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

Does anyone out there have a policy for Jehovah's Witness transfusion protocol? thanks, Simret

Hello, Let me know if this post is still open. I have a 6 years Softbank experience and validated the Softbank.

Thank you for detailed explanation. Simret

Hello all, We are in disagreement among technologists at the hospital that I am working regarding "Match Unrelated Donor samples". Once the MUD sample is received, we did type and screen on the sample and were done until recently. Regardless if the donor sample is RH negative or positive. When the HPC product comes that is from this donor, we do retype on it, immediate spin cross-match with the recipient and issue it to be transfused ( we issue it even if there is ABO disagreement/ discrepancy). Now, my question to you all is, is it necessary to perform weak D (Du) on this sample if it is RN negative? Can you share with me what you ion your hospital. Thank you Simret

Yes we do NOT do Electronic Xm. Thanks

I have 7 years experience with sunquest/ Misys and was easier then soft (I think). I least it is easier in a way when entering information in patient’s administration file. Here are my questions: v When a patient comes to the hospital for transfusion reason, for the first time we do retype. On the soft, it is setup to do both forward and reverse. Why do we need to do the reverse? This test serves to check if the first sample is indeed from the patient it says. So I don’t know the reasoning! It is time consuming and wasting reagents v In soft, I saw 7 different kind of DATs listed, DAT, DAT Gel Newborn, cord blood Gel, Cord blood evaluation, direct coombs, DIRECT COOMBS(cap letter), DATG. My question is what is all that. That is just confusing. Is this an IT/LIS/IS issue configuration of tests when installing the Softbank was not done properly? v How do you charge the patient when patient needs special units such as Hemoglobin S negative, CMV, antigen negative units? v Where do you check TAT of type and screen? (print) v Soft is not setup to stop exception report (flag) when resulting a baby reverse ABO/RH. This also sounds like an IT issue. Please let me know how to resolve those issues. Simret

Does any one uses Softbank? I have some questions regarding ABO retye, DAT, C3, and anti-D due rhogam, result entry. Please let me know Thanks Simret

Good choice .

Yes, as far as I know Ech/Neo does not recognize Mixed field. It will flag as inconclusive result and then you will have to go and see the reaction and also the patient's transfusion history , then you will make the call as mixed field. The reaction looks like 3/4 reaction and also free cells around the 3/4 reaction. That is mixed field. Simret

Gel is better in a way that you won't see a lot of "question mark reaction". Either it is weak pos (pos) or negative reaction. In Solid phase, we had problems grading the reactions. Having said that, you have to make your own judgement calling the strips pos/neg even though Immucor gives you a grading cut off. Basically, a lot of question mark reactions that we don't usually see in gel method. If you have any question let me know( inducing Neo). I have worked with Provue for while and I did not see as much problem as Echo Immucor Analyzer. Simret