US lab accreditation rules updated

Among these are revised personnel requirements and new opportunities for evaluating educational qualifications for laboratory directors and personnel.

Also updated are other requirements to improve laboratory quality, such as changes to better align with current evidence-based guidelines from accreditation and lab inspection authority, the CAP.

“These checklists ensure our laboratories elevate quality, maintain accuracy, and improve patient safety,” shared Earle S. Collum, chair of the CAP Council on Accreditation.

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, new personnel qualification options include:

• Guidelines to evaluate degree equivalency
• Clear pathways for moderate complexity testing personnel with nursing and respiratory therapy degrees.
• Opportunity for individuals in CLIA-certified labs 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.

The changes took formal effect on December 28, 2024.

“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 Collum.

Pic: Charlotte May