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Frequently Asked Questions: COVID-19 Testing at Skilled Nursing Facilities/ Nursing
Homes
1. Who will receive the testing platforms and U.S. Food and Drug Administration (FDA)-
authorized antigen diagnostic tests?
Nursing homes will receive either a Quidel Sofia 2 Instrument or Becton, Dickinson and
Company (BD) Veritor™ Plus System over the coming months along with the associated
FDA-authorized antigen diagnostic tests. To be eligible, nursing homes must have a current
CLIA Certificate of Waiver AND meet certain epidemiological criteria. The list of nursing
homes is posted
on the Centers for Medicare & Medicaid Services (CMS) COVID NHSN
data page and will be updated as new shipments go out. The U.S. Department of Health and
Human Services (HHS) will distribute the testing platforms and FDA-authorized antigen
diagnostic tests to all nursing homes with a CLIA Certificate of Waiver over the next few
months.
Nursing homes mean facilities that are certified as a Medicare Skilled Nursing Facility (SNF)
and/or Medicaid Nursing Facility (NF), otherwise referred to a Long Term Care Facility or
nursing home.
2. How is distribution of the testing platforms and FDA-authorized antigen diagnostic
tests being determined? Will these devices be sent directly to the nursing homes or to
states for distribution?
Distribution of instruments and tests are prioritized for facilities based on Centers for Disease
Control and Prevention (CDC) epidemiological hotspot data and facilities whose data
indicate an elevated risk for COVID-19 transmission. Devices will be sent directly to nursing
homes to ensure that nursing homes can begin testing as soon as they receive the devices and
complete the requisite training.
Shipping schedules are based on the availability of instruments and test kits. Facilities that
have been prioritized to receive early shipments (within the first 3 weeks) are located in CDC
epidemiological hotspot counties. Most shipments will occur in the first 4 weeks, although it
may take up to 14 weeks for all nursing homes to receive their shipment due to supply
availability.
3. When will the testing platforms and authorized point-of-care tests be distributed?
Instruments and authorized diagnostic antigen tests will begin shipping the week of July 20
and shipments will continue over the course of 14 weeks. Supplies will arrive in a single
shipment directly from the manufacturer and/or distributor.
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4. How many COVID-19 test kits will nursing homes receive?
Allotments of instruments and test kits are determined by the estimated volume of tests
needed for the facility to test all staff and residents at least once and enable a pathway to
conduct ongoing testing according to public health guidelines. This estimated volume is
based on the average number of weekly staff, and the average resident census for each
facility reported by CMS. All facilities will receive at least one instrument. A second
instrument will be allocated to facilities that were identified to receive 900 tests (facilities
identified as major outliers).
Nursing homes were categorized into 5 groupings based on their estimated testing needs:
Small facilities – 150 tests, 1 instrument;
Small-medium facilities – 240-250 tests,* 1 instrument;
Medium facilities – 325-330 tests,* 1 instrument;
Large facilities – 600 tests, 1 instrument;
Major outlier facilities – 900+ tests, 2 instruments.
*Note: The range accounts for variations in kit size between BD and Quidel. Tests for the BD
Veritor™ Plus come in kits of 30 and those for the Quidel Sofia 2 in kits of 25.
5. Who will provide training to nursing home staff? In what format will the training be
provided in?
Quidel and BD will provide training materials to nursing home staff. Training documentation
will be made widely available for all nursing homes that are receiving supplies. Quidel
training information can be found at quideltogetheragain.com. BD is offering training
services through their Learning Management System (LMS) platform to all BD Veritor
System customers at no additional cost. The eLearning training platform is available online.
6. How were nursing homes prioritized to receive a testing platform and FDA-authorized
antigen diagnostic tests?
The prioritization is based on CDC epidemiological hotspot data, as well as nursing homes
that reported the following information to the CDC by July 5th:
Current CLIA Certificate of Waiver;
Three or more confirmed or suspected new cases of COVID-19 in the last 7 days;
At least one new COVID-19 case in the last 7 days after having zero previous COVID-19
cases;
Inadequate access to testing in the last 7 days;
At least one new resident death due to COVID-19 in the last 7 days;
At least one new confirmed or suspected COVID-19 case among staff in the last 7 days.
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7. Will HHS be providing more tests after the initial shipment?
No. After the initial shipment of instruments and tests, nursing homes will be responsible for
procuring their own tests directly from the manufacturer or medical device distributor.
8. What safety precautions are required when performing these tests?
CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens
Associated with Coronavirus Disease 2019 are outlined below. States may have more
stringent requirements, so you may need to consult with your State Agency (SA Contacts) for
further guidance.
For providers collecting specimens or within 6 feet of patients suspected to be
infected with SARS-CoV-2, maintain proper infection control
and use recommended
personal protective equipment (PPE), which includes an N95 or higher-level
respirator (or facemask if a respirator is not available), eye protection, gloves, and a
gown, when collecting specimens.
Use the instrument in a location associated with a current CLIA certificate.
Perform a site-specific and activity-specific risk assessment to identify and mitigate
safety risks.
Train staff on the proper use of the instrument and ways to minimize the risk of
exposures.
Follow manufacturer recommended procedures for decontamination after
use.
Follow Standard Precautions when handling clinical specimens, including hand
hygiene and the use of PPE, such as laboratory coats or gowns, gloves, and eye
protection. If needed, additional precautions can be used, such as a surgical mask or
face shield, or other physical barriers, such as a splash shield to work behind.
When using patient swabs, minimize contamination of the swab stick and wrapper by
widely opening the wrapper prior to placing the swab back into the wrapper.
Change gloves after adding patient specimens to the instrument.
Decontaminate the instrument after each run by using an EPA-approved disinfectant
for SARS-CoV-2. Following the manufacturer’s recommendations for use, such as
dilution, contact time, and safe handling.
9. Will every nursing home receive a point-of-care instrument and associated tests?
CMS has prioritized > 3,900 nursing homes to receive instruments and tests in the coming
weeks. Once those shipments are complete, HHS will continue a phased distribution of
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antigen testing supplies to nursing homes with a current CLIA Certificate of Waiver and
based on updated epidemiological data.
10. Which nursing homes will receive instruments and tests in the first wave of shipments?
The list of nursing homes receiving instruments and tests in the first wave is available on the
CMS COVID NHSN data page
. This list will be updated as the phased distribution
progresses.
11. When will my nursing home receive the shipment of testing platforms and FDA-
authorized antigen diagnostic tests?
Instruments and tests will be shipped on a weekly basis directly to CMS-prioritized nursing
homes. Instruments and tests will begin shipping the week of July 20 and shipments will
continue over the course of 14 weeks. Each nursing home will receive one shipment that
includes supplies to facilitate baseline testing among nursing home residents and staff, and
enable a pathway to conduct ongoing testing according to public health guidelines.
12. How will states be made aware that nursing homes within their states will receive
instruments and supplies?
Facilities will be made aware of shipments directly from the manufacturers. States can refer
to the CMS COVID NHSN data page
to see which nursing homes in your state is receiving
supplies.
13. What are antigen tests? Is it required to retest negative results with a PCR test?
Antigen diagnostic tests quickly detect fragments of proteins found on or within the virus by
testing samples collected from the nasal cavity using swabs.
Negative results should generally be treated as presumptive, do not rule out SARS-CoV-2
infection and should not be used as the sole basis for treatment or patient management
decisions, including infection control decisions. If necessary, confirmation with a molecular
assay for patient management may be performed. Negative results should be considered in
the context of a patient’s recent exposures, history and the presence of clinical signs and
symptoms consistent with COVID-19, and should not be used as the sole basis for treatment
or patient management decisions, including infection control decisions.
14. How many tests can be conducted with the Quidel Sofia 2 Instrument and the BD
Veritor™ Plus System testing platforms?
Each test takes about 20 minutes to perform from start to finish. However, it is possible to
run tests in an assembly line fashion to test 20 – 30 samples per hour. To use this strategy, the
start time for each test is staggered by a few minutes. Next, at the end of the test incubation
period, each test is read one by one every few minutes. Instructions for using batch mode are
included with the Instructions for Use and vendor training.
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15. Why is the federal government sending antigen testing supplies to nursing homes if they
cannot be used to rule out SARS-CoV-2 infection and should not be used as the sole
basis for treatment?
Fighting this global pandemic requires an array of different technologies, including antigen
testing. In areas of high prevalence or for patients with known risk factors, positive results
from an antigen test can be considered confirmatory and used for diagnostic purposes. In
areas of high prevalence, confirming negative results using an alternate form of testing is
recommended. In low-prevalence areas where the patient is asymptomatic, results should be
considered in the context of a patient’s recent exposures, history and the presence of clinical
signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if
necessary, for patient management.
16. Are nursing homes required to report results of any COVID-19 tests?
Yes. All laboratories must have a CLIA Certificate and report the results of the COVID-19
tests that they conduct to the appropriate federal, state, or local public health agencies.
Laboratories must report data for all testing completed, for each individual tested. This data
must be reported within 24 hours of test completion, on a daily basis, to the appropriate state
or local public health department, based on the individual’s residence. Testing sites must
report all diagnostic test data in accordance with the
HHS Lab Data Reporting Guidance for
COVID-19 issued June 4, 2020 and meet these reporting requirements by August 1,
including providing your facility name and CLIA number when reporting results. Please visit
the
CDC website for more information about data reporting requirements.
17. Can nursing homes keep the testing platforms?
Yes. Upon receipt, the instrument(s) become the property of the nursing home and can be
used in accordance with the conditions of authorization for the test.
18. How should facilities handle indeterminate results?
Quidel Sofia 2: If the test does not flow correctly, Sofia or Sofia 2 will indicate that the result
is invalid. Should this occur, review the procedure and repeat the test with a new patient
sample and a new Test Cassette.
BD Vertior: The test results could be ‘positive’, ‘negative’, or ‘invalid’. If the test is invalid,
the BD Veritor System Instrument will display “CONTROL INVALID” and the test (or
control) must then be repeated. Do not report results. Repeat the test.
19. Do facilities need a provider order to conduct the test?
These are prescription use tests under the Emergency Use Authorization and must be ordered
by a healthcare professional licensed under the applicable state law or a pharmacist under
HHS guidance.
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20. How should the materials be stored when they arrive?
For BD, kits may be stored at 2 to 30°C. Reagents and instruments must be at room
temperature (15 to 30 °C) when used for testing. DO NOT FREEZE.
For Quidel, kits may be stored at room temperature, 59°F to 86°F (15°C to 30°C), out of
direct sunlight. Kit contents are stable until the expiration date printed on the outer box. DO
NOT FREEZE.
21. Does a Skilled Nursing Facility/ Nursing Facilities need a CLIA (Clinical Laboratory
Improvement Amendments of 1988) Certificate of Waiver in order to perform testing of
specimens for COVID-19?
A Skilled Nursing Facility/ Nursing Facility needs a CLIA certificate, which can be a
Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation, to perform
COVID-19 testing of specimens authorized by the FDA to be used in Point of Care settings
(i.e., in patient care settings operating under a CLIA Certificate of Waiver) or Waived
settings. Under CLIA, facilities are prohibited from testing human specimens for the purpose
of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. To
become CLIA-certified, facilities must comply with the accuracy, quality, and reliability
requirements as provided by the statute (CLIA Statute
). The purpose of these requirements is
to ensure that the test results that patients or their health care providers receive are accurate
and reliable. Laboratories that wish to become CLIA certified must apply for a CLIA
certificate.
If you would like to apply for a CLIA Certificate of Waiver, please refer to the brochure,
How to Apply for CLIA Certificate of Waiver and submit your application form (CMS Form
116) to the state (CLIA State Agency Contacts) where the laboratory is located. If you would
like to apply for a CLIA certificate that will allow you to perform more complex tests, please
refer to the brochure,
How to obtain a CLIA Certificate.
22. I understand that HHS will be distributing tests and test systems to Skilled Nursing
Facilities/ Nursing Facilities. What type of CLIA certificate would my facility need in
order to perform this testing?
HHS will be distributing tests that are authorized for use at the Point of Care (POC) or
inpatient care settings operating under a CLIA Certificate of Waiver. Your facility would be
required to have a CLIA Certificate of Waiver.
23. How do I apply for a CLIA Certificate of Waiver so that my Skilled Nursing Facility/
Nursing Facility can perform COVID-19 testing?
While the CLIA program is a Federal program, it contracts with State Agencies (
CLIA State
Agency Contacts) to carry out certain oversight and recording functions of the CLIA
program. The State Agency in the state where the laboratory (meaning, any facility that is
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CLIA-certified such as a nursing home that performs point of care or waived testing) is
located can answer your questions and will process your application. You may need to
consult with your State Agency (CLIA State Agency Contacts
) for further guidance regarding
any state requirements.
If you would like to apply for a CLIA Certificate of Waiver, please refer to the brochure,
How to Apply for CLIA Certificate of Waiver and submit your application form (CMS Form
116) to the CLIA State Agency (CLIA State Agency Contacts) where the laboratory is
located. The cost of a Certificate of Waiver is $180.00 and the facility will be CLIA certified
for a period of 2 years. We want to ensure that facilities located in the United States applying
for a CLIA certificate are able to begin testing for COVID-19 as quickly as possible (in most
cases, 48–72 hours). Once the laboratory has identified a qualified laboratory director and has
provided all required information on the CMS-116 application, a CLIA number will be
assigned. Once the CLIA number has been assigned, the laboratory can begin testing as long
as applicable CLIA requirements have been met. Laboratories that perform waived testing
must follow manufacturer’s instructions.
24. If my Skilled Nursing Facility/ Nursing Facility already holds a CLIA Certificate of
Waiver, can we begin performing COVID-19 testing?
Yes. If your facility already holds a CLIA Certificate of Waiver it can begin performing
COVID-19 testing that has been authorized by the FDA for use in Point of Care settings (i.e.,
in patient care settings operating under a CLIA Certificate of Waiver) or Certificate of
Waiver settings. You may need to consult with your State Agency (
CLIA State Agency
Contacts) for further guidance regarding any state requirements.
25. If my Skilled Nursing Facility/ Nursing Facility already holds a CLIA Certificate of
Waiver, am I required to update my test menu with CMS?
Facilities holding a CLIA Certificate of Waiver are generally not required to update their test
menus with CMS. However, States may have more stringent requirements so you may need
to consult with your State Agency (CLIA State Agency Contacts
) for further guidance.
26. How does my Skilled Nursing Facility/ Nursing Facility obtain the instrument, test kits
and disposables?
HHS will be distributing testing instruments and all of the disposables for performing the
test. The CMS CLIA program regulates facilities that perform testing on patient specimens
to ensure accurate, reliable and timely results. Questions related to obtaining the instruments,
test kits and all of the disposables for performing the test, payment issues for SNF/NF testing,
or any other SNF/NF questions are outside the scope of the CLIA program and should be
referred to the following mailbox: DNH_Triag[email protected]ov
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27. My Skilled Nursing Facility/ Nursing Facility is located in a CLIA Exempt State
(Washington or New York). Will we be able to get one of the new test systems?
Yes. Although Washington State’s Medical Test Site program and New York State’s
Clinical Laboratory Evaluation Program are exempt from CLIA, they do authorize a SNF
/NF to have a certificates that are equivalent to CLIA certificates, including the CLIA
Certificate of Waiver. Nursing homes in Washington State are issued a CLIA Certificate of
Waiver in addition to a Washington State License and those in New York State are issued a
Limited Service Laboratory Registration. Nursing homes in these states will also be included
in the HHS distribution program.
For those SNFs/NFs located in New York State, please refer to the following link:
https://protect2.fireeye.com/url?k=5dee6edc-01ba77a0-5dee5fe3-0cc47adc5fa2-
d45645ac8b1d5c6a&u=https://www.wadsworth.org/regulatory/clep/limited-service-lab-certs
For those SNFs/NFs located in Washington State, please refer to the following link:
https://www.doh.wa.gov/LicensesPermitsandCertificates/FacilitiesNewReneworUpdate/Labo
ratoryQualityAssurance
