vendors/shippers asking for CLIA certificates

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We have recently had some supply deliveries severely delayed only to find out that the vendor or drop shipper requires our CLIA certificate before they will ship. This last request also required the MN state pharmacy license?? Also, then because our deliveries are shipped to the address at the loading dock, the address on the CLIA doesn't match the shipping address so we have to provide clarification that this is a loading dock. 

Has anyone else had this happen? Is there some new CMS ruling that we are unaware of? We have been near to running out of test supplies due to this. 

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This is the first that I am hearing of this. Which CLIA certificate does your lab have? Mine are all certificates of waiver.
Interested in others response.

I have never had this problem (yet).  Which vendors/shippers asked for this information?

So far I have not had any POC shipment issues. This was for a couple products for our main lab - so high complexity. It's been Abbott products so far but it doesn't seem to be an Abbott request? The email says it's a UPS policy which seem very strange.

There is an order (below) that is being held due to a new UPS policy for CLIA documentation.  The delivery address does not have a registered CLIA number and therefore UPS needs confirmation that this a delivery / warehouse and testing is done at 2525 Chicago Ave, Mpls, MN.   
The current order (below) is on hold due to the shippers new requirements with CLIA verification.  We are in need of your assistance in obtaining the CLIA for the location address below. Our team has been unable to complete the CLIA validation required for this request for this Cardinal dropship order.  We cannot release the order for shipment until completed.  

Note – address on CLIA must match Ship to address on order.
Exceptions:
  • if multi location CLIA – must provide additional documentation with list of all covered locations
  • if warehouse or central receiving location, then must provide CLIA (and other license requested) for the location product will be used and that will be completing the testing and a brief explanation from customer that the location is a warehouse, etc.

Several months ago I asked generically (no company name) if anyone had been asked to supply a CLIA Certificate in order to receive a product. If I didn't ask here then I posted the question to the AACC Artery. I didn't get replies that anyone else suffered my fate.

Yes, so far only one company - Abbott; yes, a POC product (waived complexity, ID NOW strep/flu/RSV) which we've been ordering since 2019 and never was asked for a CLIA certificate by either of the 2 distributors we've used for the product. At first it was only a 'promo'/product which didn't get delivered related to CLIA info having to be collected. But now we learned that instrument replacements also are held (I'm waiting for 4 replacements I was told 2 months ago that we'd get and have had the return shipping labels for 1 month at least).

Our understanding is that the shipper requiring the CLIA info is UPS. We have been unable to find out how/on what grounds they are allowed to require the info.

I'm sure in many 'CLIA labs' it would not have gotten so complicated because the CLIA Certificate 'lab address' and the shipping address are the same. But for us, that is often not the case. 
 
The customer has to find a way to produce the documentation required (which is not sent out from CMS/CLIA at the time the CLIA Certificate is sent).  

[Note - this post is solely a statement by the poster/me and not coming from the entities involved or my institution.]

Hi!
We did have to provide this information to our distributor for all our clinics when we were getting our Cepheid FLUVID and COVID shipments.  My understanding was that it was because it was EUA.  Danyel, was the shipment an EUA test or did it include EUA testing? Mary

This was not for EUA products. Something the lab had ordered multiple times. 

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Danyel Olson
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