Linda0623

It definitely looks good. I haven't used the search function yet, which I find to be the greatest indicator of success.
On a side note: Cliff you're administrator for another website, in addition to this one, while also being a blood bank manager for a huge institution? Do you ever eat or sleep?

I will be there----Hopefully achieving my goal to become an AABB assessor for both Blood Bank and Periop activities! :-)----I got accepted into training, the rest is up to me, lol!

I will be at AABB, any plans to informally meet each other from this website?

I will be there....

I'll be there!  Haven't been since 2007...looking forward to it!

I will be there----Hopefully achieving my goal to become an AABB assessor for both Blood Bank and Periop activities! :-)----I got accepted into training, the rest is up to me, lol!

I'll be there.

LOL...let's start a crowdfunding campaign for Malcolm. I'll pick up his drink tab.

I will be there----Hopefully achieving my goal to become an AABB assessor for both Blood Bank and Periop activities! :-)----I got accepted into training, the rest is up to me, lol!

I will be there----Hopefully achieving my goal to become an AABB assessor for both Blood Bank and Periop activities! :-)----I got accepted into training, the rest is up to me, lol!

I will be there----Hopefully achieving my goal to become an AABB assessor for both Blood Bank and Periop activities! :-)----I got accepted into training, the rest is up to me, lol!

I will be there----Hopefully achieving my goal to become an AABB assessor for both Blood Bank and Periop activities! :-)----I got accepted into training, the rest is up to me, lol!

Thanks Linda for the info.
 
When we first started irradiating units here, we were taught by the Irradiator company (by way of a cooperating Blood Center) how to label the modified units and we line out the UBS FDA license number on our units too.  We have had several inspections and the FDA has never corrected us.  The reasoning sems to be that whoever modifies the unit "owns" responsibility for the unit since they have performed a modification on the unit that can affect the "safety, purity or potency" of the product.  Your operation of your facility drawing the unit first and then asking a distributor to irradiate it, may fall in a different category altogether.

In our practice, we ensure BOTH facilities information are on the final label. We collect blood, but do not irradiate on site. So if I need our blood supplier to irradiate a unit that we have collected, our LIS allows us to make the component and enter the modifying facility's ICCBBA/FDA information in the bottom right quadrant of the label, and it is linked in the audit trail of the modification of the product. It also adds the statement "Further Processing By:" preceding the FDA license/registration information. Because we are the collecting facility to which the DIN and collection /FDA registration information is linked, I would think we would be mismatching the origin of the collection if we were to scratch out the information attached to the collecting facility.
 
For cswickard----we use our FEI number as the registration number on our labels, and have had no issue during FDA inspections---and our irradiated labelling has been evaluated by them successfully as well.
Hope this helps!

I agree with all of the above, and I will raise one other consideration:
I manage a small but vital blood donor center as well as the transfusion medicine service. Therefore, we are also FDA registered. AABB with their advisory groups, etc. are like a translator for the CFR and blood guidances' "legal-ese" that we have to maintain. I will always advocate us to keep AABB accreditation as long as I am involved with donor collections and also with perioperative collections (cell salvage, PRP, BMAC etc.)---I oversee their (surgical services) quality program as well as mine. If you are going to maintain the standards anyway, why not continue with getting the credit for it? As a resource for so many things, especially cost savings through blood management, it DOES pay for itself.....

Mabel - you are correct when stating that the different regulatory agencies all have different approaches.  You can get a copy of the FDA training manual for BB inspections to see what they look for (basically that you follow your own procedures), JCAHO always just seemed interested in the transfusion process (thought I haven't been Joint inspected in quite a while).  AABB assessments have become more subjective since the inception of the Quality Plan - used to have a Yes/No checklist and citations were made by the area chair based on the checklist.  Now the assessor pretty much has the final say.  Personally I think the assessment is a much better tool than a checklist.  I have inspectors that just pore over my manuals. What a waste of time, in my opinion.  As an assessor I focused on the quality stuff - it's surprising how much info can be gleaned from looking at an institution's own assessments.  Granted, I always followed up on previous non-conformances and checked out new policies/procedures since the last assessment. 
 
I believe that the AABB process allows a lot more professional interaction between the assessor (vis-à-vis AABB) and the institution.  (Most of the time, granted there are assessors who don't get it).
 
I'm kind of rambling here - get the AABB Mabel.  It is not money wasted. 

I agree with all of the above, and I will raise one other consideration:
I manage a small but vital blood donor center as well as the transfusion medicine service. Therefore, we are also FDA registered. AABB with their advisory groups, etc. are like a translator for the CFR and blood guidances' "legal-ese" that we have to maintain. I will always advocate us to keep AABB accreditation as long as I am involved with donor collections and also with perioperative collections (cell salvage, PRP, BMAC etc.)---I oversee their (surgical services) quality program as well as mine. If you are going to maintain the standards anyway, why not continue with getting the credit for it? As a resource for so many things, especially cost savings through blood management, it DOES pay for itself.....

I agree with all of the above, and I will raise one other consideration:
I manage a small but vital blood donor center as well as the transfusion medicine service. Therefore, we are also FDA registered. AABB with their advisory groups, etc. are like a translator for the CFR and blood guidances' "legal-ese" that we have to maintain. I will always advocate us to keep AABB accreditation as long as I am involved with donor collections and also with perioperative collections (cell salvage, PRP, BMAC etc.)---I oversee their (surgical services) quality program as well as mine. If you are going to maintain the standards anyway, why not continue with getting the credit for it? As a resource for so many things, especially cost savings through blood management, it DOES pay for itself.....

I agree with all of the above, and I will raise one other consideration:
I manage a small but vital blood donor center as well as the transfusion medicine service. Therefore, we are also FDA registered. AABB with their advisory groups, etc. are like a translator for the CFR and blood guidances' "legal-ese" that we have to maintain. I will always advocate us to keep AABB accreditation as long as I am involved with donor collections and also with perioperative collections (cell salvage, PRP, BMAC etc.)---I oversee their (surgical services) quality program as well as mine. If you are going to maintain the standards anyway, why not continue with getting the credit for it? As a resource for so many things, especially cost savings through blood management, it DOES pay for itself.....

I agree with all of the above, and I will raise one other consideration:
I manage a small but vital blood donor center as well as the transfusion medicine service. Therefore, we are also FDA registered. AABB with their advisory groups, etc. are like a translator for the CFR and blood guidances' "legal-ese" that we have to maintain. I will always advocate us to keep AABB accreditation as long as I am involved with donor collections and also with perioperative collections (cell salvage, PRP, BMAC etc.)---I oversee their (surgical services) quality program as well as mine. If you are going to maintain the standards anyway, why not continue with getting the credit for it? As a resource for so many things, especially cost savings through blood management, it DOES pay for itself.....

Thanks so much for the input, but they are years away from computer crossmatching.  They are hardworking, intelligent techs who have been short-changed for quite some time now.  They don't know, what they don't know.  I worked so hard with them these past 18 months, and they were actually beginning to like and appreciate my position on quality, and giving our patients the very best experience possible.  I pray the buy-in sticks with them.
 
This is the first for-profit organization I have worked for in my 25 years, and what a difference.  Nursing is big on quality and for the most part knows the state of the lab.  I have resigned my position on principle, and really hated leaving my wonderful coworkers.  My core values in always doing the right thing, especially for patients well-being, I cannot trade in.  I reported my concerns to upper management before leaving.  Have two job offers already, but will take the next few weeks to get some sleep and hopefully grow some hair back  
 
Regards,
 
Connie

I agree with the others. This takes some courage to stand by your principles. Spell it out to them if you gat an exit interview.
 
I can only say how much I admire you for your stance.
 
I am sure that you will not regret it. I hope that there is a close by employer who values your stand.
 
All the very best.
 
Cheers
Eoin

As the younger generation would say:  "OMG!"  (I don't think I want to hear any more of the horror stories!)
 
As several others have said, I respect and congratulate you on your professional ethics.  I'm sure that was not a pleasant decision to tackle, but I bet you never regret it.  Glad that you already have a couple leads on a new job.  Good luck!
 
Donna

I join the others in applauding what had to have been a very tough decision.

WOW!! I think you did the right thing professionally.  As stated above, don't burn your bridges.  Are they hoping that if you only review 5% of the results the error rate will decrease?  It won't really but will look better on paper - until you have a sentinel event.  If you have enought Biologic Product Deviations I wouldn't be surprised if the FDA shows up . . . maybe that's what your director needs.  A really thorough investigation . . . Good luck to you.