a certain percentage of a specific population to monitor for increasing or decreasing infection rates, or prevalence, and determining the population effect from community interventions such as social distancing. 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. ## Q: Should SARS-CoV-2 antibody test results be used to assess immunity from COVID-19? (9/27/22) A: No, antibody testing should not be used to assess immunity to COVID-19. See [Antibody (Serology) Testing for COVID-19: Information for Patients and Consumers](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/antibody-serology-testing-covid-19-information-patients-and-consumers) for more information. # 727 FloodLAMP Non-Diagnostic Surveillance Testing Materials Acknowledgment and Waiver.md 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 # 292 FloodLAMP Surveillance FAQ and Links (June 2022 DRAFT).md 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: source_file_type: gdoc xfile_type: docx gfile_url: https://docs.google.com/document/d/1u7I8qHl8sGRQJo-qjH1NSAg5nSrcFb_leaJdvMTyDag xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/FloodLAMP%20Surveillance%20FAQ%20and%20Links%20%28June%202022%20DRAFT%29.docx pdf_gdrive_url: https://drive.google.com/file/d/124Vk07Y-KUmMP3Sb-QIe59oyMyX2V8cf pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/FloodLAMP%20Surveillance%20FAQ%20and%20Links%20%28June%202022%20DRAFT%29.pdf conversion_input_file_type: docx conversion: pandoc license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 292 words: 200 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 # 3,906 FloodLAMP Surveillance Information (Aug 2021 INTERNAL).md 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. # 713 Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry).md METADATA last updated: 2026-03-05 by BA file_name: Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry).md file_date: 2021-01-11 title: Memo - Surveillance Authority Plain-language Research (Jan 2021 from Senior Medical Director in Healthcare Industry) category: regulatory subcategory: surveillance tags: source_file_type: pdf xfile_type: NA gfile_url: NA xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/Memo%20-%20Surveillance%20Authority%20Plain-language%20Research%20%28Jan%202021%20from%20Senior%20Medical%20Director%20in%20Healthcare%20Industry%29.NA pdf_gdrive_url: https://drive.google.com/file/d/1kOfD2h-BXXWGXDlF6Np5gAQnxhlCntk2 pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/Memo%20-%20Surveillance%20Authority%20Plain-language%20Research%20%28Jan%202021%20from%20Senior%20Medical%20Director%20in%20Healthcare%20Industry%29.pdf conversion_input_file_type: pdf conversion: megaparse license: 3rd Party tokens: 713 words: 447 notes: summary_short: The plain-language CMS/FDA overview summarizes how “surveillance” COVID-19 testing is described in FDA guidance as population-level monitoring that FDA generally does not regulate, and explains conditions under which individual results may be returned if presumptive positives are routed to confirmatory testing in a CLIA-certified laboratory. It also cites CMS’s temporary enforcement discretion under CLIA for certain SARS-CoV-2 surveillance testing workflows, especially where non-CLIA facilities do not report definitive results but instead refer presumptive positives or inconclusives to a CLIA lab. It frames these points as a non-legal explanatory digest of agency guidance and notes that public health authorities may have additional powers to support population safety efforts. CONTENT ## Plain Language Overview of CMS, FDA regulations and current guidance. (This is not intended as legal advice. Rather - this is a simple plain-language explanation of currently available documents from FDA and CMS. No reader of this document should construe it as legal advice, or a suggestion that any methods described are reasonable, appropriate or legal.) A 'surveillance' program with validation of results with a CLIA laboratory: Surveillance testing is explicitly NOT regulated by the FDA ([cite](https://www.fda.gov/media/137599/download) and [cite](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/pooled-sample-testing-and-screening-testing-covid-19)). While surveillance testing typically does not permit the return of individual results, they are no longer enforcing this rule as long as positive results are sent to a CLIA laboratory. In addition, there is significant legal history that empowers public health authorities to protect the health and welfare of citizens. The FDA defines a range of types of tests. Surveillance, Screening and Diagnostic testing. They are described here: [FDA on types of testing](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#general-differences). 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. ## Regulation and oversight of surveillance testing Surveillance tests do NOT need to be approved by the FDA or used in a CLIA setting. [FDA on types of testing](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/faqs-testing-sars-cov-2#general-differences) A: The FDA does not generally regulate the use of a test for surveillance purposes, such as determining the prevalence of acute infections in a population. The FDA understands that results have been returned to individuals tested for COVID-19 surveillance purposes. If surveillance testing is performed by a non-CLIA certified laboratory, an individual who tests positive for SARS-CoV-2 should have a confirmatory test performed by a CLIA-certified laboratory. Surveillance with return of results and surveillance with pooled or batched testing should be validated on a test platform and test of high sensitivity and positive tests should have a confirmatory test. CMS further indicates [here](https://www.cms.gov/files/document/clia-university-lab-testing-8/28/2020.pdf): However, 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 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. ## Public health authorities Public health authorities have additional powers to ensure the safety of populations. Some discussion of this [here](https://www.cdc.gov/eis/field-epi-manual/chapters/Legal.html). # 826 Memo - USA Surveillance Strategy (Sept 2021 from non-FloodLAMP Healthcare Attorney).md 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: source_file_type: docx xfile_type: docx gfile_url: https://docs.google.com/document/d/1tfSLvt8jaY3h0b2QQmzK1x519vRKsBXz xfile_github_download_url: https://raw.githubusercontent.com/FocusOnFoundationsNonprofit/floodlamp-archive/main/regulatory/surveillance/Memo%20-%20USA%20Surveillance%20Strategy%20%28Sept%202021%20from%20non-FloodLAMP%20Healthcare%20Attorney%29.docx pdf_gdrive_url: https://drive.google.com/file/d/12xbJWniUpW7HXZmaS7r8f0ZSmyE9u5kZ pdf_github_url: https://github.com/FocusOnFoundationsNonprofit/floodlamp-archive/blob/main/regulatory/surveillance/Memo%20-%20USA%20Surveillance%20Strategy%20%28Sept%202021%20from%20non-FloodLAMP%20Healthcare%20Attorney%29.pdf conversion_input_file_type: docx conversion: pandoc license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/ tokens: 826 words: 593 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,