Navigating Change in LDT Oversight: What Labs Can Take Away from the FDA’s Recent Decision

The recent court decision to vacate the FDA’s rule on lab-developed tests (LDTs) has left many laboratories wondering, "What's next?" While the regulatory landscape for LDTs has shifted, the core principles of laboratory quality management are more critical than ever.

This focus on fundamental quality is where a dedicated system becomes invaluable. Long before the recent FDA LDT rule changes, thousands of labs have relied on tools like Vastian's Intelligent Quality Engine (IQE) to streamline their CAPA (Corrective and Preventive Action) processes. They use it not for regulatory pressure alone, but to enhance efficiency, ensure data clarity, and align their teams.

Now, with the LDT rule vacated, it’s a perfect time to reflect on the progress we've made and the tools that have been put in place to ensure quality care. Complaint management, non-conformance investigations, and corrective actions are still vital to maintaining high standards in the lab. These practices, designed to improve patient outcomes, are not just helpful—they're required under various industry standards, such as:‍

• CAP: COM.12000 (Complaint Handling), GEN.20377 (Complaint Resolution)
• CLIA: 42 CFR §493.1239 – Complaint investigations
• ISO 15189: Sections 4.8–4.12 (Complaints, Nonconformities, Corrective/Preventive Actions)
• The Joint Commission: QSA.02.08.01 – Complaint management process

While the regulatory landscape for LDTs may have shifted, the processes behind quality management in laboratories remain essential. This is where IQE continues to support labs—by providing a platform specifically designed to manage complaints, root cause analysis, and corrective actions, helping laboratories maintain their best practices and compliance.

Streamlining Quality Management Regardless of Regulations

A robust quality management system needs to be both powerful and adaptable. That's why we've continuously evolved our Intelligent Quality Engine (IQE) to help labs proactively manage quality events across every department—not just those related to LDTs. These enhancements were designed to make your compliance efforts more efficient, transparent, and effective:

• Complaints Workspaces: Centralize and streamline your entire intake process. This dedicated hub helps you launch investigations faster and keeps all related information organized in one place.
• Public Links: Easily capture complaints and non-conformance reports from external partners or even patients, ensuring all feedback is logged directly into your CAPA system without manual data entry.
• IQE Form Library: Get started immediately with pre-built, best-practice templates for everything from PT failures and SOP deviations to change control, equipment maintenance, and safety audits.
• Locations Element: For multi-site organizations, automatically route complaints and non-conformances to the correct lab or department, eliminating confusion and delays.
• Connections Element: See the full picture by linking quality events to related documents, policies, and competency records in Document Control and Compass, creating a fully integrated quality ecosystem.
• Task Assignment: Ensure accountability and that nothing falls through the cracks by assigning follow-up tasks and corrective actions to specific individuals or teams with clear due dates.
• UI Updates: Work faster and more intuitively with a refreshed interface designed for quicker event logging, easier setup, and more powerful custom reporting.

Together, these tools provide a comprehensive framework not just for managing isolated events, but for building a true culture of continuous quality improvement throughout your laboratory.

We’re Here to Support You, Every Step of the Way

As we continue to navigate this ever-changing landscape, know that we're here to help you make the most of IQE. Whether you're optimizing your current processes or exploring new ways to streamline operations, we’ve got you covered. Keep an eye out over the next couple of weeks as we roll out more helpful resources, including videos, guides, and updates to the Help Center—designed to help you unlock the full potential of IQE.

The conversation around LDT oversight will continue, but your commitment to quality doesn't have to wait. By implementing a robust non-conformance and complaint management system, you can ensure your lab is always prepared, compliant, and focused on patient safety. Vastian is here to help you elevate your lab's quality and stay ahead of the curve, no matter what comes next.