i-STAT BHCG Cartridges and Proficiency Testing

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Good afternoon,

What is everyone doing in regard to the i-STAT BHCG backorder? We've had one CAP proficiency testing shipment during the timeframe of this backorder. Used Exception Code 11, but CAP didn't give much advice on how to handle once the cartridges are off backorder (other than can find an alternative proficiency testing at the time the cartridges come off backorder). We've saved the samples, but obviously they will be out of stability. I'm reaching out to API to see if they may have any blind/survey samples for us that will still be stable hopefully if the BHCG comes off backorder this month or next. Just looking to see what our peers are doing. Thanks so much! 

3 Replies

You can run the CAP samples after the fact and compare the expected values. Write up any discrepancy

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I just received my 2nd survey that I'll need to use Exception Code 11 on.  I'm starting to worry that these cartridges are never coming back.  Has anyone heard anything about a restock date or why they're even on backorder?

Good morning, 
I would find out the stability of the samples from CAP and if you are able to freeze them.
Run the samples once you receive your cartridges.
If you pass your deadline for submission, perform a self-evaluation and compare your results to the evaluation from CAP.
Attach your self evaluation and all communication sent to you for back order for inspection purposes

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Joy Truong
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