Summary: The 2024 CAP Laboratory Accreditation Program checklists integrate key CLIA final rule changes, revised personnel requirements, and updates to align with CAP evidence-based guidelines, ensuring labs deliver high-quality results.
Takeaways:
- CLIA Final Rule Updates: The updated rules clarify personnel qualifications for lab directors and supervisors, introduce new degree evaluation guidelines, and expand role retention options for current CLIA-certified lab personnel.
- Enhanced Quality Measures: Checklist revisions include immunohistochemistry updates, new quality assessments for pathologists, and improved practices for HPV screening.
- Annual Checklist Revisions: The CAP’s ongoing updates ensure laboratories keep pace with advancements in medicine, technology, and regulatory standards to maintain compliance and excellence.
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,” says Earle S. Collum, MD, FCAP, chair of the CAP Council on Accreditation, which oversees the accreditation program.
New CLIA Final Rule Changes
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.
Additional Checklist Updates
In addition to the CLIA changes, which took effect Dec. 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,” says Collum.
Further Reading
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, says CAP. The CAP is a CMS-approved accreditation organization with deeming authority to inspect laboratories under CLIA.
Photo courtesy of CAP
