Written by
Tim Westover
Co-Founder
As you have likely seen, the FDA’s rule to regulate lab-developed tests (LDTs) was vacated by the courts on March 31 and will not be enforced.
From the start, IQE was designed to help labs manage complaints, non-conformances, root cause analysis, corrective actions, and more—long before regulatory headlines put a spotlight on LDT oversight. In fact, thousands of labs have been using IQE for years, not because they were required to—but because it made their lives easier, their data clearer, and their teams more aligned.
The LDT rule has been vacated, but we, as an industry, should take something from all the prep work we’ve done. Complaint management and non-conformance investigations are still crucial. We all want the best possible patient outcomes. Investigating errors and digging into their root causes protects patients and ensures efficient, high-quality laboratory operations. These processes remain essential—and required—under CAP, CLIA, The Joint Commission, and ISO 15189 standards, including:
- 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
IQE is purpose-built for all of this. From complaint tracking to root cause analysis and corrective actions, it’s a platform designed to help labs operate at their best.
And MediaLab is right there with you, hand-in-hand, every step of the way. When the LDT final rule was announced, we didn’t look away. We rolled up our sleeves. We lived and breathed LDTs, flexed with the winds of FDA regulation, and we’re still here, supporting laboratories with real-world tools that actually work.
While we were preparing IQE for LDTs, we decided to make major upgrades —making it even more powerful and flexible for labs managing all kinds of quality events not just LDTs. Some of these upgrades include:
- Complaints Workspaces: A centralized hub to streamline intake and jumpstart your investigations
- Public Links: Capture complaints and non-conformance reports from outside your organization, which allows you to manage your entire complaint intake and CAPA
- IQE Form Library: Pre-built templates for complaints, PT failures, change control, SOP deviations, equipment maintenance, safety audits, and more.
- Locations Element: Route and associate complaints/non-conformances to the correct lab site automatically, all coming from your actual lab and site locations.
- Connections Element: Link to related IQE forms, Document Control policies, Compass competency records, and more.
- Task Assignment: Assign follow-ups and corrective actions with due dates to specific users or groups.
- UI Updates: Faster setup, quicker event launches, and easier custom dashboards and reports.
And IQE has uses beyond non-conforming event and complaint management. We expanded our library of templates with ones for proficiency testing, change control, equipment maintenance, temperature checks, safety and ergonomics audits, and more.
If you’d like help optimizing your use of IQE or exploring new applications, we’re here. Over the next two weeks, we will be deploying a large number of additional Help videos and documentation on how best to use IQE and its many use cases. Keep your eyes out for more communications on all these new tools and further enhancements of IQE. We have also added a great deal more Help guides and information into the new Help Center.
Thank you for your partnership in continuing to improve quality and meet every standard, while also always being nimble as our world changes.