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: NO. Standards state staff are assessed at defined intervals, determined by the director or supervisor, based on the frequency with which staff members perform tests, and their technical backgrounds.
Q: When must 2 levels of control be utilized and what if the machine only has the capability for only one level of control?
A: Two levels of control must be utilized on each machine every day of use, not between each patient. If the machine has only one level capability then it is probably only approved by the FDA for single patient use and should not be utilized for multiple patients.