mhc

Right- the baby could be D neg, C pos and the mom's anti- G is reacting against the G antigen on the C pos cells.

I was way behind in reading BBT and came upon this thread- so happy to see that you and your family are safe, Malcolm!! Just to add my 2 cents to the discussion- dont forget to do a thorough process validation and computer validation (if applicable) before you implement your new process. Involve the staff with this- it will help them see that the process will work and is safe in your lab. Melanie

I dont think I've looked at any of those sections so OK by me to get rid of them. Thanks for an awesome site!

I believe it would be 24 hrs from time of thaw or the original expiry of the product, whichever is sooner.

Friday is the only night I can do it- not particular on food but Boston can be pricey. Maybe Italian might be most economical? Melanie

So nice to see that the NHS got a part in the opening ceremonies! I cant imagine the US healthcare system ever getting a mention at any event- never mind an international one. You have a lot to be proud of!:cool:

I'll be there and would like to join if my schedule permits. I know some of you, and look forward to meeting all! Melanie

In addition, you have to have a policy for reporting Biologic Product Deviations to CBER. This is required regardless of whether you are FDA registered/licensed or not.

Collection of blood from healthy subjects for research must be performed under an IRB approved protocol. The PI would be responsible for determining the guidelines for the collections and writing that into the protocol. Sometimes, it's just as simple as saying that the FDA/ AABB requirements for allogeneic donation will be met. Or they may have a special need for other criteria. All that needs to be spelled out. Google 'human research subjects'- you'll get a boatload of information. Oh, and yes, they can be compensated for their time and trouble...

"If you perform electronic crossmatches, it IS a CAP standard to perform testing on a second phelebotomy (we still do tube crossmatches)." Can you tell me which CAP standard you are referring to? I cant find it. Thanks

I think it depends on the qualifications of the "non-BB" staff. Are they techs, lab aides, clerks? In a previous life we trained BB lab aides to dispense blood products. If you have a good SOP and good training, I think they can be successfully used.

Sounds like you need to develop an algorithm for working up problems. You should not leave it to the CLS's to do whatever they want.

Great answer. Also, using an experienced laboratory architect will help. Obviously, there are codes that need to be met as well such as the aisle width, etc.

I think that if a patient has not been previously typed, that 2 forward and reverse groups are required. They can be on the same sample, but FDA recommends against it.

Do you have a low count threshold for these products where you wouldnt label/distribute them? Also, do you collect data to determine how many of these products you are collecting and the reason(s) why they do not meet the 3.0E+11 threshold?