Telehealth Clinics and Waived Testing

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Does anyone have any experience or knowledge of waived testing regulations and Telehealth clinics? We have several schools that are participating in Telehealth calls to one of our clinics. They would like to begin waived testing for Strep A and Influenza. Would we need a separate CLIA certificate for each site or can they be listed as alternate testing sites under the clinic's CLIA certificate?


 


thanks so much!

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Hi Jennifer,


I don't know what an alternative testing site means on a CLIA 116 form. ?


Are you thinking of the form 116 Part V. Multiple Sites (must meet one of the regulatory exceptions to apply for this provision)?


Under V. Multiple Sites, the exceptions include mobile units, health fairs, or temporary testing locations, or a not-for-profit or Federal, State, or local government laboratory engaged in limited public health testing and filing for a single certificate for multiple sites.


There is one more exception but that one would definitely not apply.

Thanks Peggy!

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Jennifer Detiveaux
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