Six Sigma Can Help Monitor New CLIA Proficiency Testing Changes
A PT update went into effect on January 1, focusing on revised acceptance limits, among other modifications
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ProPhase Labs’ Resolution for 2025: Nail Down a ‘Liquidity Event’
The company has lost nearly $36 million since 2023, but its CEO is aggressively pursuing new revenue options
Compliance Concerns: Laboratory Regulations in 2024 and Beyond
Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025
Amazon Makes Third Attempt to Disrupt Healthcare Business
Having twice failed to disrupt health care, Amazon opts for a different strategy this time around—and it may just work.
December 2022 FDA Watch: More Approvals in US than EU
A high volume of FDA approvals for new tests and diagnostic products made up for the relatively low number of approvals in the EU.
How to Use Mobile Apps to Optimize T&E System Performance in Labs
Automating travel and expense significantly improves performance, but adding mobility takes such improvements to a much higher level.
A Brief Look at the COVID-19 Saliva Testing Global Market
The recent FDA approval of an OTC test shows that COVID-19 saliva testing may be poised for bigger and better things in the years ahead.
Strategic Deals in DX Space Remain Low in Number, but High in Impact
Though only seven transactions were announced or closed in November, two were billion-dollar deals.
December 2022 Labs in Court: FCA and a Sex Discrimination Case Dismissed
Key cases over the past month were the usual FCA-related fare, apart from a dismissed sex discrimination case.
Compliance Tool: Model Policy on Telecommuting & Remote Work
It’s important to have a clear policy in place for approving remote work requests and ensuring employees remain productive.
December 2022 Enforcement Scorecard: Unusual Suspects
Federal enforcement actions at the end of October and first two weeks of November featured some unusual characters.
Court OKs Qui Tam Lawsuit against Lab for Not Following Medicare LCD
Could not following MAC guidance constitute evidence that a party knowingly submitted, or caused the submission of, false claims?
Lab Staffing: How to Guard Against “Digital Nomad” Liability Risks
There are potentially significant legal ramifications of employing digital nomads who work from abroad—for both you and your employee.
