The Boston Institute stopped testing for coronavirus after investigation revealed nearly 400 false-positive COVID-19 results.
Orig3n, a biotech company with dozens of nursing homes as customers, stopped testing on August 8 at the request of the Massachusetts Department of Public Health. The suspension came a few days after state health officials learned of the results of an unusually large number of coronavirus tests.
Research found more than 383 inaccurate positive results in the laboratory, and when tested again, they returned negative.
On August 27, MDPH announced that it had notified Orig3n that it had been cited as “three critical authentication flaws that put patients at immediate risk.”
In a statement with NBC News on Wednesday, a health ministry spokesman told NBC News that “the Boston Institute must respond with a written remedial plan, and if action is not taken, it could face sanctions.”
The Ministry of Health said roughly 60 nursing homes were still customers or customers of Orig3n.
One of the nursing homes that received false-positive results was the Pines Edge nursing home in the North Hill retiree community in Needham, Massachusetts. North Hill president and CEO Ted Owens said in a statement Wednesday that it was reported to Pines Edge on August 3 that 18 employees and one resident had tested positive for the virus.
Not knowing that the tests were not accurate, the facility quarantined residents and staff were sent home with paid sick leave.
In a statement, Owens said, “We of course informed residents, families and staff about the situation that caused serious concern. The cost of the facility was also significant.” “The false positive results have created tremendous fear and anxiety for employees, residents and families alike.”
On August 10, after two retests that returned negative results, the facility was able to remove the occupants from quarantine and the staff were allowed to return to work.
Cindy Dieter, whose 99-year-old cousin lives in the center, said: NBC Boston She was shocked by the confusion. “I think the tests are miserable,” she said. “I think you have to do everything right when you are connected to a nursing home.”
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 would terminate its relationship with Orig3n following the news of false positives.
A spokesman said, “After NC DHHS became aware of the Massachusetts Department of Health’s concerns about its suppliers, it issued an order to suspend its contract with Orig3n and all laboratories collected in the last week of the event were handled by NC DHHS instead.”
The Massachusetts Department of Health investigation revealed that Orig3n failed to provide care and guidance, lacked adequate testing data, and did not document daily hygiene practices.
Orig3n is COVID-19 testing can start in April, A written correction plan must be provided by September 14, the Ministry of Health said.
The lab did not immediately ask for comments on Wednesday, but told NBC Boston, “We understand the importance of the speed and precision of our COVID-19 testing and are committed to providing our customers with accurate and timely results.”
The scale of Orig3n’s false tests is unclear. Boston Globe, This is because state health authorities have not retested all samples processed by the facility. Robin Smith, the lab’s chief executive, said Orig3n has processed “tens of thousands” of coronavirus tests for customers across the country in the past 90 days.