ACT re-validation after repair

Are you doing 10 levels of QC or 10 consecutive days?

I have done 10 consecutive days of QC plus patient correlation side by side with an in-use meter.  However, the staff in our cath lab got (understandably) exasperated with this, so switched to a heparin response curve.  That too, is very cumbersome.  Wondering if just the liquid QC is enough?  This seems to be fairly arbitrary.

I think it is a requirement that you do some sort of testing.  I believe the heparin response curve is needed but I don't know where I read it.  I was wondering if we needed consecutive days or if 10 levels would work.  I can't find the standard for this.

I have an ACT analyzer I am currently putting back in to service after repair.  I did a heparin curve and am running 10 days of QC.    I was told that I also need to do comparisons with the other analyzers used in the same area.   Fortunately, my 6 month comparisons are due so this will count as that too.

I was told by Accriva that when they come back all that is needed is a precision study of 10 level 1 and 10 level 2. They say you can also run a correlation sample but that is up to each lab.

Word I recieived from Accriva stated to do a precision of level 1 and 2, passing with a CV%=<14%; and a instrument to instrument correlation, passing with a diff = <10.

I have done this all in the past, but seriously this instrument lacks precision.  I call it the "wind sock" of coag testing.  Accriva's own literature on their website states that the heparin response curve is never linear.  So, why is it valuable??

Direct from Accriva I was told that the heparin response curve is not accurate, and that is why they no longer recommend it.

The only thing the heparin response curve shows is that with increasing doses of heparin, the ACT increases.  Simple positive association.  I don't believe there were ever claims beyond that - as far as by how much or anything even approaching linearity.  But it was at least something, since there really is little that can be done with coagulation validation.

I don't know that it is necessarily the Hemochron that lacks precision, or the ACT test itself.  I have always gotten the impression that it is a crude, quick, whole blood test designed to roughly assess very large doses of heparin.  And for that purpose, it is considered good enough.  If it didn't meet needs, I would think there would be a lot more competition in the marketplace, and there's not.  Just my 2 cents :)

I was told that the Medtronic HMS Linearity Kit works well with the Hemochron.  

Instead of using it for linearity (not required) the samples can be used for competencies and correlations between multiple analyzers as the sample remains stable for 90 minutes after they are mixed with blood.

Hepline Linearity Kit #313-50  

I intend on using this for semi annual correlations.  Luck to all!

Melissa L. Perez, BS MLS(ASCP)^CM POCS(AACC)

POINT OF CARE COORDINATOR

Doctors Hospital at Renaissance

Melissa,

Thank you!  I just sent an email to Medtronic, requesting more info about this linearity kit.  Thanks for the tip!

Julia Bava, CLS, POCS(AACC)