News and Updates Affecting Laboratory Customers

April 13, 2026

The CAP will be transitioning to a more sustainable and efficient process by delivering the following documents via e-LAB Solutions Suite (ELSS), discontinuing the distribution of printed copies by mail:

• Laboratory Inspection packets
• Self-Inspection packets

The Accreditation and Inspector Inspection packets will continue to be mailed until further notice.

An email correspondence was sent to all CAP-accredited laboratories as well as laboratories seeking accreditation, with additional information regarding the transition, including a Frequently Asked Questions resource.

February 10, 2026 

Last week, Congress passed the Consolidated Appropriations Act of 2026, delaying the planned Medicare cuts to laboratory tests until 2027. While payment reductions are on hold, clinical laboratories must now prepare for upcoming PAMA reporting requirements.

Certain laboratories will be required to collect and report private payer rate data to the Centers for Medicare & Medicaid Services (CMS). This data will be used to calculate future Medicare payment rates under the Clinical Laboratory Fee Schedule.

What data is required 

• Private payer rates for applicable laboratory tests
• Data collected from January 1–June 30, 2025

When to report 

• Data must be submitted to CMS between May 1 and July 31, 2026

Before taking action, laboratories should first determine whether they meet the definition of an "applicable laboratory" under the revised PAMA rules.

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. 

May 26, 2026

Ongoing conflict in the Middle East and related airspace restrictions continue to disrupt proficiency testing/external quality assessment (PT/EQA) shipments across parts of the Middle East, Africa, and South Asia.  

These disruptions are affecting delivery timelines for some laboratories.

We recognize how this affects laboratories and are actively working to address these challenges.

What's Happening

Extended transit times and shipment holds are affecting delivery of time- and temperature-sensitive PT/EQA kit materials to some destinations.  

As a result, some shipments are delayed and others cannot be delivered as planned.

Who Is Impacted

This update applies to laboratories receiving College of American Pathologists (CAP) PT/EQA shipments to affected areas of the Middle East, Africa, and South Asia.  

Impact varies by country, carrier routing, and the specific PT/EQA event.

What You Should Do

If your laboratory is affected, take these steps:

• If your materials arrive, test immediately.
• Monitor shipping notifications. You will receive updates when shipments are released and moving.
• Review your evaluation details in e-LAB Solutions Suite (ELSS) on cap.org for program-specific instructions.
• Contact your distributor or CAP support if you need a shipment status for a specific event.

What the CAP Is Doing

The CAP is working with logistics partners and conducting pilot shipments to assess transit reliability.

We are taking steps to resume consistent delivery as shipping conditions stabilize in the region.

We will continue to monitor conditions and share updates as they become available.

Need Help?

Need help with your PT/EQA shipment or program requirements?

Contact the CAP Customer Contact Center for assistance with shipping, code 55 assignment, or alternative assessment options based on your 2026 enrollment. 

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.