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National COVID-19 Testing Implementation Forum

The National COVID-19 Testing Implementation Forum brings together key stakeholders to share information with federal leaders about SARS-CoV-2, the virus that causes COVID-19, testing and diagnostics.

The Forum participants provide their perspectives on how to best:

  • Identify and address end-to-end testing supply chain issues across commercial, public health, academic, and other sectors
  • Define optimal testing in various settings (diagnostic, screening, surveillance, others)

The Forum is not a federal advisory committee. Rather, it provides an opportunity for better communications among stakeholders. Forum participation rotates to ensure diverse input.

Further comments or questions may be sent to ntif@hhs.gov.

National Testing Implementation Forum (NTIF) Meeting Summaries

Download a print version of Meeting #1 Summary

HHS National COVID-19 Testing Implementation Forum (NTIF)
Meeting #1
Teleconference
Thursday, July 30, 2020
2-3:30 p.m. EDT

The Office of the Assistant Secretary for Health launched the National COVID-19 Testing Implementation Forum (NTIF) with this meeting. The purpose of the forum is to obtain individual input from organizations. HHS is not seeking collective advice and that the U.S. government will not make decisions at this meeting. The U.S. government will consider individual input here and in other deliberations. This meeting focused on updates from the federal government on the testing supply chain.

The Assistant Secretary for Health contextualized the forum objectives, stating that the goal of testing is to get the right test at the right time to the right person in order to provide actionable and timely results. This is to support public health isolation and contact tracing, diagnose hospitalized patients rapidly, protect particularly vulnerable populations such as those in nursing homes, support the safe reopening of schools and businesses, and enable state testing plans.

Forum participants were asked to describe their role in the organization they represent, and to state one priority they would like the NTIF to achieve. These priorities included overcoming barriers to test access, availability, and result reporting; increased transparency of testing resources and numbers; resolving supply chain issues; testing cost coverage; providing a forum for collaboration and the sharing of novel strategies for testing; and expansion of point-of-care testing.

Presentations from Federal Participants
The Department of Health and Human services gave a presentation on the status of the testing supply chain. HHS is working with manufacturers to try to break bottlenecks in the supply chain, and from August to December, HHS expects the number of tests to ramp up significantly. The federal government has supplied swabs and media to states and is routinely surging supplies to states when needed. The breakdown of the types of swabs and media that are expected to be available through the end of year was presented and HHS noted that point-of-contact antigen supplies are going to expand testing capacity in nursing homes.

The Department of Defense gave an overview of how the Defense Production Act (DPA) is being used. There are laws that restrict DPA use, and the DPA is used sparingly and only when necessary for the nation. The presentation noted that the federal government doesn’t always know what key supply chain issues are, so HHS is asking this forum what gaps exist. DPA actions are currently focused on swabs and expanding diagnostic test kit production, but additional areas of interest are reagents; consumables such as pipette tips and media; and manufacturing that supports production of these items.

Discussion
The discussion included the importance of collecting and reporting demographic data during testing, and a clarification of the roles for distributed testing equipment versus testing equipment that is pre-existing. Clarification was provided for the HHS projected number of tests for December.

The need for updated testing guidance for schools and workplaces, and where testing should be directed was discussed. There was a request to distribute the presented data on projected testing numbers.

Presentations on Testing Capacity
AdvaMed, which represents medical technology companies broadly, presented on their DX Registry which is a national registry of diagnostic supplies that can be used to give a more comprehensive view of testing capacity and to anticipate shifting demands. AdvaMed has been collecting data into this registry and has recently started publishing weekly results, each Friday, in aggregated national and state reports. The data included represents only what is available from manufacturers, but as more information becomes available the reports will include more information. The reports will also expand to include antigen tests and others represented in the NTIF were welcomed to participate in the data collection.

Discussion
The participants discussed the hurdles to the FDA authorization of lab-developed tests and potential solutions to those hurdles, as well as the need to distribute testing supplies and testing capacity to hot spots across the country as they develop.

Action Items

  • Forum participants who were unable to attend the teleconference are invited to e-mail the Office of the Assistant Secretary to state their priorities for this forum.
  • Forum participants are invited to describe specific additional information they would like to see on supply chain issues.
  • Participants of the forum asked the HHS to consider making data presented on testing and supply chain expectations more widely available.
  • The FDA will be asked to respond to the NTIF on the different paths available for authorizing COVID-19 tests.
  • The next meeting will address surveillance and what is needed for school and business reopening
  • Feedback may be provided via ntif@hhs.gov.

Download a print version of Meeting #2 Summary

HHS National COVID-19 Testing Implementation Forum (NTIF)
Meeting #2
Teleconference
Thursday, August 13, 2020
2-3:30 p.m. EDT

The Office of the Assistant Secretary for Health hosted the second meeting of the National COVID-19 Testing Implementation Forum (NTIF). These meetings are being held to gather individual input from a wide range of stakeholders. This meeting focused on surveillance and reopening strategies.

Presentations from Federal Participants
The Food & Drug Administration presented on its oversight on testing for diagnostic/screening versus surveillance purposes, stating that it does not typically regulate tests used for surveillance, i.e., monitoring infection levels in a population. The FDA does regulate tests used for individual level diagnosis or screening (when a person has no symptoms or known exposure). In the present emergency, the FDA is allowing test developers to validate tests, including tests for screening asymptomatic individuals, while pursuing FDA approval.

The Centers for Disease Control and Prevention presented on recommendations for testing for COVID-19 in the context of reopening schools. The CDC recommends testing individuals with symptoms of COVID-19 and those who have been in close contact with someone with COVID-19, and isolating them. The CDC does not recommend universal entry testing in schools because such testing poses challenges and has not been systematically studied to show that it would improve disease containment. Policies and guidance are evolving as the situation changes.

The Assistant Secretary for Health said the federal government expects results from surveillance testing in non- Clinical Laboratory Improvement Amendments (CLIA) certified environments not to be treated as diagnostic, and results are not to be reported to individuals. However, it is appropriate to refer individuals who are part of a positive pool to diagnostic testing.

Discussion
The discussion included clarifications of CDC definition of congregate settings and the FDA definition of rapid tests. The FDA also discussed additional labeling options for test developers. HHS informed the participants that recommendations for how surveillance testing should be linked to the public health system will be written, and there was discussion about the appropriateness of antigen tests for asymptomatic testing in certain contexts.

Presentations on Surveillance Testing
A presenter from University of California San Francisco discussed reopening strategies, stating that it can be considered an engineering problem to solve using existing resources. A fundamental challenge of testing to reopen is that tests from high-risk people (with symptoms or exposure) are being pooled with tests from low-risk people. The demand for screening far exceeds the available testing capacity, and screening tests are clogging the testing system. Samples should be triaged as high vs. low risk, and low-risk samples can be screened in regional high-throughput hubs separate from the diagnostic testing system.

The Rockefeller Foundation presented on its ongoing surveillance testing initiatives, and it believes that aggressively developing a separate screening system would respond to market demand, help institutions like schools reopen, and relieve pressure on the clinical testing system. Industry partners should consider how to dramatically expand screening capacity in time for winter.

Discussion
The participants discussed the need to sort out issues around test funding, and the fear that loosened testing restrictions could be exploited by unethical actors after the pandemic. An example of using machine learning to predict positive tests results was discussed as an inexpensive approach to help surveillance efforts.

Action Items

  • Continuing rapid work is needed to develop COVID-19 screening systems.
  • The meeting of NTIF on August 27 will focus on reaching minority communities.
  • Further comments or questions may be directed to ntif@hhs.gov.

Download a print version of Meeting #3 Summary

HHS National COVID-19 Testing Implementation Forum (NTIF)
Meeting #3
Topic: Engaging Minority and Underserved Communities
Thursday, September 3, 2020
2-3:30 p.m. EDT

The Office of the Assistant Secretary for Health hosted the third meeting of the National COVID-19 Testing Implementation Forum (NTIF). These meetings are being held to gather individual input from a wide range of stakeholders. This meeting focused on how to engage minority and underserved communities.

Action Items

  • The Assistant Secretary for Health welcomed input on what HHS can do better to encourage testing in more vulnerable communities.
  • Further discussion among forum participants is encouraged. Participants are encouraged to join the National COVID-19 Resiliency Network (NCRN).
  • The Rockefeller Foundation will share a handbook it has prepared on best practices in public health communication with OMH and OASH.
  • Additional information and comments may be sent to ntif@hhs.gov.
Presentations from Federal Participants

A representative of the HHS Office of Minority Health (OMH) presented on COVID-19 and minority populations, showing that rates of COVID-19 illness, and especially severe illness, are disproportionately high among Blacks and Hispanics and among American Indians/Alaska Natives (AI/AN). It was noted that demographic data is limited, and others agreed that such data collection is an area that needs improvement. OMH also presented on their efforts to address barriers to testing among vulnerable minority groups, including a national network of trusted community organizations to connect at-risk individuals to testing and other services, and private-public testing partnerships.

An administrator from the Bureau of Primary Health Care (BPHC) described community health center programs that provide a wide array of services to underserved communities. These centers provide both primary care services and COVID-19 testing.

The Assistant Secretary for Health noted that the federal government has supported retail test sites, and two-thirds of these retail sites are in what are considered vulnerable communities.

Discussion
The discussion addressed the changing demographics of testing, the importance of trust when it comes to advocating for tests and vaccines, and offers for enhanced community testing services.

The National Covid-19 Resiliency Network
Morehouse College presented on its NCRN, stating that the network was enacted with the goal of mitigating the impact of COVID-19 on vulnerable minority populations. NCRN is developing a technology platform that will engage directly with patients, collect data, and serve as a resource hub for community partners. NCRN is being built on partnerships with community members. NCRN will focus on research, community engagement, communication and dissemination.

Discussion
Morehouse encouraged the organizations represented on this call to join NCRN by contacting Morehouse or the leadership of OMH, and the Rockefeller Foundation recommended a handbook of best practices for public health communication as a resource.

Reaching Minority Communities
A representative from the National Medical Association (NMA), the organization of African American physicians, described the NMA’s strong advocacy efforts and the growing network it has engaged to improve COVID-19 equity. The organization shared its outreach actions including webinars, biweekly calls with pastors, and public appearances, for example on the radio.

A representative of the National Hispanic Medical Association (NHMA) described the organization’s efforts to improve testing access and COVID-19 preparedness in Hispanic communities including a congressional briefing on COVID-19 with the Surgeon General and monthly virtual summits and frequent policy forums.

Discussion
Discussion included the importance of targeted media campaigns and social media outreach, and the institution of a program of surge testing in places where there have been significant outbreaks.

Download a print version of Meeting #4 Summary

HHS National COVID-19 Testing Implementation Forum (NTIF)
Meeting #4
Topic: Testing Strategies for K-12 Schools
Thursday, September 24, 2020
2-3:30 p.m. EDT

The Office of the Assistant Secretary for Health is hosting a series of meetings on COVID-19 testing to gather individual input from a wide range of stakeholders. The objective for this meeting was to discuss testing strategies for K-12 schools.

Action Items

  • Future meetings will focus on testing in the context of K-12 schools again, and on reporting of test results.
  • Further comments or questions may be sent to ntif@hhs.gov.

Covid-19 Testing Strategies for K-12 Students and Staff
A representative from the Centers for Disease Control and Prevention presented on potential testing strategy considerations for schools as they reopen. The presenter emphasized that testing is an important component of a comprehensive COVID-19 mitigation strategy. Schools need to work closely with public health officials on testing guidance and implementation, and on protocols to follow when cases are detected. Decisions need to be made on who will be tested. Symptomatic individuals should be tested, and the next priority is testing asymptomatic close contacts of people who have tested positive. Schools need strategies for determining close contacts, for which the CDC offers guidance, and test results need to be reported to state or local public health departments, as well as to families.

A representative of the Rhode Island Department of Health presented on the testing regimen in the state, noting that Rhode Island has focused on testing in high-density urban settings, contact tracing, and promoting testing to at-risk groups such as young adults and people in high-contact professions. A testing program has also been specifically developed for K-12 schools. Tests for students and staff are currently being conducted at 15 sites outside schools but chosen for their accessibility, and there is a focus to ensure that that positive cases can be detected and confirmed quickly. In the future, Rhode Island hopes to administer tests within schools and take steps to help school nurses feel safer.

Large-scale Testing Strategies
A representative of the Duke-Margolis Center for Health Policy presented on strategies for surveillance testing. Repeated surveillance testing is needed in settings where people repeatedly congregate, including K-12 schools. A successful screening strategy needs to take into account local risks and the resources available and decide on actionable results. Wider-scale testing than currently available could be used to reduce infection rates nation-wide. Information on testing supply is needed to shape national testing strategies, and testing capacity should not be an obstacle to surveillance testing especially in the riskiest settings, like schools. Recommendations from the Duke-Margolis Center for Health Policy included: 1) work together to develop evidence-based and model-based guidelines for screening and surveillance testing, 2) expand pilot testing initiatives to build an evidence base for testing strategies, and 3) the federal government is needed to help develop coordinated plans to procure and distribute tests.

Discussion
Participants discussed the importance of supply chain issues in regard to rapid testing, and that bottlenecks in the speed of data flow are also an important issue as testing scales up. Some participants recommended challenging manufacturers to help develop reporting systems, noting that those systems should include fields such as demographic data. Some participants also noted that a national system of regulations are needed that operate across manufacturers, and that quick adaptation is needed as many tests come online. Examples of increased testing and successful school reopening were presented during the discussion, and during these examples multiple participants noted that there are concerns about testing that include privacy.

The Assistant Secretary for Health said a future meeting of this forum would focus on test results reporting; he said another meeting would be devoted soon to K-12 school issues.

Content created by Assistant Secretary for Public Affairs (ASPA)
Content last reviewed on October 16, 2020