• My organization is using over-the-counter (OTC) or home tests. Do we still need a CLIA waiver?

     

     

    It depends on who is gathering the samples and reading the results of the tests.

    Your organization does NOT need a CLIA waiver if

    • Adults being tested are swabbing themselves or providing saliva samples AND reading the results of their own tests
    • Children are swabbing themselves or being swabbed by their parents/guardians, AND the parent/guardian reading the results of their children's tests

    Your organization DOES need a CLIA waiver if

    • Adults being tested are being swabbed by someone else
    • Adults swab themselves, and another person looks at the test result and decides whether it's negative or positive
    • Children are being swabbed by an adult other than a parent/guardian
    • Children are swabbing themselves, and someone who is not the children's parent/guardian looks at the test result and decides whether it's negative or positive

    For further details, see the links below.

    CMS - Over The Counter (OTC) Home Testing and CLIA Applicability

    CDC - Guidance for SARS-CoV-2 Rapid Testing Performed in Point-of-Care Settings

  • I understand we need a CLIA waiver to implement most tests on-site. What is a CLIA waiver, and what is involved in obtaining one?

     

    As their website states, “The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA). . . . The objective of the CLIA program is to ensure quality laboratory testing.”

    Normally, labs need CLIA certification from CMS in order to perform testing. However, the FDA allows some tests to be performed at locations that do not have CLIA certification, as long as those sites have a CLIA waiver.

    Your organization can apply for a CLIA waiver via the CMS CLIA website or your local State Agency.

    FDA — CLIA Waiver by Application

    CMS — How to obtain a CLIA Certificate of Waiver

  • How should my organization go about implementing a testing program?

     

     

    The COVID-19 Testing Implementation Guide This guide provides practical guidance on the implementation of a COVID-19 testing program, including consideration of various supply, personnel, facilities, and documentation best practices.

    Open and Safe Schools This website, created by the Shah Family Foundation in partnership with the CDC, provides schools and early education centers with the tools to create a comprehensive COVID-19 testing program. It also includes a list of vendors as well as a database of contacts at schools willing to share their experiences with COVID-19 testing.

     

    What You Should Know About COVID-19 Testing in Schools Information and guidance on school testing programs, from the CDC.

    School Testing for COVID-19 The CDC's communication toolkit for testing programs in K-12 schools.

    Chiefs for Change Project Planning Workbook This downloadable Excel spreadsheet, created by the educational leadership group Chiefs for Change, guides administrators step-by-step through the process of designing, implementing, and managing testing in a school district.

  • I can’t afford the testing the When To Test Calculator for Organizations recommends. What should I do?

     

    First, review the questions and your inputs to make sure that your responses accurately reflect your current scenario. Misunderstanding a Calculator input could result in more costly recommendations than are necessary.

    Once you’ve determined that the results are accurate, a number of options exist:

    1. Consider how your organization might improve mitigation measures other than testing, such as by incentivizing or requiring vaccination and booster shots, encouraging or requiring everyone to wear high-quality masks properly and consistently, keeping better track of close contacts, or decreasing the size of cohorts that participate in unmasked activity together. Use the Calculator to model various scenarios and predict how improvements in these areas can change your test recommendations.
    2. Seek resources (such as those listed below) to address the cost of a recommended COVID-19 testing protocol.
    3. If your organization is unable to achieve the levels of mitigation required for safety, consider alternatives to operating in person.

    Every School Safe and Open: Federal Funding A complete list of all of the funding options the federal government has provided for COVID-19 mitigation in K-12 schools, created by SalivaDirect in partnership with the Rockefeller Foundation.

    Federal Support for School COVID-19 Testing — The federal government is supporting COVID-19 testing in K-12 schools via four funding streams. Information and links are available on the Open and Safe Schools website, created by the Shah Family Foundation in partnership with the CDC.

    US Department of Health and Human Services Expanded Testing Coordination Hubs 

    These four regional hubs aim to provide COVID-19 testing for schools and congregate settings such as nursing homes within their geographic areas.

    Midwest Hub (Colorado, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, South Dakota, Utah, Wisconsin, Wyoming)

    Northeast and South Hubs (Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, West Virginia) 

    West Hub (Alaska, Arizona, California, Hawaii, Idaho, Nevada, Oregon, Pacific Islands, Washington)

  • How can my K-12 school fund a testing program?

     

    The federal government is supporting COVID-19 testing in K-12 schools via a number of different funding streams. Three of the main ones are:

    Epidemiology and Laboratory Capacity (ELC) Reopening Schools: This money is earmarked specifically to support COVID-19 testing programs in K-12 schools and is flowing through the departments of public health in the US states, territories, and five of the largest cities (New York, Chicago, Los Angeles, Houston, and Philadelphia). For information on how your school can access this funding, contact your state, territorial, or city department of public health.

    Operation Expand Testing (ET): This program, administered by the US Department of Health and Human Services in partnership with the US Department of Defense, has established four coordinating hubs to provide testing for K-12 schools and other “congregate settings” (e.g., homeless shelters and nursing homes) in their respective regions. Schools can contact their regional hubs directly, using the links below.

    • Midwest Hub — Colorado, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, South Dakota, Utah, Wisconsin, Wyoming
    • Northeast and South Hubs — Alabama, Arkansas, Connecticut, Delaware, Florida, Georgia, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Mississippi, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, West Virginia
    • West Hub — Alaska, Arizona, California, Hawaii, Idaho, Nevada, Oregon, Pacific Islands, Washington

    Elementary and Secondary School Emergency Relief (ESSER): The US Department of Education has awarded a series of these grants to the state educational agencies in 2020 and 2021. For more information on ESSER funds, contact your state department of education.

    A complete list of all of the funding options the federal government has provided for COVID-19 mitigation in K-12 schools is available on the Every School Safe and Open website.

    Additional funding options may be available to you at the state or local level, or through private philanthropic entities.

  • How does the When To Test Calculator for Organizations work?

     

    The Calculator was developed as part of Project Isolat at MIT’s Institute for Data, Systems, and Society at MIT (IDSS). The article Simple Control for Complex Pandemics: The Impact of Testing and Contact Tracing on Heterogeneous Networks presents the model in detail.

    This short video also explains how the Calculator was developed and the science behind it.

  • How do I know if I need to test at my organization at all? When can I stop testing?

     

    If your conditions are favorable and your organization has excellent mitigation measures in place, you may not need to regularly test people without COVID-19 symptoms in order to effectively reduce the chance of an outbreak. In those cases, the Calculator will recommend “Symptomatic Screening Only,” meaning that you should continue to require COVID-19 testing for people who display symptoms, but you do not need to test those who are symptom-free.

    To reach this goal, consider how your organization might improve mitigation measures other than testing. You can make those improvements by doing any (or all) of the following:

    • Incentivizing or requiring vaccination and booster shots.
    • Encouraging or requiring everyone to wear high-quality masks properly and consistently. Keeping better track of close contacts.
    • Decreasing the size of cohorts that participate in unmasked activity together.

    Use the Calculator to model various scenarios and predict how improvements in these areas can change your test recommendations.

    Once you’ve modeled a scenario that you believe is achievable, take steps to make those improvements a reality within your environment.

     

    NOTE: The When To Test Calculator for Organization’s results for typical conditions are based upon the CDC’s estimate of R0 for the variant that is currently most common in the US, and upon the assumption that your organization has already performed baseline testing (testing 100% of all of its members prior to beginning an asymptomatic screening program). It’s a good idea to be prepared to institute asymptomatic screening should your organization’s situation change, and to frequently recheck the Calculator’s results for your organization.

  • My organization is being provided with tests (or is already using tests) that, based on the When To Test Calculator for Organization's results, are insufficient for our needs. What should I do?

     

     

    If the Calculator’s recommendations for your test type aren’t feasible for your organization, or if they indicate that you cannot prevent an outbreak using that type of test, consider how your organization might improve mitigation measures other than testing. You can make those improvements by doing any (or all) of the following:

    • Incentivizing or requiring vaccination and booster shots. 
    • Encouraging or requiring everyone to wear high-quality masks properly and consistently.
    • Keeping better track of close contacts.
    • Decreasing the size of cohorts that participate in unmasked activity together.

    Use the Calculator to model various scenarios and predict how improvements in these areas can change your test recommendations.

  • My organization is being provided with tests or has already implemented a testing program. How can I apply what I learn from the When To Test Calculator for Organizations to this situation?

     

     

    First, figure out what kind of test you are or will be using. (If you’re using pooled testing, you’ll also need to check what kind of follow-up testing you are or will be doing.)

    You can find the list of test types for which the Calculator provides results under the FAQ topic “What are the main differences between the various test types listed on the results page for the When To Test Calculator for Organizations?” If you’re not sure which type of test you are or will be using, check with your test vendor for confirmation.

    Once you know your organization’s type of test, look at your results in calculator and find the row that matches your test type. (If you’re using pooled testing, you may need to click on “View More Pooling Options” to find the type of follow-up testing your program is or will be using.) The results on that row are the Calculator’s recommended test frequency for your organization.

    If the Calculator’s recommendations for your test type aren’t feasible for your organization, or if they indicate that you cannot prevent an outbreak using that type of test, consider how your organization might improve mitigation measures other than testing. You can make those improvements by doing any (or all) of the following:

    • Incentivizing or requiring vaccination and booster shots.
    • Encouraging or requiring everyone to wear high-quality masks properly and consistently.
    • Keeping better track of close contacts.
    • Decreasing the size of cohorts that participate in unmasked activity together.

     

    Use the Calculator to model various scenarios and predict how improvements in these areas can change your test recommendations.

  • The When To Test Calculator for Organizations is telling me "Mitigations Inadequate." What does that mean?

     

    If you see this result, you will need to improve your organization's COVID-19 mitigation measures other than testing in order to help decrease the risk of an outbreak; adding testing alone will not be enough.

    Regardless of the reason why you received the warning message, improving mitigation strategies is the best way to lower your organization's risk of an outbreak. You can make those improvements by doing any (or all) of the following:

    • Incentivizing or requiring vaccination and booster shots.
    • Encouraging or requiring everyone to wear high-quality masks properly and consistently.
    • Keeping better track of close contacts.
    • Decreasing the size of cohorts that participate in unmasked activity together.

    Use the Calculator to model various scenarios and predict how improvements in these areas can change your test recommendations.

  • I thought my organization's mitigation strategies were adequate, but I get a warning message when I input those strategies. Why is this happening?

     

    There are three main reasons why you might get that result.

    Regardless of the reason why you received the warning message, improving mitigation strategies is the best way to lower your organization's risk of an outbreak. You can make those improvements by doing any (or all) of the following:

    • Incentivizing or requiring vaccination and booster shots.
    • Encouraging or requiring everyone to wear high-quality masks properly and consistently.
    • Keeping better track of close contacts.
    • Decreasing the size of cohorts that participate in unmasked activity together.
  • Why does the When To Test Calculator for Organizations recommend that we test more frequently if we're using antigen tests rather than PCR?

     

     

    In general, antigen tests are less sensitive than PCR tests. That means they are not as good as PCR tests are at finding people who aren't carrying as much virus, including children and asymptomatic adults. Testing more frequently helps to make up for the antigen tests’ lower sensitivity.

     

    In addition, people who were infected very recently often carry low levels of virus, so if you test them using an antigen test at that time, they may test negative. Once their virus levels have risen significantly (from a few hours to a day or two later), an antigen test will come back positive. Because PCR is more sensitive, it can catch an infection early in the disease course, eliminating the need for another test.

  • How can my organization improve our ability to identify and notify close contacts?

     

    For COVID-19, the definition of a close contact is someone who was within six feet of an infected person while they were contagious, for a total of at least 15 minutes over the course of 24 hours. (One exception to that rule is applicable only to schools: Students who were between three and six feet of an infected person are not considered close contacts as long as they were in school and “correctly and consistently” wearing masks.) When someone with no symptoms tests positive for COVID-19, it’s assumed that they were contagious for the 48 hours (two days) before they provided the sample that was tested.

    In practice, identifying exactly who has been in "close contact" with someone over the course of two days can be quite difficult unless your organization keeps good records. Schools often keep seating charts for classrooms, school buses, and lunch tables for this purpose. In addition, teachers may keep track of which students tend to walk next to one another in the hallways. In an office setting, keeping records of in-person meeting attendance and assembly-line stations may be helpful.

    NOTE: The When To Test Calculator for Organizations assumes that only 50% of an infected person’s close contacts are identified and notified of their status within 24 hours (a contact-tracing efficiency of 0.5). This assumption may be changed in the Calculator’s defaults under Advanced Settings: Main Calculator Settings.

    CDC – Close contact definition

    CDC — What you can expect to happen during contact tracing

    CDC — Contact tracing infographic

  • How does my organization's ability to identify and notify close contacts affect our testing needs?

     

    The faster your organization can identify and notify close contacts of an infected person, the lower your need for testing will be. The reason for this has to do with how contact tracing works and how it affects the likelihood of an outbreak.

    The goal of contact tracing is to identify the people who were in close contact with an infected person while they were contagious, so that those people can be prevented from spreading the disease to others. The faster close contacts are identified and notified of their status, the sooner they can quarantine, and the less likely it is that they will infect other people.

     

    For COVID-19, the definition of a close contact is someone who was within six feet of an infected person while they were contagious, for a total of at least 15 minutes over the course of 24 hours. (One exception to that rule is applicable only to schools: Students who were between three and six feet of an infected person are not considered close contacts as long as they were in school and “correctly and consistently” wearing masks.) When someone with no symptoms tests positive for COVID-19, it’s assumed that they were contagious for the 48 hours (two days) before they provided the sample that was tested.

    In practice, identifying exactly who has been in “close contact” with someone over the course of two days can be quite difficult unless your organization keeps good records. Schools often keep seating charts for classrooms, school buses, and lunch tables for this purpose. In addition, teachers may keep track of which students tend to walk next to one another in the hallways. In an office setting, keeping records of in-person meeting attendance and assembly-line stations may be helpful.

    NOTE: The When To Test Calculator for Organizations assumes that only 50% of an infected person’s close contacts are identified and notified of their status within 24 hours (a contact-tracing efficiency of 0.5). This assumption may be changed in the Calculator’s defaults under Advanced Settings: Main Calculator Settings.

    CDC — Close contact definition

    CDC — Contact Tracing for COVID-19

    CDC — What you can expect to happen during contact tracing

    CDC — Contact tracing infographic

  • How does mask wearing impact my organization's need for testing?

     

    The more people in your organization who wear masks consistently and properly, the less testing you will need to do to prevent an outbreak. Remember: a well-fitted mask, worn properly, covers both the nose and the mouth and does not leave gaps.

    The When To Test Calculator for Organizations asks you to estimate what percentage of people in your organization wear their masks properly at all times when indoors. Most people tend to overestimate the percentage of people in their own organizations who do this, so you may want to input a number a bit lower than you were first considering.

    The type of mask people wear also matters. Two-layer cloth masks have a filtration efficiency of about 30%. For surgical masks that fit well, without gaps, that number is about 70%. For KN95 masks, it’s about 85%. If everyone at your organization wears high-efficiency masks, your testing needs will decrease.

    Find high-quality masks at Project N95.

    CDC — Use Masks to Slow the Spread of COVID-19

     

    CDC — Improve How Your Mask Protects You

    CDC — Types of Masks and Respirators
     

  • Does the Calculator take into account how well vaccines work against variants?

     

    Yes. The Calculator uses an estimate of how well the vaccines available in the US protect against the variant that is currently dominant in the country. This estimate is based on the performance of all available vaccines, not on any one vaccine brand or type. 

    If you are using the Calculator for Organizations and want to adjust the Calculator's default so that it matches a specific vaccine, go to the Advanced Settings, click on "Main Calculator Settings," and look for "Vaccine Effectiveness."

    CDC — COVID-19 Vaccine Effectiveness Research

  • How does vaccination impact my organization's need for testing? Do vaccinated people still need to be tested?

     

    The more people in your organization who are vaccinated, the less testing you will need to do to prevent an outbreak. If most people in your organization have received booster shots, you will need to do even less testing. If you aren’t sure what percentage of your organization has been fully vaccinated or has received at least one booster, you can use published estimates for your area, available via the links below.

    If you plan to test only the unvaccinated members of your organization, then the number you enter for the "Fully Vaccinated" input should be zero.

    CDC – COVID-19 Integrated County View

    CDC – COVID-19 Vaccinations in the United States - State-by-state vaccination statistics.

    CDC - COVID-19 Vaccines

  • What are the reporting and confidentiality requirements for COVID-19 test results?

     

     

    Test results for COVID-19 must be reported to public-health authorities. Reporting requirements can be found on the websites for the US Department of Health and Human Services and the CDC.

    The confidentiality of COVID-19 test results is governed by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). If your organization is a school and is testing students, their test results are also likely to be governed under the Family Educational Rights and Privacy Act (FERPA).

    US Department of Health and Human Services — HIPAA and COVID-19

    US Department of Health and Human Services — Joint Guidance on the Application of FERPA and HIPAA to Student Health Records

  • The test my organization wants to use for our testing program isn’t authorized for use on people without symptoms. What do I do?

     

    Most of the COVID-19 tests on the market that have Emergency Use Authorization (EUA) from the FDA have received that authorization for diagnostic testing: testing individuals who have COVID-19 symptoms. Fewer tests have EUA specifically for screening: testing people who don’t have symptoms of COVID-19.

    However, as long as the tests are used under the supervision of a physician or other prescriber, the FDA supports doing off-label screening testing with COVID-19 tests that only have EUA for diagnostic testing.

    NOTE: The When To Test Calculator for Organizations assumes that tests that do not have FDA authorization for screening are used off-label under practitioner guidance.

  • How does limiting the number of unmasked people who are allowed to be in close proximity indoors or to participate in high-COVID-risk activities together indoors affect my organization's testing needs?

     

    Limiting the size of groups who participate in these kinds of activities together indoors and unmasked is an extremely effective way to reduce COVID-19 transmission risk, and thus reduce your organization’s need for testing.

    With increasing levels of vaccination in the US, many organizations have decided to do away with mask-wearing altogether. However, some activities remain higher risk than others in terms of their potential for COVID transmission. Any activity that brings a group of people together in close proximity for an extended period of time – most commonly, eating and/or drinking together at the same table – carries a high risk. Other high-COVID-risk activities are those that involve breathing heavily and/or with force, such as sports activities, singing, and playing wind instruments, whether or not the participants are in close proximity to one another.

    If your organization permits either of these types of activities indoors, then the number you would input in this section of the When to Test Calculator for Organizations is the largest group that participates in such activities together. For example, if you have a choir of 10 people and a basketball team of 25, you would input “25.” Doing so allows the Calculator to factor in the additional layer of risk added by permitting these kinds of activities to happen indoors.

    NOTE: The Calculator assumes that cohorts of people eating or drinking together are physically distanced from other people in the room. Thus, if your cafeteria has 20 tables that each seat a cohort of eight people and the tables are more than six feet apart, the size of the cohort is eight.

    However, physical distancing has its limits. If people in your organization are participating in unmasked indoor group activities that involve significant exertion or air expulsion (for example, sports, gym classes, or singing), then the cohort size should be the total number of people in the room, regardless of their distance from one another.

    CDC — Guidance for COVID-19 Prevention in K-12 Schools Search for "cohort" on this page.

    Oregon Department of Education — Cohorting