November 05, 2025
AABB’s Accreditation Department is updating its policies to reflect the revised CLIA requirements outlined in QSO-25-10-CLIA. Facilities may now perform virtual direct observation for competency assessments if permitted by law, provided all existing requirements for in-person assessments are met. This includes adherence to process steps, documentation and record retention.
Facilities should review and update their competency assessment policies to include protocols for virtual observation, ensuring alignment with CLIA regulations and AABB standards. Documentation should clearly indicate who performed the observation, the technology used and verification that all required steps were completed.
AABB reminds facilities that delegated competency assessments must be performed by personnel meeting the regulatory qualifications of a technical consultant, technical supervisor or general supervisor.
AABB will continue to provide education and guidance on implementing these updates. Facilities with questions about CLIA responsibilities or regulatory qualifications may contact AABB Accreditation via email.