Istat new meter validation

QC for 20 days is out dated. IStat has a procedure for new meter validation, it involves Cal verf, simulator, Accuracy and precision run two levels of QC in duplicate for 2 days.

Michelle,
Unless this is your first analyzer or new test analyte, the test validation does not have to be intensive.
Towards the back of the attached document is how you validate additional or replacement analyzer.
The 20 day QC testing can be used for the day -to day precision but it was also a requirement for EQC ( Equivalent QC).
EQC went out the door on Jan 1, 2016 and is replaced with IQCP.

With the attached protocol, you do linearity, QC for 2 days in duplicate, do comparison with other meters ( and your main lab analyzer) .

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

Thank you! I read our policy and procedures and thought this was a little too intense. I will recommend this to our director and make necessary changes.

Definitely the 20 days is overkill.   As for the QC for 2 days, according to the clinical specialist I worked with, it is not required or recommended, rather simply an additional option for customers.  I even think that document is no longer available or has been clarified.  We have always done the external simulator, AMR on the CHEM8 and CG4 to cover all analytes and a patient correlation with a previously validated iSTAT.  That was what was written into our IQCP and accepted by the lab director.   ivy

If this instrument is used for non waived testing, you should follow your lab policy on validation.  There are specific validation requirements for non waived testing instruments

I am interested in how  many meters  everyone is using for iSTAT to iSTAT comparisons? Trying to help someone else out and let them know what others are doing.

Valerie Kornegay

Oklahoma State University Medical Center

Tulsa, OK 74127

vkornegay@osumc.net

918-599-5140

According to the iSTAT implementations manager that I spoke with. If it's just an additional or replacement analyzer, you can do with one is to one. As long as you do the 2 levels of QC on 2 consecutive days, and cal ver as needed ( if it's for CHEM8+ or ABG cartridges) and one validated istat against an additional istat or a replacement istat.

If it is a new test that needs validation in-house(meaning the test itself is new in the facility even if the analyzer is not). You have to follow your institution policy in validating a new instrument, which I believe requires a ( minimum of 20-30 samples depending on the test cartridge according to the manufacturer's) but you do correlation istat to istat 1:1 ratio or just a representative set of analyzers, from what I have gathered as long as the analyzer had been tested with at least one sample.

 Hope this helps but you might want to contact your implementations manager and check the iSTAT system performance verification protocol in the APOC site.

I am going to bring ABGs over to the iSTAT since we already have a meter in use. Our ABG volumes are very low so a desktop analyzer is too costly to maintain. The problem is how to obtain samples to run correlations with our current ABG analyzer. I could try drawing up some venous samples from vacutainers into syringes or getting samples from a local hospital does anyone know of a synthetic, commercial product that could be used? Does anyone have any other suggestions?