While the federal government has told the public that millions of coronavirus experiments are underway, several private laboratories in the U.S. are still unable to perform their own studies, partially due to a rigorous process of government approval, say leading laboratory experts and industry groups.
One hospital facility claims it should have completed thousands of studies by now. The delays— which were also caused by a shortage of supplies and the federal government’s lack of knowledge about how often laboratories should be reimbursed — have extended waiting times to treat infected patients, as the virus has spread further, according to laboratory directors and public health experts.
According to the American Clinical Laboratory Association, which represents commercial and hospital laboratories, private laboratories have been in contact with the Department of Health and Human Services since mid-January about designing their own research. But until Feb. 29 the federal government released no new regulations speeding up the approval process for industrial, scientific, and academic laboratories.
Nonetheless, even after that, private laboratories have continued to face hurdles. Some laboratories could take weeks to get up and running, said Mark Birenbaum, administrator of the National Independent Laboratory Association, which represents laboratories in smaller cities and rural areas.
Some laboratories have been designing their own experiments for weeks but remain frustrated by a federal approval process they claim is too time-consuming and expensive.
“Instead of checking boxes, I should have checked more than 1,000 patients by now,” Dr. Melissa Miller, director of the UNC Medical Center Clinical Microbiology Laboratory in North Carolina said. Miller says her laboratory had developed a test based on guidelines from the World Health Organization before the state laboratory even had its own. Yet the UNC laboratory has not begun evaluating patients, because it is still in the process of fulfilling the Food and Drug Administration’s standards for expedited clearance, which will sign off on all new experiments.