HPC donor consent

[Cliff 407]

Our clinical program does an informed consent of the HPC donor prior to them coming to collections.  We also do a watered down consent with the donor on the day of collection.

We are not AABB accredited for stem cell collections / processing - only FACT, TJC and FDA.  If part of our process is to ensure we have a copy of the informed consent for collection on file (from days or weeks prior), do we need to consent the donor on the day of donation?  I can't find a rule that says we do.

[spavlis 15]

Cliff,

I believe the FACT regulations only say the donor screening and consent need to be completed PRIOR to the collection. Not necessarily the day of collection.

We do our screening (DHQ) and consent during the donor's pre-evaluation, which is usually a couple of weeks before the collection. No additional consent is obtained on the day of collection. Our workflow also involves checking and verifying the consents are available and completed on the day of collection.

Stephanie

[Jennie Batsel 11]

Cliff,

We too are not AABB accredited for stem cell collections - only FACT, TJC and FDA.  We recently combined the Collection consent with the Transplant consent, that is performed in the clinic weeks before collection.  I am not aware of a rule that states it must be done on day of collection.  We obtain a copy of the consent, prior to collection, to assure that it is complete, dated and signed.  Prior to the combining of consents we were doing the Collection consent the day of the first collection.  If there is a ruling otherwise someone please let me know.

Jennie

 

Jennie L. Batsel MT(ASCP)HP

Apheresis Supervisor

Infusion/Apheresis Center

University of Kentucky Hospital

859-323-6790

labjb@uky.edu

 

 

 

[Cliff 407]

Thanks, it's always scary when I recommend we stop doing something and it's nice to hear confirmation that others are doing it the same way I propose.