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CLIA / CAP / Proficiency Testing


Bet'naSBB
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We are a large blood bank in an academic medical center.  Our blood bank does just about everything in the lines of testing with exception of testing related to donors (we don't collect donors).  That being said - we get quite a few CAP proficiency testing surveys.  YEARS ago (>10) the individual samples in the PT Kits would get divided up amongst the staff where each "sample" was tested by a different tech.  In comes CLIA for an inspection of the entire Clin. Path department and they say that ONE individual must perform ALL the testing associated with the kit.  Meaning if the kit comes with 5 samples, one tech must complete ALL the testing on ALL 5 samples.  We are now under new management and are curious if other Blood Banks have experienced the same thing?  Our AABB inspector told us we were asking for trouble, and also eluded to the fact that we could get cited by CAP for doing it the way CLIA says we have to......  We have yet to find another lab that follows these CLIA "rules".

Just searching for a little "clarification"

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Interesting.  I've never read anything on that and couldn't find a reference to it either.  I've always divided my samples up so I can also use them for annual competency for the techs.

Here's the CLIA/FDA piece: https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493/subpart-H

And from the CLIA PT booklet it says: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/cliabrochure8.pdf

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Edited by RRay
adding info
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 I'd go up the food chain ladder and consult with this inspector's supervisor. 

Clearly if the lab receives five samples, giving them all to one technologist does not in any way mirror clinical practice, and thus violates the regulations. Thus my initial take on this is that is another extremely bad idea from an inspector who has no idea what they are doing. Sort of the old joke about some physicians:  "Occasionally wrong, but never in doubt." :)

Edited by Neil Blumberg
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It's not uncommon for inspectors/assessors etc to come up with their own interpretations.  Before I would bother making any changes I would certainly do as Neil suggested and go up the food chain for clarification.  Actually, my first inclination would be to ignore this on the chance you never see that inspection person/team again.  If you do need to respond in some manner then "we're looking into it" should buy some time for confirmation.  Best of luck.

:coffeecup:

 

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Well - just to follow up - we approached our Laboratory Compliance team to see what they knew and their response was. "we don't remember, but it was a "BIG DEAL".  :no:We then discussed with the Pathology Medical Director (he was the director when this happened) and he had some insight and suggested contacting the hospital's CLIA person (who was the same person who mad this "decision")

Our Path. Med. Dir. emailed them and - lo and behold - they were perfectly fine with it....... :eyepopping:   Needless to say, that email has been sent to compliance and is now added as an attachment in our QP manual so no one can dispute what we all think is correct!

Thanks for letting us know that we weren't crazy in our thought process!

 

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