Pre-Inspection Preparation: How to Ace Your Next Regulatory Visit

Pre-Inspection Preparation: How to Ace Your Next Regulatory Visit

Navigating a regulatory inspection can be intimidating, especially for newer clinical laboratories still finding their footing. Yet with adequate preparation and a proactive mindset, inspections can become far less daunting—and even serve as catalysts for quality...
Developing Comprehensive SOPs: The Backbone of a Compliant Laboratory

Developing Comprehensive SOPs: The Backbone of a Compliant Laboratory

Setting up a clinical laboratory involves countless moving parts, but one element stands out as the unifying thread that holds everything together: Standard Operating Procedures (SOPs). These documents shape your lab’s daily practices, from how samples are handled to...
Court Strikes Down FDA’s LDT Rule: What Labs Need to Know

Court Strikes Down FDA’s LDT Rule: What Labs Need to Know

Laboratory Developed Tests (LDTs) are essential diagnostic tools created and performed within a single clinical laboratory. They play a critical role in patient care, allowing labs to rapidly develop tests for rare diseases and specialized needs that commercial tests...

Transforming Into a Strategic Asset: An Upper Midwest Health System

Clinical laboratories are often seen as purely operational units within health systems—critical but sometimes undervalued in the broader strategic picture. At Colaborate, we understand the pivotal role clinical laboratories play—not just in providing timely, accurate...