A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
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Articles and Reports
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
Why You Need to Address EKRA When Selling Your Lab
When selling your laboratory, in order to remain compliant with federal code, EKRA is something you will want to consider
Marketing Your Clinical Lab
Outreach and advertising can be tricky prospects for the clinical lab—but the right questions and strategies can help guide your efforts
Special Report: The Lab Kickback Risks of “Freebies”
How to avoid six common compliance risks involving free supplies, equipment, software, and other non-monetary compensation
Tool: Third-Party Risk Management Guide for Medical Labs
Key cybersecurity points to address when working with a third party that has access to protected health information
FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
Expert Q&A: Responding to the Change Healthcare Cyberattack
Cybersecurity expert outlines steps labs and other healthcare providers should take to prepare for future cyberattacks
Understanding and Avoiding Compliance Errors
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Dx Deals: New Deal Expands Reach of Oral Cancer Test to Dental Practices
Recently announced collaboration between Viome and Henry Schein allows dentists to offer sample collection for Viome’s assay to patients
The Benefits of Group A Streptococcus NAAT
Labs that invested heavily in POC molecular tests during COVID-19 are well positioned to leverage this equipment toward GAS diagnostics
May 2024 Labs in Court
Recent enforcement actions and court cases include kickback schemes a-plenty and a reminder to focus on HIPAA compliance
