Poor laboratory practices at a Boston company that performed Covid-19 tests for dozens of nursing homes in Massachusetts put patients at risk of harm, state public-health officials said.
On Friday, Bloomberg News reported that the company, Orig3n Inc., was responsible for more than 300 false-positive results at nursing homes across the state, spurring panic at facilities already hard-hit by the pandemic and costing some tens of thousands of dollars.
Orig3n, a consumer DNA-testing company that pivoted to coronavirus screening, has faced scrutiny for laboratory issues in the past. Still, Massachusetts officials had recommended the company to long-term care facilities seeking to comply with mandatory surveillance-testing requirements.
On Monday, the Massachusetts Department of Public Health said it had found that at least 383 coronavirus tests by Orig3n were erroneously positive. Additionally, state officials said Orig3n didn’t use controls in processing its tests, a critical step that can signal the presence of false results, and didn’t comply with requirements including documenting its sanitizing of equipment. The investigation also found shortcomings in the lab director’s management.
Massachusetts issued a statement of deficiency... see more