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Logan51

FDA Question

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Hello, I'm a new Blood Bank Supervisor and have a question regarding an observation from a recent FDA inspection.  The inspector filed an observation that we were not following CFR 606.100(c) "All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product".  The inspector asserts that testing review must be performed prior to releasing products and since supervisory review is typically performed each morning, any products that were released throughout the day (or night) would not have had their associated testing reviewed prior to release.

My question to the group is how would you address this observation?  Having been a night-shift tech most of my life, I can say that products being released prior to a supervisor's review is fairly standard.  That being said I am open to improvements wherever needed, I would just like to be sure I'm not overdoing it with my response.

For informational purposes, we are a small transfusion service that operates as part of a larger clinical lab.  We don't modify products other than thawing FFP.  We perform 4-8 T+S per day and average about 1.5 products transfused per day.  We use manual tubes for immediate spin phase and gel cards for antiglobulin testing.  Our techs are all generalists and we are staffed with a single technologist on third shift.

Thank you for any help

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Hello, thanks for your inquiry.  This was not actually in reference to QC, this observation was specifically referring to ABO/Rh testing, crossmatches, etc.  We do perform a history check prior to all compatibility testing and will perform a second ABO/Rh type on all patients without history.

 

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I know that FDA can visit any hospital but curious as to why they visited you if you only thaw plasma?

 

Do you have an LIS or do you record results on logs? 

 

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3 hours ago, R1R2 said:

I know that FDA can visit any hospital but curious as to why they visited you if you only thaw plasma?

 

I had the same thought.  If you don't modify products, you don't need to have the FDA registration -- and you don't need the privilege of having them come to inspect.

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45 minutes ago, TreeMoss said:

I had the same thought.  If you don't modify products, you don't need to have the FDA registration -- and you don't need the privilege of having them come to inspect.

Agree with TreeMoss.  I would check your FDA paperwork and make sure it is correct.   I took over a transfusion service and they had registered even though they did not need to register.   I changed that right quick. 

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Don't forget that if you make reconstituted units for neonate transfusions - that counts and requires an FDA registration.  We irradiate, so already had them coming, but had to add that product after an inspection, so now, may never get rid of them!

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Hello everyone,

Thank you all for your insightful replies, your input is very helpful.

We do use a Blood Bank LIS for all of our operations and it is validated to identify typing errors. It’s relieving to know that this is taken into consideration when determining compliance with this regulation. Since we do all testing manually and since it’s not impossible for us to release some products before a second type is collected, it would be ideal if we could have a second tech confirm our first-types. However, with only one tech on-duty during certain shifts that would be impossible.

The suggestion regarding our FDA registration is also very interesting, I hadn’t previously considered our registration status up to this point. I know that in the past we had pooled some products but no longer do so. I will be certain to look into this further tomorrow morning.

Thank you all again for all of your help.

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"CFR 606.100(c) "All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of final product".  The inspector asserts that testing review must be performed prior to releasing products and since supervisory review is typically performed each morning, any products that were released throughout the day (or night) would not have had their associated testing reviewed prior to release. "

 

I don't think any of our responses helped you with this FDA observation, did they?   

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I had an FDA inspector hit us with the same thing. I asked what her expectation would be for the night shift with one tech on duty. Her response was...well you don't transfuse anyone at night, so that would solve the problem. I guess she thought that a 180 bed hospital in rural American didn't practice medicine or something. I told her that we certainly do transfuse patients at night. Her response was that we should decline to transfuse patients at night. I asked her what we were supposed to do about the trauma patient in the ER or the OB who goes bad or the active GI bleeder admitted with the 5 Hgb. Well, we would have to review the unit prior to distribution. I asked...so you are saying that we have to call someone in to perform that task? Response...isn't there someone that could do that? I asked her (with sarcasm in mind, but not in voice) what she though about a phlebotomist or an RN doing that. She said she didn't think that they would be qualified. I asked her again if she was expecting us to call someone in every time a transfusion was needed on the night shift, possibly multiple times per night. At this point she called someone back at the office and nothing more was said. We now have two techs on the night shift and no FDA registration, so this whole thing no longer applies.

Your inspector may have been a little overly zealous or misinterpreting something. Many of the inspectors I saw had no medical background and did not understand the distinction between transfusion service and blood center (though technically that doesn't really matter as far as the regs are concerned). My advice would be to contact the FDA directly - email or phone - and discuss the situation with them. I have found them to be helpful. They may have a useful suggestion. My strongest piece of advice would be to drop your registration - if you are not irradiating product and doing nothing fancier than thawing plasma or pooling cryo, you don't need it. No registration, no inspection. Meet CLIA regs and whatever standards are required for whoever else inspects your facility and you should be fine.

 

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