Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test) Date Manufacturer(s) Test Receiving EUA July … [Read more...]

FDA Watch

First Warning Letters Issued for Improper Marketing of SARS-CoV-2 Antibody Tests

No more Mr. Nice Guy. For the first time, the FDA has exercised its enforcement powers to crack down on makers of unproven serologic SARS-CoV-2 antibody tests. A 180⁰ Pivot When the public … [Read more...]

Emerging Tests

Employers Show Signs of Hesitation on COVID-19 Return to Work Testing

Business reopening and return to work was expected to create a massive new market for employer point-of-care COVID-19 workplace screening tests. However, there are troubling new indications that … [Read more...]

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...]

Employment Law Update

COVID-19, immigrant worker, discrimination and DACA developments

By Mike O'Brien bio EEOC says no to COVID-19 antibody testing: The Equal Employment Opportunity Commission (EEOC) recently (6/17/20) updated its COVID-19 guidance to indicate that employers should … [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...]

Case of the Month

Feds Launch First COVID-19 Testing Fraud Prosecution

Stop me if you’ve heard this one before. The DOJ has charged a publicly traded Silicon Valley med tech firm and its CEO with touting a sham finger stick blood test to defraud payors and rip off … [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...]

Compliance Perspectives

Use Contact Logging to Ensure Lab Employees Practice Social Distancing

Managing a lab compliance program in the age of COVID-19 poses new and unprecedented challenges. One of the biggest and most important is ensuring that lab employees and the persons they interact with … [Read more...]

Reimbursement

Feds Say Insurers Not Required to Pay for Employer Return to Work COVID-19 Testing

Since the public health emergency began, the US government has taken the position that insurers shouldn’t be allowed to make consumers pay for COVID-19 lab tests. But now comes news that insurers will … [Read more...]


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