U.S. Department of Health and Human Services

REPORT TO CONGRESSCOVID-19 Strategic Testing Plan

May 24, 2020

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Table of Contents
Executive Summary ...................................................................................................................... 3
List of Acronyms ........................................................................................................................... 4
Introduction ................................................................................................................................... 6
Testing Goals and State Plans ...................................................................................................... 8Federal Government Support to States .................................................................................... 19
Increasing Testing Capacity....................................................................................................... 27
Resources for Testing ................................................................................................................. 36
Mechanisms for Responding to Future Pandemics ................................................................. 40
Conclusion ................................................................................................................................... 43
Appendix A ................................................................................................................................... 44
Appendix B ................................................................................................................................... 52
Appendix C ................................................................................................................................... 53
Appendix D ................................................................................................................................... 69

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Executive Summary
This report to Congress is in response to the Paycheck Protection Program and Health Care
Enhancement Act, P.L. 116-139. The Act states:
Provided further, That not later than 30 days after the date of the enactment of this Act,
the Secretary, in coordination with other departments and agencies, as appropriate,shall report to the Committees on Appropriations of the House and Senate, theCommittee on Energy and Commerce of the House of Representatives, and theCommittee on Health, Education, Labor, and Pensions of the Senate on a COVID–19
strategic testing plan: Provided further, That such plan shall assist States, localities,
territories, tribes, tribal organizations, and urban Indian health organizations, inunderstanding COVID–19 testing for both active infection and prior exposure,including hospital-based testing, high-complexity laboratory testing, point-of-care
testing, mobile-testing units, testing for employers and other settings, and other tests asnecessary: Provided further, That such plan shall include estimates of testingproduction that account for new and emerging technologies, as well as guidelines fortesting: Provided further, That such plan shall address how the Secretary will increase
domestic testing capacity, including testing supplies; and address disparities in allcommunities: Provided further, That such plan shall outline Federal resources that areavailable to support the testing plans of each State, locality, territory, tribe, tribalorganization, and urban Indian health organization: Provided further, That such plan
shall be updated every 90 days until funds are expended: Provided further, That suchamount is designated by the Congress as being for an emergency requirement pursuant
to section 251(b)(2)(A)(i) of the Balanced Budget and Emergency Deficit Control Act of
1985.
This report details the COVID-19 strategic testing plan for the U.S. Department of Health andHuman Services, as executed by the Secretary among the Department’s agencies and offices, andin coordination with other departments and agencies, as appropriate.
This report is the first report pursuant to this section of the Paycheck Protection Program and
Health Care Enhancement Act and will be updated every 90 days until funds are expended, as
required by Congress.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

List of Acronyms
ACLA

American Clinical Laboratory Association

ASPR

Assistant Secretary for Preparedness and Response

BARDA

Biomedical Advanced Research and Development Authority

CBTS

Community based testing sites

CDC

Centers for Disease Control and Prevention

CLIA

Clinical Laboratory Improvement Amendments

CMS

Centers for Medicare & Medicaid Services

COVID-19

Coronavirus Disease 2019

CRISPR

Clustered Regularly Interspaced Short Palindromic Repeats

DARPA

Defense Advanced Research Projects Agency

DoE

Department of Energy

DNA

Deoxyribonucleic acid

DoD

Department of Defense

DPA

Defense Production Act

EHRElectronic health record

ELR

Electronic laboratory-based reporting

EUA

Emergency use authorization

FDA

Food & Drug Administration

FEMA

Federal Emergency Management Agency

HHS

Department of Health and Human Services

HIV

Human immunodeficiency virus

HRSA

Health Resources & Services Administration

IHS

Indian Health Service

LIMS

Laboratory information management systems

MCM

Medical countermeasure

NCI

National Cancer Institute

NGS

Next generation sequencing

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

NIAID

National Institute of Allergy and Infectious Disease

NIBIB

National Institute of Biomedical Imaging and Bioengineering

NIH

National Institutes of Health

OASH

Office of the Assistant Secretary for Health

OIG

Office of the Inspector General

OSTP

Office of Science and Technology Policy

PCR

Polymerase chain reaction

PHL

Public Health Laboratories

PHSSEF

Public Health and Social Services Emergency Fund

POC

Point-of-care

PPE

Personal protective equipment

RADx

Rapid Acceleration of Diagnostics

RNA

Ribonucleic acid

RT-PCR

Reverse transcription polymerase chain reaction

SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2
SVI

Social Vulnerability Index

VTM

Viral transport medium

WHO

World Health Organization

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Introduction
Testing is a critical component of the public health response to SARS-CoV-2 (the virus thatcauses COVID-19). It enables clinical decision making, informs resource allocation and diseaseprevalence monitoring, and is necessary to minimize economic and community disruption
through targeted infection prevention and control measures. Testing a majority of the U.S.
population, recurrently, is neither feasible nor necessary to assure safe return to work, school,
and other activities. In fact, a targeted strategy based on diagnosis, contact tracing, and smart
surveillance is the optimum approach – especially when combined with syndromic surveillanceand hygiene.
On April 27, 2020, the President released Opening Up America Again Guidelines: Testing
Overview i and Opening Up America Again Guidelines: Testing Blueprint ii. The Opening Up
America Again Guidelines: Testing Overview and Testing Blueprint are designed to facilitate
State development and implementation of testing plans and rapid response programs.
The Opening Up America Again Guidelines: Testing Overview lays out an 8-part plan in threestages:Stage 1: Launch
1. Build the foundation for diagnostic testing
2. Mobilize the private sector to develop tests
3. Issue emergency use authorizations (EUAs) for tests
4. Galvanize commercial and research laboratories and professional associations toramp up testing capacity
5. Facilitate State efforts to access and utilize all available testing capacity
Stage 2: Scale
6. Identify and expand public and private-sector testing infrastructure and capacity
7. Strengthen the supply chain for testingStage 3: Support Opening Up Again
8. Coordinate with governors to support testing plans and rapid response programs
This report supports the implementation of the 8-part plan by providing additional guidance andinformation about diagnostic technologies, platforms and inventory that States, territories andtribes can utilize to develop flexible, adaptable, and robust plans.
The Testing Blueprint supports the opening of America and outlines the roles and responsibilitiesof the Federal, State, local, and tribal governments, private sector, and professional associations.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

The Testing Blueprint provides guidance and outlines core elements for States as they develop
their testing strategies. It outlines a partnership among Federal, State, local, and tribal
governments that will result in our ability to meet testing goals now and in the future. The roleof the Federal government is to enable innovation, help scale supplies, and provide strategic
guidance. States, territories, and tribes are responsible for formulating and implementing testingplans; and the private sector will continue to develop and produce technologies, supplies, andservices to meet the needs of the States. The Paycheck Protection Program and Health Care
Enhancement Act (Public Law 116-139), signed on April 24, 2020, provides a minimum of $11
billion to State, local, territory, tribe, or tribal (SLTT) organizations to develop, purchase,administer, process, and analyze COVID-19 tests, scale-up laboratory capacity, trace contacts,
and support employer testing. States, territories, and tribes will utilize the substantial federal
resources provided to them to meet their testing goals.
When developing testing strategies, States, territories and tribes should consider testing
technologies, use cases for these technologies, and available inventory. Appendix A highlights
current diagnostic assays and potential use cases. In addition, strategies should be consideredliving documents and adapted as needed to account for the latest information about diseasetransmissibility and immunity. Strategies should be flexible enough to incorporate new
diagnostic technologies where appropriate and fit-for-purpose. At a minimum, a State’s testingplan should include the following:•

How the state, territory, and tribal area will meet testing goals/targets;•

Where testing will be performed (commercial; academic; medical centers; public healthlabs, retail sites);•

Description of the SARS-CoV-2 testing capacity and ecosystem in the State;•

Capabilities to overcome barriers to efficient testing;•

Mechanisms to leverage the entire testing ecosystem;•

Use of new and emerging technologies, as they develop;•

A reporting structure to inform clinical care and public health decision-making;•

Mechanisms to rapidly identify any newly emergent cases or clusters of COVID-19
among symptomatic and asymptomatic individuals;•

Protocols to facilitate contact tracing and isolation strategies for newly diagnosed cases;
and•A process to ensure that underserved and high-risk populations receive adequate testing
services, through the most effective means.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing PlanAs the Federal government works to mitigate the spread of the virus, save lives, and safely
reopen America, the primary purpose of this report is to discuss the country’s immediate andnear-term testing needs and how these are being addressed. Among other goals, as described inthis report, the Federal government will implement testing for at-need communities.
The first update to this report will include additional information on guidance, goals, projects,
and programs that will advance the testing ecosystem in the U.S. These innovative programs
could include activities related to:•

Robust, secure data collection and utilization systems;•

Domestic production and supply chain management capabilities for testing supplies andreagents; and•Public-private partnerships that will result in enhanced testing capacity in specificcommunities across the U.S.

In addition, it will be critical for all programs to evaluate and subsequently implement the mosteffective methods and infrastructure for reaching underserved and high-risk populations. These
items are discussed briefly in the last section of the report, “Mechanisms for Responding toFuture Pandemics,” and will be further detailed in HHS’ first update to this report to Congress on
testing plans.

Testing Goals and State Plans
Testing for active infection with SARS-CoV-2 first requires collecting a nasal, nasopharyngeal,or oropharyngeal swab from a patient. The swab is then placed into a test tube with transport
media and sent to a lab for testing; or tested directly at the point-of-care (POC) (e.g. physician’s
office, long term care facility) with a POC testing device. If the sample is sent to the laboratory
for testing, a two-step testing process is performed. The first step is the extraction of the nucleic
acid/genomic material from the virus. The second step is a reverse-transcriptase polymerase
chain reaction (RT-PCR) which amplifies the target nucleic acid from the virus present in thesample. Both steps require reagents that typically come in the form of a kit (extraction kit or RTPCR kit). See Appendix B for a more detailed description of this process.
Diagnostic assays to test for SARS-CoV-2 can be categorized as either: (1) those that test for
active infection or (2) those that test for prior infection. Currently authorized tests used to
identify active infections detect either viral nucleic acid (genetic material) or antigen (protein).
Serologic tests, which indicate prior infection, detect antibodies. Additional information about
these types of tests can be found in Appendix A. Tests for active infection (e.g. nucleic aciddetection and antigen detection tests) can be performed in either a laboratory or at point-of-care

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

(POC), e.g. at a physician’s office. At this time, serological testing (e.g. prior infection tests) areauthorized only in a laboratory setting.
Testing for the presence of active infection provides critical information that can be used to
manage the COVID-19 response. There are three primary purposes for active infection testing:•Diagnostic Testing is used to confirm or support a clinical diagnosis of viral infection
in symptomatic individuals and inform treatment and implement preventive measures tocontain further spread.

•

Testing for Contact Tracing is a process to trace, test, and monitor persons that may
have been in contact with infected individuals. This type of testing supports theidentification and rapid isolation of new cases or those with presence of virus and nosymptoms and helps to prevent further spread.

•

Surveillance Testing is used to limit the spread of disease and enable public healthauthorities to assess and manage the risks associated with COVID-19, including testing
asymptomatic individuals. Objectives of surveillance include enabling rapid detection,
isolation, testing, and management of suspected cases; guiding the implementation ofcontrol measures; detecting and containing outbreaks among vulnerable populations;and monitoring long-term epidemiological trends. iii

In addition to testing for an active infection, testing for a previous infection is performed using
serologic tests. Serology (antibody) testing complements diagnostic testing (testing for active
infection) by evaluating the prevalence of individuals in a community and across the U.S. who
were previously infected by the virus. At this time, a positive antibody test does not indicate
with certainty that an individual is immune to reinfection. Additional studies are ongoing todetermine if the presence of antibodies to the virus, and at what levels, correlates with protective
immunity.
Diagnostic testing, contact tracing, and surveillance testing are the most critical components of
our immediate testing strategy. The specific number of tests that are required in each State, andin each geographical region within each State, depends on numerous factors, including but notlimited to:•

The percent positives in a State, territory, or tribe. The World Health Organization(WHO) set an objective that the percent of tests being positive should be 10 percent or
lower, demonstrating that 10 times as many people are being tested as have the disease.
This indicates enough testing exists to ensure broad coverage of the population. The
amount of testing needed in a community is situational (based on geography,transmission, vulnerable populations, etc.), but in general, achieving this benchmark
begins to ensure rapid diagnosis of symptomatic and asymptomatic individuals.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan•

The characteristics of the population. Areas with large numbers of individuals at highrisk of contracting or transmitting the virus, or who may be highly vulnerable for having
poor outcomes, will require increased surveillance testing.

•

The degree of mitigation employed in that community. Mitigation strategies such associal distancing help control the spread of disease. In areas where mitigation strategies
are strictly implemented, there will be less contact tracing needed and less concern of
spread to vulnerable populations. When mitigation measures are relaxed, the number ofsocial contacts will increase as does the potential risk of infection – making widespread
testing and early warning more critical than during full community mitigation.

In addition to the factors listed above, there are many additional considerations such as theavailability of resources, presence of concurrent, seasonal respiratory infections (such as
influenza), prevalence of potentiating risk factors among communities, such as asthma or
diabetes, that must be taken into account when developing and or adapting a testing strategy.
Therefore, the testing strategy, as well as the specific quantitative goals for testing, should becontinually informed by epidemiological data as well as our evolving understanding of theecology of the virus.
The National Approach to Testing for SARS-CoV-2
From the onset of the pandemic, and continuing into the future, the Federal government will
work with States, territories, localities, and tribes to support the development and availability ofas many fully enabled tests as possible. This work will continue as determined by
epidemiological factors (e.g. decreased number of cases), transmission, population immunity,
and/or through availability of safe and effective vaccines that broad scale testing is no longer
needed.
In early March, only a few thousand tests for COVID-19 were performed each day. In mid-May,that number is approximately 300,000 per day, and growing steadily at 25%-30% per week.
With expanded and sustainable supply chains, novel “front ends” (e.g. retail stores, community
based testing sites) for testing, and States becoming empowered with enhanced knowledge andfunding, we will maintain our testing capacity and continue to grow these numbers significantly
over the next several months.
The Federal government is supporting and encouraging States, territories, and tribes to build amulti-layered approach that incorporates and fully leverages all components of the testing
ecosystem. State strategies should evaluate and utilize testing across their ecosystem (incommercial, academic, medical center, and public health laboratories). In addition, States andjurisdictions should apply the different types of SARS-CoV-2 testing that are appropriate fordifferent environments, fit for purpose, and currently available. The Centers for Disease Control
and Prevention (CDC) guidance on prioritizing applications of the various types of tests (e.g.
nucleic acid, antigen, and antibody detection) and testing materials will be are crucial for how
States plan, adapt, and implement robust testing strategies. iv,v

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Testing Ecosystem:•

Commercial Reference Laboratories: American Clinical Laboratory Association(ACLA)-member laboratories (for example Quest Diagnostics, LabCorp, Mayo Clinic
Laboratories, ARUP, BioReference Laboratories, and others) are regional or national inscale. These laboratories have hundreds to thousands of patient service centers (sample
collection sites) that are located throughout the nation. In fact, more than 93% of the U.S.
population lives within 10 miles of a patient service center. At the time of this report,
ACLA-member laboratories have performed more than 6.5 million tests for SARS-CoV2, approximately half of the total performed in the nation. Moving forward, ACLAmember laboratories anticipate having the capacity to perform over five million tests permonth, and perhaps double that number depending on anticipated demand and expansion.
These labs utilize high throughput, highly complex diagnostic platforms. Results are
typically available within 24-48 hours of sample collection.

•

Hospital and Academic Laboratories: The extensive network of hospitals, academic
medical centers, and university clinical laboratories are a critical component of the U.S.
testing ecosystem. Many of the laboratories are just beginning to ramp up testing for
SARS-CoV-2 and are not yet fully utilizing the maximum capacity for their instruments.
In order for the nation to meet our testing goals for SARS-CoV-2, we must ensure full
utilization of this extensive network. Clinical laboratories of this type routinely utilize
moderate to high throughput platforms. For example, a majority of the Abbott m2000 and
Thermofisher ABI7500 diagnostic instruments (used for RT-PCR) are located throughout
this network. The number of locations that use these instruments across the U.S. isextensive, with the majority of Abbott m2000’s located in academic and medical center
laboratories. In addition, the Cepheid GeneXpert System diagnostic platforms are also
widely distributed throughout medical centers (both larger and smaller community-based
centers). Cepheid instruments are the “workhorse” of small to mid-sized metropolitan
service areas and especially the smaller medical centers located in rural or remotehospitals. These instruments provide accurate results in less than an hour and can be
performed in laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) to perform high and moderate complexity tests.

•

Public Health Laboratories: These laboratories focus on the identification andsurveillance of infectious diseases and the health status of population groups. They
perform more limited diagnostic testing, reference testing, and disease surveillance. In
resource-poor areas, they provide testing of last resort. Personnel at these labs also
provide emergency response support, perform applied research, and conduct training forlaboratory personnel. State public health laboratories use a variety of diagnostic
extraction and polymerase chain reaction (PCR) platforms to conduct nucleic acid testing.
By order of prevalence, the primary extraction platforms used in public health laboratory
settings include the Roche MagNA Pure, QIAGEN QIAcube, QIAGEN EZ1 XL,

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

ThermoFisher KingFisher, BioMerieux easyMAG, and Perkin Elmer Chemagic 360
systems. Similarly, the predominant PCR platforms or combination extraction/PCR
platforms include ABI 7500 fast DX, ABI Quantstudio DX, Cepheid Gene Expert,
BioFire 2.0/Torch, Hologic Panther, ABI 7500 Fast, Abbott m2000, QIAGEN Rotogene,
Roche Light Cycler 480, and BD Max. Finally, many public health laboratories also
have various platforms to perform rapid tests, such as the Abbott ID NOW, serologicaltesting, such as the Abbott Architect, and antigen detection tests, such as the Quidel
Sofia.
•

Point-of-Care Testing: These tests are considered relatively easy and safe to use, andare performed on instruments that are primarily located in physicians’ offices and urgent
care facilities. During the COVID-19 public health emergency, the Centers for Medicare& Medicaid Services (CMS) will permit a Certificate of Waiver laboratory to extend its
existing certificate to operate a temporary COVID-19 testing site in an off-site location,such as a long-term care facility. The temporary COVID-19 testing site is only permitted
to perform waived tests, consistent with the laboratory's existing certificate and must
operate under the direction of the existing lab director.
These instruments are routinely used to test for Streptococcal Pharyngitis (‘strep throat’),influenza, and human immunodefiency virus (HIV). Examples of these types of assays
include the Abbott ID NOW COVID-19 molecular test and the Quidel Sofia 2 SARS FIA
antigen test. Approximately 350,000 Abbott ID NOW tests are currently available on thecommercial market each week. The Quidel antigen test production is currently
approximately 1 million tests per week and is projected to increase to over 2 million tests
per week on the commercial market in the next month. While some of these tests arepoint-of-care and can provide a result within 5-15 minutes, they are low throughput,meaning that only a limited number of tests can be performed each hour. Also, their
sensitivity to detect virus is generally lower than that of the other types of tests, so it ispossible that some people could test negative when they really are virus positive (false
negative). While this is possible with all tests, it is somewhat more likely with point-ofcare tests.

The Federal government has worked intensively with each component of the laboratory
ecosystem. Beginning in March, the Biomedical Advanced Research and Development Authority(BARDA) invested in adding SARS-CoV-2 tests to diagnostic systems that are now used incommercial and clinical laboratories in order to rapidly expand high-throughput and nearpatient/hospital-based diagnostic testing capacity. The Federal government has worked with
manufacturers to increase available inventory, gain insight into diagnostic instrument installbases, and procured and distributed collection supplies. As of May 19, 2020, the Food and Drug
Administration (FDA) has worked with test developers and laboratories to grant 104 EUAs. In
addition, more than 250 laboratories began testing under the regulatory flexibilities adopted in
the Center for Devices and Radiological Health March 2020 guidance (updated in May 2020).

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

HHS and the Federal Emergency Management Agency (FEMA) have worked to remove
production barriers and provide guaranteed orders to de-risk production and investments. CDC
has supported the national clinical laboratory network though promulgation of guidance, hosting
webinars, and advancing additional training. As a direct result of these actions, the Federal
government estimates that more than 28 million laboratory tests could be performed in May anda similar number of tests could be performed in June.
How Much Testing is Sufficient?
The nation has now performed over 12 million nucleic acid tests, with more than two million
tests completed each week; and the numbers continue to grow. The rates of testing vary widely
by state, with states experiencing the worst outbreaks generally performing substantially moretests than states less affected.
Estimates about how many tests are needed vary widely based on assumptions such as theprevalence of active cases, the number of contacts per case, the effectiveness of mitigation in thecommunity, the sensitivity of the assays to detect cases, and the overall level of immunity within
the community. Estimates in the literature vary from a few hundred thousand per day to twenty
million per day. For example, the simulation model vi developed by the Safra Center at Harvard
assumes: tests are 80% sensitive (actual average sensitivity of laboratory based nucleic aciddetection test is 95%); hospitalization rate is 20% (actual hospitalization rate is <5%); no effectof mitigation (actual at least 35%); days to recovery is 15 days (actual is 11 days or less). If
testing can be targeted to likely positive individuals (f = 10), the actual number of tests needed
per day is reduced from Safra’s estimate of more than three million to just over 300,000 if thecorrect assumptions are used. This number is already being achieved through the current testing
regimen, and will be far exceeded by mid-summer.
The authors of the National Covid-19 Testing Action Plan: Pragmatic steps to reopen our
workplaces and our communities, a report from the Rockefeller Foundation, suggested that U.S.
needed to increase capacity for testing to three million tests per week as soon as possible – anumber that closely matches states’ goals for May and June (see below). In order to grow U.S.
testing capacity from three million tests per week to over 30 million per week, they
recommended investing in a Testing Technology Accelerator. This accelerator would rapidly
scale up testing utilizing a mix of current and newly developed technologies. This
recommendation aligns perfectly with the Federal government’s strategy: to maximize thenumbers of current tests while coordinating with the National Institutes of Health (NIH) Rapid
Acceleration of Diagnostics (RADx) Program, BARDA, and Defense Advanced Research
Projects Agency (DARPA) efforts to incorporate new, high throughput, high performing tests
into the national strategy once developed. Additional information about these efforts can befound in the increasing testing capacity section of this document.
Modeling efforts for COVID-19 have focused on working across the Federal government andwith non-federal partners to provide the most accurate, robust, and timely data available for13

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

response decision making. HHS and our partners have created models to inform every aspect of
the Federal government’s response, including potential trajectory of virus spread at the nationaland state level, and projections related to the potential impact of mitigation strategies on both
health outcomes and associated resource utilization. A series of compartmental models of
COVID-19 transmission were developed to assess the potential impact of different intervention
strategies (e.g., social distancing strategies, changes to travel patterns, vaccines).
Modelers have quantified modeled outcomes both in terms of health outcomes (e.g., incident
infections, persons hospitalized, mortality) and associated resource utilization (i.e., personal
protection equipment (PPE), critical care beds, ventilators). Models also estimated the number of
COVID-19 cases, adjusted for treatment seeking behaviors and testing practices in the U.S.
These analyses help inform decision making at the Federal level, including determinations forthe number of tests that may be necessary, and are also shared with states via regular modeling
updates at meetings of the Council of State and Territorial Epidemiologists (CSTE).These data
are made available to the public via CDC website postings.
Positivity Rate
Many epidemiological modelers and major public health organizations including WHO have set
an objective that the proportion of positive test results (percent positive) should be 10 percent or
less. vii This is a “common sense” type of metric that is easily understood. If 20 percent or 30
percent of the tests are positive, you are likely missing many positives as well as their contacts.
If only 10 percent are positive (or less), then you are likely testing enough to assure broad
coverage of the population.
Although 10 percent is not itself a “magic number,” it is a nearly universally suggested at least as
a first estimate of sufficiency of testing. Therefore, every day the Federal government assesses
its overall performance and that of each state to this metric.
Based on the data available from May 8 to May 15, 2020, the U.S. positivity rate averaged overthat seven-day period is now 7.5 percent and is continually decreasing. The percent positive
among results originating from the three major laboratory types for this period are listed in thetable below:

Laboratory Type% Positive

Hospital Labs

6.98%

Commercial Reference Labs

7.79%

Public Health Labs

8.23%

TOTAL U.S.

7.5%

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Report to Congress: COVID-19 Strategic Testing Plan

Disaggregation of the data into individual states shows 41 states have already achieved the 10
percent positive or lower threshold (7 day averages), with the remaining states and theDistrict of Columbia continuing to improve on a daily basis as testing increases. The
jurisdictions with the highest positivity rates (D.C. and Maryland) are now below 20 percent, andeach of these plans to perform four times their cumulative totals as of April 21 during May and
June.
Interim State Plans
The Paycheck Protection Program and Health Care Enhancement Act requires each state or
jurisdiction that is receiving funding for testing to submit to the HHS a specific testing plan,
guided by ongoing technical assistance from the Department. Plans for May and June are due to
HHS on May 30, and plans for remainder of 2020 are due on June 15.
As a precursor to these formal plans, HHS has provided each state with technical assistance toestablish state goals and to help fully utilize its existing testing capacity. Specifically, amultidisciplinary Federal team with experts from the Office of the Assistant Secretary for Health(OASH), FEMA, CDC, and other agencies held calls with leadership from each state andterritory. In general, state participants included a representative from the Office of the Governor,
the state public health laboratory, the state health official, and the state epidemiologist – or theirequivalents.
The outcomes of these calls were initial testing goals for each state for May and June, anddetailed plans to maximize laboratory instrument capacity in each state with available testing
reagents. The overall goals were determined by considering multiple factors, including thecurrent rate of new cases, plans for mitigation, percent positivity, and other factors.
Table 1 provides a breakdown of the initial testing targets agreed upon by the States and theFederal team. As demonstrated, the overall target for the nation for the month of May (and June)is 12.9 million tests. On a state-by-state basis, the targets ranged from a minimum of 2% of the
population tested, to 14.9% each month.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing PlanSTATE
ALASKA
ALABAMA
ARKANSASARIZONACALIFORNIACOLORADOCONNECTICUT
DISTRICT OF COLUMBIA
DELAWARE
FLORIDAGEORGIAHAWAIIIOWAIDAHOILLINOISINDIANA
KANSASKENTUCKYLOUISIANAMASSACHUSETTSMARYLANDMAINE
MICHIGANMINNESOTAMISSOURIMISSISSIPPIMONTANANORTH CAROLINANORTH DAKOTANEBRASKANEW HAMPSHIRENEW JERSEYNEW MEXICONEVADANEW YORKOHIO
OKLAHOMA
OREGONPENNSYLVANIA
PUERTO RICORHODE ISLAND
SOUTH CAROLINA
SOUTH DAKOTATENNESSEE
TEXAS
UTAH
VIRGINA
VERMONTWASHINGTONWISCONSIN
WEST VIRGINIAWYOMING
TOTAL

ABBR.
AK
AL
AR
AZ
CA
CO
CT
DC
DE
FL
GA
HI
IA
ID
IL
IN
KS
KY
LA
MA
MD
ME
MI
MN
MO
MS
MT
NC
ND
NE
NH
NJ
NM
NV
NY
OH
OK
OR
PA
PR
RI
SC
SD
TN
TX
UT
VA
VT
WA
WI
WV
WY

POPULATION
731,545
4,903,185
3,017,804
7,278,717
39,512,223
5,758,736
3,565,287
705,749
973,764
21,477,737
10,617,423
1,415,872
3,155,070
1,787,085
12,671,821
6,732,219
2,913,314
4,467,673
4,648,794
6,892,503
6,045,680
1,344,212
9,986,857
5,639,632
6,137,428
2,976,149
1,068,778
10,488,084
762,062
1,934,408
1,359,711
8,882,190
2,096,829
3,080,156
19,453,561
11,689,100
3,956,971
4,217,737
12,801,989
3,194,000
1,059,361
5,148,714
884,869
6,829,174
28,995,881
3,205,958
8,535,519
623,989
7,614,893
5,822,434
1,792,147
578,759
331,433,753

STATE DATATOTAL TESTS TODATE April 21
11,11948,387
27,20455,152300,100
48,70464,192
14,93916,656284,206
88,14025,57927,615
17,730154,997
67,264
19,10133,328141,835
175,372
73,635
14,943
121,298
47,69756,98652,364
11,241
83,331
14,987
16,782
15,041
185,91440,87740,464649,325
94,23944,48940,045
166,851
10,62039,33342,441
12,815
108,182
205,399
72,35858,354
13,111145,031
52,461
25,435
7,386
4,185,055

TOTAL TEST TODATE PER 1,000
15
10
9
8
8
8
18
21
17
13
8
18
9
10
12
10
7
7
31
25
12
11
12
8
9
18
11
8
20
9
11
21
19
13
33
8
11
9
13
3
37
8
14
16
7
23
7
21
19
9
14
13
13

RECOMMENDED TARGET
MAY TESTS PER
MUTIPLE TARGET
THOUSAND
VS. ACTUALTESTING TARGET
20,97329
1.9
195,000
40
4.0
90,00030
3.3
150,000
21
2.7
1,200,00030
4.0
195,000
34
4.0
200,000
56
3.1
60,00085
4.080,00082
4.8
600,000
28
2.1
210,000
20
2.4
30,00021
1.2
60,00019
2.2
40,00022
2.3
620,000
49
4.0
168,000
25
2.5
60,00021
3.1
132,00030
4.0
200,000
43
1.4
700,000
102
4.0
300,000
50
4.1
60,00045
4.0
450,00045
3.7
190,000
34
4.0
200,000
33
3.5
100,000
34
1.9
45,00042
4.0
300,000
29
3.6
45,00059
3.0
40,00021
2.4
60,00044
4.0
750,000
84
4.0
150,000
72
3.7
120,000
39
3.0
1,500,000
77
2.3
375,000
32
4.0
90,00023
2.080,00019
2.0
330,000
26
2.0
60,00019
5.6
158,000
149
4.0
170,000
33
4.0
50,00057
3.9
250,00037
2.3
750,000
26
3.7
135,000
42
1.9
235,000
28
4.0
30,00048
2.3
580,000
76
4.0
210,000
36
4.0
100,000
56
3.9
12,00021
1.6
12,935,973
39
3.1

Table 1. Table columns from left to right are state name, State abbreviation, cumulative number of tests performed
by state as of April 21, 2020; testing rate (tests per thousand people, cumulative); the suggested target number oftests following discussions with the Federal government; the testing rate for the month if the suggested target weremet; and the ratio between the suggested target and the cumulative tests performed in that State.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Viewed another way, the graph below shows each state’s goal for testing per 100,000 population
per month in May and June. The Federal government recommends all states to have an objectiveof testing a minimum of 2 percent of their population in May and June, pending additional new
data on infections and impact of reducing mitigation.

Figure 1. Fully supplied state testing goals for May

Testing for Special Populations
CDC and the White House Task Force are currently developing specific guidance on how, when,and if, viral and/or serologic testing should be considered as a component of reopening
businesses and other institutions. The first set of recommendations was issued by CMS on May
18, after consultation with the Task Force and CDC, regarding specific recommendations for
integration of testing in nursing homes (Appendix C). Specifically, CMS recommends
that: “Nursing homes should have a comprehensive plan for testing. All residents should receivea single baseline test for COVID-19. Also, all residents should be tested upon identification of anindividual with symptoms consistent with COVID-19 or if an employee or staff member tested
positive for COVID-19.” In addition, “All {nursing home} staff should receive a baseline test,
and continue to be tested weekly.” Until a point in time that the pandemic is controlled, or new
data emerge, this type of aggressive regimen can optimally protect our most vulnerable within
nursing homes. CDC and the Task Force are currently developing specific recommendations for
how to integrate testing in other environments, including universities, critical infrastructure
worksites, prisons, other congregate care facilities, and other environments. These will beforthcoming during the interval before the next Congressional report.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

State Plans
State plans must establish a robust testing program that ensures adequacy of COVID-19 testing,including tests for contact tracing, and surveillance of asymptomatic persons to determine
community spread. States must assure provisions are in place to meet future surge capacity
testing needs including POC or other rapid result testing for local outbreaks. States should also
include plans for testing at non-traditional sites (e.g., retail sites, community centers, residential
medical facilities, or pharmacies); testing of at risk and vulnerable populations including theelderly, disabled, those in congregate living facilities such as prisons, and racial and ethnic
minorities and other groups at risk due to high frequency of occupational or non-occupational
contacts; testing of individuals engaged in critical infrastructure sectors, such as food andagriculture and healthcare workers, and will address any essential partnerships with academic,
commercial, and hospital laboratories to successfully meet testing demand. In May, CDC
awarded a total of $10.25 billion to states, territories, and localities to be used to implement thegoals of each jurisdiction’s testing plan. States, territories, and localities will be expected to use
these funds to purchase tests and related supplies, as necessary. See Appendix D for ELC HealthCare Enhancement: 2020 Supplement, the guidance to States on submitting State plans.
Although a number of State-specific factors will determine quantitative objectives, States arerequested to detail how a minimum of two percent of the State’s population will be tested eachmonth beginning immediately; as well as plans to increase that number by the fall of 2020.
States are requested to include a list of laboratories that will be testing in their State, along witheach laboratory’s available platforms and throughput.
Once submitted, a multidisciplinary team of experts from HHS will thoroughly review eachState’s plan to ensure that the testing plan is sufficient to mitigate the spread of the virus, protect
vulnerable groups, and accounts for enough testing supplies and reagents to cover all groups
including underserved populations. The review panel will be chaired by the Assistant Secretaryfor Health, and include subject matter experts that span the required disciplines, including
membership from the Laboratory and Diagnostics Task Force within the Office of the Assistant
Secretary for Health, NIH, CDC, and other subject matter experts. The panel will also review
State testing progress, needs assessment, and plans on a monthly basis to determine if
modifications to the plan are required, or additional assistance is needed. Modifications to theState plans may be necessary if patterns of virus transmission change or are projected to change,
increased case rates are observed, and/or additional types of testing and inventory become
available through the RADx program at NIH or other sources.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Testing Goals beyond June 2020
By September, the nation will be capable of performing at least 40-50 million tests per month.
This includes approximately 25 million POC tests, including new SARS-CoV-2 antigen tests.
Acceleration of laboratory testing – even with current platforms – could result in even higher
numbers of tests available.
HHS will re-evaluate goals and objectives for the remainder of 2020 based on the testing plansdeveloped by States as well as the ongoing epidemiology of COVID-19. HHS will continue toaggressively support and conduct programs such as RADx (detailed in the Increasing Testing
Capacity section of this report) to accelerate the development and commercialization of new
COVID-19 diagnostics for the Fall, which could add to this overall number – or improve theperformance of the testing at this numeric level.

Federal Government Support to States
To enable States to achieve the testing goals developed in coordination with the Federal
government, the Federal government has worked with manufacturers to gain insight into
diagnostic instrument install bases; procured and shipped collection supplies; and determined
reagent inventory. The Federal government then provided all information to States so they could
better determine how to optimize their testing strategy. The Federal government also purchased
and allocated POC devices and tests; developed, implemented, and facilitated community-based
testing sites across the country; and provided significant guidance and technical assistance forState plans. The increase in the numbers of tests performed since early March is a directreflection of these efforts. Moving forward, jurisdictions should use the $10.25 billion recently
provided to states, territories, and localities by the Federal government to support the purchase of
tests and related supplies, personnel for contact tracing, and reporting infrastructure, etc., fortheir jurisdictions, as needed to fulfill their approved testing plans.
Diagnostic Platform Capacity
Prior to setting State goals, Federal government research determined the number and type of highand low throughput laboratory platforms in each State, including their total capacity to perform
COVID-19 tests if utilized to 100 percent capacity. Each governor received the specific location,
type of instrument, and when possible, the actual utilization of that instrument. Figure 2 is a mapthat shows the general location and type of diagnostic instrument, but does not disclose specificaddresses or proprietary information. The map does not include the distribution of Abbott ID
NOW POC devices. There are now more than 18,000 of these widely dispersed throughout thenation, including at public health laboratories in each State. It also does not include the Quidel
Sofia 2 POC instruments, for which there are now more than 20,000 available nationwide.
The total capacity of these machines exceeds 200 million tests per month, if they were entirely
dedicated to COVID-19 testing. As a result of this analysis, it was determined that each State had

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

the capacity to meet its testing goals internally, although four States did not have excess capacity
and would likely require outside assistance. For these States, alternate plans including theutilization of national reference laboratories, such as LabCorp and Quest, were suggested andimplemented by these States.

Figure 2. Lab Testing Capacity: General location and type of diagnostic instrument

Collection Supplies
To ensure States meet their testing goals, the Federal government procured FDA authorizedswabs and transport media, and is distributing these supplies to a single location in each State
determined by the Governor’s office. For May, the Federal government will distribute 12.9
million swabs and 9.8 million tubes of transport media to the States. If States surpass their
testing goals for May, additional collection supplies are available for limited federal
supplementation if states cannot otherwise procure these supplies. The Federal government
procurement still represents much less than half of the overall U.S. commercial market
availability, so States can continue to procure supplies on their own. In addition, testing
performed by major reference labs provide their own supply of tubes and media. The Abbott ID
NOW point-of-care and Quidel tests also come complete with swab and reagents. Based on theFederal government procurements and the availability of specimen collection supplies in theprivate marketplace, there will be sufficient collection supplies to meet State needs.
To ensure that States have the collection supplies that they need through December 2020, theFederal government plans to acquire 100 million swabs and 100 million tubes of viral

20

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plantransport media, and distribute these supplies to States as requested to meet their individualState plans. This large-scale acquisition reflects a significant expansion of current capacity andis a result of the broadening of available swab and media types authorized by the FDA and use of
Title III of the Defense Production Act (DPA) to increase production of swabs.
Specifically, the Department of Defense (DoD) is investing $75.5 million in DPA Title 3 funding
to increase swab production by 20 million swabs per month starting in May. Puritan Medical
Products, which was awarded the contract, will quickly establish a new manufacturing facility
capable of doubling its current monthly output of 20 million swabs (to 40 million). The
increased production and long-term industrial capacity will help support the needs of the nation.
A diagram outlining the flow of swabs and media to the States, labs and providers offices is
included in Figure 3 below:

Figure 3. Specimen collection supply workflow

Reagents
Research performed by the Federal government has indicated that there will be at least 28
million tests available in the U.S. market in May, with that number growing substantially overthe coming months.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Table 2. Available testing reagents (May 2020)
Company

Available May Tests

COMPANY 1

2,300,000

COMPANY 2

360,000

COMPANY 3

1,500,000

COMPANY 4

4,900,000

COMPANY 5

2,500,000

COMPANY 6

3,200,000

COMPANY 7

1,400,000

COMPANY 8

12,000,000

TOTAL

28,160,000

Although these tests numerically exceed the overall goal of States, not every test is available inunlimited supply to States that may want that specific test. To solve this issue, the Federal teamhas assisted each State to match their capacity with the reagents that are available; andconversely, the Federal government has assisted industry to develop a distribution strategy tomeet the demands of each State. For example, a large availability of ThermoFisher TaqPath
COVID-19 tests led to a shift in testing strategies such that States would utilize this platform
preferentially, at least until inventory for other platforms became increasingly available. The
dynamic nature of testing availability will be complemented by additional regulatory action to
expand the number of platforms compatible with the available tests, as the FDA did recently for
the ThermoFisher TaqPath COVID-19 Combo Kit.
As opposed to collection supplies, reagents are typically manufactured by larger companies withefficient distribution channels. Therefore, there was no justification for the Federal government
to purchase reagents and then redistribute them. Instead, the Federal government has assured
allocation through pre-existing distribution channels.
Allocation of Abbott ID NOW Point-of-Care Tests
At the end of March, the FDA issued an EUA for Abbott’s ID NOW POC test for SARS-CoV-2,
which is capable of being run on any of the more than 18,000 ID NOW portable instruments
currently available in the United States. Within a week after FDA issued the EUA, the company
delivered approximately 350,000 test kits per week.
The ID NOW test can deliver positive test results in as soon as five minutes, with negative test
results taking no longer than 15 minutes. Moreover, the test does not require additional
materials, swabs, or reagents—each test comes complete with everything needed for use, and is22

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

performed in a CLIA-waived laboratory setting, meaning the test can be performed in alaboratory or POC setting that has or is associated with a CLIA certificate.
However, the test is low throughput (about 4 tests per hour) so it is not suitable for screening
thousands of individuals in an outbreak. Additionally, the test is designed to go from “nose to
instrument,” meaning that the test loses sensitivity if the swab is placed in media and thentransported to a distant site for testing, increasing the potential for a false negative result.
As such, the Federal government assessed, and acted upon the fact, that this testing platform was
uniquely suited to remote locations where there is no other testing infrastructure, as well as forthe investigation of outbreaks where an answer is needed immediately, such as in nursing homeoutbreaks or other congregate living situations.
To ensure the availability of this unique resource for these applications, the Federal government
purchased ID NOW instruments and distributed 15 instruments to at least one public health lab
in each State; 50 to the public health labs in Alaska (because of the State’s vast geography andremote locations); 250 instruments to the Indian Health Service (IHS); and a smaller number of
instruments to U.S. Pacific Islands. Additionally, instruments were deployed in support ofspecialized missions including the Department of Energy (DoE) and other critical infrastructure.
In addition to the instruments themselves, the Federal government acquired 100,000 of theavailable 350,000 tests weekly, to ensure distribution of tests for these critical needs. Although
the distribution varies somewhat by week, in general each week 60,000 tests are for the publichealth labs, 20,000 per week to IHS, and 10,000 per week for the Federal Bureau of Prisons. A
portion of these tests are stored in the Strategic National Stockpile for use in crises that require a
rapid response, such as outbreaks in meatpacking plants. The remainder of the tests support
Federal partners, including the Veterans Administration, Department of Justice, DoD,
Department of Homeland Security, and Department of Energy, as well as FedEx and UPS in
implementing Project Airbridge to transport PPE from other countries to the U.S.
To date, HHS has provided more than 297,000 test kits to public health labs in every State andterritory, and nearly 110,000 test kits to the IHS for distribution throughout tribal communities.
Quidel Sofia 2 Instrument and Tests
Quidel has recently received an EUA from the FDA for the Sofia 2 SARS Antigen FIA, a rapid
POC test (results within 15 minutes) that is performed on the Sofia 2 fluorescent immunoassay
analyzer. There are approximately 26,000 Sofia 2 instruments across the nation. Most of theseunits are located in provider and clinic settings. Because the Sofia 2 platform is small and mobile
and the assay could be very useful, especially to diagnose persons who are positive for the virus
in a community, industrial, or long-term care environment, the Federal government may
purchase a quantity of these devices and tests to support specific outbreak investigations.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Community Based Testing Sites
Collection of specimens can occur within hospitals, at provider’s offices, at public healthlaboratories, and other venues. To ensure that specimens could be collected without
overburdening the traditional health care system, the Federal government implemented –beginning March 20 – Community Based Testing Sites (CBTS) and progressively developed
these prototypes such that they are now widely available for use as part of each State’s testingplan.
The Federal government worked with State and local partners to establish federally supported
CBTS sites in locations prioritized by the CDC. The CBTS model was developed for States,
local public health agencies, healthcare systems, and commercial partners as they work together
to stop the spread of COVID-19 in their communities, focusing initially on healthcare facility
workers and first responders. The CBTS federally supported, State managed, locally executedmodel has been a profound success, testing to date, approximately 200,000 individuals.
The current CBTS model has nine core components: (1) Registration, (2) Ordering the test, (3)Self-swabbing, (4) Specimen handling, (5) Specimen Storage & Shipment, (6) Lab processing,(7) Patient Notification, (8) Logistics, and (9) Reporting.
For these initial sites, the Federal government provided a Federal physician who orders all of the
COVID-19 tests, the Federal contracts for shipping the specimens, laboratory processing, patient
notification, and logistics (to include supplies, personal protective equipment, languagetranslation services). The Federal government also utilized U.S. Public Health Service personnel
to provide data management, safety and quality control checks at each site.
Since the onset, the federally supported CBTS program has led advanced testing innovations,such as the implementation of nasal self-swabbing, which has minimized the need for trained
healthcare professionals and PPE. These advances increased access to testing supplies bybroadening the variety of swabs authorized, and between April 10-15, 20 States transitioned theirsites to State control, allowing for more flexibility in testing and reporting. In order to provide
additional testing support, the CBTS Task Force continues to support 14 sites in five States.
The Federal government will continue supporting each public site until the site is ready totransition to State-management. When the site is ready, the Federal government will support thetransition process to ensure States can fully manage and operate their CBTS locations
independently. This includes providing each site with enough supplies to continue to operate for7-14 days after the agreed upon transition date.
Building on the initial success of the CBTS model, the Federal government next leveraged
public-private partnerships with pharmacy and retail companies (CVS, Health Mart, Kroger, Rite
Aid, Walgreens, and Walmart) to accelerate testing for more Americans in more communities
across the country. The public-private partnership model operates on the federally supported,
State managed model; but the private partner is responsible for providing the nine components.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

The Federal government provides each of the private partners with a bundled payment. The
partnership builds on the experience gained from pilot sites, and:•

Provides Americans with faster, less invasive and more convenient testing•

Protects healthcare personnel by eliminating direct-contact with symptomatic
individuals•

Expands rapidly to areas that are under-tested and socially vulnerable

In determining the site selection for the retail testing locations, the Federal government focusedon communities with high social vulnerability using the CDC’s Social Vulnerability Index (SVI)
as one of the main factors to select sites. The SVI measures the resilience of communities whenconfronted by external stressors along four main themes:•

Socioeconomic Status•

Household Composition & Disability•

Minority Status•

Housing TypeThe public-private partnership-testing model has resulted in testing of over 320,000
individuals at 408 sites in 44 States and the District of Columbia, with a goal to have over
416 sites by the end of May 2020. Sixty-nine percent of these sites have at least a moderate
SVI and 31% have a high SVI.
Private retailers have also responded to the incentives created by the Federal government andhave exponentially expanded their testing capacity. CVS has announced they will beestablishing 1,000 testing sites throughout the nation outside of the public-private partnership. viii
Testing Guidelines
CDC is responsible for providing guidance for States, local governments, and tribal governments
on priorities for COVID-19 testing for active infection. According to the guidance “Evaluating
and Testing Persons for Coronavirus Disease 2019 (COVID-19)”, the highest priority groups fortesting include hospitalized patients with symptoms; healthcare facility workers; workers incongregate living settings, first responders with symptoms; residents in long-term care facilities
or other congregate living settings, including prisons and shelters, with symptoms. ix The next
highest priority group includes persons with symptoms of potential COVID-19 infection,
including: fever, cough, shortness of breath, chills, muscle pain, new loss of taste or smell,
vomiting or diarrhea, and/or sore throat; and persons without symptoms who are prioritized byhealth departments or clinicians for any reason, including but not limited to: public healthmonitoring, sentinel surveillance, or screening of other asymptomatic individuals according toState and local plans.
CDC has specific guidance on “testing considerations for nursing homes.” x Increased availabilityof testing in nursing homes has the potential to not only describe the scope and magnitude of25

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

outbreaks, but also to help inform additional prevention and control efforts designed to further
limit transmission among nursing home residents and health care professionals. This guidance isfrequently updated based on lessons from the field, new science, and modeling work. CMS
recently released “Guidance on Reopening Nursing Homes” that also includes information on
testing for nursing homes as part of safely re-opening. xi The CMS guidance recommends a
facility should have a testing plan based on contingencies, and, at a minimum, include thefollowing components:•

The capacity for all nursing home residents to receive a single baseline COVID-19
test. All residents are tested upon identification of an individual with symptoms
consistent with COVID-19, or if staff have tested positive for COVID-19. Weekly retesting continues until all residents test negative;•

The capacity for all nursing home staff (including volunteers and vendors) to receivea single baseline COVID-19 test, with re-testing every week;•

Written screening protocols for all staff (each shift), each resident (daily), and all
persons entering the facility, such as vendors, volunteers, and visitors;•

An arrangement with laboratories to process tests. The test used should be greaterthan 95% sensitive, and greater than 90% specific. Also, serologic tests should
include a confirmatory serological assay that includes an epitope from the spike
protein for specimens with a positive initial test; and•A procedure for addressing residents or staff that decline or are unable to be tested(e.g., symptomatic resident refusing testing in a facility with positive COVID-19
cases should be treated as positive).

Other vulnerable populations can be prioritized for testing as per State and local testing plans.
State and local health departments may adapt this guidance to support the development andimplementation of their plans for reopening and in response to rapidly changing local
circumstances.
Critical Infrastructure
Guidance on surveillance strategies and controls has also been issued to mitigate risk oftransmission among workers within critical infrastructure sectors. xii,xiii,xiv There are 16 criticalinfrastructure sectors whose assets are considered so vital to the U.S. that their incapacitation or
destruction would have a debilitating effect on security, national economic security, national

26

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Planpublic health or safety, or any combination thereof. xv Within
the emergency services and healthcare and public healthsectors, the increased level of exposure suffered by first
responders has resulted in large numbers of infections among
critical workers in these sectors. xvi Similarly, the food andagriculture sector has been negatively impacted by essential
workers being diagnosed with COVID-19. xvii

Critical Infrastructure Sectors• Chemical• Commercial Facilities• Communications• Critical Manufacturing• Dams• Defense Industrial Base
• Emergency Services• Energy• Financial Services• Food and Agriculture• Government Facilities• Healthcare and Public Health• Information Technology• Nuclear Reactors, Materials, and Waste• Transportation System• Water and Wastewater Systems

Ensuring the sustainability of critical infrastructure sectors is
one of the foundational aspects of the President’s Opening Up
America Again, and one of the proposed gating criteria forreopening is a robust testing strategy for workers in criticalinfrastructure sectors. The Federal government will work with
States, as needed, to develop and implement tailored testingand surveillance solutions to the challenges faced by criticalinfrastructure sectors. This may include the use of targeted testing in response to outbreaks inwork settings, by using a testing strategy to identify infected employees, conduct contact tracing,and implement measures to prevent transmission.
Continued cooperation between HHS and manufacturers will also continue to play an integralrole in providing timely updates to available guidance documents, recommendations for use of
specimen collection supplies, and the anticipated increase in serological testing. xviii,xix

Increasing Testing Capacity
Increasing testing capacity is essential to improve the availability of tests, and access to testing
resources needed for implementing robust diagnostic testing plans, timely monitoring systems,
and rapid response programs. In order to successfully increase testing capacity, efforts must be
holistic, to include cooperative planning and prioritization across Federal, State, and private
sectors. Additionally, the focus must be not only on the development and production ofcommercially available diagnostic assays, but also on the myriad of components necessary tosupport the testing enterprise, including instruments, supplies, PPE for healthcare and laboratory
personnel involved in sample collection and testing, and the underlying regulatory, laboratory,
and commercial systems that can:•leverage the full spectrum of Federal regulatory functions,•

expand the available landscape of acceptable specimen collection and laboratory
supplies and reagents,•

maximize use of available laboratory infrastructure and testing venues, and•strengthen and support State-level testing and surveillance strategies.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Coordination with Private Sector
The Federal government, through the Laboratory Diagnostic Testing Task Force, has engaged inclose coordination with commercial manufacturers and laboratories to gain a better
understanding of supply chain challenges and projected inventory. In addition, HHS has worked
diligently with these same manufacturers and laboratories to alleviate supply chain issues,
increase test production, and testing capacity. HHS and FEMA have procured swabs and viraltransport media (VTM) necessary for COVID-19 upper respiratory specimen collection, and are
currently providing these materials directly to States for storage and distribution, in support ofState-specific testing plans. In addition, the Federal government has utilized the DPA to increase
production of swabs in the U.S. and alleviate the reliance on manufacturers overseas.
Additional Federal efforts to increase COVID-19 testing capacity will capitalize on the
momentum gained from the regulatory, supply chain, and public-private partnerships
accomplishments to date; as well as build momentum in additional areas, including optimizingalignment of laboratory capacity with testing demand, and strengthening testing in underserved
and vulnerable populations. HHS will continue to work across the Department and with ourother Federal, State, and local partners to ensure availability of appropriate testing platforms (e.g.
rapid POC tests and lab-based assays). With federal technical assistance, assurance of the supply
chain, and translation of innovations into the national diagnostics ecosystem, states will be able
to ramp up testing and related efforts through the $10.25 billion provided by CDC to states,
territories, and localities. These funds will be used to implement jurisdiction-specific testingplans, including procurement of necessary tests and related supplies, implementation of contact
tracing, and other required components. In addition, through technical assistance, the Federal
Government will help support State testing plans and ensure the availability and access to testingfor vulnerable populations and facilities that are at greater risk from the pandemic (e.g.
healthcare workers and first responders; workers in meatpacking plants; long term care facilities;
and underserved populations).
Regulatory Action
Early on during the SARS-CoV-2 pandemic, the Federal government took steps to increase
testing capacity through regulatory action. The FDA provided crucial guidance for
manufacturers to help accelerate the availability of COVID-19 tests xx, and expanded of thenumber of authorized specimen collection supplies (e.g. swabs, viral transport media) andlaboratory testing kits and reagents. FDA expanded the types of swabs and transport media
acceptable for specimen collection, directly increasing the available inventory at the national
level, and expanding the types of specimens acceptable for testing. These actions increased
specimen collection throughput, while reducing both patient discomfort and the need for PPE
utilization.
Between February 4 and May 5, FDA’s actions have resulted in EUAs issued for 76 molecular
tests and 12 serology tests. xxi These authorizations included commercial manufacturers with
instruments and systems in place in laboratories around the country, point-of-care tests, and28

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Planvarious types of sample collection. These actions not only increased the laboratory capacity for
COVID-19 testing, but also provided valuable quality assurance for laboratories that purchasethose tests.
As depicted in the following table 4, CMS has also taken significant action to ensure testing isaccessible.
Table 3. CMS Regulatory Actions to ensure testing availability
CMS Focus
Area

Description••

COVID-19
Diagnostic
Testing••••

Physician orPractitioner
Order for
COVID-19
tests:

Physician or non-physician practitioners are eligible for payment for assessment andspecimen collection for COVID-19 testing using the level 1 evaluation andmanagement code CPT code 99211. In light of the public health emergency,
Medicare will recognize this billing code for all patients, not just established patients.
This approach helps physician practices to operate testing sites during the PHE.
In addition to practitioners, outpatient departments of hospitals will have a new code,
CPT code C9803 under the OPPS for HOPDs to bill for a clinic visit dedicated to
specimen collection and adopting a policy to conditionally package payment for thiscode. The OPPS will make separate payment for HCPCS code C9803 under the OPPS
when no other primary service is furnished in the same encounter. xxii
Medicare will pay the higher payment of $100 for COVID-19 clinical diagnostic lab
tests making use of high-throughput technologies developed by the private sector thatallow for increased testing capacity, faster results, and more effective means ofcombating the spread of the virus.
A higher specimen collection fee will be paid to laboratories to travel to a Medicare
beneficiary who is homebound or in a skilled nursing facility or in a home health tocollect a specimen. xxiii
Several Medicare policies are being expanded, on an interim basis, to cover FDA
authorized COVID-19 serology tests, to allow any healthcare professional authorized
to do so under State law to order COVID-19 diagnostic laboratory tests (including
serological and antibody tests), and to provide for new specimen collection fees for
COVID-19 testing under the Physician Fee Schedule and Outpatient Prospective
Payment System.22
Medicare will not require an order from a treating physician or non-physician
practitioner as a condition of Medicare coverage of COVID-19 diagnostic laboratory
testing during the PHE. CMS similarly removed these requirements for an influenza
virus and RSV diagnostic laboratory test that is necessary to establish or rule out a
COVID-19 diagnosis. FDA requirements for an order and State requirements aroundordering diagnostic tests would still apply. CMS has also removed certain
documentation and recordkeeping requirements associated with orders for COVID-19
diagnostic tests as these requirements would not be relevant in the absence of anorder. CMS still requires laboratories to furnish the results of COVID-19 tests to thebeneficiary. Consistent and regular reporting of all testing results to local officials is
critical to public health management of the pandemic; we would expect any clinician

29

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Planor laboratory receiving results to report those results promptly consistent with Stateand local public health requirements, typically within 24 hours.
•

Medicare will pay for COVID-19 tests performed by pharmacies that enroll in
Medicare as laboratories. A pharmacist also may furnish basic clinical services, suchas specimen collection, when performed under contract with a doctor or practitioner,in accordance with a pharmacist’s scope of practice and State law. As auxiliary
personnel, pharmacists can provide services incident to the professional services of aphysician or non-physician practitioner who bills Medicare Part B under the Physician
Fee Schedule (PFS) services. If incident to rules under 42 CFR 410.26 are met andpayment for the services is not made under Medicare Part D, the services must be
provided in accordance with the pharmacist’s’ scope of practice and applicable State
law. This can include working with a physician or non-physician practitioner to assessand collect specimens for COVID-19 diagnostic tests. A pharmacy that acquires a
Clinical Laboratory Improvement Amendments (CLIA) certificate can enroll with
Medicare as a clinical diagnostic laboratory to conduct and bill for clinical diagnostic
laboratory tests authorized to be performed under its CLIA certificate.

•

On March 30, 2020, CMS issued blanket waivers of the sanctions under the Stark
Law. These blanket waivers apply to financial relationships and referrals that are
related to the COVID-19 emergency. The remuneration and referrals described in theblanket waivers must be solely related to COVID-19 Purposes, as defined in theblanket waiver document. Under the waivers, CMS will permit certain referrals andthe submission of related claims that would otherwise violate the Stark Law.

Pharmacists

PhysicianSelf-referral
Law (known
as the “Stark
Law”)
Waivers

New and Emerging Technologies
As part of Stage 3 of the Testing Overview to support the reopening of America, the Federal
government is partnering with the private sector to accelerate research and development ofinnovative tests, such as highly specific and sensitive serologic tests, antigen tests, POC nucleic
acid tests, and tests using genomic sequencing technology. New and emerging technologies canhelp fulfill the need for testing capacity, by (1) making additional commercially available testing
options available for Americans, (2) improving the manufacturing capacity for diagnostic tests,and (3) creating new testing approaches that may be easier to use, better prioritize those whoneed to be tested, and enable more efficient testing.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

To date, nucleic acid testing has been the cornerstone of the Federal government’s diagnostic
response to COVID-19. More recently, the FDA has granted EUAs for both antigen andserologic tests for COVID-19, increasing the numbers and types of diagnostic technologies in the
toolbox. Over the next several months and as we move into influenza season, it will be criticalthat we work to validate new mechanisms to employ current technologies in innovative ways andsupport the development and scaling of new and emerging diagnostic tools. For example,
pooling of samples from multiple (5, 10, or 20) individuals in a single test could yield dramaticadvances for testing in circumstances where the overall prevalence of the disease is low (back toschool, military missions, energy plants operations, etc.). However, pooling has not beenvalidated to be accurate, and indeed, may compromise sensitivity of the assays. Validation of“pooling” techniques across multiple platforms including POC and laboratory-based tests will be
performed and submitted to the FDA for authorization.
In addition, development, scaling and production of multiplexed assays (respiratory panels)
should be prioritized as we head into influenza season. Multiplexed, multi-analyte diagnostic
tests allow for the simultaneous detection of different analytes from a single specimen and arereagent sparing. For SARS-CoV-2, there are currently several multiplexed, multi-analyte reverse
transcription polymerase chain reaction (RT-PCR) assays capable of detecting and differentiating
SARS-CoV-2 from a panel of over 20 respiratory pathogens. These types of assays are criticalfor ensuring rapid, accurate diagnosis and differentiation of SARS-CoV-2 and influenza patientsduring influenza and respiratory virus season.
Other Emerging Technologies and Innovative Approaches
During times of pandemic when supply chains are strained by the traditional response, investingin emerging technologies and innovative supply approaches can further expand testing capacity
by making tests simpler and easier to use for Americans. FDA recently authorized the first athome sample collection kits. At-home sample collection and shipment to a dedicated laboratory
means health care workers do not need to administer tests. This reduces health care worker
burden and saves critical PPE. Making testing more available also slows the spread of infection
by informing individuals who are currently positive for COVID-19. Promising emerging
technologies include Next-generation Sequencing (NGS), Clustered Regularly Interspaced Short
Palindromic Repeats (CRISPR), and adjunctive technologies.
NGS is a high-throughput deoxyribonucleic acid (DNA) sequencing technology that can be used
to sequence the genetic code of a virus. NGS is a promising option for rapid-scale testing,utilizing infrastructure that already exists across the country. The resolution of NGS tests
exceeds that of PCR-based tests. xxiv In addition to providing diagnostic information, NGS canprovide information about viral evolution and be utilized for additional drug and diagnostic assay
development. In additional to monitoring mutations in the viral sequence (evolution), NGS canbe used effectively in contact tracing programs, especially in areas with low transmission, toidentify chains of transmission and to potentially identify new points or sources of introduction.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing PlanNGS has been used very effectively in the 2019/20 Ebola outbreak in DRC to identify silent
chains of transmission.
However, NGS cannot be operated at POC and requires samples to be handled, transported,
analyzed, and reported back to patients and health professionals. CRISPR technology can beused to identify a specific sequence in the viral genetic code and provide a detectable signal if
the sequence is identified. This process has the potential to be done at home and without
specialized equipment. These tests, however, are still not commercially available and will
require time to develop and scale up. FDA recently authorized a CRISPR based assay that canreportedly test whether a patient sample contains SARS-CoV-2 virus in an hour. xxv These tests
should be prioritized for scaling given their lower dependence on complex supply chains.
Adjunctive technologies, or non-traditional diagnostic technologies, may be attractive becausesuch capabilities may be rapidly deployable and empower the patient and health-care provider
through remote and self-monitoring. Monitoring individuals prior to and in early stages ofsymptom onset (if symptomatic) can remove the barriers of testing largely performed at clinics
and hospitals by identifying those who need to be tested and those who can remain quarantinedor self–monitored. Such technologies include telemedicine or app-based technologies, wearables
that can monitor patient vital signs data and algorithm-based tools that can predict or inform on
risk of infection, severity or outcome. These tools may connect patients directly to health care
professionals, which is beneficial in settings where resources are limited. A comprehensive
solution instituted by BARDA includes leveraging the use of FDA-cleared technologies tomonitor biophysical markers, as well as demonstrating capability to utilize wearable technologies
such as smart watches to develop an ordinal symptom severity score to identify individuals who
may be most at risk for severe cases of COVID-19. In addition, diagnostic tools developed to
predict and inform on sepsis are being utilized in pilot studies of COVID-19 patients topotentially indicate risk of viral sepsis. Such innovations in digital health technologies could
ultimately help reduce the time between infection and testing, provide information to improve
clinical management of patients, identifying those who need additional care more quickly, andallowing individuals who test positive to self-quarantine sooner.
A key component of developing new testing technologies is tracking and ranking proposals.
BARDA established the Medical Countermeasure (MCM) Portal for Coronavirus xxvi to ensure
Federal government partners could stay current with the rapidly evolving landscape ofpromising, emerging technologies. BARDA and interagency colleagues review and prioritize
information and proposals from industry submitted to the portal. After the initial review“CoronaWatch” meetings are scheduled that allow interagency partners to evaluate and identify
the best funding opportunities. As of May 1, 2020, the MCM Portal had received 2,590
applications that have resulted in over 250 CoronaWatch meetings, 99 of which were fordiagnostics.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

BARDA Investments
To support the anticipated need for expanded diagnostic capacity, BARDA has invested in thedevelopment of tests to detect active and prior infection for SARS-CoV-2. Beginning in March,
BARDA invested in adding SARS-CoV-2 tests to systems that are routinely used in commercial
and clinical laboratories, in order to rapidly expand high-throughput and near-patient/hospitalbased diagnostic testing capacity. BARDA’s investments focused on “sample-to-answer"
systems that do not require separate extraction reagents that had been in short supply. Six SARSCoV-2 nucleic acid tests from five companies supported by BARDA received EUAs by April 3,
2020. Additional EUAs are expected in May. This, along with substantial increases in thenumber of diagnostics tests shipped by BARDA-funded test manufacturers, will further expand
testing capacity.
As of mid-May, over 4.8 million diagnostic tests have been shipped by BARDA-funded test
manufacturers for domestic use, and partners are continuing to increase production. BARDA has
also invested in advancing development of POC nucleic acid tests, antigen tests, and serologic
tests.

Figure 4. Molecular diagnostics tests shipped in the U.S. by BARDA-funded companies

In addition to the nucleic acid detection tests (RT-PCR and isothermal) that have been designed
to detect SARS-CoV-2 ribonucleic acid (RNA) in respiratory samples, BARDA plans to support
systems that integrate SARS-CoV-2 tests with tests for other respiratory pathogens. This will
improve the efficiency and effectiveness of diagnosis of COVD-19, and rule-out of COVID-19
by diagnosis of other respiratory pathogens. Additionally, BARDA will leverage existing FDA-

33

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plancleared nucleic acid systems to develop pan-coronavirus assays that detect and differentiate
coronaviruses. These tests will be useful in the current outbreak, and improve preparedness for
emergence of other coronavirus in the future. BARDA will continue investments in molecular,
antigen and antibody detection tests, focusing on laboratory and POC technologies that offer
high sensitivity and specificity.
NIH Rapid Acceleration of Diagnostics (RADx-Tech) Program
The NIH will have an increasingly important role in the development of new diagnostic
technologies and concepts of operation. The Assistant Secretary for Health will closely
coordinate with the NIH leadership team for RADx to assure that new technologies developed
will be seamlessly integrated into the testing ecosystem.
On April 29, NIH launched the RADx-Tech program to accelerate the development, validation,and commercialization of innovative point-of-care and home-based tests, as well as
improvements to clinical laboratory tests, that can directly detect SARS-CoV-2. The goal of thisprogram is to support the development and deployment of tests with improved analytical andenhanced operational performance that improve access and reduce the cost of testing.
Technologies supported through this program will be sensitive enough to identify recently
infected but asymptomatic individuals using a variety of sample types, such as nasal swabs,
saliva, or blood, while being reliable with an easy to use design. Ease of use, including ability tointegrate with mobile devices, and accessibility are key for the success of these potential new
testing technologies.
The program has garnered interest from over 1,000 developers, with 79 full applications
submitted within little more than a week of the program launch. Technologies will be put
through a highly competitive, rapid three-phase selection process to identify the best candidates
for at-home or point-of-care tests for COVID-19. During the first phase, experts in clinical,
technical, business, regulatory, and manufacturing fields will rapidly assess the technology forpotential. Promising technologies will advance to Phase I receive modest funding, and bematched with technical, business and manufacturing experts to increase the likelihood of success.
Technologies that are already relatively far along in development can be immediately placed inPhase II, where support will be provided for scale-up tests for validation, meeting regulatory
requirements, and supporting manufacture and distribution.
To ensure that innovations are available to the public as quickly as possible, NIH will leverage
established partnerships with Federal agencies assisted by the coordination of the Assistant
Secretary for Health. Partnerships include FDA, CMS, BARDA, and CDC, as well as
commercial and private entities to propel technologies developed by RADx-Tech programs into
widespread use. The goal is to make millions of accurate and easy-to-use tests per week
available to all Americans by the end of summer 2020, and even more in time for the flu season.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Monitoring Testing Capacity
The ability to monitor, evaluate, and enhance current testing efforts is a key component of HHS
testing initiatives. HHS maintains regularly updated datasets on a number of relevant testing
metrics, including cases (national, State, and county data), xxvii mortality reporting (national andState levels), xxviii and testing (county, State, and national data). xxix For several of these data,
additional disaggregation by gender, race, ethnicity, and age is available to help monitor
vulnerable populations. FDA offers useful data on the expansion of available diagnostic kits andlaboratory tests by providing a regularly updated list of those tests that have received EUAs. xxx
Vulnerable Populations
Although it is necessary to increase testing for the entire population, there are special populations
that have historically been more difficult to reach for testing, such as those who are economicallydisadvantaged, speak English as a second language, or may be isolated, culturally or
geographically. In addition, there are vulnerable populations that may be at increased risk of
COVID-19. This can be a result of their occupation, as part of a critical infrastructure sector;
through living conditions, such as in nursing homes or other congregate living situations; orthrough concurrent health conditions, such as those individuals who are living with HIV andneed to maintain access to healthcare services. State’s plans should address how the jurisdiction
will meet the testing needs for vulnerable populations. The national strategy tailors approaches
to reach each of these special populations. One of the critical parts of the strategy is to ensure atneed communities have access to testing. A significant number of HHS’ diagnostic test
investments continue to focus on technologies appropriate for use in the environments wherethese special populations need rapidly available tests, in non-laboratory settings, including tests
such as small hand-held molecular tests and rapid antigen and antibody tests.
NIH is currently developing a program to expand testing capacity in underserved populations
across the country. The RADx-UP (Rapid Acceleration of Diagnostics – Underserved
Populations) program, part of the RADx initiative, will develop infrastructure to assess andexpand evidence-based testing interventions and capacity for those populations that are
disproportionately affected by, have the highest rates of, and/or are most at risk for adverse
outcomes from contracting the virus. These populations include racial and ethnic minorities,
rural populations, populations living in underserved urban areas, those in situations that facilitatetransmission of the virus (e.g., assisted living facilities, nursing homes, jails/prisons, migrant
worker communities), people experiencing homelessness, and those with underlying conditions.
This program will establish pragmatic clinical trials at multiple sites across the country toinvestigate, in real-time, a variety of testing methods/approaches to better understand their
uptake, administration, and effectiveness in specific populations, areas, or settings. Sites will
collaborate with community health centers, houses of worship, homeless shelters, and prison
systems to identify and address the unique needs of the different communities. Additionally,
fully appreciating the scope of the sensitivities associated with this disease and the disparate toll
COVID-19 is taking on specific populations, this initiative will build an ethical and social

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

implications program to understand the range of issues associated with testing/diagnostic
technologies and information/data (including stigma associated with a positive test result) inresearch, clinical, or other settings.
Additionally, IHS is responsible for providing Federal health services to American Indians andAlaska Natives (AI/AN). There are many communities that benefit from IHS services,
representing AI/AN populations on Indian reservations and Alaska Native villages as well as inrural, urban and remote settings. For these reasons, IHS was given priority access to rapid POC
COVID-19 test systems as part of White House efforts to expand access to testing in ruralcommunities. HHS will continue to work with IHS to ensure that the resources needed areavailable to support these communities with timely surveillance, detection, and response
capabilities.

Resources for Testing
The Paycheck Protection Program and Health Care Enhancement Act (Public Law 116-139) was
signed on April 24, 2020. The law includes $100 billion for HHS in the Public Health and Social
Services Emergency Fund (PHSSEF), which includes $25 billion for testing, research anddevelopment, and response. This Act is the first piece of legislation specifically allocating
funding for testing resources.
The HHS plan for use of the $25 billion for testing, research, and development from this Act isoutlined below.
Awards to IHS, States, Localities, Territories, and Tribes for Testing ($11B)
The Act provides a minimum of $11 billion to State, local, territory, tribe, or tribal (SLTT)
organizations to develop, purchase, administer, process, and analyze COVID-19 tests, scale-up
laboratory capacity, trace contacts, and related efforts. SLTTs are required by the Act to submit atesting plan to the HHS by May 23, 2020 that contains information on monthly testing needs,
monthly laboratory and testing capacity, and how they will leverage testing resources to mitigate
COVID-19 spread. Of these funds:
o $4.25 billion is for allocation to States, localities and territories based on the number of
COVID-19 cases;o $6 billion is for allocation to States, localities, and territories consistent with the
population-based, Public Health Emergency Preparedness grant formula; xxxi ando $750 million is for allocation to the Indian health care system, in coordination with the
IHS; funds will be further allocated to IHS Healthcare facilities and programs, Tribal
Health Programs, and Urban Indian Organizations using existing funding mechanisms.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

BARDA ($1B)
The Act provides a minimum of $1 billion for additional development, manufacture, andpurchase of tests and diagnostics. BARDA plans to use funds to:o Develop laboratory and point of care diagnostics, including antigen and antibody
detection;o Increase domestic test manufacturing capacity; ando Increase sample collection kit production capacity.
CDC ($1B)
The Act provides a minimum of $1 billion for the CDC to implement testing, surveillance,
epidemiology, laboratory capacity expansion, contact tracing, and public health data
surveillance, and for analytics infrastructure modernization. CDC plans to execute the funds
using contracts, grants, and other mechanisms to increase the public health response and build
capacity, including:o Increase technical assistance nationwide;o Build laboratory capacity and strengthen clinical laboratory networks;o Increase surveillance, detection, and data analytics; ando Expand the electronic exchange of information between public health and health care.
FDA ($22M)
The Act provides $22 million for activities associated with diagnostic, serological, antigen, andother tests, and related administrative activities. FDA will use contracting vehicles and direct
funding mechanisms to:o Fortify personnel for review of diagnostics tests, prioritize review for test developers, andreduce the time it takes to review COVID-19 related submissions; ando Develop sample panels and reference materials to accelerate the development and testingof diagnostic tests.
Health Resources & Services Administration (HRSA) ($1.8B)
The Act provides $1.8 billion for programs under the purview of, or managed with thecoordination of the Department by, HRSA. This includes:
o $600 million in direct, one time, formula based funding for health centers and Federally
Qualified Health Centers to support testing;o $225 million for rural health clinics, which HRSA will execute in a similar manner as
through the Provider Relief Fund; ando Up to $1 billion more for provider reimbursement costs related to testing of uninsured
individuals, which will be executed in the same manner as funds for this purpose from theFamilies First Coronavirus Response Act (P.L. 116-127).

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

NIH ($1.8B)
The Act provides a minimum of $1.8 billion for NIH for point-of-care and rapid testing researchand implementation, including:o $306 million for the National Cancer Institute (NCI) to develop, validate, improve, andimplement for serological testing and associated technologies, including the evaluation ofcommercially available testing, clinical studies, and the establishment of centers of
excellence in serological sciences;o $500 million for National Institute of Biomedical Imaging and Bioengineering (NIBIB)
to support the RADx-Tech program, which is structured to deliver innovative testing
strategies to the public as soon as late summer 2020; ando $1 billion for the Office of the Director to support activities including rapid scale up of
diagnostics and community-engaged projects to expand testing of underserved
populations.
 The Act also provides transfer authority for the Director to move funds to otherInstitutes and Centers of the NIH. As of this date, the authority has not been used.
Other Resources ($8.3 billion)
HHS will use any additional resources available to address emerging COVID-19 response needs.
HHS’ immediate planned use for these funds include:o Purchase of rapid identification test kits for distribution across the US;o Purchase of swabs and transport media to assist State and local testing efforts; ando Serological testing demonstrations with health care workers and first responders.
Office of the Inspector General (OIG) ($6M)
The Act directs $6 million to OIG for oversight activities, which are to be available forobligation following consultation with the Appropriations Committees.
Resources from Prior Supplemental Appropriation Acts
In addition to the resources and planned use of testing funds outlined above, HHS resources fromthe prior three enacted supplemental (the Coronavirus Preparedness and Response Supplemental,
the Families First Coronavirus Response Act, and the Coronavirus Aid, Relief, and Economic
Security Act) also support testing, as described in detail in HHS spending plans (transmitted toCongress on April 3, April 17, and April 28 respectively).
While these activities are identified as directly supporting testing and diagnostic work, HHS
funds to support State and local health departments, health system capacity building, provider
reimbursement, pre and post market medical product testing, health surveillance, and otheractivities also support testing but are not described here in detail.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Amounts Available for Testing from Coronavirus Supplemental Appropriations($ in millions)

Amount($M)

ActivityCoronavirus Preparedness and Response Act (P.L. 116-123)
National Institutes of Health
NIAID – Diagnostics
Public Health and Social Services Emergency FundBARDA – Diagnostics
Families First Coronavirus Response Act (P.L. 116-127)
Indian Health Service
Testing for IHS and Tribally-operated Health Programs, and Urban Indian
Organizations
Health Resources and Services Administration
Payment of Claims for Testing of Uninsured
Coronavirus Aid, Relief, and Economic Security Act (P.L. 116-136)
National Institutes of Health
NIAID – Diagnostics
NIBIB – Point-of-Care Test and Other Diagnostics Research
Public Health and Social Services Emergency FundBARDA – Diagnostics
Paycheck Protection Program and Healthcare Enhancement Act (P.L. 116-139)
Public Health and Social Services Emergency Fund
State, Local, Tribal Awards
BARDA

29

84

64

1000

30
60

244

11000
1000

Health Resources and Services Administration
Payment of Claims for Testing of Uninsured
Rural Health Clinics
Health Centers

39

1000
225
600

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Centers for Disease Control and Prevention
Testing and Public Health Capacity

1000

Food and Drug Administration
Funds for evaluation of testing

22

National Institutes of Health
NCI - Serology Research
NIBIB - Diagnostics
OD - Support for Testing Development, Research, and Partnerships
TOTAL

306
500
1000
26505

Mechanisms for Responding to Future Pandemics
While HHS continues to increase testing capacity for COVID-19 to help facilitate States’
reopening, HHS is also working to strengthen the ability of the Department to respond to future
pandemics. These efforts will include the development of a more robust, secure data collection
and utilization system; enhancing domestic production and supply chain management
capabilities for testing supplies and reagents; and developing robust public-private partnershipsthat will result in enhanced testing capacity in strategic geographic areas across the U.S. In
addition, it will be critical for these programs to evaluate and subsequently implement the mosteffective methods and infrastructure for reaching underserved and high-risk populations. The
Department must also have a streamlined process for identifying a novel pathogen for which acommercial diagnostic test may be needed and supporting the private sector manufacturing andscaling up of production in a timely manner. HHS will use resources provided through thevarious emergency supplemental appropriations acts to support the efforts described below.
Enhancing Coordination
To support coordination needs for COVID-19 and for the future, HHS will provide strategic
oversight, subject matter expertise to States, and logistics and administrative support. This effort
is a direct evolution of the Laboratory and Diagnostics Task Force combined with the CBTS
Task Force, which successfully implemented testing under the direction of the Assistant
Secretary for Health since March 12.
This HHS capacity will support activities related to testing and staff will oversee, implement, andmodify as needed the national testing strategy. This effort will enable HHS to provide a robust,
sustained capability to execute the objectives and principles of the Guidelines and Testing
Blueprint.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

HHS will provide strategic oversight to the operational component of the COVID-19 testing anddiagnostic response. HHS will continue to work with manufacturers to bolster inventory, scalepromising technologies and invest in demonstration and technical assistance projects. In
addition, personnel will act as subject matter experts and as such provide technical assistance toStates, territories and tribes to support their testing strategies.
HHS will be staffed with diagnostic subject matter experts, data analysts and epidemiologists,
policy advisors, grants management staff, and support staff.
Automated Exchange of Laboratory Data
As testing expansion is being planned and implemented nationwide, aided by substantial Federal
support and guidance, it is critical that collection of complete data and automated electronic
exchange of those data be included in the planning. This includes defining the critical data
elements that must be collected during patient registration and ordering at every testing site, howthose data will be collected, and how they will be electronically transmitted to the testing lab;
defining required data elements, file formats, and automated transmission methods for having
test results reported to the health department; and how all deidentified line level testing data will
be reported from the health department to HHS. HHS will provide direct support and technicalassistance to testing entities and States in the short term to help ensure all testing data arereported, including point-of-care testing.
Addressing Capacity Needs
Preventing a mismatch between testing capacity and need, and ensuring easily accessible sample
collection sites is critical to addressing COVID-19 and any future pandemics. The capacity oflaboratories must be identified, which could be done through a registry of laboratory testing
capacity. During a pandemic, this registry would also include information on the laboratories
receiving test kit shipments. A registry would assist in determining where the testing needs are inorder to quickly meet those needs. A registry would also support a network of sample collection
sites to identify where individuals can go for testing.
Establishment of regional referral laboratories that maintain a state of readiness to support
performing a high volume of diagnostic testing during a pandemic, would also address capacity
needs. These regional referral laboratories would be the regional “hub” for performing tests so
POC tests can be prioritized for certain areas, like rural and remote areas. These regional referrallaboratories would also need to be stocked with testing supplies to address surge capacity needs.
Additionally, a medical and public health laboratory mechanism for working with stakeholders
to address resource adequacy is needed. A comparable example would be the North American
Electric Reliability Corporation (NERC). Its objective is to meet the electricity needs of end-use
customers even when unexpected equipment failures or other factors reduce the amount ofavailable electricity, by ensuring adequacy and security.

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Report to Congress: COVID-19 Strategic Testing Plan

Further, building and maintaining laboratory capacity for the future requires providing support tolaboratories who have experienced a decrease in an overall volume of testing needs, despite anincrease in testing for SARS-CoV-2.
Strategic National Stockpile
For the first time, the Strategic National Stockpile will be stockpiling testing supplies. This stepis critical for ensuring States have the supplies needed to address COVID-19 testing needs, andwill be necessary for future pandemic preparedness as well.
The table below represents an estimate of the supply volumes needed for 90 days of surge
demand, based on an assumption of 12 million tests completed per month (nucleic acid tests
only). Cost figures were estimated based on available market data for these products.

Table 4. Strategic National Stockpile Investments
Item

Total Volume
Estimate

Unit Cost

Total Cost

Nasal swabs

54,000,000

$0.18

$9.5M

Collection/sample tubes

36,000,000$1.05$37.8M

Transfer media

36,000,000$2.69$96.8M

Pipettes

36,000,000

$0.11

$4.0M

Pipette tips

36,000,000

$0.06

$2.3M

Advancing Regulatory Science
The ongoing COVID-19 pandemic highlights several opportunities for regulatory advancement
in order to move more swiftly, both now and during future public health emergencies. The EUA
pathway and FDA’s guidance and resources have allowed for expedited development, scaled up
manufacturing and wide availability of testing. The unprecedented challenges posed by COVID19 have demonstrated the need for FDA to more clearly identify circumstances in which it may
decide not to enforce EUA authorities. Such guidance could facilitate faster implementation ofsuch decisions and, by providing greater clarity to developers and the American public, create amore collaborative atmosphere for public-private partnership. In addition, FDA will try to
identify a more streamlined method by which it could add or remove requirements from allapplicable EUAs, rather than having to do so one EUA at a time.
Fundamentally, the regulatory architecture that applies to diagnostic testing in the United States
serves to ensure patient safety. While the need to expedite regulatory processes remains a

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Planpriority, it is implicit that this occur in manner that maintains the quality, reliability and safety ofdiagnostic testing. Concurrently, given that laboratory quality is dependent upon both theClinical Laboratory Improvement Amendments (CLIA) and FDA regulatory management of
diagnostic devices, it is necessary that FDA, CMS and CDC work collaboratively to advance
regulatory science.
Rapidly Engaging Commercial Diagnostic Manufacturers
New diseases and epidemics can emerge without warning and spread quickly. In determining
whether the public health laboratory system can meet capacity needs, or whether a highthroughput commercial diagnostic may be needed, HHS will consider the likelihood of potential
risk of emergence and the potential consequences of the pathogen. Once the threshold has been
met for determining a commercial diagnostic may be needed for a pathogen, there are numerous
activities that must occur across HHS to support a commercial diagnostic. HHS is planning tofurther develop a mechanism for identifying when a commercial diagnostic may be needed, andrapidly engaging the commercial sector, including through direct investment from BARDA and
NIH.

Conclusion
Testing is a critical component of the national plan to contain COVID-19 and minimize
morbidity and mortality, while gradually reopening institutions and commerce within America.
With support from the Federal government to ensure States are meeting goals, the State plans fortesting will advance the safe reopening of America.

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Appendix A
Testing Overview
Testing is and will be the cornerstone of the
public health response to SARS-CoV-2.
Hence, it is critically important that thenational, State, territorial, and tribal testing
strategies are robust and flexible to account for
the emergence of new technologies andscientific information. This section provides adetailed overview of various technologies andplatforms available for both active and passive
infection testing. In addition, this section offers
use case scenarios for available technologies
and platforms. Using this information, States,
territories, and tribes can build a robust testing
strategy that most effectively utilizes available
platforms in their jurisdictions.

Testing Blueprint – Core Principles• Every symptomatic patient should receive a timely andaccurate diagnostic test.
• To enable early detection, potential community spread shouldbe actively assessed through a strategic approach that identifies
asymptomatic individuals who test positive through sentinelmonitoring at critical locations, including senior and othercongregate living settings and healthcare clinics (particularly
those in underserved urban and tribal settings).
• Containment of potential outbreaks, including those uncoveredby sentinel monitoring, should be accomplished throughsystems for contact tracing.
• Testing capacity should be able to be quickly deployed to hot
spots, as indicated by monitoring tools such as the InfluenzaLike-Illness Surveillance Network (ILI Net) and the National
Syndromic Surveillance Program (NSSP) operated by theCenters for Disease Control and Prevention (CDC).
• New technologies, including POC antigen and POC nucleic
acid tests, should be leveraged to enhance testing capacity,
accuracy, capability, and speed.
• Antibody tests should be used to help assess the number ofpeople in a community who have been previously infected by
the virus, especially within critical groups like first responders,essential workers, healthcare providers, and vulnerable
populations.
• Data and evidence should drive plan adaptations.

In addition, emerging diagnostic technologies
that are currently under development but not
yet authorized for use by the FDA are briefly
described. States, territories and tribes canutilize the following information as they build
out their testing ecosystem and strategies to meet future testing goals.

Assays that are available to test for SARS-CoV-2 can be categorized as either: (1) those that test
for active infection or (2) those that help determine prior infection and potential protection.
Currently, the real-time reverse transcription-polymerase chain reaction (RT-PCR) is the mostcommon recommended assay for diagnosing COVID-19 cases. Serological tests can play animportant role in determining previous infection and in helping to understand the prevalence ofindividuals in the community who may be immune and protected. Testing for active infection
can be performed using laboratory-analyzed tests or POC tests. At this time, testing to determine
prior infection can only be performed using laboratory-analyzed tests, however POC tests may
be approved for this purpose in the future. Laboratory-analyzed tests must be sent to a laboratory
for analysis, a process that takes 1-2 days once received by the lab. Some labs can analyze
thousands of tests a day. Results from point-of-care testing may be available at the testing site inless than an hour, although the number of samples that can be processed at once may be smaller
than that of laboratory-analyzed tests. These tests are optimal for use in remote, outbreak, andcrisis locations.

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The following section describes thetypes of tests associated with each ofthese categories (active infection andprevious infection), including related
technologies and platforms. In
addition, the role of each type of test
and its use in a comprehensive
response to SARS-CoV-2 isdiscussed. Testing strategies shouldincorporate each of these types oftests in order to effectively andefficiently provide testing to different populations across various settings (i.e., LTC residents,
healthcare workers, employees in meatpacking plants). Furthermore, utilizing multiple platforms
relieves some supply chain constraints by limiting the extent to which states and laboratories are
dependent on any one reagent or combination of reagents. To augment such diversification andincrease testing capacity, states may consider working within the lab network to loan equipmentfrom labs not performing COVID-19 testing to others that are involved in testing.
Active Infection Testing
Testing with the intent to determine if an individual is currently infected with SARS-CoV-2 iscalled active infection testing. This type of diagnostic testing detects the presence of SARSCoV-2 in a clinical specimen and measures the prevalence of individuals with active COVID-19
infection at a given point in time. Active infection testing is the backbone of a comprehensive
strategy since understanding the disease prevalence is critical to mitigating further spread.
Although RT-PCR is the most widely used method for detection of active infections, other
innovative and complementary technologies such as isothermal amplification, antigen detection,and multiplexed-multi-analyte RT-PCRs have been or are currently being developed. These new
testing methods will expand the repertoire of tests available for clinicians to diagnose COVID19.
Nucleic Acid Detection
Both RT-PCR and isothermal techniques rely on amplification of viral genetic material(ribonucleic acid, RNA) to identify SARS-CoV-2. These tests detect the presence of viral
genetic material in a clinical sample. A sample is taken from a patient’s nose and/or throat usinga swab and placed in a solution that breaks open the cells in the sample to separate any viral
RNA from other viral material. Any SARS-CoV-2 viral RNA present is amplified by RT-PCR
to produce a detectable signal that supports a positive COVID-19 diagnosis.
RT-PCR requires rapid heating and cooling cycles facilitated by sophisticated thermal cycling
equipment to amplify target nucleic acids. In contrast, isothermal techniques are designed toamplify nucleic acids at a constant temperature and eliminate the need for a thermal cycler. If
SARS-CoV-2 viral RNA is present in the sample, it is quickly amplified to produce a detectable

45

U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plansignal, such as via changing color or fluorescence. Isothermal techniques offer an alternative to
traditional RT-PCR assays that could be used to provide reliable test results outside of alaboratory setting, but have not yet been widely adopted. The Abbott ID NOW COVID-19 assay
is an example of a diagnostic test that uses an isothermal method to identify SARS-CoV-2.
Beyond RT-PCR and isothermal amplification, there are other amplification methods, such as the
proprietary transcription-mediated nucleic acid amplification method employed by the Hologic
Panther instrument. Over time, it is expected that other novel methods for nucleic acidamplification will become available, broadening the range of testing technologies available foruse.
Authorized tests and testing platforms
The CDC RT-PCR test for SARS-CoV-2 was the first to receive an EUA from the FDA on
February 4. Since that time, 82 RT-PCR tests have received an EUA, including lab developed
tests. As part of the EUA process, diagnostic tests are authorized for use on specific platforms(instruments). Some higher throughput platforms are compatible with diagnostic tests frommultiple manufacturers.
RT-PCR tests that detect SARS-CoV-2 and are compatible with high throughput platforms(defined by CMS as a platform that employs automated processing of more than two hundred
specimens a day xxxii) have been produced by manufacturers such as Abbott, Hologic and Thermo
Fisher Scientific. These platforms are most often located in state and local public healthlaboratories, academic/hospital laboratories, and commercial reference laboratories. Once asample arrives at the laboratory for analysis, results can be delivered within a few days.
In addition to high throughput tests, the FDA has also authorized rapid POC assays that test for
active infection for emergency use. Platforms that run these POC assays include the Abbott ID
NOW and Cepheid GeneXpert. Mobile POC platforms (Abbott ID NOW) are small andportable, and are optimal for deployment to rural, outbreak or crisis situations. These POC
instruments typically run one sample at a time and provide a result within 5-30 minutes. Larger,
multi-chambered POC platforms (Cepheid Gene Xpert) are most often found in hospitals andsmaller medical centers. They allow for higher throughput testing than the smaller one-chamber
POC platforms (Abbott ID NOW) and typically return results in less than an hour. The
components are often self-contained, requiring fewer laboratory resources (i.e., hands-on
personnel) than other laboratory-based instruments.
Using a rapid, mobile or facility-based POC platforms to test healthcare providers andsymptomatic patients enables maintenance of the workforce (rapid return to work, prevents
nosocomial spread, and returns rapid diagnosis for critically ill patients, which also may reduceuse of personal protective equipment (PPE) among healthcare personnel treating these patients.
In addition, these types of tests are envisioned to supplement laboratory testing, which remains
the primary testing mechanism for the nation because of the ability to perform a high volume oftests at one time. However, POC testing is a powerful tool and critical component of the46

U.S. Department of Health and Human Services
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diagnostic strategy for SARS-CoV-2 (COVID-19) that enables testing to be available forcommunities and populations that cannot readily access laboratory testing or need to quickly
address emerging outbreaks. Recommended uses for POC instruments for COVID-19 diagnostic
purposes include:•

Deployment to rural hospitals or other critical care sites that lack widely available
testing.

•

Deployment to long-term care facilities or correctional institutions.

•

Rapid deployment to aid in the investigation of a newly identified emerging
cluster of cases, such as in response to an outbreak among workers at
meatpacking plants.

•

Placement in emergency departments for testing of high-priority specimens
requiring a rapid result.

There are regulatory considerations that must guide the use of POC instruments for SARS-CoV2 diagnostic purposes. Testing sites operating a POC diagnostic instrument must have a current
certificate via the Clinical Laboratory Improvement Amendments of 1988 (CLIA). During the
COVID-19 public health emergency, CMS will permit a Certificate of Waiver laboratory toextend its existing certificate to operate a temporary COVID-19 testing site in an off-site
location, such as a long-term care facility.23 The temporary COVID-19 testing site is only
permitted to perform waived tests, consistent with the laboratory's existing certificate and must
be under the direction of the existing lab director.

Figure 5. Lab based and POC Tests

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Antigen detection
Antigen detection is an alternative approach to identifying the presence of SARS-CoV-2 in aclinical specimen. Rather than identifying viral RNA, an antigen test detects specific proteinsthat are in the virus. Rapid strep tests are an example of an antigen test. Antigen tests expose asample taken from a patient to particles that bind to the antigen, indicating the presence of virus.
These tests are low complexity, rapid, and function at POC, xxxiii, xxxiv providing increased
capacity, capability, and speed to result. The first such test was granted an EUA by the FDA on
May 8, with a number of additional candidate COVID-19 antigen tests under development. xxxv
Antigen tests are very specific for the virus, but are not as sensitive as molecular PCR tests.
Therefore, positive results from antigen tests are highly accurate, but there is a higher chance offalse negatives, so negative results do not rule out infection. With this in mind, negative resultsfrom an antigen test may need to be confirmed with a RT-PCR test prior to making treatment
decisions or to prevent the possible spread of the virus due to a false negative. Antigen tests may
also yield false positives, depending on how the results are displayed. For this reason, it isimportant that results are interpreted by trained personnel. However, antigen tests are importantin the overall response against COVID-19 as they can generally be produced at a lower cost than
PCR tests and once multiple manufacturers enter the market, can potentially scale to test millionsof Americans per day due to their simpler design, helping our country better identify infection
rates closer to real time.
Other Technologies
Multiplexed, multi-analyte diagnostic tests allow for the simultaneous detection of different
analytes from a single specimen. For SARS-CoV-2, there are currently several multiplexed,
multi-analyte RT-PCR assays capable of detecting and differentiating SARS-CoV-2 from a panelof over 20 respiratory pathogens. These types of assays are critical for ensuring rapid, accurate
diagnosis and differentiation of SARS-CoV-2 and influenza patients during influenza andrespiratory virus season. The ability to differentiate influenza or other respiratory illnesses from
SARS-CoV-2 will allow for appropriate handling of patients, and will become particularly
important during flu season in the fall. In addition, because this type of assay provides results
for multiple pathogens in one test, it is also reagent sparing. The diagnostician only needs toutilize one set of reagents to get a diagnostic result for multiple pathogens.
Another important addition to the testing toolkit is self-collection and home collection of
specimens. The FDA has authorized home specimen collection with return to laboratories by
mail. The FDA also allows for self-collection in the presence of clinicians, where the individual
being tested uses a nasal swab that they then give to the observing clinician who assures proper
handling and transport. These advancements both allow easier access to testing and collection of
specimens more distant from healthcare workers to mitigate their risk of exposure to the virus
from infected individuals.

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Prior Infection
Serology testing—testing for the presence of antibodies in a clinical specimen—are used todetermine previous infection from SARS-CoV-2. Serologic tests are usually blood tests thatlook for antibodies, which are an indicator of an adaptive immune system response to exposure
to an infectious agent (pathogen) or foreign protein (antigen). Antibodies are produced overdays to weeks after infection. The strength of antibody response depends on several factors,
such as age, severity of disease, and overall health status, including conditions that suppress theimmune system. Depending on when someone was infected and the timing of the test, the test
may not find antibodies in someone with an active COVID-19 infection. Antibodies may notshow up for 1 to 3 weeks after onset of illness. Some people may take even longer to develop
antibodies, and some people may not develop detectable antibodies.
Unlike the diagnostic tests described above, which are used to confirm the presence of thepathogen, antibody tests help determine whether someone was previously infected—even if that
person never showed symptoms. However, the presence of antibodies does not necessarily
indicate immunity (resistance to infection). Additionally, while serological testing cannot be
used for confirmatory diagnosis, a positive antibody result could indicate a recent infection anddoes not mean that a person is no longer shedding virus or is no longer infectious.
Serologic tests detect different types of antibodies, most commonly IgM and IgG. IgM is one of
the first types of antibodies produced after a pathogen has entered the body and is most useful for
determining recent infection. In most infections, IgG generally develops after IgM, and may
remain detectable for months or years. Although the kinetics of antibody response to COVID-19
are not yet fully understood, a positive result from appropriately validated serologic tests that aredesigned to be very specific to the SARS-CoV-2 virus can confirm that a patient has been
infected by SARS-CoV-2. While serology tests are not used for diagnosis, they play animportant role in determining previous infection and in helping to understand the prevalence ofindividuals in the community who may be immune and protected.
Additionally, serology tests can be useful to examine demographics and geographic patterns todetermine which communities may have experienced a higher case rate, and therefore may havehigher rates of ‘herd immunity.’ Likewise, serological surveillance can be utilized to monitor
viral transmission rates and emergence in communities, and serological test results may also aid
in determining who may qualify to donate blood that can be used to manufacture convalescentplasma as a possible treatment for those who are seriously ill from COVID-19.
The core principles of the Testing Blueprint include the use of antibody tests, citing their value inassessing the number of people in a community previously infected with SARS-CoV-2,
particularly within critical groups such as first responders, essential workers, healthcare
providers, and vulnerable populations. Antibody testing is also identified as a component of the
proposed state or regional gating criteria, including in the Guidelines for Opening Up America
Again. Specifically, this type of testing is cited as a part of the requisite, robust testing program
necessary for at-risk healthcare workers.

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Figure 6. Serology test process

Authorized Tests
Laboratory serologic assays have received FDA emergency use authorization. Serologic testing
technologies include single-use, low-throughput lateral flow tests where the presence of antibody
is demonstrated by a color change on a paper strip, and laboratory-based immunoassays whichallow for processing of many samples at the same time. A number of laboratory-based
serological assays have received EUAs from the FDA, including tests manufactured by Abbott,
Ortho, and DiaSorin. Individual labs including Wadsworth New York and Mount Sinai Hospital
have also developed their own serological tests for use within their laboratory systems(laboratory developed tests, LDT), but which are not available on the commercial market.
Currently, there are no FDA-authorized COVID-19 serologic POC tests, although several are indevelopment.
Long-term Immunity
At present, it is unclear whether the development of antibodies resulting from SARS-CoV-2
infection will provide an individual with protection from a future infection. Early studies using
animal models suggest that this may be the case; xxxvi however, this remains an area of active
investigation. Representatives from BARDA, CDC, FDA, NIH, OASH, DoD, and White House
Office of Science and Technology Policy (OSTP) are working with members of academia andthe medical community to determine whether positive serologic tests are indicative of protective
immunity against SARS-CoV-2. This work includes assessing the level of antibodies requiredfor protection, the duration of that protection, and the factors associated with whether a person

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develops a protective antibody response. Answers to these questions will be critical to informing
state-level diagnostic plans, as well as the national strategy for testing.
Test Performance Criteria and Fitness for Purpose
Test performance is critical for determining the fitness of an assay for a specific purpose,
whether that be in diagnosing an active infection or identifying prior infection. Common
performance metrics include a test’s sensitivity, which is the likelihood of a positive test result
among those with disease, and specificity, which is the likelihood of a negative test among those
without the disease. These measures vary among tests and test types and in certain
circumstances; there are rationales to include tests that favor one characteristic over another. For
example, diagnostic tests used to detect virus to rule-in or rule-out disease should have higher
specificity (weighted toward defining true negatives) to avoid allowing COVID-19 positive
patients back into the general population. Alternatively, screening tests, which are typically used
to screen large numbers of asymptomatic individuals who are at risk for disease, are weighted
toward high sensitivity so as not to miss samples that are potentially positive.
Tests are also described by their positive and negative predictive values (PPV and NPV). These
measures are calculated using a test’s sensitivity, specificity, and an assumed percentage ofindividuals in the population who are positive for SARS-CoV-2 (which is called “prevalence” inthese calculations). Every test returns some false positive and false negative results. The PPV
and NPV help those who are interpreting viral detection tests understand, given how prevalenceof disease in a community, how likely it is that a person who receives a positive result from a test
truly is positive for SARS-CoV-2 and how likely it is that a person who receives a negative
result from a test is truly negative for SARS-CoV-2. The PPV and NPV of a test depend heavily
on the prevalence of what that test is intended to detect.

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Appendix B
Testing Process

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Report to Congress: COVID-19 Strategic Testing Plan

Appendix C
Nursing Home Reopening Recommendations

53

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard, Mail Stop C2-21-16
Baltimore, Maryland 21244-1850

Center for Clinical Standards and Quality/Quality, Safety & Oversight Group
Ref: QSO-20-30-NH
DATE:

May 18, 2020

TO:

State Officials

FROM:

Director
Quality, Safety & Oversight GroupSUBJECT:

Nursing Home Reopening Recommendations for State and Local Officials••

Memorandum Summary
CMS is committed to taking critical steps to ensure America’s nursing homes areprepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health
Emergency (PHE).
Recommendations for State and Local Officials: CMS is providing recommendations
to help determine the level of mitigation needed to prevent the transmission of COVID19 in nursing homes. The recommendations cover the following items:o Criteria for relaxing certain restrictions and mitigating the risk ofresurgence: Factors to inform decisions for relaxing nursing home restrictions
through a phased approach.
o Visitation and Service Considerations: Considerations allowing visitation andservices in each phase.
o Restoration of Survey Activities: Recommendations for restarting certain
surveys in each phase.

BackgroundNursing homes have been severely impacted by COVID-19, with outbreaks causing high rates ofinfection, morbidity, and mortality. The vulnerable nature of the nursing home population
combined with the inherent risks of congregate living in a healthcare setting, requires aggressive
efforts to limit COVID-19 exposure and to prevent the spread of COVID-19 within nursing
homes.
Recommendations for States
This memorandum provides recommendations for State and local officials to help them
determine the level of mitigation needed for their communities’ Medicare/Medicaid certified
long term care facilities (hereinafter, ‘nursing homes”) to prevent the transmission of COVID-19.
We encourage State leaders to collaborate with the state survey agency, and State and local
health departments to decide how these and other criteria or actions should be implemented intheir state. Examples of how a State may choose to implement these recommendations include:

54

Page 1 of 10•••A State requiring all facilities to go through each phase at the same time (i.e., waiting
until all facilities have met entrance criteria for a given phase).
A State allowing facilities in a certain region (e.g., counties) within a state to enter eachphase at the same time.
A State permitting individual nursing homes to move through the phases based on eachnursing home’s status for meeting the criteria for entering a phase.

Given the critical importance in limiting COVID-19 exposure in nursing homes, decisions on
relaxing restrictions should be made with careful review of a number of facility-level,
community, and State factors/orders, and in collaboration with State and/or local health officials
and nursing homes. Because the pandemic is affecting communities in different ways, State andlocal leaders should regularly monitor the factors for reopening and adjust their plansaccordingly. Factors that should inform decisions about relaxing restrictions in nursing homes
include:• Case status in community: State-based criteria to determine the level of community
transmission and guides progression from one phase to another. For example, a decline in
the number of new cases, hospitalizations, or deaths (with exceptions for temporary
outliers).
• Case status in the nursing home(s): Absence of any new nursing home onset 1 of
COVID-19 cases (resident or staff), such as a resident acquiring COVID-19 in thenursing home.
• Adequate staffing: No staffing shortages and the facility is not under a contingency
staffing plan.
• Access to adequate testing: The facility should have a testing plan in place based oncontingencies informed by the Centers for Disease Control and Prevention (CDC). At
minimum, the plan should consider the following components:o The capacity for all nursing home residents to receive a single baseline COVID19 test. Similarly, the capacity for all residents to be tested upon identification of
an individual with symptoms consistent with COVID-19, or if a staff member
tests positive for COVID-19. Capacity for continuance of weekly re-testing of all
nursing home residents until all residents test negative;o The capacity for all nursing home staff (including volunteers and vendors whoare in the facility on a weekly basis) to receive a single baseline COVID-19 test,with re-testing of all staff continuing every week (note: State and local leaders
may adjust the requirement for weekly testing of staff based on data about thecirculation of the virus in their community);o Written screening protocols for all staff (each shift), each resident (daily), and all
persons entering the facility, such as vendors, volunteers, and visitors;
o An arrangement with laboratories to process tests. The test used should be able todetect SARS-CoV-2 virus (e.g., polymerase chain reaction (PCR)) with greaterthan 95% sensitivity, greater than 90% specificity, with results obtained rapidly
1

A “new, nursing home onset” refers to COVID-19 cases that originated in the nursing home, and not cases where
the nursing home admitted individuals from a hospital with a known COVID-19 positive status, or unknown
COVID-19 status but became COVID-19 positive within 14 days after admission. In other words, if the number of
COVID-19 cases increases because a facility is admitting residents from the hospital AND they are practicing
effective Transmission-Based Precautions to prevent the transmission of COVID-19 to other residents, that facility
may still advance through the phases of reopening. However, if a resident contracts COVID-19 within the nursing
home without a prior hospitalization within the last 14 days, this facility should go back to the highest level of
mitigation, and start the phases over.

55

Page 2 of 10

•

•

•

(e.g., within 48 hours). Antibody test results should not be used to diagnose
someone with an active SARS-CoV-2 infection.
o A procedure for addressing residents or staff that decline or are unable to be tested(e.g., symptomatic resident refusing testing in a facility with positive COVID-19
cases should be treated as positive).
Universal source control: Residents and visitors wear a cloth face covering or facemask.
If a visitor is unable or unwilling to maintain these precautions (such as young children),consider restricting their ability to enter the facility. All visitors should maintain social
distancing and perform hand washing or sanitizing upon entry to the facility.
Access to adequate Personal Protective Equipment (PPE) for staff: Contingency
capacity strategy is allowable, such as CDC’s guidance at Strategies to Optimize theSupply of PPE and Equipment (facilities’ crisis capacity PPE strategy would notconstitute adequate access to PPE). All staff wear all appropriate PPE when indicated.
Staff wear cloth face covering if facemask is not indicated, such as administrative staff.
Local hospital capacity: Ability for the local hospital to accept transfers from nursing
homes.

Contact: For questions or concerns regarding this memo, please contact
DNH_TriageTeam@cms.hhs.gov.
Effective Date: Immediately. This policy should be communicated with all survey andcertification staff, their managers and the State/Branch training coordinators immediately.
/s/David R. WrightAttachments:
Recommended Nursing Home Phased Re-opening for States
cc: Survey & Operations Group (SOG) Management

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Page 3 of 10

Attachment 1 – Recommended Nursing Home Phased Reopening for States
The reopening phases below cross-walk to the phases of the plan for Opening Up America Again, and includes efforts to maintain rigorous
infection prevention and control, as well as resident social engagements and quality of life. Note: The Opening Up America Guidance forcommunities includes visitation guidance for “senior care facilities.” The term “senior care facilities” refers to a broader set of facilities that
may be utilized by seniors, and is not specific to Medicare/Medicare certified long term care facilities (i.e., nursing homes), whereas, thisguidance is specific to nursing homes.
Due to the elevated risk COVID-19 poses to nursing home residents, we recommend additional criteria for advancing through phases ofreopening nursing homes than is recommended in the broader Administration’s Opening Up America Again framework. For example:• Nursing homes should not advance through any phases of reopening or relax any restrictions until all residents and staff have received
a base-line test, and the appropriate actions are taken based on the results;• States should survey those nursing homes that experienced a significant COVID-19 outbreak prior to reopening to ensure the facility
is adequately preventing transmission of COVID=19; and• Nursing homes should remain in the current state of highest mitigation while the community is in Phase 1 of Opening Up America
Again (in other words, a nursing home’s reopening should lag behind the general community’s reopening by 14 days).
For additional criteria, please see the Appendix.
StatusCurrent state:
Significant
Mitigation andPhase 1 ofOpening Up
America Again

Criteria for Implementation•

Most facilities are in a posturethat can be described as theirhighest level of vigilance,
regardless of transmission
within their communities.

Visitation and Service Considerations
•

•
•

•

Visitation generally prohibited, except forcompassionate care situations. In those limited
situations, visitors. are screened and additional
precautions are taken, including social distancing, andhand hygiene (e.g., use alcohol-based hand rub uponentry). All visitors must wear a cloth face covering or
facemask for the duration of their visit.
Restricted entry of non-essential healthcare personnel.
Communal dining limited (for COVID-19 negative or
asymptomatic residents only), but residents may eat in
the same room with social distancing (limited numberof people at tables and spaced by at least 6 feet).
Non-medically necessary trips outside the building
should be avoided.

57

•

•
•
•

Surveys that will be
performed at each phase
Investigation of complaints
alleging there is an immediate
serious threat to the resident’s
health and safety (known as
Immediate Jeopardy)
Revisit surveys to confirm thefacility has removed any
Immediate Jeopardy findings
Focused infection control surveys
Initial survey to certify that theprovider has met the requiredconditions to participate in the
Medicare Program (initialcertification surveys)

Page 4 of 10

Status

Criteria for Implementation

Visitation and Service Considerations
•

•

•

•

•
•

•

•

Restrict group activities, but some activities may be
conducted (for COVID-19 negative or asymptomatic
residents only) with social distancing, hand hygiene,
and use of a cloth face covering or facemask.
For medically necessary trips away from of the
facility:o The resident must wear a cloth face covering or
facemask; ando The facility must share the resident’s COVID-19
status with the transportation service and entitywith whom the resident has the appointment.
100% screening of all persons entering the facility andall staff at the beginning of each shift:o Temperature checks
o Ensure all outside persons entering building havecloth face covering or facemask.
o Questionnaire about symptoms and potential
exposureo Observation of any signs or symptoms
100% screening for all residents:o Temperature checks
o Questions about and observation for other signs
or symptoms of COVID-19 (at least daily)
Universal source control for everyone in the facility.
Residents and visitors entering for compassionate carewear cloth face covering or facemask.
All staff wear appropriate PPE when they areinteracting with residents, to the extent PPE isavailable and consistent with CDC guidance on
optimization of PPE. Staff wear cloth face covering if
facemask is not indicated.
All staff are tested weekly. All residents are tested
upon identification of an individual with symptoms
consistent with COVID-19 or if staff have tested
positive for COVID-19. Weekly testing continues
until all residents test negative.
Dedicated space in facility for cohorting andmanaging care for residents with COVID-19; plan to58•

Surveys that will be
performed at each phase
Any State-based priorities (e.g.,
localized “hot spots,” “strike”
teams, etc.)

Page 5 of 10

StatusPhase 2 ofReopening
nursing homes
and Opening Up
America Again

Criteria for Implementation

•

•

•
•

•
•

Case status in community has
met the criteria for entry into
phase 2 (no rebound in cases
after 14 days in phase 1).
There have been no new,nursing home onset COVID
cases in the nursing home for 14
days.
The nursing home is notexperiencing staff shortages.
The nursing home has adequate
supplies of personal protective
equipment and essential
cleaning and disinfection
supplies to care for residents.
The nursing home has adequate
access to testing for COVID-19.
Referral hospital(s) have bed
capacity on wards and intensive
care units.

Visitation and Service Considerations

•

•

•

•

•

•

•

manage new/readmissions with an unknown COVID19 status and residents who develop symptoms.
Visitation generally prohibited, except forcompassionate care situations. In those limited
situations, visitors are screened and additional
precautions are taken, including social distancing, andhand hygiene (e.g., use alcohol-based hand rub uponentry). All visitors must wear a cloth face covering or
facemask for the duration of their visit.
Allow entry of limited numbers of non-essential
healthcare personnel/contractors as determined
necessary by the facility, with screening andadditional precautions including social distancing,hand hygiene, and cloth face covering or facemask.
Communal dining limited (for COVID-19 negative or
asymptomatic residents only), but residents may eat in
the same room with social distancing (limited numberof people at tables and spaced by at least 6 feet).
Group activities, including outings, limited (forasymptomatic or COVID-19 negative residents only)with no more than 10 people and social distancing
among residents, appropriate hand hygiene, and use of
a cloth face covering or facemask.
For medically necessary trips outside of the facility:o The resident must wear a cloth face covering or
facemask; ando The facility must share the resident’s COVID-19
status with the transportation service and entitywith whom the resident has the appointment.
100% screening of all persons entering the facility andall staff at the beginning of each shift:o Temperature checks
o Ensure all outside persons entering building havecloth face covering or facemask.
o Questionnaire about symptoms and potential
exposureo Observation of any signs or symptoms
100% screening (at least daily) for all residents

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Surveys that will be
performed at each phase
•

•
•
•
•
•

Investigation of complaints
alleging either Immediate
Jeopardy or actual harm toresidents
Revisit surveys to confirm thefacility has removed any
Immediate Jeopardy findings
Focused infection control surveys
Initial certification surveys
State-based priorities (e.g.,
localized “hot spots,” “strike”
teams, etc.)
See Appendix forrecommendations for prioritizing
facilities to be surveyed

Page 6 of 10

Status

Criteria for Implementation

Visitation and Service Considerations
Temperature checks
Questions about and observation for other signs
or symptoms of COVID-19
Universal source control for everyone in the facility.
Residents and visitors entering for compassionate carewear cloth face covering or facemask.
All staff wear all appropriate PPE when indicated.
Staff wear cloth face covering if facemask is notindicated, such as administrative staff.
Test all staff weekly. Test all residents upon
identification of an individual with symptoms
consistent with COVID-19, or if staff have tested
positive for COVID-19. Weekly testing continues
until all residents test negative.
Dedicated space in facility for cohorting andmanaging care for residents with COVID-19; plan to
manage new/readmissions with an unknown COVID19 status and residents who develop symptoms.
Visitation allowed with screening and additional
precautions including ensuring social distancing andhand hygiene (e.g., use alcohol-based hand rub uponentry). All visitors must wear a cloth face covering or
facemask for the duration of their visit.
Allow entry of non-essential healthcare
personnel/contractors as determined necessary by thefacility, with screening and additional precautions
including social distancing, hand hygiene, and cloth
face covering or facemask.
Communal dining limited (for COVID-19 negative or
asymptomatic residents only), but residents may eat in
the same room with social distancing (limited numberof people at tables and spaced by at least 6 feet).
Group activities, including outings, allowed (forasymptomatic or COVID-19 negative residents only)with no more than the number of people where social
distancing among residents can be maintained,
appropriate hand hygiene, and use of a cloth facecovering or facemask.

Surveys that will be
performed at each phase

o
o

•
•
•

•

Phase 3 ofReopening
nursing homes
and Opening Up
America Again

•

•

•
•

•

Community case status meets
criteria for entry to phase 3 (norebound in cases during phase
2).
There have been no new,nursing home onset COVID
cases in the nursing home for 28
days (through phases 1 and 2).
The nursing home is notexperiencing staff shortages.
The nursing home has adequate
supplies of personal protective
equipment and essential
cleaning and disinfection.
supplies to care for residents.
The nursing home has adequate
access to testing for COVID-19.

•

•

•

•

60

•
•

•
•
•
•

Normal Survey operations
All complaint and revisit surveys
required to identify and resolve
any non-compliance with healthand safety requirements
Standard (recertification) surveys
and revisits
Focused infection control surveys
State-based priorities (e.g.,
localized “hot spots,” “strike”
teams, etc.
See Appendix forrecommendations for prioritizing
facilities to be surveyed

Page 7 of 10

Status

Criteria for Implementation•

Referral hospital(s) have bed
capacity on wards and intensive
care units.

Visitation and Service Considerations
•
•

•

•

•
•
•

•

Surveys that will be
performed at each phase

Allow entry of volunteers, with screening andadditional precautions including social distancing,hand hygiene, and cloth face covering or facemask.
For medically necessary trips outside of the facility:o The resident must wear a mask; ando The facility must share the resident’s COVID-19
status with the transportation service and entitywith whom the resident has the appointment.
100% screening of all persons entering the facility andall staff at the beginning of each shift:o Temperature checks.
o Ensure all outside persons entering building havecloth face covering or facemask.
o Questionnaire about symptoms and potential
exposureo Observation of any signs or symptoms
100% screening (at least daily) for all residentso Temperature checks
o Questions about and observation for other signs
or symptoms of COVID-19
Universal source control for everyone in the facility.
Residents and visitors wear cloth face covering or
facemask.
All staff wear all appropriate PPE when indicated.
Staff wear cloth face covering if facemask is notindicated, such as administrative staff.
Test all staff weekly. Test all residents upon
identification of an individual with symptoms
consistent with COVID-19, or if staff have tested
positive for COVID-19. Weekly testing continues
until all residents test negative.
Dedicated space in facility for cohorting and managing
care for residents with COVID-19; plan to manage
new/readmissions with an unknown COVID-19 status
and residents who develop symptoms.

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APPENDIX
Additional Recommendations• Reminder: When a community enters phase 1 of Opening Up America Again, nursing
homes remain at their highest level of vigilance and mitigation (e.g., visitation restrictedexcept in compassionate care situations). Nursing homes do not begin to de-escalate orrelax restrictions until their surrounding community satisfies gating criteria and enters
phase 2 of Opening Up America Again.
• A nursing home should spend a minimum of 14 days in a given phase, with no new
nursing home onset of COVID-19 cases, prior to advancing to the next phase.
• A nursing home may be in different phases than its surrounding community based on thestatus of COVID-19 inside the facility, and the availability of key elements including, but
not limited to PPE 2, testing, and staffing. For example, if a facility identifies a new,nursing home onset COVID-19 case in the facility while in any phase, that facility goesback to the highest level of mitigation, and starts over (even if the community is in phase3).
• States may choose to have a longer waiting period (e.g., 28 days) before relaxing
restrictions for facilities that have had a significant outbreak of COVID-19 cases,
facilities with a history of noncompliance with infection control requirements, facilities
with issues maintaining adequate staffing levels, or any other situations the state believes
may warrant additional oversight or duration before being permitted to relax restrictions.
State Survey Prioritization (Starting in Phase 2 of the above chart)
States should use the following prioritization criteria within each phase when determining whichfacilities to begin to survey first.
• For investigating complaints (and Facility-Reported Incidents (FRIs), facilities with
reports or allegations of:
1. Abuse or neglect
2. Infection control, including lack of notifying families and their representatives of
COVID-19 information (per new requirements at 42 CFR 483.80(g)(3))
3. Violations of transfer or discharge requirements
4. Insufficient staffing or competency
5. Other quality of care issues (e.g., falls, pressure ulcers, etc.)
In addition, a State agency may take other factors into consideration in its prioritization
decision. For example, the State may identify a trend in allegations that indicates anincreased risk of harm to residents, or the State may receive corroborating informationfrom other sources regarding the allegation. In this case, the State may prioritize a facility
for a survey higher than a facility that has met the above criteria.
•

For standard recertification surveys:
1. Facilities that have had a significant number of COVID-19 positive cases
2. Special Focus Facilities
3. Special Focus Facility candidates

2

Facilities should review the Centers for Disease Control and Prevention’s guidance on COVID-19 for healthcare
professionals.

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4. Facilities that are overdue for a standard survey (> 15 months since last standard
survey) and a history of noncompliance at the harm level (citations of ”G” orabove) with the below items:
 Abuse or neglect Infection control
 Violations of transfer or discharge requirements
 Insufficient staffing or competency
 Other quality of care issues (e.g., falls, pressure ulcers, etc.)
For example, a facility whose last standard survey was 24 months ago and was cited for abuse at
a “G” level of noncompliance, would be surveyed earlier (i.e., prioritized higher) than a facility
whose last standard survey was 23 months ago and had lower level deficiencies. We recognizethat there are many different scenarios or combinations of timing of surveys and types ofnoncompliance that will exist. We defer to States for final decisions on scheduling surveys
consistent with CMS survey prioritization guidelines.

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Nursing Home Reopening Recommendations Frequently Asked Questions
This FAQ answers a range of questions on the topics of:•••

Reopening
Visitation
Testing Requirements

1. Where can I find the most up-to-date information from CMS on COVID-19?
For a complete and updated list of CMS actions in response to COVID-19, and otherinformation specific to CMS, please visit the Current Emergencies Website. To keep up
with the important work the White House Task Force is doing in response to COVID-19,
visit www.coronavirus.gov.
2. What is CMS releasing today?
CMS is providing recommendations to state and local officials to help determine thelevel of mitigation required to continue preventing the spread of COVID-19 within
nursing homes, especially as many states begin a phased reopening.
3. What steps should nursing homes take before reopening to visitors?
Nursing homes should continue to follow CMS and CDC guidance for preventing thetransmission of COVID-19. In addition, they should follow state and local direction.
Because nursing home residents are especially vulnerable, CMS does not recommend
opening facilities to visitors (except for compassionate care situations) until phase three
when:
•
•
•
•
•

there have been no new, nursing home onset COVID-19 cases in the nursing homefor 28 days (through phases one and two)the nursing home is not experiencing staff shortages
the nursing home has adequate supplies of personal protective equipment andessential cleaning and disinfection supplies to care for residents
the nursing home has adequate access to testing for COVID-19
Referral hospital(s) have bed capacity on wards and intensive care units

4. Why are there additional criteria for reopening nursing homes when many states
seem to be loosening restrictions on workplaces, business, stores, etc.
Nursing homes have been severely impacted by COVID-19, with outbreaks causing highrates of infection, morbidity, and mortality. The vulnerable nature of the nursing home
population combined with the inherent risks of close quarter living in a healthcare

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setting, requires aggressive efforts to limit COVID-19 exposure and to prevent the
spread of COVID-19 within nursing homes. Continued adherence to these criteria will
help to ensure residents remain safe.
5. Why isn’t CMS requiring testing in nursing homes?
The Guidelines for Opening Up America Again call for robust testing and contact
tracing. Nursing home testing is a cornerstone of these guidelines and efforts. The
guidelines direct states to be prepared to deploy testing resources first and foremost to
nursing homes so that any potential outbreak of the coronavirus among the mostvulnerable population can be monitored. Testing should be done proactively in nursing
homes and everyone should be tested – this is the backbone of building a national
coronavirus surveillance system.
To aid in this effort and rapidly expand COVID-19 testing, CMS recently issued a rulingthat Medicare will pay a rate of $100 for certain laboratory tests that use high-throughput
technologies to rapidly process large numbers of specimens for COVID-19 testing perday. On April 2, CMS issued a call to action for nursing homes and state and local
governments urging leaders to work closely with nursing homes on access to testing and
PPE.
CMS is constantly evaluating our guidance and the status of the conditions infacilities. We will continue to make changes based on those evaluations, as we haveissued an unprecedented amount of guidance to date.

6. What is CMS doing to increase testing in nursing homes?
In the Guidelines for Opening Up America Again, testing is one of the Core State
Preparedness Responsibilities. Specifically, nursing home testing is a cornerstone ofthese guidelines and efforts. The guidelines direct states to be prepared to deploy
testing resources first and foremost to nursing homes to enable close monitoring of any
potential outbreak of Coronavirus among this vulnerable population. Additionally, the
CMS issued a call to action for state and local governments that reinforced its infection
control responsibilities and urged leaders to determine the local needs for COVID-19
testing, including making testing in nursing homes a priority.
Testing should be done proactively in nursing homes and everyone should be tested –this is the backbone of building a national coronavirus surveillance system. To aid in thiseffort and rapidly expand COVID-19 testing, CMS recently issued a ruling that Medicare will
pay a rate of $100 for certain laboratory tests that use high-throughput technologies torapidly process large numbers of specimens for COVID-19 testing per day. In addition to65

5/18/2020

expanding access to diagnostic testing available to Medicare beneficiaries, CMS
expedited review of applications for a Clinical Laboratory Improvement Amendments(CLIA) certificate and ensuring that laboratories located in the United States wishing toperform COVID-19 testing are able to begin testing as quickly as possible. In early April,
CMS also implemented a change to Medicare payment policies that allows for payment
to independent laboratories for specimen collection from beneficiaries who arehomebound or non-hospital inpatients for COVID-19 testing under certain
circumstances.

7. Is COVID-19 testing required in nursing homes, or do nursing homes have to comply
with family requests for testing of residents?
CMS and our partners on the White House Coronavirus Task Force are taking aggressive
action to protect those most vulnerable to the 2019 Novel Coronavirus (COVID-19). A
dedicated Nursing Home Task Force, which includes CMS and the Centers for Disease
Control and Prevention (CDC), meets daily with a singular focus of safeguarding thehealth of the elderly residing in nursing homes.
A decision to order a COVID-19 test for a patient is made by that patient’s physician orhealth care provider. CMS continues to direct nursing homes to the latest guidance fromthe CDC on COVID-19 testing. In addition, nursing homes must follow any state or local
requirements for COVID-19 screening, testing, and reporting. Ultimately, nursing homes
are responsible for the health and safety of their residents.
CMS has taken several important actions to expand access to diagnostic testing available
to Medicare beneficiaries, individuals, nursing homes and hospitals during this publichealth emergency. Last month, CMS expedited review of applications for a CLIA
certificate and ensuring that laboratories located in the United States wishing toperform COVID-19 testing are able to begin testing as quickly as possible. In addition, inearly April, CMS implemented a change to Medicare payment policies that allows forpayment to independent laboratories for specimen collection from beneficiaries whoare homebound or non-hospital inpatients for COVID-19 testing under certain
circumstances. For a full list of actions, visit CMS’ Frequently Asked Questions (FAQs)
document.

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8. What factors should state and local health officials consider before relaxing
restrictions in nursing homes?
CMS encourages any decisions to relax requirements within nursing homes to be madeafter a careful review of facility-level, community, and state factors/orders as well as incollaboration with state and local health officials and nursing homes. Additionally, stateand local officials should consider the following as a part of a comprehensive reopeningplan:• Case status in surrounding community• Case status in the nursing home(s)• Staffing levels• Access to adequate testing for residents and staff• Personal Protective Equipment supplies• Local hospital capacity
More information can be found in the Nursing Home Reopening Recommendations
Memo (insert URL)
9. How often should a nursing home test its staff?
All staff should receive a baseline test, and continue to be tested weekly.
10. How often should a nursing home test its residents?
Nursing homes should have a comprehensive plan for testing. All residents should
receive a single baseline test for COVID-19. Also, all residents should be tested upon
identification of an individual with symptoms consistent with COVID-19 or if an employee orstaff member tested positive for COVID-19.

11. When will visitors be allowed in nursing homes?
Continuing to restrict visitation is understandably challenging for families, but isnecessary in order to protect residents from possible transmission of the virus. Nursing
homes should continue to restrict visitation in general based upon the following
recommended guidelines:
Phase One: Visitation is generally prohibited, except for compassionate care situations.
In those limited situations, visitors are screened and additional precautions are taken,

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including social distancing, and hand hygiene (e.g., use alcohol-based hand rub uponentry). All visitors wear a cloth face covering or facemask for the duration of their visit.
Phase Two: Due to the elevated risk COVID-19 poses to the health of nursing homeresidents, visitation is still generally prohibited, except for compassionate caresituations. In those limited situations, visitors are screened and additional precautions
are taken, including social distancing, and hand hygiene (e.g., use alcohol-based hand
rub upon entry). All visitors wear a cloth face covering or facemask for the duration of
their visit.
Phase Three: Visitation allowed with screening and additional precautions including
ensuring social distancing and hand hygiene (e.g., use alcohol-based hand rub uponentry). All visitors must a cloth face covering or facemask for the duration of their visit.

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U.S. Department of Health and Human Services
Report to Congress: COVID-19 Strategic Testing Plan

Appendix D
ELC Health Care Enhancement: 2020 Supplement Guidance to
the States

69

ELC ENHANCING DETECTION
Emerging Issues (E) Project: Funding for the Enhanced
Detection, Response, Surveillance, and Prevention of COVID-19
Supported through the Paycheck Protection Program and HealthCare Enhancement Act of 2020
70

ELC ENHANCING DETECTIONCONTENTS
Background and purpose ..........................................................................................................................................1
Funding strategy .......................................................................................................................................................2
Process for workplan and budget submission .........................................................................................................3
Activities ....................................................................................................................................................................5
Performance measures and reporting .....................................................................................................................9

ELC ENHANCING DETECTION
EMERGING ISSUES (E) PROJECTBACKGROUND AND PURPOSE
Over the past 25 years, the Centers for Disease Control and Prevention’s (CDC) Epidemiology and Laboratory
Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement has enhanced
the capacity of each of our recipient jurisdictions’ public health capacity to cohesively and comprehensively
address infectious disease needs. In addition to foundational support for epidemiology, laboratory, and healthinformation systems, the ELC also supports disease-specific program areas (e.g., respiratory diseases; healthcare
associated infections). The portfolio of ELC-supported activities at each jurisdiction is overseen by an ELC
Governance Team with representation from epidemiology, laboratory, and health information systems. This
structure has been successfully utilized by ELC recipients to manage activities and funding from special
appropriations provided in response to a number of infectious disease emergencies (e.g., H1N1, Ebola, and Zika).
As part of the “Paycheck Protection Program and Health Care Enhancement Act of 2020 (P.L. 116-139, Title I)”, the
ELC is awarding a total of $10.25 billion dollars to our recipient base in a program-initiated component funding
under the Emerging Issues (E) Project of CK19-1904, henceforth, ”ELC Enhancing Detection” supplement. These
funds are broadly intended to provide critical resources to state, local, and territorial health departments insupport of a broad range of COVID-19/SARS-CoV-2 testing and epidemiologic surveillance related activities. Direct
recipients are limited to existing jurisdictions covered under CK19-1904 1. These resources should complement,
not duplicate, existing funding provided to jurisdictions, including the ELC Community-based Surveillance and ELC
CARES Act supplements. Additionally, recipients should leverage and build upon existing ELC infrastructure thatemphasizes the coordination and critical integration of laboratory with epidemiology and health information
systems in order to maximize the public health impact of available resources. Ongoing monitoring of milestones
and performance measures will be utilized to gauge progress toward successful completion of priority activities
supported with these funds.
Resources provided via this award mechanism should support necessary expenses to implement and oversee
expanded testing capacity for COVID-19/SARS-CoV-2, including the ability to process, manage, analyze, use, andreport the increased data produced. Recipients will establish a robust SARS-CoV-2 testing program that ensuresadequate testing is made available according to CDC priorities, including but not limited to: diagnostic tests, tests
Only current ELC recipients are eligible to receive awards associated with the supplement described in thisguidance. While tribal nations are not included in these awards, other federal support is provided in the Paycheck
Protection Program and Health Care Enhancement Act of 2020.

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ELC ENHANCING DETECTION
for contact tracing, and surveillance of asymptomatic persons to determine community spread. Recipients should
assure that provisions are in place to meet future surge capacity testing needs including point of care or otherrapid result testing for local outbreaks. Plans should include plans for testing at non-traditional sites (e.g., retailsites, community centers, residential medical facilities, or pharmacies); testing of at risk populations including
elderly, disabled, those in congregate living facilities including prisons, racial and ethnic minorities, and othergroups at risk due to high frequency of occupational or nonoccupational contacts; and should also address any
essential partnerships with academic, commercial, and hospital laboratories to successfully meet testing demand.
Plans should explicitly detail how a minimum of 2% of the state’s population will be tested each month beginning
immediately; as well as plans to increase that number by Fall 2020. Plans should include a list of established andproposed laboratories that will be testing for SARS-CoV-2 in each state along with each laboratory’s available
platforms and throughput, that are used for testing and indicate per laboratory, testing projections by monththrough December 31st, 2020.
In conjunction with optimizing testing and increasing test volumes for COVID-19/SARS-CoV-2, resources will
support the establishment of modernized public health surveillance systems. These systems will support the publichealth response to COVID-19 and lay the foundation for the future of public health surveillance. Establishingsystems and processes to report the data categories described in this document on a daily, automated basis tostate and federal health systems is a requirement of accepting these funds, if such systems are not already inplace. These systems must be transparent and visible to communities through an open website. For each data
category, minimum required data elements will be specified by CDC for each reportable condition at a later date.
These surveillance and data reporting systems must:•••

Ensure that real-time, at least daily, complete and accurate test orders and results can be exchanged
within the healthcare/public health system and simultaneously reported to CDC and others via automatedsystems in a machine-readable format. These systems must support reporting of test results at the county
or zipcode level with additional data fields as specified by CDC. This includes not only testing for thepresence of virus (nucleic acid or antigen testing), but also serological testing documenting past infection.
Ensure real-time, at least daily, complete, automated reporting in a machine-readable format for thefollowing data categories: case, hospitalization and death reporting; emergency department syndromic
surveillance; and capacity, resources, and patient impact at healthcare facilities through electronic
reporting.
Support the display of up-to-date, critical public health information relating to COVID-19 and future
outbreaks at the county or zipcode level in visual dashboards on county or state websites, including casedata and syndromic surveillance data.

Enhancements to epidemiologic activities resulting from additional test data are also fundamental to controllingthe spread of COVID-19. Recipients must accelerate efforts to conduct robust contact tracing and then identify
and isolate new cases of COVID-19 among symptomatic or asymptomatic individuals. This information should befurther utilized to understand COVID-19/SARS-CoV-2 exposure within a community and determine appropriate
mitigation strategies.
FUNDING STRATEGY
Funding by jurisdiction will be based on population and number of cases of COVID-19/SARS-CoV-2, as further
provided in the legislative language for the Paycheck Protection Program and Health Care Enhancement Act of2020 (https://www.congress.gov/bill/116th-congress/house-bill/266/). Direct Assistance is authorized under
CK19-1904 2; however, should opportunities for direct assistance be made available, these will be shared broadly
with our recipient base and options for providing direct assistance in lieu of financial assistance may be discussed
and coordinated with the ELC and the CDC Office of Grant Services (OGS).
Legislative Authority for CK19-1904: Sections 301 and 317 of the Public Health Service Act (PHS Act), 42 USC, 241
and 247b as amended; and Funding is appropriated under Affordable Care Act (PL 111-148), Title IV, Section 4002
(Prevention and Public Health Fund), Title IV, Section 4002
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ELC ENHANCING DETECTION
Recipients should consider requesting the following when developing budgets, in furtherance of award activities:
•
•
•
•
•

•
•
•
•

Personnel (term, temporary, students, overtime, contract staff, etc.)
Laboratory equipment and necessary maintenance contracts
Collection supplies, test kits, reagents, consumables and other necessary supplies for existing testing or
onboarding new platforms
Courier service contracts (new or expansion of existing agreements)
Hardware and software necessary for robust implementation of electronic laboratory and surveillance dataexchange between recipient and other entities, including healthcare entities, jurisdictional public health and
CDC
Tools that assist in the rapid identification, electronic reporting, monitoring, analysis, and evaluation of control
measures to reduce the spread of disease (e.g. GIS software, visualization dashboards, cloud services)
Reporting and/or enrollment incentives
Contracts with academic institutions, private laboratories, and/or commercial entities
Laboratory renovations and minor construction (may be considered for unique cases where conditions do notcurrently allow for safe or effective testing)

The above list is as an example and does not represent a full list of allowable costs. Any questions about specificbudget items should be directed to the OGS and the ELC Project Officer.
Support to Local Health Departments (LHD):
Recipients should work with their LHDs to determine how local needs can be addressed with the overall available
resources. Direct ELC recipients may provide financial resources to LHDs within their jurisdiction by way of acontract or other mechanism(s) as available through their Health Department. In addition to financial resources,
ELC direct recipients may provide support to LHDs through offering non-financial resources (personnel, supplies,etc.) to address COVID-19/SARS-CoV-2 surveillance, case detection, reporting, response, and prevention needs at
the local level.
Supporting Management of Activities and Resources:
The ELC recommends that jurisdictions ensure ELC leadership staff at the recipient level are adequate for the
management of this award and its integration with the recipient’s overall portfolio of ELC funded activities. A
minimum of 1 program manager and 1 budget staff (or equivalents) is suggested for the effective management
and implementation of the recipients’ proposed activities.
PROCESS FOR WORKPLAN AND BUDGET SUBMISSION
This funding should support ELC Health Care Enhancement activities and the necessary reporting for Budget Period
1 under CK19-1904; however, recipients are reminded that expanded authority 3 applies, and activities are likely totake 30 months for completion due to the nature of COVID-19/SARS-CoV-2. Within 30 days of receipt of the Noticeof Award (NOA), the recipient is required to submit a workplan and budget describing its proposed activities.
Upon submission, budgets and workplans will be reviewed by CDC and feedback will be provided and discussedwith the recipient. Any necessary or recommended changes may be agreed upon between the jurisdiction and
CDC and documented in REDCap and/or GrantSolutions as necessary.
To appropriately document workplans, budgets, and facilitate recipients meeting the 30-day requirement:
Expanded Authority is provided to recipients through 45 CFR Part 75.308 which allows recipients to incur project
costs 90 days prior to award, initiate one-time extension to project period, and carryover unobligated balances tosubsequent budget periods.

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ELC ENHANCING DETECTION
1.
2.

3.

Workplan entries will be completed in the ‘ELC Enhanced Detection’ portal, under ‘ELC COVID-19 Projects’, in
REDCap; andRevised budgets will be completed by using the template provided via GrantSolutions Grant Notes at time of
NOA issuance.
a. Funds will be awarded under the ‘Other’ cost category;b. Recipients will adjust the cost category allocations of awarded funds to reflect the areas where
financial assistance is needed; andc. Recipients will upload the revised budget into GrantSolutions via a redirection amendment, with acourtesy copy into REDCap ‘ELC Enhanced Detection’ portal, by the 30-day post award deadline.
d. ELC and OGS will process the redirection amendment in GrantSolutions and the recipient will receivea revised NOA reflecting the requested cost category allocations.
A letter, indicating that all ELC Governance Team members have both contributed to and agreed upon theworkplan and budget submitted, must be signed by all Governance Team Members (hard copy or digital
signature) and submitted with the documents in the REDCap portal.

Workplan detail
Additional workplan guidance will be provided to recipients post-award; they will be required to provide a clear
and concise description of the time bound strategies and activities they will use to achieve the project’s outcomes,
including:
1.
2.
3.

4.
5.

6.

Description of how ‘ELC Enhanced Detection’ funding will be used in coordination with funding from CDC’s
Crisis COVID-19 Notice of Funding Opportunity (NOFO) and ELC CARES.
Specify the distinct new or enhanced activities made possible by ‘ELC Enhanced Detection’.
Plans for how the ELC recipient will work with local jurisdictions to meet local needs that support the entire
jurisdiction. These plans must include: description of activities to be supported at the local level, identificationof local partners and localities to be supported, methods to assess local needs, and description of funding
mechanisms to support local entities.
Description of expected mechanisms and frequency of interactions between the health department and/or
public health laboratory with academic/hospital and commercial laboratories.
Description of testing plan, including populations and institutional settings. Plans should align to yourjurisdictional testing plans for COVID-19 per legislation 4. Plans for May – June must be submitted by May 30,
2020. Plans for July – December must be submitted by June 15, 2020. Details about testing plan submission
will be shared with recipients via the ELC Program office.
Description of use of electronic health systems for surveillance, reporting, and public health action.

Of note: In a cooperative agreement, CDC staff is substantially involved in the program activities, above andbeyond routine grant monitoring.
CDC responsibilities include but are not limited to:
1.
2.
3.
4.

Provide ongoing guidance, programmatic support (including guidance on evaluation, performancemeasurement, and workplan changes), technical assistance and subject matter expertise to the activities
outlined in this supplemental funding announcement guidance.
Convene trainings, meetings, conference calls, and site visits with recipients.
Share best practices identified and provide national coordination of activities, where appropriate.
Coordinate with the HHS Testing Team as needed, for subject matter expertise and technical assistance tosupport States testing strategies.

In addition to the programmatic activities noted below in further detail, recipient responsibilities include but are
not limited to:4

https://www.congress.gov/bill/116th-congress/house-bill/266/
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ELC ENHANCING DETECTION
1.
2.
3.

Regular participation in calls with CDC/HHS for technical assistance and monitoring of activities supported
through this cooperative agreement.
On-time submission of all requisite reporting. This may include but is not limited to reporting of performancemeasures and progress on milestones within REDCap or provision of financial updates.
Documentation of any necessary budget change/reallocation through REDCap and, as necessary,
GrantSolutions.

Both CDC and recipients should appropriately coordinate with points of contact in relevant stakeholder
organizations to maximize the impact of federal dollars (e.g., tribal nations, Health Resources and Services
Administration (HRSA), HHS testing team, etc.).
ACTIVITIES
Data collected as a part of the Activities supported with these funds shall be reported to CDC in a form and fashion
to be determined and communicated at a later date. Recipients are required to establish electronic reporting
systems to support comprehensive, timely, automated reporting of these data to LHD, CDC and others, at afrequency to be determined and communicated at a later date, if such systems are not already in place. Suchsystems must support reporting for COVID-19, other conditions of public health significance.
Activities supported by these funds include but are not limited to the following:
Enhance Laboratory, Surveillance, Informatics and other Workforce Capacity
1.
2.
3.
4.
5.

Train and hire staff to improve laboratory workforce ability to address issues around laboratory safety,
accessioning, testing and reporting results.
Build expertise for healthcare and community outbreak response and infection prevention and control (IPC)
among local health departments.
Train and hire staff to improve the capacities of the epidemiology and informatics workforce to effectively
conduct surveillance and response of COVID-19 (including contact tracing) and other conditions of publichealth significance.
Build expertise to support management of the COVID-19 related activities within the jurisdiction and theintegrate into the broader ELC portfolio of activities (e.g., additional leadership, program and project
managers, budget staff, etc.).
Increase capacity for timely data management, analysis, and reporting for COVID-19 and other conditions ofpublic health significance.

Strengthen Laboratory Testing1.

Establish or expand capacity to quickly, accurately and safely test for SARS-CoV-2/COVID-19 (which may build
capacity to test for other pathogens with potential for broad community spread) among all symptomatic
individuals, and secondarily expand capacity to achieve community-based surveillance, including testing ofasymptomatic individuals.
a. Develop systems to improve speed and efficiency of specimen submission to clinical and referencelaboratories.
b. Strengthen ability to quickly scale testing as necessary to ensure that optimal utilization of existingand new testing platforms can be supported to help meet increases in testing demand in a timely
manner.
c. Perform serology testing with an FDA EUA authorized serological assay in order to conduct
surveillance for past infection and monitor community exposure.
d. Work with LHDs to build local capacity for testing of COVID-19/SARS-CoV-2 including within high-risk
settings or in vulnerable populations that reside in their communities.

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Apply laboratory safety methods to ensure worker safety when managing and testing samples that
may contain SARS-CoV-2/COVID-19.

2. Enhance laboratory testing capacity for SARS-CoV-2/COVID-19 outside of public health laboratoriesa.
b.

Establish or expand capacity to coordinate with public/private laboratory testing providers, including
those that assist with surge and with testing for high-risk environments.
Secure and/or utilize mobile laboratory units, or other methods to provide POC testing at publichealth-led clinics or non-traditional test sites (e.g., homeless shelters, food processing plants,
prisons, Long Term Care Facilities (LTCF), etc.).

3. Enhance data management and analytic capacity in public health laboratories to help improve efficiencies inoperations, management, testing, and data sharing.
a.
b.

Improve efficiencies in laboratory operations and management using data from throughput, staffing,billing, supplies, and orders. Ensure ability to track inventory of testing reagents by device/platform,
among other things.
Improve the capacity to analyze laboratory data to help understand and make informed decisions
about issues such as gaps in testing and community mitigation efforts. Data elements such as tests
ordered and completed (including by device/platform), rates of positivity, source of samples,
specimen collection sites, and test type will be used to create data visualizations that will be sharedwith the public, local health departments, and federal partners.

Advance Electronic Data Exchange at Public Health Labs
1. Enhance and expand laboratory information infrastructure, to improve jurisdictional visibility on laboratory
data (tests performed) from all testing sites and enable faster and more complete data exchange andreporting.
a. Employ a well-functioning Laboratory Information Management System (LIMS) system to support
efficient data flows within the PHL and its partners. This includes expanding existing capacity of thecurrent LIMS to improve data exchange and increase data flows through LIMS maintenance, newconfigurations/modules, and enhancements. Implement new/replacement LIMS where needed.
b. Ensure ability to administer LIMS. Ensure the ability to configure all tests that are in LIMS, including
new tests, EUAs, etc., in a timely manner. Ensure expanding needs for administration andmanagement of LIMS system are covered through dedicated staff.
c. Interface diagnostic equipment to directly report laboratory results into LIMS
d. Put a web portal in place to support online ordering and reporting. Integrate the web portal into the
LIMS.
e. Enhance laboratory test ordering and reporting capability.
i. Implement or improve capacity to consume and produce electronic HL7 test orders andresult reporting (ETOR) to allow laboratories and healthcare providers to directly exchange
standardized test orders and results across different facilities and electronic information
systems using agreed upon standards.
ii. 100% of results must be reported with key demographic variables including age/gender/raceiii. Report all testing to the health department and CDC using HL7 ELR.
Improve Surveillance and Reporting of Electronic Health Data
Conducting the activities in this section to enable comprehensive, automated, daily reporting to the CDC andothers in a machine-readable format, for data elements to be determined at a later date, is a requirement of
accepting these funds.

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1.

2.

3.

4.

5.

Establish complete, up-to-date, automated reporting of morbidity and mortality to CDC andothers due to COVID-19 and other conditions of public health significance, with required associateddata fields in a machine readable format, by:a. Establishing or enhancing community-based surveillance, including surveillance of vulnerable
populations, individuals without severe illness, those with recent travel to high-risk
locations, or who are contacts to known cases.
b. Monitoring changes to daily incidence rates of COVID-19 and other conditions of publichealth significance at the county or zipcode level to inform community mitigation strategies.
Establish complete, up-to-date, timely, automated reporting of individual-level data throughelectronic case reporting to CDC and others in a machine-readable format (ensuring LHD have accessto data that is reported):a. At the health department, enhance capacity to work with testing facilities to onboard andimprove electronic laboratory reporting (ELR), including to receive data from new or nontraditional testing settings. Use alternative data flows and file formats (e.g., CSV or XLS) to
help automate where appropriate. In addition to other reportable results, this should
include all COVID-19/SARS-CoV-2-related testing data (i.e., tests to detect SAR-CoV-2
including serology testing).
b. Automate receiving EHR data, including eCR and FHIR-base eCR Now, to generate initial casereport as specified by CDC for the reportable disease within 24 hours and to update overtime within 24 hours of a change in information contained in the CDC-directed casereport, including death. Utilize eCR data to ensure data completeness, establish
comprehensive morbidity and mortality surveillance, and help monitor the health of thecommunity and inform decisions for the delivery of public health services.
c. Increase connectivity with laboratory and healthcare feeds for epidemiologic analysis(including using automated single CSV files).
d. Expand eCR etc to include all conditions of public health significanceImprove understanding of capacity, resources, and patient impact at healthcare facilities throughelectronic reporting.
a. Required expansion of reporting facility capacity, resources, and patient impact information,such as patients admitted and hospitalized, in an electronic, machine-readable, as well as
human-readable visual, and tabular manner, to achieve 100% coverage in jurisdiction andinclude daily data from all acute care, long-term care, and ambulatory care settings. Usethese data to monitor facilities with confirmed cases of COVID-19/SARS-CoV-2 infection orwith COVID-like illness among staff or residents and facilities at high risk of acquiring COVID19/SARS-CoV-2 cases and COVID-like illness among staff or residents.
b. Increase ADT messaging and use to achieve comprehensive surveillance of emergency room
visits, hospital admissions, facility and department transfers, and discharges to provide an
early warning signal, to monitor the impact on hospitals, and to understand the growth ofserious cases requiring admission.
Enhance systems for flexible data collection, reporting , analysis, and visualization.
a. Implement new/replacement systems where needed. Ensure systems are interoperable andthat data are able to be linked across systems, including adding the capacity for lab data andother data to be used by the software/tools that are being deployed for contact tracing.
b. Data must be made available at the local, state, and federal level.
c. Make data on case, syndromic, laboratory tests, hospitalization, and healthcare capacity
available on health department websites at the county/zip code level in a visual and tabularmanner.
Establish or improve systems to ensure complete, accurate and immediate (within 24 hrs) datatransmission to a system and open website available to local health officials and the public by county

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and zipcode, that allows for automated transmission of data to the CDC in a machine readable
format.
a. Track and send 100% of emergency department and outpatient visits for COVID-like illness, aswell as other syndromes/illnesses, to CDC.
b. Submit comprehensive syndromic surveillance data for all facilities in the jurisdiction.
c. Send deidentified copies of all admit, discharge, and transfer (ADT) messages to the CDC
d. Submit all case reports in an immediate, automated way to CDC for COVID-19/SARS-CoV-2 andother conditions of public health significance with associated required data fields in a machinereadable format.
e. Provide accurate accounting of COVID-19/SARS-CoV-2 associated deaths. Establish electronic,
automated, immediate death reporting to CDC with associated required data fields in amachine-readable format.
f. Report requested COVID-19/SARS-CoV-2-related data, including line level testing data(negatives, positives, indeterminants, serology, antigen, nucleic acid) daily by county or zipcode
to the CDC-designated system.
g. Establish these systems in such a manner that they may be used on an ongoing basis forsurveillance of, and reporting on, other threats to the public health and conditions of publichealth significance.
Use Laboratory Data to Enhance Investigation, Response and Prevention
1.

2.

3.

Use laboratory data to initiate case investigations, conduct contact tracing and follow up, and implement
containment measures.
a. Conduct necessary contact tracing including contact elicitation/identification, contact notification,and contact follow-up. Activities could include traditional contact tracing and/or proximity/locationbased methods, as well as methods adapted for healthcare-specific and congregate settings.
b. Utilize tools (e.g., geographic information systems and methods) that assist in the rapid mapping andtracking of disease cases for timely and effective epidemic monitoring and response, incorporating
laboratory testing results and other data sources.
Identify cases and exposure to COVID-19 in high-risk settings or within vulnerable populations to target
mitigation strategies.
a. Assess and monitor infections in healthcare workers across the healthcare spectrum.
b. Monitor cases and exposure to COVID-19 to identify need for targeted mitigation strategies to isolate
and prevent further spread within high-risk healthcare facilities (e.g., hospitals, dialysis clinics, cancer
clinics, nursing homes, and other long-term care facilities, etc.).
c. Monitor cases and exposure to COVID-19 to identify need for targeted mitigation strategies to isolate
and prevent further spread within high-risk employment settings (e.g., meat processing facilities), andcongregate living settings (e.g., prisons, youth homes, shelters).
d. Work with LHDs to build local capacity for reporting, rapid containment and prevention of COVID19/SARS-CoV-2 within high-risk settings or in vulnerable populations that reside in their communities.
Implement prevention strategies in high-risk settings or within vulnerable populations (including tribal
nations) including proactive monitoring for asymptomatic case detection.
a. Build capacity for infection prevention and control in LTCFs (e.g., at least one Infection Preventionist(IP) for every facility) and outpatient settings.
i. Build capacity to safely house and isolate infected and exposed residents of LTCFs and othercongregate settings.
ii. Develop interoperable patient safety information exchange systems.
iii. Assist with enrollment of all LTCFs into NHSN and provision of related user support.
b. Increase Infection Prevention and Control (IPC) assessment capacity onsite using tele-ICAR.
c. Perform preparedness assessment to ensure interventions are in place to protect high-risk
populations.

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Coordinate as appropriate with federally funded entities responsible for providing health services tovulnerable populations (e.g., tribal nations and federally qualified health centers)

Coordinate and Engage with Partners
1.

2.

Partner with LHDs to establish or enhance testing for COVID-19/SARS-CoV-2.
a. Support appropriate LHDs with acquiring equipment and staffing to conduct testing for COVID19/SARS-CoV-2.
b. Support LHDs to conduct appropriate specimen collection and/or testing within their jurisdictions.
Partner with local, regional, or national organizations or academic institutions to enhance capacity for
infection control and prevention of COVID-19/SARS-CoV-2.
a. Build infection prevention and control and healthcare outbreak response expertise in LHDs.
b. Partner with academic medical centers and schools of public health to develop regional centers for
IPC consultation and support services

PERFORMANCE MEASURES AND REPORTING
Performance Measures: In addition to the metrics and deliverable indicated above, performance measures specific
to COVID-19-related activities will be finalized and provided to recipients within 21 days of award. The ELC will
utilize existing data sources whenever possible to reduce the reporting burden on recipients and, whereappropriate, existing ELC performance measures may be used. While more frequent reporting may be employedwithin the first year of this supplement, these requirements may be adjusted as circumstances allow. Where it ispossible, reporting will be aligned to current performance measure reporting timelines.
Consistent with current ELC practice, progress on Milestones will be reported on a quarterly basis utilizing REDCap.
Recipients will be provided 2 weeks to update their progress and note any challenges encountered since theprevious update. Financial reporting requirements shall be noted and, as necessary, updated in the Terms andConditions of the award. The ELC will work with OGS to limit the administrative burden on recipients.
Summary of Reporting Requirements:
1.
2.
3.
4.

Quarterly progress reports on milestones in approved workplans via REDCap.
Monthly fiscal reports (beginning 60 days after NOAs are issued).
Performance measure data.
CDC may require recipients to develop annual progress reports (APRs). CDC will provide APR guidance andoptional templates should they be required.

Please also note: Data collected as a part of the activities supported with these funds shall be reported to CDC in aform and fashion to be determined and communicated at a later date.

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Report to Congress: COVID-19 Strategic Testing Plani

The White House. Guidelines for Opening Up America Again: Testing Overview. Retrieved from:https://www.whitehouse.gov/wp-content/uploads/2020/04/Testing-Overview-Final.pdf
ii
The White House. Opening Up America Again: Testing Blueprint. Retrieved from:https://www.whitehouse.gov/wp-content/uploads/2020/04/Testing-Blueprint.pdf
iiiWorld Health Organization. Global surveillance for COVID-19 caused by human infection with COVID-19 virus(Interim guidance). Retrieved from: https://www.who.int/publications-detail/global-surveillance-for-covid-19caused-by-human-infection-with-covid-19-virus-interim-guidanceiv
Centers for Disease Control and Prevention (CDC). Evaluating and Testing Persons for Coronavirus Disease 2019
(COVID-19) Retrieved from: https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html
vCDC. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus
Disease 2019 (COVID-19). Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinicalspecimens.html
vi
Edmond J. Safra Center for Ethics. COVID-19 Rapid Response Impact Initiative - White Paper 6:
Why We Must Test Millions a Day. Retrieved from: https://ethics.harvard.edu/files/center-forethics/files/white_paper_6_testing_millions_final.pdf
viiMichael Ryan, executive director of the WHO Health Emergencies Program, March 10, 2020.
viii
CVS Health. CVS Health to significantly expand COVID-19 testing capabilities. April 27, 2020. Retrieved from:https://cvshealth.com/newsroom/press-releases/cvs-health-significantly-expand-covid-19-testing-capabilities
ix
CDC. Evaluating and Testing Persons for Coronavirus Disease 2019 (COVID-19). Retrieved from:https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html
xCDC. Testing Guidance for Nursing Homes. Retrieved from: https://www.cdc.gov/coronavirus/2019ncov/hcp/nursing-homes-testing.html
xiCenters for Medicare & Medicaid Services (CMS). Trump Administration Issues Guidance to Ensure States Havea Plan in Place to Safely Reopen Nursing Homes. May 18, 2020. Retrieved from:https://www.cms.gov/newsroom/press-releases/trump-administration-issues-guidance-ensure-states-have-planplace-safely-reopen-nursing-homesxiiCDC. COVID-19 Serology Surveillance Strategy. Retrieved from: https://www.cdc.gov/coronavirus/2019ncov/covid-data/serology-surveillance/index.html
xiii
CDC. COVID-19 Infection Control. Retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/hcp/infectioncontrol.html
xiv
CDC and OSHA. COVID-19 Interim Guidance from CDC and the Occupational Safety and HealthAdministration (OSHA). Retrieved from: https://www.cdc.gov/coronavirus/2019ncov/community/organizations/meat-poultry-processing-workers-employers.html
xv
Department of Homeland Security. Critical Infrastructure Sectors. Retrieved from: https://www.cisa.gov/criticalinfrastructure-sectors
xvi
Characteristics of Health Care Personnel with COVID-19 — United States, February 12–April 9, 2020. MMWR
Morb Mortal Wkly Rep 2020;69:477–481. DOI: http://dx.doi.org/10.15585/mmwr.mm6915e6
xvii
Dyal JW, Grant MP, Broadwater K, et al. COVID-19 Among Workers in Meat and Poultry Processing Facilities― 19 States, April 2020. MMWR Morb Mortal Wkly Rep 2020;69:557–561. DOI:
http://dx.doi.org/10.15585/mmwr.mm6918e3
xviii
FDA. Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care
Providers. Retrieved from: https://www.fda.gov/medical-devices/letters-health-care-providers/importantinformation-use-serological-antibody-tests-covid-19-letter-health-care-providers
xix
FDA. Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy. Retrieved from:https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-andaccuracyxx
FDA. Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Retrieved from:https://www.fda.gov/media/135659/downloadxxi
FDA. Emergency Use Authorizations. Retrieved from: https://www.fda.gov/medical-devices/emergencysituations-medical-devices/emergency-use-authorizations#covid19ivd
xxii
CMS. CMS-5531-IFC. Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional

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Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain
Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program. Retrieved from:https://www.cms.gov/files/document/covid-medicare-and-medicaid-ifc2.pdf
xxiii
CMS. Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency. Retrieved from:https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf
xxiv
Liu, L., Li, Y., Li, S., Hu, N., He, Y., Pong, R., Lin, D., Lu, L., & Law, M. (2012). Comparison of nextgeneration sequencing systems. Journal of biomedicine & biotechnology, 2012, 251364.
https://doi.org/10.1155/2012/251364
xxv
FDA. EUA for Sherlock CRISPR SARS-CoV-2 Kit. Retrieved from:https://www.fda.gov/media/137747/download
xxvi
Medical Countermeasures.gov. Request ad USG Coronawatch Meeting. Retrieved from:https://www.medicalcountermeasures.gov/request-barda-techwatch-meeting/xxvii
CDC. Coronavirus Disease 2019 (COVID-19) – Cases in the U.S. Retrieved from:https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html
xxviii
CDC. COVID-19 Death Data and Resources. Retrieved from: https://www.cdc.gov/nchs/nvss/covid-19.htm
xxix
CDC. Testing Data in the U.S. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/testing-in-us.html
xxx
FDA. Emergency Use Authorizations. Retrieved from: https://www.fda.gov/medical-devices/emergencysituations-medical-devices/emergency-use-authorizations#covid19ivd
xxxi
The Public Health Emergency Preparedness grant formula is from section 319-1(h) of the Public Health Security
Act: for the first fiscal year SLTTs cover 5 % of the costs ($1 spending by SLTT is supported by $20 of HHS
funding), with subsequent fiscal years requiring SLTTs to cover 10 % of the costs ($1 spending by SLTT is
supported by $10 of HHS funding)
xxxii
CMS. Ruling 2020-01-R. April 14, 2020. Retrieved from: https://www.cms.gov/files/document/cms-2020-01r.pdf
xxxiiiPrendergast, C. and J. Papenburg (2013). "Rapid antigen-based testing for respiratory syncytial virus: moving
diagnostics from bench to bedside?" Future Microbiol 8(4): 435-444.
xxxiv
Cheng, M. P., et al. (2020). "Diagnostic Testing for Severe Acute Respiratory Syndrome-Related Coronavirus2: A Narrative Review." Ann Intern Med.
xxxv
FIND. SARS-CoV-2 Diagnostic Pipeline. Accessed at www.finddx.org/covid-19/pipeline on 4 May 2020
xxxvi
Bao, L., et al. (2020). "Reinfection could not occur in SARS-CoV-2 infected rhesus macaques." bioRxiv:
2020.2003.2013.990226.

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