Hemochron ACT Validation and Reference Ranges
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Hi All,
My sites are moving to the Hemochron signature elite ACT-LR and ACT+ test systems. The staff is requesting that we put reference ranges into LIS. How should these reference ranges be determined since this testing is done for different procedures. Wouldn't the reference ranges be very different from one procedure to the next?
Also, anyone that uses the Hemochron signature elite, how do you validate this instrument with laboratory? There is really no lab "gold standard" to correlate with....I have been asked the question, "how do we know that the ACT numbers we are getting are accurate?"
Any and all thoughts appreciated!
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Hi Lisa-
I guess the first question is whether they are asking for reference ranges (normal population ranges) or target ranges. Reference ranges will not change, but they may not have any value in those procedures where an ACT is being used. The clinicians should be running baselines if they need to know the value and not using reference ranges for anything. You might check with them and see what they are really looking for and why they feel they need the reference ranges.
For validation there is no laboratory test with which you can compare. If you are currently running ACTs on a different system, you should perform correlation studies to define any changes to target times. That is critical as it is rare that two different systems perform identically. These would also serve as your accuracy studies. If you do not currently use an ACT, the best method would be to perform heparin dose response studies simply to demonstrate that for a given patient/ blood sample, the system responds to changes in heparin concentration in a linear manner.
Marcia
I just happen to have this because someone else ask what we were using. As you notice we attached this to all of our ACT results for both Signature Elite and Medtronic.
I'm here late doing skills day so I thought I'd try to be helpful.
Thank you Charlene for the reference range example! My next question is how did you decide on what the reference ranges would be?
Good morning- Here is what we use for validation q 6 months for Hemochron. Attached is the validation and EP Evaluator calculations. We use the Normal and Abnormal QC on two meters (50%) v. our "lab" Hemochron.
Hope this helps.
Beth