Lab That Provided False Covid Test Results Faces License Threat

Sign up here for our daily coronavirus newsletter on what you need to know, andsubscribe to our Covid-19 podcast for the latest news and analysis.

A company that performed Covid-19 tests for dozens of Massachusetts nursing homes is facing federal sanctions, including the possible loss of its license, for lab practices that resulted in “immediate jeopardy to patient health and safety.”

Last month, Bloomberg News reported that the company,Orig3n Inc., a consumer DNA-testing company that pivoted to Covid-19 testing amid the pandemic, was responsible forhundreds of false positive results at nursing homes across the state.

ln a letter to the company dated Oct. 2, theCenters for Medicare & Medicaid Services said Orig3n had not corrected problems after an earlier inspection and proposed sanctions, including revoking or suspending Orig3n’s license.

“During the past couple of months, we’ve made significant efforts to evaluate, improve and validate our processes both internally and with assistance from external experts and third-party laboratories,” Chief Executive Officer Robin Smith said in a statement. “We’re committed to addressing any questions that CMS might have.”

Orig3n has faced criticism for laboratory quality issues in the past. Still, the company secured a recommendation from state officials for long-term care facilities seeking compliance with mandatory surveillance-testing requirements. The company supplied surveillance testing to about 60 nursing homes in the state. At least 11 of them reported false positives, creating panic and confusion at facilities already hard-hit by the virus.

Two separate on-site investigations of Boston-based Orig3n found that the lab didn’t meet basic requirements for a virology lab, according to documents obtained by Bloomberg News in a Freedom of Information request.

The laboratory failed to document sanitizing of equipment used for Covid-19 testing, the report found, and failed to implement control measures that would help flag contaminated samples or follow the appropriate quality-control procedures.

False Positives

Of 3,761 samples run between July 30 and Aug. 2, 406 samples tested positive for Covid-19, according to the report. Of those, 337 positive tests were re-run and tested negative. Ultimately, Orig3n reported 383 false-positive results.

The company’s lab director told CMS that the company’s quality-control measures weren’t “adequate to detect contamination,” the agency report said

After those findings, the company was given the chance to provide evidence it had addressed the issues. In the October letter to the company, CMS found that it hadn’t. The proposed sanctions outlined by CMS include revoking the company’s license, suspending it, or a fine of $10,000 per day for each day the company isn’t in compliance with agency standards

Orig3n is best-known for DNA tests more rooted in entertainment than science, including a test intended to reveal whether a person might possess “unique superhero traits.” It was just one of many companies that abruptly pivoted to Covid-19 after a shortage in testing plagued the U.S. pandemic response.

Dog’s DNA

This was not the company’s first investigation by CMS. The agency had previously looked into Orig3n after a 2018 incident in which an investigation into home genetic tests by NBC Chicago found the company mistakenly processeda dog’s DNA, failing to recognize it wasn’t human when other testing companies did.

A year ago,Bloomberg Businessweek also reported allegations from 17 former employees claiming lab issues at Orig3n had persisted, including inaccurate tests, sample contamination, sloppy lab practices and tampering with results. At the time, the company said that the former employees were disgruntled and their accounts were “grossly inaccurate.”

Orig3n receivedemergency authorization for its Covid-19 test in April from the Food and Drug Administration. The company has the right to request a hearing or appeal sanctions once issued. The company has suspended testing for the time being.

Source: Read Full Article