The state suspended use of the California lab, NovaDX, on Wednesday, a day after The News informed Texas officials of a federal inspection report from July. The report questioned the qualifications of lab workers and found practices that could allow contamination of samples.
NovaDX has processed roughly 80,000 COVID-19 tests for Texans, a total that includes samples from two state-run test sites in southern Dallas, officials said.
The federal agency that oversees clinical labs, the Centers for Medicare & Medicaid Services, is determining whether NovaDX has fully addressed problems that inspectors found. In a statement, lab CEO Blake Anderson said his company takes seriously its commitment to lab safety and accurate testing.
This marks the second time the state has halted its use of NovaDX.
The first, in June, came after some nursing homes reported receiving false positive results for residents. The state looked into the matter and determined it was an isolated issue that had been fixed.
Around the same time, a federal inspection of NovaDX found more sweeping problems. Experts said the issues raise questions about whether to use the lab.
“The very long list of deficiencies certainly is incredibly worrisome,” said Dr. Geoffrey Baird, interim chair of the department of laboratory medicine and pathology at the University of Washington School of Medicine.
The problems point to lapses in how Texas oversees companies that are trusted -- and paid millions of dollars -- to carry out work essential to stemming the spread of the deadly virus.
The state said it triggered the federal investigation, but never received an update. The federal agency said it told Texas about the findings on Tuesday -- almost two months after demanding the lab make immediate fixes -- and will continue to update the state as the inquiry progresses.
Anderson did not answer questions about the inspection findings by CMS, as the federal agency is known.
“Nova Labs is committed to operating in accordance with federal and state regulations,” Anderson said in a written statement. “We have worked with and will continue to work closely with CMS, as needed, to resolve any concerns.” He noted the lab is still allowed to test for COVID-19.
NovaDX, also known as Nova Labs, works with at least two other states: Michigan and Missouri.
Ohio paused testing with NovaDX last month to investigate “inconsistencies” in results delivered to some assisted living facilities, the Cincinnati Enquirer reported.
Federal findings
Federal regulators inspected NovaDX over three days in June, after the lab had already run nearly 16,000 COVID-19 tests.
In late July, regulators disclosed their findings in an 82-page inspection report and letter to NovaDX that demanded immediate fixes. The lab’s deficient practices, the letter said, could result in serious harm or death.
Among the deficiencies cited by inspectors: The lab didn’t follow procedures to prevent contamination of patient samples, such as keeping patient specimens covered and ensuring workers wore fresh lab coats.
Inspectors also found that some patient samples had been tested four days after collection, instead of the maximum three days. And the lab didn’t have a freezer to store samples at the required temperature of -70 degrees Celsius.
The lab used two types of COVID-19 tests that required different equipment settings, but workers used the same one.
Also, the lab failed to ensure that employees who tested patient samples had the required education and training for the job, according to the report.
NovaDX submitted records to CMS detailing the steps to correct the problems. But in late August, CMS told NovaDX it had not addressed all the issues found by inspectors and gave it another chance to do so.
NovaDX submitted a new response last week that is under review, a CMS official said Wednesday.
The News asked for a copy of the company’s NovaDX’s responses to regulators but CMS declined, saying they cannot be released yet.
The Texas Division of Emergency Management, which manages COVID-19 test sites across the state, suspended use of NovaDX pending the federal inquiry, spokesman Seth Christensen said.
NovaDX has not been required to notify patients or others of the inspection findings, CMS said. The federal agency has not imposed sanctions against the company but still could. They include fining the company up to $10,000 per day and limiting or revoking the lab’s certificate.
Texas work
Texas’s own inquiry into NovaDX last spring was more limited.
The state began using the company in May to help process a flood of COVID-19 tests taken at nursing homes. Within weeks, Texas suspended the lab’s work due to an abnormal number of residents who tested positive but had no symptoms.
Experts say false positives can be especially dangerous in nursing homes, where infectious patients are often grouped together in dedicated COVID-19 wards. For a healthy resident who’s mistakenly thought to have the virus, moving into the ward could be a death sentence.
The state reviewed a report by NovaDX and agreed with the lab’s findings that linked the problem to a specific tube used to ship patient samples, said Chris Van Deusen, a spokesman for the Texas Department of State Health Services, which reviewed the report.
The state also provided NovaDX a batch of unused tubes which, when tested by the lab, produced some positive COVID-19 results, he said. When the state’s own lab ran the same experiment, none came back positive, Van Deusen said.
He said the state agency does not regulate labs and did not do an on-site inspection at the lab, which is located in Templeton, Calif.
The News requested a copy of NovaDX’s report but has not yet received it.
After a 9-day suspension, the state resumed sending samples to NovaDX for testing. The agency has heard of no other problems with NovaDX test results, Van Deusen said.
For the state of Texas, NovaDX is doing work under a company called Honu Management Group, including two in Dallas. The sites are at Mountain View College and Paul Quinn College, state officials confirmed.
Honu also managed another COVID-19 test site in Dallas County that was sponsored by local officials and did not use NovaDX to process those results.
Last month The News reported on potential red flags in Honu’s proposal to the city, including a reference who vouched for Honu but did not tell city officials he was a part owner of NovaDX.
The city is conducting an audit of how the Honu contract was awarded, and it has since paused its work with the company.
Honu did not respond to questions from The News for this story.
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