simret

I already have one, but It is due for a review, so I am referring to the AABB and the 31st Standards for Blood Bank and Transfusion Services. I just wanted to know what others have and analyze. I am also examining the FDA Title 21, 630.10. thanks,

Does anyone of you have a policy/ Procedure for Investigation of Donor Transmitted Infections And Other Adverse Events? thanks,

Thank you all!

Is there a guideline for RHIG reissue where the RHIG was issued and was not injected into the patient and sent back to Blood Bank? Note the RHIG ( Rhogam, Rhiphylac) was at room temp for hours? What does FDA/ AABB and CAP say besides to the manufacturer's insert? Thanks,

Does anyone out there have a revalidation plan for Scheduled LIS downtime for hours? What kind of tests do you do once the LIS comes back to make sure things are working as they are supposed to? thanks,

Thank you much Blood Bank expert!

Does any of you have a good procedure or policy reporting FDA reportable occurrences that you could share? thank you!

Excellent answers from all and thank you for sharing your worksheet lpregeno.

Could you share your policy with me. thanks,

Is Fetal screen lot to lot testing a requirement? Can someone give me an insight what you do in your institution? thank you,

We are not registered with FDA as the Blood Bank does not manufacture Blood Products.

Hello every one - Do you guys know if I need to notify regulatory agencies that our hospital is moving to new location. I know I am notifying AABB and CAP a month before the move. Do I need to notify FDA or any other regulatory agencies? thanks,

Yes you do! In accordance with 21 CFR 607.21, you must register and list the blood products you manufacture ( when you reconstitute, you are manufacturing a new product = whole blood ( new ISBT #) for commercial distribution every year between October 1 and December 31 and you must update your blood product listing every June and December. I hope that helps. Simret

Hello, I am BB (ASCP) certified. Basically if you are getting ready to take the BB certification exam, you should study all material that is outlined for SBB. The SBB is more of administrative. Go to the BOR ASCP website - you will find the details. You need to get prepared well to pass it. Good luck!

Thank you all for your insights! I will read the book you suggested and some of the web sites you suggested as well and review our policy. thanks