Irvine’s plan to provide free coronavirus testing to its residents was abruptly cancelled in a unanimous vote by the City Council Tuesday night after contract negotiations fell through.
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At its last meeting on May 12, the body authorized staff to create a contract establishing a drive-thru testing program for residents to get free testing to see if they have coronavirus and offered optional antibody testing at a cost of $10 to each resident.
The drive-thru was projected to cost the city over $90,000, according to a city staff report.
The city’s chosen testing contractor was US Health Fairs, a nonprofit health group established in February. Before COVID-19, the group’s website listed that its focus was screening for genetic links to cancer and Alzheimer’s.
The antibody, also known as serology, tests are different from the tests hospitals use to diagnose active infections, which are known as molecular or PCR tests. Antibody tests look for any sign of the antibodies that form in response to the virus, and can show if someone was exposed to the virus in the past.
The PCR tests have been given emergency use authorization by the Food and Drug Administration, but the antibody tests do not have that approval.
The day after the city approved the antibody testing, Mayor Christina Shea called for a revote on the item.
“I believed both had the (emergency use authorization) approval but I was told just now only (PCR) tests have this temporary approval,” Shea said in a text to Voice of OC on May 14.
Shea said she learned the tests were not FDA approved in a Voice of OC article published May 14.
Dr. Camellia Babaie, a board member at US Health Fairs, noted multiple times at the May 12 council meeting that there are no antibody tests approved by the FDA that could be administered via a drive thru format.
In a statement to Voice of OC last week, Babaie said the antibody tests are allowed to be distributed under the FDA’s guidelines and that they are waiting on their emergency use authorization.
“The antibody tests we are using meet all criteria for legally using them according to the FDA,” Babaie said.
But after city staff sat down to confirm the specifics on the contract and completed their “due diligence,” negotiations with the group fell apart, according to Police Chief Mike Hamel.
“Ultimately, we were unable to agree upon terms,” Hamel said. “We had questions about who was going to be collecting specimens from the residents, and we had questions over how many days it would take to receive results…we also had significant concern over the handling of test specimens.”
“Staff at this time is not recommending we sign a contract with US Health Fairs.”
Hamel also said the antibody testing that US Health Fairs was offering could no longer be given under newly approved FDA guidelines.
In a phone call Tuesday night with Voice of OC, Babaie said the new guidelines on antibody testing were a result of the changing situation in the pandemic response.
“(The FDA was) more flexible at the beginning, but they said they’re able now to tighten up the regulation,” Babaie said. “So, those antibody tests have to be performed by moderate to high complexity labs. While it can be remote, it still has to be performed there, and that’s not what we do.”
Councilwoman Melissa Fox said the collapse of the contract came after multiple misrepresentations by US Health Fairs, including the actual cost of the proposed antibody tests.
“It was as if the deal was changing all the time and we weren’t able to rely on them,” Fox said.
At its May 12 meeting, the City Council was told in the city staff’s presentation that the tests would be administered by trained nurses. According to Fox, US Health Fairs later revised that statement, and said they would be administered by medical aides without nursing licenses.
In the phone call after the meeting, Babaie said the tests would be administered by medical assistants because nurses were overqualified to just be conducting swabbing tests.
She said she did not understand the council wanted registered nurses at the meeting, and that she thought they were using it as a general term.
Fox, Hamel and Shea also mentioned concerns that US Health Fairs was not keeping an “appropriate chain of custody” with testing samples, leading to concerns that the samples may be contaminated.
“I said we can’t move forward. We have to work with an agency that provides a top level of security and service for this testing,” Shea said in a phone call with Voice of OC. “What we heard two weeks ago was not what we found out moving through the contractual situation.”
Orange County health leaders previously brought up concerns that the antibody tests weren’t necessary, stating the tests largely serve an academic purpose and antibody tests on such a small scale wouldn’t help that effort.
US Health Fairs also posted on its website that it is behind on thousands of calls to inform residents what their test results are, and another post stated the group had a server malfunction which erased patient data.
According to US Health Fairs spokesperson BC Solomon, the notifications on the server difficulties and delayed phone calls were posted in late April and has since been fixed after the company transitioned to a new server.
“That is old information and old news, and it was due to the overwhelming demand in Carson and we’ve updated to an expanded cloud system,” Solomon said.
Both notices were still live on US Health Fairs’ website as of Tuesday night.
Solomon did not respond to requests for comment after the City Council cancelled the contract negotiations.
Currently, the company is operating two sites in Pico Rivera and Carson. Irvine would have been the first city where US Health Fairs administered the antibody tests, and, according to the US Census Bureau, the city of Irvine has over three times as many residents as the other cities the group is working in currently.
According to Fox, both those cities also reported struggles with US Health Fairs response time to patients, with test results often taking a week or longer to reach patients.
All council members expressed their disappointment over the testing contract’s cancellation, but praised city staff’s response to the issue.
“This is disappointing, but it’s good you did your due diligence,” Shea said after the contract was rejected by the council on the second vote. “I know we approved it; I misunderstood their representation.”
After the council requested the tests, city staff only took around two weeks to bring US Health Fairs to the attention of the council, according to Fox.
During the meeting, Fox also said that part of why the city moved so quickly to try and establish the testing was because it felt that the county had failed to establish appropriate testing centers.
“We were trying to take the ball and do our own thing because we haven’t had any other options. So I understand the problem of having to get this done in such a short time but we don’t want to be providing services that are not up to the standards necessary,” Fox said.
The council directed city staff to continue looking for another potential supplier, with no date sent for any staff update on the issue.
Correction: An earlier version of this story said that Irvine’s testing would be administered via self swabbing. US Health Fairs sites in Pico Rivera and Carson are self swabbing, but the company had planned to role out medical aides to swab in Irvine.
Noah Biesiada is a Voice of OC Reporting Fellow. Contact him at nbiesiada@voiceofoc.org or on Twitter @NBiesiada.