DCA Vantage
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Yesterday we had a pt come in with orders for HA1c. They didn't want to do the finger stick or the venous draw. Instead they wanted a capillary draw from their arm. I wasn't here at the time, so they asked the phleb supervisor and he ok'd it. I'm thinking this draw location was 'off-label' (therefore not waived) but what do you think? Am I being too strict in my reading of the insert? (insert says fingerstick or venous whole blood)
Thank you~
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Is there a written procedure on how to collect capillary sample from the arm? I would think using a butterfly is what the patient would want.
Do you use a lancet to puncture a vein? That would be messy won't it?
Never heard of this procedure before. I am curious.
Any process outside of the manufacturers written documentation is off-label and becomes a "high complexity" test. If you validated the change in process and is approved by your medical director, then off you go, Don't forget reference range studies. Hope this helps.
Waived testing regulations require that you follow manufacture instructions or it is off label and changes the complexity. I would call Siemens and ask if other sample sites are acceptable and if they have any white papers to share.
Definitely off-label if this is not an approved sample source. Was this a diabetic who wanted to use their alternate-site lancing device? Just say no!
I'm with Pet! The patient knew about/asked for a capillary draw?
Never happened to me/us. Please share procedure used. Thanks!
I've also contacted Siemens and they are looking into this, but I'm going to say no more non-finger capillary testing. I was kind of upset when I found out the supervisor OK'd it and I asked that it not happen again. I don't want us to drift away from this being a waived test. (The patient uses a CGM device, so they (patient) decided that upper arm is good enough for a blood draw too!) Thanks everyone for your input.
Pet - Our procedure is for either a capillary draw for finger or a venous draw with a regular needle into an EDTA tube and then you can test using that sample. What the patient wanted was a lancet to the upper arm.
I volunteer at a clinic where we use DCA Vantage for A1C. WE draw venous blood if possible, so if there was a problem with the instrument, we can redo the test.
Plus our patients get their blood drawn because they have other tests done. We do fingerstick if the patient is hard stick.
Using the arm to get blood will be high complexity. The blood from the CGM is not the same as capillary or venous. CGM uses blood from interstitial fluid space. No study has been done with A1C values in blood from interstitial fluid. I am sure someone is working on that and A1C will be part of the CGM result ( in the future)
Thanks for making as aware this could be requested by patients with CGMs.
OOPS. I mean CGM uses glucose from interstitial fluid, not blood.
Yikes. I think you are right to have a conversation with the Phlebotomy supervisor. They need to understand that any deviation from the manufacturer's instructions can have some pretty big consequences.
I go over this at our orientation with new staff so that they understand that any change to how the manufacturer says to run the test, sample type ect makes this a HIGHLY complex test and all the regulations that go along with that AND how we do not hold a license for any of it.