Which statement about competency for non-waived testing is true?

Which statement about competency for non-waived testing is true?

• A. It is required for the CLIA director.
• B. It is not required for physicians in their specialty.
• C. It should be performed and documented annually for all operators.
• D. It should be performed initially after 6 months, then annually.

Answer: (C)

Non-waived testing demands that anyone who performs the test demonstrate their ability to do it correctly, and this performance must be documented. You establish competency before a person starts testing and then recheck it at least annually to ensure continued accuracy, especially as methods or instruments change or if problems arise. The statement that competency should be performed and documented annually for all operators best reflects this ongoing, universal requirement across everyone who performs non-waived tests. While the lab director has overall responsibility for ensuring compliance, the competency process itself applies to all individuals who perform the testing, not just the director. Physicians who perform non-waived tests also need to be competent, with no exemption based on specialty. Initial competency is not typically delayed until six months; it should be proven before testing begins, with annual re-assessments thereafter.

Non-waived testing demands that anyone who performs the test demonstrate their ability to do it correctly, and this performance must be documented. You establish competency before a person starts testing and then recheck it at least annually to ensure continued accuracy, especially as methods or instruments change or if problems arise. The statement that competency should be performed and documented annually for all operators best reflects this ongoing, universal requirement across everyone who performs non-waived tests. While the lab director has overall responsibility for ensuring compliance, the competency process itself applies to all individuals who perform the testing, not just the director. Physicians who perform non-waived tests also need to be competent, with no exemption based on specialty. Initial competency is not typically delayed until six months; it should be proven before testing begins, with annual re-assessments thereafter.