How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Compliance Perspectives-lca
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Articles and Reports
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Are Current Regulations Keeping Labs from Benefiting from AI?
Though needed to protect data and patient privacy, some in the industry say that more flexibility is needed
How to Prevent the Top 10 CLIA Deficiencies
A laboratory safety expert shares the most common CLIA citations from recent lab inspections, and how your lab can avoid similar problems.
10 Top CLIA Deficiencies for Labs and How to Avoid Them
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
EKRA 101: A Brief Backgrounder and How to Stay Compliant
How the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) came to be, what laboratory leaders should know about it, and how to comply
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
The Landscape of Laboratory Corruption
How widespread is corruption in the lab—and what can be done to combat it?
Staying on Top of Medical Necessity and Marketer Compliance
Recent enforcement actions show that clinical laboratories must remain vigilant about compliance relating to these areas
Digital Pathology Business Arrangements Bring Fraud and Kickback Worries
Healthcare attorneys explain three digital pathology models for laboratories to be aware of.
Who Needs to Follow the OSHA BBP Standard in the Lab?
Which staff members lab professionals should consider when developing their exposure control plans to ensure OSHA compliance.
12 Steps to Manage BYOD Risks to Lab Data
How lab leaders can manage the data security risks of staff using personal devices for work-related purposes.
Compliance Perspectives: When Do Cybersecurity Donations Violate Kickback Laws?
The compliance risks of giving referral sources software or equipment to ensure the security of protected health information.
