Q: Do the waived testing standards apply when the staff use the patient's glucometer?
A: Yes. CLIA has determined that the standards apply when staff utilize machines owned by staff, owned by the organization and owned by the patient in performing waived laboratory tests. If staff are providing only standby assistance, instruction or cueing then the standards do not apply.
Q: Do staff have to have annual competence assessments for waived testing?
A: Yes. Standards PC.16.30 EP 5 states "Competence is assessed according to organization policy at defined intervals, but at least at the time of orientation and annually thereafter"..