BOSTON — 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.
An Orig3n spokesman told Gannett New England, which first reported the story last week, that the false positives were due to “human error” at the beginning of the laboratory testing process that caused some tests to become contaminated.
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. We’ve processed tens of thousands of COVID19 tests over the past 90 days on behalf of our clients, which include schools, nursing homes, private and public employers.
— Robin Smith, Orig3n CEO
On August 1, our laboratory team identified some false positive results in our COVID-19 testing. We contacted our clients and on August 8 suspended COVID-19 testing at our Boston lab. We also retested the affected samples both internally and at an external reference lab, and communicated those results to our clients. 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.
— Robin Smith, Orig3n CEO
About 60 nursing homes have been clients of the lab, state authorities said.
Related:
As coronavirus testing ramps up, so do questions about some tests' reliability
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