Multi-aircraft Multi-site CLIA Lab Type
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Does anyone manager the CLIA(s) for medical helicopter/aircraft that operate out of multiple locations?
Background: We provide support for a third-party company that has several helicopter and fixed-wing aircraft that utilize iSTATs during critical patient transport. These aircraft operate out of several locations, and one site is not geographically close to the other two. This operation has three iSTATs. Historically, these were all under one CLIA, with facility type classified as ambulance. Although I have recently taken over CLIA maintenance, our system regulatory office is now stating that each of the locations require their own CLIA license because the iSTATs "live" in different locations. I will be asking my state contacts for clarification, but I know they are backlogged, so I was hoping someone here has experience with this type of set-up and can provide some insight on the type of CLIA and whether they are typically separate based on physical location of the POC devices.
Background: We provide support for a third-party company that has several helicopter and fixed-wing aircraft that utilize iSTATs during critical patient transport. These aircraft operate out of several locations, and one site is not geographically close to the other two. This operation has three iSTATs. Historically, these were all under one CLIA, with facility type classified as ambulance. Although I have recently taken over CLIA maintenance, our system regulatory office is now stating that each of the locations require their own CLIA license because the iSTATs "live" in different locations. I will be asking my state contacts for clarification, but I know they are backlogged, so I was hoping someone here has experience with this type of set-up and can provide some insight on the type of CLIA and whether they are typically separate based on physical location of the POC devices.
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I would highly recommend connection with CMS or your state agency on clarification of your specific situation. This was just my outcome.