Public Health

Lack of Reporting, Not Tests, Is the Bar to Mass Utilization of COVID-19 Antigen Testing

Because of their low costs, scalability and speed, antigen tests may play a crucial role in meeting the unprecedented level of demand for point of care COVID-19 screening tests, particularly in … [Read more...]

HHS Announcement

The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs

Perhaps one of the only positive things to come out of the COVID-19 crisis has been its exposure of the flaws in the FDA’s ham-handed system (if it can be called a system) of premarket regulation of … [Read more...]

Compliance Perspectives

What, If Anything, Does OSHA Require You to Do to Protect Telecommuters?

While telecommuting is nothing new, the imperative for using it has never been greater. In addition to all the cost-saving, work-life balance, recruiting and hiring advantages, letting employees work … [Read more...]

Whistleblowers

Relying on the First-to-File Rule to Protect You from Copycat Qui Tam Lawsuits

As you know, the private individuals, known as relators, the right to bring qui tam lawsuits on the government’s behalf against labs and other contractors that submit false claims to the federal … [Read more...]

Direct-To-Consumer

Walmart & Quest Provide Drone Delivery of At-Home COVID-19 Test Kits

The previous decade has seen the direct-to-consumer (DTC) diagnostics products business take quantum leaps forward thanks to collaborations between major lab companies and retail giants that enable … [Read more...]

Labs In Court

A roundup of recent cases and enforcement actions involving the diagnostics industry

Referral Arrangement Violates Kickback Laws Even If Even Only Purpose Is to Generate Illegal Referrals Case: The U.S. Attorney accused a Kentucky physician of taking a $105 per beneficiary payment … [Read more...]

Data

Genomic Testing Utilization Is Low & Geographically Inconsistent but Not Just Due to Payor Coverage

Genomic testing is inconsistently utilized in the U.S., even in states with favorable coverage policies. Those are the findings of a report from the Personalized Medicine Coalition (PMC) released in … [Read more...]

Labs in Court

OSHA Fines New Jersey Hospital for Coronavirus Respiratory Protection Violations

Case: OSHA is proposing to fine the hospital $9,639 for two serious violations: i. Failure to fit test tight-fitting respirators face piece respirators on employees required to use them; and ii. Not … [Read more...]

FDA Watch

Respiratory Panel Tests Flow from EUA Pipeline Ahead of Flu Season

The robust COVID-19 testing EUA pipeline has opened up a new opportunity for companies that produce multi-analyte panels capable of detecting not only the SARS-CoV-2 virus but other respiratory viral … [Read more...]

Compliance Perspectives

Using Waivers to Avoid Getting Sued for COVID-19 Infections

PLEASE READ NOTICE TO ALL ENTRANTS AND USERS OF THESE LABORATORY FACILITIES EXCLUSION OF LIABILITY – ASSUMPTION OF RISK THESE CONDITIONS WILL AFFECT YOUR LEGAL RIGHTS INCLUDING THE RIGHT TO … [Read more...]


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