Friday, July 3, 2020

What's an "instrument qualification" and should you think about getting one?

Whoa. This blog has suffered due to the fact that I'm just tired of writing. Or just tired. One of those. My last shift in clinical chemistry was over a dozen years ago and while the instruments have gotten much much much better, the amount of paperwork necessary to prove that your assays are valid when it really counts has....gotten better if you are thinking about thoroughness (the most important part) and...hmmm.... nah...not sure where I was going with that. I'm sleepy even though I'm staying within walking distance of my lab so I can be here ALL THE TIME! WOOOOOHOOOO!

What I thought would be interesting to ramble about over lunch is INSTRUMENT QUALIFICATION (sounds the oppositive of interesting, right? However --did you know that when you get a new instrument that you can purchase a whole ton of extra installation things to verify that your instrument does everything that you assume that it should?

It's called an "Instrument Qualification Package" and basically every vendor offers these. If you aren't in a clinic or some other regulated environment, your sales rep might not bring it up, but I think it is something everyone should at least consider with their new instrument purchase:

Why would you do this? A bunch of reasons
1) You get a bunch of stickers that are signed by a special Field Service Engineer who is approved to check all these aspects of your instrument
2) You get this special FSE around for days. After my installs I got 2-4 extra days of onsite time with an FSE who reeeeeeaaaaaally knows that instrument inside and out.
3) You get hundreds of pages of extra documentation on your instrument and its specifications:

This is just the extra documentation on the Q Exactive. What's in it? Tons of great information! 

What about a pressure test of your LCMS system and it's linearity? Do you get that during a regular install?

(Maybe they do it, but I've never gotten a hand signed report and comparison to factory data!)

Sensitivity metrics compared to factory specifications? Heck yes, you get that too!  My new QE has a really great S/N vs spec (due, primarily to low noise levels, which is likely temporary, but how cool is it to know that?)

Even cooler, maybe, is the fact that you get your software installed and pressure tested!

This might only be for targeted or for EFS/Clinical stuff, but I'm not sure. The FSEs brought their own data and processed it through the versions of software that they installed to verify 1) the software all works right and 2) it produces the data that it should AND 3) they left the data. You can quickly master the software by trying to replicate their results. How often have you wished you had a good file set for learning your new instrument software with? Turns out you can just buy that.

On top of all of this -- there are certain lab certification processes where all this information is required. Without it, you can't get contracts or jobs for some government agencies, etc.,

Worth noting, this is not free. For 3 instruments this was around $30,000 USD extra, something that I was initally annoyed about --- but I got close to 12 extra days to annoy some of the vendor's top engineers with days of uninformed questions about the inner workings of these boxes. And they installed all my software and gave me over 1,000 pages of paper, much of which they personally signed. In the end, I'll definitely do it again. Maybe soon, cause the new Exploris systems are surprisingly affordable (no joke, if you're thinking about any mass spec this year you should get some new Exploris quotes, you can score one [with a D20!] for less than most vendor triple quads.'re giving up some functionality as the number on the front of the box decreases....but I'll take a quad-Orbi that has recently been on actual fire (or possibly currently is on actual fire) over most unit resolution instruments, but if you've had the misfortune of being on this blog much, you already knew that)

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