A Boston lab suspended coronavirus testing after an investigation uncovered nearly 400 false positive COVID-19 results.
Orig3n, a biotechnology company that has dozens of nursing homes as its clients, ceased testing on August 8 at the request of the Massachusetts Department of Public Health. The suspension came days after state health officials learned of an unusually large number of positive tests for the coronavirus.
An investigation found that there were at least 383 inaccurate positive results from the lab that, after a new test, came back negative.
On August 27, MDPH said it notified Orig3n that “three significant certification deficiencies that put patients at immediate risk of harm”
“The Boston lab is required to respond with a written correction plan, and if no action is taken it may be subject to penalties,” a health department spokesman said Wednesday in a statement to NBC News.
The health department said about 60 nursing homes are still or have been Orig3n customers.
One of the nursing homes that received 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 Wednesday in a statement that on Aug.3 Pines Edge was informed that 18 employees and one resident had tested positive for the virus.
Unaware that the tests were inaccurate, the facility moved the resident into solitary confinement and employees were sent home on paid sick leave.
“We informed our community of residents, family members and employees of the situation, which understandably caused considerable 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 family members of both.”
On August 10, following two rounds of reviews that returned negative results, the facility was cleared to move the resident out of isolation and employees were able to return to work.
Cindy Dietor, whose 99-year-old cousin lives downtown, told NBC Boston she was shocked by the mix. “I think the test was unfortunate,” he said. “I think when you are in contact with a nursing home you have to do everything right.”
In addition to working with Massachusetts nursing homes, the facility has 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 Massachusetts Department of Health supplier, an arrest warrant was issued for the contract with Orig3n and all labs collected in the last week of events were processed by NC instead. DHHS, “the spokesman said.
The Massachusetts Department of Health said its investigation found Orig3n failed to provide management and direction, lacked proper testing materials, and failed to document daily sanitation practices.
Orig3n, which was allowed to begin COVID-19 testing in April, has until September 14 to provide a written correction plan, the health department said.
The lab did not immediately return a request for comment on Wednesday, but told NBC Boston, “We understand the critical importance of speed and accuracy of COVID-19 tests and are committed to providing accurate and timely results for our customers.”
Orig3n’s scale of erroneous tests remains unclear, according to The Boston Globe, as state health officials haven’t reviewed every sample the facility’s processed. The chief executive officer of the lab, Robin Smith, told the outlet that Orig3n has processed “tens of thousands” of coronavirus tests over the past 90 days for customers across the country.