A small Valley home healthcare company may have been offering COVID-19 tests to Scottsdale Unified students and families without a license from federal regulators.
In October and November, SUSD General Counsel Michelle Marhsall and Susan Segal, an outside attorney advising the district, told the state Attorney General’s office their concerns about 360Care, a concierge healthcare company based in Gilbert.
Emails obtained by the Progress show the district was concerned about allegations from some parents and staff that 360Care would not report test results to the state or was otherwise providing inaccurate testing.
A spokesperson for the Attorney General stopped short of saying it opened an official investigation but confirmed it was looking into the district’s concerns.
“These are serious allegations and we are doing everything to get to the bottom. Additionally, we’ve sent the matter to the Department of Health Services to make sure officials there are aware,” the spokesperson said.
360Care owner Tara Thompson, a registered physician’s assistant, said the company was reporting all test results to the state but is no longer offering tests.
However, the Progress found 360Care may not have had the required federal authorization to provide tests in the first place.
According to the state Department of Health Services, all facilities providing COVID-19 tests must receive CLIA certification from federal regulators.
CLIA, or Clinical Laboratory Improvement Amendment, certification is overseen by the U.S. Department of Health and Human Services through the Centers for Medicare and Medicaid Services.
A search of the online database of all CLIA-certified laboratories showed no certifications for 360Care or any other business sharing its Gilbert address.
When asked for her CLIA identification number, Thompson said “the tests are CLIA-waived” and said she would provide a waiver number but never did to the Progress.
A CMS spokesperson confirmed it has no CLIA certification on record for the firm.
“‘CLIA-waived’ does not mean waived from CLIA requirements,” the spokesman said. “A laboratory would still need to have CLIA certification for waived testing. Any facility that performs testing on human specimens and provides patient specific test results is required to be CLIA certified.”
This is not the first time 360Care has raised red flags in Scottsdale about its COVID-19 tests.
The company was booking rapid tests through 360rapidCOVIDtesting.com and promising five-minute results. That website is still active, but the scheduling feature has been disabled.
According to the site, the company was offering rapid IgM/IgG antibody tests.
Chaparral High teacher Andrea Danis told the Progress she received a false negative test from 360Care.
Danis said she was referred to 360Care by a family friend who has a child at Chaparral after she had already received a COVID-19 PCR test from Embry Women’s Health, a provider recommended by Scottsdale Unified.
A document on 360Care letterhead shared with the Progress stated “the patient named above was tested for COVID-19 using an FDA EUA approve COVID19 Rapid Test…The result was (negative).”
But days later Danis received the results of her PCR test from Embry Women’s Health showing she had an active COVID-19 infection.
The source of the confusion could be the difference in the type of tests Danis received.
PCR tests are considered highly accurate at detecting active infections, according to the FDA, but can typically take three to five days to return results.
The test administered by 360Care – rapid IgM/IgG – should not be used to diagnose an active infection because it detects SARS-CoV-2 antibodies that are typically present in the blood several days after the initial infection.
Without a proper explanation on what test they received and what it actually tested for, some individuals could have returned to school with an active infection even if they received a negative result on the antibody test like Danis.
“A negative test means that you have no COVID-19 antibodies, so you probably were not infected with the COVID-19 virus in the past,” according to the Mayo Clinic. “Because it takes time for antibodies to develop, false-negative test results can happen if the blood sample is collected too soon after your infection started. In some cases, the test may be flawed.”
Danis said Mackenzie Eastman, the medical assistant who administered her test, never explained the details of the test or the possibility of a false negative.
“Thank God I had a swab test from a reliable source,” Danis said.
Danis said Eastman provided her results in three minutes, which could have also led to inaccurate results.
A photo of Danis’ test strip shared with the Progress resembles the strips produced by China-based Assure Tech.
According to FDA literature on the Assure test, “Reading test results earlier than 15 minutes after the addition of Buffer may yield erroneous results. Do not interpret the results after 30 minutes,” according to the literature.
Danis also alleged other unprofessional behavior by Eastman.
“I was told many Chaparral families used her and didn’t think she was a quack until she pricked my finger without gloves and told me her test was 96 percent accurate,” Danis said.
Thompson confirmed Eastman worked with 360Care but said they did inform patients about the limitations of the rapid antibody tests.
SUSD Nancy Norman told the Progress seven families and one staff member contacted the district about 360Care.
Additionally, reporter Joe Ducey with ABC 15 posed as a patient and was told by Eastman that the rapid IgM/IgG antibody test would test for an active COVID infection,
Eastman also wrongly told the ABC 15 reporter she was a physician’s assistant and other individuals claim she told them she was a nurse.
According to her Facebook page, Eastman has a degree from Arizona College, which offers a 30-month medical assistant degree program.
The state Board of Nursing sent Eastman a cease-and-desist letter on Dec. 1 due to allegations that she misrepresented herself as a nurse.
“Based upon a review of nurse licensing databases, you do not have an Arizona nursing license, nor a privilege to practice nursing in Arizona,” according to the letter. “This conduct, if accurate, places both the patient and the larger public at significant risk for both infection related to the testing, and spread of COVID-19, a potentially fatal disease.”
Eastman did not respond to a request for comment through her Facebook page.