Long-term care providers expressed concern after a Missouri-based testing facility was suspended over alleged inaccurate COVID-19 test results.
Gamma Healthcare, a testing lab based in Poplar Bluff, was suspended by the Centers for Medicare and Medicaid Services (CMS) earlier this month after the federal regulator found two of the facility’s machines produced false-negative COVID-19 tests during a June inspection.
Nikki Strong, executive director of the Missouri Health Care Association (MHCA), said the closure would have drastic impacts on long-term care facilities across the Midwest — not just in Missouri.
“This will be a huge hit to the industry,” Strong told The Missouri Times. “Due to the issues that led to the removal of their lab certificate — it started with COVID testing but the bigger hit to our community and our state is the significant lab tests that are done at this lab. We’re diligently working to try to come up with new options.”
Strong said the lab provided tests for more than 2,500 nursing facilities across 11 midwestern states, including nearly 900 places in Missouri. Beyond COVID-19, the lab provided day-to-day medical testing services.
Daily results were vital to patients’ health, and the loss of Gamma’s facilities could have drastic consequences for patients in those facilities, Strong said. She gave the example of blood tests for patients on blood thinners: Tests administered by the lab caught issues with blood work and recommended adjustments to medication.
“It’s life or death for a lot of these people to have access to these labs and monitor their overall health,” she said. “It’s very significant and it goes way beyond the COVID testing. It’s going to have a drastic impact on long-term care facilities.”
Strong said the closure of the lab would force facilities to find other labs to work with, and many could face difficulties in finding one that wasn’t already overwhelmed.
U.S. District Judge Douglas Harpool declined to interfere with the suspension on Wednesday after Gamma filed a suit to stay open. According to a report from the Associated Press, Harpool said the company was essentially asking him to take on the role of a regulator himself.
The company said it voluntarily halted testing earlier this month in response to the regulator’s concerns. Gamma Healthcare lawyers indicated in court the company examined the machines in the interim and found no issues.
A CMS spokesperson said federal lab regulations and guidance were especially important in the midst of the pandemic.
Neither CMS nor Gamma Healthcare responded to a request for an interview.