i-STAT validation plan
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Hello! I am not new to the lab and validation world but I am new to POC. I am looking for someone who can share their current validation plan for their iSTAT who runs cg8, cg4, and chem8. I am at lost since the previous supervisor did not retain any information and I am not sure how to proceed with my validation. Thank you in advance!
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I do not know the size of your organization and volume. Sales rep usually help with validation (they do the testing and data crunching), training and in-service. It helps to work with company sales rep and ask for a much support as you can get to make your life easy.
Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt
Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
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In general, I always reach out to the manufacturer for suggested validation information. Even with waived instrumentation the manufacturer usually has recommendations and most standards require manufacturer recommendations at the least.
Hello,
As someone else indicated Abbott technical rep can help crafting a validation plan and will often help with executing it as well if you have new instruments (especially if you are buying a large fleet). If that's not possible then I'd suggest you do simulator check, calibration verification, then check at a minimum for linearity, precision, accuracy/correlation. The chemistries are easiest, you can use split samples or draw heparinized blood, use whole blood on istat , then centrifuge each sample and have lab use plasma for comparison (Chem 8 and chemistries in CG8). Compare iSTAT hematocrit with your hematology analyzer (split samples on same patient). ABG might be hardest, but remember you can validate a new iSTAT against a current validated iSTAT as well. So you'd basically run ABG on both devices at the same time. The iSTAT manual or Abbott Technical Service might have an entire Validation protocol outlined, so I'd start by checking that. If you have several iSTATs consider performing an IQCP as well- different issue, but also a consideration after validation.
1) External Simulator on all ISTAT's to be validated for the testing
2) Abbott Calibration Verification on all ISTATs to be validated
3) Tricontrols QC for Precision on all ITSTATs to be validated. 10 QC of each level on the sameday. Then, QC in duplicate for 5 days for each level.
4) We start the QC study for IQCP by running each QC 1x/day for 40 days and we alternate this between the ISTATs being validated and the operators training. We have our IQCP set for 30 days but go to 40 to allow some flexibility as we didn't want to hold ourselves to every exactly 30 days.
5) 25-30 patient correlations between all the ISTATs being validated, as well as against the Chem and Heme reference analyzers in Main Lab. Include more if some analytes do not pass. This is common with some of the analytes in those cartridge types.
6) Reference Range study - we use the same in house ranges as Core Lab so we write up a statement about that and we make sure to include how many patients we ran that fell within those ranges.
Our medical director will look at the validation plans supplied by Abbott, but usually changes up some of it to include more than what Abbott would do.