iSTAT Acceptable Specimens

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I am wondering if specimens collected from an IV start are considered unacceptable specimens for iSTAT creatinine testing? Furthermore, if the specimen is collected in a syringe and immediately transferred to a green top tube, is it still following a waived test process, technically and regulatorily speaking?

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Hi Dean,


This is exactly our process for running waived I-STAT creatinine. Our MRI staff collect a venous whole blood sample from and IV start into a syringe. Immediately the sample is placed into a lithium heparin tube, mixed, and then resampled into a new syringe to load the CREA cartridge.


We developed our procedure right from Abbott's 'I-STAT Waived Testing Regulatory Guide', 'I-STAT 1 system manual for Waived Tests', and 'The I-STAT System and Waived Status' found in the 'I-STAT 1 System Manual'. You can find it on the Abbott Point of Care website.


 


Ruth Harmala, MLS (ASCP)CM


ruth.harmala@mghs.org


Point of Care Coordinator, Laboratory


UP Health System-Marquette


(906) 225-7492

Our imaging center starts an IV, use a vacutainer adapter and put the green top tube in to collect sample.
Then they clamp the IV line. They use Safe_Kem ( Safe Evac) to put sample into the cartridge.
As soon as the result is out, then they can inject the dye in the same line.
No transferring involved.

Pet Maniquis, MPA, MT(ASCP) POCS (AACC)
Laboratory Point-of Care Coordinator
Providence Medical Center/ Saint John Hospital
8929 Parallel Parkway, Kansas City, KS 66112
Ph: 913-596-4727; Fax: 913-596-4728
PManiquis@primehealthcare.com

From: Dean Derhaag via POCT Listserv (Groupsite) [mailto:users+1234043@poct.groupsite.com]
Sent: Wednesday, February 20, 2019 3:21 PM
To: Perpetua Maniquis (PMC)
Subject: [POCT Listserv] iSTAT Acceptable Specimens

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Thank you both for commenting. I know the iSTAT literature doesn't mention anything specifically about IV starts, but for some reason it was recommended in our testing procedure to not use IV start samples (I am the new POCT TS and am reviewing). I think Pet's process is really great. I might have to implement that in the near future, but for now I think I will leave it the same- similar to how Ruth's is performed.


-Dean Derhaag MS, MLS(ASCP)

Pat, I am not able to find Safe_Kem (Safe Evac). Can you give me more specific information on what that is and who offers it?


Betty, email me separately and I will send you the info.


pmaniquis@primehealthcare.com


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Dean Derhaag
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