In May of 2025, laboratories across the US will face a critical change in the FDA’s posture towards Laboratory Developed Test (LDT) regulations. From May 6th onwards, more extensive monitoring and oversight will be required for any laboratory using these tests.
The new rule classifies LDTs as medical devices and with that change in definition, additional requirements come into play. One of the most potentially impactful changes is the FDA’s increased focus on data integrity and greater scrutiny of audit trails for inspections. You will need to demonstrate through whatever system you currently use or plan to use that your laboratory tests are trackable and that your data is both secure and backed up.
It will likely no longer be viable to manually track compliance and documentation, so it is highly recommended that you have a plan for how to deal with these new requirements.
The Centers for Medicare & Medicaid Services (CMS) also advocates for a proactive approach to these coming changes as it relates to the financial side of laboratory operations. Improper documentation represents a large portion of auditing failures, and this could be an incentive for organizations to adopt a digitized system.
This will not only help during auditing and inspections by allowing auditors access to an easily searchable system, but it will also decrease your chances of inadvertently missing something since errors and other issues can be automatically flagged and addressed before you reach the auditing stage.
Laboratory Information Systems (LIS) can help you futureproof your organization from auditing mishaps, and your staff will appreciate the added advantage brought to documentation processes.
The changes coming in May will occur in stages over the next four years so organizations will have time to adjust. Stage One includes new provisions for Complaint Files, Medical Device Reporting (which will affect LDTs), and Correction and Removal Reporting, so if you don’t already have a solution addressing these points, now would be the optimal time to revisit one.
If you’d like to learn more about how StaffReady can help you create and manage your laboratory tests and documentation, you can book a meeting with one of our experts here and accelerate your organization’s progress toward being ready for an inspection.
