How many COVID-19 screening tests per month will it take for the U.S. to reopen safely? One new report estimates the number as around 200 million, which is far below the 25 million tests currently … [Read more...]
EUA
FDA to Issue Emergency Use Authorization for Multi-Analyte Respiratory Panels During the Pandemic
September 17, 2020
The convergence of flu season with the global COVID-19 pandemic will create the need for new multi-analyte respiratory panel tests that are capable of not only detection of but also differentiation … [Read more...]
PANDEMIC
Hospitals, Labs, LTCs Face Big Fines for Failing to Meet New CMS COVID-19 Test Daily Reporting Rules
September 17, 2020
Nursing and other long-term care (LTC) facilities have been a hotspot for COVID-19 infection since the public health emergency began. On Aug. 27, CMS issued a new Interim rule requiring LTC facilities … [Read more...]
Tool
Telecommuter Home Office Hazard Assessment & Inspection Checklist
September 8, 2020
While not an OSHA obligation, it’s highly advisable to take measures to protect the health and safety of telecommuting lab employees who work from home. How? By having employees seeking approval to … [Read more...]
LDTs
FDA Breaks New Ground by Authorizing SARS-CoV-2 Tests for Sample Pooling
September 8, 2020
It’s not uncommon for the FDA to revise the Emergency Use Authorization (EUA) for a particular diagnostics test to permit a new clinical use. In most cases, these expansions don’t even get an official … [Read more...]
Testing Strategy
Labs to HHS: Since We Can’t COVID-19 Test Everyone, Let Us Prioritize the Symptomatic
September 4, 2020
Labs continue to lack the resources necessary to meet the demands for timely COVID-19 testing. In July, industry groups called on the White House to take control and resolve, or at least allay the … [Read more...]
