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CONTENT
# _archive-combined-files_external-programs-reports_60k (12 files, 60,440 tokens)
# 2,429 _AI_RADx Program Overview - NIH Rapid Acceleration of Diagnostics.md
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last updated: 2026-02-20 RT initial creation
file_name: _AI_RADx Program Overview - NIH Rapid Acceleration of Diagnostics.md
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title: RADx Program Overview - NIH Rapid Acceleration of Diagnostics
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notes: Created by Claude Opus 4.6 Max during archive preparation. **NOT HUMAN VERIFIED - MAY CONTAIN ERRORS** AI-generated overview of the NIH RADx initiative combining information from FloodLAMP archive documents with public web sources (NIH, NIBIB, PMC). Source archive documents include: RADx 2020 Submitted Proposal, RADx 2022 Solicitation, RADx 2022 Submitted Proposal, and 2024-03-01 RADx Tech Report on COVID-19 Diagnostic Technologies. Web sources include NIH RADx program pages, NIBIB RADx Tech timeline, and NIH Director's Blog.
summary_short: An overview of the NIH Rapid Acceleration of Diagnostics (RADx) initiative, covering its $1.5 billion congressional appropriation, four program arms (RADx Tech, RADx-UP, RADx-rad, RADx ATP), milestone-driven innovation funnel structure, key accomplishments including 55 FDA EUAs and 7.8 billion tests of U.S. capacity, and ongoing expansion beyond COVID-19 into multiplex respiratory diagnostics and other public health applications.
CONTENT
## Prompt (Verbatim)
Okay, so here provide a general summary of what RADx was and just have this only be a paragraph. Kind of how long they operated, what agency they were under, and how much funding.
Oh, I meant for you not to just draw from the archive, but overall you can search the web.
Yes - Go ahead and do that search and create the updated information. You know, it can be longer than a paragraph and I think it's going to be better to do some of it as bullet points and structure it in Markdown and start with heading level two, not heading level one. And I think I'm going to pull out the Rad-X stuff and do it as a separate file or a couple of files. It's because it's so important. So for now, in this processed commentary, I'm just going to leave a placeholder for this as a work in progress.
## Prompt (Cleaned)
Provide a general summary of what the NIH RADx program was, structured in markdown with level-two headings. Cover how long it operated, what agency it was under, how much funding it received, and its key accomplishments. Search the web for comprehensive public information in addition to drawing from FloodLAMP archive documents. Use bullet points and structured formatting rather than a single paragraph. This will be saved as a standalone reference file in the archive because the RADx program is important enough to warrant dedicated coverage.
**Files included in context window:**
- _context-commentary_various-fl-proposals_INITIAL.md
- prompt_context-commentary_interview.md
- RADx 2020 Submitted Proposal - FloodLAMP (Aug 2020 - 1M - Not Funded).md
- RADx 2022 Solicitation - High-Performance COVID-19 Rapid Tests (Oct 2022).md
- RADx 2022 Submitted Proposal - FloodLAMP (Oct 2022 - 3M - Not Funded).md
- 2024-03-01_RADx Tech Report on COVID-19 Diagnostic Technologies.md
- prompt_save-ai-response-to-archive-md.md
- Waste Disposal and Risk Assessment.md
## RADx Program Overview
The Rapid Acceleration of Diagnostics (RADx) initiative was launched by the National Institutes of Health (NIH) on April 29, 2020, just five days after Congress appropriated $1.5 billion to NIH for SARS-CoV-2 testing through the Paycheck Protection Program and Health Care Enhancement Act (signed April 24, 2020). The initiative was created to dramatically accelerate the development, validation, and commercialization of COVID-19 diagnostic testing technologies, compressing development timelines from years to months. Funding support later transitioned to the American Rescue Plan Act of 2021.
RADx was led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), operating in collaboration with the NIH Office of the Director (OD). The program leveraged the existing NIBIB Point-of-Care Technologies Research Network (POCTRN) infrastructure and coordinated closely with the FDA, CDC, BARDA, ASPR, and the Department of Defense. Approximately 900 collaborators from government, academia, and the private sector participated in the RADx Tech network.
## Four RADx Programs
The RADx initiative comprised four distinct programs:
### RADx Tech
The flagship technology development arm, focused on speeding the development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improved clinical laboratory tests. RADx Tech used a competitive, milestone-driven "innovation funnel" that matched test developers with teams of technical, business, manufacturing, and regulatory experts. The first solicitation offered up to $500 million across all phases of development. Three separate solicitation rounds were conducted:
- **RADx Tech I (2020)**: Initial call for rapid COVID-19 testing technologies. Received 716 applications before the portal closed in August 2020. Within the first 24 hours alone, 400 proposals were submitted.
- **RADx Tech II (2021)**: Focused on advanced-readiness technologies including multiplex tests, tests with PCR-comparable performance, and variant-detecting tests. Only considered technologies that could reach market in 2021.
- **RADx Tech III (2022)**: Two sub-solicitations -- one for accessible OTC tests usable by persons with disabilities, and one for high-performance OTC/POC tests with universal design features and performance approaching or exceeding lab-based tests. Funded 25 Work Package 1 projects.
### RADx-UP (Underserved Populations)
Focused on understanding and reducing COVID-19 testing disparities in vulnerable and underserved populations, including racial and ethnic minorities, residents of nursing homes and correctional facilities, rural communities, underserved urban populations, pregnant women, and people experiencing homelessness. RADx-UP established clinical research sites across the country and collaborated with community organizations such as tribal health centers, houses of worship, and homeless shelters. The program supported 142 awarded projects.
### RADx-rad (Radical)
Supported non-traditional, "outside-the-box" approaches to COVID-19 testing and surveillance. The program awarded over $107 million to fund 49 research projects across 43 U.S. institutions. Focus areas included:
- Non-traditional viral screening using biological or physiological markers
- Novel analytical platforms with new chemistries or engineering approaches
- Wastewater detection methods for community-level surveillance
- AI-integrated diagnostic systems
- Breath-based and airborne detection biosensors
- Smell and taste function tests as infection indicators
### RADx ATP (Advanced Technology Platforms)
Supported late-stage development of innovative point-of-care and home-based tests along with improved clinical laboratory tests to increase U.S. testing capacity.
Additionally, the **Independent Test Assessment Program (ITAP)** was launched in collaboration with the FDA to accelerate authorization of tests produced outside the U.S. ITAP independently conducted analytical and clinical validation according to FDA-agreed protocols, allowing the FDA to authorize new tests in a matter of days after data submission. ITAP accounted for approximately half of the increased testing capacity in the U.S.
## Innovation Funnel Structure
The RADx Tech innovation funnel used a stage-gated process to maximize efficiency:
- **Rolling Review**: Proposals evaluated by external expert panels on technical, clinical, regulatory, and commercial feasibility.
- **Deep Dive**: Selected projects underwent a two-week intensive examination by RADx Tech experts to identify risks and develop milestone-driven work plans.
- **Work Package 1 (De-Risking)**: Addressed high-risk barriers to success. Milestone-driven funding with close NIBIB monitoring.
- **Work Package 2 (Implementation)**: Full range of activities for FDA authorization, manufacturing, and commercialization. Funding contingent on WP1 milestone achievement and market competitiveness.
Initial Phase 2 contract awards in 2020:
| Date | Amount | Contracts |
| --- | --- | --- |
| July 31, 2020 | $248.7 million | 7 contracts |
| September 2, 2020 | $129.3 million | 9 contracts |
| October 6, 2020 | $98.4 million | 6 contracts |
| | | |
## Key Accomplishments
As reported in the March 2024 RADx Tech program report:
- Evaluated over 1,000 proposals from 47 states/territories and 23 countries
- Funded over 250 organizations to develop diagnostic technologies
- 242 applications (15-20% of total) underwent in-depth review by RADx expert teams
- 68 projects received funding for de-risking and validation
- 50 projects received funding for authorization and deployment
- Produced 55 FDA Emergency Use Authorization tests
- U.S. capacity exceeding 7.8 billion tests and test products
- First-ever EUA for a COVID-19 OTC diagnostic test (December 2020)
- 18 FDA-authorized OTC COVID-19 tests
- 12 OTC COVID-19 devices authorized through ITAP
- A POC test received an EUA within 10 weeks of program launch
- 125 publications by RADx Tech members and collaborators
- First EUA granted for a test aligned with accessibility design principles
- Best-practice guidelines for accessible test design published June 20, 2023
Monthly U.S. test production scaled rapidly in 2020: from over 16 million in September to over 24 million in December. By February 2022, U.S. testing capacity reached over 1.2 billion tests monthly, with more than 85% being rapid home or point-of-care tests -- compared to fewer than 8 million tests performed in April 2020.
## Community Programs and Distribution
RADx Tech established several programs beyond direct test development:
- **RADx MARS (Mobile At-Home Reporting through Standards)**: Standardized how self-reported home test results are collected and transmitted to state, federal, and local health systems.
- **Make My Test Count**: Website for self-reporting home test results, launched November 2022, replacing manufacturer apps with a single reporting pathway. Supported all FDA-authorized OTC COVID-19 and COVID-19/Flu multiplex tests.
- **Say Yes! COVID Test (SYCT)**: Cooperative effort with state and local health departments, NIH, and CDC that distributed over 2 million free home tests in select communities. Demonstrated that home testing can impact behavior and reduce community transmission. Lessons learned enabled the covidtests.gov nationwide free test distribution.
- **Home Test-to-Treat**: Virtual community health intervention providing free COVID-19 tests, telehealth consultations, and treatments to eligible individuals at home. Later expanded to include influenza testing and treatment.
- **COVID-19 Test Accessibility Program**: Partnership with HHS agencies and disability advocates to develop and publish best-practices for universally accessible test design, hosted on the U.S. Access Board website.
## Ongoing Operations and Expansion
As of the March 2024 program report, RADx Tech continues to operate and has expanded beyond COVID-19. The RADx infrastructure is being leveraged for:
- Multiplex home and POC diagnostic products for COVID-19, Flu, and RSV
- POC multiplex tests for lesion-presenting diseases including Mpox, HSV1/2, VZV, and Syphilis
- POC test for Hepatitis C to support a U.S. elimination program
- Fetal Monitoring Challenge to reduce fetal mortality
- Blueprint MedTech for medical devices addressing pain and nervous system diseases
- Maternal Health Challenge for devices to reduce maternal mortality in underserved settings
- Advanced Platforms for HIV Viral Load Testing at the POC
## Sources
- NIH RADx program pages: https://www.nih.gov/research-training/medical-research-initiatives/radx
- NIBIB RADx Tech timeline: https://www.nibib.nih.gov/covid-19/radx-tech-program/radx-tech-timeline
- NIBIB RADx Tech program: https://www.nibib.nih.gov/programs/radx-tech-program
- RADx Tech March 2024 White Paper: https://www.nih.gov/sites/default/files/research-training/initiatives/radx/RADx-Tech-White-Paper-March-2024.pdf
- NIH news release on RADx-rad: https://www.nih.gov/news-events/news-releases/nih-support-radical-approaches-nationwide-covid-19-testing-surveillance
- PMC article "Radical solutions": https://pmc.ncbi.nlm.nih.gov/articles/PMC8023346/
- FloodLAMP archive: 2024-03-01_RADx Tech Report on COVID-19 Diagnostic Technologies.md
# 822 _context-commentary_various-external-programs-reports.md
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last updated: 2026-02-18 RT
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CONTENT
## Context
This subcategory contains a curated selection of external reports and reference documents related to COVID-19 testing programs, particularly K-12 school surveillance testing. None of the files were produced by FloodLAMP Biotechnologies, and the organizations represented had no formal affiliation with the company. The collection is not exhaustive. It represents a fraction of the external reports that FloodLAMP reviewed during its operational period but provides a representative cross-section of how institutions at various levels approached COVID-19 testing in schools.
The majority of the files (seven of ten) focus specifically on school testing. They span from a September 2020 compendium by UnitedHealth Group on safe school reopening strategies, through state- and district-level implementation documents from Massachusetts, San Francisco, Rhode Island, and California, to federal guidance from the CDC on funding and deploying screening testing in K-12 settings. These documents collectively illustrate the evolving operational complexity of school testing programs during the pandemic: early-stage planning frameworks, procurement processes (including a detailed SFUSD RFP and Q&A), pooled testing protocols, "test to stay" policies, and state-level public health guidance for the 2021-22 school year.
Two files sit outside the school-testing focus. The Testing Commons overview from ASU and the Rockefeller Foundation provides a snapshot of the global COVID-19 diagnostic test landscape as of mid-2021, cataloging FDA EUA tests by type and technology. The RADx Tech report from March 2024 summarizes the NIH/NIBIB Rapid Acceleration of Diagnostics program, describing its innovation funnel approach and program outcomes, including 55 FDA EUA tests and a U.S. capacity exceeding 7.8 billion tests and test products.
The final file is a FloodLAMP-compiled index of links and notes on testing programs, playbooks, lab partners, and operational references from various organizations, including Color Genomics, Curative, Ginkgo Bioworks, Mirimus, Poplar Healthcare, and several school districts. This index served as a working reference during FloodLAMP's pilot development and provides a snapshot of the testing program landscape as it appeared in mid-2021.
This subcategory connects to several other parts of the archive. The school testing reports provide context for FloodLAMP's own pilot programs documented in the Pilots collection, particularly the school-based surveillance programs. The regulatory landscape referenced in these documents (FDA EUAs, surveillance vs. clinical testing distinctions) aligns with material in the Regulatory collection, especially the fda-policy and fda-euas subcategories. The Testing Commons and RADx materials relate to the broader diagnostic technology ecosystem in which FloodLAMP operated, relevant to the lamp-tech and papers subcategories in the Various collection.
## Commentary
There were a lot of reports generated during the pandemic, and what's in this subcategory is a small and somewhat arbitrary selection. Most of these documents date from 2020 to 2022, with the exception of the RADx Tech report from March 2024. That means there's likely been considerable additional post-mortem analysis published since 2022 that isn't captured here.
One thing of note is that these reports, taken together with the much larger body of pandemic testing literature that exists, may be an important resource. With AI tools, this material could be systematically sourced, analyzed, and compiled, particularly with a focus on what worked and what didn't for scalable testing and screening programs. The school testing documents in particular capture a specific operational challenge that recurs: how do you set up and sustain high-volume, decentralized testing programs with limited infrastructure and varying levels of institutional readiness? That's the same problem FloodLAMP was working on.
This subcategory is not at all comprehensive. It's more of a snapshot of what we were looking at while building our own programs. But for someone interested in the operational side of pandemic testing at the institutional level, these files provide concrete examples of how school districts, state departments of education, and federal agencies approached the problem at different scales and at different points in the pandemic timeline.
# 13,104 2020-09-01_School Testing_UnitedHealth Group - Safe and Strategic Return to School.md
METADATA
last updated: 2026-03-06 by BA
file_name: 2020-09-01_School Testing_UnitedHealth Group - Safe and Strategic Return to School.md
file_date: 2020-09-01
title: UnitedHealth Group - Safe and Strategic Return to School (Sept 2020)
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summary_short: UnitedHealth Group’s Safe and Strategic Return to School (September 2020) compiles COVID-19-era recommendations for reopening and keeping K–12 schools open, including a community transmission “action level” framework tied to in-person/hybrid/remote models. It lays out practical operational guidance on ventilation, distancing, cleaning, transportation, symptom screening, testing (including pooling), communication, and outbreak response. A “Safe Health Compact” summarizes shared responsibilities for schools and families to support compliance and continuity of instruction.
CONTENT
UNITEDHEALTH GROUP
***INTERNAL TITLE:*** Safe and Strategic Return to School
September 2020
With over 150 million people reliant on UnitedHealth Group (UHG) services, we are committed to using our entire ecosystem to improve the health of the people we serve. The following information is a compendium of sourced recommendations based on local and national guidelines. UHG offers this guidance covering the following topics to support safe and strategic in-person education:
1. **Know the prevalence and risk for your community**
a. Data for the school's service area should confirm flattening curves (fewer new cases)
b. Confirm appropriate healthcare system capacity
2. **Support your school system**
a. Prepare your buildings:
i. Evaluate traffic flow through common areas to avoid crowding
ii. Ensure adequate ventilation
iii. Reset classrooms to create space for learning with social distancing guidelines
b. Evaluate ancillary processes, such as transportation and meal delivery, to ensure safe delivery of these services
c. Ensure frequent and open communication with stakeholders, including staff, students, families, and community members
3. **Support your staff, students, and parents**
a. Develop a social contract to instill mutual trust and accountability
b. Educate staff on symptoms and risk factors, ensuring adequate protection for high-risk staff
c. Supply staff with personal protective equipment (PPE)
d. Supply students with masks
e. Implement a symptom tracking program, which could include temperature tracking
f. Consider surveillance testing (if available)
g. Provide mental health supports for all staff and ensure that robust mental health supports are available for students and families
h. Educate families on symptoms and risk factors, ensuring that alternative models of education are available for high-risk students
i. Create protocols for special education students
4. **Take steps to keep your classrooms open**
a. Create a decision-making process that incorporates local guidance and the Community Action Level for Schools
b. Evaluate hybrid or wave models to return to the classroom
c. Review all extracurricular activities and modify for safety
d. Develop a comprehensive plan to support staff and students if an outbreak occurs
## Introduction
As school leaders prepare for the 2020–2021 academic year, schools will need effective science- and data-driven strategies to form plans to reopen and remain open which balance quality of education with the health and safety of students, teachers, and staff.
Schools are essential to successful communities and long-term disruptions to school can be catastrophic for children. For example, Hurricane Katrina, which closed New Orleans schools for several months in 2005 and displaced thousands of students, had significant consequences for children as they returned to New Orleans. School leaders reported that students returned to school more than two years below grade level, and it took multiple years of individualized attention to resolve learning losses. In 2015, Louisiana topped the nation with the highest number of opportunity youth—ages 16 to 24—who are neither working nor in school and who would have been elementary students when Katrina hit. The COVID-19 pandemic's interruption of education may have a lifetime impact on an entire generation of children. Care must be taken to lessen this impact as much as possible.
However, schools cannot remain open at any cost. The safety of students and staff must be prioritized. A Gallup survey from July 2020 found that 57% of teachers are very concerned about being exposed to coronavirus in the workplace compared to 21% of all other US workers, and 24% of teachers are at heightened risk of COVID-19 infection. Additionally, according to the Kaiser Family Foundation, a majority of mothers worry that their child (77%) or another family member (77%) will get sick if their child returns to school in person and 73% are concerned that schools will be unable to comply with public health recommendations. It is apparent that clear communication strategies paired with accommodations for high-risk individuals are critical for ensuring success and reducing anxiety in order to keep children in the classroom.
With over 150 million people reliant on UnitedHealth Group (UHG) services, we are committed to using our entire ecosystem to improve the health for the people we serve. Health is comprised of the physical, mental, social, financial, and spiritual wellbeing of a person or population, and—according to the World Health Organization—the traditional healthcare system only contributes about 10% to overall health, with the balance being composed of social, environmental, behavioral, and genetic factors. As such, it is important to address all of these aspects of a person's community in order to reduce the risk of future illness and increasing the chance to be a productive member of society. With this aim in mind, UHG offers this guidance covering the following topics to support safe and strategic in-person education:
1. Know the prevalence and risk for your community
2. Support your school system: buildings, classrooms, and processes
3. Support your staff, students, and parents: social contract, education, communication, and protocols
4. Take steps to keep your classrooms open: establishing routines and auditing performance
## 1. Know the Prevalence and Risk for Your Community
Keeping staff and students in schools starts with understanding the infection rate within your community. Stabilizing or declining case counts ("flattening the curve"), testing and contact tracing availability, hospital capacity, and PPE availability, as well as state and local guidelines, will determine whether a community is able to safely continue in-person learning.
UHG's Community Alert Level—Schools (Table #1) provides guidance for levels of community transmission and the appropriate actions that should be taken at each level. Monitoring school and community health department data are also important for identifying potential spikes in infectivity and taking action to anticipate and manage outbreaks.
### Table #1: Community Action Level—Schools
| Sum of New Cases in District Area (last 14 days) | Procedure | People | Symptom Checking | Temperature Testing | Other Protocol (each level is additive) |
|--------------------------------------------------|-----------|--------|-------------------|---------------------|----------------------------------------|
| Level 1 <10/100,000 | In-Person Classes for All Students | Students | Daily | Not required | • Hygiene protocols in place
• No groups of more than 50 |
| Level 1 <10/100,000 | In-Person Classes for All Students | Faculty & staff | Daily | Not required | • Hygiene protocols in place
• No groups of more than 50 |
| Level 1 <10/100,000 | In-Person Classes for All Students | Delivery/contractors/etc. | Daily | Not required | • Hygiene protocols in place
• No groups of more than 50 |
| Level 1 <10/100,000 | In-Person Classes for All Students | Visitors | Day of visit | Not required | • Hygiene protocols in place
• No groups of more than 50 |
| Level 2 10-199/100,000 | In-Person Classes for Most Students | Students | Daily, 7 days prior | Not required | • High-risk stay home
• Enhanced cleaning protocols in place
• Mandatory 6' physical distancing or strict mask use when distancing not possible due to behavior or physical space |
| Level 2 10-199/100,000 | In-Person Classes for Most Students | Faculty & staff | Daily, 7 days prior | Not required | • High-risk stay home
• Enhanced cleaning protocols in place
• Mandatory 6' physical distancing or strict mask use when distancing not possible due to behavior or physical space |
| Level 2 10-199/100,000 | In-Person Classes for Most Students | Delivery/contractors/etc. | Daily | Not required | • High-risk stay home
• Enhanced cleaning protocols in place
• Mandatory 6' physical distancing or strict mask use when distancing not possible due to behavior or physical space |
| Level 2 10-199/100,000 | In-Person Classes for Most Students | Visitors | Daily, 7 days prior | Not required | • High-risk stay home
• Enhanced cleaning protocols in place
• Mandatory 6' physical distancing or strict mask use when distancing not possible due to behavior or physical space |
| Level 3 200-399/100,000 | Hybrid Classes | Students | Daily, 12 days prior | Daily | • High-risk stay home
• Hybrid learning using groups rotating 3 days in and 2 days out (3-2) model
• Restrictions on common areas
• Essential visitors only |
| Level 3 200-399/100,000 | Hybrid Classes | Faculty & staff | Daily, 12 days prior | Daily | • High-risk stay home
• Hybrid learning using groups rotating 3 days in and 2 days out (3-2) model
• Restrictions on common areas
• Essential visitors only |
| Level 3 200-399/100,000 | Hybrid Classes | Delivery/contractors/etc. | Daily | Daily | • High-risk stay home
• Hybrid learning using groups rotating 3 days in and 2 days out (3-2) model
• Restrictions on common areas
• Essential visitors only |
| Level 3 200-399/100,000 | Hybrid Classes | Visitors | Daily, 12 days prior | Day of visit | • High-risk stay home
• Hybrid learning using groups rotating 3 days in and 2 days out (3-2) model
• Restrictions on common areas
• Essential visitors only |
| Level 4 400-599/100,000 | Hybrid Classes | Students | Daily, 14 days prior | Daily | • High-risk stay home
• Hybrid learning using groups rotating 4 days in 10 days out (10-4) model
• No in-person group extracurricular activities |
| Level 4 400-599/100,000 | Hybrid Classes | Faculty & staff | Daily, 14 days prior | Daily | • High-risk stay home
• Hybrid learning using groups rotating 4 days in 10 days out (10-4) model
• No in-person group extracurricular activities |
| Level 4 400-599/100,000 | Hybrid Classes | Delivery/contractors/etc. | Daily | Daily | • High-risk stay home
• Hybrid learning using groups rotating 4 days in 10 days out (10-4) model
• No in-person group extracurricular activities |
| Level 4 400-599/100,000 | Hybrid Classes | Visitors | No visitors | No visitors | • High-risk stay home
• Hybrid learning using groups rotating 4 days in 10 days out (10-4) model
• No in-person group extracurricular activities |
| Level 5 >=600/100,000 | Distance Learning for All Students | Students | Daily | Daily | • Close facility except for essential workers and essential services |
| Level 5 >=600/100,000 | Distance Learning for All Students | Faculty & staff | Daily | Daily | • Close facility except for essential workers and essential services |
| Level 5 >=600/100,000 | Distance Learning for All Students | Delivery/contractors/etc. | Daily | Daily | • Close facility except for essential workers and essential services |
| Level 5 >=600/100,000 | Distance Learning for All Students | Visitors | No visitors | No visitors | • Close facility except for essential workers and essential services |
||
### Declining Case Counts
Stabilizing the rate of infections is important for preventing ongoing virus transmission and stabilized or declining case counts are required for safely staying in the classroom. School leaders should look at their community's 14-day average case count per hundred thousand population as the primary indicator of viral transmission in the community. This metric is calculated as follows:
1. Divide the population of the school's service area by 100,000
2. Add all new cases in the last 14 days in the service area
3. Divide the total new cases (2) by the output of the first division (1)
This metric could be analyzed at the zip code level or the county level depending on the district area and the data available from the local health department. This metric provides guidance as to whether there are low enough levels of viral transmission to allow for in-person instruction.
#### Testing and Contact Tracing Capacity
Adequate regional capacity for rapid diagnostic testing is crucial for keeping active infections at a safe enough level for remaining in school. This means available testing for (1) hospitalized patients, (2) healthcare workers, (3) all other essential workers in public-facing roles, (4) anyone seeking outpatient care for symptoms, and (5) close contacts of those with confirmed diagnoses. Modeling shows that in populations with adequate physical distancing measures, contact tracing can act synergistically with other containment measures as part of a back-to-work strategy. State health departments may have the most up-to-date information about regional testing and contact tracing.
### Healthcare System Capacity
Regional hospital capacity should be adequate to treat everyone requiring hospitalization at the standard of care, as opposed to a crisis standard of care, as defined by the Institute of Medicine. This should include adequate ICU bed availability and adequate PPE for the healthcare workforce.
Adequate ICU bed availability is defined, according to the Society of Critical Care Medicine, as capacity to expand to 5–7 beds per 10,000 adults, allowing for regional variation and including adequate staffing (with emergency plans in place to increase that number to 30 beds per 10,000 adults in case of a surge). The Centers for Disease Control (CDC) publishes a dashboard on national and state-level hospital bed availability.
Adequate PPE, as recommended by the CDC, includes gloves, N95 respirators, face masks, shields, and isolation gowns for all healthcare providers, along with face masks for patients with confirmed or suspected cases. Many state health departments have the most up-to-date information about regional PPE supply chains.
#### International Guidance
Some countries have returned to in-person education, and the outcomes of these initial openings can be used to inform the development of plans for maintaining in-person education in the US. ISC Research, a provider of English-medium K-12 international school data, is tracking back-to-school plans in the US and internationally and may be a useful source of updates. In addition, the European Union is tracking the responses of its member states for opening schools.
#### State and Local Guidelines
School leadership should evaluate their state and local guidelines for additional guidance, if available.
## 2. Support Your School System
Building and classroom preparation are required. Adequate space to accommodate physical distancing, robust ventilation systems, modified transportation capacity, and frequent cleaning are critical for safely remaining in the classroom.
### Building Capacity to Support Physical Distancing
Classrooms need to be modified to ensure that students and staff have adequate space for physical distancing. Desks and workstations should be spaced or blocked to provide six feet of distance between people working. If workstations are to be occupied by different individuals throughout the school day, the workstations should be fully disinfected between uses. Plexiglass dividers can be used in areas where distancing may not be achievable. Close or modify common areas, gymnasiums, and cafeterias.
Students should avoid unnecessary travel and exposure to other students. Consider having teachers or educators move between classrooms for different subjects whenever possible instead of the traditional movement of students between classrooms. Keeping students in classes or pods can limit transmission if a positive case occurs in the school.
Outside the classroom, consider adding signage to limit the number of people in elevators or other tight spaces. Encourage one-way traffic flow in hallways and stairwells. Signage and floor stickers can remind students and staff of distancing requirements. If possible, modify entrances, cafeterias, and other common spaces to reduce or eliminate crowding. Minimize touchpoints, such as using automated door openings or modifying door handles to allow for pushing doors open.
School leaders should consider modifying start and end times to allow for staggered arrivals to reduce crowding at the beginning and end of each school day as well as during breaks, if transportation and other policies can accommodate.
Conduct routine audits to evaluate the effectiveness of current physical distancing practices. These audits will use current CDC and OSHA guidelines for ongoing best practices. Physical distancing audits could consider how the organization has altered or should continue to alter its personnel policies in order to maintain the lowest risk of virus transmission. These audits would review policies regarding procedures for reintroducing employees into traditional school settings and allowing them to safely remain in these settings, as well as preparedness measures in the event of employees being exposed to COVID-19. Audits of which policies are working may result in revisions to school policy in order to follow best practices, such as dismissal and physical distancing practices.
### Residential Schools
Residential schools should consider additional modifications to living areas. For common areas (shared kitchens, dining rooms, laundry rooms, bathrooms, activity rooms, exercise rooms, etc.), restrict access to a limited number of people at one time and reconfigure space to allow for adequate physical distancing. Shared kitchens and bathrooms merit particularly frequent and careful cleaning.
Residential schools should also provide isolation and quarantine areas for residents who contract or are exposed to COVID-19. If on-campus housing is not feasible, consider off-campus locations for isolation and quarantine. Similar accommodations are recommended for students who live off campus. Any isolation and quarantine facilities must be physically separated from residential spaces and must bear proper signage indicating that they are restricted areas but should not indicate their purpose due to concerns of stigma and FERPA/HIPAA violations. Rooms for isolation and quarantine should have private bathroom facilities and be provided with a thermometer, sanitizing wipes, tissues, soap, hand sanitizer, and toiletries.
### Ventilation
Adequate ventilation is key for reducing aerosol transmission. Consider reviewing the ventilation systems in school buildings in consultation with HVAC professionals to ensure best practices whenever possible, with considerations for local weather and air quality. These can include increasing the percentage of outdoor air circulating in the building by both opening windows (if local air quality permits) and opening minimum outdoor air dampers as high as 100% if systems permit. Increase central air filtration to the highest filtration available and run filtration systems 24/7 whenever possible to ensure continuous air flow. Ventilation is also important when cleaning and disinfection are taking place.
School leaders should explore the feasibility of using other community spaces or outdoor spaces for classrooms, both to increase ventilation and to achieve physical distancing. In Italy, for example, schools are using closed movie theaters, church halls, and tented outdoor space for additional classroom space.
### Hygiene
Signage and handwashing stations can help encourage students and staff to regularly wash their hands and reduce crowding at existing sinks or bathrooms. Use automated soap dispensers whenever possible to reduce touchpoints. The CDC recommends washing with soap and water because it is more effective than hand sanitizers at removing germs and chemicals, especially when hands are dirty. When soap and water are not available, students and staff should have access to hand sanitizer containing at least 60% alcohol. To prevent poisonings from the ingestion of hand sanitizer, place immovable dispensers in highly visible locations where use can be monitored. To preserve skin health and prevent irritation that can accompany frequent hand washing and the use of hand sanitizers and other disinfectants, consider making hypoallergenic hand lotion available. Disinfecting wipes should also be accessible for students and staff to clean desks and keyboards.
### Cleaning Protocols
Cleaning services should regularly disinfect all classrooms, common areas, and workspaces. Consider providing cleaning staff with training or educational materials on the safe handling of cleaning products, adequate protective equipment, and clear protocols for preventing overexposure to chemicals.
The coronavirus has been found to live on glass, metal, ceramic, or paper surfaces for five days, wood for four days, plastics or stainless steel for two to three days, cardboard for one day, copper for four hours, and aluminum for two to eight hours.
Schools should follow research-backed disinfecting practices as closely as possible. The CDC has issued interim recommendations for cleaning and disinfecting community facilities. For disinfecting hard, non-porous surfaces, most common EPA-registered household disinfectants are effective. Household bleach will be effective against coronaviruses when properly diluted (1/3 cup per gallon of water). For soft, porous surfaces such as carpeted floors or rugs, clean with appropriate cleaners indicated for use on those surfaces. If items can be laundered, launder using the warmest appropriate water setting for the items and then dry completely. For electronics, follow the manufacturer's instructions for all cleaning and disinfection and consider use of wipeable covers for electronics. If no manufacturer guidance is available, use alcohol-based wipes or sprays that contain at least 70% alcohol. Dry surfaces thoroughly. Remind employees to adhere to the recommended "wet time" (time the surface must remain wet with the cleaning product in order to kill bacteria, virus, and parasites) for the product used.
Consider providing staff and students with disinfecting wipes to use on their individual workstation to reinforce the importance of cleaning and hygiene.
#### Cleaning after Exposure
When persons suspected or confirmed to have COVID-19 have been in a school facility, that site should be decontaminated. CDC guidelines for cleaning and disinfection of facilities where there have been suspected or confirmed cases recommend closing off areas visited by the ill persons and, if possible, opening outside doors and windows, using ventilating fans to increase air circulation in the area, and then waiting 24 hours or as long as practical before cleaning and disinfecting. Cleaning staff should then clean and disinfect all areas used by the infected persons, focusing on frequently touched surfaces.
Consider using foggers or misting equipment from a professional decontamination service. This would allow a site to be closed for a period of time so the infectious droplets could settle and then be effectively cleaned by standard protocols, or to introduce sufficient ventilation to effectively disperse the infected particles.
Conduct internal sanitation audits regularly to document what is being done correctly or incorrectly and identify areas where improvement is required. Consider noting in any routine sanitation audits any surfaces in the building most likely to harbor germs, including chairs, coffee stations, desks, door handles, light switches, reception areas, tables, elevator buttons, etc., and creating a plan to address any issues identified in the audits.
### Transportation
Evaluate school transportation options to determine what modes of transportation can maintain optimal physical distancing. Buses can be modified to maintain social distancing guidelines. For example, a 77-passenger bus can be modified to hold 13 students at six feet apart, or 26 students at five feet apart. Siblings can sit together, which can increase available capacity. Use signage or tape to mark where students can and cannot sit. Sequential seating should be encouraged, where students take the rear-most available seat. Seating charts can be used to support contact tracing efforts.
If a school district requires families to do symptom checking, parents should complete symptom tracking before they leave for the bus stop. Masks should be required for students while on the bus; extra masks should be available for students if they forget theirs at home. To protect bus drivers, plexiglass can be used as a barrier around the driver's seat. Bus drivers should also wear masks. Whenever possible, windows should be open to encourage air flow. Buses should be disinfected in between uses or as frequently as possible.
Shared transportation in smaller vehicles (such as carpooling or shuttles) should be avoided for both students and employees.
### Meals
Meals should be prepared following standard food safety guidelines. Whenever possible, meals should be delivered to classrooms and students should eat at their individual desk or workstation with sufficient physical distance rather than in a cafeteria setting to minimize exposure to large groups. Re-evaluate "open campus" high school policies that allow teaching staff and older students to leave campus for lunch based on community health data.
Given that food insecurity has increased and that students from lower-income families may have received one or two meals per day at school before distance learning began, schools should consider ways to make lunches available for students to pick up when they are not at school in person. Other than continuing to order from schools' usual food providers, food banks and other community organizations in many areas are partnering with school districts to provide meals to students.
### Communication Plan
Develop and implement an ongoing communication plan to provide training and health and safety information for students, parents, and staff. Consider developing and testing information-sharing systems for schools and parents/guardians so that COVID-19-related information can be communicated quickly and effectively. These information-sharing systems should include the following:
- Day-to-day reporting on disease surveillance (with two-way reporting between schools and parents/guardians)
- The ability to track the occurrence of symptoms
- Connection and access to local health officials
## 3. Support Your Staff, Students, and Parents
A Gallup survey from July 2020 found that 57% of teachers are very concerned about being exposed to coronavirus in the workplace compared to 21% of all other US workers, and 24% of teachers are at heightened risk of COVID-19 infection. Clear communication strategies, paired with accommodations for high risk individuals, are critical to ensure success in maintaining in-person education and reduce anxiety amongst staff. Inviting teachers and staff to participate in the planning process can build shared trust and ensure multiple perspectives are considered.
Students, parents or guardians, and families also need clear communication throughout the school year. Recent polling suggests that 59% of responding parents were not comfortable with returning to school in the fall, yet 66% of parents have concerns about how distance learning will impact their children's mental health. Families should be provided with transparent information throughout the process and be prepared in advance for changes to models throughout the year.
### Social Contract
Develop a social contract that lays out the school, staff, student, and parent/guardian commitment to health and safety. A social contract between administrators, staff, students, and families can build mutual trust, ground decision-making in shared values, and ensure that all perspectives are considered when determining when to return to the classroom. A social contract instills mutual trust and can drive compliance for all participants. The most successful social contracts rely on mutual trust between those involved, rather than formal attestation. People choose to abide by the commitments in a social contract when they believe their leaders demonstrate commitment to those values and see each participant fulfilling their duties as part of the contract.
Social contracts should consider behaviors both at school and outside of school. Viral transmission at large group gatherings are common and even heightened in certain circumstances that could occur outside of school (e.g., choir rehearsals, weddings, sporting events). Although these happen outside of the school day, students and parents need to consider how all their actions impact the school community.
Schools should also consider potential consequences for students who show poor adherence to the school's social contract, such as exclusion from participating in extracurricular activities or from attending school in person.
### Pandemic Education Materials
As part of the social contract, consider providing materials specific to faculty and staff on the school's plans and guidelines to create and maintain a safe and effective learning environment. Also provide age-appropriate educational materials to students and parents to explain the school's plans, guidelines, and expectations. Engage parents as early and as often as possible, both to provide updates and seek input. This includes training/education on updated school safety, hygiene policies, and resources (possibly leveraging CDC or WHO materials).
Content could include the following:
- Respiratory hygiene: The CDC now recommends that all people wear cloth face coverings whenever they leave their homes ("universal masking") in addition to typical guidance for respiratory hygiene (i.e., cover mouth and nose when coughing or sneezing, use tissues and immediately discard the tissue, wash hands or use a hand sanitizer after touching mouth or nose).
- Hand hygiene: Studies show that adequate handwashing (20 seconds with soap) and use of alcohol-based hand sanitizer are key measures for stopping the community spread of infection.
- Physical distancing (based on school guidelines in previous section).
- When to stay at home. This includes assessing paid time off and sick leave policies for staff. To decrease the chance of workplace transmission, these policies should be designed such that employees are not penalized for staying home if they experience symptoms and are not incentivized to continue working if they are sick. The CDC recommends that people stay home if they have ANY of the following:
Major symptoms, as defined by the CDC, include:
- Fever over 100.4 degrees
- New or worsening cough
- Shortness of breath or difficulty breathing
- New loss of taste or smell
Minor symptoms include:
- Fatigue
- Muscle or body aches
- Headache
- Sore throat
- Congestion or runny nose
- Vomiting
- Nausea
- Diarrhea
### High-Risk Identification
School leadership needs to determine policies that accommodate high-risk staff or those with high-risk family members. Staff should be able to self-identify as high risk or as living with a high-risk individual without having to disclose the reasons and without fear of retribution. School leadership needs to determine policies that accommodate high risk students, or those with high risk family members. Educate families on what factors are considered high risk to help families make the best choices for their situations.
The CDC indicates that people of any age with the following conditions are at increased risk of severe illness from COVID-19:
- Cancer
- Chronic kidney disease
- COPD (chronic obstructive pulmonary disease)
- Immunocompromised state (weakened immune system) from solid organ transplant
- Obesity (body mass index of 30 or higher)
- Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
- Sickle cell disease
- Type 2 diabetes mellitus
Based on what is known at this time, the CDC indicates that people with the following conditions might be at an increased risk for severe illness from COVID-19:
- Asthma (moderate to severe)
- Cerebrovascular disease (affects blood vessels and blood supply to the brain)
- Cystic fibrosis
- Hypertension or high blood pressure
- Immunocompromised state (weakened immune system) from blood or bone marrow transplant, immune deficiencies, HIV, use of corticosteroids, or use of other immune weakening medicines
- Neurologic conditions, such as dementia
- Liver disease
- Pregnancy
- Pulmonary fibrosis (having damaged or scarred lung tissues)
- Smoking
- Thalassemia (a type of blood disorder)
- Type 1 diabetes mellitus
Children who have medical complexity, who have neurologic, genetic, metabolic conditions, or who have congenital heart disease might be at increased risk for severe illness from COVID-19 compared to other children.
Staff that have identified as high risk, or who have identified that they have family members who are high risk, need proper support to successfully work from home. Consider stipends or purchasing programs to provide access to necessary technology and equipment and ensure reliable broadband access. To accommodate high risk children and families, consider offering "virtual school:" an enrollment option for online or distance learning for the entire school year.
### Hygiene Practices
Continually reinforce the importance of personal hygiene practices with students and families. Proper handwashing techniques can be taught in class, and consider incorporating frequent handwashing or hand sanitizing into daily classroom routines.
In addition to masks, remind students and families of proper respiratory hygiene: covering your mouth with your elbow when coughing or sneezing and washing your hands after you cough or sneeze.
### Personal Protective Equipment
#### Provide Staff with PPE
Adequate personal protective equipment will significantly reduce the risk of transmission. Provide surgical N95 masks for all staff with regular contact with students that is fit-tested to ensure optimal usage whenever possible. If N95 face masks are unavailable, surgical face masks or cloth face masks can be worn.
Adequate personal protective equipment will significantly reduce the risk of transmission. Schools should consider requiring students to wear cloth face masks inside the school, with removal only allowed while eating or drinking. Consider providing parents and guardians with information on why face masks reduce transmission and how to care for reusable face masks, as well as teaching students how to wear and not to touch or adjust their face masks.
Beyond providing PPE, educate staff on the importance of PPE and the appropriate use. Teach staff how to use and care for N95 or other face masks. Acknowledge staff's concerns with PPE, which may include ability to speak or use facial expressions.
Face shields alone are not considered adequate protection from potential transmission. The CDC does not recommend their use without also wearing a mask because they do not reliably provide adequate coverage of the nose and mouth and can therefore allow for the spread of airborne particles. In addition, those that are designed for more than a single use need to be regularly sanitized, and frequent sanitization can affect their fit or surface integrity. However, clear face shields may be considered appropriate when teaching the deaf or hard of hearing, ESL students, students with disabilities, or young students learning to read.
#### Supply Students with Masks
Masks are an item to be added to school supply lists for students to bring to school with them. Whenever possible, schools should provide students with masks to wear when at school to ensure that all students have them.
#### Ensure Appropriate Mask-Wearing and Respectful Behavior Toward Those Unable to Wear Masks
In general, students aged five and under should not be required to wear a mask unless recommended by local guidelines, and nor should those with severe cognitive or respiratory impairments who may have trouble tolerating a mask or would have difficulty removing a mask without help. Students aged 12 and above should wear masks under the same conditions and circumstances as adults.
Students who are unable to wear a mask may experience stigma or bullying from other students. Schools should develop a plan to help prevent this from happening and for addressing it as necessary.
### Symptom Tracking
Major COVID-19 symptoms, as defined by the CDC, include:
- Fever over 100.4 degrees
- New or worsening cough
- Shortness of breath or difficulty breathing
- New loss of taste or smell
Minor symptoms include:
- Fatigue
- Muscle or body aches
- Headache
- Sore throat
- Congestion or runny nose
- Vomiting
- Nausea
- Diarrhea
Schools should implement a formal symptom tracking process for all staff and students. This can be done on an honor system or staff and students can be required to report their symptoms each day to clear them to attend school. Parents or guardians need to monitor a student's symptoms daily.
Symptom tracking tools such as ProtectWell™ are designed for employers to use CDC guidelines to assess whether a staff member should go to work that day. Staff members complete a brief symptom questionnaire each morning and are cleared to go to work if they are symptom-free. If they report symptoms, the staff member is guided on a course of action, which can include testing or isolating at home.
Schools using symptom tracking platforms should consider positioning a person at each employee entrance to view and scan each person's phone to ensure that they are able to enter that day. It may be necessary to restrict people to a single entrance to reduce the number of people required to conduct scans. Supply these people with appropriate PPE whenever possible.
Policies and procedures should be reviewed to ensure that employees showing symptoms can stay home without negative consequences. School leadership should implement a plan to ensure that adequate substitute teachers are available to step in if a teacher develops symptoms suddenly.
Before returning to school, students and staff must have passed at least three days (72 hours) since recovery, defined as resolution of fever without the use of fever-reducing medications and improvement in respiratory symptoms (e.g., cough, shortness of breath); and, at least seven days have passed since symptoms first appeared. Alternatively, students and staff must be symptom-free and have had two negative diagnostic tests at least 24 hours apart.
#### Temperature Checking
Encourage or require staff and students to check their temperature each day. Those with temperatures above 100.4 degrees Fahrenheit should be asked to stay at home. This can be done on an honor system or people can be required to report their temperature each day to clear them for in-person attendance. Alternatively, temperature checkers can be placed at each entrance and can use temporal thermometers to quickly check each person entering. However, precautions are necessary to ensure physical distancing if multiple people queue for temperature checks.
#### Testing
School administrators should consider a testing process for staff and students, either when they present with symptoms or for surveillance testing. While surveillance testing is cost-prohibitive for most schools, school administrators should consider a testing process for those who develop symptoms during the day. Schools could look for community partners, such as health systems, to create a seamless workflow for testing.
Consider testing staff and students with a rapid COVID-19 test at a regular frequency of at least every 48 hours. If there is a known exposure within the school or community, they should undergo testing and follow any exposure mitigation protocols. Rapid tests may include point-of-care polymerase chain reaction (PCR) testing, antigen testing, or loop mediated isothermal amplification (LAMP) testing. Given the need to act quickly based on the results, it is recommended to avoid slower-turnaround testing such as mail-out PCR.
#### Test Pooling
As students are kept together in smaller cohorts, it is possible to pool samples to obtain faster, equally accurate results and reduce the amount of testing supplies needed. Point-of-care PCR testing is an option to test an entire classroom with one test. If positive, the cohort can either be re-tested individually or managed at home following positive COVID guidelines and be taught remotely until isolation is completed. This maintains the in-person experience for the rest of the school.
#### Establish Priority Testing Relationship for Expedited Results
Teaming up with the local health department is essential for testing and contact tracing. When there is an outbreak at a school, partnering with local resources to provide rapid testing for teachers and staff will help keep schools open safely.
### Mental Health Support
Supporting staff, student, and family mental health is critical during this time. Building resilience in staff members is important to help them cope with change, operate continually in high stress environments, and prepare for future stressors. Building resilience in students and families is critical to help them adapt to changes and prepare for future stressors.
School staff need access to multiple mental health support tools, which can include mobile applications, web portals, call centers, and in-person or virtual support services (e.g., support groups or learning communities). Tools should assess the user's level of resilience and provide integrated resources based on the user's baseline resilience level as well as specific concerns or areas of interest. School leadership can ensure that mental health supports are not overwhelming for users and are tailored to the school staff population, including cultural and language considerations. Leadership can promote such tools by reinforcing how they will strengthen and support staff rather than framing the need for tools as a weakness. Combating stigma around mental health is critical to drive adoption of support systems.
Students and families need access to multiple, age-appropriate mental health supports in various mediums, including mobile applications, videos, telephonic, and in-person or virtual support groups. Tools should assess the user's level of resilience and offer suggested resources based on the user's baseline resilience level as well as specific concerns or areas of interest. School leadership should ensure that any mental health supports are not overwhelming for users and are tailored to the school population, including cultural and language considerations.
### Students with Individual Education Plans
Schools need to ensure that students have access to the tools and equipment needed to support their education. Students with physical or cognitive disabilities and students with individual education plans need a customized approach to ensure that their education is accessible. Considerations should be made for students who may not tolerate face masks, such as students with sensory or behavioral issues. Face masks with clear windows are available for staff who work with hard-of-hearing students. Cleaning solutions, particularly those with a strong scent, may negatively affect students who are sensitive to smells.
All students can benefit from behavioral reinforcement of new norms, such as frequent handwashing. Using picture schedules, timers, or other visual cues can help students adjust to new expectations.
### Staff Gatherings
Large face-to-face gatherings of staff should be avoided, and many can be replaced with conference calls or video conferencing. Implement reduced capacity in conference rooms and breakrooms to allow for social distancing, with signage to reinforce capacity limits. If large meetings are unavoidable, all participants should wear masks and keep appropriate distance. Consider holding such meetings outdoors to further reduce risk.
### Special Circumstances
School leadership should consider special circumstances, including two-household families, students who move between homes, students who have high-risk family members at home, and dorm life. Ensure that all individuals who are directly involved in students' lives are aware of relevant policies, procedures, and resources.
## 4. Take Steps to Keep Your Classrooms Open
### Decision-Making on In-Person Education
The Community Action List for Schools (Table #1) provides guidance in how community spread should impact learning models. School administrators should partner with local health departments to ensure access to community viral levels and determine if education models need to change based on community transmission. This grid and the associated metrics should be reviewed daily to ensure ongoing safety.
### Hybrid Models
If community caseload levels are not low enough to keep schools fully open, school administrators can consider various hybrid models to allow smaller groups of students in the school. Hybrid models can provide smaller classes and lower bus ridership. One example is two days per week for students. Half of the student population attends class in the school on Monday and Tuesday, and the other half attends class on Thursday and Friday. If a student is not in the classroom, they should be attending school virtually in the other three days. Wednesdays will be used to clean facilities.
A five-day on, ten-day off model includes half of students attending classes in person on Monday, Tuesday, and Wednesday. The second half of students attend class on Thursday, Friday, and the following Monday, Tuesday, and Wednesday. The halves switch every week to ensure that all students attend five school days over a 14-day period. Under this model, ensure extra attention to cleaning and disinfecting on Wednesday nights and weekends, between group switches. Students continue distance learning on days they are not in school physically.
However, hybrid models are not without risk. Students and families in hybrid models may need additional childcare coverage during remote days. Alternative childcare arrangements may increase exposure to other students, thus increasing the potential for transmission.
Staggering the timing of students' return to full-time in-person education is another crucial consideration for maximizing health and safety. Studies suggest that physical distancing measures have the most sustained effect if return to school is staggered. A staggered return is estimated to significantly reduce the median number of infections throughout the first year). In addition, staggered approaches should start with children who are ten years old or younger as transmissibility and attack rates appear to be lower and less aggressive than in older children.
A "wave model" is a way to execute a staggered re-entry for schools. This entails bringing employees and students back in three- to four-week waves, as long as local infection rates continue to decline (with students continuing distance learning until they return in person). The staggered return will also minimize risk for transmission by allowing for greater physical distancing during the earliest stages of reintegration and ensuring more employees and students rejoin the workspace only as community infection rates decline. The wave model resembles the evidence-based tiered strategy:
- Tier 1: School administrators return to test protocols and ensure safety
- Tier 2: School employees to train on new protocols
- Tier 3: Elementary students return for school-day only activities
- Tier 4: Middle- and high-school students return for school-day only activities
- Tier 5: Resume extracurricular activities
### Auditing Performance
Consider documenting through internal sanitation audits what is being done correctly, as well as areas where improvement is required.
Consider the most effective frequency of social distancing audits, and regularly remind students and staff of the best practices for distancing.
### Sports and Extracurricular Activities
Consider whether sports and extracurricular activities should be allowed to resume. Some sports, such as football or wrestling, have a high degree of contact and are not considered safe. In general, outdoor sports are safer, but no event is completely safe. Even for sports where social distancing can be achieved (e.g., cross country, golf), review whether locker rooms can accommodate social distancing and be frequently cleaned.
Non-sport extracurricular activities need review as well. Many clubs or activities can be modified to achieve social distancing and can continue in an adapted fashion. Activities that include verbal projection—such as choirs, musicals, or performances—have a higher degree of risk. Choir rehearsal, or any group singing activity, creates a high risk for viral transmission.
#### Consider Alternative Methods that would Allow for More Activities
Band, choir, theatre, and physical education all involve students producing more droplets into the air and are thus riskier activities. These activities should be moved outside, where possible, or into larger areas in the school. Reducing group sizes participating in those activities will also help mitigate the risk. Musical instruments should not be shared. These activities may also have to be altered or moved online.
### Changing Models
If cases increase, or if a case is diagnosed within a school, schools may need to shift to distance learning abruptly. School administrators should consider the most effective ways to ensure that staff and families are aware of the potential for abrupt changes, and flexibility should be encouraged. Communicating this possibility throughout the school year will help parents and families prepare, and if the decision is made to move to online learning, communication will be essential not only to help families adjust but also to help them understand why the decision was made.
Students and staff attending classes in person must bring required technology and supplies home each day in case of abrupt school closures.
Once cases are consistently decreasing, schools can gradually reopen, shifting from hybrid models to fully in-person models of education. Beyond caseloads, schools should consider whether all of the factors covered in this document are accounted for to the best of their ability before reopening.
#### Build Distance Learning into In-Person Classrooms
With the possibility of quarantine occurring frequently for whole or partial classes or schools, curriculum needs to be built to ensure students that have to stay home are not having a break in education. Teachers cannot be expected to separately teach students both online and in the classroom. If possible, all homework should be able to be completed and turned in online. For students that must remain at home, there should either be learning exercises that help them learn the concepts for the homework or an ability to watch or listen to the lessons remotely should be offered. Schools should also prepare for the possibility of an entire class moving to quarantine at once. All students and staff should prepare for that class to then move entirely online for learning for the duration of that quarantine period.
#### Maintain Continuous Communication with Parents and Students
The uncertainty of school reopening requires flexibility and clear communication with parents and students. A person or team should disseminate all information to parents and students about COVID-19 policies. All expectations and protocols should be clearly disseminated before the problems arise. All parents should understand how they will be notified and what to do in the event a student tests positive in their child's classroom before that event occurs. While student privacy must be maintained, when there is a suspected or confirmed COVID-19 case in the classroom, students and parents should be notified quickly so they can follow quarantine procedures.
#### Provide Consistent Recommendations to Parents and Students About When to Stay Home
One of the best ways to mitigate outbreaks in the school is to keep students that may have COVID-19 at home. The expectations of when to keep students home should be communicated clearly and consistently. All students with symptoms should stay home until 72 hours after recovery from symptoms. If any household member has tested positive for COVID-19, the student should be in quarantine for 14 days.
### Handling Outbreaks
School administrators need to consider a comprehensive plan for handling outbreaks.
If a student or staff member presents with a temperature or with symptoms at the beginning of the day, keep them either outside or quarantined in the school until they can arrange for medical care.
Quarantine students or staff who develop symptoms during the day until they can seek medical care. If testing is recommended, provide guidance on where and how to get tested and consider arranging access to low- or no-cost testing for students or staff without insurance.
If a case of COVID-19 is confirmed, distance learning may need to be implemented only for that student or staff member's cohort if rapid frequent testing or pooled testing had been implemented. Students and staff within the same classroom as the positive case should be encouraged to seek testing and required to isolate until they have a negative test result or for 14 days.
If a full school closure is necessary, school leadership needs to communicate to students, families, and staff immediately. Local health officials will support school leadership in decision-making on the scope and duration of school closures, including extracurricular group activities, school-based afterschool programs, and large events, and support the school to determine what additional steps are needed to ensure a safe return.
Communication with students, families, and the local community is critical. Consider including messages to counter potential stigma and discrimination while maintaining the confidentiality of the infected student or staff member.
To ensure a safe environment after an exposure, consider closing off areas used by any individual diagnosed with COVID-19 for up to 24 hours to reduce exposure by cleaning crews. Open windows and doors whenever possible to increase air circulation and disinfect surfaces as needed.
## References
1. Hill, Paul "What Post-Katrina New Orleans Can Teach Schools about Addressing COVID Learning Losses." Center for Reinventing Public Education, April 2020.
2. Reckdahl, Katy. "The Lost Children of Katrina." The Atlantic. 2 April 2015.
3. K-12 Teachers Worried About COVID-19 on the Job, Gallup, July 24, 2020 https://news.gallup.com/poll/316055/teachers-worried-covid-job.aspx
4. How Many Teachers Are at Risk of Serious Illness If Infected with Coronavirus? https://www.kff.org/coronavirus-covid-19/issue-brief/how-many-teachers-are-at-risk-of-serious-illness-if-infected-with-coronavirus/
5. It's Back to School amid COVID-19, and Mothers Especially Are Feeling the Strain. https://www.kff.org/policy-watch/its-back-to-school-amid-covid-19-and-mothers-especially-are-feeling-the-strain/
6. Gottlieb, Scott, Caitlin Rivers, Mark B. McClellan, Lauren Silvis, and Crystal Watson. 2020. "National Coronavirus Response: A Road Map to Reopening." American Enterprise Institute. https://www.aei.org/wp-content/uploads/2020/03/National-Coronavirus-Response-a-Road-Map-to-Recovering-2.pdf.
7. Kretzschmar, Mirjam E., Ganna Rozhnova, and Michiel E. van Boven. 2020. "Isolation and Contact Tracing Can Tip the Scale to Containment of COVID-19 in Populations with Physical distancing." MedRxiv. April, 2020.03.10.20033738. https://doi.org/10.1101/2020.03.10.20033738.
8. National Academy of Sciences. 2010. "Related IOM Work on Crisis Standards of Care." National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK32749/.
9. Centers for Disease Control: Current Hospital Capacity Estimates. https://www.cdc.gov/nhsn/covid19/report-patient-impact.html
10. Coronavirus COVID-19 Update. https://www.iscresearch.com/coronavirus-covid-19-update
11. Responses from our member States. https://www.coe.int/en/web/education/responses-from-our-member-states
12. Pandemics: Considerations for Social Distancing. https://na.theiia.org/periodicals/Public%20Documents/IIA-Bulletin-Pandemics-Considerations-for-Social-Distancing.pdf
13. Information About Social Distancing. https://www.cidrap.umn.edu/sites/default/files/public/php/185/185_factsheet_social_distancing.pdf
14. Living in Shared Housing https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/shared-housing/index.html
15. COVID-19 Guidance for Shared or Congregate Housing
16. Schoen, Lawrence. "Guidance for Building Operations During the COVID-19 Pandemic." ASHRAE Journal. May 2020.
17. Bennhold, Katrin. "Schools Can Reopen, Germany Finds, but Expect a Roller Coaster." The New York Times. 26 August 2020.
18. "Show Me the Science – When & How to Use Hand Sanitizer in Community Settings | Handwashing | CDC." 2020. April 23, 2020. https://www.cdc.gov/handwashing/show-me-the-science-hand-sanitizer.html.
19. Hand washing and hand sanitizer on the skin and COVID-19 infection risk. https://www.the-hospitalist.org/hospitalist/article/219484/aesthetic-dermatology/hand-washing-and-hand-sanitizer-skin-and-covid-19
20. How Long Does the Coronavirus Live on Surfaces? https://www.webmd.com/lung/how-long-covid-19-lives-on-surfaces
21. Cleaning and Disinfection for Community Services. https://www.cdc.gov/coronavirus/2019-ncov/community/organizations/cleaning-disinfection.html
22. The In-House Sanitation Audit. https://www.qualityassurancemag.com/article/the-in-house-sanitation-audit/
23. COVID-19: 7 Best Practices for Cleaning and Sanitizing Your Building. https://home.akitabox.com/blog/covid-19-cleaning-and-sanitizing-practices
24. Daprile, Lucas. "Buses At 17% Capacity, Smaller Recesses: Here's How SC Schools Could Change This Fall." The State, May 6, 2020. https://www.thestate.com/news/coronavirus/article242533756.html.
25. Transfinder Corporation. "Transfinder-NAPT: Going Back to School Before the Kids - An Actual Return to School Roadmap-Part II.." Transfinder Corporation video, May 13, 2020. https://www.youtube.com/watch?v=ahaQj0j1lYI&feature=youtu.be.
26. Coronavirus: Facts, Not Fears. https://www.buses.org/about/consumer-information/coronavirus-facts-not-fears#keep-facilities-clean
27. Interim Guidance for Businesses and Employers Responding to Coronavirus Disease 2019 (COVID-19), May 2020. https://www.cdc.gov/coronavirus/2019-ncov/community/guidance-business-response.html
28. The Impact of the Coronavirus on Child Food Insecurity. https://www.feedingamerica.org/sites/default/files/2020-04/Brief_Impact%20of%20Covid%20on%20Child%20Food%20Insecurity%204.22.20.pdf
29. The Impact of the Coronavirus on Food Insecurity. https://hungerandhealth.feedingamerica.org/wp-content/uploads/2020/03/Brief_Covid-and-Food-Insecurity-3.30.pdf
30. K-12 Teachers Worried About COVID-19 on the Job, Gallup, July 24, 2020 https://news.gallup.com/poll/316055/teachers-worried-covid-job.aspx
31. How Many Teachers Are at Risk of Serious Illness If Infected with Coronavirus? https://www.kff.org/coronavirus-covid-19/issue-brief/how-many-teachers-are-at-risk-of-serious-illness-if-infected-with-coronavirus/
32. CivicScience "Back to School Report." 7 August 2020.
33. UnitedHealth Group Consumer Insights "Back to School Custom Tracking Questions." August 2020.
34. Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities. https://www.cdc.gov/coronavirus/2019-ncov/hcp/dialysis.html
35. Hand washing and hand sanitizer on the skin and COVID-19 infection risk. https://www.the-hospitalist.org/hospitalist/article/219484/aesthetic-dermatology/hand-washing-and-hand-sanitizer-skin-and-covid-19
36. CDC. 2020. "Coronavirus Disease 2019 (COVID-19)." Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html.
37. CDC. 2020. "Coronavirus Disease 2019 (COVID-19) – Symptoms." Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html.
38. ProtectWell mobile application
39. CDC https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html
40. What alternatives to face coverings or masks (e.g., face shields) are being considered or used for non-healthcare workers returning to work sites, who cannot tolerate wearing facial coverings? https://acoem.org/COVID-19-Resource-Center/COVID-19-Q-A-Forum/What-alternatives-to-face-coverings-or-masks-(e-g-,-face-shields)-are-being-considered-or-used-for-n#:~:text=Some%20may%20find%20a%20bandana,who%20cannot%20tolerate%20face%20coverings.
41. Guidance for K-12 School Administrators on the Use of Masks in Schools. https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/cloth-face-cover.html
42. Q&A: Children and masks related to COVID-19. https://www.who.int/news-room/q-a-detail/q-a-children-and-masks-related-to-covid-19#:~:text=WHO%20and%20UNICEF%20advise%20that,transmission%20in%20the%20area.
43. Advice on the use of masks for children in the community in the context of COVID-19. https://www.who.int/publications/i/item/WHO-2019-nCoV-IPC_Masks-Children-2020.1
44. Guidance for K-12 School Administrators on the Use of Masks in Schools. https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/cloth-face-cover.html
45. ProtectWell mobile application
46. Centers for Disease Control "COVID-19 FAQs for Business." https://www.cdc.gov/coronavirus/2019/community/general-business-faqs.hmtl
47. https://www.who.int/docs/default-source/coronaviruse/mental-health-considerations.pdf?sfvrsn=6d3578af_8
48. Centers for Disease Control "Guidance for School Operations." https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools.html
49. Hanage, William. "'Hybrid' School Plans Sound Safe, but They're the Riskiest Option We Have." Washington Post. 14 August 2020. https://www.washingtonpost.com/outlook/2020/08/14/hybrid-learning-coronavirus-risk/
50. Opening Up America Again. https://www.whitehouse.gov/openingamerica/
51. The effect of control strategies to reduce social mixing on outcomes of the COVID-19 epidemic in Wuhan, China: a modelling study. https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(20)30073-6/fulltext
52. Spread of SARS-CoV-2 in the Icelandic Population. https://www.nejm.org/doi/full/10.1056/NEJMoa2006100
53. https://doi.org/10.1093/cid/ciaa450
54. https://www.nature.com/articles/d41586-020-01354-0
55. Centers for Disease Control "Guidance for School Operations." https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/schools.html
## Safe Health Compact
| School Responsibilities | Student, Faculty, & Staff Responsibilities |
|-------------------------|-------------------------------------------|
| Provide a Safe Environment
• Give students, faculty, and staff the tools and equipment to be safe
• Follow recommendations from health authorities
• Create policies that allow students, faculty, and staff to safely return to school
• No retribution for employees unable to return to work – offer equal opportunities to all no matter the worksite | Be safe in your actions
• Follow all health guidelines for worksite safety and when to return to school
• Complete surveys, testing, and use PPE as required
• Be honest on when you should not go to school
• Your actions impact not just your health, but that of your co-workers, family, friends, and community |
| Educate
• Provide up to date information on community health status
• Provide up to date information on school programs and policies
• Provide material to increase knowledge of students, faculty, and staff | Be Flexible
• Stay up to date with educational material and adjustments to policies
• Embrace continuous improvement and understand policies will change as community health risk changes |
| Listen and Communicate
• Create a safe environment for student, faculty, and staff communication
• Be open and non-judgmental to feedback and ideas
• Be transparent in school and district status, health goals, etc | Listen and Communicate
• Do not stigmatize or judge co-workers or peers based on their health decisions and return to school status
• Give constructive, focused feedback to leaders to help the school do better |
| Lead
• Manage with our school values at the core of our decision making | |
||
# 1,594 2021-01-08_School Testing_Massachusetts Dept of Education - Memo on Pooled Testing in K-12 Schools.md
METADATA
last updated: 2026-03-06 by BA
file_name: 2021-01-08_School Testing_Massachusetts Dept of Education - Memo on Pooled Testing in K-12 Schools.md
file_date: 2021-01-08
title: Massachusetts Dept of Education - Memo on Pooled Testing in K-12 Schools (Jan 2021)
category: various
subcategory: external-programs-reports
tags: school testing, massachusetts
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summary_short: The Massachusetts Department of Education memo (January 8, 2021) outlines a statewide K–12 COVID-19 pooled PCR screening program, explaining weekly anterior nasal swab pooling with 24–48 hour results and individual follow-up testing (primarily Abbott BinaxNOW) after a positive pool. It describes a no-cost 6-week early launch with a contracted testing service provider supplying kits, logistics, training, software, and support, with optional continuation funded by federal stimulus dollars. The memo also summarizes consent requirements and clarifies that pooled results are not reported to DPH while individual diagnostic follow-up results are.
CONTENT
*Massachusetts Department of*
*Elementary and Secondary Education*
*75 Pleasant Street, Malden, Massachusetts 02148-4906*
*Telephone: (781) 338-3000*
*TTY: N.E.T. Relay 1-800-439-2370*
Jeffrey C. Riley
*Commissioner*
## MEMORANDUM
To: Superintendents, Charter School Leaders, and Leaders of Educational Collaboratives and Approved Special Education Schools
From: Jeffrey C. Riley, Commissioner of Elementary and Secondary Education
Date: January 8, 2021
Subject: Pooled Testing in K-12 Schools
In preparation for the start of the 2020-2021 school year, the Department of Elementary and Secondary Education (DESE) released a series of guidance documents outlining the key health and safety requirements for in-person learning. These mitigation requirements include rigorous hygiene and handwashing, use of masks/face coverings, physical distancing, reducing interaction between groups, and staying home when sick. DESE, in collaboration with the Department of Public Health (DPH), has begun to introduce COVID-19 testing in K-12 public schools and approved special education schools as an additional mitigation strategy.
In late fall 2020, DESE announced how districts can request a state-sponsored mobile testing unit if a potential cluster of COVID-19 is identified and transmission appears to have occurred within school. In early November, DESE announced a phased rollout of the Abbott BinaxNOW antigen testing for an initial group of districts and schools, with plans to expand the use in early 2021.
In the coming weeks, DESE and DPH are seeking to introduce COVID-19 screening testing using a pooled strategy in the school setting. This memo provides a brief overview of the pooled testing strategy, a description of the state’s early launch of this initiative, the related reporting and consent requirements, and the role of the testing service provider. If after reviewing this information your district or school is interested in participating, we strongly encourage you to fill out the brief survey below to register for this initiative and attend an optional informational webinar on Tuesday, January 12, from 10:00-11:15 a.m. We will be joined in this webinar by district leaders who are currently using and finding success with pooled testing, and the webinar will be recorded and posted afterward.
### Survey Link
[https://survey.alchemer.com/s3/6123054/Pooled-Testing-Interest-Survey](https://survey.alchemer.com/s3/6123054/Pooled-Testing-Interest-Survey)
Please complete the survey by close of business on January 15 if you are interested in participating.
### Optional Informational Webinar
Date: January 12, 2021
Time: 10:00-11:15 a.m.
[https://us02web.zoom.us/j/86143176665?pwd=bFpSa3B5dHpTeEQyMXVkUFdkRlFQdz09\&from=addon](https://us02web.zoom.us/j/86143176665?pwd=bFpSa3B5dHpTeEQyMXVkUFdkRlFQdz09&from=addon)
### Overview of Pooled Testing
Pooled testing involves mixing several test samples together in a “batch” or “pool” and then testing the pooled sample with a PCR test for detection of SARS-CoV-2\[1\]. This approach increases the number of individuals that can be tested using the same amount of resources as a single PCR test. The test is performed at least once per week with anterior nasal swab for all students and staff members. Results are delivered within approximately 24-48 hours. If a pooled test result is negative, then all individuals within that pool are presumed negative and may continue to remain in school. If a pooled test result is positive, then all individuals in the pool must quarantine until they are retested individually. The Abbott BinaxNOW rapid point-of-care antigen test will be the primary source of this individual follow-up testing. More detailed guidance on protocols addressing positive/negative pooled test results will be available prior to the launch of this program. The test kits, training, and testing software will be provided by a third-party vendor and tests will be analyzed at an authorized laboratory.
### Description of 6-Week Early Launch
During an initial 6-week period, participating districts and schools will receive the test kits, support from a testing service provider, and the testing software to track results, all at no cost to them. In most cases, districts and schools will administer the tests using existing staff resources. Following the initial 6-week launch, districts and schools may continue using pooled testing by purchasing the tests and any other accompanying testing materials, software, or support from a statewide contract using their federal stimulus dollars.
A district or school providing any type of in-person instruction, such as full-in person or hybrid instructional models or in-person services for high needs students, is invited to participate in this initiative. In addition, districts and schools that are currently in a remote instructional model but intend to return to in-person learning are also invited to participate. Private and parochial schools are not able to participate in the early launch, but they are able to purchase tests, materials, and software directly from testing services providers.
### Consent Requirements, Reporting, and Testing Service Providers
*Consent Requirements*
Individuals may participate in pooled testing only with valid consent. DESE and DPH will provide further information on the consent and authorization that districts and schools participating in this initiative must obtain. This process will include obtaining consent from students’ parents/guardians prior to administering the tests to students.
*Reporting*
Neither Schools nor Local Boards of Health need to report results from pooled tests to the Department of Public Health. Conversely, schools and Local Boards of Health must provide results from individual diagnostic tests (both positive and negative) done following a positive pooled test result to the Department of Public Health using the established reporting mechanism. Further guidance on reporting is forthcoming.
*Testing Service Provider*
Under a statewide contract, districts and schools will work with a testing service provider who will manage the logistics (e.g., delivery of tests to schools, operations hardware, and coordination with the testing lab), and provide training for schools and districts, software associated with pooled testing, and technical assistance/customer support to district/school personnel. DESE will assume the costs of the testing service provider and other materials associated with pooled testing for the first 6 weeks of the program. Following the 6 weeks, districts and schools may use their federal stimulus funding to continue the program. In most cases, districts and schools will use existing staff resources to administer the tests and to manage onsite logistics.
### Conclusion
If your district or school is providing any form of in-person instruction (full in-person, hybrid, or services solely for high needs students), you are well positioned to participate in this pooled testing initiative. We hope you will complete [this survey](https://survey.alchemer.com/s3/6123054/Pooled-Testing-Interest-Survey) by January 15 to indicate your interest in participating.
---
\[1\] FDA, Pooled sampled testing and screening for COVID-19, (2020, August 24). Available at: [https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/pooled-sample-testing-and-screening-testing-covid-19](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/pooled-sample-testing-and-screening-testing-covid-19)
# 12,124 2021-02-01_School Testing_San Francisco Unified School District - COVID Testing Implementation and Coordination.md
METADATA
last updated: 2026-03-06 by BA
file_name: 2021-02-01_School Testing_San Francisco Unified School District - COVID Testing Implementation and Coordination.md
file_date: 2021-02-01
title: San Francisco Unified School District - COVID Testing Implementation and Coordination (Feb 2021)
category: various
subcategory: external-programs-reports
tags: school testing, san francisco
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xfile_type: NA
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summary_short: San Francisco Unified School District’s February 2021 RFP seeks an end-to-end vendor to run a 12–18 month asymptomatic COVID-19 testing program for students and staff, including registration/scheduling/results, staffing and site operations, lab testing, reporting, and billing. It specifies high-volume capacity (up to 1,000–5,000 tests/day initially, with targets up to 10,000–15,000 weekly), 24–48 hour turnaround goals, multilingual access, data integration with district systems, and compliance with HIPAA/FERPA and California reporting standards. The document also lays out the procurement timeline, minimum qualifications checklist, and proposal evaluation criteria for selecting one or more contractors.
CONTENT
San Francisco Unified School District RFP SFC 2021
***INTERNAL TITLE:*** END-TO-END COVID-19 STUDENT & STAFF ASYMPTOMATIC TESTING SERVICES
### Background
The San Francisco Unified School District (SFUSD) seeks to provide student and staff COVID-19 asymptomatic testing for the next 12-18 months to mitigate the spread of the disease and protect the health and safety of the SFUSD community.
To this end, SFUSD seeks a firm to integrate, assemble, and manage end-to-end testing of SFUSD students and staff. The asymptomatic testing program should have the operational flexibility to adapt to multiple testing contexts, populations, and advancements in science and technology. Critical COVID-19 end-to-end testing services include, but are not limited to, the following Scope of Work:
A. Project management, data management, and reporting
B. Registration, Scheduling, Resulting, Reporting
C. Staffing & On-Site Management of test sites
D. Other On-Site Logistics and Supplies
E. Lab Testing
F. Billing
### Anticipated Contract Term
The anticipated contract term for the contract resulting from this RFP is one (1) year, with the option to extend the contract for two (2) additional years. The actual contract term may vary but in no case would last longer than three (3) years. The contract term will depend upon service and project needs and will be at SFUSD's sole discretion. Contractor must be available to commence work on or before March 15, 2021.
### Anticipated Daily COVID-19 Testing Volume
On or before March 15, 2021, the selected end-to-end testing team should be capable of processing up to 1,000-5,000 COVID-19 tests per day, six days per week, at SFUSD sites and mobile units as needed.
Interested parties should follow the link to view and download the bid package:
https://www.sfusd.edu/partnering-sfusd/current-rfps-rfqs-rfos-rfis
Please look for the "RFP for End-to-End Covid-19 Aysmptomatic Testing Services" under "Current RFPs, RFQs, RFOs & RFIs". All related documents for this RFP will be posted here. Responses to the RFP must be received by the District's Purchasing Department, on or before the due date and time specified herein. Proposals received after the due date and time will be rejected.
- Proposals must be submitted electronically as attachments to the District's Director of Procurement at UdomA@sfusd.edu. The RFP number and the name must be included in the subject line of the email. Proposals submitted by any means other than as stipulated here will not be considered.
- Proposers are required to respond according to the instructions indicated in the RFP. Proposers shall respond utilizing the format, forms and other criteria indicated in the RFP. Proposals that do not comply with the format, forms and other instructions indicated, may be rejected.
- The District reserves the right to refuse any and all proposals, and to waive any irregularities or informalities in any proposal. To preserve the integrity of this RFP, the proposers are prohibited from contacting any individual associated with the District, including but not limited to employees and Board members, other than the individual listed herein. The District reserves the right to amend this RFP as necessary.
- All materials submitted to the District in response to this RFP shall remain the property of the District.
- The District shall not be responsible for the costs of preparing any proposal in response to the RFP.
| Schedule* | |
|-------|------|
| RFP Issued | 2.1.2021 |
| Deadline for RFP Questions | 2-8-2021 (1pm PT) |
| RFP Answers available online | 2-10-2021 (5pm PT) |
| Deadline for Email for Intent to Respond | 2-15-2021 (3pm PT) |
| **Deadline for RFP Proposals** | 2.22.2021 (5pm PT) |
| Notice of Intent to Award a Contract | **3.05.2021** |
| Asymptomatic Surveillance testing begins | 03.15.2021 |
||
### Terms and abbreviations used throughout this RFP include:
a. **Asymptomatic Testing** - Testing of individuals who are not exhibiting COVID 19-like symptoms. Asymptomatic testing can be used for surveillance or screening (described below).
b. **Asymptomatic Screening Testing** - Screening testing is indicated for situations associated with higher risk (higher community transmission, individuals at higher risk of transmission (e.g., adults and high school and usually occurs a cadence of every 2 weeks or less frequently, to understand whether schools have higher or lower rates of COVID19 rates than the community, to guide decisions about safety for schools and school administrators, and to inform LHDs about district level in-school rates.
c. **Asymptomatic Surveillance Testing** - Surveillance testing may include frequent regular testing of all staff and students at a regular cadence or periodic testing in a sample of staff or students, as guided by the California Department of Public Health, the San Francisco Department of Public Health, or other state or federal public health authority.
d. **CARES Act** – The Coronavirus Aid, Relief, and Economic Security Act of 2020.
e. **COVID-19** – The disease caused by the new coronavirus that is called SARS-CoV-2, or sometimes "novel coronavirus."
f. **FERPA** - The Family Educational Rights and Privacy Act
g. **Firm** – Any business entity including, but not limited to, companies, nonprofit organizations, educational institutions, and individuals.
h. **HCP** – licensed/certified and trained health care provider.
i. **HIPAA** – The Standards for Privacy of Individually Identifiable Health Information (Privacy Rule) establishes a set of national standards for the protection of certain health information. The U.S. Department of Health and Human Services issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
j. **Patients** - SFUSD staff and students
k. **PPE** – Personal protective equipment (PPE) refers to protective clothing, helmets, gloves, face shields, goggles, facemasks, and/or respirators or other equipment designed to protect the wearer from injury or the spread of infection or illness.
l. **Proposal** – A Proposer's written response submitted in response to this Request for Proposals. Also called a Response.
m. **Proposer** – Any entity and its subcontracted partners that submits a proposal to this Request for Proposals
n. **RFP** – This request for proposals
o. **San Francisco Unified School District or SFUSD** - The San Francisco Unified School District and its departments and divisions. Also called the District.
p. **State** – The State of California
q. **Vendor** – The Proposer(s) and its subconsultants awarded the contract for services under this RFP. Also called a Contractor.
## 1.2 Background of the San Francisco Unified School District
**What is the SFUSD?**
San Francisco Unified School District (SFUSD) is the seventh largest school district in California, educating over 57,000 students every year who speak more than 44 languages across 132 schools in San Francisco. We aim for every student who attends SFUSD schools to discover his or her spark, along with a strong sense of self and purpose, and that all students graduate from high school ready for college and career, and equipped with the skills, capacities and dispositions outlined in SFUSD's Graduate Profile. San Francisco is both a city and a county; therefore, SFUSD administers both the school district and the San Francisco County Office of Education (COE). This makes SFUSD a "single district county."
## 1.3 Statement of Need and Intent
**What Does SFUSD Seek?**
On January 14, 2021, the California Department of Public Health released its guidance on school testing titled [COVID-19 K-12 School Testing Considerations Information 1-14-21](https://www.cdph.ca.gov/Pages/PageNotFoundError.aspx?requestUrl=https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/COVID-19/K12_School_Testing_Considerations_Information.pdf). This release mandates School Districts to adopt a scalable COVID-19 testing program as part of their plans to return to in-person learning. Through this RFP, the District seeks to ensure the availability of accessible student and staff asymptomatic testing for two purposes 1) surveillance COVID-19 testing and 2) screening testing to mitigate the spread of the disease and to protect the health and safety of the SFUSD community. To this end, the District would like obtain one or more contracts with with a firm to integrate, assemble, staff and manage end-to-end testing for its testing program with the operational flexibility to adapt to multiple testing contexts, populations, changing technology, and fluctuating demand during this pandemic based on the Tier the county is in.
The Vendor shall manage all aspects of a comprehensive student and staff asymptomatic testing program for COVID-19, ensure that the solutions across all Work Threads are operationally-integrated, provide testing turnaround times that are between 24-48 hours, manage reporting needs and requests, and be the District's single point of contact for all testing issues under the scope of work. The Vendor must be able to handle high volumes of appointments across multiple collection site types (e.g., walk-through and/or drive-through stationary sites, mobile units). Daily collection volumes will vary by collection site and could range from 2,000-3,000 daily samples across all sites for a total of 10,000 to 15,000 weekly. The volume may decrease as CDPH and SFDPH guidance changes.
The Asymptomatic testing will begin March 15, 2021 and operate for 12-18 months from the start date. The vendor will work with the District to create an Asymptomatic testing calendar and scheduling that will be posted to SFUSD's website for staff to access. The volume of testing will vary based on the County Tier per the [California Department of Public Health](https://www.cdph.ca.gov/Programs/CID/DCDC/CDPH%20Document%20Library/COVID-19/Consolidated_Schools_Guidance.pdf) Consolidate Schools Framework:
- **Red and Purple Tier**: Every 2 weeks asymptomatic screening testing for 5,000 staff and 10,000 students. Bi-Weekly asymptomatic testing assumes the use of a PCR test. If antigen testing is used, testing should be at a twice weekly cadence.
- **Orange & Yellow Tier**: Asymptomatic screening testing per [SFPH school guidelines](https://www.sfdph.org/dph/alerts/covid-guidance/2020-33-Guidance-TK12-Schools.pdf): A sampling of students and staff, frequency to be determined by SFDPH.
Proposers may be a single firm or a partnership of the primary firm and its subcontractor(s) who are able to deliver a complete testing program comprising the Scope of Work described in Section 2.
## 2. Scope of Work
This scope of work is a general guide of the work the District expects to be performed and is not a complete listing of all services that may be required or desired.
### A. Project management, data management, and reporting
The District is seeking a complete, end-to-end, flexible solution for student and staff asymptomatic testing that can meet current and evolving City, State, and Federal guidelines and requirements. Specimen collection testing sites (sites) will vary by testing need and span across various SFUSD facility types and locations. To that end, all proposals must provide the following items which will ensure a cohesive and effective testing experience for the patient.
#### Project Management
1. Planning: project schedules, dependencies and project critical path, implementation plans, and development and management of a project plan with roles, dates, deliverables, milestones, and tasks clearly documented.
2. Project Teams and Subconsultant Management: data integration management, data flow diagrams, resources, technical/information system project components, and project manager coordination; clear roles and responsibilities for Vendor staff and District staff (where necessary); meeting facilitation; agenda development
3. Issue/Risk Management: identification and classification by impact and risk, status and resolution tracking, mitigation, and contingency plans for risks
4. Budget Management: status reports, risk identification, and mitigation
5. Communication: regular status reports detailing metrics and status of Key Performance Indicators as defined by the District.
6. Training and Change Management: development/provision of training resources for staff and families in the SFUSD identified languages, including written and video content; stakeholder engagement and change management strategies to prepare the SFUSD community of staff, families, and students for asymptomatic testing.
#### Data Management
The Vendor shall be required to cooperate, plan, implement, and update key testing data requirements, reporting, and transmission methods as determined by the District to ensure confidential integrated results and reporting within the end-to-end testing and notification process. The District is looking for a Vendor who can provide flexibility in defining and implementing custom data schemes and formats such as extensible mark-up language (XML), eLR standards, Ed-Fi standards, flat file formats, and Excel, as well as various data exchange methodologies with configurable frequency and content to include bi-directional secure file-transfer protocol (FTP), secure web services, APIs, and website data export.
The Vendor shall provide the District with a secure, automated format based on district requirements to extract any and all data fields identified by the District and establish the integration with District systems, in real-time or at a minimum on a nightly or daily scheduled basis. Priority District systems include:
- Return to School data management system powered by Smartsheets
- SFUSD dashboards hosted in Drupal and Tableau at sfusd.edu
- SFUSD operational data store
The Vendor shall provide, at the District's request and on an as-needed basis, secure direct access to and/or downloads of electronic data, documentation, and reporting in a usable format to integrate with District's Return to School data management system with Smartsheets; and will work with the District to ensure accurate data integration
The Vendor shall provide the District with its data structure.
- The data structure must include unique identifiers that can be associated with an individual student, such as Student ID and/or student email. Unique identifiers will be determined by SFUSD in consultation with the vendor.
- The structure must allow for district central staff to access data across testing site locations through a common entry point/portal; and be flexible so that specific, identified data elements can be shared across testing locations for ease of use, scheduling and registration.
All District data shall be stored on secure servers located within the continental United States.
#### Reporting functionality
Robust reporting functionality that encompasses and integrates data from all work streams described in Scope of Work and can be modified on an as-needed basis and integrated SFUSD's Return to School data management system powered by Smartsheets and accessible on SFUSD's district dashboards, when appropriate, hosted at sfusd.edu, a Drupal-based content management system.
1. Daily report on the number of SFUSD staff and students (patients) who did and did not complete their appointments by testing event (specimen collection site and/or population type)
2. Daily summary report of results and patient name and demographics by site location including individual line listed data set of students and staff tested with results, demographics, school, age, grade etc. will be provided to the SFDPH
3. Daily report of patients residing outside of San Francisco who completed appointments
4. Dashboard of testing statistics in aggregate by each location, updated no less than daily
5. Other ad-hoc reports as needed
### B. Registration, Scheduling, Resulting, Reporting
Vendor will create/enable an online patient registration, appointment scheduling, and results notification using a HIPAA-compliant and flexible framework, while adhering to applicable and evolving City, State, and Federal guidelines and requirements. The proposed solution should be user-friendly, have a consistent look and feel, preferably aligned with the District's websites, adhere to the District's [accessibility standards](https://www.sfgov.org/web-accessibility-standards-and-guidelines), be supported on a wide variety of operating systems (e.g., Android, iOS, Windows) and browsers (Chrome, Safari), and be mobile-friendly. Data collected will need to integrate between all Work Threads. Key specifications include but are not limited to the following:
1. **Registration**: This module shall allow for flexible updating of data captured as City, State, and Federal requirements may evolve. Initial data elements for the registration module must include all data fields required by the California Reportable Disease Information Exchange ([CalREDIE](https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/CalREDIE-ELR.aspx)) system and other state and federal reporting agencies and/or as deemed appropriate by the District, including but not limited to the patient' name, address, email, phone number, birthdate/age, sex, race/ethnicity, insurance coverage (if applicable), occupation, primary contacts' information, travel history, presenting symptoms, pre-existing conditions, healthcare provider/service facility, test results, etc. In addition, the registration module must also capture mandated reporting requirements per the CARES Act and State requirements as modified. Additional registration functionality may include but is not limited to the following:
a. Registration of minors and incorporation of parental approvals
b. Tracking of patients who are non-San Francisco residents and their county/city of residence
c. Inclusion of patients' primary contacts' information to assist in timely contact tracing for patients with a positive test result
d. Distinguishing between patient types (e.g., a District staff member versus a District student)
e. Minimal barriers to registration and user steps (such that patients without email addresses could register)
f. Data elements required for billing and claims management
g. Language translation into Arabic, Chinese, Samoan, Spanish, Tagalog, and Vietnamese
h. Data elements determined by SFUSD including SFUSD ID, SFUSD email, and other school-related demographics
2. **Scheduling**: This module must be able to schedule for multiple stationary sites and mobile unit locations on a daily basis. Additional scheduling functionality may include but is not limited to the following:
a. Automatic scheduling and push notification to students and staff to schedule their required asymptomatic test appointment every two weeks.
b. Status of appointment to ensure students and staff complete their required testing
c. Ability to schedule a test at any of the sites at district facilities.
d. Language translation into Arabic, Chinese, Samoan, Spanish, Tagalog, and Vietnamese
3. **Resulting**: This module must comply with Federal/FERPA, State and HIPAA clinical reporting requirements regarding the routing of lab test results by phone and by secure patient portal access. The solution shall support email and text notifications to the patient that results are available in HIPAA-compliant location (e.g., via patient portal, phone). The methods by which results are returned to the patient may change over time and may need to offer some flexibility depending on the population type and level of access to technology.
a. Both negative and positive results shall be accessible to the patient in their preferred language in a downloadable written record.
b. The District may also request the downloading and exporting of results to other assigned City entities as needed (e.g., City Department of Public Health (DPH) Contact Tracers, specimen collection sites, other DPH teams).
4. **Staffing of Call Center**: Registration functionality must include a patient help line and a fully staffed call center to support patient registration, scheduling, and resulting.
a. The call center shall be available during business hours of 8:00 am – 5:00 pm, seven days a week, including holidays.
b. The call center shall have the ability to register and schedule patients for tests.
c. The call center shall provide support to patients experiencing issues with using the Registration/Scheduling/Resulting module(s) and/or needing language assistance.
d. Language translation into Arabic, Chinese, Samoan, Spanish, Tagalog, and Vietnamese
### C. Staffing & On-Site Management of test sites:
- The Vendor shall provide appropriate licensed/certified and trained health care providers (HCPs) and will oversee staff coordination to perform clinical services associated with safe sample collection and cultural sensitivity. Specific health care services and on-site management may include but are not limited to the following:
- Specimen collection and oversight of self-collection methods, including specimen collection as appropriate for students at all ages, grade levels and abilities.
- Setup of stationary, mobile, outdoor, walk-through, and/or drive-through specimen collection sites. Rapidly-deployed sites would need to be set up within a maximum of seven days.
- Greeters to maximize patient flow and to separate out symptomatic patients to create a separate flow for them.
- On-site management, including the development and implementation of safety and security plans to enable the safe execution of specimen collection services and minimize risk exposure.
- Requisition and labeling of sample collection
- Language translation into Arabic, Chinese, Samoan, Spanish, Tagalog, and Vietnamese
- Registration Verification and Support: The Vendor shall verify completed appointment registration upon arrival and may need to provide registration assistance to walk-in patients who may not yet have an appointment. Vendor staff shall verify that all patient registration demographic data required by federal guidelines (e.g., patient age, sex, race, ethnicity, zip code) is successfully entered into the Registration module while maintaining HIPAA compliance. The Vendor will need to supply tablets/laptop stations and Wi-Fi to support onsite registration as needed. The Vendor shall ensure that the patient is successfully registered prior to specimen collection.
- Collection Methods: The Vendor may need to support various specimen collection methods by an appropriate HCP, such as performing nasal swabbing or overseeing patient self-swabbing. Collection methods may vary by testing site and change with evolving technology, and the City may request the Vendor to flexibly support multiple methods.
- Specimen Pick-Up: The Vendor shall ensure that completed specimens are handled, stored, and transferred to the desired lab locations in accordance with lab protocols and requirements.
- Patient Encounter Recording: The Vendor shall record patient encounters so that the District can develop rosters and reports of scheduled versus completed specimen collection of patients to identify staff and students who are not participating in asymptomatic testing schemes. The Vendor may be required to cooperate, plan, and implement key testing data requirements, reporting, and transmission methods as determined by the District to ensure integrated resulting and reporting as specified in Section 2.A - Data management.
### D. Other On-Site Logistics and Supplies:
The Vendor shall provide the following, as needed:
a. Personal Protective Equipment (PPE) for all staff and patients
- For staff: face coverings, face shields, disposable gloves
- For patients: Access to disposable face masks
b. Disinfectant and hand sanitizer
c. Site equipment, including, where needed, secure Wi-Fi, laptops/tablets, power generators (as needed), tents, cones, signage, traffic flow support, etc. (in multiple languages as needed)
- Contractor will be responsible for obtaining permits for gas-powered generators through the San Francisco Fire Department
d. Handwashing station(s)
e. Portable toilets for staff and patients
f. Janitorial services to provide ongoing cleaning and proper waste disposal at the site(s)
g. secure Wi-Fi for online systems
### E. Lab Testing
The objective of Lab Testing Scope of Work is to test and result patient specimen samples retrieved from specimen collection sites in a laboratory setting. The Vendor and/or its subconsultant(s) shall be CLIA-certified and licensed in California and shall follow CLIA regulations regarding collection, transportation, testing, and reporting. The Vendor shall provide the appropriate lab staffing, tools, materials, equipment, travel, and reporting to support efficient and effective testing while adhering to State and Federal guidelines and requirements.
COVID-19 test types, order volumes, and needed result turnaround times may vary by testing projects, by collection site, and/or as the testing technology evolves. SFUSD reserves the right to require new types of FDA-authorized confirmatory COVID-19 tests, after selection of the Vendor. Key lab testing services include but are not limited to the following:
1. **Test Kits and Transport to Lab**: The Vendor shall supply specimen collection kits (including suitable transport media) for specimen collection and courier specimen samples from collection sites to their lab on the same day of collection.
2. **Testing Volumes/Turnaround Times**: The Vendor shall have a proven ability to handle high volumes of tests across multiple concurrent orders with efficient turnaround times. Within one month after contract award, the selected end-to-end testing team should be capable of processing up to 5,000 COVID-19 tests per day, six days per week. Daily volumes may range from a few hundred to up to a several thousand tests by testing project and site. The Vendor shall support testing result turnaround times within ideally 24-48 hours, but no longer than four days for most sites, to support effective contact tracing and minimize COVID-19 spread.
3. **Lab Testing & Quality Assurance**: The Vendor shall, at the minimum, provide molecular, antigen, and/or genomic COVID-19 testing and shall statistically validate assays as needed for any changes to various collection methods (e.g., nasal swab, oral swab, saliva, for supervised or self-collection) and transport media. Certain testing projects and sites may require pooled testing or screening for populations with anticipated lower COVID-19 prevalence. Labs should retest "indeterminant" tests before asking for recollection.
Prior to awarding the contract, the winning proposer will be required to provide 20 test samples to the San Francisco Department of Public Health lab for results verification. Should DPH not deem validation appropriate, the Proposer may be rejected.
4. **Resulting & Reporting**: The Vendor shall comply with CLIA, State, Federal, HIPAA, and [eLR](https://www.cdc.gov/elr/about.html) clinical reporting requirements and send results to the ordering provider and the California Reportable Disease Information Exchange ([CalREDIE](https://www.cdph.ca.gov/Programs/CID/DCDC/Pages/CalREDIE-ELR.aspx)) system in a timely fashion. Results shall align with [SNOMED](https://confluence.ihtsdotools.org/display/snomed/SNOMED%2BCT%2BCOVID-19%2BRelated%2BContent) coding for ease of interpretation by DPH Epidemiology and Surveillance and other DPH staff. The District may request the i) routing of results to other assigned entities (e.g., stationary testing sites, congregate living facilities, DPH teams, or other counties) as allowable under HIPAA and health orders; and/or ii) the establishment of direct access to the results database for more real-time reporting. The Vendor may be required to cooperate, plan, and implement key testing data requirements, reporting, and transmission methods as determined by the District to ensure integrated resulting and reporting as specified in Section 2.I.B. Data management.
### F. Billing
The objective of the Billing Scope of Work is to have a billing agency/entity that can manage the medical claims processing, billing, follow-up, collection, etc. with commercial insurance and government payors (e.g., Medi-Cal/Medicaid/Medicare) for COVID-19 testing services provided through this RFP. These services may be performed directly by the Vendor and or its subconsultant(s) who rendered the reimbursable testing services. The Vendor and/or its subconsultant(s) shall manage claims for maximum collections in compliance with all commercial and government regulatory billing requirements, using a HIPAA-compliant framework, while adhering to applicable and evolving state and federal guidelines for reimbursement.
1. **Claims Processing**: The Vendor shall integrate appropriate patient and insurance data from the Registration module (See Work Thread #1 – Registration, Scheduling, and Resulting) to extract the required data elements for processing a "1500 Health Insurance Claim Form" (1500 Claim Form) and/or a 837P Electronic Claims file, as per the National Uniform Claim Committee (NUCC) guidelines. The Vendor shall perform the following claims management tasks:
a. Enrollment in Electronic Data Interchange (EDI) services to obtain a trading partner ID and to transmit and receive 837/835 files with payors
b. Electronic billing, including producing the 1500 Claim Form and "e-837-P File Form" and receipt of the Claim Acknowledgement (277 File)
c. Support of paper claim forms, as needed
d. Receipt of payment determinations or ingesting the "835 Payment File" which provides the claim adjudication (e.g., paid, denied)
e. Follow-up collection actions such as appeals to conventional insurance companies, Claim Information Forms (CIFs) to Medi-Cal/Medicaid payors and Medicare Claim Adjudication through the Medicare Direct Data Entry (DDE) system
f. Sending appeals and requested information, as applicable, to appeal non-payments, underpayments, and denials
g. Rebilling of claims upon discovery of insurance
h. Identification and tracking of payment by payor, including collecting proof of payment
2. **National Provider Index (NPI)**: The Vendor and/or its subconsultant(s) could maintain its own NPI as an independent agency.
3. **Payors**: The Vendor shall be knowledgeable in government and commercial medical claims processing, guidelines, and regulations for COVID-19 testing and otherwise, and may have significant experience with major commercial insurance providers in California (e.g., Anthem Blue Cross, United Healthcare, Aetna, Cigna, Kaiser), and government payors such as Medi-Cal, Medicaid, and Medicare.
4. **Current and Future Reimbursement Opportunities**: The Vendor shall be knowledgeable on all funding sources and claims procedures for COVID-19 testing available to providers and be able to submit claims for all COVID-19 testing reimbursement programs under:
a. The Families First Coronavirus Response Act (FFCRA) Relief Fund
b. The Public Health and Social Services Emergency Fund
c. The Paycheck Protection Program and Health Care Enhancement Act
d. The Coronavirus Aid, Relief, and Economic Security (CARES) Act; and
e. Any other Federal, State, or local program providing reimbursement to providers for COVID-19 testing
5. **Reporting**: The Vendor shall submit regular reports on the progress of their billing claims management as requested and defined by the District.
## 3. District-Proposer Communications
There will not be a Pre-Proposal Conference for this RFP. Proposers are specifically directed NOT to contact any employees or officials of the District other than those specifically designated in this RFP and its Attachments. Unauthorized contact may be cause for rejection of Proposals at the District's sole and absolute discretion.
### 3.1 Deadline for RFP Questions
Please email any questions to Albie Udom, Procurement Director at UdomA@sfusd.edu. No oral questions will be accepted. Questions, in accordance with the below schedule, must be in writing and received before the Deadline for RFP Questions. No questions will be accepted after this time except for those concerning District vendor compliance. All questions and inquiries should include the number and title of the RFP in the subject line of the email. Substantive replies will be memorialized in written addenda to be made part of this RFP. This RFP will only be governed by information provided through written addenda.
### 3.2 Summary of Information Requested and Presented
A summary of all addenda, questions, and answers pertaining to this RFP will be posted on the District's website indicated on the first page. It is the Proposers' responsibility to check this website for any updates. The District recommends that Proposers check the website for updates on a daily basis at a minimum.
### 3.3 Letter of Intent via Email Submission
Please email a Letter of Intent to Albie Udom, Procurement Director at UdomA@sfusd.edu. Letter of Intent must be in writing and received before the Deadline for Email for Intent to Respond, and should include the number and title of this RFP and Proposer's name.
### 3.4 District Communication Following Receipt of Proposals
The District may contact the Proposers for clarification or correction of minor errors or deficiencies in their Proposals prior to deeming a Proposal as non-responsive. Clarifications are "limited exchanges" between the District and a Proposer for the purpose of clarifying certain aspects of the Proposals and do not give a Proposer the opportunity to revise or modify its Proposal. Minor errors or deficiencies are defined as those that do not materially impact the District's evaluation of the Proposal. For information regarding the District's Evaluation Process, see RFP Section 5 – Evaluation Criteria.
## 4. Proposal Submission Requirements
### 4.1 Time and Place for Submission of Proposals
Late submissions will not be considered. Proposals and all related materials, including all CMD forms, must be received by Deadline for RFP Proposals. Proposals must be submitted electronically Via email to UdomA@sfusd.edu
### 4.2 Proposal Checklist
Complete, but concise Proposals, are recommended for ease of review by the Evaluation Team. Proposals should provide a straightforward, concise description of the Proposer's capabilities to satisfy the requirements of the RFP. Marketing and sales type information should be excluded. All parts, pages, figures, and tables should be numbered and clearly labeled.
For word processing documents, the department prefers that text be unjustified (i.e., with a ragged-right margin) and use a clear font (e.g., Arial), that pages have margins of at least 1" on all sides (excluding headers and footers) and that pages be numbered. Please include a Table of Contents.
Please note that there is a page limit of 20 pages including Letter of Introduction, Minimum Qualifications Checklist and Budget Template. If your firm submits more than 20 pages, only the first 20 pages will be evaluated.
### 4.3 Content
Firms interested in responding to this RFP must submit the following information:
1. Introductory Letter
2. Minimum Qualifications Checklist
3. Scope of Work Narrative Section. Click [here](https://docs.google.com/document/d/1xg-jue64zYQ_9_sIo4b6DCHvc2DPUSEQ6_GmbXHRC0M/copy) to make a copy and download the SOW Narrative
4. Cost Proposal. Click [here](https://docs.google.com/spreadsheets/d/17KgkbH1SIbO-vWv4m8XKQfUsbDljbKuFO8mOxhS1m5g/copy) to make a copy and download the COST proposal excel sheet
Proposals received under this RFP that fail to address each of the requested items in sufficient and complete detail to evidence that the Proposer meets the District's minimum qualifications will be deemed non-responsive and will not be evaluated. Note that Proposals stating, "to be provided upon request" or "to be determined" or the like, or that do not otherwise provide the information requested (left blank) are not acceptable and shall be deemed non-responsive.
### 4.4 Public Records
The California Public Records Act (California Government Code Section §6250 et. Seq) provides that public records shall be disclosed upon written request and that any citizen has a right to inspect any public record unless the document is exempted from disclosure. Said section defines a public record as any writing containing information relating to the conduct of the public business.
Proposers should be aware that all information submitted in response to this RFP is itself a public record except to the extent permissible by law, a Proposer's financial information. Additionally, any contract awarded under this RFP is a public record in its entirety.
Submission of any materials in response to this RFP, other than financial information clearly marked "CONFIDENTIAL" constitutes a waiver by the submitting party of any claim that the information is protected from disclosure. By submitting materials, (1) the submitting party is consenting to the release of such materials by the SFUSD if requested under the California Public Records Act without further notice to the submitting party (2) the submitting party agrees to indemnify and hold SFUSD harmless for release of such information.
## 5. Evaluation Criteria
This section describes the guidelines used for analyzing and evaluating the Proposals. Any Proposer(s) selected from this RFP are not guaranteed a contract. This RFP does not in any way limit the District's right to solicit contracts for similar or identical services if, in the District's sole and absolute discretion, it determines the RFP does not meet its needs. As in all contracts, the District reserves the right to accept other than the lowest price offer and reject all proposals that are not responsive to this request.
There are two phases to the evaluation process. District staff first performs an Initial Screening as described in Section 5.1. Proposals that pass the Initial Screening process (5.1) including Minimum Qualifications (5.2) will proceed to the Evaluation of Firms (that met Minimum Qualifications) described in Section 5.3.
District representatives will serve as the Evaluation Team responsible for evaluating the proposals, and the District reserves the right to include subject-matter experts from other public entities and institutions. Specifically, the team will be responsible for the evaluation and scoring of the Proposals, and for interviews, if desired by the District.
### 5.1 Initial Screening
The District will review each Proposal for initial determination on responsiveness and acceptability in an Initial Screening process. Elements reviewed during the Initial Screening include, without limitation: compliance with format requirements, Proposal completeness, compliance with Minimum Qualification requirements (Section 5.2), and inclusion of verifiable Past Project References (Section 5.3.1.C).
Proposals are not scored during the Initial Screening process. Initial Screening is a pass/fail determination as to whether a Proposal meets the threshold requirements described above. Any Proposal that does not demonstrate that Proposer meets requirements in Section 5.1 will not be eligible for consideration in the Evaluation of Firms (that met Minimum Qualifications) described below in Section 5.3. The District reserves the right to request clarification from the Proposer prior to rejecting a Proposal for failure to meet the Initial Screening requirements. Clarifications are "limited exchanges" between the District and a Proposer for the purpose of clarifying certain aspects of the Proposal and will not give a Proposer the opportunity to revise or modify its Proposal.
### 5.2 Minimum Qualifications Checklist
Proposer must check each below requirement either as "Yes" or "No." An answer of "No" will result in failure to meet the Minimum Qualifications. To download a copy of the Minimum Qualifications Document click [here](https://docs.google.com/document/d/1lWb-eQ3lt3eCIWh6YNJ9mKjFmkC4flhrcqu_CGzbFLQ/copy)
| Minimum Qualifications | Yes | No |
|------------------------|-----|-----|
| **Project Management, Data Management, and Reporting** |||
| Will the Proposer provide an end-to-end, flexible solution for student and staff surveillance testing that can meet current and evolving City, State, and Federal guidelines and requirements. | □ | □ |
| Will the Proposer's data structure include unique identifiers that can be associated with an individual student, such as Student ID and/or student email. Unique identifiers will be determined by SFUSD in consultation with the vendor ? | □ | □ |
| Will the Proposer's data structure allow for district central staff to access data across testing site locations through a common entry point/portal; and be flexible so that specific, identified data elements can be shared across testing locations for ease of use, scheduling and registration? | □ | □ |
| Will the Proposer's reporting functionality encompasses and integrates data from all work streams described in Scope of Work which can be modified on an as-needed basis and integrated SFUSD's Return to School data management system powered by Smartsheets and accessible on SFUSD's district dashboards, when appropriate, hosted at sfusd.edu, a Drupal-based content management system? | □ | □ |
| **Registration, Scheduling, Resulting, Reporting** |||
| Will the Proposer and its team possess the licenses, certifications, and/or permits necessary to perform the services specified registration, scheduling, resulting and reporting as required by the laws of the United States and the State of California by the start of the contract? | □ | □ |
| **Staffing & On-Site Management of test sites** |||
| Will the Proposer have the staffing and resources to provide multilingual services for on site management of test sites? | □ | □ |
| **Other On-Site Logistics and Supplies** |||
| Will the proposer have the resources to stand up test sites including provide secure internet and staffing resources for set up and storing as needed? | □ | □ |
| **Lab Testing** |||
| Will the Proposer or all proposed subcontractors lab(s) be CLIA-certified by the proposal due date? Please provide the license/certification ID number or a copy of the certificate/license if already certified. If this certification is in progress, please so indicate and provide evidence that the certification will be obtained by the proposal due date. | □ | □ |
| If the Proposer or any proposed subcontractors is an out-of-state lab, will it be licensed by the California Laboratory Field Services (CA LFS) by the proposal due date? Please provide the license/certification ID number or a copy of the certificate/license if already licensed. If this license is in progress, please so indicate and provide evidence that license will be obtained by the proposal due date. | □ | □ |
| Can the Proposer or its subcontracted lab(s) provide molecular, antigen and/or genomic COVID-19 testing that is FDA approved for asymptomatic screening and surveillance? | □ | □ |
| **Billing** |||
| Will the Proposer's solution support billing and claims management so that employees do not have to pay out of pocket? | □ | □ |
||
### 5.3 Proposal Evaluation Criteria (100 points)
#### Evaluation Team
District representatives, along with potential subject matter experts from other public entities and institutions, will serve as the Evaluation Team responsible for evaluating Proposers. Specifically, the team will be responsible for the evaluation and rating of the Proposals, conducting reference checks, and conducting interviews, if desired by the District.
Each RFP Proposal that meets the Minimum Qualifications will be evaluated in accordance with the criteria below.
#### 5.3.1 Proposer Team Structure and Qualifications – 10 points
**Proposer Team Structure and Qualifications**
- Describe how the Proposer's qualifications can successfully fulfill the objectives and services in the Scope of Work.
- Describe the Proposer's team structure and partnerships with any proposed subconsultant(s). Please describe the project management structure and resourcing.
- Describe no more than two of the Proposer's past projects, experience, and success applicable to the Scope of Work. Discuss how the past project(s) are relevant (e.g., in scale, breadth of scope, subject matter) to this RFP. Provide a reference for each past project discussed.
#### 5.3.2 Approach - 70 points
**Project Management, Data Management, and Reporting - 10 points**
- Describe the Proposer's services and deliverables that meet and/or exceed the Scope of Work. Explain any special resources, procedures, and/or approaches that make your services particularly advantageous for the District.
- How will the Proposer ensure that the solutions and data across the tasks in the Scope of Work are operationally integrated, and testing turnaround times are as efficient as possible?
- How would the Proposer secure, make accessible and/or integrate data across the Scope of Work areas? What standards and APIs does the Proposer employ?
- Describe the Proposer's reporting capabilities and ability to flexibly support updates based on changing needs (e.g., changing logic, new data fields).
- Briefly describe the Proposer's plan and timeline for the implementation of services.
**Registration, Scheduling, Resulting and Reporting - 10 points**
- Describe the Proposer's services and deliverables that meet and/or exceed the Scope of Work for this RFP.
- How would the Proposer support a call center, language translation, and other culturally-sensitive services?
- What is the Proposer's approach to user design/experience?
- How would the Proposer collaborate and/or partner with community based organizations that may partner with SFUSD to support Asymptomatic testing services.
**Staffing & On-Site Management of test sites - 10 points**
- Describe the Proposer's ability to manage and execute specimen collection testing sites that may vary in size, population, and/or context (e.g., stationary, mobile, drive-through, walk-through).
- Describe the Proposer's testing site process details and team staffing for a site collection project and how that may vary by testing context.
- Describe the Proposer's experience and/or approach to testing students of all ages and abilities from pre-K to high school
- Describe the Proposer's capacity to flexibly implement rapidly-deployed mobile units and other stationary sites.
- Describe the Proposer's ability to support various types of sample collection (e.g., nasal swabbing or patient self-swabbing) and evolving technology. Please indicate the type(s) the Proposer currently supports.
- Describe how the Proposer's staff can support language translation and other culturally-sensitive services.
**Other On-Site Logistics and Supplies - 10 points**
- Describe the Proposer's ability to stand up test sites including provide secure internet and staffing resources for set up and storing as needed?
**Lab Testing - 15 points**
- Where is the Proposer's testing lab located? Describe the proposed handling process for specimens collected in San Francisco from collection to testing and resulting.
- Identify which type(s) of COVID-19 testing the Proposer conducts (e.g., molecular, antigen, antibody).
- Describe the Proposer's ability to adapt to new COVID-19 testing methods.
- Please specify whether the Proposer can support pooled testing and/or screening.
- Identify the Proposer's daily lab capacity/throughput after one month after contract award (at a fuller capacity).
- Identify the Proposer's typical result turnaround times range and any guarantees.
- Describe the assays the Proposer is running and their sensitivity. Please provide the Proposer's standard operating procedures for your COVID-19 assays.
- Describe how the Proposer will transport specimens collected at SFUSD sites.
- For the proposer and any subcontractor(s), provide the CLIA-certified license/certification ID number or a copy of the certificate/license if already certified. If this certification is in progress, please so indicate and provide evidence that the certification will be obtained by the proposal due date.
- For the proposer and any subcontractor(s) who are out of State, provide the California Laboratory Field Services (CA LFS) license/certification ID number or a copy of the certificate/license if already certified. If this certification is in progress, please so indicate and provide evidence that the certification will be obtained by the proposal due date.
**Billing - 15 points**
- Indicate the Proposer's level of experience performing medical billing, accounts receivable management, and collection services.
- Describe the Proposer's approach to perform and/or support billing and claims management?
- What is the Proposer's approach with Electronic Data Interchange EDI processes, and does the Proposer have these processes in place?
- Describe how the Proposer would flexibly adhere to evolving federal and state COVID-19 guidelines for claims management.
- Describe how the Proposer would ensure sufficient information is collected from patients being tested to maximize successful insurance billing while maintaining an open testing site for the uninsured.
**Completeness of Proposal Submitted- 5 points**
- Proposal conforms with RFP requirements and concisely but comprehensively addresses RFP requirements within the page limits.
- Proposal is professionally presented and contains organized content and format.
#### 5.3.3 Cost – 15 points
For the purposes of this RFP, develop TOTAL cost proposal combining Part 1A and 1B below:
Part 1A: all-inclusive cost per COVID-19 test for:
- One (1) or more stationary specimen collection District-directed testing sites with walk-through and drive-through capacity and a combined average daily volume of 2,500 tests; and
- One (1) mobile specimen collection unit with walk-through capacity with an average daily volume of 250 tests
For this portion of the cost proposal, costs for use of District directed sites (e.g., leases and permitting) will be covered by the District and should not be included here. Include total start-up costs for the services and supplies outlined in the Scope of Work in RFP as well as monthly cost. The monthly cost should be based on testing operations that would run for one year, six days a week, 6 hours per day. This will be considered the "Base Cost Proposal – Part 1A."
Part 1B: Billing and anticipated billing reimbursements.
Provide a Billing cost structure and proposal that addresses the costs for services included in Scope of Work. Please identify your billing costs, whether you would propose an offset to the per COVID-19 test cost in Part 1A with the reimbursement to the Proposer or reimbursement directly back to the District, and your assumed rate of return (e.g., % of claims accepted within a certain amount of months).
For the purposes of preparing this proposal, Proposers should factor in that approximately 75% of staff surveillance tests administered are for patients with medical insurance and 50% of student surveillance tests are for patients with medical insurance. When considering claim acceptance rates, proposers should project that current federal and state regulations regarding COVID-19 testing remain in place for the duration of the contract.
Part 1A and Part 1B costs will be combined to develop one final cumulative total Total Cost Proposal."
The firm with the lowest pricing across Part 1A and Part 1B will receive all 15 points. Points will be assigned to all other proposals by dividing the lowest "Base Cost Proposal" (for Part 1A and Part 1B) by the other proposal(s) cost and multiplying by 15 points.
Oral Interviews (Optional)
As noted earlier, the District at its sole discretion may decide to conduct interviews as part of this RFP process. If the District decides to conduct oral interviews, the Proposers that met the Minimum Qualifications will be invited to attend the interview before the Evaluation Team. The interview will consist of an oral presentation by the proposer followed by questions and answers. The maximum points possible for the oral interview is 100.
Final Score and Ranking
At the conclusion of the interview (if held), the points awarded for interviews will be combined with the points awarded at the Proposal Evaluation phase to reach a final score for each Proposer. The scores are then ranked from the highest to the lowest.
Reference Checks
Reference checks, including but not limited to prior clients as indicated in SOW Narrative– Prior Project References, may be used to determine the applicability of Proposer experience to the services the District is requesting, the quality of services and staffing provided to prior clients, adherence to schedules/budgets and Proposer's problem-solving, project management and communication abilities, performance on deliverables and outcomes, and effectiveness in meeting or exceeding project objectives. If reference checks deem that information included in a Prior Project References or elsewhere in the Proposal is untruthful, then the District will reject the Proposal.
Release and Waiver Agreement
To effectuate the candid completion of the reference check above, Proposer is required to sign the RFP Attachment I, Section 14, Release of Liability.
### 5.4 Other Terms and Conditions
The selection of any prequalified Proposer for contract negotiations shall not imply acceptance by the District of all terms of the Proposal, which may be subject to further negotiation and approvals before the District may be legally bound thereby.
The District will select the most qualified and responsive Proposer with whom District staff will commence contract negotiations. If a satisfactory contract cannot be negotiated in a reasonable time with the selected Proposer, then the District, in its sole discretion, may terminate negotiations and begin contract negotiations with the next highest scoring Proposer it deems qualified.
The District, in its sole discretion, has the right to approve or disapprove any staff person assigned to a firm's projects before and throughout the contract term. The District reserves the right at any time to approve, disapprove or modify proposed project plans, timelines and deliverables. Such approvals will not be unreasonably withheld.
## 6. Protest Procedures
### 6.1 Protest of RFP Terms
Should a proposer object on any ground to any provision or legal requirement set forth in this RFP, the proposer must, not less than 72 hours prior to the RFP deadline, provide written notice to the District via email to UdomA@sfusd.edu setting forth with specificity the grounds for the objection. The failure of a proposer to object in the manner set forth in this paragraph shall constitute a complete and irrevocable waiver of any such objection.
### 6.2 Protest of Non-Responsiveness Determination
Within five working days of the District's issuance of a notice of non-responsiveness, any firm that has submitted a proposal and believes that the District has incorrectly determined that its proposal is non-responsive may submit a written notice of protest. Such notice of protest must be received by the District on or before the fifth working day following the District's issuance of the notice of non-responsiveness. The notice of protest must include a written statement specifying in detail each and every one of the grounds asserted for the protest. The protest must be signed by an individual authorized to represent the proposer, and must cite the law, rule, local ordinance, procedure or RFP provision on which the protest is based. In addition, the protestor must specify facts and evidence sufficient for the District to determine the validity of the protest.
### 6.3 Protest of Contract Award
Within five working days of the District's issuance of a notice of intent to award the contract, any firm that has submitted a responsive proposal and believes that the District has incorrectly selected another proposer for award may submit a written notice of protest. Such notice of protest must be received by the District on or before the fifth working day after the District's issuance of the notice of intent to award. The notice of protest must include a written statement specifying in detail each and every one of the grounds asserted for the protest. The protest must be signed by an individual authorized to represent the proposer, and must cite the law, rule, local ordinance, procedure or RFP provision on which the protest is based. In addition, the protestor must specify facts and evidence sufficient for the District to determine the validity of the protest.
### 6.4 Delivery of Protests
All protests must be received by the specified dates and time deadlines specified in Section 6.1, 6.2 and 6.3. Protests or notice of protests made orally (e.g., by telephone) or by fax will not be considered.
Protests must be delivered via:
Email: UdomA@sfusd.edu
### 6.5 Protest Review
The District's Purchasing Department will confirm receipt of notice of protest by Proposer which must be submitted in accordance to Section 6.1, 6.2, 6.3, and 6.4.
If a Proposer submits a complete and timely protest, the Purchasing Department will review notice of protest soon after receipt of the protest to determine validity of notice, including but not limited to: i) receipt by due date; ii) inclusion of a written statement specifying in detail each and every one of the grounds asserted for the protest; iii) signed by an individual authorized to represent the Proposer; iv) citation of the law, rule, local ordinance, procedure, or RFP provision on which the protest is based; and v) specification of facts and evidence sufficient for the District to determine the validity of the protest.
A Proposer may not rely on a Protest submitted by another Proposer but must timely pursue its own Protest.
The District, at its discretion, may make a determination regarding a protest without requesting further documents or information from the Proposer who submitted the protest. Accordingly, the initial protest must include all grounds of protest and all supporting documentation or evidence reasonably available to the prospective Proposer at the time the protest is submitted. If the Proposer later raises new grounds or evidence that were not included in the initial protest, but which could have been raised at that time, then the District may not consider such new grounds or new evidence.
If the notice of protest is determined to be valid, the Purchasing Department shall review facts and evidence to determine the outcome of the protest, citing any applicable laws, rules, ordinances, procedures, and/or provisions. The review shall be an informal process conducted by the Purchasing Department or its designee, and will be based upon the information submitted by the Proposer in its protest letter. The Purchasing Department may seek input from the District's Legal Office, and/or other District departments as needed or appropriate. The Controller's Office will notify the Proposer in writing of its decision at the conclusion of the review. The Purchasing Department or its designee shall make the final determination regarding the outcome of the protest. The decision of the Purchasing Department is final.
# 1,517 2021-02-11_School Testing_San Francisco Unified School District - RFP Questions and Answers Document.md
METADATA
last updated: 2026-03-06 by BA
file_name: 2021-02-11_School Testing_San Francisco Unified School District - RFP Questions and Answers Document.md
file_date: 2021-02-11
title: San Francisco Unified School District - RFP Questions and Answers Document (Feb 2021)
category: various
subcategory: external-programs-reports
tags: school testing, san francisco
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summary_short: San Francisco Unified School District’s February 11, 2021 Q&A addendum clarifies expectations for its RFP for end-to-end student and staff asymptomatic COVID-19 testing services. It confirms the selected vendor must deliver the full stack (data systems, call center, onsite operations, hardware/Wi-Fi, and an identified certified lab partner) and operate testing Monday–Saturday, with multilingual interpretation available via a language vendor. The responses also address testing methodology (PCR required for screening unless antigen is twice-weekly), note BinaxNOW availability subject to inventory, and reiterate that SFUSD will not split scope across multiple contracts or deviate from the stated evaluation criteria.
CONTENT
San Francisco Unified School District
***INTERNAL TITLE:*** RFP for End-to-End Covid-19 Student and Staff Asymptomatic Testing Services
Reply to Questions Received Through February 8, 2021 at 5:00 P.M. (PST)
**Date:** February 11, 2021
**To:** All Prospective Respondents
**From:** Albie Udom, Director of Procurement
This notice responds to the questions received by the San Francisco Unified School District regarding the RFP for End-to-End Covid-19 Student and Staff Asymptomatic Testing Services.
---
**Question 1:** Are we expected to provide everything from database, to laboratory subcontracting etc.
**Answer 1:** Yes, the winning proposer would be expected to provide everything from database, to laboratory subcontracting etc.
---
**Question 2:** Lab testing is there a specific lab the tests are being sent to?
**Answer 2:** If this is related to the tests that are completed at the test sites, the answer is that the vendor is to identify the lab that they are sending the tests to for analysis.
---
**Question 3:** 6 days per week, Is it Mondays-Saturdays?
**Answer 3:** The winning proposer would be expected to provide testing six days a week from Monday to Saturday.
---
**Question 4:** How would the Proposer secure, make accessible and/or integrate data across the Scope of Work areas? What standards and APIs does the Proposer employ? (are they expecting us to have a database system or are we logging on to something that has already been created for the project?)
**Answer 4:** There is not a single data management system but rather multiple data systems that the Proposer will need to integrate with. The proposer will need to develop the APIs, or leverage existing APIs, to support the integration of data across the Scope of Work areas. System integrations include:
- Smartsheets for tracking and monitoring contact tracing. Smartsheets provides a data uploader that the Proposer will need to integrate with.
- CA state surveillance system in compliance with its requirements
- SFDPH
---
**Question 5:** Will the Proposer and all proposed subcontractors lab(s) be CLIA-certified by the proposal due date? (is this just for the lab, do we need to have a lab partnership prior to the proposal or are labs applying as well)
**Answer 5:** The request is for end-to-end testing services which includes a partnership with an identified laboratory. It is preferred that the proposer has identified a lab that already has the required certifications (CLIA, CMS, CDPH).
---
**Question 6:** Registration /staffing onsite management: Language translation into Arabic, Chinese, Samoan, Spanish, Tagalog, and Vietnamese (is this in the database system or do we have to have the interpreters at the site or through a language vendor)
**Answer 6:** This can be achieved through a language vendor. The contractor may not need all those languages available at the testing sites but must be able to connect with an interpreter as needed either by telephone or in person.
---
**Question 7:** Staffing or call center 7 days a week (8-5) including holidays- (is this staffed by us or does the city have this vendor)
**Answer 7:** The request is for end-to-end testing services. The winning proposer would have to provide and staff a call center.
---
**Question 8:** Will the vendor need to supply tablets/laptop stations and Wi-Fi to support onsite registration as needed?
**Answer 8:** Yes. SFUSD will not provide technology hardware or support for the testing at sites. By providing its own hardware and WiFi, the contractor can guarantee that their platform is compatible with the required technology and provide the necessary support.
---
**Question 9:** Would SFUSD be open to awarding contracts for "Staffing Only" proposals that would meet the staffing needs of this RFP but not the lab-specific requirements?
**Answer 9:** The request is for end-to-end testing services from one firm with or without subcontractors. SFUSD will award only one contract for the services. SFUSD does not intend to award different contracts for different parts of the scope of work.
---
**Question 10:** Asymptomatic COVID-19 screening via PCR presents several issues: turnaround time means infected individuals continue to spread while awaiting results, and an individual's PCR result may remain positive long after the individual is no longer infectious. Will rapid antigen surveillance testing be given preference over PCR in order to avoid these issues?
**Answer 10:** Antigen testing will not be preferred over PCR as this is an FDA off-label use of antigen tests. For asymptomatic screening testing, the test must be PCR or it can be antigen testing if it is done on a twice weekly cadence. The lower sensitivity of antigen testing is mitigated by frequent testing (i.e., to not miss the early period of infectiousness). The proposer may indicate the testing algorithms they intend to use (e.g., confirmation of antigen with PCR, cadence, using the Ct values,) the reviewers can evaluate.
---
**Question 11:** What is SFUSD's plan for staff and teachers presenting cold or flu-like symptoms in order to rule out COVID-19 infection? Lost time for symptomatic teachers, staff and students is an issue already faced by opened schools. It typically takes 2-4 days for a PCR test to confirm a COVID-19 negative result which could mean the loss of a week of in person school.
**Answer 11:** Please refer to information in the RFP regarding Asymptomatic Testing.
---
**Question 12:** In the case of staffing shortage due to quarantine or illness of teachers or staff, what is SFUSD's plan for rapidly clearing substitutes to safely enter school buildings?
**Answer 12:** Please refer to the information in the RFP regarding Asymptomatic Testing.
---
**Question 13:** Will SFDPH distribute BinaxNOW rapid tests to schools? These tests have proven highly effective in community testing programs here in San Francisco.
**Answer 13:** Yes, subject to inventory levels and compliance with requirements.
---
**Question 14:** Can you provide a specific breakdown of testing numbers and roll out timing for (a) teachers/staff, (b) middle school, (c) high school, (d) elementary school, (e) special education and/or non-age specific groups?
**Answer 14:** Please use the information in the RFP which reflects the information we have currently.
---
**Question 15:** What is the district's budget for the initial term of the contract (first 12 months)?
**Answer 15:** This District will not provide this information at this time because it does not consider this information essential for a proposer to submit their proposal.
---
**Question 16:** We would be proposing a solution that would fulfill the intent of this RFP and not impact surrounding neighborhoods and district property, however, we would be unable to answer 'Yes' to all of the initial evaluation criteria. The instructions clearly state that if we answer 'no' to any of the evaluation criteria, we will be automatically disqualified. How should we go about submitting an alternative proposal?
**Answer 16:** The District will not deviate from the evaluation criteria stated in the RFP.
---
# 4,189 2021-06-31_Testing Commons - ASU and Rockefeller.md
METADATA
last updated: 2026-03-06 by BA
file_name: 2021-06-31_Testing Commons - ASU and Rockefeller.md
file_date: 2021-06-31
title: 2021-06-31_Testing Commons - ASU and Rockefeller
category: various
subcategory: external-programs-reports
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notes:
summary_short: The TestingCommons.com Pandemic Review is a slide-style overview from Arizona State University’s COVID Diagnostics Commons that summarizes global COVID-19 tests and regulatory statuses, including U.S. FDA EUA categories and key attributes (lab/POC/home, screening, serial screening, pooling). It compiles pandemic-era counts and charts (through 6/30/21) showing distributions by test type and technology, plus related safety actions and communications.
CONTENT
## Slide 1: COVID-19 Testing Commons
**TestingCommons.com**
A one-stop reliable source for comprehensive information about COVID-19 tests worldwide. Search all tests in the market and in the pipeline by multiple parameters including test type, technology, regulatory status, country of origin and more.
TestingCommons.com, part of COVID Diagnostics Commons initiative at Arizona State University's College of Health Solutions Testing Commons is made possible with support from The Rockefeller Foundation
## Slide 2: TestingCommons.com Pandemic Review
_horizontal bar chart showing count (x-axis) by test/authorization status category (y-axis), including FDA EUA, LDT, CE-IVD, Research Use Only, Development, and FDA Revoked._
FDA EUA - Molecular, Antigen, Serology, & T-Cell Tests, Patient Management, Combination Respiratory Panels, and Collection Kits
LDT - Schedule IV notifications & Umbrella Molecular EUAs¹
CE-IVD - EU self-certification
Research Use Only - Authorized by government jurisdiction in country outside of US/EU
Development - Tests & Technologies publicly announced to be under development
FDA Revoked - Revoked, Rejected, Withdrawn, Warning letter, Fraud (DOJ)
1. nla after 10/7/20 when HHS/FDA announced policy to not require authorization for any LDT
2. 19% of tests with approval internationally have been granted EUA by the US FDA
Pandemic Total through 6/30/2021
## Slide 3: US FDA EUA Test Classifications
* Tests:
* Molecular Tests (including Appendix A LDTS and Flu panels)
* Antigen Tests (including Flu panels)
* Patient Management Tests (IL6)
* Serology (Antibody) Tests (including cellular immunity)
* Collection Kits
* Home Collection Kits (Nasal Swabs or Saliva)
* Test Attributes:
* Test Location (Lab VS. POC VS. Home)
* Screening (Asymptomatic)
* Serial Screening
* Pooling
* OTC VS Prescription
## Slide 4: US FDA Emergency Use Authorizations
_bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_
Molecular
- 88% RTqPCR
- 9% Isothermal
- 3% Sequencing
- 1% CRISPR
Antigen
- 88% Lateral Flow
- 8% Chemiluminescence
- 4% other
Antibody
- 60% ELISA
- 31% Lateral Flow
- 6% Chemiluminescence
Other
- Collection Kits
- Flu/RSV Panels
- Patient Management
Pandemic Total through 6/30/2021
## Slide 5: Timeline of EUA Issuances and Amendments
_stacked bar chart showing month (x-axis) versus number of tests (y-axis), broken down by Molecular, Antigen, Antibody, Flu/RSV, and Collection Kit._
## Slide 6: Profile of US FDA - EUA's
Lab Authorized to Analyze Sample
_bar chart showing lab authorization type (x-axis) versus number of tests (y-axis) for labs authorized to analyze samples (CLIA high/moderate complexity, CLIA waived/POC, self test)_
Sample Type Collected(1)
_bar chart showing sample type collected (x-axis) versus number of tests (y-axis) (anterior nasal swab, nasopharyngeal swab, saliva, venous blood, fingerstick blood)_
Person to Collect Sample(2)
_bar chart showing sample collector (x-axis) versus number of tests (y-axis) (healthcare/trained tech vs self)_
1. Only a single Swab type per test counted here, in least to most invasive priority order: Saliva; ANS; lastly NPS/OPS. All PCR tests are sensitive enough to work with nearly all of these swab types: later authorizations: specify ANS in addition to
other swab methods.
2. No specific Healthcare Professional training is required by the EUA (at Laboratory discretion)
## Slide 7: 11 EUA's for Comprehensive At-Home Tests
| | Molecular Tests (3) | Antigen Tests (8) |
| ------------- | -------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| RX Tests (4) | • Lucira COVID-19 All-In-One Test Kit | • Abbott BinaxNOW COVID-19 Ag Card Home Test
• OraSure InteliSwab COVID-19 Rapid Test Rx
• Quidel QuickVue At-Home OTC COVID-19 Test |
| OTC Tests (7) | • Cue COVID-19 Test for Home and Over The Counter (OTC) Use
• Lucira CHECK-IT COVID-19 Test Kit | • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test
• Abbott BinaxNOW COVID-19 Antigen Self Test
• Ellume COVID-19 Home Test
• OraSure InteliSwab COVID-19 Rapid Test
• Quidel QuickVue At-Home OTC COVID-19 Test |
||
Pandemic Total through 6/30/2021
## Slide 8: EUA's for Asymptomatic Screening & Serial Screening
A. PROPOSED INTENDED USE
FDA recommends including the following in the requested intended use:
[...individuals without symptoms or other epidemiological reasons to suspect COVID-19
infection, when tested twice over two (or three) days with at least 24 hours (and no more than
36 hours) between tests.]
Collection Kit, 10 <-- *3 saliva
Antigen Home, 1
Molecular Home, 2
Molecular POC, 36 <-- *4 saliva
Screening (49)
Antigen Home, 5
Antigen POC, 6
Molecular POC, 3 <-- *1 saliva
Serial Screening (14)
## Slide 9: 28 Antigen Tests with EUAS
| | CLIA High/Moderate (Laboratory) | CLIA Waived (Physician Office) | Home |
| --------------- | ----------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Instrument read | Celltrion Sampinute
DiaSorin LIAISON
Ortho VITROS
Qorvo Omnia
Quanterix Simoa | BD Veritor
BD Veritor + Flu A/B
Luminostics Clip
LumiraDx
Quidel Sofia FIA
Quidel Sofia2+Flu | Ellume OTC |
| Visual read | | Access Bio CareStart
BinaxNOW Card
BinaxNOW 2 Card
Celltrion DiaTrust
InBios SCoV-2
OraSure InteliSwab Pro
Princeton Status+Flu
Salofa Sienna-Clarity
Quidel QuickVue | BinaxNOW Home Rx
BinaxNOW Self OTC
BinaxNOW Telehealth
OraSure InteliSwab RX
OraSure InteliSwab OTC
Quidel QuickVue Rx
Quidel QuickVue OTC |
||
Pandemic Total through 6/30/2021
## Slide 10: 18 EUA's for Respiratory Panels (Flu, RSV, etc.)
_bar chart showing test type (x-axis) versus number of tests (y-axis), comparing Molecular and Antigen tests_
Molecular (15)
- 67% Lab
- 33% POC
Antigen (3)
- 100% POC
Pandemic Total through 6/30/2021
## Slide 11: 18 EUA's for Respiratory Panels (Flu, RSV, etc.)
Molecular Respiratory Combination Tests (15)
•Abbott Alinity m Resp-4-Plex
•BD for BD MAX system
•BioFire Diagnostics Respiratory Panel 2.1 EZ
•Bio-Rad Reliance
•CDC Flu C2 Multiplex Assay
•Cepheid Xpert Xpress
•GenMark ePlex Respiratory Pathogen Panel 2
•Hologic Aptima
•Luminex NxTAG Respiratory Pathogen Panel + SARS-CoV-2
•NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay
•QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel
•Quest RC COVID-19+Flu RT-PCR
•Roche cobas
•Roche cobas for use with Liat system
•Thermo Fisher TaqPath
Antigen Respiratory Combination Tests (3)
•BD Veritor System for Rapid Detection of
SARS-CoV-2 & Flu A+B
•Princeton BioMeditech Corp. Status
COVID-19/Flu
•Quidel Sofia 2 Flu + SARS Antigen FIA
Pandemic Total through 6/30/2021
## Slide 12: 28 EUA’s for Testing of Pooled Samples
| Pool size | Tests |
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 2 (1 Test) | BayCare [SARS-CoV-2 RT PCR Assay] |
| 4 (2 Tests) | CDC [RT-PCR Diagnostic Panel]
Quest [SARS-CoV-2 rRT-PCR] |
| 5 (15 Tests) | Abbott [Alinity m SARS-CoV-2 assay]
Amazon DTC [Real-Time RT-PCR Test for Detecting SARS-CoV-2]
Amazon [Real-Time RT-PCR Test for Detecting SARS-CoV-2]
Applied BioCode [SARS-CoV-2 Assay]
Enzo [AMPIPROBE SARS-CoV-2 Test System]
Hologic [Aptima SARS-CoV-2 assay]
Hologic [Panther Fusion SARS-CoV-2 Assay]
Labcorp [COVID-19 RT-PCR Test]
Labcorp [Pixel Home Collection Kit]
OPTI [Sars-CoV-2 RT-PCR Test]
PerkinElmer [New COVID Nucleic Acid Detection Kit]
SML GENETREE [Ezplex SARS-CoV-2 G Kit]
Thermo Fisher TaqPath
UCSD [RC SARS-CoV-2 Assay]
Viracor Eurofins [SARS-CoV-2 assay] |
| 6 (2 Tests) | Quest [RC SARS-CoV-2 Assay]
Roche [cobas SARS-CoV-2] |
| 7 (1 Test) | Poplar [TMA Pooling assay] |
| 8 (2 Tests) | BioFire [COVID-19 Test]
Cepheid [Xpert Xpress SARS-CoV-2] |
| 12 (2 Tests) | Quadrant Biosciences [Clarifi COVID-19 Test Kit]
Verily [COVID-19 RT-PCR Test] |
||
Pandemic Total through 6/30/2021
## Slide 13: 16 EUA's for Independent Home Specimen Collection Kits
Note: Does not include collection kits included with proprietary assays; only kits separately authorized with independent EUA's
_bar chart showing sample type (x-axis) versus number of tests (y-axis), comparing Swab and Saliva tests_
Swab (10)
- 50% Rx
- 50% DTC
Saliva (6)
- 67% Rx
- 33% DTC
Pandemic Total through 6/30/2021
## Slide 14: 16 EUA's for independent Home Specimen Collection Kits
Swab Collection Kits (10)
•binx health At-Home Nasal Swab COVID-19 Sample Collection Kit
•Clinical Enterprises EmpowerDX COVID-19 Home Collection Kit DTC
•Color COVID-19 Self-Swab Collection Kit
•Color COVID-19 Self-Swab Collection Kit DTC
•Color COVID-19 Self-Swab Collection Kit with
Saline
•Everlywell COVID-19 Test Home Collection Kit
•Everlywell COVID-19 Test Home Collection Kit DTC
•GetMyDNA COVID-19 Test Home Collection Kit
•Kroger Health COVID-19 Test Home Collection Kit
•RapidRona Self-Collection Kit
Saliva Collection Kits (6)
•DNA GenoTech OMNIgene·ORAL OM-505 and OME-505
(OMNIgene·ORAL) Saliva Collection Device
•DNA GenoTech ORAcollect·RNA OR-100 and
ORAcollect·RNA ORE-100 Saliva Collection Device
•Phosphorus Diagnostics LLC Pinpoint by Phosphorus COVID-
19 Test Home Collection Kit DTC
•Spectrum Solutions SDNA-1000 Saliva Collection Device
•WREN Laboratories COVID-19 Saliva Test Collection Kit DTC
•Yale School of Public Health SalivaDirect
Pandemic Total through 6/30/2021
## Slide 15: CE-IVD Certified Tests (Mostly Europe)
_bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_
Molecular
- 91% RTqPCR
- 8% Isothermal
- 1% Sequencing
Antigen
- 78% Lateral Flow
- 5% ELISA
- 15% Other
Antibody
- 49% Lateral Flow
- 42% ELISA
- 6% Other
Other
- Collection Kits
- Flu/RSV Panels
Pandemic Total through 6/30/2021
## Slide 16: Research Use Only Tests Authorized outside US & EU
_bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_
Molecular
- 88% RTqPCR
- 9% Isothermal
- 1% Sequencing
Antigen
- 69% Lateral Flow
- 27% ELISA
- 4% Other
Antibody
- 51% Lateral Flow
- 47% ELISA
- 3% Other
Other
- Collection Kits
- Flu/RSV Panels
Pandemic Total through 6/30/2021
## Slide 17: Tests in Development Worldwide
_bar chart showing test type (x-axis) versus number of tests (y-axis) for Molecular, Antigen, Antibody, and Other_
Molecular
- 40% RTqPCR
- 23% Isothermal
- 16% CRISPR
- 14% Sequencing
Antigen
- 56% Lateral Flow
- 18% ELISA
- 10% Breath
- 16% Other
Antibody
- 63% Lateral Flow
- 25% ELISA
- 12% Other
Other
- Breath / VOC
- Mass Spec
- Raman Spec
Pandemic Total through 6/30/2021
## Slide 18: Companies with the largest number of EUAS
_bar chart showing company/vendor (x-axis) versus number of tests (y-axis)_
Abbott
- 4 Molecular
- 5 Antigen
- 3 Antibody
Siemens
- 1 Molecular
- 10 Antibody
Quidel
- 3 Molecular
- 5 Antigen
Roche
- 6 Molecular
- 1 Antigen
- 2 Antibody
Quest
- 6 Molecular
- 1 Antigen
- 2 Antibody
BD
- 4 Molecular
- 1 Antigen
- 2 Antibody
Color Health
- 4 Molecular
- 1 Antigen
- 2 Antibody
Diasorin
- 1 Molecular
- 1 Antigen
- 3 Antibody
Thermo Fisher
- 3 Molecular
- 2 Antibody
Pandemic Total through 6/30/2021
## Slide 19: FDA Revoked EUA's and Other Safety Communications
* Safety Communications: FDA posts Medical Device Safety Communications to describe FDA's analysis of a current issue and provide specific regulatory approaches and clinical recommendations for patient management.
* Letters to Healthcare Providers: FDA posts the letters it sends to health care providers about safety concerns with medical devices used in health care facilities.
_pie chart_
Letters to Healthcare Providers (9)
Safety Communications (5)
Revoked Antigen EUA (5)
Revoked Molecular EUA (7)
Revoked Antibody EUA (167)
Pandemic Total through 6/30/2021
## Slide 20: Other FDA Safety Communications by Subject
_pie chart_
Letters to Health Care Providers
- BD Max
- ThermoFisher
- Roche
Letters to Health Care Providers
- Antibody Testing (2)
- Transport Media
- Self Testing / Nasal Swabs
- Rapid Antigen Tests
- Variants
Safety Communications
- Antibody Testing
Safety Communications
- Curative
- Leccurate
- Lepu Medical
- Innova
Pandemic Total through 6/30/2021
## Slide 21: EUA's for Management of COVID-19 Patients
IVDs for Management of COVID-19 Patients (3)
- Roche Diagnostics Elecsys IL-6 (June 2020)
- Beckman Coulter, Inc. Access IL-6 (October 2020)
- Siemens Healthcare Diagnostics Inc. ADVIA Centaur IL6 Assay
Pandemic Total through 6/30/2021
## Slide 22: New EUAS by Technology Q1 2021 (n=41)
Total Q1 2021 New EUA's
_stacked bar chart showing test category (x-axis) versus number of new EUAs in Q1 2021 (y-axis)_
Molecular Tests
1 - Comprehensive At-Home Tests
6 - Flu/RSV Combo Tests
14 - Lab /POC COVID only
Antigen Tests
3 - Comprehensive At-Home Tests
1 - Flu/RSV Combo Tests
3 - Lab /POC COVID only
Serology Tests
10 - Lab /POC COVID only
Collection Kits
3 - Lab /POC COVID only
Collection Kits are listed separately as their own category by Testing Commons
Pandemic Total through 6/30/2021
## Slide 23: New EUAs by Technology Q2 2021 (n=43)
Total Q2 2021 New EUA's
_stacked bar chart showing test category (x-axis) versus number of new EUAs in Q2 2021 (y-axis)_
Molecular Tests
1 - Comprehensive At-Home Tests
6 - Flu/RSV Combo Tests
13 - Lab /POC COVID only
Antigen Tests
2 - Comprehensive At-Home Tests
5 - Lab /POC COVID only
Serology Tests
8 - Lab /POC COVID only
Collection Kits
9 - Lab /POC COVID only
# 6,296 2021-08-02_CDC ELC Reopening Schools - Support for Screening Testing to Reopen and Keep Schools Operating Safely.md
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last updated: 2026-03-06 by BA
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summary_short: The CDC ELC Reopening Schools guidance (updated 8/2/2021) describes how American Rescue Plan funding (Project E) should support K–12 screening testing and related prevention activities to keep schools open safely during the 2021–2022 school year. It outlines required tasks, allowable costs (including testing supplies, staffing, IT/reporting systems, diagnostics support, and optional prevention measures like HEPA filtration), and reporting expectations for districts and jurisdictions. It also specifies activity requirements for deploying resources, submitting updated K–12 testing plans aligned to CDC guidance, and implementing and monitoring screening programs over time.
CONTENT
***INTERNAL TITLE:*** ELC REOPENING SCHOOLS: SUPPORT FOR SCREENING TESTING TO REOPEN & KEEP SCHOOLS OPERATING SAFELY
UPDATED GUIDANCE: 8/2/2021
Project E: Emerging Issues
Supported through the American Rescue Plan Act of 2021
## CONTENTS
| | |
| ------------------------------------------------- | ---: |
| Executive Summary | 1 |
| Background and Purpose | 2 |
| Funding Strategy & Support to School Districts | 2 |
| Allowable Costs | 4 |
| COVID-19 Terms and Conditions | 5 |
| Supporting Management of Activities and Resources | 7 |
| Process for Workplan and Budget Submission | 7 |
| Required Tasks | 8 |
| Activities | 9 |
| Performance Measures | 10 |
| Summary of Reporting Requirements | 10 |
||
## EXECUTIVE SUMMARY
Since the publication of the ELC Reopening Schools Guidance the pandemic has evolved. While students over 12 years are presently eligible to receive the COVID-19 vaccine, significant numbers of K-12 students still remain unvaccinated or may be ineligible to receive the vaccine due to age. Additionally, because the pandemic has persisted, communities may soon be dealing with seasonal influenza in addition to COVID-19. Because some of the symptoms of flu, COVID- 19, and other respiratory illnesses are similar, the difference between them cannot be made based on symptoms alone. Testing remains critically important to identify and appropriately mitigate the spread of respiratory illness throughout communities.
Updates to the previously published guidance reflect the current needs of recipients as they implement plans to address COVID-19 during the 2021-2022 school year. The red font throughout this guidance indicates new or updated content. A high-level summary of updates includes:
1. Activities now explicitly include both detection and prevention of COVID-19 in schools, with a continuing focus on screening testing as a mitigation strategy. Recipients are expected to utilize CDC guidance to implement the appropriate strategies for detecting and mitigating the spread of COVID-19 in K-12 schools. Please refer to CDC guidance: [Operational Strategy for K-12 Schools](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html).
2. Expansion of allowable costs, in addition to required screening testing activities, to include:
a. Support for diagnostic testing
b. Testing events that may also involve other mitigation activities (e.g., promotion of vaccine) to limit the spread of COVID-19.
c. The promotion of vaccinations as part of testing/contact tracing activities, and when characterized as a mitigation strategy to prevent widespread COVID-19 within the school and the community.
d. Costs related to prevention may also include portable high-efficiency particulate air (HEPA) fan/filtration systems or other small items that may allow for improved air circulation.
3. Required reporting frequency for test volume by school district has been reduced from weekly to monthly. Any weekly data collected after July 5 may be submitted via an attachment in REDCap.
4. Recipients will be required to submit an updated K-12 plan that details screening testing strategies and other activities to reduce the spread of COVID-19 and maintain safe operations in schools as community transmission and/or vaccination rates change. Whenever possible, the proposed plans should align with CDC guidance. Templates for the plan will be provided or information collected via REDCap.
## BACKGROUND AND PURPOSE
To support safe, in-person instruction in kindergarten through grade 12 (K-12) schools, screening testing provides another important layer of prevention to protect students, teachers, and staff, and slow the spread of SARS-CoV-2, the virus that causes Coronavirus Disease 2019 (COVID-19). While it is critical for schools to remain open for academic, social, emotional benefits, it is equally important to do so safely ([Operational Strategy for K-12 Schools](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html)). Since funds were awarded to ELC recipients in April of 2021, made available from the American Rescue Plan Act of 2021, P.L. 117- 2, recipients have been working to integrate screening testing in an overall prevention strategy to allow their schools to safely open for in-person instruction in the Fall, and remain open throughout the 2021-2022 school year. The goal is to maximize in-person learning days.
In addition to the $10 billion provided as a part of this award, approximately $30 billion had already been awarded to public health departments to support activities, including screening testing, through the ELC Enhancing Detection (ED) and ELC ED Expansion supplements. Using those supplemental funds, public health departments increased their ability to provide screening testing broadly to their communities, including congregate settings, like schools. The resources available through this award are aimed at providing support for schools to detect and prevent the transmission of COVID-19 within schools. Recipients should ensure equitable access to the support being provided by this opportunity and where appropriate, coordinate with other initiatives that may already be targeting areas with high Social Vulnerability Index (SVI).
## FUNDING STRATEGY & SUPPORT TO SCHOOL DISTRICTS
As the pandemic has evolved and vaccine coverage increased, strategies used to prevent the spread of COVID-19 continue to be important, including tools like screening testing emphasized in the original iteration of the ELC Reopening Schools guidance.
The objectives and goals of this funding are primarily focused on providing needed resources to implement screening testing programs Recipients should, whenever possible, align their approach with CDC recommendations for K-12 ([Operational Strategy for K-12 Schools](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html)).
As stated in the original guidance, a minimum of 85% of the award total must be allocated to supporting prevention efforts in school districts. This support can include directly providing funds to schools or indirectly by providing support to increase screening testing and support for related prevention strategies in all K-12 schools (public or private) within the recipient’s jurisdiction. Recipients may use a combination of approaches (examples follow below) to successfully provide the necessary support to schools.
Up to 15% may be used by direct recipients for coordination, management, technical assistance, monitoring, and data collection and reporting activities to support K-12 screening testing programs and/or provide necessary support for prevention strategies. These funds may not be applied to expenditures incurred before the date of award. However, recipients can use previously awarded funds for any school screening testing activities that are consistent with those awards and in a way that is not a duplication of effort but an enhancement or complementary effort. School screening testing is an allowable activity under the prior two supplemental awards: ELC Enhancing Detection and ELC Enhancing Detection Expansion.
Examples of providing funding directly to support school districts, public charter schools, and private schools include, but are not limited to:
1. Contracting with testing companies to directly implement programs in K-12 schools and school districts.
2. Partnering with local or chain pharmacies to provide screening testing for K-12 schools and school districts (e.g., contract or fee-for-service model).
3. Partnering directly with laboratories with or without established regional footprints.
4. Directly contracting with K-12 schools and school districts within a recipient’s jurisdiction for the completion of the activities in this guidance.
5. Establishing an account or a mechanism to allow K-12 schools and school districts to be reimbursed for costs associated with screening testing.
6. Coordinating with the state or jurisdictional Department of Education to facilitate financial support for K-12 schools and school districts.
7. Sub-awarding to Local Health Departments to support school screening testing directly.
8. Supporting IT systems to monitor screening testing in K-12 schools and school districts and ensure positive results are linked to public health action.
*Each jurisdiction is different; it is assumed that any proposed approach will align with existing jurisdictional laws, regulations, and business practices, while remaining consistent with this award.
**Examples of indirectly providing materials and services to school districts, public charter schools, and private schools include, but are not limited to:**
1. Recipient using purchasing authorities to obtain screening testing kits, and necessary supplies, and providing them to school districts, public charter schools, and private schools within their jurisdiction.
2. Providing courier services to improve turn-around time for results.
3. Providing Personal Protection Equipment (PPE) or other items, such as appropriate air filters, directly to the school.
4. Providing laboratory support.
5. Personnel support, onsite, such as a screening testing coordinator, for sample collection, or other additional staff needed to implement testing programs, etc.
6. Logistical and operational support, including IT systems and data management, as needed.
Financial expenditures will be monitored and assessed with recipients monthly.
## ALLOWABLE COSTS
The financial resources provided are required, by law, to support school-based screening testing activities intended to support open, in person K-12 school environments during the COVID-19 pandemic. Additionally, these resources may be used to support items or activities aimed at implementation of prevention strategies necessary to curtail the spread of COVID-19. Recipients should review the updated [Operational Strategy for K-12 Schools](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html) and consider requesting the following when revising their ELC Reopening Schools budgets:
1. Personnel (term, temporary, students, overtime, contract staff, etc.).
2. Laboratory equipment used for COVID-19 testing and necessary maintenance contracts.
3. Collection supplies, test kits, reagents, consumables, and other necessary supplies for existing testing (screening or diagnostic) or onboarding new platforms to support this testing.
4. Personal Protective Equipment Please see the most current CDC guidance for details ([Operational Strategy for K-12 Schools](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html)).
5. Hygiene and cleaning supplies.
6. Hardware and software necessary for reporting to public health and communication and coordination of follow up on any positive cases detected.
7. Tools that assist in the rapid identification, electronic reporting, monitoring, analysis, and evaluation of control measures to reduce the spread of COVID-19, that may be translatable to other diseases (e.g., GIS software, visualization dashboards, cloud services).
8. Contracts with academic institutions, private laboratories, other non-commercial healthcare entities, and/or commercial entities that may provide all or part of the screening testing needs. This may include contracts with companies that offer comprehensive support for screening testing in K-12 (e.g., sample collection, screening testing, and reporting).
9. Software or systems to assist with laboratory resource management (e.g., software for inventory management, temperature notifications, etc.), quality management, biosafety, or training needs.
10. Leasing/purchasing vehicles (e.g., mobile screening testing, providing K-12 screening testing services in underserved areas, etc.). Note: Recipients will need to submit quotes with their revised budgets and receive prior approval from the Office of Grant Services (OGS). If need arises before or after the revised Notice of Grant Award (NOA) is issued, requests for leasing/purchasing must be made through GrantSolutions and include the necessary quotes.
11. Portable high-efficiency particulate air (HEPA) fan/filtration systems or other small items that may allow for improved air circulation
12. Public health events that include students and other community members and are aimed at providing opportunities for increased detection and prevention of COVID-19. Please note that promotion of vaccination may be considered a prevention strategy for preventing further spread of COVID-19; however, recipients are asked to coordinate these activities between ELC and Immunization staff within the jurisdiction. Additionally, coordination with ELC Project Officer and Immunization Project Officer is crucial to ensure there is not duplication between the two sources of financial support.
13. Program incentives may be considered to encourage individuals to participate in screening testing. Recipients interested in exploring this option must submit a plan that covers all of the following elements: (a) justification, (b) cost savings [e.g., how it will defray costs or have a positive return on investment], (c) defined amount (not to exceed $25 per instance), (d) qualifications for issuance, and (e) method of tracking. When submitting the revised budget within 60 days of award issuance, the program incentive plan must be included in the ‘budget justification’ section of the ELC budget workbook and receive CDC approval before implementation. After the revised NOA is issued, any subsequent requests for using funds to support program incentives must be made in GrantSolutions, including the program incentive plan, and must receive CDC approval before implementation.
14. Wrap-around (e.g., hoteling, food, laundry, mental health services, etc.) services for those who test positive.
15. Expenses associated with outreach and assistance (e.g., support provided through community-based organizations).
16. Costs associated with transporting individuals to get tested.
17. Expenses associated with technical assistance to establish school-based screening testing programs (NGOs, academic institutions, foundations, etc.).
18. ELC Reopening Schools funds can be used to cover screening and diagnostic testing costs (e.g., administration, etc.) fully. Recipients should follow all appropriate federal laws and regulations pertaining to testing reimbursements, including assuring that charges are not covered both by ELC funds and other reimbursement sources.
19. Testing events that may also involve other mitigation activities (e.g., promotion of vaccination) to limit the spread of COVID-19.
20. The promotion vaccinations when characterized as a mitigation strategy to prevent widespread COVID-19 within the school and the community.
21. Costs related to prevention may also include portable high-efficiency particulate air (HEPA) fan/filtration systems or other small items that may allow for improved air circulation.
The above list covers the anticipated, most relevant costs associated with achieving the activities in this guidance. This list does not represent a full list of allowable costs. Recipients are referred to the cost principles regulation found at 45 CFR Part 75 Subpart E – Cost Principles.
In determining if costs are allowable, consideration must be given to applicable regulations; the overall underlying cooperative agreement (CK19-1904); be considered necessary and reasonable; and be considered allocable (see: 45 CFR 75.403). Any questions about specific budget items should be directed to the OGS and the ELC Project Officer.
Please also note, the CDC is not prescribing the specific tests that may be used for implementing screening testing; however, recipients are encouraged to adhere to CDC and FDA guidance when selecting a test type and determining the approach to testing.
## COVID-19 TERMS AND CONDITIONS
**Coronavirus Disease 2019 (COVID-19) Funds:** A recipient of a grant or cooperative agreement awarded by the Department of Health and Human Services (HHS) with funds made available under the Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123); the Coronavirus Aid, Relief, and Economic Security Act, 2020 (the “CARES Act”) (P.L. 116-136); the Paycheck Protection Program and Health Care Enhancement Act (P.L. 116- 139); the Consolidated Appropriations Act and the Coronavirus Response and Relief Supplement Appropriations Act, 2021 (P.L. 116-260) and/or the American Rescue Plan of 2021 [P.L. 117-2] agrees, as applicable to the award, to: 1) comply with existing and/or future directives and guidance from the Secretary regarding control of the spread of COVID- 19; 2) in consultation and coordination with HHS, provide, commensurate with the condition of the individual, COVID-19 patient care regardless of the individual’s home jurisdiction and/or appropriate public health measures (e.g., social distancing, home isolation); and 3) assist the United States Government in the implementation and enforcement of federal orders related to quarantine and isolation.
In addition, to the extent applicable, Recipient will comply with Section 18115 of the CARES Act, with respect to the reporting to the HHS Secretary of results of tests intended to detect SARS–CoV–2 or to diagnose a possible case of COVID–19. Such reporting shall be in accordance with guidance and direction from HHS and/or CDC. HHS laboratory reporting guidance is posted at: https://www.hhs.gov/sites/default/files/covid-19-laboratory-data-reporting- guidance.pdf.
Further, consistent with the full scope of applicable grant regulations (45 C.F.R. 75.322), the purpose of this award, and the underlying funding, the recipient is expected to provide to CDC copies of and/or access to COVID-19 data collected with these funds, including but not limited to data related to COVID-19 testing. CDC will specify in further guidance and directives what is encompassed by this requirement.
This award is contingent upon agreement by the recipient to comply with existing and future guidance from the HHS Secretary regarding control of the spread of COVID-19. In addition, in accordance with HHS’ regulatory requirements for pass-through entities at 45 CFR 75.352, recipient is expected to flow down these terms to any subaward, to the extent applicable to activities set out in such subaward.
To achieve the public health objectives of ensuring the health, safety, and welfare of all Americans, Recipient must distribute or administer testing without discriminating on non-public-health grounds within a prioritized group.
**Acknowledgement of Federal Funding:** When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as tool-kits, resource guides, websites, and presentations (hereafter “statements”)--describing the projects or programs funded in whole or in part with U.S. Department of Health and Human Services (HHS) federal funds, the recipient must clearly state:
1. The percentage and dollar amount of the total costs of the program or project funded with federal money; and,
2. The percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.
When issuing statements resulting from activities supported by HHS financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following or a similar statement.
If the HHS Grant or Cooperative Agreement is NOT funded with other non-governmental sources:
- This [project/publication/program/website, etc.] [is/was] supported by the [full name of the OPDIV/STAFFDIV] of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $XX with 100 percent funded by [OPDIV/STAFFDIV]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by [OPDIV/STAFFDIV]/HHS, or the U.S. Government. For more information, please visit [OPDIV/STAFFDIV website, if available].
The HHS Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:
- This [project/publication/program/website, etc.] [is/was] supported by the [full name of the OPDIV/STAFFDIV] of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award totaling $XX with XX percentage funded by [OPDIV/STAFFDIV]/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by [OPDIV/STAFFDIV]/HHS, or the U.S. Government. For more information, please visit [OPDIV/STAFFDIV website, if available].
The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement.
Any amendments by the recipient to the acknowledgement statement must be coordinated with the HHS Awarding Agency.
If the recipient plans to issue a press release concerning the outcome of activities supported by HHS financial assistance, it should notify the HHS Awarding Agency in advance to allow for coordination.
**Termination**
This award may be terminated in whole or in part consistent with 45 CFR 75.372.
CDC may impose other enforcement actions in accordance with 45 CFR 75.371- Remedies for Noncompliance, as appropriate.
## SUPPORTING MANAGEMENT OF ACTIVITIES AND RESOURCES
There are special reporting requirements (see ‘Summary of Reporting Requirements’ in the ‘Performance Measures and Reporting’ section) which will likely require dedicated personnel resources to ensure timeliness and completeness of data being reported. Please note that these requirements have been updated.
Examples of support in the form of coordination, management, technical assistance, monitoring and reporting, include but are not limited to:
1. Contracting for the development of a web-based platform, linking school districts, public charter schools, and private schools with testing service providers, with a program overview, toolkit and resources, and communication materials (e.g., COVID-19 Educational Testing).
2. Adapting, modifying or implementing testing program toolkits or playbooks to support school districts, public charter schools, and private schools in program design (e.g., The Rockefeller Foundation Playbook for Educators and Leaders).
## PROCESS FOR WORKPLAN AND BUDGET SUBMISSION
At the time of guidance update, recipients should have provided resources to districts and/or determined the method(s) with which support to school districts will be conducted. Please see the ‘Activities’ section of this guidance for details pertaining to the updated required activities under this award. A K-12 plan for implementing screening testing and other measures is required and should be submitted via REDCap (due within 30 calendar days of release of this guidance via GrantSolutions).
This funding was awarded in the ELC Budget Period 2 (BP2) (i.e., August 1, 2020 – July 31, 2021) under CK19-1904. However, recipients should note that this supplemental funding is for a 16-month project period and will end on July 31, 2022. The expanded project period coincides with the end of Budget Period 3 (BP3) (i.e., August 1, 2021 – July 31, 2022) of the ELC Cooperative
Agreement (CK19-1904). Recipients are reminded that expanded authority[1] applies, in terms of carryover of unobligated from one budget period to the next budget period to cover the approved workplan activities.
[1] Expanded Authority is provided to recipients through 45 CFR Part 75.308, which allows carryover of unobligated balances from one budget period to a subsequent budget period. Unobligated funds may be used for purposes within the scope of the project as originally approved. Recipients will report use, or intended use, of unobligated funds in Section 12 "Remarks" of the annual Federal Financial Report.
## REQUIRED TASKS
Note: If a recipient does not meet the below required tasks and has not received written approval for an extension from CDC, recipient may have their funds restricted in the Payment Management System (PMS) for specific costs/activities.
Recurring or repeat non-compliance may result in additional restrictions or other actions being taken, consistent with applicable grant regulations.
In addition to the programmatic activities noted below in further detail, recipient responsibilities include but are not limited to the following:
1. Regular participation in calls with CDC/HHS for technical assistance and monitoring of activities supported through this cooperative agreement. Please note, at the time of guidance update, at least one call with CDC should have taken place.
2. On-time submission of all requisite reporting. This may include but is not limited to reporting of performance measures, progress on milestones, and/or financial updates within REDCap.
3. Report expenditures and unliquidated obligations (ULOs) on a monthly basis. On the 5th day of the month, the expenditures and ULOs from the prior month shall be reported in the REDCap ‘ELC Reopening Schools: COVID Award’ portal under the ‘ELC Reopening Schools Financial Reporting’ page.
4. Documentation of any necessary budget change/reallocation through GrantSolutions and REDCap.
5. Updated reporting:
In accordance with previous guidance, recipients should have already been reporting the following items on a weekly basis through July 7 via REDCap:
a. The number of tests conducted by school district;
b. Test type; and
c. Cases identified.
Testing reporting changes are effective immediately upon publication:
a. Weekly reporting of test volume data from K-12 schools will be moved to a monthly reporting schedule
b. Recipients are required to submit an updated K-12 plan that details strategies used to reduce the spread of COVID-19 and maintain safe operations in schools as community transmission and/or vaccination rates change. All plans must describe the role of screening testing in as it pertains to the changing conditions of the pandemic. Wherever possible, recipients should follow the CDC guidance for K-12 schools ([Operational Strategy for K-12 Schools](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html)). A template will be provided, and the plans should be submitted to REDCap per instruction. Plans will be due within 30 days of publication in GrantSolutions unless otherwise communicated.
The ELC may be add performance reporting on other mitigation/prevention activities, TBD.
## ACTIVITIES
This award has three (3) required overarching activities that are designed to meet the immediate needs to safely reopen schools and the ongoing efforts to keep schools operating safely.
**Activity 1: Rapid deployment of screening testing resources** (At the time of this guidance update, this activity is complete)
The focus for Activity 1 is to jumpstart the ability for jurisdictions to implement school testing (estimated timeframe April to June). A minimum of 85% (direct and indirect) of the award must be allocated to support schools (public or private) that cover all or some K-12 grades within the recipient’s jurisdiction. Recipients may use a combination of mechanisms to successfully provide the necessary support to schools. While not exhaustive, examples of mechanisms to provide financial support are listed in the ‘Funding Strategy’ section above. Additionally, examples of types of support may be found under the ‘Allowable Costs’ section. Recipients will need to support school district implementation with technical assistance and monitoring, as well as identifying public health actions needed based on school screening testing information. Recipients should assure that school districts, public charter schools, and private schools have adequate plans for action when they identify a positive test result.
Recipients may also plan and implement support for screening programs in school-affiliated summer programs, including camps and summer instruction. Recipients can also consider summer programs outside of schools that focus on providing equitable access to educational and recreational activities.
**Updated Activity 2: Development and submission of K-12 screening testing implementation plan**
Please note that support for prevention strategies that extend beyond screening testing have been added as allowable (optional) costs.
Recipients are required to submit an updated K-12 plan that details screening testing strategies and other activities used to reduce the spread of COVID-19 and maintain safe operations in schools as community transmission and/or vaccination rates change. All plans are required to include screening testing in the approach. Wherever possible, recipients should follow the CDC guidance for K-12 schools ([Operational Strategy for K-12 Schools](https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strategy.html)). A template will be provided, and the plans should be submitted to REDCap per instruction. Unless otherwise communicated, plans will be due within 30 days of the revised guidance being uploaded into GrantSolutions.
**Activity 3: Implementation screening testing action plan**
Using the screening testing plan as a guide, recipients will progress through the stepwise implementation of the plans to support schools safely opening/remaining open for the 2021-2022 school year. The implementation plan should include methods to monitor effectiveness and integrate modifications as needed based on lessons learned over time.
Please note that additional supplemental guidance may be released to recipients based on information collected from performance measures, milestone progress reporting, and/or additional scientific understanding of SARS-CoV-2.
## PERFORMANCE MEASURES
Should additional performance measures be requested beyond the reporting requirements noted below, the ELC will work with recipients to maximize the impact of the measures being collected. Whenever possible the ELC utilizes existing data sources.
## SUMMARY OF REPORTING REQUIREMENTS
The following is an updated summary of reporting requirements for the ELC Reopening Schools award, effective upon publication.
1. For those conducting screening over the summer, weekly test data collected after July 5, may be submitted via an attachment in REDCap.
2. Within 30 days of the revised guidance being uploaded into GrantSolutions , recipients should submit an updated K-12 plan for screening testing and the prevention strategies that will be utilized to prevent the spread of COVID-19 in the 2021-2022 school year. A template for this summary will be made available in REDCap.
3. Monthly reporting of test volume data from K-12 schools.
4. Monthly fiscal reports, entered in REDCap with final report in GrantSolutions via Grant Note, beginning 30 days after NOAs are issued. On the 5th day of the month, the expenditures and ULOs from the prior month shall be reported in the REDCap ‘ELC Reopening Schools: COVID Award’ portal under the ‘ELC Reopening Schools Financial Reporting’ page.
5. Performance measure data.
6. CDC may require recipients to develop annual progress reports (APRs). CDC will provide APR guidance and optional templates should they be required.
The ELC will be adding performance reporting on other mitigation/prevention activities, TBD.
# 4,213 2021-12-13_School Test to Stay Playbook from Barrington RI.md
METADATA
last updated: 2026-03-06 by BA
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summary_short: The Barrington Public Schools “Test to Stay” playbook (updated Dec. 13, 2021) lays out Rhode Island’s school-based protocol that allows unvaccinated or partially vaccinated close contacts to remain in school if they test negative on a rapid antigen test daily for seven days after exposure and follow strict quarantine rules outside of school. It details eligibility, consent, testing logistics (including weekend activity testing), layered mitigation measures, and quarantine exceptions, with practical examples and Q&A to guide school staff implementation and contact tracing.
CONTENT
***INTERNAL TITLE:*** Rhode Island Test to Stay Playbook - Barrington Public Schools
**Updated: BPS December 13, 2021**
## Table of Contents
[Layered Mitigation Strategies with Test to Stay Program](#layered-mitigation-strategies-with-test-to-stay-program) **3**
[Overview of Test to Stay](#overview-of-test-to-stay) **4**
[Eligibility](#eligibility) **5**
[Testing](#testing) **6**
[Testing Cadence](#testing-cadence) **8**
[Quarantine Guidelines](#quarantine-guidelines) **11**
[Q & A](#q-a) **12**
[Glossary](#glossary) **14**
Our focus is on ensuring a safe in-person learning environment with minimal disruptions, especially among those who have not had access to or have not yet been able to get fully vaccinated. Our goal is to keep students in school while keeping our communities safe.
## Layered Mitigation Strategies with Test to Stay Program
The Rhode Island Department of Health (RIDOH) and the Rhode Island Department of Elementary and Secondary Education (RIDE) encourage schools to continue using the health and safety guidance provided in order to prevent outbreaks and to promote safe indoor practices throughout the Test to Stay Program.
- BPS will promote symptom screening for students and staff.
- Students will be seated at least three feet apart, at all times, and wear a mask, except at lunch.
- BPS understands that the Test to Stay Program is not an alternate protective measure to, or substitution for, vaccination.
- Symptomatic individuals cannot participate in the Test to Stay Program and will be sent home.
- Thorough contact tracing by the district COVID-19 team within 48 hours of the confirmed positive case, regardless of the number of close contacts and positive cases.
- BPS will provide the list of exposed students and staff to RIDOH when an individual gets a positive test result.
- BPS will continue to promote vaccinations for eligible students and staff.
## Overview of Test to Stay
Students participating in Test to Stay may ride school transportation, attend all instructional activities at school, and participate in school-sponsored extracurricular activities, including athletics. Test to Stay is only available to those individuals who have been identified as close contacts due to exposure to COVID-19 in the school setting. It does not allow anyone who has tested positive to stay in school.
**Test to Stay is only available to individuals who are not yet fully vaccinated; individuals who have not received any COVID-19 vaccination dose or have only received their first dose of the Moderna or Pfizer vaccine may participate.**
Individuals who are participating in Test to Stay will not have to quarantine if they are identified as a close contact due to school exposure. If participating in Test to Stay, the individual must test negative on a rapid COVID-19 antigen test every day before proceeding to class. If the individual is participating in a school-sponsored activity on the weekend, the individual must test negative on a rapid COVID-19 antigen test before participating in the activity. The individual will participate in daily testing for a minimum of seven days from exposure. In the case that an individual participating in Test to Stay has a second close contact exposure during their initial Test to Stay testing period, the testing sequence must be restarted for the most recent close contact. The student should monitor for symptoms for 14 days following the last exposure.
**Test to Stay does not change self-isolation requirements for those who have tested positive for COVID-19 and are within the infectious period.**
**If an individual participating in Test to Stay exhibits COVID-19 symptoms requiring self-isolation, the individual must self-isolate at home pending confirmation of a negative PCR test for COVID-19. If COVID-19 is confirmed, then self-isolation continues for 10 days following the day that symptoms began.**
## Eligibility
- Students in pre-kindergarten through 6th grade identified as a close contact due to a school exposure, who do not have COVID-19 symptoms, and who have consented to testing.
- Symptomatic students and staff must stay home, isolate, and get tested for COVID-19. Symptomatic individuals may not participate in Test to Stay.
- Test to Stay is only available to individuals who are not yet fully vaccinated; individuals who have not received any COVID-19 vaccination dose or have only received their first dose of the Moderna or Pfizer vaccine may participate.
**Key Considerations**
- Students in prekindergarten through 6th grade are recently eligible to receive COVID vaccinations, while older students have been eligible since May 2021. The best way to protect students against COVID-19 is vaccination; thus, schools should strongly promote vaccination amongst students as the primary strategy to reduce quarantines and keep students safe.
- Elementary school students identified as close contacts have been expected to quarantine at a very high rate (97%). Getting these students vaccinated will greatly reduce the number of missed school days due to quarantine.
**COVID-19 Symptoms**
- Fever or chills;
- Cough (new);
- Shortness of breath or difficulty breathing;
- Fatigue;
- Muscle or body aches;
- Headache;
- Sore throat;
- New loss of taste or smell;
- Congestion or runny nose (new);
- Nausea or vomiting; or
- Diarrhea.
## Testing
If not fully vaccinated, close contacts of COVID-19 infectious individuals have two options. The primary option is participation in a Test to Stay program. Individuals opting not to participate in Test to Stay must quarantine at home to help stop the spread of COVID-19, which is the secondary option.
- Students who choose to participate in the Test to Stay program must be tested at school (on school days) for quick and easy verification.
- Weekend testing is required for students when participating in school activities over the weekend. Weekend testing will either be administered at school sites or via home testing.
- Students identified as a close contact who are participating in the Test to Stay program must quarantine when at home and cannot attend non-related school activities.
**Key Considerations**
- Weekend testing: In order to safely support students who participate in extracurricular activities, participants of the program must follow the same protocol as when attending school: 1) get tested before participating in an activity or attending a class during the weekend and 2) wear a mask indoors. (There must be adult supervision to ensure mask-wearing.)
- It is recommended schools consider having tests on hand to conduct PCR testing when students or staff become symptomatic to expedite results and case identification.
**Visual Testing Examples**
_Page of diagrams illustrating testing cadence timelines for Test to Stay program scenarios, showing day-by-day testing schedules for students identified as close contacts._
## Testing Cadence
- A rapid antigen test will be administered at the start of the school day for up to seven days from the date of exposure.
- If the seventh day of quarantine falls on the weekend or on a holiday, the student is required to get tested the next day at school.
**Key Considerations**
Seven-day antigen testing is required:
- Serial testing with rapid antigen tests results in the likelihood of a higher Positive Predictive Value (PPV) than one-time testing.
- Daily testing is easier to implement, and it is easier to track students who require tests.
**Testing Cadence Examples**
**Example 1: Testing begins on Tuesday, no participation in weekend extracurriculars**
Scenario: An individual began showing symptoms on Monday, and received a positive result on their PCR test that same day. Their close contacts are identified and notified, and those who opt-in begin participating in the Test to Stay program on Tuesday.
Below is an example of a student who will receive a rapid test when they arrive at school on Tuesday through Friday and the following Monday. S/he does not participate in any school extracurricular activities on the weekend, so s/he will quarantine at home when the student’s school day ends and for the two weekend days. His/her last day of rapid testing will be on Monday, assuming all tests are negative, and no other student or staff test positive during the testing period. The student will continue to monitor for symptoms for a full 14 days from last exposure.
**Example 2: Testing begins on Tuesday, with a long weekend and no participation in extracurriculars**
Scenario: An individual began showing symptoms on Monday, and receives a positive result on their PCR test that same day. Their close contacts are identified and notified, and those who opt in begin participating in the Test to Stay program on Tuesday.
Below is an example of a student who will receive a rapid test when they arrive at school on Tuesday through Friday and the following Tuesday. S/he does not participate in any school extracurricular activities on the weekend and there is no school on Monday, so s/he will quarantine at home when the student’s school day ends and at home for those 3 days. His/her last day of rapid testing will be the following Tuesday, assuming all tests are negative and no other students or staff are identified during the testing period. The student will continue to monitor for symptoms for a full 14 days from last exposure.
**Example 3: Testing begins on Friday, and student participates in weekend extracurriculars**
Scenario: An individual began showing symptoms on Tuesday, and receives a positive result on their PCR test on Thursday. Their close contacts are identified and notified, and those who opt in begin participating in the Test to Stay program on Friday.
Below is an example of a student who will receive a rapid test when they arrive at school on Friday, on Saturday before his/her sports practice, and the following Monday through Thursday. S/he does not participate in any school extracurricular activities on the Sunday, so s/he will quarantine at home for that day. His/her last day of rapid testing will be on Thursday, assuming all tests are negative. The student must quarantine when not participating in school related activities and monitor for symptoms for the 14 days from the last exposure.
**Example 4: Student is identified as a close contact again, while still during initial testing period**
Scenario: an individual began showing symptoms on Tuesday, and receives a positive result on their PRC test that same day. Their close contacts are identified and notified, and those who opt in begin participating in the Test to Stay program on Wednesday. The student began testing daily via Test to Stay on Wednesday. S/he does not participate in any school extracurricular activities on the Sunday, so s/he will quarantine at home for that day.
Though the student’s last day of testing would have been on Tuesday, s/he was identified as a close contact of a second positive case and was exposed on Friday but was not aware until Monday. Because s/he was a close contact a second time and exposed on Friday, s/he would participate in testing through the following Friday.
## Quarantine Guidelines
Students who choose to participate in the Test to Stay program:
- May attend school and school-related extracurricular activities where there is adult supervision to ensure mask-wearing;
- May take the school bus to and from school;
- May attend before and after-school care that is sponsored or regulated by RIDE where there is adult supervision to ensure mask-wearing;
- May not attend non-school-related activities (e.g., Girl Scouts, club sports, etc.); and
- Must abide by quarantine guidelines outside of school.
Individuals who are exempt from quarantine should not participate in TTS. Exemptions to quarantine are:
- People with documented COVID-19 infection in the last 90 days;
- Fully vaccinated individuals;
- Those who meet the PreK-12 Close Contact Quarantine Exception criteria;
- PreK-12 students or staff and the exposure happened during outdoor recess at school; or
- Were exposed on a PreK-12 school bus when windows were open, everyone wore face masks, and both the driver and at least one additional adult were present to confirm proper mask use and open windows.
**Key Considerations**
- Close contact is in quarantine when not at school: The student is still at risk of testing positive, and attending non-school related activities is a risk for community transmission.
- School-run transportation
- School-run transportation is a key support for some children to be able to attend school and is an equity issue.
- All riders on the bus must continuously wear a face mask and windows should be open.
- Participation in school-related extracurricular activities only
- School-related extracurricular activities have, and enforce, layered mitigation strategies which help to minimize risk of spreading to the community.
- The purpose of this initiative is to enable children to attend school and reduce education gaps.
- Attendance at in-district/in-school childcare only.
- There are some complexities involved in operationalizing the use of facilities that are not run by schools as they must be notified by RIDOH.
**PreK-12 Student Close Contact Exception**
A PreK-12 student exposed to another PreK-12 student infected with COVID-19 doesn’t need to quarantine if all of the following are true:
- Both the infected person and exposed close contact are Pre K-12 students;
- The exposure occurred in an indoor Pre K-12 classroom or structured outdoor pre K-12 setting where mask use can be observed;
- Both the exposed close contact student and the infected student wore face masks at all times during the close contact exposure; and
- At least three feet of physical distance was maintained at all times during the exposure.
## Q & A
**1. How is this different from the way that students can already test out of quarantine?**
According to Executive Order 21-105, students who don’t have symptoms can shorten the quarantine period to 7 days (from 10) if they get a negative result from a lab-processed PCR test taken at least 5 days after the exposure. In this case, the person would be required to stay home for 7 days, returning to school and activities on the eighth day.
**2. If parents/guardians have already given consent for surveillance testing, are districts required to obtain new consent for students' participation in Test to Stay?**
Yes, parents/guardians must provide consent specifically to Test to Stay, as it is not the same program nor testing frequency as other testing that may already be conducted at the school.
**3. Must all students in PreK through 6th grade participate in Test to Stay?**
No, the TTS program is available for districts to implement in PreK through 6th grade, but it is at the discretion of the implementing district regarding which of these grade levels they will make TTS available for, given school configurations and staffing availability. Additionally, only students who are unvaccinated and/or partially vaccinated may participate in TTS.
**4. If a student is notified that they’re a close contact during the school day, do they need to get tested that same day?**
No. If students are notified that they’re close contacts during a school day, they will begin their seven days of antigen testing on the next school day. If initial notification occurs on a Friday, and the students have a school-related event over the weekend, they’ll either be sent home with tests to administer over the weekend or be tested on-site before their weekend school event.
**5. Can students participating in TTS take the bus to school?**
Yes. Students participating in TTS are permitted to use school-run transportation. Students must wear a mask and sit in their assigned seat while riding the bus.
**6. Can students participate in extracurricular activities when in TTS?**
Students who remain asymptomatic and test negative may attend school-related extracurricular activities. However, they must continue to follow quarantine guidelines outside of school and shall not attend non-school related activities during their quarantine period
**7. Can students get tested outside of school for TTS?**
No. Students must be tested at school to participate in TTS.
**8. What if a student in TTS starts having symptoms of COVID-19?**
Any student who isn’t feeling well must follow existing school sick policies and stay home until they’ve completed the testing and isolation requirements for symptoms of COVID-19.
**9. If the school is participating in TTS, can we go back to the way things were before COVID-19?**
No. The purpose of TTS is to ensure that students can attend in-person learning as much as possible. This program reduces the number of instructional days missed because it allows students to remain at school, as long as they do not have symptoms of COVID-19, and get negative test results every day during their seven-day quarantine period. TTS is not a substitute for other safety and mitigation practices used in schools. To ensure student and staff safety, we will still need to ensure proper mask-wearing and distancing, screen for symptoms daily, keep students in cohorts, improve ventilation, maintain seating charts, and track student movement throughout the building for contact tracing purposes.
**10. What if students participating in TTS are late to school?**
School staff are responsible for ensuring that students participating in TTS and identified as close contacts get tested before proceeding to class. If a student is late to school, the school must have a process for verifying their participation in TTS upon arrival and ensuring they get tested.
**11. What happens if a student is absent and misses one of their days of testing?**
Only asymptomatic students are eligible to participate in TTS. If a student is asymptomatic and is absent from school, they will continue daily testing when they return to school the following day.
If a student is symptomatic and is absent from school due to this reason, they should stay home, isolate, and get tested for COVID-19. They may not resume participation in TTS if they are absent due to symptoms.
## Glossary
**Close contact:** Being within six feet of an infected person (with or without a face mask) for a total of 15 minutes, in a 24-hour period or having unprotected direct contact with secretions or excretions of a person with confirmed COVID-19 during the infectious period in either an indoor or outdoor setting.
**Confirmed case:** A person who has tested positive for SARS-CoV-2 infection (the virus that causes COVID-19).
**Contact tracing:** Process of identifying individuals who have had close contact (see definition above) with someone infected with COVID-19.
**COVID-19:** Abbreviation for the disease caused by the novel coronavirus SARS CoV-2.
**Infectious period:** Time during which an infected person is contagious and most likely to spread sears to others.
- Infectious period for asymptomatic cases: Two days prior to testing (the date of the swabbing was conducted) until CDC criteria to discontinue isolation are met.
- Infectious period for symptomatic cases: Two days before symptom onset until CDC criteria to discontinue isolation are met.
**Isolation:** The process of separating someone who is sick or who tested positive for COVID-19 away from others by staying home from school, work, and/or other activities while infectious. Isolation lasts a minimum of:
- 10 days from symptom onset if symptomatic.
- 10 days from the date of specimen collection (test) is asymptomatic.
- 20 days for individuals with severely immunocompromising conditions.
**Quarantine:** Process of separating and restricting the movement of individuals who were in close contact with someone who tested positive or had symptoms of COVID-19. Persons in quarantine should self-monitor for 14 days for symptoms and seek medical advice as needed. RIDOH recommends all close contacts of people with COVID-19 get tested on day 5 of quarantine or later.
**RIDE:** Rhode Island Department of Education
**RIDOH:** Rhode Island Department of Health
**Symptomatic individual:** A person who is experiencing one or more of the symptoms of COVID-19 as defined in [CDC guidelines](https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html).
**Testing:** Three types of tests are available to detect COVID-19: viral tests, antigen tests, and antibody tests.
- Viral tests and antigen tests indicate if you have a current infection For viral tests there are two types: molecular tests, often referred to as PCR tests, and antigen tests
- Antibody tests indicate a previous infection.
# 3,760 2022-04-06_California State CDPH - COVID-19 Public Health Guidance for K-12 Schools California.md
METADATA
last updated: 2026-03-06 by BA
file_name: 2022-04-06_California State CDPH - COVID-19 Public Health Guidance for K-12 Schools California.md
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summary_short: California Department of Public Health guidance for K-12 schools during the 2021-22 school year, providing comprehensive safety measures including masking recommendations, physical distancing, ventilation, testing, isolation protocols, and extracurricular activity guidelines to maintain safe in-person instruction during the COVID-19 pandemic.
CONTENT
***INTERNAL TITLE:*** COVID-19 Public Health Guidance for K-12 Schools in California, 2021-22 School Year
**State of California—Health and Human Services Agency**
**California Department of Public Health**
**April 6, 2022**
**TO:** All Californians
**SUBJECT:** COVID-19 Public Health Guidance for K-12 Schools in California, 2021-22 School Year
This guidance is no longer in effect and is for historical purposes only. See the 2022/23 K-12 School Guidance for updated information.
**Related Materials:**
- Group-Tracing Approach to Students Exposed to COVID-19 in K-12 Setting
- 2021-2022 K-12 Schools Guidance Q&A
- CDPH Guidance for the Use of Face Coverings
- K-12 Schools Testing Framework 2021-2022 (PDF)
- Safe Schools for All Hub
- American Academy of Pediatrics COVID-19 Guidance for Safe Schools
- More Languages
The following guidance is designed to keep California K-12 schools open for in-person instruction safely during the COVID-19 pandemic, consistent with the current scientific evidence. The foundational principles are ensuring access to safe and full in-person instruction for all students and keeping equity at the core of all efforts described below. In-person schooling is critical to the mental and physical health and development of our students.
COVID-19 has impacted children in both direct and indirect ways, and California's response to conditions in schools has adapted to the dynamic challenges of the pandemic, based on humility and the evolving scientific understanding of the virus. To-date during the 2021-22 school year, the state has weathered two COVID-19 surges while prioritizing the safety of students and staff and in-person instruction. Hospitalizations for COVID-19 (including pediatric hospitalizations) and disruptions to in-person learning, although never inconsequential, have been substantially lower in California than in comparable states. As the most recent surge wanes and we collectively move forward, the next phase of mitigation in schools focuses on long-term prevention and our collective responsibility to preserve safe in-person schooling.
SARS-CoV-2, the virus that causes COVID-19, is transmitted primarily by inhalation of respiratory aerosols. To mitigate in-school transmission, a multi-layered strategy continues to be important, including but not limited to getting vaccinated, wearing a mask, staying home when sick, isolating if positive, getting tested, and optimizing indoor air quality.
COVID-19 vaccination for all eligible people in California, including teachers, staff, students, and all eligible individuals sharing homes with members of our K-12 populations is crucial to protecting our communities. More information on how to promote vaccine access and uptake is available on the California Safe Schools Hub and Vaccinate All 58 – Let's Get to Immunity.
On February 28, 2022, California announced that, based on a review of epidemiologic indicators and modeling projections, the universal indoor mask mandate in K-12 school settings would transition to a strong recommendation after March 11, 2022.
Masks remain one of the most simple and effective safety mitigation layers to prevent transmission of SARS-CoV-2. High quality masks, particularly those with good fit and filtration, offer protection to the wearer and optimal source control to reduce transmission to others. To best protect students and staff against COVID-19, CDPH currently strongly recommends continuing to mask indoors in school settings.
CDPH will continue to assess conditions on an ongoing basis to determine if updates to K-12 school guidance are needed, with consideration of the indicators and factors noted below, as well as transmission patterns, global surveillance, variant characteristics, disease severity, available effective therapeutics, modeling projections, impacts to the health system, vaccination efficacy and coverage, and other indicators.
## General Considerations
The guidance below is designed to help K-12 schools continue to formulate and implement plans for safe, successful, and full in-person instruction during the 2021-22 school year. It applies recommendations provided by the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) to the California context. The guidance is effective immediately, unless otherwise stated, and will continue to be reviewed regularly by the California Department of Public Health (CDPH). Additional guidance, including additional requirements, may be issued by local public health officials, local educational agencies, and/or other authorities.
This guidance includes mandatory requirements, in addition to recommendations and resources to inform decision-making. Implementation requires training and support for staff and adequate consideration of student and family needs.
When applying this guidance, consideration should be given to the direct school population and the surrounding community. Factors include: (1) community level indicators of COVID-19 and their trajectory; (2) COVID-19 vaccination coverage in the community and among students, teachers, and staff; (3) local COVID-19 outbreaks or transmission patterns; (4) indoor air quality at relevant facilities; (5) availability and accessibility of resources, including masks and tests; (6) ability to provide therapeutics in a timely and equitable manner as they become available; (7) equity considerations, including populations disproportionately impacted by and exposed to COVID-19; (8) local demographics, including serving specialized populations of individuals at high risk of severe disease and immunocompromised populations; and (9) community input, including from students, families, and staff.
In workplaces, employers are subject to the Cal/OSHA COVID-19 Emergency Temporary Standards (ETS) or in some workplaces the Cal/OSHA Aerosol Transmissible Diseases Standard, and should consult those regulations for additional applicable requirements.
## Safety Measures for K-12 Schools
1. Masks
a. No person can be prevented from wearing a mask as a condition of participation in an activity or entry into a school, unless wearing a mask would pose a safety hazard (e.g., watersports).
b. CDPH strongly recommends that all persons (e.g., students and staff) wear masks in K-12 indoor settings, with consideration of exemptions per CDPH face mask guidance.
c. Persons exempted from wearing a face covering due to a medical condition are strongly recommended to wear a non-restrictive alternative, such as a face shield with a drape on the bottom edge, as long as their condition permits it.
d. Schools must develop and implement local protocols to provide masks to students who inadvertently fail to bring a face covering to school and desire to use one.
e. Public schools should be aware of the requirements in AB 130 (Chapter 44 of the Statutes of 2021) to offer independent study programs for the 2021-22 school year.
f. In situations where use of masks is challenging due to pedagogical or developmental reasons, (e.g., communicating or assisting young children or those with special needs), a face shield with a drape (per CDPH guidelines) (PDF) may be considered instead of a mask while in the classroom.
2. Physical distancing
a. CDPH recommends focusing on the other mitigation strategies provided in this guidance instead of implementing minimum physical distancing requirements for routine classroom instruction.
3. Ventilation recommendations
a. For indoor spaces, indoor air quality should be optimized, which can be done by following CDPH Guidance on Ventilation of Indoor Environments and Ventilation and Filtration to Reduce Long-Range Airborne Transmission of COVID-19 and Other Respiratory Infections: Considerations for Reopened Schools (PDF), produced by the CDPH Air Quality Section.
4. Recommendations for staying home when sick and getting tested
a. Follow the strategy for Staying Home when Sick and Getting Tested from the CDC.
b. Get tested for COVID-19 when symptoms are consistent with COVID-19.
c. Advise staff members and students with symptoms of COVID-19 infection not to return for in-person instruction until they have met the following criteria:
1. At least 24 hours have passed since resolution of fever without the use of fever-reducing medications; AND
2. Other symptoms are improving; AND
3. They have a negative test for SARS-CoV-2, OR a healthcare provider has provided documentation that the symptoms are typical of their underlying chronic condition (e.g., allergies or asthma) OR a healthcare provider has confirmed an alternative named diagnosis (e.g., Streptococcal pharyngitis, Coxsackie virus), OR at least 10 days have passed since symptom onset.
4. If the student or staff member tests positive for SARS-CoV-2, follow the guidance for isolation in Section #10 below.
5. Screening testing recommendations
a. CDPH has a robust State- and Federally-funded school testing program and subject matter experts available to support school decision making, including free testing resources to support screening testing programs (software, test kits, shipping, testing, etc.).
1. Resources for schools interested in testing include: California's Testing Task Force K-12 Schools Testing Program, K-12 school-based COVID-19 testing strategies (PDF) and Updated Testing Guidance; The Safe Schools for All state technical assistance (TA) portal; and the CDC K-12 School Guidance screening testing considerations (in Section 1.4 and Appendix 2) that are specific to the school setting.
6. Case investigation and reporting
a. Per AB 86 (2021) and California Code Title 17, section 2500, schools are required to report COVID-19 cases to the local public health department.
b. Schools or LEAs should have a COVID-19 liaison to assist the local health department with activities related to COVID-19.
7. Recommendations for Students exposed to COVID-19
Schools may consider permitting asymptomatic exposed students, regardless of their COVID-19 vaccination status or location of exposure, to continue to take part in all aspects of K-12 schooling, including sports and extracurricular activities, unless they develop symptoms or test positive for COVID-19. It is strongly recommended that exposed students wear a well-fitting mask indoors around others for at least 10 days following the date of last exposure, if not already doing so.
a. Exposed students, regardless of COVID-19 vaccination status, should get tested for COVID-19 with at least one diagnostic test (e.g., an FDA-authorized antigen diagnostic test, PCR diagnostic test, or pooled PCR test) obtained within 3-5 days after last exposure, unless they had COVID-19 within the last 90 days.
1. Exposed students who had COVID-19 within the last 90 days do not need to be tested after exposure but should monitor for symptoms. If symptoms develop, they should isolate and get tested with an antigen test.
2. If the exposed student has symptoms consistent with COVID-19, they should stay home, get tested and follow the guidance in Section #4 above.
3. If the exposed student tests positive for COVID-19, follow the guidance for isolation in Section #10 below.
b. Follow the Group Tracing Guidance for notification recommendations for exposures that occur in a school setting.
Sections 8-9 have been retired.
10. Isolation recommendations
a. Everyone who is infected with COVID-19, regardless of vaccination status, previous infection or lack of symptoms, follow the recommendations listed in Table 1 (Isolation) of the CDPH Guidance on Isolation and Quarantine for the General Public.
11. Hand hygiene recommendations
a. Teach and reinforce washing hands, avoiding contact with one's eyes, nose, and mouth, and covering coughs and sneezes among students and staff.
b. Promote hand washing throughout the day, especially before and after eating, after using the toilet, and after handling garbage or removing gloves.
c. Ensure adequate supplies to support healthy hygiene behaviors, including soap, tissues, no-touch trashcans, face coverings, and hand sanitizers with at least 60 percent ethyl alcohol for staff and children who can safely use hand sanitizer.
12. Cleaning recommendations
a. In general, routine cleaning is usually enough to sufficiently remove potential virus that may be on surfaces. Disinfecting (using disinfectants on the U.S. Environmental Protection Agency COVID-19 list) removes any remaining germs on surfaces, which further reduces any risk of spreading infection.
b. For more information on cleaning a facility regularly, when to clean more frequently or disinfect, cleaning a facility when someone is sick, safe storage of cleaning and disinfecting products, and considerations for protecting workers who clean facilities, see Cleaning and Disinfecting Your Facility.
c. If a facility has had a sick person with COVID-19 within the last 24 hours, clean AND disinfect the spaces occupied by that person during that time.
d. Drinking fountains may be open and used by students and staff. Routine cleaning is recommended.
13. Food service recommendations
a. Maximize physical distance as much as possible while eating (especially indoors). Using additional spaces outside of the cafeteria for mealtime seating such as classrooms or the gymnasium can help facilitate distancing. Arrange for eating outdoors as much as feasible.
b. Per routine practice, surfaces that come in contact with food should be washed, rinsed, and sanitized before and after meals.
c. There is no need to limit food service approaches to single use items and packaged meals.
14. Vaccination verification considerations
a. To inform implementation of prevention strategies that vary by vaccination status (testing, contact tracing efforts, and quarantine and isolation practices), refer to the CDPH vaccine verification recommendations.
15. COVID-19 Safety Planning Transparency Recommendations
a. In order to build trust in the school community and support in-person instruction, it is a best practice to provide transparency to the school community regarding the school's safety plans. At a minimum, it is recommended that all local educational agencies (LEAs) post a safety plan that communicates the safety measures in place for 2021-22, on the LEA's website and at schools and disseminate the plan to families.
**Note:** With the approval of the federal American Rescue Plan, each local educational agency receiving Elementary and Secondary School Emergency Relief (ARP ESSER) funds is required to adopt a Safe Return to In-Person Instruction and Continuity of Services Plan and review it at least every six months for possible revisions. The plan must describe how the local educational agency will maintain the health and safety of students, educators and other staff. Reference the Elementary and Secondary School Relief Fund (ESSER III) Safe Return to In-Person Instruction Local Educational Agency Plan Template (PDF).
16. School-Based Extracurricular Activities
The requirements and recommendations in this guidance apply to all extracurricular activities that are operated or supervised by schools, and all activities that occur on a school site, whether or not they occur during school hours, including, but not limited to, sports, band, chorus, and clubs.
Indoor mask use remains an effective layer in protecting against COVID-19 infection and transmission, including during sports, music, and related activities, especially activities with increased exertion and/or voice projection, or prolonged close face-face contact. Accordingly:
- Masks are strongly recommended indoors at all times for teachers, referees, officials, coaches, and other support staff.
- Masks are strongly recommended indoors for all spectators and observers.
- Masks are strongly recommended indoors at all times when participants are not actively practicing, conditioning, competing, or performing. Masks are also strongly recommended indoors while on the sidelines, in team meetings, and within locker rooms and weight rooms.
- When actively practicing, conditioning, performing, or competing indoors, masks are strongly recommended by participants even during heavy exertion, as practicable. Individuals using instruments indoors that cannot be played with a mask (e.g., wind instruments) are strongly recommended to use bell coverings and maintain a minimum of 3 feet of physical distancing between participants. If masks are not worn (or bell covers are not used) due to heavy exertion, it is strongly recommended that individuals undergo screening testing at least once weekly, unless they had COVID-19 in the past 90 days. An FDA-authorized antigen test, PCR test, or pooled PCR test is acceptable for evaluation of an individual's COVID-19 status.
## Additional considerations or other populations
1. Recommendations for students with disabilities or other health care needs
a. When implementing this guidance, schools should carefully consider how to address the legal requirements related to provision of a free appropriate public education and requirements to reasonably accommodate disabilities, which continue to apply.
b. For additional recommendations for students with disabilities or other health care needs, refer to guidance provided by the CDC, AAP, and the Healthy Kids Collaborative.
2. Visitor recommendations
a. Schools should review their rules for visitors and family engagement activities.
b. Schools should limit nonessential visitors, volunteers, and activities involving external groups or organizations with people who are not fully vaccinated.
c. Schools should not limit access for direct service providers, but can ensure compliance with school visitor polices.
d. Schools should continue to emphasize the importance of staying home when sick. Anyone, including visitors, who have symptoms of infectious illness, such as influenza or COVID-19, should stay home and seek testing and care.
3. Boarding schools may operate residential components under the following guidance
a. Strongly recommend policies and practices to ensure that all eligible students, faculty and staff have ample opportunity to get vaccinated.
b. Strongly recommend that unvaccinated students and staff be offered regular COVID-19 screening testing.
c. Consider students living in multi-student rooms as a "household cohort." Household cohort members, regardless of vaccination status, do not need to wear masks when they are together without non-household cohort members nearby. If different "household cohorts" are using shared indoor space when together during the day or night, continue to strongly recommend mask use, and healthy hygiene behaviors for everyone.
The non-residential components of boarding schools (e.g., in-person instruction for day students) are governed by the guidelines as other K-12 schools, as noted in this document.
Childcare settings and providers remain subject to separate guidance.
*Originally published on July 12, 2021*
# 2,970 2024-03-01_RADx Tech Report on COVID-19 Diagnostic Technologies.md
METADATA
last updated: 2026-03-06 by BA
file_name: 2024-03-01_RADx Tech Report on COVID-19 Diagnostic Technologies.md
file_date: 2024-03-01
title: 2024-03-01_RADx Tech Report on COVID-19 Diagnostic Technologies
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summary_short: The RADx Tech March 2024 report summarizes NIH/NIBIB’s Rapid Acceleration of Diagnostics program, describing its stage-gated “innovation funnel,” ITAP collaboration with FDA, and partnerships used to validate, authorize, and scale COVID-19 tests. It highlights program outcomes (e.g., dozens of EUAs, billions of tests/test products enabled, and major shifts to at-home/POC testing) and outlines ongoing expansion into multiplex and accessibility-focused diagnostics for future public health needs.
CONTENT
***INTERNAL TITLE:*** RADx Tech: Delivering COVID-19 Diagnostic Technologies at Unprecedented Speed and Scale
MARCH 2024
## Table of Contents
Executive Summary .......................................................... 2
Program Overview and Structure ............................................. 2
Program Accomplishments .................................................... 4
Community Engagement ....................................................... 5
Impact and the Path Moving Forward ........................................ 7
Conclusion ................................................................ 8
## Executive Summary
The Rapid Acceleration of Diagnostics (RADx ®) Tech program was launched in April 2020 as a collaboration between the Office of the Director (OD) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB). As a part of the overall RADx initiative, RADx Tech's focus was to generate a robust pipeline of innovative diagnostic technologies to provide tests for COVID-19 to the nation. This effort enabled the validation, de-risking, manufacturing, scale-up, and deployment of novel at-home and point-of-care (POC) tests through an optimized pipeline in as little as six months. As a result, RADx Tech produced a U.S. capacity of over 7.8 billion tests and test products during the pandemic and shifted testing from labs to home and POC. RADx Tech continues to develop tests that target unmet needs, such as multiplex tests for respiratory illnesses and more accessible home tests that can be used independently by persons with disabilities.
## Program Overview and Structure
NIBIB established the RADx Tech innovation funnel, a milestone-driven funding structure, to maximize the efficiency of developing and deploying COVID-19 testing technologies. It compressed the customary technology development process from years to months. The program leveraged the existing NIBIB Point-of-Care Technologies Research Network (POCTRN) infrastructure, including three core resource centers that support test validation, clinical studies, and test deployment.
The RADx Tech innovation funnel is structured to provide escalating support to awardees in a stage-gated manner. Technology proposals undergo a highly competitive, accelerated three- phase review and selection process to identify the best candidates for over the counter (OTC), POC tests, lab tests, and test products for COVID-19. Test developers are matched with technical, business, and manufacturing experts to guide the development process and increase the chance of success.
Over 900 collaborators from government, academia, and the private sector partnered to make the funnel mechanism a success. The program began with a national call for applications, seeking innovative diagnostic technologies that could be readied for regulatory authorization within months. Subsequent solicitations to meet emerging needs has led to more than 1,000 submissions to date. Applications were evaluated by a diverse team of external consultants and experts from across the NIH.
Projects that were deemed promising by a panel based on proposed technical, clinical, regulatory, and commercial factors then underwent an intensive review process. The first step in this process was a two-week examination during which a team of RADx Tech experts worked closely with developers to understand all aspects of the technology and its promise for rapid deployment to the market. Technologies that were approved by the practitioners then moved into a de-risking phase, where detailed, milestone-driven workplans were developed and executed to mitigate technology risk. RADx Tech experts worked closely with companies during this phase and coordinated independent analytical and clinical validation through the RADx Tech resource cores. Successful projects moved into the final deployment phase, during which studies were conducted to support Food and Drug Administration (FDA) Emergency Use Authorization (EUA). During this phase, RADx worked with the companies to support and accelerate manufacturing and commercialization.
Since launching in 2020, there have been three separate solicitations from RADx Tech, each with a different focus to spur innovation and commercialization of testing technologies. The first instance of the RADx Tech innovation funnel urged all scientists and inventors with a rapid testing technology to compete in a national COVID-19 testing challenge for a share of up to $500 million over all phases of development. The goal of this first call for applications was to make millions of accurate and easy-to-use tests per week available to all Americans by the end of summer 2020. The second RADx Tech solicitation sought proposals to further advance SARS- CoV-2 testing technologies in order to accelerate validation, manufacturing scale up, and commercialization of innovative COVID-19 testing capabilities including multiplex tests, tests with better performance such as a level of detection comparable to lab-based tests, and tests that could detect variants. This solicitation only considered proposals for technologies in an advanced stage of readiness that could reach the market in 2021. The most recent funnel, RADx Tech III, had two distinct solicitations that applicants could apply to. The first solicitation was for accessible OTC tests that can be used by persons with disabilities, specifically blindness, low vision, fine motor skill difficulties, and aging-related disabilities. The second solicitation focused on improving performance of OTC and POC tests as well as integrating universal design features to ensure ease of use. Tests should aim to minimize or eliminate the need for serial testing and performance should be unaffected by variants. RADx Tech III has recently completed application review and has funded a total of 25 Work Package 1 projects (WP1s).
RADx Tech adopted elements of the Innovation Funnel in 2021 to greatly expand the U.S. test market by accelerating FDA authorization of tests that were already being produced and sold in other countries. In close collaboration with the FDA, RADx Tech launched the Independent Test Acceleration Program (ITAP) to rapidly validate the performance of non-U.S. tests and shave weeks to months off the regulatory authorization timeline. ITAP independently conducted analytical and clinical analysis of tests according to protocols agreed upon by the FDA, allowing the FDA to authorize new tests in a matter of days after submission of the RADx data.
## Program Accomplishments
Since launching in 2020, the RADx Tech program has yielded 55 FDA EUA tests and, as of April 2023, has produced a U.S. capacity of more than 7.8 billion tests and test products. By producing an abundance of OTC tests, RADx Tech enabled the shift of testing away from central labs and into peoples’ homes. Other notable achievements include:
* Evaluation of 1,042 proposals, submitted from 47 different states/territories and 23
countries
* Over 250 organizations were funded to develop diagnostic technologies
* 242 applications (15-20% of total applications) were reviewed in depth by RADx
expert teams
* 68 projects received funding for de-risking and validation
* 50 projects received funding for authorization and deployment
* A POC test received an EUA within 10 weeks of the program launch
* The first ever EUA for a COVID-19 OTC diagnostic-test in December 2020
* 18 FDA-authorized OTC COVID-19 tests
* Best practice guidelines published on June 20, 2023, for accessible test designs that
can be used independently by people with disabilities
* The first EUA granted for a test that aligns with accessibility design principles
* 125 publications by RADx Tech members and collaborators
Coordination with other federal agencies has been key to the success of this program. The ITAP partnership between the NIH and the FDA is an extension of RADx Tech and streamlines regulatory authorization of mature technologies. To date, 12 OTC COVID-19 diagnostic devices have received authorization with support from ITAP. ITAP accounts for approximately half of the increased testing capacity in the U.S.
Close coordination with Administration for Strategic Preparedness and Response (ASPR) and Biomedical Advanced Research and Development Authority (BARDA) resulted in securing supplies and other material resources for RADx-supported projects, while collaboration with the Department of Defense (DoD) early in the pandemic helped overcome supply chain bottlenecks.
## Community Engagement
In April 2022, in response to public demand, NIBIB partnered with Health & Human Services (HHS) agencies and other organizations to address the need for COVID-19 home tests that could be used independently by people with disabilities. Working closely with disability advocates and design experts, the RADx COVID-19 Test Accessibility program published a best-practices document (hosted on the [U.S. Access Board website](https://www.access-board.gov/tad/radx/)) with universal design recommendations for test developers. Additionally, RADx Tech launched its third innovation funnel to support the development of accessible and high-performance tests. To date, RADx Tech has funded five projects that aim to improve accessibility for test users and recently supported an EUA for the first at-home COVID-19 test to conform to accessible design principles. Efforts are ongoing to bring more widely accessible tests to the market.
In addition to working closely with other federal agencies and advocacy groups, the RADx Tech program established multiple programs to aid in COVID-19 test distribution and case tracking throughout the U.S.. The RADx Mobile At-Home Reporting through Standards (MARS) program promotes an approach built on IT communication standards to report COVID-19 self- test results and establishes best practices for future reporting of remote diagnostics. By standardizing how self-reported test results are collected, RADx MARS can transmit the data to state, federal, and local health systems. The Make My Test Count website for self-reporting results of home tests launched in November 2022 and effectively replaced manufacturer apps to provide a single reporting pathway for home test results to state and federal databases. The site currently supports reporting for all FDA-authorized/cleared OTC tests for COVID-19 and COVID-19/Flu multiplex tests, with over 152,000 test results self-reported to date.
Say Yes! COVID Test (SYCT) was a cooperative effort with state and local health departments, NIH, and Centers for Disease Control and Prevention (CDC). The program offered access to free, rapid, at-home COVID-19 testing in select communities throughout the U.S. The goal was to pilot test distribution mechanisms and understand if access to frequent, at-home testing for COVID-19 impacts community spread of the virus. Through SYCT, more than 2 million COVID-19 home tests have been distributed and results demonstrated that home testing can impact behavior and reduce transmission in a community. Lessons learned from this effort, along with increased test availability through ITAP, enabled the USG [covidtest.gov](https://www.covidtest.gov/) distribution of free tests nationwide. More recently, the RADx Tech program launched the Home Test-to-Treat program: an entirely virtual community health intervention that provides free COVID-19 tests, telehealth consultations, and treatments to eligible individuals in their own homes. The program initially launched in three geographically targeted areas and has since expanded to eligible participants nationwide and added influenza testing and treatment in addition to COVID-19.
Home Test to Treat is a collaboration between NIBIB, ASPR, and CDC. The goal of this program is to better understand how technologies such as at-home tests and telemedicine can improve healthcare access for individuals across the country.
## Impact and the Path Moving Forward
The success of RADx Tech can be attributed in part to three key factors. First, providing an interdisciplinary consulting team to each test developer allowed projects to quickly accelerate past development hurdles and gave each team rapid access to in-kind program resources, such as analytical and clinical testing, as the needs arose. Second, the availability of flexible, rapid, and responsive funding mechanisms allowed stage-gated funding that focused increasing resources on the most successful projects. Third, close partnerships with HHS and other federal agencies created synergies that accelerated the entire development and deployment timeline across the domains of individual agencies. The ITAP collaboration with the FDA and the supply chain partnership with the DoD are notable examples of the power of government partnership to speed the path of new technologies to the public. While these relationships initially took time, they helped rapidly accelerate progress once established. Keeping a “warm base” of engagement in non-emergency times could help accelerate future efforts and avoid starting from square one.
Another important lesson learned in RADx Tech is the importance of universal design principles in developing technologies for home use. Many of the RADx Best Practices for Accessible Design can be applied to any technology marketed to the public and serve as a unique resource to the entire home medical device industry. Consideration of these principles benefits everyone through greater simplicity and usability and ensures that everyone can use home medical devices independently.
The RADx Tech Innovation Funnel and ITAP approaches can be effectively applied beyond COVID-19 to address a range of unmet health needs. RADx has expanded to develop multiplex home and POC diagnostic products for COVID-19, Flu, and RSV. ITAP has enabled two EUAs for multiplex COVID/flu tests to date. ITAP has also enabled the first EUA for a POC Mpox (formally known as monkeypox) diagnostic and has submitted an EUA package for an Mpox home self-swabbing kit. By maintaining the RADx infrastructure, NIBIB is leveraging funding from government and non-government organizations to solve other pressing health needs, including:
* POC multiplex tests for the detection of lesion-presenting diseases including Mpox,
HSV1/2, VZV, and Syphilis
* A POC test for Hepatitis C to support a program to eliminate the disease in the U.S.
* A Fetal Monitoring Challenge to accelerate development of technologies to reduce fetal
mortality
* Blueprint MedTech, a program to develop groundbreaking medical devices for pain and
diseases of the nervous system
* A Maternal Health Challenge to develop devices to reduce maternal mortality in
underserved settings
* Advanced Platforms for HIV Viral Load Testing at the POC to reduce HIV transmission
## Conclusion
The RADx Tech program has been extremely successful in accelerating the development and availability of COVID-19 diagnostics. The RADx Tech infrastructure has been adapted to develop and translate technologies to address a range of other public health concerns, such as fetal and maternal health, nervous system disorders, Mpox, Hepatitis-C, and HIV. RADx Tech will continue to support meaningful projects, such as the Home Test-to-Treat and Test Accessibility programs, to help address community health inequity issues within our nation. RADx Tech is well-positioned to adapt to future needs within the COVID-19 landscape, and, through funding partnerships, to respond to other emerging pathogens and health emergencies beyond COVID-19.
# 2,202 FL INDEX_Testing Programs and Playbooks Index SHARED.md
METADATA
last updated: 2026-03-06 by BA
file_name: FL INDEX_Testing Programs and Playbooks Index SHARED.md
file_date: 2021-05-21
title: Compilation of Links to Testing Programs and Playbooks - Index SHARED (May 2021)
category: various
subcategory: external-programs-reports
tags: compilation, testing programs
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conversion: pandoc
license: CC BY 4.0 - https://creativecommons.org/licenses/by/4.0/
tokens: 2202
words: 604
notes:
summary_short: The “Testing Programs and Playbooks” index is a curated compilation of links and brief notes on COVID-19 testing strategies, school surveillance programs, pooled-testing pilots, lab partners, and related guidance (national and state). It’s useful for quickly finding comparable playbooks, vendor/program examples, and operational references when designing or evaluating a testing program.
CONTENT
### National Links
[https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf](https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf)
[https://covidactiongroup.net/](https://covidactiongroup.net/)
[https://www.covidcollaborative.us/](https://www.covidcollaborative.us/)
[Rockefeller new plan](https://www.prnewswire.com/news-releases/the-rockefeller-foundations-new-plan-provides-covid-19-testing-strategy-to-open-all-of-americas-public-schools-by-march-301194114.html)
### CALIF State Testing Lab
[https://testing.covid19.ca.gov/wp-content/uploads/sites/332/2020/11/CDPH-Valencia-Branch-Laboratory-Playbook.pdf](https://testing.covid19.ca.gov/wp-content/uploads/sites/332/2020/11/CDPH-Valencia-Branch-Laboratory-Playbook.pdf)
Perkin Elmer lab - sesntive PCR test (swab only based?)
Color providing digital - just raised $167M for last mile healthcare
CA Safe Schools $2B [https://youtu.be/DmHNwJalkPg?t=1000](https://youtu.be/DmHNwJalkPg?t=1000)
Naomi Bardoch point person from UCSF
[https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/COVID-19Guidance.aspx#](https://www.cdph.ca.gov/Programs/OSPHLD/LFS/Pages/COVID-19Guidance.aspx#)
[https://testing.covid19.ca.gov/covid-19-testing-task-force-laboratory-list/](https://testing.covid19.ca.gov/covid-19-testing-task-force-laboratory-list/)
### Memphis and Poplar
[https://covid19.memphistn.gov/test-to-protect/](https://covid19.memphistn.gov/test-to-protect/)
Lists Poplar and 2 other labs
[Home swabbing video](https://www.youtube.com/watch?v=Qs8FMxchFC8)
Looks like they are using Steripak swabs
[https://dailymemphian.com/article/17167/how-memphis-medical-lab-poplar-healthcare-mobilized-to-right-covid](https://dailymemphian.com/article/17167/how-memphis-medical-lab-poplar-healthcare-mobilized-to-right-covid)
Dr. Manoj Jain, a local infectious disease physician, advising the city on its COVID-19 response
Jim Sweeney - CEO Poplar
[https://www.phc-covid.com/organization/pod-testing/](https://www.phc-covid.com/organization/pod-testing/)
### Ginkgo
5 week pilot 100's [https://twitter.com/jrkelly/status/1341852769918078976](https://twitter.com/jrkelly/status/1341852769918078976)
Ned says internall called pooled swabbing "Randy method"
Shared them on detailed prodecured for swabbing and on-site pooling (get link)
Looks like they are using green shaft cleanroom swabs (\*ask Christina)
[https://www.concentricbyginkgo.com/our-plan-to-provide-simple-affordable-testing-to-every-school-in-america/](https://www.concentricbyginkgo.com/our-plan-to-provide-simple-affordable-testing-to-every-school-in-america/)
Looks like they are planning this as a sample collection program far beyond their own NGS test
"Scalable: Existing labs running individual molecular tests (i.e. PCR) can also run pooled samples. This means pooling could multiply our existing testing capacity by twenty times or more"
_X/Twitter Screenshots_
Matt Condon Retweeted
Kim Driscoll @MayorDriscoll · Jan 3
Starting tomorrow, thru Jan 6th all @SalemSchoolsk12 students + family members living in the same household are able to participate in FREE COVID-19 testing. This testing is a saliva based model. A sample pic of the test kit is below - it’s super easy - just spit in the tube!
_Photos of testing kits, before and after usage_
Matt Condon @condonmatt · Dec 24, 2020
@Ginkgo Bioworks Launches COVID-19 Pooled Classroom Testing Pilot for K-12 Schools. Collins Middle @cmshappenings was one of the first schools to provide testing for our scholars. @SalemSchoolsk12 @SzrikeSPS #LEGACY 🦨
Ginkgo Bioworks Launches COVID-19 Pooled Clas…
/PRNewswire/ – Today Ginkgo Bioworks, the organism company, announced the launch of its pil…
prnewswire.com
Dueling projects, Salem has connections
### NSV
[https://www.glenbard87.org/covid-19-surveillance-faq/](https://www.glenbard87.org/covid-19-surveillance-faq/)
[https://www.safeguardscreeningllc.com/](https://www.safeguardscreeningllc.com/) Ed Campbell saliva LAMP testing company
### JCMA
provides software and logistics solution for school testing, takes care of running entire program and delivers tubes to labs to run
[Google Doc on JCMA](https://docs.google.com/document/d/1HGp-SwfV8PWSnnsy_t4GnQydNxCyQUOGnByHy52Z1mw/edit?usp=sharing)
### Darwin Biosceinces
Colorado
### O'Connor
[https://openresearch.labkey.com/wiki/Coven/page.view?name=field-testing](https://openresearch.labkey.com/wiki/Coven/page.view?name=field-testing)
[https://openresearch.labkey.com/wiki/Coven/page.view?name=antigen\_testing\_schools](https://openresearch.labkey.com/wiki/Coven/page.view?name=antigen_testing_schools)
### Wellesley Schools in Mass
[https://wellesleyps.org/viral-testing/](https://wellesleyps.org/viral-testing/)
“WPS COVID-19 Pool Surveillance Testing”
*“DO YOUR PART: Help Schools Start & Stay in Person”*
Contracted with [Mirimus Saliva Clear website](https://www.salivaclear.com/)
Once a week, on a designated morning, each staff member and student picks up their barcoded SalivaClear sample collection kit from school. They register it via a Google Form, entering in their barcode number and their consent agreement. They then **self-collect** their saliva sample (guided by visual and video instruction materials), seal it, and immediately return it to the school staff.
The samples are then transported to a Mirimus clinical lab, where they are **pooled and tested the same day**. Any pools that test positive will be immediately retested at a pool level of 2 samples.
The school is notified of any pair of samples that contains a positive result, and the 2 people in that pair are directed to obtain a physician’s order for a diagnostic COVID test. The diagnostic tests may be performed by Mirimus (which uses the [MeentaSafe reporting platform](https://marketplace.meenta.io/)) or by another clinical lab.
### Mirimus
[Mirimus Saliva Clear website](https://www.salivaclear.com/)
uses the [MeentaSafe reporting platform](https://marketplace.meenta.io/)
### Mass Schools
[Massachusetts Dept of Education Memo - Jan 8](https://docs.google.com/document/d/1nyWydcwPYk9sM5kbzpk2WDA0ZELwS7wD1reLOcoXWII/edit?usp=sharing)
[https://covidedtesting.com/pooled-testing-in-watertown-public-schools](https://covidedtesting.com/pooled-testing-in-watertown-public-schools)
### UnitedHealth Group Visby School Pilot
### UnitedHealth Group Calculator and Plans
[https://calculator.unitedinresearch.com/complex\_dashboard](https://calculator.unitedinresearch.com/complex_dashboard)
### Rockefeller
[Rockefeller - Dec20 Plan SHARED](https://drive.google.com/file/d/15I8sCoo7J_-jg4P9Emdygejyw3CHxlwZ/view?usp=sharing)
[Covid-19 Antigen Testing in K-12 Schools: Early Lessons from Six Pilot Sites](https://www.rockefellerfoundation.org/report/covid-19-antigen-testing-in-k-12-schools-early-lessons-from-six-pilot-sites/)
### ICGEB NEB Gates LAMP project in Africa
[https://www.icgeb.org/gates-foundation-to-fund-icgeb-collaboration-with-new-england-biolabs/](https://www.icgeb.org/gates-foundation-to-fund-icgeb-collaboration-with-new-england-biolabs/)
[https://www.icgeb.org/icgeb-cape-town-covid-19-diagnostic-testing-activities/](https://www.icgeb.org/icgeb-cape-town-covid-19-diagnostic-testing-activities/)
[https://www.icgeb.org/wp-content/uploads/2020/03/Protocol002\_Covid19\_RT\_qPCR.pdf](https://www.icgeb.org/wp-content/uploads/2020/03/Protocol002_Covid19_RT_qPCR.pdf)
[https://www.cnbc.com/2020/04/29/coronavirus-testing-chief-says-no-way-on-earth-us-can-test-5-million-a-day.html](https://www.cnbc.com/2020/04/29/coronavirus-testing-chief-says-no-way-on-earth-us-can-test-5-million-a-day.html)
### Recent Papers
[Curative NP Comparison](https://www.medrxiv.org/content/10.1101/2021.01.26.21250523v1.full.pdf)
[BinaxNow MD DPH](https://www.medrxiv.org/content/10.1101/2021.01.09.21249499v1)