NORTHFIELD, Ill. (December 10, 2025) — The College of American Pathologists (CAP) has released the 2025 edition of its Laboratory Accreditation Program Checklists, emphasizing patient safety and regulatory clarity through updates that reflect advances in digital pathology and specimen self-collection.
“When a laboratory follows our accreditation checklists, patients can trust that every test has been produced under rigorous quality standards.” said Earle S. Collum, MD, FCAP, chair of the CAP Council on Accreditation, which oversees the accreditation programs. “Accreditation directly supports patient safety by minimizing errors and helping ensure the right diagnosis and treatment every time.”
New provisions to the 2025 Checklist Edition support digital pathology, remote data review, and specimen self-collection which will help laboratories to confidently integrate emerging technologies. At the same time, regulatory updates aligned with recent Centers for Medicare & Medicaid Services (CMS) clarifications simplify compliance and modernize personnel requirements.
Key updates include:
- Digital Pathology Including Remote Data Assessment: This section now includes expanded introductory text with new use cases across laboratory disciplines and revised requirements addressing factors that may impact the quality of images and data used for final interpretation.
- Specimen Self-Collection: A new Phase II requirement addresses the self-collection of specimens by patients, including those collected with caregiver assistance. Laboratories must provide written instructions that address quality issues potentially affecting testing. The requirement covers a broad range of specimens suitable for self-collection, such as vaginal specimens for HPV testing.
Updated annually, the CAP’s accreditation checklists help laboratories and biorepositories stay current with advances in pathology and laboratory medicine, including technological advances and regulatory expectations. Through this ongoing effort, the CAP continues to strengthen patient safety and support laboratories in delivering accurate, reliable results that guide patient care decisions.
The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA.
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About the College of American Pathologists
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.