A Boston-based coronavirus testing lab that counts dozens of nursing homes among its clients has been suspended by the state after it returned nearly 400 false positive tests, state officials say.
The Massachusetts Department of Public Health opened an investigation in early August after it became aware of an unusually high positive rate of COVID-19 tests reported by Orig3n Laboratory, the agency said in a statement Tuesday.
Retests found at least 383 false positives that were actually negative.
The state late last month notified Orig3n of "three significant certification deficiencies that put patients at immediate risk of harm," including failure of the lab's director to provide overall management and a failure to document the daily sanitizing of equipment used for coronavirus testing.
The state issued the genetics lab a statement of deficiency last Friday, and the lab must now respond with a written plan of correction by Sept. 14, according to the department. If no action is taken, the state can impose sanctions.
Orig3n CEO Robin Smith said in a statement that false positives were detected Aug. 1 and suspended testing at the Boston lab a week later, retesting samples internally and at an outside lab.
"We then put a plan in place to prevent future incidents. We’re currently working with the state of MA to finalize steps that will enable us to resume testing in our Boston lab," Smith said.
About 60 nursing homes have been clients of the lab, state authorities said.
"These were out of proportion. And didn’t make any sense at all,” said Cindy Dietor, whose 99-year-old cousin lives in the nursing home at North Hill in Needham.
Dietor says she wishes there was more oversight with the lab.
"It’s shocking," she said. "I think the testing has been wretched. I think when you’re connected with a nursing home you have to do everything right.”
Needham resident Peter Metz says, "It obviously shook people up for a while.”
Metz, who lives in the apartments at North Hill, adds, "our management was suspicious of the results right away.”
Orig3n, a home genetics company, which is FDA approved to do COVID testing around the country, says, “We understand the critical importance of speed and precision in COVID-19 testing, and we’re committed to providing accurate, timely results for our clients.”
But for Dietor, the false positives meant families couldn’t visit loved ones at the nursing home for weeks, and that's time that they won’t get back.
“For a period of two weeks that was taken away and that was on hard on everybody,” she said. "But I must say that here at North Hill at Pines Edge and all over the campus everything has been extremely transparent.”
Gannett New England first reported the story last week.
Public health officials in North Carolina have also ordered Orig3n to stop providing COVID-19 testing on their behalf.
A spokeswoman for the North Carolina Department of Health and Human Services said Orig3n was one of three vendors it hired to provide testing at community events. The Massachusetts Department of Public Health had recently shared concerns about its work, however, prompting North Carolina to issue a stop work order, the spokeswoman said.
Untested samples were sent to a state lab in North Carolina for processing instead, she said.
The Massachusetts Department of Public Health on Tuesday reported 168 newly confirmed coronavirus cases and eight additional fatalities.
There have now been more than 121,000 confirmed cases in the state and 8,900 deaths.