OraQuick In-Home Test Kit

Here is what I found.
https://www.cms.gov/files/document/over-counter-otc-home-testing-and-clia-applicability.pdf

I have the OraQuick Advance HIV-1/2 Rapid Antibody test on my desk now to evaluate at the request of our teen clinics. This is a waived test to be used as POC in clinics. I am trying to implement but I am having problems with sales reps returning my messaging. One left the company and the new one may have as well because I have not heard back from them yet. 

Response: Yes, a facility where a staff member is performing testing and/or interpreting / reporting test results needs a CLIA certificate to perform testing, even if the test is authorized by the FDA for home use. This includes testing using OTC home tests performed by someone other than the individual in a facility.

It's not so much whether the test/kit is rated as "in-home" use, but rather the CLIA complexity, waived vs. non-waived.  Yes, most "in-home" tests are CLIA-waived.  But anything other than self-testing constitutes the need for an ongoing CLIA Waived Certificate in any health care facility, from the federal government.  You can have the clinic doing any test they want, waived or non-waived, provided they have the appropriate CLIA certificate and meet all the requirements.  I definitely would not recommend a clinic/physician office performing any test that does not have CLIA-waived status.