Hemochron ACT Cuvette Shipment/Lot Verification

We do use them and we do lot to lot testing performing same QC and comparing current lot with new lot. Acceptable criteria for what CAP expects in peer comparisons is our choice in lot to lot acceptability for all of our test methods. I believe for ACT it is 3SD of the QC used.

What are others using?

I too perform lot to lot comparison.  This is what I have written in my Hemochron policy:  

Lot to lot comparison is accomplished in the following manner: 

·  Cuvettes:  the new cuvette lot number is tested with the current lot of control solution (low and high). 

·  Liquid Quality Control:  the new control lot solution (low and high) is tested with the current cuvette lot (and new cuvette lot, if received concurrently); the current control solution (low and high) is tested with the current cuvette lot (and new cuvette lot, if received concurrently).  

 

Manufacturer supplied control mean, as provided on the Acceptable Performance Range(s), will be used as the “reference”.  Using the formula below, the percent (%) difference between the control mean and test value must not exceed the acceptability ranges as defined:

 

a)           % difference =  difference of values 

                 (test value – control mean) ÷ control mean x 100. 

                 Example, INR:  (2.4 – 2.3) ÷ 2.3 x 100 = 4.4% difference
                 Example, ACT-LR:  (156 - 163) ÷ 163 x 100 = 4.3% difference 

b)           Acceptability Ranges* 

                (1)          INR                   =         + 20% 

                (2)         ACT+               =          + 20%

                (3)         ACT-LR            =          + 20%

 

Corrective action, should the cuvette and/or liquid quality control not fall within established acceptability ranges, is documented.

*ACT-LR, ACT+ and PT-INR are all clot based tests.  Our laboratory uses Evaluation Criteria for INR as published in the most recent CAP Participant Summary for WP6.

@David Thrash:  Curious, do you manage the ordering of the cuvettes for all of your OR areas? Or does each area order their own?
Also are your instruments interfaced?

Autilia - Yes, I manage the ordering of cuvettes and controls for OR, Cath Lab and Radiology.  Yes, my hemochron signature elite instruments are interfaced via RALS.