Morristown, NJ

No, You Can’t Run a COVID-19 Testing Center Out of Your Home

Morristown Minute

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Morristown Minute

Many Morristown residents have, in an attempt to help their communities, begun running COVID testing centers out of their homes. Unfortunately, they’re likely doing so illegitimately.

Have you encountered a neighbor or friend offering COVID-19 tests to your community out of their home?

The kindness of our neighbors is seemingly unlimited. Many Morristown residents have begun to offer COVID-19 tests at no cost to neighbors right out of their homes.

Unfortunately, these kind souls are likely doing so illegitimately.

The CDC requires that all COVID-19 testing facilities submit a CMS-116 application for a Clinical Laboratory Improvement Amendment (CLIA) Certificate of Waiver (CoW) to perform SARS-CoV-2 testing authorized by the FDA.

Due to the severity of the pandemic, the CDC allows those who have submitted a CLIA CoW to begin testing prior to the approval of the application. However, your home will likely not qualify under the CDCs rules and regulations.

This means many performing tests for their neighbors out of their homes are doing so without permission. Continually, any results received from these unauthorized testing centers will not meet requirements for air travel or federal regulations.

Laboratories that test for COVID-19 are required to report results to state and local public health authorities in accordance with applicable state or local laws. COVID testing centers must also report results to the Department of Health and Human Services during the pandemic. When the FDA issues Emergency Use Authorization for a COVID-19 test, laboratories must have a process in place to report test results to healthcare providers and relevant public health authorities.

To apply for a CLIA certificate, the testing center must have a qualified and certified laboratory director. To qualify as a laboratory director the director must hold a doctoral degree in a chemical, physical, biological, or clinical laboratory science from an accredited institution and be certified by a board-approved by the Department of Health and Human Services.

Certified boards include:

1. ABB – American Board of Bioanalysis

2. ABB public health microbiology certification

3. ABCC – American Board of Clinical Chemistry

4. ABFT – American Board of Forensic Toxicology (limited to individuals with a doctoral degree with Fellow status) *

5. ABMGG – American Board of Medical Genetics and Genomics (formerly known as American Board of Medical Genetics (ABMG))

6. ABMLI – American Board of Medical Laboratory Immunology

7. ABMM – American Board of Medical Microbiology

8. ACHI -American College of Histocompatibility and Immunogenetics (formerly known as American Board of Histocompatibility and Immunogenetics (ABHI))

9. NRCC – National Registry of Certified Chemists (limited to individuals with a doctoral degree) *

* These boards certify non-doctoral individuals also.

The gist:

You cannot run a COVID testing center out of your home unless your home meets all the requirements put in place by the CDC. You must also be qualified and certified as a laboratory director, meaning you hold a doctoral degree in an approved subject and are certified by an approved HHS board.

If you receive a COVID-19 test from a neighbor running a testing center out of their home, it will likely not hold up to the COVID-19 testing requirements needed for travel.

You and your neighbors can distribute free, approved, at-home COVID-19 tests to fellow residents. However, you are not legally allowed to test your neighbors yourself if you have not met the above requirements.

Your best option is to seek a certified testing center in your area.

For Morristown residents your COVID testing center options are as follows:

Passport Health, 290 Madison Ave., Morristown, NJ 07960 – Building 3B. P: 732-345-0029 (Open T, Th, F 9 AM-4:30 PM)

- Antigen/Active COVID Testing (nasal and saliva test)

- Antibody testing

- No Rapid tests

- Call to make an appointment. Will only take patients for travel or work-related reason. Out of pocket charges may apply.

- Website: Passport Health USA

Zufall Health Center, 4 Atno Ave. Morristown, NJ 07960 P: 973-267-0002 (open 8 AM-7 PM)

- Antigen/Active Testing (results in 1-2 days)

- No Antibody tests

- No Rapid tests

- Will charge insurance directly. If uninsured/underinsured, the federal CARES Act will cover the fee.

- Appointments required. Make an appointment at the Morristown Zufall website

CVS Pharmacy, 117 Speedwell Avenue, Morristown, NJ 07960 P: 973-5391909 (open 8 AM-8 PM)

- Antigen rapid-result testing (results within hours)

- PCR/NAAT lab test (results 1-2 days) *accepted test for most travel

- Rapid-result PCR (results within hours) *accepted for most travel

- Make an appointment

Morristown Medical Center – Gagnon West End Testing Center, 100 Madison Avenue, Morristown, NJ 07960 P: 973-829-7940 (open 9 AM-3 PM)

- PCR testing

- Appointment required, no walk-in testing

- Call 973-829-7940 or chat online to book an appointment, or contact your doctor for a COVID test prescription

Quest Diagnostics, 95 Madison Avenue, 4tgh floor, Morristown, NJ 07960 P: 973-993-0933

- Non-rapid test results (1-3 days)

- COVID and Flu nasal swab testing

- Antibody testing

- Appointment required, schedule here

- At-home test kits are available

FastER Urgent Care, 130 Speedwell Avenue, Morris Plains, NJ 07950 P: 862-242-8053 (open 8 AM-8 PM)

- Non-rapid testing results (2-3 days)

- Antibody testing

- “Please arrive before 6 PM M-F for COVID testing and before 2 PM on weekends. If not symptomatic please come in but if showing signs of COVID please ring the doorbell for further instructions. The test is not free please contact your insurance before arrival if applicable.”

- Phone verified, call to schedule an appointment

More Morris County Testing Locations

To order a free, at-home COVID-19 test:

Order your free, at-home testing kit (no cost to you) from vault health, offered to all NJ residents free of cost.

Avoid the headache of receiving an invalid COVID-19 test and go directly to an approved and certified source.

Thank your neighbors for thinking of their community but remind them that there are requirements put in place by the CDC to standardize testing and prevent invalid results.

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Sources:

For COVID-19 information call the CDC at (800)232-4643

CDC.gov: https://www.cdc.gov/

Frequently asked questions: https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html#:~:text=The%20federal%20CLIA%20program%20contracts,CMS%20Coronavirus%20Informationexternal%20icon.

SARS-CoV-2 Point of Care Testing and CLIA Certificate of Waiver Applications: https://www.cms.gov/files/document/covid-sars-cov-2-point-care-testing-and-clia-certificate-wavier-applications.pdf

COVID-19 Related Test Data and Reporting: FAQs on Testing for SARS-CoV-2: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-related-test-data-and-reporting-faqs-testing-sars-cov-2

Certification Boards for Laboratory Directors of High Complexity Testing: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certification_Boards_Laboratory_Directors

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