Contamination at CDC Lab Delayed Rollout of Coronavirus Tests
A major scientific breakdown at the Centers for Disease Control and Prevention's (CDC) central laboratory complex in Atlanta led to the failure by the agency to quickly produce a test kit for detecting the novel coronavirus, according to a determination by federal regulators. The facilities that assembled the kits violated sound manufacturing practices, resulting in contamination of one of the three test components used in the highly sensitive detection process, scientists with knowledge of the matter said. The cross-contamination most likely occurred because chemical mixtures were assembled into the kits within a lab space that was also handling synthetic coronavirus material. The scientists also said the proximity deviated from accepted procedures and jeopardized testing for the virus. FDA officials reportedly separately concluded that CDC violated its own laboratory standards in making the kits. The substandard practices exposed the kits to contamination. After the difficulty emerged, CDC officials took more than a month to remove the unnecessary step from the kits, exacerbating nationwide delays in testing, according to an examination of federal documents and interviews with more than 30 present and former federal scientists and others familiar with the events. In testimony, CDC Director Robert Redfield described in general terms what may have caused the kits' failure. "The third control did not perform the way we wanted it to perform," he said, adding that the cause was either "a contamination" or an unspecified “biologic” factor that caused the test materials to malfunction.
CMS Doubles Medicare Payment for Coronavirus Lab Tests
Medicare's reimbursement rate for clinical diagnostic labs' high-throughput COVID-19 molecular tests were increased from about $51 to $100 by the Centers for Medicare and Medicaid Services (CMS). The agency points out that the tests can process more than 200 specimens per day and require specialized personnel. CMS also said the higher payment would help curb the spread of COVID-19 in nursing homes. The new payment policy took effect on April 14. The American Clinical Laboratory Association (ACLA) commended CMS' action, which will assist labs' efforts in responding to the pandemic. ACLA said it hopes other payers will follow CMS' example and raise their reimbursement rates. Commercial labs are leveraging high-throughput testing platforms regarded by the Trump administration and ACLA as essential for broadening the nation's testing capacity. ACLA has been warning the federal government for weeks that the financial strain on commercial labs as a result of uncompensated COVID-19 testing services along with rising costs for testing supplies such as swabs, reagents, and personal protective equipment. ACLA President Julie Khani said, "The lack of predictable reimbursement for tests performed has been a barrier to entry for some laboratories, and today's decision will help encourage all laboratories with the appropriate expertise to come to the table and perform COVID-19 testing."
Private Labs Say Demand for Coronavirus Tests Is Down and They Can Test More People Who Aren't as Sick
The American Clinical Laboratory Association (ACLA) says demand for COVID-10 testing at private labs nationwide has declined so much that they now have "considerable" unused capacity and can test more lower-priority patients. These patients include symptomatic patients, mildly symptomatic patients in heavily affected areas, and asymptomatic health care workers and first responders. However, the labs still lack the capacity for mass testing of asymptomatic members of the general public. Hurdles to increasing the capacity include shortages of testing swabs, reagents, and other supplies. The number of COVID-19 tests conducted daily by private labs peaked on April 5 at 108,000, declining to under 100,000 per day after that. From April 12 to April 13, the number of daily tests fell from 75,000 to 43,000. An ACLA spokesperson notes that orders from physicians' offices also have been declining. Although delays and backlogs were a major problem as clinical labs worked to ramp up testing for weeks, ACLA member labs no longer have backlogs. Most state health departments have been telling physicians to prioritize high-risk patients, health care workers, and people with severe symptoms. The recommendation, which is in line with guidance from the Centers for Disease Control and Prevention, was based on a shortage of testing capacity.