Body Fluid Validation
I was once asked by a peer from another hospital if I had
formed a plan to a new checklist question on the CAP All Common checklist. She said we now have to validate body fluids
and a disclaimer such as “This test has not been validated on this fluid type”
was not going to be enough.
According to the CAP question COM.40620; Methods for body
fluid analysis have been validated or verified.
In the note section it gave me a clue for how to accomplish this… “by
performing an appropriate study (e.g. a dilution study using admixtures of samples,
spiking samples, further dilution)”.
As my serum assays are validated, by plan was to take a representative
number of assays and make a 1:1 dilution of a body fluid and serum. Knowing the initial body fluid result, the
serum result, and the expected recovery, I would be able to calculated the
expected recovery and compare expected to realized and see if that was with-in
with-in a TAE set by my medical director.
I set up 10 specimens and tested for ALB, GLU, LDH, and TP. The chart below provides an explanation for
the needed results and a place for pass/fail criteria.
All passed and with this study tucked away I can show an
inspector we validated Body Fluids.
Hope this works for you!
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