A Boston lab suspended coronavirus testing after an investigation uncovered nearly 400 false positive COVID-19 results.
Orig3n, a biotechnology company which counts dozens of nursing homes as its clients, ceased testing on Aug. 8 at the request of the Massachusetts Department of Public Health. The suspension came days after state health officials became aware of an unusually high number of positive coronavirus tests.
An investigation found that there were at least 383 inaccurate positive results from the lab that, upon re-testing, came back as negative.
On Aug. 27, the MDPH said it notified Orig3n they had been cited with "three significant certification deficiencies that put patients at immediate risk of harm."
"The Boston lab is required to respond with a written plan of correction, and if action is not taken it can face sanctions," a health department spokesperson said in a statement to NBC News on Wednesday.
The health department said roughly 60 nursing homes either still are or have been clients of Orig3n.
One of the nursing homes that did receive false positive results was the Pines Edge nursing center at the North Hill Retirement Community in Needham, Massachusetts. Ted Owens, president and CEO of North Hill, told NBC News in a statement Wednesday that on Aug. 3 Pines Edge was notified that 18 employees and one resident had tested positive for the virus.
Unaware that the tests were inaccurate, the facility moved the resident into isolation and the employees were sent home with paid sick leave.
"We notified our community of residents, family members and employees about the situation, which understandably caused significant concern. The costs to the facility were also significant," Owens said in his statement. "The false positive results created tremendous fear and anxiety among employees, residents and the family members of both."
On Aug. 10, following two rounds of re-testing that returned negative results, the facility was allowed to move the resident out of isolation and the employees could return to work.
Cindy Dietor, whose 99-year-old cousin lives at the center, told NBC Boston that she was shocked about the mix-up. "I think the testing has been wretched," she said. "I think when you're connected with a nursing home you have to do everything right."
In addition to working with Massachusetts nursing homes, the facility also partnered with the North Carolina Department of Health and Human Services. In a statement on Wednesday, the department said it will sever ties with Orig3n following news of the false positives.
"After NC DHHS became aware of concerns about the vendor from the Massachusetts Department of Health, a stop order was issued for the contract with Orig3n and all labs collected in the final week of events were instead processed by NC DHHS," the spokesperson said.
The Massachusetts health department said its investigation found that Orig3n failed to provide management and direction, lacked proper testing materials, and did not document daily sanitization practices.
Orig3n, which was allowed to begin COVID-19 testing in April, has until Sept. 14 to provide a written plan of correction, the health department said.
The laboratory did not immediately return a request for comment on Wednesday, but told NBC Boston, "We understand the critical importance of speed and precision of COVID-19 testing, and we're committed to providing accurate, timely results for our clients."
The scale of Orig3n's erroneous testing remains unclear, according to The Boston Globe, since state health officials did not re-test every sample the facility processed. The lab's chief executive, Robin Smith, told the outlet that Orig3n processed "tens of thousands" of coronavirus tests over the past 90 days for clients across the country.