Competency assessment for personnel performing moderately complex testing (which is the majority of non-waived POCT) is the responsibility of the technical consultant. This is the requirement for CLIA compliance. The laboratory director may act as the technical consultant and may perform a competency assessment IF the director also meets the personnel qualification requirements of education, experience, and training for the position in order to fulfill the responsibilities. Qualifications for a technical consultant are defined in 42 CFR §493.1411. The laboratory director bears the responsibility that all competency assessments are completed and that the testing personnel is competent and consistently reports accurate test results.
Competency assessment may also be performed by any personnel that would qualify as a technical consultant, but do not serve in that role. Testing personnel who are peers may serve in the role of assessing competency IF the qualifications for a technical consultant are met.
