MEG

We currently BDS test everything. We sample at 24 and read at 18. So am I understanding this correctly? I can either sample at 36-48 and effect my shelf life availability. Or we can secondary test at issue for all products and that secondary test is only valid for 4 hours?

We did away with 30 minutes, it is really not acceptable anymore. We take the temperature and appearance for reissue. We do use safe t vues for units that are stored in refrigerators outside Blood Bank. For platelets were do visual appearance of swirling. We did put a 30 min. limit on return time, I figure the longer they have it the more things could happen to it, but just because they return it within 30 does not mean it is acceptable for reissue. We actually just rewrote this procedure.

It is not an FDA reportable. You can and will be cited by the AABB and Joint if it is discovered. This is my recommendation: I would write it up as a non conforming event. This way it shows that you realized there was an issue and took steps to prevent it occurring again. You should also have an internal hospital Quality/Risk Department that these issues are reported to. I would do that as well. See AABB standard 5.11.1.1, 5.25.5 and 5.27.1. Hopefully, this will help.

No, I have never heard of this in my 20 years!!! My jaw is hanging open. Yes, it is a problem. You are required to one document vitals, and two monitor the patient through out the transfusion. I think that you will have to explain to the Dr., nurses and patient that he is receiving an FDA regulated drug(if you think about it is actually a liquid organ transplant) when he signs the consent for transfusion that is consenting to stay put until 1 hour post transfusion. If he is not willing to do so that is refusal of treatment. Remember, if anything goes bad during this transfusion your facility is responsible!!!!! I have done an FDA Fatality report and they are not fun. To be honest, I don't know how you would explain this. Your state Health Department can be called in as well and they can and will shut you down. Not only that but you risk losing any certifications you carry. I am truly mortified and speechless. I hope this helps, I wish you luck.:eek:

Not to sound stupid, but when you say hit the clamp what exactly are you talking about?

Thank you so much for your reply. Yes, I did file the BPD and do my Market withdrawal which was quite lengthy. Thanks again

Recently, in my facility I had an issue with freezer temperature monitoring. One of our freezers that contains FFP had the temperature chart quit working. For six days the daily temperature of the chart was documented(written on the daily log) for a chart that was not working. So I had no temperature chart for 6 days. I discarded the FFP as I could not provide continuous temperature monitoring for that freezer. One of the techs involved felt that I should not have discarded the units. The reason being that in the AABB technical manual it states that if continuous temp monitoring of FFP during storage is not possible, the FDA requires that the component be stored in such a manner as to allow detention of thawing. Then is goes on to explain how to track the air bubble in the plasma. I interpreted this to me a couple things. Even if I can not continuously monitor I am required to monitor every 4 hours correct? We only documented every 24(I don't believe that was correct because different temps were written down for a chart that was not recording the temp). I do not have a policy for reviewing plasma that may have or have not thawed because of freezer malfunction. The air bubble is covered by my label, and I could not feel it on some of the units. Even though the freezer alarm can be heard 24/7, I have documentation in the past were my techs have not documented the alarm sounding. I am just wondering if I am off base in my thinking or is my interpretation correct? Any input is greatly appreciated as this is the 3rd time this has occurred and I keep getting the same questions from the FDA: Provide dates and temperatures( I only have one for every 24 hour period. Provide an SOP for re qualifying the units(I don't have one).

Yes, the panel would still need to be repeated every three days. There are other antigens on those cells that the patient has potential to develop antibodies to. There is also the possibility of one tech grading reactions one way and the next tech reading reactions differently. Although they should all be reading fairly closely, in my facility this is not always the case.

We are actually going with Bio-Rad reagent.

Currently my facility is using PEG for screens and antibody ID. We want to go to LISS. We are finishing up our validation study and of course the LISS is not as sensitive as PEG. Our Medical Director was not happy with the % of sensitivity and specificity that I was using. I must admit I used the % that was used for another similar study. Here is my question, am I barking up the wrong tree looking at the % of sensitivity and specificity? I already know LISS will be lower than PEG. Should I be looking at the Predictive Values and Efficiency of the test rather than comparing the two out right? I am so frustrated at this point any and all help would be greatly appreciated. I am ready to switch my reagents I just need to get this issue solved.

I agree that was my first response, but Clinical had to unplugg the cellwasher and take it 4 floors down to their department, and he did not have a cart he carried it. So there was opportunity to drop it or bump it. Thanks for you input, it helps so have others perspectives :redface:

Recently, one of our Helmer cell washers was unplugged, and removed from the department for a few hours. The hinges for the lid needed tightened. I asked the staff to do optimum time of centrifugation on the cell washers. They were not happy and felt this was not needed. I looked in the manufacturer's manual and of course nothing speaks to this. In the AABB Technical Manual it say do what the manufacturer recommends. I feel that if the equipment is moved or unplugged there is potential for malfunction. Am over the top on this?

Thanks. I truly appreciate you taking the time to answer my question.

Is it important to prove if a previously demonstrating antibody is still demonstrating? Should a rule out of this antibody be done?. Does it even matter because you have to give antigen negative for previously demonstrating antibodies anyway? The antibody is a big C, patient is 56. If anyone can provide me with literature that references this that would be so great!!!

Our blood bank has half walls between work stations. We have been told by several reps to get rid of them. I am a talker, so I would be oart of your problem. I usually talked to myself. I think that the honest approach is the best, just ask them to talk quietly. They have all worked together so they know when a co worker needs so quite and space. They are just beginning to know you, so be honest. I do not think I would put a sign up, you will definately end up in the 2 or 3 category. Remeber the blood bank is only as good as its workers, and happy workers are good workers. Good Luck!