Regulatory News and Updates for Laboratories

June 3, 2025

The College of American Pathologists (CAP) and The Joint Commission (TJC) have revised their joint collaborative agreement. As a result, effective immediately, the CAP will now permit advance notification of laboratory accreditation inspections at TJC-accredited hospitals. This change aligns with the Centers for Medicare & Medicaid Services (CMS) CLIA regulations.

What This Means for Your Lab:

• You may receive advance notice of up to 14 calendar days for scheduled inspection activity.
• Unannounced inspections will still apply in cases involving complaints or follow-up inspections due to prior noncompliance.

This change reflects the CAP’s ongoing commitment to supporting our laboratory quality partners by promoting readiness and continuous improvement. We appreciate your patience as we fully transition to the 14-day notice. 

October 16, 2024

On December 28, 2023, the CMS released the Final Rule - Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees, Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories (CMS-3326-F). This ruling includes changes to the CLIA regulations addressing personnel qualifications and histocompatibility testing, which will take effect on December 28, 2024. The CAP is in the process of incorporating necessary changes into the 2024 checklist edition, which is expected to published by the end of 2024. Laboratories must continue to follow their current checklist edition until that time.

Register for Upcoming Webinars: 

Staying in Sync: CAP Accreditation Checklist Changes for 2024

Learn about the 2024 checklist changes on our next Focus on Compliance webinar, Wednesday, December 18, 2024 from Noon – 1:15 PM CT. Presenters Stephen Sarewitz, MD, FCAP, and Gregory A. Gagnon, MD, FCAP, will review the rationale for the 2024 requirement changes, identify laboratory/practice improvement opportunities to align with 2024 requirements, and explain how laboratories can use CAP resources to identify changes and compliance solutions. This will allow for a deeper discussion of the new checklist requirements, with limited focus on the CLIA personnel final rules.

Personnel Essentials: A Deep Dive into Personnel Roles and Qualifications

Plan on joining us on Wednesday, February 19, 2025, from 12:00 –1:00 PM CT for our Focus on Compliance webinar discussing CLIA roles and responsibilities, including updates to the provisions from the CLIA Final Rule changes. Gain a better understanding on who can assess competency, how to evaluate transcripts from “other” degrees, and see the new templates and tipsheets available in the Accreditation Resources section in e-LAB Solutions Suite (ELSS).

March 31, 2025

A US District Court judge nullified the Food and Drug Administration (FDA) regulation on the oversight of laboratory-developed tests (LDTs), agreeing with plaintiffs' and the College of American Pathologists' (CAP) arguments that the rule should be vacated.    

Get Ready for the PT CLIA Changes: Stay Ahead, Stay Compliant

• Watch the webinar recording, read FAQs, and download the presentation slides (PDF) from June 27, 2024 webinar, led by experts from the CAP Clinical Chemistry and Microbiology committees.
• Refer to the table linked here to review the new 2025 regulated analytes, their acceptance limits, and corresponding program codes and revised scoring criteria established by the Centers for Medicare & Medicaid Services (CMS) that meet all updated CLIA requirements.

May 22, 2024

The CMS released a final rule, CMS–3355–F, Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance, published in the Federal Register on July 11, 2022. This is the first significant update to the CLIA regulations since 1992.

Based on the final rule, there are two dates that may impact some laboratories:

• January 1, 2025: Proficiency Testing Final Rule (CMS–3355–F) requirements related to PT program providers and laboratories, including PT enrollment, while effective July 11, 2024, will be implemented on January 1, 2025.
• August 10, 2022: CMS clarified that effective on this date, if a laboratory chooses to perform PT for waived testing, they will be subject to the same regulations and sanctions related to PT referral as laboratories that perform non-waived testing (§§ 493.20 and 493.25).

Access the following for the latest CAP guidance:

• The May 2024 issue of CAP Today, Q&A section
• Your laboratory's 2024 PT program participant summary (PS), accessible via e-LAB Solutions Suite
  • Participant summaries include detailed program-specific information on grading criteria changes
  • Participant summaries with detailed information are indicated by a note on the cover page

Proficiency testing is required for regulated analytes. To determine which results are submitted to CMS, the CAP follows a predefined precedence, unless otherwise specified by the laboratory. Our CMS Analyte Reporting Selections (PDF) reference guide helps you navigate your way through the process. Log in to e-LAB Solutions Suite to access your current analyte reporting selections.