Regulators suspend Missouri nursing home COVID-19 test lab

Regulators suspend Missouri nursing home COVID-19 test lab

SeattlePI.com

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COLUMBIA, Mo. (AP) — A federal judge refused to intervene Wednesday to keep open a Missouri lab that handled coronavirus tests for about 2,500 nursing homes in 11 states after the federal government suspended the lab for what it alleged were serious violations that put patients’ health at risk.

U.S. District Judge Douglas Harpool said that the lab, Gamma Healthcare, was in effect asking him to step into a role that belongs to federal health and safety regulators.

Missouri nursing homes are worried that loss of the lab’s services will slow down testing for their elderly and frail patients.

Gamma Healthcare's Poplar Bluff lab handled COVID-19 testing for thousands of long-term care centers in Arkansas, Illinois, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, Tennessee and Texas.

Attorneys for the Medicare agency, or CMS, in court documents wrote that two testing machines at the lab operated for months producing false-negatives on over a quarter of known-positive COVID-19 samples. Regulators also found multiple false-positive COVID-19 test results at the lab.

A CMS spokeswoman in an email said following federal lab regulations is especially important during the coronavirus pandemic to ensure accurate test results and slow the spread of the virus.

Gamma Healthcare lawyers said the Poplar Bluff lab voluntarily stopped COVID-19 tests earlier this month in response to issues raised by regulators. But attorneys said the labs have fixed the issues and sued in federal court to stay open, arguing that suspending the labs’ licenses would leave thousands of nursing homes “without crucial laboratory services.”

Harpool on Wednesday denied Gamma Healthcare's request.

In his ruling, Harpool wrote that the company was asking him to “second guess”...

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