Regulatory News and Updates for Laboratories

November 3, 2025

Effective immediately, the College of American Pathologists (CAP) updated the 2024 Checklist Edition to reflect the enforcement discretion and revised guidance issued by the Centers for Medicare and Medicaid Services (CMS) in communications released on June 23, 2025, that offer more flexibility for laboratories:

• QSO-25-10-CLIA-Revised (Revisions to the State Operations Manual (SOM), Appendix C – Advance Copy)
• QSO-25-21-CLIA (CLIA Enforcement Discretion and Clarification on Personnel Regulations)

Log onto e-LAB Solutions Suite (ELSS) now to download your updated Laboratory General and Director Assessment checklists and review the latest CAP Personnel Guidance Document and Q&A resources.

Summary of Changes 

• Laboratory Director and Clinical Consultant qualifications – Removed provisions added to DRA.10100 and GEN.53650 based on the CLIA Final Rule implemented on December 28, 2024, requiring 20 CE credit hours in laboratory director responsibilities to align with the discretion provided in CMS memorandum QSO-25-21-CLIA.
• Dermatopathology Laboratory Director qualifications - Revised DRA.10100 to allow individuals qualifying as dermatopathology technical supervisors (as defined in CLIA regulation 42CFR493.1449(f)(2)) to serve in this role to align with the updates in the CMS interpretive guidelines in QSO-25-10-CLIA REVISED.
• Bachelor of Nursing Degree Holders – Revised GEN.54750 to include a limited exception to allow individuals with Bachelor of Science in Nursing to perform high complexity glucose meter testing to align with the CMS interpretive guidelines in QSO-25-10-CLIA REVISED.

Competency Assessment – Virtual Direct Observation 

While there are no edits in the 2024 Checklist Edition, the CAP now allows laboratories to use virtual direct observation for competency assessment, where permitted by national, state (or provincial), and local laws and regulations based on updates in QSO-25-10-CLIA REVISED. All provisions applicable to in-person direct observation for competency assessment also apply to virtual direct observation, including those for personnel qualifications, delegation, record retention, and policies/procedures. A clarifying statement will be included in the 2025 checklist edition.  

September 23, 2025

On September 23, 2025, the Centers for Medicare & Medicaid Services (CMS) released a revised post-public health emergency (PHE) guidance regarding reviewing digital images of cytology slides. CMS is discontinuing its temporary exercise of enforcement discretion that previously allowed remote review of cytology digital slides at locations separate from the primary CLIA-certified cytology laboratory. This is in addition to the discontinuance of the previous CMS enforcement discretion for review of glass slides communicated on May 11, 2023.  In order for CMS to be in compliance with CLIA statute which states that "all cytological screening be done on the premises of a laboratory that is certified," this change is required.

Below are FAQs to help you prepare your laboratory for this change by the required date of March 23, 2026.

What is "remote review"?

Electronic review of digital images by qualified personnel under CLIA from a location that is NOT considered part of the main laboratory (e.g., pathologist’s home or an offsite location). 

If I am currently remotely reviewing digital cytology slides, what do I need to do to prepare for this change?

CMS will require that laboratories that want to continue reviewing digital images of cytology slides at a remote location (after March 23, 2026) need to obtain a CLIA certificate for that location, separate from the main laboratory.

How long do I have to be in compliance with this guidance?

Per CMS, laboratories have six months from the issue date of the memorandum to comply. Laboratories must have an additional CLIA certificate for each location outside of the main laboratory if they want to continue remote review of digital cytology images by March 23, 2026.

We currently remotely review digital surgical pathology slides; will we be out of compliance if we continue?

No, the updated guidance only applies to remote review of cytology digital slides.

October 6, 2025

The interim self-inspection plays a critical role in maintaining laboratory quality and ensuring compliance throughout the accreditation cycle. To reduce administrative burden and streamline your accreditation experience, the CAP has updated the requirements for the Self-Inspection Verification Form.

Effective immediately: 

• Laboratories are no longer required to submit the completed Self-Inspection Verification Form to the CAP, unless specifically requested to do so.
• Completing an interim self-inspection remains mandatory. Failure to meet interim self-inspection requirements may result in a deficiency and could affect your accreditation status.

What this means for your laboratory: 

• Retain all documentation related to your interim self-inspection, including findings and corrective action plans.
• Documentation must be kept on file and made available to the inspection team during your next routine on-site inspection.

For additional guidance, refer to GEN.23584 and the Self-Inspection Toolbox available under Accreditation Resources via e-LAB Solutions Suite.

If you have any questions, please contact the CAP at 800-323-4040 or accred@cap.org.

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.