Northfield, Ill. (Jan. 6, 2025) – The 2024 edition of the College of American Pathologists (CAP) Laboratory Accreditation Program checklists features Clinical Laboratory Improvement Amendments (CLIA) final rule changes, including revised personnel requirements and new opportunities for evaluating educational qualifications for laboratory directors and personnel. It also updates other requirements to improve laboratory quality, such as changes to better align with current CAP evidence-based guidelines.
“These checklists ensure our laboratories elevate quality, maintain accuracy, and improve patient safety,” shared Earle S. Collum, MD, FCAP, chair of the CAP Council on Accreditation, which oversees the accreditation program.
The CLIA final rule changes include removal of a doctoral degree in physical science as a qualifying director degree, and clarification that the training and experience needed to qualify for director and supervisory roles must be in the testing of human specimens. In addition to these updates, the final rule introduces new personnel qualification options, which include:
- Guidelines to evaluate degree equivalency (e.g., doctoral, master’s and bachelor’s degrees).
- Clear pathways for moderate complexity testing personnel with nursing and respiratory therapy degrees.
- The opportunity for individuals in CLIA-certified labs as of December 28, 2024, to keep their roles if they have served continuously since the final rule took effect.
- New requirements for director onsite visit frequency, when the laboratory director is not routinely onsite.
In addition to the CLIA changes, scheduled to take effect December 28, 2024, other enhancements to the checklist include:
- Updated immunohistochemistry predictive marker requirements to align checklist requirements with a recently published CAP evidence-based guideline on the Principles of Analytic Validation of Immunohistochemical Assays.
- A new requirement for participation in an annual quality assessment for pathologists interpreting certain predictive markers assays.
- Significant revisions to the Cytopathology Checklist and a new Microbiology Checklist requirement to address quality practices for primary human papillomavirus (HPV) screening for cervical cancer.
- Expanded individualized quality control plan (IQCP) eligibility to include all microbiology culture media (including media previously considered non-exempt).
“Laboratories use our checklists to deliver reliable results that support accurate diagnosis and better patient care. These changes are important to allow them to continue to provide that level of service to their physicians and patients,” stated Dr. Collum.
Updated annually, the checklists ensure laboratories stay current with rapidly evolving advances in laboratory medicine, technology, and regulatory requirements. Through this ongoing effort, the CAP continues to support its laboratory partners and their patients by delivering rigorous standards that uphold compliance while promoting excellence in modern laboratory practices. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA.
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.
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