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
Essential
Subscribe today for access to
Articles and Reports
Out with the Old: The 2024 Clinical Lab Experience
What challenges and opportunities affected the experience of medical lab professionals in 2024—and what might the new year bring?
FDA Watch: How Could the Change in US Government Affect IVDs and Labs?
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
Lab Sales & Marketing Compliance: The Current State of EKRA
Sales and marketing operations liability risks and the measures labs should and shouldn’t take to manage those risks.
Lab Companies See Massive Layoffs and Restructuring
Economic volatility and uncertainty is also making a significant impact on merger and acquisition activity in the diagnostics space.
Building an Effective Business Case for Your Lab
An effective business case communicates need, benefit, and risks.
FDA Watch: 2022 510(k) Lab Test Approvals Year in Review
Abbott and Roche garnered the lion’s share of new 510(k) lab test approvals in 2022.
Labs Partner with Pharma Companies to Develop New CDx Tests
There were three notable CDx alliances announced in January 2023, all of which involved cancer-related solutions.
Digital Health Fundraising Falls in 2022 but May Not Have Bottomed Out
According to a new report, tough macro-economic conditions caused digital health fundraising levels to fall off dramatically in 2022.
Does a Concierge Business Model Make Sense for Your Lab?
Factors to consider when determining if the concierge business model is best for your laboratory.
How to Regulate Workplace Romance in Your Lab
Labs and other companies need a proactive strategy for dealing with romance and fraternization between employees.
Model Conflict of Interest Policy for Employees Romantically Involved with Co-Workers
Here’s a template for a conflict of interest policy that you can adapt for your lab based on its specific situation and HR policies.
Model Workplace Romance ‘Love Contract’
Having employees involved in office romances disclose their relationship and follow key ground rules can help avoid negative impacts on the lab.
