Tool

Model COVID-19 Contact Log Sheet

Maintaining social distancing will be the price that labs and other businesses will have to pay to reopen and remain open until the COVID-19 threat goes away. But for social distancing to work, there … [Read more...]

Compliance Briefing

How to Comply with the New HHS COVID-19 Test Data Reporting Rules

The U.S. Department of Health and Human Services (HHS) has ordered labs that perform COVID-19 testing to report test data to state and local public health agencies by August 1, 2020. What makes the … [Read more...]

GAO Report

Federal COVID-19 Testing Data Collection Effort Has Been Ineffective

The federal government has done a poor job of collecting and reporting COVID-19 testing data to the CDC since the pandemic began. That’s the conclusion of a U.S. Government and Accountability Office … [Read more...]

LDTs

FDA Sets the Bar on Specimen Pooling & Asymptomatic Screening for SARS-CoV-2 Test Development

On June 16, the US Food and Drug Administration (FDA) issued new guidance addressing two key issues related to SARS-CoV-2 testing: validation processes for test pooling of samples for test development … [Read more...]

Focus On

The Next Round of COVID-19 Legislation: What It Will Take to Prevent a Second Outbreak?

The next wave of federal COVID-19 relief legislation is in the works and the lab industry is doing its level best to ensure that it includes the necessary support for lab testing that the previously … [Read more...]

New Products

First SARS-CoV-2 Antigen Test Gets EUA Clearance from the FDA

First came the molecular and then the serologic assays. And last month, the FDA granted emergency use authorization (EUA) for a COVID-19 assay based on a third kind of testing methodology: antigen … [Read more...]

Congress to HHS

Give Labs the Money They Need to Develop COVID-19 Testing Capacity

This is a bad time to be a clinical lab in the U.S. Although a recovery seems to be in the works, the pandemic has drastically reduced testing for just about anything and everything other than … [Read more...]

Two New Bills

New Federal Legislation Would Give Labs Grants to Expand COVID-19 Testing Capacity

We all hope the worst of the pandemic is over and that life can get back to something like normal. But even as America reopens, the disturbing truth remains that the virus is still out there and that … [Read more...]

New Laws

HHS Requires Labs to Report Extensive & Unprecedented COVID-19 Testing Data by August 1

Three months into the pandemic, HHS has decided that it would be a good idea for labs that perform COVID-19 testing to report not only test results but other real-time data that labs generally don’t … [Read more...]

Focus On

Doctors & Nurses Eager to Get Back to Work Despite COVID-19 Anxieties

Layoffs and furloughs are a new thing for many medical professionals who’ve come to expect stability in their employment. So, it’s not surprising that a new survey suggests that medical professionals … [Read more...]


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