Replacement meter

We run the simulator, then a linearity for ABG, chemistry/Hct, and the cardiac cartridges. I also throw in a hyperbaric level of QC to verify that end of things on the ABG.

Jillian, probably not the recommendation that you will want to hear, but........

If you are speaking specifically about the i-STAT, your initial validation took care of the individual test cartridges.  When replacing the handheld meter, you simply need to validate that the electronic functions are working appropriately, unless your accreditory agency, state or local governing body indicates a more detailed process.  That being said, I strongly encourage you to have a policy in place that provides your facility's individualized process for each type of POC device and what is required for each device.  For the i-STAT you may simply run the Electronic Simulator and two levels of QC material for each test cartridge utilized on that specific device.  Some facilities may choose to run multiple levels of Cal Verification material....you decide.  For a urinalysis instrument, you may require 5 runs of both normal and abnormal QC material in a precision run in one day.  If you have an IQCP in place for any device, you would want to reference that risk assessment.

For every response you get, you will have a different recommendation.  You need to have a guidance document and follow it.  The process can either be a stand alone document, or incorporate the replacement process into your instrument specific SOP. An inspector may ask about your written process and validate what you do/did matches.

Best wishes.

Verification of new - replacement handhelds.6.16.15.png

Jillian,

     I got this from listserv a while back.  See link above.

 i-STAT Technical bulletin Art 720619-00B " Verification of Additional New or Replacement Handheld

Hope it helps.

Lois Snider

This is part of the technical bulletin from i-STAT.
This is what I follow when I have to replace a meter or add new ones.

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

I kindof go over the top for our IQCP.

Check page 6

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

I still can't find this bulletin and what page 6 are you talking about.

Sent via Groupsite Mobile.

720625-00D ACT pv.pdf 720624-00F (PTINR).pdf 720619-00D chem abg hct pv protocol.pdf

This is what I was sent from Abbott.  Where she is speaking of is about page 6 on these documents I believe.