As 2024 draws to a close, we know you are gearing up for the updated CLIA requirements set to take effect January 1, 2025. These changes emphasize expanding the scope of regulated analytes, refining reporting protocols, and enhancing laboratory readiness to meet the needs of modern diagnostics. Some subspecialties of proficiency testing will be more impacted than others. Read our quick guide to ensure your team is equipped to navigate these changes seamlessly.
Building on the key takeaways from WSLH Proficiency Testing’s article “CLIA PT Requirements”, this follow-up article explores actionable steps laboratories can take to stay ahead of these regulatory updates.
Refresher on the 2025 Updates
The upcoming amendments to CLIA include:
- Expansion of Regulated Analytes: More tests and analytes will fall under the umbrella of required proficiency testing. This aligns with advancements in diagnostics, particularly in molecular and genetic testing. View our CLIA 2025 webpage for a detailed table of updated analytes.
- Refined Reporting Standards: Laboratories will face stricter requirements for reporting PT results, with greater emphasis on accuracy and timeliness.
- Increased Emphasis on Documentation: CLIA will require more comprehensive record-keeping, from enrollment details to PT performance evaluations.
Key Areas for Laboratory Preparation
- Review Your PT Menu
Ensure your PT program aligns with the updated list of regulated analytes.
Actionable Step: Cross-check your laboratory’s testing menu against the 2025 CLIA amendments. Identify any new analytes requiring enrollment in PT programs.
Tip: Reach out to PT providers like WSLH Proficiency Testing for guidance on enrolling in new programs.
- Invest in Staff Training
Updated requirements often mean new challenges for laboratory staff.
Actionable Step: Conduct training sessions focused on new regulated analytes and revised reporting protocols.
Tip: Consider training and competency assessment tools from WSLH PT, in partnership with Medical Technology Solutions, to ensure staff are well-prepared for testing and reporting requirements. You may also provide competency and training products as an added job perk for your staff.
- Optimize Workflow and Documentation
CLIA’s focus on accuracy and timeliness makes efficient workflows a necessity.
Actionable Step: Audit your current documentation processes. Are you tracking PT shipments, testing, and results in a way that meets CLIA’s updated standards?
Tip: Explore add-on digital tools with WSLH PT such as quantitative data automation or explore our laboratory information system (LIS) offered in partnership with Labgnostic PT to streamline record-keeping and reporting. Contact WSLH PT Customer Service ptservice@slh.wisc.edu to inquire about these services.
- Prepare for Molecular Testing Expansion
The inclusion of more molecular analytes under PT regulation is a significant change.
Actionable Step: Evaluate whether your laboratory has the equipment and expertise needed to handle molecular PT samples.
Tip: Connect with WSLH PT’s technical coordinators who specialize in molecular programs to access support and tailored training.
2024 Year-End Checklist for CLIA 2025 Readiness
Based on the information above, here is a quick checklist to assure each of your facilities are prepared for proficiency testing in 2025.
- Confirm Enrollment: Verify your laboratory is enrolled in all required PT programs for 2025.
- Update Procedures: Incorporate CLIA 2025 requirements into your laboratory’s quality management protocol or system.
- Evaluate Staff Competency: Use tools and training kits to ensure your team understands the changes.
- Document Thoroughly: Review your centralized system for recording all PT-related activities.
- Plan for Audits: Conduct an internal audit to identify potential gaps in compliance before CLIA inspections.
- Test Equipment Readiness: Ensure all instruments are calibrated and capable of handling expanded PT requirements. For calibration verification material, visit our webpage at: https://wslhpt.org/mls-competency-ce-courses/. WSLH PT offers calibration verification and linearity products offered in partnership with AUDIT MicroControls.
The 2025 CLIA amendments represent an important evolution in laboratory quality assurance. While the changes may seem daunting, a proactive approach can turn challenges into opportunities. You continue to play a crucial role in preparing your team and laboratories overall.
WSLH Proficiency Testing is committed to helping laboratories navigate regulatory changes with confidence. Let our team assist you as 2025 approaches: Receive one-on-one consultations and resources tailored to your laboratory’s unique testing menu. Upload your testing menu and request a quote, or call Customer Service at (800) 462-5261 to get started today.
Let’s make 2025 a year of success and growth in laboratory proficiency. WSLH Proficiency Testing is here to support you every step of the way. For more information or to explore our PT programs, visit our Clinical Catalog and Ordering page.
