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.

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Hi Tracy! I have had some recent experience with a CMS inspection that was directly after our CAP accreditation inspection. Note: I am in Michigan. While we have ground ambulances, what I can contribute is how this situation applies to the CMS-116 form filled out for the CLIA. In section V., where you must select if you are applying for "Multiple Sites", where you indicate which of the following regulatory exceptions applies to your facility's operations. You can only select one option out of the three. The form does not state that yet but I did request it be updated. We had selected #1. not at a fixed location and #3 as a multisite...but that was not allowed and we are in the process of obtaining a CLIA for our mobile units. there is more clarification described in  CLIA requirements described in 42 CFR 493. 493.35(b)(1-3), 493.43(b)(1-3) and 493.55(b)(1-3) Hospice and HHA could qualify for an exception. 

I would highly recommend connection with CMS or your state agency on clarification of your specific situation. This was just my outcome. 

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Tracy Tuzzolino
14 days ago
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