Hello everyone, I am so glad I found the group for all the blood bank information.

Now, I have FDA registration question. My sister hospital provides blood products to the infusion center (xm RBCs and platelets) that is at least 10 miles away (infusion center is part of the hospital system, same name). We reached out to FDA CBER for information, but no response. All the transfusion services at the hospital have CA biologics license. 
If our sister hospital provides blood products to the infusion center outside of the facility, do we need to apply for FDA registration? So far this is what i found on the website. However, the legal terms are so confusing. Can anyone help me? Thank you!

 

Who is responsible for the crossmatch?

Who is issuing the blood?

Do you wash, split, irradiate, or manipulate the products in any other way?

The hospital transfusion service is performing the crossmatch and issuing the products. And it gets shipped to the infusion center directly. We do not wash, split or irr. 
We do thaw FFP and cryo and prepare syringe for neonatal transfusion. So under the exemption, we don't have to apply for FDA registration, but i'm concerned about issuing products to the infusion center that is part of the same hospital entity. 

25 minutes ago, San Diego Blood Banker said:

but i'm concerned about issuing products to the infusion center that is part of the same hospital entity. 

I assume they have an FDA registration?  If so, I don't think this involves your hospital at all, regardless of it being part of a larger system.  They sound like they mange 100% of the process.

26 minutes ago, San Diego Blood Banker said:

We do thaw FFP and cryo and prepare syringe for neonatal transfusion.

The bold part is the only part I am not sure of.  We never did that.  I'd try reaching out to you local office again, replies can take a LONG time.

If the infusion center is part of the hospital and served by the hospital transfusion service, they do not need a separate FDA registration because they are not a transfusion service.  The FDA does not regulate nor inspect infusion centers. They regulate and inspect transfusion services and blood banks.

Provision of products to an infusion center would not require FDA registration per se. That is determined by what services you provide overall.

Edited January 14Jan 14 by Neil Blumberg

agree with @Neil Blumberg.  We courier blood / platelets to our off site infusion centers on a daily basis and also to our small sister facilities that might need products.  none of them have a separate FDA registration.  We also send out WB, Plasma and RBC's on neighboring county EMS units and our in house Air units and none of them need FDA registration.  Our medical director checked with his FDA "connection" and they sent an email stating as such.

4 minutes ago, Bet'naSBB said:

agree with @Neil Blumberg.  We courier blood / platelets to our off site infusion centers on a daily basis and also to our small sister facilities that might need products.  none of them have a separate FDA registration.  We also send out WB, Plasma and RBC's on neighboring county EMS units and our in house Air units and none of them need FDA registration.  Our medical director checked with his FDA "connection" and they sent an email stating as such.

I was involved in starting the first MedFlight blood transport on their helicopters and ground ambulance in MA (it was a while back).

Initially, FDA made us get a distribution registration for each of their four facilities.  Our blood bank was only registered, not licensed, so we needed a contract with ARC (our primary supplier), to get in units from them each week as MedFlight often went over state lines.  FDA said they would only allow that in rare circumstances, and since this was pre-planned, and frequent, we could not ship units from our donor center.

About a year in, FDA changed their minds and said we did not need registrations for the MedFlight facilities.  The Joint Commission did spend a fair amount of time there though.

Thank you so much everyone! <3.