Age rrequirements for waived testing

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Have any of you heard of a requirement that persons performing waived testing be at least 18yrs. of age? We have some 16 & 17 year old nurses aids and I would assume that as long as they are trained, they can perform testing.  Thoughts?

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Unless it says explicitly in the manufacturers directions that testing personnel must be 18+, there is no CLIA regulation (to my knowledge) stating anything about age requirements for testing personnel.

I should have also mentioned that you should check with your legal department if you think there is a state specific law regarding minors performing diagnostic testing.

Doesn't CLIA say that they must have a high school diploma to perform waived tests?  Are they high school graduates at 16?

I am not aware of a "Waived" category in the testing personnel qualifications section of Subpart M.


Here are the minimum moderate complexity laboratory requirements:


(i) Have earned a high school diploma or equivalent; and


(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Such training must ensure that the individual has...

"The Joint Commission standards require compliance with the personnel qualifications specified in the Centers for Medicare & Medicaid Services (CMS) Clinical Laboratory Improvement Amendments (CLIA). These personnel requirements differ depending on the complexity of testing an individual is performing, specifically waived, moderate or high complexity testing. Moderate and high complexity are sometimes discussed together and referred to as "non-waived" testing.

For waived testing, the federal regulations do not specify the education requirements and an organization may establish its own. The organization must maintain evidence that the testing personnel meet the education requirements established by their job descriptions."


From The Joint Commission Website


No age specified. Educational attainment specific.


High school diploma or GED for waived and moderate complex tests; Biological Sci, ,MD, PHD  for high complexity.


I would check with your state's department of labor. There may be restrictions on age and their use of the sharps (lancets) and/or chemicals.

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Lisa Bain
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