GEM7000 Validation Question
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Let me preface this with I have only worked in a clinical lab for 8 months, and thus am new to everything.
I am validating our new GEM7000 Blood Gas Analyzers. I am told that I need to validate venous, arterial, capillary and cord samples as those are the ones we will be testing on the floors. My question is, what do I actually need to do to validate these sample types? I know that is a naive question, and that I sound quite ignorant to this topic, but I am lost. No one else in my lab has ever worked with these analyzers and is unfamiliar with this process too.
I appreciate all the help I can get right now, and please go easy on me (again, just a baby here). Thanks!
I am validating our new GEM7000 Blood Gas Analyzers. I am told that I need to validate venous, arterial, capillary and cord samples as those are the ones we will be testing on the floors. My question is, what do I actually need to do to validate these sample types? I know that is a naive question, and that I sound quite ignorant to this topic, but I am lost. No one else in my lab has ever worked with these analyzers and is unfamiliar with this process too.
I appreciate all the help I can get right now, and please go easy on me (again, just a baby here). Thanks!
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Honestly, we did not compare capillary or cord samples during the validation since it is difficult to get samples and most likely they comparison results most likely will not meet our allowable acceptance criteria. Werfen actually performed the validation for/with us.
Word of caution coming from years of experience: The vendors will typically tell you what they think is required to validate that their analyzer is functioning correctly. This does NOT always line up with what is regulatorily required. In a few cases that I've been involved in, when vendor was shown the actual regulations that dictated what need to be done, they still argued against them.
Thank you for that word of caution. That actually gave me a bit more direction. We are implementing the GEM7000, Avox, and Hemochron at the same time, while also building a new lab from the ground up. So I am very overwhelmed and learning everything as I go.
Do you have another blood gas analyzer methodology to compare with?
Do you have easy access to the specimen types you need to validate?
The blood gas analyzer currently used is at our reference lab. I do have an Avox for co-ox and the iSTAT for the rest of POC blood gas. We have already correlated venous to those. As for arterial, cord and capillary, I don't have easy access to those specimen types. RT may be able to help me get arterial and potentially cord, but capillary will have to be from volunteers. We currently only have an interim lab director and our medical director works for our reference lab and has not answered my questions yet, so I will ask my interim director again what they would like to see happen for these other sample types.
I had already talked to everyone I could in my lab before asking the question here. I now have my answer thankfully!