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Analyser Validation AABB

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I'm currently in the process of validating a new analyser, the Ortho Vision. I have validated this particular analyser before in the UK back in 2015. Now I'm working for a lab that is currently going through the process of AABB accreditation so I want to make sure I have covered all their requirements as this is my first experience with AABB. So far I have done comparisons, reagent on-board stability, carry over for antibodies (tested up to the Ortho claimed limit of 1:1024 titre), I also intend to do repeatability, running the same samples 5 times in a row to make sure the grading and interpretation is correct, the pathologist wanted 20 but I pointed out there is no way we will get 20 runs out of a transfusion sample. This is as much as I did in the UK and we had ISO shortly after and they were very satisfied with what we had done.

As I have no experience with AABB I would like to hear from anyone who has gone through this process and has AABB experience. Is there anything I'm missing? 



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In the long ago past, we had to make up our own validations.  While not realizing we were doing so, we based them on risk assessments of the process.  For instance, what is the risk of switching your Anti-A from one vendor to another?  If you follow of the manufacturer's instructions, and they are both licensed by the FDA, the risk is close to zero.  In my humble opinion ABO QC is a waste of time.  In the tens of thousands of times I've seen it performed in our organization, it has never failed.  Regardless, yes we perform QC.

Now, you buy a complex analyzer, it is nearly impossible to develop a good risk assessment without the assistance of the vendor.

I always start by asking the vendor for a validation plan.  Some provide Word docs that you can edit for your own facility.  We always do what they recommend at a minimum, and usually more.  We've been lucky in that our vendors provides these plans.  Moving forward, that will also be part of my negotiation for new equipment, that I will ask for them to include a validation plan.

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On 10/9/2019 at 5:30 AM, Cliff said:

I always start by asking the vendor for a validation plan.  

When I asked Ortho in the UK for a Validation plan back in 2015 when I validated the Visions they wouldn't provide one as they said it wasn't allowed under ISO, UKAS who undertake the ISO accreditation in the UK confirmed this and said "verification" as they call it is the customers responsibility and the supplier should be impartial. Interestingly out here in the UAE the vendors run most of the validation/verification tests then analyse the data for you and give you the report which ISO inspectors here seem perfectly happy with. So much for international standards!

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