Body Fluid Chemistry validation issue.

[Torsed]

Interestingly, a sister hospital's laboratory got dinged on a CAP inspection for not validating body fluid chemistry. Now everyone in the system is freaking out about this silly citation.

Apparently, body fluids other than CSF in Chemistry do not share the same QC matrix as serum, plasma or CSF so therefore, there is no QC material available commercially to purchase.

There is the suggestion now that body fluids cannot be ran in-house due to the fact there is no QC material available to ensure our hospital lab is running and resulting out accurate results.

The lab supervisors want to discontinue testing which would jeopardize our pulmonologists as they rely on total protein and glucose in body fluids for trans/exudate etc.

In researching this, it seems only big labs like Mayo have validation. I think that these are staples of diagnostic medicine, not sure why there are not good methods to validate. Sounds like to me an inspector had an axe to grind.

Does anyone have any similar experiences or opinions, I'd love to hear them. Thanks.

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[chooks]

Yes. Similar experience. My understanding is that the FDA clearance for those assays is specific for serum/plasma/CSF. Usage for other specimen types would constitute an LDT under current standards and would hence require a more extensive validation plan than those for the FDA cleared uses.

I believe that certain companies do provide some materials for AMR and linearity on body fluids -- not sure if those would also double as QC (probably since they are assayed) or what you do for PT (maybe CAP offers, not sure -- otherwise figure out an alternative assessment).

We d/c body fluid testing and send to reference lab now (TAT < 24 hours typically) and have not had any complaints. Except for one guy looking for amniotic fluid chemistry (which has been ordered once in maybe 5 years) and another one looking for creatinine levels on JP drains.

 

[Pingu]

We got the same citation on our CAP inspection. We also had to d/c testing and send to a reference lab. Our only complaints have been from the guy who will complain about anything.

 

[Napoleon1801]

Similar issues here too. We mostly send these out to the reference lab for that exact reason.

 

[wholeheartedly]

It might seem silly, but I worked at one of those "big name places" as lead on several body fluid validations and it turns out it's not so silly and those matrix differences can have huge impacts on results. We saw major differences in specimen stability, precision, linearity and dilutions primarily, but there were other surprises as well. I'd like to see the analyzer companies such as Roche and whoever validate some of the more common body fluids. Validating body fluids was a pain because there was often something behaving strangely and they wound up requiring much more work and troubleshooting.

There was also some discussion if x,y,z facility validated say synovial fluid and published in a peer rviewed journal could that make it ok for other places to test those fluids. Some companies make body fluid matix QC but we didn't use those when I was there (except your standard urine and csf). My former lab director published a small guide to validating body fluids if there's more common ones you'd prefer not to send out. We routinely got consulted to help outside facilities and while it's been a couple years since I've worked there, I'd be willing to try to field any questions you might have.

 

[AZpath]

VALIDATE&REG PRODUCTS

www.mainestandards.com

Our lab manger found this company that provides validation materials for body fluids.

 

[Torsed]

Thank you for the link to that company, AZPath, very useful. I do appreciate it.

Good insight wholeheartedly. If I have any ? I'll pitch them.